Report: Safeguarding bioethics in clinical trials in a competitiveness-driven EU
The event discussed how to protect patients and uphold medical ethics while adapting to this changing research landscape and regulatory framework.
Recent months have seen much activity on the competitiveness of the EU’s life sciences and biotechnology sector. In 2024, Mario Draghi’s influential report called for greater use of health data for research purposes. The European Health Data Space is seen as a milestone for the clinical use of patient data and holds potential for further use in research. More recently, the Biotech Act proposal looks at reforming rules to support innovation in Europe, including a revision of the Clinical Trials Regulation.
Alongside the potential benefits for patient care, these developments raise questions about data privacy, ethical safeguards and equitable access to treatments.
In a discussion under the Chatham House Rule, invited stakeholders and the European Commission presented their views. Following the event, we interviewed several speakers for this report.
Dr Ole Johan Bakke (CPME President) said that there is a legitimate demand for research and innovation to access health data spaces to improve treatments and competitiveness. However, he stressed that medical ethics, scientific progress and patients’ rights are not competing priorities, but inseparable.
Dr Christofer Lindholm (Chair of the WMA Medical Ethics Committee) added that it is vital that ethical safeguards are not weakened in the name of innovation.
He emphasised that competitiveness and bioethics are not opposing goals. Ethical rigor is essential to scientific credibility, public trust, and sustainable medical progress.
Dr Otmar Kloiber (WMA Secretary General) noted that the Biotech Act introduces new methods and new types of regulations, which in part are experimental, in order to reduce bureaucracy and streamline clinical trials. This comes at a time of increasing use of AI, big data and biobanks which are being used for generating new information.
He called for regulation which does not hinder ethical review and respects the ethical principles laid down in the Declaration of Helsinki. This provides a protection for the people which are in clinical trials, be they patients or volunteers, and provides safety for the researchers because they know that they do ethical research.
The speakers explained that ethics committees are independent, multidisciplinary bodies that protect the rights, safety, and informed consent processes for human research participants.
Dr Bakke said that ethics committees need to have decent conditions and be properly financed and staffed, to be able to work with the real ethical problems and challenges.
Dr Monique Al (Co-chair of MedEthicsEU) said she is pleased that role of medical research ethics committees has been strengthened in the Biotech Act. She reiterated the importance of securing sufficient resources to fulfil their roles and responsibilities.
Claudia Louati (Head of Policy, European Patients Forum) said that it is essential that patients’ safety and needs remain at the heart of the review of the Clinical Trials Regulation. She highlighted the definition of unmet medical needs, involvement of patients in the design of protocols, and in the redesign of the research, and the access to the medicines and innovations that address patients needs.
Dr Christiaan Keijzer (CPME Immediate Past President) said that the Biotech Act has the potential to improve the role of ethics committees, strengthening position of patients. However, he emphasised that we must look closely at the position of patients throughout the negotiations on the regulation.
Prof. Dominique Sprumont (Council for International Organizations of Medical Sciences) concluded that we are at the crossroads, both at European and international level, on promoting innovation whilst balancing the respect for human rights and the dignity of the participants.
He said that the Biotech Act is setting a useful basis, but further clarifications are needed. For example, improving the recruitment of patients especially in multinational clinical trials must be considered.
Dr Péter Álmos (CPME Vice President) said CPME will continue to be an active partner in the further development of the regulations.