Dr Jacques de Haller, President of the Standing Committee of European Doctors (CPME) said: ,,The re-use of health data in the context of medical research is at the centre of EU discussions. If medical research using Big Data has the potential to increase knowledge for the benefit of society, it is equally important to guarantee patients autonomy and their rights to self-determination. The WMA Declaration of Taipei provides ethical guidelines which are needed to guarantee an ethical and transparent re-use of health data".
On 8 April 2017, the Standing Committee of European Doctors (CPME) endorsed the WMA Declaration of Taipei on ethical considerations regarding health databases and biobanks, which was adopted by the General Assembly of the World Medical Association (WMA) in October 2016. This Declaration lays down ethical guidelines for physicians involved in the collection and use of identifiable health data and biological material, building on the WMA Declaration of Helsinki and on the importance of obtaining informed consent before using personal health data and biologic materials.
The Declaration of Taipei also provides a transparent governance process in cases where obtaining informed consent is impractical. This governance framework is based on a multiple-step mechanism involving an ethical review of the justification for the establishment of a database, the securing of an initial consent given on the basis of limited information and a third party oversight by an ethics committee before any re-use of the personal data (consent plus governance solution).
CPME considers that this Declaration provides the additional safeguards needed to complement the new EU General Data Protection Regulation (GDPR) that was adopted in April 2016. While the GDPR introduces the notions of ‘privacy by design’ and ‘privacy by default’, it was left to the Member States the possibility to provide for appropriate safeguards for the processing of personal data for secondary purposes, including scientific research.
The Declaration of Taipei on ethical considerations regarding health databases and biobanks is available on the website of the WMA:
https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/