EMA consults public on plan to increase transparency of drug trial data

BMJ 2013; 346 doi: (Published 26 June 2013) Cite this as: BMJ 2013;346:f4124
  1. Deborah Cohen
  1. 1BMJ

The European Medicines Agency has stated its commitment to publishing clinical trial information on all drugs submitted as part of the licensing process, whether or not they are approved.

In a new draft policy document that has been distributed for consultation,1 the agency suggests that opening up its data would have many benefits for public health. Not only would it make drug development more efficient and aid the gathering of new knowledge, the European regulator said, but it would also allow better informed use of drugs and “enable third parties to verify the regulatory authority’s positions and challenge them where appropriate.”

Academics who have campaigned for access to trial data have broadly welcomed the move.

Tom Jefferson, one of the Cochrane Collaboration team that has accessed and analysed data submitted to the EMA concerning the influenza treatment oseltamivir (Tamiflu) (see, told the BMJ that the agency’s move was a big step forward. “The European regulator blows away all the restrictive archaic concepts of secrecy and commercial confidentiality in favour of public health and an open and frank society, while rightly adopting a cautious approach to identifiable personal data,” he said.

Clinical data submitted to regulators are complex and take many forms. The EMA said that its policy applies not just to randomised controlled trials but also to other types of interventional or observational clinical research methods, such as large simple trials, cohort studies, and case-control studies, and to registry data.

The agency said that the policy would come into effect on 1 January 2014 and would apply only to drugs that it reviewed on or after 1 March that year, after which date certain data would be publicly accessible on its website—although some information would be held back.

In an attempt to assuage concerns over protection of patient data and commercial confidentiality, the EMA said it is to put data into different categories and to allow different levels of access, according to the category. Submitted data may be “open access” (publicly available shortly after a decision has been made), “controlled access,” or “commercially confidential information.”

Controlled access information is that in which there is a need to protect personal data and is essentially “raw data” or patient level data. Such data may be made appropriately unidentifiable,2 or researchers can apply for access if they fulfil stringent criteria.

However, information about investigators and those involved in conducting a study would be accessible, as the agency said that “these persons have a role and responsibility for public health in ensuring the integrity of trial data.”

Peter Gøtzsche, director of the Nordic Cochrane Centre, also welcomed the move, but he pointed out some areas that might need careful scrutiny. He was concerned that some of the caveats in the policy preventing automatic disclosure of data—such as those concerning aspects of commercial confidentiality and patient protection—may be exploited by companies seeking to stop researchers getting access.

He told the BMJ, “The EMA should state explicitly that if companies submit applications that contain patient identifiable information they will be sent back without evaluation in order to prevent the situation from happening that companies deliberately include patient identifiable information in their applications to ensure that independent researchers cannot analyse the serious harms of their drugs.”

The EMA told the BMJ that concerns that the policy may be undermined by current legal action may not be justifiable. The US drug company AbbVie has taken legal action against the agency to try to prevent it from releasing data it holds on the safety and efficacy of one of its drugs, arguing that the information was commercially confidential.3

An agency spokeswoman told the BMJ, “The consultation on the new draft policy is a step adopted independently from the court cases. We expect a clarification on what is considered commercially confidential information from the General Court of the European Union.”


Cite this as: BMJ 2013;346:f4124