European Medicines Agency receives interim decisions of the General Court of the EU on access to clinical and non-clinical informationPress release
The European Medicines Agency [EMA] has been ordered by the General Court of the European Union not to provide documents as part of two access-to-documents requests until a final ruling is given by the Court. These interim rulings were made as part of court cases brought by two pharmaceutical companies, AbbVie and InterMune. The companies are challenging the Agency’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.
While the Agency welcomes the opportunity for legal clarification of the concept of commercially confidential information, it notes with regret the decisions of the President of the General Court to grant interim relief to AbbVie and InterMune and to order the EMA not to release the concerned documents until a final judgement in the main cases is made. The EMA is considering whether to appeal the interim decisions. The EMA remains committed to transparency and openness of information to meet the legitimate public interests to enable scrutiny of the Agency’s recommendations on medicines.
Pending the outcome of the final judgement on the main cases, the EMA will continue with its policy to grant access to documents. Requests for access to documents similar to those contested by AbbVie and InterMune will be considered on a case-by-case basis in the light of the Court Orders. 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, national competent authorities, members of the Agency’s Management Board, Members of the European Parliament, academic institutions, non-governmental organisations, citizens’ initiatives and scientific journals, some of whom have also applied to formally intervene in defence of the EMA at the Court.In 2012, the EMA started a process towards proactive publication of data from clinical trials supporting the authorisation of medicines once a marketing-authorisation decision has been taken. The Agency will continue the process of drafting its policy on proactive publication of clinical-trial data and will publish today the final advice from the five advisory groups which were set up to inform the Agency on specific aspects of the policy.
EMA Ordered Not To Release Trial Data, For Now
by Ed Silverman
A few weeks ago, two drugmakers filed requests for an injunction to prevent the European Medicines Agency from releasing detailed patient-level data from studies about their drugs. The moves by AbbVie and Intermune are the first such challenges to a three-year-old agency policy to provide access to documents and were made in response to a pair of Freedom of Information requests made to the EMA last year to release “raw data” on safety and efficacy. AbbVie, for instance, is trying to prevent rivals from obtaining data about its best-selling Humira treatment for rheumatoid arthritis.
Today, the General Court of the European Union ordered the EMA not to provide any documents to the drugmakers that filed the Freedom of Informatoin requests, at least until a final ruling is given. In a statement, the EMA says it is considering whether to file an appeal. Nonetheless, the agency plans to continue releasing documents on a case-by-case basis, depending upon the outcome of these challenges. Since November 2010, the EMA says more than 1.9 million pages of documents have been released in response to access requests.Since the challenges were filed, the EMA claims to have received more than 30 statements of support from European Ombudsman, members of the European Parliament, academic institutions, non-governmental organizations and scientific journals, among others. Conversely, US and European pharmaceutical industry trade groups have filed papers supporting the drugmakers…
We can expect this kind of thing to go on and on. See, they think they’re right too. They know that if there had been Data Transparency from the start, far fewer CNS drugs would’ve made the cut and been approved. But more important than that, the false claims could have been debunked – vetted by do-gooders like you and me [who are all over the place]. There are some drugs that shouldn’t have been approved, but worse, most CNS drugs had fictitious indications, inflated efficacy claims, and inaccurate adverse effects profiles [several post-doc fellows could’ve gotten tenure on Paxil alone].
AllTrials isn’t perfect as it stands. This "panel approval for access" clause is a problem. Then there’s "study reports" versus "raw data", or that "commercial interests loop-hole" [upper right image]. But in my estimation, AllTrials is "close enough for government work" – because it has the word "All" right there in its name. If we get that far, the intent will be on the books. Then it’s our fight to fight. Without "All", it’s nickle and dime ’til the end of time…