EU Parliament approves new rules on clinical trials
Proposals include creating a publicly accessible EU trials database
The European Parliament’s Committee on Environment and Public Health (ENVI) has adopted draft EU rules on clinical trials of new medicines.
A regulation designed to encourage research while protecting patients' rights is to replace an existing directive with ‘simpler, more uniform rules’.
The new regulation makes specific provision for low-risk trials, clarifies the duties of ethics committees, and details how to obtain informed consent from patients.
The next step is to negotiate an agreement with EU ministers to try to take the legislation forward.
Committee rapporteur Glenis Willmott, who is steering the legislation through Parliament, said the first version of the Clinical Trials Directive was ‘geared towards trials sponsored by pharmaceutical companies’ rather than non-commercial sponsors, and was widely believed to have led to an increase in ‘unnecessary bureaucracy’.
Getting better legislation in place soon is crucial to enable and encourage life-saving research
‘Between 2007 and 2011, the number of clinical trials started in Europe fell by 25%,’ she said. ‘Getting better legislation in place soon is crucial to enable and encourage life-saving research.’
The proposals introduce a series of measures, including the creation of 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 healthcare system. For other clinical trials, the sponsor would be deemed liable for damages, but could make use of a national indemnification system which all EU Member States should set up to reduce high insurance costs.
Specific rules would also apply to clinical trials on pregnant or breastfeeding women, on persons deprived of liberty and on people with specific needs, according to the ENVI Committee.