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Time to reboot the EU’s health programme

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March13_2013_20712441_DrDrawingMolecule_PersonalizedMedBioP2718276218By European Alliance for Personalised Medicine Executive Director Denis Horgan

This week has seen the European Commission’s health strategy come in for considerable criticism in sections of the Brussels-based press, from stakeholders in the health arena, and even from the EC’s own staff.  Some have argued that, actually, there’s no real strategy at all and, even if there is, that it’s implementation currently leaves a great deal to be desired.

For example, some officials in the Commission's health unit have reportedly said that legislation is being held up by slow decision-making from the EU Executive’s Vice President in charge of Better Regulation Frans Timmermans.

The result has been a delay in publication of numerous reports related to health and consumer issues, they say.  Other officials have, of course, denied that this is the case but the grumbles continue to rumble. There are, of course, many challenges in terms of health today. These include issues posed by demography and Europe’s aging population, patients’ lifestyles, inequalities, the question of how to properly apply exciting new genetics-based science, plus the need for investment in R&D and to bring regulatory systems up to date.

While the Commission, Parliament and Council have combined in recent years to move legislation along while taking on board the views of various stakeholders – most notably patients – many big issues remain, not least within the Commission’s own infrastructure at the present time.

The European Medicines Agency currently has no boss, due to a recruitment error, while the same applies to the European Centre for Disease Control. Meanwhile, the Commission has had no director-general for health for six months, and the Innovative Medicines Initiative (IMI) can only point to an interim head. This is hardly a perfect environment in which this relatively new Commission can pursue an agenda.

On the upside, progress has been made in recent times in the vital areas of the Clinical Trials Directive, Data Protection Regulation, Big Data issues, Horizon 2020, IMI I and II (lack of a current chief notwithstanding) and the legislation on In Vitro Diagnostics.  And elsewhere, the Commission’s new Semester process could potentially aid health care systems if used wisely and in a forward-thinking manner.

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Against this backdrop, the Brussels-based European Alliance for Personalised Medicine (EAPM) believes that the true potential of new science, built around genetic profiling and individual DNA, needs to be fully realised and, among other things, cooperation among member states in areas such as Big Data, research, sharing of best-practice, education for healthcare professionals, tackling pricing issues when it comes to medicines, and more, needs to be stepped up dramatically for this to occur.

One problem, of course, is that individual countries’ health budgets are not an EU competence and member states closely guard their right to self-administration in this regard. This may help them, but EAPM maintains that this very often does not help the most important people – the patients. That’s a potential 500 million citizens in 28 member states. However, in a recent move regarding expensive orphan drugs that treat rare diseases, the Belgium and Netherlands health ministries have joined forces to negotiate prices with pharmaceutical companies, to try to exploit economies of scale. There is also a chance of a third smaller nation joining the scheme.

Most price deals for new medicines are struck between a company and a single member state, and it will be interesting to see how successful this new partnership is in negotiating terms that save money and, in the end, benefit patients.  As it happens, the Netherlands will take over the rotating presidency of the European Union on 1 January next year, and plans to focus on European cooperation on drug prices.  Another key element of the presidency, the Dutch have said, will be a drive to bring innovative medicines to the market faster — a shot in the arm for advocates of personalised medicine across its broad stakeholder base.

But what about right now? On a collective level, the European Union has consistently pledged to deliver “a high level of human health protection” and, yet, six months into the mandate of the new Commission, things have suddenly slowed down in many areas.

EAPM believes that initiatives such as that of the Netherlands and Belgium offer a good example of the type of co-operation necessary to improve the lives of our citizens and that, crucially, the Commission must do all in its power to facilitate and encourage the breaking down of silo mentalities in the health arena – within stakeholder groups and within member states themselves.  One way to start would be by setting out a clear, long-term health agenda and quickly appointing the right people to carry it through.

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