Study on best practices in the public procurement of medicines : final report.
Date: 2022-12-14
Institutions: European Health and Digital Executive Agency
Subjects: EFTA, EU Member State, European Economic Area, United Kingdom, competitiveness, crisis management, environmental protection, medicinal product, pharmaceutical legislation, public health, public procurement, report, security of supply

Study on Best Practices in the 
Public Procurement of 
Medicines 

Final Report 

Gesundheit Österreich Beratung GmbH 
Tetra Tech International Development 
September 2022 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EUROPEAN COMMISSION 

Directorate-General for Health and Food  
Directorate B Health systems, medical products and innovation Unit D.2 Medical products: quality, safety, 
innovation  
Contact: Laure GESLIN 

E-mail:  SANTE-ATF@ec.europa.eu  

HADEA-HP-TENDER@ec.europa.eu  

European Commission 
B-1049 Brussels 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EUROPEAN COMMISSION 

Study on Best Practices in the 
Public Procurement of Medicines 

Final Report 

Authors: 

Sabine Vogler (Gesundheit Österreich Beratungs GmbH) 

Maximilian Salcher-Konrad (Gesundheit Österreich Beratungs GmbH) 

Katharina Habimana (Gesundheit Österreich Beratungs GmbH) 

Supported by: 

Gonzalo Dominguez (Tetra Tech) 

Margit Gombocz (Gesundheit Österreich Beratungs GmbH) 

Valentin Kandler (Gesundheit Österreich Beratungs GmbH) 

Peter Schneider (Gesundheit Österreich Beratungs GmbH) 

Nina Zimmermann (Gesundheit Österreich Beratungs GmbH) 

Procurement expertise and input: 

Eveli Bauer (Estonian Health Insurance Fund) 

Nina Uldal, Trine Ann Behnk (Amgros) 

Jean-Michel Descoutures (Réseau des Acheteurs Hospitaliers, RESAH) 

Helena Panayiotopoulou (Ministry of Health Cyprus)  

Quality assurance: 

Mariana Dates (Tetra Tech) 

Jaime Espin (Andalusian School of Public Health – EASP) 

Project assistant: 

Monika Schintlmeister (Gesundheit Österreich Beratungs GmbH) 

October 2022 

2022 

Directorate-General for Health and Food  
Third Health Programme 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Study on Best Practices in the Public Procurement of Medicines – 
Final Report 

ACKNOWLEDGEMENTS 

The  study team  would like to  express  their  thanks to  the  large  number  of experts  in 
procurement  and  pharmaceutical  pricing  and  reimbursement  who  have  volunteered 
their  time  to  provide  their  insights  on  procurement  practices  in  Europe.  Their 
contributions were essential in developing this report. 

In particular, the study team would like to thank the experts at the following institutions 
who reviewed and validated country fiches: 

  Austria: Tirol Kliniken 

  Belgium: Az Glorieux Ronse 

  Bulgaria: Ministry of Health and Public Procurement Agency 

  Croatia: Ministry of Health, Agency for medicinal products and medical devices of 

Croatia (HALMED), and UHC Rijeka 

  Cyprus: Ministry of Health 

  Denmark: Amgros and Danish Medicines Council 

  Estonia: Estonian Health Insurance Fund 

  Finland: Ministry of Health and Social Affairs 

  France: Réseau des Acheteurs Hospitaliers (Resah) 

  Germany: Ministry of Health 

  Hungary: National Health Insurance Fund Management (NEAK) 

 

 

 

Iceland: Landspitali 

Ireland: Health Service Executive (HSE) 

Italy: Consip 

  Latvia: Procurement Division of the National Health Service 

  Lithuania: Ministry of Health, National Health Insurance Fund under the Ministry of 

Health, and Central Procurement Organisation CPO LT 

  Luxembourg: Health Directorate at Ministry of Health 

  Malta: Directorate of Pharmaceutical Affairs (DPA) at MFH & Central Procurement & 

Supplies Unit (CPSU) at Ministry for Health (MFH) 

  Norway: Norwegian Medicines Agency (NoMA) and a senior procurement expert at 

Sykehusinnkjøp (LIS) 

  Portugal: Shared Services for Ministry of Health (SPMS) 

  Romania: Ministry of Health 

  Slovenia: University Medical Center (UMC) Ljubljana 

  Slovakia: Ministry of Health 

  Sweden: Stockholm Region 

  Switzerland: Federal Office of Public Health (FOPH) 

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The study team further expresses their gratefulness to the following: 

 

interview partners and others who agreed to formal and informal discussions 
providing important background information for the study; 

  everyone participating in the online survey and coordinating responses across 

different institutions in their countries; 

  participants in a series of four online workshops; 

  everyone providing us with contacts and connecting us to the right people in the 

study countries to learn more about procurement practices. 

The study team gratefully acknowledges the support of the European Commission that 
commissioned this study. Several Services and Agencies (DG SANTE, DG GROW, HaDEA, 
DG HERA) provided valuable comments to a draft version of this study. 

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ABSTRACT 

English 

Public procurement of medicines (PPM) is a strategic policy option to foster competition 
and  improve  access  to  medicines,  as  well  as  addressing  important  further  policy 
objectives,  including  ensuring  security  of  supply,  protecting  the  environment,  and 
improving  crisis  preparedness.  In  this  study,  PPM  practices  across  32  European 
countries (EU-27 plus EEA/EFTA countries and the UK) were mapped and analysed. The 
report presents findings regarding the organisational form of procurement for different 
types of medicines (ranging from facility-based procurement and group procurements 
to  centralised  procurement  at  regional  or  national  levels)  in  the  study  countries, 
application  of  different  forms  of  procedures  and  techniques  (including  the  use  of 
different  award  criteria,  such  as  the  Most  Economically  Advantageous  Tender),  and 
specific forms of procurement in the hospital sector. Possible impacts of PPM practices 
on  a  set  of  policy  objectives  (access  to  medicines,  affordability  and  availability  of 
medicines,  security  of  supply,  competitive  market,  protecting  the  environment,  and 
supporting  crisis  preparedness)  were  assessed.  The  study  also  reports  on  the  use  of 
supporting policies, such as horizon scanning and health technology assessment, and 
the experience with cross-country joint procurements. The study includes a set of best 
practices for optimising PPM in Europe. 

French 

Les  marchés  publics  de  médicaments  (MPM,  en  anglais:  PPM,  public  procurement  of 
medicines)  sont  une  option  politique  stratégique  pour  favoriser  la  concurrence  et 
améliorer l'accès aux médicaments. Ils répondent aussi à d'autres objectifs politiques 
importants, notamment le besoin d’assurer la sécurité de l'approvisionnement, protéger 
l'environnement et améliorer la préparation aux crises. Dans cette étude, les pratiques 
MPM de 32 pays européens (UE-27 plus les pays de l'EEE/AELE et le Royaume-Uni) ont 
été  cartographiées  et  analysées.  Le  rapport  présente  des  conclusions  concernant 
l’organisation de l'approvisionnement pour différents types de médicaments (allant de 
l'approvisionnement  en  établissement  et  des  achats  groupés  à  l'approvisionnement 
centralisé  au  niveau  régional  ou  national)  dans  les  pays  de  l'étude,  l'application  de 
différents  types  de  procédures  et  de  techniques  (y  compris  l'utilisation  de  différents 
critères d'attribution, tel que celui de l'offre économiquement la plus avantageuse) et 
des  formes  spécifiques  de  passation  des  marchés  dans  le  secteur  hospitalier.  Les 
impacts possibles des pratiques MPM sur un ensemble d'objectifs politiques (accès aux 
médicaments,  accessibilité  financière  et  disponibilité  des  médicaments,  sécurité 
d'approvisionnement, marché concurrentiel, protection de l'environnement et soutien à 
la  préparation  aux  crises)  ont  été  évalués.  L'étude  rend  également  compte  de 
l'utilisation de politiques de soutien, telles que l'analyse prospective et l'évaluation des 
technologies  de  la  santé,  et  de  l'expérience  des  achats  conjoints  entre  pays.  L'étude 
comprend un ensemble de bonnes pratiques pour optimiser les MPM en Europe. 

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Study on Best Practices in the Public Procurement of Medicines – 
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KEY FINDINGS 

English 

Public procurement of medicines (PPM) is defined as all aspects surrounding the process 
of purchasing medicines by a contracting authority from economic operators chosen by 
the  contracting  authority.  PPM  can  be  applied  strategically  to  improve  access  to 
(affordable) medicines as well as addressing further policy objectives such as fostering 
competition  in  the  market,  encouraging  greener  pharmaceutical  manufacturing, 
supporting security of supply, and ensuring crisis preparedness and handling. 

A mapping of PPM policy and practices in outpatient and inpatient pharmaceutical 
sectors  in  the  32  study  countries  (all  European  Union  (EU)  member  states,  Iceland, 
Liechtenstein, Norway, Switzerland, and the UK) showed the following key findings: 

  Organisation of PPM: The organisation of PPM varies depending on the medicines 

purchased and the health care sector. Within countries, most common 
organisational forms are facility-based PPM (mainly in the inpatient sector, i.e. 
procurements conducted by hospitals) and national centralised PPM (usually done 
for selected medicines, such as vaccines or products included in national health 
programmes). A few study countries have also been collaborating with other 
countries to jointly procure medicines (e.g. the Baltic countries jointly procure 
vaccines, and some of the Nordic countries had joint Nordic tenders to purchase 
old hospital medicines). 

  PPM procedures: Open procedures are predominantly used across the study 

countries. Two-stage procedures and negotiated procedures are less commonly 
applied. 

  PPM techniques: Around one quarter of PPM procedures (documented in the 

European Commission TED database) are conducted as framework agreements 
that define the terms for contracts to be awarded for a certain period of time for 
recurring purchasing to one or more suppliers. 

  Award criteria: Most contracts are awarded based on the price as sole award 
criterion. The EU Procurement Directive encourages a more strategic approach 
through consideration of a well-chosen set of award criteria (Most Economically 
Advantageous Tender (MEAT) criteria), and there is potential for more frequent 
use of MEAT criteria. 

  Hospital procurement: In the inpatient sector, PPM is mainly organised at facility 
level (either by individual hospitals or a group of hospitals) but more centralised 
forms (mainly through a national centralised purchasing body (CPB), such as in 
Denmark, Norway or Portugal) have also been established. 

  Biosimilar procurement: Biological medicines with high price tags are frequently 
used in the hospital setting, suggesting scope for leveraging competition from 
biosimilar medicines into substantial savings. However, barriers for more 
widespread use of biosimilars have been identified, including practices of biological 
originator suppliers to disincentivise or impede procurement of biosimilars and 
policy frameworks that do not encourage biosimilar uptake (e.g. prescribers not 
permitted to switch patients to a biosimilar or pharmacists not allowed to 
substitute products). 

  Interface management: Overall, there is limited coordination across inpatient 
and outpatient sectors, even though the initiation of a therapy in the hospital 
setting is known to impact on further prescribing in the community. Some best 
practice examples of so-called interface management measures that aim to bridge 
the gap between inpatient and outpatient care include cross-sectorial formularies, 
cross-sectorial (reimbursement) committees and funding mechanisms at the 
interface as well as capacity-building and collaboration projects. 

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Analysis  of  different  PPM  policies  and  practices  across  the  study  countries  led  to  the 
following conclusions: 

  Variety of PPM practices: Procurement practices vary across European 

countries, often reflecting the heterogeneity in health care systems. As a result, in 
terms of optimising public procurement of medicines, no one size fits all, and 
procurement policies need to be integrated into the national set-up of the 
healthcare system. 

  PPM system: The set-up of a PPM system consists of a variety of procedures and 

procurement techniques, as well as accompanying non-procurement related 
policies and tools. Thus, optimising PPM can be achieved through several of these 
features. 

  Different levels of maturity of PPM across countries: Countries that use a 

range of PPM policies and practices as well as supporting policies were observed to 
generally also have a well-developed pharmaceutical pricing and reimbursement 
policy framework, higher spending on pharmaceutical expenditure and, in some 
but not all cases, higher availability of medicines. 

  Impact on prices: According to data analysed in this study, countries with more 

advanced PPM systems (using more centralised procurement, applying a variety of 
PPM procedures and techniques, and using supporting policies) were found to have 
lower unit prices. This finding is consistent with previous studies on savings from 
PPM. 

  Joint procurement: Joint procurement, including within country and cross-

country, can help achieve lower prices and make small markets attractive for 
suppliers, as well as providing other benefits, such as information sharing and 
capacity building; however, implementation is resource intensive. 

  Security of supply: Security of supply may be addressed through use of relevant 

award criteria, awarding multiple winners, and joint procurement. 

  Environment: Environmental criteria are starting to be used, but evidence on 
their impact is still developing. Experience suggests that thorough consultation 
with suppliers ahead of introduction of environmental criteria leads to suppliers 
being able to comply with criteria without negatively impacting prices or the 
number of competitors submitting bids. 

  Balancing trade-offs: Trade-offs between policy objectives (e.g. lower price, 
security of supply, green pharmaceutical design) need to be made. Applying a 
strategic approach to PPM can support negotiating these trade-offs, such as 
consideration of further award criteria in addition to the price (through MEAT) and 
awarding multi-winner contracts to balance competition and security of supply. 

  Barriers: Major barriers to optimisation of PPM include the limited attractiveness 
of (small) markets for suppliers, limited capacity of procurers and lack of funding, 
as well as, particularly related to off-patent medicines, shortages and PPM 
practices of originator companies to impede uptake of off-patent medicines. 

  Good practice examples: A toolbox of best practices in PPM includes 

collaboration (across countries and across sectors) and communication (e.g. 
dialogue with users and suppliers), e-procurement, strategic use of PPM 
procedures and techniques aligned with the stage of the medicine in the product 
life cycle, and application of supporting policies and tools (e.g. horizon scanning, 
health technology assessment).  

  Policy recommendations: Policy-makers are encouraged to develop and 

communicate a PPM vision and strategy, to support their implementation through 
investments such as into capacity-building and to adapt the strategy, if necessary, 
based on findings from evaluations. Intra-country and cross-country collaboration 
shall be a major principle in implementation. 

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French 

Les  marchés  publics  de  médicaments  (MPM,  en  anglais:  PPM,  public  procurement  of 
medicines) sont définis comme l'ensemble des aspects entourant le processus d'achat 
de médicaments par un pouvoir adjudicateur auprès d'opérateurs économiques choisis 
par  le  pouvoir  adjudicateur.  Les  MPM  peuvent  être  appliqués  de  manière  stratégique 
pour  améliorer  l'accès  à  des  médicaments  (abordables)  ainsi  que  pour  répondre  à 
d'autres objectifs politiques tels que le renforcement de la concurrence sur le marché, 
l’encouragement d’une fabrication pharmaceutique plus verte, le soutien à la sécurité 
de l'approvisionnement et la préparation et la gestion des crises. 

Une  cartographie  de  la  politique  et  des  pratiques  des  MPM  dans  les  secteurs 
pharmaceutiques ambulatoires et hospitaliers dans les 32 pays de l'étude (tous les États 
membres de l'Union européenne (UE), l'Islande, le Liechtenstein, la Norvège, la Suisse 
et le Royaume-Uni) a montré les principales conclusions suivantes: 

  Organisation des MPM : L'organisation des MPM varie selon les médicaments 

achetés et le secteur de la santé. Au sein des pays, les formes organisationnelles 
les plus courantes sont les MPM en établissement (principalement dans le secteur 
des patients hospitalisés, c'est-à-dire les achats effectués par les hôpitaux) et les 
MPM centralisés au niveau national (un système généralement utilisé pour certains 
médicaments, tels que les vaccins ou les produits inclus dans les programmes de 
santé nationaux). Quelques pays de l'étude ont également collaboré avec d'autres 
pays pour acheter conjointement des médicaments (par exemple, les pays baltes 
achètent conjointement des vaccins et certains pays nordiques ont lancé des 
appels d'offres conjoints pour acheter d'anciens médicaments hospitaliers). 

  Procédures des MPM : Les procédures ouvertes sont principalement utilisées 
dans les pays de l'étude. Les procédures en deux étapes et les procédures 
négociées sont moins couramment appliquées. 

  Techniques des MPM : Environ un quart des procédures MPM (documentées dans 
la base de données TED de la Commission européenne) sont conduites sous la 
forme d'accords-cadres qui définissent les termes des contrats à attribuer pendant 
une certaine période pour des achats récurrents à un ou plusieurs fournisseurs. 

  Critères d'attribution : La plupart des marchés sont attribués sur la base du prix 

comme seul critère d'attribution. La directive européenne sur les marchés publics 
encourage une approche plus stratégique en tenant compte d'un ensemble bien 
choisi de critères d'attribution (critères de l'offre économiquement la plus 
avantageuse (MEAT, en anglais: Most Economically Advantageous Tender)), et il 
est possible d'utiliser plus fréquemment les critères MEAT. 

  Approvisionnement des hôpitaux : dans le secteur des patients hospitalisés, les 

MPM sont principalement organisés au niveau de l'établissement (soit par des 
hôpitaux individuels, soit par un groupe d'hôpitaux), mais des formes plus 
centralisées (principalement par le biais d'une centrale d’achat (CPB, en anglais: 
centralised purchasing body), comme au Danemark, en Norvège ou Portugal) ont 
également été créées. 

  Approvisionnement en médicaments biosimilaires : les médicaments 

biologiques dont le prix est élevé sont fréquemment utilisés en milieu hospitalier, 
ce qui suggère qu'il est possible de tirer parti de la concurrence des médicaments 
biosimilaires pour réaliser des économies substantielles. Cependant, des obstacles 
à une utilisation plus répandue des biosimilaires ont été identifiés, notamment les 
pratiques des fournisseurs des médicaments biologiques pour dissuader ou 
entraver l'achat de biosimilaires et les cadres politiques qui n'encouragent pas 
l'adoption des biosimilaires (par exemple, les prescripteurs ne sont pas autorisés à 
faire passer les patients à un biosimilaire ou les pharmaciens ne sont pas autorisés 
à délivrer des produits de substitution). 

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  Gestion de l'interface : Dans l'ensemble, la coordination entre les secteurs des 
patients hospitalisés et des patients externes est limitée, même si l'on sait que 
l'initiation d'un traitement en milieu hospitalier a un impact sur la prescription 
ultérieure dans la communauté. Parmi les exemples de meilleures pratiques de 
mesures dites de gestion d'interface qui visent à combler le fossé entre les soins 
hospitaliers et ambulatoires, citons les formulaires intersectoriels, les comités 
intersectoriels (de remboursement) et les mécanismes de financement à l'interface 
ainsi que les projets de renforcement des capacités et de collaboration. 

L'analyse  des  différentes  politiques  et  pratiques  des  MPM  dans  les  pays  de  l'étude  a 
conduit aux conclusions suivantes: 

  Variété des pratiques des MPM : Les pratiques d'approvisionnement varient 
d'un pays européen à l'autre, reflétant souvent l'hétérogénéité des systèmes de 
soins de santé. Par conséquent, en termes d'optimisation des marchés publics de 
médicaments, il n'y a pas de solution unique et les politiques d'achat doivent être 
intégrées dans la configuration nationale du système de santé. 

  Système des MPM : La mise en place d'un système de MPM comprend une 

variété de procédures et de techniques d'achat, ainsi que des politiques et des 
outils d'accompagnement non liés à l'achat. Ainsi, l'optimisation des MPM peut être 
obtenue grâce à plusieurs de ces caractéristiques. 

  Différents niveaux de maturité des MPM selon les pays : Les pays qui 

utilisent une gamme de politiques et de pratiques des MPM ainsi que des politiques 
de soutien ont généralement aussi un cadre de politique de tarification et de 
remboursement des produits pharmaceutiques bien développé, des dépenses plus 
élevées pour les dépenses pharmaceutiques et, dans certains cas, mais pas tous, 
une plus grande disponibilité des médicaments. 

 

 Impact sur les prix : Selon les données analysées dans cette étude, les pays 
disposant de systèmes de MPM plus avancés (utilisant des achats plus centralisés, 
appliquant une variété de procédures et de techniques des MPM et utilisant des 
politiques de soutien) se sont avérés avoir des prix unitaires plus bas. Ce résultat 
est cohérent avec les études précédentes sur les économies réalisées grâce aux 
MPM. 

  Achats conjoints : Les achats conjoints, y compris à l'intérieur d'un pays et entre 

pays, peuvent aider à obtenir des prix plus bas et rendre les petits marchés 
attractifs pour les fournisseurs, tout en offrant d'autres avantages, tels que le 
partage d'informations et le renforcement des capacités; cependant, la mise en 
œuvre nécessite beaucoup de ressources. 

  Sécurité d'approvisionnement : La sécurité d'approvisionnement peut être 

assurée par l'utilisation de critères d'attribution pertinents, la sélection de plusieurs 
lauréats et l'approvisionnement conjoint. 

  Environnement : Les critères environnementaux commencent à être utilisés, 

mais les preuves de leur impact sont encore en cours d'élaboration. L'expérience 
montre qu'une consultation approfondie des fournisseurs avant l'introduction de 
critères environnementaux permet aux fournisseurs de se conformer aux critères 
sans impact négatif sur les prix ou sur le nombre de concurrents soumettant des 
offres. 

  Équilibrer les compromis : des compromis entre les objectifs politiques (par 

exemple, prix plus bas, sécurité d'approvisionnement, conception pharmaceutique 
verte) doivent être consentis. L'application d'une approche stratégique aux MPM 
peut soutenir la négociation de ces compromis comme, par exemple, la prise en 
compte de critères d'attribution supplémentaires en plus du prix (par le biais de 
l’offre économiquement la plus avantageuse ou MEAT) et l'attribution de contrats à 
plusieurs gagnants pour équilibrer la concurrence et la sécurité 
d'approvisionnement. 

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  Obstacles : les principaux obstacles à l'optimisation des MPM comprennent 

l'attractivité limitée des (petits) marchés pour les fournisseurs, la capacité limitée 
des acheteurs et le manque de financement, ainsi que, en particulier en ce qui 
concerne les médicaments hors brevet, les pénuries et les pratiques MPM des 
entreprises qui entravent l'adoption de médicaments non brevetés. 

  Exemples de bonnes pratiques : une boîte à outils des meilleures pratiques en 

matière de MPM comprend la collaboration (entre les pays et entre les secteurs) et 
la communication (par exemple, le dialogue avec les utilisateurs et les 
fournisseurs), l'approvisionnement en ligne, l'utilisation stratégique des procédures 
et des techniques des MPM alignées sur le stade du médicament dans le cycle de 
vie du produit et l'application de politiques et d'outils de soutien (par exemple, 
l’analyse prospective et l’évaluation des technologies de la santé). 

  Recommandations politiques : les décideurs politiques sont encouragés à 

développer et à communiquer une vision et une stratégie MPM, à soutenir leur 
mise en œuvre par des investissements tels que le renforcement des capacités et à 
adapter la stratégie, si nécessaire, sur la base des conclusions des évaluations. La 
collaboration intra-pays et transnationale sera un principe majeur de la mise en 
œuvre. 

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EXECUTIVE SUMMARY 

Background and study objectives 

Public procurement of medicines (PPM) is a strategic policy option to foster competition 
and  improve  access  to  medicines,  as  well  as  to  address  important  further  policy 
objectives, as highlighted in the 2020 “Pharmaceutical Strategy for  Europe”.1 Against 
this  backdrop,  the  European  Health  and  Digital  Executive  Agency  (HaDEA)  as 
contracting  authority  under  the  mandate  of  the  European  Commission  (EC) 
commissioned a study on best practices in PPM.2 

The general study objective was to collect and analyse evidence to optimise PPM 
as a tool that can contribute to accessibility, affordability, and availability of medicines, 
and to encourage greener pharmaceutical design and manufacturing in both outpatient 
and hospital sectors, as well as supporting security of supply, and crisis preparedness 
and handling in these sectors. For the purpose of the study, PPM is defined as all aspects 
surrounding the process of purchasing medicines by a contracting authority, such as a 
body  of  public  law  (e.g.  governments,  local  health  authorities,  and  social  health 
insurance  institutions)  or  an  institution  affiliated  to  the  public  sector,  from  economic 
operators  (suppliers)  chosen  by  the  contracting  authority.  The  general  objective  is 
operationalised through six specific objectives: a mapping of all relevant stakeholders 
related to PPM in the study countries, a mapping of PPM policy and practices in the 
study countries with a view for optimisation, an investigation of possible impacts of 
optimised PPM in the study countries, an identification of barriers to optimised PPM, 
a  development  of  best  practices  in  PPM  and  an  update  and  extension  of  the  2010 
PHIS Hospital Pharma report on medicines management in the inpatient sector. 

The  32  study  countries  include  all  27  European  Union  (EU)  member  states,  the 
European  Free  Trade  Association  (EFTA)  countries  Iceland,  Liechtenstein,  Norway, 
Switzerland, as well as the UK. Both outpatient and inpatient sectors are investigated. 

Methods 

The  study  applies  a  mix  of  qualitative  and  quantitative  methods  to  address 
research questions in six areas  of interest, none  of which are dealt with through one 
methodological  approach  alone.  Instead,  triangulation  of  methods  and  data 
sources is used across the study. Research methods used included a literature review 
(covering both academic and grey literature), which was partly used to populate country 
fiches (fact sheets) for each of the 32 study countries. The country fiches were reviewed 
by  country  experts.  Several  stakeholder  consultation  activities  were  performed, 
including  a  series  of  four  online  workshops,  exploratory  interviews,  and  an  online 
survey,  allowing  stakeholders  (including  national  authorities 
for  pricing  and 
reimbursement  of  medicines,  public  procurers,  payers,  pharmacists,  patient 
representatives, and representation of the pharmaceutical industry and wholesalers) to 
provide  input  and  assess  the  potential  of  PPM  practices  to  impact  on  various  policy 
objectives. Finally, quantitative analysis of procurement data (sourced from the Tenders 
Electronics Daily (TED) database of the EC) and pharmaceutical sales data (provided by 
the healthcare data provider IQVIA) was performed to assess the relationship between 
different  PPM  practices  and  outcomes,  including  access  to  medicines,  affordability, 
availability,  security  of  supply,  competition  in  the  market,  environment,  and  crisis 
preparedness. 

1 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52020DC0761&from=EN 
2 The study was commissioned through the Framework contract SANTE/2016/a1/039 concerning the  provision 
of  services  in  the  area  of  evaluation,  impact  assessment,  monitoring  and  implementation  and  of  other 
relevant services, in relation to the health and food policies (LOT 1) with reopening of competition. 

XIII 

 
 
 
 
 
                                                 
Study on Best Practices in the Public Procurement of Medicines – 
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Public procurement of medicines across the study countries 

Mapping of PPM policies and practices 

The study found important variation in how PPM is conducted and integrated into the 
in  the  study  countries  (Table I).  Four  core 
heterogenous  health  systems 
organisational  forms  of  PPM  within  countries  were 
identified:  centralised 
procurement  at  national  or  at  regional  levels,  group  procurement  (voluntary  joint 
procurement) and facility-based procurement (done by individual health care facilities). 
Most study countries use more than one PPM organisational form, depending on 
the type of medicines and the sector. Overall, the two most common forms are facility-
based procurement (particularly for the hospital setting) and a national centralised 
procurement system (however, in many cases only done for few selected products). 

Table I: Organisation of PPM in the study countries 

Organisational form 

Medicines and sectors 

CAs 

National centralised PPM: 
Medicines are purchased by the CA for 
the whole country (at least for one 
sector, e.g. inpatient sector) 

l
a
n
o

i
t
a
N

Regional centralised PPM: 
Medicines are purchased by the CA for 
a region or for a group of users (at 
least for one sector, e.g. inpatient) 
Group PPM: 
Voluntary collaboration of purchasers 
to jointly procure medicines 

Facility-based PPM: 
Procurement done at the level of the 
individual healthcare facility (e.g. 
hospital, local health unit) 

-
s
s
o
r
C

l
a
n
o

i
t
a
n

Cross-country collaboration in 
PPM: 
Voluntary collaboration of countries to 
jointly procurement 
International pooled PPM: 
Medicines are purchased by a CA for 
several countries that are the users 

Frequently used for vaccines and 
medicines under a national health 
programme 
In some countries: All or nearly all 
medicines (both sectors or the 
inpatient sector only) 
In some countries: All or nearly all 
medicines (usually both or the 
inpatient sector only) 

Defined medicines (selected on a 
case-by-case basis) 
Mainly done in the inpatient sector 
(collaboration of hospitals) 
All or selected medicines 
Mainly done in the inpatient sector 
(predominant organisational form 
for hospital procurement in many 
countries) 
Selected medicines (e.g. 
medicines with high price tags, 
off-patent medicines) 

National CPBs (in 
some countries 
only operating in 
the inpatient 
sector) 

Regional CPBs 

Individual CAs 
(definition of a 
lead procurer) 

Individual CAs 

Usually individual 
CAs (definition of 
a lead procurer) 

E.g. joint procurement of COVID-
19 vaccines 

A supra-national 
CA 

CA = contracting authority, CPB = central purchasing body, PPM = public procurement of medicines 

Source: Authors 

Additionally,  some  countries  operate  tendering-like  systems  for  off-patent 
medicines in the outpatient setting, where public payers launch tenders per off-patent 
active substance and the winning bid (or bids) is assigned preferential reimbursement 
status for a defined period of time. 

Table I also presents cross-national PPM, which can, in principle, take two forms: 

  Voluntary cross-country PPM collaboration of (usually national) contracting 

authorities of different countries; examples of procurement collaborations include 
the Baltic Procurement Initiative (joint procurement of vaccines included in the 
national immunisation schedules of at least two of the three member countries 
Estonia, Latvia, and Lithuania) or the joint Nordic tenders conducted by some of 
the members of the Nordic Pharmaceutical Forum (Denmark, Iceland, Norway, 
Sweden) to jointly purchase mainly “old” (well-established) hospital medicines; 
and 

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Study on Best Practices in the Public Procurement of Medicines – 
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  Pooled PPM with the involvement of a supranational institution, such as the 
joint  procurement  of  COVID-19  vaccines  by  EU  member  states  (organised  by  the 
EC) and of COVID-19 therapeutics (through the Joint Procurement Agreement). 

According to EC TED data, open procedure tenders were by far the most frequently 
used procurement procedure from 2008-2021 (Figure I). 

Figure I: Key PPM procedures for medicines in the study countries, 2008-2021 

Restricted
2.00%

Negotiated with a CFC
1.11%

Open

Restricted

Negotiated with a CFC

Competitive dialogue

No data

Open
96.83%

Procurement procedures describe award processes to conduct a procurement. They include according to EU 
Directive 2014/243: Open procedure: a formal procurement method where any interested economic 
operator may submit a tender in response to a call for competition; restricted procedure: a formal, two-
stage procurement method where any economic operator may submit a request to participate in response to 
a call in the first stage but only pre-qualified suppliers may submit tender in the second stage; competitive 
procedure with negotiations (negotiated with a call for competition / CFC): a two-stage 
procurement method that involves pre-selection of suitable potential suppliers by the contracting authority 
and negotiations of submitted tenders; competitive dialogue: a two-stage procurement method where the 
contracting authority pre-selects potential suppliers based on their initial submissions and initiates a 
dialogue with them to identify the best possible method to address a need specified. 

Source: European Commission TED data, analysis by authors 

Procurement  techniques  relate  to  different  methods  for  managing  a  procurement 
procedure,  e.g.  by  making  use  of  e-procurement  or  repetitive  calls  for  recurring 
purchases. A commonly applied procurement technique is a framework agreement, 
which describes an arrangement between one or more contracting authorities and one 
or more suppliers that provides the terms which govern contracts to be awarded for a 
certain  period  of  time  for  recurring  purchasing.  More  than  one  quarter  of  all 
procurements of pharmaceutical products in the study countries were conducted under 
framework  agreements  (aggregated  data  for  all  study  countries  from  2008-2021, 
according to the EC TED database). Framework agreements were reported to be used 
for different types of medicines, including generics and biosimilars, medicines with high 
price tags as well as vaccines. 

According to the EU Directive, contracts should be awarded to the Most Economically 
Advantageous Tender (MEAT), which allows several (including non-price) criteria to 
be used together. While this approach comes into increasing use in the study countries, 
it currently still accounts for a minority of PPM procedures, and most are awarded based 

3  Directive  2014/24/EU  of  the  European  Parliament  and  of  the  Council  of  26  February  2014  on  public 
relevance) 

procurement 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32014L0024 

2004/18/EC 

repealing 

Directive 

(Text 

with 

EEA 

and 

XV 

 
 
 
 
 
 
                                                 
Study on Best Practices in the Public Procurement of Medicines – 
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on price only (Figure II). Overall, use of award criteria may vary between contracting 
authorities.  Further  relevant  award  criteria  include  (added)  therapeutic  value  and 
– increasingly – security of supply. Environmental criteria are not yet widely used 
but there is experience in some countries (e.g. the Nordic countries in both national and 
joint  tenders).  Local  production  does  not  play  a  role  as  award  criterion  in  the  study 
countries. 

Figure II: Award criteria in PPM in the study countries, 2008-2021 

14%

24%

Lowest price

MEAT

No data

62%

MEAT = Most Economically Advantageous Tender 

Source: European Commission TED data, analysis by authors 

In most study countries, contracts are usually awarded to a single winner, at least 
for some medicines. 

PHIS Hospital Procurement Update 

To  account  for  the  developments  during  the last  decade  (e.g.  high-priced  medicines, 
frequently  biologicals,  that  enter  the  hospital  markets,  increase  of  pharmaceutical 
spending  on  medicines  in  absolute  terms  and  as  a  share  of  total  pharmaceutical 
expenditure,  the  launch  of  biosimilar  medicines  and  implementation  of  policies  to 
encourage their uptake), the 2010 PHIS  Hospital Pharma Report4 was updated for all 
countries covered in this study, with a focus on procurement practices: 

 

In the majority of study countries, the main route for procurement of hospital 
medicines is facility-based. CPBs exist and are responsible for most PPM activities 
in hospitals in some countries (e.g. Amgros in Denmark, LIS in Norway), and they 
are set for an expanding role in other countries (e.g. Estonia). There appears to be 
a trend towards more centralised PPM in the hospital sector. 

  Most hospitals in the study countries have their own hospital pharmaceutical 

formulary (HPF) even when some (or all) medicines used in hospitals are subject 
to centralised procurement (at national or regional levels within a country). In 
facility-based PPM, medicines need to be included in the HPF (based on a decision 
by the Pharmaceuticals and Therapeutics Committee, which is usually 
established at hospital level). 

  Medicines used in hospitals are usually funded through a diagnosis-related 
groups (DRG) system, but some countries have specific funding schemes for 
defined medicines (e.g. dedicated funds to support purchasing and uptake of 
medicines with high price tags). 

4  Vogler  S,  Habl  C,  Leopold  C,  Morak  S,  Mazag  J,  Zimmermann  N.  PHIS  Hospital  Pharma  Report. 
2010. 

Pharmaceutical 
https://ppri.goeg.at/sites/ppri.goeg.at/files/inline-files/PHIS_Hospital%20Pharma_Report_2.pdf 

Information 

Gesundheit 

Österreich: 

System. 

Vienna, 

Health 

XVI 

 
 
 
 
 
 
                                                 
Study on Best Practices in the Public Procurement of Medicines – 
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  To afford high-priced medicines and to manage uncertainty, managed-entry 

agreements (MEAs) are in place for some inpatient medicines in almost all study 
countries. MEAs may be concluded at national (or regional) levels, or, rather 
frequently, by the procuring hospitals. 

 

 

In several study countries, hospital systems are decentralised which contributes 
to limited data availability on procurement practices in individual hospitals as well 
as the prices paid. 

In most countries, there is limited coordination between the hospital and the 
outpatient sectors, despite the fact that medicines selected for the start of a 
therapy (often in inpatient care) can have a major impact on the follow-up 
prescribing (often in outpatient settings). In some countries, there are good 
practice examples of interface management measures to bridge the gap 
between inpatient and outpatient care, such as cross-sectoral formularies, cross-
sectoral committees, specific funding mechanisms, IT projects, and capacity-
building initiatives across the sectors. 

Key findings related to biosimilar procurement include the following: 

  Uptake of biosimilar medicines varies greatly, both between European 

countries and within individual countries. Similarly, and potentially related to 
uptake, procurement practices for biosimilar medicines vary. The vast 
majority of study countries includes biosimilars in public procurement activities. In 
most countries, the same organisational framework applies as for the procurement 
of other medicines. Framework agreements and dynamic purchasing systems 
(DPS) are commonly applied PPM techniques for purchasing biosimilar medicines. 

  Specific aspects of biosimilar procurement include the monitoring of patent 

expiry to optimise timing of tenders and working with prescribers to ensure 
procured products are being used (e.g. through use of treatment guidelines). 

  Supplier practices in relation to procurement may impede competition and 
thus reduce savings potentials. For instance, manufacturers of biologicals have 
been offering large discounts to hospitals to disincentivise them to switch to a 
biosimilar after patent expiry. In the Netherlands, such a discounting scheme for 
the originator of an anti-rheumatic biological (etanercept) has led to an 
intervention by the competition authority. 

  Policies to encourage uptake of biosimilars in hospital settings are yet to be 
implemented in several countries (e.g. prescribing of biological medicines by the 
international non-proprietary name (INN), or substitution of a biological originator 
by a biosimilar). Adoption of an appropriate biosimilar-supporting regulatory and 
policy framework has been urged by several hospital pharmacists. 

Evaluation of the impact of PPM policies and practices 

PPM  can  be  implemented  using  a  variety  of  procedures  and  techniques  as  well  as 
supporting policies and tools. Design choices for PPM depend on the policy objectives to 
be  targeted,  existing  policy  frameworks  and  institutional  set-ups,  and  the  type  of 
medicine to be procured. Analysing the impact of PPM therefore requires disentangling 
the different PPM components. Table II summarises the findings of the impact evaluation 
per core objective based on a mix of data sources, including stakeholder assessment. 

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Table II: Analysis of impact of PPM design on achieving policy objectives 

PPM design 

Afford  Avail  Secur  Comp  Green  Crisis 

Comments 

Centralisation/ 
pooling 
(joint PPM) 

+* 

++* 

+ 

+ 

+ 

++ 

PPM approaches which exploit the 
potential of larger volumes as well 
as improved capacity through 
collaboration have been successful in 
making (small) markets attractive 
and optimising PPM processes. Lower 
prices are not necessarily the major 
objective (availability of medicines 
and security of supply can be key 
drivers for joint procurement). 
Suppliers only consider pooling 
beneficial in crisis situations, but not 
for achieving other objectives, 
including maintaining a competitive 
market with good availability of 
medicines and security of supply in 
the long-term. 
Different procedures are appropriate 
for different types of medicines; 
framework agreements and DPS 
were found to be suitable tools for 
off-patent medicines, as they help to 
encourage competition, resulting in 
lower prices while keeping several 
suppliers in the market. 
Use of MEAT criteria, in which the 
price criterion is strategically 
accompanied by a mix of other 
award criteria, can help achieve 
defined policy objectives (including, 
but not limited to, affordability). 

++*  ++*  ++*  ++* 

0 

+ 

+ 

++*  ++*  ++*  ++* 

+ 

Strategic use 
of PPM proce-
dures and 
techniques, 
based on a life 
cycle 
approach 

Award criteria: 
use of MEAT 
criteria 

Selection of 
winner(s): 
multiple bids 

Supporting 
tools (e.g. 
HTA, comm.) 

+ 

++ 

++ 

++ 

0 

++  Multiple winner approaches are in 

++* 

++ 

+ 

+/- 

++ 

+ 

particular supportive for the security 
of supply and sustainable PPM. 

Selection of appropriate supporting 
policies and tools (not necessarily 
PPM features) was found to be 
beneficial for achieving several 
different objectives. 

Abbreviations for objectives: afford = affordability for procurers (e.g. expressed in lower prices), avail = 
availability (i.e. medicines in the formulary), secur = security of supply (e.g. no or low number of shortages 
and disruptions), comp = competition (e.g. number of bids received, participation rate in a call), green = 
greener design and manufacturing (e.g. reduced ecological footprint), crisis = preparedness and ability to 
handle (public health) crisis such as a pandemic 
Further abbreviations: comm. = communication, HTA = Health Technology Assessment, MEAT = Most 
Economically Advantageous Tender, PPM = public procurement of medicines 
Classification: ++ = strongly contributing to achieving the policy objective, + = contributing to the policy 
objective,- = not supporting the policy objective, -- = strong barrier / disincentive to achieving the policy 
objective, +/- = supporting and hindering, depending on design and conditions or conflicting views of 
stakeholder group, 0 = neither supporting nor hindering. Data accompanied by an asterisk (*) are based on 
more robust evidence (literature and data analysis in this study), data not marked are largely based on 
stakeholder assessment. 

Source: Authors based on a triangulation of methods 

Data on the impact of PPM procedures and techniques is limited in some cases. In those 
cases,  stakeholder  perceptions served  as  guidance  for  the  impact  analysis.  However, 
perspectives of procurers and suppliers may differ. For instance, purchasers have 
stressed  the  benefits  of  pooled  procurement,  whereas  suppliers  are  hesitant  and 
consider this only as an instrument for crises. 

Analysis  of  quantitative  data  showed  that  lower  unit  prices  were  observed  in 
countries  with  more  advanced  PPM  (i.e.  more  centralised  procurement,  use  of 
different  PPM  procedures  and  techniques,  MEAT  award  criteria,  and  application  of 

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supporting policies and tools). This is in line with evidence from previous studies which 
generally reported savings from PPM. 

Overall, countries with higher level of PPM maturity were usually those with a well-
developed  pharmaceutical  pricing  and  reimbursement  policy  framework,  higher 
spending  on  pharmaceutical  expenditure  and,  in  some  but  not  all  cases,  higher 
availability of medicines (earlier launch countries). 

Joint procurement, including within country and cross-country, can help achieve lower 
prices  and  make  small  markets  attractive  for  suppliers,  thereby  achieving  better 
availability  of  medicines  and  mitigating  the  risk  of  shortages.  Joint  procurement  also 
provides  other  benefits,  such  as  information  sharing  and  capacity  building.  However, 
implementation is resource intensive. 

Some  policy  objectives  (e.g.  low  prices,  security  of  supply,  green  pharmaceutical 
design) may be conflicting and thus some trade-offs need to be made. Applying MEAT 
criteria  allows  appropriate  consideration  of  further  award  criteria  beyond  the  price. 
Award  multi-winner  contracts  also  support  achieving  potentially  conflicting  policy 
objectives such as competition and security of supply. 

Policy implications and conclusions 

Barriers to optimising PPM 

The study identified barriers to optimising PPM at several levels: they can relate 
to limitations in PPM policy and practices which could be addressed through optimisation 
of  procedures  and  challenges  in  the  context  of  PPM  in  the  broader  sense,  including 
potential  impacts  of  PPM  on  policy  objectives  such  as  availability,  affordability  and 
similar. Key barriers encountered in several countries include issues with availability 
of medicines due to limited attractiveness of the market to suppliers (in particular 
for smaller countries, although this challenge was experienced by the majority of study 
countries), limited capacity of procurers (e.g. understaffing, low and inappropriate 
skills), and lack of funding. 

Key barriers related to procurement of off-patent products include the following: 

  Supply issues, which appear to be more common in smaller countries. 

Commercial reasons for non-supply may also apply to on-patent medicines when 
products are not registered in a particular market. 

  Practices by suppliers to impede market entry and uptake of competitor 

products, in particular for biosimilar products (e.g. pricing structures that lock 
hospitals into continued use of higher-priced originators, “loss leader” practices to 
initiate treatment with a specific product in hospital at reduced price followed by 
higher prices for treatment continuation in the outpatient setting, subsidising out-
of-pocket payments for patients to continue using the product, as well as practices 
to impede the chances of competitor products being selected as winners in 
tenders). 

  Lack of uptake of biosimilars which may be due to lack of interaction between 

procurers and prescribers. Procurers therefore need to work with prescribers to 
ensure that procured products meet the needs of patients and are being 
prescribed. 

Barriers specific to the hospital sector include a lack of (transparent) data to compare 
procurement  practices  and  outcomes  (including  prices),  and  lack  of  collaboration 
between  individual  hospitals.  The  fragmented  landscape  for  hospital  procurement  in 
most countries impedes a strategic approach to procurement. 

Challenges  which  purchasers  encountered  in  cross-country  joint  procurement 
include the differences between national legal, policy and administrative systems and 

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processes,  the  requirement  for  more  resources  compared  to  national  procurement, 
limitations  in  the  extent  to  which  countries  can  participate  due  to  fragmented  health 
system,  possible  hesitancy  on  the  supplier  side  to  respond  to  cross-country  tenders, 
and the need to address language issues. 

Best practice examples for PPM 

Some best practices to address the challenges mentioned above and providing wider 
optimisation potential in PPM were identified, including: 

  Cross-country collaboration, with the intention to jointly procure medicines (to 

make smaller markets more attractive), as well as sharing knowledge and 
experiences across countries (not necessarily linked to solely PPM). 

  E-procurement, which allowed (easier) implementation of valuable PPM 

techniques such as framework agreements and DPS, 

  Use of a range of PPM procedures and techniques, aligned to the policy 

objective and the type of medicines (e.g. monopoly products with high price tags 
versus off-patent medicines) and linking PPM to supporting pricing and 
reimbursement policies and tools as well as necessary demand-side measures (e.g. 
to allow switching and substitution of biosimilar medicines, with a view to 
encourage biosimilar uptake) 

o 

In this context, awareness of a product’s position in the life cycle helps identify 
suitable procurement processes (ranging from less competitive forms such as 
negotiations for newly marketed, on-patent products to more competitive 
procedures such as open tenders as more competitor products become 
available) and criteria (considering security of supply criteria as products 
approach the later stages of their life cycle). Such a product life cycle 
approach to procurement, was pioneered by AMGROS, the CPB for public 
hospitals in Denmark. 

  Dialogue with suppliers and systematic collaboration of public procurers of 

medicines 

  Legal changes (to allow for implementation of novel PPM procedures and 
techniques), and transparent, clear operational rules and procedures 
(administrative management) 

  Specific policies to ensure bridging the gap between outpatient and inpatient 
sector, such as through measures related to formulary development or funding 
schemes  

Policy recommendations 

Policy-makers are encouraged 

 

 

 

 

to develop and communicate a PPM vision and strategy, based on a holistic 
perspective where PPM is one major component of the pharmaceutical policy 
framework, 

to support the implementation of the PPM strategy through investments 
such as into capacity-building as well as changes in the legal and institutional 
framework, 

to monitor and adapt the strategy, if necessary, based on findings from 
evaluations, and 

to consider intra-country and cross-country collaboration as a key principle in 
implementation. 

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In operational terms, strategic selection of PPM policies and practices should be 
aligned with the objectives defined at the strategic level and the product’s place in 
the life cycle. Important practices to be considered include application of MEAT criteria 
and multiple-winner approaches, data collection and analysis. Transparent and 
clear  processes,  and  improvement  in  IT  systems  are  considered  beneficial  and 
supportive approaches. 

The  European  Commission  may  support  these  policy  recommendations  by  offering  a 
platform to facilitate exchange of experiences between PPM practitioners as well 
between  procurement  experts  and  further  experts,  e.g.  those  working  in  public 
authorities for pharmaceutical pricing and reimbursement. 

Conclusions 

Procurement is a key pharmaceutical policy that can help achieve better access 
to medicines, including making more medicines available at lower prices. Procurement 
practices vary  across  European countries, often reflecting the heterogeneity in health 
care systems. In terms of optimising public procurement of medicines, no one size fits 
all,  and  procurement  policies  need  to  be  integrated  into  the  national  set-up  of  the 
healthcare system. A life cycle approach to procurement which considers the place of 
a medicine along the pharmaceutical value chain can help determine which procurement 
procedure (less vs. more competitive) to use and what award criteria are most relevant. 
Understanding the market can be helped by thorough market research and engagement 
with suppliers ahead of the launch of procurement procedures. 

Importantly, through its leverage as key area for procurement, PPM can help address 
further  policy  objectives,  including  security  of  supply  and  crisis  preparedness  for  the 
health  sector,  a  competitive  market  for  pharmaceuticals,  as  well  as  environmental 
objectives.  However, not  all objectives  may be  simultaneously  attainable. A  strategic 
approach to pharmaceutical procurement is therefore needed. 

Policy-makers are encouraged to put attention to PPM and to (further) develop a PPM 
vision and strategy, which can be then operationalised based on learnings on how to 
optimise PPM in technical terms. 

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RÉSUMÉ 

Contexte et objectifs de l'étude 

Les  marché  publics  de  médicaments  (MPM,  en  anglais  PPM:  public  procurement  of 
medicines)  sont  une  option  politique  stratégique  pour  favoriser  la  concurrence  et 
améliorer l'accès aux médicaments, ainsi que pour atteindre d'autres objectifs politiques 
importants, comme le souligne la «Stratégie pharmaceutique pour l'Europe» de 2020.5 
Dans ce contexte, l'Agence exécutive européenne pour la santé et le numérique (HaDEA, 
en  anglais:  European  Health  and  Digital  Executive  Agency),  en  tant  que  pouvoir 
adjudicateur sous mandat de la Commission européenne (CE), a commandé une étude 
sur les meilleures pratiques en matière de MPM.6 

L'objectif  général  de  l'étude  était  de  collecter  et  d'analyser  des  preuves  pour 
optimiser  les  MPM  en  tant  qu'outil  pouvant  contribuer  à  l'accessibilité,  y  compris 
financière  et  à  la  disponibilité  des  médicaments.  L’optimisation  doit  également 
encourager une conception et une fabrication pharmaceutiques plus écologiques dans 
les secteurs ambulatoire  et hospitalier,  et soutenir la sécurité de l'approvisionnement 
des médicaments, ainsi que la préparation et la gestion des crises dans ces secteurs. 
Dans le cadre de cette étude, les MPM sont définis comme tous les aspects entourant le 
processus d'achat de médicaments par un pouvoir adjudicateur, tel qu'un organisme de 
droit  public  (par  exemple  les  gouvernements,  les  autorités  sanitaires  locales  et  les 
organismes sociaux et d'assurance maladie) ou une institution affiliée au secteur public, 
auprès  d'opérateurs  économiques  (fournisseurs)  choisis  par  le  pouvoir  adjudicateur. 
L'objectif  général  est  opérationnalisé  à  travers  six  objectifs  spécifiques:  une 
cartographie de toutes les parties prenantes liées aux MPM dans les pays de l'étude, 
une cartographie de la politique et des pratiques MPM dans les pays de l'étude en 
vue de leur optimisation, une enquête  sur les  impacts possibles de l’optimisation 
des MPM dans les pays de l'étude, une identification des obstacles à l'optimisation des 
MPM, un développement des meilleures pratiques sur les MPM et une mise à jour et 
extension du rapport PHIS Hospital Pharma de 2010 sur la gestion des médicaments 
dans le secteur hospitalier. 

Les 32 pays étudiés comprennent les 27 États membres de l'Union européenne (UE), 
les  pays  de 
l'Islande,  le 
Liechtenstein, la Norvège, la Suisse, ainsi que le Royaume-Uni. Les secteurs ambulatoire 
et hospitalier sont étudiés. 

l'Association  européenne  de 

libre-échange  (AELE), 

Méthodes 

L'étude  applique  un  mélange  de  méthodes  qualitatives  et  quantitatives  pour 
aborder les questions de recherche dans six domaines d'intérêt, dont aucun n'est traité 
par  une  seule  approche  méthodologique.  La  triangulation  des  méthodes  et  des 
sources de données est utilisée tout au long de l'étude. Les méthodes de recherche 
utilisées  ont  consisté  en  une  revue  de  la  littérature  (couvrant  à  la  fois  la  littérature 
académique et la littérature grise), qui a été en partie utilisée pour remplir les fiches 
pays (fiches d'information) pour chacun des 32 pays de l'étude. Les fiches pays ont été 
examinées  par  des  experts  nationaux.  Plusieurs  activités  de  consultation  des  parties 
prenantes  ont  été  menées,  notamment  une  série  de  quatre  ateliers  en  ligne,  des 
entretiens exploratoires et une enquête en ligne, permettant aux parties prenantes (y 
compris les autorités nationales de tarification et de remboursement des médicaments, 
les acheteurs publics, les payeurs, les pharmaciens, les représentants des patients et la 
représentation  de  l'industrie  pharmaceutique  et  les  grossistes)  afin  de  fournir  des 
informations  et  d'évaluer  l’impact  potentiel  des  pratiques  MPM  sur  divers  objectifs 

5  “Pharmaceutical  Strategy  for  Europe”,  COM(2020)  761,  available  at  https://eur-lex.europa.eu/legal-

content/EN/TXT/HTML/?uri=CELEX:52020DC0761&from=EN 

6 L’étude a été réalisée via le Contrat cadre SANTE/2016/a1/039 relatif à la provision de services dans les 
domaines de l’évaluation, des evaluations d’impact, du suivi et de la mise en oeuvre, et d’autres services 
pertinents,  dans  le  secteur  des  politiques  de  santé  et  alimentaire  (LOT  1)  avec  réouverture  de  la 
concurrence.  

XXII 

 
 
 
 
 
                                                 
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politiques.  Enfin,  une  analyse  quantitative  des  marchés  (provenant  de  la  base  de 
données  Tenders  Electronics  Daily  (TED)  de  la  CE)  et  des  données  de  ventes 
pharmaceutiques (fournies par le fournisseur de données de santé IQVIA) a été réalisée 
pour évaluer la relation entre les différentes pratiques sur les MPM et leurs résultats, 
couvrant l'accès aux médicaments, l'accessibilité financière, la disponibilité, la sécurité 
d'approvisionnement, la concurrence sur le marché, l'environnement et la préparation 
aux crises. 

Marchés publics de médicaments dans les pays de l'étude 

Cartographie des politiques et pratiques MPM 

au  niveau  national 

L'étude a révélé d'importantes variations dans la manière dont les MPM sont dirigés et 
intégrés dans les systèmes de santé hétérogènes des pays étudiés (Tableau I). Quatre 
types  de  base  de  MPM  au  sein  des  pays  ont  été  identifiés:  l'approvisionnement 
centralisé 
groupé 
(approvisionnement  conjoint  volontaire)  et  l'approvisionnement  par  établissement 
(effectué  par  des  établissements  de  santé  individuels).  La  plupart  des  pays  étudiés 
utilisent  plus  d’un  type  de  MPM,  selon  le  type  de  médicaments  et  le  secteur.  Dans 
l'ensemble,  les  deux  formes  les  plus  courantes  sont  l'approvisionnement  par 
établissement  (en  particulier  pour  le  milieu  hospitalier)  et  le  système  national 
d'approvisionnement centralisé (cependant, dans de nombreux cas, uniquement pour 
quelques produits sélectionnés). 

l'approvisionnement 

régional, 

ou 

Tableau I: Organisation des MPM dans les pays de l'étude 

Type 

Medicament et secteur 

PA 

MPM centralisé au niveau national: 
Les  médicaments  sont  achetés  par  le 
CA pour l'ensemble du pays (au moins 
pour  un  secteur,  par  exemple  le 
secteur des patients hospitalisés) 

MPM centralisé au niveau régional: 
Les  médicaments  sont  achetés  par  le 
CA pour une région ou pour un groupe 
d'utilisateurs  (au  moins  pour  un 
secteur,  par  exemple 
les  patients 
hospitalisés) 
MPM 
groupe: 
Collaboration volontaire des acheteurs 
pour  se  procurer  conjointement  des 
médicaments 

de 

MPM par établissement: 
Approvisionnement effectué au niveau 
de  l'établissement  de  santé  individuel 
(par  exemple  hôpital,  unité  de  santé 
locale) 

Collaboration  transnationale  dans 
les MPM: 
Collaboration volontaire des pays pour 
des achats conjoints 

In some countries: All or nearly all 
medicines  (both  sectors  or  the 
inpatient sector only) 
Fréquemment  utilisé  pour 
les 
vaccins et les médicaments dans le 
cadre d'un programme national de 
santé 
Dans  certains  pays  :  (Presque) 
tous  les  médicaments  (les  deux 
secteurs  ou  le  secteur  hospitalier 
uniquement) 
Dans  certains  pays  :  (Presque) 
tous  les  médicaments  (les  deux 
secteurs  ou  le  secteur  hospitalier 
uniquement) 

(collaboration 

Médicaments  définis  (sélectionnés 
au cas par cas) 
Fait principalement dans le secteur 
hospitalier 
des 
hôpitaux 
Tous  les  médicaments ou certains 
médicaments 
Fait principalement dans le secteur 
hospitalier 
(forme 
prédominante 
organisationnelle 
pour 
l'approvisionnement 
hospitalier  dans  de  nombreux 
pays) 
Médicaments  sélectionnés 
(par 
exemple,  médicaments  à  prix 
élevé, médicaments hors brevet) 

MPM international mutualisé: 
Les  médicaments  sont  achetés  par  un 
CA pour plusieurs pays utilisateurs 

Par  exemple:  achats  conjoints  de 
vaccins COVID-19 

nationales 
CA 
(dans 
certains 
pays,  seulement 
dans 
le  secteur 
hospitalier) 

CA régionales 

individuels 

PA 
(définition 
d’acheteur 
principal) 

PA individuels 

En  général,  PA 
individuels 
(définition 
d’acheteur 
principal) 
PA 
Un 
national 

supra-

l
a
n
o

i
t
a
N

-
s
n
a
r
T

l
a
n
o

i
t
a
n

PA = pouvoir adjudicateur (en anglais, CA: contracting authority), CA = centrale d'achat (en anglais, CPB: 
central  purchasing  body),  MPM  =  marché  public  de  médicaments  (en  anglais,  PPM:  public  procurement  of 
medicines) 

XXIII 

 
 
 
 
 
 
 
 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
Final Report 

Source : Auteurs 

De  plus,  certains  pays  appliquent  des  systèmes  de  type  appels  d'offres  pour  les 
médicaments  hors  brevet  dans  le  secteur  ambulatoire,  où  les  payeurs  publics 
lancent  des  appels  d'offres  par  substance  active  hors  brevet  et  l'offre  (ou  les  offres) 
gagnante se voit attribuer un statut de remboursement préférentiel pour une période 
de temps définie. 

Le  tableau  I  présente  également  les  MPM  transnationaux,  qui  peuvent,  en  principe, 
prendre deux formes : 

  Collaboration volontaire transnationale des MPM entre les pouvoirs 

adjudicateurs (généralement nationaux) de différents pays ; des exemples de 
collaborations en matière d'approvisionnement incluent la Baltic Procurement 
Initiative (achat conjoint de vaccins inclus dans les calendriers nationaux de 
vaccination d'au moins deux des trois pays membres, l'Estonie, la Lettonie et la 
Lituanie) ou les appels d'offres nordiques conjoints menés par certains des 
membres du Nordic Pharmaceutical Forum (Danemark, Islande, Norvège, 
Suède) pour acheter conjointement des médicaments hospitaliers principalement 
« anciens » (bien établis); et 

  MPM mis en commun avec l'implication d'une institution supranationale, 
comme l'achat conjoint de vaccins contre le COVID-19 par les États membres de 
l'UE (organisé par la CE) et de médicaments contre le COVID-19 (via l'accord 
d'achat conjoint). 

Selon les données du portail TED de la CE, les appels d'offres ouverts ont été de loin la 
procédure de passation de marchés la plus fréquemment utilisée de 2008 à 2021 (Figure 
I). 

Figure  I  :  Principales  procédures  de  MPM  pour  les  médicaments  dans  les  pays  de 
l'étude, 2008-2021 

Restreinte…

Négociée avec un AAC…

Ouverte

Restreinte

Négociée avec un
AAC

Dialogue
compétitif

Pas de données

Ouverte
96,83%

Les procédures de marché décrivent les processus d'attribution d’un marché. Ils comprennent, conformément 
à  la  Directive  UE  2014/247:  Procédure  ouverte:  une  méthode  formelle  de  passation  de  marché  où  tout 
opérateur économique intéressé peut soumettre une offre en réponse à un appel à la concurrence; procédure 
restreinte:  une  méthode  formelle  de  passation  de  marché  en  deux  étapes  dans  laquelle  tout  opérateur 
économique peut soumettre une demande de participation en réponse à un appel lors de la première étape, 
mais  seuls  les  fournisseurs  présélectionnés  peuvent  soumettre  une  offre  lors  de  la  deuxième  étape; 
procédure  concurrentielle  avec  négociations  (négociée  avec  appel  à  la  concurrence,  AAC,  en 
anglais CFC: call for competition):  méthode  de  passation des  marchés  en  deux  étapes,  qui  implique  la 
présélection des  fournisseurs potentiels  appropriés par  le pouvoir  adjudicateur et  la  négociation  des offres 

7 Directive 2014/24/UE du Parlement européen et du Conseil du 26 Février 2014 sur la passation des marches 
l’EEE) 

publics  et  abrogeant 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32014L0024 

la  directive  2004/18/CE 

(Texte  présentant  de 

l’intéret  pour 

XXIV 

 
 
 
 
 
 
                                                 
Study on Best Practices in the Public Procurement of Medicines – 
Final Report 

soumises  ;  dialogue  compétitif:  méthode  de  passation  des  marchés  en  deux  étapes  où  le  pouvoir 
adjudicateur  présélectionne  les  fournisseurs  potentiels  sur  la  base  de  leurs  offres  initiales  et  engage  un 
dialogue avec eux pour identifier la meilleure méthode possible pour répondre à un besoin spécifié. 

Source: données TED de la Commission européenne, analyse des auteurs 

Les  techniques de  passation  de marchés  concernent  différentes  méthodes  de  gestion 
d'une procédure de passation de marchés, par exemple le recours à l'e-procurement ou 
aux  appels  répétitifs  pour  des  achats  récurrents.  Une  technique  de  passation  des 
marchés couramment appliquée est un accord-cadre, qui décrit un arrangement entre 
un ou plusieurs pouvoirs adjudicateurs et un ou plusieurs fournisseurs qui prévoit les 
conditions régissant les contrats à attribuer pour une certaine période de temps pour 
des achats récurrents. Plus d'un quart de tous les achats de produits pharmaceutiques 
dans  les  pays  de  l'étude  ont  été  effectués  dans  le  cadre  d'accords-cadres  (données 
agrégées pour tous les pays de l'étude de 2008 à 2021, selon la base de données TED 
de  la  CE).  Des  accords-cadres  ont  été  signalés  comme  étant  utilisés  pour  différents 
types de médicaments, notamment les génériques et les biosimilaires, les médicaments 
à prix élevé ainsi que les vaccins. 

l'UE, 

la  directive  de 

les  contrats  doivent  être  attribués  à 

Selon 
l'offre 
économiquement  la  plus  avantageuse  (MEAT),  ce  qui  permet  d'utiliser  plusieurs 
critères (y compris non tarifaires). Bien que cette approche soit de plus en plus utilisée 
dans  les  pays  étudiés,  elle  ne  représente  encore  actuellement  qu'une  minorité  de 
procédures de MPM, et la plupart des marches sont attribués uniquement sur la base du 
prix (Figure II). Dans l'ensemble, l'utilisation des critères d'attribution peut varier d'un 
pouvoir  adjudicateur  à  l'autre.  D'autres  critères  d'attribution  pertinents  incluent  la 
la  sécurité 
valeur  thérapeutique  (ajoutée)  et  –  de  plus  en  plus  – 
d'approvisionnement.  Les  critères  environnementaux  ne  sont  pas  encore 
largement utilisés, mais il existe une expérience dans certains pays (par exemple, les 
pays  nordiques  dans  les  appels  d'offres  nationaux  et  conjoints).  La  production  locale 
n’est pas un critère d'attribution dans les pays étudiés. 

Figure II: Critères d'attribution dans les MMP dans les pays de l'étude, 2008-2021 

14%

24%

Prix le plus bas

MEAT

Pas de données

62%

MEAT = Offre économiquement la plus avantageuse 

Dans  la  plupart  des  pays  étudiés, les  contrats  sont  généralement  attribués à un  seul 
lauréat, du moins pour certains médicaments. 

