The European Consumer Organisation (BEUC) has been granted leave to intervene in support of the European Medicines Agency (EMA) during pending legal proceedings over the agency’s policy of releasing clinical study reports (CSRs) and other information from marketing authorisation applications (MAAs).
BEUC lodged a request a few months ago to intervene in the case awaiting a final verdict from the General Court of the European Union. The British Medical Association was given permission to intervene on the EMA’s behalf last July.
Following legal action by AbbVie and InterMune, the General Court delivered an interim ruling on 30 April instructing the EMA not to release data (including CSRs) submitted in MAAs by the two companies, citing commercial confidentiality.
The EMA said it would continue granting, in line with its revised policy introduced in 2010, access on a case-by-case basis to requested documents similar to those disputed by AbbVie and InterMune, until the General Court made its final decision.
In the meantime, the agency has put out for consultation a draft policy on publication of, and access to, clinical-trial data.
Under these proposals, clinical-trial data, information or documents not subject to restrictions on access to commercially confidential information or personal data would, from 1 January 2014, be available to download once the agency had published its European public assessment report on an application for centralised authorisation.
Stand for transparency
BEUC director general Monique Goyens said the permission to intervene in support of the EMA was “great news for consumers”.
By participating in the General Court case, the organisation would “show that the public at large is interested in test results, be they good or bad”, Goyens added. “The European Medicines Agency chose to stand for transparency, and this is where we stand too.”
While waiting for the court ruling, though, BEUC remains concerned about the “various delays imposed” on revisions to the European Union’s Clinical Trials Directive.
Under amendments introduced in the European Parliament to the Commission’s proposed regulation on clinical trials, sponsors in the EU would have to publish full clinical study reports once a marketing-authorisation decision had been taken.
“We urge Member States to support the Parliament’s position advocating for more transparent clinical trials results,” Goyens commented.
“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.”