Motion 20.3211 (Damian Müller)

Newsticker

30 August 2023 – Expert Report «Comparison of regulatory systems regarding safety of medical devices from the USA and EU»

During the parliamentary debate on Motion 20.3211, the Federal Administration expressed among other things concerns regarding safety without, however, providing any concrete evidence. Swiss Medtech has commissioned an expert report to evaluate the concerns expressed. The report written by the Johner Institute comes to the following conclusions:

  1. From today’s perspective, medical devices approved for the U.S. by the FDA are, in principle, at least equally safe as CE-marked medical devices complying with EU regulations.
  2. Medical devices under both regulatory jurisdictions are developed, manufactured, and monitored according to comparably high standards. 
  3. Overall, no significant safety concerns were found.

For more information: Daniel Delfosse, daniel.delfosse@swiss-medtech.ch, +41 31 330 97 74 
 

Expert Report

30 August 2023 – Legal Assessment «Is a revision of the Therapeutic Products Act necessary to implement Motion 20.3211?»

Swiss Medtech has commissioned a legal assessment of whether an amendment of individual provisions of the Therapeutic Products Act (TPA) is necessary to allow expansion of the Swiss market to include «medical devices from non-European regulatory systems». The focus is primarily on medical devices which can be legally marketed in the United States of America (USA). 

The in-depth legal assessment written by Prof. Dr iur. Tomas Poledna and Dr iur. Remus Muresan examines the individual medical device provisions of the TPA. The legal assessment concludes that a revision of the TPA is not necessary to enable such expansion. Any individual legal framework conditions requiring adaption or creation can be carried out at the ordinance level – primarily through a revision of the Medical Devices Ordinance (MedDO). 

For more information: Sandra Rickenbacher-Läuchli, sandra.rickenbacher@swiss-medtech.ch, +41 31 330 97 75

Legal Assessment (in German )

15 August 2023 – MDR Chaos is weakening innovation

«This is how innovation gets stifled,» says Iwan Märki, co-founder of Lausanne-based start-up Abionic. 

Why the Federal Council (BR) must now shift into high gear.

NZZ article, Benjamin Triebe (in German)

11 August 2023 – Current situation in the hospitals

«We have rarely experienced such a situation in the past. We are faced with consistant short-ages of a wide variety of medical consumables,» says Daniel Borer, Head Physician
of the Clinic for Anesthesiology at Winterthur Cantonal Hospital. 

H+ publication (in German)

30 June 2023 – Policies to guide implementation of Motion 20.3211

Based on intensive dossier work in the Board and within the industry, Swiss Medtech is committed to ensuring that the authorities adhere to the following three key principles when implementing the mandate.

  • Medical devices authorised in the USA may be utilised in Switzerland.
  • National laws will only be adapted where absolutely necessary.
  • The underlying concept can be applied for other non-European systems.

Policies to guide implementation

10 May 2023 – Position and Supporting Arguments regarding Motion 20.3211

Swiss Medtech expects the Federal Council to now implement Parliament’s mandate – swiftly and pragmatically. It is the only way to guarantee a sustainable and sufficient supply of safe medical products for the Swiss population. This is currently not the case. Switzerland’s dependence on medical devices which comply with European medical device regulations has become a risk for patients. Swiss Medtech also expects the Federal Council to use the mandate from Parliament as an opportunity to promote progressive regulations and strengthen Switzerland’s position as a location for research, innovation, and business.

Position Paper

25 April 2023 – Sometimes life hangs on a «few small tubes»

The ARD München Report programme begins by saying «Sometimes life hangs on a few small tubes. Outcomes can be fatal when hospitals run out of exactly these items». The video highlights how the aim of the original EU Medical Devices Regulation – to increase patient safety – has failed its mark. It is now endangering lives. ARD TV programme München Report (from minute 19, in German)

29 March 2023 – Federal Council announces revision of national MedDO

The Federal Council announced in a recent press release that it will amend the national Medical Devices Ordinance (MepV) by autumn 2023 and extend the deadline for certification of medical devices in accordance with the EU Medical Device Regulation (MDR). Swiss Medtech strongly emphasises that this measure is nowhere near sufficient – either quantitatively or qualitatively – to ensure long-term supply of medical devices to the population. The supply problems throughout Europe are impossible to ignore. For this reason, Swiss Parliament passed Motion 20.3211 submitted by State Councillor Damian Müller in November 2022 instructing the Federal Council to establish new procedures for the procurement of medical devices for the Swiss population. Swiss Medtech calls for the Federal Council to utilise the planned national Medical Device Regulation revision for a parallel implementation of the parliamentary mandate.

20 March 2023 – Swiss parliament has been validated

The EU has adopted amendments to the Medical Device Regulation (MDR); specifically, the extension of the transitional periods for existing products (under certain conditions). The EU is now simply attempting to put out the flames. However, the MDR system has underlying weaknesses which cannot be corrected with selective changes. Implementation of Motion 20.3211 titled «For more room for manoeuvre in the procurement of medical devices for the care of the Swiss population» proposed by Councillor of States Damian Müller has become more urgent than ever. The Swiss Parliament should feel strengthened in its mandate to the Federal Council. 

Opinion

22 February 2023 – The medical profession is alarmed: Medical devices in short supply

Diverse stakeholders – medical professionals, hospital purchasers, manufacturers, importers and Swiss Medtech – are speaking out and communicating their respective points of view in a Swiss Medical Journal article entitled «The market for medical devices has dried up», which describes supply problems arising as a result of the European Medical Device Regulation (MDR). Motion 20.3211 titled «For more room for manoeuvre in the procurement of medical devices for the care of the Swiss population» submitted by Councillor of States Damian Müller is specifically referenced as a lifeline solution.

