EMA drug reviews must be independent of pharma influence as an example to others, says AMF

By Gareth Macdonald contact

- Last updated on GMT

Related tags: Pharmacology, European medicines agency

EMA independence a must for global leadership role says AMF
EMA independence a must for global leadership role says AMF
The EMA's assessment of new drugs must be independent of pharmaceutical industry influence as an example to others, according to the Access to Medicines Foundation (AMF)

Last week, the European Medicines Agency (EMA) confirmed that any employee who intends to work in the pharmaceutical industry will cease all involvement in drug reviews as soon as they communicate their intentions to the agency.

The measure is part of an agency effort to develop more robust conflict of interest (COI) rules in response to concerns voiced by the European Court of Auditors (ECA) and the European Parliament in 2012​.

The EMA’s decision was welcomed as a positive step by Dutch non-Governmental organisation (NGO) Health Action International, although the group did also call for all COI declarations to be made public.

The Access to Medicines Foundation (AMF) - an organisation focused on assessing industry efforts to improve access to drugs in developing countries – set the EMA’s new COI measures in the context of its role as a model for other regulators.

AMF researcher Delphi Coppens told us: “The EMA is one of the strongest regulatory bodies globally. Its decisions are often adopted by developing countries.

Therefore it is very important that EMA committees function independently for the efficacy and safety of medicines beyond Europe" she continued.

COI policy

The COI policy was developed after questions were raised about the conduct of former EMA execs​ and after the agency was criticised by the ECA and urged to update its COI rules.

Back then the ECA said​ the London-based drug agency “did not adequately manage conflict of interest situations​” and recommended that it develop measures to address post-employment issues.

This view was shared by the European Parliament, which had earlier refused to sign off on the EMA’s budget citing concerns about its COI policy​.

The revised EMA COI policy​ was welcomed by the Parliament in a draft document published last November​.

Related topics: Markets & Regulations, Regulations

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