COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Addressing medicine shortages in the EU
Date: 2023-10-27
Institutions: European Commission, Secretariat-General
Subjects: antibiotic, coronavirus disease, epidemic, generic drug, healthcare industry, international cooperation, security of supply, shortage, supply chain, vaccine

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 27.10.2023  COM(2023) 672 final/2  CORRIGENDUM This document corrects COM(2023)672 final of 24.10.2023 Concerns the EN version only Minor formatting adjustment which does not affect the substance of the text The text shall read as follows: COMMUNICATION FROM THE COMMISSION  TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Addressing medicine shortages in the EU  
 
 
1. 

INTRODUCTION  

Continued availability of medicines is  essential: shortages put the health  and well-
being of citizens at risk. The COVID-19 pandemic and the Russian military aggression 
against Ukraine exposed Europe’s supply chains dependencies and the risk that economic 
dependency  could  be  weaponised.  This  has  also  heightened  awareness  of  the  risk  of 
medicine  shortfalls,  experienced  across  all  Member  States1  and  involving  both  original 
and  generic  medicines2.  During  the  winter  of  2022-2023  shortages  of  key  medicines, 
such as antibiotics, triggered particular public and political concern.  

A  new  approach  is  needed  to  better  tackle  medicines  shortages  in  the  European 
Health Union. This was highlighted in the call from the June 2023 European Council for 
urgent  measures  to  ensure  sufficient  production  and  availability  of  the  most  critical 
medicines and components3. This feeds into a broader strategic agenda, confirmed by EU 
leaders  at  their  meeting  in  Granada  in  October  2023,  of  putting  in  place  a  concerted 
approach  to  boost  the  EU's  resilience  and  sustainable  competitiveness  through 
diversification and risk management in the spirit of open strategic autonomy4. 

The EU has a strong and competitive pharmaceutical sector, a global leader in the 
production  of  medicines  and  a  major  contributor  to  the  EU  economy,  directly 
employing some 800.000 people. It is particularly strong in the research and development 
of innovative medicines. However, the landscape for pharmaceutical manufacturing has 
evolved  in  recent  decades.  Production  of  inputs  for  generic  medicines  has  increasingly 
moved outside Europe, in particular to China and India. Pharmaceutical production in the 
EU  has  focused  on  more  complex  products,  which  require  high-tech  infrastructure,  a 
skilled  workforce  and  sophisticated  processes5.  At  the  same  time,  almost  70%  of  the 
medicines dispensed in Europe are generics. 

Ensuring  that  this  strong  basis  carries  through  into  a  secure  medicines  supply 
meeting  patients’  needs  means  addressing  the  vulnerabilities  affecting  supply 
chains.  The  delocalisation  of  the  manufacturing  of  Active  Pharmaceutical  Ingredients 
(API)  to  a  limited  number  of  locations  outside  the  EU  has  accentuated  concerns  about 
security of supply inside the EU. Addressing vulnerabilities in the supply chain of critical 
medicines is key as a springboard for enhanced resilience of EU healthcare systems. In 
addition  to  labour  shortages  that  may  hamper  ambitions  to  increase  local  production, 
demographic changes are also having an impact  on access to  certain  critical medicines, 
by raising demand for medicines tailored to age-related conditions and geriatric care, thus 
influencing pharmaceutical R&D priorities.      

1   A  Commission  study  confirmed  that  the  problem  was  widespread: “Future-proofing  pharmaceutical 

legislation – Study on medicine shortages (2021)”. 

3 
4 

2  A generic medicine is a medicine that is developed to be the same as a medicine that has already been 
authorised.  A  company  can  only  market  a  generic  medicine  once  the  regulatory  and  intellectual 
property protections of the original medicine have expired.  
June 2023 European Council conclusions. 
See  Commission  Communication  “Towards  a  more  resilient,  competitive  and  sustainable  Europe” 
(COM(2023)  558)  and  https://www.consilium.europa.eu/en/press/press-releases/2023/10/06/granada-
declaration/. 
Impact  assessment  report  and  executive  summary  accompanying  the  revision  of  the  general 
pharmaceutical legislation, annex 5, 2023. 

5 

1 

 
 
 
The EU market for medicines remains fragmented, despite the EU  having a single 
market and being the second largest market for pharmaceuticals in the world. The 
organisation  of  healthcare  systems  is  a  national  competence  of  Member  States:  this 
allows decisions closer to the patient, but also brings major divergences in both pricing 
and patient access. Better and closer coordination between national authorities opens the 
door to a more efficient and effective supply of medicines throughout the EU.  

The continued availability of safe, effective and affordable medicines for patients is 
a foundation of the strong European Health Union now being built6. The reinforced 
mandate  of  the  European  Medicines  Agency  (EMA)  has  already  strengthened  the 
coordinated  and  collaborative  EU  level  management  of  critical  shortages.  The 
Commission’s  Health  Emergency  Preparedness  and  Response  Authority  (HERA) is 
supporting  with  foresight  and  emergency  preparedness  to  ensure  the  availability  of 
medical countermeasures. The Union Civil Protection Mechanism is providing stockpiles 
of  critical  medical  countermeasures  that  can  be  quickly  deployed  when  Member  States 
cannot cope with a health emergency. The upcoming HERA review will further look into 
reinforcing HERA's capacity to act in this  area, in order to reinforce security of supply 
and ensure the availability of medicines for healthcare systems and patients in the EU at 
all times.  
The  reform  of  the  EU  pharmaceutical  legislation7  is  essential  to  take  the  work  on 
critical  shortages  and  security  of  supply  forward,  building  a  pharmaceutical  ecosystem 
that  is  competitive,  future-proof  and  with  a  single  market  in  medicines  benefitting  all 
Europeans.  The  Commission  therefore  calls  on  the  European  Parliament  and  the 
Council to ensure its swift adoption, as did the European Council8.  

This Communication builds on the work under way and sets out steps the EU can take to 
make  a  difference  in  the  availability  of  medicines  to  patients  across  the  EU,  for  the 
coming winter and more structurally. This work  will cover both generic and innovative 
medicines, as well as their ingredients. The Communication puts forward a broad set of 
short-term and longer-term actions to address shortages of medicines and enhance their 
security  of  supply  in  the  EU,  by  providing  predictability  and  a  comprehensive  and 
coordinated  approach  with  stakeholders  at  EU  and  global  level.  The  key  goals  are  to 
prevent or mitigate critical shortages at EU level and to assure a particular focus on the 
most critical medicines for which security of supply needs to be assured in the EU at all 
times, in normal times, and in times of crisis.  

