SWITZERLAND Trends and Developments Contributed by: Tobias Meili and André Berne, Wenger Plattner
Wenger Plattner Aeschenvorstadt 55 PO Box 462 CH-4010 Basel Switzerland Tel: +41 61 279 70 00
Email: basel@wenger-plattner.ch Web: www.wenger-plattner.ch
Initiatives and Challenges Impacting the Development of the Swiss Life Sciences Sector In Switzerland, key legislation at federal level relating to the healthcare system is subject to federal referendums. This leads to a high level of acceptance in the population. In substance, the Swiss healthcare system is not only char- acterised by the high quality of its medical ser- vices but also by a persistent rise in costs and a generally high expenditure level. In Europe, Switzerland spends both the highest propor- tion of GDP and the most financial resources per capita on healthcare, which is reflected in constantly increasing cost pressure and rising patient demands. Regarding innovation, Switzerland is one of the world’s foremost innovators in biomedi- cal research and life sciences technology. The chemical and pharmaceuticals industry is Swit- zerland’s largest export sector and contributes approximately 5% to the country’s GDP. There are about 1,000 companies active in this indus- try, with Novartis and Roche (both headquar- tered in the life sciences hub of Basel) being among the top ten global pharma companies. Most products in the Swiss life sciences sector are exported to the EU, which is why the EU regulatory framework is highly relevant.
Given that Switzerland’s largest trading partner is the EU, the Swiss legislator strives for a far- reaching harmonisation of Swiss and EU legisla- tion. Consequently, developments in the Swiss life sciences sector often mirror EU regulatory developments. Thus, various EU regulations sig- nificantly inform Swiss legislation, even though Switzerland is not a member state of the EU. Considering these aspects, the Swiss life sci- ences sector is currently undergoing significant changes. This overview highlights some recent initiatives in the sector. Ongoing revision of the Federal Therapeutic Products Act The Federal Therapeutic Products Act (TPA), which contains the most basic regulations on the handling of medicinal products (ie, phar- maceuticals) and medical devices, entered into force in 2002 and is currently being revised. The revision draft was presented in December 2023 and the consultation period ended in March 2024. Once the results of the consultation pro- cess have been analysed, the Swiss legislator will tackle the drafting work. The main focuses of attention in the revision are the implementa- tion of e-prescriptions and the improvement of patient medication safety, as well as drug safety in paediatrics. These strategic thrusts serve to
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