COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Reform of the pharmaceutical legislation and measures addressing antimicrobial resistance
Date: 2023-04-26
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: antimicrobial resistance, competitiveness, innovation, medicinal product, pharmaceutical legislation, pricing of medicines, right to health, security of supply, shortage, sustainable product

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 26.4.2023  COM(2023) 190 final  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Reform of the pharmaceutical legislation and measures addressing antimicrobial resistance   
 
 
1. 

Introduction 

For over 50 years, the EU pharmaceutical legislation has set the highest standards of quality, 
safety and efficacy for the authorisation of medicines while promoting the functioning of the 
industry.  However,  ongoing 
internal  market  and  a  competitive  pharmaceutical 
transformations together with the lessons learned from the COVID-19 pandemic and Russia’s 
brutal  invasion  of  Ukraine,  call  for  resolute  action  to  modernise  the  EU’s  pharmaceutical 
framework to make it more resilient, fair and competitive. 

Today medicines authorised in the EU are not reaching patients quickly enough and are not 
equally accessible for patients in all Member States. There are significant gaps in addressing 
unmet medical needs, rare diseases and the development of new antimicrobials to tackle the 
growing problem of antimicrobial resistance (AMR). Furthermore, high prices for innovative 
treatments are a challenge to ensuring timely and affordable access to medicines. Shortages 
of medicines are also a growing concern, which can have serious consequences for patients. 

To  remain  an  attractive  place  for  investment  and  a  world  leader  in  the  development  of 
medicines, the EU needs to adapt the regulatory system to developments such as the digital 
transformation  and  new  technologies  to  administer  medicines  to  patients.  To  support  EU 
competitiveness,  it  is  necessary  to  reduce  administrative  burden  and  streamline  procedures. 
Addressing  the  environmental  impact  of  medicines  is  important  to  align  this  initiative  with 
the objectives of the Green Deal and green economy. 
In  November  2020,  the  Commission  put  forward  a  Pharmaceutical  Strategy  for  Europe1 
which aims to create a future-proof and patient-centred pharmaceutical environment in which 
the  EU  industry  can  innovate,  flourish,  and  continue  to  be  a  global  leader.  An  EU 
pharmaceutical ecosystem that is crisis-resilient and fit for today’s landscape and tomorrow’s 
challenges is one of the central pillars of a strong  European Health Union2 that delivers for 
citizens.  It  will  complement  other  key  initiatives,  including  the  reinforcement  of  the  EU 
health  security  framework  with  the  new  legislation  on  cross-border  threats  to  health  and 
stronger  mandates  for  EU  health  agencies,  the  establishment  of  the  Health  Emergency 
Preparedness and Response Authority (HERA) as well as Europe’s Beating Cancer Plan and 
the European Health Data Space. 

As  a  key  part  of  the  EU’s  comprehensive  response  to  these  challenges,  the  Commission  is 
proposing  an  ambitious  revision  of  the  EU  pharmaceutical  legislation  to  achieve  five  main 
objectives: 

1.  Make  sure  all  patients  across  the  EU  have  timely  and  equitable  access  to  safe, 

effective, and affordable medicines. 

2.  Enhance  security  of  supply  and  ensure  medicines  are  always  available  to  patients, 

regardless of where they live in the EU.  

3.  Offer  an  attractive,  innovation-  and  competitiveness  friendly  environment  for 

research, development, and production of medicines in Europe. 

4.  Make medicines more environmentally sustainable. 

5.  Address  antimicrobial  resistance  (AMR) 

through  a  One  Health  approach, 

encompassing human health, animal health and the environment. 

1 Communication from the Commission, Pharmaceutical Strategy for Europe (COM/2020/761 final). 
2 https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/promoting-our-european-way-
life/european-health-union_en 

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To  deliver  on  these  objectives,  the  Commission  is  proposing  to  reform  the  EU’s 
pharmaceutical legislation, including through a proposal for a new Directive and a proposal 
for a new Regulation, to modernise, simplify and replace the following existing legislation: 
Directive  2001/83/EC3  and  Regulation  (EC)  No  726/20044  (referred  to  as  the  ‘general 
pharmaceutical  legislation’),  Regulation  (EC)  No  1901/2006  on  medicines  for  children 
(‘Paediatric Regulation’)5, and Regulation (EC) No 141/2000 on medicines for rare diseases 
(‘Orphan  Regulation’)6. 
is  proposing  a  Council 
Recommendation on AMR to complement and strengthen the EU’s response. 

the  Commission 

In  addition, 

Reforming  the  pharmaceutical  legislation  is  an  opportunity  to  create  a  patient-centred, 
forward-looking, and sustainable framework that brings benefits for patients, our society and 
healthcare systems in Europe while ensuring the EU industry remains globally competitive. It 
will  require cooperation between different  stakeholders to  bring about  positive  change. The 
role  of  industry  will  be  fundamental,  both  for  meeting  patients’  needs  and  for  driving 
innovation and competitiveness, in an area where the EU must maintain its global leadership 
and  strengthen  its  resilience.  The  proposed  reform  draws  on  extensive  consultations  of  all 
relevant stakeholders7. 

This Communication provides an overview of the key elements in the proposed reform of the 
pharmaceutical legislation and the proposed Council Recommendation on AMR. 

2.  A reform to deliver better access and affordability of medicines for patients across 

the EU 

Promoting timely and equitable patient access to medicines 

A central objective of the reform is to ensure that all patients across the EU have timely and 
equitable  access  to  safe  and  effective  medicines8.  Today,  this  is  not  always  the  case, 
especially for innovative medicines, as patient access varies depending on the Member State 
in which patients live9. 

To reach patients, medicines require a marketing authorisation and must be launched on the 
market  by  the  company  that  holds  the  authorisation.  Most  innovative  medicines  receive  a 
central  marketing  authorisation  in  the  EU  which  allows  them  to  be  on  the  market  in  all 
Member  States  at  the  same  time.  However,  the  decision  to  launch  a  medicine  in  a  given 
Member State is a commercial decision by the company based on factors such as market size, 
promotion  and  distribution  networks,  and  national  pricing  and  reimbursement  policies. 

3 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community 
code relating to medicinal products for human use. 
4 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down 
Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and 
establishing a European Medicines Agency. 
5 Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on 
medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, 
Directive 2001/83/EC and Regulation (EC) No 726/2004. 
6 Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan 
medicinal products. 
7 Impact Assessment Report on the revision of the general pharmaceutical legislation, Annex 2: Stakeholder 
Consultation. 
8 In line with the Principle 16 of the European Pillar of Social Rights, (OJ C 428, 13.12.2017, p. 10). 
9 Impact Assessment Report on the revision of the general pharmaceutical legislation, chapter 2. 

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Consequently, smaller or less wealthy Member States often  face limited or delayed product 
entries on their markets10. 

The  proposed  reform  aims  to  facilitate  faster  patient  access  to  innovative  medicines  across 
the  EU.  The  measures  include  facilitating  timely  marketing  authorisations  (see  chapter  4), 
while ensuring a robust evaluation of the quality, safety and efficacy of medicines. Moreover, 
companies will be incentivised to launch their products in all EU Member States and develop 
products  that  address  unmet  medical  needs  (see  chapter  4  for  further  details  on  regulatory 
protection incentives and regulatory support). 

The  proposed  reform  will  also  facilitate  earlier  market  entry  of  generic  and  biosimilar 
medicines. For  new medicines that do not  benefit  from  the  proposed  conditional  regulatory 
protection  periods  (see  chapter  4),  market  entry  of  competing  generics  and  biosimilars  will 
occur  earlier  than  under  the  current  rules.  Moreover,  procedures  to  authorise  generics  and 
biosimilars will be simplified and thereby accelerated. 

