SWITZERLAND Law and Practice Contributed by: Annemarie Lagger, Amina Chammah and Isabell Schellhas, Walder Wyss Ltd
Partial Revision of the Swiss Therapeutic Products Act In the light of new technologies and legal develop - ments in the EU, Switzerland is currently revising the Swiss Therapeutic Products Act , inter alia, in relation to drug safety for patients and drug safety in paedi - atrics, namely by creating a legal basis for a manda - tory electronic medication plan or by establishing an obligation to use electronic systems to calculate drug dosages for children. In light of Regulation (EC) No 2007/1394, new regulations in relation to advanced therapy medicinal products (ATMPs) shall also be implemented in order to grant access to new prod - ucts and create a comparable level of safety to that in the EU. In relation to veterinary medicinal prod - ucts, the partial revision aims to ensure equivalence of the Swiss law with EU law and to guarantee market access to novel and innovative therapies. The draft is currently under revision by the Parliament. In parallel, a further partial revision (TPA 3b) is already in prepa - ration. It is expected to address measures against supply shortages, an extension of chiropractors’ competences, the individual dispensing of medicinal products, and a supervisory fee for medical devices. The consultation phase is planned for Q2 2026. Packaging A new Ordinance on Packaging (draft version) is expected to enter into force in spring 2027, replac - ing the current Ordinance on Beverage Containers. The new ordinance introduces, inter alia, fundamental requirements for the production and design of pack - aging materials, ensuring that resource efficiency and recyclability are considered from the design stage. It also establishes requirements for the take-back and recycling of single-use plastic packaging and bever - age cartons, and extends the advance disposal fee to glass packaging used for food and cosmetic products. Sustainability Reporting and Due Diligence Obligations The Swiss Federal Council has prepared a draft of the new Federal Act on Sustainable Corporate Gov - ernance (NUFG), aiming to replace the current due diligence and reporting duties in the fields of human rights and environmental protection. The revised rules are based on the European CSRD and CSDDD and extend the scope of reporting and due diligence obli -
ment than alternative options. In addition, it authorises the Federal Council to impose obligations regarding the disposal and life cycle of products and packaging. 3.2 Future Policy in Product Liability and Product Safety There are several areas of focus concerning future policy development in respect of product liability or product safety. The following developments are note - worthy. Partial Revision of the Swiss Product Safety Act With the entry into force of the Regulation (EU) 2023/988 on General Product Safety and the new European Market Surveillance Regulation 2019/1020, the Swiss Product Safety Act will partially be revised to incorporate the essential elements of these two EU regulations into Swiss law. This ensures that a compa - rable level of safety for the placing of products on the market is maintained in Switzerland, as has been the case to date. A first draft of the revised legislation was submitted for public consultation in June 2026. The proposed amendments address, in particular, e-com - merce, market surveillance, national and international co-operation, access to European information and alert systems, and data protection. The partial revision aims to ensure that the Product Safety Act continues to provide a level of product safety equivalent to that of the EU. At the same time, it is intended to facilitate access for Swiss exporters to the EU internal market. Swiss Product Liability Act – Mandate for Revision is Still Missing On 8 December 2024, the new Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/ EEC entered into force. With its entry into force, the existing system on product liability has been adapted to developments linked to transition towards a cir - cular and digital economy as well as AI. Since the Swiss Product Liability Act has been aligned with the repealed Directive 85/374/EEC, an adaption of Swiss law to such new developments seems conceivable. However, the competent Swiss authority has not yet received a mandate to initiate a revision of the Swiss Product Liability Act (as of date of publication of this chapter of the guide).
268 CHAMBERS.COM
Powered by FlippingBook