Draconian privacy rules threaten future health breakthroughs

The clock’s ticking. Alex France, CC BY-SA

Patient records are an irreplaceable resource for health research for the benefit of individual patients and populations. They allow researchers, for example, to examine how our lifestyles might determine the incidence of disease.

A great tradition of strong, productive research in the UK using this kind of data includes pioneering population studies that found associations between smoking and cancer, atmospheric pollution and cardiovascular and respiratory risk, and between low folic acidin pregnancy and the risk of defects in a developing foetus.

Improving public health depends on such research. Unfortunately, our ability to produce and use this research is severely threatened by soon-to-be introduced European legislation.

Disease registries

European collaborations using disease registries have also proved extremely powerful in improving screening and assessing genetic and environmental factors in chronic diseases.

In the EU, the use of patient data is presently governed by the Data Protection Directive. It is now being revised as a regulation with worthy objectives to help the flow of data across borders when necessary, and enhance protection of personal privacy.

The original draft regulation acknowledged that research generates valuable information for society and introduced a proportionate mechanism for protecting privacy while enabling such research to continue. And this exemption – to allow sensitive personal information, including health data, to be processed for research without consent – was subject to strict safeguards.

But during passage of the regulation through the European Parliament, the lead committee on civil liberties, justice and home affairs amended articles 81 and 83, which very significantly reduced the scope of the research exemption.

If these draconian amendments are implemented the uses of personal data – whether identifiable or pseudonymised (key-coded to protect an individual’s privacy while permitting justified access) in research without specific, explicit informed consent – would be prohibited or rendered impossible in practice.

This additional requirement for consent ignores the current reality where such research is already conducted within a robust ethical and governance framework with stringent confidentiality controls on accessing and processing data.

Research ethics committees play a crucial role in ensuring personal data is only collected and used in a way that is proportionate to the potential benefit of society as a whole. The proposed, disproportionate amendments are unnecessary to protect subjects, but they do put at risk the significant investment made in epidemiological studies, genetics, biobanks and disease registries, as well as use of data collected routinely by the health services.

Wasting time

In a further twist, these amendments would also waste the valuable contribution that patients have already made in allowing their data to be used for research, and the contributions of scientists and funding bodies in enabling that research – the consequences of which raise substantial issues by squandering resources already generated.

A health research coalition is raising awareness of these worrying consequences with parliamentarians and ministers across Europe. The breadth of this coalition comprises of those who benefit from research – patients and medical charities – as well as those who commission, fund and produce research, underscores the importance of the issues for us all.

Many of our previous achievements in public health innovation would not have been possible within this amended legislation. Other new, ambitious European studies will be undermined, for example those aiming to clarify relationships between nutrition and cancer, linking of multiple health datasets with chronic disease, and modelling how the brain works to understand its disorders.

As the new president of the Federation of European Academies of Medicine I have been privileged to be part of previous efforts by the scientific community to inform other EU legislation. Our contributions to reforming the Clinical Trials Regulation has helped to clarify guidance, simplify monitoring requirements, address research sponsorship issues and introduce the principle of risk-proportionate assessments for clinical trials. Our collective efforts have helped to prevent the inadvertent introduction of obstacles to research and patient care.

We’re approaching a critical time when European parliamentarians and ministers decide their final positions on the Data Protection Regulation and it is imperative that the European Commission’s original research provisions are restored.

This all comes at at time when the need for better research has come up against fears of a loss of privacy. But it is something that we must consider carefully. Opting for privacy (without considering what safeguards are already adequately in place) risks losing a much bigger prize.

We can all agree that protecting privacy is essential but it is also vital that we appreciate what will be lost if we do not keep health research alive. Using the existing safeguards, it is possible and ethically imperative to strike an appropriate balance between the secure use of personal data and the interests of the individual.