The issue of open access to clinical trial data is getting more attention among EU decision makers – as shown by a lunch discussion in the European Parliament on 6th June. About fifty people attended, with many turned away for lack of room.
In a sometimes technical paper, Dr Wolf-Dieter Ludwig from the Drug Commission of the German Medical Association (DCGMA), argued that important health policy strategies were based on data that are … “held only by commercial organisations” and that “have not been subject to full external scrutiny and review. Open access to all relevant trial data is a necessity to make ethical decisions in healthcare.” Speaking from the perspective of clinicians he said bluntly that the German Medical Association simply does not have enough information to advise doctors and patients.
Peter Gotsche, whom I have mentioned before, argued that limits on access to trial data led to thousands of avoidable deaths, avoidable misery for millions of patients, unnecessary research and avoidable waste of taxpayers’ money.
Dr. Hans-Georg Eichler, Senior Medical Officer at the European Medicines Agency (EMA) and one of the authors of the article mentioned in my previous blog again supported the principle of open access but worried about the possibilities of misuse or abuse of data when published.
(It occurred to me that much data is already abused or misused by the fact of keeping it secret and closed to external scientific scrutiny.)
The draft proposal for the revision of the Clinical trials Directive should soon be published, according to Stefano Soro of the European Commission.
The event was a lunch discussion and was not part of the formal proceedings of the European Parliament. Anyway, for the benefit of my US reader(s), the Parliament cannot itself initiate legislation although it can amend proposals for legislation when they are made, including the proposed revision of the Clinical Trials Directive.
We don’t know what will be in the proposal when it is published but, sadly, I am not hopeful. I have seen little or no interest in the Commission in the issue of open access, or more generally in the quality of the scientific and evidence base for policy making on medicines. Indeed, at the recent Consumer Summit the Director General of DG Sanco said in effect that European legislation on medicines was very good and was not something that consumer organisations should work on – although she acknowledged that they were free to do so. My old organisation, BEUC ,will decide for itself as usual, but I hope her words will not have a dampening effect on patient groups and other organisations that receive a grant or subsidy from DG Sanco.
And, I look to the European Parliament for a more progressive view.Author : Jim Murray