Open Medicine EU

Well, it’s been a long time since my last post but I have not been neglecting the subject of science and medicine. I have been following the progress of the European Commission’s proposed regulation to revise the Clinical Trials Directive, and have just published an article on the subject in Euractiv, which you can find here.

The European Parliament was to begin to debate the proposal on 24th April in the Committee on the Environment, Public Health and Food Safety, with the Committee vote scheduled for 29th May.

The Rapporteur, Glenis Wilmott, a British Labour MEP and part of the S&D Group, has prepared a Draft Report proposing some 74 amendments – not a lot for such a complex and important dossier. Other MEPS have proposed 657 amendments, which is a lot, making a total of 731.

You can find the proposal here, and all the amendments here – if you have the time to go through them. Being retired, I did have the time.

I focused on those amendments that will determine whether, how and when the results of clinical trial may be disclosed, and whether there will be more or less transparency about clinical trials in the future. My conclusions are too long for a blog but my good friends in Euractiv kindly agreed to publish my article on the subject.

In brief, I think the Commission’s proposal does aim for more transparency but probably would not achieve very much in that regard. The Rapporteur’s amendments would greatly increase transparency, by requiring in effect the publication of a Clinical Study Report within a year of the conclusion of each trial. Amendments from a few other MEPs would go even further but most of the amendments from other MEPs, especially those from the PPE and ALDE groups in the Parliament would actually reduce transparency, either in terms of substance or in terms of timing. You can read more about this in the article.

MEPs from across the political spectrum clearly felt that the Commission’s proposal did not give enough attention to ethics. Applications for clinical trias must be assessed by a “reporting” member state and, separately and in a more limited way, by each member state in which the trial will be conducted (the “Part II Assessment”). Many MEPs have proposed mandatory consultation with an ethics committee in the Part II assessment. I think the Commission might argue that member states are free to do this anyway, but I have not gone into this issue in any detail. Nor have I analysed the amendments regarding the reporting of adverse and unexpected events in clinical trials; this obviously is a vital issue and one that is the subject of many amendments. There are also some complex amendments regarding the definition of “low intervention” or as some would have it “low risk”- trials that could require a lower level of scrutiny in the application process.

When the Committee debates the proposal they will probably work from a set of consolidated amendments rather than go through every amendment from 1 to 731. The debate in Plenary is scheduled for the 10th June, but that will not the end of the story. The Parliament is a “co-legislator” and the final text of the regulaton will have to be agreed between the Parliament, 27 national governments (the Council) and the Commission – all the targets of many lobbyists.END

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