Currently,  there  are  already  provisions  that  allow  developers  of  generics  and  biosimilars  to 
conduct  studies  for  future  marketing  authorisation  while  the  originator  product  is  still 
covered by patent/Supplementary Protection Certificate (SPC)11 protection (so-called ‘Bolar 
exemption’).  The  proposed  reform  will  broaden  these  provisions  and  make  them  more 
predictable  for  the  generics  and  biosimilars  industry,  by  harmonising  their  implementation 
EU  wide.  Concretely,  it  will  allow  to  conduct  studies  to  support  future  pricing  and 
reimbursement as well as the manufacture or purchase of patent-protected active substances 
for  the  purpose  of  seeking  marketing  authorisations  during  that  period,  contributing  to  the 
market entry of generics and biosimilars on day one of loss of the patent/SPC protection. For 
orphan  medicines,  the  reform  will  also  ensure  that  generics  and  biosimilars  can  enter  the 
market as soon as the market exclusivity12 period ends. 

Boosting cooperation and transparency to improve affordability of medicines 

Affordability  of  medicines  is  a  persisting  challenge  for  EU  healthcare  systems  and  patients 
that  have  to  pay  for  them.  For  reimbursed  medicines,  high  prices  can  put  the  financial 
sustainability  of  health  systems  at  risk.  For  medicines  that  are  not  fully  reimbursed,  high 
prices  can  have  an  important  impact  on  patients’  financial  situation  and  lead  to  direct 
negative health consequences for patients who cannot afford their medicine. 

To  make  medicines  more  affordable,  the  Pharmaceutical  Strategy  for  Europe  announced 
actions  to  support  cooperation  of  Member  States  on  pricing,  reimbursement  and  payment 
policies,  which  is  an  area  of  national  competence.  The  Commission  has  transformed  the 
group of National Competent Authorities on Pricing & Reimbursement and public healthcare 
payers (NCAPR) from an ad-hoc forum to a platform for continuous voluntary cooperation. 
The  Commission  is  committed  to  stepping  up  this  cooperation  and  further  supporting 
information  exchange  among  national  authorities,  including  on  public  procurement  of 
medicines, while fully respecting the competences of Member States in this area. 

Joint procurement of medicines can be a successful form of increased cooperation to improve 
affordability  as  well  as  access  to  medicines  and  security  of  supply.  This  has  been 
demonstrated  by  the  joint  procurement  of  COVID-19  therapeutics  and  monkeypox 

10 Impact Assessment Report on the revision of the general pharmaceutical legislation, chapter 2 and Annex 14. 
11 See chapter 4 for further details on intellectual property rights like patents and SPC. 
12 See chapter 4 for further details on regulatory protection incentives like market exclusivity. 

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vaccines13.  Member  States  interested  in  joint  procurement  of  medicines  can  make  use  of 
available  regulatory  tools  under  the  current  EU  rules,  such  as  the  Public  Procurement 
Directive14, the Joint Procurement Agreement15 and the Financial Regulation currently under 
revision16.  Upon  request  from  the  Member  States,  the  Commission  stands  ready  to  further 
support and facilitate access to medicines for European patients, in particular for medicines 
for rare and chronic diseases. 

The  proposed  reform  of  the  pharmaceutical  legislation  includes  a  number  of  measures  that 
will contribute to greater affordability. Measures to facilitate earlier market entry of generic 
and  biosimilar  medicines  will  increase  competition  between  medicines,  reduce  their  prices 
and promote affordability for patients and the sustainability of healthcare systems. Moreover, 
the  generation  of  comparative  clinical  data  will  be  incentivised  to  strengthen  further  the 
assessment  of  medicines  and  support  downstream  decision-making  on  pricing  and 
reimbursement.  In  addition,  improved  cooperation  between  authorities  responsible  for 
technology  assessment  (HTA)17,18  and  pricing  and 
marketing  authorisation,  health 
reimbursement will promote a more coherent approach on issues such as evidence generation 
along the medicine’s lifecycle (see chapter 4). 

Transparency  of  public  funding  could  also  contribute  to  a  reduction  in  medicine  prices. 
Today,  the  extent  of  public  financial  support  that  has  contributed  to  the  research  and 
development  of  a  given  medicine  is  unclear.  This  lack  of  transparency  regarding  the  risks 
borne  by  the  public,  as  opposed  to  the  investor,  creates  an  uneven  playing  field  during 
negotiations  between  industry  and  pricing  and  reimbursement  authorities.  In  response  to 
strong  calls  from  patient  organisations  and  other  stakeholders,  the  proposed  reform  will 
introduce  measures  towards  greater  transparency  around  public  funding  for  medicine 
development.  Under  the  proposed  reform,  pharmaceutical  companies  will  be  required  to 
publish  information  on  all  direct  financial  support  received  from  any  public  authority  or 
publicly funded body to support activities related to research and development of medicines. 
This  information  will  be  easily  accessible  to  the  public  on  a  dedicated  webpage  of  the 
company  and  through  the  database  of  medicinal  products  for  human  use  authorised  in  the 
Union. Such transparency, in turn, is expected to support Member States in their negotiations 
with pharmaceutical companies, ultimately making medicines more affordable. 

Supporting improved affordability of medicines  
  Facilitating  earlier  market  entry  of  generics  and  biosimilar  medicines,  to  increase 

competition and thereby reduce prices. 

  Incentivising  the  generation  of  comparative  clinical  data,  to  support  Member  States  in 

more timely and evidence-based decision-making on pricing & reimbursement. 

  Increasing  transparency  around  public  funding  for  medicine  development,  to  support 

Member States in their price negotiations with pharmaceutical companies. 

13 The Commission published a study on public procurement of medicines providing recommendations to 
optimise (joint) procurement. Available at https://data.europa.eu/doi/10.2925/044781. 
14 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. 
15 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious 
cross-border threats to health and repealing Decision No 1082/2013/EU. 
16 Proposal for a Regulation of the European Parliament and of the Council on the financial rules applicable to 
the general budget of the Union (recast) COM/2022/223 final. 
17 Health technology assessments evaluate the added value of new medicines compared to existing medicines. 
18 Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health 
technology assessment and amending Directive 2011/24/EU. 

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  Supporting,  through  non-legislative  action,  cooperation  between  the  national  competent 
authorities  on  pricing  and  reimbursement,  through  exchange  of  information  and  best 
practices on national pricing and procurement policies. 