Source: données TED de la Commission européenne, analyse des auteurs 

Mise à jour de l'approvisionnement hospitalier du PHIS 

Pour tenir compte des développements au cours de la dernière décennie (par exemple 
les  médicaments  à  prix  élevé,  souvent  biologiques,  qui  entrent  sur  les  marchés 
hospitaliers, l'augmentation des dépenses pharmaceutiques en médicaments en termes 
absolus  et  en  pourcentage  des  dépenses  pharmaceutiques  totales,  le  lancement  de 
médicaments biosimilaires et la mise en œuvre des politiques visant à encourager leur 

XXV 

 
 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
Final Report 

adoption), le rapport PHIS Hospital Pharma de 20108 a été mis à jour pour tous les pays 
couverts par cette étude, en mettant l'accent sur les pratiques d'approvisionnement: 

• Dans la majorité des pays étudiés, la principale voie d'approvisionnement en 

médicaments hospitaliers est basée sur les établissements. Les centrales 
d’approvisionnement (CPB) existent et sont responsables de la plupart des 
activités de MPM dans les hôpitaux de certains pays (par exemple, Amgros au 
Danemark, LIS en Norvège), et elles sont appelées à jouer un rôle croissant dans 
d'autres pays (par exemple l'Estonie). Il semble y avoir une tendance vers des 
MPM plus centralisés dans le secteur hospitalier. 

• La plupart des hôpitaux des pays de l'étude ont leur propre formulaire 

pharmaceutique hospitalier (HPF, en anglais: hospital pharmaceutical 
formulary) même lorsque certains (ou tous) les médicaments utilisés dans les 
hôpitaux font l'objet d'un approvisionnement centralisé (au niveau national ou 
régional dans un pays). Dans les MPM par établissement, les médicaments doivent 
être inclus dans le HPF (sur la base d'une décision du comité pharmaceutique 
et thérapeutique, qui est généralement établi au niveau de l'hôpital). 

• Les médicaments utilisés dans les hôpitaux sont généralement financés par le 

biais d'un système de groupes liés au diagnostic (DRG, en anglais: diagnosis-
related groups), mais certains pays ont des régimes de financement spécifiques 
pour des médicaments définis (par exemple des fonds dédiés pour soutenir l'achat 
et l'utilisation de médicaments à prix élevé). 

• Afin d'acheter des médicaments à prix élevé et de gérer l'incertitude, des accords 
d'accès contrôlé (MEA, en anglais: managed-entry agreements) sont en place 
pour certains médicaments destinés aux patients hospitalisés dans presque tous 
les pays de l'étude. Les MEA peuvent être conclus au niveau national (ou régional) 
ou, assez fréquemment, par les hôpitaux acheteurs. 

• Dans plusieurs pays étudiés, les systèmes hospitaliers sont décentralisés, ce qui 

contribue à la disponibilité limitée des données sur les pratiques 
d'approvisionnement dans les hôpitaux individuels ainsi que sur les prix payés. 

• Dans la plupart des pays, il existe une coordination limitée entre les secteurs 

hospitalier et ambulatoire, malgré le fait que les médicaments sélectionnés pour le 
début d'une thérapie (souvent en soins hospitaliers) peuvent avoir un impact 
majeur sur la prescription de suivi (souvent en ambulatoire). Dans certains pays, il 
existe des exemples de bonnes pratiques de mesures de gestion d'interface 
pour combler le fossé entre les soins hospitaliers et ambulatoires, tels que les 
formulaires intersectoriels, les comités intersectoriels, les mécanismes de 
financement spécifiques, les projets informatiques et les initiatives de 
renforcement des capacités dans tous les secteurs. 

Les  principales  conclusions  liées  à  l'approvisionnement  en  biosimilaires  sont  les 
suivantes: 

  L'adoption des médicaments biosimilaires varie considérablement, tant entre 
les pays européens qu'au sein de chaque pays. De même, et potentiellement liées 
à l'adoption de ces médicaments, les pratiques d'approvisionnement en 
médicaments biosimilaires varient. La grande majorité des pays étudiés inclut 
les biosimilaires dans les marchés publics. Dans la plupart des pays, le même 
cadre organisationnel s'applique que pour l'achat d'autres médicaments. Les 
accords-cadres et les systèmes d'achat dynamiques (DPS: en anglais: dynamic 
purchasing systems) sont des techniques de MPM couramment appliquées pour 
l'achat de médicaments biosimilaires. 

8  Vogler  S,  Habl  C,  Leopold  C,  Morak  S,  Mazag  J,  Zimmermann  N.  PHIS  Hospital  Pharma  Report. 
2010. 

Pharmaceutical 
https://ppri.goeg.at/sites/ppri.goeg.at/files/inline-files/PHIS_Hospital%20Pharma_Report_2.pdf 

Information 

Gesundheit 

Österreich: 

System. 

Vienna, 

Health 

XXVI 

 
 
 
 
 
                                                 
Study on Best Practices in the Public Procurement of Medicines – 
Final Report 

  Les aspects spécifiques de l'approvisionnement en biosimilaires comprennent la 

surveillance de l'expiration des brevets pour optimiser le calendrier des appels 
d'offres et la collaboration avec les prescripteurs pour s'assurer que les 
produits achetés sont utilisés (par exemple grâce à l'utilisation de directives de 
traitement). 

  Les pratiques des fournisseurs en matière d'approvisionnement peuvent 

entraver la concurrence et donc réduire les potentiels d'économies. Par 
exemple, les fabricants de produits biologiques ont offert d'importantes remises 
aux hôpitaux pour les dissuader de passer à un biosimilaire après l'expiration du 
brevet. Aux Pays-Bas, un tel système de rabais pour le princeps d'un 
antirhumatismal biologique (etanercept) a conduit à une intervention de l'autorité 
de la concurrence. 

  Les politiques visant à encourager l'adoption des biosimilaires en milieu 

hospitalier doivent encore être mises en œuvre dans plusieurs pays (par 
exemple, la prescription de médicaments biologiques par la dénomination 
commune internationale (DCI) ou la substitution d'un princeps biologique par un 
biosimilaire). L'adoption d'un cadre réglementaire et politique approprié à l'appui 
des biosimilaires a été préconisée par plusieurs pharmaciens hospitaliers. 

Evaluation of the impact of PPM policies and practices 

Les  MPM  peuvent  être  mis  en  œuvre  en  utilisant  une  variété  de  procédures  et  de 
techniques  ainsi  que  des  politiques  et  des  outils  de  soutien.  Les  choix  de  conception 
pour les MPM dépendent des objectifs politiques à cibler, des cadres politiques et des 
structures  institutionnelles  existants,  et  du  type  de  médicament  à  acheter.  Analyser 
l'impact des MPM nécessite donc de démêler les différentes composantes des MPM. Le 
tableau II résume les conclusions de l'évaluation d'impact par objectif principal sur la 
base d'un mélange de sources de données, y compris l'évaluation des parties prenantes. 

XXVII 

 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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Table II: Analyse d’impact du design des MPM sur la réalisation des objectifs politiques 

Design des 
MPM 

Acces
s 

Dispo  Secur  Conc 

Vert 

Crise 

Commentaires 

Centralisation/ 
pooling 
(MPM conjoint) 

+* 

++* 

+ 

+ 

+ 

++ 

Utilisation 
stratégique 
des 
procédures  et 
techniques 
MPM basée sur 
l’approche  du 
cycle de vie 

Critères 
d’attribution: 
utilisation  du 
critère MEAT 

de 

Sélection 
gagnant(s): 
offres 
multiples 
Outils 
soutien 
ETS, comm) 

de 
(ex. 

++*  ++*  ++*  ++* 

0 

+ 

+ 

++*  ++*  ++*  ++* 

+ 

+ 

++ 

++ 

++ 

0 

++ 

++* 

++ 

+ 

+/- 

++ 

+ 

à 

de 

de 

des 

une 

n'est 

grâce 

volumes 

capacités 

procédures 

Les  approches  MPM  qui  exploitent  le 
potentiel 
plus 
importants ainsi que l'amélioration 
des 
la 
collaboration  ont  réussi  à  rendre  les 
(petits)  marchés  attractifs  et  à 
optimiser  les  processus  MPM.  La 
baisse 
pas 
prix 
nécessairement l'objectif principal (la 
disponibilité  des  médicaments  et  la 
l'approvisionnement 
sécurité 
peuvent  être  les  principaux  moteurs 
de l'approvisionnement conjoint). Les 
fournisseurs  considèrent  que  la  mise 
en commun n'est bénéfique que dans 
les situations de crise, mais pas pour 
atteindre 
objectifs, 
d'autres 
notamment  le  maintien  d'un  marché 
concurrentiel 
bonne 
avec 
disponibilité  des  médicaments  et  la 
sécurité  de  l'approvisionnement  à 
long terme. 
Différentes 
sont 
appropriées  pour  différents  types  de 
médicaments  ;  les  accords-cadres 
et  les  DPS  se  sont  avérés  être  des 
outils 
les 
médicaments  hors  brevet,  car  ils 
contribuent 
la 
concurrence,  entraînant  une  baisse 
des prix tout en maintenant plusieurs 
fournisseurs sur le marché. 
L'utilisation  des  critères  MEAT,  dans 
le  critère  de  prix  est 
lesquels 
stratégiquement 
accompagné 
d'un  mélange  d'autres  critères 
d'attribution, peut aider à atteindre 
des  objectifs  politiques  définis  (y 
compris,  mais  sans  s'y 
limiter, 
l'abordabilité). 
Les  approches  à  gagnants  multiples 
sont  particulièrement  favorables  à  la 
sécurité d'approvisionnement et à des 
MPM durables. 
La  sélection  de  politiques  et  d'outils 
de 
(pas 
nécessairement  des  caractéristiques 
des MPM) s'est avérée bénéfique pour 
atteindre 
objectifs 
plusieurs 
différents. 

encourager 

appropriés 

appropriés 

soutien 

pour 

à 

Abréviations pour les objectifs : access = accessibilité financière pour les acheteurs (exprimée par exemple 
en  prix  plus  bas),  dispo  =  disponibilité  (c'est-à-dire  médicaments  dans  le  formulaire),  secur  =  sécurité 
d'approvisionnement  (ex.  absence  ou faible  nombre de pénuries  et  de  perturbations),  conc  = concurrence 
(ex.  nombre  d'offres  reçues,  taux  de  participation  à  un  appel),  vert  =  conception  et  fabrication  plus 
écologiques (par exemple, empreinte écologique réduite), crise = préparation et capacité à gérer une crise 
(de santé publique) telle qu'une pandémie 

Autres abréviations : comm. = communication, ETS = évaluation des technologies de la santé (en anglais, 
HTA  =  Health  Technology  Assessment),  MEAT  =  offre  économiquement  la  plus  avantageuse  (Most 
Economically Advantageous Tender), MPM = marché public de médicaments 

Classification  :  ++  =  contribue  fortement  à  la  réalisation  de  l'objectif  politique,  +  =  contribue  à  l'objectif 
politique,- = ne soutient pas l'objectif politique, -- = obstacle important/dissuasion à la réalisation de l'objectif 
politique,  +/-  =  soutient  et  entrave,  en  fonction  de  la  conception  et  des  conditions  ou  des  points  de  vue 
contradictoires du groupe de parties prenantes, 0 = ni soutien ni entrave. Les données accompagnées d'un 
astérisque (*) sont basées sur des preuves plus solides (littérature et analyse des données dans cette étude), 
les données non marquées sont largement basées sur l'évaluation des parties prenantes. 

Source : Auteurs sur la base d'une triangulation des méthodes 

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Les données sur l'impact des procédures et techniques MPM sont limitées dans certains 
cas. Dans ces cas, les perceptions des parties prenantes ont servi de guide pour l'analyse 
d'impact. Cependant, les points de vue des acheteurs et des fournisseurs peuvent 
différer.  Par  exemple,  les  acheteurs  ont  souligné  les  avantages des  achats  groupés, 
alors que les fournisseurs sont hésitants et n'y voient qu'un instrument de crise. 

L'analyse des données quantitatives a montré que des prix unitaires inférieurs ont 
été  observés  dans  les  pays  dotés  d'un  MPM  plus  avancé  (c'est-à-dire  un 
approvisionnement plus centralisé, l'utilisation de différentes procédures et techniques 
de MPM,  les critères  d'attribution  du  MEAT  et  l'application  de  politiques  et  d'outils de 
soutien).  Cela  est  conforme  aux  preuves  d'études  précédentes  qui  ont  généralement 
fait état d'économies grâce aux MPM. 

Dans l'ensemble, les pays ayant un niveau de maturité des MPM plus élevé étaient 
généralement ceux qui avaient un cadre politique de tarification et de remboursement 
des  produits  pharmaceutiques  bien  développé,  des  dépenses  pharmaceutiques  plus 
élevées  et,  dans  certains  cas  mais  pas  tous,  une  plus  grande  disponibilité  des 
médicaments (pays de lancement antérieur). 

L'approvisionnement conjoint, y compris à l'intérieur d'un pays et entre pays, peut 
aider  à  obtenir  des  prix  plus  bas  et  à  rendre  les  petits  marchés  attractifs  pour  les 
fournisseurs, améliorant ainsi la disponibilité des médicaments et atténuant le risque de 
pénurie. L'approvisionnement conjoint offre également d'autres avantages, tels que le 
partage d'informations et le renforcement des capacités. Cependant, la mise en œuvre 
demande beaucoup de ressources. 

Certains  objectifs  politiques  (par  exemple,  prix  bas,  sécurité  d'approvisionnement, 
conception pharmaceutique verte) peuvent être contradictoires et certains compromis 
doivent  donc  être  faits.  L'application  des  critères  MEAT  permet  une  prise  en  compte 
appropriée  d'autres  critères  d'attribution  au-delà  du  prix.  L'attribution  de  contrats  à 
la  réalisation  d'objectifs  politiques 
plusieurs 
potentiellement  contradictoires 
la  sécurité  de 
l'approvisionnement. 

lauréats  contribue  également  à 

la  concurrence  et 

tels  que 

Implications politiques et conclusions 

Obstacles à l'optimisation des MPM 

L'étude a identifié des obstacles à l'optimisation des MPM à plusieurs niveaux: ils 
peuvent être liés aux limites de la politique et des pratiques des MPM qui pourraient être 
résolues  par  l'optimisation  des  procédures  et  des  défis  dans  le  contexte  des  MPM  au 
sens large, y compris les impacts potentiels des MPM sur les objectifs politiques tels que 
la disponibilité, y compris la disponibilité financière et d’autres objectifs similaires. Les 
principaux  obstacles  rencontrés  dans  plusieurs  pays  couvrent  les  problèmes  de 
disponibilité des médicaments en raison de l'attractivité limitée du marché pour les 
fournisseurs (en particulier pour les petits pays, bien que ce défi ait été rencontré par 
la majorité des pays de l'étude), la capacité limitée des acheteurs (par exemple, le 
manque de personnel, l’insuffisance et le manque de compétences) et le manque de 
financement. 

Les principaux obstacles liés à l'achat de produits non brevetés sont les suivants: 

  Les problèmes d'approvisionnement, qui semblent être plus fréquents dans les 

petits pays. Des raisons commerciales de non-approvisionnement peuvent 
également s'appliquer aux médicaments brevetés lorsque les produits ne sont pas 
enregistrés sur un marché particulier. 

  Pratiques des fournisseurs pour empêcher l'entrée sur le marché de produits 
concurrents et leur adoption, en particulier pour les produits biosimilaires (par 
exemple, les structures de prix qui enferment les hôpitaux dans l'utilisation 
continue de princeps plus chers, les pratiques de « produit d'appel » pour initier un 
traitement avec un produit spécifique à l'hôpital à prix réduit suivi de prix plus 
élevés pour la poursuite du traitement en ambulatoire, subvention des paiements 

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directs pour que les patients continuent à utiliser le produit, ainsi que des 
pratiques visant à empêcher les produits concurrents d'être sélectionnés comme 
gagnants dans les appels d'offres). 

  Le manque d'adoption des biosimilaires qui peut être dû au manque 

d'interaction entre les acheteurs et les prescripteurs. Les acheteurs doivent 
donc travailler avec les prescripteurs pour s'assurer que les produits achetés 
répondent aux besoins des patients et sont prescrits. 

Les obstacles spécifiques au secteur hospitalier comprennent un manque de données 
(transparentes)  pour  comparer  les  pratiques  d'approvisionnement  et  les  résultats  (y 
compris  les  prix),  et  le  manque  de  collaboration  entre  les  hôpitaux  individuels.  Le 
paysage  fragmenté  de  l'approvisionnement  des  hôpitaux  dans  la  plupart  des  pays 
empêche une approche stratégique de l'approvisionnement. 

Les défis rencontrés par les acheteurs dans le cadre des achats conjoints entre pays 
comprennent  les  différences  entre  les  systèmes  et  processus  juridiques,  politiques et 
administratifs nationaux, la nécessité de disposer de plus de ressources par rapport aux 
achats nationaux, les limites dans la mesure dans laquelle les pays peuvent participer 
en  raison  d'un  système  de  santé  fragmenté,  la  possible  hésitation  du  côté  des 
fournisseurs à répondre aux appels d'offres internationaux et la nécessité de résoudre 
les problèmes linguistiques. 

Exemples de bonnes pratiques pour les MPM 

Certaines bonnes pratiques pour relever les défis mentionnés ci-dessus et fournir un 
potentiel d'optimisation plus large dans les MPM ont été identifiées, notamment: 

  Collaboration transnationale, avec l'intention d'acheter conjointement des 

médicaments (pour rendre les marchés plus petits plus attractifs), ainsi que de 
partager les connaissances et les expériences entre les pays (pas nécessairement 
liées uniquement aux MPM). 

  E-procurement, qui a permis la mise en œuvre (plus facile) de précieuses 
techniques de MPM tels que les accords-cadres et les systèmes d'achat 
dynamiques (DPS en anglais: dynamic purchasing systems). 

  Utilisation d'une gamme de procédures et de techniques de MPM, alignées 

sur l'objectif politique et le type de médicaments (par exemple, produits 
monopolistiques à prix élevé par rapport aux médicaments hors brevet) et liant les 
MPM aux politiques et outils de tarification et de remboursement ainsi qu'aux 
mesures de demande nécessaires (par exemple, pour permettre le changement et 
la substitution de médicaments biosimilaires, en vue d'encourager l'adoption des 
biosimilaires). 

o   Dans ce contexte, la connaissance de la position d'un produit dans le cycle de 

vie aide à identifier les processus d'approvisionnement appropriés (allant de 
formes moins compétitives telles que des négociations pour des produits 
nouvellement commercialisés et brevetés à des procédures plus compétitives 
tels que des appels d'offres ouverts à mesure que davantage de produits 
concurrents deviennent disponibles) et leurs critères (en tenant compte des 
critères de sécurité d'approvisionnement à mesure que les produits 
approchent des dernières étapes de leur cycle de vie). Une telle approche du 
cycle de vie des produits pour l'approvisionnement a été lancée par 
AMGROS, la centrale d’achat pour les hôpitaux publics au Danemark. 

•  Dialogue avec les fournisseurs et collaboration systématique des 

acheteurs publics de médicaments. 

•  Modifications juridiques (pour permettre la mise en œuvre de nouvelles 

procédures et techniques de MPM) et règles et procédures opérationnelles 
transparentes et claires (gestion administrative). 

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  Politiques spécifiques visant à combler le fossé entre le secteur ambulatoire 

et le secteur hospitalier, par exemple par le biais de mesures liées à 
l'élaboration de formulaires ou de programmes de financement. 

Recommandations politiques 

Les décideurs politiques sont encourages à: 

• développer et communiquer une vision et une stratégie MPM, basées sur une 
perspective holistique où les MPM sont une composante majeure du cadre de la 
politique pharmaceutique, 

• soutenir la mise en œuvre de la stratégie MPM par des investissements tels 

que le renforcement des capacités ainsi que des changements dans le cadre 
juridique et institutionnel, 

• suivre et adapter la stratégie, si nécessaire, sur la base des résultats des 

évaluations, et 

• considérer la collaboration intra-pays et transnationale comme un principe clé de la 

mise en œuvre. 

En termes opérationnels, la sélection stratégique des politiques et pratiques MPM 
doit  être  alignée  sur  les  objectifs  définis  au  niveau  stratégique  et  sur la place  du 
produit  dans  le  cycle  de  vie.  Les  pratiques  importantes  à  prendre  en  considération 
comprennent l'application des critères MEAT et des approches à gagnants multiples, 
la  collecte  et  l'analyse  des  données.  Des  processus  transparents  et  clairs  et 
l'amélioration  des  systèmes  informatiques  sont  considérés  comme  des  approches 
bénéfiques et favorables. 

La  Commission  européenne  peut  soutenir  ces  recommandations  politiques  en  offrant 
une  plate-forme  pour  faciliter  l'échange  d'expériences  entre  les  praticiens  MPM 
ainsi  qu'entre  les  experts  en  passation  de  marchés  et  d'autres  experts,  par  exemple 
ceux qui travaillent dans les pouvoirs publics pour la tarification et le remboursement 
des médicaments. 

Conclusion 

Les  marchés  publics  de  médicaments  sont  une  politique  pharmaceutique  clé  qui 
peut  contribuer  à  un  meilleur  accès  aux  médicaments,  notamment  en  rendant 
plus de médicaments disponibles à des prix plus bas. Les pratiques d'approvisionnement 
varient d'un pays européen à l'autre, reflétant souvent l'hétérogénéité des systèmes de 
soins de santé. En termes d'optimisation des marchés publics de médicaments, il n'y a 
pas  de  solution  unique  et  les  politiques  d'achat  doivent  être  intégrées  dans  la 
configuration  nationale  du  système  de  santé.  Une  approche  du  cycle  de  vie  de 
l'approvisionnement qui tient compte de la place d'un médicament tout au long de la 
chaîne  de  valeur  pharmaceutique  peut  aider  à  déterminer  quelle  procédure 
d'approvisionnement utiliser (plus ou moins compétitive) et quels critères d'attribution 
sont les plus pertinents. La compréhension du marché peut être facilitée par une étude 
de  marché  approfondie  et  un  dialogue  avec  les  fournisseurs  avant  le  lancement  des 
procédures d'approvisionnement. 

Il est important de noter que grâce à leur effet de levier en tant que domaine clé pour 
les achats, les MPM peuvent aider à atteindre d'autres objectifs politiques, notamment 
la  sécurité  de  l'approvisionnement  et  la  préparation  aux  crises  pour  le  secteur  de  la 
santé,  un  marché  concurrentiel  pour  les  produits  pharmaceutiques,  ainsi  que  des 
objectifs environnementaux. Cependant, tous les objectifs ne peuvent pas être atteints 
simultanément. Une approche stratégique de l'approvisionnement pharmaceutique est 
donc nécessaire. 

Les décideurs politiques sont encouragés à prêter attention aux MPM et à développer 
(plus  encore)  une  vision  et  une  stratégie  des  MPM,  qui  peuvent  ensuite  être 
opérationnalisées sur la base des apprentissages sur la manière d’optimiser les MPM 
en termes techniques. 

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TABLE OF CONTENTS 

ACKNOWLEDGEMENTS .................................................................................................. V 

ABSTRACT ................................................................................................................. VII 

KEY FINDINGS ........................................................................................................... VIII 

EXECUTIVE SUMMARY ................................................................................................ XIII 

RESUMÉ ................................................................................................................... XXII 

TABLE OF CONTENTS .............................................................................................. XXXII 

LIST OF ABBREVIATIONS ....................................................................................... XXXVII 

LIST OF COUNTRY NAME ABBREVIATIONS ................................................................ XXXIX 

1. 

INTRODUCTION .................................................................................................... 1 
Background ................................................................................................................ 1 
Motivation for this study and purpose ............................................................................ 3 
Research questions addressed in this study and scope ..................................................... 3 

1.1. 
1.2. 
1.3. 

2.5. 

2.1. 
2.2. 
2.3. 
2.4. 

2.  METHODS ............................................................................................................. 5 
Triangulation of methods ............................................................................................. 5 
Literature review ......................................................................................................... 5 
Country fiches and expert review .................................................................................. 7 
Stakeholder consultation: workshops, interviews, online survey ........................................ 8 
2.4.1.  Workshops ............................................................................................................ 9 
Interviews ............................................................................................................10 
2.4.2. 
Stakeholder consultation: online survey ...................................................................10 
2.4.3. 
Data analysis .............................................................................................................12 
TED data ..............................................................................................................12 
2.5.1. 
2.5.1.1.  Use of TED data in the study ..................................................................................13 
2.5.1.2.  Challenges in working with TED data .......................................................................14 
2.5.2. 
IQVIA data ...........................................................................................................15 
2.5.2.1.  Use of IQVIA data in the study ................................................................................16 
2.5.3. 
Impact analysis .....................................................................................................16 
2.5.3.1.  Outline of analytical approach .................................................................................17 
2.5.3.2.  Grouping of medicines for analysis ..........................................................................19 
2.5.3.3.  Limitations of the impact analysis ............................................................................21 
Development of an online dashboard ............................................................................22 

2.6. 

3. 

3.1. 
3.2. 
3.3. 

POLICY ANALYSIS IN THE STUDY COUNTRIES .......................................................... 24 
Stakeholder mapping ..................................................................................................24 
Organisation of PPM ...................................................................................................32 
PPM practices ............................................................................................................36 
PPM procedures ....................................................................................................36 
3.3.1. 
PPM techniques .....................................................................................................39 
3.3.2. 
3.3.2.1.  Framework agreements .........................................................................................39 
3.3.2.2.  Dynamic purchasing systems (DPS) .........................................................................41 
3.3.2.3.  Single vs. multiple winner awards ...........................................................................41 
Award criteria ............................................................................................................42 
Supporting tools and impacting policies ........................................................................45 
Horizon scanning and HTA ......................................................................................45 
Managed-entry agreements ....................................................................................46 
PPM-supporting elements .......................................................................................46 
PPM procedures and practices for biosimilar medicines ....................................................47 

3.5.1. 
3.5.2. 
3.5.3. 

3.4. 
3.5. 

3.6. 

4. 

EVALUATION OF THE IMPACT OF PPM ..................................................................... 49 
Impact of PPM procedures and practices on access to medicines ......................................49 
Impact of PPM procedures and practices on affordability of medicines ...............................54 

4.1. 
4.2. 

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4.2.1. 
4.2.2. 
4.2.3. 

4.3. 
4.4. 
4.5. 
4.6. 
4.7. 

Relationship between centralised procurement and affordability ..................................54 
Impact of PPM techniques and award criteria on affordability ......................................57 
Impact of PPM procedures and practices on availability of medicines ............................62 
Impact of PPM procedures and practices on security of supply .........................................64 
Impact of PPM procedures and practices on the environment ...........................................66 
Impact of PPM procedures and practices on competition ..................................................67 
Impact of PPM procedures and practices on crisis preparedness .......................................69 
Issues with data availability to assess impact of PPM ......................................................70 

5. 

5.1. 

5.2. 

5.1.1. 

5.2.1. 
5.2.2. 
5.2.3. 
5.2.4. 
5.2.5. 
5.2.6. 
5.2.7. 
5.2.8. 

PHIS HOSPITAL PROCUREMENT UPDATE ................................................................. 72 
Background on hospital procurement ............................................................................72 
Update of PHIS Hospital report ...............................................................................72 
Public procurement of medicines in hospitals .................................................................74 
Hospital and hospital pharmacy landscape ................................................................74 
Medicines in hospitals ............................................................................................77 
Hospital funding of medicines .................................................................................79 
Reimbursement lists for medicines used in hospitals ..................................................82 
Pharmaceuticals and Therapeutics Committees in hospitals ........................................83 
Use of MEAs by hospitals ........................................................................................83 
Organisational framework for PPM in hospitals ..........................................................85 
Procedures and techniques applied in hospital procurement ........................................89 
Award criteria in hospital procurement ..........................................................................92 
Interface management................................................................................................98 
Cross-sectoral formularies and formulary committees .............................................. 100 
Funding mechanisms ........................................................................................... 104 
Further interface management measures ............................................................... 105 
Developments in the last decade ........................................................................... 106 
Biosimilar use and procurement in hospitals ................................................................ 107 
Biosimilar use in hospitals ................................................................................... 107 
5.4.1. 
Biosimilar procurement in hospitals ...................................................................... 110 
5.4.2. 
5.4.3. 
Measures to enhance the uptake of biosimilar use .................................................. 113 
5.4.3.1.  Guidelines for biosimilar prescribing (including switches) ......................................... 113 
 .............................................................................................. 114 
5.4.3.2. 
5.4.3.3.  Substitution 
 .............................................................................................. 114 
Information and education activities ..................................................................... 115 
5.4.3.4. 

5.3.1. 
5.3.2. 
5.3.3. 
5.3.4. 

INN prescribing 

5.2.9. 
5.3. 

5.4. 

6. 

6.1. 
6.2. 

COLLABORATIONS IN PPM ................................................................................... 117 
Reasons for conducting joint procurement and variants................................................. 117 
Cross-country collaborations in PPM and learnings ........................................................ 118 
Cross-country collaborations in the study countries ................................................ 118 
6.2.1. 
6.2.1.1.  Baltic Procurement Initiative ................................................................................ 119 
6.2.1.2.  Nordic Pharmaceutical Forum............................................................................... 121 
6.2.1.3.  Beneluxa Initiative ............................................................................................. 122 
European initiatives for joint public procurement in crisis response ........................... 123 
6.2.2. 
6.2.2.1. 
Joint procurement agreement .............................................................................. 124 
6.2.2.2.  EU COVID-19 vaccines procurement ..................................................................... 124 
International collaborations in PPM of relevance ..................................................... 125 
6.2.3. 

7. 

7.1. 

POLICY IMPLICATIONS OF THIS STUDY ................................................................. 126 
Key barriers for optimising PPM .................................................................................. 126 
Product-group specific barriers ............................................................................. 128 
Setting-specific barriers ...................................................................................... 129 
Cross-country specific barriers ............................................................................. 130 

7.1.1. 
7.1.2. 
7.1.3. 

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7.2. 

7.3. 

7.2.1. 
7.2.2. 
7.2.3. 

Best practice toolbox ................................................................................................ 130 
Implementation of best practices in the study countries .......................................... 130 
Optimising PPM policy and practices ..................................................................... 132 
Best practices for joint procurement ..................................................................... 134 
Policy recommendations ............................................................................................ 135 

8. 

9. 

CONCLUSIONS ................................................................................................... 138 

REFERENCES ..................................................................................................... 139 

10.  LIST OF ANNEXES .............................................................................................. 156 

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Table of tables 

Table 1: Participation in the workshops on PPM ............................................................................................... 9 
Table 2: List of stakeholder groups invited to participate in the online survey ............................................... 11 
Table 3: List of indicators for TED data ............................................................................................................ 13 
Table 4: IQVIA data - coverage of study countries .......................................................................................... 15 
Table 5: List of indicators for IQVIA data ......................................................................................................... 16 
Table 6: List of indicators of PPM practices ..................................................................................................... 17 
Table 7: Outcomes indicators for six policy areas............................................................................................ 19 
Table 8: Main categories of medicines for analysis ......................................................................................... 21 
Table 9: Components of the online dashboard ................................................................................................ 22 
Table 10: List of procurement bodies involved in PPM at national level in the study countries ...................... 26 
Table 11: List of regional CPBs involved in PPM in the study countries ........................................................... 31 
Table 12: Differences between the 2010 PHIS Hospital Pharma Report and the 2022 PHIS Hospital 
Procurement Update ....................................................................................................................................... 73 
Table 13: Hospital landscape and ownership in the study countries, 2019 ..................................................... 75 
Table 14: Relevance of hospital pharmacies and their role in serving patients .............................................. 76 
Table 15: “DRG carve-outs”, innovation funds, state budget procurement and further special financial 
schemes for defined medicines used in hospitals ............................................................................................ 80 
Table 16: Establishment of Pharmaceuticals and Therapeutics Committees (PTC) in the study countries ..... 83 
Table 17: Use of managed entry agreements in hospitals .............................................................................. 84 
Table 18: Organisation of PPM (main and other routes of PPM) in hospitals in the study countries .............. 85 
Table 19: Use of open procedures for procurement of hospital medicines in the study countries .................. 90 
Table 20: Examples for application of criteria other than price in the hospital sector (non-exhaustive list) .. 95 
Table 21: Biosimilars procurement in hospitals in the study countries ......................................................... 112 
Table 22: Government-initiated cross-country collaborations in the study countries ................................... 119 
Table 23: Barriers, constraints and challenges with regard to the PPM in the study countries .................... 126 
Table 24: Best practices applied in the study countries ................................................................................. 130 

Table of figures 

Figure 1: Triangulation of methods ................................................................................................................... 5 
Figure 2: Use of facility-based procurement in the study countries ................................................................ 34 
Figure 3: Use of group (joint) procurement in the study countries .................................................................. 34 
Figure 4: Use of centralised procurement at the regional level in the study countries ................................... 35 
Figure 5: Use of centralised procurement at the national level in the study countries ................................... 35 
Figure 6: Procedures used for procurement of medicines included in TED database in the study countries, 
2008-2021 ....................................................................................................................................................... 37 
Figure 7: Use of framework agreements for procurement of medicines in the study countries, 2008-2021 .. 40 
Figure 8: Award criteria used in procurement procedures in the study countries, 2008-2021 ........................ 43 
Figure 9: Relationship between degree of PPM and affordability of medicines .............................................. 50 
Figure 10: Relationship between degree of PPM and availability of new medicines ...................................... 51 
Figure 11: Level of PPM (within a country) most likely to contribute to access to medicines (responses >3 per 
stakeholder group), per stakeholder group ..................................................................................................... 53 
Figure 12: Relationship between degree of PPM and proxy unit prices .......................................................... 55 
Figure 13: Relationship between use of central purchasing body in a country and proxy unit prices ............. 56 
Figure 14: Assessment of potential contribution of PPM procedures to different policy objectives, per 
stakeholder group ........................................................................................................................................... 58 
Figure 15: Assessment of potential contribution of PPM techniques to different policy objectives, per 
stakeholder group ........................................................................................................................................... 58 
Figure 16: Relationship between use of framework agreements in a country and approximated unit prices  59 
Figure 17: Relationship between use of security of supply criteria and approximated unit prices ................. 60 
Figure 18: Relationship between use of environmental criteria and approximated unit prices ...................... 60 
Figure 19: Relationship between use of MEAT criteria in a country and approximated unit prices ................ 61 
Figure 20: Ranking of importance of PPM award criteria by policy objective ................................................. 61 
Figure 21: Assessment of potential contribution of PPM award criteria to different policy objectives, per 
stakeholder group ........................................................................................................................................... 62 

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Study on Best Practices in the Public Procurement of Medicines – 
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Figure 22: Relationship between use of a central purchasing body and number of molecules within a group 
of medicines available in a country ................................................................................................................. 64 
Figure 23: Relationship between use of MEAT criteria and number of molecules within a group of medicines 
available in a country ...................................................................................................................................... 64 
Figure 24: Relationship between use of framework agreements and competition ......................................... 68 
Figure 25: Relationship between use of MEAT criteria and competition......................................................... 69 
Figure 26: Stakeholder assessment of the level of PPM most likely to contribute to preparedness ............... 70 
Figure 27: Proportion of total pharmaceutical expenditure spent by hospitals, 2000-2019 ........................... 78 
Figure 28: Pharmaceutical market size in EUR billion and share of hospital sector, in total pharmaceutical 
sales, 2021 ....................................................................................................................................................... 79 
Figure 29: Use of hospital pharmaceutical formularies (HPF) in the study countries ...................................... 82 
Figure 30: Main route for procurement of medicines in hospital setting ........................................................ 85 
Figure 31: Product life cycle approach applied and promoted by the Danish CPB Amgros ............................. 90 
Figure 32: Study countries applying price as sole criterion for PPM in hospitals ............................................ 93 
Figure 33: Cross-sectoral (joint inpatient and outpatient) reimbursement lists in the study countries ........ 100 
Figure 34: Cross-sectoral reimbursement committees in the study countries ............................................... 103 
Figure 35: Share of biosimilar medicines sales in the hospital vs. retail sectors, 2021 .................................. 108 
Figure 36: Share of biosimilar medicines in total hospital pharmaceutical sales, 2021 ................................ 109 
Figure 37: INN prescribing policies for biological medicines in the study countries ...................................... 114 
Figure 38: Biosimilar substitution policies in the study countries .................................................................. 115 

Table of boxes 

Box 1: Tendering or tendering-like procedures for off-patent, outpatient medicines – country examples ..... 39 
Box 2: Examples of supplier practices impeding biosimilar competition ......................................................... 48 
Box 3: Key findings: PPM processes and access to medicines ......................................................................... 49 
Box 4: Key findings: PPM practices and affordability ...................................................................................... 54 
Box 5: Key findings: PPM practices and availability of medicines ................................................................... 62 
Box 6: Key findings: PPM practices and security of supply .............................................................................. 65 
Box 7: Key findings: PPM practices and affordability ...................................................................................... 66 
Box 8: Key findings: PPM practices and competition ....................................................................................... 67 
Box 9: Central procurement bodies (CPB) at national level in the study countries .......................................... 88 
Box 10: Dynamic purchasing system (DPS) for medicines in Italy ................................................................... 92 
Box 11: Challenges in implementing MEAT criteria in PPM............................................................................. 94 
Box 12: Use of environmental criteria in Nordic tenders for hospital medicines ............................................. 95 
Box 13: “Interface management” – definitions and concepts ......................................................................... 99 
Box 14: Cross-sectoral formulary management in Sweden and Scotland ..................................................... 102 
Box 15: Interface management initiatives in Austria .................................................................................... 104 
Box 16: “H prescriptions” in Norway – paying for the medicine use in the other sector ............................... 105 
Box 17: “The lock” system in the Netherlands to assess high-budget impact medicines for hospital use .... 105 
Box 18: Biosimilar tendering in Norway ........................................................................................................ 110 
Box 19: Mandatory multi-winner contracts for biosimilar medicines in Italy ................................................ 110 
Box 20: Denmark: successful switch of adalimumab within six weeks .......................................................... 116 
Box 21: Benefits of joint PPM ........................................................................................................................ 117 

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Study on Best Practices in the Public Procurement of Medicines – 
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LIST OF ABBREVIATIONS 

AIFA 

AIM 

APC 

ATC 

BBG 

BCG 

CA 

CAN 

CDF 

CEPI 

CFC 

Agenzia Italiana del Farmaco / Italian Medicines Agency 

International association of mutual benefit societies 

Area Prescribing and Medicines Management Committees 

Anatomical Therapeutic Chemical Classification system (of the WHO) 

Bundesbeschaffung GmbH / Austrian Federal Procurement Agency (Austria) 

Bacille Calmette-Guerin (vaccine) 

Contracting authority 

Contract Award Notices 

Cancer Drugs Fund (UK) 

Coalition for Epidemic Preparedness Innovations 

Call for Competition 

COVAX 

COVID-19 Vaccine Global Access Facility 

COVID-19 

Coronavirus disease 2019 

CPB 

CPM 

CPSU 

CPV 

DKMA 

DPS 

DRG 

EAHP 

EC 

EEA 

EFPIA 

EFTA 

EHIF 

EHPPA 

EMA 

EPF 

Central Purchasing / Procurement Body 

Centralised Procurement of Medicines 

Central Procurement & Supplies Unit (Malta) 

Common Procurement Vocabulary (of the EU) 

Danish Medicines Agency 

Dynamic purchasing system 

Diagnosis-related group 

European Association of Hospital Pharmacists 

European Commission 

European Economic Area 

European Federation of Pharmaceutical Industries and Associations 

European Free Trade Association 

Estonian Health Insurance Fund 

European Health Public Procurement Alliance 

European Medicines Agency 

European Patients’ Forum 

EphMRA 

European Pharmaceutical Market Research Association 

ESIP 

EU 

EXPH 

EXPP 

FAAP 

FOPH 

European Social Insurance Platform 

European Union 

Expert Panel on effective ways of investing in health 

EC Government Experts Group on Public Procurement 

Fair and Affordable Pricing initiative 

Federal Office of Public Health 

G-CSF 

Granulocyte colony-stimulating factor 

GIRP 

GÖ B 

GÖG 

HaDEA 

HERA 

European Healthcare Distribution Association 

Gesundheit Österreich Beratungs GmbH / Austrian National Public Health Institute 

Gesundheit Österreich GmbH / Austrian National Public Health Institute 

European Health and Digital Executive Agency 

European Health Emergency preparedness and Response Authority 

HIV / AIDS 

Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome 

HIO 

HMA 

HOM 

Health Insurance Organisation (Cyprus) 

Heads of Medicines Agencies 

Hospital-only medicine 

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Study on Best Practices in the Public Procurement of Medicines – 
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Hospital pharmaceutical formulary / formularies 

Human papillomavirus 

Health Service Executive (Ireland) 

Health Technology Assessment 

International Horizon Scanning Initiative 

Innovative Medicines Fund (UK) 

Joint Procurement Agreement 

Közbeszerzési és Ellátási Főigazgatóság (KEF) / Directorate-General for Public 
Procurement and Supply (Hungary) 

Key Performance Indicator 

Low- and middle-income country(ies) 

Legemiddelinnkjøpssamarbeid / Norwegian Drug Procurement Cooperation (Norway) 

Managed-entry agreement 

Most Economically Advantageous Tender 

Medizinische Einzelleistungen / Single medical services (Austria) 

Ministry of Health 

Member State (of the EU) 

Network of competent authority / authorities for pricing and reimbursement of 
medicines 

Nemzeti Egészségbiztosítási Alapkezelő /National Health Insurance Fund (Hungary) 

National Health Service 

National Institute for Health and Care Excellence (United Kingdom) 

Neue Untersuchungs- und Behandlungsmethoden / New Methods for Diagnostics and 
Treatment (Germany) 

Organization for Economic Co-operation and Development 

Pan American Health Organization 

Pharmaceutical Health Information System (project) 

Public procurement of medicines 

Pharmaceutical Pricing and Reimbursement (project and network) 

Pharmaceuticals and Therapeutics Committee 

Réseau des Acheteurs Hospitaliers (France) 

Specific objective 

Serviços Partilhados do Ministério da Saúde / Shared Services of the Ministry of Health 
(Portugal) 

Státní ústav pro kontrolu léčiv / State Institute for Drug Control (Slovakia) 

Tenders Electronic Daily 

Tandvårds- och läkemedelsförmånsverket / National Dental and Pharmaceutical Benefits 
Agency 

HPF 

HPV 

HSE 

HTA 

IHSI 

IMF 

JPA 

KEF 

KPI 

LMIC 

LIS 

MEA 

MEAT 

MEL 

MoH 

MS 

NCAPR 

NEAK 

NHS 

NICE 

NUB 

OECD 

PAHO 

PHIS 

PPM 

PPRI 

PTC 

Resah 

SO 

SPMS 

SUKL 

TED 

TLV 

UNICEF 

United Nations International Children's Emergency Fund 

VEAT 

WHO 

ZSG 

Voluntary ex ante transparency 

World Health Organization 

Zielsteuerung Gesundheit (health care sector reform process in Austria) 

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LIST OF COUNTRY NAME ABBREVIATIONS 

AT 

BE 

BG 

CH 

CY 

CZ 

DK 

EE 

ES 

FI 

FR 

DE 

EL 

HR 

HU 

IS 

IE 

IT 

LI 

LV 

LT 

LU 

MT 

NL 

NO 

PL 

PT 

RO 

SE 

SI 

SK 

UK 

Austria 

Belgium 

Bulgaria 

Switzerland 

Cyprus 

Czech Republic 

Denmark 

Estonia 

Spain 

Finland 

France 

Germany 

Greece 

Croatia 

Hungary 

Iceland 

Ireland 

Italy 

Liechtenstein 

Latvia 

Lithuania 

Luxembourg 

Malta 

Netherlands 

Norway 

Poland 

Portugal 

Romania 

Sweden 

Slovenia 

Slovakia 

United Kingdom 

XXXIX 

 
 
 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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1.  INTRODUCTION 

Public  procurement  of  medicines  (PPM)  is  highlighted  in  the  European  Commission’s 
(EC)  “Pharmaceutical Strategy  for  Europe”  as  an  area  where  actions  can  be taken  to 
improve access to medicines for patients in the European Union (EU) [1]. Against this 
background,  and  with  upcoming  changes  to  the  legislative  environment  for 
pharmaceuticals in the EU, the European Health and Digital Executive Agency (HaDEA) 
as contracting authority (CA), under the  mandate of the  EC,  commissioned a “Study 
on  Best  Practices  in  the  Public  Procurement  of  Medicines”.  The  study  was 
conducted by Gesundheit Österreich Beratungs GmbH (Austrian National Public Health 
Institute  /  GÖ  B)  and  Tetra  Tech  Sp.  z  o.o.,  as  members  of  a  consortium  led  by 
Economisti  Associati,  and  under  the  Framework  contract  SANTE/2016/a1/039 
concerning  the  provision  of  services  in  the  area  of  evaluation,  impact  assessment, 
monitoring and implementation and of other relevant services, in relation to the health 
and food policies (LOT 1) with reopening of competition. The findings of this study are 
presented  in  this  report.  The  background  to  the  study  and  research  questions  to  be 
addressed  are  described  in  the  present  Chapter  1,  while  research  methods  are 
presented  in  Chapter  2.  The  study  provides  an  overview  procurement  and  related 
policies in Europe (Chapter 3), and assesses their impact on different policy objectives 
(Chapter  4).  The  report  includes  dedicated  sections  on  PPM  in  hospital  settings, 
including  procurement  of  biosimilar  medicines  (Chapter  5),  and  cross-country 
collaborations (Chapter 6). Finally, barriers and best practices are presented (Chapter 
7), and the  report closes with a set  of  conclusions (Chapter 8). Following the list of 
references  (Chapter 9),  additional  documents  and  information  are  provided  in  the 
Annexes  (Chapter 10).  Note  that the  outline of  this report  is  aligned with  the  study 
objectives and work packages of this study as described below. 

1.1. Background 

Public  procurement  is  a  commonly  applied  policy  option  to  achieve  and  improve 
sustainable  access  to  affordable  medicines.  The  use  of  tendering  has  been 
recommended  by  the  World  Health  Organization  (WHO)  in  conjunction  with  other 
policies,  contingent  on  applying  additional  evaluation  criteria  than  price  alone  when 
awarding contracts [2]. 

Public procurement of medicines (PPM) is applied in many countries, in particular in low- 
and  middle-income  countries  (LMIC).  In  Europe,  PPM  is  most  commonly  used  in  the 
hospital  setting  and  for  public  services  (e.g.  national  immunisation  programmes  and 
pandemic  plans);  products  frequently  subject  to  PPM  include  vaccines  and  medicines 
with competition, such as generics and biosimilars [2-6]. 

Some forms of PPM have particularly attracted attention of policy makers. Specifically, 
there  is  interest  in  potential  benefits  of  pooling  purchase  volumes  through  joint 
procurement, and procurers have already gained some experience with this form of 
PPM  [7].  Pooling  in  PPM  can  take  place  in  different  ways,  both  intra-country  (e.g. 
centralised procurement  through a  national or  regional  centralised  procurement body 
(CPB)  or  group  procurements  of  hospitals)  and  cross-country.  Cross-country  joint 
procurement  may  be  organised  through  a  designated,  e.g.  supra-national,  institution 
which  performs  procurement  on  behalf  of  countries,  (such  as  the  Revolving  and 
Strategic Funds of the Pan American health Organization (PAHO)), or as cooperation of 
different  countries  (e.g.  the  joint  procurement  of  the  Gulf  Cooperation  Council)  [8]. 
Moves towards joint PPM have also been observed in Europe: some European countries 
introduced national centralised procurement for some or all medicines, especially in the 
hospital sector [9], and joint tenders  were  conducted by cross-country collaborations 
established during the last decade (e.g. the Nordic Pharmaceutical Forum) [10]. 

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Study on Best Practices in the Public Procurement of Medicines – 
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PPM is thus a well-established policy, which has been used for long in several countries, 
and there  are  principles  for  good  practice  on  how  to  conduct PPM  [11].  Nonetheless, 
there  are  few  (systematic)  reviews  that assessed  the  impact of  PPM on  access  to 
medicines or on individual components of access. 

Most analyses focused on lower prices and/or savings for public budgets achieved 
by PPM, usually compared to other pricing policies or a situation of no policy action [5, 
12-28]. Lower prices were attributed to competition and/or larger volumes as result of 
pooling. 

Some  studies  also  examined  further  impacts  of  PPM  (or  of  specific  organisational 
frameworks  and  designs  of  PPM,  e.g.  centralised  procurement).  Endpoints  of  these 
analyses included competition in the market (e.g. expressed by the number of bidders) 
[22, 23, 29-31], timely delivery (centralisation was found to slow down process and 
prolong delivery times) [25, 32], accountability and anti-corruption (lower risk of 
corruption in centralised processes) [33-35], rational selection [36], and availability 
[37]. A major concern in this respect is that PPM practices that aim for the lowest price 
may  lead  to  shortages  and  withdrawals  of  suppliers  from  the  market  [5,  38]. 
However, there is yet a lack of robust evaluations on this topic. 

The  methodological  approaches  of  existing  studies  evaluating  PPM  practices  vary, 
including quantitative as well as some qualitative or even descriptive works. However, 
several publications (e.g. [32, 39-46]) highlighted the importance of the design of 
PPM (e.g. PPM organisational framework, practices and techniques), which should be 
aligned  with  the  goals  of  PPM,  and  of  supporting  measures.  The  latter  include 
information systems, e-procurement and strengthening the capacity of public procurers 
[3,  47].  Since  medicines  are  special  goods  given  their  sensitive  character  and  the 
particularities of the health system, further policies and supporting instruments such as 
horizon scanning to identify promising medicine candidates with potential high budget 
impact [48] and health technology assessment (HTA)[49], which are used to manage 
the  entry  of  new  medicines  in  the  health  system,  and  demand-side  measures  to 
encourage the uptake of off-patent medicines [50], also play a role as accompanying 
measures. 

The  body  of  evidence  described  above  as  well  as  learnings  from  anecdotal  reports 
suggest  a  strategic  approach  to  PPM  may  be  most  promising  in  achieving  improved 
access to medicines. This includes, among other features, consideration of further award 
criteria than the price of the medicines (including the promotion of “green” and socially 
responsible public procurement), collaborative approaches, innovation in procurement, 
and aligning  the  choice  of  PPM  practices  and  techniques  to  the  policy objectives,  the 
type of medicines to be procured and their position in the pharmaceutical value chain. 
The “strategic procurement” concept [51] (not solely related to medicines) has been 
promoted  by  supranational  institutions  such  as  the  EC  [52-57],  the  Organisation  for 
Economic  Co-operation  and  Development  (OECD)  [58]  and  the  WHO  [59,  60]. 
Furthermore, to address the challenges in public procurement in the health sector, the 
Expert Panel on effective ways of investing in health (EXPH, an independent group of 
expert  established  by  the  EC)  issued  recommendations  about  optimising  PPM  in  a 
strategic way, including by ensuring those engaged in public procurement understand 
how  the  process  can  be  used  to  promote  wider  social,  economic  and  environmental 
objectives, and encouraging cooperative procurement in beneficial circumstances [3]. 

Stakeholders also addressed some of the elements subsumed under strategic public 
procurement  in  their  position  papers:  industry  associations  (European  Federation  of 
Pharmaceutical  Industries  and  Associations  (EFPIA)  and  “Medicines  for  Europe”) 
appreciate use of different award criteria than solely price and avoidance of a “winner-
take-it-all”  approach,  but  maintain  a  critical  view  on  joint  procurement  beyond 
emergency  situations  [61-66],  whereas  the  European  Associations  of  Hospital 

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Study on Best Practices in the Public Procurement of Medicines – 
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Pharmacists  (EAHP)  urged  for  the  involvement  of  pharmacists  in  the  procurement 
processes [67]. 

1.2. Motivation for this study and purpose 

As described in the previous section, there are strong indications that PPM can contribute 
to improved access to medicines, in particular if used more strategically. 

PPM as strategic policy option to foster competition and improve access, and to address 
important further policy objectives, is also highlighted in the 2020 “Pharmaceutical 
Strategy for Europe” [1]. The strategy calls on public procurers to “design smart and 
innovative procurement procedures,  e.g. by  assessing  the  role  of  ‘winner-takes  it  all’ 
procedures and improving related aspects (such as price conditionality, timely delivery, 
‘green production’ and security and continuity of supply)”[1]. 

Public procurers in the EU have been benefiting from the 2014 revision of the EU public 
procurement  legislation,  resulting  in  Directive  2014/24/EU  of  the  European 
Parliament and of the Council of 26 February 2014 on public procurement and repealing 
Directive 2004/18/EC [68] (EU Public Procurement Directive) which provided the legal 
framework  for  the  use  of  valuable  tools.  The  Directive  specifies  different  forms  of 
procedures  (open  tenders  and  various  forms  of  restricted  procedures,  including 
provisions  for  innovation  procurement)  and  the  conditions  under  which  these  can  be 
used,  as  well  as  PPM  techniques  to  implement  these  procedures.  The  Directive  also 
specifies  that  contracts  should  be  awarded  to  the  Most  Economically  Advantageous 
Tender (MEAT), which allows for explicit consideration of a combination of criteria other 
than price. However, use of such optimised public procurement practice is only partially 
known for medicines, since knowledge on PPM implementation, including challenges and 
good practice examples, has not yet been systematically collated and studied for the EU 
Member States (MS). 

Against this backdrop, this study aims to collect and analyse evidence in the study 
countries to optimise public procurement  of medicines as a tool that is able to 
contribute to accessibility, affordability and availability of medicines, and to encourage 
greener  pharmaceutical  design  and  manufacturing  as  well  as  to  support  crisis 
preparedness  and  handling  in  both  outpatient  and  hospital  sectors.  Study  countries 
include all EU countries, EEA/EFTA9 countries, and the UK. A legal investigation on 
compliance of MS with EU public procurement directives is not scope of this study. 

1.3. Research questions addressed in this study and scope 

The general study objective of a collection and an analysis of evidence to optimise 
PPM is operationalised through the following six specific objectives (SO) with defined 
research questions: 

  SO1: To map all relevant stakeholders involved in PPM, impacting PPM or targeted 

by PPM in the study countries (Stakeholder Mapping); 

  SO2: To map existing policies and practices in PPM in the study countries and to 

explore avenues for improvement (Policy Analysis); 

  SO3: To assess the impact of PPM practices in the study countries on different 

policy objectives, including affordability and availability of medicines, security of 
supply, protecting the environment, maintaining a competitive market, and crisis 
preparedness and handling (Impact Analysis); 

9 EEA (European Economic Area) comprises EU MS and Iceland, Liechtenstein, and Norway. EFTA (European 

Free Trade Association) comprises all countries mentioned before as well as Switzerland. 

3 

 
 
 
 
 
                                                 
Study on Best Practices in the Public Procurement of Medicines – 
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  SO4: To identify barriers and constraints in PPM in the study countries and to 

develop approaches to address them (Barriers Analysis); 

  SO5: To develop sets of best practices in PPM for the study countries, in particular 
with regard to the application of MEAT criteria other than price alone, fostering 
environmentally sustainable manufacturing, more resilient and secure supply 
system and to be prepared for handling health crises well and joint procurement 
(Best Practices Toolbox); 

  SO6: To update and extend the analyses and recommendations of the 2010 PHIS 

Hospital Pharma report (PHIS Hospital Update). 

Specific research questions for each SO are listed in Annex 1. This annex also provides 
an  overview  where  relevant  findings  for  each  research  question  are  described  in  this 
study report. 

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Study on Best Practices in the Public Procurement of Medicines – 
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2.  METHODS 

The specific objectives of the study are being addressed through a mix of methods. 
This  chapter  provides  an  overview  of  all  methods  applied  in  the  study,  including 
limitations of the methodological approaches and/or underlying data. 

2.1. Triangulation of methods 

The  study  applies  a  mix  of  qualitative  and  quantitative  methods  to  address 
research  questions  in  six  areas  of  interest  (SOs).  Importantly,  none  of  the  six 
overarching SOs are addressed through  one methodological approach alone. Instead, 
triangulation of methods and data sources is used across the study.  Figure 1 presents 
an overview of the specific methodological approaches and data sources used to address 
research questions in the six SOs. The specific contributions are described in more detail 
in  Chapters 2.2-2.5  below.  The  figure  also  shows  which  information  is  presented in 
the  study’s  online  dashboard.10  While  not  technically  a  research  method  itself,  the 
dashboard (described in more detail in Chapter 2.6) contains data collected or prepared 
during  this  study  and  was  used  by  the  study  team  to  analyse  data  presented  in  this 
report.  Moreover,  the  dashboard  contains  more  data  than  the  findings  that  could  be 
included  in  the  report.  The  dashboard  therefore  presents  an  opportunity  for  users  to 
conduct further analyses and explore data on their own. 

Figure 1: Triangulation of methods 

Specific 
objective

General question

Literature 
review

Country fiches 
and expert 
review

Workshops

Interviews

Online survey

TED data

IQVIA data

Impact 
analysis

Presentation of 
findings in 
online 
dashboard

Stakeholder consultation

Quantitative data

SO1

SO2

SO3

SO4

SO5

SO6

Which stakeholders are involved in 
PPM, and in which role?

What are current national PPM policies 
in the studied countries?

How can PPM contribute to savings?

Barriers to optimise PPM?

Which are best practices to optimising 
PPM?

Which are current hospital PPM 
practices?

No

Yes

Yes

Partly

Partly

Yes

 Major data source

 Supplementary data source / use in some cases

 Method not used for this question

 data collection and analysis

 field research method

Source: Authors 

2.2.  Literature review 

The study team conducted a narrative review of peer-reviewed and grey literature 
as  the  basis  for  identifying  relevant  stakeholders  and  their  roles  in  PPM  in  the  study 
countries (SO1: Stakeholder mapping), obtaining an overview of current PPM policies 
and practices in the study countries (SO2: Policy analysis), including in hospitals (SO6: 
PHIS  Hospital  Update),  and  for  identifying  barriers  as  well  as  best  practices  for 
optimising PPM (SO4: Barriers analysis and SO5: Best practices toolbox). In addition to 
addressing the study questions listed above, which reflect the planned contributions of 
the literature review according to the work plan at the outset of the study, the literature 
review was also found to be a source of valuable information for assessing the impact 
of  PPM  on  various  policy  objectives  (SO3:  Impact  Analysis).  Overall,  the  aim  of  the 
literature review was therefore to survey descriptive information as well as analytical 
studies  of  the  performance  of  PPM  in  the  study  countries.  The  literature  review  was 

10 The dashboard will be submitted as a deliverable to the CA / EC who will then decide on its future use. 

5 

 
 
 
 
 
                                                 
Study on Best Practices in the Public Procurement of Medicines – 
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conducted to support  specific tasks within the study, rather than to develop a stand-
alone, systematic literature review on the topic of PPM. 

Literature was identified from several sources to ensure comprehensive coverage of all 
relevant reports. Source selection was informed by the specific purposes for which the 
literature review was conducted (i.e. the specific objectives mentioned above). 

First, general searches for PPM-related literature were conducted. General search 
terms  related  to  PPM,  including  “public  procurement”  and  “pharmaceuticals”  and 
variations of these terms, were used to search bibliographic databases Google Scholar 
and  MEDLINE  via  PubMed.  Similar  terms  were  used  (where  applicable)  to  search  the 
websites  of  relevant  international  and  supranational  organisations,  including  the  EC, 
EUROSTAT,  Organization  for  Economic  Co-operation  and  Development  (OECD),  the 
Pharmaceutical  Pricing  and  Reimbursement  (PPRI)  network,  United  Nations 
International Children's Emergency Fund (UNICEF), World Health Organization (WHO), 
and the World Bank. A structured search was also conducted in MEDLINE via PubMed 
for existing systematic reviews on PPM. This search retrieved eight existing systematic 
reviews [5, 12-15, 47, 69, 70], which were reviewed to identify any relevant original 
studies. In addition, studies and reports on pharmaceutical policies in general as well as 
PPM  policies  that  the  study  team  were  already  familiar  with  were  reviewed.  These 
included  reports  from  the  PPRI  network  of  competent  authorities  on  pharmaceutical 
pricing and reimbursement and the Pharmaceutical Health Information System (PHIS) 
[6, 71-114], studies authored by the study team [4, 9, 115-120], and other studies [3, 
14, 16, 18, 19, 26, 44, 121-135].11 

Second,  targeted country-specific  database searches  were  conducted  to  identify 
relevant literature relating to the PPM set-up and experiences in each of the 32 study 
countries. This information was used to populate country fiches for each of the study 
countries. The country fiche template is available in Annex 2 and further information on 
development and use of country fiches is presented in Chapter 2.3. 

Targeted literature searches in electronic databases were conducted for each of the 
study countries, combining search terms for public procurement of medicines with the 
name of each country. Literature searches were primarily conducted in Google Scholar, 
with supplemental searches conducted in MEDLINE via PubMed in case of no or low yield 
of relevant records from the primary source. Google Scholar was selected as the primary 
literature  database  because  it  contains  both  academic  (peer-reviewed)  and  grey 
literature such as reports by governmental institutions and international organisations. 
Procurement-specific database  searches were  supplemented by  targeted  searches  for 
procurement-specific  information  in updated  published  country  profiles  or  briefs  from 
the PPRI network [136] and the European Observatory on Health Systems and Policies 
[137] and targeted searches for pharmaceutical-specific information in country reports 
on public procurement by the EC and the OECD [138, 139]. These included published 
reports  of the PPRI network12 dating back to 2009/2010, as well as information from 
eight  further  countries13  which  was  available  either  as  draft  national  PHIS  Hospital 
Pharma Report or provided to a survey of the PHIS project management to the authors 
affiliated  to  GÖG  who  conducted  the  2008-2010  PHIS  project  [140].  Further,  key 
publications on public procurement of medicines, or in health care (such as the Opinion 
of the Expert Panel on effective ways of investing in health (EXPH)) on this matter [3], 
were reviewed to identify any PPM-related examples or details from the study countries. 
When  central  purchasing  bodies  were  identified  from  prior  research,  the  websites  of 
these bodies were also searched for relevant information. 

11 Not an exhaustive list. 
12 Reports were available for Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, 

Latvia, Lithuania, Malta, the Netherlands, Norway, Poland, Portugal, Slovakia, Sweden and the UK. 

13 Germany, Estonia, Hungary, Ireland, Italy, Romania, Slovenia and Spain 

6 

 
 
 
 
 
                                                 
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One part of the literature and documentation review was the development of a glossary 
(see Annex 3, [141]) to present key concepts of PPM. This was an additional, unplanned 
deliverable,  which,  the  study  team  considered  important  to  ensure  common 
understanding and clarity in communication with stakeholders (see Chapters 2.3 and 
2.4). The development of this glossary was guided by legal texts, in particular the EU 
Procurement Directive 2014/24/EU [68], as well as existing glossaries on related topics 
[142, 143]. 

Third, stakeholders and country experts  were consulted to identify any additional 
literature not retrieved through database searches or included in previously identified 
reports. Country experts were involved in the study to review country fact sheets and 
were  also  asked  by  the  study  team  about  additional  nationally  relevant  reports. 
Stakeholder input for the study was obtained through interviews and workshops (see 
Chapters 2.3 and 2.4) and stakeholders had the opportunity to refer the study team 
to relevant literature.  

Several sources were used for the literature review, including consultation with country 
experts,  to  avoid  solely  relying  on  reports  indexed  in  academic  databases  and  solely 
available in English.  

All  identified  references  and  their  full  texts  (where  available)  were  compiled  into  a 
single, searchable bibliographic reference management database (EndNote X9). 
As of 27 September 2022, the database contained 858 unique entries. Due to this large 
number  of  entries  and  the  variety  of  sources  used  to  populate  it,  the  database  itself 
became a key complementary source of literature for the various work streams. Study 
team  members  used  the  search  function  of  the  reference  management  software 
(including  searching  full  texts  of  included  reports)  to  identify  potentially  relevant 
references, in addition to searching other repositories (see above). 

2.3. Country fiches and expert review 

Country fiches (fact sheets) were developed for each of the 32 study countries as a 
key resource for mapping PPM practices across Europe. These documents contain mostly 
standardised  information  about  PPM  in  the  study  countries  and  were  used  to 
address  questions  related  to  all  specific  objectives.  The  country  fiches  provide,  in  a 
compact form, triangulated information on who the relevant actors are for PPM in each 
country (SO1: Stakeholder mapping), what PPM procedures and techniques are being 
applied (SO2: Policy analysis), what the (expected or actual) impact of different policies 
is (SO3: Impact analysis), what barriers exist for PPM (SO4: Barriers analysis), whether 
there are any best practices that can be shared (SO5: Best practices toolbox), and how 
procurement  and  medicines  provision  work  in  the  inpatient  care  setting  (SO6:  PHIS 
Hospital update). 

