On 5 February 2018 the CJEU issued long-awaited judgments in three cases in one day concerning release to third parties of medicinal product registration documentation. These rulings confirm the European Medicines Agency’s current data transparency policy. How are conflicting interests weighed regarding release of medicine registration data?
Under Regulation (EC) 1049/2001, every European Union citizen, or natural or legal person with their place of residence or registered office in an EU member state, has a right of access to documents of EU institutions. Anyone can request access to documents filed with the European Medicines Agency by pharmaceutical companies during the medicinal product registration process. The EMA can refuse access if release would breach laws regarding the protection of personal data of an individual or commercial interests of a pharmaceutical company, including the right to protection of the company’s intellectual property. To make interpretation of those provisions easier, the EMA has published the European Medicines Agency policy on publication of clinical data for medicinal products for human use (which we comment on in more detail here) and detailed guidance on identification of confidential information.
EMA classification of information
The EMA guidance document states that registration documentation information can be classed as follows:
- Commercially confidential information (CCI)
- Protected personal data (PPD)
- Information that can be released on a case-by-case basis (CBC)
- Information that can be released (after preliminary review) (CBR).
Commercially confidential information and protected personal data may be released to third parties, including competitors, but the EMA makes the final assessment of the particular case and the decision as to placement of information in a particular category.
CJEU: no express presumption of confidentiality
At the CJEU, the following cases were heard by the General Court regarding the EMA’s transparency policy:
- PTC Therapeutics International v EMA (T-718/15)—request for access to report on clinical trials (concerning study of efficacy and safety of phase 2B with a placebo)
- MSD Animal Health Innovation and Intervet International v EMA (T-729/15)—release of a toxicology report
- Pari Pharma v EMA (T-235/15)—release of similarity and superiority reports on an orphan medicine.
These cases were prompted by EMA decisions to release information in registration documents against the wishes of the proprietors to third parties requesting the information (competitors). The firms tried to have release blocked before the CJEU, claiming that the information was confidential in its entirety. The EMA, and subsequently the CJEU, held that there is no presumption of confidentiality for medicine registration documentation, including study reports. In particular, reports on clinical trials and toxicology examinations were classed as documents that can be released. In such a situation, individual sections can be kept confidential if they contain protected personal data, signatures, or information relating to innovative research methods. The decision to release a similarity and superiority report on an orphan medicine should be made however on a case-by-case basis. If a document contains information concerning the composition and development of a product, the active substance, or detailed descriptions of the control and production process, that information is considered commercially confidential and cannot be released. For this reason the CJEU concurred with the EMA and confirmed that by refusing to release documents the EMA would have been in breach of its obligation under Regulation 1049/2001. This is because there is no presumption of confidentiality for the documents in question and it is precisely the EMA, in the form of a “specific and individual examination of each document,” that is responsible for ensuring that the information in the document should be kept confidential. Ultimately, the CJEU dismissed all of the actions brought against the EMA.
Weighing of interests
This strongly suggests that the interpretation of provisions on the EMA’s transparency policy tends towards the broadest possible access to information. In the balance, the values of scientific development and the interests of patients increasingly outweigh commercial confidentiality. This is not good news for pharmaceutical companies, because a third party requesting access to information is usually a market competitor. Considering that the burden of proving that the information cannot be released lies with the pharmaceutical company, proprietors of documentation need to present compelling arguments in their communications with the EMA.
The following test can be used as a guide:
- Does all of the information continue to be confidential (has it been released before, for example in an academic publication)?
- Does the information constitute a business secret?
- Does release of the information pose a threat to the pharmaceutical company’s protected interests, and if so, what will the consequences be if they are breached?
- Does the information have to be released in order to safeguard an overriding public interest (are there alternative ways of protecting the public interest)?
In view of these recent CJEU judgments, even if a pharmaceutical company demonstrates that the information has not been released before, it is a business secret, and disclosure could have adverse consequences for its business, there is a danger that the EMA will argue for release of the information on the grounds of safeguarding an overriding public interest.
Time will tell whether the CJEU judgments on the EMA’s transparency policy have an impact on the current policy of Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocides, which does not have to follow the transparency rules described above when registering medicines in a national procedure, and rarely releases information in registration documents for medicines registered in that procedure.
Joanna Krakowiak, legal adviser, Life Science & Regulatory Practice, M&A and Corporate Practice, Wardyński & Partners
Emilia Korytowska, M&A and Corporate Practice, Wardyński & Partners