Edging European Legislation Uphill From Vilnius

July 11, 2013
Peter O'Donnell
Peter O'Donnell

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

Applied Clinical Trials

The European Union's bid to update its clinical trials rules, "is particularly important for better competitiveness at global level, by encouraging research and innovation, maintaining a strong pharmaceutical industry and more clinical trials in Europe, and seeking better access to drugs for EU citizens."

The European Union's bid to update its clinical trials rules, "is particularly important for better competitiveness at global level, by encouraging research and innovation, maintaining a strong pharmaceutical industry and more clinical trials in Europe, and seeking better access to drugs for EU citizens."

That was the encouraging statement by Vytenis Povilas Andriukaitis, the Lithuanian minister of health, when he addressed the European Parliament's health committee on July 11. And why should the opinion of the Lithuanian minister of health, however estimable he may be personally, merit any significance? Lithuania is, after all, one of the smallest of the now 28 EU member states, after Croatia, another small country, joined the EU this month. The significance lies in the arcane arrangements of the EU itself. For the last six months of 2013, the rotating presidency of the EU is held by Lithuania. It is taking up the chair of many of the EU's meetings that was held by Ireland in the first half of this year, and will hand the chair on to Greece at the end of December. And the country that sits in this rapidly-rotating chair is able to influence a great deal of what gets onto the agenda of EU meetings, and how they are approached in discussion.

So Mr. Andiukatis has just chaired an informal meeting of EU health ministers in Vilnius, Lithuania's capital, right at the beginning of the Lithuanian presidency, and he will chair a formal health council in December.  And in between, Lithuanian diplomats and officials will chair the numerous meetings in Brussels that prepare for those ministerial-level discussions. What they choose to focus on, and how hard they work to secure compromises that reconcile conflicts of view, are critical elements in the amount of EU business that gets done, and of what is achieved.

The minister's assessment of the clinical trials proposal is enthusiastic but guarded. He went on to recognize, in his speech to the parliament, that "there are discussions ongoing on certain issues concerning the transparency requirements, the involvement of ethical committees in the process of authorization of clinical trials, and protection of vulnerable subjects." His view that a "rational well-balanced solution is needed to implement the very important goals" of the proposed rules is therefore more than a polite form of words.

He has set the Lithuanian presidency goals high. He aims to reach a "general approach" on the proposal - EU-speak for an agreement in principle. And if that is not possible, then he aims at least "to make significant progress on the proposal seeing that most member states and the European Parliament are interested in reaching common agreement on this very important issue".  He assured the members of the parliament committee "that we are ready to work hard together with you by continuing the work of our Irish colleagues and seeking maximum progress".  And he expressed the hope that the parliament as a whole also "does its job", by being ready to contemplate reaching agreement with member states before the parliament dissolves early next year for new elections.

It is a tight timetable. It is still feasible. But only just. Watch this space.

Related Content:

News | Blogs