Who and what will shape health policy in the coming years?

????????????????????????????????????????????????????????????????????????????????By this time next week, we may be starting to witness momentous change in the European Union: new people, a new policy direction, and a new paradigm in the way the institutions relate to each other. But where will these changes leave health policy?

The results of the broader policy discussions that affect the healthcare sector – and in particular the pharmacutical and medical devices industries – may take a while to become clear. The results of negotiations over the Transatlantic Trade and Investment Partnership (TTIP) and reform of the Troika could take several years to become clear, although we can begin to predict the impact the new European Commission and European Parliament will have on them.

In some cases, this could mean more battles ahead: for example, Martin Schulz – the Party of European Socialists‘ candidate for the Commission presidency –  has stated his commitment to TTIP, but many Socialists are reluctant to accept many key elements of the potential agreement, such as the investor-state dispute settlement, and this opposition could cause headaches for European businesses.

In more detailed healthcare policy terms, there is perhaps more clarity, and also a bit more certainty following the developments of the last five years.

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Achievements include the revision of two flagship pieces of legislation: the Tobacco Products Directive – with amendments secured in the face of heavy tobacco-industry lobbying – and the Clinical Trials Regulation, which aims to launch a new era of research and development in Europe, ending the confusion and incoherency of the previous Directive. The Commission and member states have also made substantial progress in implementing the Cross-Border Healthcare Directive, and we are seeing the development of a fully-fledged identity and set of rights for Europe’s patients.

So what lies ahead?

It has now been more than a decade since the pharmaceutical package – the key piece of legislation governing medicines – was agreed by the European institutions. It is very possible that elements of this package will be reviewed and amended during the course of the next five years. There are many elements of the current marketing authorisation and intellectual property rights regimes which are due an overhaul, and matters such as ‘off-label’ use of medicines and adaptive licensing need updating.

??????????????????????????????????????????????????????????????????????????????????????????????????????In personnel terms, the last five years have been eventful: John Dalli, a health commissioner who was seen by most MEPs as a relatively safe pair of hands, left his post in acrimonious circumstances following allegations and counter-allegations of tobacco industry manoeuvres. His replacement, Tonio Borg, received a fairly rough ride in his hearing, with his voting record in the Maltese Parliament and views on social issues coming under scrutiny. However, after overcoming that hurdle, Borg’s delivery of the Tobacco Products Directive and Clinical Trials Regulation has been deservedly praised.

Due to a change in government in Valetta, Borg will almost certainly leave this year (the Maltese government having already named former tourism minister Karmenu Vella as the country’s nominee to the Commission). The next health commissioner could come from among the ranks of former healthcare professionals and health ministers from smaller member states (such as Lithuania’s Vytenis Andriukaitis) or Neven Mimica, who is likely to return and who, as Commissioner for Consumer Protection, already knows DG Health and Consumers.

In the Parliament, many stalwarts – such as such as Peter Liese and Linda McAvan (pictured above right)– are due to return for another mandate. Both are among the potential contenders to chair the Committee on the Environment, Public Health and Food SafetyDagmar Roth-Behrendt, an MEP whose influence on health policy over the past few mandates is difficult to overstate, is standing down; other health ‘champions’, such as Antonyia Parvanova and Nessa Childers, may return after the elections but face a tough electoral battle.