3.  Enhancing security of supply of medicines and addressing shortages 

Medicines shortages have become a growing public health concern for many EU countries19, 
but also globally. They represent potential serious risks to the health of patients in the EU and 
impact  on  the  right  of  patients  to  access  appropriate  medical  treatment.  Parliament 
resolutions20, Council conclusions21, Member States and relevant stakeholders have signalled 
a rise in shortages of medicines in recent years. 
The Structured Dialogue on security of supply of medicines22, as well as recent events such 
as the COVID-19 pandemic, Russian military aggression in Ukraine and high inflation rates, 
brought  to  the  fore  questions  regarding  the  security  of  supply  of  medicines  in  the  EU.  As 
noted  in  the  Commission  study  on  medicine  shortages,  the  root  causes  of  shortages  are 
multifactorial, with certain challenges identified along the entire pharmaceutical value chain, 
including in relation to manufacturing23. In particular, shortages of medicines can result from 
the  increased  complexity  and  specialisation  of  supply  chains,  the  lack  of  geographical 
diversification  when  sourcing  certain  key  ingredients  and  medicines,  and  perceived 
regulatory  complexity.  The  EU’s  dependency24  on  a  limited  number  of  third  countries  to 
produce  ingredients  and  medicines  is  growing,  constituting  potential  supply  chain 
vulnerabilities. 
While key elements set out in the associated Staff Working Document25 on Vulnerabilities of 
the  global  supply  chains  of  medicines  are  integrated  in  the  proposed  reform,  a  number  of 
additional  measures  have  also  been  initiated  or  planned  to  address  challenges  that  were 
identified  through  that  process.  As  noted  in  the  Staff  Working  Document,  the  Industrial 
Strategies26,27  already  provide  a  strong  base  for  action  to  improve  the  security  of  supply  of 
medicines.  Future  work  will  also  focus  on  the  promotion  of  green  innovation,  digital 
innovation  and  enhanced  cooperation  among  key  players  both  within  the  EU  and  globally. 
The Commission is also supporting Member States’ effort to pool their public resources via 
Important Projects of Common European Interest (IPCEI) in the area of health  to foster the 
development  of  innovative,  economically  and  environmentally  sustainable  technologies 
going beyond the current state of the art in the sector, and allowing to address market failures.  

19 See, for instance, European Parliament, Committee on the Environment, Public Health and Food Safety, 
Report of 22 July 2020, Shortage of medicines – how to address an emerging problem, 2020/2071(INI). 
20 For instance, European Parliament Resolution of 17 September 2020 on the shortages of medicines – how to 
address emerging problem (2020/2071(INI)), recital G. 
21 For instance, Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient 
EU (2021/C 269 I/02), recital 5. 
22 https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/structured-dialogue-security-
medicines-supply_en  
23 https://op.europa.eu/en/publication-detail/-/publication/1f8185d5-5325-11ec-91ac-01aa75ed71a1/language-
en/format-PDF/source-245338952  
24 In particular, China and India are becoming major producers of pharmaceutical inputs, constituting the centre 
of production in Asia. Not only is production regionally concentrated, but for many ingredients also limited to a 
few manufacturers in these countries.  
25 https://health.ec.europa.eu/system/files/2022-10/mp_vulnerabilities_global-supply_swd_en.pdf  
26 Communication from the Commission. A New Industrial Strategy for Europe. COM(2020) 102 final. 
27 Communication from the Commission. Updating the 2020 New Industrial Strategy: Building a stronger Single 
Market for Europe’s recovery. COM(2021) 350 final. 

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As  part  of  the  building  blocks  of  the  European  Health  Union  and  addressing  some  of  the 
weaknesses  exposed  during  the  COVID-19  pandemic,  the  mandate  of  the  European 
Medicines Agency (EMA) was extended28 to allow for the coordination and management of 
specific  medicines  shortages  during  crises.  In  addition,  the  European  Health  Emergency 
Preparedness and Response Authority (HERA)29 was established to ensure the availability of 
medical  countermeasures  needed  for  public  health  emergencies  and  address  market 
challenges, through measures such as supply chain monitoring, stockpiling30 or procurement. 
As an element in relation to supply chains, the proposed Critical Raw Material Regulation31 
will secure the availability of certain materials relevant for the production of medicines. 

While efficient processes have been established within this framework, there is a clear need 
for  greater  EU-wide  coordination  and  appropriate  measures  to  safeguard  the  supply  and 
availability  of  medicines  for  EU  citizens  not  only  during  public  crisis  but  also  in  normal 
times. 

The reform proposes measures to address supply and availability challenges beyond those in 
EMA’s  extended  mandate  and  HERA’s  role,  which  are  limited  to  crisis  preparedness  and 
response.  It  will  address  systemic  shortages  and  improve  security  of  supply  of  critical 
medicines  at  all  times  by  introducing  stronger  obligations  on  supply,  earlier  notification  of 
shortages  and  withdrawals,  and  a  stronger  role  of  EMA  in  coordinating  actions  against 
shortages. In addition, under the proposed reform, medicines that are considered most critical 
for  EU  health  systems  will  be  identified  in  an  EU  list.  This  will  allow  for  an  analysis  of 
supply chain vulnerabilities of those medicines, followed by recommendations on measures 
to  be  taken  to  improve  security  of  supply  (e.g.  contingency  stocks  to  be  maintained)  by 
marketing  authorisation  holders,  Member  States,  or  other  entities.  In  this  context,  Member 
States will also have to report to EMA the measures that they have been taking to strengthen 
the supply of that medicine. 

This way, the EU can efficiently pre-empt supply challenges and ensure continuity of supply 
of those medicines to EU citizens. 

Addressing medicines shortages and supply chain challenges at all times 
  The proposed reform introduces requirements for continuous monitoring of shortages of 
medicines by competent authorities at national level and EMA. Obligations on marketing 
authorisation holders will be strengthened, including earlier and harmonised reporting of 
shortages of medicines and maintenance of shortage prevention plans. 

  EMA will be empowered with a strengthened coordination role, to monitor and manage 
critical  shortages  of  medicines  at  EU  level  at  all  times,  together  with  the  Executive 
Steering Group on Shortages and Safety of Medicinal Products. In this context, Member 
States will also have to report to EMA any foreseen or taken actions at the national level 
to mitigate or resolve the shortages of a given medicine. Transparency on shortages will 

28 https://eur-lex.europa.eu/legal-content/EN/TXT/?toc=OJ:L:2022:020:TOC&uri=uriserv:OJ.L_.2022.020.01. 
0001.01.ENG 
29 https://health.ec.europa.eu/system/files/2021-09/hera_2021_decision_en_0.pdf  
30 HERA has a budget of 1.2bn EUR to stockpile medical countermeasures under rescEU. Part of this budget 
will  be  used  to  stockpile  antibiotics,  while  taking  care  not  to  exacerbate  existing  shortages.  The  stockpiled 
antibiotics could be deployed to Member States in case of need through the Union Civil Protection Mechanism. 
31 Proposal for a Regulation of the European Parliament and of the Council establishing a framework for 
ensuring a secure and sustainable supply of critical raw materials and amending Regulations (EU) 
COM/2023/160 final 

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be achieved through the publication of information on shortages of medicines at national 
and EU level.  

  An EU-wide list of critical medicines will be established by the Commission and supply 

chain vulnerabilities will be assessed for those medicines. 

  For critical shortages, marketing authorisation holders of medicines will have to work to 
resolve  those  shortages,  taking  into  account  recommendations  and  report  the  results  of 
measures  taken.  Examples  of  such  recommendations  could  be  to  increase  or  reorganise 
manufacturing capacity or adjust distribution to improve supply. 

4. 

 A reform boosting innovation and EU competitiveness 

An effective incentives framework for innovation, access and addressing unmet medical 
needs 

The EU is after the US  the second largest  market  in  the world  for pharmaceuticals and the 
pharmaceutical  industry  in  the  EU  is  strong  and  competitive.  It  is  one  of  Europe’s  top 
performing high-technology sectors, directly employs 840 000 people and three times more 
indirectly in upstream and downstream employment. Europe (the EU, UK and Switzerland) is 
the second biggest R&D investor in pharmaceuticals with EUR 39.7 billion in 2020, trailing 
only US investments of EUR 63.5 billion32. In terms of manufacturing high-tech medicines, 
the  EU  is  a  clear  global  leader,  also  evidenced  by  the  EU’s  leading  role  in  supplying  the 
world with COVID-19 vaccines.  In 2021 the EU exported pharmaceuticals worth EUR  235 
billion, which is EUR 136 billion more than its imports33. The EU spends around 1.5% of its 
GDP on medicines, or EUR 230 billion in 2021, of which more than 80% goes to innovative 
products34. The EU pharmaceutical market accounts for 17% of the global market, making it 
the second most attractive market for industry, especially for innovators.  