A country fiche template (available in Annex 2) was developed by the study team and 
reviewed and piloted by PPM experts (the study sub-contractors).  

Information on public procurement processes to be included in the country fiches was 
collated  from  three  main  sources.  Information  from  all  three  main  sources  was 
triangulated to populate the final versions of the country fiches. 

Firstly, information was retrieved from publicly available documents, as described 
in  the  literature  review,  specifically  reports  identified  from  targeted  country-specific 
searches (see Chapter 2.2), including published reports of the PPRI network and from 
the  PHIS  project  [6,  71-114],  as  well  as  information  available  from  CPBs  (where 
applicable).  PPM-specific  examples  or  details  from  the  study  countries  were  also 
extracted from other publications [3, 14, 16, 18, 19, 26, 44, 121-135]. 

7 

 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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fiche, 

Secondly,  information  obtained  from  publicly  available  documents  was  validated 
through  a  review  conducted  by  public  procurement  experts  in  the  study 
countries. Country experts were primarily identified through existing networks (PPRI 
and  PHIS  networks),  as  well  as  the  EC  Government  Experts  Group  on  Public 
Procurement (EXPP), Subgroup on Health Public Procurement. Given the scope of the 
country 
to  wider 
pharmaceutical policy areas such as pricing and reimbursement, country experts were 
only asked to review the sections of the country fiche that fell into their area of expertise. 
Country  experts  then  either  liaised  with  other  experts  in  their  country  to  review  the 
remaining  sections,  or  the  study  team  identified  experts  for  those  sections.  Country 
experts were also asked to provide additional information on procurement practices that 
was not covered in publicly available documents. Review of pre-populated country fiches 
was either done electronically or through phone interviews. 

from  specific  procurement-related  aspects 

ranging 

Finally, country-specific information on PPM was also obtained through a series of three 
online workshops on optimisation of public procurement of medicines. Each workshop 
focused on different aspects of public procurement (see Chapter 2.4.1) and featured 
presentations by procurement experts on procurement policies and practices, providing 
country-specific  insights,  as  well  as  group  discussions  where  participants  were 
encouraged to draw on their country-specific experience. 

While the study team have been able to rely on their own networks and those of the EC 
to  identify  public  procurers  and  other  public  bodies  involved  in  the  pharmaceutical 
system  in  the  study  countries,  not  all  contacted  experts  have  responded  to 
invitations  to  review  country  fiches,  or  have  not  been  able  to  validate  all  the 
contents  in  the  country  fiches.  As  of  26  September  2022,  country  fiches  have  been 
fully validated for 19 countries (AT, BG, CH, CY, DE, DK, EE, FI, ES, FR, HR, IE, IT, LV, 
LT, MT, NO, PT, SK) and partly validated (i.e. information was reviewed in some sections 
only) for seven countries (BE, HU, IS, LU, RO, SI, SE). No validation was performed for 
six countries (CZ, EL, LI, NL, PL, UK). 14  Lack of validation for some countries is therefore 
acknowledged  as  a  limitation  of  this  study.  Where  no  validation  through  country 
experts was possible, only information deemed robust (e.g. information from published 
studies and reports, or from official sources such as reports by procurement bodies and 
other public bodies) was used. The country fiches are available in Annexes 4.1 – 4.32 
and are referred to as “PPM country fiches” as sources throughout the remainder of 
the report. 

2.4. Stakeholder consultation: workshops, interviews, online survey 

An important source of information for this study are stakeholder consultations which 
were conducted through four online workshops, interviews, and an online survey. These 
stakeholder  engagement  activities  serve  multiple  purposes,  including  collating 
different perspectives and views from relevant stakeholder groups on aspects of PPM, 
learning  about  different  country  examples  and  experiences,  and  informing  relevant 
stakeholder groups about the ongoing study, introducing some of the topics it analyses, 
and  obtain  feedback  on  specific  aspects.  Offering  several  stakeholder  engagement 
activities ensured that all stakeholder perspectives could be considered, even if not all 
stakeholders participated in all activities. 

Stakeholder consultation provides information to address all study questions, including 
questions relating to who conducts and is affected by PPM in the study countries (SO1: 
Stakeholder mapping), how PPM is organised and conducted in the study countries and 
what procedures are used to procure different types of medicines (SO2: Policy analysis), 
what  impacts  can  be  expected  from  optimising  PPM  (SO3:  Impact  analysis),  what 
barriers  and  best  practices  exist  (SO4:  Barriers  analysis  and  SO5:  Best  practices 

14 Even for countries, which were listed as “fully validated”, country experts could not validate and provide 

missing information to some questions and topics beyond their scope of expertise. 

8 

 
 
 
 
 
                                                 
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toolbox), and what specific aspects need to be considered in procurement of hospital 
medicines (SO6: PHIS Hospital Procurement Update).  

2.4.1. Workshops 

A total of four online workshops were held in February and March 2022. The first 
three  workshops  addressed  different  aspects  of  PPM  with  a  view  to  optimising 
procurement,  whereas  the  fourth  workshop  focused  on the  online  dashboard  built  by 
the study team: 

  Workshop 1: Optimising PPM to increase competition, availability, security of supply 

and “green” manufacturing (16 February 2022); 

  Workshop 2: Optimising PPM to ensure preparedness and handling of public health 

crises and emergencies and joint procurement practices (21 February 2022); 

  Workshop 3: Optimising PPM in the hospital setting (24 February 2022); 

  Workshop 4: An online dashboard on PPM in Europe (7 March 2022). 

All  workshops  were  held  virtually.  The 
invitation  policy  aimed  to  balance 
representation of all relevant stakeholder groups while providing all participants 
with a fair chance to interact and share their experience and perspective. Participation 
was possible upon invitation only, and the different stakeholders were contacted through 
their  network  or  group,  or  their  associations.  Table  1  provides  an  overview  of  the 
participation  rate  per  stakeholder  group  in  the  four  workshops.  The  group  of  public 
procurement  experts  was  underrepresented  compared  to  competent  authorities  for 
pharmaceutical pricing and reimbursement. In a few cases there were more participants 
than  originally  addressed  by  the  invitation  policy,  usually  with  prior  notice  and 
permission of the study team after consultation with the CA / EC. 

Table 1: Participation in the workshops on PPM 

Stakeholder group 

Workshop 1  Workshop 2  Workshop 3  Workshop 4 

MS: Public procurement 
MS: Competent authorities for PR, 
payers 
Social health insurance 
Patients a/o consumers 
Industry and wholesale 
Hospital / community pharmacy 
European Commission 
Contractor1 
Total 

10 
18 

4 
0 
5 
6 
10 
6 
59 

10 
18 

5 
1 
6 
3 
13 
8 
64 

7 
13 

1 
0 
10 
25 
5 
8 
702 

8 
9 

- 3 
- 3 
- 3 
- 3 
6 
7 
30 

Notes: PR = pricing and reimbursement (of medicines) 
1 Excluding procurement experts supporting the core study team (counted as part of the “MS: public 
procurement” group) 
2 One participant could not be identified to which group s/he belonged 
3 No participation from this stakeholder group planned for this workshop 

Source: Authors 

All four workshops followed a similar structure. After an introduction to the study and 
the aims of the workshop, two to three brief presentations in the plenary session were 
dedicated to the topic of the respective workshop. One presentation was given by the 
study team and further input and experience was provided by (procurement) experts 
(apart  from  the  fourth  workshop  where  only  the  study  team  gave  presentations). 
Following  the  plenary  presentations,  three  break-out  sessions  were  held  in  parallel. 
Break-out  sessions  were  moderated  by  procurement  experts  or  core  team  members 
according to a pre-defined set of questions tailored to the specific topic of the workshop. 
Participants were encouraged to draw on the experience from their countries, allowing 
the study team to gain insights into country-specific procurement processes and issues. 

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All  participants  discussed  the  same  questions,  independent  of  the  break-out  session 
they had  been  assigned to.  Key  points  discussed  during  the break-out  sessions  were 
reported back to the plenary where there was scope for additional discussions. During 
the  plenary  sessions,  interactive  polls  and  word  clouds  allowed  additional  input  from 
workshop  participants. Moderated  break-out  sessions and  interactive  elements  in  the 
plenary sessions allowed all participants to provide input.  

Further details on the organisation of the workshops and their findings are available in 
a dedicated summary report (Annex 5). 

2.4.2. Interviews 

Between  January  and  July  2022,  semi-structured  exploratory  interviews  were 
conducted  with  country  experts,  as  well  as  with  representatives  from  UNICEF,  the 
European Commission (DG SANTE) Expert Panel on effective ways of investing in health 
(EXPH), the (DG GROW) Commission Government Experts Group on Public Procurement 
(EXPP), Subgroup on Health Public Procurement (HPP), and the European association of 
research-based pharmaceutical companies (EFPIA).15 Interview partners were selected 
based  on  their  hands-on  experience  with  PPM  or  recent  work  related  to  the  subject. 
Interview partners were sent an outline of questions and topics to be addressed during 
the interview in advance. These outlines served as a guide for the interview but there 
was scope for deviating from the guide when necessary (e.g. to follow up on specific 
points or to prioritise specific areas). Interviews were conducted online by one member 
of the study team while a second member of team took notes. The notes were shared 
subsequently with the interview partner for review and approval. 

2.4.3. Stakeholder consultation: online survey 

Stakeholder input was further provided through an online survey that aimed to obtain 
the views of participants (broken down by stakeholder group) on how specific PPM 
practices and procedures impact on different policy objectives, including overall access 
to medicines.  

PPM  practices  and  procedures  assessed  in  the  survey  match  those  reviewed  in  the 
country  fiches  and  include  the  form  of  organisation  of  PPM  (e.g.  centralised,  facility-
based,  cross-country),  specific  procedures  as  described  in  EU  legislation  (open 
procedure,  restricted  procedure,  competitive  dialogue  with  or  without  negotiation), 
procurement  techniques  such  as  dynamic  purchasing  system  (DPS)  or  framework 
agreements, award criteria and processes, and supporting policies and tools. The policy 
objectives  being  assessed  include  those  immediately  related  to  access  to  medicines 
(affordability and availability), as well as additional policy focus areas of the study, i.e. 
security  of  supply,  crisis  preparedness,  competition,  and  the  environment.  The 
contribution  of  each  PPM  practice  or  procedure  to  a  specific  policy  objective  was 
assessed on a Likert scale or through a ranking exercise, allowing a quantification of its 
potential  to  affect  positive  outcomes,  and  relative  ranking  of  different  policy  options. 
Responses  were  weighted  by  representation  of  different  stakeholder  groups  in  the 
sample  (average  ranks  /  average  importance  /  average  contribution  to  a  policy 
objective). 

The full survey is shown in Annex 6. The survey was conducted via EUSurvey and a 
draft  survey  was  piloted  with  procurement  experts  (sub-contractors),  the  EC,  and 
colleagues  who  were  not  involved  in  the  study.  Annex  7  provides  further  details  on 
survey methodology, challenges encountered while conducting the survey, and results.  

15 Note that Medicines for Europe, the association of generic and biosimilar companies, participated in other 
stakeholder consultation activities (workshops and survey). 

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Invitations  to  participate  in  the  survey  were  shared  with  public  procurers, 
pharmaceutical  pricing  and  reimbursement  authorities,  regulatory  bodies,  social 
insurances  and  payer  organisations,  pharmaceutical  companies  and  wholesalers, 
hospital  and  community  pharmacists,  and  patient  and  consumer  organisations  (see 
Table 2). At the closure date of the survey, 58 responses had been submitted.  

Table 2: List of stakeholder groups invited to participate in the online survey 

Stakeholder group 

Public procurers 

National competent authorities 
for pricing and reimbursement 

National competition 
authorities 
Regulatory bodies 

Social insurance 

Patients and consumers 

Industry 

Wholesalers 

Hospital pharmacists 

Community pharmacists 

 

 
 

 

 

 

 

 

 

 

 

 
 

 

 
 
 

 

 

 

 

How invited 

Personal invitations sent to participants of four project workshops 
(PPM 1, PPM 2, Hospital procurement, Dashboard) 
Personal invitations sent to sub-contractors of the study 
Invitations sent via DG GROW to the Subgroup on Health Public 
Procurement of the EXPP and the health group of the Big Buyers 
network 
Invitations sent via the European Health Public Procurement 
Alliance (EHPPA) 
Personal invitations sent to participants of four project workshops 
(PPM 1, PPM 2, Hospital procurement, Dashboard) 
Invitations sent via the Network of competent authority / 
authorities for pricing and reimbursement of medicines (NCAPR) 
Invitations sent via DG COMP to the European Competition 
Network 
Invitations sent via the Heads of Medicines Agencies (HMA) 
network 
Personal invitations sent to participants of three project workshops 
(PPM 1, PPM 2, Hospital procurement) 
Invitations sent via the International association of mutual benefit 
societies (AIM) and the European Social Insurance Platform (ESIP) 
Personal invitations sent to participants of three project workshops 
(PPM 1, PPM 2, Hospital procurement) 
Invitations sent via European Patients’ Forum (EPF) 
Personal invitations sent to participants of three project workshops 
(PPM 1, PPM 2, Hospital procurement) 
Invitation sent to the European Federation of Pharmaceutical 
Industries and Associations (EFPIA) who declined to participate  
Invitations sent via Medicines for Europe 
Invitations sent via European Cluster Collaboration Platform 
Personal invitations sent to participants of three project workshops 
(PPM 1, PPM 2, Hospital procurement) 
Invitations sent via the European Healthcare Distribution 
Association (GIRP) 
Personal invitations sent to participants of three project workshops 
(PPM 1, PPM 2, Hospital procurement) 
Invitations sent via the European Association of Hospital 
Pharmacists (EAHP) 
Personal invitations sent to participants of three project workshops 
(PPM 1, PPM 2, Hospital procurement) 

Source: Authors 

Analysis  of  the  survey  results  was  adapted  according  to  the  number  of  responses 
available  for  each  question.  The  overall  number  of  58  responses  was  considered 
sufficient by the study team conduct quantitative analysis, including for obtaining valid 
results  for  subgroups  (individual  stakeholder  groups).  For  some  figures  and  tables 
stakeholder  groups  with  fewer  than  4  answers  were  not  represented.  Whenever 
respondents did not assess a specific question, the report highlights this.  

The  analyses  were  performed  in  a  descriptive  and,  to  the  extent  possible, 
quantitative  way  (counts  of  answers,  counts  of  ranks,  average  ratings,  average 
points, average importance / inversed rankings). Qualitative rankings performed by the 
respondents  on  Likert  scales  were  transformed  into  figures  (e.g.  assessments  of  the 
contribution  of  a  given  policy  ranging  from  “fully  contributing”  to  “a  barrier”  were 
translated  into  numbers ranging  from  2  to  -2)  to  allow  the  calculation  of  an average 
point indicator (see Annex 7 for details). 

11 

 
 
 
 
 
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2.5. Data analysis 

Analysis of quantitative data is used to better understand what procurement practices 
are  applied  in  the  study  countries  (SO2:  Policy  analysis),  including  for  biosimilar 
medicines  and  in  hospital  settings  (SO6:  PHIS  Hospital  update),  what  the  potential 
impacts  of  PPM  practices  are  on  savings  and  other  policy  objectives  (SO3:  Impact 
analysis), and what best practices are for optimising PPM (SO5: Best practices toolbox). 

Data  sets  analysed  include  procurement-specific  data  on  contract  notices  and 
contract award notices for publicly procured medicines from EU MS, EEA countries, and 
Switzerland  which  are  submitted  to  the  Tenders  Electronic  Daily  (TED)  portal  by 
participating  countries  [144],  and  data  on  pharmaceutical  sales,  as  collected  by 
IQVIA  [145].  Methods  for  preparing  these  two  data  sets  for  analysis  and  challenges 
encountered  are  described  in  Chapters  2.5.1  and  2.5.2,  while  Chapter  2.5.3 
describes  how  the  analysis  of  the  impact  of  PPM  on  different  policy  objectives  was 
conceptualised. For the latter, data from the survey were also used, adding a third data 
set to the list of sources contributing to address SO3 (Impact analysis). 

2.5.1. TED data 

TED is the online version of the “Supplement to the Official Journal” of the EU, dedicated 
to public procurement procedures that are subject to European public procurement rules 
[144]. An invitation to tender must be published in the Supplement – and is therefore 
included in the TED database – for contracts with values above EUR 144,000 (for central 
government authorities) or above EUR 221,000 (for sub-central contracting authorities) 
[68].  On  its  website,  TED  publishes  up  to  676,000  contract  award  notices  per  year, 
including 258,000 contract notices which are worth approximately EUR 670 billion. TED 
data sets are divided in three groups16: 

  Calls for Competition (CFC):17 This data set contains contract notices (invitations 
to  tender)  from  2006  up  to  2020  and  has  more  than  6  million  rows.  It  includes 
information  about  the  contracting  authority,  the  subject  of  the  tender  (see 
description of the vocabulary of products used below), what procedure is being used 
and details on the procurement process, such as the use of different award criteria. 
Procedures  as  per  EU  Directive  2014/24  include  open  procedures,  restricted 
procedures,  competitive  procedures  with  negotiation,  competitive  dialogues, 
innovation partnerships, and negotiated procedure without prior publication. These 
procedures are described in the study glossary (Annex 3). 

  Contract Award Notices (CAN): The data set of contract awards electronic notices 
contains data from 2006 up to 2020 and has  approximately 8.5 million rows with 
information about awarded contracts. 

  Voluntary  ex  ante  transparency  (VEAT):  This  comparatively  small  data  set 
(around 175,000 rows) contains notices about contracts with low value that can be 
awarded  without  publishing  an  open  contract  notice.  Procurers  can  voluntarily 
publish these notices but are not obliged to do so. The data set is therefore unlikely 
to be representative of lower-value procurements and has been excluded from the 
analysis. 

16 

TED 

data 

at 
https://data.europa.eu/data/datasets/ted-csv?locale=en  and  the  individual  electronic  notices  in  XML 
format are available via FTP at ted.europa.eu (user: guest, password: guest). 

download 

available 

format 

online 

(text) 

CSV 

sets 

are 

to 

in 

17 The dataset is labelled “Contract Notices” (abbreviated CN) on the TED website. In this report, it is referred 
to as “Calls for Competition” (abbreviated CFC) to avoid confusion with the first dataset (Contact Award 
Notices, or CAN). 

12 

 
 
 
 
 
                                                 
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TED  data  set  records  are  tagged  with  codes  according  to  the  Common  Procurement 
Vocabulary (CPV) which establishes a single classification system for public procurement 
aimed  at  standardising the  references  used  by  contracting  authorities  and  entities  to 
describe the subject of procurement contracts.18 Relevant CPV codes from the group of 
pharmaceutical products were identified and used to retrieve PPM procedures from two 
of the three data sets mentioned above: Contract Award Notices (CAN) and Calls 
for Competition (CFC). The list of CPV procurement codes and further details on the 
process of cleaning and preparing TED data for analysis are provided in Annex 8. 

2.5.1.1.  Use of TED data in the study 

Through  descriptive  analysis,  TED  data  were  used  to  gain  insights  on  how 
procurement is done in the study countries. A list of key performance indicators for 
procurement were used to compare procurement practices across countries as well as 
across different types of medicines (see Table 3). Indicators  were selected to  obtain 
insights into different aspects  of procurement,  including obtaining an overview  of the 
volume of public procurement of medicines, which procedures are used and by whom, 
what  offers  are  submitted,  and  how  contracts  are  awarded.  Selected  indicators  from 
Table 3 are presented in the results chapters of this report. All indicators are available 
in the online dashboard.  

In addition to mapping procurement practices, TED data were combined with IQVIA 
data to allow assessments of the relationship between procurement practices used in a 
country  (and  for  a  given  type  of  product)  and  policy-relevant  outcomes,  such  as 
affordability and availability of medicines (see Chapter 2.5.3). 

Table 3: List of indicators for TED data 

Indicator 
group 

Overall 

Awards/calls 

Analysis of 
procedures/ 
calls 

Shares per 
types of 
procedures 

Procedures by 
type of call(er) 

Procedures by 
type of criterion 

Analysis of 
offers 

Offers 

Indicator 

Number of contract awards 
% of contract notices resulting in contract awards (% of 
contracts awarded) 
% of contracts with general CPV code (33600000) 
without any specification 
Number of contract awards 
Share of procedure for contract notice (procedures: 
accelerated open procedure, accelerated restricted 
procedure, competitive dialogue, contest, design 
contest, innovation partnership, negotiated procedure 
with contract notice, competitive procedure with 
negotiations, open procedure, restricted) 
% of tender received electronically of all tenders 
received 
% of cancelled procedures 
% of corrected procedures 
% of main activity of procuring body 
% of procedures involving joint procurement 
Average number of awards per call planned 
% of procedures involving central procurement bodies 
% of type of contract in the call 
% of procedures under a framework agreement 
% of contracts divided into lots 
% of procedures awarded by lowest price (i.e. price 
being the sole attribution criterion)  
% of procedures awarded through other criteria in 
addition to price 
Number of offers received per call 
Sub-indicator: % of contracts for which there was a 
single bid (excluding frameworks) 
% of electronical offers 

Source 

CFC 
CFC 

CAN/CFC 

CAN 
CFC 

CFC 

CFC 
CFC 
CFC 
CFC 
CFC 
CFC 
CFC 
CFC 
CFC 
CFC 

CFC 

CAN/CFC 

CAN/CFC 

CAN 

18 

CPV 

codes 

are 

listed 

in 

EC 

Regulation 

213/2008: 

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008R0213 

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Study on Best Practices in the Public Procurement of Medicines – 
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Indicator 
group 

Indicator 

Source 

Analysis of 
contracts 

Contracts per 
type of industry 

% of calls with no offer 
Average number of offers per call 
% of contracts awarded to non-EU-based companies  
% of contracts awarded to EU-based companies 
% of contracts awarded to SMEs 

Contract value 

Average value per contract/lot 

CFC 
CFC 
CAN 
CAN 
CAN 

CAN 

Source: Authors. 

2.5.1.2.  Challenges in working with TED data 

Through its mandate (publication of procedures subject to European public procurement 
rules),  TED  represent  the  most  comprehensive  publicly  available  data  set  on  public 
procurement in Europe. Nevertheless, some challenges were encountered in working 
with TED data, resulting in possible limitations to the inferences drawn from the analyses 
conducted, as described below. 

Firstly, only procurements above the threshold value are required to be reported 
in the TED database. Lower value procurements are therefore likely to be missing, an 
issue that might be more relevant for smaller countries compared to larger countries, 
and  for  countries  where  procurement  is  conducted  decentralised  for  relatively  small 
volumes.  Due  to  lack  of  data  on  procedures  below  the  threshold,  the  extent  of  this 
limitation is unclear. However, the study did not solely rely on TED data; the analysis 
was complemented by collecting qualitative information on procurement practices in the 
study countries. 

Secondly, TED data entries do not always provide sufficient details on specific types of 
medicines to be procured: 35% of procedures were labelled with the generic code for 
pharmaceutical products (without further details on the types of medicines procured), 
while for the remaining procedures, most (73%) used codes equivalent to Anatomical 
Therapy  Class  (ATC)-1  level  (representing  14  main  anatomical  or  pharmacological 
groups).  Less  than  5%  used  codes  equivalent  to  ATC-3  level  or  a  more  granular 
classification that allows inference about the chemical, pharmacological or therapeutic 
subgroup or even individual product to be procured. The lack of granular information 
presents a limitation, even if some procedures relating to a product of interest can be 
identified  (other  procedures  with  that  same  product  are  likely  to  be  “hidden”  in  a 
procedure with the code for general pharmaceutical products). In addition, analyses of 
the relationship between PPM practices and outcomes are limited to an aggregate (i.e. 
non-product-specific) level, with scope for confounding. 

Finally,  exploratory  analyses  identified  some  possible  errors  in  the  data,  including 
issues with the reliability of contract values (see Annex 8). To the extent possible, 
data  were  validated,  and  non-validated  data  were  excluded  from  the  analyses.  Upon 
further  exploration  of  the  contract  values  (including  consultation  with  experts  at  DG 
GROW who extensively use this data set), the study team decided not to use contract 
values as proxies for prices of publicly procured products due to two reasons: firstly, 
contract award values entered into TED may not be accurate, as revealed by data checks 
described  in  Annex  8;  secondly, tenders  often  include  different products  (resulting in 
the  use  of  a  generic  code  for  “pharmaceutical  products”  without  further  details,  as 
described above) and contract values and product volumes are not available separately 
for the various products included. This precludes the use of TED data for analysis of unit 
prices for medicines. 

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2.5.2. IQVIA data 

In addition to publicly available data on public procurement of medicines obtained from 
TED, the study analyses IQVIA MIDAS sales data that were provided by the EC to the 
study team through a project-specific arrangement. 

The IQVIA MIDAS data set compiles sales data in a standardised and comparable 
way, including cross-country analysis of performance for most of the study countries 
(excludes Cyprus, Iceland, Liechtenstein, Malta, see Table 4). The metrics include:  

  Geographic information and where a product is used: region, country, sector 

  Manufacturer details: corporation, manufacturer 

  Product categorisation: ATC level 2,3 and 4 

  Product information on molecule(s), salt, route of administration (New Form Code 

(NFC) 123, an international classification developed by the European 
Pharmaceutical Market Research Association, EphRMA) 

  Product information on international prescription status 

  Product information on whether patent has expired (Generic Product Classification)  

Data measures in IQVIA MIDAS include: 

  Sales (USD, EUR, fixed and variable exchange rates) 

  Volume (kilogram / international units / Standard Units) 

It should be noted that prices included in the IQVIA data set correspond to list prices 
and do not represent real (net) prices. Lack of availability of real (net) price data is 
an issue commonly encountered in pharmaceutical policy research. However, there is 
uncertainty about the source of price data included in the IQVIA data set: prices may 
not reflect list price as published in the official price data sources but instead have been 
calculated based on sales and volume data, which may not be fully representative if not 
all  distribution  channels  in  a  country  are  surveyed).  IQVIA  price  data  are  therefore 
labelled “price proxies” or “proxy unit prices” in this study. 

Table 4: IQVIA data - coverage of study countries 

COUNTRY 
AUSTRIA 
BELGIUM 
BULGARIA 
CROATIA 
CYPRUS 
CZECH  
DENMARK 
ESTONIA 
FINLAND 
FRANCE 
GERMANY 
GREECE 
HUNGARY 
ICELAND 
IRELAND 
ITALY 
LATVIA 
LIECHTENSTEIN 
LITHUANIA 
LUXEMBOURG 
MALTA 
NETHERLANDS 
NORWAY 
POLAND 
PORTUGAL 
ROMANIA 
SLOVAKIA 
SLOVENIA 
SPAIN 

Hospital sector covered 
YES 
YES 
YES 
YES 
NO 
YES 
NO 
NO 
YES 
YES 
YES 
NO 
YES 
NO 
YES 
YES 
NO 
NO 
YES 
NO 
NO 
YES 
YES 
YES 
YES 
YES 
YES 
NO 
YES 

Retail sector covered 
YES 
YES 
YES 
YES 
NO 
YES 
YES 
YES 
YES 
YES 
YES 
YES 
YES 
NO 
YES 
YES 
YES 
NO 
YES 
YES 
NO 
YES 
YES 
YES 
YES 
YES 
YES 
YES 
YES 

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COUNTRY 
SWEDEN 
SWITZERLAND 
UK 

Hospital sector covered 
YES 
YES 
YES 

Retail sector covered 
YES 
YES 
YES 

Source: Authors based on IQVIA meta data information 

2.5.2.1.  Use of IQVIA data in the study 

IQVIA data were analysed descriptively to obtain information on pharmaceutical sales 
volumes  in  the  study  countries.  This  contributes  to  the  policy  analysis,  as  well  as 
addressing specific questions related to procurement of different types of products, e.g. 
medicines used in hospitals or biosimilars. In addition to the descriptive analysis, IQVIA 
data are combined with TED data to answer questions about the relationship between 
PPM practices and availability and affordability of medicines (see Chapter 2.5.3). 

Table  5  provides  a  list  of  indicators  based  on  IQVIA  data.  Selected  indicators  are 
presented in the report. All indicators can be assessed for each country in the data set, 
and for each group of products, in the online dashboard.  

Table 5: List of indicators for IQVIA data 

Indicator group 

Pharmaceutical sales  Market 

Type of product 

Prices 

Average proxy 
unit prices 

Indicator 

% of sales in the hospital vs. retail market 
% of sales that are prescription medicines vs. non-
prescription products 
% of sales that are originator products 
% of sales that are generic products 
% of sales that are biosimilar products 
Average yearly proxy unit price in EUR across all products 
Average yearly proxy unit price in EUR for originator 
products 
Average yearly proxy unit price in EUR for generic products 
Average yearly proxy unit price in EUR for biosimilar 
products 

Note: The data source used for all indicators in this table are IQVIA MIDAS sales data [145] 

Source: Authors 

2.5.3. Impact analysis 

As stated in the EU Pharmaceutical Strategy for  Europe [1], PPM is seen as a tool to 
improve access to medicines. Furthermore, PPM may also contribute to other national 
policy objectives. The study therefore aimed to assess the potential impacts of PPM 
on different policy objectives (SO3: Impact analysis). 

Firstly, the relationship between PPM practices and overall access to medicines was 
assessed.  Access  to  medicines  is  defined  as  the  patient’s  ability  to  obtain  medicines 
[142]. To operationalise this complex concept consisting of multiple domains, access to 
medicines  is  typically  broken  down  into  two  core  components  that  are  rooted  in  the 
human  right  to  health  approach  and  reflected  in  the  United  Nations  Sustainable 
Development Goals [146-148]: availability (i.e. whether a medicine is within reach of a 
patient; this is also linked to security of supply, as lack of and/or gaps in the availability 
of  medicines  may  be  due  to  problems  in  the  supply  chain)  and  affordability  (i.e.  the 
extent to which medicines are available to the people who need them at a price they / 
their health system can pay). 

Secondly, the potential impact of different PPM practices (such as forms of organisation, 
use of different PPM procedures and techniques) on six specific policy objectives was 
assessed19: 

  Availability of medicines 

19 Indicators for these policy objectives are described below in Table 7. 

16 

 
 
 
 
 
                                                 
Study on Best Practices in the Public Procurement of Medicines – 
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  Affordability of medicines 

  Competition in the market 

  Security of supply of medicines 

  Environmental protection 

  Crisis preparedness 

Following the triangulation approach (see Chapter 2.1), a mix of methods was applied 
to assess potential impacts of PPM. This includes quantitative analysis of procurement 
(TED)  and  sales  (IQVIA)  data,  which  is  described  in  detail  below.  In  addition,  data 
collected  through  the  stakeholder  survey  (stakeholders  assess  whether  in  their 
opinion and experience policies contribute to the six policy objectives, for details on the 
methodology  see  Chapter  2.4.3),  evidence  from  published  literature  (Chapter 
2.2), and qualitative data from stakeholder workshops and interviews (Chapters 
2.4.1 and 2.4.2) were analysed. 

2.5.3.1.  Outline of analytical approach 

For each policy objective, the analysis compares how countries applying specific PPM 
practices  (PPM  organisation,  processes,  and  award  criteria)  fare  compared  to 
countries  that  do  not  apply  that  practice.  In  addition,  a  composite  indicator  for  the 
maturity  (degree)  of  PPM  in  a  country  was  constructed.  The  degree  of  PPM  was 
calculated as the sum of sub-indicators for the use of PPM at centralised national level, 
centralised  regional  level,  group  level,  or  facility  level,  the  application  of  a  variety  of 
procedures and techniques, the application of MEAT criteria, and the use of a range of 
PPM supporting policies (for details see Table 6). 

PPM practices were divided into three main domains: organisation of PPM (i.e. what 
is  the  institutional  set-up  of  PPM  in  a  country?),  PPM  processes  (i.e.  what  types  of 
procedures and techniques are used in a country?), and award criteria (i.e. how are 
contracts  awarded?).  Indicators  for  the  PPM  domains  are  listed  in  Table  6.  The 
indicators were drawn from different sources, including TED and IQVIA data sets and 
the PPM country fiches. 

The analysis was conducted at the aggregate level rather than a country-specific 
level  (i.e.  countries  were  grouped  according  to  the  policies  applied).  This  allowed 
identification of possible relationships between PPM practices and outcomes independent 
of the specific country context, providing an opportunity to draw out learnings that can 
be applied to other countries. For analyses using maturity (degree) of PPM, countries 
were grouped into high, moderate, and low degree of PPM based on the distribution of 
scores across the study countries. The list of study countries, their PPM degree ranking 
and assigned group are provided in Annex 9.  

Table 6: List of indicators of PPM practices 

PPM domain 
Organisation of 
PPM 
PPM processes 

Award criteria 

Degree of PPM 

Indicator 

% of procedures awarded by central purchasing body 
% of procedures involving joint procurement 
% of procedures as open tenders 
% of procedures under framework agreements 
% of procedures using electronic auctions 
Frequent vs. no / low use of dynamic purchasing system 
(DPS) 
% of procedures using MEAT 
Frequent vs. no / low use of security of supply criteria 
Frequent vs. no / low use of environmental criteria 
Composite indicator of degree of PPM in a country. Sum of the 
following sub-indicators: 
  Use of different organisational forms of PPM for inpatient 

and outpatient sector (1-4 points for use of facility-based, 
group procurement, centralised procurement at regional 

Source 

TED 
TED 
TED 
TED 
TED 
PPM country fiches 

TED 
PPM country fiches 
PPM country fiches 
PPM country fiches 

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PPM domain 

Indicator 

Source 

level, and at national level, respectively; weighted 
(multiplied) by the use of these organisational forms for 
one sector only or both sectors; standardised according to 
whether only one or several of the organisational forms 
were applied in the country) 

  Use of a variety of PPM practices, including the different 

procedures specified in the EU public procurement 
Directive, PPM techniques including framework 
agreements, DPS, and multi- and single-winner awards (1 
point awarded for each applied practice; weighted by 
their use in one or both sectors; standardised according 
to the maximum number of points available) 

  Use of MEAT criteria (points awarded for use in one or 

both sectors; standardised with a factor of 1:7 based on 
the total the number of potentially applicable award 
criteria as assessed in the PPM country fiches) 
  Use of PPM supporting policies (points awarded for 
systematic or irregular use of each of a range of 22 
different supporting policies, such as market research, 
horizon scanning, HTA, logistics management, MEA, 
engagement with suppliers, users of PPM, and patients; 
standardised by the maximum number of points 
available) 

Source: Authors 

Outcomes for the six policy objectives and for overall access to medicines were 
assessed  using  selected  outcome  indicators  (see  Table  7).  For  access  to  medicines, 
indicators  at the  country  level  were  selected  which  do  not  take  therapeutic  area  into 
consideration.  These  are  intended  to  be  indicators  at  the  meta-level,  representing 
overall  access  to  medicines  in  a  country.  Overall affordability is measured  through 
the share of public health expenditure that is spent on pharmaceuticals. This measure 
focuses  on  affordability  of  medicines  for  the  health  system  while  taking  into  account 
varying  levels  of  public  spending  on  health  (note  that  this  measure  does  not  include 
other aspects that may include affordability to individual patients, such as out-of-pocket 
payments). Overall availability is measured as the share of newly approved medicines 
that are included in a country’s reimbursement list and are therefore in theory routinely 
available to patients (note that patients may still face hurdles in accessing reimbursed 
medicines, e.g. through co-payments). A separate aspect of availability – the time until 
newly  approved  medicines  are  available  in  a  country  –  was  not  included  as  separate 
measure. A robustness check showed similar results when comparing the rankings of 
PPM characteristics of the study countries and their rankings by availability of medicines 
or time to availability. 

For each of the six policy objectives, indicators were selected after review of existing 
indicators and availability of data in the TED and IQVIA data sets as well as other publicly 
available data sets (e.g. OCED, Eurostat). Differently from the analysis of overall access 
to  medicines,  these  indicators  were  analysed  for  different  groups  of  medicines  (at 
WHO  ATC-2  level)  in  order  to  account  for  possible  differences  in  the  impact  of  PPM 
practices according to therapeutic area and product type (see below for details on the 
groups of medicines). The availability of medicines within each group was assessed 
through  the  number  of  individual  products  (molecules,  as  indicated  by  WHO  ATC-5 
codes) used in a country. This indicator therefore measures whether countries are able 
to  access  all  available  medicines  in  a  therapeutic  area.  Affordability  is  measured 
through the average approximated unit price for a product in the group of medicines. 
While  this  proxy  is  not  meaningful  for  any  specific  product,  the  average  across  all 
products indicates price levels and therefore affordability across countries. Competition 
in  the  market  was  measured  as  the  average  number  of  offers  for  procurement 
procedures conducted for products in that group of medicines. This indicator assesses 
the  extent  to  which  suppliers  compete  for  contracts  in  a  given  therapeutic  area.  For 
security  of  supply,  the  selected  indicator  (share  of  products  within  a  group  of 
medicines for which sales data have been recorded throughout the study period) aims 

18 

 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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to identify any shortages during the study period. Medicines shortages are notoriously 
difficult  to  assess  and  compare  across  countries  [149].  Therefore,  an  indicator  that 
would  approximate  whether  individual  products  are  sold  throughout  a  given  period, 
without  necessarily  indicating  a  shortage  (products  may  also  be  discontinued  in  a 
country)  was  used.  No  suitable  indicators  could  be  identified  for  the  domains  of 
environment and crisis preparedness. Potential impacts of PPM practices on these 
two policy objectives were therefore only assessed through the online survey. 

Table 7: Outcomes indicators for six policy areas 

Policy area 
Access to medicines 

Indicator 
  Affordability of medicines: Share of public health 

expenditure spent on pharmaceuticals 

Source 
  Eurostat [150] 
  EFPIA Patients 

  Availability of medicines: Share of new medicines 

W.A.I.T. Survey [151] 

Availability of 
medicines 
Affordability of 
medicines 
Competition in the 
market 
Security of supply of 
medicines 
Environment 

Crisis preparedness 

approved by the EMA from 2017-2020 and 
included in a country's reimbursement list 

Number of different WHO ATC-5 codes per 
therapeutic area 
Average proxy unit price 

IQVIA MIDAS [145] 

IQVIA MIDAS [145] 

Average number of offers per procedure 

TED [144] 

Share of pharmaceuticals with sales data throughout 
study period (2008-2021)  
No indicators for quantitative analysis; impact was 
assessed through stakeholder survey (see Chapter 
2.4.3 and Annex 7) 
No indicators for quantitative analysis; impact was 
assessed through stakeholder survey (see Chapter 
2.4.3 and Annex 7) 

IQVIA MIDAS [145] 

- 

- 

Source: Authors 

2.5.3.2.  Grouping of medicines for analysis 

Due  to  discrepancies  in  the  underlying  classification  systems  used  to  categorise 
medicines  in  the  TED  and  IQVIA  data  sets,20  a  new,  common  categorisation  was 
developed that allows the two data sets to be matched. The new classification consists 
of eleven main categories of medicines (see Table 8). Some of these categories (or 
sub-categories)  were  selected  for  further  analysis,  as  described  below;  all  categories 
are available in the online dashboard. 

Grouping  of  medicines  was  primarily  based  on  “classes”  used  in  the  pharmaceutical 
products  group of the  CPV  categorisation.21  These  classes  (identified  by the  first  four 
digits of the CPV code) largely correspond to WHO ATC-1 levels, i.e. they are grouped 
by  the  anatomical  system  which  the  medicines  are  used  for.  However,  CPV  classes 
merge some of the ATC-1 levels (e.g. ATC-1 levels B and C  fall under the same CPV 
class). These mergers were reviewed and, where a split of CPV classes into several 
smaller  groupings  was  deemed  of  value  for  assessing  public  procurement  of 
medicines, new groupings were created.22 An “unspecified” group was required to reflect 
the  large  number  of  notices  in  the  TED  database  with  a  generic  “pharmaceutical 
products”  coding.  Given  the  lack  of  information  about  what  products  these  notices 
concerned, no further analysis was conducted for this group. Annex 10 provides details 

20  TED  uses  the  Common  Procurement  Vocabulary  (CPV)  listed  in  EC  Regulation  213/2008  (https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008R0213),  while  IQVIA  uses  an  ATC  categorisation 
developed by EphRMA. 

21 See EC Regulation 213/2008: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008R0213  
22 This was the case for CPV class 3365, which included general anti-infectives for systemic use, vaccines, 
antineoplastic  and  immunomodulating  agents.  For  the  purpose  of  assessing  public  procurement,  having 
three separate groupings for anti-infectives, vaccines, and antineoplastic and immunomodulating agents 
was  deemed  more  valuable,  since  procurement  would  typically  be  conducted  for  agents  within  each  of 
these  groupings  individually  (e.g.  vaccine  procurement  is  often  done  at  a  centralised  level,  whereas 
procurement of potentially high-cost antineoplastic immunomodulating agents may be of particular interest 
to hospitals). 

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on specific CPV and WHO ATC codes summarised under the main groups of medicines 
shown in Table 8. 

As elaborated in the product life cycle approach to procurement employed by the 
Danish CPB for hospitals, Amgros, different PPM procedures and techniques may be best 
suited  to  different  types  of  products  [152].  For  analysis  of  possible  impacts  of  PPM 
practices, groups of medicines representing different stages of the product life 
cycle, as well as vaccines (which are often subject to different procurement routes than 
other products), were selected. For each of the stages, a “tracer” group or subgroup 
of medicines was selected and the analysis of the relationship between PPM practices 
and outcomes  was assessed  for  each tracer  group.  Due  to  limited granularity of  TED 
data  (as  described  in  Chapter  2.5.1.2),  these  tracer  groups  were  restricted  to  the 
aggregate  levels  of  WHO  ATC-1  or  ATC-2  level  equivalents,  rather  than  representing 
individual products. Types of medicines according to their product life cycle stage and 
their selected tracer groups are described below:  

  On-patent products: Over the past 5 years (2017-2021), antineoplastic agents 

(WHO ATC code L01) represented more than 20% of all new marketing 
authorisations for new drugs granted by the European Medicines Agency (EMA) 
[153]. This constitutes by far the largest category of new medicines and 
antineoplastic agents were therefore selected as tracer group for on-patent 
medicines. Only non-generic products from this group were included in the 
analysis. 

  Products with analogue competition: A therapeutic area with previously high 
unmet need and a number of new treatment options emerging over the past two 
decades is Hepatitis C. Procurers may build on the analogue competition between 
different antivirals for systemic use (WHO ATC code J05), as is done by Amgros in 
its procurement of hospital medicines for Danish hospitals [154].   

  Generic products: Antithrombotic agents (WHO ATC code B01) constitute the 

group with the highest number of generics approved by the EMA behind 
antineoplastic agents [153]. Since the latter have already been selected as tracer 
group for on-patent products, antithrombotic agents were selected for generic 
products. Only generic products from this group were included in the analysis. 

  Biosimilar products: Biological products with competitors (biosimilars) are most 
commonly found for antineoplastic and immunomodulating agents (accounting for 
more than two-thirds of all EMA-authorised biosimilars [153]). From that group, 
immunosuppressants (WHO ATC code L04) were selected as tracer group since the 
other group with a similarly high share of biosimilars (antineoplastic agents (L01)) 
was already selected to represent on-patent products. Only biosimilar products 
from this group were included in the analysis. 

  Vaccines: All vaccines are grouped in the same main category. Analysis of 

vaccines was deemed relevant because these products are often procured 
separately from other medicines, e.g. through ministries of health or other CPBs 
for use in national immunisation programmes. 

20 

 
 
 
 
 
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Table 8: Main categories of medicines for analysis 

Group no. 
1 
2 
3 

Main group of medicines 

Unspecified 
Alimentary tract and metabolism 
Blood, blood-forming organs and 
cardiovascular system 

4 

5 
6 

7 
8 

Dermatology and musculo-skeletal 
system 
Genitourinary system and hormones 
General anti-infectives 

Vaccines 
Antineoplastic and immunomodulating 
agents 

Use for impact analysis 

No 
No 
Antithrombotic agents (a subgroup of group 3) 
were selected to represent generic products (only 
generic products were included in the analysis) 
No 

No 
Antivirals for systemic use (subgroup of group 6) 
were selected to represent products with 
analogue competition 
Used for analysis on vaccines 
 Antineoplastic agents (subgroup of group 8) 

were selected to represent on-patent products 
(only non-generic products were included in the 
analysis) 

 Immunosuppressive agents (subgroup of group 

8) were selected to represent biosimilar 
medicines (only biosimilar medicines were 
included in the analysis) 

9 
10 
11 

Nervous system and sensory organs 
Respiratory system 
Various medicinal products 

No 
No 
No 

Source: Authors 

Descriptive analyses of procurement and pharmaceutical sales data were performed. 
For access to medicines indicators, rankings of countries by degree of PPM on the one 
side  and  indicators  for  affordability  and  availability  on  the  other  were  compared.  For 
other domains, countries were grouped according to the PPM practices of interest or the 
overall  degree  of  PPM  and  average  values  within  each  group  were  calculated  for  the 
outcome of interest. No tests for statistical significance were  conducted. The analysis 
did  not control  for  any  other  variables  than  the PPM  practice  being  assessed.  Due  to 
these limitations, quantitative analysis was complemented by evidence obtained from 
the  literature  as  well  as  from  stakeholder  consultations.  Accordingly,  no  claims  of 
causality can be made with respect to the impact of PPM practices. 

The  raw  but  cleaned  IQVIA  and  TED  data  are  also  available  in  the  study’s  online 
dashboard (see Chapter 2.6). Indicators on procurement procedures, sales volumes, 
and price proxies were defined by the study team to provide snapshots of PPM and the 
pharmaceutical market in the study countries for which data are available.   

2.5.3.3.  Limitations of the impact analysis 

Some limitations in the analysis of potential impacts of PPM should be acknowledged. 

Firstly, challenges with measuring access to medicines are well-known, and there 
are research projects dedicated solely to the purpose of defining adequate indicators23. 
Besides technical issues with identifying and consistently measuring specific indicators, 
a key challenge is the need to view access to medicines in the context of complex health 
systems,  resulting  in  access  being  subject  to  barriers  at  the  individual  (household), 
regional,  national,  and  international  levels  [155].  Similar  considerations  apply  to  the 
other policy objectives assessed in this study. The study team decided to focus on a 
small  number  of  indicators  for  the  core  policy  objectives  of  interest  to  allow  a 
meaningful analysis (acknowledging the constraints of what was measured), rather than 
assessing a broad array of indicators that would be difficult to interpret. The selected 

23  E.g. 

the  Access 

to  Medicine 

Index  created  by 

the  Access 

to  Medicine  Foundation: 

https://accesstomedicinefoundation.org/    

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indicators are readily available or constructible based on data already held by the study 
team. 

Secondly,  there  is  no  clear  causal  pathway  leading  from  PPM  practices  (i.e. 
exposures)  to  the  different  policy  objectives  (i.e.  outcomes)  that  is  free  of  potential 
confounders. For example, availability of medicines in a given country may be partially 
impacted  by  procurement  practices  as  well  as  a  multitude  of  other  factors,  including 
medical  needs  of  the  population,  medical  practices,  marketing  strategies  of 
manufacturers, institutional set-up for reimbursement and pricing, and ability to pay for 
medicines, among others. Any analysis is therefore limited to establishing associations 
between PPM practices and outcomes. While such analysis can produce essential insights 
for policy making, it is important to acknowledge that PPM practices need to be seen 
in  the  context  of  other  policies  as  well  as  structural  factors  in  place  in  the  study 
countries. A health systems perspective was therefore applied in this study [155], 
which  was  implemented  by  including  information  on  the  pharmaceutical  pricing  and 
reimbursement  system  in  the  assessment  of  PPM  systems  in  the  study  countries. 
Nevertheless, the nuances of this information cannot be represented in the quantitative 
assessment of potential impacts of PPM. 

Thirdly,  and  related  to  the  confounding  issue  mentioned  above,  due  to  limited 
granularity in the information contained in TED files (see Chapter 2.5.1.2), the analysis 
is limited to the aggregate level, (i.e. main groups of medicines as shown in Table 8), 
rather  than  conducted  at  product  level.  The  analysis  at  aggregate  level  itself  is  a 
mitigation measure to address the issue of limited ability to match IQVIA and TED data 
at the product level. 

2.6. Development of an online dashboard 

Data  collected  using  the  methods  described  in  Chapters  2.2-2.5  are  visualised  and 
prepared for analysis in the study’s online dashboard.  

The  dashboard  was  used  in  the  study  as  a  tool  to  visualise  and  analyse  data,  in 
particular  quantitative  data  on  procurement  and  sales  of  medicines  (TED  and  IQVIA 
data). Beyond its function as an analytical tool, the dashboard is also used to present 
findings  from  the  study,  including  results  from  the  policy  analysis  and  analysis  of 
possible impacts of PPM and thereby acts as a dissemination tool. Core components 
of the dashboard are listed in Table 9. 

Table 9: Components of the online dashboard 

Dashboard page 
Policy mapping 

Contents 
  Mapping of PPM organisational set-up, practices, award criteria, and 

Country information 
Indicators 

 
 
 
 

 

supporting policies in the study countries 
Brief written summaries of the PPM system in the study countries 
Indicators on PPM practices (TED data) 
Indicators on medicines sales and price proxies (IQVIA data) 
Indicators on relationship of PPM practices with availability, 
affordability, competition, and security of supply 
Key results from the online stakeholder survey on potential impacts of 
PPM  

PPM glossary 
Downloads 

  Online version of the study’s glossary of procurement-related terms 
 

List of files for download 

Source: Authors 

The dashboard was implemented in Power BI due to its primary use as a data analysis 
tool. Power BI allows handling of large data sets in an online environment. It includes 
an array of customisable presentation options for data, such as maps and various charts, 
with options for the user to further customise these using filters and drill-down menus. 

22 

 
 
 
 
 
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Development of the dashboard was initially informed by the needs of the study team. 
However, stakeholders who may utilise the dashboard to inform procurement decisions 
and pharmaceutical policy making were invited to provide feedback on a draft version 
of the dashboard in March 2022 (see Chapter 2.4.1 and Annex 7). In a dedicated online 
workshop,  representatives  from  procurement  bodies  and  authorities  responsible  for 
pharmaceutical  pricing  and  reimbursement  in  the  study  countries,  as  well  as 
representatives from the EC, were briefed on the development of the dashboard and its 
current and planned functions, and were invited to provide feedback to take into account 
for further development. 

Note that access rules to the dashboard have not yet been defined. The dashboard will 
be submitted as a project deliverable to the CA / EC who will then decide on its future 
use. 

23 

 
 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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3.  POLICY ANALYSIS IN THE STUDY COUNTRIES 

3.1. Stakeholder mapping 

The first  specific objective  of the study was to  map relevant stakeholders involved in 
PPM. Note that these findings may be influenced by the maturity of PPM systems in the 
study  countries.  While  some  countries  have  more  advanced  PPM  systems,  with 
established  CPBs  that  can  provide  reliable  information,  other  countries  have  highly 
decentralised and less developed systems where reliable information is more difficult to 
obtain. 

While most countries have some form of dedicated procurement body for medicines 
(either as a stand-alone  organisation or attached to another key player in the health 
care system, such as the ministry of health (MoH) or a payer organisation, see Table 
1024),  the  mandate  of  these  bodies  varies  in  scope,  ranging  from  a  CPB  function 
responsible  for  conducting  all  or  almost  all  procurement  for  hospital  medicines  (e.g. 
Amgros in Denmark, LIS in Norway) or any medicine (MoH in Cyprus performing PPM 
for all inpatient medicines and an outpatient sector that is mainly private) to a more 
limited  role  responsible  for  procurement  of  specific  medicines  such  as  vaccines  and 
other products for national health programmes (e.g. BBG in Austria, EHIF in Estonia), 
or  a  support  function  for  facility-based  procurement  (e.g.  HSE  in  Ireland).  Variation 
exists  with  regard  to  the  level  of  legal  obligation  of  use  of  CPB:  for  instance,  in 
Denmark, use of Amgros is mandatory for all hospitals, while in Norway hospitals could 
also  conduct  their  own  procurements.  Obligations  may  also  be  limited  to  defined 
medicines (e.g. in Portugal certain medicines must be procured by the CPB SPMS based 
on a list, whereas hospital and health units can procure other medicines on their own or 
request SPMS to procure on their behalf). 

Key players in PPM are public hospitals or non-public hospitals that are qualified 
as bodies governed by public law (see Chapter 5). While procurement is centralised 
for  hospitals  in  some  countries,  the  dominant  form  of  PPM  of  hospital  medicines  is 
facility-based  procurement.  This  is  often  complemented  by  voluntary  occasional  joint 
procurements with other hospitals (group procurement) and/or making use of non-for-
profit, or sometimes private companies which offer procurement services. 

As a result, CPBs have not only been identified at national level, but regional CPBs in 
line with the EU Procurement Law also exist in several countries (see Table 10). Some 
of  the  CPBs  active  at  regional  or  local  level  offer  services  for  public  procurers  in  the 
region (or in the municipalities), whereas some CPBs target university or other hospitals 
in  a  country.  Most  regional  CPBs  identified  only  procure  for  the  inpatient  sector. 
Exceptions are CPBs in Italy and Spain. Regional CPBs may not operate strictly according 
to  regional  geographical  or  administrative  boundaries.  For  example,  CPBs  in  Belgium 
such as Mercur Hosp or HospiLim focus their services on hospitals in a specific region 
but are not necessarily bound to operating in these regions only.  

In some countries, private companies offer procurement services, including for hospitals 
and community pharmacies. These were not included in the stakeholder mapping which 
focused on public procurement only. 

A few countries apply tendering or tendering-like policies in the outpatient sector (e.g. 
Denmark, Germany, the Netherlands, Sweden). In these countries, the public payers 
for  outpatient  medicines  (e.g.  NHS,  social  health  insurance)  launch  tender-like 
procedures for an active ingredient, and the winner (or multiple winners) will be awarded 
a place on the reimbursement list (for details see Box 1 in Chapter 3.3.1). 

24 Note that the table only shows CPBs involved in PPM. In many countries, CPBs for the public sector exist 

but are not involved in PPM.  

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In  the  hospital  setting,  prescribers  and  hospital  pharmacists  can  play  important 
roles  for  PPM,  as  they  collaborate  with  procurers  in  preparing  tender  specifications. 
Procurement  committees  consisting  of  the  three  professions  (procurers,  doctors, 
pharmacists; in some cases also other professions, such as nurses, health economists, 
legal  experts,  or  representatives  from  the  hospital  senior  management  staff)  are 
common in the study countries and can exist both at hospital level and at regional or 
national  level.  For  example,  in  Belgium,  the  hospital  pharmacy,  procurement 
department,  clinical  department,  and  the  legal  department  of  a  hospital  are  often 
involved in preparing tenders. In Iceland, the procurement department of the country’s 
largest hospital (which conducts centralised procurement of hospital medicines as well 
as other high-cost medicines) works closely with the Pharmaceuticals and Therapeutics 
Committee  (PTC),  as  well  as  specialist  doctors  and  the  hospital  pharmacy  when 
preparing  tenders.  Similar  arrangements  are  in  place  in  other  countries  that  use 
procurement through CPBs or at facility level. 

Prescribers and pharmacists thus provide essential input into procurement procedures. 
Involving these  professions  early in  the procurement  process  is also  seen  as  success 
factor  to  ensure  uptake  of  procured  medicines  (e.g.  when  biosimilar  medicines  are 
procured, see Chapters 3.6 and 5.4.2). 

Pharmaceutical pricing and reimbursement authorities, as well as HTA bodies, 
are typically not directly involved in PPM in the study countries. However, these bodies 
may work closely with procurers, as the decisions taken by authorities and HTA bodies 
can heavily influence procurement activities. For example, in the UK, any medicine that 
is recommended for routine use upon assessment by the national HTA body, the National 
Institute for Health and Care Excellence (NICE), has to be made available to patients in 
the National Health System (NHS) and therefore needs to be purchased by health care 
providers  for  their  patients.  In  Norway,  health  economic  advisers  form  part  of 
committees preparing national tenders for hospital medicines. While not a procurement 
activity per se, pricing and reimbursement authorities play an important role in setting 
up  and  organising  tender-like  systems  in  the  off-patent,  outpatient  market  through 
selection of a product with preferred reimbursement status for a limited period of time 
(e.g. TLV in Sweden, DKMA in Denmark, NEAK in Hungary). 

The  pharmaceutical  industry  and  wholesalers  are  involved  in  PPM  as  suppliers. 
However,  the  extent  to  which  products  are  procured  directly  from  manufacturers  vs. 
wholesalers  varies  across  countries.  For  example,  in  Estonia  and  Slovakia,  bids  for 
tenders  are  mostly  submitted  by  wholesalers,  with  no  presence  of  pharmaceutical 
manufacturers in the country. Associations of pharmaceutical companies can also play 
important  roles  in  shaping  the  framework  under  which  medicines  are  purchased.  In 
Ireland  and  the  UK,  the  associations  of  the  research-based  pharmaceutical  industry 
negotiate agreements about price ceilings with the relevant authorities. 

Patient and public involvement in procurement activities is not commonly practiced 
in the study countries. Patients may be involved in reviewing medicines for inclusion in 
national or regional reimbursement lists or hospital formularies through participation in 
Pharmaceuticals  and  Therapeutics  Committees  (PTCs)  and  other  committees  (e.g. 
Austria, Denmark, Estonia, Lithuania, Malta, UK). While this does not constitute a direct 
role  in  procurement,  patients  therefore  contribute  to  determining  which medicines  to 
procure in some countries. 

Successful cross-country collaborations in PPM in the study countries have so far 
either been driven by procurers in the participating countries (supported by political will 
to  implement  cross-country  initiatives  [117]),  with  one  procurement  body  taking  the 
lead for a given procedure, or it was organised centrally through the EC. The latter has 
only been used for joint procurement of medicines during the COVID-19 pandemic (with 
different  instruments  used  for  vaccines  and  therapeutics,  respectively,  see  Chapter 
6.2.2).  Since  2021,  a  new  Directorate-General  for  European  Health  Emergency 

25 

 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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preparedness and Response Authority (DG HERA) is responsible for joint procurements 
at  the  EU  level.  Chapter  6.2.1  provides  for  descriptions  of  how  cross-country  joint 
procurement was conducted in the Nordic and Baltic countries, respectively. 

Table  10:  List  of  procurement  bodies  involved  in  PPM  at  national  level  in  the  study 
countries 

Country 

Austria 

Belgium 

Bulgaria 

Name of the institution (national 
language and English) 
Bundesbeschaffung GmbH (BBG) / 
Bundesbeschaffung Austria GmbH 

Service public fédéral - Stratégie et 
Appui (SPF) / Federal Public Service 
- Policy and Support (FPS) 
Central Purchasing Authority at the 
Ministry of Health (CPB-HS) 

Агенцията по обществени поръчки 
(АОП) / Public Procurement Agency 
(PPA) 

Croatia 

Ministarstvo zdravstva / Ministry of 
Health (MoH) 

Cyprus 

Czech 
Republic 
Denmark 

Φαρμακευτικές Υπηρεσίες / Ministry 
of Health (MoH) -Purchasing and 
Supply Services Department  

Not appl. 

Not appl. 

Lægemiddelstyrelsen / Danish 
Medicines Agency (DKMA) 

Amgros 

Estonia 

Procurement Department in Eesti 
Haigekassa / Social Health 
Insurance 

Finland 

National Advisory Committee on 
Pharmaceuticals 

CPB 

Yes 

Yes 

Yes 

No 

Yes 

Yes 

No 

Yes 

Yes 

No 

Sector 

Not spec. 

Not spec. 

Not spec. 

Not spec. 

Not spec. 

Inpatient 

Not appl. 

Outpatient 

Inpatient 

Not spec. 

Inpatient 

Involvement in 
PPM 
In some cases if 
requested by the 
federal state or 
hospitals 
Can launch national 
tenders 

Responsible for 
establishing 
framework 
agreements between 
suppliers and health 
care providers 
Only providing 
support to contracting 
authorities; not 
conducting 
procurement on its 
own 
Acts as CPB for 
defined procedures 
(tendering and 
framework 
agreements) 
Performs central PPM 
procedures for all 
inpatient medicines, 
the outpatient sector 
is mainly private 
Not appl. 

Involved in the 
tendering-like system 
for pricing outpatient 
medicines 
Acts as CPB for all 
medicines used in 
public hospitals (note 
that hospitals – and 
Amgros – are owned 
by the Danish 
regions) 
Acts as CPB for some 
medicines for national 
health programmes, 
vaccines, and 
selected medicines for 
hospital use 
Not an agency, but 
the Committee was 
established by 
hospital districts in 
early 2021 for the 
procurement of new 
medical products for 
hospital use. In 
practice, the HUS 
Pharmacy of the 
Hospital District of 
Helsinki and Uusimaa 
takes care of the 
negotiations phase for 
the whole of Finland 
for novel therapies. 

26 

 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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Country 

France 

Name of the institution (national 
language and English) 
Réseau des Acheteurs Hospitaliers 
(Resah) 

CPB 

Yes 

UniHA (Union des Hôpitaux pour les 
Achats) 

Yes 

Germany 

Greece 

Paul-Ehrlich-Institut, 
Bundesministerium für Gesundheit 
(BMG) / Ministry of Health (MoH) 
Bundesinstitut für Arzneimittel und 
Medizinprodukte (BfArM) / Federal 
Institute for Medicines and Medical 
Devices (a business area of the 
MoH) 

Zentrum für Pandemie-Impfstoffe 
und –Therapeutika (ZEPAI) / Center 
for Pandemic Vaccines and 
Therapeutics (a business area of the 
MoH) 
Bundesamt für Ausrüstung, 
Informationstechnik und Nutzung 
der Bundeswehr (BAAINBw) / 
Federal Office of Bundeswehr 
Equipment, Information, Technology 
and In-Service Support 
Sickness funds 

Ενιαία Ανεξάρτητη Αρχή Δημοσίων 
Συμβάσεων (ΕΑΑΔΗΣΥ) / Hellenic 
Single Public Procurement Authority 
(HSPPA) 

Εθνική Κεντρική Αρχή Προμηθειών 
Υγείας (EKAPY) / National Central 
Authority of Health Procurements 

Hungary 

Közbeszerzési és Ellátási 
Főigazgatóság (KEF) / Directorate-
General for Public Procurement and 
Supply  

Nemzeti Egészségbiztosítási 
Alapkezelő (NEAK) / National Health 
Insurance Fund  

Állami Népegészségügyi és 
Tisztiorvosi Szolgálat (ÁNTSZ) / 
National Public Health and Medical 
Officer Service (NPHMOS) 

Yes 

No 

No 

Yea 

No 

No 

Yes 

Yes 

Yes 

Yes 

Involvement in 
PPM 
Regional CPB for 
metropolitan region 
of Paris but 
designated by the 
direction générale de 
l'offre des soins 
(DGOS) as national 
procurer for hospital 
procurement 
Regional CPB in the 
Lyon region but 
designated by the 
direction générale de 
l'offre des soins 
(DGOS) as national 
procurer for hospital 
procurement 
Procurement of 
vaccines 

Operationally 
involved in the 
procurement of 
therapeutics, 
coordinates the needs 
assessment 
Operationally 
involved in the 
procurement of 
vaccines and 
therapeutics 
One of the four 
federal CPBs, 
framework 
agreements for 
medicines and 
medical devices 
Involved in the 
tendering-like system 
for pricing outpatient 
medicines 
Involved in public 
procurement 
strategy, no 
procurement of 
medicines 
CPB mainly for the 
inpatient sector; 
established in in 2018 
as successor of the 
Health Procurement 
Committee (EPY) 
CPB responsible for 
centralised 
procurement 
procedures for the 
public sector, 
including for health 
care. Conducts 
procurement of some 
medicines used by 
hospitals (use of 
centralised 
procurement by 
hospitals is 
voluntary). 
Organises centralised 
tenders for some 
inpatient medicines. 
Involved in the 
tendering-like system 
for pricing outpatient 
medicines. 
Conducts 
procurement of some 
vaccines 

Sector 

Inpatient 

Inpatient 

Outpatient 

Outpatient and 
inpatient 

Outpatient and 
inpatient 

Outpatient 

Outpatient 

Not spec. 

Mainly inpatient 

Inpatient 

Not spec. 

