European doctors’ proposed amendments to EU Biotech Act: Futureproofing innovation hand-in-hand with medical ethics

Dr Ole Johan Bakke (CPME President) said “Access to pharmaceuticals is facing new and severe challenges. Therefore the Biotech Act has a legitimate emphasis on research and innovation in Europe to improve effectiveness and availability of treatments to our patients. For European doctors, this innovation goes hand-in-hand with medical ethics.

“We see good proposals in the Biotech Act towards strengthening ethics, for example  in the Clinical Trials Regulation, but we need to futureproof this. We also emphasise the need to ensure access is realised in practice. Therefore we reject the extension of Supplementary Protection Certificates. Lastly, we underline the importance of patient-centred research, and the need to clarify their rights and roles in research.”

Dr Christiaan Keijzer (CPME Immediate Past President) said “The Biotech Act has the potential to strengthen medical ethics in research, but to achieve this, ethics committees need to be adequately and sustainably resourced. We also need to ensure their independence:  coordination between ethics committees and competent authorities should not be used to override or unduly influence the ethical review of an ethics committee.

“We also welcome the reference to the World Medical Association’s Declaration of Helsinki and emphasise its importance as a global consensus. We also propose to add a reference to the Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks as a complement which guides also new avenues of research.”

A report on January’s joint event with the World Medical Association is available here.

Image: iStock / Totojang