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EU market continuity and renewing the MRA remain top priorities for the Swiss medtech industry and market. But alongside that runs an ambitious plan to allow US-approved devices into Switzerland.
The UK’s MedTech Directorate is undergoing a partial relaunch, with a new director set to take the reins and a new strategy being finalized. The medtech industry hopes the renewed impetus will put long-overdue attention to value-based procurement for medtech goods.
The UK regulator is likely to establish mid-2024 as the new deadline for the standstill period during which CE-marked devices may access the UK market. Compulsory UKCA marking would accordingly also be delayed by a year.
New UK health secretary Thérèse Coffey has been given the dual role of deputy prime minister in Liz Truss’s government, implying that Robert Jenrick and the rest of the health ministry team will be more prominent in health policy matters.
If there are any medtech dividends for former EU members or associate countries that find themselves outside the club, one must be the ability to accept innovations approved in jurisdictions not just in but also beyond the EU.
Non-EU markets, notably Israel, Singapore and Australia, have shown how blending regulatory systems can work to optimum effect for local patients. The UK, too, is keen to explore the possibilities of a multiplicity approach to overseas-approved devices as it continues to build its own post-Brexit medtech regulatory system.
But the Swiss parliament has taken the notion further and faster, in debating the practicalities and merits of allowing medtech innovations from outside Switzerland/the EU – including those approved by the US Food and Drug Administration (FDA) ̶ onto its local market.
Two separate motions, one from each Swiss parliament chamber, are currently going through the parliamentary process aimed at securing just that. A decision on one of the motions is expected in December, Sandra Rickenbacher, head of public affairs and legal counsel at industry association Swiss Medtech, told Medtech Insight.
Although not an EU member state or even part of the European Economic Area, Switzerland enjoyed unfettered access to the EU single market by means of a mutual recognition agreement (MRA) and its pledge to abide by the EU’s four freedoms (goods, capital, services and people).
Regardless of the imperfections, perceived or actual, of the Medical Device Regulation and associated EU regulatory infrastructure, for the Swiss industry the MRA with the EU continues to be the top priority. It holds onto the hope that the door has not been shut on the MRA for all time.
Indeed, the stated position of Swiss Medtech is to continue to work with “unwavering commitment with partners and alliances to ensure that Switzerland’s relationship with the EU regains a solid and lasting foundation.”
That was the message at the annual conference of the association in Bern, in mid-October. But while it encourages EU and Swiss representatives to heal the rift and reinstate the MRA, thereby facilitating direct access to the single market once more, Swiss Medtech is also keen to ensure the current hiatus does not impact negatively on Swiss patients.
Accordingly, Swiss Medtech director Peter Biedermann told the meeting of 400 delegates: “In light of the uncertainty and restrictions associated with third-country status and the MDR, Switzerland should accept medical devices with FDA approval in order to safeguard the supply of its own population.”
Accepting “extra-European” devices would be in addition to and alongside Switzerland’s continued acceptance of medical devices bearing the CE-marking, Swiss Medtech insists.
The two motions aimed at securing Switzerland’s ability to accept FDA-approved devices, in particular, are currently being considered by the Swiss parliament. They were submitted more than two years ago, while the MRA was still valid. They have the full support of Swiss Medtech.
To industry’s mind, the signs were not favorable that the MDR would be able to deliver results in time by May 2024, the current grace period deadline. (The wider industry is hopeful that the European Commission’s EPSCO meeting on 9 December will broach a postponement of that deadline.)
Delfosse said “We are worried because already today more than 50% of EU companies – and even Swiss companies ̶ have planned to seek first approval in the US and not in Europe ” He added: “This has the consequence that these new technologies will not be available on the Swiss market at all, or with a delay of several years.”
He asserted Swiss industry’s overriding priority of securing an update of the MRA with the EU. “Nevertheless, we cannot rely on an MDR-system that doesn’t work. That’s why we have to enlarge the opportunities to procure medical devices for the Swiss population. ”
The parliamentary process entails much time and effort. Parliamentary members may submit motions in both the national and the state council, the Nationalrat and Ständerat, respectively, Rickenbacher explained.
One of the two current motions to permit extra-European devices onto the Swiss market has made significant progress. Sponsored by state council member Damian Müller (canton of Lucerne), it was approved by the council in May, having passed through the health committee and plenary. The motion is now following the same path through the other chamber.
The national council’s health and foreign policy committees both voted in favor in mid-October, and recommended that the plenary of the national council adopt the motion. The final decision will be made in December, during the winter parliamentary session.
Approval at that stage would see the motion submitted to the federal council, which would have a mandate to transpose it within two years. That is not the end of the story, however.
At that stage, other questions must be broached, such as: will a revision of current laws be necessary, or simply of the ordinances? The latter course requires less time.
A legal review by Swiss Medtech shows that Swiss law would still be equivalent to EU regulations were FDA-products to be accepted in Switzerland. In other words, Switzerland can accept products approved in other jurisdictions without jeopardizing the equivalence of current EU and Swiss regulations.
US-approved products used in Switzerland may not be re-exported.
All FDA-approved devices would be covered by the parliamentary motion. Companies would actively select their US-approved products to be sent through the Swiss system.
In practical terms, the process would revolve around national regulator, Swissmedic. Definition of the actual process is something that Swiss Medtech would volunteer to help shape, Delfosse said. It might entail a simple safety check, he said: a rather quick process.
“We hope for forward-looking decisions from the politicians,” Biederman told the Swiss Medtech meeting.
However, the priority for the Swiss medtech industry remains the EU market. “Our position is that it’s important to have CE-marked products in parallel to FDA-approved products. The latter has to go hand in hand and in parallel,” Rickenbacher said.
“We don’t want Switzerland to move away from the CE marking at all,” Delfosse stressed. Should the parliamentary motion succeed, “we must avoid erecting any hurdles to the CE mark in Switzerland,” he added.
Outside Switzerland, observers might see Swiss Medtech’s position as wanting the best of both worlds. It would not be the first country to accept both the EU and US systems ̶ but it would be the first in Europe.
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Subject: Switzerland Moves Closer To Accepting US FDA-Approved Medtech
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183
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