Outpatient 

27 

 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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Country 

Iceland 

Name of the institution (national 
language and English) 
Landspitali 

CPB 

Yes 

Ireland 

Health Service Executive (HSE) 

Yes 

Italy 

Consip 

Latvia 

Liechtenstein 
Lithuania 

Iepirkumu nodaļa / Procurement 
Division of the National Health 
Service 

n.a. 
Centrinė perkančioji organizacija 
(CPO LT) / Central Procurement 
Organization (CPO LT) 

Yes 

Yes 

n.a. 
Yes 

Luxembourg 
Malta 

Not appl. 
Yes 

Not appl. 
Central Procurement & Supplies Unit 
(CPSU) at Ministry for Health (MFH) 
with support and guidance from 
other MFH units and  several 
committees 

Emergency Response Unit at the 
CPSU at MFH (ERU) 

Netherlands 

Sickness funds 

No 

Involvement in 
PPM 
National hospital 
conducting 
centralised 
procurement for 
hospital medicines 
(voluntary centralised 
procurement) as well 
as for all high-cost 
medicines funded 
from a separate 
budget (including 
those used in 
hospitals and 
outpatient settings; 
mandatory use of 
centralised 
procurement) 
Acts as CPB for a few 
selected medicines 
(e.g. Hepatitis C 
medication, direct 
acting anti-retroviral 
drugs, orphan drugs, 
and vaccines). Also 
runs a DPS for 
hospitals and 
supports hospital 
procurers. 
Federal CPB for public 
administration, 
including health care 
(for inpatient and 
outpatient medicines, 
mainly off-patent) 
Acts as CPB for 
defined medicines 
(inpatient and 
outpatient) 
n.a. 
Responsible for 
centralised 
procurement (not 
only medicines) upon 
contract with 
authorities. Runs e-
catalogue platform. 
Not appl. 
CPSU manages 
sourcing and supply 
of materials, works 
and/or services 
across the National 
Healthcare Services.   
ERU may launch 
emergency calls for 
medicines in case of 
shortages or 
inavailability of 
medicines from stock 
lists.  
Involved in the 
tendering-like system 
for pricing outpatient 
medicines 

Sector 

Not spec. 

Not spec. 

Not spec. 

Not spec. 

n.a. 
Not spec. 

Not appl. 
Outpatient and 
Inpatient, all 
medicines centrally 
procured 

Outpatient 

28 

 
 
 
 
 
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Country 

Norway 

Name of the institution (national 
language and English) 
Sykehusinnkjøp HF (LIS) / 
Norwegian Drug Procurement Co-
operation 

CPB 

Yes 

Helsedirektoratet / Norwegian 
Directorate of Health 

Yes 

Poland 

Folkehelseinstituttet (FHI) / 
Norwegian Institute of Public Health 
(NIPH) 
Zakład Zamówień Publicznych przy 
Ministrze Zdrowia (ZZP) / Public 
Procurement Department at the 
Ministry of Health 

Yes 

Yes 

Narodowy Fundusz Zdrowia (NFZ) / 
National Health Fund 

Yes 

National Institute of Public Health – 
National Institute of Hygiene 
(Narodowy Instytut Zdrowia 
Publicznego – Państwowy Zakład 
Higieny, NIZP-PZH) 
Serviços Partilhados do Ministério da 
Saúde (SPMS) / Shared Services of 
Ministry of Health 

Yes 

Yes 

Portugal 

Sector 

Not spec. 

Outpatient 

Outpatient 

Not spec. 

Not spec. 

Outpatient 

Not spec. 

Involvement in 
PPM 
LIS negotiates prices 
and conducts tender 
competitions with 
manufacturers for all 
medicines used in 
specialist care 
(inpatient) as well as 
medicines that are 
covered by the 
National Insurance 
Scheme (including 
some medicines used 
in the outpatient 
setting). Note that 
LIS is owned by the 
regional health 
authorities. 
Acts as contracting 
authority, as well as 
overseeing contracts 
and supplier 
management, for a 
pilot project for 
centralised 
procurement of 
medicines in the 
outpatient setting 
(PCSK9 inhibitors). 
Responsible for 
procuring vaccines 

Procurement of 
vaccines for national 
immunisation 
programmes, 
medicines for the 
national reserve (e.g. 
typhoid vaccines), 
treatment of bleeding 
disorders and 
HIV/AIDS, and some 
other medicines 
According to 
legislation, 
responsible for the 
organisation of joint 
procedures for the 
purchase of 
medicines 
Conducts public 
procurement for some 
medicines 

Mainly responsible for 
PPM in Portugal for 
SNS institutions (not 
limited to medicines) 
and provides services 
to the users of PPM 
(hospitals and ARS) 
and serves as key 
contact to suppliers 

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Country 

Romania 

Name of the institution (national 
language and English) 
Agenția Națională pentru Achiziții 
Publice (ANAP) / National Agency for 
Public Procurement 

CPB 

Yes 

Ministerul Sanatatii / Ministry of 
Health 

Yes 

Slovakia 

Ministry of Health of the Slovak 
Republic 

No 

Slovenia 
Spain 

Sweden 

Vseobecná Zdravotná Poistovña 
(VsZP) / General Health Insurance 
Not appl. 
Instituto Nacional de Gestión 
Sanitaria, Ministerio de Sanidad 
(INGESA) / National Institute for 
Health Management under the 
Ministry of Health 
Adda 

Tandvårds- och 
läkemedelsförmånsverket (TLV) / 
Dental and Pharmaceutical Benefits 
Agency 

Switzerland 

Bundesamt für Gesundheit (BAG) / 
Federal Office of Public Health 
(FOPH) 

United 
Kingdom 

NHS England Commercial Medicines 
Unit (CMU) 

NHS National Services Scotland 
National Procurement and Logistics  

Yes 

Not appl. 
Yes 

Yes 

No 

Yes 

Yes 

Yes 

Sector 

Not spec. 

Not spec. 

Not spec. 

Not spec. 

Not appl. 
Not spec. 

Outpatient 

Outpatient 

Not spec. 

Inpatient 

Not spec. 

Involvement in 
PPM 
Contract/tender 
design, promotion 
and implementation 
of public procurement 
policies, 
establishment and 
implementation of the 
system of verification 
and control of unitary 
application of legal 
provisions, 
procedures in the 
field of public 
procurement, 
monitoring the 
efficient functioning 
of the public 
procurement system 
Yes, for few 
medicines (vaccines 
and medicines in 
national health 
programmes (such as 
antituberculosis 
medication and 
antiretrovirals (HIV))) 
Prepares several 
centralised 
procurement 
procedures in health 
field, including the 
establishment of DPS 
for medicines 
Procurement of some 
high-cost medicines 
Not appl. 
National CPB for 
some defined 
medicines 

Company operated by 
the association of 
local authorities, 
conducting 
procurement for some 
medicines e.g. 
vaccines 
Involved in the 
tendering-like system 
for off-patent 
outpatient medicines. 
TLV indicates the 
“product-of-the-
month” based on the 
lowest price 
submitted by 
manufacturers. 
Overall responsibility 
is for positive lists of 
medicines containing 
the prices and tariffs 
that are reimbursed 
by public health 
insurance, but acts as 
CPB for pandemic 
supplies and vaccines 
Responsible for 
procurement and 
supply of medicines 
for public hospitals in 
England 
National procurement 
service for high-
spend items used in 
hospitals and the 
health service in 
Scotland  

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Country 

Name of the institution (national 
language and English) 
Procurement and Logistics Service 
(PaLS) 

CPB 

Yes 

NHS Wales Shared Services 
Partnership (NWSSP) 

Yes 

Involvement in 
PPM 
Provides procurement 
and logistics services 
to all public Health 
and Social Care 
(HSC) organisations 
in Northern Ireland, 
including 
procurement of 
medicines 
Services include a 
procurement and 
logistics services for 
medicines Wales 

Sector 

Not spec. 

Not spec. 

Note: appl. = applicable, n.a = not available, spec. = specified 
Not all abbreviations of institutions only mentioned in this table were included in the list of abbreviations 

Source: PPM country fiches 

Table 11: List of regional CPBs involved in PPM in the study countries 

Country 

Name of the institution (national language and 
English) 

Involvement in PPM 

Sector 

Austria 

Belgium 

Bulgaria 
Croatia 
Cyprus 
Czech 
Republic 
Denmark 
Estonia 
Finland 

France 

Germany 

Greece 
Hungary 
Iceland 
Ireland 
Italy 

Provincial hospital funds which own hospitals, e.g. 
Landeskrankenanstalten-Betriebsgesellschaft des 
Landes Kärnten (KABEG), Steiermärkische 
Krankenanstaltengesellschaft m.b.H. (KAGES), 
Burgenländische Krankenanstalten-Ges.m.b.H. 
(KRAGES), Niederösterreichische 
Landesgesundheitsagentur (LGA), 
Oberösterreichische Gesundheitsholding GmbH 
(OÖG), Salzburger Landeskliniken 
Betriebsgesellschaft mbH (SALK), Tirol Kliniken, 
Wiener Gesundheitsverbund (WGV) 
Procurement units of religious order’s hospitals 
Regional CPBs such as Mercur Hosp or HospiLim; 
regional health authorities 

Not appl. 
Not appl. 
Not appl. 
Not appl.  

Not appl. 
Not appl. 
University hospitals (representing five expert 
responsibility areas (ERAs) for specialised care) 

Several group purchasing organisations such as 
Groupement de Coopération Sanitaire Achats du 
Centre, Agence Générale des Equipements et 
Produits de Santé (AGEPS) l’Assistance Publique – 
Hôpitaux de Paris, UNICANCER Achats 

AGKAMED (not a regional CPB, but a group 
procurement organisation) 
Dienstleistungs- und Einkaufsgemeinschaft 
Kommunaler Krankenhäuser eG im Deutschen 
Städtetag (GDEKK, not a regional CPB, but a group 
procurement organisation) 
Regional CPBs 
Not appl. 
Not appl. 
Not appl. 
Centrali di Committenza Regionali / Regional central 
procurement bodies 

Latvia 
Liechtenstein 

Not appl. 
Not appl. 

For the hospitals in their group 

Inpatient 

For the hospitals in their group 
Hospital CPBs purchase for 
hospitals in their group; 
regional authorities conduct 
regional tenders for vaccines 
Not appl. 
Not appl. 
Not appl. 
Not appl. 

Not appl. 
Not appl. 
Conducting procurement in 
their expert areas for 
hospitals. For novel medicines 
HUS Pharmacy of the Hospital 
District of Helsinki and 
Uusimaa takes care of the 
negotiations for the whole of 
Finland. 
For the hospitals in their 
group. Hospitals or hospital 
groups not linked to a CPB 
may join a regional and a 
central procurement body 
depending on the type of 
medicines required. 
Note that Resah and UniHA 
have been assigned as 
national CPBs in 2019. 
For member hospitals and 
rehabilitation clinics 
For district hospitals 

For hospitals in their region 
Not appl. 
Not appl. 
Not appl. 
Procurement of medicines in 
their region 

Not appl. 
Not appl. 

Inpatient 
Outpatient 
and 
inpatient 

Not appl. 
Not appl. 
Not appl. 
Not appl. 

Not appl. 
Not appl. 
Inpatient 

Inpatient 

Inpatient 

Inpatient 

Inpatient 
Not appl. 
Not appl. 
Not appl. 
Outpatient 
and inpatient 

Not appl. 
Not appl. 

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Country 

Lithuania 
Luxembourg 
Malta 
Netherlands 

Name of the institution (national language and 
English) 

Not appl. 
Not appl. 
Not appl. 
Inkoopcombinatie Ziekenhuis Apothek-en 
Academische Ziekenhuizen (IZAAZ) / Group 
purchasing hospital pharmacy of university hospitals 

Norway 
Poland 
Portugal 
Romania 
Slovakia 
Slovenia 
Spain 

Not appl. 
Not appl. 
Not appl. 
N.a. 
Not appl.  
Not appl. 
Regional CPBs, such as Consorci de Salut i Social de 
Catalunya / Catalan Health and Social Care 
Consortium 

Andalusian regional health service 

Sweden 

Regioner / Regions 

Switzerland 

United 
Kingdom 

Grouping of hospitals, e.g. Centrale d'achats et 
d'ingénierie biomédicale (CAIB) des Hôpitaux 
Universitaires Genéve (HUG) et des Centre 
hospitalier universitaire vaudois (CHUV) 
Regional procurement hubs (in England) include 
NHS Commercial Solutions (CS), NHS North of 
England Commercial Procurement Collaborative 
(NOE CPC), East of England NHS Collaborative 
Procurement Hub (EOE), NHS London Procurement 
Partnership (LPP) 

Involvement in PPM 

Sector 

Not appl. 
Not appl. 
Not appl. 
Inpatient 

Not appl. 
Not appl. 
Not appl. 
N.a. 
Not appl. 
Not appl. 
Outpatient 
and 
inpatient 

Outpatient 

Inpatient 

Inpatient 

Inpatient 

Not appl. 
Not appl. 
Not appl. 
For university hospitals which 
part of Nederlandse Federatie 
van Universitair Medische 
Centra (NFU) / Netherlands 
Federation of University 
Medical Centers (eight medical 
centers) 
Not appl. 
Not appl. 
Not appl. 
N.a. 
Not appl. 
Not appl. 
Regional CPBs are commonly 
used for inpatient medicines 

Operates a regional tendering 
system for outpatient off-
patent medicines 
Procurement body in each 
region is responsible for 
administering the process of 
procuring medicines for 
inpatient settings 
For hospitals in their region 

The purchasing groups 
conduct joint procurement of 
hospital medicines on the 
basis of framework 
agreements concluded by the 
CMU 

Note: appl. = applicable, n.a = not available, spec. = specified 
Not all abbreviations of institutions only mentioned in this table were included in the list of abbreviations. 
Note that no reliable information on use of regional CPBs could be found for Romania. 

Source: PPM country fiches 

3.2.  Organisation of PPM 

The second specific objective of this study was to map existing policy and practices in 
PPM  in  the  study  countries.  This  addresses  the  following  study  question:  what  are 
current national PPM policies and practices in the study countries? 

It should be noted that the findings presented may be subject to information bias: while 
some countries (with more advanced PPM systems) are able to provide more and reliable 
information,  other  countries  (with  less  developed  systems)  may  be  less  well 
represented. 

Figure 2 through Figure 5 below show how different forms of procurement are used in 
the study countries. Overall, the two most common forms of organisation for PPM are 
facility-based procurement and a national centralised procurement system. 

While  facility-based  procurement  is  common  for  hospital  medicines  (see  also 
Chapter  5),  it  is  more  rarely  used  for  outpatient  medicines  (Figure  2).  Similarly, 
voluntary  group  procurement,  i.e.  joint  procurement  by  groups  of  contracting 
authorities such as hospitals, is mostly only used for procurement of hospital medicines, 
although  Italy  is  a  special  case  with  regional  centralised  procurement  for  outpatient 
medicines  in  primary  care  units  (see  Figure  3).  Other  countries  with  facility-based 
procurement in both sectors include Luxembourg and Switzerland. Group procurement 
and facility-based procurement also typically go hand in hand: in almost all countries 
where  group  procurement  is  used,  individual  facilities  also  conduct  their  own 

32 

 
 
 
 
 
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procurement. Group (joint) procurement and facility-based procurement may be used 
by  the  same  institutions  but  for  different  products.  An  exception  is  Sweden,  where 
medicines  used  in  the  hospital  setting  are  primarily  procured  at  regional  level,  with 
group procurement between individual hospitals as supplementary route (and de facto 
no facility-based procurement).  

Centralised procurement at the regional level (i.e. regional procurement conducted 
through a CPB) is conducted for medicines in both inpatient and outpatient settings (see 
Figure  4).  Regional  CPBs  were  identified  in  12  countries  where  they  mostly  serve 
hospitals, but sometimes also additionally the outpatient sector (see also Table 11). 
Regional  CPBs  include  regional  or  municipal  health  authorities,  but  also  not-for-profit 
associations organised at the regional level and regionally operating health insurances 
(in Germany and Spain). 

Centralised procurement at the national level through a CPB is common throughout 
Europe,  both  for  inpatient  and  outpatient  medicines  (Figure  5).  The  only  two  study 
countries where no centralised procurement at national level is conducted are Czechia 
and Finland (in Finland there is no CPB, but for novel therapies, the HUS Pharmacy of 
the Hospital District of Helsinki and Uusimaa takes care of the negotiations phase for 
the whole of Finland at once). However, the scope of medicines for which centralised 
procurement  is  done  varies  across  countries,  with  some  countries  using  this  form  of 
organisation for effectively all medicines (e.g. Malta) while others use it for effectively 
all medicines in the inpatient setting (e.g. Denmark, Norway), and yet several others 
only  use  it  for  specific  types  of  medicines  (e.g.  vaccines  for  national  health 
programmes). Note that the figure does not distinguish between these different forms 
of national centralised procurement of medicines (CPM). 

In  most  countries  that  use  some  form  of  centralised  procurement,  this  is 
complemented by facility-based procurement for inpatient medicines (although in these 
countries one form of procurement may dominate, and the other is only used for specific 
products). Exceptions are Cyprus, Denmark, and Malta where effectively all medicines 
that can  be centrally procured  are  indeed purchased through that  route  (in  Denmark 
and Cyprus, this only applies to hospital medicines; in the case of the latter, centralised 
PPM at national level is de facto only used for hospital medicines). 

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Figure 2: Use of facility-based procurement in the study countries 

Figure 3: Use of group (joint) procurement in the study countries 

Source: PPM country fiches 

Note: Group procurement refers to joint (pooled) procurement by two or more public procurers, but without 
involvement of a formal, institutionalised CPB. 

Source: PPM country fiches 

34 

 
 
 
 
 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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Figure 4: Use of centralised procurement at the regional level in the study countries 

Note: Centralised procurement at regional level refers to procurement that is conducted jointly by a 
centralised procurement body for several buyers in a region. 

Source: PPM country fiches 

Figure 5: Use of centralised procurement at the national level in the study countries 

Note: In some countries, centralised procurement may only be done for very few, selected products (e.g. 
vaccines or therapeutics used in national health programmes, such as for treatment of HIV/AIDS or 
Hepatitis C). These countries are shown as applying CPM at national level in the figure but should not be 
confused with countries that systematically apply CPM at national level for all products (e.g. Malta).  

Source: PPM country fiches 

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Study on Best Practices in the Public Procurement of Medicines – 
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3.3. PPM practices 

In  this  chapter,  the  use  of  various  procurement  practices  in  the  study  countries  is 
described.  This  includes  forms  of  formal  procedures  (generally  those  specified  by  EU 
Directive 2014/24, although national legislation may include other procedures; Chapter 
3.3.1), as well as procurement techniques (Chapter 3.3.2). The latter refer to methods 
of implementing and facilitating procurement procedures, including through framework 
agreements,  platforms  for  efficiently  processing  procurements  (to  allow  for  dynamic 
purchasing system / DPS), and the number of suppliers being awarded a contract. Note 
that additional procedures techniques are described in EU Directive 2014/24. 

3.3.1. PPM procedures 

EU Directive 2014/24 specifies the following types of procedures [68]: 

  Open procedure: a formal procurement method where any interested potential 

supplier may submit a tender. In this one-stage procedure, suppliers respond to an 
open call for competition set up by the purchaser (contracting authority) which 
details the criteria used for awarding the contract. 

  Restricted procedure: a formal, two-stage procurement method where any 

interested potential supplier can submit a request to participate in the first stage, 
but only suppliers who fulfil pre-qualification criteria set out by the purchaser 
(contracting authority) may submit tenders in the second stage. 

  Competitive procedure with negotiation: a two-stage procurement method 
that involves pre-selection of suitable potential suppliers by the purchaser 
(contracting authority) and negotiations of submitted tenders. 

  Competitive dialogue: a two-stage procurement method that involves the 

purchaser (contracting authority) pre-selecting potential suppliers based on their 
initial submissions and initiating a dialogue with them to identify the best possible 
method to address the need specified by the purchaser. Competitive dialogue 
leaves more space for the best way to address a need compared to the competitive 
procedure with negotiation, where the purchaser uses pre-specified criteria to 
assess bids. 

  Negotiated procedure without prior publication: a variant of the negotiated 

procedure for exceptional cases where it is known that only a specific supplier can 
fulfil the procurement needs. In PPM, this may be the case for on-patent medicines 
without therapeutic alternatives where there is a single supplier, or for addressing 
needs arising from emergency situations, e.g. a pandemic.  

  Innovation partnership: a procurement method intended for situations where 
innovative solutions are required because the needs of the purchaser cannot be 
addressed by existing products, services, or works. Innovation partnership includes 
selection of one or more partners based on their proposed research and 
development projects. 

Innovation partnership and negotiated procedure without prior publication are 
intended for exceptional circumstances. In the case of the latter, a voluntary ex ante 
transparency notice can be published, but there is no obligation to do so. 
Comparatively few notices were included in the specific TED database reporting on 
these cases and the database was therefore excluded from the analysis (see Chapter 
2.5.1). 

Among  the  key  procurement  procedures  listed  in  EU  Directive  2014/24  [68],  open 
procedure tenders are most frequently used across study countries. Open procedures 
were used in 97% of all contract notices included in the TED database from 2008-2021 
(see Figure 6). Other procedures, including restricted procedure, negotiated procedure, 
and competitive dialogue, jointly accounted for just over 3% of procurements conducted 

36 

 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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in this period. Comparatively more non-open procedures were conducted for antivirals 
for  systemic use  (4.6%  restricted  procedures)  and  vaccines  (5.5%  procedures)  while 
antineoplastic and antithrombotic agents were both almost exclusively procured through 
open procedures. 

Figure 6: Procedures used for procurement of medicines included in TED database in 
the study countries, 2008-2021 

All pharmaceutical products

Antineoplastic agents

Antithrombotic agents

Open
99.60%

Open
99.74%

Antivirals for systemic use

Vaccines

Open
96.83%

Open
93.1%

Open
96.83%

Open

Competitive dialogue

No data

Restricted

Negotiated with a CFC

Note: Figure shows the proportion of different types of publicly listed procedures aggregated for all study 
countries, and for all medicines (classified as “pharmaceutical products” in the TED database) and selected 
groups of products. 

Source: European Commission (TED) data [144], analysis by authors 

Open procedures also emerged as the most common form from a review of country 
practices  in  the  PPM  country  fiches.  26  of  the  study  countries  use  this  open  form  of 
tenders in some capacity, 20 of which use it in both inpatient and outpatient settings.  
In  some  countries,  open  procedure  tenders  are  used  for  products  with  no  or  limited 
competition (e.g. Portugal, Slovakia, UK), although others also use this procedure for 
off-patent  (but  possibly  still  high-cost)  medicines  (e.g.  Belgium  and  Hungary  for 
selected  medicines,  and  more  widely  used  in  Croatia,  Cyprus,  Estonia,  Ireland,  and 
Iceland).  At  the  national  centralised  level,  open  procedures  are  commonly  used  to 
procure vaccines (e.g. Austria, Estonia, Hungary, Ireland, Luxembourg, Norway, Poland, 
UK).  CPBs  for  hospitals  also  commonly  use  open  procedures  (e.g.  Cyprus,  Denmark, 
Norway,  Sweden,  UK).  In  some  countries,  these  are  restricted  to  specific  types  of 
medicines,  e.g.  high-cost  medicines  or  biosimilars  (e.g.  Estonia,  Hungary,  Latvia, 
Lithuania, Poland). At the facility-level, open procedures are commonly used because 
they represent the simplest procedure form.  

Some  countries  use  open  procedures  to  identify  suitable  suppliers  with  whom  to 
conclude framework agreements (Austria, Bulgaria, Latvia). 

Competitive procurement with negotiations and competitive dialogue were less 
frequently used and typically only for specific products or in specific situations. These 
procedures are used for facility-level procurement as well as centralised procurement at 
the regional or national levels.  In Belgium, Ireland, and Poland, competitive dialogue 
has  been  used  to  procure  medicines  used  to  treat  haemophilia  (extended  half-life 
recombinant factor VIII). Competitive procurement with negotiations is being used for 
new  (patented)  medicines  in  Cyprus,  Finland,  and  Ireland,  and  for  other  situations 
where there is only one supplier in Estonia. In Portugal, competitive procurement with 
negotiations is a fall-back option when other procedures are not possible, e.g. because 

37 

 
 
 
 
 
 
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of time constraints. In Slovakia, competitive procurement with negotiations is used for 
active  substances  with  annual  expenditure  between  15,000  and  30,000  per  hospital. 
Austria also uses negotiated procedures to find suppliers for framework agreements.  

Restricted  procedures  were  not  commonly  applied,  although  some  countries  use 
them in the context of dynamic purchasing systems (DPS, see Chapter 3.3.2.2). 

As described, procurement is mainly used in the inpatient sector. However, tendering 
or  tendering-like  procedures  are  also  applied  in  the  outpatient  sector  by  some 
countries.  These  systems  are  targeted  at  off-patent  medicines;  the  winner  (or 
sometimes the winners) will gain access to the positive list (i.e. reimbursement list for 
publicly  funded  medicines)  for  a  defined  period  of  time,  and  usually  doctors  will  be 
obliged, or at least encouraged, to prescribe the selected medicines and/or, in case of 
generic substitution, pharmacists have to dispense the medicines which won the bids. 
Box 1 provides some country examples; further countries with tendering or tendering-
like systems in the outpatient sector include Malta, Hungary, Romania and some regions 
in Spain (e.g. Andalusia, however meanwhile no longer in place). Belgium applied this 
policy, informally known as the “Kiwi light model”, for only two substances (amlodipine 
and simvastatin) in 2007 and 2008 and then stopped the practice as the winner of the 
second tender could not supply [116]. 

Evidence  on  the  impact  of  tendering-like  systems  for  off-patent  products  in  the 
outpatient  sector  is  mostly  restricted  to  savings  gained  (see  Chapter  4.2.1).  As  for 
competitive  tendering  in  general,  concerns  about  shortages  and  supply  issues  exist. 
While the number of shortages has increased in the last decade [156], the contribution 
of tendering practices for outpatient medicines to shortages could not be assessed (for 
details  of  a  few  studies,  e.g.  on  the  Dutch  preference  price  policy  and  the  Swedish 
“product of the months”, that analysed the impact see Chapter 4.3). 

38 

 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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Box 1: Tendering or tendering-like procedures for off-patent, outpatient medicines – 
country examples 

Tendering-like system with bi-weekly changes in Denmark: Manufacturers submit price bids for 
reimbursable outpatient medicines to the Medicines Agency on a bi-weekly basis. The winner is awarded 
(almost) the entire reimbursement market of the respective active ingredient for a period of two weeks, 
and the price of the lowest-priced medicine is calculated as the reimbursement price. However, in case 
of only small price differences between prescribed and preferred product, pharmacists are allowed to 
dispense the prescribed medicine. If the winner fails to supply the market, the medicine will be removed 
from the price list for the two-week contract period, and the supplier who offered the second-lowest 
price is asked to supply at the price it bid. Denmark has been operating this system since the mid-
1990s, and has optimised it, e.g. by strong IT system which conducts the price recalculations 
automatically (e.g. in case of supply issues). Concerning the logistical challenge due to bi-weekly 
changes, there is option for pharmacies to return the stock to suppliers and wholesalers who provide a 
credit note [116]. 

“Rabattverträge” in Germany: The sickness funds (competing health insurers) conclude so-called 
“discount contracts” with the suppliers of off-patent outpatient medicines. While the payers receive 
confidential discounts, they ensure exclusivity in prescribing and dispensing of the medicines included in 
the contracts. One commonly used type is the so-called “open house contracts” in which a sickness fund 
defines the requested discount, and all manufacturers of the respective active ingredient can join, 
without any further negotiations, if they agree to grant the determined discount [157]. 

“Preference price policy” in the Netherlands: In 2005, Dutch health insurers started to launch 
tenders for a few off-patent active ingredients, but after a court ruling in 2008 which forbid joint 
tenders, as health insurers are obliged to compete, the insurers have been launching individual tenders 
of generics and some of them also biosimilars medicines. Over the years, the system was adapted, for 
instance most insurers decided to extend contract duration of initially six months to one year and longer, 
as frequent changes could possibly irritate patients. Furthermore, some health insurers have adapted 
the policy by moving away from the “winner-takes-it-all” principle [116]. 

“Product of the month” in Sweden: For defined active ingredients, the generic which has offered the 
lowest price is considered as the preferred product for the respective month, and it will be dispensed in 
the pharmacies due to the mandatory generic substitution. Biologicals are not included in the “Product of 
the Month” system [113, 119]. 

3.3.2. PPM techniques 

3.3.2.1.  Framework agreements 

An important PPM technique for contracting authorities are framework agreements. 
These are typically concluded by a CA, frequently a CPB, with one or more suppliers to 
set the conditions for procurement of medicines over a defined time period, including in 
some cases the price of the product. Details of the procurement process (e.g. volumes 
purchased or which supplier to purchase from) can still be decided by individual health 
care  providers  (e.g.  individual  hospitals).  Framework  agreements  may  also  address 
security of supply concerns and some countries use them to contract multiple suppliers 
to reduce the risk of shortages due to one supplier failing to deliver. 

Framework agreements are commonly used in European countries and are particularly 
often used in the off-patent market. In fact, in some countries, framework agreements 
are the most commonly used  form of procurement. For  example, the Danish CPB for 
hospitals, Amgros, uses framework agreements as default option for medicines that face 
any  competition  (including  medicines  with  analogue  competition,  generics,  and 
biosimilars). 

Examples of where framework agreements are used by CPBs include: 

  Austria (vaccines and medicines used in the inpatient setting, including high-cost 

medicines), 

  Belgium (medicines used in the inpatient setting), 

  Bulgaria (medicines used in the inpatient setting), 

  Croatia (not limited to specific products), 

39 

 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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  Denmark (used for medicines with analogue competition, generic and biosimilar 

medicines), 

  Estonia (used for medicines used in national health programmes (HIV/AIDS and 
tuberculosis medicines; vaccines), high-priced hospital medicines and biosimilar 
medicines),  

  France (for off-patent medicines or medicines attributed to therapeutic classes), 

  Hungary (used for centrally tendered inpatient medicines and vaccines), 

 

Italy (mainly used for off-patent medicines), 

  Latvia (used for vaccines, standard tuberculin, peritoneal dialysis products, 
products for phenylketonuria and other genetic disorders, immunobiological 
preparations, and parenterally administered oncological medicines),  

  Norway (medicines used in the inpatient setting), 

  Portugal (mainly used for off-patent medicines), 

  Sweden (used for vaccines), 

  Slovakia (used for off-patent medicines), 

 

the UK (used for generic medicines; branded medicines, biosimilar medicines, and 
IV fluids; blood products, dose banded chemotherapy, and flu vaccines for 
hospitals). 

Framework  agreements  are  also  used  by  individual  hospitals,  including  in  Estonia, 
France, Ireland, Slovakia, and Slovenia. 

Across all study countries, routine procurement data entered in the TED database show 
that  framework  agreements  were  used  for  26%  of  all  procedures  (see  Figure  7). 
Framework  agreements  were  particularly  commonly  used  for  antineoplastic  agents 
(41% of procedures). 

Figure 7: Use of framework agreements for procurement of medicines in the study 
countries, 2008-2021 

i

g
n
v
o
v
n

l

i

s
e
r
u
d
e
c
o
r
p

f
o

n
o

i
t
r
o
p
o
r
P

s
t
n
e
m
e
e
r
g
a

k
r
o
w
e
m
a
r
f

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

All pharmaceutical products

Antineoplastic agents

Antivirals for systemic use

Antithrombotic agents

Vaccines

Framework agreement

No framework agreement

Note: Figure shows the proportion of publicly listed procedures that involved establishment of a framework 
agreement. Data were aggregated for all study countries and are shown for all pharmaceutical products (as 
a defined category in the TED database) and selected groups of products. 

Source: European Commission (TED) data [144], analysis by authors 

40 

 
 
 
 
 
 
 
 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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3.3.2.2.  Dynamic purchasing systems (DPS) 

Dynamic purchasing systems (DPS) are not yet well established in Europe. DPS is 
a  procurement  technique  for  making  recurring  purchases  while  allowing  economic 
operators to join the system  on an ongoing basis. Currently, eight countries (France, 
Ireland,  Italy,  Lithuania,  Romania,  Slovakia,  Spain,  Sweden)  are  using  DPS  for 
procurement  of  medicines  in  some  capacity.  However,  DPS  use  is  limited  in  some 
countries  and  only  some  contracting  authorities  may  use  it  (including  in  Spain  and 
Sweden).  

Other countries report favourable experiences with their DPS, including Italy where this 
procurement  technique  is  used  systematically  and  for  a  wide  range  of  off-patent 
medicines, and France, where the DPS allows quicker launching of procedures for off-
patent  medicines  compared  to  standard  procedures.  However,  DPS  in  Italy  was  only 
possible  after  transformation  of  the  EU  Procurement  Directive  [68]  into  national  law. 
The Italian Budget Law 2020 allowed application of the DPS for the call of single and 
multi-contractor open procedures; this added to an amendment in the Budget Law 2019 
which  regulated  the  purchase  of  biological  and  biosimilar  medicines  through  the 
mandatory use of framework agreements, which enhanced their uptake. 

DPS  may  gain  in  importance  for  PPM  in  Europe.  For  example,  Ireland  only  recently 
introduced  a  DPS  system  to  procure  off-patent  medicines,  following  recommendation 
for implementing this in a strategy paper by the HSE Drugs Management Programme 
[158].  Since  introduction  of  the  DPS  in  January  2020,  this  has  been  used  by  some 
groups of hospitals. The stage 1 supplier qualification is done at a national level, while 
each individual hospital agrees criteria for inclusion in the mini-competition that meets 
their individual requirements. 

3.3.2.3.  Single vs. multiple winner awards 

Study  countries  showed  some  variation  with  respect  to  the  application  of  single-  vs- 
multi-winner  contracts.  In  most  countries,  awarding  a  single  winner  remains  the 
default  for  at  least  some  medicines.  This  may  be  due  to  the  characteristics  of the 
product  in  question:  for  on-patent  products,  this  may  be  the  only  possible  award 
mechanism. In the UK, single-winner contracts are also used for products that just came 
off-patent.  However,  single-winner  contracts  may  also  be  selected  based  on  market 
characteristics:  in  smaller  countries,  a  limited  number  of  suppliers  are  typically 
operating (e.g. in Estonia and Latvia). Splitting contracts may not be feasible when there 
is a single possible supplier (for on-patent medicines). Finally, single-winner contracts 
remain widely used due to their ease of implementation. 

Single-winner contracts are also common for tendering-like systems for off-patent 
medicines in the outpatient sector. In these systems, a single product within a group 
is typically  selected  on  the  basis  of  bids and  designated as the  preferred  product  for 
dispensing and reimbursement (see also Box 1). The incentive for suppliers is that a 
winning bid contracts the entire market, or a large sub-market (for a limited period of 
time). 

However,  single-winner  contracts  raise  the  issue  of  possible  shortages  should  the 
winning supplier fail to deliver. Some countries have legal and contractual measures in 
place to mitigate this risk (e.g. a ban on exporting medicines when there is a shortage 
in the country; substituting the product for an available alternative; penalty payments 
in case of failure to supply) or use security of supply criteria in the tender specifications 
(see Chapter 3.4). 

Alternatively,  when  multiple  suppliers  are  in  the  market,  contracts  for  products  with 
competition  (either  off-patent  or  through  therapeutic  competition)  may  be  split. 
Awarding multiple winners with contracts can therefore address security of supply 

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concerns, however, depending on the respective market shares attributed to the winner 
and also their capacity to supply in case of deliveries of competitors. As shown in the 
survey conducted for this study (see also the country fiche in Annexes 4.1-4.32), multi-
award procedures have been reported for medicines used in the inpatient and outpatient 
settings. In some countries, multi-award procedures are the default for some types of 
medicines,  e.g.  for  biosimilars  (Italy),  supply-critical  products  (Austria,  Belgium, 
France), high-cost medicines used in the inpatient setting with more than one supplier 
(Estonia, Latvia), or  medicines used for national health programmes (e.g. hepatitis C 
treatment and vaccines in Ireland). Other countries award multiple winners as default 
when possible (e.g. Bulgaria, Portugal). 

As  with  all  procurement  procedures  and  techniques,  there  may  be  variation  within 
countries when procurement is de-centralised. For example, in Sweden, some regions 
use multi-winner awards for inpatient medicines, but each region has its own processes, 
including whether to use single- or multiple-winner awards. 

3.4. Award criteria 

According  to  EU  Directive  2014/24,  contracts  should  be  awarded  to  the  most 
economically advantageous tender (MEAT) which allows use of several (price and 
non-price) criteria. The MEAT is to be defined  by each CA according to its needs and 
may be based on price or cost alone, or on the best price-quality ratio. This allows for 
the inclusion of other criteria that may be relevant for the procurement of medicines, 
including  technical  and  functional  aspects,  environmental  and  social  criteria,  delivery 
conditions, and value-added services such as training and assistance. While MEAT may 
also be defined on the basis of price alone, the concept is intended to explicitly state 
which criteria are used to identify what constitutes the most economically advantageous 
offer.   

Despite the intention of promoting the use of different criteria, MEAT is only used in a 
minority  of  PPM  procedures.  Figure  8  shows  that  only  24%  of  procedures  for  all 
pharmaceutical  products  were  awarded  according  to  MEAT  criteria  across  the  study 
countries  from  2008-2021.  However,  use  of  MEAT  criteria  varies  across  therapeutic 
areas,  with  substantially  heavier  use  among  procedures  for  vaccines,  while  price 
dominates as award criterion for other categories (e.g. used for 84% of procedures for 
antineoplastic agents). 

MEAT requires transparency about the method for  assessing which tender  is the 
most advantageous, i.e. how criteria are weighted. These criteria may include price, 
which remains to be most commonly used, but in some  countries (Denmark, France, 
Ireland) some tenders were conducted where price was weighted at less than 50%. In 
the UK, where MEAT criteria are used to award most contracts for inpatient medicines, 
there is currently still a strong emphasis on costs, although other criteria also feature 
(including  product  training).  However,  there  is  an  expectation  in  the  UK  that  award 
criteria will increasingly focus on outcomes for patients.  

Including  award  criteria  other  than  price  may  result  in  higher  unit  prices.  The  use  of 
MEAT therefore requires an assessment about the willingness to pay for the added value 
generated by these additional criteria, which can be challenging and create a barrier to 
using MEAT. Accordingly, some  countries are  more hesitant in using MEAT and price 
still dominates as award criterion for PPM (see Figure 8). In Estonia and Portugal, 
while legislation provides for use of MEAT, it is rarely applied. Malta has abandoned use 
of MEAT criteria and instead awards contracts to the tender with the best price-quality 
ratio.25 Price is used in some form in essentially all procedures in Europe. However, most 

25 The best price-quality ratio can be the basis for awarding the MEAT, but other approaches, including price 

only or a cost-effectiveness approach, can also be used. Malta only applies the best price-quality ratio. 

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countries report that price is used in combination with other criteria for at least some 
procedures.  

Reasons  for  using  price  alone  were  provided  by  procurement  experts  participating  in 
stakeholder engagement activities (see Annex 5) and reviewing the PPM country fiches 
(see Annexes 4.1-4.32). These include the notion that price is the easiest criterion to 
assess,  requiring  the  least  resource  input  from  procurers.  This  may  be  particularly 
relevant for facility-based procurement where no dedicated resources are available to 
develop and assess other criteria than price. In small markets with little competition, 
price may be the only criterion to differentiate suppliers, as not all suppliers would 
be  able  to  fulfil  additional  criteria.  This  may  also  be  true  for  larger  markets  when 
procuring products that are not expected to vary with respect to any other criteria 
than price. For example, in Norway, so-called “H-prescriptions” (medicines initiated in 
specialist  care,  but  continued  in  the  outpatient  setting)  are  procured  based  on  price 
alone  because  the  products  are  considered  equal.  Quality  criteria  about  the  product 
characteristics  may  also  be  included as minimum  criteria,  e.g.  when  only  pre-filled 
syringes (rather than vials) are to be purchased. In that case, quality criteria are fulfilled 
by all potential suppliers and price remains as the only award criterion. Procurers also 
mentioned the potential for legal appeals when contracts are awarded based on 
other criteria; price – the most commonly used criterion – may therefore be the safest 
bet to avoid litigation after a procedure.  

It  should  be  noted  that  the  use  of  award  criteria  may  vary  between  individual 
procurers  within  a  country.  For  example,  different  regional  health  authorities  in 
Hungary used different award criteria to procure HPV vaccines. These ranged from price 
only  for  some  procedures  to  considering  effectiveness  in  combination  with  price  in 
others, while others used product characteristics [159]. 

Figure 8: Award criteria used in procurement procedures in the study countries, 
2008-2021 

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o

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o

i
t
r
o
p
o
r
p

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i

a
i
r
e
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r
a
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a

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p

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

All pharmaceutical products

Antineoplastic agents

Antivirals for systemic use

Antithrombotic agents

Vaccines

Lowest price

MEAT

No data

Award  c riteria used

Note: Figure shows the proportion of publicly listed procedures awarded according to lowest price or most 
economically advantageous tender criteria for all pharmaceutical products and for selected categories of 
medicines. 

Source: European Commission (TED) data [144], analysis by authors 

The literature review and workshops highlighted supply issues as key considerations 
for PPM. Security of supply can feature in the award criteria and this can be reflected 
in  combining  it  with  other  criteria  to  award  the  contract  to  the  MEAT.  Security  of 
supply  is  used  as  an  award  criterion  together  with  other  criteria  in  some  countries 

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(Belgium,  Bulgaria,  Denmark,  France,  Iceland,  Ireland,  Latvia,  Netherlands,  Norway, 
Spain, Sweden). The criterion can take different forms. For example, there may be a 
requirement for holding stock for a minimum number of months’ supply (two months in 
Iceland), or a requirement for a bank guarantee (Latvia). In other countries, security of 
supply  is  not  used  as  criterion  but  the  concept  is  acknowledged  as  important  by 
procurers.  For  example,  in  Austria,  security  of  supply  may  be  addressed  by  splitting 
contracts. In Malta, supply is partly managed through the use of delivery time in the 
tender specifications. In Bulgaria, security of supply used to be addressed through the 
requirement  for  a  certificate  from  the  bidders  to  acknowledge  awareness  of  the 
quantities  to  be  supplied.  However,  this  was  found  to  violate  the  principles  of  non-
discrimination and equal treatment in public procurement by a court.  

Non-compliance of suppliers with contractual obligations (e.g. non-delivery, delays) 
is perceived as a major issue for procurers. Penalties in case of non-compliance can be 
built into contracts, and reporting of shortages by the supplier can be enforced through 
penalties.  Monitoring  of  shortages  may  also  require  cooperation  between  public 
institutions  to  allow  procurers  to  react  in  a  timely  fashion:  in  Italy,  notifications  of 
upcoming shortages submitted to the regulatory body, AIFA, are shared with the CPB, 
Consip. 

Local production does not play an important role for PPM in Europe. The criterion is 
not  used  in  18  of  the  32  study  countries,  and  information  was  missing  for  13.  Local 
production criteria may run against legal provisions about fair competition. In Belgium, 
no local criteria are used, but production in a “low risk” region is applied as criterion. 
France is planning on using it to address security of supply issues in upcoming tenders 
but has not yet implemented it. 

Environmental criteria are not yet widely used in PPM. Pilot projects are underway in 
some countries and using public procurement to achieve environmental goals is clearly 
a topic of interest to procurers and policy makers. For example, the Austrian government 
has published a guide for sustainable procurement [160]. However, due to the mostly 
decentralised  nature  of  PPM,  uptake  of  the  recommendations  for  pharmaceutical 
procurement  remains  to  be  seen.  Activities  in  other  countries  also  show  increased 
awareness about incorporating the  environment into public procurement (e.g. the EC 
has  issued  a  handbook  on  green  public  procurement  [161],  the  public  procurement 
office  in  Slovakia  created  a  working  group  on  this  topic  [162],  in  Czech  Republic,  a 
research project investigated uptake of green procurement (following 2020 adaptions 
in  the  Waste  Act  and  the  End-of-Life  Products  Act)[163]),  and  in  Cyprus  tendering 
documents and contracts may include environmental aspects.  

Scandinavian  countries  have  gained  more  experience  with  environmental 
criteria for procurement of pharmaceuticals. In Norway, the CPB for hospitals (LIS) 
has  included  environmental  criteria  about  the  manufacturing  of  antibiotics,  which 
contribute 30%  to  the  award  criteria  [164].  LIS acknowledge  that  the  environmental 
standards  it  desires  may  not  be  attainable  by  all  suppliers  and  that  performance  on 
these  indicators  would  need  to  be  assessed  comparatively,  i.e.  selecting  the  supplier 
that  performs  best  among  its  peers.  In  Denmark,  the  CPB  for  hospitals  (Amgros) 
reported  overall  positive  experience with  the  inclusion of  environmental  criteria in its 
tenders, including for joint Nordic tenders with Norway and Iceland (see Annex 5 and 
[165]). Criteria used so far have focused on packaging and transport (documentation 
on  what  the  suppliers  have  done  to  prevent  pollution  and  wastewater)  and  were 
developed after intensive consultations with suppliers. Suppliers were able to fulfil the 
criteria,  and  the  number  of  bids  did  not  change  after  these  additional  criteria  were 
added. However, assessing additional criteria requires more resources on behalf of the 
procurers.  For  further  information  on  environmental  and  further  award  criteria  in 
hospital procurement see also Chapter 5.2.9). 

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Overall, the use of environmental criteria is still continuing to evolve. Stakeholders from 
both  the  procurer  and  supplier  side  have  mentioned  issues  with  identifying  suitable 
criteria that are meaningful and operational at the same time (see Annex 5). 

Added  therapeutic  value is  used  as  an  award  criterion  in  some  countries.  In  most 
cases,  this  only  relates  to  medicines  used  in  the  hospital  setting  and  is  not  used 
systematically  (Belgium,  Germany,  Denmark,  Ireland,  Netherlands, Norway, Sweden, 
Slovakia),  although  Spain  also  applies  it  in  the  outpatient  setting.  In  Estonia,  added 
therapeutic value has been used for procurement of the HPV vaccine. Added value may 
be assessed by external bodies, e.g. HTA bodies or other institutions collaborating with 
procurers  (e.g. in  Denmark, the Danish  Medicines  Council provides  an assessment  of 
the  therapeutic  value  of  new  hospital  medicines,  and  this  information  is  used  by  the 
procurement body, Amgros, when conducting price negotiations with manufacturers). 
Added therapeutic value was not reported to be used in most other countries (Austria, 
Bulgaria,  Cyprus,  Finland,  France,  Hungary,  Iceland,  Italy,  Lithuania,  Luxembourg, 
Latvia, Malta, Poland, Portugal). 

Additional details on the use of different award criteria for procurement of medicines in 
the hospital setting are provided in Chapter 5.2.9. 

3.5. Supporting tools and impacting policies 

PPM  policy  and  practices  are  to  be  seen  in  the  larger  context  of  pricing  and 
reimbursement policies, and their supporting tools. 

3.5.1. Horizon scanning and HTA 

Horizon scanning is considered a valuable but resource-intensive tool both generally 
and  in  the  context  of  PPM  (i.e.  as  a  preparatory  measure  for  strategic  procurement 
decisions and preparation of procedures). The current leading horizon scanning system 
is  the  International  Horizon  Scanning  Initiative  (IHSI),  a  spin-off  of  the  Beneluxa 
Initiative  (a  cross-country collaboration  that,  among  others,  aims  to  jointly  negotiate 
prices but does not aim to conduct joint procurement).  

Some  countries  involved  in  the  Nordic  Pharmaceutical  Forum  (Denmark,  Norway, 
Sweden) are also members of IHSI [48]. These countries also have their own horizon 
scanning  systems  as  part  of  systematic  approaches  to  introducing new  medicines. In 
the case of Denmark, horizon scanning is done by the CPB for the hospital sector, and 
in Sweden, the regions (who are responsible for procurement of specialist medicines) 
are collaborating on horizon scanning. In Norway, this is conducted by the Norwegian 
Medicines  Agency (NoMA)  which  does  not  conduct procurement  itself.  In  the  UK,  the 
PharmaScan  database  is  used  to  systematically  identify  emerging  medicines.  In  its 
framework  for  commercial  agreements  about  market  introduction  of  new  medicines, 
NHS  England  includes,  as  the  first  step  towards  market  access,  manufacturers 
submitting information about new products to the database [166]. Other countries with 
horizon  scanning  systems  in  place  (although  not  always  used  systematically)  include 
Austria,  Cyprus,  Ireland,  Italy,  Lithuania,  Malta,  and  the  Netherlands.  The  recently 
adopted EU Regulation on health technology assessment (HTA) also foresees a “horizon 
scanning” activity aimed at facilitating joint HTA (Art 22) [167]. 

HTA is conducted in all study countries, however, there is variation in how much HTA 
is  embedded  in  the  pricing  and  reimbursement  process  and  how  sophisticated  the 
methodology  is  [6].  With  regard  to  procurement,  HTA  seems  not  to  be  applied  in 
procurement  processes  with  the  exception  of  procurement  bodies  who  purchase 
centrally for the whole country or a region (e.g. Amgros in Denmark, individual regions 
in Sweden). HTA – typically performed by a dedicated body or unit, or outsourced to 
third  parties  –  may  be  used  by  procurers  in  the  preparation  of  negotiations  when 
introducing new medicines.  

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3.5.2. Managed-entry agreements 

For monopoly medicines with high price tags (e.g. cancer medicines, orphan medicinal 
products) and sometimes also low-price, high-volume products with high budget impact, 
the  study  countries  frequently  negotiate  so-called  managed-entry  agreements 
(MEAs),  either  financial  or  performance-based  [168-171].  Procurement  bodies  are 
usually not involved in these negotiations which are led by payers or pricing authorities. 
However,  a  few  CPBs  (e.g.  the  Ministries  of  Health  in  Malta,  Amgros  in  Denmark) 
reported negotiating MEAs, and hospitals may also conclude MEAs on their own in some 
countries  (see  Chapter  5.2.6).  In  some  countries,  pricing  and  reimbursement 
authorities also act as CPBs for some medicines. In these cases, MEAs are also concluded 
by the procuring body (e.g. NEAK in Hungary). If procurers are not involved in MEAs, 
they may not know the negotiated discounted price (e.g. reported from Portugal [32]); 
their  reported  savings  from  PPM  are  thus  overestimated  as  based  on  the  official  list 
prices. 

3.5.3. PPM-supporting elements 

Several but not all countries have national procurement strategies in place. In some 
cases, these are regularly or  semi-regularly updated.  Procurement strategies may be 
used  to  map  out  major  reforms  in  the  procurement  set-up,  as  has  happened  in 
Bulgaria where reforms including the establishment of a CPB for the health sector were 
laid  out  in  a  national  procurement  strategy;  in  Ireland,  where  plans  for  the  (now 
implemented)  establishment  of  a  DPS  and  leveraging  of  joint  purchasing  power  for 
hospital  medicines  were  described;  and  in  Greece,  where  major  reforms  including  a 
centralisation of procurement was planned. In other countries, procurement strategies 
relate to the operational principles of conducting efficient procurement (e.g. Amgros 
in  Denmark  follows  a  strategic  approach  to  procurement  along  the  pharmaceutical 
product life cycle; the NHS in England has issued frameworks for commissioning of new 
medicines and biologicals; and LIS in Norway has published a strategy for how to further 
develop the organisation).  

Procurement strategies also exist for non-centralised procurement. For example, NHS 
hospital  trusts  in  the  UK  regularly  publish  their  procurement  strategies  which  may 
include  considerations  about  the  general  vision  for  procurement,  approaches  to 
procurement  (category  management  and  value-based  procurement),  involvement  of 
stakeholders,  and  supply chain  transformation,  as  well  as operational considerations, 
such as use of contract management and stock management.26 

Another  important  supporting  tool  for  optimising  PPM  is  capacity-building  for 
procurement  staff.  For  example,  national  procurement  agencies  in  Bulgaria  and 
Sweden, which are not involved in procurement themselves, provide basic and advanced 
training  to  public  procurers.  These  agencies  may  also  offer  guidance  and  support  to 
procurers on specific topics, e.g. on green procurement in Sweden. In other countries, 
training is mostly hands-on, which may include dedicated training sessions on specific 
procurement  procedures  (e.g.  Denmark,  Estonia,  Italy,  Malta).  In  the  UK,  a  general 
framework  (not  specific  to  health)  exists  to  guide  capacity  building  among  public 
procurers (Commercial Skills and Competency Framework). 

Other important supporting policies that are widely used across the study countries and 
conducted by procurers include market research in preparation of tenders and needs 
assessment of the users of medicines.  

26 See for example the published procurement strategies of Frimley, Oxford University Hospitals, and Salisbury 

NHS foundation trusts [172-174]. 

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3.6. PPM procedures and practices for biosimilar medicines 

In most countries, no unique PPM processes are used to procure biosimilar medicines 
(i.e. there are no specific procedures  or techniques that are only used for biosimilars 
and not for other medicines). For example, in Denmark, England, and Spain, framework 
agreements are generally used by national or regional CPBs for off-patent medicines in 
the  inpatient  setting,  including  for  generic  (non-biological)  and  biosimilar  products, 
Cyprus generally uses open procedures for off-patent products, including for biosimilars, 
Lithuania  includes  biosimilars  in  its  regular  centralised  procurement  processes  for 
hospital medicines, and in Italy and France, DPS are also mostly used for these products. 
Some countries exclude biosimilars from tendering (e.g. Latvia). 

Procurers are aware of the specificities of biosimilars – in particular, the complex 
nature of these products and the patents protecting intellectual property rights, large 
potential  for  cost  savings  compared  to  biological  originator  products,  and  potential 
actual  or  perceived  limitations  regarding  their  interchangeability  –  and  use  existing 
practices accordingly [42]. This relates in particular to the frequency of procedures, 
which are longer for biological medicines compared to others in a number of countries 
(e.g. every two years in Ireland, and for centralised tenders in Hungary, Sweden, and 
the UK, every four years in Malta), although not in all (e.g. annual tenders in Poland). 
In addition, preparation of tenders for biological medicines may require additional input 
from clinical specialists and hospital pharmacists. Involving specialists may also help 
ensuring that the winning product is used, as – despite existing evidence demonstrating 
interchangeability  of  reference  products  and  biosimilars  with  respect  to  efficacy  and 
safety  [175]  -  there  is  still  some  scepticism  among  prescribers  and  patients  (see 
Chapter 5.4.3). 

Due to their cost-saving potential, biosimilars are often targeted in pilot schemes to 
optimise PPM, e.g. through centralised or other joint procurement forms. In Estonia, 
the  CPB  at  the  health  insurance  fund  is  expanding  its  mandate  to  procure  more 
medicines  used  in  the  inpatient  setting,  including  those  with  the  highest  cost 
containment potential (previously conducted at hospital level). This expansion follows 
successful pilot projects for centralised procurement of biosimilars. Another example of 
novel  procurement  practices  being  used  for  biosimilars  is  Ireland.  These  cases  are 
described  in  a  dedicated  chapter  in  the  PHIS  hospital  procurement  update 
included in this report, which provides more details on biosimilar use and procurement 
in the inpatient setting (see Chapter 5.4). 

A  key  supporting  policy  for  procurement  of  biosimilars  is  the  monitoring  of  patent 
expiry dates. This provides procurers with the market knowledge required to design 
efficient procedures, including when to issue new tenders. Patent expiries are used to 
inform  the  timing  of  tenders  in  Belgium,  Croatia,  Cyprus,  Denmark,  Estonia,  France, 
Hungary, Lithuania, Norway, and the UK, although other countries may also apply this 
practice. In England, guidance was developed by the NHS for procurement of biological 
medicines. This guidance highlights the importance of timing of procedures being in line 
with  market  entry  of  biosimilars,  but  also  includes  considerations  about  supporting 
mechanisms to ensure uptake of biosimilars, e.g. by implementing a switch programme 
through a local project management approach that involves all stakeholders [176].  

An instrument to ensure optimal use of potential cost savings through biosimilar use is 
to have flexibility in contracts to allow issuing new tenders when biosimilars become 
available. An example is England, where shorter contract durations are used for products 
that just came off-patent. The regular two-year cycle of tenders may also be interrupted 
by  so-called  transition  tenders  which  are  used  to  place  new  products  on  the  market 
[176].  In  Romania,  contracts  may  also  be  opened  when  new  competitors  become 
available, but this has not been used in practice yet.  

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Monitoring of patent expiries is not necessarily done by the procurers themselves.  In 
Lithuania, public institutions including the State Patent Bureau and the State Medicines 
Control  Agency  collaborate  to  monitor  patent  expiries  and  possible  market  entry  of 
competitor products.  

In the outpatient setting, countries that have tendering-like systems in place may 
have specific provisions for biological medicines within them. In Hungary, price bids for 
biosimilars are submitted every year, rather than every six months (as is the case for 
other generic products), to identify the preferred product that is reimbursed at 100%. 
The  longer  time  frame  is  intended  to  avoid  frequent  switching  of  patients  [177].  In 
Germany,  some  sickness  funds  specify  a  target  discount  rate  for  specific  active 
substances and then  contract with any supplier willing to provide that  rate (so-called 
“Open House” contracts) [119]. Biosimilar substitution is not allowed in countries using 
tendering-like  systems,  including  Germany,  Denmark,  Hungary,  and  the  Netherlands 
(see Chapter 5.4.3.3), although this was planned to be introduced in Germany in 2022. 

Another  specificity  of  biosimilar  procurement  is  the  scope  for  supplier  actions  to 
effectively extend the period of market exclusivity for originator products. Such 
actions include contractual agreements and pricing structures, patient schemes, as well 
as  legal  rulings  on  multiple  patents  protecting  intellectual  property  rights  (known  as 
“patent  thickets”  in  the  US  [178])  that  impede  market  entry  or  significant  uptake  of 
competitor products. Recent examples of such cases in the Netherlands and Romania 
are described in Box 2. 

Box 2: Examples of supplier practices impeding biosimilar competition 

Netherlands: discount scheme to tie hospitals to originator etanercept 

In the Netherlands, the manufacturer of originator etanercept, Pfizer, recently had to abandon a pricing 
strategy that effectively locked hospitals into purchasing their product rather than switching to cheaper 
biosimilars. Supply contracts for the purchase of originator etanercept included clauses that 
disincentivised switching to competitor products, as discounts agreed with Pfizer would decrease in line 
with reduced future purchase volumes. Hospitals attempting to switch to biosimilars would therefore lose 
access to the originator product at the negotiated price. The Netherlands Authority for Consumers and 
Markets investigated these contracts and found that they were likely to breach competition rules, 
leading to the manufacturer agreeing voluntarily to stop using the discount clauses in its contracts. 

Romania: delaying market entry of biosimilars for rituximab, trastuzumab, and erlotinib 

In Romania, the manufacturer of originators rituximab and trastuzumab, Roche, was found guilty for two 
different sets of practices impeding market entry and uptake of biosimilar products in the national 
centralised procurement system. In the first case, the manufacturer offered its products to wholesalers 
participating in a national tender for rituximab and trastuzumab at a higher price than its own bid. This 
practice ensured that the wholesalers, who – if successful in winning the tender – could also supply 
competitor products, would not win a national contract, thereby effectively cementing the monopoly 
position of the originator products.  

In the second case, the manufacturer was found guilty for delaying market access for biosimilar erlotinib 
by steering patients towards its own product using a patient card, call centre, and by subsidising the 
price difference between the originator and biosimilar products in order for patients to continue using 
the originator. 

Belgium: including free-of-charge additional services in bids to hospitals 

In Belgium, it is not allowed to request (by a hospital) or provide (by a supplier) a medicine with free of 
charge additional services including patient support programmes or training on the correct use of the 
product and educational material or software for patient monitoring. In addition, services (such as 
software) that are not related to the supply of medicines cannot be integrated in any way (even at cost) 
to a request or offer. 

The Belgian medicines agency FAMHP reminded both hospitals and suppliers in 2019 that it is illegal to 
do so and that the law on medicinal products allows a range of penalties for a violation of the 
specifications. FAMHP also insisted that the hospital, as a contracting authority, must respect equal 
access and fair competition. 

Source: [179-181] 

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4.  EVALUATION OF THE IMPACT OF PPM 

The third specific objective of this study was to measure the impact of PPM in the study 
countries  due  to  optimised  practice  in  PPM,  aiming  to  answer  the  following  study 
question: how can PPM contribute to different policy objectives? 

Actual  and  potential  impacts  were  assessed  through  a  mix  of  methods.  Firstly, 
quantitative data on procurements conducted in Europe from 2008-2021 as well as data 
on  pharmaceutical  sales  in  that  period  were  used  to  assess  the  relationship  between 
PPM  practices  and  a  set  of  six  policy  objectives  (availability  and  affordability  of 
medicines, competition in the market, security of supply, protecting the environment, 
and  crisis  preparedness,  see  Chapter  2.5.3).  Secondly,  stakeholders  were  asked  to 
assess  the  potential  contribution  of  different  PPM  practices  on  each  of  these  policy 
objectives (see Chapter 2.4.3 and Annex 7). Stakeholder views on the impact of PPM 
on  different  policy  objectives  were  also  voiced  during  stakeholder  workshops  and 
interviews  (see  Chapters  2.4.1  and  2.4.2  and  Annex  5).  Finally,  evidence  on  PPM 
impacts from published studies was also taken into consideration. 

4.1. Impact of PPM procedures and practices on access to medicines 

Access  to  medicines  is  conceptualised  as  consisting  of  two  core  components: 
affordability and availability of medicines. Key findings regarding the relationship of PPM 
and  access  to  medicines  based  on  the  triangulation  of  quantitative  analysis  of 
procurement  and  sales  data,  online  survey  of  stakeholders,  and  qualitative  research 
with stakeholders are summarised in Box 3. Detailed results are described below. 

Box 3: Key findings: PPM processes and access to medicines 

 

 

 

Countries with more mature PPM systems (using more centralised PPM, using a variety of 
practices, applying MEAT, and using supporting policies) are those with higher public spending 
on medicines. 

The relationship between maturity of PPM systems and availability of newly marketed 
medicines (i.e. number of medicines included in the reimbursement list) is heterogeneous, as 
countries with high, moderate, and low degrees of PPM are generally all able to have most 
products available at some point (not taking into consideration differences in time to availability). 
However, accounting for data inconsistencies, countries with high degree of PPM appear to have 
more new medicines included in their reimbursement lists compared to other countries. 

Stakeholders generally view PPM as an important tool to improve access to medicines, although 
there were discrepancies in how specific forms of procurement were assessed: while authorities 
considered centralised PPM at national level to be the most likely to positively impact on 
access to medicines, procurers themselves assessed centralised PPM at regional level as most 
beneficial, and suppliers considered less centralised forms of procurement to be contributing 
most. 

Source: Authors 

Figure  9  shows  the  relationship  between  maturity  of  PPM  systems  and 
pharmaceutical expenditure. Countries with a higher degree of PPM (i.e. countries 
with  more  centralised  procurement,  applying  different  forms  of  procurement,  using 
MEAT  criteria, and using supporting policies) have higher average public spending on 
pharmaceuticals  (as  proportion  of  total  public  health  expenditure)  compared  to 
countries  with  low  degrees  of  PPM,  but  not  compared  to  countries  with  moderate 
degrees  of  PPM.  This  suggests  a  complex  relationship  between  PPM  system  and 
medicines  affordability.27  In  fact,  the  top-6  highest-spending  countries  all  come  from 
the heterogeneous group of countries with moderate degree of PPM. The comparison of 
countries with high vs. low degrees of PPM suggests that high degrees of PPM are often 
observed in countries that spend more on pharmaceuticals (see Chapter 4.2.1 for the 
analysis of degree of PPM and proxy unit prices). It is important to note that the maturity 

27 Ranking of countries and assignment to groups of high, moderate and low degree of PPM is provided in 

Annex 9. 

49 

 
 
 
 
 
                                                 
Study on Best Practices in the Public Procurement of Medicines – 
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of  the  PPM  system,  as  defined  in  this  study,  is  linked  to  other  characteristics  of  the 
pharmaceutical care set-up which impact on access to medicines, e.g. the systematic 
use  of  HTA  and  horizon  scanning.  Furthermore,  it  is  likely  that  other,  unmeasured 
characteristics  of  more  developed  pharmaceutical  systems  are  associated  with  a 
strategic approach to PPM.  

