31 January 2016

Joint Response by Prescrire, The International Society of Drug Bulletins and the Nordic Cochrane Centre. Paving the way to faster approvals but at what cost?

> Click here to download the Joint Response (pdf, 77 Ko)

Summary

EU pharmaceutical legislation provides that, as a general rule, before a medicine is authorised it has to undergo "extensive studies to ensure that it is safe, of high quality and effective for use in the target population". The requirement for the demonstration of solid evidence about benefits and harms before a medicine is approved protects patients' safety. It contributes to medical innovation by requiring companies to generate meaningful clinical data.
 
Over the last 2 years, the European Medicines Agency has launched several initiatives that aim to change the interpretation of the current legal framework for market authorisations in the European Union (EU) and to promote faster approvals for "innovative" medicines in the EU. This concerted move is promoted under the guise of increasing access to patients, yet fails to address the underlying shortcomings of accelerated procedures and their over-reliance in post-marketing surveillance.
 
In this joint response, we highlight several fundamental aspects:

1. Post-authorisation commitments are often not honoured;
2. Surrogate endpoints do not guarantee that a drug will affect health status in a clinically meaningful way for patients;
3. The rights of European citizens are  to access any documents produced or received by European institutions, also apply to documents from post-authorisation efficacy studies.
    

©Prescrire, ISDB, Nordic Cochrane Centre 2016

> Click here to download the Joint Response (pdf, 77 Ko)