The new General Data Protection Regulation will have a significant impact on how medical research is conducted on the one hand, and how a patient’s privacy is protected on the other. Lawmakers disagree on what is the perfect balance between these two. Too strict privacy protection laws will hinder scientific progress, but legislation that is too permissive will breach a patient’s privacy. But where would patients strike the balance? The report ‘The Voice of Patients on Data Protection’, sheds light on this issue by focussing on what patients have to say.
Striking the right balance
Medical research is significantly affected by the rules for data protection as in many cases large datasets of personal data is used. How to strike a balance between the use of personal data for research purposes and protecting one’s privacy? The position of European lawmakers diverges strongly on this issue, but there is also common ground. All stakeholders involved, including the Commission and the European Parliament, support scientific progress and created specific measures for the use of data for research purposes. The report reveals that patient and patient organisations also support scientific progress and privacy protection, but find it difficult to strike the right balance between these two. Results show no clear consensus on the most pressing issues. Perhaps it is an unfair question to ask patients as they are the most important beneficiaries of medical research and thus have an important stake in scientific progress. At the same time, patients are individuals that want their privacy protected. Therefore the report recommends that the stakeholders involved should demonstrate better how both scientific progress and the protection of privacy could go hand in hand. Patient organisations, representing the individual patients, have a key role to play in this.
The scope of consent
One of the most heated debates is about the way in which patients give consent to the use of their personal data. Will a general consent suffice, or do patients need to give consent every time their data is used? The proposal of the Commission seems to indicate that general consent should be adequate. The resolution of Parliament, however, seems to suggest a stricter regime with their requirement that ‘consent shall be purpose-limited.’ The survey results show that patients find the requirement of consent important, but their positions on general consent, however, are mixed. Patients do believe that they should always have the right to withdraw the given consent.
Still time for action
The study reveals that the proposals by the Commission and the Parliament contain several ambiguities, rules that leave much up for interpretation. This observation opens the door to action. The final proposal will most likely contain provisions that need further interpretation, once the new legislation will be implemented. This leaves room for stakeholders to continue to have their voices heard.
Status quo
By November, the further trilogue-meetings on the GDPR will take place. The Commission, the European Parliament and the Council of the EU have agreed on a roadmap to finalise the negotiations before the end of 2015. However, it is expected that negotiations will continue in 2016 during the Dutch presidency of the EU.
By Gertieme Fahner & Tim Buiting
More information
Survey: The Voice of Patients on Data Protection
Press release: EU Data protection reform on track: Commission proposal on new data protection rules in law enforcement area backed by Justice Ministers
Neth-ER article: Data protection in research: a healthy business?
