EC announces new Pharmaceutical Strategy for Europe

The European Commission (EC) has adopted a Pharmaceutical Strategy for Europe to ensure that patients have access to innovative and affordable medicines and to support the competitiveness, innovative capacity and sustainability of the EU’s pharmaceutical industry.

According to the agency, the strategy will allow Europe to cover its pharmaceutical needs, even in times of crisis, through robust supply chains and will be a key component of building a stronger European Health Union. One that is future-proof and crisis-resilient.

The strategy has four main objectives:

• Ensuring all patients have access to affordable medicines and addressing unmet medical needs, such as antimicrobial resistance, cancer and rare diseases;

• Supporting competition, innovation and sustainability within the EU’s pharmaceutical industry and, by connection, the development of high quality, safe, effective and more environmentally friendly medicines;

• Addressing security of supply and enhancing crisis preparedness and responsemechanisms; and

• Promoting a high level of quality, efficacy and safety standards.

The EC said that while the strategy is more than a crisis-response instrument, it draws lessons from the initial response to the COVID-19 pandemic to make Europe’s pharmaceutical sector better prepared and more resilient.

The plan also prevents concrete actions to ensure accessibility, availability and affordability of medicines, while also supporting diversified and secure supply chains and promoting environmentally sustainable pharmaceuticals.

The EC said the strategy will also support patient centred innovations and accommodate digital and technological change.

Stella Kyriakides, Commissioner for Health and Food Safety, commented: “Today we launch the work to ensure that safe and effective medicines are accessible and affordable at all times and to all patients across the EU. With our Pharmaceutical Strategy for Europe, we are delivering on our commitment 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. It is our long-term vision for open strategic autonomy, and our response to the challenges of today and the vulnerabilities exposed by COVID-19. Today we put in place another pillar of the European Health Union.”

The EC added that implementing this strategy over the next three years will include both legislative and non-legislative actions covering the whole ecosystem of pharmaceuticals and some aspects of medical devices.

Some of the key actions include:

• A revision of the basic pharmaceutical legislation to make the framework future-proof and innovation friendly;

• A revision of the regulations on medicines for children and rare diseases;

• Using dialogue to identify vulnerabilities in the global supply chain of critical medicines and shape policy on strengthening the continuity and security of EU supply;

• Cooperation between national authorities on pricing, payment and procurement policies, to improve the affordability and cost-effectiveness of medicines;

• Creating a robust digital infrastructure, including a proposal for a European Health Data Space; and

• Actions to promote innovative approaches to R&D and public procurement for antimicrobials (and their alternatives) as well as measures to restrict and optimise their use.