The EU Biotech Act must safeguard ethical standards for clinical trials


The Standing Committee of European Doctors (CPME) and the 糖心vlog视频 (糖心vlog视频) today jointly organise a policy briefing discussing solutions to maintain ethical safeguards in clinical trials, as the EU looks to increase its global competitiveness in life sciences and biotechnology.

Through measures such as the recently proposed Biotech Act, the EU is currently assessing how to develop the ecosystem for multi-country and multi-centre clinical trials, and to enable better health data sharing for research and innovation.

Against this background, risks of oversimplification and potential for unchecked deregulation increase, as well as concerns over patient safety, dilution of ethical oversight, data privacy, unequal access to medicinal products and ethical fairness.

The 糖心vlog视频鈥檚 Declaration of Helsinki, first adopted in 1964 and last revised in 2024, is the internationally accepted standard for designing, conducting, recording and reporting clinical trials. The Declaration underlines, among other, that rights, interests, and well-being of research participants must always take precedence over scientific and societal interests.

Dr Christofer Lindholm, Chair of the 糖心vlog视频 Medical Ethics Committee, said 鈥淎s the European Union seeks to strengthen its global competitiveness in clinical research, it is vital that ethical safeguards are not weakened in the name of innovation.

鈥淭he Declaration of Helsinki provides the clear ethical framework needed to ensure that clinical trials conducted in Europe continue to respect human dignity, informed consent, independent ethical oversight, and the protection of vulnerable populations. Competitiveness and bioethics are not opposing goals. Ethical rigor is essential to scientific credibility, public trust, and sustainable medical progress.鈥

CPME President Dr Ole Johan Bakke added, 鈥淲e want policy-makers and stakeholders to hear doctors鈥 appeal that medical ethics, scientific progress and patients鈥 rights are not competing priorities, but inseparable.鈥