Last update: August 31th 2010
December 01th 2011

Revised proposal for a Directive on...

Some improvements, but risks of DTCA (direct-to-consumer advertising) remain

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November 02th 2011

Pharmacovigilance in Europe. Signal detection...

Answer to the consultation on the "Concept paper on pharmacovigilance implementing measures"
read (292 KB)

October 21th 2011

Joint analysis

Revised proposals on "information" to patients: still an open door to advertising of prescription-only medicines by pharmaceutical companies
read (279 KB)

for members only

Press Release - EMEA & other regulatory issues

April 30th 2010

Transparency of European drug regulatory authorities: improvements needed

Download the Joint Consultation (234 Kb)

The European Medicines Agency Road Map to 2015: Independence should be the priority (Joint Contribution to EMA Consultation, April 2010)

Joint contribution to the public consultation

Brussels, 30 April 2010

HAI Europe, ISDB and Medicines in Europe Forum answer to EMA’s public consultation on its road map to 2015.

They denounce a number of practices that create conflicts of interest, among them:

  • over 80% direct funding by pharmaceutical companies (fees);
  • the generalisation of "scientific advices", advices provided to pharmaceutical companies by the EMA with the payment of fees, presented as a mechanism to reach agreement on how to prepare and submit a successful market authorisation dossier;
  • lack of transparency.

According to them, the Agency’s financial and intellectual independence from pharmaceutical companies should be the priority if the EMA is to improve its accountability to citizens.

Download the Joint Consultation (234 Kb)

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