What if medical technology took Brussels to court?

It is a congress that takes place every year. But under the circumstances, the conference hosted by Swiss Medtech on Tuesday looked like an extraordinary meeting. In pavilion 1.3 of the Bernexpo center, the event sold out. More than 500 branch professionals responded to their umbrella association’s invitation. The objective: to take stock of the situation in the Swiss medical technology sector. With a clear question, formulated by the organizer: “How is he, after being demoted to the level of a third estate?”

Here, May 26, 2021 still resonates with a crushing blow. This is the day that the Federal Council stopped negotiations on the framework agreement with the EU, but also the day that the European Commission decided not to renew the Mutual Recognition Agreement (MRA) for medical devices. Although they are far from being resolved, the problems are identified. The next concerns, from 2022, new Swiss barriers to European medical device imports. A hardening that could lead to “serious supply problems”, according to Swiss Medtech’s Daniel Delfosse.

Read too: How Swiss medical technology is quelling the wrath of Brussels

But there is also, on the export side, this new obligation for any Swiss manufacturer to use a European agent to have their products certified in a market that represents half of the 12 billion francs of annual exports in the sector. Companies saw this deadline arrive and prepared for it, guarantees Daniel Delfosse. At the end of the day, representatives of Straumann or Ypsomed also came to tell how they made the regime change.

“Switzerland missed the mark”

Swiss Medtech, Swissmedic, Seco, FOPH… In front of them, on stage, the interlocutors followed one another and presented with acronyms, ordinances and articles of law their vision of the current regulatory framework and their hypotheses about what is to come. Then came the pause: “I didn’t warn the organizers, but I’m not going to show my Powerpoint today”, warns Andreas Balsiger.

The former head of Swissmedic’s legal department, now a senior partner at the law firm Sidley, was asked by Swiss Medtech for legal knowledge of the situation. And once he is given the floor, he does not hesitate to express his “dismay” at the waiting position adopted by the Swiss authorities. “We have to go to court. I assure you that the EU is regularly put in order.”

The problem, he continues, is that Switzerland missed the mark. It was possible to appeal the European decision until 5 August. Too expensive for SMEs, too sensitive for authorities. In a still groggy field, only three companies out of the fifty involved expressed interest in making use of this right of appeal, according to Daniel Delfosse. Then nothing happened.

a shape problem

It is not followed by a round of applause. But Andreas Balsiger’s proposal piques interest in the room. Who, how and when? wonder two participants. “The complaint must be filed by one or more companies that have a problem with customs or a control body of a Member State”, summarizes the lawyer. The court must then appeal to the European Court and question this famous notice published on May 26 by Brussels. Because it is this document, according to him, that constitutes the weak point of the European position. In this form, the Commission can no longer accept the Mutual Recognition Agreement (MRA) with Switzerland on behalf of the EU.

Read too: 54 Swiss SMEs sacrificed on the altar of the framework agreement?

Before, perhaps, going on the offensive, the branch must manage its day-to-day life. Michael Maier, partner of Medidee Services, is a true user’s guide to establishing a relationship with an EU-based agent. Liabilities, insurance, information flow, confidentiality, contracts, exclusions, labeling, etc. On each page of his presentation, participants’ cellphones flash off.

Then Michael Maier ends up addressing the branches that weren’t in the room on Tuesday. “All this, as we have seen, is manageable for our industry. But we must not forget that the consequences of not extending ARM that we are facing will gradually affect other industries! We will see a gradual erosion of relations with the EU if nothing is done”.

Request a court? “I know that Switzerland has an aversion to this type of arbitration,” concludes European law professor Thomas Cottier. But the legal path is sometimes enough to advance political negotiations.”

Read again: Thomas Cottier: “In the framework agreement, parliament can cancel the decision of the Federal Council”

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