The Commission is today calling on Member States to ensure that Europeans have access to essential medicines during the coronavirus outbreak. The pandemic has highlighted significant challenges in ensuring the supply of the critical medicines needed and the impact such an outbreak can have on the supply chain of medicines in the EU. The Commission guidelines focus on the rational supply, allocation and use of vital medicines to treat coronavirus patients as well as medicines which may be at risk of shortage due to the pandemic. The proposed actions should allow for a more coordinated approach across the EU, preserving the integrity of the Single Market whilst protecting public health.
Commissioner Stella Kyriakides, in charge of Health and Food Safety, said: “This unprecedented health crisis is putting our health care systems under enormous strain – with stocks of essential medicines in many European hospitals at risk of running low. We cannot afford to have shortages of life-saving medicines at such a critical moment. Today, we are presenting concrete actions to Member States to proactively prevent shortages and ensure that our hospitals have the essential medicines needed to save lives. I call on the solidarity and responsibility of the EU pharmaceutical industry to increase the production of medicines needed to treat seriously ill coronavirus patients.”
The Commission guidelines on the optimal and rational use of medicines stress the need for national authorities to:
- Show solidarity through the lifting of export bans and restrictions, ensuring that essential medicines are available in hospitals and pharmacies and that national stockpiling is avoided. National authorities should also fight misinformation that could lead to unnecessary stockpiling due to panic buying.
- Ensure supply by increasing and reorganising production through the monitoring of stocks and production capacities, the coordination of joint efforts by industry and implementing demand support and procurement initiatives to encourage supply. Where Member States need to support industry increasing their manufacturing capacity through fiscal incentives and state aid and implement regulatory flexibility, the Commission stands ready to provide guidance and legal certainty.
- Promote the optimal use of medicines in hospitals, in particular by adapting existing hospital protocols or establishing new validated protocols to prevent the overuse of medicines, as well as providing the possibility to extend the expiry dates of medicines.
- Optimise sales in community pharmacies to avoid hoarding through the introduction of restrictions on sales for medicines at risk of shortages and temporarily considering the limitation of online sales of essential medicines.
Over the past weeks, the Commission, with the support of the European Medicines Agency (EMA), has been gathering data on current challenges with a view to monitor, assess and identify medicines at risk of shortages. This includes monitoring overall demand from Member States, as well as the impact of third country export bans.
The risk of shortages is due primarily to the increase in demand for medicines to treat coronavirus patients in hospitals. Stockpiling by citizens, an increased demand for experimental medicines for coronavirus, the introduction of protectionist measures within and outside the EU such as export bans and national stockpiling, as well as transportation barriers between countries, also play a role.
Additionally, Executive Vice-President Margrethe Vestager in charge of competition policy, is putting forward a temporary framework explaining when and how firms can obtain guidance or written comfort that cooperation to avoid shortages of essential scarce products and services is in line with competition rules.