Swiss Medical Journal (in German)

16 February 2023 – US Webinar on Motion 20.3211

The international community is very interested in Switzerland’s approach. Sandra Rickenbacher-Läuchli appeared as a guest speaker in a webinar organised by the Massachusetts Medical Device Industry Council (MassMEDIC, the largest regional medical technology association in the USA). She spoke about the background and key points regarding implementation of Motion 20.3211 titled «For more room for manoeuvre in the procurement of medical devices for the care of the Swiss population» submitted by Council of States member Damian Müller.

Recording of the speechPresentation

8 February 2023 – Why many medical devices are disappearing from the market

ARD programme plusminus reports on the negative consequences of the EU Medical Device Regulation (MDR) on patient care and safety. Another focus: innovation is migrating. Many manufacturers are opting to apply for medical device approval in the USA as a first step, instead of in Europe. The video clip highlights Switzerland’s strategies, including Councillor of States Damian Müller’s Motion 20.3211 titled «For more room for manoeuvre in the procurement of medical devices for the care of the Swiss population».

ARD plusminus TV programme

28 November 2022 – Mandate issued to Federal Council: Swiss Medtech welcomes Parliament’s forward-looking decision

Now that both chambers of parliament have accepted Motion 20.3211 titled «For more room for manoeuvre in the procurement of medical devices for the care of the Swiss population» by Council of States member Damian Müller – the Council of States on 30 May and the National Council on 28 November – the mandate to the Federal Council has been issued. Swiss Medtech welcomes the parliament’s far-sighted decision. It is now important that the Federal Council implements the mandate swiftly and pragmatically. Waiting cannot be an option when patient safety is at stake.

Swiss Medtech Media Release

28 November 2022 – National Council passes Motion 20.3211

The National Council resolves to adopt Motion 20.3211, titled «For more room for manoeuvre in the procurement of medical devices for the care of the Swiss population» by Councillor of States Damian Müller – with 100 positive to 79 negative votes and 0 abstentions. 
Video of the National Council debate (in German)Voting in the National Council by roll call (in German)

21 October 2022 – SGK-N urges National Council to accept Motion 20.3211

The Committee for Social Security and Health of the National Council (SGK-N) recommends the adoption of Motion 20.3211 titled «For more room for manoeuvre in the procurement of medical devices for the care of the Swiss population» submitted by Councillor of States Damian Müller – with a vote of 14 to 8.SGK-N Media Release (in German)

18 October 2022 – APK-N urges the SGK-N to accept Motion 20.3211

The Foreign Affairs Committee of the National Council (APK-N) has considered Motion 20.3211, titled «For more room for manoeuvre in the procurement of medical devices for the supply of the Swiss population» by Council of States member Damian Müller, within the framework of a joint report to the Committee for Social Security and Health of the National Council (SGK-N). An amendment to the text aiming to recognize medical devices from non-European regulatory systems only in the event of a shortage in supplies was rejected by 14 votes to 11. The APK-N voted 14 to 11 to recommend that the SGK-N accept the original motion with unchanged text.APK-N Media Release (in German)

29 June 2022 – Federal Council sees no need for action: Swiss Medtech disagrees

The Federal Council has debated whether measures to ensure the supply of medical devices in Switzerland are needed. The basis for discussion was a study report commissioned by the Federal Department of Home Affairs (FDHA) in spring 2021. Swiss Medtech does not share the Federal Council’s conclusions that «the supply of safe and efficient medical devices in Switzerland is guaranteed» and that «there is currently no urgent need for action to adapt the current law». The Federal Council is ignoring the seriousness of the situation. The reality is in particular that: 1) problems with implementation of the European Medical Device Regulation (MDR) has as significant negative impact on the availability, diversity, and quality of medical devices throughout Europe and 2) initial innovation products are increasingly being launched on the US market and not in the EU.

30 May 2022 – Council of States passes Motion

The Council of States votes 23 to 12 with 3 abstentions to accept Motion 20.3211 titled «For more room for manoeuvre in the procurement of medical devices for the care of the Swiss population» submitted by Councillor Damian Müller. 
Video of the debate in the Council of StatesVote in the Council of States by roll call

26 April 2022 – SGK-S proposes that Council of States accept Motion 20.3211

The Committee for Social Security and Health of the Council of States (SGK-S) recommends approval of Motion 20.3211 titled «For more room for manoeuvre in the procurement of medical devices for the care of the Swiss population» by Damian Müller, Member of the Council of States, by 7 votes to 0 with 3 abstentions. 
SGK-S Media Release (in German)

21 September 2020 – Council of States to submit Motion 20.3211 to SGK-S for preliminary consideration

Erich Ettlin, member of the Council of States, proposes to the Council of States that Motion 20.3211 titled «For more room for manoeuvre in the procurement of medical devices for the care of the Swiss population» be referred to the relevant committee for preliminary discussion. The Council of States adopts the motion with the support of the author of the motion.Video of the Council of States debate

4 May 2020 – Damian Müller submits Motion 20.3211 to Council of States

Damian Müller, member of the Council of States, has submitted Motion 20.3211 titled «For more room for manoeuvre in the procurement of medical devices for the care of the Swiss population» to the Council of States. The motion petitions the Federal Council to create legal provisions authorising medical devices which comply with European medical device regulations (CE certificate); as well as medical devices from non-European regulatory systems, in particular medical devices approved by the U.S. Food & Drug Administration (FDA). Swiss Medtech unreservedly supports Motion 20.3211 and will closely follow the parliamentary process of this important political initiative. 
Motion 20.3211 (in German)