Court rules against EMA disclosure
pharmafile | May 2, 2013 | News story | Medical Communications, Research and Development, Sales and Marketing | AbbVie, EMA, Roche, transparency
The European Medicines Agency (EMA) has been ordered in an interim ruling by the General Court of the European Union not to release pharma-related documents in two cases for the time being.
In March AbbVie issued injunctions against the EMA to prevent the regulator revealing data about rheumatoid arthritis drug Humira.
US firm InterMune brought a similar case against the EMA regarding third party access to information about its lung disease drug Esbriet.
The EU court says the EMA – which is working on exactly how it will release clinical trial data from next year – must wait in these cases until a final ruling is given by the court.
The companies are challenging the EMA’s decisions to grant access to non-clinical and clinical information – including clinical study reports – submitted to support market authorisation applications for their drugs.
The agency is considering whether to appeal and says it ‘notes with regret’ the decision, adding that it has released over 1.9 million pages in response to such requests and that this is the first time the policy has been legally challenged.
The EMA says it will continue to grant access to documents pending the outcome of the final judgment on the main cases – and insists it will consider requests for access to documents similar to those contested by AbbVie and InterMune “on a case-by-case basis”.
The legal spat comes as the EMA released details of five working parties’ deliberations on the whole issue of how information should be released, and the agency will publish its draft policy on data disclosure at the end of June.
There will then be a consultation lasting until the end of September, with a final policy emerging in November and proactive publication of trial data – which it does not consider commercially sensitive and once the authorisation process has ended – to come into force on 1 January 2014.
Trust in the system by which drugs are approved for use is at the heart of the debate over data release – but pharma companies are concerned about the potential abuse of their intellectual property.
The Cochrane Collaboration, which has been locked in a battle with Roche over releasing Tamiflu data, has found that pharma companies – rather than researchers – have been behind the majority of requests for data filed with the EMA.
“This underscores our concern that commercially confidential information contained in EMA filings could be used by other companies to compete against the originator of the medicine,” suggested Dirk van Eeden, AbbVie’s senior director, public affairs, when the company filed its original suits.
Adam Hill
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