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European Medicines Agency: more independence is needed

HAI Europe, ISDB and the Medicines in Europe Forum have jointly answered the EMA’s public consultation on its road map to 2015. They decry a number of practices that create conflicts of interest, and argue that the Agency’s financial and intellectual independence from pharmaceutical companies should be the priority if the EMA is to improve its accountability to citizens.

Key points

• To guarantee the EMA’s independence, and prevent difficulties in sustainability due to fewer applications and subsequent fluctuations in fee revenues, any direct financial relationship between the Agency and industry should be avoided. This could be achieved by channelling industry fees to the European Commission, and by restructuring EMA’s budget so that fees would make up but a small proportion of its overall budget.

• "Earlier and continuous" scientific advice increases risks of conflicts of interest.

• The benefit-risk assessment of health products needs to be evidence-based.

• Risk management systems and post-authorisation "efficacy and safety" studies create countless perverse effects.

• Cost-effectiveness assessment needs to remain independent from the Drug Regulatory Agencies.

• Patient safety needs to be strengthened.

Concrete proposals
To be able to carry out its public health tasks, the European Medicines Agency needs to:

• be weaned off a fee-for-service relationship with pharmaceutical companies through public funding from the European Union;

• reconsider its proposal to give systematic scientific advice that places the Agency in an untenable position in terms of conflict of interest;

• concentrate on evidence from clinical studies that have been designed to meet health needs, and assess the benefit-risk balance of medicinal products on a comparative basis;

• improve and enforce its transparency requirements to effectively prevent conflicts of interest;

• encourage interaction with independent civil society representatives;

• prevent "conditional", "accelerated" or "staggered" marketing authorisations from becoming the rule rather than the exception, if no genuine unmet medical need is at stake, so as to prevent unnecessary exposure to avoidable harm;

• coordinate activities by its various committees, coordination groups and working parties, while guaranteeing the separation of powers among committees that approve medicinal products from the pharmacovigilance committee.

> Click here to download the Joint Consultation (pdf, 234 Ko).

> Click here for Prescrire's online Dossier "Medicines in Europe"

©Prescrire June 2010

Click here to download the
Joint Consultation
Pdf, 234 Ko, Free