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European drug agency wins victory over drug companies that wanted to withhold data

BMJ 2018; 360 doi: https://doi.org/10.1136/bmj.k604 (Published 07 February 2018) Cite this as: BMJ 2018;360:k604
  1. Nigel Hawkes
  1. London

The European Medicines Agency (EMA) has won an important court ruling backing its policy of open data.

In an eagerly awaited judgment, the European Court of Justice backed data transparency and rejected claims by companies fearful that competitors may exploit the data.

The case arose from challenges to the EMA’s transparency rules, introduced in 2010, which established the principle that all documents underlying a successful application for a drug licence should be made accessible.

Three separate challenges were made: by the German company Pari Pharma, over its orphan drug Vantobra (tobramycin in a nebuliser solution) for treating pulmonary infections in patients with cystic fibrosis; by PTC Therapeutics, based in Ireland, over Translarna (ataluren) for treating Duchenne muscular dystrophy; and by Intervet (part of MSD Animal Health), over Bravecto (fluralaner), a veterinary medicine for flea and tick treatment.

The companies opposed the release of the reports on the grounds of commercial confidentiality, although the EMA had argued from the start that the amount of commercially confidential information was limited and that it had redacted a few pages for this reason. Other redactions had been made to protect personal information.

In September 2015 Pari Pharma was granted an interim injunction by the president of the court prohibiting the EMA from releasing the company’s data, and in July 2016 similar interim rulings were made for the other two companies. The issue needed to go to a full hearing, the president said. An appeal by the EMA against the injunctions was rejected.

The court, composed of three judges, has now ruled in favour of the EMA, overturning the interim injunctions. In the PTC Therapeutics case, for example, the ruling finds no general presumption of confidentiality protecting documents that are submitted to support an application for a drug licence.

This means that, under the regulations, the report at issue (a clinical study) could be deemed commercially confidential only if all of its data constituted commercially confidential information. “That is not the case here,” the judges said.

Stefano Marino, head of the EMA’s legal department, said, “We are very pleased that the General Court affirmed that the information contained in these documents cannot be considered commercially confidential in its entirety. 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.”

At the time of the 2016 interim rulings Marino said, “Clinical reports may contain some residual commercially confidential information which should be redacted. However, a sort of ‘blanket’ protection from disclosure for documents supporting an authorisation for a medicine seems neither consistent with the legislation nor advocated by our stakeholders, including an overwhelming majority of pharmaceutical companies.”

The ECJ ruling has upheld this position, enabling the EMA to continue to make available huge volumes of material submitted to it. The agency said that, on the basis of the court’s guidance, it would continue “to diligently assess each individual request for access to documents submitted under the transparency regulation and in accordance with its policy on access to documents.”

Costs were awarded against the drug companies.

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