The European Union’s highest court has ruled for the first time on whether there is a mandatory presumption of confidentiality for clinical data reports submitted to the European Medicines Agency for marketing authorisation (MA). Upholding General Court decisions that there is no such presumption, it held in two parallel rulings that pharmaceutical companies seeking to exempt their data from disclosure must provide specific evidence at an early stage concerning the commercial damage that will be done by sharing the information.
The decisions create risks around life sciences companies’ data – increasingly one of their most important assets – as well as their trade secrets and patentable inventions. Businesses therefore need to ensure that they have a thorough data strategy in place as part of their broader approach to IP protection.
The opinions relate to two cases in which the EMA had granted third party competitors access to study reports, against the wishes the companies that had submitted the data, on the basis of the EU’s public access to documents regulation 1049/2001.
In PTC Therapeutics v EMA, the dispute involved clinical data submitted to support MA for PTC’s Translarna; while MSD Animal Health Innovation v EMA related to a toxicity report relating to one of MSD’s veterinary products.
Having had their cases rejected by the EU General Court, PTC and MSD argued to the CJEU that the EMA should have treated the category of reports involved in these disclosures as presumptively confidential under the exceptions spelled out in Article 4(2) of regulation 1049/2001. This states that: “The institutions shall refuse access to a document where disclosure would undermine the protection of: commercial interests of a natural or legal person, including intellectual property…unless there is an overriding public interest in disclosure.”
The disclosure of study reports submitted for MA was bound to cause commercial damage, they argued, by providing potential competitors with a “road map” on how to file an MA. Several categories of document have already been recognised as being presumptively confidential, and clinical study reports should be one of them. In any case, the EMA and General Court had applied too high a standard for establishing a commercial interest with regard to these particular documents.
Advocate General Hogan gave the appellants cause for optimism, when he advised the court to grant their appeal in his opinions, published (here and here) in September last year. “The preparation of a CSR is likely to be hugely expensive and involve a series of complex clinical trials,” he noted. “In these circumstances, it is hard to see how disclosure of a CSR would not be of considerable advantage to any potential competitor, the provisions for data exclusivity and market exclusivity notwithstanding.”
But the CJEU came to the opposite conclusion, finding that, while certain general presumptions had been recognised for practical purposes, EU institutions are never bound to follow these presumptions and may always carry out a specific examination of the documents covered by a request for access – as is the EMA’s policy on clinical study reports.
This does not mean that clinical study reports, or sections thereof, cannot be exempted from disclosure. But, the court added, exceptions under Article 4(2) of 1049/2001 cannot be established by “a mere unsubstantiated general risk of misuse”. The party seeking to exempt aspects of its document from disclosure must provide, prior to the EMA’s decision, “additional details, concerning the nature, purpose and scope of the data” to show how disclosure “would be likely concretely and reasonably foreseeably to undermine the commercial interests of the persons concerned thereby”.
This means that life sciences companies need to produce detailed arguments as to why their clinical data (produced at great cost) should not be disclosed. Professor Timo Minssen of the University of Copenhagen comments: “It is therefore clear that companies who want to avoid the disclosure of sensitive data will have to spend more resources and thoughts in arguing their case and will need well-founded evidence why the data disclosure would undermine their innovation strategy and commercial interests. This should be born in mind in the early stages of any R&D process.”
While data exclusivity periods remain intact - and the judgments confirm that there is no need to demonstrate “serious” commercial harm - the decisions suggest that much data that businesses would otherwise prefer to keep confidential will be disclosed. It is important also to consider the knock-on implications for trade secrets and potential patents.
The greater access to information expected under the Clinical Trials Information System, to be set up in accordance with the Clinical Trial Regulation, will accentuate these needs. And, Minssen suggests, other global medicines regulators may be guided by the EMA’s example, leading to more data disclosures around the world.