Member States were divided over joint procurement of medicines to meet potential shortages in the EU, during a discussion with the European Commission organised by the Swedish Presidency of the EU Council on Tuesday 14 March at the Health Ministers meeting.
The Czech Republic presented a series of proposals in a note supported by Cyprus, Greece, Hungary, Italy, Lithuania, Malta, the Netherlands and Portugal, seeking a strengthening of discussions between stakeholders and third countries, a discussion on the coordination of national regulatory frameworks and more transparency and information on supply chains.
Commissioner for Health Stella Kyriakides said that many shortages had been resolved at national level through measures to anticipate shortages, based on notifications from companies and through supply chain actors.
Stella Kyriakides highlighted the efforts made through the management and monitoring system coordinated by the European Medicines Agency (EMA) under its strengthened mandate. To address medical emergencies, the European Health Emergency Response and Preparedness Authority (HERA) will identify countermeasures and solutions to address weaknesses in the supply chain.
The Commissioner said that the revised pharmaceutical legislation, which will be communicated on 29 March, would offer solutions.
Emer Cooke, Executive Director of the EMA, spoke about the measures implemented by her Agency, such as the activation of the network of Single Points of Contact for the pharmaceutical industry (i-SPOC) or the encouragement to Member States to show regulatory flexibility.
Mrs Cooke presented measures adopted to facilitate imports of medicines into Europe in collaboration with producers outside the EU.
To avoid shortages next winter, the EMA is monitoring supply and demand levels of certain critical medicines in cooperation with HERA.
The Member States agreed that the risk of a shortage persists, but were divided on joint European procurement.
Germany opposed the use of such joint procurement procedures outside of crises. The Czech Republic sees these as “complex and time-consuming” mechanisms.
Austria stressed that the situation was different for small markets.
Belgium invited the Swedish Presidency and the European Commission to explore solutions for joint European action, including a solidarity mechanism in situations where a Member State is faced with a total shortage of a specific medicine. Belgium reassured Germany that such mechanisms would remain limited to emergency situations.
France has declared itself in favour of joint procurement at European level, if it is done on a voluntary basis.
Medicines shortages will be on the agenda of the informal meeting of Health Ministers on 4-5 May.
Link to the Czech Republic’s note: https://aeur.eu/f/5rw (Original version in French by Émilie Vanderhulst)