english.prescrire.org > Topics > Advancing healthcare policy > Advancing healthcare policy in Europe: a chronological recap of actions > 2015 Recap > Marketing authorisation flexibilities should only respond to true needs and must protect patients' safety (9/2015)

Advancing healthcare policy

Advancing healthcare policy in Europe: a chronological recap of actions

A recap of actions in 2015
Marketing authorisation flexibilities that enable early access to medicines should only respond to true unmet medical needs and must protect patients' safety (September 2015)

Paris, 30 September 2015

Joint response to an EMA public consultation on the Guidelines to implement accelerated assessment and conditional marketing authorisation for medicinal products for human use.

HAI, ISDB and MiEF highlight the importance of the pharmaceutical marketing authorisation procedure as a health protection measure. Whilst timely access to needed medicines is fundamental, it should not be in detriment of patient safety. Existing flexibilities for market access (i.e. conditional approval, exceptional circumstances and accelerated assessment) must apply in fully justified circumstances only. Thus far, the EMA has not published any review, nor shared any quantitative or qualitative data with the public to document eventual shortcomings of the accelerated or conditional procedures. It is therefore surprising to read that the Agency is considering implementing, through soft guidelines, several measures that would de facto change the existing flexibilities for early market access.

©HAI, ISDB, MiEF September 2015

> Click here to download the joint response (pdf, 797 Ko)