Zum Hauptinhalt
Reform of the EU pharmaceutical legislation

Affordable, accessible, and innovative medicines

What will the pharmaceutical sector reform change?

  1. Single Market
    creating a Single Market for medicines
  2. Regulatory framework
    reducing the administrative burden for medicines to reach patients faster
  3. Medicines for all
    ensuring better access to affordable medicines
  4. Medicine supply
    addressing shortages of medicines and ensuring security of supply
  5. Innovation
    promoting innovation and competitiveness
  6. Environmentally friendly
    making medicines more environmentally sustainable
  7. Saving lives
    tackling antimicrobial resistance (AMR)
  8. Transparency
    informing better about public funding used to develop medicines

Putting patients at the centre

How will I benefit from a patient-centred approach? 

  • Better access to effective and affordable medicines 
  • Reduced shortages and increased availability of medicines 
  • Earlier market entry of biosimilar medicines to reduce medicine prices
  • More medicines for children and rare diseases 
  • Increased representations of patients in the approval of medicines
  • Easier access to product information 
  • More environmentally sustainable medicines 

Reducing the risk of critical shortages during the winter and beyond

In October 2023, we took further steps to prevent and reduce critical shortages of medicines in the EU. Recent critical medicine shortages, including of certain antibiotics last winter, show that continued coordinated action is needed to address supply challenges and to make Europe’s medicine supply chains more resilient in the long run.

To better prepare for the winter of 2023/24, the Health Emergency Preparedness and Response Authority and the European Medicines Agency have already identified key antibiotics for which they anticipate the risk of critical shortages ahead of this and future winters.

Actions to address medicine shortages in the EU are structured around three pillars

  • immediate and short-term actions to mitigate critical shortages
  • structural measures to support long-term security of supply
  • international partnerships for supply

In the immediate, the Commission launched a European Voluntary Solidarity Mechanism for medicines on 24 October 2023. This allows a Member State to flag their needs for a given medicine to other Member States, that can respond by indicating the medicines available for redistribution. 

Further actions include

  • establish an EU list of critical medicines (by the end of 2023) to analyse where additional measures are needed in the supply chain of selected medicines 
  • set up a dedicated Joint Action in 2024 to enable Member States to use rule exemptions to allow medicines to reach patients
  • organise exchanges of best practices on pricing and reimbursement between Member States
  • issue EU guidance, by early 2024, on obtaining medicines to strengthen security of supply
  • launch EU joint purchasing of antibiotics and respiratory viruses for the winter of 2024/25

Supporting long-term security of supply

To encourage production of more diverse critical medicines, the Commission will set up a Critical Medicines Alliance in early 2024. This will allow national authorities, industry, civil society representatives, the Commission and EU agencies to coordinate action at EU level against the shortages of medicines and to address supply chain vulnerabilities. This could pave the way for a possible “Critical Medicines Act” in the future.

In the first half of 2024, the Commission and Member States will also develop a common strategic approach to medicines stockpiling to prevent shortages.

Beyond the EU, we will establish a network of international partners to address supply chain resilience. We will also set up strategic partnerships with non-EU countries for the production of critical medicines, reflecting both local demands and needs at the EU and global level.

Driving innovation for a competitive pharmaceutical industry

To establish this system, the Commission is proposing a directive that contains all the requirements for authorisation, monitoring, labelling and regulatory protection, placing on the market and other procedures for all medicines authorised at EU level and at national level and harmonises the authorisation rules in the EU.

How will a competitive pharmaceutical sector be achieved? 

  • Promoting world-class innovation 
  • Reducing administration and speeding up authorisation of innovative medicines 
  • Incentivising research and development 
  • Tackling antimicrobial resistance 

Tackling antimicrobial resistance

Antimicrobials are medicines used to prevent and treat infections in humans, animals and plants. Antimicrobial resistance (AMR) occurs when microbes stop responding to medicines designed to kill them, and is caused by overuse or misuse of antimicrobials such as antibiotics.

A silent pandemic

The proposal recommends:

1. Marketing authorisation and surveillance of antimicrobials

  • Marketing authorisation of antimicrobials to include prudent use measures
  • Additional surveillance and monitoring of the consumption of antimicrobials, better infection prevention and control; more awareness of the public, education and training of professionals.

2. Prudent use of antimicrobials

Only half of EU citizens are aware that antibiotics are ineffective against viruses. The overuse and misuse of antimicrobials such as antibiotics means AMR is increasing.

The Commission is advocating for a more prudent use of antimicrobials setting itself a target for reduced use of antibiotics and is recommending Member States set corresponding national targets:

  • - 20% in consumption of antibiotics in the EU by 2030
  • recommend national-level targets in addition

3. Ensuring the availability of antibiotics

Prudent use of antibiotics is essential to tackle AMR, but this also affects sales volumes and return on investment for medicine developers.

We therefore need to encourage the development of innovative antimicrobials and to ensure access to and availability of antimicrobials.

The Commission is proposing:

  • a transferable data exclusivity voucher giving developers of new antimicrobials an extra year of market protection, making it more attractive to develop innovative antimicrobials without direct financial contributions from Member States.
  • Procurement mechanisms to provide access to antimicrobials, including those under development.

4. Fighting AMR globally

AMR cannot be tackled by one sector, one country or one continent in isolation. This means:

  • Keeping AMR at the centre of the EU’s Global Health Strategy
  • Pushing for more global cooperation for example by addressing AMR in a potential WHO international agreement on pandemic prevention, preparedness and response.