The new Pharmaceutical Strategy of the European Commission features R&I, and related programmes among its most prominent areas for support.
On 25 November, the European Commission (EC) adopted a Pharmaceutical Strategy for Europe. The Strategy aims 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. Given the current COVID-19 crisis, the strategy should also allow Europe to cover its pharmaceutical needs with robust supply chains in a crisis-resilient manner.
The strategy builds on four main objectives: 1. Ensuring access to affordable medicines for patients, and addressing unmet medical needs, particularly in the area of cancer, rare diseases and antimicrobial resistance. 2. Supporting competitiveness, innovation and sustainability of the EU’s pharmaceutical industry and the development of high quality, safe, effective and greener medicines. 3. Enhancing crisis preparedness and response mechanisms, and addressing security of supply. 4. Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.
The implementation of the Pharmaceutical Strategy will last over the coming years and include legislative and non-legislative actions, among them the proposal for an EU Health Emergency Response Authority (HERA), which is on the EC’s agenda for the second half of 2021. The Pharmaceutical Strategy will cover the entire life cycle of a medicine, whereof research and innovation (R&I) are always the first steps. Therefore, support to R&I figures prominently in the tabled flagship actions, with a specific mention of Horizon Europe and the EU4Health programme. In the eyes of the EC, specific needs are R&I for new treatments, antibiotics and vaccines and the alignment of clinical trials to patient and health system requirements. R&I will also contribute to the digitalisation and new technologies’ goals of the strategy; they will enable cutting-edge new products and ways of manufacturing them as well as a general technological transformation including robust digital infrastructures and a European Health Data Space.
R&I stakeholders are welcoming the Pharmaceutical Strategy. The Guild published a statement supporting the Strategy’s acknowledgement of R&I, and the related programmes Horizon Europe and EU4Health. Specifically, the Guild appreciates planned actions to increase cooperation in scientific advice on clinical study design, an issue, which was already highlighted in a The Guild position paper in September 2020. With this respect, the Guild re-iterates their call for a dedicated framework to facilitate the pursuit of multinational clinical studies within the EU, backed by adequate funding. The Guild also believes that an EU Health Data Space as proposed in the Strategy will remove obstacles to scientific discoveries by enabling the sharing and re-use of health data.
European Health Ministers shared their views on the Pharmaceutical Strategy in a meeting on 2 December. The ministers expressed their support for the strategy, and agreed on its objectives to secure Europe’s supply to safe medicines and help the European pharmaceutical industry to remain an innovator and world leader. In the face of the crisis, ministers also believe that the strategy should help the EU prepare to face future health related challenges.