The competent Working Party on Pharmaceutical and Medical Devices of the Council of the European Union discussed on Friday 28 May a draft EU Council conclusion on access to medicines and medical devices in the EU.
“The Covid-19 pandemic has highlighted, inter alia, the problems of access and availability, exacerbating the growing problem of shortages for medicines, especially off-patent medicinal products, and medical devices”, the text states in its introduction.
A recent report by the Pharmaceutical Group of the EU has indeed shown a worsening situation since 2019 (see EUROPE 12645/14).
The other European institutions, starting with the Commission (see EUROPE 12609/10), have also taken up the subject. In the European Parliament, the issue of access to medicines has been regularly highlighted by MEPs in recent weeks, in the context of discussions on the legislative package to better prevent future health crises (see EUROPE 12700/17, 12704/2).
Like many MEPs, the EU Council stresses in these draft conclusions, a copy of which EUROPE has obtained, the importance of acting as a 27-member body to deal with supply difficulties.
It describes the unprecedented European cooperation (joint negotiation and procurement) to ensure availability and access to Covid-19 vaccines as an “important output”.
The draft conclusions also show the support of the Member States for the proposed creation of a Steering Group on Shortages and Safety of Medicinal Products within the European Medicines Agency (EMA) (see EUROPE 12600/24). They advocate that this steering group should be set up on a permanent basis.
Procurement obligations
The Member States also “welcome” in the draft conclusions the European Commission’s willingness to “reinforce the obligation of supply by industry to mitigate the problems of shortages”.
Indeed, the Commission has indicated in its pharmaceutical strategy that it will consider, in 2022, a legislative initiative to impose stricter obligations on the industry to ensure the supply of medicines, earlier notification of shortages and withdrawals, and greater transparency of stocks throughout the supply chain.
Also on the industrial side, the draft conclusions highlight the “interdependence” between the EU’s pharmaceutical strategy and its industrial strategy (see EUROPE 12713/6). It calls for the diversification of suppliers of active ingredients, the diversification of supply lines, as well as the strengthening of manufacturing capacities for essential medicines within the EU.
The EU Council should also encourage the Commission to draw up a comprehensive inventory of potential and existing European manufacturing capacities.
Finally, it emphasises the importance of supporting innovation and addressing the issue of data collection to ensure and monitor the EU’s supply of medicines. (Original version in French by Agathe Cherki)