If you live in an EU member state we need your help this week. Will you write to your country’s health minister to ask your Government to support the good progress towards clinical trial transparency in the draft Clinical Trial Regulation in debates in Europe next month.
Thanks to the letters you sent to MEPs last May some very good additions were made to the draft Regulation. These new parts of the law would mean that all clinical trials taking place in Europe would have to be registered and summary results published within a year of its ending. We need to make sure that these additions make it into the final law, and we don’t have much time as the next stage of the process starts in the first week of November.
The next stage is a series of ‘trilogue’ discussions between the European Parliament, Commission and Council. We understand that the European Council hasn’t decided its position yet. The Council is made up of representatives of all of the individual Governments of European countries so your Government’s position is very important. There’s no time to lose – please write to your health minister this week and urge them to support the good additions to the Clinical Trials Regulation.
What you need to do now
You’ll find a sample letter below including details of the specific parts of the Regulation that we need Governments to support. The amendments for the Clinical Trials Regulation that will be discussed can be found here.
Details of how to contact your health minister are on this page (if they are not already at the top of the translated letters). Please let us know if you get a reply from your health minister – we’re listing any received here.
So far we have translations in many languages (see the drop-down list below). If you can translate the letter into more European languages, please get in touch.
Sample letter to health minister
Subject: Will you support transparency in the EU Clinical Trials Regulation?
RE: Proposed European legislation on Clinical trials on medicinal products for human use 2012/0192(COD)
Dear Health Minister
I am writing to urge you and [YOUR COUNTRY]’s Government to support amendments to the European regulation on clinical trials that would mean more of the findings from clinical trials done in Europe will be available to researchers, doctors and pharmacists. Only around 50% of all clinical trials are published – this means that doctors and researchers do not know what was found in them, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated. All clinical trials should be registered and the results reported.
The specific amendments I am asking you to support are:
- Amendment 191 which would ensure that clinical trials are registered before they commence.
- Amendment 30 and amendment 250 which say that data in clinical trial reports should not be considered commercially confidential. These amendments would ensure that commercial considerations don’t override the interest in public health research.
- Amendment 193 and 253 which would ensure that if a detailed clinical study report is produced about a clinical trial, it should be made publicly available.