30 May 2013

After months of discussion by the European Parliament on the update of legislation on clinical trials in Europe, MEPs have tabled 40 compromise amendments that unify diverging positions. The subject of data confidentiality, on the other hand, is still divisive.
The regulation proposed by the European Commission, on 17 July 2012, repeals Directive 2001/20/EC, which everyone agrees establishes very burdensome rules. The aim is to give fresh impetus to clinical research in Europe by simplifying procedures and differentiating trials in terms of risks.
Members of the Committee on Environment and Public Health (ENVI) amended, on 29 May, the report by Glenis Willmott (S&D, UK). They introduced a definition of ethics committees and put down in writing that consultation of such committees is necessary before clinical trials can be authorised. The Commission, out of concern that member states would use the subsidiarity argument, had avoided the subject.
Committee members spelled out conditions for informed consent, insisting that subjects in clinical trials must be informed orally and in writing, including on compensation to which they would be entitled in case of injury.
The subject of transparency divided MEPs. Some were receptive to arguments by NGOs demanding the availability of all raw data, while others were more in tune to the interests of the pharmaceuticals industry.
A compromise on the publication of findings was adopted. It provides for publication of a summary of results presented in terms that are easily understandable to a layperson, whether the study is conclusive or abandoned. A clinical study report must also be submitted to the European database once marketing authorisation has been issued for a medicine, but also in all cases where a marketing authorisation process has been completed.
Those who feared a race to the bottom in multinational trials, due to the Commission's proposal to give promoters the choice of reporting member state that would review the clinical trial request, will be reassured: this member state will not be chosen by the laboratory but by the states themselves.
To the dismay of proponents of transparency, the consolidated amendments by Parliament's left wing (S&D, Greens, GUE) on data confidentiality were not adopted. While the Commission proposes to make the EU database public unless confidentiality is required to protect personal data and business information, the left-of-centre MEPs find that clinical study reports should not be considered commercially confidential once marketing authorisation has been granted or the authorisation process completed.

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