Clinical Trials Caught in the Fallout From Dalli-Gate


Applied Clinical Trials

The abrupt departure of Europe's health commissioner continues to resonate across the European Union - and to leave plans for new clinical trials legislation without a patron.

John Dalli, the former Maltese finance minister, was forced out of his job as Europe's health supremo in mid-October, over suggestions that he had got too close to companies hostile to his plans to tighten controls on tobacco.

The arguments over the legitimacy of his sacking are still raging across Brussels, in public disputes between the disappointed Dalli and the man who fired him, European Commission President Jose Manuel Barroso. The exchanges are doing nothing to clarify the situation, and everything to damage the authority and credibility of the entire European Commission.

But meanwhile the proposal that Dalli launched in July for a new clinical trials regime in Europe -  a proposal that has already run into rough water from critics over recent weeks - now risks finding itself becalmed.

The link between a commissioner and the legislation that he or she proposes is an important factor in the progress that any new EU rule makes through the complex machinery in Brussels. Not only does the commissioner have to achieve the right balance between opposing views in making the proposal, and win support from 26 fellow-commissioners before formally announcing it. It also falls to the commissioner to help maintain momentum on the proposal as discussions take place on its merits in the European Parliament and among national ministers in the EU Council. And when - as is usually the case - three-way compromises have to be reached between the initial proposal and the parliament and the council, the influence of the commissioner can be decisive.

Take away the commissioner, and much of that impetus is imperilled.

Supporters of the Dalli proposal on clinical trials - and there are many - are still optimistic that his departure will not torpedo the draft legislative text. "Hopefully there will no effect", said one senior industry figure, relying on the fact that all the staff that supported Dalli are still in post. But a well-placed source in a regulatory agency observed: "It will be interesting to see whether this slows down or alters the direction of travel for the clinical trials discussions".  And a leading figure in the European clinical trials community reported a sense of shock among members of the European Parliament preparing to debate the proposal. A seasoned observer of EU health legislation, and no admirer of the proposal, also lamented the hiatus: "Dalli’s version on clinical trials is bad, but it could be improved in Parliament – now everything is up in the air."

Not only up in the air. Perhaps dead in the water, too. Before real work can resume, a Maltese replacement has to be found for Dalli (each of the 27 EU member states has a commissioner). The country's deputy prime minister, Tonio Borg, is the nominated candidate - and he will undergo a hearing at the European Parliament in November to assess his suitability. Approval is an open question, and still weeks away. Given the lengthy and tortuous procedures for agreeing EU rules, any slowing down in the examination of the clinical trials proposal threatens its future. The remorseless timetable of European Parliament elections is now beginning to look uncomfortable: the current parliamentary session ends in 2014 - and any legislative initiative not completed well before then is likely to lose its validity.

So there is more at stake here for the clinical trials community than who did what in a spat over tobacco legislation.

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