Figure 9: Relationship between degree of PPM and affordability of medicines 

1

6

11

16

21

26

31

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Degree of PPM

Pharmaceutical expenditure

Note: Figure  shows  31  study countries  (no  data  available  for  Liechtenstein) ranked  by degree  of  PPM  (left 
column) and corresponding rankings for pharmaceutical spending, measured as the proportion of public health 
expenditure spent on pharmaceuticals in 2019 (or latest available year). 

Source: Authors’ analysis based on PPM country fiches and Eurostat [150] 

50 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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Figure 10: Relationship between degree of PPM and availability of new medicines 

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Degree of PPM

Availability of medicines

Note: Figure  shows  31  study countries  (no  data  available  for  Liechtenstein) ranked  by degree  of  PPM  (left 
column) and corresponding rankings for availability of newly approved medicines in Europe from 2017-2020. 
Availability  typically  means  that  products  are  included  in  the  reimbursement  list  in  that  country.  Data  on 
availability were limited for Malta (group of countries with high degree of PPM), Cyprus, and Croatia (both 
moderate degree of PPM). 

Source: Authors’ analysis based on PPM country fiches and IQVIA/EFPIA [151] 

51 

 
 
 
 
 
 
 
 
 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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Figure 10 shows a similarly complex picture of the relationship between PPM maturity 
and availability of medicines. Countries with high degree of PPM had, on average, 
similar numbers of newly marketed medicines included in their reimbursement lists as 
countries with moderate or low degree of PPM. This relationship may be impacted by 
limited data availability for new medicines for Malta, one of the top-ranked country in 
terms  of  degree  of  PPM.28  When  Malta  is  excluded,  the  group  of  countries  with  high 
degree  of  PPM  achieved  considerably  better  availability  than  the  other  two  groups  of 
countries.  Nevertheless,  the  picture  remains  heterogeneous:  of  the  top-10  ranked 
countries in terms of availability, two have high degree of PPM, seven moderate degree, 
and one low degree of PPM. 

The  notion  that  countries  with  high  degree  of  PPM  may  achieve  better  availability 
outcomes is  supported  by  the  analysis  of  stakeholder  responses  to  the  online  survey 
conducted as part of this study (Figure 11). While authorities from the study countries 
considered  centralised  PPM  at  national  level  to  be  the  most  likely  to  positively 
impact  on  access  to  medicines  (followed  by  centralised  PPM  at  regional  level), 
procurers  themselves  assessed  centralised  PPM  at  regional  level  as  the 
organisational  form  most  likely  to  contribute  to  access  to  medicines.  The  analysis  of 
availability  of  new  medicines  (measured  as  eligibility  for  reimbursement)  appears  to 
support the notion of generally better availability of medicines in countries with more 
centralised  procurement  systems  compared  to  countries  with  highly  decentralised 
systems.29 Suppliers, on the other hand, often considered less centralised forms of 
procurement to be more beneficial. 

The  views  of  public  authorities  and  procurers  as  obtained  through  the  online  survey 
were  also  confirmed  through  workshops  and  interviews  with  stakeholders  and 
procurement experts, as well as documented in the literature. For example, centralised 
procurement of biosimilars in Norway – accompanied by an institutionalised and well-
respected  set-up  of developing  and  disseminating  treatment  recommendations –  was 
found to contribute to lower prices [30]. Similarly, centralised procurement of hospital 
medicines in Denmark was found to lead to higher numbers of patients being treated 
with biosimilars [182]. However, centralised procurement does not necessarily result in 
improved access to medicines. An example is Hungary, where centralised tenders for 
granulocyte-colony  stimulating  factors  (G-CSFs)  conducted  by  the  National  Health 
Insurance Fund Administration (NEAK) resulted in reduced expenditure, but also a slight 
decrease in the number of patients treated [177]. While the reasons for the decrease in 
the  number  of  patients  treated  is  not  clear,  this  experience  highlights  the  need  for 
careful implementation of centralised procurement.  

The pharmaceutical industry is sceptical of the contribution of more centralised 
forms of procurement to access to medicines. As shown in Figure 11, suppliers 
(representing manufacturers of generic medicines) mostly considered centralised PPM 
at regional and national level as barriers to access to medicines. Representatives from 
the research-based industry (who did not participate in the online survey) also do not 
consider organisational forms of procurement that pool purchases (joint procurement) 
as suitable for  regular  procurement and instead view this as procurement instrument 
for exceptional circumstances [61]. 

28 Malta, alongside Cyprus and Luxembourg were included for the first time in the 2021 IQVIA/EFPIA Patient 
W.A.I.T. survey that are used to measure availability of medicines and submitted an incomplete data set 
[151]. 

29  Figure  10  shows  the  relationship  between  availability  of  medicines  and  degree  of  PPM,  which  includes 
centralised procurement as a sub-indicator. A similar pattern emerges when restricting the analysis to the 
organisational  forms  of  procurement  used  in  the  study  countries  (centralised  PPM  at  national  level, 
centralised PPM at regional level, group procurement, facility-based procurement; data not shown). 

52 

 
 
 
 
 
                                                 
Study on Best Practices in the Public Procurement of Medicines – 
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Figure 11: Level of PPM (within a country) most likely to contribute to access to medicines (responses >3 per stakeholder group), per stakeholder 
group 

60%

50%

40%

30%

20%

10%

0%

++

+

0

-

--

++

+

0

-

--

++

+

0

-

--

++

+

0

-

--

Facility-based

Group procurements

Regional CPM

Centralised CPM

Authority

5%

27% 14% 5%

9%

9%

27% 5%

14% 0%

9%

27% 5%

14% 0%

41% 23% 0%

Procurer

17% 17% 39% 11% 0%

22% 33% 28% 0%

0%

22% 33% 28% 0%

0%

28% 50% 6%

0%

0%

0%

6%

Supplier

54% 8%

15% 0%

0%

8%

23% 23% 23% 0%

8%

23% 23% 23% 0%

46% 0%

8%

23% 15%

Source: Online survey

53 

 
 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
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A positive contribution of PPM to access to medicines can be expected across 
the  spectrum  of  medicines.  In  an  online  survey  conducted  as  part  of  this  study, 
stakeholders  considered  a  strategic  approach  to  procurement  to  be  almost  equally 
beneficial for access to high-cost medicines, on-patent medicines, off-patent medicines, 
biosimilars,  orphan  medicines,  oncology  medicines,  and  vaccines  (detailed  results 
shown  in  Annex  7).  Furthermore,  stakeholders  also  mentioned  potentially  positive 
contributions  of  PPM  for  access  to  medicines  with  analogue  competition  (i.e.  where 
therapeutic alternatives exist), older medicines with no alternatives, medicines with low 
supply  volume  but  that  are  clinically  important,  and  some  specific  medicines  (anti-
infectives and antimicrobials). 

4.2. Impact of PPM procedures and practices on affordability of medicines 

Affordability of medicines is defined as the ability of a patient or a health system to pay 
for  the  medicines  they  need.  Key  findings  regarding  the  relationship  between  PPM 
practices and affordability are summarised in Box 4 (detailed results shown below). 

Box 4: Key findings: PPM practices and affordability 

 Lower average proxy unit prices were generally observed in countries with higher degrees of 
PPM (i.e. using more centralised PPM, using a variety of practices, applying MEAT, and using 
supporting policies). This is consistent with previous studies which have generally found that joint 
procurement (e.g. through the use of a CPB) results in lower prices. Within study countries, 
savings from PPM compared to list prices or historic spending have been reported between 1% 
and 40-50%. 

 While more mature (and centralised) PPM systems appear to be found in countries with lower 

unit prices, the relationship between affordability and specific PPM characteristics is not 
straight-forward: lower average proxy prices were observed in countries with lower numbers of 
procedures conducted by CPBs, procedures under framework agreements, and procedures using 
MEAT criteria to award contracts. However, use of CPBs, framework agreements and MEAT 
criteria are associated with countries with highly developed pharmaceutical pricing and 
reimbursement systems with generally higher price levels.  

 Stakeholders from the public sector generally consider PPM to positively impact 

affordability. More advanced procurement practices, such as the use of framework agreements, 
DPS, and application of MEAT criteria were assessed as contributing to improved affordability in 
an online survey.  

 Multiple-winner award procedures were considered to have a positive impact on affordability 

compared to single winner tenders, as assessed through stakeholder consultation. In particular, 
suppliers saw potential for a negative impact on affordability through some practices, such as 
winner-takes-it-all. 

 Stakeholders also stressed the importance of adjusting the use of the different PPM procedures 

and techniques according to the type of product procured. 

 There are possible trade-offs between affordability and other policy objectives, in 

particular greener manufacturing and transport and security of supply. 

Source: Authors 

4.2.1. Relationship between centralised procurement and affordability 

Pooling of purchase volumes and using PPM practices according to the type of medicine 
to be procured is expected to lead to reduced prices. Data analysed for this study shows 
that  lower  unit  prices  were  observed  in  countries  with  more  mature  PPM 
systems  (see  Figure  12). Approximated  unit prices  were  averaged  across  countries 
with low, moderate or high degree of PPM and are displayed in relation to the highest 
average  proxy  unit  price  across  these  three  groups.  This  mode  of  presentation  was 
selected  to  display  all  five  tracer  groups  together  which  required  accounting  for 
differences in absolute unit prices across product groups. Across all five tracer product 
groups, the lowest average proxy unit prices were found in the group of countries with 
high  degree  of  PPM  (i.e.  using  more  centralised  PPM,  using  a  variety  of  practices, 
applying MEAT, and using supporting policies). While the analysis does not account for 

54 

 
 
 
 
 
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other factors that may impact on unit prices, it is in line with most studies assessing the 
relationship  between  PPM  and  affordability  of  medicines,  which  have  tended  to  find 
savings associated with more centralised procurement [41]. 

Within  individual  countries,  reported  savings  from  centralised  procurement 
ranged  from  marginal  gains  to  substantial  savings.  For  example,  savings  from 
centralised  procurement  for  pharmaceutical  and  other  consumables  in  hospitals  in 
Croatia  amounted  to  approximately  1%  in  2019,  whereas  the  CPBs  for  hospitals  in 
Denmark  and  Norway  reported  average  savings  of  42.3%  and  49%,  respectively, 
compared  to  retail  prices  in  2021  [183,  184],  and  the  MoH  in  Cyprus  performing 
nationally  centralised  PPM  reported  savings  of  50.7%  in  2017  based  on  tender  price 
compared to lowest wholesale prices (list prices) [18]. In England, the joint procurement 
of antiretroviral drugs for treatment of HIV/AIDS through joint therapeutic tenders by 
clinics in London saved 5.2% of annual expenditure on these drugs between 2011 and 
2014 [185]. 

Figure 12: Relationship between degree of PPM and proxy unit prices 

o
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Antineoplastic agents

Antivirals for systemic use

Antithrombotic agents

Immunosuppressive agents

Vaccines

Countries with low
degree of PPM

Countries with
moderate degree of
PPM

Countries with high
degree of PPM

Note: Figure shows aggregated data for 2008-2021 for countries with low, moderate, or high degree of PPM 
and the average proxy unit price in those countries for five categories of medicines. The vertical axis shows 
the average approximated unit price for the five categories of medicines in relation to the maximum average 
approximated unit price within that category (e.g. for antineoplastic agents, the maximum average proxy unit 
price was observed in countries with low degree of PPM; for this category of medicines, the average proxy 
unit  price  in  countries with  moderate  degree of  PPM  was  90%  of  that  maximum  average  unit  price,  etc.). 
Proportional unit prices were used to avoid distorting the scale of the figure (unit prices varied approximately 
200-fold across the different categories of medicines).  

Source: Authors’ analysis based on IQVIA [145] and PPM country fiches 

While  proxy  unit  prices  were  lowest  in  countries  with  more  mature  PPM  systems 
according  to  the  composite  “degree  of  PPM”  indicator,  zooming  in  on  specific 
characteristics  of  PPM  practices  reveals  the  complexities  of  the  relationship  between 
prices  and  PPM  practices.  Countries  with  a  higher  share  of  procurement 
conducted  by CPBs  had  higher  approximated  unit  prices  (see  Figure  13).  The 
highest  average  approximated  unit  prices  for  product  groups  representing  medicines 
with high shares of on-patent products (antineoplastic agents), products with analogue 
competition  (antivirals  for  systemic  use),  products  with  biosimilar  competition 
(immunosuppressive agents), and vaccines were observed in Denmark, the only country 
with 40-59% of procedures conducted by a CPB, followed by two countries with 20-39% 
of procedures conducted centrally at national level (Norway and Luxembourg; the latter 
only procures vaccines centrally). For products with high levels of generic competition 
(antithrombotic agents), the highest average approximated unit price was observed in 

55 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
Final Report 

countries with 20-39% of procedures conducted by CPBs, followed by Denmark (40% 
or more of procedures conducted by a CPB). 

Figure 13: Relationship between use of central purchasing body in a country and proxy 
unit prices 

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Antineoplastic agents

Antivirals for systemic use

Antithrombotic agents

Immunosuppressive agents

Vaccines

0-19%

20-39%

40-59%

Proportion  of procedures  awarded by a c entral purc hasing  body

Note: Figure  shows  aggregated  data  for  2008-2021 for  the proportion of procedures  awarded by  a central 
purchasing body (CPB) in a country and the average proxy unit price in that country for five categories of 
medicines. Countries were grouped according to the proportion of procedures awarded by a CPB for each of 
the five categories of medicines (horizontal axis; no country had more than 59% of procedures awarded by a 
CPB).  Note  that  the  40-59%  category  comprises  only  one  country:  Denmark.  The  vertical  axis  shows  the 
average  approximated  unit  price  for  the  five  categories  of  medicines  in  relation  to  the  maximum  average 
approximated unit price within that category (e.g. for antineoplastic agents, the maximum average proxy unit 
price  was  observed  in  the  country  with  40-59%  of  procedures  awarded  by  a  CPB;  for  this  category  of 
medicines, the average proxy unit price in countries with 0-19% procedures awarded by a CPB was 51% of 
that maximum average unit price, etc.). Proportional unit prices were used to avoid distorting the scale of the 
figure (unit prices varied approximately 200-fold across the different categories of medicines).  

Source: Authors’ analysis based on IQVIA [145]and TED data [144] 

The finding is at odds with general findings about the price impact of pooling purchase 
volumes  (e.g.  through  joint  procurement  or  through  centralised  procurement  for 
multiple contracting authorities) and may be explained by generally higher price levels 
in countries that use CPBs extensively.30 This highlights the methodological challenges 
of the ecological analysis described in Chapter 2.5.3.3. 

There  was  limited  evidence  on  efficiency  gains  from  PPM  available  from  peer-
reviewed studies for most study countries. There is evidence from Italy that central 
procurement  (through  a  CPB)  leads  to  lower  prices  for  medicines  [33],  as  well  as  a 
decrease  in  health  expenditure,  although  the  contribution  of  pharmaceuticals  to  an 
overall  decrease  in  spending  may  be  small  compared  to  other  categories  [21].  In 
Cyprus,  the  largest  savings  from  CPM  were  observed  for  generic  medicines  (94.8% 
reduction in expenditure for the same volume of products), although savings were also 
made for branded medicines (33.4% reduction) [16]. Another Italian study found that 
tendering for biosimilars led to expected results, with prices decreasing as the number 
of  competitors  increases  [23].  Similarly,  a  Norwegian  study  that  explored  the 
competition effect of biosimilar entry in centralised tenders for TNF-inhibitors found that 
in this group prices for biological medicines decreased as more competitors entered the 
market, and that the Norwegian strategy of promoting biosimilar uptake and thereby 

30 The three countries with the highest use of CPBs according to TED data (Denmark, Luxembourg, Norway) 
are also the three top-ranking countries in a comparison of pharmaceutical prices across European countries 
[186]. 

56 

 
 
 
 
 
 
                                                 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study on Best Practices in the Public Procurement of Medicines – 
Final Report 

increased biosimilar market share was accompanied by lower average prices paid [30]. 
The  potential  for  a  centralised  system  for  procuring  hospital  medicines  and 
implementing system-wide therapeutic changes was also demonstrated through savings 
of more than 80% after a nation-wide switch from originator adalimumab to biosimilar 
in Denmark in 2018 [123]. 

In Spain, regional tenders for outpatient, off-patent medicines in Andalusia led to 
27%  savings on  average  in  2015, with the  potential for  savings of  between  EUR 160 
million and 201 million for Andalusia and between EUR 1.08 billion and 1.35 billion for 
Spain  if  all  procurement  was  done  through  such  tenders  [187].  A  Swedish  study 
investigated  the  tendering-like  system  of  price  bids  for  off-patent  medicines  in  the 
outpatient setting and found evidence for savings in the short and long term, but at the 
cost of decreased competition over time [188]. In Germany, the tendering-like system 
of preferred suppliers for outpatient, off-patent medicines was found to be an effective 
tool to shift from originators to generic manufacturers [129]. Similarly, the price bidding 
system  for  off-patent,  outpatient  medicines  in  Hungary  was  found  to  have  led  to 
decreased expenditures for G-CSFs [177]. Statistics on the Dutch preference price policy 
published by the Dutch National Health Care Institute highlighted increasing savings for 
the health insurers due to this tendering policies, amounting to 352 million in 2009, 654 
million in 2012 and 679 million in 2014 [116]. 

There  was  limited  evidence  on  procurement  of  vaccines.  In  a  comparison  of 
procurement  of  human  papillomavirus  (HPV)  vaccines  across  15  European  countries, 
prices  paid  for  regionally  procured  vaccines  were  almost  9-fold  higher  compared  to 
prices paid at the national level [159]. Other factors, such as purchase volume, number 
of  offers, type  of  vaccine,  and income  level  of  the  country  were  also  associated with 
price differences. 

4.2.2. Impact of PPM techniques and award criteria on affordability 

The potential for PPM procedures and practices to impact on the affordability of 
medicines  was  overall  assessed  favourably  by  stakeholders  participating  in  an 
online survey (see Figure 14). The procedures included in the EU legislation (i.e. open 
procedure,  restricted  procedure,  competitive  dialogue,  competitive  procurement  with 
negotiation)  were  overall  considered  to  be  contributing  to  affordability,  although  one 
stakeholder  group  (suppliers)31  assessed  the impact  of  competitive  procurement  with 
negotiation to be negative. An overall positive assessment of different PPM techniques 
was also provided in the online survey (see Figure 15). Framework agreements and 
DPS were considered to contribute to affordability by all stakeholders, while electronic 
auctions and electronic dialogue were regarded as contributing factors by procurers 
and authorities, and as barriers by suppliers. Suppliers considered that electronic tools 
(while  rendering  the  procurement  process  more  efficient)  contribute  to  driving  down 
prices, which can lead to a negative price spiral that – in the view of suppliers – hinders 
competition. 

However, stakeholders also stressed the importance of using the right procedure 
and  technique  for  the  right  product.  Indeed,  a  more  differentiated  picture 
emerges  when  analysing  proxy  unit  prices  in  relation  to  the  use  of  framework 
agreements (see Figure 16). Higher proxy unit prices were observed in countries with 
moderate  use  of  framework  agreements  (20-39%  of  procedures)  for  antivirals  for 
systemic use, antithrombotic agents, and vaccines (i.e. in categories where competition 
can  be  expected),  but  for  antineoplastic and  immunosuppressive  agents (both  falling 
into the larger category of antineoplastic and immunomodulating agents) were highest 
in  countries  with  60-79%  procedures  under  framework  agreements,  respectively.  A 
common pattern across all groups of products analysed was that the lowest proxy unit 

31  Suppliers  participating  in  the  online  survey  represented  the  generic  medicines  industry  (representatives 

from research-based industry decided not to participate in the survey). 

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prices were observed in countries with low use of framework agreements (less 
than 20%). Both the use of framework agreements and price levels may be impacted 
by  various  characteristics  of  the  countries  and  health  systems  in  place,  therefore  no 
causal link between the two can be established through this analysis. 

Figure 14: Assessment of potential contribution of PPM procedures to different policy 
objectives, per stakeholder group 

Note: In “all” stakeholders, patients (1 participant), providers non procuring (1 participant) and research (3 
participants) are included. 

Source: Authors based on online survey 

Figure 15: Assessment of potential contribution of PPM techniques to different policy 
objectives, per stakeholder group 

Note: In “all” stakeholders, patients (1 participant), providers non procuring (1 participant) and research (3 
participants) are included. 

Source: Authors based on online survey 

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Figure 16: Relationship between use of framework agreements in a country and 
approximated unit prices 

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Proportion  of proc edures  under  framework  agreements

Note:  Figure  shows  aggregated  data  for  2008-2021  for  the  proportion  of  procedures  conducted  under 
framework agreements in a country and the average proxy unit price in that country for five categories of 
medicines. Countries were grouped according to the proportion of procedures under framework agreements 
for each of the five categories of medicines (horizontal axis). The vertical axis shows the average approximated 
unit  price  for  the  five  categories  of  medicines  in  relation  to  the  maximum  average  unit  price  within  that 
category (e.g. for antineoplastic agents, the maximum average proxy unit price was observed in countries 
with 60-79% of procedures under framework agreements; for this category of medicines, the average unit 
price in countries with 0-19% procedures under framework agreements was 25% of that maximum average 
unit price, etc.). Proportional unit prices were used to avoid distorting the scale of the figure (unit prices varied 
approximately 200-fold across the different categories of medicines).  

Source: Authors’ analysis based on IQVIA [145]and TED data [144] 

Affordability  may  not  be  the  only  policy  objective  pursued  by  procurement.  During 
interviews and workshops, stakeholders have generally stressed that trade-offs may 
need to be made between achieving low prices and other objectives, such as security of 
supply,  promoting  green  manufacturing  and  transport,  and  maintaining  sustainable 
levels  of  competition  in  the  market.  Indeed,  Figure  17  and  Figure  18  suggest  that 
countries  that  frequently  apply  security  of  supply  or  environmental  criteria  face 
higher proxy unit prices for medicines. Across all tracer groups, approximated average 
list  prices  were  between 5%  and  29%  higher  in  countries  that  apply  these  non-price 
criteria compared to countries that do not or do not frequently apply the criteria. The 
analysis  did  not  take  into  consideration  other  factors  that  may  impact  on  prices  and 
therefore only represents an exploratory assessment of the relationship between award 
criteria and price levels at the aggregate (i.e. country-group) level. Individual countries 
may  have  different  experiences:  for  example,  Denmark  reported  that  pilot  projects 
applying environmental criteria did not lead to higher unit prices.  

Considerations  other  than  the  affordability  of  medicines  can  be  taken  into  account 
through  the  use  of  advanced  award  criteria,  e.g.  through  the  use  of  MEAT  criteria. 
However, Figure 19 shows that proxy unit prices tended to be lower in countries that 
extensively use MEAT criteria, specifically for antineoplastic agents, immunosuppressive 
agents, and vaccines), although for one group of medicines (antivirals for systemic use), 
the highest average proxy unit prices were observed in countries with very high use of 
MEAT.  Coincidentally,  and  somewhat  in  contrast  to  qualitative  statements  provided 
during interviews and workshops, in the online stakeholder survey, participants ranked 
MEAT as more important for the policy objective of affordability than any other award 
criteria, including price only (see Figure 20). 

These potential trade-offs, in particular in relation to security of supply and maintaining 
a competitive market, may also be addressed by awarding contracts to multiple winners. 

59 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Winner-takes-it-all procedures are seen particularly critically by suppliers (see Figure 
21). 

Figure 17: Relationship between use of security of supply criteria and approximated 
unit prices 

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Note: Figure shows aggregated data for 2008-2021 for overall application of security of supply criteria in a 
country and average proxy unit price in that country for five categories of medicines. The vertical axis shows 
the average approximated unit price for the five categories of medicines in relation to the maximum average 
unit  price within  that  category  (e.g.  for  antineoplastic  agents,  the  maximum  average proxy  unit  price was 
observed in countries that regularly use security of supply criteria; for this category of medicines, the average 
unit price in countries that do not or do not frequently use such criteria was 83% of that maximum average 
unit price, etc.). 

Source: Authors’ analysis based on IQVIA [145] and PPM country fiches 

Figure 18: Relationship between use of environmental criteria and approximated unit 
prices 

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Note:  Figure  shows  aggregated  data  for  2008-2021  for  overall  application  of  environmental  criteria  in  a 
country and average proxy unit price in that country for five categories of medicines.  

Source: Authors’ analysis based on IQVIA [145] and PPM country fiches 

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Figure 19: Relationship between use of MEAT criteria in a country and approximated 
unit prices 

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Proportion  of procedures  using  MEAT criteria

Note: Figure shows aggregated data for 2008-2021 for the proportion of procedures in a country using MEAT 
criteria to award contracts and the average proxy unit price in that country for five categories of medicines. 
Countries  were grouped  according  to  the proportion  of  procedures  using  MEAT  criteria  for  each  of  the five 
categories of medicines (horizontal axis). The vertical axis shows the average approximated unit price for the 
five  categories  of  medicines  in  relation  to  the  maximum  average  unit  price  within  that  category  (e.g.  for 
antineoplastic  agents,  the  maximum  average  proxy  unit  price  was  observed  in  countries  with  20-30%  of 
procedures using MEAT criteria; for this category of medicines, the average unit price in countries with 0-10% 
procedures under framework agreements was 34% of that maximum average unit price, etc.). Proportional 
unit  prices  were  used  to  avoid distorting  the scale of  the  figure  (unit  prices varied  approximately  200-fold 
across the different categories of medicines). 

Source: Authors’ analysis based on IQVIA [145]and TED data [144] 

Figure 20: Ranking of importance of PPM award criteria by policy objective 

Source: Authors based on online survey 

61 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Figure 21: Assessment of potential contribution of PPM award criteria to different policy 
objectives, per stakeholder group 

Note: In “all” stakeholders, patients (1 participant), providers non procuring (1 participant) and research 
(3 participants) are included. 

Source: Authors based on online survey 

4.2.3. Impact of PPM procedures and practices on availability of medicines 

Availability of medicines is a key objective for PPM. Availability means that a product is 
available to patients, which typically involves a valid marketing authorisation and that 
the product has been launched and is still being marketed in a country, and is covered 
by  a  health  insurance  /national  health  system,  or  is  available  to  be  purchased  by 
individuals.  Key  findings  regarding  the  relationship  between  PPM  practices  and 
availability of medicines are summarised in Box 5 (detailed results shown below). 

Box 5: Key findings: PPM practices and availability of medicines 

 Joint procurement is seen as a tool to improve availability of medicines, in particular for 

smaller markets that may otherwise not be prioritised by suppliers. 

 Suppliers are critical of procurement practices that, in their view, reduce competition and 

subsequently availability of medicines, including joint procurement, awarding single winners, and 
using price as sole award criterion. 

 Stakeholders generally agreed that awarding multiple winners and using additional criteria 

other than price contributes to availability of medicines. 

 Globally, studies have generally found joint procurement to contribute to availability of 

medicines, although studies quantifying the impact of procurement practices on availability from 
European countries are lacking.  

Source: Authors 

Potential  impacts  of  PPM  on  availability  have  been  documented  in  the  literature, 
although mostly focusing on LMICs. Overall, studies found that pooling volumes through 
joint  procurement  was  associated  with  improved  availability  of  essential 
medicines,  although  potential  risks  associated  with  awarding  single  winners  without 
properly  vetting  them  were  also  highlighted  [14,  41].  There  is  comparatively  little 
quantitative evidence on availability of medicines in relation to procurement practices 
in European countries. 

Authorities and public institutions participating in workshops for this study considered 
joint procurement  as  a  useful  tool  to  help  make  small  markets  more  attractive  for 
suppliers, and therefore contributing to availability of medicines that would otherwise 

62 

 
 
 
 
 
 
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not be supplied. Rather than seeing it as a tool to drive down prices, some procurers 
consider joint procurement as a key instrument to improve availability of medicines. An 
example  is  Iceland,  which  benefitted  from  cross-country  joint  procurement  with 
Denmark  and  Norway  (joint  Nordic  tenders)  to  increase  the  number  of  medicines 
available  to  patients  [165].  Suppliers  (and  some  hospital  pharmacists),  on  the  other 
hand, hold a more critical view of joint procurement (intra- or cross-country), warning 
about the risk of reduced competition and an associated threat to long-term availability 
of medicines.  

Awarding multiple winners (when possible, i.e. for products with competition) was 
identified as a key PPM technique contributing to availability of medicines in European 
countries by stakeholders participating in online workshops for this study. This technique 
was also considered as beneficial to availability by all stakeholders participating in the 
online  survey  (see  Figure  21).  Awarding  a  single  winner,  on  the  other  hand,  was 
considered a potential barrier to availability. 

In terms of award criteria, stakeholders (mainly, but not exclusively, from the supplier 
side)  voiced  concerns  that  the  use  of  price  as  sole  criterion  presents  a  threat  to 
availability of  medicines  in  the  long  term,  as  suppliers  may  leave  the  market.  In  the 
online survey, the potential contribution of price as an award criterion towards the policy 
objective of availability was also most often top-ranked compared to other award criteria 
(see Figure 20). 

For the study countries, an inverse relationship between use of a CPB in a country and 
the availability of medicines was observed (see Figure 22). Countries with low use of 
CPBs recorded sales for the highest number of individual molecules within each of 
the five tracer groups. A similar picture emerged when analysing the use of framework 
agreements, although for antivirals for systemic use, the highest number of individual 
molecules was sold in countries with moderate – not low – use of framework agreements 
(data not shown). There was some variation in availability of individual molecules and 
the use of MEAT criteria, overall suggesting that fewer individual molecules were sold in 
countries with higher use of MEAT (see Figure 23). 

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Figure  22:  Relationship  between  use  of  a  central  purchasing  body  and  number  of 
molecules within a group of medicines available in a country 

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Proportion  of procedures  awarded by a c entral purc hasing  body

Note: Figure shows aggregated data for 2008-2021 for the proportion of procedures awarded through a CPB 
and  the  number  of  individual  molecules  in  that  country  for  five  categories  of  medicines.  Countries  were 
grouped  according  to  the  proportion  of  procedures  awarded  by  a  CPB  for  each  of  the  five  categories  of 
medicines (horizontal axis). The vertical axis shows the number of molecules within each of the five categories 
of medicines in relation to the maximum number of molecules within that category (e.g. for antithrombotic 
agents, the maximum number of molecules was observed in countries with 0-19% of procedures using MEAT 
criteria; for this category of medicines, in countries with 20-39% procedures under framework agreements, 
only 65% of that maximum number of molecules was available, etc.). 

Source: Authors’ analysis based on IQVIA [145]and TED data [144] 

Figure 23: Relationship between use of MEAT criteria and number of molecules within 
a group of medicines available in a country 

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Note: Figure shows aggregated data for 2008-2021 for the proportion of procedures in a country using MEAT 
criteria  to  award  contracts  and  the  number  of  individual  molecules  in  that  country  for  five  categories  of 
medicines. Countries were grouped according to the proportion of procedures using MEAT criteria for each of 
the  five  categories  of  medicines  (horizontal  axis).  The  vertical  axis  shows  the  number  of  molecules  within 
each of the five categories of medicines in relation to the maximum number of molecules within that category 
(e.g. for antithrombotic agents, the maximum number of molecules was observed in countries with 0-19% of 
procedures using MEAT criteria; for this category of medicines, in countries with 20-39% procedures under 
framework agreements, only 98% of that maximum number of molecules was available, etc.). 

Source: Authors’ analysis based on IQVIA [145]and TED data [144] 

4.3. Impact of PPM procedures and practices on security of supply 

Key findings regarding the relationship between PPM practices and security of supply, 
defined as the avoidance  of or  reduction in disruption and shortages in the supply of 
medicines, are summarised in Box 6 (detailed results shown below). 

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Box 6: Key findings: PPM practices and security of supply 

 

 

 

There  may  be  trade-off  between  security  of  supply  and  other  policy  objectives. 
Maintaining  a  competitive  market  with  sufficient  number  of  suppliers  may  reduce  the  risk  of 
medicines shortages. Stakeholders agreed that multi-award contracts contribute to security 
of supply. 
Joint  procurement  is  seen  by  procurers  as  a  tool  to  ensure  security  of  supply.  Industry 
representatives, on the other hand, consider joint procurement a barrier to security of supply, 
in particular when resulting in single winners being awarded. 
Empirical  data  on  the  impact  of  PPM  on  security  of  supply  are  lacking.  Anecdotal  reports 
have linked shortages to awarding single winners.  

Source: Authors 

There may be trade-offs between security of supply and other policy objectives. As for 
other policy objectives, stakeholders from the industry as well as others highlight the 
importance of maintaining a competitive market with sufficient number of suppliers to 
ensure security of supply in the long term (see Annex 5). A possible reduction in the 
number  of  suppliers,  possibly  due  to  contracts  being  consistently  awarded  to  single 
suppliers and price dominating as award criterion, may carry an increased risk of supply 
shortages.  Diversifying  and  having  multiple  supply  sources  in  PPM  was  also 
recommended  as  one  of  the  measures  to  address  supply  shortages  in  an  EC-
commissioned study [156]. 

Nevertheless, empirically, the impact of PPM practices on shortages is not clear 
as most evidence is restricted to anecdotal reports. For example, shortages have been 
reported in relation to the procurement of bevacizumab in Italy, where a single supplier 
was awarded the contract for multiple regions [61]. In the outpatient setting, tendering-
like systems exist in some European countries and have been the subject of quantitative 
studies. For Sweden, the decrease in prices associated with a tendering-like set-up was 
shown  to  result  in  a  reduced  number  of  suppliers  in  the  long  term  [188].  However, 
shortages were not investigated by the study. In other countries with similar systems, 
the experience with respect to shortages has been mixed: in Belgium, issues with tender 
winners  not  being  able  to  supply  required  medicines  contributed  to  abandoning 
tendering  in  the  outpatient  sector,  and  shortages  have  also  been  reported  in  the 
Netherlands (for both medicines subject to tendering and others), while no supply issues 
have been reported in Denmark [116]. Related to shortages, analyses found that the 
Dutch preference price policy highlighted that no suppliers left the market due to this 
policy [116], while a Swedish study found that fewer suppliers were left in the market 
in the long term [188]. 

In the online survey conducted as part of this study, stakeholders assessed potential 
impacts of PPM practices (see Annex 7 for details). MEAT and quality/safety were 
the  top-ranked criteria  in terms  of  their  contribution  to  security of  supply (Figure 
20). Local production was not considered a top priority for ensuring security of supply. 
There was strong preference among both suppliers and procurers as well as authorities 
that multi-award contracts were best suited to achieve security of supply compared 
to  single-winner  awards.  In  addition,  and  somewhat  related  to  awarding  multiple 
winners,  most  participants  considered  framework  agreements  as  contributing  to 
security of supply. 

In workshops and reviews of country experiences, joint procurement emerged as an 
important tool to address medicines shortages. Mitigating supply issues for older 
medicines  is  seen  as  an  important  purpose  of  cross-country  joint  procurement 
collaborations  (possibly  more  so  than  achieving  lower  prices),  including  for  the  joint 
procurement  of  vaccines  by  the  Baltic  countries  (Baltic  Procurement  Initiative,  see 
Chapter  6.2.1.1)  and  the  joint  Nordic  tenders  (see  Chapter  6.2.1.2).  The  Nordic 
Pharmaceutical Forum initiated joint Nordic tenders for Denmark, Norway, and Iceland 
in order to overcome restrictions of the comparatively small markets of the individual 
countries. The experience of the two Nordic tenders conducted so far has been positive, 
with  high  participation  rates  in  calls  and  beneficial  prices  despite  the  introduction  of 

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some  potentially  challenging  environmental  criteria  [165,  189].  The  three  Baltic 
countries (Estonia, Latvia and Lithuania) have been collaborating for nearly a decade in 
the  cross-country  procurement  of  vaccines  [10,  117].  Potential  benefits  of  joint 
procurement in addressing medicines shortages are not limited to small countries: in an 
OECD report on shortages, France was reported to consider international collaborations 
including joint procurement as strategic pillar to address medicines shortages [149].  

Procurers  tended  not  to  be  directly  involved  in  measures  to  mitigate  shortages. 
Instead, national medicines agencies or other institutions are responsible for monitoring 
shortages.  Procurers  may  then  work  with  these  institutions  to  address  needs  arising 
from  shortages.  Collaboration  between  public  institutions  is  therefore  a  key 
success factor for ensuring security of supply. For example, the Italian body responsible 
for  regionally  centralised  procurement,  Consip,  runs  a  DPS.  This  is  seen  as  useful 
infrastructure  for  efficient  procurement.  Consip  relies  on  the  shortages  monitoring 
system established by the Italian medicines agency, AIFA, to identify possible shortages 
that  need  to  be  address  through  additional  procedures  launched  through  the  DPS. 
Similarly, in Estonia, rapid procurement responses to address potential shortages by the 
CPB at the Estonian Health Insurance Fund (EHIF) are enabled by information shared 
between public institutions.  

To  the  best  of  the  study  team’s  knowledge,  the  impact  of  PPM  policies  on  medicines 
shortages  has  not  been  quantitatively  assessed  in  the  literature.  This  may  be 
related to challenges with consistently measuring and comparing medicines shortages 
across  countries,  which  have  previously  been  documented  [149,  190].  In  this  study, 
possible shortages in the study countries based on sales data could only be investigated 
on a yearly basis (potentially missing shorter periods of products not being available). 
At this level, no noticeable variation in availability of sales data throughout the study 
period were detected with respect to PPM techniques and award criteria sued. Products, 
when  grouped  at  ATC-4  level,  were  mostly  consistently  sold  across  the  period  2008-
2021 (with the exception of some minor variation for antineoplastic agents), although 
the  three  countries  with  the  highest  use  of  nationally  centralised  PPM  (Denmark, 
Luxembourg,  Norway)  had  larger  shares  of  individual  products  not  being  sold  in  the 
market compared to other countries. 

4.4. Impact of PPM procedures and practices on the environment 

Key findings regarding the relationship between PPM practices and the environment are 
summarised in Box 7 (detailed results shown below). 

Box 7: Key findings: PPM practices and affordability 

  The impact of PPM practices on environmental outcomes is unclear, as environmental 

criteria are only starting to be used. 

  Including environmental criteria is likely to have the biggest contribution towards sustainable 
and green manufacturing and supply of medicines, according to stakeholders. Leveraging 
purchasing power may help implement environmental standards. 

  A trade-off between affordability and use of environmental criteria is likely. However, 

experience from the joint Nordic tenders suggests that suppliers are able to fulfil environmental 
criteria and that price differences are not related to environmental standards. 

Source: Authors 

Environmental award criteria are only starting to be used in PPM (see Chapter 3.4). 
There is therefore no evidence available on the impact of “green” practices in PPM on 
environmental outcomes.  

In  this  study,  the  potential  for  PPM  practices  and  procedures  to  impact  on  the 
environment was assessed through the online survey since no suitable indicators could 
be identified to evaluate the actual impact of PPM on the environment. The inclusion of 

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environmental  criteria  for  awarding  contracts  was  considered  most  important  for 
achieving  environmental  aims,  but  environmental  criteria  were  considered  least 
important for achieving any of the other policy objectives (Figure 20). Overall, there 
was uncertainty about the possible contribution of specific PPM procedures and 
techniques towards the policy objective of sustainable and green manufacturing and 
supply of medicines. Awarding a single winner may help achieve environmental goals 
by leveraging the incentive of winning a large contract for the entire market, although 
possible  drawbacks  of  single-winner  procedures  (such  as  risks  to  the  supply  of 
medicines) should be considered.  

Stakeholders have pointed out that – similar to security of supply – procurers may have 
to  face  a  trade-off  between  different  policy  objectives,  namely  that  the  use  of 
environmental  criteria  may  lead  to  higher  prices  and/or  lower  levels  of  competition. 
While environment may play an increasingly important role in procurement, addressing 
patient needs is considered the priority. At the aggregate level, use of environmental 
criteria appears to be associated with higher approximated unit prices (see Figure 18). 
Countries that frequently use environmental criteria had overall higher proxy unit prices 
compared to  countries  that do not or do not frequently use them, with differences of 
between 17% (for antithrombotic agents) and 79% (for antivirals for systemic use) for 
average  price  levels.  However,  this  analysis  only  considered  general  use  of 
environmental criteria at the country-level, rather than their use for specific products. 
Experience  from  Scandinavian  countries  suggests  that  the  introduction  of 
environmental criteria for tenders conducted by the Danish CPB for hospitals, Amgros, 
and  for  joint  Nordic  tenders  by  Denmark,  Iceland,  and  Norway,  has  not  negatively 
impacted  on  the  number  of  bids  submitted,  and  that  differences  in  prices  between 
bidders were not driven by these criteria [165]. 

4.5. Impact of PPM procedures and practices on competition 

Key findings regarding the relationship between PPM practices and competition in the 
market are summarised in Box 8 (detailed results shown below). 

Box 8: Key findings: PPM practices and competition 

  Creating competition is an inherent aim of public procurement. According to stakeholder 

assessments, PPM processes contributing to competition in the long run include multi-winner 
contracts and using MEAT criteria. 

  Countries frequently using MEAT criteria attracted higher number of bids compared to countries 

that do use MEAT criteria less frequently. 

  Competition may be fostered by pooling purchase volumes through joint procurement, in 

particular for markets that were previously underserved by suppliers. 

Source: Authors 

Tendering,  by  design,  is  expected  to  increase  competition.  By  inviting  bids  from 
interested suppliers, incentives are created for economic operators to join the market. 
The  challenge,  then,  is  how  to  maintain  levels  of  competition.  During  stakeholder 
consultations  (including  in  workshops,  interviews,  and  the  online  survey),  industry 
representatives  stressed  the  importance  of  several  PPM  practices  to  maintain  a 
competitive market, i.e. to incentivise suppliers to remain in the market. These practices 
include awarding multi-winner contracts and using additional criteria rather than 
price  alone.  Hospital  pharmacists  also  stressed  potential  risks  to  maintaining 
competition  in  the  long  term  if  tendering  is  based  on  the  lowest  price  alone.  These 
assessments  were  generally  shared  by  all  stakeholders  participating  in  the  online 
survey: MEAT was the top-ranked criterion contributing to competition, and multi-award 
contracts  were  assessed  as  contributing  most  towards  competition  (see  Figure  20, 
Figure  21 and Annex  7). However, while procurers and authorities also saw positive 
contributions from single-award contracts (although to a lesser extent than multi-winner 

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awards),  these  were  seen  as  barriers  to  a  competitive  market  by  industry 
representatives.  

Given  the  larger  purchase  volumes  involved  and  potential  focalisation  on  single 
suppliers, joint procurement is seen as detrimental to competition in the market by 
industry  representatives  as  well  as  some  procurers  at  facility  level.  Compared  to 
procurement conducted at lower levels (e.g. by individual facilities), joint procurement 
may present fewer opportunities for suppliers to submit bids which may result in some 
suppliers leaving the market.  

However, centralisation may also foster competition. In Italy, the DPS run by Consip as 
a tool to make procurement for the regions more efficient, allows new suppliers to join 
the  market  with  relatively  low  friction  cost  (see  Annex  5).  In  other  countries,  joint 
procurement  resulted  in  the  market  becoming  more  attractive  to  suppliers  and 
incentivising them to enter these markets in the first place. The experience of Iceland 
in joining the joint Nordic tenders demonstrated how a small country can benefit from 
the increased competition associated with suppliers competing for contracts [165]. 

Analysis  of  the  use  of  centralised  procurement  and  levels  of  competition  was  not 
instructive due to lack of relevant data recorded in TED. However, other PPM practices 
reveal some patterns in relation to the number of bids submitted for procedures. Firstly, 
different to what may be expected on the basis of framework agreements allowing more 
companies  to  supply  products,  competition  levels  and  the  use  of  framework 
agreements  do  not  appear  to  follow  a  systematic  trend  (see  Figure  24).  While  for 
some groups of medicines, competition levels were highest in countries with low levels 
of  framework  agreements  (antivirals  for  systemic  use,  immunosuppressive  agents), 
they were low in these countries and higher in countries with moderate use of framework 
agreements  for  other  groups  of  medicines  (antineoplastic  agents,  antithrombotic 
agents). Secondly, competition levels were highest in countries with high use of 
MEAT criteria across all groups of medicines (other than vaccines, where number of 
bids did not vary notably, see Figure 25). 

Figure 24: Relationship between use of framework agreements and competition 

e
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100%

90%

80%

70%

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50%

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20%

10%

0%

Antineoplastic agents

Antivirals for systemic use

Antithrombotic agents

Immunosuppressive agents

Vaccines

0-19%

20-39%

40-59%

60-79%

80-100%

Proportion  of procedures  under  framework  agreements

Note: Figure shows aggregated data for 2008-2021 for the proportion of procedures in a country run under 
framework  agreements  and  the  number  of  bids  submitted  for  procedures  for  five  categories  of  medicines. 
Countries were grouped according to the proportion of procedures under framework agreements for each of 
the five categories of medicines (horizontal axis). The vertical axis shows the average number of bids within 
each  of  the  five  categories  of  medicines  in  relation  to  the  maximum  average  number  of  bids  within  that 
category. 

Source: Authors’ analysis based on TED data [144] 

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Study on Best Practices in the Public Procurement of Medicines – 
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Figure 25: Relationship between use of MEAT criteria and competition 

r
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100%

90%

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20%

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0%

Antineoplastic agents

Antivirals for systemic use

Antithrombotic agents

Immunosuppressive agents

Vaccines

0-19%

20-39%

40-59%

60-79%

Proportion  of procedures  using  MEAT criteria

Note: Figure shows aggregated data for 2008-2021 for the proportion of procedures in a country using MEAT 
criteria to award contracts and the number of bids submitted for procedures for five categories of medicines. 
Countries  were grouped  according  to  the proportion  of  procedures  using  MEAT  criteria  for  each  of  the five 
categories of medicines (horizontal axis). The vertical axis shows the average number of bids within each of 
the five categories of medicines in relation to the maximum average number of bids within that category. 

Source: Authors’ analysis based on TED data [144] 

4.6. Impact of PPM procedures and practices on crisis preparedness 

Preparedness  for  health  crises  and  emergencies  is  a  pillar  of  the  European  Health 
Union32. It requires anticipation of potential threats and appropriate measures in place 
to handle them, including procurement of required medicines.  

Stakeholders  considered  well-applied  PPM  as  important  tool  for  crisis  preparedness 
overall. In the study’s online survey, participants most often selected vaccines as the 
category  of  medicines that  would  benefit  most from  crisis  preparedness  through  PPM 
(see Annex 7 for details). There was variation in the assessment of different forms of 
PPM for crisis preparedness (see Figure 26). Joint procurement forms at national 
or cross-national level (including joint procurement at EU-level) were most favourably 
assessed overall. This assessment was shared by authorities, most procurers, and some 
suppliers.  However,  other  suppliers  (and  individual  procurers)  considered  centralised 
PPM, and in particular joint PPM at EU or at other cross-national level as detrimental to 
crisis preparedness.  

32 https://health.ec.europa.eu/health-security-and-infectious-diseases/overview_en 

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Figure  26:  Stakeholder  assessment  of  the  level  of  PPM  most  likely  to  contribute  to 
preparedness 

100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%

Facility-based
PPM

Group
procurements

Regional CPM National CPM Joint PPM EU

level

Joint PPM
some
countries

fully contributing
partly a barrier
blank

partly contributing
a barrier

Neutral
cannot assess

Source: Authors based on online survey 

Learnings  from  the  joint  procurement  of  COVID-19  vaccines  by  the  EU  and  the  Joint 
Procurement Agreement are described in Chapter 6.2.2. 

No  quantitative  analysis  of  the  relationship  between  PPM  processes  and  crisis 
preparedness  was  conducted  since  no  suitable  indicator  for  this  policy  objective  was 
identified. 

4.7. Issues with data availability to assess impact of PPM 

Across  study  countries,  data  availability  on  savings  made  from  public 
procurement  was  comparatively  poor.  While  procurers  may  compare  prices 
achieved by their organisation over time to monitor performance, these data are often 
not  made  publicly  available.  As  a  consequence,  few  peer-reviewed  studies  analysing 
savings made from public procurement were identified by the study team. An example 
of  an  organisation  that  consistently  make  savings  data  available  on  its  website  is 
Amgros, the Danish CPB for hospitals. However, even Amgros only publishes aggregate 
savings and does not provide details on savings achieved in individual tenders. 

Monitoring of savings at national level is often hampered by poor data availability. 
In the hospital setting, individual facilities may regularly analyse their expenditure and 
potential savings made through optimised PPM, but this information is not shared with 
other facilities or authorities at the national level. For example, in Belgium, monitoring 
of prices and savings analysis are done systematically, but individually for each hospital. 
Countries with centralised procurement system tend to have systematic monitoring of 
savings in place (e.g. Cyprus, where savings of centrally tendered products compared 
to list prices are published regularly).  

Some of these limitations may be addressed by using routine data on procurement, as 
recorded  in  the  TED  data  set.  However,  the  study  team  encountered  challenges  in 
working with TED data, as described in more detail in Chapter 2.5.1.2. Briefly, the key 
challenge  relates  to  the  lack  of  granularity  in  this  routine  data  set  which  hinders 
product-level analysis that would be required to better understand the use of specific 

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procurement  practices  and  their  potential  impacts.33  Importantly,  lack  of  granularity 
about individual products procured creates a challenge for linking TED to other data sets 
that could provide important insights, e.g. IQVIA data about pharmaceutical sales and 
volumes.  Granular  data  about  individual  products  being  procured  may  be  extracted 
through data mining processes from the contract notices. However, this is a resource-
intensive  process  that  requires  identifying  relevant  product  names,  potentially  in 
different  languages  used  across  the  EU,  and  expert  knowledge  for  processing  these 
data.  The  lack  of  coded  information  about  products  procured  therefore  presents  an 
important challenge for routinely using TED data to generate insights into procurement, 
e.g. for monitoring and benchmarking procurement processes against other countries. 
In addition to the granularity, there may be issues with data reported in TED not being 
accurate, requiring data cleaning and verifying to use for analysis. 

33  The  suspected  main  reason  for  lack  of  coded  data  about  individual  products  procured  is  that  the  same 
procedure is used for procuring several products. In these cases, the person responsible for entering data 
into TED may use the general code for pharmaceuticals rather than entering individual codes for the different 
products.  

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5.  PHIS HOSPITAL PROCUREMENT UPDATE 

The  sixth  specific  objective  of  the  study  was  to  collate  and  analyse  procurement  of 
medicines in the hospital setting. Specifically, the study aimed to update procurement-
related aspects of the 2010 PHIS Hospital Pharma report [140] (see below). This work 
addressed the following study questions: what are current PPM practices in hospitals, 
and how could they be optimised?  

5.1. Background on hospital procurement 

Public  procurement  of  medicines  is  a  policy  that  is  of  particular  relevance  for  the 
inpatient  sector  since,  in  European  countries,  most procurements  are  conducted  with 
the  aim  to  ensure  supply  to  hospitals  [6,  118].  Given  its  importance,  hospital 
procurement is a focus area in this study.  

Hospital  procurement  has  some  specificities.  There  are  different  institutional 
frameworks  (for  different  types  of  medicines),  ranging  from  individual  procurements 
conducted by hospitals (hospital pharmacy in collaboration with procurement units) at 
facility level to voluntary collaboration in the form of group purchasing and centralised 
procurement  at  regional  level  (sub-national)  or  at  national  level.  Furthermore,  some 
medicines used in hospitals are subject to different (stricter) requirements in terms of 
safety,  storage  and  use  compared  to  outpatient  medicines.  From  the  perspective  of 
hospital  pharmacists,  who  are  usually  strongly  involved  in  procurement,  the 
procurement activities are aimed to contribute to quality assurance, security of supply 
and  cost-containment  [189].  The  last  decade  has  seen  the  launch  of  several  new 
medicines  with  high  price  tags  that  have  been  a  driver  for  public  pharmaceutical 
expenditure, and some of these new therapies are exclusively or predominantly applied 
in hospitals [133, 191, 192]. 

5.1.1. Update of PHIS Hospital report 

This chapter presents an update of procurement-related aspects of the PHIS Hospital 
Pharma Report, published in 2010 [140]. The 2010 report was produced as part of the 
Pharmaceutical Health Information System (PHIS) project, commissioned by the 
Executive  Agency  for  Health  and  Consumers  (EAHC)  and  co-funded  by  the  Austrian 
Federal Ministry of Health. One work package of the PHIS project, running from 2008 
till 2011, was dedicated to exploring pharmaceutical policies (not exclusively focused on 
procurement) that are applied in the hospital sector. 

The interest in the hospital sector resulted from a recommendation of the final report 
of  the  2005–2007  PPRI  (Pharmaceutical  Pricing  and  Reimbursement  Information) 
project which concluded: “Pharmaceutical policies in the hospital sector need to 
be further investigated. The pharmaceutical service in the inpatient sector plays an 
important role and influences the provision of pharmaceuticals, and also pharmaceutical 
expenditure,  in  the  outpatient  sector.  However,  pricing  policies  and  practices  in  the 
hospital sector have not been addressed by the PPRI project neither have they been the 
focus of other European research projects. There is a need for paying greater attention 
to the hospital sector with regard to the intramural rational use of pharmaceuticals and 
to  the  interface  between  the  inpatient  and  the  outpatient  sector.  Therefore, 
pharmaceutical policies in hospitals shall be surveyed, and, additionally, initiatives for a 
better  cooperation  between 
inpatient  and  outpatient  sector  shall  be 
promoted.”[193]. 

the 

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The PHIS Hospital Pharma research and network activities resulted in: 

  National PHIS Hospital Pharma Reports and a compilation of 

pharmaceutical policies in the inpatient sector in 27 European countries, 
which informed about procurement policies, procedures and award criteria as well 
as pricing and reimbursement policies in the hospital sector and “interface 
management” measures to improve collaboration between inpatient and outpatient 
sectors; 

  An investigation of the medicine price set-up methodology in hospitals (at macro 

level), e.g. use of discounts; 

  Five in-depth country case studies, which comprised a survey of medicines 

prices, including “real” discounted prices, for 12 selected active ingredients; 

  Establishment of the PHIS network of competent authorities for 

pharmaceutical pricing and reimbursement policies (already members of the PPRI 
network established in the previous PPRI project) and hospital pharmacists and 
managers as well as relevant stakeholder associations such as the European 
Association of Hospital Pharmacists (EAHP) and the European Hospital and 
Healthcare Federation (HOPE). 

While the 2010 PHIS Hospital Pharma Report had a broader focus on all aspects of 
pharmaceutical care provided in hospitals (including tendering as a tool for 
procurement), this study’s 2022 update focuses specifically on procurement. Table 12 
lists the differences between the 2010 report and its 2022 update. 

Table 12: Differences between the 2010 PHIS Hospital Pharma Report and the 2022 
PHIS Hospital Procurement Update 

Element 

2010 Report 

2022 Update 

Year of survey 

2009 – 2010 

2022 

Countries 

27 European countries (25 EU Member 
States as of 2009, Norway and Turkey) 

Survey methods  Country reports written by country 

Project 
organisation 

Research on 
procurement 

Prices 

Consumption 

representatives (alternatively: 
information filled in a questionnaire) and 
comparative analysis by the study team 
Project management of 4 institutions 
(GÖG, Slovak Medicines Agency SUKL, 
Italian Medicines Agency AIFA, SOGETI) 
Advisory Board of European and 
international institutions 
Network of competent authorities for 
pricing and reimbursement of medicines 
and representatives of hospitals 
(hospital pharmacists and managers) 
involved as network members in the 
project (“PHIS network”1) 
As part of medicines management in 
hospitals: Only tendering & negotiations 

High-level survey of award criteria 

Optimisation of PPM was not scope 

Understanding and interpreting 
medicines prices in hospitals was a 
major topic of the study: 
Price survey in 5 selected countries, 
including discounted prices 
High-level information, no primary data 
collection 

32 study countries (27 EU Member 
States, EEA/EFTA countries, UK) 
Survey through country fiches (shared 
for validation with country experts) and 
comparative analysis by the study team 

Project management: Tetra Tech, GÖ B 
4 procurement experts (from Cyprus, 
Denmark, Estonia and France) and 1 
researcher involved in the study as 
quality assurance 
Country representatives and further 
stakeholders not involved in the study as 
network members but approached as 
stakeholders 

Detailed survey of PPM procedures and 
techniques as listed in the EU 
Procurement Directive 
Analysis of award criteria (supported by 
TED data) 
Strategies to optimise PPM to be 
analysed 
No major topic 
Price developments analysed (list prices 
or price proxies as included in IQVIA 
data) 

Analysis of IQVIA sales data 

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Element 

Pricing and 
reimbursement 

Surveyed as a major topic 

2010 Report 

2022 Update 

Included to contextualise procurement 
information 
Interest in hospital reimbursement / 
funding 

Definition of hospital setting – not 
addressed 
Hospital pharmacy – surveyed as one 
topic 

Yes 

Yes, important elements of analysis 

Hospital 
landscape 

Definition of hospital setting was a major 
topic 
Hospital pharmacy also a major topic 

Yes, and it gained importance during the 
study 
No 

Interface 
management 
Biosimilar 
medicines 
Cross-country 
collaboration 

No 

Yes, important elements of analysis 

1 The PHIS network was based on the PPRI network of competent authorities for pharmaceutical pricing and 
reimbursement, which was established as part of the PHIS-predecessor PPRI project, as well as hospital 
representatives. Note that “PHIS Hospital Pharma” was one of several work packages in the PHIS project 
and the sole one specifically related to the hospital setting. The other work packages (e.g. glossary, library 
of country information, meta-indicators to assess pricing and reimbursement systems, database) related to 
both outpatient and inpatient sectors [194]. After the official end of the PHIS project co-funded by the 
European Commission (2011), the activities of the PHIS network continued (e.g. meetings, information of 
sharing), coordinated by GÖG. At the same time, the activities of the PPRI network also continued low-level 
after the end of the respective project (2007). Since, to a large extent, same experts were involved in the 
PPRI and PHIS networks, consolidation was requested by the network members, and it was decided to 
continue with one network, under the name “PPRI”. The authors, involved in the PPRI Secretariat, cannot 
inform on the institutions that are members of PPRI, since PPRI members requested the PPRI Secretariat to 
not disclose member organisations. Only public authorities (and some supranational institutions) are eligible 
for PPRI membership; PPRI members commit to sharing information and providing inputs to their peer 
colleagues and the PPRI Secretariat [71] but there is no third party funded research project as it were at the 
time of the initial PPRI project (2005-2007) and the PHIS project (2008-2011). 

Source: Authors 

The aim of the PHIS Hospital Procurement Update is to characterise public procurement 
of  medicines  for  hospital  use  in  European  countries.  A  descriptive  approach  was 
applied  which  combined  quantitative  data  about  the  hospital  sector  in  the  study 
countries  with  qualitative  data  about  procurement  practices  and  other 
pharmaceutical policies related to procurement of hospital medicines. The PHIS Hospital 
Procurement Update was based on information obtained through literature review and 
country expert consultation as part of populating country fiches (see Chapters 2.2 and 
2.3),  workshops  with  procurement  and  pharmaceutical  pricing  and  reimbursement 
experts (including a dedicated workshop on hospital procurement, see Chapter 2.4.1 
and Annex 5), and descriptive analysis of data on pharmaceutical sales, consumption, 
and the hospital landscape from IQVIA ([145], see Chapter 2.5.2), EUROSTAT [150], 
and OECD [195], respectively. 

5.2. Public procurement of medicines in hospitals 

Procurement of medicines for hospital use varies greatly across Europe. This variation 
should be seen against the backdrop of how inpatient care – including pharmaceutical 
care in hospitals – is organised in each country. This chapter therefore first provides an 
overview of the landscape of hospitals and hospital pharmacies in the study countries 
and discusses medicines use in hospitals and how they are paid for, before describing 
the organisational framework for public procurement of hospital medicines, and which 
procedures, techniques, and award criteria are used. 

5.2.1. Hospital and hospital pharmacy landscape 

The  number  of  hospitals  varies  among  the  study  countries.  When  comparing  the 
number of hospital beds (total hospital beds including acute and chronic care beds), the 
figures  range  from less than three (UK, Denmark,  Ireland and Iceland) to more than 
seven beds per 1,000 population (Austria and Germany). Also – as health care systems 

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are  differently  organised  and  financed  in  the  study  countries  –  the  percentage  of 
hospitals  publicly  owned  varies  (see  Table  13).  There  are  also  hospitals  that  are 
privately owned, yet publicly financed. 

It should be noted that hospitals can be defined differently in the study countries. 
For example, different forms of outpatient care provision may occur in institutions that 
are  defined  as  hospitals.  The  OECD  includes  such  care  provision  in  its  definition  of 
hospital,  which,  at  its  core,  states  that  hospitals  “comprise  licensed  establishments 
primarily engaged in providing medical, diagnostic and treatment services that include 
physician,  nursing,  and  other  health  services  to  inpatients  and  the  specialised 
accommodation services required by inpatients.” [196]. 

Table 13: Hospital landscape and ownership in the study countries, 2019 

Country 

Number of hospitals 

Austria 
Belgium 
Bulgaria 
Croatia 
Cyprus 
Czech Republic 
Denmark 
Estonia 
Finland 
France 
Germany 
Greece 
Hungary 
Iceland 
Ireland 
Italy 
Latvia 
Liechtenstein 
Lithuania 
Luxembourg 
Malta 
Netherlands 
Norway 
Poland 
Portugal 
Romania 
Slovakia 
Slovenia 
Spain 
Sweden 
Switzerland 
United Kingdom 

n.a. = not available 

264 
164 
n.a 
n.a 
n.a 
258 
n.a 
30 
239 
3,008 
3,026 
270 
163 
8 
86 
1,056 
61 
n.a 
94 
10 
n.a 
568 
n.a 
1,236 
238 
n.a 
129 
29 
777 
n.a 
281 
1,978 

Total hospital beds per 
1,000 population 
7.19 
5.57 
n.a. 
n.a. 
n.a. 
6.58 
2.59 
4.53 
3.35 
5.84 
7.91 
4.18 
6.91 
2.8 
2.88 
3.16 
5.42 
n.a. 
6.35 
4.26 
n.a. 
3.08 
3.47 
6.17 
3.51 
n.a. 
5.76 
4.43 
2.95 
2.07 
4.59 
2.45 

Percentage of publicly 
owned hospitals 
54.17 
23.17 
n.a 
n.a 
n.a 
61.24 
n.a 
66.67 
69.46 
45.01 
24.79 
45.93 
n.a 
100.00 
77.91 
40.91 
73.77 
n.a 
90.43 
n.a 
n.a 
0.00 
n.a 
60.44 
46.64 
n.a 
n.a 
89.66 
44.14 
n.a 
n.a 
100.00 

Source: OECD [195] 

Information on the share of public hospitals in the study countries with a hospital 
pharmacy  was  collected  and  validated  in  the  PPM  country  fiches.  This  ranges  from 
around 12% in Germany (of all hospitals, including private) to 100% (see Table 14). 
Hospital  pharmacies  in  most  countries  are  only  entitled  to  serve  inpatients  (patients 
admitted  to  the  hospital).  Some  exceptions  exist,  which  may  have  been  maintained 
historically or to allow for more “seamless” treatment pathways from the inpatient to 
outpatient  sector  for  specific  conditions  (e.g.  outpatient  cancer  care;  for  interface 
management  measures  identified  in  the  study  see  Chapter  5.3)  or  in  cases  where 
medicines are not  readily available from community pharmacies. In several countries 
legislation allows for patients to receive medication for a few days at discharge.  

In some countries hospital pharmacies also serve outpatients on a more regular 
basis.  In  Norway  and  Sweden,  (almost)  all  hospital  pharmacies  generally  also  serve 
outpatients  and  in  Germany  patients  visiting  outpatient  departments  in  hospitals  are 

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served. In Hungary some dedicated hospital pharmacies serve outpatients (see Table 
14). However, dispensing to outpatients is often done through a separate pharmacy on 
the  premises  of  the  hospital,  with  different  funding  procedures  for  the  medicines 
dispenses (e.g. the Netherlands, which this practice was allowed around 20 years ago 
[197]). 

Table 14: Relevance of hospital pharmacies and their role in serving patients 

Country 

% of 
(public) 
hospitals 
with 
pharmacy 

Target 
customers 
(inpatients only 
or also 
outpatients) 

Austria 

~15% 

only inpatients, 
with exceptions 

100%  
(mandatory 
by law) 

only inpatients, 
with exceptions 

Belgium 

Bulgaria 

Croatia 

73%  
(2021) 

95% 

Cyprus 

100% 

Czech 
Republic 
Denmark 

75% 

16% 

only inpatients  

inpatients and 
outpatients 
only inpatients, 
with exceptions 
only inpatients, 
with exceptions 
only inpatients  

Estonia 

n.a. 

only inpatients  

Finland 

low 

France 

100% 

Germany 

~12%  
(of all 
hospitals) 

Greece 

90% 

Hungary  

73% 

Iceland 

n.a. 

