english.prescrire.org > Spotlight > Archives : 2016 > "Adaptive licensing": the European Medicines Agency's unwise proposals. A discussion-debate at the annual Prescrire Awards

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"Adaptive licensing": the European Medicines Agency's unwise proposals. A discussion-debate at the annual Prescrire Awards

Pilule d'Or Prescrire 2016Speeding up patients' access to new drugs only makes sense if those drugs have an acceptable, and adequately studied, harm-benefit balance. On 28 January 2016 the non-profit French medical journal Prescrire held its annual awards ceremony, with a discussion-debate on "adaptive pathways" for marketing authorisations, as proposed by the European Medicines Agency.

The discussion-debate featured a presentation by Ancel.la Santos Quintano, a Policy advisor at Health Action International (HAI) Europe.

The "adaptive pathways" proposed by EMA aim to speed up the marketing authorisation of drugs, by reducing the requirements for proof of efficacy and safety, as compared to a classic marketing authorisation.

The alleged benefits of "adaptive pathways" include quick access to new drugs for patients and earlier revenue for pharmaceutical companies. But there are already many accelerated marketing authorisation procedures in place that allow patients with serious illnesses in treatment failure to have early access to new drugs.

"Adaptive pathways" involve transferring clinical evaluation to the post-authorisation phase. However, conditional approval mechanisms exist already, and pharmaceutical companies’ promises regarding post-marketing-authorisation studies are rarely kept.

"Adaptive pathways" also imply close collaboration between pharmaceutical companies and regulatory authorities. The regulators become both players and referees in the development of new drugs, which results in regulatory capture.
The adoption of  "adaptive pathways"  could lead to a situation where early marketing authorisation becomes the rule, even when there is no pressing public health need, thereby creating unnecessary health risks for EU citizens.

Texts and videos of the presentations are available (in French) > HERE

©Prescrire 1 February 2016

For more information:

"Adaptive licensing" or
"adaptive pathways":
Deregulation under the
guise of earlier access
(October 2015)
healthcare policy

See also:

The Prescrire
Awards for 2015
(February 2016)