Approved in November 2020, the EU Pharma Strategy aims to build up more access to affordable medicines, boost competitiveness, innovation and sustainability of the pharmaceutical industry in the EU, rethink crisis preparedness and response, and draw up a stronger role for the EU in the pharmaceutical market.
One of the key initiatives under this strategy is the revision of the basic pharmaceutical legislation, initially foreseen for the end of 2022. Major changes are meant to be carried out with regard to access to affordable medicines, innovation, security of supply, scientific and technological developments and bureaucracy. However, a recent negative opinion by the Regulatory Scrutiny Board means that the Commission will have to re-write its impact assessment, potentially delaying the launch of the proposal.
EU legislators will have to decide if they want to rush through it to reach an agreement quickly once the proposal is presented or wait until the new Parliament is elected in mid-2024 to complete this process. This decision will have consequences on the outcome of this revision and most importantly on whether it will serve to improve the availability, accessibility, and affordability of medicines for EU citizens. Among the issues that need to be tackled is the lack of transparency, and the EU has recognised it can influence access for patients. So, how can transparency be improved?
To answer this question, we interviewed three experts:
- Tilly Metz, Member of the European Parliament
- Ellen ‘t Hoen, Director of Medicines Law & Policy
- Ella Wegen, Global health advocate at Wemos
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