Criticism of EU law is often aimed at an amorphous “Brussels,” but in many cases member states are the problem—as with the proposal to revise the Clinical Trials Directive.
The proposal envisages a central EU portal and database of applications, assessments, safety reports, and other information about clinical trials. How comprehensive will that information be, and will it be public?
On trial results, the proposal would require summary results, in a designated format, to be posted to the database, normally within one year of conclusion or discontinuance of a trial.
The European Parliament, led by Glenis Willmott MEP in this case, would strengthen the provisions on safety reports and on trial results. For trials intended for an application for a medicines authorisation, the parliament wants the posting of Clinical Study Reports within thirty days after the granting or refusal of an authorisation, or a decision not to proceed with an application. The parliament also supports, and would strengthen, the requirement to post trial summaries within one year of conclusion or discontinuance.
The parliament’s amendments would bring the database somewhere close to the information that the All Trials campaign would like to see published and would be a big step forward, compared to now.
Unfortunately, the parliament’s proposal on Clinical Study Reports applies only to trials intended for use in an application for authorisation, and may therefore exclude many academic, comparative, or post-marketing trials. This may please academic researchers, but it is not good.
The parliament’s amendments need the agreement of the Council (the 28 member states) and the European Commission. The three institutions are now negotiating behind closed doors in the so called “Trilogue.” Here the parliament is facing problems with the member states and the commission—both of which tend to favour the industry view. Sadly, it is difficult to influence the decisions of 28 member states without the kind of resources at national and European level available to industry. I encourage all public interest groups to try to influence their own governments (health ministries) on this issue, now. All Trials are already doing so—please support them.
Moving from content to access, the database would be subject to the general EU rules on access to information, which include exceptions on grounds of personal privacy, commercial confidentiality, and in this case, law enforcement by enforcement authorities.
Protecting privacy is uncontentious as a principle, although practical issues can arise in its application. The critical question will be defining the scope of commercially confidential information. It cannot be merely what the industry says it is—it will be determined by general principles or criteria. For the EMA, the European Ombudsman laid down a set of principles to follow. The parliament has proposed in effect that these principles be incorporated into law and that Clinical Study Reports should not be regarded as commercially confidential.
We need a good revision of the Clinical Trials Directive, along the lines proposed by the European Parliament, with a clear definition of commercial confidentiality inspired by the public interest.
Competing interests: I declare that that I have read and understood the BMJ Group policy on declaration of interests and I have no relevant interests to declare.
Jim Murray is a former director of BEUC the European Consumers Organisation, having previously been the first director of the Office of Consumer Affairs and Fair Trade in Ireland. He writes here in a personal capacity. During his time with BEUC, he was a founder and one time president of the Transatlantic Consumer Dialogue. Currently he is a member of the European Commission’s High Level Group on Administrative Burdens, and president of the European Foundation for Financial Inclusion.
Correction: This blog was amended on 20 November. It previously said Glenys Willmot rather than Glenis Willmot.