The European Commission has adopted a new Pharmaceutical Strategy for Europe [1], as of 25 November 2020.
This pharmaceutical strategy aims to ensure affordable, accessible, innovative and safe medicines are available to all. In addition, it hopes to support the European Union’s (EU) pharmaceutical industry by fostering competitiveness, innovative capacity and sustainability. The strategy was also developed to be future-proof and crisis-resilient and will lead to the creation of a strengthened European Health Union with robust supply chains. It draws on lessons learnt from the COVID-19 pandemic to help ensure the pharmaceutical sector has security of supply and is prepared for future health crises.
The EU strategy places emphasis on improving access to generic, biosimilar and value-added medicines. Here, there will be support for targeted policies to stimulate generics and biosimilars competition. This will involve more strict application of EU antitrust rules to prevent companies that hold drug patents from hindering entry or expansion of generics or biosimilars competitors.
The EU will take certain pharmaceutical industry related actions in 2022 and among those possible, it is proposed that the EU may remove barriers that delay generics market entry. In addition, it will increase their uptake by health systems and create clearer provisions to conduct clinical trials on patented products to aid generics marketing authorization applications. By this time, it is also thought that there will be a review of the incentives and obligations of pharmaceutical companies to facilitate wider drug distribution and competition. This could also require companies to make their patented drugs available in all EU Member States, including those that are small and of less economic interest to companies.
Overall, to facilitate access to generics and biosimilars the strategy needs to:
- Ensure that off-patent medicines are always available and causes of medicine shortages are identified and eliminated
- Ensure access to generic, biosimilar and value-added medicines for all patients, by removing barriers to off-patent medicines
- Modernize through digitalization of medicine regulatory systems to speed up processes and provide improved information on products and their supply, that is harmonized across Europe
- Support resilient manufacturing and industrial policy that increases competitiveness, creates jobs and improves supply resilience.
The strategy also highlights the reality of unmet medical needs in Europe and hopes to stimulate innovation and development in these areas. These include medicines for neurodegenerative conditions and certain rare diseases and cancers. There are also some drug shortages, such as certain antibiotics, and drugs for children and for rare diseases. Such shortages were exacerbated during the first wave of the COVID-19 pandemic due to export bans and trade restrictions and, in light of this, the strategy aims to develop Europe’s strategic autonomy.
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Reference
1. European Commission. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Pharmaceutical Strategy for Europe. {SWD(2020) 286 final} [homepage on the Internet]. [cited 2021 Jan 8]. Available from: https://ec.europa.eu/health/sites/health/files/human-use/docs/pharmastrategy_com2020-761_en.pdf
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