Februar 22, 2024
Regulatory Switzerland

Swiss Medtech Supports Negotiations for a Bilateral III Package

For the Swiss medical technology industry, legal certainty in the relation with the EU is essential. Swiss Medtech therefore supports the Federal Council in its efforts to stabilise and further develop the bilateral approach. For the Swiss medtech industry, barrier-free access to the EU internal market, access to qualified labour, cross-border cooperation in research, and a secure energy supply are key. It is important that the Federal Council begins negotiations as soon as possible.

On 15 December 2023, the Federal Council adopted the draft mandate for negotiations with the European Union (EU) and submitted it for consultation. Swiss Medtech appreciates the Federal Council’s transparency regarding the negotiation guidelines and provides the following comments. «The EU is the most important trading partner for the medical technology industry. One in three jobs in the Swiss medtech sector depends directly on orders from the EU,» says Dr Beat Vonlanthen, President of Swiss Medtech; underlining the importance of regulated relations and legal certainty between Switzerland and the EU.

The association sees negotiations on a Bilateral III package as an opportunity for Switzerland to further advance the bilateral approach, and supports the Federal Council in this endeavour. Swiss Medtech expressly welcomes the overall package approach, the integration of institutional rules into market access agreements, and the rejection of guillotine clauses. Under no circumstances should individual agreements be made legally dependent on one another. The medtech association also supports the integration of negotiations regarding agreements on electricity, healthcare and food safety into the package.

The following points are particularly important for the Swiss medtech industry:

- Agreement on mutual recognition in relation to conformity assessments (MRA): On 26 May 2021, the Swiss medical technology industry lost direct access to the EU single market following EU refusal to update the MRA in absence of an institutional agreement. Since that time, the industry has had to meet bureaucratic third-country requirements to trade with the EU. According to the negotiating mandate, the MRA would in future be part of Single Market Agreements that directly incorporate the institutional elements. Swiss Medtech emphatically welcomes this step. Regardless, the Federal Council should also press ahead with the long overdue MRA update.

- Agreement on the Free Movement of Persons: The success of the medtech sector is largely dependent on the availability of qualified personnel. The shortage of skilled professionals is a major concern for the entire industry and affects not only academic professions, but also production-related apprenticeships and specialised areas such as marketing authorisation. Swiss Medtech therefore rejects proposals – such as the federal popular initiative «No 10 million Switzerland!» – which would terminate the Agreement on the Free Movement of Persons.

- EU collaboration programmes for research, education and innovation: Swiss medtech companies invest around 10% of their turnover in Research & Development. The strength of the Swiss medtech sector is a direct result of fruitful collaboration with researchers from the ETH Domain, universities, and universities of applied sciences. Switzerland’s timely and wide-ranging participation in EU programmes focusing on research (Horizon), education (Erasmus), and innovation is crucial for the medtech sector.

- Agreement on electricity: The medtech industry depends on a reliable and sustainable supply of electricity. Swiss Medtech considers the finalisation of an agreement on electricity with the EU to be a central element of Switzerland’s future electricity supply. Such an agreement would grant Switzerland access to the EU Single Market and guarantee it the same treatment as EU member states.
     
Swiss Medtech also strongly supports the proposed dispute settlement procedure. «The medtech industry has experienced the consequences of compensation measures imposed unilaterally by the EU, as well as Switzerland’s inability to defend itself against them,» says Dr Beat Vonlanthen. A joint committee and arbitration tribunal with equal representation would change this situation. «Switzerland could assert its interests within the framework of a constitutionally clear procedure.»

Source: Swiss Medtech