The reform  of the pharmaceutical  legislation  aims to  maintain and reinforce the position of 
the EU pharmaceutical industry, both within the EU and globally. The regulatory framework 
will continue to support innovation and ensure that patients in the EU can benefit from state-
of-the-art  healthcare  and  medicines.  As  COVID-19  has  shown,  innovation  is  essential  to 
develop  new  and  better  therapies,  including  new  medicines  and  new  uses  for  existing 
medicines.  

Conducting research on medicines is a complex process, incurring significant costs and risks 
for  developers  (e.g.  related  to  the  cost  and  scientific  complexity  of  pre-clinical  and  clinical 
research). Moreover, there is international competition to attract pharmaceutical research and 
development  by  providing  not  only  a  future-proof  and  stable  legal  framework  but  also  a 
favourable  environment.  Issues  like  access  to  capital,  available  infrastructure  and  a  skilled 
and qualified labour force are key enablers for medicine development and driving innovation. 
The  revision  of  the  pharmaceutical  legislation  takes  account  of  the  EU  competitiveness 
dimension  both  from  a  regulatory  and  an  industrial  policy  perspective.  A  proper  balance  is 
established between the promotion of innovation, access to medicines and their affordability. 
The development of new medicines and the availability of medicines that our health systems 
need depend on a thriving pharmaceutical industry which is a key asset to the EU economy. 

32 The Pharmaceutical Industry in Figures, Key Data. EFPIA, 2022. 
33 Trade surplus in medicinal products records high. Eurostat, 2022. 
34 IQVIA MIDAS database 

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In  the  EU,  a  strong  system  of  intellectual  property  rights  (patents  and  Supplementary 
Protection  Certificates  (SPC)35)  is  complemented  by  regulatory  protection  incentives 
provided  by  the  pharmaceutical  legislation.  Both  intellectual  property  rights  and  regulatory 
protection incentives safeguard and foster innovation and compensate for the risks and costs 
that developers of innovative medicines incur. At the same time, this system also provides a 
clear framework for generics and biosimilars to enter the market once the relevant intellectual 
property rights and regulatory protection periods end. 

Medicines can be protected by patents and  SPC under national,  European and international 
legal frameworks, including the EU Regulation on  SPC36. This protection can last for more 
than  20  years  from  the  time  the  first  patent  is  filed,  usually  at  an  early  stage  of  medicine 
development.  In  addition, from the time of  marketing  authorisation,  the  EU  pharmaceutical 
legislation  provides  innovative  medicines  with  10  years  of  regulatory  protection,  which 
includes  8  years  of  regulatory  data  protection37  and  2  years  of  market  protection38.  This 
period can be extended up to 11 years if a new therapeutic indication is added after the initial 
marketing  authorisation.  In  the  case  of  medicines  for  rare  diseases  (orphan  medicines), 
innovative medicines  are granted 10  years of market  exclusivity39.  In addition  to  the above 
protections,  medicines  which  have  conducted  the  paediatric  development  plan  agreed  with 
EMA receive a six month extension of their SPC. 

Together,  intellectual  property  rights  and  regulatory  protection  create  a  strong  system  for 
innovation  in the EU which  is  very  competitive  compared to  that of other countries  around 
the world. 

However, current  investments in  developing  medicines do not  always prioritise the greatest 
unmet medical needs. This is particularly true for diseases that face scientific challenges (e.g. 
limited  understanding  of  the  disease,  limited  fundamental  research)  or  limited  commercial 
interest (e.g. rare diseases). As a result, there are serious diseases, such as certain cancers or 
neurodegenerative diseases, where satisfactory treatments are still lacking. In addition, there 
are  over  6 000  known  rare  diseases40,  with  95%  currently  having  no  treatment  option41. 
Concerning  medicines  for  children,  there  has  been  good  progress  in  areas  where  paediatric 
and adult needs overlap, as development is still steered by the needs of adults.  However, in 
cases where diseases are biologically different in adults and children, like paediatric cancers, 
mental and behavioural disorders or neonatal conditions, only a limited number of medicines 
has been developed. 

35 The supplementary protection certificate is an intellectual property right that serves as an extension to a patent 
right. 
36 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the 
supplementary protection certificate for medicinal products. 
37  Regulatory  data  protection  refers  to  the  period  after  the  initial  authorisation  of  a  medicine  during  which 
companies  wishing  to  develop  generic  or  biosimilar  versions  of  the  medicine  cannot  refer  to  the  results  of 
preclinical tests and clinical trials on the medicine included in the initial dossier. 
38 Market protection refers to a period during which generic and biosimilar marketing authorisation applications 
can already be filed and assessed and the respective marketing authorisations be granted. However, the generic 
or biosimilar product can only be placed on the market after the expiry of that period. 
39  Market  exclusivity  refers  to  a  period  after  marketing  authorisation  during  which  similar  medicines  for  the 
same indication cannot be placed on the market. 
40 https://www.orpha.net/consor/cgi-bin/Education_AboutRareDiseases.php?lng=EN  
41  Joint  evaluation  of  Regulation  (EC)  No  1901/2006  of  the  European  Parliament  and  of  the  Council  of  12 
December  2006  on  medicinal  products  for  paediatric  use  and  Regulation  (EC)  No  141/2000  of  the  European 
Parliament and of the Council of 16 December 1999 on orphan medicinal products SWD(2020) 163. 

8 

 
 
 
 
 
 
 
                                                           
Moreover,  even  when  innovative  medicines  have  been  developed  and  authorised,  not  all 
patients across the EU have access to them in a timely manner. 

The  proposed  reform  of  the  pharmaceutical  legislation  will  move  the  regulatory  protection 
system  from  ‘one  size  fits  all’  to  a  more  targeted  approach  that  promotes  patient  access  to 
affordable  medicines  across  EU  Member  States  and  addresses  unmet  medical  needs. 
Moreover,  innovation  in  areas  of  unmet  medical  needs  will  also  be  promoted  by  targeted 
EMA regulatory support (see strengthened PRIME scheme discussed in the next section). 

Under  the  proposed  reform,  innovative  medicines  will  benefit  from  a  standard  period  of 
regulatory protection, which is slightly shorter than today, but which can be extended if the 
product  delivers  on  certain  public  health  objectives  (see  box  below).  With  the  additional 
conditional  protection  periods,  the  maximum  period  of  regulatory  protection  that  can  be 
granted will be even higher than today: Under the proposed reform, the regulatory protection 
periods can add up to a maximum of 12 years for innovative medicines (if a new therapeutic 
indication is added after the initial marketing authorisation), while today the maximum is 11 
years.  For  orphan  medicines  that  address  a  high  unmet  medical  need,  regulatory  protection 
periods can add up to maximum of 13 years, while today the maximum is 10 years.  

The  EU  will  thus  continue  to  offer  one  of  the  most  attractive  regulatory  environments 
worldwide. Other countries offer from 6 years (Israel, China) to 8 years (Japan, Canada) of 
regulatory protection on average. 

