“Opening up EU clinical trial data” lunch event in EP, Brussels, 13-11-12



Opening up EU clinical trial data

for safe and effective medicines

Doctors can have no idea about the true effects of the treatments they give. Does this drug really work, or have I been deprived of half to the data? No one can tell. Is this expensive drug really worth the money, or has the data simply been massaged? No one can tell. Will the drug kill patients? Is there evidence that it is dangerous? No one can tell. This is a bizarre situation to arise in medicine, a discipline in which everything is supposed to be based on evidence“.

Dr. Ben Goldacre in The Guardian, 25-9-2012

The European Parliament is presently considering the Clinical Trials Regulation (http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm#rlctd). This proposal is an opportunity to reinforce high ethical standards, comprehensive safety reporting systems and to promote open access to clinical studies reports and data – all of which can safeguard public health. Opening up access to medical research data is one way to promote ethical and efficient new medicines in the EU.  

At this event, academic, experts, policy makers, EU regulators and the European Commission will give their opinions on this subject which directly affects the health of all of us. 

Date: Tuesday, November the 13th

Time: 12h30 – 14h00

Room: Members’ Salon private dining- room, European Parliament, Brussels

Organized with support from

 Transatlantic Consumer Dialogue and

Health Action

 International Europe


12h40 – 12h45: Opening by MEP Margrete Auken

12h45 – 12h55: Dr. Ben Goldacre, medical doctor and psychiatrist, author of Bad Science and Bad Pharma:

How patients and the public are harmed when trial data is withheld

12h55 – 13h05: Prof. Dr. Peter Gøtzsche, medical doctor and Director of the Nordic Cochrane Centre:

Open access to all data is a moral obligation towards the patients”

13h05 – 13h15: Dr. Trudo Lemmens, Professor in the Faculties of Law and Medicine of the University of Toronto:

Clinical Trial transparency and human rights


13h15 – 13h20: Response by Mr. Stefano Soro, Head of Unit, Medicinal products – quality, safety and efficacy European Commission DG SANCO


13h20 – 13h25: Response by Mr. Fergal O’Regan, Adviser to the European Ombudsman

13h25 – 13h50: Open discussion with speakers and respondents

13.50 – 14.00: Conclusions by MEP Peter Liese

Please register by sending an email before November the 2nd to katrina@haieurope.org

Note – to get access badge to the European Parliament, please, include the following information:

full name, date of birth, nationality, type of ID (passport, ID, driving license) and ID number.

In case of any special food requirements, please, mention it in the registration mail.