Trialogue talks must strike balance between data protection and vital health research

By European Alliance for Personalised Medicine Executive Director Denis Horgan

The debate about the use of Big Data in research is hotting up, and it is clear that the strict lines of personal versus anonymous data will need to be reworked somehow. Due to the explosion in data capture, storage and sharing, the European Commission put forward a new General Data Protection Regulation, or GDPR back in 2012. The European Parliament then put forward a varied version in May 2014. The latter text takes the view that processing personal data will require informed consent. But this does not take into account the age of the data (how can you get consent from somebody who has passed away?) the use of the data, nor whether or not privacy-enhancing technology is used – partly anonymized, as it were.

As it stands, may well be applied across the board, much to the dismay of researchers everywhere and stakeholders in, for example, the European Alliance for Personalised Medicine (EAPM).

The Alliance has argued, and continues to do so, that the Parliament’s version, which appears to envision only two types of data – personal and anonymous - could seriously jeopardize health research. This is because data used in health research often contains indirect identifiers. In the summer of 2015, however, the Council of Ministers tabled its own version of the GDPR – a much more research-weighted proposal in which further use of personal data is not viewed as being incompatible with the original use for which the data were processed. Under this proposal, broad-based consent would be allowable, while any research taking place without consent would be left to Member States’ own legislation. This is, in fact, as it currently stands under the EU’s existing directive, and represents the Europe-wide standard for processing personal data. This is because Directives require enshrinement into member state law. Essentially, if the Council’s version were to prevail, total EU-led harmonisation would not be reached for research from personal data used without consent. Crucially, the Parliament’s proposal ignores research that contributes to health-care systems, allowing learning as they go forward.

And as it stands, any research based on registries of millions of patients would need the informed consent of every single patient. Apart from anything else, this makes a mockery of calls to reduce waste in research regulation and management, as well as initiatives focused on responsible sharing of individual data linked to clinical trials.Generally speaking, patient organizations (as well as researchers) much prefer the Council proposals, with surveys suggesting that most patients are happy to share their data for certain types of research – as long as trust is there.

In late June the trilogue between Commission, Parliament and Council began in a bid to negotiate the final text. As mentioned above, EAPM, its members and other stakeholders – not least patients – hope that the eventually agreed version will not be over-protective and certainly leave room for vital medical research. In short, any laws need to weigh risks and benefits proportionately.There is no doubt that the improved use of health-related data can transform both our healthcare systems and the lives of patients. Despite this, there is currently the legal uncertainty already outlined. But the Alliance believes that Europe needs a responsive system of regulation that offers high levels of protection for individuals as well as, but not instead of, high-quality data access for researchers and healthcare providers.Without doubt, data protection is a fundamental issue. Yet EAPM holds that the next steps in improving European healthcare are critically dependent upon the use of data. This will require a system in which data can be accessed in a secure and efficient way for appropriate purposes, for the benefit of current and future generations of EU citizens.

Share this article: