Recently, members of the European Parliament’s environment, health and food safety committee voted for greater transparency in the European Commission’s proposal to revise EU rules on clinical trials.
Draft EU rules on clinical trials of new medicines were endorsed by the Public Health Committee on Wednesday May 29 2013. A regulation designed to encourage research whilst protecting patients’ rights is to replace an existing directive with simpler, more uniform rules. The new text makes specific provision for low-risk trials, clarifies the duties of ethics committees and details how to obtain informed consent from patients. The new law features simplified reporting procedures, and empowers the European Commission to do checks. Once a clinical trial sponsor has submitted an application dossier to a member state, the member state would have to respond within fixed deadlines.
MEPs amended the draft to improve transparency. This would require that detailed summaries be published in a publicly accessible EU database, with full Clinical Study Reports published once a decision on authorisation is complete. Sponsors who do not comply with these requirements would face fines, said the committee.
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.
The EFPIA stated that it welcomes the European Parliament’s support of the Commission proposal for an effective, safe, simplified and robust clinical trials authorisation process in Europe, which will according to EFPIA ensure patients’ early access to new and innovative treatments.
“EFPIA member companies support ongoing efforts to continue improving the diverse means of sharing clinical trial data to benefit patients, foster scientific discovery and support ongoing investment into innovation. This requires industry, regulators, researchers and society to work together to ensure that patient privacy, the integrity of regulatory systems, and incentives to invest in biomedical research are maintained. Together with our international colleagues, we are now working to enhance data sharing with researchers and to enhance access to clinical study results after approval in the interests of advancing science and patient health. The details and mechanisms will be developed in the next few months in close collaboration with stakeholders including the scientific and patient community”, said Richard Bergström, Director General of EFPIA in a press release.