Amendments to European Data Protection Regulation will damage medical research, warn science organisations

The original draft Regulation set out a mechanism for protecting privacy, while enabling research to continue; it included a requirement for specific and explicit consent for the use and storage of personal data, but provided an exemption for research, subject to certain safeguards. This recognised that individuals’ interests can be protected through strong ethical and governance safeguards, such as approval by a research ethics committee.

However, in October the Civil Liberties, Justice and Home Affairs (LIBE) Committee of the European Parliament proposed amendments to the Regulation which very significantly reduce the scope of this research exemption. The use of personal data in research without specific consent would be prohibited or become impossible in practice, despite the fact that this research is subject to ethical approval and strict confidentiality safeguards, and that the identity of individuals is often masked.

Today, a coalition of research organisations, led by the Wellcome Trust, has begun contacting all MEPs and the Council of Ministers, urging them to reject the proposed amendments. The European Parliament is expected to vote on these amendments this spring, while Council discussions are ongoing.

Dr Jeremy Farrar, Director of the Wellcome Trust, says: “Concerns about patient confidentiality are legitimate and it is essential that people’s privacy is protected. But when the safeguards become disproportionate, they benefit no one. The original Regulation was measured and sensible, and struck the right balance between protecting the individual and making possible huge benefits for all of our health. The proposed amendments are disproportionate and put at risk future medical research and improvements in health.”

Professor Dermot Kelleher, President of the Federation of European Academies of Medicine, adds: “Modern scientific research generates important benefits for individual patients and for populations through improving our understanding of health and wellbeing and the complex factors that lead to disease. If implemented, the amendments would substantially hinder or prevent our ability to make further gains in our understanding of common chronic diseases that affect large numbers of European patients, such as Alzheimer’s disease and cancer.”

Personal data, such as individual patient records, provide a vital resource for research for the benefit of society. For example, personal data allow researchers to compare different factors, such as lifestyle, and the incidence of disease at an individual level. These observational studies have led to breakthroughs such as identifying the association between smoking and lung cancer, preventing neural tube defects such as spina bifida in newborns, and informing treatment of infection in unborn babies.

Research using personal data follows a robust ethical and governance framework to ensure that an individual’s personal data are only used in research when this is proportionate to the potential benefits for society as a whole. Researchers are given access to personal data only under strict confidentiality controls, which have been effective at preventing misuse and harm to data subjects.

The amendments from the LIBE Committee would make it very difficult, if not impossible in practice, to use pseudonymised data concerning health – where an individual’s identity is masked to protect privacy – without specific consent. They would also prohibit the use of identifiable personal data in scientific research without specific consent. Researchers only use identifiable data without consent where other approaches are not practicable, and this is currently only allowed subject to ethical approval and strict confidentiality safeguards. Sometimes researchers need details such as age, postcode and information on a health condition that together could disclose the identity of an individual, but the study would not be possible without it.

In many studies that would be affected, individuals have voluntarily given broad consent for their data to be used in research to further our understanding of society, health and disease. Their contributions could be wasted if the amendments become law.