Ireland 

100% 

Italy 
Latvia 

95% 
~50%  

Lithuania 

54% 

Luxembourg 

~100% 

Malta 

~100% 

only inpatients, 
with exceptions 

only inpatients, 
with exceptions 

inpatients and 
outpatients 

only inpatients, 
with exceptions 

inpatients and 
outpatients 

inpatients and 
outpatients 

only inpatients, 
with exceptions 

only inpatients  
only inpatients  
only inpatients, 
with exceptions 
only inpatients, 
with exceptions 

inpatients and 
outpatients 

Comment 

In addition, for historic reasons, five hospital 
pharmacies also run a community pharmacy on the 
premises of a hospital for outpatients. 
A few exceptions for outpatient service (e.g. oral 
anticancer medicines) are made. It is planned to 
entrust hospital pharmacies with tasks related to the 
outpatient sector such as medication reconciliation or 
outpatient antimicrobial therapy. 
- 

- 

In exceptional cases (e.g. high-priced medicines) 
hospital pharmacies may also serve outpatients 
- 

- 
In some cases, medicines used in the outpatient 
setting are issued by the hospital (according to the 
service list financing model) 
Outpatients can only receive medicines from the 
hospital pharmacy at discharge from hospital to 
ensure continuity of their care. 
MA specific hospital reimbursement list defines, which 
medicines may be provided to outpatients. 
Inpatients visiting outpatient departments may be 
served by hospital pharmacies. 

Hospital pharmacies dispense to outpatients under 
special pharmacotherapy (e.g. in cancer treatment) 
and to patients that receive their medicines free of 
charge (only from the hospital pharmacies) under 
social insurance. 
Dedicated hospital pharmacies are permitted to serve 
outpatients on the hospital premises. 
There are only two hospital pharmacies in Iceland. 
Other hospitals have contracts with local pharmacies / 
pharmacists who purchase according to tender 
agreements made by Landspitali (university hospital). 
Only medicines that are not readily available in the 
outpatient sector can be dispensed based on special 
arrangements. 
- 
- 
- 

Only medicines that are not readily available from 
community pharmacies can be dispensed. 
Hospital pharmacies also serve outpatients (mainly 
recently discharged patients, until outpatient 
pharmacy services through the Pharmacy of Your 
Choice Scheme (POYC) take over).   

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Country 

% of 
(public) 
hospitals 
with 
pharmacy 

Target 
customers 
(inpatients only 
or also 
outpatients) 

Netherlands 

~100% 

Norway 

Poland 

100% 

~100% 

Portugal 

~100% 

Romania 
Slovenia 
Slovakia 

~100% 
~70% 
~70% 

Spain 

n.a. 

Sweden 

100% 

inpatients and 
outpatients 
inpatients and 
outpatients 
only inpatients 

only inpatients, 
with exceptions 

only inpatients 
only inpatients 
only inpatients 

only inpatients, 
with exceptions 

inpatients and 
outpatients 

Switzerland 

n.a. 

n.a. 

United 
Kingdom 

n.a. 

only inpatients, 
with exceptions 

No information available for: Liechtenstein 

5.2.2. Medicines in hospitals 

Comment 

Hospital-based community pharmacies in the premises 
of hospitals 
All hospital pharmacies also serve outpatients. 

- 
Some public hospital pharmacies serve outpatients for 
specific treatments (specific conditions, without co-
payment by the patient) and sometimes for patients of 
private hospitals. 
- 
- 
- 
Outpatients can receive medicines for hospital use 
from hospital pharmacies. Outpatient dispensing is 
limited to hospital prescriptions. 
The hospital pharmacy almost always includes an 
outpatient dispensing 
No legal requirement to employ a pharmacist in a 
hospital in Switzerland and no mandatory 
requirements for the provision of clinical pharmacy 
services.  
Hospital pharmacies can serve outpatients who visit 
hospitals for consultation or treatment without being 
admitted to a hospital as inpatient 

Source: PPM country fiches; [198] 

Hospital care accounts for the largest proportion of total health expenditure in Europe. 
In 2019, on average 36.4% of total health expenditure was spent on hospital care [199]. 
the  proportion  of  total  pharmaceutical  expenditure  that  is  spent  in  hospitals  is 
increasing. While this figure varies across countries (ranging from less than 1% to more 
than 20% within the EU), a trend of increased spending on hospital medicines can 
be  observed  among  countries  without  breaks  in  availability  of  data  on  hospital 
expenditure  (see  Figure  27).  There  are  limitations  in  the  reporting  of  hospital 
expenditure  data  [200].  However,  the  trend  of  increased  spending  on  hospital 
pharmaceuticals is observed both in Eurostat data (as displayed in the figure) and OECD 
data for different sets of countries [201]. 

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Figure 27: Proportion of total pharmaceutical expenditure spent by hospitals, 2000-
2019 

s
l
a
t
i
p
s
o
h

y
b

t
n
e
p
s

e
r
u
t
i
d
n
e
p
x
e

l

a
c
i
t
u
e
c
a
m
r
a
h
p

l

a
t
o
t

f
o

n
o

i
t
r
o
p
o
r
P

18%

16%

14%

12%

10%

8%

6%

4%

2%

0%

Belgium

France

Cyprus

Lithuania

Portugal

Switzerland

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

Note: Figure only shows data for countries without breaks in data availability from 2010-2019. Expenditure 
includes both pharmaceuticals and other medical non-durable goods. 

Source: Eurostat [150] 

Higher spending on hospital care is partly driven by hospital medicines, which account 
for  a  growing  share  of  hospital  expenditure.  Hospitals  may  use  medicines  that  are 
available  in  the  outpatient  sector  as  well  as  specialised  treatments  that  can  only  be 
administered in inpatient settings. The latter, so-called hospital-only medicines (HOM), 
are not universally defined. Approximately half of European countries maintain lists of 
products  to  be  used  exclusively  in  hospitals  [140],  which  can  be  defined  by  national 
medicines agencies or the EMA at the time of marketing authorisation or by pricing and 
reimbursement authorities when deciding on the reimbursement status (which may be 
limited to use in hospital settings). 

Over  the  past  decade,  spending  on  medicines  used  in  hospitals  has  outpaced 
retail expenditure, the latter in some countries even contracting in the aftermath of 
the 2008 financial crisis. An OECD report estimated that the average annual growth rate 
of pharmaceutical expenditure between 2010 and 2019 was higher in the hospital sector 
compared  to  the  retail  sector  in  13  of  the  14  countries  for  which  reliable  data  were 
available [201]. Annual growth in spending on hospital medicines reached as high as 
15.2% in Iceland during that period. This is attributable to medicines  with high price 
tags entering the hospital market. 

The  growing  importance  of  hospital  medicines  is  also  reflected  in  its  market  size.  In 
2019, hospital medicines accounted for more than 50% of all pharmaceutical sales in 
four of the study countries (Belgium, Italy, Spain, UK) and for more than one-third of 
sales in  five  more  countries (Czechia, France,  Croatia,  Norway,  Portugal;  see  Figure 
28). On the other hand, the share of hospital medicines sales was less than 20% in four 
of the study countries (Germany, Lithuania, Netherlands, Slovakia).   

Figure  28  also  demonstrates  vast  variation  in  the  size  of  national  markets  for 
hospital medicines, with the largest five economies (France, Germany, Italy, Spain, 
UK) recording hospital sales of between EUR 8 billion and EUR 23.4 billion in 2021, while 
sales in many other countries remained well below EUR 1 billion. This variation indicates 

78 

 
 
 
 
 
 
 
 
 
 
 
 
 
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a potential motivation for pooling purchase volumes at the regional, national, or cross-
country level for smaller countries, in particular (see also Chapter 6.1).  

Figure 28: Pharmaceutical market size in EUR billion and share of hospital sector, in 
total pharmaceutical sales, 2021 

1
2
0
2

,
R
U
E

n
o

i
l
l
i

b

n

i

l

s
e
a
s

l

a
c
i
t
u
e
c
a
m
r
a
h
P

60

50

40

30

20

10

0

AT BE BG CH CZ DK* DE EE* EL* ES FI

FR HR HU IE

IT

LT LU* LV* NL NO PL

PT RO SE SI* SK UK

All pharmaceutical sales in EUR

Pharmaceutical sales in hospitals in EUR

Note: No hospital sales data available for DK, EE, EL, LV, LU, SI. No pharmaceutical sales data for IS, LI, MT. 

Source: IQVIA [145] 

The trend towards increased pharmaceutical spending in hospitals can at least partly be 
ascribed to more expensive new medicines entering the market which are primarily used 
to  treat  inpatients  [118].  Some  of  the  most  expensive  specialty  drugs  to  treat 
neuromuscular, immunological, and oncological conditions require administration by a 
health care professional, often provided in hospital settings. In some countries, the high 
costs  of  these  new  medicines  provide  a  rationale  for  re-thinking  procurement 
processes. For example, in Estonia, procurement of high-priced inpatient medicines is 
set to be delegated from individual hospitals to a central purchasing body, while Sweden 
uses a system of managed entry agreements for high-priced new medicines. 

A  key  barrier  to  better  understanding  the  hospital  medicines  market  is  the  limited 
availability  of  comprehensive  data  [118,  201,  202].  In  many  countries,  hospitals 
are not organised and owned centrally, and data on pharmaceutical consumption and 
spending are not readily available. In addition, price data are often not available due to 
confidential  arrangements  between  manufacturers  and 
individual  hospitals. 
International comparisons of hospital pharmaceutical spending are therefore hampered 
by patchy data and research efforts have tended to focus more on the retail sector. The 
increase  in  hospital  spending  on  medicines  suggests  a  bigger  focus  on  hospital 
medicines  is  warranted.  This  includes  the  need  for  more  systematic  monitoring  of 
pharmaceutical consumption, spending, and prices, but also a better understanding of 
the processes for purchasing medicines in the hospital sector. 

5.2.3. Hospital funding of medicines 

In  the  study  countries,  medicines  in  hospitals  are  usually  funded  through  a 
diagnosis-related groups (DRG) scheme, or a DRG-like mechanism. In the design 
of the national DRG systems, there is heterogeneity across European countries [203]. 
However,  the  underlying  principle  is  the  same  for  any  DRG  or  DRG-like  system: 
Hospitals  are  remunerated  for  the  services  (procedures)  per  patient,  and  this  is 
independent  from  what  they  actually  spend.  Medicines  are  included  in  the  bundled 
financing mechanism of the DRG systems. This is different to the outpatient sector, in 
which medicines are reimbursed on an individual level. 

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In some countries, defined medicines are eligible for special financing schemes which 
provide  for  product-specific  reimbursement.  As  these  are  exceptions  from  standard 
DRG-based financing, they are also called “DRG carve-outs” [204]. 

Such “DRG carve-outs” are known from a few countries, including Austria, France and 
Germany. The Netherlands and Slovenia used to have such lists (in the Netherlands with 
cost-sharing  between  the  hospital  and  health  insurer  [97],  thus  an  interface 
management approach, see Chapter 5.3.2), but in both countries they were abolished 
as  part  of  the  introduction  of  new  reimbursement  mechanisms  (such  as  the  “lock 
system” in the Netherlands). 

In addition, special financing schemes also comprise “(innovation) funds” for defined 
medicines, which are expensive but still considered important for patients, so they are 
financed  out  of  funds  that  bypass  the  “standard”  reimbursement  processes  (for 
medicines used in outpatient and inpatient sectors). 

Furthermore, in some countries, some defined medicines, usually those with high 
budget  impact  (e.g.  Onasemnogene  abeparvovec /  Zolgensma®),  are  covered  by  a 
different payer than the usual one for hospitals, e.g. dedicated funds are made available 
from the state budget (in some cases linked to state procurement). 

Table  15  provides  an  overview  of  special  financing  schemes  identified  in  the  study 
countries.  The  rationale  for  these  funding  schemes  is  to  ensure  patient  access  to 
medicines  that  would  normally  not  be  possible,  as  they  are  unaffordable  and/or 
challenging for the sustainability of the system. These access schemes may be based 
on  payers  compromising  on  funding  medicines  with  limited  (evidence  of)  added 
therapeutic value (e.g. the English Cancer Drug Fund, in its initial form, was criticised 
for  funding  medicines  that  were  assessed  as  not  cost-effective  [205,  206]).  Special 
funding systems also create “parallel worlds” to the regular processes and standards for 
reimbursement.  In  France,  the  financing  scheme  of  the  “liste  en  sus”  is  intended  to 
include medicines on a temporary basis, and with the inclusion of new medicines, others 
should  be  transferred  back  into  the  DRG  system.  However,  in  practice,  this  happens 
rather rarely, and as a result, the “liste en sus” has considerably grown [75]. 

In  addition  to  these  pathways,  patients  may  also  access  medicines  through  named 
patient  and  compassionate  use  programmes,  and  hospitals  may  obtain  cost-free 
provisions of medicines (although these are not allowed in all study countries). 

Table 15: “DRG carve-outs”, innovation funds, state budget procurement and further 
special financial schemes for defined medicines used in hospitals 

Country 

Austria 

Belgium 

Bulgaria 

Croatia  

Special financing schemes for medicines used in hospitals 

“Medizinische Einzelleistungen” (MEL / “single medical procedures”): for oncology 
medicines, inclusion in the MEL list can be requested, through which funding on a 
product basis is provided (request to be renewed once a year). 
For some defined medicines, specific funding mechanisms are agreed at regional level 
between regional sickness funds and regions (hospital owners), see also Box 15. 
Onasemnogene abeparvovec therapy is funded out of a separate fund. 
Temporary funding out of the “Special Solidarity Fund” (SSF) for orphan medicines 
which have not received a positive reimbursement decision under certain conditions 
(treatment of a rare disease requiring a specific physio pathologic treatment, 
treatment of a rare disease requiring a continuous and complex treatment, treatment 
of chronically ill children, involvement of innovative treatment techniques or 
otherwise requiring medical treatment abroad) and when all of other treatment 
options have been exhausted. Not limited to medicines used in hospitals. 
Some medicines used in hospitals for treating particular diseases are paid out of the 
state budget. 
Some defined medicines (biologicals for the treatment of cancer, autoimmune and 
rare diseases), which are mainly used in hospital are funded from the “Especially 
Expensive Medicines Fund” of the health insurance fund. 

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Country 

France 

Germany 

Hungary 

Iceland 

Italy 

Latvia 

Netherlands 

Poland 

Portugal 

Slovakia 

Slovenia 

United Kingdom 

Special financing schemes for medicines used in hospitals 

“Liste en sus”: Product specific funding for expensive medicines which meet the 
following criteria: mainly used in hospitals, important therapeutic benefit, added 
therapeutic benefit, price of the medicine is too high to be covered through DRG 
system. 
A second list, the “rétrocession” list, exists for medicines with limitations in supply, 
dispensing or administration or which require prescription and delivery monitoring; 
included are e.g. medicines derived from blood, ARV, chronic hepatitis B or C 
medicines, antibiotics, antifungals, orphan medicines and cancer medicines. 
Compared to the “liste en sus”, the “rétrocession list” is less intended to encourage 
access and uptake of innovation and instead aims to manage supply limitations 
(rétrocession list medicines can also be dispensed in community pharmacies). 
Product-specific funding through the NUB list (Neue Untersuchungs- und 
Behandlungsmethoden / New diagnostic and treatment methods): hospitals can 
request inclusion of medicines in the NUB list for one year. The rationale is that the 
consideration of new medicines in updated DRG calculations would take too much 
time. 
For high-cost new inpatient medicines, individual product-specific funding (i.e. 
reimbursement outside the DRG system) is possible. High-cost inpatient medicines 
which require additional budget and/or legislative adjustments are purchased through 
centralised tenders. Products that fall under this itemised reimbursement scheme are 
approved on a case-by-case basis and hospitals receive allocated quotas of the 
product. 
A separate budget exists for high-cost new medicines. This budget is used to fund 
products used in the inpatient and outpatient setting and is held by Landspitali, the 
only teaching hospital in Iceland. The procurement department at Landspitali 
conducts centralised procurement for these products. 
New innovation funds of EUR 500 million each (one for cancer medicines, one for 
other innovative medicines) since 2017, merged into one “innovation fund” in 2020. 
Included medicines must meet the criteria of unmet medical need, added therapeutic 
value, robustness of evidence. Not limited to medicines used in hospitals. Eligible 
medicines are funded out of the funds for a period of 36 months, which frees funding 
for the regions (which are the payers of medicines. 
In case of funding limitation of hospitals, some high-cost medicines used in hospitals 
are funded out of the state budgets. A special fund also exists for the treatment of 
rare diseases in children. 
Some inpatient high-priced medicines can be reimbursed individually upon joint 
request of the health insurer and the prescriber. 
Some highly specialised therapies (including some medicines) are funded out of the 
state budget. In addition, a new Medical Fund was launched in 2020 which aims to 
provide funding for access to products that are innovative or of high clinical value, as 
well as emergency access to drug technologies (i.e. access to drugs for individual 
patients when all other treatment options have been exhausted). For the latter, 
hospitals can now decide whether a patient should receive treatment as part of the 
emergency access to drug technologies programme (after receiving a positive opinion 
from a national or provincial consultant), rather than applying for funding from the 
MoH. 
Medicines of a defined list of indications (e.g. Multiple Sclerosis, Hepatitis C, Lennox-
Gastut syndrome, Cystic fibrosis) which must be supplied by hospital pharmacy to 
outpatients. 
Some medicines (e.g. growth hormone factors, beta-interferons) are procured and 
funded by sickness funds (these medicines are to be used in specialised centres). 
For inpatient medicines not on the formulary, decisions are taken by hospital 
pharmacy and prescribing physician upon request. For very expensive medicines, 
approval by the hospital director is needed. 
England: Cancer Drug Fund (CFD): in the beginning (established in 2010) separate 
funding of cancer medicines that the NHS would normally not cover after the HTA 
body (NICE) had assessed them as not cost-effective or an HTA had not yet been 
performed. Not limited to medicines used in hospitals. Reformed in 2016 with a 
change into a “managed access” mechanism to fund oncology medicines for a 
maximum period of two years. During this time, the medicines have to undergo an 
HTA performed by NICE. 
In 2022, another fund, the “Innovative Medicines Fund” (IMF) was established for 
potentially lifesaving (e.g. in the areas of spinal muscular atrophy and cystic fibrosis), 
not limited to medicines in hospital. The IMF shall have the same budget (additional 
GBP 340 million) as the CDF and shall function according to the principle as the CDF. 

Source: PPM country fiches 

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5.2.4. Reimbursement lists for medicines used in hospitals 

Usually,  only  medicines  which  have  been  included  in  the  hospital  pharmaceutical 
formulary (HPF) are procured. As a principle, only medicines that have been included 
in these formularies can be procured; however, under certain conditions also medicines 
which are not on the HPF may be procured. This is also reflected in a statement by the 
EAHP:  “Procurement  should  be  according  to  the  medicine  formulary  and informed by 
the formulary selection process. A robust process should also be in place to appropriately 
procure medicines not included in the formulary where their use is indicated for the safe 
and effective care of individual patients."[207]. 

In  most  study  countries,  hospitals  have  their  own  hospital  pharmaceutical 
formulary  (HPF)  even  if  some  (or  all)  medicines  used  in  hospitals  are  subject  to 
centralised  procurement  (at  national  or  regional  levels  within  a  country).  The  sole 
countries with aggregate lists, and no HPF at hospital level, are Denmark, Cyprus and 
Malta  with  a  national  formulary,  Iceland  with  regional  list  and  Sweden  with  regional 
prescribing  recommendations  (“Wise  Lists”  for  rational  prescribing,  which  add  to  the 
national larger reimbursement lists). In Norway, there is centralised procurement for all 
public hospitals, but this is on a voluntary basis, and hospitals may also have their own 
HPF [208] and procure medicines individually. Figure 29 visualises at what level HPFs 
exist in the study countries. 

The individual HPF differ across hospitals, as each hospital decides on its own, 
in  their  respective  Pharmaceuticals  and  Therapeutics  Committee  (PTC,  see 
Chapter  5.2.5).  The  decision  to  include  medicines  in  the  HPF  may  be  based  on  an 
overarching reimbursement decision (joint cross-sector reimbursement list covering the 
outpatient and inpatient sector). More frequently, the decisions on inclusion of medicines 
in the HPF are taken irrespective of reimbursement status of medicines in the outpatient 
sector (for further information see Chapter 5.2.3). 

Figure 29: Use of hospital pharmaceutical formularies (HPF) in the study countries 

Source: PPM country fiches 

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5.2.5. Pharmaceuticals and Therapeutics Committees in hospitals 

Pharmaceuticals and Therapeutics Committees (PTC) are generally responsible for the 
maintenance of the HPF in a hospital, for a group of hospitals, in a region and/or at 
national level. Table 16 presents the level of use of PTC in the study countries. In most 
of  the  study  countries  for  which  information  was  available,  PTC  are  established  at 
hospital level only (i.e. each hospital has its own PTC). Countries may apply different 
PTC at several levels. 

Table 16: Establishment of Pharmaceuticals and Therapeutics Committees (PTC) in the 
study countries 

Country 

All/most hospital have 
their own PTC 

(Additional) PTC of 
group(s) of hospitals or in 
a region 

(Additional) national PTC 

Austria 
Belgium 
Bulgaria 
Cyprus 
Czech Republic 
Denmark 
Estonia 
Finland 
France 
Germany 
Greece 
Hungary 
Iceland 
Ireland 
Italy 
Latvia 
Lithuania 
Luxembourg 
Malta 
Netherlands 
Norway 
Poland 
Portugal 
Romania 
Slovenia 
Slovakia 
Spain 
Sweden 
Switzerland 
United Kingdom 

X 
X 
X 
- 
X 
- 
X 
X 
X 
X 
X 
X 
- 
X 
X 
- 
X 
X 
- 
X 
X 
X 
X 
X 
X 
X 
X 
- 
X 
X 

X 
- 
- 
- 
X 
X 
- 
X 
X 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
X 
- 
- 
- 
X 
X 
- 
- 

- 
- 
- 
X 
- 
- 
- 
- 
- 
- 
- 
X 
X 
- 
- 
X 
- 
- 
X 
- 
- 
- 
X 
- 
- 
- 
- 
- 
- 
- 

Note: No information available for Croatia and Liechtenstein 

Source: PPM country fiches 

5.2.6. Use of MEAs by hospitals 

Managed entry agreements (MEAs) are arrangements about access to new medicines 
subject to pre-specified conditions. They are typically concluded for products with high 
prices  and /  or  uncertain  evidence  about therapeutic benefit.  Arrangements  can  take 
many different forms but can generally be categorised into financial-based (e.g. price-
volume  agreements)  and  performance-based  contracts  (e.g.  payment  conditional  on 
patients achieving a specified outcomes) [169, 171]. 

MEAs are in place for inpatient medicines in almost all study countries, with the 
exceptions of Hungary and Latvia (MEAs in the outpatient setting only) (see Table 17). 

MEAs  include  as  contract  partners  the  manufacturer  of  a  product  on  one  side  and  a 
health care payer or another institution responsible for access of the population to new 

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medicines, such as a regional health authority, HTA body, or health care provider, on 
the other. In most countries, MEAs are only concluded by the national competent 
authority or the CPB. In some countries, MEAs form part of the procurement process: 
in  Denmark,  Iceland,  and  Malta,  the  CPBs  (Amgros,  procurement  department  at 
Landspitali, and CPSU, respectively) are concluding an MEA. More commonly, however, 
are  models  where  the  pricing  and  reimbursement  authority  concludes  the  MEA.  For 
example,  in  Cyprus,  the  Health  Insurance  Organisation  (HIO)  started  entering  into 
financial-  and  performance-based  MEAs  in  both  inpatient  and  outpatient  settings  for 
selected, high-cost medicines. Similarly, the HSE in Ireland concludes MEAs for selected 
medicines, e.g. for nusinersen (Spinraza®) and patisiran (Onpattro®). 

An MEA can also be concluded between manufacturers and individual hospitals, and 
this was a common model across study countries. Hospitals or hospital groups may be 
able  to  conclude  MEAs  with  manufacturers  after  the  public  authority  has  made  their 
decision on pricing and / or reimbursement of the product, including any potential MEA 
at national / regional level. This is the case in France, where hospitals or CPBs for the 
hospital sector can conclude an MEA after the pricing and reimbursement decision was 
taken at the national level. In the United Kingdom, MEAs (patient access schemes) are 
concluded by the National Health Service (NHS), but hospitals are also free to procure 
medicines directly from manufacturers and obtain discounts. Confidential discounts and 
rebates are also the most common form of MEAs in Austria, where the focus was shifted 
away from earlier performance-based contracts (payment by results) due to their large 
administrative burden.  

In  some  other  countries,  there  are  no  MEAs  concluded  by  the  national  competent 
authority for pricing and reimbursement, but such arrangements can be concluded at a 
lower level. For example, in Sweden, procurement of hospital medicines is conducted 
by  the  regions  and  any  MEA  for  inpatient  medicines  would  also  be  concluded  by  the 
regions. Since 2014, the Council for New Therapies (NT-rådet) has provided guidance 
to the regions on the introduction of new medicines, and has also concluded some MEAs 
on their behalf. 

Table 17: Use of managed entry agreements in hospitals 

Contractual arrangements including managed-
entry agreements (MEAs) 

Hospitals conclude specific arrangements (e.g., 
MEAs) after the pricing and reimbursement decision 
of the public authority (which may include 
conclusion of an MEA) 
No MEAs conducted by the national competent 
authority for pharmaceutical pricing and 
reimbursement but there are contractual 
arrangements including MEAs in hospital 
procurement 
No MEAs in hospital procurement are concluded but 
there are MEAs concluded by the national competent 
authority for pharmaceutical pricing and 
reimbursement 
MEAs are used in the inpatient setting (no further 
details available) 
No MEAs are used in the inpatient setting 

Countries 

Austria, Finland, Greece, Romania, Slovakia, 
Slovenia, Switzerland, United Kingdom 

Bulgaria, Czech Republic, Luxembourg, Sweden 

Belgium, Cyprus, Denmark, Estonia, Iceland, 
Ireland, Italy, Lithuania, Malta, Netherlands, 
Norway, Portugal, Spain 

Croatia, Germany, France, Poland 

Hungary, Latvia 

Note: In Denmark, Iceland, and Malta, MEAs are not concluded by the national competent authority for 
pricing and reimbursement, but by the responsible CPBs. In Spain MEAs can either be concluded at national 
or regional level. In Cyprus MEA are concluded by the Health Insurance Organisation for a few very 
expensive medicines. No information available for Liechtenstein. 

Source: PPM country fiches 

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5.2.7. Organisational framework for PPM in hospitals 

PPM  may  be  organised  at  different  levels,  including  at  the  facility  level,  through 
voluntary group (joint) procurement, or centrally at regional (within-country) or national 
level. As discussed in Chapter 3.2, key forms of procurement in the inpatient sector 
are facility-based PPM and procurement through a CPB (at national or regional level).  

Figure 30 gives an overview on which main route study countries use for procurement 
of medicines in their (public) hospital setting. Table 18 elaborates on whether besides 
the main route further routes of PPM are applied in a study country. 

Figure 30: Main route for procurement of medicines in hospital setting 

Note: France uses both regional and national-level centralised procurement as main procurement route. 

Source: PPM country fiches 

Table 18: Organisation of PPM (main and other routes of PPM) in hospitals in the study 
countries 

Country 

Austria 

Main route(s) for 
procurement of 
medicines for inpatient 
use 
Centralised procurement 
at regional level 

Belgium 

Bulgaria 

Croatia 

Facility-based 
procurement  
Centralised procurement 
at national level 
Centralised procurement 
at national level 

Additional route(s) for procurement of inpatient 
medicines 

In some cases, individual hospitals may conduct their own 
procurement. 
In addition, when Austria was involved in the Joint 
Procurement Agreement of the EU with regard to COVID-
19 medicines, procurement was done by the Federal 
Ministry of Social Affairs, Health, Long Term Care and 
Consumer Protection and medicines where then 
distributed to hospitals with COVID-19 patients. 
Procurement through regional CPBs ((e.g. MercurHosp). 

No 

Yes, facility-based procurement for products outside the 
List of Medicinal Products prescribed by law, medicines 
from emergency import and new medicines that have not 
yet been contracted at the national level. 

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Country 

Cyprus 

Main route(s) for 
procurement of 
medicines for inpatient 
use 
Centralised procurement 
at national level 

Denmark 

Czech Republic  Facility-based 
procurement 
Centralised procurement 
at national level 
Facility-based 
procurement 

Estonia 

Finland 

France 

Joint (group-based) 
procurement 

Centralised procurement 
at national (or regional) 
levels 

Germany 

Greece 

Facility-based 
procurement 
Facility-based 
procurement 

Hungary  

Facility-based 
procurement 

Iceland 

Centralised procurement 
at national level 

Ireland 

Italy 

Latvia 

Facility-based 
procurement 
Centralised procurement 
at regional level 
Centralised procurement 
at national level 

Lithuania 

Centralised procurement 
at national level 

Luxembourg 

Malta 

Facility-based 
procurement 
Centralised procurement 
at national level 

Additional route(s) for procurement of inpatient 
medicines 

No  

Joint (group-based) procurement 

No 

The procurement unit at EHIF, acting as a quasi-CPB, has 
conducted pilot projects for centralised procurement of 
selected inpatient medicines (products with larger cost 
containment potential and biosimilars). The role of 
centralised procurement of inpatient medicines is 
expected to increase over time. 
Facility-based procurement (and for novel medicines 
procurement at national level by one of the hospital 
pharmacies) 
Centralised procurement through national CPBs such as 
Resah and UniHA and regional CPB. Joining these CPBs is 
voluntary, and use of these services are also voluntary. 
Thus, hospital may procure themselves some medicines 
and some others through the CPB. 
Some hospitals have joined (private) hospital purchasing 
companies or form group purchasing organisations. 
Centralised procurement at national and regional level. 
Since 2012, PPM has been gradually shifted towards the 
regional level and to the central level, as – as part of the 
bail-out programme – a CPB for health service was 
established in 2018. 
There is centralised tendering for some hospital 
medicines, including high-cost medicines that are not 
covered by the DRG system (conducted by the National 
Health Insurance Fund Management, NEAK), but most 
procurement is done by individual facilities. As part of a 
reform to centralise health care in Hungary, hospitals 
were put under state ownership, and synergies were 
expected to be realised from centralised procurement 
(conducted by the Directorate-General for Public 
Procurement and Supply, KEF). Some medicines are 
therefore also procured via KEF, but hospitals are not 
obliged to participate in procedures organised by KEF. 
Facility-based procurement is also possible since not all 
medicines are tendered, and centralised procurement is 
only mandatory for high-cost medicines. For other 
medicines, other hospitals may procure through 
Landspitali (where tenders are issued), but are not obliged 
to. When not subject to tendering, medicines are 
purchased at the registered price by hospital 
pharmacy/pharmacies. 
Groups of 2-4 hospitals have started to pool volumes for 
the purchase of biosimilars.  
Facility-based procurement (through Consip DPS) for 
every kind of medicine. 
Facility-based procurement for all medicines not on the 
list of centrally tendered products. Health care institutions 
are responsible for their own procurement. 
Facility-based procurement: hospitals also carry out 
procurement procedures themselves using the tools of the 
Central Portal of Public Procurements if medicines are not 
available in the catalogue of the Central Procurement 
Organization (CPO LT). In exceptional cases (for example 
low value procurements, very urgent simplified 
procurements) hospitals may not use the tools of Central 
Portal of Public Procurements. 
Voluntary group procurements 

No 

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Country 

Netherlands 

Main route(s) for 
procurement of 
medicines for inpatient 
use 
Facility-based 
procurement 

Poland 

Portugal 

Facility-based 
procurement 
Centralised procurement 
at national level  

Romania 

Slovenia 

Slovakia 

Facility-based 
procurement 
Facility-based 
procurement 
Facility-based 
procurement 

Spain 

Sweden 

Norway 

Switzerland 

Centralised procurement 
at regional level 
Centralised procurement 
at regional level 
Centralised procurement 
at national level 
Facility-based 
procurement 

United 
Kingdom 

Centralised procurement 
at regional level 

No information available for Liechtenstein 

Additional route(s) for procurement of inpatient 
medicines 

Some hospitals (e.g. university teaching hospitals) do 
group purchasing. 
For medicines with high budget, prices are negotiated by 
the Ministry of Health. Welfare and Sports 
No 

Facility-based procurement. Procurements centrally 
conducted by SPMS based on a needs assessment by 
public hospitals. Hospitals may procure based on 
framework agreements negotiated at national level and 
individually if necessary (e.g. at the beginning of the year 
when CPM not yet conducted or medicines not available 
through framework agreements) 
No  

No  

In addition, for some high-cost cost medicines (e.g. blood 
derivatives, beta interferons) there is centralised 
procurement by the Vseobecná Zdravotná Poistovña 
(VsZP) / General Health Insurance or other sickness 
funds. 
In hospital groups owned by Territory Regional Units joint 
procurement is used. 
Facility-based procurement (by hospital) and for some 
medicines central procurement. 
Procurement may also be done by informal groups of 
individual hospitals or groupings of counties. 
Hospitals may also procure medicines on their own, at 
different prices than the ones negotiated by LIS. 
(Joint) group procurements (e.g. in Zurich) and in two 
regions (cantons) Vaud and Geneva centralised regional 
procurement. 
Hospitals can also conduct their own procurement. 
Hospitals may procure products individually to address 
specific needs or to cover short-term demand. 

Source: PPM country fiches 

Centralised  procurement  at  national level  refers  to  a national  CPB  (or  any  other 
central authority or institution acting as a CPB, such as a Ministry of Health) performing 
all  or  most  of  the  procurements  for  the  (public)  hospital  sector.  Nine  of  the  study 
countries  (Bulgaria,  Cyprus,  Denmark,  Iceland,  Latvia,  Lithuania,  Malta,  Norway, 
Portugal) use centralised procurement at national level as the main (or only) route for 
procurement of medicines in the hospital setting. Box 9 provides an overview of how 
the central purchasing bodies (CPB) are organised in some of these countries. 

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Box 9: Central procurement bodies (CPB) at national level in the study countries 

Some central procurement bodies may purchase not only medicines but other services and goods for the 
public sector. When such body is responsible for PPM, these are referred as central PPM bodies. Several 
study countries perform (at least parts) of their PPM at a national level through a central PPM body.  

Bulgaria and Cyprus – MoH departments responsible for PPM in hospital sector 

In Bulgaria and Cyprus, the central PPM body is incorporated in the services of the Ministry of Health (MoH), 
e.g. by establishment of a dedicated department for procurement.  

After joining the EU in 2007, public procurement in Bulgaria underwent major changes to comply with EU 
legislation, resulting in a new national public procurement legislation. A CPB was established at the MoH 
in 2015 for procurement in the public health care sector. The CPB is responsible for the procurement of 
medicines included in the positive medicinal list used by medical establishments (various types of inpatient 
care facilities). 

For  centralised  PPM  of  hospital  medicines,  the  CPB  concludes  framework  agreements  on  behalf  of 
individual contracting authorities (the health care providers). Individual procurement procedures are then 
conducted as electronic auctions at the facility level.  

Similar  to  Bulgaria,  in  Cyprus  the  central  procurement  body  is  established  in  the  form  of  a  specific 
department for PPM at the MoH – the Purchasing and Supply Services Department. The MoH purchases 
medicines under the mandate of the Health Insurance Organisation (HIO)34 or medicines which have not 
been reimbursed by the HIO for mainly the inpatient (and formerly outpatient sector) at a central level. 
The centralised national PPM system is obligatory, no parallel procedures on other levels (such as regional 
or facility-based) are performed, except for outpatient medicines by private pharmacies.  

The procurement procedures applied – either  open procedure tenders or competitive procurement 
with negotiations - depend on the type of the medicine. Open procedure tenders account for around 75% 
of procedures  and  are  mainly  used for off-patent  medicines  with  increased competition and  biosimilars, 
while  competitive  procurement with  negotiations  is  applied for on-patent  and  innovative  medicines  with 
competition (around 25% of all medicines).  

Norway and Denmark – Central procurement bodies owned by regions 

In Denmark and Norway, the central PPM body is owned by regions and performs PPM for public hospitals 
with different degrees of obligation for hospitals to participate (Denmark mandatory, Norway voluntary). 

for  public  hospitals 

Procurement  of  medicines 
centrally  by 
Legemiddelinnkjøpssamarbeid  (LIS)/  Norwegian  Drug  Procurement  Cooperation.  LIS  was 
established in 1995 as a cooperation for procurement between some counties and was later integrated into 
the hospital procurement body Sykehusinnkjøp. As of today, all publicly funded hospitals are members 
of LIS. Its role in procurement for specialist medicines has grown considerably since then, and notably so 
since  the  funding  for  medicines  previously  reimbursed  through  the  national  insurance  scheme  was 
transferred to hospitals.  

is  performed 

in  Norway 

In a narrow sense, procurement activities by LIS (tendering and negotiations) only relate to the price 
of medicines, which is then communicated to public hospitals. Purchase decisions, including whether the 
lowest-priced medicine should be bought and at what volume, are made by the hospitals and their owners, 
the  four  regional  health  authorities.  However,  an  important  part  of  LIS’  procurement  set-up  is  the 
establishment  of  expert  groups  for  different  groups  of  medicines.  These  groups,  comprising  nationally 
renowned specialists in their respective therapeutic areas, prepare tenders and – based on the results – 
issue treatment recommendations. Take-up of these recommendations (while not mandatory) is high 
and  ensures  that  the  winning  product  is  widely  used.  Nevertheless,  hospitals  are  not  obliged  to 
participate  in  the  centralised  procurement,  and  they  may  deviate  from  LIS’  guidance  by  choosing 
different medicines for their patients than the ones recommended. However, there is evidence on higher 
prices from individual procurements. 

In Denmark, the central purchasing/procurement body, Amgros, is jointly owned by the five Danish 
regions. Amgros is responsible for procurement and price negotiations for inpatient medicines on behalf 
of  the  regions.  Nearly  all  (98%)  of  medicines  used  in  public  hospitals  are  purchased  through  tenders 
organised by Amgros.  

Tendering  (i.e.  use  of  formal  and  competitive  procurement  methods)  is  the  most  commonly  used 
procurement procedure for medicines with analogue competition (i.e. interchangeable medicines within the 
same therapeutic area), generic and biosimilar medicines. Four different types of tender contracts are used: 
framework contracts, fixed volume tender contracts, regional tender contracts and contracts for 
new products.  

34 The HIO – responsible for PPM since 2020 - is still using the Purchasing and Supply Services Department 
(formerly responsible for PPM) for tendering procedures due to its high expertise in this field. Further to that 
the Purchasing and Supply Department of the MOH is responsible for the public procurement of medicines 
without market interest in Cyprus or even without marketing authorization in the EU. 

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Amgros  also  performs  other  services  than  PPM  that  contribute  to  providing  the  right  medicines  for 
patients  in  public  hospitals,  including  horizon  scanning  activities,  logistic  services,  consultancy  for  the 
government, and collaboration with the Danish Health Technology Assessment (HTA) institute.  

Portugal – central procurement as a shared service between the ministries of health and finance 

The  ministries  of  health  (MoH)  and  finance  (MoF)  are  responsible  for  strategy  development  and 
budgeting  for  the  PPM  activities  performed.  The  Serviços  Partilhados  do  Ministério  da  Saúde  /  Shared 
Services of the Ministry of Health (SPMS) is the central procurement body and performing Centralised PPM 
and  concluding  framework    agreements  for  the  National  Health  Service  (SNS)  institutions  both  in  the 
inpatient sector for public hospitals and the outpatient sector for Regional Health Administrations  (ARS). 
SPMS was created in 2010 and is a public enterprise. The Central Administration of the Health System 
(ACSS) commissions and pays for the activities of SPMS. 

SPMS performs both open procedure tenders (called centralised procurement of medicines - CPM) based 
on a list of medicines as of 2016 and negotiates framework agreements (mainly for a duration of four 
years) for both the outpatient and inpatient sectors. In addition, users of PPM (hospitals and ARS) may 
conduct  individual  procurement  at  facility  level  if  neither  CPM  or  framework  agreements  cover  the 
medicine  or  are  (temporarily)  not  (yet)  available  through  CPM  or  framework  agreements  (e.g.  at  the 
beginning of calendar years). 

SPMS is a service provider to the users of PPM (hospitals and ARS) and serves as key contact to suppliers. 
Its  work  goes  beyond  medicines  (procurement  of  services  for  example,  provision  of  IT  services  and 
representation in eHealth cross-border activities). 

Latvia – a central procurement body at National Health Service (NHS) for some products 

Public procurement of medicines in Latvia is centralised for a defined list of products. Procurement for 
these products is organised by the Procurement Division of the National Health Service (Iepirkumu 
nodaļa)  which  acts  as  a  centralised  purchasing  body.  For  inpatient  medicines  on  the  list  of  centrally 
tendered products, individual hospitals enter contracts with suppliers on the basis of framework agreements 
created  by  the  CPB.  For  other  medicines,  hospitals  (with  the  hospital  pharmacies  being  responsible  for 
PPM) conduct their own procurement.  

Open  tenders  are  the  main  procurement  procedure  for  centrally  tendered  inpatient  medicines.  Upon 
conclusion of the open tender, framework contracts are created with suitable suppliers as the basis for 
subsequent supply contracts with individual hospitals. 

Source: PPM country fiches; [19, 89, 120, 211-217] 

A distinct form is centralised procurement by a regional CPB. These bodies exist 
for  hospitals  in  13  study  countries.  However,  their  use  is  often  limited  and  only 
represents  the  main  route  for  procurement  of  hospital  medicines  in  five  countries 
(Austria, Italy, Spain, Sweden, UK; see Table 18). In four of these countries (all except 
the UK), regional procurement is aligned with the regional administrative responsibility 
for inpatient care, i.e. regions are responsible for organising (and partly also financing) 
hospital  care.  However,  this  responsibility  does  not  necessarily  translate  into 
procurement structures at the same level in other countries: in Denmark and Norway, 
where hospital care is also organised by regions, procurement of hospital medicines was 
centralised  at  national  level  through  a  CPB  that  is  jointly  owned  by  and  operates  on 
behalf of the regions (see Box 9). 

In  most  of  the  other  study  countries,  public  hospitals  procure  medicines 
individually  (i.e.  at  hospital  level).  However,  for  certain  medicines  and  in  certain 
situations,  the  hospitals  collaborate  in  voluntary  group  purchasing.  Some  public 
hospitals have joined established group procurement collaborations or companies. 

5.2.8. Procedures and techniques applied in hospital procurement 

Procurement  procedures  describe  award  procedures  that  are  defined  by  law  to 
conduct a procurement, such as open procedure tenders, restricted procedure tenders, 
competitive  dialogue  procedures,  and  competitive  procedures  with  negotiation  as 
defined by EU Public Procurement law [68], whereas procurement techniques relate to 
different methods for managing a procurement procedure, e.g. by making use of 
e-procurement  or  repetitive  calls  for  recurring  purchases.  See  also  Chapter  3.3  for 

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descriptions of the various procedures and techniques and their use for PPM as well as 
the “Glossary for procurement terms” compiled for this study (Annex 3). 

The use of the different procurement procedures and techniques depends on the type 
of medicines, in particular with regard to its location in the product life cycle. The CPB 
Amgros, which is responsible for procuring medicines for public hospitals in Denmark 
(see Box 9), has been stressing the product “life cycle” approach to procurement 
[152]: while monopoly medicines are procured via negotiations (which may involve the 
conclusion of MEAs, see Chapter 5.2.6), more competitive procedures and techniques 
may be used when alternatives in the same therapeutic area (analogous competition), 
or  even  competitors  based  on  the  same  active  substance  (generics  and  biosimilars) 
become  available  (see  Figure  31).  Competition  is  therefore  leveraged  not  only  for 
products  with  direct  competitors  that  use  the  same  active  substance,  but  also  for 
products  with  therapeutic  alternatives.  This  model  is  based  on  close  collaboration 
between Amgros and other institutions, including the Danish Medicines Council, which 
conducts HTA and issues treatment guidelines that are aligned with the results of the 
tenders [218]. 

Figure 31: Product life cycle approach applied and promoted by the Danish CPB Amgros 

Source: Amgros [152] 

In the study countries, a mix of procurement procedures and techniques is being used 
for purchasing medicines used in hospitals. Overall, hospital procurers follow the Amgros 
pharmaceutical life cycle approach, with frequent application of (mainly open) tender 
procedures,  framework  agreements  and  negotiations,  depending  on  the  type  of 
medicines. Given that potentially innovative medicines in areas with unmet need (i.e. 
where no alternative treatment exists) are typically relevant for specialist care provided 
in hospital settings, hospital procurers may rely on competitive dialogue procedures 
or competitive procurement with negotiations for these products. However, such 
procurements are comparatively rare and other procedures are more frequently used. 
The  most  common  procedure  are  open  tenders  which  are  used  across  all  types  of 
medicines in the hospital setting (see Table 19 and Chapter 3.3.1). Open procedures 
may also be used to  find suitable suppliers for  a framework  agreement. Additional 
details on the use of framework agreements in study countries is available in Chapter 
3.3.2.1.  

Table 19: Use of open procedures for procurement of hospital medicines in the study 
countries 

Country 

Austria 

Applied in centralised PPM at regional level and in facility-based PPM. May be used to 
award contracts or to find suppliers for a framework agreement 

Use of open procedures 

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Country 

Belgium 

Bulgaria 

Cyprus 

Czechia 
Denmark 
Estonia 

Finland 

France 

Croatia 

Hungary 

Iceland 
Ireland 

Italy 
Lithuania 

Latvia 

Malta 
Norway 

Poland 

Portugal 

Romania 
Sweden 

Slovenia 

Slovakia 
United 
Kingdom 

Use of open procedures 

Most commonly used procedure for procurement in the inpatient setting, including for 
centralised PPM at national and regional levels, group procurement, and facility-based 
procurement 
Used for the majority of procedures for medicines. Open procedures are used in 
centralised national PPM (by the CPB for the health sector) to conclude framework 
agreements on behalf of the contracting authorities for medicines included in the 
positive medicinal list, and by individual facilities for procurement of medicines not 
included in the list (and for which therefore no framework agreements exist). 
Most commonly applied procedure in centralised PPM at national level. Used mainly for 
off-patent medicines with increased competition and biosimilar medicines. Worldwide 
calls for tenders (often at ATC-5 level, and sometimes at ATC-4 level) are issued by the 
MoH every two years. 
Used for procurement at facility-level. 
Applied in centralised PPM at national level. 
Most commonly form of procedure in centralised PPM at national level for medicines 
used for national health programmes, hospital medicines with large cost containment 
potential, and biosimilars. Open procedure tenders (every 1-2 years) are the only form 
of procurement used in facility-based PPM.  
Applied in group and facility-level procurement for all medicines used in hospitals (apart 
from novel medicines that may be procured centrally by one of the hospital 
pharmacies). 
Applied in all forms of hospital procurement, including national, regional, group-based 
and facility-level procurement.  
Most commonly used form of procurement for all medicines used in inpatient settings 
(applied in centralised PPM at national level and for facility-based procurement). 
Used when there is more than one potential supplier for centrally tender inpatient 
medicines, including high-cost medicines not covered by the DRG when there is more 
than one potential supplier (tenders conducted by NEAK), and other centrally tendered 
inpatient medicines (tenders conducted by KEF). Tenders are generally conducted every 
1-2 years. 
Mandatory use of tenders for products where there is competition in the market. 
Applied in group-based or facility-level PPM for off-patent hospital medicines (medicines 
with more than one possible supplier). 
Applied in regional centralised PPM 
Applied in national centralised PPM for procurement of high-cost medicines and in 
facility-level procurement for all medicines used in hospitals. 
Main procedure for centralised national PPM to identify suppliers for framework 
agreements (centrally tendered inpatient medicines include vaccines, standard 
tuberculin, peritoneal dialysis products, products for phenylketonuria and other genetic 
disorders, immunobiological preparations, and parenterally administered oncological 
medicines). 4-6 tenders are conducted annually. At facility-level, hospitals also use 
annual open procedures for medicines not subject to central tendering. 
Used in appr. 80% of procedures conducted at the central national level. 
Most commonly used procedure for procurement of medicines used in specialist care, 
which is typically conducted at central national level. Facility-based procurement is 
rarely used, but when individual hospitals conduct their own procurement, they use 
open procedure tenders. 
At central level, open procedures are used for medicines for bleeding disorder, 
treatment of HIV/AIDS, and some other medicines. For facility-based and joint (group-
based) PPM, open procedures are used for all inpatient medicines. 
Applied in national centralised PPM for inpatient medicines. Tenders are conducted 
annually.  
Applied in national centralised PPM and facility-level PPM. 
Applied in regional centralised PPM and group-based (joint) PPM. At regional level, 
tendering is done for all inpatient medicines (including biologicals). Tenders can be 
molecule-based (for biologicals) or therapeutic indication-based, and are typically 
conducted every 1-2 years. 
Applied in facility-based PPM for inpatient medicines. For some years (2017-2019) 
hospitals performed PPM within a centralised PPM system. Currently, hospitals carry out 
their own procurements according to tenders issued by the procurement department. 
Used for on-patent medicines for centralised PPM at national level and at facility level. 
Applied in centralised regional PPM for procurement of generic medicines, including 
products that just came off-patent, branded medicines, and biologicals. Open procedure 
tenders are used to establish framework contracts for branded medicines and biologicals 
(including biosimilars). Individual hospitals may also use open procedures to address 
short-term needs. 

Note: While no details on open procedure use for hospital medicines were available for the remaining 
countries, it is likely that open procedures are still used for at least some medicines. 

Source: PPM country fiches 

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In addition, use of new techniques such as electronic auctions and DPS (see Box 10 for 
use  in  Italy)  has  also  been  observed  in  some  of  the  countries  (e.g.  use  by  a  CPB  at 
national and regional levels).35 

Box 10: Dynamic purchasing system (DPS) for medicines in Italy 

Consip is the CPB at national level which is responsible for procurement of any goods and services in the 
public sector (voluntary use for the hospitals). Consip uses DPS (in Italian: Sistema dinamico di acquisto 
(Sdapa)) as a major procurement technique. Introduced in 2011, more than 300 competitive tendering 
procedures were launched as part of the DPS since then. For instance, in 2021, there were 62 DPS 
procedures amounting to a total of about 8 billion euros. 

According to their needs, hospitals can call negotiated procedures through the DPS provided by Consip or 
they can also join on-going procedures at regional levels. Consip does not perform any needs assessment 
or aggregation but offers the technical environment, in particular an e-platform hosted by the Ministry of 
Economy. 

Consip has made very favourable experiences with DPS and considers this technique as the ideal 
procurement technique for homogenous medicines. A well-functioning e-procurement platform is 
prerequisite. 

Source: PPM country fiche for Italy based on national data and literature [9] 

5.2.9. Award criteria in hospital procurement 

Details  on  the  use  of  different  award  criteria  in  the  study  countries,  including  MEAT, 
price  only,  security  of  supply,  local  production,  environment,  and  added  therapeutic 
value are described in Chapter 3.4. 

In all study countries for which information was available, price is used as an award 
criterion in hospital procurement procedures (independent of which main route of 
procurement  is  implemented).  Most  study  countries  apply  price  in  combination  with 
other criteria, which could include environmental, social, quality or other aspects. A few 
study countries use price as sole criterion without generally taking into account other 
criteria. However, among countries labelled as using price together with other criteria 
in the figure are some that would use price only in some circumstances. For example, 
the regions in Sweden generally use price as the main criterion for biosimilars because 
these  are  considered  interchangeable  with  respect  to  other  characteristics.  Similarly, 
Hungary uses price as the main criterion for central national tenders of biosimilars. 

35  A  wide  range  of  procurement  procedures  and  techniques  – much  more  than  the  ones  described  in 

Chapter 4.2.1 of the 2010 PHIS Hospital Pharma report [140] – are applied. 

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Figure 32: Study countries applying price as sole criterion for PPM in hospitals 

Source: PPM country fiches 

MEAT  criteria  come  into  increasing  use  in  the  study  countries,  allowing  the 
combination of price and other criteria. Specifically for smaller markets, where security 
of  supply  can  be  a  challenge  and  competition  in  tenders  is  low,  such  criteria  help  to 
mitigate  these  risks.  While  the  use  of  MEAT  would  generally  be  taken  to  mean  that 
several criteria are used, MEAT can also be based on price or cost alone. The following 
countries apply MEAT in (at least some of) their procurement procedures in the inpatient 
setting: 

 

 

 

 

 

In Austria, MEAT is used in some procedures. 

In  Belgium,  MEAT  is  implemented  through  the  use  of  additional  criteria  for 
quality/safety, supply, environment, among others. 

In Croatia, MEAT is dominated by price which makes up 90% of the weight (with the 
remaining 10% being used for delivery date and environmental criteria so far). 

In  Denmark,  MEAT  is  used  for  centralised  PPM  at  national  level,  where  national 
tenders are obliged to award contracts to the MEAT as per the respective EU Directive 
and the Danish Act on Public Procurement. Yet, Denmark also uses price as criterion 
in some cases in combination with quality criteria (weighted at >50%).  

In Finland, MEAT is the preferred approach to award contracts and includes criteria 
such as price, usability, patient and work safety, and expenses for switching from 
formerly  used  products.  Price  only  is  used  as  criterion  for  ‘less  sophisticated’ 
medicines. 

 

In France, MEAT is supported by procurers. A range of criteria are used, including 
price. 

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 

 

In Greece public contracts may be awarded on the basis of MEAT criteria, which can 
be  identified  either  on  the  price  or  cost,  or  on  the  basis  of  the  best  price-quality 
ratio. 

In Ireland tenders issued by individual hospitals or groups of hospitals, as well as 
tenders for national health programmes state that the MEAT criteria will be applied, 
and that this will be based on the criteria indicated in the tender documents. 

 

In Iceland, price is always used together with other criteria. 

  Romania  applies  MEAT  criteria  for  all levels  of  PPM.  Out of 17,856 procedures  for 

which contracts have been concluded in 2019, 3,492 used MEAT as award criteria. 

 

 

In Spain, MEAT are most commonly used to award contracts. 

In the UK, MEAT criteria are used to award most contracts. This includes cost as well 
as other criteria. 

In some countries, MEAT is reported to be widely used. Note that the reported use may 
differ from actual use as recorded in the TED database (see Figure 8 for a breakdown 
of  MEAT  vs.  price  only  across  procedures  (inpatient  and  outpatient)  in  the  study 
countries).  Box  11  describes  some  challenges  in  implementing  MEAT  criteria  in  the 
study countries. 

Box 11: Challenges in implementing MEAT criteria in PPM 

Some study countries are trying to implement MEAT criteria in their PPM systems and procedures, but 
they face some challenges in increasing its use: 

 

 

 

 

 

In Malta, the Central Procurement & Supplies Unit (CPSU) within the Ministry of Health, which 
procures all medicines for the public hospitals, aimed for the introduction of MEAT criteria in 
tendering. As authorities were hesitant and reluctant to use MEAT, the best price-quality-ratio (which 
still represents an integral part of MEAT criteria) was defined as sole criterion. 

Latvia applies MEAT criteria for a small percentage of procurement procedures. Overall (across all 
sectors, not specifically health sector), MEAT criteria were applied in 20% of procedures in 2014. 

In Portugal the Public Procurement Code (PPC), which translated the EU Procurement Directive into 
national law, would allow the application of MEAT criteria, but it is in practice rarely applied. 

Austria applies MEAT criteria depending on the product only at facility-based PPM level. 

In Estonia and Lithuania, MEAT has so far only been used for procurement of vaccines, not for 
medicines used in the hospital sector. 

Source: PPM country fiches 

For all non-price criteria that may be applied, examples are provided in Table 20. Note 
that the  table  only  provides  a  non-exhaustive  list  of  the  application  of  these  criteria. 
Award  criteria  may  vary  between  individual  procurers  within  a  country,  and  not  all 
possible applications of all criteria may be reflected in the table. 

Environmental  criteria  are  gaining  in  importance  and  some  countries  have  started 
applying  or  are  considering  applying  these  criteria,  either  directly  in  specific  tenders 
and/or by piloting environmental criteria in tenders. Aspects of environmental criteria 
include  for  example  waste  reduction  (packaging,  plastic  use  etc.),  water  recycling, 
principles of fair trade or ethical requirements with respect to the environment. Box 12 
provides  an  overview  of  green  procurement  of  hospital  medicines  in  the  Nordic 
countries,  while  additional information  on  use  of  environmental  criteria  in  PPM in  the 
study countries can be found in Chapter 3.4. 

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Box 12: Use of environmental criteria in Nordic tenders for hospital medicines 

Denmark 

In line with its “green agenda”, the first national (Danish) tenders with environmental criteria were launched 
in 2021. For the development of environmental criteria for hospital procurement, Amgros included expert 
opinion from the technical university, public authorities and stakeholders. Environmental criteria include 
packaging and transport criteria. Amgros received similar response rates as to previous tenders (without 
environmental  criteria).  Environmental  criteria  accounted  for  around 20%  of  the  award criteria  in  these 
tenders. Even if the number of bidders was comparable to tenders without environmental criteria, resources 
to assess the bids increased significantly. 

Norway 

Regarding environmental criteria inclusion Norway is active and has performed pilot studies on antibiotics 
and hormones.   

The Nordic Pharmaceutical Forum 

The cross-country collaboration “Nordic Pharmaceutical Forum” of Denmark, Norway, Finland, Iceland 
and Sweden conducted two successful Nordic tenders for medicines used in hospitals (for details and 
learnings see relevant Chapter 6.2.1.2 on cross-country procurement). 

There was some concern that tenders would not generate enough response from suppliers, but this fear 
did not materialise. Even though new criteria were included in the tenders (such as security of supply or 
environmental criteria), competition was not affected, yet prices increased. Environmental award criteria 
were weighted at 30% of the overall award criteria in the second joint tender. 

Environmental criteria in the Nordic tenders included: 
 

following good practice to ensure zero carbon emissions and clean wastewater at the bidder’s and their 
sub-suppliers’ production sites;  
documentation on environmental certification; 
documentation of eco-friendly transport (reducing greenhouse gas emissions) 

 
 

Source: literature and workshops with procurement experts 

Examples of other criteria are provided in Table 20. Social criteria are not commonly 
used in the study countries. Social criteria are mainly indirectly used as part of MEAT 
criteria.  Social  criteria  seem  as  well  to  be  interconnected  with  environmental  criteria 
(ethical  requirements,  fair  trade,  etc.).  Quality  and  safety  of  product  are  used 
together with other criteria in some study countries. It may include various aspects from 
packaging to storage and clinical and literacy aspects. Security of supply criteria are 
used  together  with  other  criteria  in  some  study  countries.  For  example,  in  Ireland, 
security of supply was used for procuring hepatitis C medicines in a national tender and 
in a tender on trastuzumab and infliximab. Added therapeutic value criteria are used 
together  with  other  criteria  in  some  study  countries.  Denmark  for  example  uses  the 
criterion for new hospital medicines. 

Table  20:  Examples  for  application  of  criteria  other  than  price  in  the  hospital  sector 
(non-exhaustive list) 

Award 
criteria 
Environmental 
criteria 

Example 

  AT: In Austria, a pilot about including environmental criteria in the tender was 

performed. The difficulty was to include it as award criteria without running risk of 
appeals while in commercial negotiations it is easier to consider such criteria. 
  BE: Belgium applies environmental criteria such as waste reduction or water 

recycling. 

  CY: Cyprus partly applies environmental criteria. There is a provision in the tendering 

documents and in contracts establishing environmental issues. 

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Award 
criteria 

Example 

  CZ: Czech Republic uses environmental criteria. Legislation on Public Procurement 
(Act 134/2016 Coll, and Act. 543/2020 Coll.) makes it mandatory for every public 
contracting authority to consider possible environmental, social and also innovative 
potential of every tender. Implementation is attained through e.g. setting special 
conditions for participation using labels to have environmental or social criteria 
proven, or by using a quality evaluation criterion. 

  DK: Denmark uses the criterion for centralised PPM at cross-country level and has 

also launched its first national tender with environmental criteria in 2021 for products 
in ATC groups G and H. Criteria focused on packaging and transport.  

  EL: In Greece, in principle, legislation provides for consideration of environmental 

and/or social aspects in MEAT criteria. 

  ES: tenders launched by national CPBs have included environmental criteria. 
  FR: Environmental criteria in relation to logistics are used. 
  HR: For centralised procurement at national level, implementation of an 

environmental management system according to ISO 14001 was used as part of 
MEAT criteria (price making up 90% of the weight). 

  IE: Environmental criteria are used for all PPM through the DPS. Varying award 

criteria for suppliers to provide medicines in recyclable packaging. 

  IS: Bidders are required to describe their environmental strategy. Iceland is working 

on improving environmental criteria. 

  NO: Norway uses environmental criteria for centralised PPM at national level. The use 
of environmental criteria for the procurement of new antibiotics was a pilot project. 
LIS engaged with the regional health authorities, the Norwegian Association of 
Pharmaceutical Manufacturers (LMI), representatives from generic suppliers, the 
Norwegian Medicines Agency, and colleagues in Sweden to include environmental 
criteria. 

  RO: Romania applies the environmental criterion as sub criterion for all levels of PPM. 
The Governmental Decision on National Strategy for Sustainable Development for 
Romania (GD 877/2018) provides a strategic framework for including environmental 
factors into procurement (e.g. principles of fair trade, ethical requirements). 

  SE: There is a legal requirement to include environmental criteria in publicly awarded 

contracts. 

No  use  of  environmental  criteria:  Estonia,  Finland,  Hungary,  Italy,  Latvia,  Lithuania, 
Luxembourg, Malta, Poland, Portugal, Slovenia, Switzerland 
Unclear whether environmental criteria are used for hospital procurement: Bulgaria  
No information on use of environmental criteria: Germany, Liechtenstein, Netherlands 
  CZ: Legislation on Public Procurement (Act 134/2016 Coll, and Act. 543/2020 Coll.) 

makes it mandatory for every public contracting authority to consider possible 
environmental, social and also innovative potential of every tender. Implementation is 
attained through e.g. setting special conditions for participation using labels to have 
environmental or social criteria proven, or by using a quality evaluation criteria. 
  EL: In Greece, in principle, legislation provides for consideration of environmental 

and/or social aspects in MEAT criteria. 

  No use of social criteria or no information available for all other study countries. 
  AT: Austria applies qualitative criteria such as storage, supply conditions, availability 

of different dosage forms (e.g. for children) in national and regional PPM.  

  BE: Different criteria in the field of quality and safety linked to the subject of the 

tender are used (e.g. data matrix scanning, stability, clinical evidence, indications, 
clarity of packaging and labelling, patient education). 

  DK: In Denmark qualitative criteria may be used together with other criteria for 

centralised PPM at national level. Examples of quality criteria used previously include 
storage life, safe administration of products or routes of administration that minimise 
risk of dosing errors, production processes that minimise the contamination of 
container surfaces (safety for staff handling products), product quality including 
packaging (container design that minimises risk of mix-up), and compatibility with 
existing products. 

  FR: Quality criteria usually make up 50% of the criteria and may include solubility, 

quality of the packaging, differentiation in the strengths, identification of the medicine 
on the unit dose, data matrix on the vial or the unit dose, among others. 

  HU: Hungary applies the Quality / safety of product criterion for centralised PPM and 
facility-based PPM. Award criteria for inpatient medicines include price, as well as 
some quality aspects like supply conditions, storage, etc. 

  IE: Ireland uses qualitative criteria together with other criteria for all levels of PPM. 

Quality criteria included shelf life, reported side effects, presentation, and treatment 
dosage and duration (jointly, 10% of total weight). Quality criteria were also used in 
tenders for hospital medicines conducted by individual hospitals or groups of hospitals 
(e.g. product suitability, supply chain, and support services contributed jointly over 
50% to tenders for infliximab). 

