clinical trials

On December 28, 2022, the Spanish Data Protection Authority (“AEPD”) published a statement on the interplay between its recently approved Spanish code of conduct for the pharmaceutical industry and the European Federation of Pharmaceutical Industries and Associations’ (“EFPIA”) proposal for an EU code of conduct on clinical trials and pharmacovigilance.  The statement relates specifically to the legal basis for processing personal data in the context of clinical trials.Continue Reading The Spanish AEPD Publishes Statement on the Interplay Between its Code of Conduct for the Pharmaceutical Industry and the Potential EU Code of Conduct on Clinical Trials

In February 2021, the European Commission (“Commission”) released a report on European Union (“EU”) Member States’ laws governing the processing of health data.  The report discusses three general types of health data uses:

  • primary use for health care services;
  • secondary use for public health purposes; and
  • secondary use for scientific research purposes.

For each of these general purposes, the report assesses real-world use cases.  For example, for health care services, the report considers e-health applications, among others.  For public health purposes, the report considers pharmacovigilance and product approvals.  The section on scientific research purposes, meanwhile, considers issues such as research by public bodies, sharing of data with third-party researchers, and the use of genetic data.Continue Reading European Commission Publishes Report on EU Member States’ Rules in Relation to Health Data

On October 23, 2018, the European Federation of Pharmaceutical Industries in cooperation with the Future of Privacy Forum and the Center for Information Policy Leadership will organize a workshop entitled, “Can GDPR Work for Health Research.”  In the first session, the workshop will discuss the implications of the General Data Protection Regulation (“GDPR”) on clinical…

On 19 December 2012, the European Data Protection Supervisor (EDPS) and the Assistant Supervisor, M. Giovanni Buttarelli, published a new Opinion that sets out their views on the Commission proposal for a new Regulation on Clinical Trials on Medicinal Products for Human Use (the Regulation).  The Commission proposal, released in July 2012, touches on a variety of data protection issues, ranging from the legal basis that clinical research organisations (CROs) must rely on when processing sensitive health data gathered in clinical trials to the establishment of a centralized database at the European Medicines Agency (EMA) that is intended to store records of clinical investigators and adverse event reports from across Europe.

In general, the EDPS appears to have welcomed the Commission’s approach;  apparently, the Commission draft was altered to adapt to early informal EDPS criticisms, and so already contains provisions that are relatively sensitive to data privacy concerns.  Perhaps surprisingly, the EDPS also refrains from commenting extensively on the Regulation’s approach to the issue of how clinical trial participants may provide informed consent to their participation in the trial.  However, the EDPS nevertheless does make a number of suggestions about how the draft Regulation should be further modified.  We discuss the particular suggestions after the jump.Continue Reading EDPS Suggests Amendments to the Commission Proposal for a new Regulation on Clinical Trials on Medicinal Products for Human Use