The Report on Clinical Trials agreed yesterday in the ENVI Committee would bring more transparency than before, but less than was originally proposed by the Rapporteur, Glenis Wilmott.
She had proposed the publication of a Clinical Study Report within one year of the completion or termination of a trial. The compromise agreed a two stage approach – the submission of an extended summary for every trial within one year of completion or termination and, for trials submitted with an application for a Medicines Authorisation, the publication of a Clinical Study Report within 30 days of the decision on the authorisation. This will not bring disclosure of all clinical trials, or timely disclosure of results in many cases, as I explained in my previous post, but it would be better than what we have now.
You can read the definition of the required summary here. It may have limited value in terms of science or prescribing. I would welcome comments on this point – or any other.
Access to the summary would also be subject to an exception for “protecting commercial confidentiality”. Unfortunately, an amendment seems to have slipped through from Anna Rosbach (DK, European Conservatives and Reformists Group) to extend this phrase to say “ protecting commercially confidential information, in particular through taking into account the authorization status of the product”. This would muddy the waters and reduce transparency.
However, another amendment would greatly improve access to Clinical Study Reports (after a decision on authorisation). It states in part “ in general the data included in clinical trial study reports should not be considered commercially confidential once a marketing authorisation has been granted or the decision-making process on an application for marketing authorisation has been completed”. This is very good, but support was not unanimous. Industry will no doubt fight very hard to try to keep it from the final text of the regulation, to be agreed between Commission, Council and Parliament.
If this amendment is in the final text, as I hope it will be, the two companies taking legal action against disclosure by the European Medicines Agency may be wasting their time, whatever the outcome of their cases.
Another amendment also takes the side of the EMA in this context in stating “The definition of what is considered as commercial confidential shall be in accordance with EMA guidelines and shall not be allowed to override the interest of public health research.” That precise wording will not make its way into the final text of the regulation but I hope the sentiment will. This amendment actually has very wide support in that it was proposed by the Industry Committee of the Parliament.
On other points, there was near universal agreement on the issue of ethics committees. There was majority support for complicated amendments dealing with definitions of clinical trials, and around such concepts as “low intervention”, “non-intervention” and “low risk” in relation to clinical studies and trials. The implications of these amendments will need careful study, and more knowledge than I have.
The next stages will include negotiations between Commission, Council and Parliament for a final text, and a vote in Plenary in the Parliament – possibly in October. It’s not over yet. END