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Social criteria 

Quality / 
safety of 
product 
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Award 
criteria 

Example 

Security of 
supply criteria 

Added 
therapeutic 
value criteria 

  IT: Italy applies the quality / safety of product criterion for centralised PPM at regional 
level. In some rare cases the regional body awarded tenders which also considered 
qualitative elements, such as the number of dosages available and the quality of 
customer service. 

  LV: Latvia applies qualitative criteria for national PPM. Quality aspects such as 

delivery terms and quality of the product may be used together with price and other 
criteria. 

  PL: According to public procurement legislation, the contract shall be awarded on the 

basis of quality criteria and the price or cost. 

  SE: Sweden applies the quality / safety of product criterion for centralised PPM at 

national level. 

  UK: Award criteria applied in the hospital sector are price and quality (jointly, these 

constitute MEAT criteria). 

  In some countries, quality and safety of a product is indirectly considered through the 

existence of a marketing authorisation: Iceland, Portugal, Slovenia, Switzerland 
  Other countries applying this criterium without further detail: Germany, Greece, 

Slovakia, Spain 

No  use  of  quality  /  safety  of  product  criterion:  Bulgaria,  Cyprus,  Estonia,  Finland, 
Luxembourg, Malta (not as a criterium per se but as part of the BPQR), Norway, Romania 
No information available: Croatia, Czech Republic, Liechtenstein, Lithuania, Netherlands 
  BG: Provisions to require documentation on security of supply from suppliers were 

challenged and overturned in court. 

  DK: Denmark uses the criterion for centralised PPM at cross-country level. (e.g. used 
for the 2021 joint Nordic procurement, together with price and environmental criteria. 

  FR: Stock levels are used as criterion for major therapeutic medicines. 
  IE: Ireland uses the Security of supply criterion for all levels of PPM. Was used 

together with other criteria (cost, quality of product, other contract management 
criteria) for procuring hepatitis C medicine in a national tender (security of supply was 
weighted at 3%). Other examples include 5% weighting for a tender on trastuzumab 
(criteria included confirmation of number of months of buffer stock in Ireland, details 
on previous stock-out situations, and details on number of manufacturing sites) and 
12% on a tender for infliximab. 

  IS: Requirement to have 2 months’ supply in a warehouse. 
  Other countries applying this criterium without further detail: Belgium, Latvia, 

Norway, Spain, Sweden, Switzerland 

  NL uses security of supply criteria for outpatient medicines in its preferential pricing 

system. 

No use of security of supply criterion: Austria, Cyprus, Estonia, Finland, Hungary, Italy, 
Lithuania,  Luxembourg,  Malta  (only  indirectly  through  delivery  times  specifications), 
Poland, Portugal, Slovenia 
No  Information  available:  Croatia,  Czech  Republic,  Germany,  Greece,  Liechtenstein, 
Romania, Slovakia, UK 
  BE: Belgium asks for additional clinical evidence (however: the therapeutic value has 
been established by the national authority in the evaluation for market acceptance). 
  DK: Denmark uses the criterion for centralised PPM at national level. For new hospital 

medicines, added value (in six categories ranging from major added value to non-
demonstrable added value) is assessed by the Danish Medicines Council and informs 
the price negotiations conducted by Amgros. Added therapeutic value indirectly 
features as a criterion for procurement of newly introduced medicines as it informs 
price negotiations and is used to determine an acceptable price range. 

  NO: Norway applies added therapeutic value as criterion. It has been used for 

selected tenders (effects of medicine as well as side-effects). 

  SE: Sweden applies this criterion for centralised PPM at regional level. Priority is given 
to quality aspects of the tender, i.e. the medical and pharmaceutical value, although 
price also features.  

  Other countries applying this criterium without further detail: Germany, Netherlands, 

Slovakia, Spain. Switzerland 

  EE: Estonia has used added therapeutic value for procurement of vaccines, not for 

hospital medicines. 

No use of added therapeutic value as criterion: Austria, Bulgaria, Cyprus, Finland, France, 
Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, 
Slovenia 
No Information available: Croatia, Czech Republic, Greece, Ireland, Liechtenstein, UK 

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Award 
criteria 
Other criteria 

Example 

  IE: Ireland uses other criteria: Value-added services. Some element of value-added 

services was included in all tenders for infliximab, including as core criterion or 
additional consideration. In one example from a hospital in Dublin, patient-support 
resources (i.e. age-appropriate information material for children and self-
management tools) and therapeutic drug monitoring (TDM), antibody, and 
calprotectin measurements were weighted at 15% of the award criteria. 

  NO: Norway uses other criteria: User-friendliness, packaging and product range for 
centralised PPM at national level and service for centralised PPM at national level. 
  FR: France considers considering the local production criterion in next tenders, to 

support security of supply. 

Source: PPM country fiches 

5.3. Interface management 

In  several  cases, a therapy  is  started  when  a  patient is  admitted  to  the  hospital  and 
continues after her/his discharge, frequently resulting in a long-term continuous therapy 
in the outpatient setting. 

Thus,  the  medicines  selected  for  the  start  of  the  therapy  can  have  a  major 
impact on the follow-up prescribing. For instance, when a hospital therapy starts 
with the prescribing of a high-cost medicine, such as the originator (biological) medicine, 
despite  availability  of  equivalents  and  alternatives  (e.g.  generics  or  biosimilars), 
outpatient  physicians  may  experience  the  switch  to  a  lower-priced  medicine  as 
challenging. Even if doctors in the outpatient sector are obliged (or at least encouraged) 
in  many  countries  to  switch  to  a  lower-priced  alternative  in  line  with  (prescribing) 
guidelines  of  the  social  health  insurance  or  NHS,  this  may  entail  additional 
communication with the patient to ensure switches are understood and do not negatively 
impact on adherence. There is empirical evidence (from France) that hospital medicine 
use impacts pharmaceutical consumption in the outpatient sector [219]. 

In  this  context,  hospital  procurement  plays  an  important  role.  Compared  to 
reimbursement lists (positive lists, formularies) applied in the outpatient sector which 
usually include several equivalents per active ingredient, in addition to originator and/or 
reference  medicine,  hospital  pharmaceutical  formularies  are  narrower  and  frequently 
only contain one medicine per active ingredient. As a result of marketing strategies of 
pharmaceutical companies (higher discounts and even cost-free provision in countries 
where it is allowed), medicines with, in principle, higher price tags (in the subsequent 
outpatient use) are procured in hospitals, because they are provided at lower costs for 
them [220]. This practice of offering so-called loss leaders, mainly for chronic diseases, 
to  hospitals,  with  the  expectation  of  companies  for  a  return  on  investment  in  the 
outpatient sector in the long-term run, has been documented in previous research [219, 
221] and has been investigated by competition authorities due to the effect of impeding 
market  entry  and  uptake  of  generic  and  biosimilar  products  [180,  222].  In  addition, 
prescribers in hospitals have a stronger role (through their application to, and possible 
involvement  in  the  PTC)  in  what  is  being  procured  compared  to  the  interaction  of 
outpatient physicians in decisions on the inclusion of medicines in the reimbursement 
list. 

Thus, what is procured and subsequently prescribed in hospitals has an impact on the 
outpatient sector and eventually the whole health and pharmaceutical system. Savings 
for hospital procurers may result in overall higher pharmaceutical expenditure 
borne by the taxpayers. 

The  outpatient  and  inpatient  pharmaceutical  (procurement)  systems  differ,  with 
different mechanisms, regulations, policies, institutional and organisational set-up and 
sometimes  also  differ  funding  bodies  (even  if  eventually  it  is  all  public  money).  In 
Chapter  5.2,  the  specificities  of  hospital  procurement  were  described.  In  contrast, 

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public procurement generally plays a less important role in the outpatient sector. There 
are exemptions: some smaller countries use PPM for almost all their medicines needs 
(e.g. Cyprus for all inpatient medicines, the outpatient sector is private [16, 18], Malta 
for  all  medicines  both  in  the  inpatient  and  outpatient  sector).  Additionally,  some 
countries  apply  tendering  or  tendering-like  policies  for  off-patent  medicines  in  the 
outpatient setting:  public payers  invite  bids per  active  ingredient,  and  the product  of 
the winning bidder (and in some cases also of the second and third winner) is included 
in the reimbursement list and must be prescribed (e.g. the “Preferential Pricing Policy” 
in  the  Netherlands,  “discount  contracts  in  Germany,  the  “product  of  the  month”  in 
Sweden, a tendering-like system with changes every two weeks in Denmark [116, 127, 
223]; see also Box 1). Normally, for a medicine used in the outpatient sector, the public 
payer decides whether or not a medicine is reimbursed (positive list) and will thus be 
publicly  funded  (at  least  to  some  extent).  Physicians  are  expected  to  prescribe, 
according  to  the  guidelines,  medicines  included  the  reimbursement  list,  unless  the 
patient is willing to pay out-of-pocket for a non-funded medicine. 

Given the interconnectivity of the inpatient and outpatient sectors that are frequently 
organised  in  separated  settings,  there  has  been  for  long  a  call  for  collaboration 
mechanism  to  bridge  between  the  two  sectors.  In  the  PHIS  Hospital  Pharma  Report 
2010,  this  mechanism  was  called  “interface  management”,  a  term  that  was 
subsequently  used  by  the  management  and  the  members  of  the  PHIS  network  (a 
network  of  competent  authorities  for  pharmaceutical  pricing  and  reimbursement 
information resulting from the PPRI network plus hospital managers), and by the WHO 
that followed up on this concept. In the literature, further terms, in particular “seamless 
care” and “continuity of care” were also used (see Box 13). For this study, which follows 
on the PHIS work, the term “interface management” continues to be used. 

Box 13: “Interface management” – definitions and concepts 

For  the  purpose  of  this  study,  the  term  “interface  management”  is  used,  and  it  is  defined  as  followed: 
“Mechanisms of cooperation between the hospital and the outpatient sector” [142]. 

Further commonly used concepts to this cross-sector collaboration include: 

 

 

 

Seamless care: “the desirable continuity of care delivered to a patient in the health care system 
across the spectrum of care and their environments. Pharmacy care is carried out without 
interruption such that when one pharmacist ceases to be responsible for the patient’s care, another 
pharmacist or healthcare professional accepts responsibility for the patient’s care” [224], cited in 
[225]. 

Integrated care (comprehensive care, transmural care): “Integrated care is a concept bringing 
together inputs, delivery, management and organization of services related to diagnosis, treatment, 
care, rehabilitation and health promotion. Integration is a means to improve services in relation to 
access, quality, user satisfaction and efficiency”[226]. 

Continuity of care: Continuity is “the degree to which a series of discrete healthcare events is 
experienced as coherent and connected and consistent with the patient’s medical needs and personal 
context” [227]. 

The concepts and definitions of seamless care, integrated care and continuity of care are a focus on the 
“care”  aspect,  involving  the  health  professionals  offering  services.  The  term  “interface  management”  is 
broader as it aims to also consider features of the institutional, organisational and funding framework (e.g. 
pharmaceutical policies). 

Identified  policies  and  measures  in  the  study  countries  include  reimbursement  lists 
applicable  for  both  sectors,  joint  reimbursement  committees,  specific  funding 
mechanisms  to  avoid incentivising the  transfer  of  financial  responsibility  between  the 
sectors, supporting instruments to generate evidence implemented from a holistic point 
of  view,  capacity  building  and  networking  (collaboration)  activities  of  health 
professionals, discharge programmes to support seamless care, and IT projects. 

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5.3.1. Cross-sectoral formularies and formulary committees 

In the majority of the study countries, reimbursement lists (formularies) relate mainly 
to  the  outpatient  sector,  while  hospitals  have  national,  regional  and/or  facility-based 
hospital  pharmaceutical  formularies  (see  also  Chapter  5.2.4).  As  described  above, 
sector-specific  formularies  imply  that  prescribers  and  procurers  do  not  consider  the 
needs  of  those  responsible  for  procurement,  inclusion  into  reimbursement  and 
prescribing in the other sector (usually the outpatient setting, which is the “downstream” 
sector).  Cross-sectoral  formularies,  or  at  least  involvement  of  representatives  of  the 
“other  sector”  in  the  formulary  management,  are  a  key  instrument  to  address  this 
barrier. 

Several countries (Belgium, Bulgaria, Cyprus, Czech Republic, Greece, Hungary, Malta, 
Italy,  Portugal,  Romania,  Slovenia,  Sweden,  UK  (applying  only  to  Scotland))  have  a 
joint formulary for outpatient and inpatient sectors (see Figure 33). It should be 
noted  that  in  some  countries  (e.g.  Bulgaria,  Czech  Republic,  Hungary,  Portugal, 
Slovenia)  a  comprehensive  cross-sector  reimbursement  list  is  in  place,  which  is 
supplemented  by  HPF.  Box  14  reports  in  more  detail  some  cases  of  such  cross-
sectoral reimbursement lists.  

Figure 33:  Cross-sectoral  (joint inpatient and  outpatient)  reimbursement  lists  in  the 
study countries 

AT: Specific HPF, no joint reimbursement list. 
BE: In addition to the cross-sectoral formulary in place, HPF are applied. 
BG: Joint reimbursement lists for outpatient and inpatient sector, plus hospital pharmaceutical formulary (HPF). 
Medicines included in the cross-sectoral formulary are reimbursed. However, there may be differences with regard 
to medicines that may be used in the outpatient sector (based on ICD codes) and the inpatient sector (based on 
authorised indications). 
CH: Specific HPF, no joint reimbursement list 
CY: Joint reimbursement lists for outpatient and inpatient sector, plus hospital pharmaceutical formulary (HPF). 
Until end of August 2020 a formulary of medicines (positive list) was maintained by the Ministry of Health advised 
by the Medicines Council for the inpatient sector separately from the general reimbursement list which was then 
integrated to the responsibilities of the Social Insurance (HIO) and its committees.  
CZ: Joint reimbursement lists for outpatient and inpatient sector, plus hospital pharmaceutical formulary (HPF). 
SÚKL has been processing and publishing the list of reimbursed medicines and foods for special medicinal 
purposes. The list is processed on the basis of decisions about maximum prices and conditions and levels of 
reimbursements. This list constitutes the basis for reimbursement in the inpatient sector and can be supplemented 
by HPF. 

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DE: Specific HPF, no joint reimbursement list. 
DK: Specific HPF, no joint reimbursement list. 
While no cross-sectorial formularies exist for the outpatient and inpatient sectors, inclusion of medicines in the 
regional HPF takes into consideration potential price differences between the two sectors (low price inpatient vs. 
high price outpatient). 
EE: Specific HPF, no joint reimbursement list. 
EL: Joint reimbursement lists for outpatient and inpatient sector, plus hospital pharmaceutical formulary (HPF). The 
Greek pharmaceutical systems regulates maximum hospital prices, which are set in relation to ex-factory prices of 
products included in the positive list. Hospitals usually have their additional own formularies, but the regulated 
prices of the positive list serve as a ceiling for PPM. 
ES: Specific HPF, no joint reimbursement list. 
FI: Specific HPF, no joint reimbursement list (or only partly on municipality level). 
FR: Specific HPF, no joint reimbursement list. The national reimbursement list consists of two distinct parts: one list 
of reimbursable medicines used in the outpatient sector (liste des medicaments remboursables agréés aux assurés 
sociaux) and another list for the hospital sector (liste des médicaments agréés aux collectivités or réserve 
hospitalière). 
HR: No Information available. 
HU: Joint reimbursement lists for outpatient and inpatient sector, plus hospital pharmaceutical formulary (HPF). 
There is a single process for applying for inclusion of new medicines in the reimbursement list for both inpatient 
and outpatient sectors. For most medicines, the National Health Insurance Fund (NEAK) decides on the inclusion of 
medicines in the cross-sector reimbursement list. For some high-cost medicines, the ministries of health and 
national economy are involved. 
IS: Specific HPF, no joint reimbursement list. 
IE: Specific HPF, no joint reimbursement list. 
IT: Joint reimbursement lists for outpatient and inpatient sector, plus hospital pharmaceutical formulary (HPF). 
Medicines to be included in the HPF must have been included in the national positive list (PNF – applicable for both 
outpatient and inpatient sectors). Additionally, there is formulary “hospital – outpatient” - of direct distribution 
(Prontuario Ospedale – Territorio PHT) which lists medicines that can be supplied “in direct distribution”, i.e. 
directly by local health authorities for community pharmacies which dispense these medicines to the patients, 
discharged from hospitals. The rationale is that health authorities may get lower prices. There has been some 
discussion since it has not been regularly updated. 
LI: No Information available. 
LT: Specific HPF, no joint reimbursement list. 
LU: Specific HPF, no joint reimbursement list. 
LV: Specific HPF, no joint reimbursement list. 
MT: Joint reimbursement lists for outpatient and inpatient sector, no HPF. 
There is a Government Formulary List (free of charge / covered by social health system for patients), yet in 
addition there are also separate lists for the outpatient and inpatient sectors. 
NL: Specific HPF, no joint reimbursement list. 
NO: Specific HPF, no joint reimbursement list. 
PL: Joint reimbursement lists for outpatient and inpatient sector, plus hospital pharmaceutical formulary (HPF). 
The positive reimbursement list for outpatient medicines informs procurement decisions in the inpatient sector. 
PT: Joint reimbursement lists for outpatient and inpatient sector, plus hospital pharmaceutical formulary (HPF), but 
the HPF at hospital level play a more important role, kindly confirm. 
RO: Joint reimbursement lists for outpatient and inpatient sector, plus hospital pharmaceutical formulary (HPF). 
SK: Specific HPF, no joint reimbursement list. 
SE: Joint reimbursement lists for outpatient and inpatient sector, no HPF. 
The Stockholm “Wise List” aims to improve prescribing practices in the Stockholm area by providing a single set of 
recommendations across inpatient and outpatient settings. Similar initiatives exist in other regions. 
SI: Joint reimbursement lists for outpatient and inpatient sector, plus hospital pharmaceutical formulary (HPF). 
A positive list (full coverage), a positive list with up to 30% co-payment and an intermediate list (with higher co-
payments) are in place. 
UK: While there is no national joint reimbursement list in England, Scotland has introduced such a list to improve 
quality and safety of prescribing (including considerations about polypharmacy). Cost considerations increasingly 
played a role and a single budget for inpatient and outpatient care was introduced. Joint medicines lists 
(formularies) are developed by drug and therapeutics committees which comprise physicians from both sectors. 
The joint formularies are informed by joint guidelines for both sectors, which are developed based on 
recommendations by the Scottish Medicines Consortium (SMC), the Scottish HTA body.  
In England, several initiatives have developed joint formularies between inpatient and outpatient sectors through 
Regional Medicines Optimisation Committees. 

Source: PPM country fiches 

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Box 14: Cross-sectoral formulary management in Sweden and Scotland 

The “Wise List” in Stockholm – a cross-sector formulary managed by a joint committee 

Sweden has a decentralised pharmaceutical system, with the regions paying for medicines. To ensure 
rational use of prescribing, the Stockholm region developed the so-called “Kloka Lista” (translated as 
“Wise List”). The “Wise List” contains those medicines which physicians are encouraged to prescribe; it is 
a selection of medicines that have been assessed by the National Dental and Pharmaceutical Benefits 
Agency (Tandvårds- och läkemedelsförmånsverket / TLV) as eligible for reimbursement. Regular 
information activities targeted at physicians aim to enhance prescribing compliance with the “Wise List” 
which is closely monitored, and in case of deviated prescribing behaviour prescribers are approached. The 
“Wise List” is also actively communicated to the patients, with a booklet in laypeople’s language. 

Introduced in 2000, the “Wise List” was first intended to target prescribing in the outpatient sector. 
However, in the course of further developing the “Wise List”, it was expanded in 2006 to also cover 
medicines used in the hospitals. 

The “Wise List” is updated on an annual basis, based on suggestions that expert panels developed and 
submit to the PTC of the Stockholm region. Given the cross-sector character of the “Wise List”, the 
Committee comprises experts from different fields, to be able to cover both medicines for hospital and 
outpatient use. 

The “Wise List” recommends around 200 medicines for treating common diseases in outpatient and 
hospital care and additional 100 medicines for specialised care. 

While the Stockholm region pioneered the “Wise List” concept, the other regions have similar lists in 
place. 

Cross-sectoral formularies and committees for primary and hospital care in Scottish regions 

Scottish regions have a joint list of medicines that are recommended for outpatient and inpatient use. For 
instance, in Lothian (one region), the Area Drug and Therapeutic Committee (ADTC) formed a Formulary 
Subcommittee to produce a Lothian Joint Formulary, which was first launched in 2001. The concept of 
joint formularies even dates back to the 1980s, with the Health Board of the Grampian region to 
introduce a joint formulary in 1993. In 1993, the Scottish Office advised that each health board in 
Scotland should produce a similar joint formulary covering both primary and hospital care, with the aim 
to improve the quality and cost-effectiveness of prescribing. 

In the regional PTC, physicians of the outpatient and inpatient setting are involved to develop 
recommendation and guidelines. Formulary guidance aims to apply equally to outpatient and hospital 
care, and no “carte blanche” is given to specialist care. Prescribing medicines that are not included in the 
formularies is only permitted if a justification is provided by the prescriber. 

Source: Sweden [228, 229], Scotland [228, 230, 231] 

Cross-sectoral  reimbursement  committees  are  not  frequently  used  in  the  study 
countries  and  have  mostly  been  established  in  the  countries  with  cross-sectoral 
formularies  (see  Figure  34).  In  Austria  for  example,  there  are  no  reimbursement 
committees across the sectors but in the PTC a representative of the sickness fund (i.e. 
payer  for  outpatient  medicines)  is  involved,  however  without  voting  rights.  Still,  this 
change which was legally implemented more than a decade ago helped create a better 
understanding of all members of the PTC for the other sector [232]. In addition, Austria 
established (and then put on hold) a “Medicines Commission” of representatives of the 
outpatient and inpatient sector with the aim of better coordination between sectors (see 
Box  15  for  further  information,  as  this  Commission  was  part  of  a  large  interface 
management initiative). 

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Figure 34: Cross-sectoral reimbursement committees in the study countries 

AT: Representatives of sickness funds (payer for medicines used in the outpatient sectors) are members 
without voting right in the PTC of hospitals. 
BE: Social health insurance decides on the reimbursement of medicines both for outpatient and inpatient 
sectors. 
CY: The Advisory Committee on medicines assesses the application and makes a recommendation to the 
HIO Board of Directors on whether the pharmaceutical product should or should not be reimbursed. 
DK: Joint implementation committee /clinical task force for biosimilar stakeholders. 
ES: Some committee with representation of outpatient and inpatient sectors. 
FI: Cross-sectoral reimbursement committees only partly on municipality level. 
FR: CEPS (Interministerial Economic Committee for Health Products) negotiates the prices of medicines 
used in hospitals and part of the DRG system (instead included in the national reimbursement lists 
applicable for medicines in the hospital). CEPS also negotiates the prices of medicines included in the 
outpatient list. 
IS: The same PTC (based at the national hospital, Landspitali) is responsible for assessing new medicines 
and determining their benefit to patients in the inpatient and outpatient sector. 
LV: The same committee is responsible for defining the lists of reimbursed medicines in the inpatient and 
outpatient sectors. 
MT: The Government Formulary List Advisory Committee (GFLAC) and Advisory Health Care Benefits 
Committee (ACHBC). 
SE: The Stockholm “Wise List” model includes a joint committee making recommendations about essential 
medicines to be used in the inpatient and outpatient sectors. 
UK: Cross-sectoral committees are implemented at regional level in Scotland only. 

Source: PPM country fiches 

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Box 15: Interface management initiatives in Austria 

Long-term cross-sector health reform agenda 

In Austria, a reform process has been on-going for more than a decade to improve the interface 
management in several areas of health care (so-called “Zielsteuerung Gesundheit” (ZSG) process, with 
the three ZSG partners: federal state (represented by the Ministry of Health), the regions (main owner of 
hospital), and social health insurance (funding outpatient services including medicines used in the 
outpatient sector). 

The legal framework is based provided by the Federal ZSG Agreements (resulting in ZSG Agreements at 
regional levels), one running from 2013 till 2016 followed by another from 2017 till 2021 (negotiations 
for a new Agreement currently taking place). The agreements define numerous reform project to improve 
collaboration between the three ZSG partners and thus also at the interface of outpatient and hospital 
sectors. 

Cross-sector “Medicines Commission” for high-cost medicines 

The 2013-2016 agreement provided for the establishment of a “Medicines Commission” for outpatient 
and inpatient care to determine the “point of care” (POC) of a medicine based on the medical-
therapeutic, health care and security of supply criteria. Members of this “Medicines Commission” were 
delegates of the social health insurance and the regions as well as scientific experts nominated by the 
federal state who chaired the Commission. The social health insurance or a region could submit an 
application for an eligible medicine (only medicines with high budget impact or speciality medicines) to 
the Commission to ask for clarity on the POC and thus the funding responsibility. 

The “Medicines Commission” was established and received some applications, but eventually the project 
was discontinued as no aggregate consumption data (both outpatient and inpatient sector) for the first 
medicine discussed could be collated, which could have been needed for taking an informed decision. 

Procurement practitioners’ conference 

To improve the exchange and collaboration between the outpatient and inpatient sectors, a meeting of 
ZSG partners, the central procurement agency and procurers at facility-level (hospital pharmacists) was 
organised in 2016. A key-note speaker of the Danish CPB Amgros reported about their experience with 
centralised procurement. Similar follow-up conferences are considered. 

Cross-sector joint procurement plans 

The 2017-2021 ZSG agreement listed the intention to establish the necessary organisational and legal 
prerequisites to conduct joint procurements across the sectors (outpatient and inpatient), across regions 
and across EU Member States. The project has been put on hold. 

Source: ZSG Agreements [233, 234], information of involved experts 

5.3.2. Funding mechanisms 

In  countries  with  a  fragmented  pharmaceutical  system,  with  different  payers  for  the 
outpatient  and  inpatient  sectors,  funding  mechanisms  bridging  between  or 
aligning  the  two  sectors  constitute  a  major  interface  management  measure. 
One funding measure (also presented in the 2010 PHIS Hospital Pharma Report [140]) 
that  used  to  serve  this  aspect  was  one  of  the  two  “DRG  carve-out  lists”  (see  also 
Chapter  5.2.3)  applied  in  Dutch  hospitals.  Medicines  included  in  the  “NZa  list  of 
expensive  medicines”  were  largely  (80%)  funded  by  the  social  health  insurance,  but 
20%  had  to  be  paid  by  the  hospitals  out  of  their  budget,  with  the  explicit  aim  “to 
stimulate  hospitals  to  use  these  medicines  in  an  efficient  way”  [235].  This  funding 
mechanism  in  the  Netherlands  was  meanwhile  abolished  and  replaced  a  different 
system. The “H prescriptions” in Norway (see Box 16) is the only mechanism of funding 
for the “other” sector with the aim to strengthen awareness and financial responsibility 
that had been identified in the study countries. While it should be noted that high-priced 
medicines (e.g. Onasemnogene abeparvovec / Zolgensma®, see Chapter 5.2.3) can be 
covered by a different payer than the standard funding routine, this appears to be based 
rather  on  financial  considerations  (to  ensure  access  to  medicines  which  the  regular 
payers,  e.g.  regions,  would  not  be  able  to  afford)  and  was  thus  not  classified  as  an 
interface management measure. 

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Box 16: “H prescriptions” in Norway – paying for the medicine use in the other sector 

In Norway, hospitals pay for medicines that are used by patients in the outpatient sector, usually 
medicines whose initial therapy is started in a hospital and then continued in outpatient care. With this 
measure, a shift of funding responsibility from social health insurance (regular payer for outpatient 
medicines) to the hospitals took place for defined medicines. The rationale was and is to incentivise 
hospital doctors to prescribe more economically, as the subsequent expenditure has to be borne by the 
hospitals. 

At its start in 2006, medicines under the “H prescriptions” measure were tumour necrosis factor (TNF) 
inhibitors and Multiple Sclerosis medicines. However, it was extended over the years to also include some 
oncology medicines and medicines for the treatment of HIV, Hepatitis B and Hepatitis C. 

Source: PPM country fiches; [92, 114, 228] 

5.3.3. Further interface management measures 

Further  measures  to  improve  the  collaboration  regarding  pharmaceutical  care  at  the 
interface  of  hospital  and  outpatient  sectors  are  described  below.  Given  the  lack  of  a 
clear  definition  of  what  constitutes  an  interface  management  measure,  these  are 
intended to provide an overview of possible initiatives, rather than aiming to provide an 
exhaustive list of all existing measures. 

Extend (supporting) policies from the outpatient to the inpatient sector or vice versa: 

  Netherlands: The “lock” system to assess expensive medicines used in hospitals 

(see Box 17). 

  Norway: Extension of the “Nye Metoder” system for the managed introduction of 
new health technologies, including medicines, which was introduced for specialist 
health services (hospital care) in 2013, to the outpatient sector in 2016. The “Nye 
Metoder” system provides for conducting HTA (different types, such as mini-HTA, 
single technology assessment or full HTA, depending on the findings of a preceding 
horizon scanning exercise) 

Box 17: “The lock” system in the Netherlands to assess high-budget impact medicines 
for hospital use 

The Netherlands used to perform an HTA only for medicines included in the outpatient reimbursement 
list. With the advance of an increasing number of new medicines with high price tags to be procured by 
the hospitals and thus publicly funded, without an evaluation of their evidence, the government 
introduced the “lock” system in 2014. 

Medicines intended for the hospital sector and whose budget impact is estimated to amount to more than 
EUR 40 million for all patients or to EUR 50,000 per patient annually plus total cost of EUR 10 million per 
patient over the years are blocked from the previously applied “automatic funding” and are put in the 
“lock”. This means that a full HTA will be conducted, and its findings will determine the subsequent 
processes (e.g. decision in favour or against funding, price negotiations, possible conclusion of an MEA). 

Source: [236, 237] 

Examples  of  IT  projects /  cross-sector  collection  and  exchange  of  data  include  the 
following: 

  Cyprus: Electronic system fed by data of the social health insurance and the 

Purchase and Supply Services of the Ministry of Health with comprehensive data 
including stocks and prescriptions 

  Spain: In Catalonia, an electronic system allows sharing of clinical data between 

outpatient and hospital medical records 

  Sweden: Pharmaceutical sales in inpatient and outpatient sectors are monitored by 
the Swedish eHealth agency (E-hälsomyndigheten). The agency collects data on 

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sales from all pharmacies, retailers and wholesalers who are obliged by law to 
supply the data 

Examples  of  measures  and  programmes  with  regard  to  discharge  of  patients  from 
hospitals: 

  Austria: The discharge letter (in some regions) indicates the recommended therapy 

by its International Non-Proprietary Name (INN) to facilitate subsequent 
prescription of lower-priced medicines, if available (overall, as a rule, neither INN 
prescription nor generic substitution is allowed in Austria) 

  Czech Republic: Patients receive medicines prescribed in hospitals and needed 

after discharge from the hospitals in order to avoid that patients fill the 
prescription elsewhere 

  Portugal: Patients with ambulatory surgery are entitled to free medication (for up 

to five days) after discharge 

Initiatives  that  aim  to  provide  treatment  recommendations,  and  foster  capacity-
building and collaboration: 

 

Italy: Collaborative SIFO-FARE project of outpatient and inpatient procurers: SIFO 
(Società Italiana di Farmacia Ospedialiera e dei Servizi Farmaceutici delle Aziende 
Sanitaria / Italian Society of Hospital Pharmacists) and FARE (Federazione delle 
Associazioni Regionali Economi e Provveditori della Sanità / Italian Federation of 
Regional Association of Public Buyers in Healthcare) launched a collaboration 
project to jointly further develop the procurement rules (the 2014 EU Procurement 
Directive [68] was transposed into Italian law in 2016), while fully accepting the 
interprofessionality (different background of the two professions). There were 
capacity-building events and four publications regarding to the further 
development of PPM. 

  Latvia: Adding to a cross-sectorial committee to decide on the inclusion of 

medicines in the lists of outpatient and sectors (see Chapter 5.3.1) hospitals are 
responsible for developing and issuing treatment recommendations for outpatient 
care. 

  Spain / regional of Andalusia: There are so-called “integrated areas” (“Areas 
Integradas” (Integrated areas) where the manager of the Area is both the 
manager / director of the hospital and the community centers in the area. 

  Sweden (Stockholm): Training and education for prescribers to inform about the 

concept and context of the “Wise List” (see Box 14) 

  UK: Area Prescribing and Medicines Management Committees (APC) with 

outpatient and hospital care commissioners and providers to discuss medicines 
management approaches, including prescribing issues. 

5.3.4. Developments in the last decade 

Since the 2008/2009 survey conducted for the PHIS Hospital Pharma Report [140], no 
major changes in terms of organisational and funding measures to improve the interface 
management have taken place. To the knowledge of the authors, as far as observable 
in  literature  and  the  country  surveys,  no  further  countries  introduced  joint 
reimbursement  lists  and  committees  or  funding  mechanisms  to  disincentivise  the 
shifting  of  financial  responsibility  between  the  outpatient  and  inpatient  sector.  With 
regard to the latter, Norway extended its list of “H prescription” medicines, and Austria 
aimed  to  implement  an  interface  management  project  which  was  eventually 
discontinued. 

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In  the  last  decade,  some  further  measures  to  improve  bridging  between  the  sectors 
were taken, and they can be classified into two overarching categories: 

  Supporting policies: In light of pressure on public budgets of new medicines with 
high price tags and uncertainty, supporting instruments such as horizon scanning 
and HTA to generate evidence required for decision-making have gained 
importance. These instruments are introduced and/or further developed with a 
holistic view of the pharmaceutical system; examples from some countries (the 
Netherlands, Austria) highlight increased political interest in the hospital sector. 

  Collaboration projects: Some projects were launched to improve processes at 

the discharge of patients (discharge letter, exchange between health professionals 
of the two sectors) as well as collaboration initiatives between community and 
hospital pharmacists with the aim to learn more about the other sector. 

These measures are no procurement activities per  se, but are part  of  the package of 
policies and initiatives to support equitable patient access to affordable medicines from 
a holistic point of view. 

5.4. Biosimilar use and procurement in hospitals 

Biological medicines are based on a biological substance that is more complex compared 
to other, non-biological medicines. Biologicals are used in patients with often seriously 
debilitating  and  life-threatening  conditions  which  are  typically  treated  in  hospitals, 
including  in  oncology,  neurological  degenerative  diseases,  and  rheumatoid  arthritis, 
among  others.  Biosimilar  medicines  are  biological  medicines  that  are  similar  in  their 
active substance to a reference product and can only enter the market once the patent 
of the reference product has expired [142].   

Use of biosimilar medicines has seen consistent annual growth since the first products 
entered the market in 2006. As of June 2020, biosimilar medicines accounted for 9% of 
the  sales  value  of  biological  medicines  in  Europe,  while  list  prices  in  markets  with 
biosimilar competition have decreased by almost one-third [238]. Due to the typically 
high prices charged for biological medicines, creating competition for their markets 
through  the  introduction  of  biosimilar  versions  can  generate  substantial  cost  savings 
[239].  

This chapter provides an overview of how biosimilar medicines are used in inpatient care 
in European countries, how hospitals conduct procurement of these products, and what 
factors contribute to or hinder more widespread uptake. 

5.4.1. Biosimilar use in hospitals 

The potential for substantial savings makes biosimilar medicines an attractive target for 
optimising  procurement  policies.  This  is  particularly  relevant  for  the  hospital  sector, 
which accounts for the lion share of biosimilar medicines in most European countries. 
In 2021, the share of biosimilar medicines sales in hospitals (as opposed to the retail 
sector)  was  50%  or  greater  in  15  of  the  study  countries,  and  seven  countries  had  a 
larger share of sales in the retail setting (see Figure 35). 

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Figure 35: Share of biosimilar medicines sales in the hospital vs. retail sectors, 2021 

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

AT

BE

BG

CH

CZ

DE

ES

FI

FR

HR

HU

IE

IT

LT

NL

NO

PL

PT

RO

SE

SK

UK

Hospital sales in % of all biosimilar sales

Retail sales in % of all biosimilar sales

Note: Only retail sector data available for DK, EE, EL, LV, LU, SI. No pharmaceutical sales data for IS, LI, 
MT. 

Source: IQVIA [145] 

Uptake  of biosimilar medicines varies greatly, both between  European countries 
and within. At the national level, the share of sales of biosimilar medicines among all 
pharmaceutical  sales  in  hospitals  ranged  from  less  than  2%  in  Bulgaria  and  the 
Netherlands  to  8%  and  more  in  Finland,  Ireland,  Norway,  Sweden,  and  the  UK  (see 
Figure 36). Norway, which invested heavily in generating and disseminating evidence 
about  safety  of  switching  patients  to  biosimilar  medicines  and  where  procurement  of 
hospital medicines is conducted centrally, had the highest proportion of biosimilar sales 
at 16.5% of hospital pharmaceutical sales (see Box 18 for description of the tendering 
system for biosimilars in Norway). 

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Figure 36: Share of biosimilar medicines in total hospital pharmaceutical sales, 2021 

18%

16%

14%

12%

10%

8%

6%

4%

2%

0%

7.8%

16.5%

8.6%

8.5%

12.4%

9.5%

7.1%

6.8%

6.0%

6.0%

5.0%

4.4%

2.5%

2.5% 2.6%

1.6%

2.1%

2.8%

2.4%

2.4%

2.8%

0.2%

AT

BE

BG

CH

CZ

DE

ES

FI

FR

HR

HU

IE

IT

LT

NL

NO

PL

PT

RO

SE

SK

UK

Note: No hospital sales data available for DK, EE, EL, LV, LU, SI. No pharmaceutical sales data for IS, LI, 
MT. 

Source: IQVIA [145] 

Substantial  variation  in  biosimilar  uptake  may  also  occur  within  countries.  While 
biosimilar  uptake  overall  is  comparatively  high  in  Sweden,  this  varies  greatly  by 
individual region. In 2017, the market share of biosimilar infliximab ranged from 18% 
to 96% across the 21 counties [240]. In Hungary, there was wide variation in biosimilar 
uptake  across  different  products,  with  biosimilars  dominating  the  market  for  G-CSFs 
while  for  indications  where  infliximab  was  used,  originator  products  continued  to  be 
prescribed after biosimilar infliximab became available [241, 242]. 

Variation  may  be  partly  explained  by  the  use  of  different  policies  to  encourage 
uptake, including how procurement is done, but may also occur due to other factors 
that act as barriers and facilitators for uptake, respectively. A Swedish study found 
that variation in uptake of biosimilar infliximab was partially explained by differences in 
prices between originator and biosimilar products, as well as the views of key opinion 
leaders, local guidelines, and hospital initiatives [240]. Lack of trust in the safety and 
efficacy of biosimilars was also identified as a potential key barrier to biosimilar uptake 
in  other  countries.  In  Norway,  this  was  addressed  by  generating  evidence  on  safety 
through a large, state-sponsored randomised controlled trial and regular communication 
with prescribers about biosimilar safety and efficacy through seminars [128, 243]. Other 
examples  of  barriers  for  the  uptake  of  biosimilar  medicines  from  study  countries 
include the transactional costs associated with switching treatments (including the need 
for  enhanced  communication  with  the  patient),  lack  of  knowledge  about  biosimilars 
among patients and physicians, regulations around the timing of switching a patient (in 
Portugal, this  is  only  allowed  after  six  months[120]),  lack of a biosimilar  substitution 
policy  (which  means  that  only  the  prescribing  physician  could  initiate  a  switch  to  a 
biosimilar),  and  lack  of  clear  guidance  steering  prescribers  towards  the  cheapest 
available alternative. Finally, suppliers may take actions to impede market entry 
or  uptake  of  biosimilars,  including  through  contract  clauses  that  disincentivise 
hospitals to switch to biosimilars, restricting supply conditions to ensure their product 
wins a tender, and legal actions (see Chapter 3.6 and Box 2). 

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Box 18: Biosimilar tendering in Norway 

In  Norway,  procurement  of  medicines  for  public  hospitals,  including  biosimilar  medicines,  is  organised 
through a central tendering system by Sykehusinnkjøp (LIS) / Norwegian Drug Procurement Cooperation. 
While LIS’ tenders only relate to the price of the product (hospitals decide individually which product and 
how  much  to  procure,  and  doctors  are  not  bound  by  the  results  of  the  tenders),  the  organisation  has 
established a system to ensure widespread uptake of the winning bids. Firstly, there is close involvement 
of clinicians, pharmacists, patient organisations, and other relevant stakeholders in preparing tenders and 
communicating their results. For each category of medicines, an expert group is formed to provide input 
for the design of the tenders (e.g. an expert group for TNF-inhibitors was convened to prepare a tender for 
these products). The panel then endorses the results of the tender by issuing recommendations indicating 
the  preferred  treatment  choice.  Secondly,  the  results  of  tenders  are  disseminated  to  clinicians  through 
seminars  that  are  seen  as  key  resources  to  learn  about  recommended  treatments.  The  seminars  are 
particularly important to educate prescribers about efficacy and safety of biosimilar medicines. Part of this 
evidence (specifically, the effects of switching patients from originator to biosimilar infliximab) comes from 
a  national,  state-funded  randomized  clinical  trial  (NOR-SWITCH  study)  that  was  initiated  as  part  of 
Norway’s process to accelerate uptake of biosimilars.  

An example of significant savings achieved through central tendering that attracted international attention 
was the 2015 tender for biological medicines to treat rheumatological conditions, and stomach, intestinal 
and  skin  diseases.  Biosimilar  infliximab  was  offered  at  a  price  that  was  69%  lower  than  that  of  the 
originator,  starting  a  process  of  replacing  the  originator  from  the  market  for  TNF-inhibitors.  Within  two 
years of market entry, the market share of biosimilar had increased to 40%. 

Source: [30, 244, 245] 

Box 19: Mandatory multi-winner contracts for biosimilar medicines in Italy 

Given the concern that the “winner-takes-it-all” approach may lead to availability issues, Italy introduced 
in 2017 the obligation to grant multi-award contracts for off-patent biological medicines if three or more 
medicines of an active substance have been marketed. All bidders are granted a defined quote. This “multi-
winner approach” is obligatory for outpatient and hospital sectors. 

There has been some research on biosimilar tenders in Italy (as of 2012, before the multi-winner contract 
obligation was introduced, and no limited to hospital), and it showcased the association between limited 
number of bidders (low competition) and difficulty to achieve low prices. The practice of splitting up large 
tenders into many lots also contributed to lower competition. 

Source: multi-winner award contracts [100, 246], research on biosimilar tendering [22, 23] 

5.4.2. Biosimilar procurement in hospitals 

Procurement practices for biosimilar medicines vary across study countries (see 
Table 21). While biosimilar medicines are not part of regular tendering processes for 
hospital  medicines  in  some  countries  (Croatia,  Latvia),  the  vast  majority  of  study 
countries  includes  biosimilars  in  public  procurement  activities.  In  most 
countries, the same organisational framework applies as for the procurement of other 
medicines  (see  Chapter  5.2.7).  For  example,  regardless  of  the  type  of  medicine 
(biosimilar or other), procurement of hospital medicines is organised at the facility level 
in Belgium, at the regional level in Italy, and the national level in Norway (see Table 
21  for  descriptions  of  other  countries).  However,  due  to  the  potentially  significant 
budget impact of biosimilar medicines, deviations from standard procurement practices 
exist.  In  Estonia  and  Hungary,  procurement  of  biosimilar  medicines  is  conducted 
through  central  tenders  while  the  main  route  for  other  medicines  is  facility-based 
procurement. In Estonia, centralised procurement of biosimilars forms part of a wider 
transition of procurement activities from individual facilities to the procurement unit at 
the Estonian Health Insurance Fund (EHIF).  

The case of Estonia highlights the scope for biosimilar procurement as catalyst for 
optimising  PPM  (see  also  Chapter  3.6).  Due  to  the  cost-saving  potential  of 
biosimilars,  they  provide  an  opportunity  to  try  out  new  PPM  practices.  In  Estonia, 
centralised procurement of some biosimilars paved the way for an expanded role for the 
CPB  at  EHIF  in  the  inpatient  setting.  Having  experienced  benefits  from  centralised 
procurement for biosimilars in pilot projects, individual hospitals are welcoming further 
joint  procurements.  In  Ireland,  where  procurement  of  medicines  in  hospitals  is  also 

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predominantly  done  at  the  facility-level,  groups  of  hospitals  have  started  joint 
procurements of biosimilars. Irish hospitals have also started using the newly introduced 
DPS for biosimilars.  

In some countries, public procurement of biological medicines is conducted only at ATC-
5  level  (i.e.  separate  procedures  are  conducted  for  each  active  substance,  e.g. 
Hungary,  Ireland).  In  contrast,  some  other  countries  include  biosimilar  medicines  in 
tenders by therapeutic indication when there is analogue competition (i.e. several 
product have a valid marketing authorisation for a specific indication and could therefore 
win the tender). For example, in Cyprus, tendering for biosimilars is done both at active 
substance  (ATC-5)  level  and  at  therapeutic  indication  level.  The  Czech  Republic  and 
Norway also conduct therapeutic tenders for biosimilar medicines. 

What is common to countries that use tendering for biosimilar medicines in hospitals is 
that some consideration is given during the procurement process to the specificities of 
these products and how their use can be increased (see also Chapter 3.6 for additional 
details  on  biosimilar  procurement  practices  in  the  study  countries).  Details  on  other, 
non-procurement related measures to encourage uptake of biosimilars are presented in 
Chapter 5.4.3. 

Firstly, even though biosimilars have been in use for almost two decades, knowledge 
gaps  about  the  safety,  efficacy,  and  product  quality  of biosimilar  medicines still exist 
among  physicians  and  there  is  a  need  to  build  trust  so  they  feel  comfortable 
prescribing biosimilars. This can be achieved through general educational activities 
(see  Chapter  5.4.3)  but  also  through  engagement  with  prescribers  during  the 
procurement process and provision of clear treatment guidelines. Denmark had 
a pioneering role in achieving cost savings through centralised tenders for biosimilars, 
ensuring  their  swift  uptake  through  early  engagement  with  prescribing  doctors  and 
preparing  nationwide  switches  from  originator  to  biosimilar  products  (see  Box  20). 
Following this model, Norway established a national system of expert panels who are 
involved  in preparing the  tender  and subsequently issue  treatment  recommendations 
about the preferred product (the winner of the tender, see Box 18). In other countries, 
procurement  is  done  at  the  facility  level  where  involvement  of  physicians  and  other 
health care professionals for procurement decisions is good practice to ensure buy-in. 
For biosimilars in particular, engagement with the prescribing doctors at the facility prior 
to conducting procurement procedures can ensure that the procured product is better 
received. PTC often play an important role in procurement decisions and are influential 
in steering prescribing behaviour. 

Secondly, procurers need to be mindful of the trade-off between cost savings from 
awarding  a  contract  based  on  the  lowest  price  and  possible  additional  costs 
incurred by switching to a new product. In theory, these trade-offs should be addressed 
by using MEAT criteria, but there are challenges with implementing this (see Box 11). 
In addition, there may be concerns about the impact of frequent switching on patients. 
In Ireland, where procurement is generally done at a facility-level, a group of hospitals 
created harmonised treatment protocols and conducts joint procurement for biosimilars. 
A key principle of the procurements is to avoid subjecting patients to too many switches. 
As a result, tenders are awarded for two years. In Malta, contracts for biosimilars are 
awarded in four years cycles. 

Finally, considerations about creating a sustainable competitive environment also 
apply  to  biosimilars  [42].  During  a  workshop  on  procurement  of  hospital  medicines 
conducted as part of this study (see Annex 5), participants discussed potential risks of 
single-winner procedures to security of supply and long-term price levels if these lead 
to  a  monopoly  situation  where  only  one  supplier  remains  in  the  market  for  a  given 
biosimilar. Some countries have therefore introduced multi-award procedures where the 
tender is split between suppliers if they are ranked sufficiently close to each other (e.g. 
if prices of the second-ranked supplier fall within a specified range of the winning bid). 

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The  example  of  Italy,  where  multi-winner  contracts  are  mandatory  for  biosimilar 
medicines, is described in Box 19. 

Table 21: Biosimilars procurement in hospitals in the study countries 

Country 

Austria 

Belgium 

Biosimilars procurement in hospitals 

Tendering is used for procurement of biosimilar medicines in the hospital setting (at the 
hospital level). The PTC is the central body in which decisions on the inclusions of 
medicines on the hospital formulary are taken, and guidelines on the purchasing of and 
handling of medicines are developed. Promoting the use of biosimilars is mainly dependant 
on the position of the persons in the PTC. No official guidelines exist regarding the use of 
biosimilars in the inpatient sector, but due to the Austrian DRG system hospitals and 
hospital owners have an incentive to encourage the use of biosimilars. 

Tendering is used for procurement of biosimilar medicines in the hospital setting (at the 
hospital level). However, there are no specific procedures used for biosimilars. When 
biosimilars enter the market, a procurement file is published and the awarded product is 
procured by hospital pharmacists. Awarding is in cooperation with prescribing physicians. 
Switch rules are determined by each hospital individually, through the Medical 
Pharmaceutical Committee which determines which medicines can be used within the 
hospital. No specific process for procurement of biosimilars is in place in hospitals. 
Switching from biological to biosimilar medicines is prohibited for hospital pharmacists. 

Croatia 

Biosimilars are not included in tender processes. 

Cyprus 

Czech 
Republic 

Biosimilars are mainly purchased through open tendering commonly at the ATC-5 level and 
sometimes at the ATC-4 level (analogue competition). 

HPF are based both on the choice of active ingredient (from a certain ATC group) and on 
the choice of a particular medicine. Hospital pharmacies buy pharmaceuticals based on the 
results of public procurement or negotiations. In case of medicines with identical active 
substance, the selection of the provider most often depends on the best offer (the lowest 
price). If requested by health insurance companies or by manufacturers / wholesalers, 
SUKL CZ is authorised to announce competition for the lowest retail price of the medicine 
in specific reference group (group of different active substances with similar effect). 

Denmark 

Amgros, the procurement body for public hospitals, uses tenders for biosimilar medicines. 

Estonia 

Finland 

France 

Procurement of hospital medicines in general is conducted at the facility-level. However, 
for some high-priced medicines and biosimilars, centralised procurement by the Estonian 
health Insurance Fund (EHIF) was initiated. Successful pilot projects for the procurement 
of monoclonal antibodies helped convince individual hospital to conduct more centralised 
procurement in the future. 

Tendering is used for procurement of biosimilar medicines (as for most hospital medicines) 
in the hospital setting (at the hospital level, but hospitals may create procurement pools). 

Tendering is used for procurement of biosimilar medicines in the hospital setting (at the 
hospital level or through joint procurement at the regional level). 

Germany 

Tendering is used for procurement of biosimilar medicines in the hospital setting (at the 
hospital level). 

Hungary 

Tendering for biological medicines (at ATC-5 level) is done centrally every two years. 

Iceland 

Tendering is used for procurement of biosimilar medicines in the hospital setting. 

Ireland 

Italy 

Latvia 

Malta 

Individual hospitals conduct tenders for biosimilars approximately every two years. Some 
hospitals also conduct group procurement for biosimilars. Tendering is done at ATC-5 level 
(same substance), rather than at therapeutic level. There is no HTA for biosimilars. 

Tendering at the regional level is used for procurement of biosimilar medicines. Mandatory 
use of multi-award contracts for biosimilars (if more than 3 in the market) is also relevant 
for hospitals. Each Region has its own guideline for prescribers (e.g.: use of the cheapest 
drug for all patients/ use of the cheapest drug for new patients in compliance with 
therapeutic continuity). 

Biosimilars are not subject to tendering. 

Biosimilars procurement in hospitals represents a challenge for the CPB in Malta. However, 
with horizon scanning and evidence-based decision making, CPSU looks out for managing 
upcoming biosimilars and awards in a 4-year cycle to avoid changeovers.  

Netherlands  Tenders are used to procure biosimilar medicines by individual hospitals, groups of 

hospitals, or in collaboration with insurance companies. 

Norway 

Biosimilar procurement for hospitals is conducted through centralised, national tenders 
(using the same system as for other medicines). An expert group consisting of clinicians, 
and a researcher, pharmacist, patient representative, health economist, and medicines 

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Country 

Biosimilars procurement in hospitals 

agency representative provides input for the design of tenders and issues treatment 
recommendations about preferred products based on the results of the tender. Tenders are 
at the therapeutic level. For active substances with bioequivalent competition, two winners 
may be announced to address risk of shortages. 

Portugal 

No specific processes applied in comparison to other hospital medicines.  

Romania 

Slovakia 

Slovenia 

Spain 

Sweden 

A central task of the hospital’s PTC is to analyse opportunities to modify specific 
therapeutic protocols based on documents provided from the hospital pharmacy. This 
includes the enhanced use of biosimilars in hospitals 

Tendering is used for procurement of biosimilar medicines in the hospital setting (at the 
hospital level). 

The use of biosimilars is encouraged. In tenders usually one slot is reserved for original 
medicines and the other(s) for biosimilars. If more than one biosimilar is used, there are 
several slots for biosimilars provided in the tender. 

Tendering is used for procurement of biosimilar medicines in the hospital setting (at the 
hospital level). 

Sweden uses tendering as the regular procurement method for biosimilars in the inpatient 
setting. This is done at the level of the regions, although the regions may also collaborate 
in the procurement of medicines. Switching to biosimilars is encouraged but not 
mandatory. Prescribing physicians may decide that switching is not appropriate for 
individual patients. Councils applied different strategies to switching from originator to 
biosimilar infliximab, including rapid switch to the biosimilar winning a tender based on 
lowest price (Skåne), delayed switch after gradually introducing the biosimilar 
(Stockholm), and no switch when there was no price difference between originator and 
biosimilar (Västra Götaland). 

Switzerland  Most hospitals procure medicines at facility level (i.e. for their hospital pharmacy only).  

United 
Kingdom 

Biosimilar medicines are subject to central tenders by the NHS. 

No information available for: Bulgaria, Greece, Liechtenstein, Lithuania, Luxembourg, Poland 

Source: PPM country fiches 

5.4.3. Measures to enhance the uptake of biosimilar use 

As shown in Chapter 5.4 and also highlighted by hospital pharmacists participating in 
a workshop on hospital procurement conducted as part of this contract (see Annex 5), 
ensuring the uptake of biosimilar medicines is a major prerequisite to make use of 
the  efficiency  potential  of  biosimilar  medicines.  If  the  use  of  biological  medicines 
cannot be shifted from originator to biosimilar products, any savings due to procurement 
policies  are  not  sufficiently  exploited.  Thus,  the  WHO  Guideline  of  Country 
Pharmaceutical  Pricing  Policies  recommends  promoting  off-patent  medicines,  where 
available,  and  the  2020  update  of  the  guideline  [2]  explicitly  mentions  biosimilar 
medicines (not included in the original 2013 /2015 version [247]). 

To enhance the uptake of biosimilars, two linked approaches are necessary. First, the 
legal  framework  to  implement  appropriate  policies  needs  to  be  created.  Relevant 
practices include prescribing (and switching) recommendations for biosimilars, 
switching,  INN  prescribing  and  substitution.  Second,  but  equally  important, 
awareness-raising  and  capacity-building  measures  are  required  to  ensure 
implementation and enforcement of policies to encourage biosimilar uptake, in particular 
when they were introduced on a voluntary basis. These include training, education and 
information activities, which should complement legal provisions. 

5.4.3.1.  Guidelines for biosimilar prescribing (including switches) 

Most study countries support prescribing of biosimilars: usually prescribing guidelines 
recommend starting with a biosimilar (unless some justified reasons exist to not do 
so)  for  treatment-naïve  patients.  Switching  from  the  biological  reference  to  a 
biosimilar or between biosimilars is, in principle, allowed but should, as a rule, follow 
specific prerequisites (e.g. monitoring, consultation with patients). In any case, it is also 

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the responsibility of the doctors to manage the process  of switching and identify any 
potential reasons not to switch a patient. There may also be active substance-specific 
treatment  or  switching  recommendations:  for  instance,  in  Hungary,  doctors  have  to 
switch  patients  to  the  tender  winner  product  for  infliximab,  but  there  is  no 
recommendation for a switch for other biosimilars. 

5.4.3.2.  INN prescribing 

Some  hesitancy  with  regard  to  biosimilars  has  also  been  seen  with  regard  to  the 
regulation for INN prescribing (see Figure 37). In all of the study countries except for 
Austria, Denmark and Sweden, INN prescribing is in place, and it is mandatory in ten 
countries (although this may be restricted to treatment-naïve patients, as is the case in 
Latvia).  However,  some  countries  excluded  biologicals  from  INN  prescribing, 
including  some  where  INN  prescribing  is  mandatory  for  other  medicines  (France, 
Lithuania,  Malta,  Romania,  Slovakia,  Spain)  and  others  where  INN  prescribing  is 
voluntary (Belgium, Estonia, Ireland, UK). 

Figure 37: INN prescribing policies for biological medicines in the study countries 

Note: In Latvia, INN prescribing is mandatory for newly diagnosed patients and indicative (voluntary) for 
others.  

Source: PPM country fiches 

5.4.3.3.  Substitution 

Generic  and  biosimilar  substitution  is  usually  a  measure  targeting  community 
pharmacists. While generic substitutions is in place in ten of the study countries (thereof 
mandatory in two countries), it is not allowed in 20 countries (no information available 
for Liechtenstein and Luxembourg; see Figure 38). 

These policies can also impact substitution by hospital pharmacists. Overall, there are 
mixed  positions  on  biosimilar  substitution.  In  the  workshop  on  hospital  procurement 
[189],  the  possibility  of  automatic  biosimilar  substitution  in  the  hospital  setting  was 
raised once sufficient experience with a product has been gained. 

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Figure 38: Biosimilar substitution policies in the study countries 

In Germany, introduction of biosimilar substitution is planned for summer 2022. 

Source: PPM country fiches 

5.4.3.4.  Information and education activities 

Knowledge gaps about the safety, efficacy, and product quality of biosimilars remain. 
Information  and  education  activities  are  therefore  needed  to  address  these  gaps  and 
possible  associated  concerns  about  initiating  and  /  or  switching  to  biosimilars.  In  a 
workshop  with  hospital  pharmacists,  public  procurement  agencies,  pricing  and 
reimbursement  authorities,  and  representatives  from  the  pharmaceutical  industry, 
educating physicians was identified as the single most promising route for promoting 
uptake of biosimilars.36  

Efforts are underway in the study countries to address this gap. In Norway, the hospital 
drug  procurement  cooperation,  LIS,  is  actively  involved  in  information  and  education 
activities  by  setting  up  regular  seminars  on  biosimilars.  The  seminars  are  used  as 
general  education  channels  for  biosimilars  in  general  but  also  to  communicate  the 
results  of  centralised  tenders,  so  prescribers  are  aware  of  what  the  recommended 
treatments  will  be  in  the  coming  year  (see  Box  18  for  an  overview  of  biosimilar 
procurement  in  Norway).  The  need  for  engagement  with  prescribers  has  also  been 
recognised  in  other  countries.  In  Ireland,  the  national  health  service,  HSE,  is 
implementing a strategy to achieve a biosimilar prescribing rate of 50% by working with 
clinical pharmacists and clinical teams. Early engagement with prescribers was also 
instrumental for the success of a rapid, nationwide switch from originator to biosimilar 
adalimumab in Denmark, where biosimilars effectively replaced the originator within a 
few weeks (see Box 20). In the Danish example, these activities were not limited to 

36 Other important routes were generating evidence on effectiveness and safety of biosimilars, and making 

changes to treatment guidelines. 

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doctors. A biosimilar task force also provided patients with information and engaged in 
a dialogue with patient organisations.  

Box 20: Denmark: successful switch of adalimumab within six weeks 

Denmark has held a pioneering role in achieving cost savings through widespread biosimilar uptake. This 
was made possible through the systematic approach to procurement of medicines by the CPB for Danish 
hospitals, Amgros, which involves close collaboration with all stakeholders, including prescribers, hospital 
pharmacists, the Danish Medicines Council, suppliers, and – for some activities – patients (see Box 9 for 
a  description  of  how  Amgros  operates  and  its  product  life  cycle  approach  to  procurement).  The  Danish 
model for achieving cost savings is built on generating competition among suppliers, either within the same 
active  ingredient  or  within  therapeutically  analogue  alternatives,  and  the  ability  to  influence  prescribing 
patterns throughout the country with evidence-based, standardised treatment guidelines. 

Denmark’s  experience  of  moving  from  originator  to  biosimilar  adalimumab  provides  an  example  of  a 
successful  nationwide  switch  over  a  short  time  period.  While  biosimilar  substitution  is  not  allowed  in 
Denmark, the system of centralised procurement through Amgros coupled with a well-established system 
for issuing treatment recommendations by the Danish Medicines Council resulted in a near-complete switch 
of patients treated with adalimumab to biosimilars.  

Upon patent expiry of the originator in October 2018, most patients were immediately switched to one of 
three biosimilars (one for children, and two products used for adults in different regions). Within just six 
weeks,  the  market  share  of  biosimilars  increased  to  95.1%.  While  the  total  number  of  patients  treated 
increased over the following year, the total costs of adalimumab were cut to approximately one-fifth of the 
expenditure before market entry of biosimilars.  

Success factors for the near-complete switch to biosimilar adalimumab included engagement with clinical 
staff as well as patients to prepare for the switch (a biosimilar task force prepared information material for 
patients), clear guidelines issued by the Danish Medicines Council that prescribing physicians could rely on, 
the expectation of significant savings from the switch (cost reductions of 87% were reported ahead of the 
switch), and the existence of an experienced CPB with market knowledge to conduct successful tenders. 

Sources: [123, 182, 218, 248] 

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6.  COLLABORATIONS IN PPM 

6.1. Reasons for conducting joint procurement and variants 

Joining  forces  in  public  procurement  – not  necessarily  focusing  on  health  care  or 
medicines –  has  been  promoted  for  long  in  public  administration,  under  different 
terms  (e.g.  collaborative  purchasing,  alliance  purchasing,  bundled  purchasing, 
collaborative purchasing, collective purchasing, combined purchasing, joint purchasing, 
mutual purchasing, shared purchasing) [122, 249-254]. The predominant argument in 
favour  of  joint  (or  pooled)  procurement  is  to  achieve  lower  prices  due  to  higher 
volumes (improved economies of scale) and thus also becoming a more attractive client. 
Other  reasons  for  conducting  pooled  procurement  are  to  improve  availability  of 
medicines,  ensure  access  to  high-quality  products,  and  more  efficiency  in 
procurement  due  to  reduction  of  transaction  costs  [41].  Another  frequently 
mentioned argument supporting joint procurement concerns the ability to strengthen 
the  bargaining  power  of  the  purchasers  and  their  capacity  (see  also  an  EC 
commissioned  study    [138]  which  maps  the  administrative  capacity  of  public 
procurement across the EU member states), including improvement in transparency, 
accountability and anti-corruption [21, 34, 40, 255, 256]. 

These arguments have also been brought forward when it comes to pooling in public 
procurement in health care, including for medicines. A seminal work by Huff-Rousselle 
[7] more than a decade ago stressed the benefits of pooled (or joint) PPM, which go 
beyond savings for the public budgets (see Box 21). 

Box 21: Benefits of joint PPM 

Based on a literature review and experience with pooled PPM intra-country and cross-country, with a focus 
on LMIC, Huff-Rousselle identified the following benefits: 

  Reduction in purchase prices, 

  Improved quality assurance, 

  Improved rational choice through better-informed selection and standardisation, 

  Reduction in operational costs and administrative burden, 

  Creation of a professional network and increased equity between the members of procurement 

collaboration 

  Strengthening the role of the host organisation, 

  Improved supply of commodities to populations in needs. 

In  a  recent study on  intra-country collaboration  in  European  countries  (national  centralised  PPM),  these 
benefits were largely confirmed. Some additional (partially overlapping) benefits were identified: 

  Improved governance and enhanced transparency (e.g. on processes and methods), 

  No discrimination between the suppliers, 

  Opportunity to develop measures to improve the attractiveness of the market, 

  Building capacity, 

  Increasing competition, 

  Improved data availability and generation, 

  Accelerated processes and avoidance of waste (e.g. stockpiling) 

Source: Authors’ compilation based on Huff-Rousselle 2012 [7] and Vogler et al. 2022 [9] 

Pooled (or joint) PPM can be designed intra-country or cross-country [7], and this 
can be implemented through collaboration between different public procurers or through 
procedures conducted by a designated procurement body (e.g. a CPB) as defined lead 
procurer (see also Chapter 1.1). Implementation of intra-country collaboration in PPM 
(e.g. national or regional centralised PPM, group procurements) has been mapped for 

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the  study  countries  in  this  report  (see  Chapters  3.1,  3.2,  and  5.2.7);  details  on 
collaboration  in  PPM  (including  intra-country  and  cross-country)  are  provided  in  the 
country fiches (see Annex 4.1-4.32). A recently published study on national centralised 
PPM  system  in  six  European  countries  confirmed  the  challenges  identified  by  Huff-
Rousselle  [7]  and  identified  a  few  further  advantages  (see  also  Box  21),  while  also 
acknowledging  challenges  which  need  to  be  addressed  appropriately  from  the  very 
beginning [9]. 

