9 April 2013
Joint open letter by 11 European or International Organisations
CLINICAL TRIALS REGULATION
PROTECT PUBLIC HEALTH: CHOOSE TRANSPARENCY!
Dear Member of the European Parliament,
As researchers, doctors, scientists, patients and civil society representatives we are asking you to support the inclusion of strong transparency provisions in the Clinical Trial Regulation that is currently being discussed.
In particular, we ask you to:
– support amendments that require the public disclosure of a complete clinical study report (CSR) as outlined by ENVI rapporteur MEP Glenis Willmott;
– reject amendments strengthening the protection of so-called “commercially confidential” or “commercially sensitive” information which would be a major step back and undermine the accountability of the European pharmaceutical regulation system.
Please find attached our joint letter (2 pages). http://a2knetwork.org/
The submission and subsequent disclosure of complete reports in the EU Portal would greatly help the advancement of biomedical research and lead to more rational and better healthcare.
The lack of complete information on the efficacy and safety of medicines causes significant harm to millions of citizens, stifles scientific progress and often leaves healthcare professionals in the dark concerning the medicines they choose to prescribe and dispense.
Recognising and enforcing transparency and access to information within the legal framework is an effective tool to promote both informed decision-making at the individual level and collective democratic participation.
We count on your commitment, as Members of the European Parliament, to carry this message forward and support transparency.
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The signatory organisations:
AGE Platform Europe
Association Internationale de la Mutualité (AIM)
Cochrane Collaboration European AIDS Treatment Group (EATG)
European Social Insurance Platform (ESIP)
Health Action International (HAI)
Europe International Society of Drug Bulletins (ISDB)
Medicines in Europe Forum (MiEF)
PLOS Medicine TransAtlantic Consumer Dialogue (TACD)
WEMOS