Out-Law / Your Daily Need-To-Know

EMA policy on access to clinical reports finalised

Out-Law News | 03 Oct 2014 | 4:46 pm | 2 min. read

Clinical reports submitted by drugs companies to the European Medicines Agency (EMA) in support of their case for permission to be granted to market new drugs are to be accessible to third parties for non-commercial purposes from next year.

The EMA has outlined a new policy on the publication of clinical reports (22-page / 244KB PDF). The reports contain some data from clinical trials carried out on prospective new medicines.

"The Agency takes the view that access to clinical data will benefit public health in future," the EMA said in its new policy document. "The policy has the potential to make medicine development more efficient by establishing a level playing field that allows all medicine developers to learn from past successes and failures."

"Furthermore, it will enable the wider scientific community to make use of detailed clinical data to develop new knowledge in the interest of public health. Access to clinical data will allow third parties to verify the original analysis and conclusions, to conduct further analyses, and to examine the regulatory authority's positions and challenge them where appropriate," it said.

Under the new policy, which will be effective from 1 January 2015, anyone will be able to register to access and search data in clinical reports published after that date on a view-only basis. The EMA said that any commercially confidential information contained in the clinical reports would be redacted before the reports are made publically available.

Registered "identified users" who provide the EMA with details of their identity, including possibly their passport number and affiliation to third party organisations, will also be able to download the reports.

Access to the reports on both bases is intended to facilitate "non-commercial research" and is subject to terms and conditions. The terms of use include requiring those accessing the reports to commit not to attempt to "re-identify the trial subjects or other individuals from the information", use the reports in support of their own marketing authorisation applications or generally "make any unfair commercial use of the clinical reports".

The EMA also explained that researchers that make use of the information contained in the clinical reports will be required to disclose their "secondary analyses" of the data publically "for further scrutiny by the scientific community".

The Agency said it also wants to vet any proposed new articles on the information in the clinical reports before they are published.

"Those who perform secondary analysis of clinical data published in accordance with this policy, are encouraged to provide the Agency with a copy of any article resulting from such secondary analysis before publication, in particular in those circumstances where the secondary analysis might result in the need for regulatory action to protect public health," the EMA said in its policy. "This is a critical consideration in view of the Agency’s role and responsibilities for a timely review of all available information which might have an impact on the benefit/risk ratio of centrally authorised products."

The EMA's executive director Guido Rasi said the new policy "sets a new standard for transparency" in medical research and claimed the "unprecedented level of access to clinical reports" will serve to benefit patients, health care officials, researchers and drugs companies. The EMA said its policy would "serve as a useful complementary tool ahead of the implementation of the new EU Clinical Trials Regulation", which expected to come into force by May 2016.

Life sciences expert Paul Ranson of Pinsent Masons, the law firm behind Out-Law.com, recently said that the EMA is still separately to outline its policy on the disclosure of individual patient data stemming from clinical trials.