This chapter presents some cross-country collaborations in PPM in the study countries 
and examples of other initiatives. This information presented is informed by literature 
and information provided by experts involved (e.g. during the workshops in the course 
of this study, validation of documents by procurement experts). 

6.2. Cross-country collaborations in PPM and learnings 

Globally, procurement has been an important area of cooperation between countries. In 
Europe,  where  pricing,  reimbursement  and  also  procurement  are,  to  a  major  extent, 
national competences of the EU MS, collaborative approaches in the peri-launch phase 
(i.e. between marketing authorisation and launch of a product into the market) have 
emerged more recently, mostly in the last decade. Cross-country collaboration in Europe 
was prompted by an increasing emergence of new medicines with very high price tags 
(challenging  financial  sustainability)  and  frequently subject  to  uncertainty about their 
therapeutic value, and by emergency situations such as pandemics. 

6.2.1. Cross-country collaborations in the study countries 

Currently, there  are  five  collaborations  established  at  the  initiative of national 
governments,  in  which  study  countries  are  involved  and  whose  (planned)  areas  for 
collaboration  include  PPM  or  related  activities  such  as  joint  price  (or  reimbursement) 
negotiations.  Table  22  provides  an  overview  of  these  five  initiatives  as  well  as  two 
further government-initiated collaborations, with related areas of collaboration that are 
relevant for procurement. Three initiatives that have conducted joint procurements or 
price negotiations are described in more detail in Chapters 6.2.1.1-6.2.1.3. Learnings 
about challenges and best practices for cross-country collaborations in PPM from these 
initiatives are also taken up in Chapter 7. 

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Table 22: Government-initiated cross-country collaborations in the study countries 

Initiative 

Start 

Countries 

Areas of collaboration 

Status of PPM 

Baltic 
Procurem. 
Initiative 
Beneluxa 
Initiative 

20101  EE, LV, LT 

2015 

BE, NL, LU, 
AT, IE 

FAAP 

2017 

CZ, HU, LT, 
PL, SK 

PPM 

Yes 

No, but 
joint 
nego-
tiations 

Yes 

FINOSE 
IHSI 

2018 
2019 

FI, NO, SE 
BE, NL, DK, 
IE, NO, PT, 
CH, SE 

Nordic 
Pharma. 
Forum 
Valletta 
Declaration 

2015  DK, IC, NO, 
SE 

2017 

HR, CY, EL, 
IE, IT, MT, PT, 
RO, SI, ES 

No 
No 

Yes 

Yes 

Further activities 
Lending of medicines and 
medical devices in case of 
non-availability 
Horizon scanning 
HTA 
Price and reimbursement 
negotiations 
Information sharing 
HTA 
Price and reimbursement 
negotiations 
Information sharing 
HTA 
Horizon scanning 

Joint vaccines 
tenders successfully 
concluded 
Not appl. for PPM 
Joint negotiations 
successfully 
concluded 

No joint tender / 
negotiation yet started 

Not appl. 
Not appl. 

Horizon scanning 
Manufacturing 
Security of supply 
HTA 
Price negotiation 

Two joint tenders 
successfully 
conducted 
No joint tender / 
negotiation yet started 

FAAP = Fair and Affordable Pricing, IHSI = International Horizon Scanning Initiative, not appl. = not 
applicable, Pharma. = pharmaceutical, Procurem. = pharmaceutical, for country abbreviations see the 
respective list of abbreviations 
1 Task force started in 2010, the partnership agreement was signed in 2012 

Source: [10, 48, 117], updated by authors 

In  addition,  there  are  indications  of  further  (planned)  and  examples  of  previous 
(unsuccessful)  joint  procurement  initiatives  between  individual  countries,  such  as 
between Bulgaria and Romania, or between Spain and Portugal. In case of the latter, 
plans  for  joint  PPM  were  eventually  postponed  due  to  other  priorities  during  the 
management  of  the  COVID-19  pandemic. Due  to  lack  of  robust information  on  these 
additional procurement initiatives, no further details are presented in this report. 

To note that there are additional collaborative networks in Europe, in which competent 
authorities  for  pricing  and  reimbursement  and/or  public payers  are  involved,  such as 
the Pharmaceutical Pricing and Reimbursement Information (PPRI) network [71] or the 
Piperska group [257]. These networks are  focused  on information-sharing but do not 
collaborate technically in procurement, pricing or reimbursement. In addition, there is 
the  Network  of  Competent  Authority  Responsible  for  Pricing  and  Reimbursement 
(NCAPR), which is coordinated by the European Commission in coordination with EU MS 
[258].  Still,  they  are  of  relevance  for  the  exchange  and  possible  dissemination  of 
experience of collaborations. Further platforms for sharing of information and practices 
include  European  associations  of  public  procurers  (e.g.  European  Health  Public 
Procurement  Alliance  (EHPPA)  [259],  or  payers  (e.g.  European  Social  Insurance 
Platform (ESIP)). 

6.2.1.1.  Baltic Procurement Initiative 

The  Baltic  Procurement  Initiative  started  in  2012  based  on  a  partnership  agreement 
signed  by  the  competent  authorities  (ministries  of  health,  or  of  social  affairs, 
respectively) of the three Baltic countries Estonia, Latvia, and Lithuania. This agreement 
followed up on the political mutual understanding of the government of three countries, 
expressed by their prime ministers in 2010 by establishment of a task force [117]. 

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The Baltic Procurement Initiative has two objectives [117]: 

 

Joint procurement of medicines (by now, this joint endeavour only related to 
vaccines that are in the immunisation schedule of at least two of the three 
countries); 

  Lending of medicines and medical devices among the countries without 

charging any costs in cases of shortages. 

The Baltic Procurement Initiative has successfully concluded some joint tenders. 
The  lead  partner  is  defined  on  a  case  by  case  basis  for  each  procurement;  the  lead 
partner receives the official (written) mandate by the other countries to proceed on their 
behalf. The procurement is conducted in accordance with procurement legislation of the 
lead partner’s country. The identification of the candidate vaccines for joint PPM is done 
jointly by all three countries. In some cases, only two of the countries procure jointly, 
where  required  vaccines  included  in  national  immunisation  schedule  match.  For  the 
future, moving to joint procurement of other medicines beyond vaccines is considered. 

The initiative faced a steep learning curve. The first joint tender, launched by all three 
countries, for  the  bacille  Calmette-Guerin  (BCG)  vaccine against  tuberculosis  in  2015 
had to be declared unsuccessful since no bids were received. There was only one BCG 
vaccine  that  was  authorised  in  all  three  countries.  This  unsuccessful  joint  PPM 
highlighted the importance of market research. 

In the following years, the initiative conducted four successful tenders: 

 

rotavirus vaccine in 2016 (involvement of Estonia and Latvia), 

  pneumococcal conjugate vaccine in 2017 (Latvia and Lithuania), 

 

rotavirus vaccine, and a hexavalent vaccine in 2018 (Estonia and Latvia), and 

  again a rotavirus vaccine, and a hexavalent vaccine in 2018 (all three countries) in 

2021. 

In all procurements, open procedures were used, and except for one procurement, price 
was considered as the key evaluation criterion. Apart from one case, the prices achieved 
in the joint PPM were lower than in national procedures. 

Another important step was the move to more strategic action, with the development 
of  the  first  strategic  procurement  plan  for  the  Baltic  Procurement  Initiative  in  2019, 
which also ended the years of a pilot phase. 

Key lessons learned from the Baltic Procurement Initiative include the following: 

  Political support: This collaboration was set up as a high-level political initiative. 
Having the political support was important for the technical experts who reported 
that the interest of their political leaders who asked about the progress was 
important especially in the early years when no successful procurement had yet 
been performed. 

  Mutual understanding and trust: Building trusting between the experts was 

considered as a key prerequisite to good cooperation. However, a high number of 
face-to-face meeting slowed down the process in the beginning. As soon as trust 
and clarity on division of work and processes has been achieved, collaboration 
went much smoother. Face-to-face meetings were reduced to minimum one 
meeting per year; email correspondence is an important communication channel. 

  Clear responsibilities (role of lead procurer): The Baltic Procurement Initiative 

moved from representation of all three participating countries (in the first 
unsuccessful tender) to a working model based on a lead procurer for each joint 
procurement. Under this model, the country being the lead procurer takes a major 

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responsibility and a large share of the workload in the respective joint tender. The 
lead procurer is given a strong mandate by the other countries, which is important 
for the conduct of the procedure. Given the workload, rotation of the lead procurer 
proved to be useful. 

  Flexibility and alignments to country specificities: Countries can decide on a 
case-by-case basis whether or not they want to participate in the joint tender. 
Usually, the criterion as to whether the vaccine to be procured is in the national 
immunisation schedule will be the decision criterion. While there is this flexibility to 
decide on a voluntary basis whether or not to participate, it is clear that as soon as 
the decision in favour of participation has been taken, it is a commitment. 

  Relevance of market research: The failure of the first joint tender highlighted 
the importance of knowing the markets. Market feasibility analyses, including 
exploring the capacity of possible bidders to supply, was a major learning from this 
first failure. 

  Simplification of procedures and clarity (language): Legal issues and 
processes should be clarified before the tender is launched. Value is seen in 
keeping the PPM procedures, and also documents, as simple as possible. As a 
practical learning, the Initiative aims to keep the procurement documents short 
(with a maximum length of ten pages). From the second joint tenders, the Baltic 
Procurement Initiative produced the procurement documents in English, which 
facilitated collaboration. For the terminology, the Initiative moved from using 
English translations of the national public procurement law to the ones used in the 
EU Public Procurement Directives. 

  Learnings over the years (move to strategic procurement): The beginning of 
the collaboration, with slow progress (no successful tender in the first year) was 
difficult, but there were learnings over time, and it becomes easier each time. After 
a pilot phase, the Initiative developed further towards improved professionalism 
and strategic approaches. 

6.2.1.2.  Nordic Pharmaceutical Forum 

The  Nordic  Pharmaceutical  Forum  started  as  a  cross-country  collaboration  in  2015, 
initiated by the Danish CPB for public hospitals, Amgros, as a bottom-up initiative (in 
contrast  to  other,  more  politically-driven  collaborations).  The  Nordic  Pharmaceutical 
Forum is a collaboration of Denmark, Norway, Iceland, Sweden and Finland. 

The initiative was founded to provide a platform for exchange between the Nordic 
countries on issues related to access to medicines and identify areas for collaboration. 
Joint action areas include horizon scanning, manufacturing, logistics, security of supply, 
and joint procurement and negotiations.  

By joining forces, the initiative aims to increase purchasing power and to ensure 
security of supply. Joint procurement of medicines has been one of the objectives of 
the  Nordic  Pharmaceutical  Forum  from  the  beginning,  as  the  involved  procurement 
agencies from Denmark and Norway were the respective CPBs for the hospital sector. 
However,  Sweden  could  not  get  involved  in  the  hospital  procurement  because  of  its 
fragmented hospital sector (hospital procurement is done by the regions, see Chapter 
5.2.7). 

In the beginning, the member countries had the intention to work together on new high-
priced  medicines  which  put  pressure  on  public  health  budget.  However,  the  focus 
increasingly  shifted  towards  security  of  supply,  as  all  involved  countries  experienced 
supply  issues.  Individually,  the  Nordic  markets  were  considered  too  small  and 
unattractive to  be  served  with  both new  as  well  as  “old”, well-established  medicines. 
Aiming to address the security of supply issue, the collaboration focused on procuring 
“old” medicines which usually have rather low prices.  

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The Nordic Pharmaceutical Forum has concluded two successful joint tenders for 
off-patent  medicines  (including  ampicillin,  anagrelide,  ceftazidime,  ceftriaxone, 
cefuroxime,  ciprofloxacin,  gentamicin,  meropenem,  methotrexate,  metronidazole, 
ondansetron,  paracetamol,  vancomycin).  All  of  these  products  fall  into  the  final  two 
phases  of the  pharmaceutical life cycle (consisting  of  six  phases, ranging from  newly 
introduced products to products at risk of or with actual supply security issues; for the 
Amgros life cycle approach see Figure 31). 

  First preparations for the joint procurement date back to the summer of 2017 
when members of the collaboration met to discuss options for a pilot joint 
procurement exercise. 

 

In September 2018, the Nordic Pharmaceutical Forum conducted a market survey 
with the aim to collect potential suppliers’ views on a preliminary list of suitable 
products. 

  This was followed by six weeks of hearings with potential suppliers to consult with 

them on the draft call for tender. 

  The call for the first Nordic tender was launched in April 2019, with agreements for 

the deliveries starting in February 2020. 

  Based on the overall success of the first tender, the Nordic Pharmaceutical Forum 
published a second call in June 2021. Bids were awarded, and the procurement 
period for these tenders will run from April 2022 till March 2024. 

Adding to the security of supply focus, the Nordic Pharmaceutical Forum also included 
environmental criteria as award criteria (see Chapters 3.4, 5.2.9 and Box 12). 

Key lessons learned from Nordic Pharmaceutical Forum include the following [10, 117, 
165]:  

  Joint procurement can improve access to medicines and security of supply 
for smaller countries, as evidenced by the positive experiences with the joint 
Nordic tenders. 

  Excellent knowledge of the market and market research is a prerequisite. 

  The extensive dialogue with the suppliers helped to improve the procurement 

documents and ensure adequate participation rate. 

  Need to budget sufficient resources for planning and preparing: compared 
to “regular”, national tenders, more time resources were required (minimum one 
full-time member of staff). 

  Participating countries could leverage the expertise of experienced agencies in 
hospital procurement (with experience from national centralised procurement). 

  Technical expertise is required at operational levels (bottom-up initiative), 

complemented by high-level political support. 

  New, potentially challenging award criteria (e.g. environmental criteria) could 
be successfully used in the procurement and did not impact on participation rate of 
bidders. 

  Logistic aspects (e.g. delivery of the products) needs to be considered at an early 

stage. 

6.2.1.3.  Beneluxa Initiative 

The  Beneluxa  Initiative  was  initiated  by  the  health  ministers  of  Belgium  and  the 
Netherlands in 2014. The two countries were joined by Luxembourg and Austria in 2015 
and 2016, respectively, giving the Initiative its name (“BeNeLuxA”). Ireland joined as 
fifth member country in 2018. 

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The  overarching  aim  of  the  initiative  is  to  ensure  sustainable  access  to  innovative 
medicines at affordable costs [260]. Member countries cooperate in the following four 
action areas: 

  Horizon scanning: collaboration to identify newly emerging – typically high-cost 
– medicines, resulting in horizon scanning reports. This action area has resulted in 
a spin-off (IHSI) with additional participants. 

  HTA: joint assessments are performed and participating countries also re-use 

existing HTA reports from the other countries. This action area is expected to grow 
in the future and a joint template for HTA is being developed. 

  Information sharing: member countries engage in regular exchange on topics of 

interest. This may result in joint statements, e.g. recently on methodological 
considerations for assessment of CAR-Ts. 

  Price and reimbursement negotiations: Joint price and reimbursement 
negotiations are linked to the other action areas (e.g. informed by horizon 
scanning and HTA).  

Differently to the other two initiatives described above, Beneluxa is focusing on high-
cost,  potentially  innovative  medicines  and  does  not  conduct  joint  procurement. 
However, member countries have conducted joint price negotiations. After an initial 
unsuccessful  joint  negotiation  for  the  combination  product  lumacaftor  /  ivacaftor  in 
2017,  two  of  the  member  countries  (Belgium  and  the  Netherlands)  successfully 
conducted  price  negotiations  for  nusinersen  (Spinraza®),  a  high-cost  medicine  for 
treatment  of  spinal  muscular  atrophy.  The  price  was kept  confidential and  may  have 
differed between the two countries, as final price and reimbursement decisions remain 
at  the  national level  (e.g. slightly  different reimbursement  conditions  were  applied  in 
Belgium and the Netherlands).  

Key lessons learned from the Beneluxa Initiative include the following [10]: 

  A holistic view on the pharmaceutical value chain is required to understand 

issues with access to innovative medicines and address them. The initiative 
therefore cooperates on horizon scanning, HTA, and negotiations. 

  Accept country differences and collaborate where possible: pricing and 

reimbursement decisions are made at the country level, and countries may have 
different requirements for medicines and different thresholds for what they are 
willing and able to pay. The initiative has therefore accepted that its joint actions, 
including joint price negotiations, may lead to different outcomes in participating 
countries. 

  Key challenges in cross-country collaboration are due to differences in the 
legal set-up and the different pricing and reimbursement processes. These 
differences need to be acknowledged. 

  Successful price negotiations require time and buy-in from all parties. 
Convincing manufacturers to participate in joint price negotiations with several 
countries may be challenging and therefore require a value proposition for all 
participating parties. For manufacturers, this may be to base negotiations on 
added value of the product, rather than price alone. 

6.2.2. European initiatives for joint public procurement in crisis response 

Crisis preparedness was highlighted as a key action area for the EU in the COVID-19 
pandemic.  In  response,  a  new  Directorate-General,  the  European  Health  Emergency 
preparedness  and  Response  Authority  (HERA),  was  set  up  in  October  2021.  HERA 
therefore  has  taken  up  the  task  of  the  implementation  of  the  previously  established 
mechanism for joint procurement (JPA, see below) and other measures taken by the EU 
to address security of supply, such as central stockpiling among others. 

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6.2.2.1.  Joint procurement agreement 

The  Joint  Procurement  Agreement  (JPA)  for  medical countermeasures  was  developed 
following the H1N1 pandemic influenza, in which weaknesses in access and purchasing 
capacity of EU MS to procure needed medicines and medical devices became evident. 

The  Council  Conclusion  of  13  September  2010  requested  the  EC  to  develop  a 
mechanism to jointly procure medical countermeasures, which would support fair 
and equitable access to, and distribution of, pandemic influenza vaccines for the future. 
In response, the EC developed the JPA [261], with the aim to improve the preparedness 
of the MS to serious cross-border threats to health. 

In 2014, the EC approved the JPA, and soon signed it together with more than half of 
the  EU  MS  at  the  time.  As  of  April  2020,  the  JPA  has  been  signed  by  37  countries, 
including all EU MS [262]. 

The JPA is a voluntary mechanism. A joint procurement procedure can be initiated if 
at  least  four  EU  MS  and  the  EC  are  willing  to  participate.  In  parallel,  countries  may 
launch a national public procurement procedure on the same subject matter, as well as 
to engage in negotiations with the same companies participating in a joint procurement 
procedure. 

The  scope  of  the  JPA  is  defined  by  medical  countermeasures,  such  as  vaccines  and 
antivirals. In the beginning, there was discussion as to whether the JPA instrument could 
also  be  used  to  jointly  procure  high-priced  medicines  (such  as  orphan  medicines, 
oncology  medicines).  However,  this  was  not  possible  since  the  legal basis  of  the  JPA 
only allows procuring medical countermeasures for cross-border health threats. 

Before the COVID-19 pandemic, the EC considered the signature of the framework 
contracts for pandemic influenza vaccines in March 2019 as a major achievement 
under the JPA.  

During the COVID-19 pandemic, the JPA was used in a number of joint procurement 
procedures  to  purchase  medical  equipment  and  therapeutics.  Medicines  procured 
through  the  JPA  included  remdesivir  (Verklury  ®),  medicines  used  in  intensive  care 
units, including the corticosteroid dexamethasone, and monoclonal antibodies including 
sotrovimab (Xevudy ®), and the combination products casirivimab / imdevimab (Regn-
COV2  ®)  and  bamlanivimab  /  etesevimab.  For  the  procurement  of  remdesivir,  36 
countries (all EU MS and nine others) participated. The procedure was conducted as a 
negotiated  procedure  without  prior  publication  as  justified  by  the  urgency  of  the 
pandemic  situation.  A  framework  agreement  was  created  that  allowed  participating 
countries to purchase the product from the manufacturer. 

In 2022, the European Commission launched a study to assess the functioning of the 
JPA. In particular, the evaluation will look into the effectiveness, efficiency, relevance, 
coherence, and added value of both the legal framework and the implementation of the 
Agreement against  the  underlying policy objectives  defined  in  the legal  framework  in 
two different periods and contexts (i.e. until and since the COVID-19 pandemic). The 
results are expected before the end of 2022. 

6.2.2.2.  EU COVID-19 vaccines procurement 

While  the  JPA  was used  for  joint procurement of  COVID-19  therapeutics  and  medical 
equipment, it was not used to purchase vaccines. The JPA, designed as preparedness 
mechanism with set roles for the MS and the EC, was not seen as suitable in the situation 
of extreme urgency and global competition for a scare resource of strategic importance 
(a COVID-19 vaccine) which had not yet been developed when the pandemic started.  

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The  procurement  of  COVID-19  vaccines  by  the  EU  was  overall  seen  as  success  by 
stakeholders participating in the workshops conducted for this study (see Annex 5). MS 
authorities,  procurers,  patient  and  public  representatives,  and  hospital  pharmacists 
(although not industry representatives) considered the joint procurement as example 
of  how  MS  can  collaborate,  and  some  participants  expected  this  experience  to  be 
used  for joint procurements in other areas as  well. At the  same time, concerns were 
raised  about  a  lack  of  transparency  about  the  EU  vaccines  procurement  process, 
including lack of transparency on prices, and failure to tackle pertinent issues around 
intellectual property rights.  

6.2.3. International collaborations in PPM of relevance 

Other examples of successful international PPM collaborations, with different mandates 
and  focus  areas,  include  the  PAHO  Revolving  and  Strategic  Fund  and  the  joint 
procurement activities of the Gulf Health Council. These initiatives have been conducting 
joint procurements since the 1970s.  

The PAHO Revolving Fund has been operating since 1975 as a cooperation mechanism 
for  producing  vaccines  and  related  supplies  for  countries  in  Latin  America  and  the 
Caribbean. The Fund is coordinated by the Pan American Health Organization (PAHO), 
the regional office of the WHO for the America, and has 41 participating countries who 
delegate  the  authority  to  conduct  procurement  of  vaccines  on  their  behalf.  The 
“revolving” nature of the fund is an important aspect of the procurement initiative, as it 
allows PAHO to pay suppliers before being reimbursed by participating countries, which 
may occur in local currency, thus supporting weaker economies [8]. In 2021, the Fund 
procured 47 vaccines from 38 suppliers [263]. The Fund pools the needs of participating 
countries  and  issues  joint  tenders  for  required  supplies  of  vaccines.  Estimates  for 
required  quantities  are  either  supplied  by  the  countries  or  developed  jointly  with  the 
Fund as part of its supporting activities. The Fund not only organises the joint tenders, 
but it also monitors deliveries and helps countries with other issues related to the roll-
out of vaccination campaigns. 

The Gulf Health Council conducts joint procurement of medicines and other medical 
goods for member countries of the Gulf Cooperation Council (Bahrain, Kuwait, Oman, 
Qatar, Saudi Arabia, United Arab Emirates) and Yemen. Among other activities in the 
health sector, the Gulf Health Council has been running a joint procurement programme 
since 1976. The scope of the programme includes pharmaceuticals, sera, vaccines, and 
medical  devices  for  human  and  veterinary  use.  Tenders  are  conducted  in  different 
therapeutic areas, typically once per year [264]. Differently from the PAHO Revolving 
Fund,  the  Gulf  Health  Council’s  role  is  limited  to  organising  the  tenders,  selecting 
suppliers  and  adjudicating  the  process,  but  does  not  purchase  the  products  itself. 
Instead, member countries conduct their own procurement on the basis of the tenders 
selected by the Council [8]. 

Joint procurement received additional attention during the COVID-19 pandemic. The 
COVAX facility, a new procurement initiative, was founded by the WHO, Coalition for 
Epidemic Preparedness Innovations (CEPI), and Gavi, initiated the COVAX facility as 
mechanism to equitable distribution of COVID-19 vaccines around the world. COVAX is 
the vaccines pillar of the WHO Accelerator, which aims to accelerate the development 
and production  of  COVID-19  vaccines, tests, and  treatments.  COVAX  was  founded in 
response to concerns about unequitable access to vaccines during the H1N1 influenza 
pandemic,  when  resource-poor  countries  were  unable  to  purchase  vaccines  in  the 
quantities  needed  as  supply  was  bought  up  by  high-income  countries.  In  the  early 
stages of the COVID-19 pandemic, COVAX aimed to implement a formula for equitable 
distribution  of  vaccines,  allowing  all  participating  countries  to  initially  secure  enough 
doses  to  vaccinate  20%  of  their  population  before  purchasing  more  doses  [265]. 
However, while high-income countries were willing to donate vaccine doses to COVAX, 
they  did  not  adhere  to  principles  of  equitable  distribution  and  instead  sought  other 
routes to procure vaccines for their population.  

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7.  POLICY IMPLICATIONS OF THIS STUDY 

Based  on  the  analysis  of  available  evidence,  key  barriers  to  and  best  practices  for 
optimisation of PPM were identified. These serve as policy implications of this study: 
what  issues  need  to  be  addressed  and  how  in  order  to  optimise  PPM?  The  following 
chapter  addresses  the  relevant study  questions  related  to  specific objectives  4  (what 
are the barriers to optimising PPM?) and 5 (what are best practices to optimising PPM?). 

7.1. Key barriers for optimising PPM 

The barriers analysis is based on multiple sources. For country-specific input, barriers 
were included as a topic in the country fiches which were shared with country experts 
for  validation.  Identified  country-specific  barriers  were  pre-filled  for  validation.  Thus, 
the section on “barriers” in all country fiches contained a standardised list of potential 
barriers that may exist in PPM, with the aim to encourage respondents assessing the 
relevance  of  these  barriers  in  their  national  contexts.  These  barriers  were  largely 
identified based on literature [9, 60, 120]. Additional information about barriers was 
obtained in some interviews and in particular in the three multi-stakeholder workshops 
(see  Annex 5).  Barriers  relating  to  cross-country  procurement  were  mainly  identified 
from literature [7, 10, 60, 117] as well as the stakeholder workshops.  

Barriers can be identified at several levels: they can relate to limitations in PPM policy 
and  practices  which  could  be  addressed  through  optimisation  of  procedures;  or  to 
challenges  in  the context  of  PPM  in  the  broader sense,  including  potential impacts of 
PPM  on  policy  objectives  such  as  availability,  affordability  and  similar.  Furthermore, 
barriers can be considered solely from the procurers’ perspective, from the perspective 
of  other  stakeholders  (e.g.  suppliers),  or  from  a  broader  public  health  perspective. 
Table 23 provides a summary of key findings of the barrier analysis and the relevance 
of the challenges identified in the study countries for different levels, and for different 
stakeholders. These barriers are further analysed according to whether they relate to 
product-specific challenges or setting-specific challenges below. 

Table 23: Barriers, constraints and challenges with regard to the PPM in the study 
countries 

Barriers / challenges  

Relevance 

Description and comments 

External factors 
Small volumes 

No competitors 
marketed 

Frequent 
(due to facility-based PPM in the 
inpatient sector in many 
countries; even with centralised 
PPM country markets might be 
too small to be attractive) 
Frequent 

Disruption in the 
supply chain 

Increasingly frequent 

Small volumes limit the bargaining power of 
procurers and may result, in a worst case, 
in not attracting any bids. 

More competitive procurement procedures 
and techniques are possible if a higher 
number of alternatives is available. 
Monopoly products may come with high 
price tags. 
Due to circumstances in the production 
and/or transportation, independent from the 
procurement process, supply issues exist. 

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Barriers / challenges  

Relevance 

Description and comments 

PPM practice and policy 
Non-transparency, 
corruption, and issues 
with good governance 

Indication on issues for a few 
countries according to literature 
[31, 33, 34, 211, 255, 266], no 
further information obtained 

High administrative 
burden, cumbersome 
legislation 

Mentioned in particular with 
regard to joint procurement 

Lengthy procedures, 
insufficient flexibility to 
adapt to new situations 

Low participation rate 
in bids 

Mentioned in particular with 
regard to some procedures 
(e.g. open or restricted tenders) 
Limited use of “new” PPM 
techniques, as provided by the 
EU Procurement Directive [68], 
was observed in some countries 
Reported from several 
countries, in case of limited 
number of competitors 

Appeals 

Some countries 

Paper-based PPM / 
limitations in e-
procurement  

Lack of knowledge on 
efficiency and impact 
of PPM 

E-procurement has been 
implemented in all study 
countries. In some countries, e-
procurement needs to be 
improved. 
In several countries, data are 
missing to monitor the impact 
of PPM, and PPM monitoring and 
evaluation are not conducted on 
a regular basis. 

Lack of political vision 
and guidance 

Not known, indication of issues 
from a few countries 

Lack of budgets, 
delayed payments 

Indication from some countries, 
in particular at facility-based 
PPM 

Lack of mitigation 
strategies in case of 
failures 
Limited tools to ensure 
enforcement of legal 
obligations 

Several countries 

Several countries 

In principle, PPM is a policy that contributes 
to improved governance, accountability, and 
transparency. Appropriate legislation 
supports the application of these principles. 
Still, literature suggests issues in a few 
countries, such as reporting on “direct 
conflicts of interest, biased decision-making 
and clientelistic networks” [266] in health 
sector procurement  and “collusion” of 
suppliers resulting in limited levels of 
competition [31]. This may result in low 
trust in public procurement [211]. 
Procurers and “users” (e.g. hospitals, which 
order through a CPB) consider some 
workflows as time-consuming. Differences 
across cross-specific legislation are 
considered a major challenge for cross-
country PPM. 
Depending on the type of product, different 
PPM procedures and techniques are to be 
selected, and some are less flexible and 
require long preparation period. Lengthy 
procedures and slow response rates hinder 
use of these practices in emergency 
situations. 
No or low participation of bidders may result 
in failure of a tender. This also restricts the 
procurement techniques that can be used 
(e.g. winner-takes-it-all by default). 
For some procedures, bidders launched an 
appeal. 
E-procurement has considerably improved, 
facilitated and accelerated PPM processes, 
and allows some of the “newer” PPM 
techniques such as DPS. However, 
optimisation potential may still exist. 
Lack of monitoring hinders targeted and 
appropriate development and optimisation 
of PPM. Policy makers (and the public and 
further stakeholders) miss the information 
whether or not PPM has been able to 
achieve identified PPM policy. 
Further development of PPM, piloting of 
“new” PPM policy and practices may be 
difficult for procurement bodies if the vision 
and policy objectives of the policy makers 
are not known. 
Limited funds weaken the bargaining power 
and attractiveness of the procurers. Delayed 
payments and debts with suppliers damage 
the relationship between procurers and 
suppliers (no trust). 
If suppliers cannot deliver as agreed, 
strategies to mitigate the risk of shortage 
would be needed. 
If suppliers fail to meet the contractual 
obligations, mechanisms to provide 
sanctions and/or ensure avoidance of such 
situations would help in the longer run. 

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Barriers / challenges  

Relevance 

Description and comments 

Related to procurers, suppliers and other stakeholders 
Limited capacity of 
procurers (e.g. 
understaffing, low and 
inappropriate skills) 

Frequent: understaffing is an 
issue in some countries, 
indications of lack of PPM-
specific qualifications 

Supplier action 
impeding market entry 
and uptake of 
competitor products 

Some countries 

Limited interaction with 
suppliers 

In some countries, due to staff 
and time restraints 

Limited interaction of 
procurers with other 
public institutions (e.g. 
pricing and reimburse-
ment authorities, 
competition 
authorities) 
Limited interaction with 
prescribers 

Identified as an issue in some 
countries (concerns both 
“users” in case of centralised 
PPM as well as further public 
authorities) 

Some countries 

Capacity is required in both quantitative as 
well as qualitative terms. PPM, in particular 
in specific settings (e.g. specialised hospital 
care), may require very specific (clinical) 
knowledge. Legal and procurement 
expertise is not sufficient for PPM; further 
staff with specific qualifications (e.g. 
suppliers management, communication) is 
also needed and is frequently missing. 
There have been cases of suppliers 
engaging in practices that impede market 
entry or uptake of competitor products, in 
particular biosimilars. Practices include 
contractual agreements and pricing 
structures that lock contracting authorities 
into continued use of the originator product 
or shut out competition from tenders, as 
well as schemes to tie patients to the 
product [179, 180, 222, 267]. 
Low participation rate may also result from 
limited capacity (e.g. limited skills) on 
behalf of suppliers (e.g. in case of new PPM 
practices, such as consideration of social 
and environmental awarded by the 
contracting authority, tender of cross-
country collaboration) 
Limited interaction hinders exchange of 
required data and information to inform 
preparation of PPM procedures. 

Prescribers would be needed to support use 
and uptake of off-patent medicines (e.g. 
biosimilar medicines). They need to 
understand why certain medicines were 
procured and should (must) be prescribed 
as preferred products. 

Source: Analysis done by authors 

7.1.1. Product-group specific barriers 

For off-patent products, an important barrier to efficient procurement are practices 
by  suppliers  to  impede  market  entry  and  uptake  of  competitor  products,  in 
particular for biosimilar products. Examples of such practices include pricing structures 
that lock hospitals into continued use of higher-priced originators, “loss leader” practices 
to  initiate  treatment  with  a  specific  product  in  hospital  at  reduced  price  followed  by 
higher  prices  for  treatment  continuation  in  the  outpatient  setting,  subsidising  out-of-
pocket  payments  for  patients  to  continue  using  the  product,  as  well  as  practices  to 
impede the chances of competitor products being selected as winners in tenders (see 
also  Box  2  for  descriptions  of  cases  investigated  by  competition  authorities  in  the 
Netherlands and Romania) [179, 180, 222, 267]. 

Another challenge of particular relevance for biosimilar products is the lack of uptake 
which  may  be  due  to  lack  of  interaction  between  procurers  and  prescribers. 
Challenges with gaps in knowledge about the efficacy and safety of biosimilars still exist 
(see also Chapter 5.4.3). Successful procurement of a lower-priced biosimilar product 
(which may allow treatment of more patients) therefore partly depends on the uptake 
of that product: if prescribers are hesitant to switch patients to the biosimilar product, 
then procurement of that product will not be considered supportive to providing patients 
with access to medicines. Procurers therefore need to work with prescribers to ensure 
that procured products meet the needs of patients and are being prescribed. 

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Supply issues are particularly prominent for off-patent products, and more commonly 
encountered in smaller  countries.  In the debate, there has been the assumption that 
prices were too low to be attractive for suppliers, which may contribute to supply issues. 
Commercial  reasons  for  non-supply  (i.e.  small  volumes  in  small  markets  which  are 
considered  not to  be  attractive) may  also  apply to  on-patent medicines. Measures to 
mitigate shortages were not always implemented or successful, also because shortages 
and supply limitations are a multi-faceted issue. 

Lack  of  funding  is  a  frequently  encountered  challenge.  This  may  pose  particular 
problems  for  procuring  high-cost,  potentially  innovative  medicines  which  have 
significant budget implications for the health care sector [268]. Several countries have 
introduced  specific funding mechanisms that operate outside the regular system (see 
Table  15  for  an  overview  of  these  schemes  in  the  study  countries  in  the  hospital 
setting).  However,  budgetary  constraints  generally  apply  to  procurement  of  all 
medicines:  as  pharmaceutical  expenditure  grows,  spending  constraints  become  more 
likely. In some countries, hospitals have reported difficulties to procure with available 
budgets [269, 270]. 

7.1.2. Setting-specific barriers 

An  important  barrier  to  optimising  PPM  for  the  hospital  sector  is  the  lack  of 
(comprehensive)  data  about  procurement  practices  and  prices  paid  by  individual 
hospitals,  and  the  lack  of  cooperation  and  information  sharing  due  to 
fragmentation  in  the hospital  setting. In  many  countries,  hospitals  are  owned  by the 
regions  and/or  operate  as  independent  health  care  facilities  and  are  therefore 
responsible  for  their  own  procurement.  Without  institutionalised  collaboration  (e.g. 
through joint procurement organised by CPBs, as is the case in Denmark and Norway), 
individual hospitals may not know what other hospitals are paying for the same products 
and may therefore find themselves in a weakened negotiating position. Nevertheless, 
individual procurers may engage in informal exchange. 

The  decentralised  organisation  of  hospital  care  in  many  countries  also  impedes  the 
possibility for implementing a strategic approach to procurement. While individual 
hospitals  may  develop  their  own  procurement  strategies,  these  may  not  reflect  the 
priorities of the health system overall. Short-term goals, such as securing the required 
supplies for the next year within the available budget, are more likely to trump long-
term considerations when a strategic approach is missing. Centralising the procurement 
for  the  hospital  sector  may  help  address  the  lack  of  strategic  vision,  but  this  faces 
barriers  in  itself,  notably  that  hospitals  may  perceive  centralised  procurement  as  a 
threat to their autonomy.  

Lack of a joined-up approach to formulary development across inpatient and outpatient 
sectors and different funding mechanisms per sector can create a barrier to continuation 
in the uptake of medicines (seamless care) and access to medicines. These challenges 
at the interface between inpatient and outpatient care and possible measures to 
address  them  were  described  in  Chapter  5.3.  While  individual  procurers  may  not 
perceive the interface between the two sectors as challenge (typically, procedures would 
only be conducted for one sector, and in many cases only for an individual contracting 
authority in that sector), lack of cross-sectoral thinking poses a challenge from a health 
system perspective, also because of incentives to shift medication (and patients) from 
one sector to the other. Importantly, procurement decisions in the inpatient setting may 
have implications for the outpatient sector with respect to the continuation of a specific 
therapy that was initiated in the hospital.  

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7.1.3. Cross-country specific barriers 

Additional challenges have been identified for  cross-country collaborations. These are 
informed  by  more  detailed  descriptions  of  learnings  from  cross-country  initiatives 
described  in  Chapter 6.2.1.  Key  challenges that  cross-country  initiatives have  faced 
included the following: 

  Differences in national legislation and procedures (related to PPM as well as 

pricing and reimbursement processes and supporting tools such as HTA), 

  More resource-intensive and time-consuming than national procurements and 

lack of investment in resources in quantitative and qualitative terms, 

  Fragmented health systems may limit or prevent country’s participation in 

cross-country procurement (who would be the country representative for procuring 
a hospital medicine if in the country procurement is done at facility level?), 

  Lack of clarity about leadership and lead procurer, 

  Lack of political support to address above-mentioned barriers, 

  Suppliers’ hesitancy to respond to calls for a cross-country tender, 

  Language issues due to different countries and legislations (including regarding 

the packaging of procured medicines). 

7.2. Best practice toolbox 

Given the heterogeneity of health care systems across Europe, best practices might not 
be applicable to all countries. Nevertheless, identifying possible best practices can help 
procurers and policy makers select suitable approaches for adaptation in their country. 

The methodical approach to identify best practices was similar to the one applied in the 
barriers  analysis  (see  Chapter  7.1).  Information  was  mainly  gained  from  the  PPM 
country fiches and the stakeholder workshops, as well as the stakeholder survey 
and analysis of IQVIA and TED data. In the country fiches, good practices were outlined 
in  a  section  of  its  own,  which  contained  pre-filled  categories  of  good  practice  areas. 
Information  about  cross-country  procurements  were  sourced  from  literature  [7,  10, 
117] as well as previous projects conducted by the study team. 

7.2.1. Implementation of best practices in the study countries 

Table  24  shows  the  frequency  with  which  different  best  practices  are  applied  in  the 
study countries. These practices can address several of the policy objectives of interest 
in  this  study:  access  to  medicines  (having  medicines  available  at  affordable  prices), 
security  of  supply,  creating  a  competitive  market,  protecting  the  environment,  and 
strengthening crisis preparedness. 

Table 24: Best practices applied in the study countries 

Best practice 

Number of 
countries 

Cross-country collaboration 
e-procurement, IT projects 
Use of specific supporting policies (e.g. negotiations, horizon scanning, HTA) 
Seminars (webinars), capacity-building measures 
Use of specific procurement practices, procedures and techniques (e.g. market 
research, MEAT, framework agreements) 
Dialogue with suppliers (e.g. in preparation of calls) 
Legal change(s) 
(Systematic) collaboration of public procurers of medicines 
Specific projects to encourage uptake of biosimilar medicines 

23 
20 
19 
19 
17 

17 
15 
14 
13 

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Best practice 

Number of 
countries 

Internal rules and procedures, procurement contacts (administration 
management) 
Strengthening of clinical hospital pharmacy 
Leadership in centralised procurement agency or other procuring institution 
Specific funding schemes 
Specific projects to improve collaboration at the interface of hospital and 
outpatient sector 
Institutional change(s) 
Logistics management 

Note: Table only lists best practices mentioned for more than one country. 

12 

11 
10 
9 
9 

8 
8 

Source: PPM country fiches 

Most widely used were cross-country collaborations, although these varied in scope. 
Some, as described in Chapter 6.2.1, engage in joint procurement (Baltic Procurement 
Initiative, Nordic Pharmaceutical Forum) or joint price negotiations (Beneluxa Initiative, 
Valletta  Declaration)  while  others  are  primarily  used  to  exchange  information  and 
provide  a  platform  for  potential  closer  collaboration  on  issues  related  to  access  to 
medicines.  Going  beyond  lower  prices  achieved  through  pooled  purchase  volumes, 
cross-country  collaborations  provide  benefits  to  participating  countries  by  pooling 
expertise and information. In interviews, workshops and reviews, procurement experts 
and  other  national  technical  experts  (e.g.  of  pricing  and  reimbursement  authorities) 
stressed  the  importance  of  collaboration  which  goes  beyond  the  technical  aspects  of 
joint  PPM,  but  the  exchange  of  experiences,  motivation  through  meeting  of  people 
working in  similar  areas  and  with  similar  mind-set and  capacity-building is  seen  as a 
major value. 

E-procurement  was  also  commonly mentioned.  Today, e-procurement is  considered 
common in many European countries, but procurers remember the time of paper-based 
procurement.  E-procurement  helped  facilitate  and  speed  up  processes,  was  a 
prerequisite for application of certain techniques (e.g. DPS) and increased transparency 
and accountability.  

Use of supporting policies and the linkage of PPM to pricing and reimbursement 
policy  (see  Chapter  3.5)  were  also  widely  reported.  In  Norway,  centralised 
procurement of medicines used in hospitals is integrated into the “system for introducing 
new health technologies” (so-called “Nye metoder”). This includes horizon scanning and 
HTA (the HTA method, i.e. rapid review or full HTA, is determined by the outcome of 
horizon scanning), followed by tendering and pricing negotiations of LIS. Another best 
practice  example  is  the  Danish  CPB  for  hospitals,  Amgros,  which  aims  to  have 
mechanisms in place to follow medicines used in hospitals at each stage of the product 
life cycle, including horizon scanning to identify emerging medicines, price negotiations 
with  suppliers  about  newly  marketed  medicines  on  the  basis  of  a  clinical  and  health 
economic assessment  of  the  Danish Medicines  Council  regarding  the potential role  of 
the treatment in Danish hospitals, as well as using specific procurement procedures 
and techniques for products with analogue competition and generics. Other countries 
also  use  supporting  policies  along  the  pharmaceutical  value  chain  (e.g.  Netherlands, 
Sweden, UK). 

Investment in human resources in quantitative and qualitative terms is needed 
to achieve best results. Ensuring sufficient capacity (staffing) and appropriate training 
are considered a prerequisite for good PPM. Appropriate staffing of a procurement body 
is not limited to legal expertise; technical experts in the subject matter (in the case of 
PPM:  pharmacists,  ideally  with  clinical  knowledge  in  specific  disease  areas),  IT 
specialists  (for  data  monitoring) and  communication  experts  are  required,  to  name  a 
few. 

Dialogue  with  suppliers  was  highlighted  as  a  key  best  practice  in  preparation  of 
specific procedures and can take various forms. Some procurers also consider dialogue 

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with suppliers a prerequisite for successful procurement. At a minimum, procurement 
plans should be communicated to potential bidders, e.g. through annual procurement 
plans  published  on  the  websites  of  contracting  authorities  (mandatory  in  some 
countries). More advanced forms of supplier dialogue include direct engagement, e.g. 
through  questionnaires  and  interviews  to  elicit  feedback  on  procurement  plans  and 
award  criteria. Finally, supplier dialogue may  not only be used in preparation of  calls 
but also to shape the procurement system more generally.  

Institutional and legal changes are comparatively rare but carry significant potential. 
Optimisation  of  PPM  was  reported  in  some  countries  after  appropriate  changes  in 
legislation.  This  included  institutional  changes  such  as  the  set-up  of  a  dedicated 
procurement body (e.g. Bulgaria, Denmark, Norway) with appropriate mandate, funding 
and staffing. In addition, some legal changes helped or even permitted introduction of 
some  PPM  policies. Use  of  DPS  in  Italy required,  however, the  legal  basis  in national 
legislation  (see  also  Chapter  3.3.2.2).  In  the  Czech  Republic  2020  adaptions  in  the 
Waste  Act  and  the  End-of-Life  Products  Act  completed  the  transformation  towards 
sustainable  public  procurement  as  legislation  requires  to  consider  environmental  and 
innovative aspects in the award criteria. Experience from the Nordic countries suggests 
that the inclusion of environmental criteria does not impact negatively on competition. 
However,  there  seems  to  be  agreement  among  stakeholders,  as  voiced  at  the 
workshops, that environmental criteria may lead to higher prices. This is not necessarily 
the case, as Cyprus reported no impact of adding environmental criteria to tenders on 
prices.  

Such  changes  require  a  political  vision  and  strategy  for  PPM.  This  enables  the 
development (e.g. to strengthen the PPM system, e.g. optimising it in terms of efficiency 
and  resilience)  and  to  test  more  “innovative”  approaches.  In  addition  to  political 
leadership, leadership at the level of the procurement body is required. Amgros, 
for  instance,  piloted  environmental  criteria  because,  among  others,  the  company’s 
leadership urged to move forward this direction. 

Collaboration of procurers and sharing of information informally and also formally 
through  joint tenders  is considered as a major  asset.  This  can be  done  intra-country 
and cross-country.  For  instance, some  procurers  mentioned  the  usefulness  of  the  EC 
Government Experts Group on Public Procurement (EXPP), Subgroup on Health Public 
Procurement. 

Communication  by  the  procurers  with  users  of  procurement  is  key.  In  case  of 
centralised PPM, interaction with the users (e.g. hospital pharmacists) ensures better 
understanding,  acceptance  and  uptake  of  centrally  procured  medicines.  Thus,  a 
helpdesk  should  be  sufficiently  staffed;  communication  to  users  should  be  pro-active 
and may contain capacity-building elements. In Norway, the procurement body holds 
annual seminars about the procured medicines which should be used as a priority. 

7.2.2. Optimising PPM policy and practices 

Adding to the best practice examples documented for the study countries summarised 
in the previous chapter (for details see the country fiches), several features, approaches 
and  principles  relating  to  PPM  and  the  overall  pharmaceutical  policy  framework  have 
been  mentioned  in  literature,  the  workshops  organised  in  the  frame  of  this  study, 
interviews and the stakeholder survey. Some key optimisation proposals are presented 
in this chapter. It is important to note that they may address more than one of the best 
practices explained above, and they are sometimes cross-cutting topics. 

In PPM, a range of policy objectives can be of interest, notably access to medicines, as 
well  as  ensuring  availability  of  effective  and  safe  medicines,  creating  a  competitive 
market  in  the  long  term,  ensuring  security  of  supply,  supporting  environmental 
protection, and strengthening resilience and crisis preparedness. MEAT criteria can be 

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used to incorporate various award criteria and can therefore be seen as a tool to promote 
policy objectives other than affordability (i.e. price or cost alone). 

The use of a life cycle approach to procurement, as pioneered by Amgros (see Figure 
31), emerged as a best practice to address multiple policy objectives. There is no 
one size-fits-all approach in procurement but PPM procedures and techniques have to 
be well selected. Awareness of a product’s position in the life cycle helps identify suitable 
procurement  processes  and  set  procurement  goals.  For  example,  negotiating  an 
affordable price is most relevant for products without competitor to ensure that such a 
potentially innovative medicine is available to patients, while procedures that leverage 
competition between suppliers (including open tenders) are of interest when there are 
alternatives either through other treatments (analogue competition) or through generic 
or biosimilar products (after patent expiry). This approach also highlights the need to 
be  aware  of  market  entry  of  competitor  products,  which  can  be  achieved  through 
systematic  horizon  scanning.  Knowledge  of  upcoming  competitor  products  allows  for 
leveraging the new competitive environment through timely issued tenders. Finally, the 
life  cycle  approach  makes  it  clear  that  security  of  supply  should  be  built  into 
procurement as products approach the later stages of their life cycle. MEAT criteria may 
be  tilted  towards  security  of  supply  for  these  products,  as  price  becomes  less  of  a 
concern compared to the risk of shortages. 

Market  research  and  engaging  in  dialogue  with  suppliers  are  also  suited  to 
addressing  multiple  objectives.  The  EU  Procurement  Directive  [68]  encourages 
preliminary market consultations between contracting authorities and suppliers with the 
aim of facilitating better specifications, better outcomes and shorter procurement times. 
Firstly,  this  ensures  knowledge  of  the  market,  including  the  number  of  potential 
suppliers  and  their  interest  in  winning  contracts  in  the  planned  procurement  period. 
Market research can therefore avoid availability issues through a situation where no or 
few  suppliers are  willing  or  able  to  submit  bids.  Secondly, supplier  dialogue can  help 
prepare  tenders  with  relevant  award  criteria  to  support  participation  from  sufficient 
numbers of suppliers to create a competitive environment. Before launching their first 
joint Nordic tender call, Amgros held six weeks of hearings with suppliers, which helped 
strengthen the procurement documents [10]. Engaging with suppliers was also seen as 
key success factor for introducing environmental criteria in the joint Nordic tenders by 
Denmark,  Iceland, and Norway (see  Box 12). Finally, market research is required to 
implement  a  strong  prequalification  process  where  applicable  to  mitigate  risks  of 
shortages:  robust  pre-qualification  criteria  should  be  used,  and  sanctions  may  be 
imposed for suppliers who do not comply with their contractual obligations. 

Awarding contracts to multiple winners can help to address security of supply and 
maintaining a competitive environment for products with off-patent competition.  Multi-
winner contracts are used for all or at least some off-patent medicines in most study 
countries in order to mitigate supply risks. Multi-winner contracts have been particularly 
recommended for biosimilars [42]. Sometimes these are used only for products where 
shortages  would  have  a  critical  impact  (e.g.  in  Austria  for  antibiotics  and 
immunoglobulin G), but some countries aim to apply multi-award contracts wherever 
possible (Portugal). Some countries also use multi-award contracts for procurement of 
vaccines for national immunisation programmes (e.g. Ireland). Industry representatives 
also  stress  the  importance  of  awarding  multiple  winners  to  maintain  a  competitive 
market with multiple suppliers operating.  

In  the  outpatient  setting,  tendering-like  systems  based  on  regular  price  bids  and 
preferential reimbursement status for the winning product may combine the economic 
incentive for suppliers to win a contract for the entire market (for a limited period of 
time, i.e. until the next round of bidding starts) with considerations for security of supply 
by building in a mechanism that allows the  second-  or third-ranked bidder to step in 
when there are supply issues. 

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Related to multi-winner contracts is the use of framework agreements. Concluding a 
framework contract with multiple suppliers allows the contracting authority flexibility in 
addressing  its  needs  and  provides  some  security  should  one  of  the  suppliers  fail  to 
deliver.  Framework  agreements  can  therefore  address  security  of  supply  concerns. 
Framework agreements may also be welcomed by suppliers as they can provide them 
with some flexibility for efficient manufacturing and delivery (e.g. by shifting between 
countries  according  to  demand  rather  than  being  locked  into  contracts  with  set 
volumes). Framework agreements were also the procurement technique of choice for 
joint procurement at the EU level for pandemic preparedness through the JPA. 

For successful PPM to achieve its goals, monitoring and evaluation through selected Key 
Performance Indicators (KPIs) is important. Some CPBs (e.g. AMGROS in Denmark, 
Resah in France, for details see the country fiches) are applying a strategic set of KPIs. 
Still, this good practice of selecting a set of useful KPIs has apparently not been fully 
implemented in all study countries. 

is  to 

While  not  strictly  related  to  procurement,  some  interface  management  measures 
may also help address issues with access to medicines. These measures are intended 
to  bridge  the  gap  between  inpatient  and  outpatient  care,  addressing,  among  others, 
issues  of  affordability  and  availability  of  medicines  (where  high-cost  therapies  are 
initiated  in  the  hospital  setting  without  consideration  of  future  treatment  after 
discharge).  One  such  measure 
introduce  cross-sectoral  formularies 
(reimbursement  lists)  and  committees.  In  the  majority  of  the  study  countries, 
formularies relate mainly to the outpatient sector, while hospitals have national, regional 
and/or  most  commonly  facility-based  hospital  pharmaceutical  formularies.  However, 
several countries have a cross-sectorial formulary for outpatient and inpatient sectors. 
Some of these countries also have cross-sectoral committees to define formularies. 
Other interface management initiatives include funding mechanisms to disincentivize 
transfer  of treatment across sectors for  financial reasons (e.g. in Norway),  extending 
policies from the outpatient to the inpatient sector or vice versa, IT projects / cross-
sectoral  collection  and  exchange  of  data,  programmes  with  regard  to  discharge  of 
patients from hospitals, issuing treatment recommendations, and engaging in capacity-
building and collaboration. 

7.2.3. Best practices for joint procurement 

Potential benefits of joint procurement (within-country or cross-country) are described 
in  Chapter  6.1  and  in  the  impact  analysis  (Chapter  4.3).  Briefly,  these  include 
achieving  lower  prices,  better  availability  of  high-quality  medicines  and  improved 
security  of  supply,  as  well  as  fewer  tangible  benefits  such  as  capacity  building  for 
procurers, improved standards and efficiency of the procurement process, and better 
transparency and accountability.  

From existing cross-country initiatives in Europe (see Chapter 6.2.1), key learnings on 
prerequisites and good practice for cross-country joint procurement can be drawn:  

  There is a need to budget sufficient time for planning and preparing; as 
compared to “regular” national tenders, more time resources are required; 

  Technical expertise is required at operational levels (bottom-up initiative), 

complemented by high-level political support; 

  Mutual understanding of the country representatives involved is considered as a 
key success factor; clarity of all general provisions and technical procedures before 
conducting the procurement is needed and may require frequent communication 
between participating countries; 

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  Clear, well-defined and yet simple and not too long procurement documents; 

  There is a need to define the lead partner who will be responsible and has to 

take leadership; 

  Similar processes in pricing and reimbursement are helpful (e.g. in the case 
of vaccine procurement, to have the vaccine in the vaccination schedule of the 
countries involved), 

  Logistical aspects (e.g. delivery of the products) need to be considered at an 

early stage. 

 

In relation to joint procurement at EU level in the context of the COVID-19 
pandemic, an important learning is that communication between EC and MS is 
key. 

There  is  some  overlap  in  learnings  and  best  practices  for  within-country  joint 
procurement,  in  particular  in  relation  to  the  need  for  technical  expertise,  shared 
understanding  of  the  goals  and  technical  specifications  of  the  procurement,  and  the 
need to consider logistical aspects.  

Similarly  to  cross-country  joint  procurement,  having  a  designated  lead  for  the  joint 
procurement  within  a  country  is  needed.  This  may  be  a  CPB,  which  might  be  most 
suitable to the role of a “service provider” – a key asset in ensuring joint procurement 
is of benefit to the contracting authorities. 

It  is  acknowledged  that  joint  procurement  is  a  major  challenge,  in  particular  in  the 
beginning,  when  processes  are  yet  to  be  defined  across  jurisdictions  given  legal  and 
institutional  complexities  (see  Chapter  6.1).  At  the  same  time,  collaborative 
procurement  models  are  among  the  most  prominent best  practice  examples.  In  joint 
procurement, pooling is not restricted to purchase volumes (making markets more 
attractive),  but  includes  pooling  of  knowledge  and  expertise,  which  increases 
bargaining  power.  Literature  has  confirmed  advantages  of  joint  procurement  in  its 
different  formats  (group  procurement  of  hospitals,  centralised  procurement  at  intra-
country regional level or national level, cross-country collaboration). Major benefits were 
lower prices and thus savings of public expenditure [9, 14, 19, 271-274] and with regard 
to further policy objectives (mainly availability due to the prospect of larger markets, 
security of supply as well as accountability, standardisation of quality) [7, 9, 10, 14, 26, 
32,  273,  275-277].  It  should  be  noted  that  suppliers  are  hesitant  towards  joint 
procurement as default option, predicting availability issues and limited competition in 
the long term. 

7.3. Policy recommendations 

Based on the findings regarding overarching approaches to PPM as well as PPM practices 
at  operational  level  (including  examples  described  in  the  best  practices  toolbox),  the 
study concludes by proposing a set of policy recommendations targeted at policy-
makers: 

1.  Policy-makers are encouraged to develop a procurement-related strategy, 
which considers different aspects of PPM (e.g. PPM procedures and techniques, 
award criteria) aligned to the policy objectives to be achieved. Evidence on impact 
of different PPM policy and practices, as identified in this study, should be taken 
into consideration. 

2.  In the development of the procurement strategy, policy-makers are encouraged to 
apply a holistic perspective, in which PPM is one component of the toolbox for 
improving patient access to medicines. Using such an approach, accompanying 
tools and techniques related to procurement as well as further policies can have an 
important role in the overall pharmaceutical policy development. 

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3.  Policy-makers are encouraged to communicate their strategic vision of PPM to 
procurers (contracting authorities), users, suppliers and also to the public, and to 
invest in changes needed to implement and operationalise the procurement 
strategy (e.g. changes in legislation, institutional reforms, etc.). 

4.  As part of the investment into an optimisation of PPM, policy-makers are 

encouraged to provide for sufficient funding to foster these optimisation 
processes, and to ensure sufficient capacity-building of procurers and users of 
PPM. Capacity-building should consider transfer and gaining of knowledge in 
operational skills, procedures and techniques which were identified to be beneficial. 

5.  Applying and optimising PPM as one important instrument of pharmaceutical policy 
to improve equitable and sustainable access to affordable medicines for patients, 
policy-makers are thus encouraged to adjust the procurement strategy, if 
needed, based on regular monitoring and evaluation conducted on a regular basis, 
to account for changes of policy objectives and reductions in the impact of PPM 
policies and practices resulting from changes in the environment. 

6.  In developing and optimising the PPM strategy, policy-makers are encouraged to 
consider collaboration as a guiding principle, both intra-country (across 
regions, facilities and cross-sectorial) as well as cross-country, as well as for 
procurement and further policy implementation. 

At  a  more  technical-operational  level,  the  study  findings  suggest  considering  the 
following policy and practices in a PPM strategy and action plan: 

  Availability (in legal basis and technical capacity) of a range of PPM policies and 
practices, with clear understanding of most appropriate conditions of use for each 
of them, 

  Application of the MEAT criteria, to allow for consideration of further criteria in a 

strategically well-defined mix, 

  Awarding contracts to multiple winners instead of pursuing a single-winner 

approach,  

  Move to more centralised PPM or, at least, through voluntary collaboration 

through group procurements and cross-country PPM involving several contracting 
authorities, 

  Developing joint formularies and treatment recommendations for at least 
some medicines, which are used in both outpatient and inpatient settings, 

 

Introduction of regular interchange (meetings, seminars) in an institutionalised 
format between procurers and suppliers, as well as between centralised 
contracting authorities (CPBs) and users, 

  Ensuring transparent, clear processes, 

  Continuation and optimisation of the IT environment of supporting PPM (e-

procurement), 

  Definition of required information in preparation of a call (e.g. market research, 

knowledge of upcoming patent expiries), during the procedure and after awarding 
the contract, and ensuring systematic collection of these data and regular 
analysis and communication of key findings to policy-makers, 

  Communication with prescribers, to inform about (the rationale) of procured 
medicines, in particular with regard to biosimilar medicines, to support their 
support in prescribing and switching. 

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The  study  confirmed  that  there  is  large  potential  in  optimising  PPM,  but  for  some 
improvements  and  novel  routes,  projects  are  yet  evolving  or  in  a  pilot  phase.  The 
European Commission could support in this context by facilitating information-sharing 
and exchange of experience through: 

  Organisation of targeted meetings and seminars of PPM practitioners to discuss 
plans and implementations of new PPM methods (“how does it work in practice?”), 

  Documentation on updated experiences of PPM practitioners and development 

of training materials to facilitate knowledge brokerage to further countries 
interested, 

  Communication to other stakeholders in pharmaceutical policy (e.g. pricing 
and reimbursement authorities, HTA body) about new developments to improve 
vertical collaboration between policy-makers and technical experts. 

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8.  CONCLUSIONS 

Procurement is a key pharmaceutical policy that can help achieve better access 
to medicines, including making more medicines available at lower prices. Procurement 
practices vary  across  European countries, often reflecting the heterogeneity in health 
care systems. In terms of optimising public procurement of medicines, no one size fits 
all,  and  procurement  policies  need  to  be  integrated  into  the  national  set-up  of  the 
healthcare system. A life cycle approach to procurement which considers the place of 
a medicine along the pharmaceutical value chain can help determine which procurement 
procedure (less vs. more competitive) to use and what award criteria are most relevant. 
Understanding the market can be helped by thorough market research and engagement 
with suppliers ahead of the launch of procurement procedures. 

Importantly, through its leverage as key area for procurement, PPM can help address 
further  policy  objectives,  including  security  of  supply  and  crisis  preparedness  for  the 
health  sector,  a  competitive  market  for  pharmaceuticals,  as  well  as  environmental 
objectives.  However, not  all objectives  may be  simultaneously  attainable. A  strategic 
approach to pharmaceutical procurement is therefore needed. 

Policy-makers are encouraged to put attention to PPM and to (further) develop a PPM 
vision and strategy, which can be then operationalised based on learnings on how to 
optimise PPM in technical terms. 

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10.  LIST OF ANNEXES 

Annex 1: List of study questions 

Annex 2: Country fiche template 

Annex 3: Glossary of public procurement terms 

Annex 4: PPM country fiches  

Annex 4.1: PPM country fiche Austria 

Annex 4.2: PPM country fiche Belgium 

Annex 4.3: PPM country fiche Bulgaria 

Annex 4.4: PPM country fiche Croatia 

Annex 4.5: PPM country fiche Cyprus 

Annex 4.6: PPM country fiche Czech Republic 

Annex 4.7: PPM country fiche Denmark 

Annex 4.8: PPM country fiche Estonia 

Annex 4.9: PPM country fiche Finland 

Annex 4.10: PPM country fiche France 

Annex 4.11: PPM country fiche Germany 

Annex 4.12: PPM country fiche Greece 

Annex 4.13: PPM country fiche Hungary 

Annex 4.14: PPM country fiche Iceland 

Annex 4.15: PPM country fiche Ireland 

Annex 4.16: PPM country fiche Italy 

Annex 4.17: PPM country fiche Latvia 

Annex 4.18: PPM country fiche Liechtenstein 

Annex 4.19: PPM country fiche Lithuania 

Annex 4.20: PPM country fiche Luxembourg 

Annex 4.21: PPM country fiche Malta 

Annex 4.22: PPM country fiche Netherlands 

Annex 4.23: PPM country fiche Norway 

Annex 4.24: PPM country fiche Poland 

Annex 4.25: PPM country fiche Portugal 

Annex 4.26: PPM country fiche Romania 

Annex 4.27 PPM country fiche Slovakia 

Annex 4.28: PPM country fiche Slovenia 

Annex 4.29: PPM country fiche Spain 

Annex 4.30: PPM country fiche Sweden 

Annex 4.31: PPM country fiche Switzerland 

Annex 4.32: PPM country fiche United Kingdom 

Annex 5: Summary report of workshops conducted for the PPM study 
Annex 6: Full questionnaire of online survey 

Annex 7: Full report of online survey 

Annex 8: TED data cleaning and identification of relevant CPV codes 

Annex 9: Degree of PPM in study countries 

Annex 10: Categorisation of CPV and ATC codes into main medicines groups 

Annex 11: Ex post review by procurement experts 

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