Is Switzerland ‘leaving’ the EU?
Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.
Is Switzerland ‘leaving’ the EU?
The answer is both ‘yes’ and ‘no’.
First of all the ‘no’. Switzerland is (of course) not an EU Member State. However, as a result of bilateral agreements, Switzerland can benefit from most advantages comparable to being a Member State. Examples are i.a. free movement of persons, recognition of technical certificates, civil aviation, research (i.a. Horizon 2020), overland transport.
Then the ‘yes’. Because of the implications, we will explain in detail.
- In 1972 the (now) EU and Switzerland signed the Free Trade Agreement.
- Following the rejection of EEA membership, Switzerland and the EU have signed in 1999 the ‘Bilateral I’ package. These are 7 agreements, which are legally linked with each other by the so-called ‘guillotine clause’. This clause stipulate that if one agreement is terminated, the others will automatically also terminate 6 months later.
- In 2004 Switzerland and the EU signed the ’Bilateral II’ package. These included i.a. Schengen, taxation of savings, fight against fraud, pension, etc.
- In addition to the Bilateral I & II, several other agreement were signed between Switzerland and the EU.
2004: Europol
2008: Eurojust
2012: Cooperation with the EU Defence Agency EDA
2013: Cooperation between competition authorities and satellite navigation
2019: Police cooperation Prüm
In total there are currently 120 agreements between Switzerland and the EU.
According to the EU, the main problem with this multitude of bilateral agreements is there are no overarching rules that govern the participation of Switzerland in the EU. This will gradually lead to a lack of homogeneity, uncertainty and ultimately and in the end in inequality in the application of legislation for economic operators.
To ensure a level playing field between Switzerland and the EU, it is the EU’s wish is to come to common rules and supervision of these rules, that will benefit Switzerland as well and the EU, called ‘Institutional Framework Agreement’ (IFA).
The negotiations for the IFA began back in 2014. In November 2018 a full draft text was agreed. In June 2019, the Swiss Federal Council (the highest executive authority in the country) said it could not agree on the agreed draft text and wanted further ‘clarifications’ on the issues of State aid, protection of Swiss wages, ‘flanking measures’ and Freedom of movement of persons. After 2 years of no progress, the discussion resumed in January 2021.
In May 2021 the Swiss Federal Council informed the EU of their decision to terminate the negotiations on the IFA.
What happens next?
Following a statement of the EU Commission: “Its core purpose [the IFA] was to ensure that anyone operating in the EU Single Market, to which Switzerland has significant access, faces the same conditions. That is fundamentally a matter of fairness and legal certainty. Privileged access to the Single Market must mean abiding by the same rules and obligations. […] Without this agreement, this modernisation of our relationship will not be possible and our bilateral agreements will inevitably age: 50 years have passed since the entry into force of the Free Trade Agreement, 20 years since the Bilateral I and II agreements.”
Without the IFA, no new agreement with Switzerland will be concluded. Existing agreements may not be updated. Without modernisation, the existing agreements will in time ‘simply’ expire. Already the development, manufacture and trade in medical devices in EU member states and Switzerland have no longer been uniformly regulated since the entry into force of the EU Medical Devices Regulation (MDR) on 05.26.2021 Read more on this here: https://www.reuschlaw.de/news/update-mutual-recognition-agreement-zwischen-der-schweiz-und-der-eu-ist-gescheitert/
What are the implications for ProductIP technical files?
- Of course all existing technical files remain to exist
- Up to now due to interdependency between Switzerland and the EU, ProductIP saw no reason to treat Switzerland as a non-EU-country (which it actually is)
- We will continually update the information on ProductIPedia on the IFA as it develops and keep you up to date
