Restriction of marketing authorisation of a medicinal product due to insufficient evidence of efficacy for an indication

Facts

Parties and procedural history:

The appellant, a public limited company with its registered office in Switzerland, manufactures the medicinal product [B.] , which has been authorised in Switzerland since 1966 for the treatment of muscle spasms in painful diseases of the skeletal muscles. On 14 July 2015, Swissmedic, the Swiss Agency for Therapeutic Products, restricted the marketing authorisation to the indication spasticity due to cerebrospinal lesions following a stroke or as an adjunctive measure in multiple sclerosis (indication B) and revoked the authorisation for the indication treatment of muscle spasms in painful diseases of the skeletal muscles, in particular of the spine and the joints close to the trunk (indication A). In addition, a breach of the reporting obligation was found.

The appellant filed an appeal with the Federal Administrative Court, which partially upheld the appeal with a judgment of 24 July 2018 and set aside the finding of a breach of the reporting obligation, but dismissed the appeal in all other respects. The Federal Supreme Court set aside this judgment with a judgment 2C_844/2018 of 12 June 2020 and referred the matter back to the Federal Administrative Court for a new decision, as the latter had not sufficiently considered the appellant's objections regarding the studies. The Federal Administrative Court confirmed the contested decision again in part with a judgment C-3076/2020 of 17 May 2022 and dismissed the appeal in all other respects. The appellant filed an appeal against this judgment with the Federal Supreme Court in public law matters.

Appellant's request:

The appellant requested that the judgment of the Federal Administrative Court of 17 May 2022 be set aside insofar as the appeal was dismissed and the contested decision was confirmed. It sought an adjustment of the marketing authorisation for indication A to a second-line therapy in combination with anti-inflammatory agents or as an alternative in cases of contraindications to such agents. It also requested that the specialist and patient information be adapted accordingly.

Considerations

1. Admissibility of the appeal:

The appeal was filed in due time and form and concerns a matter of public law in the field of the TPA. The appellant participated in the proceedings before the lower court and is particularly affected in its protectable interests by the contested judgment. The appeal is therefore admissible and the Federal Supreme Court shall take cognisance thereof.

2. Subject matter of the appeal:

In light of the Federal Supreme Court's referral decision 2C_844/2020 of 12 June 2020, the subject matter of the appeal is limited to the assessment of the studies submitted by the appellant in the lower court proceedings to prove the efficacy of [B.] for indication A. The lower court was solely required to address this issue, as the Federal Supreme Court had criticised the lower court's cognisance.

3. Formal objections raised by the appellant:

The appellant alleges a violation of the right to be heard (Art. 29 para. 2 Cst.) and of the principle of investigation (Art. 12 APA). It complains that the lower court did not sufficiently examine the studies and guidelines submitted by it and did not carry out further fact-finding. The Federal Supreme Court notes that the lower court thoroughly assessed the “Rao et al. study” from 2012 and other studies. The appellant has not shown that the three older studies from 2001, 2002 and 2004, on which Swissmedic based its decision, prove the efficacy of the medicinal product. The lower court therefore did not act arbitrarily in assuming that further fact-finding would not change its conviction. There is no violation of the right to be heard or of the principle of investigation.

4. Substantive assessment of efficacy:

The appellant alleges a violation of Art. 10 para. 1 lit. a TPA, as the lower court denied the sufficient efficacy of [B.] for indication A. The Federal Supreme Court confirms that the efficacy of a medicinal product must be proven according to the current state of science and research by means of phase III studies with a randomised, double-blind study design. The lower court examined the studies submitted by the appellant and found that they did not meet the requirements.…