On Tuesday 12 May, European health ministers are due to meet again by videoconference to discuss the Covid-19 crisis and how it should determine the future strategy on medicines. In particular, they will be invited to comment on the relevance of a new dialogue platform intended to prevent medicine shortages.
Voluntary cooperation
The issue of medicine shortages has been discussed for a long time in the Council of the EU but no long-term solutions have been found so far. At best, a few voluntary cooperations have emerged, such as the Beneluxa, Valletta, V4 +, FINOSE and Nordic Pharmaceuticals Forum (NLF) projects (see EUROPE 11922/10).
However, the current pandemic, which has highlighted mainland Europe’s dependence on China and India and certain overstocking practices, is forcing ministers to rethink their approach. The demand for certain medicines has increased by more than 2000% during the crisis (see EUROPE 12460/17).
Currently, EU legislation (2001/83/EC) requires the industry to ensure a continuous supply of medicines marketed in the Member States. However, the notification of shortages and their management is mainly dealt with at national level by the competent national authorities. Cooperation to address shortages at EU level is voluntary and coordinated by the Heads of Medicines Agencies working group on the Availability of Authorised Medicines.
More permanent mechanisms?
In a discussion paper, the Croatian Presidency of the Council of the EU stresses that “the most efficient way to tackle shortages on the internal market would be to address their multiple root causes”. The paper suggests several courses of action such that “a certain level of regulatory flexibility may enable the reduction of the complexity and the cost of EU regulation”.
The document also refers to regulatory measures in the pharmaceutical field through, for example, earlier notification of shortages, transparency of quotas and wholesale transactions, or even stockpiling requirements for pharmacies. It also suggests the idea of creating market conditions that would reward security of supply.
During their exchange of views, which will take place behind closed doors, the ministers will be invited to discuss these different avenues and to comment in particular on the advisability of creating a permanent dialogue platform with the pharmaceutical industry (or building on existing mechanisms).
These ideas could feed into the EU Pharmaceutical Strategy initially planned for the end of the year. With the Covid-19 crisis, it seems that the Commission has revised its timetable, since it is already planning a discussion within the College of Commissioners on 29 July. (Original version in French by Sophie Petitjean)