Patients and economic operators need legal certainty – right now  

The Federal Council’s answers to Interpellation 20.3079 by Jacqueline de Quattro make it clear that the Swiss medical device sector is in the middle of trade policy disputes between Switzerland and the European Union (EU). General and hardly usable answers are a direct consequence of this. However, with the new EU MDR regulation, legal certainty would be of central importance, for product availability and for Swiss economic operators.

Since a year now, the Federal Council’s answers to the interpellations on medical devices have left Swiss economic operators similarly helpless. Whether questions are raised by Beat Vonlanthen (19.3736), Damian Müller (19.4453) or Jacqueline de Quattro (20.3079), all the answers are primarily influenced by the uncertainty of relations with the EU and contain hardly any information of substantial value to the medical devise sector. With their medical devices, Swiss economic operators are amid a political debate on how to shape the future relationship between Switzerland and the EU. In this context it is incomprehensible that health policy has had to subordinate itself to trade policy. Obviously neither Switzerland nor the EU can (or want to) put an end to this trade dispute, which is dangerous to patients and therefore also extremely unethical. In a time marked by COVID-19 this is difficult to understand, as there are already considerable gaps in the supply of medical devices.

The general responses of the Federal Council to the de Quattro interpellation require a technical addition from an industry perspective:

Answer 1: The deblocking of the MRA to be updated can only be carried out by political bodies of the EU Commission. This has been demonstrated by the WEF-talks 2020 in Davos. They made it clear that progress is needed on the institutional agreement. Merely technical progress in the revision of the “medical devices” chapter of the MRA will hardly be sufficient.

Answer 2: The Federal Council’s awareness of the need for rapid legal certainty should now be followed by clear signals. It is of little help in this respect if, on the Müller Interpellation, it is explained to the medical device sector that Switzerland’s view of the continued applicability of the MRA does not agree with that of the EU. The sector must now be told how and for what it must prepare with the MDR in just less than one year.

Answer 5: The mentioned survey by Swiss Medtech was conducted before the current pandemic and before the announcement of the one-year postponement of the date of application of MDR. The 91% of companies that will make it to 2021 without the MRA must therefore be put into perspective under the current conditions.

Answer 6: The Swiss medical devices ordinance revision, in its version of the consultation of 15 May 2020, is the only known version. It requires a revised MRA (see Swiss Medtech answer). The medical device sector can only adapt to the further adjustments mentioned by the Federal Council if it is aware of them. Any additional costs and time required will of course have an additional distorting effect on competition.

Conclusion: Since a year now, the answers to the interpellations on the medical device sector have only been of limited help. Considering the current pandemic experience, however, it is now high time to call for concrete measures to ensure national product availability and the ability of Swiss economic operators to act. As an example take care of the motion Damian Müller “Für mehr Handlungsspielraum bei der Beschaffung von Medizinprodukten” (20.3211).

Author: Peter Studer (Senior Advisor)