On 1 January 2014, the joint Principles for Responsible Clinical Trial Data Sharing (“the Principles”) endorsed by the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) and Pharmaceutical Research and Manufacturers of America (“PhRMA”) entered into force. EFPIA and PhRMA endorsed these Principles on 24 July 2013. The Principles are available at EFPIA website.
The aim of the Principles is to permit access to clinical trial data by “qualified scientific and medical researchers” with the aim of enhancing research, promoting scientific knowledge, advancing patient care and improving public health. According to EFPIA and PhRMA, the implementation of the principles will “dramatically” increase the amount of clinical trial data available to researchers, patients and members of the general public in the European Union (“EU”) and the US.
The Principles are based on three overarching objectives. When sharing clinical trial data, the members of EFPIA and PhRMA must ensure that:
- the privacy of the clinical trial patients is safeguarded;
- the integrity of the national regulatory systems is respected; and
- the incentives for investment in biomedical research are maintained.
Members of EFPIA and PhRMA commit to sharing clinical trial data in response to requests submitted by “qualified scientific and medical researchers” seeking access to the data for the purpose of conduct of “legitimate research”. The Principles do not define either the terms “qualified scientific or medical researcher” or “legitimate research”. However, the researcher requesting access to clinical trial-data would be required to submit a research proposal demonstrating the legitimacy of the proposed research activities and the qualifications of the researcher.
Each member of EFPIA and PhRMA is required to establish a scientific review board composed of scientists and/or healthcare professionals who are not employees of the company. The board shall participate in the assessment of the research proposals submitted by the researchers requesting access to clinical trial data.
The Principles require the members of EFPIA and PhRMA to publish the procedure that they have established for the submission and assessment of requests for access to clinical trial data. The Principles also require that the identity of the members of scientific review board be publicly disclosed, together with information concerning any relationship between the pharmaceutical company and each of the members of the scientific review board.
The Principles describe the clinical trial data and information to be shared by the members of EFPIA and PhRMA with qualified researchers for the purposes of legitimate research. This includes patient-level data, clinical trial protocols, and clinical trial reports relating to clinical trials conducted with medicinal products that were authorised to be placed on the market in the EU and the US after 1 January 2014. The Principles do not apply to data or information relating to clinical trials conducted with medicinal products that were authorised to be placed on the market in the EU and the US before this date.
The Principles impose on the members of EFPIA and PhRMA an obligation to ensure that patients’ personal data and commercially confidential information are protected when clinical trial data is shared with researchers. Patient-level data may be disclosed only if it is irreversibly anonymised and if it does not permit the identification of individual patients.
The Principles also expect researchers who are granted access to clinical trial data to publish the findings of their analysis of the clinical trial data. Researchers are not, however, permitted to share the clinical trial data with third parties that are not identified in the research proposal on the basis of which access was requested or to use the clinical trial data for purposes other than the legitimate research that is the basis of the request.
Members of EFPIA and PhRMA who grant access to clinical trial data must also publish the results of clinical trials that they have conducted. Members are required to publish at least the results of all Phase III clinical trials and the results of any other clinical trials if such results are of “significant medical importance”. This requirement applies independently of whether the outcome of the clinical trial was positive or negative. The Principles do not include a definition of the term “significant medical importance”.
In addition, the Principles impose on the members of EFPIA and PhRMA a requirement to make synopses of clinical trial reports submitted to the competent authorities in the EU and US after 1 January 2014 in support of applications for the marketing authorisation of a medicinal product or the variation thereof publicly available. The synopses must be made publicly available after the competent authorities have granted or varied the marketing authorisation for the related medicinal product. Moreover, the Principles require the members of EFPIA and PhRMA to work with the competent authorities in the EU and the US in order to establish mechanisms for providing clinical trial patients with factual summaries of the results of the clinical trials.
EFPIA and PhRMA will track progress in the implementation of the Principles. They are expected to issue a joint progress report in the course of 2014.
The context surrounding the entry of force of the Principles
EFPIA and PhRMA endorsed the Principles at a time when the European Medicines Agency (“EMA”) has initiated a process for the finalisation and adoption of the Agency’s Policy governing publication of and access to clinical trial data submitted to the Agency by pharmaceutical companies. On 24 June 2013, the EMA published a related draft Policy. The draft Policy was released for public consultation on the same day. The public consultation process was open until 30 September 2013.
A press release published by the EMA on 17 December 2013 indicated that the Agency was moving away from its original plan to have this Policy operational on 1 January 2014. This is discussed in further detail in our previous blog post dedicated to the Policy.
The Principles enter into force at a time when the pharmaceutical industry also anticipates the forthcoming rulings of the General Court of the European Union (“General Court”) in pending cases concerning the EMA’s decisions to grant third party access to clinical trial data. AbbVie and InterMune have challenged decisions by the EMA to grant access by requesting third parties to clinical trial data submitted by these companies. Our blog post of 6 December 2013 discusses these court proceedings in further detail.