The way we use data has changed enormously since the last EU-wide legislation on data protection was passed twenty years ago. We now have more data about ourselves in the cloud than would have fitted on our home computers in 1995. Data use and data volume has changed in the worlds of healthcare and biomedical research just as much as it has changed in our personal lives. The genomic revolution is well underway, and the data from each and every human genome sequenced will not fit on the computer I sit at today. We have ‘big data’ too, which has just as much potential to revolutionise our knowledge about our own health.
In 1995, the legislation was a Directive, tweaked by every Member State of the European Union as it was implemented. This time around the proposal has been for a Regulation, a choice intended to create an environment in which every Member State’s approach to data protection is the same. Of course, getting every Member State to agree on a single approach is difficult, as is getting the European Parliament, the European Commission and the European Council to agree as to what that approach should be.
These difficulties threaten one of the original aims of the new legislation: a harmonised approach to data protection in Europe. Part of the problem here is that the scope of the Regulation is so broad: this is a single piece of regulation designed to govern the sharing of photos from my weekend and the consented use of my genome sequence for biomedical research. So let us focus on biomedical research. What is the benefit of harmonisation to patients interested in the outcomes of biomedical research specifically?
EGAN is particularly interested in research into rare and genetic conditions (almost all genetic conditions meet the EU definition of rare: fewer than 5 in 10,000, and around 80% of rare conditions are genetic). For very rare conditions, it is challenging to find a population of sufficient size to study effectively in a single country. The scientific community needs to share its resources and has come up with some great ways to do this. Biobanks, registries and databases have been built that store data from across the planet for the purpose of better understanding the rare diseases that cause so much unmet health need in the EU and the rest of the world. Patient organisations too have registries that cover case histories from across the globe, and a significant fraction of new treatments for rare diseases that have emerged in the past ten years have relied on one of these.
The Data Protection Regulation, currently the topic of negotiation between the Council, the Commission and Parliament, represents an opportunity to build a foundation on which these approaches may be fostered over the next generation of data use.
The outcome of the process, and the new Data Protection Regulation itself will be judged, in part, by how harmonised an approach to data protection it creates. It is already clear, though, that there will be some compromises in the final outcome. So do we compromise on harmonisation?
One thing we can be clear on is that we do not want harmonisation at the expense of a permissive environment for ethically approved biomedical research. It will be enormously beneficial to biomedical research in the rare disease sector if all member states can agree on the legal basis for use of data in research, and under what terms consent can be given; but if it is limited to an agreement on a narrow and inflexible approach, then we will have stepped backwards, rather than forwards. We will have to compromise to harmonise.
About the author
Nick Meade is Director of Policy at Genetic Alliance UK, the national charity of over 180 patient organisations supporting all those affected by genetic conditions, and a member of the Patients’ Network for Health and Medical Research (EGAN). Genetic Alliance UK’s and EGAN’s policy work focuses on research and innovation to facilitate progress towards cures and treatments for unmet health need, on the commissioning of healthcare services and access to therapies, on genetic testing and genomic technologies, and on reproductive choice.
Genetic Alliance UK’s work includes leading the Rare Disease UK campaign and the SWAN UK group which supports families of children with undiagnosed conditions; Nick oversees both of these projects. Nick represents patients on panels and committees in the UK and Europe, including NHS England, UK Rare Disease Forum, UK Genetic Testing Network, National Institute for Health and Care Excellence and the European Medicines Agency.