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The European Medicines Agency's public consultation on yet another aspect of transparency on clinical trials data has elicited further critical comment about excessive official secrecy.
The European Medicines Agency's public consultation on yet another aspect of transparency on clinical trials data has elicited further critical comment about excessive official secrecy. This time, the debate is not about the agency's own rules - the discussions that took up much of the last couple of years as EMA struggled to agree how to put into effect the pro-active release of data that it had announced it would provide, and which finally came into effect in January. Now the debate has switched to the European Union's own rules on clinical trials - and to how the agency plans to put into effect the transparency requirements that come as part of the new clinical trials regulation, which will start to take effect as from next year.
Under the terms of the new regulation, EMA is responsible for the development and maintenance of the portal and database foreseen for submitting clinical trial applications in the EU (while the authorization and oversight of clinical trials will remain with the member states). The portal and database will be the source of information to the public, in line with the regulation's provisions for transparency on the authorization, conduct, and results of clinical trial applications assessed, and on all clinical trials conducted in the EU. For each trial, the public will be able to access details including the major characteristics of the trial, the start and end of recruitment, end date of the trial and substantial modifications.
However, the regulation makes exceptions about access to the database for protection of personal data, protection of commercially confidential information (in particular in light of the marketing authorization status) "unless there is an overriding public interest", protection of confidential communication between member states as they prepare their assessment, and protection of the supervision of trials. EMA says its proposal for applying these rules aims to "balance the right of patients and the public to access extensive and timely information on clinical trials, and developers’ and researchers’ need to benefit from investments".
Unsurprisingly, it is in its attempt to strike this balance that the agency has already come under attack from campaigners for public access to information. The agency is "steering away from transparency by misinterpreting the exception provisions", according to a coalition of health campaigners, warning that the proposal "can jeopardize the transparency advances obtained" through the hard-fought regulation. They accuse EMA of bowing to industry pressure in "watering down" the transparency provisions. In support, they cite the call that the European Federation of Pharmaceutical Industries and Associations issued last year, when the regulation was finalised, for “the Commission and EMA [to] interpret the clinical trial regulation in a manner that respects (...) incentives for companies to make long-term investments in biomedical research”. And they conclude "EMA has responded to industry demands".
The EMA definition of commercially confidential information is too broad, they say, and would allow sponsors to circumvent the obligation to publish trial protocols, subject information sheets, investigator brochures, or the investigational medicinal product dossier, "simply on the grounds that their economic interests might be potentially undermined".
The International Society of Drug Bulletins, Health Action International, Prescrire, the Association Internationale de la Mutualité, and the Medicines in Europe Forum unite in urging the agency to "stay true to the regulation". In a separate response, the European Public Health Alliance says the EMA approach raises "important transparency-related questions, notably regarding the nature and scope of what may or may not be classified as ’commercially confident information’", and called for EMA’s definition "to be narrowed down", and for more clarity on "how the concept of ’overriding public interest’ could be applied".
The European consumers association, BEUC, also says "the EMA interpretation of what constitutes commercially confidential information is too broad" and "will hinder the proper access to clinical trials data intended by legislators". It would "undermine any meaningful disclosure of information", and "greater weight should be given to public health arguments". BEUC adds that "some have been using misleading arguments about patients’ privacy to undermine the transparency developments", and calls for clearer distinctions so that there is no bar to the release of anonymous patient data sets "useful for reanalysis". It should be clear, says BEUC, that "public disclosure is the general rule and that non-disclosure is the exception".
In the circumstances, EFPIA has been curiously shy about its own views. It issued a press release at the end of the consultation period, saying it had made a submission, but declined to provide any information about the content of its submission. Since the submissions will be made public through the EMA, "we are intending to just let that be the route for public access", EFPIA told this journalist. In answer to the obvious follow-up question of "since it will become public, why the timidity?", the response was "We are just part of the wider process." And in answer to the other obvious question of "why bother announcing the submission?", no answer has yet been offered. All the more curious given that the entire debate turns on questions of transparency…