6  Commission Communication on Building a European Health Union: Reinforcing the EU’s resilience 

for cross-border health threats 

7  COM(2020) 761; COM(2023) 193 and 192. 
8 
June 2023 European Council conclusions. 

2 

 
 
 
The EU system today: supporting Member States’ efforts to address shortages  

Member States are responsible for the supervision of medicines supply in their territory 
and  most  shortages  are  managed  and  resolved  at  national  level.  However,  the  EU  has 
been  building  tools  to  address  critical  shortages  which  require  EU-level  coordinated 
action,  as  well  as  to  bring  more  structural  support  to  security  of  supply  of  critical 
medicines:  

•  Obligations  on  suppliers:  companies  have  a  legal  obligation  to  “ensure  appropriate 
and continued supplies”, so that the needs of patients in the Member State in question 
are  covered9.  In  addition,  companies  should  notify  any  interruption  of  supply  to  the 
competent  authority.  This  has  not  prevented  shortages  arising  due  to  unforeseen 
events  outside  of  the  control  of  the  companies  (such  as  manufacturing  issues  or 
natural  disasters)  or  commercial  decisions  (including,  most  obviously,  a  lack  of 
profitability). 

•  EU-level coordination: over recent years, the EU has improved coordination between 
Member States to better respond to critical shortages in a timely and coherent manner. 
Under the European Health Union, the EMA’s mandate has been reinforced, so that it 
can more effectively  monitor and mitigate shortages by  coordinating, in  cooperation 
with  Member  States,  EU-level  management  of  critical  shortages,  as  well  as  the 
response  to  specific  public  health  emergencies10.  The  added  value  of  this  enhanced 

9   Article  81(2)  of  Directive  2001/83/EC  on  the  Community  code  relating  to  medicinal  products  for 

human use, OJ L 311, 28.11.2001, p. 67.   

10   This  is  coordinated  through  an  Executive  Steering  Group  on  Shortages  and  Safety  of  Medicinal 
Products  (MSSG),  composed  of  representatives  of  Member  States,  the  Commission,  EMA  and 
observers from patients and healthcare professionals’ organisations. 

3 

 
 
 
cooperation  has  been  shown  in  recent  cases  of  shortages  of  a  medicine  dissolving 
blood clots and a medicine against vision loss. Joint policies and guidance on shortage 
prevention, management and communication to the public, including to avoid the risk 
of hoarding by citizens,  have been also developed11. In addition, HERA plays a key 
role  in  ensuring  availability  of  medical  countermeasures,  as  shown  by  the  EU 
Vaccines Strategy and joint procurements of COVID-19 therapeutics.  

•  Dialogue with industry: for critical shortages, regulators consult with a broad range of 
industry  through  the  EMA,  working  with  Member  States  to  assess  the  situation  and 
decide  whether  specific  recommendations  should  be  adopted.  The  coordination  with 
industry beyond regulatory context is now complemented by HERA, including by the 
Joint Industrial Cooperation Forum.  

•  Joint  procurement:  the  joint  procurement  of  medicines  or  the  procurement  of 
medicines  on  Member  States’  behalf  (e.g.  in  the  case  of  the  COVID-19  pandemic) 
provided  a powerful  tool to  improve access,  affordability, and security of supply, of 
particular benefit in smaller EU markets.  

•  Stockpiling:  the  work  of  the  Union  Civil  Protection  Mechanism  (UCPM)  to 
coordinate  in-kind  assistance  extends  to  cross-border  health  threats12.  Strategic 
reserves at EU level under rescEU were created during the COVID-19 pandemic and 
have  been  further  developed  as  a  safety  net  in  the  event  that  national  stocks  do  not 
suffice. With the creation of HERA, EUR 1.2 billion has been devoted to this work. 

These  steps  have  provided  vital  experience  for  building  a  more  comprehensive  and 
effective  EU  approach  to  address  critical  shortages  and  secure  supply  of  critical 
medicines.  

2.  MITIGATING  CRITICAL  SHORTAGES  IN  THE  IMMEDIATE  AND 

SHORT TERM  

During the winter of 2022-2023, many Member States experienced critical shortages of 
certain  antibiotics,  endangering  the  health  of  patients  and  risking  the  development  of 
antimicrobial  resistance.  These  critical  shortages  were  the  result  of  changing  infection 
patterns,  which  strongly  increased  demand.  On  the  supply  side,  the  long  lead  times 
needed  to  boost  production  made  it  difficult  to  respond  quickly.  This  experience 
underlined the need for a dedicated effort – from the industry, as well as from Member 
States and the EU level to address the issue of critical shortages.  

There  are  many  ways  in  which  the  EU  can  already  act  to  prevent  and  tackle  critical 
shortages.  Further implementing these measures represents a major enhancement of the 
EU’s ability to address the risk of medicine shortages in a coordinated manner. 

Avoiding critical shortages of key antibiotics over the coming winter  

To better prepare for winter 2023-2024, the EMA and HERA have identified a subset of 
key antibiotics (including specific paediatric formulations) for which they have simulated 

11   Through the coordinated work of  the Heads of national medicines agencies and the EMA  and Based 

on the EU Medicines Agencies Network Strategy to 2020 (europa.eu).  

12   Examples of support from the UCPM in the case of medicine shortages include Doxycyline in Brazil 
(2021)  and  immunoglobulin  in  Romania  (2018,  2022).  Health  emergencies  managed  through  the 
UCPM  include  Ebola  (DRC  2021,  Guinea  2020,  West  Africa  2014),  and  the  UCPM  has  delivered 
medicines in many other emergencies, including the Russian military aggression against Ukraine. 

4 

 
 
 
the planned supply and estimated demand, to anticipate the risk of critical shortages. This 
work has been conducted in close collaboration and with the support of Member States 
and the industry. 

The following measures aim to improve availability of certain key antibiotics in 2023-24: 

•  Continuous  monitoring  of  forecasts  of  supply  and  demand,  in  cooperation  with 

• 

companies and national authorities. 
Interaction between Commission, EMA and companies, so that measures to prevent 
potential  shortages  through,  for  example,  increased  manufacturing  capacity  have 
been put in place. 

•  Deploying regulatory flexibilities (see below) where needed to prevent and manage 

critical shortages. 

•  Deploying,  where  needed,  the  Voluntary  Solidarity  Mechanism  for  medicines  (see 

• 

below). 
Intensified  exchange  of  information  with  international  regulators,  as  a  channel  for 
early warning of critical shortages identified elsewhere in the world. 

•  Targeted  joint  procurement  or  procurement  on  Member  States’  behalf  of  medical 

• 

• 

countermeasures enabling prevention13. 
International  solidarity  through  work  to  establish  two-way  donation  channels  of 
antibiotics  with  countries  in  the  Southern  Hemisphere  (as  the  winter  peak  occurs 
there at another time of the year). 
Information  to  the  public  on  measures  taken  at  EU  level  to  prevent  shortages  of 
antibiotics in the EU, also promoting the prudent use of antibiotics and highlighting 
the need to avoid hoarding by all relevant stakeholders. 

•  Deploying the available rescEU stockpile of antibiotics, in case of critical shortage14. 

