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European Union court pushes back against EMA transparency policy

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By Cormac Sheridan
Staff Writer

DUBLIN – The EMA’s big drive for transparency has received pushback from the Court of Justice of the European Union, which has dismissed two appeals the EMA brought against earlier court decisions that barred it from releasing trial data on two drug dossiers.

The EMA had launched the appeals last September, after the court issued interim orders preventing its release to third parties of data on Translarna (ataluren), the muscular dystrophy drug for which its developer, PTC Therapeutics Inc., has controversially received conditional marketing authorization in Europe, and Bravecto (fluralaner), a veterinary drug marketed by the animal health arm of Merck & Co. Inc. (See BioWorld Today, Oct. 5, 2016.)

PTC and Merck both argued that release of data under the EU’s Transparency Regulation (1049/2001) and the EMA’s 2010 policy on access to documents would undermine their rights to protect commercially confidential information. Ominously for transparency campaigners, the court has, for now at least, taken a restrictive view of what constitutes commercially confidential information, a key concept that has never received a binding legal definition in Europe.

The court’s published ruling on the Translarna case – the judgment on Bravecto is not yet available – states that the drug’s transparency requirements are satisfied by the EMA’s routine publication of the product’s characteristics (intended for general public consumption), the patient information leaflet and the associated European public assessment report (Epar), a more detailed evaluation of the evidence supporting a particular drug’s approval.

The court ruled that all documents submitted as part of a marketing authorization application (MAA), particularly documents containing data on preclinical and clinical studies, “should enjoy a general presumption of confidentiality under Regulation No 1049/2001.”

The ruling is interim in nature, pending the delivery of judgment in the main proceedings, which are ongoing. But if that line of thinking were to be upheld, it could unravel what is arguably the EMA’s biggest achievement over the last seven years.

The agency has, after a prolonged series of consultations, court cases and bureaucratic wrangling, put in place a two-tier structure for making clinical trial data contained in MAAs available to third parties. Last October, it launched a portal – clinicaldata.ema.europa.eu – for the routine publication of all clinical trial data included in support of MAAs submitted on or after Jan. 1, 2015. It will not be fully up to speed until the end of 2017, but the site currently contains detailed data on 11 drug dossiers. Third parties can gain access to data in MAAs filed before the Jan. 1, 2015, cut-off date through the EMA’s access-to-documents procedure, which has been in place since 2010. (See BioWorld Today, Oct. 24, 2016.)

These days, the EMA takes the view that, in general, clinical trial data cannot be considered commercially confidential. Companies seeking to have any of their data redacted before its release must be able to justify its position, in accordance with its published guidance.

The EMA’s own position on commercial confidentiality has evolved over the years. It has often found itself between the rock of industry interests and the hard place of civil society and scientific campaigners. Transparency advocates have argued that a restrictive transparency regime undermines legitimate scientific scrutiny of drug data and also slows innovation as it requires extensive duplication of experiments and trials. Pharmaceutical developers have embraced the transparency agenda with differing levels of enthusiasm. The operation of the EMA’s clinical data portal does not appear to have generated much visible unrest, but the European Confederation of Pharmaceutical Entrepreneurs (Eucope), an industry lobby group that represents midsized pharma and biotech companies, also joined the proceedings, in support of PTC.

While obeying the present rulings, which are specific to Translarna and Bravecto, the EMA will continue to operate its transparency policy as usual, while awaiting verdicts from the wider proceedings. The present rulings will no doubt ratchet up anxiety levels among transparency advocates and EMA officials alike. Similar rulings in the main cases would have significant implications for both.

The court ordered the EMA to pay PTC’s costs as well as its own.