Open access to clinical data on new EU medicines

From 20th October 2016, clinical data are publically accessible to all courtesy of the European Medicines Agency (EMA). The agency has introduced open access to clinical data for every new medicines for human use authorised in the European Union (EU).

The EMA states that “citizens, including researchers and academics, will be able to directly access thousands of pages from clinical reports submitted by companies to EMA in the context of marketing authorisation applications.

The EMA which have a longstanding commitment to transparency on clinical data, is the first regulatory authority worldwide to provide such broad access to clinical data.

A similar level of transparency is proposed in the new Clinical Trials Regulation, but the implementation of this regulation is at least 2 years so the execution of this initiative is a bridge between now and the Clinical Trials Regulation coming into effect.

The EMA promote a positive outcome to providing access to the data being that patients and healthcare professionals will be able to find out more information about the data underpinning the approval of medicines they are taking or prescribing. It will be interesting to see how what the level of use is by this population. Review of the information by academics and researchers seems likely to be high. This should increase scientific knowledge and potentially further inform regulatory decision making in the future. The EMA also says that increased transparency will benefit innovation. The shared knowledge about a medicine should help drug developers learn from the experience of others and lead to more efficient medicine development programmes. It should however be noted that terms and conditions state permit use of the site for ‘general information purposes’ or for ‘academic and other non-commercial research purposes.

As a first step, the EMA has published data for two medicines, Kyprolis (carfilzomib), an orphan cancer medicine for the treatment of multiple myeloma, and Zurampic (lesinurad), a medicine for gout . The data represent a very large approximate 260,000 pages of information from over 100 clinical reports. The intention is to progressively add data online for all applications concerned since the policy entered into force. This will be a learning curve for the Agency and all its stakeholders, as they start to apply the policy for the first time. While the policy gives an unprecedented proactive access to clinical data, it also demands the highest standard of protection of patients’ personal data.

Once the process is fully implemented and the backlog has been dealt with, EMA aims to publish the reports 60 days after a decision on an application has been taken, or within 150 days after the receipt of the withdrawal letter. The EMA is committed to these timelines but whether or not they can comply with them remains to be seen. Based on current estimates, the EMA expects to offer access to approximately 4,500 clinical reports per year.

For the EMA press announcement click here.

To access the clinical data, you have to open an account. Click here to register.