Administrative marketing authorizations for medicinal products: confidentiality or transparency?

Spain International

The Court of Justice (CJEU) recently delivered two judgments on the ongoing conflict between transparency and confidentiality. In particular, there is a clash between the right to access the administrative documents included in the file relating to marketing authorizations (MAs) for medicinal products and the MA holder’s interest in keeping those documents confidential.

Administrative marketing authorizations for medicinal products: confidentiality or transparency?
January 29, 2020

The Court of Justice (CJEU) recently delivered two judgments on the ongoing conflict between transparency and confidentiality. In particular, there is a clash between the right to access the administrative documents included in the file relating to marketing authorizations (MAs) for medicinal products and the MA holder’s interest in keeping those documents confidential.

These two judgments were issued on January 22, 2020, in cases C-175/18 P (PTC Therapeutics) and C-178/18 P (MSD Animal Health). The cases related to conflicts between MA holders for an orphan and a veterinary medicinal product respectively, and the European Medicines Agency (EMA). The CJEU examined the presumption of confidentiality regarding files relating to MA procedures for medicinal products and the exceptions to the right of access laid down in article 4 of Regulation 1049/2001 on transparency, applicable to both cases. In particular, the CJEU examines whether access to these documents would undermine “the protection of commercial interests of a natural or legal person, including intellectual property.

This is not a new conflict in Spain. The scope of confidentiality of MA files for medicinal products was already discussed in patent infringement cases. Also, in these two judgments, the CJEU examines the limits to the right of access, which are similar to those applied by the Spanish Agency of Medicinal Products and Medical Devices in applications for access to medicinal product MA files subject to Spanish Act 19/2013, of December 9, on transparency.

The CJEU pointed out that there is no obligation for the EMA to apply a general presumption of confidentiality to MA files. The CJEU also confirmed the principle of the widest possible public access to documents set out in Regulation 1049/2001. Therefore, any exceptions to this principle must be strictly interpreted. The CJEU admits that these exceptions could apply in case of identifying “a concrete and reasonably foreseeable risk that certain unpublished data contained in a report such as the reports at issue, which cannot be regarded as being a matter of common knowledge within the pharmaceutical industry, could be used in one or more third States by a competitor of that undertaking for the purpose of obtaining an MA, thereby unfairly benefiting from the work done by that undertaking.” This is without prejudice that in the case at hand there was no evidence of the said risk.

In conclusion, these are two significant judgments regarding procedures before the EMA. The principles underlying these two CJEU judgments can help in domestic MA procedures due to the similarities with the applicable regulation. In Spain, the applicable regulations are the Act on transparency and, regarding MAs for medicinal products, articles 16(4) of Royal Legislative Decree 1/2015, of July 24, along with articles 15 and 22 of Royal Decree 1345/2007, of October 11.

Author: Jorge Llevat

January 29, 2020