More targeted incentives for innovation with a focus on patient access and unmet medical 
needs 
  Under the proposed reform, the minimum period of regulatory protection for innovative 
medicines will be 8 years, which includes 6 years of data protection and 2 years of market 
protection. Companies can benefit from additional periods of regulatory data protection if 
they launch the medicine in all Member States (+2 years) or if they develop a medicinal 
product  addressing  unmet  medical  needs  (+6  months)  or  conduct  comparative  clinical 
trials  (+6  months).  An  additional  year  of  data  protection  can  be  granted  for  a  new 
therapeutic indication. 

  These above new rules on regulatory protection will also apply to paediatric medicines. In 
addition,  medicines  which  have  conducted  the  paediatric  development  plan  agreed  with 
EMA will continue to receive an extension of 6 months of their SPC. Moreover, rules on 
paediatric  development  plans  will  be  adapted  to  further  stimulate  research  and 
development of medicines for diseases that affect only children. 

  Specific provisions will apply to orphan medicines, to boost research and development in 
rare diseases. The standard duration of market exclusivity for orphan medicines will be 9 
years.  Companies  can  benefit  from  additional  periods  of  market  exclusivity  if  they 
address a high unmet medical need (+1 year), launch the medicine in all Member States 
(+1  year),  or  develop  new  therapeutic  indications  for  an  already  authorised  orphan 
medicine (up to 2 extra years). 

  The  additional  regulatory  protection  for  market  launch  in  all  Member  States  will  be 
granted  if  the  medicine  is  continuously  supplied  in  sufficient  quantity  in  all  Member 
States within two  years  of marketing authorisation, or within  three  years for  companies 
with  limited  experience  in  the  EU  system  e.g.  small  and  medium-sized  enterprises 
(SMEs). If a Member State issues a waiver (e.g.  because it wishes for market launch to 
take place only at a later point in time), the additional regulatory protection will still be 
granted. 

9 

 
 
 
 
 
 
 
  New therapeutic uses of established medicines (repurposing) can benefit from a four year 
data  protection  period.  Furthermore,  non-profit  entities  will  be  able  to  submit  to  EMA 
evidence  supporting  new  therapeutic  indications  addressing  unmet  medical  needs  for 
already authorised medicines. 

It  is  important  to  note  that  the  proposed  reform  of  the  pharmaceutical  legislation  will  not 
affect  intellectual  property  (patent  and  SPC)  protection.  In  this  respect,  the  Commission  is 
presenting  in  parallel  a  reform  of  the  SPC  regulation,  which  will  create  a  centralised 
examination  procedure  for  the  granting  of  national  SPCs  and  a  unitary  SPC  for  medicines, 
without  changing  the  substance  of  the  applicable  rules  (e.g.  eligibility  conditions,  duration, 
etc.).  For  SPC  applicants,  the  proposed  reform  will  considerably  alleviate  the  costs  and 
administrative burden of the current SPC regime, which is currently implemented at a purely 
national  level.  By  improving  the  legal  certainty  and  transparency  of  the  SPC  regime,  this 
initiative  will  also  be  beneficial  for  generics  producers.  Importantly,  the  initiative  will  also 
ensure  that  innovative  pharmaceutical  industry  can  reap  the  benefits  of  the  unitary  patent 
through a corresponding unitary SPC. 

In  conclusion,  the  combination  of  patents/SPC  and  regulatory  protection  will  continue  to 
safeguard the EU’s competitive edge globally in pharmaceutical development, while steering 
research  and development  towards the  greatest  patient  needs  and  ensuring more timely  and 
equitable patient access to medicines across the EU. 

Rewarding innovation in areas of unmet medical need by boosting regulatory support 
for the development of promising medicines 

EMA  offers  scientific  support  to  medicine  developers  on  the  most  appropriate  way  to 
generate  robust  evidence  on  a  medicine's  benefits  and  risks  (e.g.  scientific  guidance  on  the 
design of clinical trials), with the aim to support the timely and sound development of high-
quality, effective and safe medicines for the benefit of patients. 

The  proposed  reform  will  further  strengthen  EMA’s  scientific  support,  particularly  for 
promising medicines under development for unmet medical needs, building on the experience 
gained with the priority medicines scheme (so called PRIME)42. Such priority medicines will 
receive  enhanced  scientific  and  regulatory  support  and  benefit  from  accelerated  assessment 
mechanisms.  This  strengthened  PRIME  scheme  will  boost  innovation  in  areas  of  unmet 
medical  needs,  allow  pharmaceutical  companies  to  speed  up  the  development  process  and 
promote earlier patient access. 

In  addition,  the  reform  will  make  it  easier  to  repurpose  off-patent  medicines  for  new 
therapeutic  uses,  with  a  dedicated  EMA  support  scheme  for  SMEs  and  not-for-profit 
developers. 

The  reform  will  also  expedite  the  assessment  of  promising  medicines  by  leveraging  the 
possibility  of  a  ‘rolling  review’  approach  that  reviews  data  in  phases  as  they  become 
available. This approach has proven effective during the COVID-19 pandemic and the reform 
seeks to extend it to promising medicines that offer an exceptional therapeutic advancement 
in areas of unmet medical needs. A temporary emergency marketing authorisation at EU level 
will be introduced for public health emergencies where there is a major interest in developing 
and authorising safe and effective medicines as quickly as possible. 

42 https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines  

10 

 
 
 
 
 
 
 
                                                           
Improving the regulatory system for Europe to remain an attractive place to invest and 
innovate 

An  efficient  and  agile  EU  regulatory  system  plays  a  crucial  role  in  supporting  the 
development  and timely  authorisation  of medicines and their availability  to  patients.  It  also 
creates a favourable environment for boosting the innovation capacity and competitiveness of 
the pharmaceutical industry. 

Currently, the scientific evaluation of medicines for an EU marketing authorisation involves 
significant  ‘clock-stops’  during  which  companies  prepare  responses  to  EMA  requests  for 
information  missing  from  the  initial  application.  The  proposed  strengthening  of  EMA’ 
scientific support to medicine developers, before the submission of applications for marketing 
authorisation, will improve the quality of initial applications, reduce delays caused by ‘clock-
stops’ and expedite evaluations for marketing authorisation. Incomplete applications will be 
invalidated  during  the  evaluation,  if  applicants  fail  to  provide  the  missing  data  within  set 
deadlines.  This  will  free  resources  and  optimise  the  evaluation  system.  Additionally,  the 
reform  proposes  to  reduce  the  scientific  assessment  time  from  210  days  today  to  180  days 
and the time for the Commission to authorise the medicine from 67 to 46 days. For medicines 
which are of major interest from the point of view of public health the assessment time will 
be 150  days. These  reduced timelines together with the above mentioned support measures 
will ensure that medicines reach patients faster. 

Moreover,  the  proposed  reform  will  improve  EMA’s  structure  and  governance,  by 
simplifying  the  structure  of  its  scientific  committees  and  by  increasing  its  expertise-based 
capacity.  It  will  avoid  duplication  of  work,  increasing  efficiency  and  reducing  evaluation 
times  of  medicines,  while  maintaining  the  high  standards  and  scientific  expertise. 
Additionally,  the  reform  includes  various  measures  to  simplify  regulatory  procedures  and 
foster  digitisation,  thereby  reducing  the  administrative  burden  for  medicine  developers  and 
competent authorities (see box below). 

Small and medium-sized enterprises (SMEs) and not-for-profit entities involved in medicine 
development  will  benefit  particularly  from  the  proposed  reform,  as  it  will  reduce  their 
regulatory burden. EMA will also offer targeted scientific and regulatory support, including 
fee reductions or waivers schemes, to SMEs and not-for-profit entities. 

