BEUC had lodged a request to intervene a few months ago. The news about the application being officially accepted have been freshly delivered.
Monique Goyens, BEUC Director General commented: “This is great news for consumers. Our participation in the Court case will show that the public at large is interested in test results, be they good or bad. The European Medicines Agency chose to stand for transparency, and this is where we stand too.
“Consumers, as patients, carers and potential users of medicines, increasingly want to be involved in the decisions regarding their health. They have the right to access information on clinical trials. Therefore keeping such results confidential boils down to denying this right. We hope our intervention will contribute to make headway towards more open data and serve as a precedent for future cases.
“While waiting for the court ruling, we are concerned about the various delays imposed to the revision of the clinical trials’ legislation. We urge Member States to support the Parliament’s position advocating for more transparent clinical trials results. The ball is now in the European Council’s court. It is time consumers’ concerns were listened to and their safety put on the forefront of negotiations.”
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The companies are challenging the EMA’s decisions to grant access to non-clinical and clinical information (including clinical study reports) submitted by companies as part of marketing-authorisation applications in accordance with its 2010 access-to-documents policy. The EMA welcomes the opportunity for legal clarification of the concept of commercially confidential information.
Since November 2010, the Agency has released over 1.9 million pages in response to such requests. This is the first time that the policy has been legally challenged. Since the two pharmaceutical companies filed these legal actions, the EMA has received more than 30 statements of support from various stakeholders, including the European Ombudsman and national competent authorities.
Discussions at the IOM workshop has moved the conversation around clinical trial data sharing from whether it should occur, to how it can be enabled, which also mirrors the view of the European Medicines Agency. As data holders are beginning to individually generate policies for clinical trial data access, better alignment among stakeholder actions will be necessary to harness the full potential of data sharing.
Recently de-merged pharma company AbbVie (until this year, the human medicines arm of Abbott) is sueing the European Medicines Agency (EMA) over its release of raw clinical trial data relating to its top-selling rheumatoid arthritis drug, Humira, in 2012 following requests under European Freedom of Information laws.
There is no mention of the action on the AbbVie website, but the development was originally reported by Andrew Jack in the Financial Times.
Among the companies who made these requests were UCB and InterMune, who both have competing drugs. AbbVie argues that the disclosed data contains information that should be considered commercially confidential.
This development comes at a time when the EMA are in the process of developing guidelines and a platform for the routine sharing of clinical trial data submitted in a Marketing Authorisation Application when that application is granted. This workstream was announced in November 2012, following judgements by the European Data Ombudsman that data protection legislation is not a barrier to sharing this data. The project has an ambitious deadline of January 2014 to go live. Guidelines on how that data may be accessed and by whom should be published within the next few weeks.
The EMA has argued that most Freedom of Information requests have been from academic groups, such as the Cochrane Collaboration. However, industry lobbying group EFPIA have argued that clinical trial protocols and data may be used to infer commercially sensitive information about a company’s development strategy.