Paris, 30 January 2019

In their joint response to the EU Ombudsman's consultation on the pre-submission "scientific advice" provided by EMA to pharmaceutical companies, ISDB and Prescrire argue that it is high time to put an end to EMA's opaque and confidential practice of early scientific advice and to take resolute action to promote independence and transparency.

> Click here to download the joint response to the consultation (pdf, 196 Ko)

In January 2019, ISDB and Prescrire published their joint response to the European Ombudsman's public consultation on the pre-submission "scientific advice" provided by EMA to pharmaceutical companies. To protect public health and foster trust in the regulatory process, ISDB and Prescrire advocate for transparency of scientific advice to enable independent analysis of its impact and verification of its scientific basis.

Providing scientific advice secretly to individual medicine developers, with no accountability check, is harmful, antithetical to EMA's remit, and undermines its impartiality and credibility. In the absence of transparency, European citizens are kept in the dark about the quantity and scope of these activities, and cannot assess their usefulness or check whether they expose EMA to the risk of regulatory capture. Currently, only pharmaceutical companies and EMA itself are in a position to evaluate the impact of EMA's advice, yet patients and health professionals are directly concerned.

For ISDB and Prescrire, experts involved in providing national pre-submission scientific advice must not be involved in any subsequent evaluation of EU marketing applications for the same medicine. It is essential to limit situations that expose EMA staff and experts to the risk of institutional capture that could compromise their impartiality and objectivity.

Rather than promoting more intensive use of early confidential interactions with individual companies, EMA should make greater efforts to produce detailed, publicly accessible, written guidelines on clinical research. A registry or annual publication of a list of medicines for which scientific advice was sought, including the advice provided, and provision of detailed information in the EPAR would enable independent analysis of the quality of EMA's advice and its impact on clinical trial design. Over the years, EMA has had the opportunity to accumulate a wealth of information on the types of questions posed in each therapeutic field. Making available "Questions & Answers" documents for each therapeutic field would be a useful step towards information sharing and greater transparency.

©Prescrire January 2019

> Click here to download the joint response to the consultation (pdf, 196 Ko)

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