Regulatory support and simplification measures to reduce regulatory burden 
  Strengthening the early regulatory support by EMA, particularly for promising medicines 

under development for unmet medical needs. 

  Introducing,  for  promising  medicines  that  offer  an  exceptional  therapeutic  advancement 
in  areas  of  unmet  medical  needs,  the  possibility  for  EMA  to  reviews  data  in  phases,  as 
they become available. 

  Setting up a temporary emergency marketing authorisation at EU level for public health 
emergencies  where  there  is  a  major  interest  in  developing  and  authorising  safe  and 
effective medicines as quickly as possible. 

  Optimising EMA’s structure (e.g. fewer scientific committees), with a focus on expertise 

and capacity-building within the network of competent authorities. 

  Simplifying  regulatory  procedures  (e.g.  abolishing  marketing  authorisation  renewal  in 
most  cases,  and  simplifying  requirements  for  authorising  generic  and  biosimilar 
medicines). 

  Reducing the assessment time by EMA from 210 days (in practice, on average 400 days) 
today to 180 days and the time for the Commission to authorise the medicine from 67 to 

11 

 
 
 
 
 
 
 
46  days.  In  addition,  products  addressing  unmet  medical  needs  and  bringing  major 
contributions to public health needs could benefit from an accelerated procedure and be 
assessed in 150 days.  

  Digitisation (e.g. electronic submission of applications, electronic product information). 

The  improved  EMA  structure  combined  with  the  strengthened  EMA  scientific  support, 
simplified procedures and digitisation will reduce the time needed to evaluate and authorise 
medicines.  This  will  contribute  to  improving  the  competitiveness  of  the  EU  regulatory 
system,  while  also  facilitating  timely  patient  access  to  innovative  medicines,  generics  and 
biosimilars. 

Moreover, a number of future-proofing measures  will ensure that the regulatory system can 
keep  pace  with  scientific  and  technological  progress,  and  create  an  enabling  regulatory 
environment  for  promising  new  therapies  and  breakthrough  innovation,  in  line  with  the 
Innovation  Principle43.  This  also  comprises  promoting  innovative  methods,  including  those 
aimed at reducing animal testing. The reform will enable for the first time the possibility for 
regulatory sandboxes in the field of medicines. They provide a structured testing environment 
in  which  innovative  methods  and  novel  medicinal  products  can  be  tried  out  under  the 
supervision of regulators. Regulatory sandboxes offer an opportunity to learn not just about 
innovation,  but  also  about  the  rules  and  regulations  underpinning  it  and  how  they  are  best 
applied  to  future  technologies.  The  learnings  from  those  sandboxes  can  be  over  time 
translated  into  adapted  regulatory  frameworks,  another  new  element  of  the  reform,  thereby 
creating  tailored  horizontal  rules  that  meet  the  required  regulatory  standards,  while  fully 
accommodating innovative elements. 

The secondary use of health data has the potential to enhance the efficiency and effectiveness 
of medicines development, reduce costs, and improve patient outcomes. For instance, health 
data  can  be  used  to  identify  unmet  medical  needs,  to  optimise  clinical  trial  design,  and  to 
support evidence generation for marketing authorisation. Additionally, real-world data can be 
used  to  monitor  the  safety  and  efficacy  of  medicines  post-authorisation  and  to  support 
continuous  learning  and  improvement  in  healthcare.  The  reform  of  the  pharmaceutical 
legislation together with the European Health Data Space will facilitate access to and use of 
health data, while protecting patient privacy. Opening the way for the secondary use of health 
data  for  regulatory  purposes  will  offer  a  unique  opportunity  for  innovation  and  boost  the 
competitiveness of the pharmaceutical industry in the EU. 

Future-proofing the regulatory framework 
  Facilitate  use  of  real-world  evidence,  and  of  health  data  for  regulatory  purposes,  while 

protecting patient privacy. 

  Improved clarity on the interplay between EU legislative frameworks for medicines and 

for other health technologies (e.g. medical devices, substances of human origin). 

  Regulatory  sandboxes  for  testing  new  regulatory  approaches  for  novel  technologies 

before formal regulation. 

  Adapted frameworks with specific regulatory requirements tailored to the characteristics 

of certain novel medicines. 

  Promote use of new methodologies to reduce animal testing. 

43 https://research-and-innovation.ec.europa.eu/law-and-regulations/ensuring-eu-legislation-supports-
innovation_en  

12 

 
 
 
 
 
 
 
                                                           
The  proposed  reform  will  promote  cooperation  among  the  various  public  authorities  in  the 
EU involved in different aspects of a medicine’s lifecycle. For example, EMA will coordinate 
a mechanism to facilitate exchange of information and knowledge on scientific and technical 
issues of common interest among authorities responsible for marketing authorisation, clinical 
trials, health technology assessment (HTA), and pricing and reimbursement of medicines in 
the EU. This will enable a more coherent approach to issues such as unmet medical needs and 
evidence  generation  along  the  medicine’s  lifecycle.  The  reform  will  also  facilitate 
cooperation between EMA and other EU agencies, such as those in the field of chemicals, in 
line with the ‘one substance, one assessment’ approach. 
The Pharmaceutical Committee44 will serve as a forum for discussing policy issues related to 
medicines, such as the application of the rules on the regulatory incentive for market launch, 
to  ensure  enhanced  dialogue,  close  interaction,  and  a  proactive  exchange  of  information 
between  the  Member  States  and  the  Commission.  Other  national  authorities  (e.g.  for  HTA, 
pricing and reimbursement) may be invited to participate in discussions of the Pharmaceutical 
Committee.  The  measures  for  cooperation  among  public  authorities  will  improve  policy 
coherence  and  create  a  more  predictable  and  consistent  environment  for  investors  and 
innovators in the EU. 

Overall,  these  reforms  represent  an  important  step  towards  a  more  efficient  and  effective 
regulatory  framework,  better  equipped  to  address  emerging  challenges  and  to  support  the 
competitiveness of the pharmaceutical sector and innovation that benefits patients in the EU. 

5.  Making medicines more environmentally sustainable 

To  achieve  the  environmental  sustainability  ambitions  of  the  Pharmaceutical  Strategy  and 
other  initiatives  in  the  European  Green  Deal45  (e.g.  the  EU  Action  Plan  ‘Towards  a  Zero 
Pollution for Air, Water and Soil’46), the pharmaceutical industry needs to curb the negative 
impact of its products and processes on the environment, biodiversity and human health. 

Scientific  evidence  shows  that  pharmaceuticals  are  present  in  the  environment  because  of 
manufacture, patient use, and improper disposal of unused or expired products47. The fact that 
antimicrobials  have  been  detected  in  wastewater  treatment,  manufacturing  effluent,  surface 
and ground waters is of particular concern, as their presence boosts antimicrobial resistance 
(see  chapter  6).  Pharmaceuticals  present  in  the  environment  are  affecting  not  only  the 
environment; if they  enter the water  cycle or the food  chain, they  also  affect human health 
directly. 

Such negative effects have been considered in the recently adopted Commission proposal for 
the  Urban  Waste  Water  Treatment  directive48,  which  includes  an  Extended  Producer 
Responsibility scheme that also applies to pharmaceuticals and in the Commission proposal 
for amending the water directives,49 which is addressing pharmaceuticals that are present in 
surface and groundwaters. 