Together  with  EMA,  the  Commission  continues  to  closely  monitor  the  situation  as  it 
evolves, keeping day-to-day contact with the relevant companies and other stakeholders 
to  detect  early  any  unexpected  shortfall  of  supplies  of  certain  key  antibiotics,  and  to 
monitor  the  continued  supply  of  other  medicines  commonly  used  in  the  autumn/winter 
season such as cough syrups, ibuprofen and paracetamol.  

The  information  available  today  suggests  that  –  if  demand  in  the  coming  winter 
season does not differ significantly from the demand of recent years – the supply to 
the EU of key antibiotics seems to generally match demand. However, this depends 
on  the  compliance  by  relevant  companies  with  their  legal  obligation  to  ensure 
supply and their ability to adapt.  

Sharing medicines between Member States 

A “Voluntary Solidarity Mechanism for medicines” is being launched in October 2023 
to support Member States experiencing critical shortages15. The scheme allows Member 
States  to  flag  needs  for  a  given  medicine  in  critical  shortage  at  national  level  to  other 
Member  States,  so  that  they  can  indicate  the  availability  of  stock  that  could  be 
redistributed.   

In cases when Member States are overwhelmed and in urgent need of a given medicine, 
the  Union  Civil  Protection  Mechanism,  via  its  24/7  available  European  Response 

13   Involving  vaccines  and  therapeutics  for  respiratory  syncytial  virus  (RSV)  to  prevent  aggravation  of 
shortages due to increased demand of antibiotics to treat co-infections between RSV and bacteria. 

14   When a Member State has triggered the Union Civil Protection Mechanism. 
15  https://www.ema.europa.eu/en/documents/other/mssg-solidarity-mechanism_en.pdf 

5 

 
 
Coordination Centre (ERCC) can be activated to coordinate and logistically support the 
voluntary transfer of medicines. This requires good coordination between health and civil 
protection  authorities  at  national  level.  Such  a  redistribution  of  stocks,  drawing  on 
national reserves, will build on existing examples of European solidarity, and will further 
strengthen cooperation among Member States in the European Health Union.   

Building  on  this  work  and  on  the  experience  of  the  COVID-19  Clearing  House  for 
medical  equipment16,  the  Commission  will  also  establish  by  Q2  2024  a  matchmaking 
platform, where economic operators and developers will be able to flag their capabilities 
and  collaboration  needs.  The  Commission  will  also  foster  networking  and  business 
relationships  through  the  HERA  Industry  Days17,  dedicated  to  medicines  and  medical 
countermeasure.  

Defining a Union list of critical medicines 
Medicines are deemed critical medicines18 when essential to ensure the continuity of care 
and  the  provision  of  quality  healthcare,  and  to  guarantee  a  high  level  of  public  health 
protection in Europe, and also when their unavailability results in serious harm or risk of 
serious harm to patients.  

 The  Commission will publish a Union list of critical medicines , building on work with 
EMA and the Member States, as a first step to ensure the security of supply. This work is 
under way19, and a first version of the Union list of critical medicines will be available by 
the  end  of  2023.  The  list  will  be  updated  to  ensure  coverage  of  all  relevant  critical 
medicines, including possibly paediatrics and antibiotics, based on continued analysis of 
all types of medicines. 

The  Commission,  together  with  Member  States,  and  based  on  information  from  other 
stakeholders,  will  analyse  the  vulnerabilities  in  the  supply  chain  of  a  first  tranche  of 
critical  medicines  on  the  future  list  by  April  2024.  This  will  provide  the  basis  for 
decisions on further remedial action, such as recommendations that companies diversify 
suppliers  or  increase  production  within  the  EU,  investment  incentives,  additional 
regulatory  obligations  for  companies,  and  procurement  with  strong  contractual 
obligations for delivery.  

Improving demand and supply forecasting to prevent risks of critical shortages  

The forecasting of demand by industry - as part of their existing regulatory obligation to 
ensure  continuous  supplies  -,  but  also  by  public  authorities,  plays  a  major  role  in 
providing early warning of potential critical shortages, alongside supply and production 
capacity information.  

The Commission, EMA and national medicine agencies have provided a set of practical 
recommendations  to  support  the  demand  forecasting  at  national  level,  drawing  on 
experience  under  the  COVID-19  pandemic20.  This  could  be  complemented  by  a  best 
practice  model  to  help  the  comparability  of  demand  forecasts.  The  Commission  is  also 

16   In April 2020, the Commission set up a Clearing House for medical equipment to facilitate the timely 

availability of the medical supplies needed to fight the virus. 

17  HERA Work Plan 2022 (europa.eu) 
18  See also article 2 (13) of COM (2023) 193. 
19   A  draft  methodology  to  identify  critical  medicines  was  put  forward  in  the  2022  Commission  Staff 

Working Document on vulnerabilities of the global supply chains of medicines. 

20  https://www.ema.europa.eu/en/documents/other/reflection-paper-forecasting-demand-medicinal-

products-eu/eea_en.pdf 

6 

 
 
 
working on an EU Mechanism for Demand Signalling to pull the information together to 
empower  the  collective  EU  public  sector  in  its  decisions.  Better  knowledge  of  longer-
term  demand  trends  could  help  in  specific  cases  to  directly  support  research,  facilitate 
market launches in the EU and make the EU market even more attractive for companies. 
The  Commission  will  also  work  with  the  European  Centre  for  Disease  Prevention  and 
Control on building reliable forecasts  of potential threats  beyond the current  short-term 
horizons.  

The ongoing development of new IT tools will also help to harness the data behind the 
monitoring of demand and supply of medicines. A new European Shortages Monitoring 
Platform for reporting information regarding available stocks and shortages of medicines 
is  expected to  become operational  in  202521.  Artificial  intelligence  will also be used  to 
provide information about trends in demand and supply from existing data22. The future 
European  Health  Data  Space  would  offer  additional  opportunities  for  European  and 
national authorities of using existing health data to analyse trends. The interoperability of 
databases, at EU and with national level, as well as cybersecurity measures23 is critical to 
maximise the potential of this data for the benefit of healthcare systems in Member States 
and ultimately EU citizens. 

Accelerating and anticipating the pharmaceutical reform to enhance security of supply  

The proposed reform of the pharmaceutical legislation introduces structural measures to 
improve availability of medicines.  

Key elements include a new European alert system with earlier notification of shortages 
and  withdrawals  by  companies,  harmonised  reporting  criteria,  mandatory  shortage 
prevention  plans  and  coordinated  management  of  shortages  by  EMA24.  The  reform 
would  reinforce  and  strengthen  companies’  obligation  to  ensure  appropriate  and 
continued supply.  

In addition, the reform brings a major overhaul of the incentives provided to companies 
and  would  reward,  for  newly  authorised  medicines,  continuous supply  in sufficient 
quantity  in all  Member  States25.  Administrative  burden  has  also  been  reduced,  making 
the  marketing  authorisation  process  faster  and  easier.  The  proposed  reform  would  also 
facilitate  earlier  market  entry  of  generic  medicines,  once  the  exclusivity  period  of  the 
originator ends.  

