EC ROADMAP FOR A PHARMACEUTICAL STRATEGY

The strategy has the overall goal of ensuring Europe’s supply of safe and affordable medicines and supporting the European pharmaceutical industry’s innovation efforts.

European Commission roadmap

The strategy will cover all levels of the pharmaceutical value chain, from research and development, to authorisation and patients’ access to medicines. It will look at how to put scientific and technological advances into practice and how to fill market gaps. Lessons learned from the pandemic around preparedness and supply chains will also inform the strategy. The roadmap roadmap identifies several challenges:

• the major impact a rapidly changing global context can have on access to medicines in the EU, such as the EU’s growing dependency on imports of medicines and active pharmaceutical ingredients (APIs) produced outside the EU;
• unequal access to medicines that are not always affordable for patients and national health systems across the EU, such as innovative therapies, including cancer medicines;
• shortages of medicines, which often concern off-patent medicines (on which the patent has expired), such as antibiotics, cancer medicines and vaccines;
• innovation efforts that are not always aligned with public health and health systems’ needs, resulting in therapies or medical technologies not being developed because of limitations to the science, or lack of interest from industry to invest;
• challenges for the EU pharmaceuticals innovation ‘ecosystem’, meaning research done by smaller biotech companies is not always translated into commercially exploited innovation;
• technological and scientific developments that may challenge the regulatory framework and lead to unintended barriers to innovation, such as gene and personalised therapies, smart health applications and artificial intelligence;
• the need to improve the way environmental risks are addressed, such as those resulting from the production, use and disposal of medicines, and in particular, antimicrobial resistance (AMR).

Based on the above considerations, the Commission identifies four specific objectives for the strategy:

1. Make sure patients across Europe have new medicines and therapies in their countries quickly and under all circumstances, and that there are fewer shortages of medicines;
2. Help make medicines more affordable, and increase the ‘value for money’ of medical expenses;
3. Take advantage of digitalisation, and make sure innovation and emerging science and technology cater to patients’ therapeutic needs, while reducing the environmental footprint;
4. Reduce direct dependence on raw materials sourced from non-EU countries, influence other countries to harmonise international standards for the quality and safety of medicines, and help European pharmaceutical companies compete globally on an equal footing.

Stakeholder views and expectations

Stakeholders welcome the Commission’s roadmap, broadly agreeing with its goals.

1. The International Association of Health Mutuals (AIM) believes the strategy needs to guarantee that developments in evidence-generation, such as those coming from real-world data , or AI, deliver meaningful information to decision-makers.
2. The Association of the European Self-Care Industry (AESGP) believes the strategy needs to acknowledge the specificities of different pharmaceutical products and their regulatory pathways. It should seize on the benefits of improved availability of non-prescription medicines.
3. The European Federation of Pharmaceutical Industries and Associations (EFPIA) considers much can and should be done already now within the existing framework, through recognition and efficient implementation of the lessons learned from Covid‑19. Regarding access to vaccines and treatments, EFPIA calls on the Commission to create a High-Level Forum on Better Access to Health Innovation, as proposed by the European Health Coalition. Acknowledging the EU’s focus on enhancing its strategic autonomy in specific areas, EFPIA notes that Europe’s pharmaceutical industry already has a strong in-built resilience, with 76 % of the APIs used in the manufacture of innovative medicines in Europe now being sourced in the EU.
4. The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) sees a need for a strategy that enables research and attracts investments in Europe, alongside a solid regulatory framework that promotes science and development of new medicines.
5. According to the generic, biosimilar and value-added medicines lobby Medicines for Europe, the strategy should build on existing pharmaceutical manufacturing capacity and invest in a globally competitive medicines manufacturing sector. It should improve medicines’ availability, recognising that industry and governments have a shared responsibility to improve access to medicines.