44 Council Decision 75/320/EEC of 20 May 1975 setting up a pharmaceutical committee. 
45 Communication from the Commission. The European Green Deal. COM (2019) 640 final. 
46 Communication from the Commission. Pathway to a Healthy Planet for All EU Action Plan: 'Towards Zero 
Pollution for Air, Water and Soil' COM (2021) 400 final. 
47 OECD: Pharmaceutical Residues in Freshwater Hazards and Policy Responses, 2019. 
48 Proposal for a Directive of the European Parliament and of the Council concerning urban wastewater 
treatment (recast) COM (2022) 541 final. 
49 https://environment.ec.europa.eu/publications/proposal-amending-water-directives_en 

13 

 
 
 
 
 
 
 
                                                           
The proposed reform of the pharmaceutical legislation responds to a number of commitments 
in  the  Strategic  Approach  to  Pharmaceuticals  in  the  Environment50.  It  strengthens  the 
environmental risk assessment (ERA) of medicines to ensure a better evaluation and limit the 
potential  adverse  impacts  of  medicines  on  the  environment  and  public  health.  Today,  the 
ERA is mandatory for all pharmaceutical companies placing their medicines on EU markets 
and covers the use and disposal of medicines into the environment. Moreover, in the future, 
work on promoting EU environmental standards internationally will continue.51 

Strengthening the environmental risk assessment under the marketing authorisation 
  Enhancing  ERA  by  introducing  a  refusal  ground  for  the  marketing  authorisation  where 
companies do not provide adequate evidence for the evaluation of the environmental risks 
or  if  the  proposed  risk  mitigation  measures  are  not  sufficient  to  address  the  identified 
risks. 

  Setting  clearer  ERA  requirements,  including  compliance  with  scientific  guidelines, 

regular ERA updates, and post-authorisation obligation for additional ERA studies. 

  Extending the ERA scope to cover the risks to the environment from the manufacturing of 

antibiotics. 

  Extending  ERA  to  all  products  already  in  the  market  and  potentially  harmful  to  the 

environment. 

For  investigational  medicines  containing  or  consisting  of  genetically  modified  organisms 
(GMOs), the reform establishes one single EU ERA procedure for clinical trials. As a result, 
a single harmonised, EU-wide  assessment will replace Member State  assessments, meaning 
that sponsors of clinical trials will no longer have to submit multiple authorisation requests. 
Additionally, the ERA requirements for the assessment of medicines containing or consisting 
of GMOs for the purpose of authorisation will be based on the principles set out in Directive 
2001/18/EC52, but will be adapted to take into account the specificities of medicines. These 
changes  will  remove  significant  and  time-consuming  regulatory  hurdles,  facilitate  clinical 
trials  in  the  EU  and  optimise  evaluation  and  authorisation  of  innovative,  life-changing 
treatments. 

6.  Combating antimicrobial resistance 

Antimicrobials53  are  among  the  most  essential  medicines.  However,  over  the  years,  their 
overuse and misuse have led to an increase in antimicrobial resistance (AMR), meaning that 
they become ineffective, and infections are becoming increasingly difficult, if not impossible, 
to treat. AMR, the ‘silent pandemic’, is responsible for more than 35 000 deaths every year in 
the  European  Union54  and  leads  to  high  costs  for  healthcare  systems55.  AMR  is  considered 
one of the top three health threats in the EU56. 

50 Communication from the Commission. European Union Strategic Approach to Pharmaceuticals in the 
Environment. COM (2019) 128 final. 
51 For more information see Section 7 of the Staff Working Document on Vulnerabilities of the global supply 
chains of medicines, https://health.ec.europa.eu/system/files/2022-10/mp_vulnerabilities_global-
supply_swd_en.pdf. 
52 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate 
release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC 
(OJ L 106, 17.4.2001, p. 1). 
53 Antimicrobials include antibiotics, antivirals, antifungals and antiprotozoals. 
54 https://www.ecdc.europa.eu/sites/default/files/documents/Health-burden-infections-antibiotic-resistant-
bacteria.pdf  

14 

 
 
 
 
 
 
 
                                                           
To  address  increasing  AMR,  it  is  essential  to  ensure  both  access  to  existing  antimicrobials 
and  the  development  of  novel  effective  ones.  To  avoid  that  microorganisms  develop 
resistance against those antimicrobials, measures for their prudent use are also proposed. 

However, curbing the use of antimicrobials has an impact on sales volumes and on the return 
on  investment  for  marketing  authorisation  holders,  which  is  responsible  for  the  market 
failure. That is why incentives for developing innovative antimicrobials and securing access 
to antimicrobials are needed. 

Development of, access to, and prudent use of antimicrobials 

Incentives for development of and access to antimicrobials 
The EU needs  both  push incentives  (i.e.  funding  for antimicrobial  research  and innovation, 
primarily  via  research  grants  and  partnerships)  and  pull  incentives  (both  regulatory  and 
financial)  to  reward  successful  development  and  secure  access  to  effective  antimicrobials. 
The Commission is proposing the following pull incentives: 
  Temporary  mechanism  consisting  of  transferable  data  exclusivity  vouchers,  for  the 

development of novel antimicrobials to be granted and used under strict conditions. 

  Procurement  mechanisms  for  access  to  new  and  existing  antimicrobials  that  would 
guarantee revenue for antimicrobials marketing authorisation holders, regardless of sales 
volumes. 

The  EU  needs  to  find  smart  ways  to  enable  the  development  of  novel  antimicrobials  as  a 
matter  of  urgency.  This  is  why  the  reform  proposes  to  test  for  15  years  a  transferable  data 
exclusivity  voucher  scheme  for  novel  antimicrobials.  The  voucher  will  grant  an  additional 
year of regulatory data protection57 to the developer of the antimicrobial, which the developer 
can either use for one of its own products or sell to another marketing authorisation holder. 
The eligibility to the scheme will be restricted to game-changing antimicrobials that address 
antimicrobial resistance and the priority pathogens recognised by WHO. Strict conditions will 
govern the use of the voucher, so that the main reward goes to the developer of the innovative 
antimicrobial.  The  proposed  scheme  also  includes  conditions  for  the  supply  of  the 
antimicrobial to ensure its delivery when required. 

A  voucher  scheme  creates  an  attractive  business  case  for  the  development  of  innovative 
antimicrobials  for  which  the  current  research  pipeline  is  very  limited.  This  scheme  will 
ultimately  transfer  the  costs  of  the  vouchers  to  the  Member  States’  health  systems,  by 
delaying the market entry of generics of the products covered by the vouchers. To curtail the 
costs  for  the  health  systems,  the  reform  will  restrict  the  number  of  vouchers  reserved  for 
novel antimicrobials to maximum 10 vouchers that can be granted over a period of 15 years. 
Therefore,  the  vouchers,  if  applied  under  strict  conditions,  represent  a  credible  measure 
against AMR as their benefits and costs need to be weighed against the cost of inaction and 
the impact of AMR on public health and the economy. After the 15 years period, the voucher 
scheme will be evaluated. 

55 https://www.oecd.org/health/health-systems/AMR-Tackling-the-Burden-in-the-EU-OECD-ECDC-Briefing-
Note-2019.pdf , 2019. 
56  The  other  two  key  priority  threats  are  according  to  the  assessment  carried  out  by  Commission  services, 
together  with  the  Member  States,  pathogens  with  high  pandemic  potential  as  well  as  chemical,  biological, 
radiological and nuclear (CBRN) threats. 
57 The concept of regulatory data protection is explained in more detail in chapter 4 of this document. 

