MEPs on the Committee on the Environment and Public Health call on the European Commission to make the medicines shortage one of the pillars of its future pharmaceutical strategy. This is what they are calling for in a non-legislative resolution adopted on Tuesday 14 July, which will be put to a plenary vote in September.
The text, prepared by Nathalie Colin-Oesterlé (EPP, France), invites the Commission and Member States to quickly take the necessary measures to ensure the security of supply of medical products, reduce the EU’s dependence on non-Member States and support local pharmaceutical manufacturing for medicines of major therapeutic interest.
It asks the Commission to publish the results of its study on the causes of shortages in the EU by the end of the year and to complement it with a study on the effects of medicine shortages on patient care, treatment and health.
“Public health has become a geostrategic weapon that can bring a continent to its knees”, the rapporteur said, stressing that the Covid-19 pandemic must make the EU more ambitious.
Ensuring minimum stocks
One of the report’s key proposals is to set up an emergency European reserve for strategically important and health-related medicines at high risk of shortage, to be distributed among the Member States under the supervision of a regulatory authority.
The text invites the Commission to develop European health strategies on the basis of a common basket of medicines for the treatment of cancer, infections, rare diseases and other therapeutic means particularly affected by shortages. It also invites the Commission to examine the possibility of harmonising price criteria to make these medicines affordable.
Member States should adopt shortage prevention and management plans requiring producers to identify medicinal products of major therapeutic interest. The Commission, for its part, should publish guidelines for framing national reserves so that they are proportionate.
Reducing Europe’s dependency
The draft resolution also seeks to reduce Europe’s dependence on the rest of the world in the production of medicines and active ingredients.
It suggests examining the possibility of setting up “one or more European non-profit pharmaceutical companies operating in the public interest” to manufacture health medicines and for strategic importance for health care.
It asks the Commission to draw up a map of European production sites in non-Member State and an evolving map, to be used as a reference, of existing and potential production sites in the EU.
In legislative terms, the text refers to the possibility of: - revising Directive 89/105/EC relating to the transparency of measures regulating the prices of medicinal products in order to better reflect investments and production costs; - reviewing Regulation 726/2004 establishing the European Medicines Agency in order to temporarily authorise the granting of compulsory licences in the event of a health crisis. (Original version in French by Sophie Petitjean)