Federal Supreme Court, Decision 1C_692/2020 from 9 December 2021

23 gennaio 2022 – In the decision at hand, the Court had to assess whether Swissmedic rightfully granted (limited) access to the incident reports on the MaxiMOM prosthesis of the appellant to a journalist. The appellant argued that current Swiss law would allow the Court to exempt the entire system of materiological monitoring from the principle of transparency and to provide for confidentiality of the data. This was all the more appropriate as according to the appellant, the fear of legal action may deter users and manufacturers from reporting incidents. Moreover, the appellant argued that this chilling effect could not be prevented by (solely) redacting the data, which may prove incomplete. However, the Court held that all documents would be redacted of any personal data concerning the patients, the medical establishment, the practitioners and any other person concerned. The user reports thus contain only a description of the incident with the dates of implantation and explanation of the prosthesis, and a brief description of the patient's condition, generally limited to chromium and cobalt levels. According to the Court, it was difficult to understand how such information could provide a basis for legal claims, except for the patient himself, who in any event already knows the data in question. Moreover, contrary to appellant’s arguments, the Court did not find mistakes in the redaction of the data. Furthermore, the Court stipulated that it was not comprehensible why the possibility to access these reports would deter the users from reporting incidents to Swissmedic pursuant to their legal obligation. The same could be said for the manufacturers. Finally, according to the Court the balance of interests in this context was clear. The Court ruled that the interests of consumers to be aware of possible problems in the use of a particular health product, in this case a hip prosthesis, but above all, the interest to be able to review the way in which Swissmedic fulfils its supervisory function and, more generally, to be able to evaluate the efficiency of the material safety system, were important and obvious public interests that must prevail in the present case.

Therefore, the Court dismissed the appeal.

For more information, see here.