Pharmaceutical Strategy for Europe: Reflections on Public Health-Driven Drug Development, Regulation, and Policies.

Never before has the central role of medicines and other health care interventions for society been so recognized. Europe’s pharmaceutical sector is a major contributor to the European Union’s economy. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), it contributes with more than €110 billion to the EU trade balance and employs almost 800,000 people across Europe. In 2019, it invested an estimated € 37,500 million in R&D in Europe (European Federation of Pharmaceutical Industries and Associations, 2020). However, despite these investments, the drug market is not without some low-value drugs and alleged innovations, resulting in an excess of public and private spending that could be reduced in favour of other health-related activities. A survey by the independent scientific journal Prescrire found that only 10% of the new authorisations in 2019 presented a notable therapeutic advance (Prescrire, 2020), a view shared by the German Institute for Quality and Efficiency in Health Care (IQWiG) (Wieseler et al., 2019). On 25 November 2020, in the midst of the COVID-19 pandemic, the European Commission adopted a new “Pharmaceutical strategy for Europe,” after intense rounds of consultation with stakeholders and the public between July and September 2020. This pharmaceutical strategy “aims to ensure the quality and safety of medicines, while boosting the sector’s global competitiveness” (European Commission, 2020a). It is a roadmap based on four specific pillars (Table 1), an inventory of actions. Some will make the legislative cut by the end of the current European Commission’s term. Unquestionably, this document offers an opportunity for thorough reflection on drug development, regulation, and policies. TABLE 1 Pillars of the pharmaceutical strategy and key proposals.