Pharmaceuticals: Switzerland and USA sign MRA

With a trade volume of 900 billion Swiss francs, the USA is now Switzerland's most important trading partner. The United States is also a major export market for the Swiss pharmaceutical industry: 26 percent of drug exports now cross the Atlantic. Until now, however, trade has been associated with a number of administrative hurdles. For example, drugs must be produced in accordance with internationally agreed Good Manufacturing Practices (GMP). Compliance with these rules is checked twice: in Switzerland by Swissmedic and in the USA by the Food and Drug Administration FDA. 

Lower hurdles for drug approval

The agreement signed on 12 January 2023 now ensures mutual recognition (Mutual Recognition Agreement MRA) of GMP. This means that Swissmedic and the FDA will refrain from inspecting the production sites of medicinal product manufacturers in the other country following an in-depth examination of the partner country's inspection practices. This is a win-win situation for both sides, as such inspections tie up resources and cost time and money - "quickly more than a million francs" according to the industry association Interpharma. These funds can now be invested in innovation now that reciprocal inspections are no longer necessary. 

The agreement removes a so-called non-tariff trade barrier. According to the Federal Department of Economic Affairs, Education and Research (EAER), the GMP MRA also contributes to the diversification of trade relations, including Switzerland's cross-border production and supply chains. In this way, the MRA supports the security of supply and resilience of the Swiss economy, which is dependent on foreign trade, especially in view of the ongoing global upheavals with regard to international trade, according to the statement published on the subject.

Motion calls for similar MRA for medical devices

Comparable GMP MRAs already exist between the USA and the EU as well as the UK. Switzerland, for its part, has already concluded GMP MRAs with the EU, the UK and South Korea. The agreement is intended to create a level playing field for Switzerland as a pharmaceutical location for the US market compared to the EU and the UK. However, medical devices that do not fall within the pharmaceutical sector are still excluded. A motion by National Councillor Damian Müller wants to change this and is calling for an MRA with the USA and other countries for the approval of medical devices (e.g. insulin pumps, medical protective masks, prostheses, etc.). After the EU's new Medical Devices Regulation comes into force in 2021, Switzerland will be considered a "third country" because there is no framework agreement between Switzerland and the EU. This means a high administrative hurdle for the approval of medical devices and may mean that certain products will no longer be available in Switzerland in the medium to long term.

Sources: economiesuisse, WBF/Swissmedic, interpharma

This article originally appeared on m-q.ch - https://www.m-q.ch/de/arzneimittel-schweiz-und-usa-unterzeichnen-mra/