E-DRUG: Prescrire's analysis of EMA's transparency policy over last 10 years
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Dear all,
Prescrire is an independent, not-for profit drug journal, aiming to improve the quality of patient care. Prescrire publishes reliable and independent information about treatments and pharmaceutical policy in Europe, as a basis for truly informed decision-making. Prescrire is funded exclusively by its subscribers.
We would like to share with you our recent analysis of the European Medicines Agency's transparency policy over the last 10 years and related problems just published in the May issue of our journal Prescrire International.
The article is available on the Prescrire website:
https://english.prescrire.org/en/81/168/64317/0/NewsDetails.aspx
As pointed out in our analysis, EMAâ's transparency policy evolved over time. Since late 2010, thanks to complaints from researchers and the civil society and the intervention of the European Ombudsman, the EMA embarked on a transparency policy consistent with the high standards of transparency required within the EU.
However, in 2022, the Agency is still putting up barriers to transparency. For example, when requesting access to documents held by the EMA, Prescrire has come up against new procedures in recent years that have the effect of withholding information, with response times of several months. And important information, in particular on clinical data, is redacted on the grounds that pharmaceutical companies feel that its disclosure could jeopardise their commercial interests.
As regards the procedure for handling access-to-documents requests, we doubt that the current situation is still in line with the objectives of the Regulation 1049/2001, in particular a prompt handling of requests for access to documents. We consider it is high time to launch an official inquiry on the EMA's rules to process access requests to unpublished documents and its queuing system, their evolution over time, and the effects on applicants.
Transparency is not a fad or an end in itself. In the pharmaceutical field, it is a prerequisite for better and safer patient care. There is no valid reason to hide information about clinical trials, their methodology or their results, or evaluation data obtained on drugs after their market introduction, particularly data on adverse effects.
The publication of our critical assessment of the level of transparency at the EMA is intended as a wake-up call for policy makers to take the necessary steps to improve the EMA's operational practices commensurate with a bold transparency policy and the disclosure of all the information necessary for patient care and safety.
1 https://www.prescrire.org/fr/Summary.aspx
2 Prescrire Editorial Staff 'European Medicines Agency: transparency policy marred by too many failings' Prescrire Int 2022; 31(237): 130-139
With kind regards,
Séverine Carré-Pétraud
Publishing Director
Editorial: https://english.prescrire.org/en/81/168/64314/0/NewsDetails.aspx
For further questions please contact
rkessler@prescrire.org