The  benefits  will  only  be  felt  in  full  when  the  new  legislation  is  in  place.  However, 
Member  States,  EMA  and  the  Commission  have  already  started  actions  that  go  in  the 

21  Established by Regulation 2022/123 on a reinforced role for the European Medicines Agency in crisis 

preparedness and management for medicinal products and medical devices. 

22   Through  two  systems  (EU-MED  and  ATHINA)  currently  under  development  by  HERA.  ATHINA 
will  support  the  monitoring  and  the  analysis  of  supply  chains  of  crisis-relevant  medical 
countermeasures and, thus, guide national and EU-level actions to increase supply chain resilience. 

23  ENISA Threat Landscape 2022.pdf 
24  The  revision  was  informed  by  the  Commission’s  Structured  Dialogue  with  actors  in  the 
pharmaceutical  manufacturing  value  chain  and  public  authorities.  In  October  2022,  the  Commission 
published a Staff Working Document summarising the findings of the Structured Dialogue. This work 
complemented the results of the study analysing the root causes of medicine shortages and the analysis 
fed into the reform of the pharmaceutical legislation. 

25    Supplying  all  Member  States  within  two  years  after  the  marketing  authorisation  would  bring  an 
additional  two  years  of  regulatory  protection  for  medicines  authorised  after  the  pharmaceutical 
revision becomes applicable. 

7 

 
 
direction  of  the  proposed  reform  to  coordinate  on  preventing  and  mitigating  critical 
shortages risks26.  This process should be accelerated. 

Elements of the new pharmaceutical legislation that could be anticipated include:   

•  Earlier notification of the risk of a shortage by companies;   
•  Shortage prevention plans for all medicines by all companies; 
• 

Increased information sharing on critical shortages amongst Member States and with 
EMA to help the EU to  use existing systems and processes to the full. This would 
include  information  on  planned  measures  or  measures  already  taken,  including 
unilateral  actions  by Member States,  such  as export bans  or prohibition  of parallel 
trade; 

•  Recommendations  from  the  Commission/EMA  to  manage  critical  shortages  and 

improve future security of supply (such as maintaining contingency stocks);  

•  Continuous  consultation  by  EMA  of  all  relevant  industry  stakeholders  during  a 

critical shortage; 

•  To limit the impact of medicines withdrawals from the market, facilitate the transfer 

of the marketing authorisation to a third party. 

This could be complemented by other steps, such as proactive communication on critical 
shortages.  For  example,  Member  States  could  launch  information  campaigns  to 
discourage  hoarding  or  take  actions  to  avoid  waste27,  at  any  level  of  the  supply  chain, 
from wholesalers to patients.  

National capacity in the area of shortages is being supported through a €10 million Joint 
Action on shortages under EU4Health, including a ‘best practice’ IT concept model for 
use  at  national  level.  Participating  authorities  can  also  benefit  from  EU  support  to 
enhance national capacity with respect to shortages management.  

Making use of all flexibilities  

Regulatory flexibilities can be an important tool to manage and mitigate shortages of 
critical medicines. This includes measures to facilitate the quick authorisation and roll-
out of alternatives; the upscaling of production or approval of alternative suppliers of raw 
materials or finished products; temporarily extending shelf-life; or measures to facilitate 
redistribution between Member States.  

Over  recent  years,  EU  regulators  have  gained  experience  with  those  flexibilities, 
especially during the COVID-19 pandemic. This offers confidence that they can be used 
without compromising safety and quality standards28. A new Joint Action  will promote 
effective  use  of  regulatory  flexibilities  and  other  flexibilities  that  could  be  applied  at 
national level, such as how the magistral preparations of local pharmacies might be used 
to mitigate certain shortages.  

26  Guidance  from  the  EMA  and  national  medicines  agencies  has  already  been  issued  to  support  the 
anticipation of some of these elements: Good practice guidance for patient and healthcare professional 
organisations  on  the  prevention  of  shortages  of  medicines  for  human  use  (europa.eu)  and  Good 
practices for industry for the prevention of human medicinal product shortages (europa.eu) 

27   Some  countries  introduced  measures  requiring  pharmacies  to  sell  the  exact  quantity  of  prescribed 

medicines, instead of whole packages that would require subsequent disposal. 

28  Supported by MSSG toolkit and recommendations on regulatory flexibility,  published on 24 October 

2023. 

8 

 
 
 
 
 
Pricing and reimbursement policy   

While  pricing  and  reimbursement  policies  for  medicines  are  a  national  competence, 
cooperation in this area is essential in order to avoid that decisions in one Member State 
create  shortages  in  other  Member  States.  While  the  price  paid  within  a  given  Member 
State  reflects  the  preference  of  a  national  health  system,  more  coordination  on  pricing 
and  procurement  could  contribute  to  more  equal  and  timely  access  to  medicines, 
including for Member States with lower purchasing power. Voluntary collaboration will 
be further facilitated by the Commission, including in the group of National Competent 
Authorities  on  Pricing  &  Reimbursement  and  public  healthcare  payers  (“NCAPR”).  In 
this  group,  Member  States  share  experience  from  national  pricing,  reimbursement  and 
procurement policies, which are relevant for affordability and security of supply.  
In  the  longer  run,  evaluation  of  the  existing  Transparency  Directive29  gives  the 
opportunity to look at an important tool for cooperation on pricing and reimbursement.    

Using procurement to enhance security of supply 

Practices  in  procurement  procedures  for  medicines  differ  between  Member  States  and 
long-term availability is rarely a primary consideration. The 2014 Procurement Directive 
encourages  a  more  strategic  approach  through  award  criteria,  including  criteria  beyond 
price. Using the lowest price as the main selection criterion may reduce incentives for the 
industry to build for long-term supply in the EU. At the same time, vulnerability may be 
increased  when  public  procurement  procedures  award  contracts  to  a  single  company. 
Where challenges with access to a critical medicine and related affordability may be an 
issue,  Member  States  can  work  together  to  increase  buying  power:  existing  examples 
include the Baltic Procurement Initiative and the Nordic Pharmaceutical Forum.  

Joint procurement between Member States can act as a powerful tool to improve access, 
affordability and security of supply, of particular benefit in smaller EU markets. This can 
improve the negotiating position of Member States to incentivise production capacities, 
as  well  as  diversifying  supply  chains.  In  specific  cases,  those  instruments  could  also 
support  enhanced  predictability  through  multi-annual  contracts.  The  Commission  will 
look  at  using  joint  procurement  for  antibiotics  and  treatments  for  respiratory  viruses 
ahead of winter 2024-25. 

