The reform of the EU’s pharmaceutical sector is a milestone of the European Health Union and a crucial step in our collective effort to pave the way towards a healthier, more resilient, and more equal Europe. It is an opportunity to make this crucial sector more agile, flexible, and adapted to the needs of the 21st century. It is the largest reform in over 20 years.
Access to medicine varies across Europe. Some Europeans have to wait for 4 months on average to find a given medicine in their nearest pharmacy, while others have to wait more than 2 years for the same medicine. There is also growing concern about possible shortages of medicines, such as antibiotics and painkillers.
The European Commission is therefore proposing to modernise the pharmaceutical sector with a patient-centred approach, that also fully supports an innovative and competitive industry. Its approach will preserve the EU's high standards for the authorisation of safe, effective, and quality medicines.
What will the pharmaceutical sector reform change?
- Single Marketcreating a Single Market for medicines
- Regulatory frameworkreducing the administrative burden for medicines to reach patients faster
- Medicines for allensuring better access to affordable medicines
- Medicine supplyaddressing shortages of medicines and ensuring security of supply
- Innovationpromoting innovation and competitiveness
- Environmentally friendlymaking medicines more environmentally sustainable
- Saving livestackling antimicrobial resistance (AMR)
- Transparencyinforming better about public funding used to develop medicines
Putting patients at the centre
All patients should have the same access to medicine in Europe. Medicine should reach patients when they need it, and all Member States should receive the medicine at the same time. This legislative proposal aims to give a better access to effective and affordable medicines to all.
In practice, this means making sure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines. To this end, new incentives encourage companies to make their medicines available to patients in all EU countries, while EU legislation on medicines for children and rare diseases will also be revised.
Putting patients first also means enhancing security of supply and ensuring medicines are always available to patients, regardless of where they live in the EU.
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
The EU aims to offer an attractive and innovation-friendly environment for research, development, and production of medicines in Europe. The EU will create this environment by promoting world-class innovation, governed by stable and consistent rules that keep pace with innovation and which increase competitiveness while reducing red tape and costs.
It will seek to ensure faster authorisation of innovative medicines by implementing simpler rules and procedures and through more patient involvement in the medicines assessment processes without compromising safety.
And in terms of research and development in unmet medical needs, innovation which benefits patients will be rewarded through a globally-competitive incentives system.
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
When you consider that, without action, the death toll from AMR could rise to as many as 10 million deaths globally per year by 2050, it is clear why tackling it is a key focus of the proposal. Between 2016 and 2020 the number of infections and deaths due to AMR in in the EU/EEA increased significantly. It causes 35,000 deaths every year in the EU and leads to high costs, including €1.5 billion annually for our healthcare systems.
The European Commission put forward a Council Recommendation on stepping up EU actions to combat AMR to provide solutions for human, animal, and environmental health. The Council adopted the proposed Recommendation on 13 June 2023.
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.