Medicinal products

A pharmaceutical strategy for Europe

"I want you to look at ways to help ensure Europe has the supply of affordable medicines to meet its needs. In doing so, you should support the European pharmaceutical industry to ensure that it remains an innovator and world leader.“ (Mission letter of Stella Kyriakides, European Commissioner for Health and Food Safety)

On 25 November 2020, the Commission adopted a “Pharmaceutical strategy for Europe”.

People across the EU expect to benefit from equal access to safe, state-of-the-art and affordable therapies. Medicines play an important role in this regard, as they offer therapeutic options for diagnosis, treatment and prevention of diseases. Europe’s pharmaceutical sector is a major contributor to the EU economy in terms of creation of highly skilled jobs and investment in innovation.

Digitalisation and innovation in the use of real world data open new possibilities in how medicines are developed and used. However, innovative therapies do not reach all patients across Europe quickly and patients might not have access to medicines they need due to shortages. The unprecedented coronavirus pandemic further demonstrated how important it is to have a crisis-resistant system and ensure availability of medicines under all circumstances. At the same time, Europe’s population is ageing and faces a rising burden of diseases and emerging health threats such as COVID-19. Moreover, health systems and patients have difficulty bearing the cost of medicines. The EU is also becoming increasingly dependent on third countries for importing medicines and their active ingredients and issues such as Anti-Microbial Resistance and environmental sustainability of medicines is a concern.

The Pharmaceutical strategy for Europe aims to address these issues by creating a future proof regulatory framework and support industry in promoting research and technologies that actually reach patients and fulfil their therapeutic needs while addressing market failures. It will also take into account the weaknesses exposed by the coronavirus pandemic and factor-in appropriate actions to strengthen the system.

It will be based on 4 specific pillars, which include legislative and non-legislative action:

  • Ensuring access to affordable medicines for patients, and addressing unmet medical needs (e.g. in the areas of antimicrobial resistance, 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, diversified and secure supply chains, address medicines shortages;
  • Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.

This initiative is in line with the new Industrial Strategy for Europe and the priorities outlined in the European Green Deal, Europe’s Beating Cancer Plan, the European Digital Strategy.

Next steps

The Commission Communication on a Pharmaceutical Strategy for Europe includes a set of actions. Work in some areas, which are more mature, is already well under way, such as the revision of the legislation on rare diseases and children. The implementation of the strategy will span the mandate of this Commission and will notably see a proposal for revision of pharmaceutical legislation in 2022. 

More details on upcoming work and its progress will be published here in the coming weeks. 

Consultation activities in developing the Communication on the Pharmaceutical Strategy for Europe

Since the publication of the strategy Roadmap in June 2020, the Commission has conducted a series of consultations and meetings to inform the inception of the strategy. An online public consultation on the Pharmaceutical strategy for Europe closed on 15 September 2020.

The Commission has taken account of the positions and priorities raised by stakeholders and the public and has been working closely with Member State authorities in the context of its consultative committees.

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