The European Medicines Agency (EMA) has won a landmark battle about the amount of data from clinical dossiers that may be made public. The European Court of Justics (EJC) rejected the demand of three drug developers not to publish what they called confidential information under the EMA’s transparency rules.
In all three cases, the EMA granted access to documents under the EU’s transparency policy (Zitat), which were part of the companies submission for market authorisation, after the market authorisation had been granted. The judgments concern Case T-235/15, Pari Pharma v EMA, in relation to the disclosure of similarity and superiority reports on the orphan medicine, prepared by the Committee for Medicinal Products for Human use (CHMP); Case T-718/15, PTC Therapeutics International v EMA, on the disclosure of a pivotal Phase IIb clinical study report for the company’s drug Translarna (ataluren), conditionally approved for Duchenne Muscular Dystrophy in 2014; and Case T-729/15, MSD Animal Health Innovation and Intervet international, regarding five toxicology study reports for the veterinary medicine. In all three cases, the pharmaceutical companies challenged EMA’s decision to release the concerned documents in accordance with the Transparency Regulation and EMA’s 2010 policy on access to documents (Policy 0043).
In the PTC vs EMA case, PTC with support of EUCOPE wanted to block the EMA from publication of the entire study, report which it claimed to include confidential data that should not be passed to the undisclosed pharmaceutical company who in 2015 requested information under the EMA’s transparency policy. The court, however, dismissed an preliminary order of its President and Vice-president from 2016 not to make the report public saying a general presumption of confidentiality, would run counter to the letter and spirit of Regulation No 1049/2001. Additionally, the Court confirmed that the EMA had the right to redact the dossier according to EU transparency rules without consulting the applicant to prevent disclosure of confidential (i.e manufacturing) and personal data (the EMA did so). Third, as the applicant was not able to specify why the document submitted was confidential as a whole, and pointed to the fact that parts of it had been published in the public domain before.
In the Pari Pharma vs EMA case, the EMA passed similarity and superiority assessment reports submitted in April 2015 to the CHMP from nebulisation specialist Pari GmbH’s approved cystic fibrosis drug Vantobra (tobramycin administered with Pari’s Tolero inhaler)
to Novartis Europharm Ltd. which marketed the orphan drug product tobramycin administered with the TOBI Podhaler since 2006. Novartis requested data access to Pari’s submission in April 2015. After achieving a confidentiality agreement on the data submitted with Novartis, Pari ordered the EMA not to disclose information marked a confidential relating to a market survey, contained in the CHMP assessment report relating to the clinical superiority of Vantobra, and that identified on pages 9 to 12 of the assessment report by that committee relating to the similarity of Vantobra and TOBI Podhaler. The Court said the data were only refinements of public data and Paris was not able to show that publication of them would damage Pari’s business.
In the third case, MSD Animal Health Innovation GmbH and Intervet international BV tried to block the EMA from granting access to five preclinical toxicity studies submitted in 2012 as part of a MAA for the veterinary medicinal product Bravecto, a treatment for tick and flea infestations in dogs. Under general presumption of confidentiality, the applicants marked the parts they claimed to be confidential. The EMA accepted only parts of the redactions made as it emphasised that they do not qualify as confidential business information and that, accordingly, it could not have balanced any overriding public interest in disclosure against the non-disclosure of the documents.
The EMA welcomed the Court’s decisions. „We are very pleased that the General Court affirmed that the information contained in these documents cannot be considered commercially confidential in its entirety”, said Stefano Marino, EMA’s Head of Legal Department. “We understand that with these rulings the General Court endorses our implementation of the Transparency Regulation that focuses on the interest of patients and public health”.