Brussels, 23/01/2014 (Agence Europe) - On 23 January, the European Parliament's committee on the environment, public health and food safety (ENVI) unanimously adopted the compromise text on the regulation relating to clinical trials for human health. The agreement had been reached on 12 December by the Council of Ministers-European Parliament-European Commission trialogue (see EUROPE 10989). The draft legislation aims to encourage research while protecting patients' rights with simpler and more uniform rules for all member states concerned, with a single assessment outcome.
The new text sets out specific provisions for low intervention clinical trials, clarifies the role of ethics committees in the authorisation process, and gives details on how to obtain informed consent from patients. Pharmaceutical companies and academic researchers will be under an obligation to upload the results of all their European clinical trials to a publicly accessible database. “Around half of all trials have never been published, usually those with negative or disappointing results. It is vital that we know about negative outcomes - otherwise trials can be conducted repeatedly before it becomes public knowledge that some products are ineffective, or even dangerous””, said the rapporteur, Glenis Willmott (S&D, UK). The new law simplifies reporting procedures and empowers the European Commission to perform checks. It also facilitates cross-border cooperation in order to allow more far-reaching and more reliable trials, as well as those on products for rare diseases. MEPs have amended the legislative draft in order to increase transparency, calling for detailed summaries of the trials to be published in a European database accessible to the public. Reports on clinical trials should also be published as soon as a decision to market the product tested is taken or if the marketing authorisation application is withdrawn. The legislation will be discussed and put to the vote in plenary during the 2-3 April session. (IL/transl.jl)