The Wellcome Trust has collaborated with a number of leading medical research organisations to lobby the European Parliament and the Council of Ministers against amendments to the proposed EU Regulation, which could severely restrict the future growth of the life sciences sector in the EU.
The lobby group comprises of the European Organisation for Research and Treatment of Cancer, the Federation of European Academies of Medicien, France’s Institut Pasteur, Sweden’s Vetenskapsradet, Germany’s VolkswagenStifung and ZonMw, and the Netherlands Organisation for Health Research and Development. The group intends to urge the European Parliament to reject amendments to the proposed General Data Protection Regulation (the Regulation) previously successfully voted on by the European Parliamentary Committee on Civil Liberties, Justice and Home Affairs (LIBE) in October 2013 (see our previous blog.)
The original draft proposal for the Regulation, first released in January 2012, included a requirement for specific and explicit consent for the use and storage of personal data for secondary purposes; however, provided an exemption from this requirement for research purposes subject to stringent safeguards. As a result, this initial draft was considered “measured and sensible and struck the right balance between protecting the individuals and making possible huge benefits for all our health,” commented Wellcome Trust Director Jeremy Farrar in a statement to Bloomberg BNA 29 January.
However, LIBE’s amendments, if approved by the European Parliament and Council of Ministers, propose to remove the exemption from the consent requirement making the use of pseudonymised health data in research without specific consent illegal at worst, and unworkable at best. In effect, this could make it difficult, if not near on impossible, for research bodies such as the Wellcome Trust to use pseudonymised health data for secondary research purposes without specific consent. This could impose severe restrictions on the biotechnology industry, preventing growth in clinical trials and scientific research for the benefits of the health of European Citizens. The coalition lobby group aims to convince MEPs that health data is a vital resource for scientific breakthroughs, which will become impossible if the current draft of the Regulation is not challenged further.
One key argument of the lobby group is that the current position under the EU Directive 95/46/EC already offers a sufficiently robust governance framework which ensures an individual’s data is only used for research in the public interest and within the constraints of strict confidentiality measures. Furthermore in reality, the majority of participants of research studies already voluntarily provide their consent, rendering the requirement for specific consent under the Regulation superfluous. Reform of the EU data protection law as currently drafted therefore represents the worst case scenario for bodies such as the Wellcome Trust.
Reinforcing the coalition group’s campaign, UK Advocacy Group, the Fresh Start Project released a report titled ‘EU Impact on Life Sciences’ which similarly deplores the draft EU Regulation as exemplifying a biotech hostile regulatory framework. It condemns the Regulation for leaving member states with little room for manoeuvre to determine their own policies for data protection. It is perceived that if amendments to the Regulation are approved, this will constrain growth in health and scientific research, creating a ‘global slow lane for biotechnology’ and undermining Europe as a hub of biotechnology. This could effectively force Europe to take a backseat in a biotechnology revolution, inhibiting the chances of securing future investment for economic growth. Furthermore, this will put at risk significant European investments currently in place, including ‘The European Prospective Investigation Into Cancer and Nutrition Study’ involving more than half-a-million European citizens, not to mention plans for the European Medical Information Framework project worth €56 million, due to link together existing health data from sources across Europe to provide a central bank of information available to researchers for vital studies.
It remains to be seen whether the European Parliament will listen to concerns of the lobby group and examine the provisions of the draft Regulation in more detail. The fear is that such lobbying will go unheard. This is in light of recent comments from Vice President Viviane Reding, indicating that European Parliament is keen to adopt the current draft of the Regulation as approved by LIBE, in order to push forward full speed ahead for the much-anticipated EU data protection reform in 2014.