Highest European Court Confirms: No Presumption of Confidentiality Over Documents Submitted in Marketing Authorization Dossier
On January 22, 2020, the Court of Justice of the European Union (CJEU) found that there is not a general presumption of confidentiality over documents containing clinical and preclinical data provided to the European Medicines Agency (EMA) to support a marketing authorization application. However, the CJEU indicated that certain information may be protected if the interested party can specifically show that the disclosure will cause it harm. This is the first time the CJEU has ruled on this matter, upholding the EMA’s approach to handling access to documents requests.
This is the last step in the long-running cases of PTC Therapeutics (C‑175/18 P) and MSD Animal Health and Intervet (C‑178/18 P). In both cases, which have been managed together, the claimants had been challenging the approach of the EMA to disclosure requests. The two cases concerned third-party requests for the disclosure of, on the one hand, a clinical study report (CSR) submitted for the MA application for PTC’s Translarna, an ultraorphan drug, and, on the other, five preclinical, toxicology study reports relating to MSD’s veterinary medicine Bravecto.
A number of similar legal cases for annulment of the EMA’s decisions to disclose documents had been brought before the General Court (GC) (Intermune, Abbvie, Pari Pharma, Amicus Therapeutics), although some were withdrawn before judgment. The GC had repeatedly stated that under the Transparency Regulation all such data was by default disclosable unless one of the narrow exceptions provided in the regulation applied, and even these exceptions are subject to whether there is an “overriding public (or private) interest” in favor of disclosure. Effectively, the GC’s position has been the same for proactive and reactive disclosure of data held by the EMA, providing for increased access to clinical data. In a surprising opinion, Advocate-General Gerard Hogan found that the high commercial and financial value of the underlying data meant that this data should be withheld, if that meant protection from unfair commercial use.
Judgment and implications
The CJEU re-emphasised that the Transparency Regulation provides a broad right of access to documents held by the EU institutions, and although there are exceptions to that right (such as information that qualifies as confidential commercial information, or CCI), those must be “interpreted and applied strictly” and are, nevertheless subject to limitations based on public (or private) interest. It is important to highlight that the CJEU has not excluded that such documents could contain information that, if disclosed, would harm the commercial interest of a company. But it is for the owner of the data to demonstrate that the information is CCI, by identifying “concrete and reasonably foreseeable,” not “purely hypothetical,” risks that the disclosure of data would harm the commercial interest of the company. Helpfully, the court made a comment, obiter, in both judgments that there is no need to show “serious” harm; it would suffice for the affected party to show the possibility of any level of harm.
This judgment came following intense pressure to support the EMA’s approach to broad disclosure of documents in line with the decisions of the Ombudsman. Following AG Hogan’s opinion delivered on September 11, 2019, an open letter signed by over 30 organizations supporting openness in the drug approval process (including Germany’s health technology assessment body IQWiG and advocacy group European Public Health Alliance) has cautioned against “watering down” the transparency policy and instead permitting public access to clinical study reports. In addition, the expected entry into force of the Clinical Trial Regulation will impose further clinical trial data transparency obligations.
Although the pharmaceutical industry has supported transparency as a principle underpinning the proper functioning of the European institutions, the commercial and strategic implications from wide access to sensitive commercial data cannot be disregarded. Pharmaceutical companies will continue to ensure that they can provide inclusive data supporting their MA applications while considering how best to preserve their valued know-how.