Could data protection law jeopardise vital research and development in healthcare?
New data protection rules that came into force in Europe in May 2018 are impacting different people in different ways, but in the broadest terms, the principles of the General Data Protection Regulation (GDPR) are:
– It increases privacy rights for individuals
– It strengthens the obligations of companies
– It increases the penalties for non-compliance
For research and development work in the pharma sector, the new law raised a number of questions that haven’t yet been answered. And we could live without the uncertainty.
Take away legally acceptable patient consent and we have no clinical trials.
Take away clinical trials and we have no new products.
Take away new products and people die. It’s that simple.
So what level of patient consent do we need to move research and development forward with confidence?
Informed consent under the existing Clinical Trials Regulation (CTR) is not the same as freely given, explicit consent under the GDPR. Consent under the CTR is based on the guidance of the Helsinki Declaration and draws on ethical considerations such as the dignity and respect patients are shown. GDPR rules are more black and white, offering straightforward protection of individuals when it comes to the processing of their personal data. And even when a patient gives both informed and explicit consent for use of that personal data, it could be argued that it’s not freely given. If a patient’s health and well-being depends on them taking part in a clinical trial, are they really in any position not to give their consent?
Clinicians and researchers who have acted professionally and ethically for trial after trial, year after year now have new boxes to tick. When consent is given for initial research, what happens when the first round of results comes in? In the normal course of events, data would be shared and published for the common good. If GDPR puts up barriers to these acts or puts the brakes on what might be classed as commercial use of research data, the entire purpose of clinical trials could be jeopardised.
In time, a sensible compromise will surely prevail, showing due respect for patient privacy without losing sight of the essential needs of the Life Sciences sector and the people whose well-being it safeguards. The right to data privacy doesn’t have to preclude the right to good health, and ultimately it won’t. In the meantime, while we’re still hacking our way through the legislative jungle, one thing is clearer than ever.
Dotting your ‘i’s and crossing your ‘t’s really matters. Attention to detail really matters. It matters on every project, in every sector and in every language. We’re living in a new age of consent, and there are no prizes for failing to comply.