EU seeks to empower EMA on cross-border health

Out-Law News | 23 Nov 2020 | 12:21 pm | 2 min. read

Plans to give the European Medicines Agency (EMA) new powers to enable it to lead a more effective EU-wide response to health crises have been published by EU policy makers.

The proposed reinforced mandate for the EMA is part of a package of measures outlined by the European Commission intended to improve crisis preparedness and create a more joined up approach to cross border health issues among member states.

The new powers envisaged for the EMA under the Commission's 'European Health Union' proposals would enable it to:

  • monitor the levels of critical medicines and medical devices and take action to mitigate shortages;
  • provide scientific advice on medicines which may have the potential to treat, prevent or diagnose the diseases causing those crises;
  • coordinate studies to monitor the effectiveness of vaccines;
  • coordinate clinical trials.

The European Parliament has overwhelmingly supported the proposals, voting in favour of them by 615 votes to 34, with 39 abstentions.

The Parliament stated that Covid-19 had exposed weaknesses in member states' health care and a more joined up approach was needed to provide better monitoring of medicines, make essential products more available and affordable and reduce dependence on third countries for the EU supply chain.

The Parliament will now seek negotiations with member states so that the programme can be implemented from the beginning of 2021.

However, health is a competence of national governments and, as a result, the Commission's proposals need the buy-in of member states – this is not guaranteed.

In a paper published ahead of the Commission's proposals the Netherlands, Romania and Sweden acknowledged that better joint working across member states is desirable in a crisis situation. However, they recommended that this integrated function resides in the Council of Ministers rather than the Commission.

The former executive director of the EMA, Guido Rasi, welcomed the Commission's plan to reinforce its mandate in his final remarks as head of the organisation. However, he called for the EMA to be backed with greater resources in order to deliver on its core business, as well as its extended brief. Rasi's comments reiterated those he made at the annual TOPRA Symposium earlier in the year, when he discussed the EMA regulatory science strategy to 2025. The purpose of this strategy is to integrate and underpin the implementation of the European Commission's pharma strategy and the European medicines regulatory network (EMRN) strategy. The five goals of the EMA regulatory science strategy align closely to those of the Commission's European Health Union proposal.

The European Health Union proposals were published ahead of the European Commission's expected new pharmaceutical strategy for Europe, which is anticipated on Tuesday 24 November. They also build on the commitments made by Commission president Ursula von der Leyen in her first State of the Union address in September. As part of this framework, the Commission aims to: 

  • Strengthen preparedness by preparing an EU health crisis and pandemic preparedness plan and recommendations which are intended for adoption at national levels;
  • Reinforce surveillance by developing an integrated surveillance system to monitor threats across the EU;
  • Improve data reporting by requiring member states to improve their reporting of health systems indicators such as the availability of hospital beds and the number of medically trained staff;
  • Enable the declaration of an EU emergency situation to trigger increased coordination and allow for the development, stockpiling and procurement of crisis relevant products.