For affordable, accessible and safe medicines for all
The European Commission has adopted a Pharmaceutical Strategy for Europe to ensure patients have access to innovative and affordable medicines and to support the competitiveness, innovative capacity and sustainability of the EU's pharmaceutical industry.
The Strategy will allow Europe to cover its pharmaceutical needs, including in times of crisis, through robust supply chains. A key component of building a stronger European Health Union, as called for by Commission President von der Leyen in her State of the Union Speech, the Strategy will help to establish a future-proof and crisis-resilient EU pharmaceutical system.
Europe's Pharmaceutical Strategy has four main objectives:
- Ensuring access to affordable medicines for patients, and addressing unmet medical needs (e.g. in the areas of antimicrobial resistance, cancer, rare diseases);
- Supporting competitiveness, innovation and sustainability of the EU's pharmaceutical industry and the development of high quality, safe, effective and greener medicines
- Enhancing crisis preparedness and response mechanisms, and addressing security of supply;
- Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.
Although the Strategy is much more than a crisis-response instrument, it draws lessons from the initial response to the COVID-19 pandemic and makes Europe's pharmaceutical sector better prepared and more resilient.
The Strategy presents concrete actions to ensure accessibility, availability and affordability of medicines. It supports diversified and secure supply chains, ensuring the EU's open strategic autonomy in the world, and it promotes environmentally sustainable pharmaceuticals.
The Strategy will also ensure that the EU's pharmaceutical policy continues to serve public health in an ever-changing environment of scientific and commercial transformations. It will support patient-centred innovations and accommodate digital and technological change.
The Pharmaceutical Strategy for Europe marks the beginning of a process: its implementation includes an ambitious agenda of legislative and non-legislative actions which will be launched over the coming years.
Actions will cover the whole ecosystem of pharmaceuticals, but also some aspects of medical devices. It creates synergies with the Green Deal and our actions under the EU Strategic approach of pharmaceuticals in the environment to reduce their environmental risk, address pollution from pharmaceutical residues and promote greener manufacturing, use and disposal (a progress report is available). It is also linked to the action plan on Intellectual Property presented today.
The flagship actions of the Strategy include:
A revision of the basic pharmaceutical legislation (Directive 2001/83/EC and Regulation (EC) No 726/2004)
- (Target date for a proposal: 2022) with a view to making this framework future-proof and innovation friendly;
- A proposal for a EU Health Emergency Response Authority (proposal: 2nd semester 2021);
- A revision of the regulations on medicines for children and rare diseases
- Initiating a structured dialogue with and between all actors in the pharmaceutical manufacturing and public authorities to identify vulnerabilities in the global supply chain of critical medicines and shape policy options to strengthen the continuity and security of supply in the EU;
- Cooperation between national authorities on pricing, payment and procurement policies, to improve the affordability, cost-effectiveness of medicines and health system's sustainability;
- The creation of a robust digital infrastructure, including a proposal for a European Health Data Space (target date for a proposal: 2021);
- Support to research and innovation, notably via Horizon 2020 and EU4Health;
- Actions to promote innovative approaches to EU R&D and public procurement for antimicrobials and their alternatives and measures to restrict and optimise their use.
The Strategy will be discussed at political level at the EPSCO Council Meeting on 2 December 2020.
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