A new task force has been set up to explore how medicines regulators in the EU can use big data to improve human and animal health. The task force has been established by the European Medicines Agency (“EMA”), in conjunction with the EEA Heads of Medicines Agencies (“HMA”) (the “task force”), and was announced 23 March 2017. This announcement follows a workshop held by EMA in mid-November 2016, where organisations including IBM Watson Health, Google Cloud Platform, UK Biobank, the European Federation of Pharmaceutical Industries and Associations, and several academic institutions spoke about how to identify opportunities for big data in medicines development and regulatory science. This new task force aims to leverage big data for health improvements through supporting research, innovation and robust medicines development.

Big data can be used for large-scale information processing which enables the development of more useful information and insights about customers and users, and may be used in, for example, process automation or improved decision making. It will usually require specialised computational tools to enable its analysis and exploitation. Big data that may be useful to improving health includes electronic patient records, genomics, social media content, clinical trials, and spontaneous adverse reaction reports. Further innovations in healthcare, such as the use of apps to monitor glucose levels or review blood test results for signs of acute kidney issues, will only increase the amount of big data which could be used to improve health.

The task force is chaired jointly by the EMA and Danish Medicines agencies, and staffed with members from EEA medicines regulatory agencies. The task force includes representatives from Germany, Denmark, Spain, Finland, Hungary, Ireland, Netherlands, Norway, Romania, and the UK. Their work may be supported as needed by experts in big data analysis.

Over the next year and a half, the task force will focus on:

  • mapping sources and characteristics of big data;
  • exploring the potential applicability and impact of big data on medicines regulation, and developing recommendations on necessary changes to legislation, regulatory guidelines or data security provisions;
  • creating of a roadmap for the development of big data capabilities for the evaluation of applications for marketing authorisations or clinical trials in the national competent authorities; and
  • collaborating with other regulatory authorities and partners outside the EEA to consider their insights on big data initiatives.

The EMA has stated that the vast volume of data has the potential to contribute significantly to the way the benefits and risks of medicines are assessed over their entire lifecycle. Further information will be made available on the EMA website.