Release of documents under the Transparency Regulation on two medicines temporarily halted

Two appeals lodged by the EMA against interim measures imposed by the General Court relating to the release of documents requested by third parties under Regulation (EC) 1049/2001 have been dismissed.

Whilst both cases contend that release of the documents in question would infringe their right to protection of commercially confidential information in their MAs, the crux of the issue being debated in the Translarna case is whether it should be presumed that any document submitted to the EMA in support of obtaining a MA is confidential, where that document contains information that is not already in the public domain. The EMA contends that this is an incorrect interpretation of Article 73 of Regulation No 726/2004, which provides that Regulation No 1049/2001 applies to documents held by the EMA. In accordance with Article 4(2) of Regulation No 1049/2001, the EMA must grant applications for access to documents covered by industrial and commercial secrecy when justified by an overriding public interest in disclosure. The EMA amended its policy on access to documents in November 2010 to state that after an MA has been granted, documents submitted to the EMA in support of the assessment for that MA may be released. The complexity in the interpretation of this legislation is that it must strike a balance between, on the one hand the protection of confidential information and encouragement of innovation in the industry, and on the other, the necessity of transparency, avoiding duplication of clinical studies and the protection of public health.

In relation to the Translarna (ataluren) case, this is a centralised product owned by PTC Therapeutics, for the treatment of Duchenne muscular dystrophy, a rare and disabling genetic disorder that gradually causes weakness and loss of muscle function. The centralised license was granted as a conditional MA for Translarna as an orphan medicinal product on the 31st July 2014. In October 2015 a request was made by another pharmaceutical company for the release of the report on the main clinical trial carried out to support the granting of the conditional MA, the Phase IIB, placebo-controlled study investigating the efficacy and safety of Translarna in subjects with nonsense mutation Duchenne and Becker muscular dystrophy. The CSR presents the results of the main clinical study for Translarna, and therefore contains more details than the information currently available in the public domain. PTC argue that disclosing the CSR would make it possible for other pharmaceutical companies to obtain information concerning the development of that product, including the strategy for the conduct of that trial, in turn allowing for that company to exploit this information to accelerate development of their own competitive products.

The second case relates to Bravecto (fluralaner), a veterinary medicine used to treat flea and tick infestations in dogs and cats owned by Intervet. The particulars of this case have not yet been published on the Court of Justice website.

The order related to the Translarna court case is available on the Court of Justice website. The second order will also be published on the Court of Justice website when it is available.

EMA website link here.