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Image header Agence Europe
Europe Daily Bulletin No. 11123
Contents Publication in full By article 18 / 25
SECTORAL POLICIES / (ae) health

Questions raised over industry paying for EMA advice

Brussels, 16/07/2014 (Agence Europe) - Several organisations working in access to medicines and health (Health Action International Europe, International Society of Drug Bulletins, Medicines in Europe Forum and the Association internationale de la Mutualité) have criticised the actions of the European Medicines Agency (EMA) which, in exchange for a fee, has been providing pharmaceutical companies with advice on their development plans for new medicines. The EMA is now trying to extend these practices to national Health Technology Assessment (HTA) bodies in the EU. In a joint response published as part of the public consultation begun by the EMA on “best practice guidance for pilot EMA HTA parallel scientific advice procedures”, the organisations express their grievances. Ancel-la Santos Quintano, an adviser for Health Action International, underlined that the opinions are paid for and this creates a real risk of conflicts of interest given that, at a later stage of the process, it is the EMA's responsibility to provide market authorisation for these medicines. Joerg Schaaber, President of the International Society of Drug Bulletins stated: “When the EMA and national HTA bodies sell scientific advice to pharmaceutical companies to aid in drug development, they essentially become co-developers of medicines and financially dependent on the pharmaceutical industry… Establishing financial and business ties with the pharmaceutical industry undermines the independence of HTA bodies, as well as the critical roles of both the EMA and HTA bodies in protecting public health”. The organisations critical of the EMA practices say that, rather than providing pharmaceutical companies with customised advice, the EMA should continue to develop guidelines that help the medicines manufacturers make development decisions that address genuine public health needs. (IL)

 

Contents

A LOOK BEHIND THE NEWS
EUROPEAN COUNCIL
EUROPEAN PARLIAMENT PLENARY SESSION
SECTORAL POLICIES
ECONOMY - FINANCE
EXTERNAL ACTION