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EMA's advice to drug companies: conflicting roles

The European Medicines Agency (EMA) offers "scientific advice" to drug companies to help them compile their marketing authorisation applications, giving rise to suspicions that the agency may be placing pharmaceutical companies' interests over and above patients' health.

A public drug regulatory agency would be expected to set standards for clinical trials, such as which endpoint, method and comparator to use, through transparent, public, detailed written guidelines, not through confidential tailored advice. This secret, personalised scientific advice, for which the EMA sometimes charges a fee, could undermine the Agency's impartiality and credibility.

EMA advice is commonly sought for conditional marketing authorisations, i.e. those granted early along with a request for additional post-marketing evaluation. For example, the EMA issued advice on 18 of the 30 conditional marketing authorisations it granted between 2006 and 2016. And 71% of conditional marketing authorisation applications that adhered to the EMA's scientific advice were approved, versus 40% of those that did not adhere to it.

These figures are open to various interpretations. Given the lack of transparency in the procedures in place to safeguard the EMA's objectivity in these situations, one interpretation is that it is compromised by the close working relationships created between EMA and drug company employees.

The European Ombudsman is concerned by this risk and has rightly called for transparency regarding these activities. The EMA's credibility in its role of patient protection is at stake. Lack of transparency fuels the suspicion that it may actually be protecting pharmaceutical companies instead of public health.

©Prescrire 1 March 2018

"EMA's opaque advice to drug companies" Prescrire Int 2018; 27 (191): 59. (Pdf, free).

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See also;

No to EMA's provision
of confidential scientific advice
to drug companies
Advanding healthcare policy
(November 2017)

Health groups call on
European medicines agencies
to address independence and
transparency problems
Advanding healthcare policy
(July 2015)