The European Medicines Agency (EMA) has been ordered by the General Court of the European Union (EU) not to provide documents as part of two access-to-documents requests until the Court gives a final ruling.The Court has given these interim rulings as part of the court cases brought by drugmakers AbbVie and InterMune, which 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 (MA) applications in accordance with the Agency's access-to-documents policy of 2010.
The EMA said yesterday (April 30) it is considering whether to appeal the interim decisions. While it "welcomes" the opportunity for legal clarification of the concept of commercially-confidential information, it says it also "notes with regret” the decisions of the President of the General Court to grant interim relief to AbbVie and InterMune and to order the Agency not to release the relevant documents until a final judgement in the main cases is made.
However, the EMA adds that, pending the outcome of the final judgement on the main cases, it will continue with its policy of granting access to documents. It will consider requests for access to documents similar to those contested by AbbVie and InterMune on a case-by-case basis in light of the Court Orders, it says, pointing out that since November 2010 it has released over 1.9 million pages in response to such requests, and that this is the first time that this policy has been legally challenged.
Also, since AbbVie and InterMune filed their legal actions, EMA has received more than 30 statements of support from various stakeholders, says the Agency. These have included the European Ombudsman, national competent authorities, members of the EMA Management Board, Members of the European Parliament (MEPs), academic institutions, non-governmental organisations, citizens' initiatives and scientific journals. Some of these have also applied to formally intervene in defence of the EMA at the Court, it adds.
EMA executive director Guido Rasi was reported yesterday as warning that if the Court orders the Agency to stop the release of data, "that would be the worst possible boomerang for the industry. The most powerful weapon we have to tackle distrust is transparency," he said.However, the Pharmaceutical Research and Manufacturers of America (PhRMA) commented that while biopharmaceutical companies support "responsible data-sharing that protects patient privacy, maintains the integrity of the regulatory review process and preserves incentives for biomedical research…unfortunately, the EMA's current and proposed policies fail to respect these principles."
- EMA has also said that it will continue the process begun in 2012 towards proactive publication of data from clinical trials supporting the authorisation of medicines once an MA decision has been taken, and will continue with the process of drafting its policy on proactive publication of clinical trial data