On 22 March 2017, the European Medicines Agency (EMA) launched a call for applications for data protection experts to set up a Technical Anonymisation Group (TAG) to help the Agency develop best practices for the anonymisation of clinical reports. The group will consist of 20 members and applications should be sent by 28 April 2017. The initiative comes as part of the implementation by the EMA of phase 1 of its Policy 0070 on publication of clinical trial data for human medicines (the EMA Transparency Policy), pursuant to which the EMA has started publishing clinical reports for medicinal products on its dedicated website as of 20 October 2016.
The protection of personal data is one of the major challenges related to the publication of clinical trial data by the EMA. The EMA Transparency Policy mandates “adequate personal data protection” and full compliance with applicable data protection regulations in the EU. As recently as in December 2016, the EMA adopted guidance on the anonymisation of clinical reports, which provides information on e.g. some of the anonymisation techniques that are available to marketing authorisation holders/applicants.
The overall objective of the TAG is to establish best practices for the anonymisation of clinical reports, by monitoring and addressing any issues arising in the context of the implementation of phase 1 of the EMA Transparency Policy. According to the EMA’s press release, the TAG will assist the EMA in keeping up with technological developments in this rapidly evolving field. Specifically, the TAG will identify best anonymisation practices, assess privacy risks, and investigate how alternative anonymisation methodologies impact the scientific utility of the published data, including for secondary analysis purposes.
Based on the outcome of the work of the TAG, which is expected to last two years, the EMA will make the necessary amendments to its guidance on anonymisation of clinical reports, develop additional guidance (e.g. a Q&A) to clarify certain aspects of the methodology described in the guidance, and draft a critical review of the impact of new technological developments on the anonymisation of clinical reports.
Another major challenge arising from the present transparency trend is the protection of companies’ commercially confidential information (CCI). Policy 0070 states that the EMA “respects and will not divulge CCI”. The question is therefore what data represents CCI. The EMA has issued guidance on this point, and we may receive further guidance from the EU General Court following the hearing on the merits in the access to documents challenge by Pari Pharma, which took place on 14 February 2017.
To date, clinical reports for about 13 medicinal products have been published on the dedicated EMA website. Original statistics showed that only very few pages of these reports contained redacted CCI. In phase 2 of the implementation of its Transparency Policy, the timing of which is yet unclear, the EMA will also publish individual patient data (e.g. per patient/per visit line listings) contained in these clinical trial reports.
The work performed by the TAG is also likely to be relevant for the implementation of the EU Clinical Trials Regulation (EU) No. 536/2014, expected to enter into force no earlier than October 2018, after the EU portal and database of clinical trial data set up by the Regulation become fully operational. Under the Regulation, all information available through the EU database will be publicly accessible, excluding personal data and CCI, among other things.