15 

 
 
 
 
 
 
 
                                                                                                                                                                                     
In  addition  to  the  voucher  scheme,  financial  pull  incentives  –  in  the  form  of  procurement 
mechanisms  –  could  be  brought  in.  A  Commission  study  on  bringing  AMR  medical 
countermeasures to the market58, assessed four major types of procurement mechanisms that 
may  help  increase  the  expected  revenue  for  developers:  revenue  guarantee,  market  entry 
rewards  combined  with  revenue  guarantee,  lump-sum  market  entry  rewards  and  milestone 
payments.  With  the  annual  revenue  guarantee  mechanism,  the  public  authorities  ‘top  up’ 
revenue for developers to reach the ‘guaranteed’ amount. If sales reach the threshold amount, 
no further ‘top up’ is awarded. Market-entry rewards consist of a series of financial payments 
to an antibiotic developer for successfully achieving regulatory approval for an antibiotic that 
meets  specific  pre-defined  criteria.  Milestone-Based  Reward  is  an  early-stage  financial 
reward  upon  achieving  certain  R&D  objectives  prior  market  approval  (e.g.  successful 
completion of phase I). While these mechanisms would serve primarily to provide access to 
existing antimicrobials, they could also support new antimicrobials in the development phase. 
The  initial  pre-feasibility  assessment  determined  that  all  options  may  be  implemented  as 
procurement transactions – notwithstanding some notable restrictions and considerations that 
require further in-depth investigation. Both EU and Member State contributions will probably 
be required. 

Global support for the development of antimicrobials is greatly needed. The EU will have to 
step up cooperation through existing fora, notably the G7, G20, the Transatlantic Task Force 
on  Antimicrobial  Resistance,  the  Quadripartite  (World  Health  Organization,  UN  Food  and 
Agriculture  Organization,  World  Organisation  for  Animal  Health  and  United  Nations 
Environment  Programme),  the AMR  Multi-Partner Trust Fund  and in  the negotiations on a 
potential  World  Health  Organization  international  agreement  on  pandemic  prevention, 
preparedness and response59 and with regional institutions such as the African Union. 

Measures for prudent use of antimicrobials  

  Through  the  reform  of  the  pharmaceutical  legislation,  measures  for  prudent  use  will 
become  part  of  the  marketing  authorisation  process,  covering  the  prescription  status, 
adequate pack size, specific patient/healthcare professional information, an antimicrobial 
stewardship  plan  including  risk  mitigation  measures,  and  monitoring  and  reporting  of 
resistance to the antimicrobial.  

  Through  the  proposal  for  a  Council  Recommendation,  additional  support  measures  will 
be  proposed,  including  recommended  targets  and  measures  to  promote  high  levels  of 
infection  prevention  and  control,  to  improve  awareness,  education  and  training  and  to 
foster cooperation between stakeholders from all relevant sectors. 

Recommended targets for antimicrobial consumption and resistance 

The  proposed  Council  recommendation  provides  for  concrete  measurable  targets  to  reduce 
antimicrobial consumption (AMC) and the spread of AMR in the human health. These targets 
were designed  with the support of the European Centre for Disease Prevention and Control 
taking  into  account  national  situations  and  the  different  levels  of  AMC  and  spread  of  key 
resistant  pathogens  across  the  Member  States.  They  allow  for  targeted  support  and  for 
monitoring the progress in the coming years. 

58  European  Commission,  European  Health  and  Digital  Executive  Agency,  Study  on  bringing  AMR  medical 
countermeasures  to 
:  final  report,  Publications  Office  of  the  European  Union,  2023, 
https://op.europa.eu/en/publication-detail/-/publication/51b2c82c-c21b-11ed-8912-01aa75ed71a1/language-en  
59 https://www.who.int/news-room/questions-and-answers/item/pandemic-prevention--preparedness-and-
response-accord  

the  market 

16 

 
 
 
 
 
 
 
                                                           
Other recommended measures to combat antimicrobial resistance 

The proposed Council Recommendation also aims to boost national One Health action plans 
on AMR, foster research and innovation, reinforce surveillance and monitoring of AMR and 
antimicrobial consumption, enhance global actions and incentivise the development of other 
AMR  medical  countermeasures  such  as  vaccines  and  rapid  diagnostics,  which  are  also 
pivotal. The proposed Council Recommendation will also contribute to a stronger framework 
to  fight  AMR,  combining  a  One  Health  approach  with  other  EU  policies,  the  Common 
Agricultural Policy60, the Farm to Fork Strategy61 , the Zero Pollution Action Plan62 aiming at 
reducing  by  50%  the  overall  EU  sales  of  antimicrobials  for  farmed  animals  and  in 
aquaculture  by  2030,  the  EU’s  Horizon  Europe  programme63  and  the  recent  Commission 
proposals leading to stricter environmental monitoring of AMR64. 

7.  Conclusion 

The proposed reform of the pharmaceutical legislation will pave the way for a stronger and 
more resilient European Union that better protects the health of its citizens.  It will promote 
timely  and  equal  access  to  a  continuous  supply  of  safe,  effective  and  affordable  medicines 
that  meet  the  medical  needs  of  patients  across  the  EU.  At  the  same  time,  it  will  stimulate 
further  innovation  and  support  the  pharmaceutical  industry’s  competitiveness.  And  it  will 
enhance the environmental sustainability of medicines throughout their lifecycle. 

In parallel, the proposed Council Recommendation on antimicrobial resistance, together with 
the  related  measures  proposed  under  the  reform  of  the  EU  pharmaceutical  legislation,  will 
complement  and  extend  actions  under  the  2017  EU  One  Health  Action  Plan  against  AMR. 
Together they will equip the EU with the tools it needs to combat this silent pandemic. 

As a result, the ambitious package of proposals that are part of the reform will bring lasting 
health,  social,  economic  and  environmental  benefits  to  EU  citizens.  It  will  support  the 
innovation capacity and competitiveness of the pharmaceutical sector in the EU. It will help 
address  global  challenges  like  AMR  and  environmental  sustainability,  while  strengthening 
the  EU’s  global  leadership  in  the  pharmaceutical  field,  complementing  the  EU’s  role  in 
global health and supporting the rollout of the EU Global Health Strategy. 

60 https://agriculture.ec.europa.eu/common-agricultural-policy/cap-overview/cap-glance_en  
61 Communication from the Commission to the European Parliament, the Council, the European Economic and 
Social  Committee  and  the  Committee  of  the  Regions  A  Farm  to  Fork  Strategy  for  a  fair,  healthy  and 
environmentally-friendly food system, COM/2020/381 final. 
62 Communication from the Commission to the European Parliament, the Council, the European Economic and 
Social  committee  and  the  Committee  of  the  Regions  Pathway  to  a  Healthy  Planet  for  All  EU  Action  Plan: 
'Towards Zero Pollution for Air, Water and Soil', COM/2021/400 final. 
63  Regulation  (EU)  2021/695  of  the  European  Parliament  and  of  the  Council  of  28  April  2021  establishing 
Horizon  Europe  –  the  Framework  Programme  for  Research  and  Innovation,  laying  down  its  rules  for 
participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 
170, 12.5.2021, p. 1). 
64  Commission  proposal  of  26  October  2022  for  a  Directive  of  the  European  Parliament  and  of  the  Council 
amending  Directive  2000/60/EC  establishing  a  framework  for  Community  action  in  the  field  of  water  policy, 
Directive  2006/118/EC  on  the  protection  of  groundwater  against  pollution  and  deterioration  and  Directive 
2008/105/EC on environmental quality standards in the field of water policy. COM(2022) 540 final 2022/0344 
(COD)  and  Commission  proposal  of  26  October  2022  for  a  Directive  concerning  urban  wastewater  treatment 
(recast) COM(2022) 541 final, 2022/0345 (COD). 

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