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24 August 2016

Has the EU become obsolete in health policy?

Written by: Sofia Marcha, Consultant at Edelman

Brexit, Government Affairs, Health

When the European Commission President, Jean-Claude Juncker, and his College took office in 2014, many wondered whether a ‘streamlined’ approach focused on ‘better regulation’ would be sustainable in the long run.

Half way through the mandate, the legislative pipeline more or less dried out, especially on health topics. The institutions have been “busy” closing pending dossiers (e.g. medical devices), but there has been little to no new EU legislative initiatives on health.

So, does this mean that the EU has become obsolete in health policy?

The short answer is: no. Despite the lack of binding (or non-binding) legislation, the EU is more relevant than ever when it comes to driving access-relevant health policy.

The number of European Parliament (EP) questions, declarations, resolutions and other “political-stating” tools continue to flourish on traditional issues (such as diabetes, health security and infectious outbreaks, electronic health records) and newer ones (around healthcare systems’ ability to cope with the migration crisis). This reflects the continuous health advocacy and stakeholder presence.

Supporting healthcare systems’ sustainability by comparing performances and the development of the HTA concept have emerged as a top priority. As the launch of the Hepatitis C treatment came with what some called “exorbitant” prices, it exacerbated discussions on wider access to medicines in Europe, health advocates started and maintained the demand for policy action. The industry and governments alike have been repeatedly called upon to improve patient access to innovative treatments.

But isn’t healthcare delivery something Member States firmly claim sovereignty over and an area of competence that they will never give up on?

It seems not as the current EU Presidency trio (the Netherlands, Slovakia and Malta), have made access to innovative medicines a health priorities and adopted on 17 June, (non-binding) Council Conclusions on “Strengthening the balance in the pharmaceutical systems in the EU”. The document, agreed by 28 member states, calls for greater collaboration towards better access to medicines, by, among others, “exploring possible strategies on voluntary joint price negotiations”, “considering further investments at national and EU level in the development of innovative medicines for clearly defined unmet medical needs” and “exploring obstacles (…) and consider new solutions to address market failure, particularly in small markets”.

The Parliament, which is the only institution directly elected by the citizens of Europe, is also developing an own-initiative report on “EU options for improving access to medicines” under the leadership of Spanish socialist Soledad Cabezon Ruiz. What the document will include and call for, is yet to be seen and shaped. These examples serve to show how the EU is continuously on the move and, directly or indirectly, influencing healthcare at national level.

However, in the wake of a “British-less” Europe, while healthcare policy making will undoubtedly continue, processes and procedures are likely to be slowed down and/or overshadowed by the discussions on the Brexit impact – from the next sit of the European Medicines Agency to the overall future of the European Union.

Image: Fotos593 /

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