The latest stage of Europe’s attempt to update its clinical trials rules offered a mildly distressing spectacle of the intrusion of politics into policy, writes Peter O’ Donnell.
It is inevitable, of course, that legislation should be colored by politics in any democracy, since legislators, being elected, are by nature political animals. But in an area as technical as clinical trials, a severe polarization of opinion along party lines can be seen as discordant with the objectives of achieving effective regulation.??
Right at the end of May, the health committee of the European Parliament agreed its position on the proposal that the European Commission made last year. In many respects, the committee’s position reflected some of the improvements that the Commission had urged — faster approvals, simpler procedures, some streamlining of decisions across the EU’s 27 member states (and 28, from next month, when Croatia becomes a member).
But in one area in particular — disclosure of trial data — the committee diverged. It introduced provisions that will require much earlier, much fuller, and much more public disclosure of trial data in an accessible database. All positive and negative results would have to be made available in summary form one year after the end of the trials or the inclusion of the last participant. Full clinical study reports would also have to be published once a decision on authorization is made. The sponsors will have 30 days to publish after the decision. Fines would be imposed on sponsors who do not comply with these requirements.
The choice may not be so remarkable against the background of ever-growing demands for transparency — and not just in the pharmaceutical sector. What is more remarkable is the attitude underlying
the amendments, and the tone in which it is occasionally expressed.
Green health spokesperson Margrete Auken stated, “There need to be clear and robust transparency requirements for the data generated in clinical trials. The people that participate do so to support the advancement of medical research – not for the sake of the generating corporate profits. It is no longer acceptable that pharmaceutical companies can withhold data from clinical trials on medicines for which they seek or already have obtained authorization. Clinical study reports should be made publicly accessible because nothing in them is commercially confidential.”
Portuguese far-left MEP Alda Sousa greeted the committee’s vote as “a clear and unanimous political defeat for the European Commission who wanted to facilitate flexibility and liberalize the practice of clinical trials in the European Union without effective ethical control or any regard for medical standards.”
And these are only the mildest of some of the accusations that have been levelled at the European Commission and the pharmaceutical industry over the months that this committee has been debating the proposal. Suggestions have frequently bordered on alleging that the Commission and the industry are engaged in some sort of conspiracy to delude and defraud patients and the public. At the same time, the industry — customarily more moderate in tone, at least in public — has resisted many of the attempts to ease access to data, arguing that both patient confidentiality and profit are at risk. In the middle of this debate, Abbvie has ignited still more passion by launching a legal action against parallel but separate plans by the European Medicines Agency for greater access to data.
The parliament committee’s vote is not the end of the debate. The next stage is for the parliament to negotiate with health ministers from the EU member states over the final form of the new rules. The stage is set for continued confrontation. The European Federation of Pharmaceutical Industries and Associations has already announced that it will pursue the battle against what it terms “the unbalanced approach adopted by the committee.”
And the European consumers association — one of the leading advocates for greater transparency — welcomed the way the committee vote had gone, “despite strong pressure from the pharma industry.” But it expressed anxiety over the final outcome in view of the upcoming discussions with member state ministers: “We are only halfway there,” said the consumers’ health spokesperson.
Differences of opinion over the shape of clinical trials rules are normal — even healthy — and are bound to flow from the different interests of distinct groups. But I cannot help but wonder how far it will be possible for the upcoming discussions, which will define the final shape of the new rules, to focus on effective policy if the atmosphere in which they are conducted is already so sharply politicized.
Peter O’ Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.