EU institutions have finally agreed a new data protection law that will govern the use of individuals' data across areas such as social media and marketing, and also research. Since researchers rely on analysing individuals' health data to understand more about health and disease, we've been working hard to ensure the new law works for them.
Beth Thompson,from Wellcome's Policy team, explains what the outcome means for research.
After four years of debate and negotiation, agreement was reached on the Data Protection Regulation on 15 December. This huge piece of legislation will update Europe’s data privacy laws which hadn't been changed since 1995.
At Wellcome, we think it's vital that the law facilitates research with personal data while ensuring that individuals' data is kept safe and used appropriately. That's why we've been working on the Data Protection Regulation since the outset in January 2012 to make sure that it strikes this balance.
The outcome for research is very positive. But it didn't always look like it would work out that way. We had been extremely concerned about amendments proposed by the European Parliament, which would have had a devastating impact on research involving personal data concerning health.
The initial draft Regulation proposed by the Commission set out a proportionate mechanism for protecting privacy, while enabling health and scientific research to continue. However, over the summer of 2013, Edward Snowden's leaks about the use of personal data by the US National Security Agency increased concerns about how technology companies and governments use data.
In response, the Civil Liberties and Home Affairs (LIBE) committee of the European Parliament supported a package of amendments to the Regulation intended to strengthen protections for data across all sectors. Research became an unfortunate victim of this reaction, since these amendments would have tightly restricted the way personal data can be used in research, all but removing a vital exemption from specific consent.
Requiring specific consent in almost all cases would have made much research involving personal data at worst illegal, and at best unworkable
We led opposition to these amendments, working with a coalition of research and patient organisations across Europe. We set out our concerns in many meetings, briefing papers, letters, blogs, news pieces and a social media campaign that was supported by over 7,000 individuals.
We're delighted that the EU institutions have listened to these concerns and the evidence we presented and that the Parliament's amendments have not been included in the final compromise text.
Instead the legislators have succeeded in their difficult task of finding an important balance in the text, and we're glad that this result will work for both individuals and researchers, by reinforcing existing safeguards.
The text now has political agreement having been supported by the LIBE committee of European Parliament and Member State representatives. Formal votes will take place next year, followed by a two year implementation period.
The final result is a significant achievement and a huge relief for the research community. Thanks to all of you who supported our work and contributed to this important outcome. Researchers will now be able to continue exploring new research opportunities with data under laws that are fit for purpose.
Wellcome will continue to work on securing a strong outcome for research as the Data Protection Regulation is implemented.