Public procurement practices supporting security of supply of medicines: 

There are a variety of tools which can already be used in relation to availability of critical 
medicines:  

-  Preliminary market consultation;  
-  Awarding contracts to multiple winners, to reduce the risk of supply disruptions and 

- 

maintain a competitive environment;  
Increased use of most economically advantageous tender (MEAT) award criteria in 
public tenders, using qualitative criteria such as security of supply and production in 
the  EU/EEA  or  in  countries  with  which  the  EU  has  concluded  an  agreement  on 
government procurement;  

29  Directive 89/105/EEC on the transparency of measures regulating the prices of medicines for human 
use  and  their  inclusion  in  the  scope  of  national  health  insurance  systems.  A  study  has  been 
commissioned  with  the  purpose  to  analyse  the  functioning  of  Council  Directive  89/105/EEC (better 
known as the “Transparency Directive”) and the results are expected in November 2023. 

9 

 
 
 
- 

Joint  procurement  (group  procurements  and  cross-country  procurements)  to 
overcome access challenges of smaller market sizes. This would increase scale and 
negotiating  power,  while  also  opening  the  door  to  steps  fostering  competitive 
markets and disincentivising supply chain consolidation; 

-  Ensuring that the duration of contracts is tailored to favour predictability of demand 

and long-term availability. 

Through continued work with experts and national authorities, the Commission will issue 
EU guidance on procurement by early 2024. The focus will be on procurement practices 
that  can  make  a  direct  contribution  to  security  of  supply  and  availability  through 
effectively integrating supply security as an award criterion30, whilst having regard to the 
EU’s international commitments.  This will further support Member States and procurers 
in their procurement practices.  
More  generally,  the  Commission  proposal  to  recast  the  Financial  Regulation31  would 
ensure  further  options  as  regards  procurement  instruments  at  EU  level  beyond  crisis 
situations.  Where  there  is  Member  State  interest  and  there  is  a  specific  legal  basis,  the 
Commission  could  not  only  procure  medicines  jointly  with  Member  States,  but  also 
procure  medicines  on  their  behalf,  on  the  basis  of  a  mandate.  This  could  cover  critical 
medicines  and  ancillary  products  beyond  the  current  scope  of  the  Joint  Procurement 
Agreement to procure medical countermeasures. 

One  issue  to  be  looked  at  in  the  forthcoming  review  of  HERA  is  the  extent  to  which 
action  should  cover  response  beyond  serious  cross-border  health  threats  across  the  full 
range of medicines.  

The Commission, together with the EMA and the Member States, will intensify work 
ahead of the forthcoming winter to prevent critical shortages: 

•  Deploy the new Voluntary Solidarity Mechanism for medicines;  
•  Use regulatory flexibilities where appropriate; 
•  Deploy the rescEU stockpile of antibiotics if UCPM is triggered. 

In  addition,  the  Commission,  together  with  the  EMA  and  the  Member  States,  will 
deliver in a short to mid-term the following actions to support long-term security of 
supply of critical medicines in the EU:  

•  Publish  the  Union  list  of  critical  medicines  by  the  end  of  2023  and  analyse  the 

vulnerabilities of a first tranche of critical medicines by April 2024; 

•  Anticipate  proposed  measures  under  the  pharmaceutical  reform  to  ensure  more 

systematic and coordinated notification and mitigation of critical shortages; 

•  Set  up communication  tools  for better supply and demand  forecasting, such as a 
matchmaking platform (by Q2 2024); an EU Mechanism for Demand Signalling; 
and the European Shortages Monitoring Platform; 

•  Prepare  to  launch  in  2024  a  Joint  Action  on  regulatory  flexibilities,  including 

magistral preparations; 

27        For  example,  in  Germany,  a  law of  July  2023  stipulates  the  production  of  the active  pharmaceutical    
ingredient  in  the  EU  or  the  European  Economic  Area  as  a  mandatory  criterion  in  tenders  for  the 
purchase of certain medicines (https://dserver.bundestag.de/btd/20/068/2006871.pdf). 

31   COM(2022) 223 final; Proposal for a Regulation on the financial rules applicable to the general budget 

of the Union (recast), 16 May 2022. 

10 

 
 
 
 
 
•  Develop a best practice guidance for the public procurement of medicines by early 
2024, as part of wider efforts to leverage procurement to better support security of 
supply. 

Member States are invited to:  

•  Monitor and fully enforce the supply obligations of companies; 
•  Develop effective communication plans to inform and reassure about availability 

of medicines32; 

•  Consider  how  national  procurement  rules  and  criteria  can  increase  security  of 

supply. 

Pharmaceutical industry stakeholders are invited to:  

•  Assure to the full the supply obligation for companies under EU law 
•  Continuously  monitor  the  evolution  of  demand  and  supply  of  critical  medicines 
and  provide  complete  information  to  regulatory  authorities  as  early  as  possible; 
Implement recommendations, both on regulatory flexibilities and on the elements 
of  the  pharmaceutical  revision  that  could  already  be  applied,  such  as  earlier 
notifications of shortages and withdrawals.  

3.  STRUCTURAL MEASURES FOR THE MID AND LONG-TERM  

Ensuring  that  Europeans  receive  the  medicines  they  need,  when  they  need  them, 
regardless  of  where  they  live  in  the  EU  is  a  central  objective  of  the  European  Health 
Union.  Boosting  the  competitiveness  of  the  European  pharmaceutical  industry  and 
assuring better availability of medicines and more equal and timely access for patients is 
a key deliverable of the proposed EU pharmaceutical reform. While the reform foresees 
structural measures to strengthen the security of supply in the EU, including for generic 
medicines, it will not address the industrial dimension of medicines shortages.  
In addition to existing and planned policy, legislative and regulatory measures33, the EU 
needs a strategic and coordinated industrial approach to enhance security of supply of the 
most  critical  medicines.  Strengthening  the  EU’s  security  of  medicines  supply  may 
require  new  legislation.  A  legislative  initiative  for  an  EU  “Critical  Medicines  Act” 
would require thorough  preparation, including  the assessment  of economic dimensions. 
The  Commission  will,  to  that  end,  launch  a  dedicated,  preparatory  study  by  the  end  of 
2023, paving the way for an impact assessment. 

A Critical Medicines Alliance: Working together to boost security of supply  

The EU and Member States have many tools which can be used to promote a coordinated 
industrial approach, bringing together public and private actors from the European health 
and industrial ecosystem.  

32  https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/good-practice-guidance-

communication-public-medicines-availability-issues_en.pdf 

33  Based  on  the  learnings  of  the  Structured  Dialogue  and  concrete  MSSG  recommendations  on  critical 

medicines set out in the pharmaceutical reform. 

11 

 
 
 
 
 
 
The Commission intends to set up a “Critical Medicines Alliance” by early 2024. This 
would allow national authorities, industry, civil society representatives, the Commission 
and EU agencies to come together to develop coordinated action at the EU level against 
the  shortages  of  medicines,  in  compliance  with  the  competition  rules  and  EU’s 
international commitments.  

