Out-Law News | 27 Jan 2015 | 12:56 pm | 3 min. read
The EMA has launched a consultation (28-page / 278KB PDF) on proposals which would flesh out more detail on what information pharmaceutical companies and other medical researchers would need to publish on a new publically-accessible database, as well as the timings of those disclosures, under the EU's new Clinical Trials Regulation. The EMA is responsible for developing and maintaining the database under the new framework.
The Regulation sets new standards on transparency for clinical trials conducted in the EU. The framework, which was finalised last year, is scheduled to be applied to new clinical trial tests beginning on or after 28 May 2016.
Information to be disclosed via the database under the new regime will include descriptions about the kind of trials being conducted and a summary of the results, whilst clinical study reports will also have to be published after medicines have been approved for sale.
However, there are some exceptions to the disclosure requirements. One exception is where information about clinical trials is "commercially confidential" and where there is not an overriding public interest in its disclosure.
The EMA said that 'commercially confidential information' under the new EU clinical trials rules, should be defined as "any information contained in the data or documents submitted to the database that is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the sponsor".
It said that a clinical trial sponsors can be said to have a 'legitimate economic interest' if they intend to obtain "a marketing authorisation for the investigational medicinal product or because they need to obtain research funding for that and future trials".
Whether information is commercially sensitive or not will be determined with reference to "the nature of the trial and status of the medicinal product being studied". The identity of the sponsor and whether they are a commercial or non-commercial organisation will not be factors considered as part of that determination, the EMA said.
The EMA said clinical trial sponsors might be able to withhold information about clinical trials if they are planning future research in the same area.
"It may be commercially confidential because the clinical trial is conducted to further basic or applied research on medicines and as such may be part of a process for which research funds have been obtained or may contribute to the obtaining of future research funds," the EMA said, "The sponsor may need to retain some confidentiality of research plans in order to sustain their ability to conduct original research and maintain funding for that research, the ability to publish that research in journals and to pursue their research programme in the future."
"Since these concepts are necessary to research funding they can also be considered to represent legitimate economic interests and fulfil the definition of commercial confidentiality … for the purposes of application of this Regulation," it said.
The EMA has said that a "graduated approach" should be taken to the disclosure of information that is commercially sensitive and relates to the marketing authorisation status of drugs that have been developed using clinical trials.
"The extent of information made public could progressively increase during the development period to the marketing authorisation of a medicine from first in human Phase I trials to post-authorisation Phase IV and low-intervention trials," the EMA said.
The EMA's consultation, which also addresses the issue of disclosing personal data under the new Clinical Trials Regulation, is open until the end of 18 February 2015.
Life sciences expert Helen Cline of Pinsent Masons, the law firm behind Out-Law.com, said: "The staggered approach to the release of information the EMA is proposing seeks to strike the right balance between transparency and public access, the need to protect the economic interests of companies and research organisations so that they are not placed at a competitive disadvantage and the need to protect patient privacy."
Martyn Ward, head of clinical trials for the UK's Medicines and Healthcare products Regulations Agency (MHRA) said: "It is important that information on clinical trials is made available to the research community, patients and the public but at the same time we must ensure that researchers in Europe are not put at a competitive disadvantage compared to other parts of the world."