The draft Clinical Trials Regulation was endorsed by the Public Health Committee of the European Parliament, following a series of votes yesterday. The report drafted by Glenis Willmott (S&D, UK) was adopted unanimously. Ms Willmott received a mandate to negotiate an agreement with EU ministers. The draft is expected to go before a plenary sitting of the European Parliament on October 8th.
In a press release, the Parliament commented on specific aspects of the proposed Regulation:
- MEPs amended the draft to improve transparency, by requiring that detailed summaries be published in a publicly accessible EU database, with full Clinical Study Reports published once a decision on authorisation is complete. Fines would be imposed on sponsors who do not comply with these requirements.
- For low-risk clinical trials, compensation for damages would be covered by the general compensation system established under the national security or health care system. For other clinical trials, the sponsor would be deemed liable for damages, but could make use of a national indemnification system which all Member States should set up to reduce high insurance costs.
- MEPs also clarified the role of ethics committees in authorising a clinical trial. Rules on obtaining a person’s informed consent to taking part in a trial are laid down in detail, so as to ensure proper access to information and compensation for damages. Specific rules would also apply to clinical trials on pregnant or breastfeeding women, on persons deprived of liberty and on people with specific needs.
A consolidated draft of the Regulation, including the committee’s amendments, is expected in due course.