The starting point would be the shared vulnerability analysis of supply chain bottlenecks 
of  the  critical  medicines  on  the  Union  list  (over-dependency  on  a  limited  number  of 
external suppliers, limited diversification possibilities, limited production capacities, etc). 
This  evidence-based  process  would  result  in  identifying  a  limited  number  of  critical 
medicines with the highest risk of shortages and impact on healthcare systems. Through 
this process, the Alliance would be able to identify the most appropriate tools to respond 
to these vulnerabilities in the most optimal way.   

This  work  could  draw  on  a  varied  toolbox,  including  a  set  of  actions  to  mitigate  these 
structural  risks,  notably  reinforcing  supply  by  making  demand  more  predictable, 
encouraging diversification and increased manufacturing for the most critical medicines, 
as well as EU stockpiling if needed:  

•  Public procurement  

Coordination at EU level could offer a  strategic frame to enhance security of supply of 
the  identified  critical  medicines  through  public  procurement.  This  could  draw  on 
Commission  guidance  and  common  criteria  for  the  procurement  of  critical  medicines, 
such  as  green  production  and  prioritisation  of  supplies  in  Europe  at  times  of  critical 
shortages.  

Such  an  approach  could  also  help  in  defining  adequate  supply  in  relation  to  critical 
medicines and, thereby, compensate and incentivise industry, and support the application 
of these criteria in a coordinated way, at EU level. Predictability of supply would also be 
helped  by  medium-term  contractual  incentives  to  diversify  and  attract  the  next 
generation  of  manufacturing  investments  in  Europe.  More  generally,  it  would  explore 
common approaches on how to  encourage security  of supply, on which Member States 
could  draw  when  taking  forward  joint  procurements  at  EU  level.  Another  possibility 
could be to use capacity reservation contracts, using the model of EU FAB. 

•  Diversification of global supply chains  

The  Alliance  could  also  help  in  exploring  how  to  diversify  global  supply  chains  for 
critical  medicines.    Identifying  priority  countries  for  strategic  partnerships  with  third 
countries  concerning  the  security  of  supply  of  critical  medicines  would  help  coherence 
and  potential  synergies between  Member  States’ and  EU  cooperation  with  third 
countries.  

•  Boosting innovation and manufacturing capacity    

Another strategic focus of the Alliance would be how to help to boost Europe’s capacity 
to  produce  and  innovate  in  the  manufacturing  of  critical  medicines  and  ingredients  in 
coordinated  and  competitive  way.  This  would  enhance  security  of  supply,  strengthen 
availability and reduce some of the EU’s supply chain dependencies.  

All the national and EU support should be compatible with the state aid framework. The 
Alliance  would  coordinate  efforts  to  identify  security  of  supply  needs  for  critical 
medicines,  based  on  the  identified  vulnerabilities.    In  this  context,  Services  of  General 
Economic  Interest  (SGEI),  coordinated  at  EU  level  and  covering  several  criteria, 
including  priority  rated  order  for  EU  market,  could  be  envisaged  by  Member  States  to 
limit the risk of critical medicines shortages at the EU level.  The Alliance could play a 
role in promoting a harmonised approach across the EU.  

12 

 
Furthermore, Member States in the framework of the Alliance could discuss whether to 
support  the  development  of  advanced  and  innovative  green  technologies,  including  for 
off  patent  medicines  production,  possibly  as  part    of  a  new  Important  Project  of 
Common  European  Interest  (IPCEI)  focusing  on  critical  medicines.  It  could 
complement  the  ongoing  work  of  the  existing  IPCEI  in  the  health  area,  which  aims  to 
support  the  development  of  innovative  treatments  on  antimicrobial  resistance,  rare 
diseases  and  cancer,  as  well  as  innovative  production  processes  and  products.  A  new 
IPCEI  could  focus  on  developing  innovative  and  sustainable  manufacturing  and 
production technologies and processes for generic medicines. This would both enable to 
increase  innovative  domestic  production  and  foster  environmental  standards.  It  would 
also  be  an  opportunity  for  the  EU  to  lead  in  the  greening  of  generic  medicines 
production. 

•  EU stockpiling of critical medicines 

Several  Member  States  already  have  provisions  in  national  legislation  obliging  the 
different  actors in  the supply  chain  to  maintain a contingency stock, in  order to  have  a 
buffer when short-term shortages occur.  

When stockpiles are already built up before shortages occur, they can help to bridge the 
supply gap before production increases or provide the input materials in shortage, needed 
to  boost  the  quantities  that  can  be  manufactured.  However,  national  stockpiling  can 
impact availability of medicines in other Member St ates,  be  costly  and  potentially 
wasteful,  particularly  if  not  used  in  tandem  with  mitigation  measures  to  address  the 
shortage itself.   

The  Commission  and  Member  States  should  develop  a  common  strategic  approach  to 
medicines  stockpiling  in  the  first  half  of  2024.  Building  upon  experience  under  the 
Union Civil Protection Mechanism (UCPM) and its existing rescEU stockpile, this would 
look  at  the  conditions  required  for  stockpiling  to  be  an  appropriate  and  cost-effective 
option. A first step would be to define the needs for stockpiling of critical medicines at 
the  EU  level,  based  on  the  vulnerability  analysis  of  supply  chains.  To  complement  the 
strategy, the Commission intends to launch a Joint Action on stockpiling in 2024, which 
will support Member States to enhance and/or improve national stockpiling strategies in 
an efficient and coordinated manner.  

The speed with which the UCPM can act will mean that it will continue to be a key part 
of  the  EU  approach.  If  the  UCPM  is  to  be  complemented  with  a  long-term  stockpiling 
system, this would require sustainable financing.  

•  Skills for the pharmaceutical industry 

European pharmaceutical producers face rapidly evolving skills needs. The digitalisation 
of  the  industry  puts  the  emphasis  on  artificial  intelligence,  robotics,  and  big  data 
processing.  The  health  industrial  ecosystem  is  highly  regulated,  and  compliance  with 
standards requires professionals well-versed in regulatory frameworks, quality assurance 
and control.  The green transition  calls for skills,  including  green chemistry, sustainable 
engineering, life cycle assessment, sustainable sourcing and energy management.  

The pharmaceutical industry is also characterised by jobs for highly skilled workers and a 
high density of cross-national collaborations. It is therefore highly dependent on labour 
mobility,  with  the  free  movement  of  workers  an  enabler  of  innovation  and  growths. 
Pharmacists are among the regulated professions, allowing for an easier adjustment of the 
curricula  for  this  profession  and  benefiting  from  EU  measures  to  facilitate  free 
movement.  

13 

 
 
 
The EU Skills Agenda addresses the widespread issue of skills gaps across the EU. More 
specifically,  it  aims  to  contribute  to  the  increase  of  STEM  (Science,  Technology, 
Engineering and Mathematics) graduates, by raising the attractiveness of STEM studies 
and careers, with focused actions to attract girls and women, and by encouraging a cross-
disciplinary and innovative teaching and learning approach in schools, VET and higher 
education. The 'Pact for Skills' aims to tackle the most pressing industry skills gaps with 
active  involvement  of  industry  and  key  actors  in  education  and  training.  A  strong 
emphasis is put on a complementary skills partnership for the health industry, including 
pharmaceuticals, with a partnership agreement expected by the end of 2023, with active 
involvement  of  the  members  of  the  Joint  Industrial  Cooperation  Forum.  One  area  for 
cooperation would be better common identification of skills needs, as an encouragement 
to pooling of training. 

