SWITZERLAND Trends and Developments Contributed by: Tobias Meili and André S. Berne, Wenger Plattner
In Switzerland, key legislation at federal level relat- ing to healthcare is subject to federal referendums. This leads to a high level of acceptance in the popula- tion. In substance, the Swiss healthcare system is not only characterised by the high quality of its medical services but also by a continuing rise in costs and a generally high expenditure level. In Europe, Switzer- land spends both the highest proportion of GDP and the most financial resources per capita on healthcare, which is reflected in constantly increasing cost pres- sure and rising patient demands. Regarding innovation, Switzerland is one of the world’s foremost innovators in biomedical research and life sciences technology. The chemical and pharmaceuti- cal industry is Switzerland’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 headquartered in the life sciences hub of Basel) being in the top ten of the global pharma companies. Most products in the Swiss life sciences sector are exported to the EU, which is why the regulatory framework of the EU is highly relevant. Given that Switzerland’s largest trading partner is the EU, the Swiss legislature strives for a far-reaching har- monisation of Swiss and EU legislation. Consequently, developments in the Swiss life sciences sector often mirror EU regulatory developments. Thus, various EU regulations materially inform Swiss legislation, even though Switzerland is not a member state of the EU. Considering these aspects, the Swiss life sciences 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, pharmaceuticals) 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. In September 2025, the Federal Council – ie, the Swiss government, submitted the proposed
revision to the Parliament for deliberation. The focus areas 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 paediat- rics. A primary goal for this revision is to establish a legal basis for the electronic issuance and digital transmis- sion of prescriptions for therapeutic products. The exclusively digital transmission of e-prescriptions aims to guarantee better legibility and thus contribute to increasing patients’ safety. Electronic prescriptions aim to prevent prescription forgeries and unauthorised duplicate prescriptions in the future. The framework conditions under which the e-prescription will be used are specified in the TPA. Nonetheless, patient autonomy and unrestricted pharmacy selection ought to be upheld. The revision also aims at creating a legal basis for a mandatory electronic medication plan and for the implementation of medication reconciliation when pre- scribing, dispensing or using medicinal products. The proposed law empowers patients to request a printed copy of their medication plan or receive it electroni- cally. The objective is to improve medication safety, acceptability and treatment compliance, in addition to fostering greater openness and information sharing among all treating healthcare providers. Children’s medication is another significant challenge. Few medications are specifically approved for use in children; however, dosages must be determined for each child based on actual age, weight, body size and other pertinent considerations. The Federal Council has already issued a national directory with standardised dosage recommendations for the use of pharmaceuticals in paediatrics (Article 67a TPA). However, this does not include a calculator function for individual dosage calculations. To avoid calculation errors as far as possible and thus increase the safety of the use of medicines in children, the revision aims to make the use of electronic systems for calculating drug dosages (so-called “Clinical Decision Support Systems”) mandatory. Furthermore, reflecting the high pace in the devel- opment of advanced therapy medicinal products
359 CHAMBERS.COM
Powered by FlippingBook