EMA releases draft policy on access to clinical trial data

The European Medicines Agency released draft guidance Monday on the publication and access to clinical trial results as the regulator looks to balance access to data with the need to protect personal information. Under the proposal, the agency separated clinical data into three categories of access: commercially confidential information; open-access data that do not contain patients' personal information; and controlled-access data that will only be granted after the requester fulfills certain requirements, including the signing of a data-sharing agreement.

The agency began consultations on the publication of clinical trial data in November of last year. The EMA indicated that comments will be accepted on the draft guidance for three months, and a finalised policy will be published by the end of the year. The new policy is expected to come into force at the beginning of 2014 depending on the outcome of legal challenges and pending legislation.

Sanofi CEO Chris Viehbacher argued that the proposal could undermine the competitiveness of the industry because confidential information, such as details about manufacturing processes, could be accessed by competitors. "The manufacturing process is often where the know-how of the company is, and this is particularly true of biological processes," he said, adding that "if all of this stuff is laid out, then we could have competitors from any country, particularly outside of Europe." The executive, who took over as president of the European Federation of Pharmaceutical Industries and Associations (EFPIA) on Monday, suggested the policy could also stifle investment by pharmaceutical companies in Europe. The EMA's plans to release clinical trial data was also criticised by PhRMA, while Richard Bergstrom, director general of EFPIA, said that the association will release its position on the issue "any day now."

The EMA has since November 2010 released two million pages of detailed information about drugs it has assessed as part of its policy aimed at pooling research information and increasing transparency in the industry. In April, AbbVie and InterMune won an injunction preventing the EMA from releasing the companies' clinical trial documents until a final ruling is given. In particular, AbbVie sought an injunction preventing the agency from releasing clinical trial data about Humira (adalimumab), while InterMune's lawsuit related to information wanted by academic researchers.

For related analysis, read ViewPoints: Sanofi CEO Viehbacher surveys battleground Europe as he assumes presidency of EFPIA.

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