•  Financial support 

An important benefit of a common strategic approach as part of an Alliance would be to 
better  leverage  and  align  EU  and  national  funding.  This  would  offer  more  long-term 
investment  predictability  for  the  private  sector,  as  well  as  avoiding  unnecessary 
duplication  and  ensuring  that  other  horizontal  priorities  be  factored  in  (such  as 
facilitating the participation of SMEs).  

There is already substantial EU funding support for medicines. Around EUR 4 billion are 
dedicated  to  supporting  medicines,  including  research  under  Horizon  Europe34, 
development  and  production  of  medicines  under  the  European  Regional  Development 
Fund35, support for the development and production of anti-microbials and other medical 
countermeasures under the EU4Health Programme36, as well as the funding for medical 
stocks under the Union Civil Protection  Mechanism. Broader support to  health systems 
as a whole comes through EUR 43 billion under Recovery and Resilience Facility.  

The Strategic Technologies for Europe Platform (STEP)37, proposed as part of the mid-
term  review  of  the  Multiannual  Financial  Framework,  aims  at  boosting  investments  in 
critical technologies in Europe, either to promote innovation or to contribute to reduce or 
prevent strategic dependencies of the Union. The STEP seeks to reinforce and leverage 
existing EU instruments for a quick deployment of financial support for the development 
or manufacturing in the Union of critical technologies in several fields, including biotech. 
More  specifically,  the  Commission  proposal  covers  pharmaceuticals  and  medical 
technologies  vital  for  health  security  as  examples  of  biotechnologies  that  should  be 
covered by STEP. STEP projects could be supported through several programmes, such 

34  For example, more than EUR 180 million is devoted to clinical trials and support research in new anti-
microbials,  anti-virals  or  vaccines  that  could  be  used  in  case  of  a  new  pandemic.  In  addition,  the 
Innovative Health Initiative with a total budget of EUR 2.4 billion for the period 2021-2027, funded 
jointly  by  the  EU  and  by  industry  associations  representing  Europe’s  life  science  industries  aims  to 
translate  health  research  and  innovation  into  tangible  benefits  for  patients  and  society.  Its  activities 
include but are not restricted to medicine research and development. 

35  The  European  Regional  Development  Fund  supports  mostly  SMEs  in  projects  linked  to  medicines 
development  and  production  through  over  EUR  200  million  for  research,  upskilling,  investments  in 
fixed capital/immaterial assets of enterprises, greening of production processes and infrastructure. 
36  HERA  Invest  is  a  EUR  100  million  top-up  to  the  InvestEU  Programme  that  supports  sustainable 
investment, innovation and job creation in Europe. In addition, EUR 160 m are dedicated to EU-FAB, 
which  aims  to  support  ever-warm  capacities  that  could  also  be  extended  to  critical  medicines.  In 
addition, over EUR 100 m are dedicated under the EU4Health Programme for the development of and 
access to innovative technologies and critical medicines, including antibiotics. 

37   https://commission.europa.eu/strategy-and-policy/eu-budget/strategic-technologies-europe-

platform_en;  

14 

 
 
 
as  cohesion  policy  programmes,  the  Recovery  and  Resilience  Facility,  EU4Health, 
Horizon Europe or InvestEU. Moreover, the STEP also proposes to create a Sovereignty 
Seal, with the objective to promote synergies amongst existing programmes.38   

The  Technical  Support  Instrument  could  also  be  used  to  enhance  the  administrative 
capacity of Member States in managing shortages and producing critical medicines. 

Actions for the medium and long-term  

The  Commission  will  discuss  with  Member  States  the  establishment  of  a  Critical 
Medicines  Alliance  to  provide  a  strategic  frame  to  promote  structural  support  for 
critical medicines supply. It should aim to be up and running by early 2024. 

The Commission will also:  

•  Launch a study by the end of 2023 on whether legislation could help to offer long-

term structural support to critical medicines supply; 

•  Develop  a  common  strategic  approach  on  medicines  stockpiling    with  Member 

States, to be completed by June 2024; 

•  Conclude  strategic  partnerships  with  third  countries  for  production  of  critical 
medicines, reflecting both local demand and needs at the EU and global level. 

Member States are invited to:  

•  Use available  funds to invest in priorities identified by the Alliance, in line with 

State aid rules when applicable; 

•  Develop  national  stockpiling  approaches  consistent  with  an  overall  EU  

stockpiling approach for medicines; 

•  Support  the  launch  of  a  partnership  for  skills,  with  a  focus  on  needs  of  the 

pharmaceutical sector.  

4. 

INTERNATIONAL PARTNERSHIPS FOR SUPPLY  

The EU, acting as Team Europe, has been at the forefront of forging a global approach to 
health:  this  was  set  out  in  full  in  the  November  2022  Global  Health  Strategy39.  A  key 
aspect of this has been through support to those in need, shown most strikingly with the 
large-scale donation40 of COVID-19 vaccines from the EU to international partners. The 
COVID-19  pandemic  also  illustrated  the  critical  importance  of  global  supply  chains  to 
ensuring essential medical supplies. International cooperation and the genuine integration 
of  the  global  pharmaceutical  industry  is  a  key  determinant  for  the  availability  of 
medicines  in  the  EU  and  across  the  world:  many  partners  have  their  own  difficult 
experience of shortages and recognise the value of a collective approach. 

38   STEP can also become a powerful instrument to support the production of critical medicines. In line 
with the need to reduce EU’s strategic  dependencies, including on critical medicine shortages, STEP 
will be able to promote a more coordinated approach at EU level for the financing and of such actions, 
in  particular  with  the  Sovereignty  Seal  that  will  increase  synergies  between  programmes  like 
EU4Health,  Horizon  Europe  on  the  one  hand  and  cohesion  policy  funds  and  the  RRF  on  the  other 
hand. 

39   https://health.ec.europa.eu/system/files/2023-03/international_ghs-report-2022_en.pdf 
40 

If needed, through the European Humanitarian Response Capacity (EHRC) 

15 

 
 
 
 
Diversification of supply chains 

Diversification helps to reduce supply chain vulnerabilities resulting from dependencies. 
Given the complexity of pharmaceutical supply chains, EU industry needs to have access 
to  a broad range of essential  inputs. Trade  policy and  partnerships  aim at  opening  new 
markets and diversifying sources of supply and complement enhanced efforts to reduce 
excessive  dependencies  for  critical  supply  chains.  Identifying  risks  and  vulnerabilities, 
especially  for  critical  medicines,  gives  a  focus  for  mitigating  measures  and  to  build 
resilience in the global trading system and global pharmaceutical market. This is one of 
the goals of the EU’s 42 preferential trade agreements with 74 different trading partners, 
as well as of the work within international fora such as the G20, the G7 and the WTO. 

