On 20 May 2014, the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) launched a new clinical trials data portal gateway concerning clinical trials conducted in the European Union (“EU”) by EFPIA member companies.

The development of an online gateway to clinical trials data was established as part of the Joint Commitments on clinical trials data transparency adopted by EFPIA and the Pharmaceutical Research and Manufacturers of America (“EFPIA-PhRMA Joint Principles”).

EFPIA and PhRMA member companies are required to adopt the EFPIA-PhRMA Joint Principles, which came into force on 1 January 2014, as part of their membership of these organisations. With respect to the member companies’ commitment to clinical trials data transparency, the companies have pledged to share clinical trial data, including patient-level clinical data, concerning medicinal products which are authorised in the EU. In addition, the member companies have committed to sharing clinical trial protocol data for the authorised medicinal products.

According to the EFPIA-PhRMA Joint Principles, the member companies will share the clinical data and protocol data following a request by a qualified scientific and medical researcher. The companies are required to establish a scientific review board to review such requests for data to determine whether the requests meet certain criteria, including criteria regarding the qualifications of the researcher and the legitimacy of the purposes of the research. The scientific review board must include external scientists and/or healthcare professionals who are not employees of the member company in question.

The EFPIA clinical trial data portal gateway contains links to the websites of the member companies which provide further information concerning the process for the review of a request for data submitted to these member companies that has been established.

The request for data must be accompanied by a research proposal which will be evaluated against the following information:

  • a description of the data being requested, including the hypothesis to be tested;
  • the rationale for the proposed research;
  • the analysis plan;
  • a publication and posting plan;
  • qualifications and experience of the proposed research team;
  • a description of any potential conflicts of interest, including the potential competitive use of the data; and
  • the source of any research funding.

Furthermore, the member companies will publish the identity of the participating external scientists and/or healthcare professionals and any existing relationships between these external scientists and/or healthcare professionals and external board members of the member company.

Member companies are also required to ensure that any disclosure of patient-level clinical data complies with the EU Data Protection Directive and its related national data protection laws of the EU Member States. Consequently, the companies must ensure that all patient-level data is anonymised to ensure that there is no direct or indirect identification of the patients. If the disclosure of clinical data requested by the researchers is prohibited on the basis of a written agreement or patient informed consent form, the member companies must cooperate to provide a summarised version of the clinical data requested.