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EMA policy on clinical trials data: What are the main changes?

15 January 2015 Federica Benassi

On January 1, 2015, the European Medicines Agency (EMA) started to proactively publish clinical data concerning applications for centralised marketing authorisation. The policy initiative is unprecedented and represents a considerable shift in the approach adopted by the EMA on transparency. In fact, although the EMA made it possible to access documents, including clinical-trial reports, since November 2010, information were only disclosed to the individuals that filed a formal request - defined by the EMA 'reactive approach'. According to reports from the agency, between November 2010 and April 2013, the Agency provided access to more than 1.9 million pages of clinical-trial data. With the implementation of the new EMA policy, access to data is likely to further expand.

A proactive approach to clinical data disclosure
The new policy foresees that clinical reports will be immediately made available to the wider public to consult after a decision on marketing authorisation is reached - as part of the EMA's proactive approach. The EMA has distinguished, however, between two different levels of access to the documents. For general information purposes, the terms of uses exclusively allows a "view-on-screen-only" mode. Conversely, for academic and other non-commercial research purposes, documents can be downloaded, printed, and saved. This option is expected to offer the opportunity to third parties to re-evaluate evidence as well as potentially expand current knowledge.

With regard to commercially confidential information (CCI), the EMA takes the view that clinical reports generally are not CCI. This position has been challenged by the European Federation of Pharmaceutical Industries and Associations (EFPIA) in the comments submitted to the EMA on the occasion of a three-month public consultation on the agency's data disclosure policy. In the comments submitted to the EMA, EFPIA maintained that the policy will "weaken incentives for companies to invest in biomedical research by disclosing (CCI), without due consideration of the competing interests that may or may not justify disclosure". The EMA, however, provides the possibility for marketing authorisation holders and applicants to request the removal of CCI from the documents published. In addition, the EMA assures that protection will also be guaranteed in terms of patient privacy and personal data protection in compliance with existing EU legislation.

Implementation of the new policy
The EMA policy will be implemented in two separate phases; on the 1 January 2015 information on new medicines that receive authorisation for commercialization will be published. Then from 1 July 2015, access to clinical reports will also be provided for drugs approved for line extensions and extensions of indications.

The publication of the policy has been followed by a key transitional period for the EMA. In fact, the European Union Civil Service Tribunal has issued a judgment annulling the procedure that selected the candidates for the position of executive director of the agency in 2011. The EU court's decision has resulted in the resignation of Guido Rasi from his role of executive director of the EMA and the EMA Deputy Director, Andreas Pott, has assumed managing and operational responsibilities. The interim Director will be, therefore, responsible for managing the implementation of the new policy in 2015.

Certainly, the EU has significantly increased its focus on clinical data transparency and the effects of these changes are likely to become tangible over the next couple of years. In fact, the EMA policy does not represent an isolated initiative, but it was designed to complement regulation 536/2014 on clinical trials on medicinal products for human use approved by the European Parliament in April 2014 and which will enter into force in the EU in May 2016. Meanwhile, the US Department of Health and Human Services (HHS), in collaboration with the National Institutes of Health (NIH), recently put forward a proposal for improving public access to clinical trial information. Furthermore, the World Health Organisation has released an official statement on Public Disclosure of Clinical Trial Results to increase accessibility of clinical trials results for the public. Therefore, it will be interesting to see whether a similar focus on data disclosure will be given, although in different forms, by other countries.

Federica Benassi is a life sciences analyst for IHS
Posted January 15. 2015

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