The  EU  also  works  with  key  trading  partners  at  bilateral  level  to  avoid  disruption  of 
supply chains. The EU is currently negotiating a free trade agreement with India, and the 
existing Trade and Technology Council also offers a forum to discuss how to enhance the 
value  chains  in  the  pharmaceutical  sector,  given  India’s  key  strategic  importance.  
Bilateral  meetings  with  China  provide  a  platform  to  raise  issues  affecting  access  to 
medicines supply chains. Dialogue with Latin America reflects an increasingly important 
trade relationship. The Commission will seek to set up strategic partnerships with third 
countries for production of critical medicines and APIs. These could define commitments 
on concrete actions of mutual interest. These actions could be tailor-made to reflect the 
potential of different  partners to  help  secure supply  or whether a third country requires 
additional  monitoring,  prevention  and  minimisation  of  environmental,  social  or  legal 
impacts.  

International cooperation to ensure regulatory convergence and a level playing field 

Regulatory  convergence  can  help  to  reduce  obstacles  and  bottlenecks  to  supply. 
Compliance  with  good  manufacturing  practice  was  a  goal  of  the  Pharmaceutical 
Strategy,41 to ensure the highest quality for products marketed in the EU and produced in 
third countries.  

Regulatory convergence and harmonisation of standards for pharmaceuticals is achieved 
and promoted through active engagement in relevant multilateral fora, such as ICH (the 
International Council for Harmonisation of Technical Requirements for Pharmaceuticals 
for  Human  Use)  and  ICMRA  (International  Coalition  of  Medicines  Regulatory 
Authorities). It is also important to support  the World Health Organisation work in this 
area to strengthen regulatory convergence. 

Harmonisation can also be promoted through Free Trade Agreements, with an obligation 
that  both  parties  take  into  account  international  provisions/practices  and  guidelines  for 
pharmaceuticals42.  This  enhances  the  quality  of  products  worldwide  and  ensures  that 
differing  standards  do  not  become  an  obstacle  to  trade.  Another  key  tool  is  mutual 
recognition agreements (MRAs) with third-country authorities concerning the conformity 
assessment  of  regulated  products,  allowing  for  mutual  confidence  in  inspections  and 
exchange  of  information.  Such  agreements  facilitate  the  trade  of  medicines  with 
Australia,  Canada,  Israel,  Japan,  New  Zealand,  Switzerland  and  the  United  States. 

41   The  European  Medicines  Agency  has  led  this  dialogue  for  the  EU,  notably  through  the  Global 
Regulatory  Working  Group  on  Drug  Shortages  and  the  International  Coalition  of  Medicines 
Regulatory Authorities, focused on G7 partners and the World Health Organisation.  

42   Notably  those  elaborated  by  WTO,  OECD,  ICH,  and  IMDRF,  and  the  Pharmaceutical  Inspection 

Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/s) 

16 

 
 
Bilateral arrangements with the United States and the Republic of Korea also enable the 
sharing of non-sensitive market knowledge to anticipate possible problems.  

Subject to applicable State aid and antitrust rules, the Commission will broaden this work 
by creating and fostering a network of international partners, aiming to address supply 
chain resilience, and to boost access to medicines and critical medical countermeasures. 
The network could be established within a year, bringing together manufacturers and key 
consuming  countries.  Its  goal  would  be  to  foster  general  knowledge  sharing  and  crisis 
preparedness,  with  a  focus  on  supply  diversification 
local 
manufacturing capacities.  

including 

through 

Support production capacity at global level 

More sustainable and more diverse production worldwide will benefit people around the 
world,  including  in  the  EU.  Under  the  Global  Gateway,  the  EU  is  supporting  local 
manufacturing  of  health  products.  Team  Europe  has  mobilized  EUR  1.1  billion  for  the 
flagship  initiative  on  manufacturing  and  access  to  vaccines,  medicines  and  health 
technologies  in  Africa.  This  allows  for  increased  and  equitable  access  to  high-quality 
health  products,  by  focusing  on  supporting  local  and  regional  demand  and  supply,  and 
also  contributes to  diversification and strengthening  of international  supply chains.  The 
Commission is setting up another Team European Initiative in Africa on health security, 
using  the  One  Health  Approach,  working  closely  with  African  partners  to  improve 
pandemic preparedness, prevention and response. An EU-Latin America and Caribbean 
Partnership on manufacturing and access to vaccines, medicines and health technologies 
and  strengthening  health  systems  has  also  been  set  up.  Supporting  more  diverse 
production is also one of the EU’s goals in the current negotiations to develop the global 
health architecture.   

Lastly,  the  EU  will  continue  to  support  the  provision  of  critical  medicines  in 
humanitarian  contexts,  through  the  UCPM  and  the  European  Humanitarian  Response 
Capacity and working closely with its humanitarian partners on the ground.  

Action to support availability on the global level 

The EU should:  

•  Establish a network of international partners and companies to boost the exchange of 

information on supply issues;  

•  Develop  further Team  Europe initiatives to  support production capacity  and access 
in  low-  and  middle-income  countries,  and  reinforce  cooperation  on  prevention  and 
preparedness; 

•  Conclude  strategic  partnerships  with  third  countries  for  production  of  critical 

medicines, reflecting both local demand and needs at the EU and global level. 

5.  CONCLUSION 

Availability of medicines in the EU is at the core of the strong European Health Union. 
Securing  supply  of  critical  medicines  is  part  and  parcel  of  building  up  a  resilient  and 
sustainable basis for the future that saves lives and brings benefits beyond the EU. 

Building a sustainable single market for medicines in the interests of all patients entails 
supporting a strong and competitive pharmaceutical sector.  

17 

 
The  experience  of  the  COVID-19  pandemic  showed  what  is  possible  with  collective 
unity of purpose: EU action can make an important difference in ensuring the availability 
of critical medicines and softening the impact of critical shortages when they occur. This 
requires  solidarity  and  a  high  degree  of  coordination,  with  the  Commission,  EMA, 
national  governments  and  regulators,  and  also  with  industry,  patients  and  healthcare 
professionals. It also requires a whole of government approach at national and European 
level,  and  a  deep  engagement  with  the  international  community.  This  Communication 
shows that further action can be taken to prevent shortages this winter and beyond, but 
also to ensure the long-term supply of critical medicines in the EU. Reinforcing security 
of supply of critical medicines means acting at every stage, from essential inputs to the 
finished medicine. 

A Critical Medicines Alliance is the opportunity to develop coordinated action at the EU 
level on shortages of medicines through the range of tools available at EU and national 
level. It would be a direct policy response to the need to enhance security of supply and it 
could pave the way for a possible future Critical Medicines Act. 

18