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EU Clinical Trials Rules: One Step Closer But Not Yet a Done Deal


Pharmaceutical Executive

To believe the European Parliament, the battle to create new clinical trials rules for the European Union is over.

To believe the European Parliament, the battle to create new clinical trials rules for the European Union is over. Last week, the parliament’s health committee adopted the draft report prepared last year by one of its leading members.

“Clearer rules, better protection for patients,” trumpeted the parliament’s press machine after the vote. “Pharmaceutical companies and academic researchers will be obliged to upload the results of all their European clinical trials to a publicly accessible database,” it said.

The draft legislation was informally agreed just before the year-end with national ministers – the other half of the EU’s decision-making process. The approval by the health committee is certainly an important step. But despite the unqualified enthusiasm of the parliament’s press office, this is not yet a done deal.

The draft legislation is to replace the existing directive with what the parliament announcement calls “simpler, more uniform rules.” The parliament recites without hesitation the glib description of the measure as “designed to encourage research whilst protecting patients’ rights,” and goes on to repeat all the easy rhetoric that lay behind the initial proposal in 2012.

But it may be getting ahead of its own game. While it is true to say – as the parliament does – that “the new text makes specific provision for low-intervention trials,” the nature of that provision remains far from satisfactory to many of the clinical trials community in Europe. Similarly, the bald statement that the new agreement “clarifies the role of ethics committees in the authorization process, and details how to obtain informed consent from patients,” risks counting chickens before they are hatched.

In truth, the complexities of the role of ethics committees, particularly in Europe’s highly-variegated patchwork quilt of divergent national practices, are far from resolved by the terms outlined in the deal between parliament and national ministers. Nor is it yet time to claim, as the parliament is doing, that the new deal “will streamline the rules on clinical trials across Europe, facilitating cross-border cooperation to enable larger, more reliable, trials, as well as those on products for rare diseases.” In the best of all cases it might. But agreeing the small print – of which there is a great deal that has not yet been finalized – could yet undermine the agreement. As the parliament admits, it is still only an informal agreement with ministers. And even within the parliament, this is only an agreement by one parliamentary committee.

What has to happen next is for the entire parliament to debate the plans. A date has been set in early April for this possible dénouement. If the parliament meeting in plenary also gives its accord, that will be another step forward. But that is not yet guaranteed. And even if that happens without a hitch, agreement among national ministers still has to be formalized.

Meanwhile, mutterings are growing louder among the clinical trials community about apparent flaws and imprecisions in the draft deal that was struck before the winter break, and has now been endorsed by the health committee. In addition, the triumphalist tone of the key MEP, Glenis Willmott of the UK, is likely to inflame sentiment in parts of the industry. “For too long, unflattering studies on new medicines have gone undisclosed”, she proclaimed as the committee vote concluded. A familiar assertion, beloved of opponents of the drug industry. But many people following this debate have argued cogently that there are risks in this sort of simplification.

People who love familiar assertions might do well to remember another familiar assertion: “There is many a slip between cup and lip.”

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