The EU ombudsman this week said that it believes that the European Medicines Agency (EMA) should not allow the same experts to provide scientific advice to medicine developers prior to an application and evaluate the same medicine, claiming such overlap runs the risk of damaging impartiality or creating the perception of bias.

In response to the comments, following a two-year inquiry into EMA’s interactions with drug developers, EMA said Friday: “Early interactions with medicine developers and provision of scientific advice are well-established processes with demonstrated added value in medicines regulation, and contribute positively to public health by helping to bring new, safe and effective medicines to patients. At the same time, EMA recognises the importance of guaranteeing the independence of the medicine assessment which takes place at a later stage.”

EMA also explained how for some diseases or conditions, the pool of experts is small.

“EMA said that it is confident that the current system guarantees impartiality. The fact that there may be overlaps between those involved in providing advice to medicine developers (the coordinators) and those involved in the subsequent evaluation of an MAA [marketing authorization application] for the same medicine (the rapporteurs) is justified because, in certain areas of science and medicine, qualified experts can be scarce,” the inquiry decision said.

The ombudsman responded: “Where EMA finds that it has no choice but to appoint a rapporteur who was a coordinator for the same medicine, it should document the reasons for doing so and make this information public.”

The ombudsman also seemed to suggest that an expert helping to design a trial would be biased if he or she had to decide whether such a trial is fit-for-purpose in the evaluation of the medicine.

“A coordinator who provides scientific advice to a medicine developer on how to design and carry out a clinical trial, and who later acts as a rapporteur for the MAA of the same medicine, may change his or her views on whether the trial was fit-for-purpose. This could happen if knowledge of the therapeutic area has developed, or simply where the rapporteur subsequently considers that the advice he or she had previously provided was not optimal. However, it is natural that a person who has given specific advice may be reluctant to take a different view subsequently. Certainly, there could be a public perception that this is the case,” the ombudsman added.

EMA, meanwhile, told the ombudsman that the content of the scientific advice is considered confidential and should not be made public prior to the submission or during the assessment of an MAA.

The regulator also said it has begun an initiative to provide more information on scientific advice in the public assessment report that underpins the marketing authorization.

Decision in strategic inquiry OI/7/2017/KR on how the European Medicines Agency engages with medicine developers in the period leading up to applications for authorisations to market new medicines in the EU

EMA takes note of the European Ombudsman’s decision on pre-submission activities

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