Opinion of AG Hogan in Case C-175/18 P, PTC Therapeutics International Ltd v European Medicines Agency (EMA)
On September 11, 2019 Advocate General (AG) Hogan issued an important Opinion in an access to documents appeal against a judgment of the General Court in Case T-718/15, whereby the General Court dismissed PTC Therapeutic's application for annulment of EMA's Decision to grant access to a clinical study report (CSR) submitted in support of a marketing authorisation application (MAA) for 'Translarna', an orphan medicinal product intended for the treatment of Duchenne muscular dystrophy.
The question at the heart of the appeal is whether clinical study reports (CSRs) constitute commercially confidential information protected by Article 4(2) of transparency Regulation (EC) No 1049/2001. This is the first case where this particular issue has come for consideration before the Court of Justice of the EU (CJEU). The CJEU judgment is still pending.
Interestingly, the AG's Opinion departs from the pro-transparency views that the General Court has previously held in access to documents cases involving the EMA.
In disagreement with the General Court, the AG concludes that there should be a general presumption of confidentiality in favour of non-disclosure to third parties of clinical study reports (CSRs) submitted in support of a MAA. He bases this conclusion on the following two considerations:
First, that disclosure of a CSR would be liable to undermine the commercial interests protected under Article 4(2) of Regulation (EC) No 1049/2001. In this respect, the AG observes that "the preparation of a CSR is likely to be hugely expensive and involve a series of complex clinical trials. (…) 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."
Second, that under Article 39(3) of the TRIPS Agreement, sufficient steps must be taken to "ensure" that the data submitted in support of a MAA are protected against unfair commercial use. The AG is of the view that the regulatory data protection and orphan market exclusivity protection conferred by EU legislation do not ensure such protection since these provisions apply "only" within the territory of the EU/EEA. There is a risk that a competitor outside the EU might rely on the CSR to get a MA for its own product even prior to the end of the data exclusivity period.
Despite concluding that there is a general presumption of confidentiality, AG Hogan considers that the EMA is not required to base its decision on such a presumption. The EMA is still entitled to carry out a specific examination of the requested documents and to reach a conclusion based upon that specific examination. In this particular context, the AG offers a detailed analysis of how the commercial interests' exception found in Article 4(2) of Regulation No 1049/2001 should, in his view, be interpreted. Contrary to the views of the General Court, AG Hogan considers that it is sufficient to show that disclosure would "undermine" the commercial interests of the undertaking in question (as opposed to "seriously undermine" as the General Court had concluded). AG Hogan also states that the public interest counter-exception found in Article 4(2) must be "exceptional" and "pressing".
The above considerations lead the AG to conclude that the CJEU should set aside the General Court's judgment under appeal. Since the case requires legal assessment of complex issues of fact, the AG recommends that the CJEU should refer the case back to the General Court for judgment in the light of the reasoning set out in his Opinion.