EMA Finalises Access to Clinical Trials Advice

The European Medicines Agency (EMA) has just released its final advice resulting from the clinical trial advisory groups set up last year. The next step will be the drafting of a policy on proactive access to clinical-trial data ready for consultation mid-2013.



Due to the on-going debate about transparency of clinical trial information, the EMA set up advisory groups to support the drafting of its policy on this topic. The advisory groups were designed to inform the EMA on five specific aspects: protecting patient confidentiality, clinical-trial-data formats, rules of engagement, good analysis practice and legal aspects. Between January and April 2013, over 200 people have participated in these groups.

At the time the groups were originally announced, the executive director of the EMA, Guido Rasi, stated that the agency "is committed to proactive publication of clinical-trial data, once the marketing-authorization process has ended. We are not here to decide if we publish clinical trial data, but how".

 

The EMA stresses that a sustained and high level of investment in pharmaceutical research is important for future improvements in public health. “The EMA’s policy will be designed to guard against any unintended consequences” including on intellectual property that might dis-incentivise future investment in research and development. Essentially, it needs to strike the right balance between ensuring transparency in the best interest of public health without impinging on the company’s intellectual property rights.

The data makes for interesting reading. For example, no agreement was reached by the group looking at whether the marketing authorisation holder be consulted before EMA discloses clinical trial data, in regards of commercial confidential information (CCI). They discussed the position that the EMA should only disclose CCI from non-clinical and clinical study reports and patient level data when there is an overriding public interest reason for doing so, under conditions which serve that interest. In addition, the final advice from this group recommended that the EMA should always consult with the marketing authorisation holder disclosure, to allow any necessary steps to be taken to protect against unfair competition and/or prejudice to regulatory data protection, patent or other IP rights.

A draft policy is anticipated to be ready for three months of public consultation by the end of June 2013. With the final policy anticipated to be published at the end of November 2013. In writing this the EMA will be taking into consideration the number of current court cases which will provide additional legal clarification around the concept of commercially confidential information. The EMA expects that the policy on proactive publication of clinical-trial data will come into force on 1 January 2014.