Jim Murray: Volte-face by the European Medicines Agency?

jim_murrayThe European Medicines Agency (EMA) has recently published to a targeted audience final consultation draft papers on its new “proactive” transparency policy on clinical trial results. As reported, information published under the draft policy would be on a screen-read only basis, would not include commercially confidential information (CCI) as defined by the EMA, would be subject to strict terms of use to be signed in advance by users, and with disputes to be settled under English law and (on a non-exclusive basis) in English courts.

This seems to me to be a major volte-face on the early promise of a proactive policy that was about “establishing trust and confidence, and enabling independent re-analysis of the evidence used by the EMA scientific committees to determine the benefits and risks of medicines”

In my view, the draft policy will not achieve either of these aims—see here the views of a number of NGOs.

Without repeating all the criticisms made elsewhere, I would mention the following points:

  • In excluding certain information on the grounds that it is CCI, the draft seems to imply that the information that will be disclosed is not CCI. Why then the highly restrictive terms of use and disclosure on a screen-read basis, which must be accessed in one way only and that may not be downloaded, saved, edited, photographed, or printed?
  • If forced to agree and accept a company’s claims of copyright and other intellectual property rights (IPR), users may not be able to challenge spurious IPR claims when seeking to establish a right of access under EU law or in the implementation of the transparency provisions under the new clinical trials regulation.
  • The limitation on disclosing (all?) secondary endpoints in clinical trial results will sharply reduce whatever scientific value there may be in the results as a whole. (For example, when secondary endpoints are used as a basis for off-label prescribing, there is no way of assessing the results on which such claims are based.)
  • It is wrong to require, for example, a French researcher, seeking information from a French company, to accept that all disputes should be governed by English law and be subject to trial in an English court.

The draft policy has been presented as separate from the EMA’s obligation under the rules on access to documents and, of course, is also separate from the transparency obligations under the recent Clinical Trials Revisions Regulation. Certainly, terms of use, restrictive or otherwise, may not be imposed under EU Directive 1049/2001 on access to documents. The clinical trials regulation also implies a more proactive policy of disclosure and states that CSRs are generally not to be considered as CCI. These are only two of the many ways in which the EMA draft policy clearly runs counter to the wording and principles behind Directive 1049/2001 and the recent Clinical Trials Regulation. Furthermore, the agency’s definition of CCI and its procedures for determining what is CCI may be used to influence adversely the definition of CCI in the transatlantic trade negotiations (TTIP), in the new clinical trials regulation, and in the procedures on access to documents.

The European ombudsman, Emily O’Reilly, has written to the agency expressing her concern about an apparent change of policy on transparency, and a reply is requested before 31 May.

According to some reports, the agency has rejected the ombudsman’s concerns, but the case is not yet closed.

Jim Murray is a former director of BEUC—the European Consumers Organisation, having previously been the first director of Consumer Affairs and Fair Trade in Ireland. He writes here in a personal capacity. During his time with BEUC, he was a founder and one time president of the Transatlantic Consumer Dialogue. Currently he is a member of the European Commission’s High Level Group on Administrative Burdens, and president of the European Foundation for Financial Inclusion.