Clinical trial data to be available for download for academic and non-commercial purposes

Out-Law News | 19 Jun 2014 | 10:32 am | 3 min. read

Clinical trial data submitted as part of marketing authorisation applications in the European Union will be available for downloading, saving and printing for academic and non-commercial research purposes, the European Medicines Agency (EMA) has said.

In an apparent change to its draft disclosure policy announced last month the EMA has now said that its newly agreed policy on publication of clinical trial data "will not only allow the agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications, but also give the possibility to download, save and print the trial data for academic and non-commercial research purposes."

The development follows concerns expressed by European Ombudsman Emily O'Reilly last month that the EMA's draft disclosure policy planned to allow clinical data only to be seen on-screen, which the Ombudsman said would prevent researchers from downloading the data.  

Responding to the EMA's announcement that its agreed policy will allow data to be downloaded, a statement by O'Reilly's office said: "If implemented, the Ombudsman would welcome this change."

However O'Reilly pointed out that she remains "unaware" whether the EMA has suggested any changes relating to two other aspects of its clinical trials data policy which she said gave her "grave concerns" when they were published in its draft policy. She described these as "broad legal conditions on the access to and use of such data" and measures which allowed only "limited access to clinical trial data by redacting significant information".

"The Ombudsman welcomes the fact that the management board of the EMA seems to have responded to the concerns of the scientific community concerning on-screen access," O'Reilly's statement said. "The Ombudsman is unaware whether the management board has suggested any changes relating to the other two concerns."

"The change to the draft policy requested by (EMA's) management board will now require the EMA to make changes to the draft terms of use," the Ombudsman's statement said. "The Ombudsman will carefully examine the terms of use when they are modified to reflect the outcome of the management board meeting. The Ombudsman will also, in that context, examine how the EMA intends to redact the documents."

O'Reilly, who is responsible for investigating alleged maladministration in EU institutions and bodies, last month wrote to the EMA expressing concern at "what appears to be a significant change of policy concerning clinical trial data transparency". O'Reilly said that the EMA's draft policy envisaged limiting access to clinical trial data by imposing "strict confidentiality requirements" including allowing data to be seen only on screen using an interface provided by the EMA and imposing "wide restrictions" on the use of such data.

At the time the EMA, which is the EU agency with responsibility for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU, rejected the Ombudsman's suggestions that its draft policy could undermine the public's right of access to clinical trial data.

The EMA has now said it will finalise the wording of the policy, including practical arrangements for academic and non-commercial research users, with a view to its adoption by its management board by mid-July. The policy is due to be effective from 1 October 2014, the EMA said.

"Importantly, the agency will ensure that the policy will not prejudice citizens’ rights under existing access to documents legislation and the new clinical trials regulation," a statement by the EMA said. "Since embarking on its plans for the proactive publication of clinical trial data, the agency has aimed to achieve the broadest possible consensus among its stakeholders and their often competing views and interests."

Helen Cline of Pinsent Masons, the law firm behind Out-Law.com, said: "The last minute changes to the EMA’s transparency policy seem reasonable. Researchers, amongst others, were openly critical of the accessibility provisions under the original proposal."

"Pharmaceutical companies have had concerns about the proposed transparency policy particularly around disclosure of individual patient data," said Cline. "The EMA has listened to these concerns and will continue its dialogue with companies and other stakeholders to shape policy in this sensitive area.  In the first instance only clinical study reports will be disclosed and only after the product assessment process has been completed."

"The current policy, along with the proposed terms of use, has gone some way to reassuring companies that their commercially confidential information will be protected, although there are still concerns about validation of the identity of users. Only an email address is required for registration under the current scheme," said Cline. "In advance of the policy coming into force later this year, possibly October, companies may want to review the content of their clinical study reports."

The EMA's policy on clinical trials data is part of wider measures across the EU to address issues surrounding clinical trials. The EU Clinical Trials Regulation has now been published in the Official Journal of the EU, and is expected to apply from 28 May 2016.

The regulation will replace the existing EU Clinical Trials Directive and is designed to streamline the authorisation process and harmonise requirements for clinical trials in Europe. Under the forthcoming system, applicants will submit a single application for a clinical trial via a single EU portal.

Rules will be harmonised across the 28 EU countries, in contrast to the current situation where each state has its own set of rules to implement the existing directive. The regulation will apply from 28 May 2016 unless the IT infrastructure underpinning it is not fully functional, which would lead to a delay.