Therapeutic Products Act: Partial revision
The Therapeutic Products Act, which has been in force since 2002, is currently being revised for the third time. The Federal Council submitted the dispatch on the proposed legal text to Parliament on 3 September 2025. You can find out which topics are affected on this page.
Following various previous revisory actions, Parliament and the Federal Council identified a need for further revision of the Therapeutic Products Act (TPA) in the areas of
- drug safety for patients
- electronic prescribing using e-prescriptions and
- drug safety in paediatrics.
Advanced therapy medicinal products (ATMPs) will now also be regulated more appropriately and clearly in the Therapeutic Products Act. The development of ATMPs is increasing worldwide, as is their importance in medical practice.
Finally, in the field of veterinary medicinal products, equivalence to the new EU veterinary medicinal products legislation is to be created as far as possible
- to avoid trade barriers
- to prevent the development of antibiotic resistance and
- to ensure market access to innovative therapies in veterinary medicine.
The following points were addressed under the present proposed revision.
Advanced therapy medicinal products (ATMPs)
New scientific advances in biomedicine have led to the development of various therapeutic options which in the EU are referred to collectively as 'advanced therapy medicinal products' (ATMPs). Regulated under their own separate regulation (Regulation (EC) No. 2007/1394), these comprise:
- gene therapy medicinal products
- somatic cell therapy medicinal products
- bioengineered tissue products and
- a combination of ATMPs and medical devices.
In its own present proposed regulation, Switzerland is adopting EU law as far as possible to guarantee the Swiss population’s access to innovative and high-quality therapies and new products.
This will also create comparable levels of safety and will promote competitiveness and compatibility between the EU and Swiss markets.
Digitalisation in the prescription, dispensing and use of therapeutic products
Digitalisation plays a central role in the healthcare sector and must be further extended. Parliament has referred corresponding initiatives to the Federal Council. The implementation of these initiatives should help promote digitalisation in the healthcare sector and contribute to achieving the objectives of the Federal Council’s 2020-2030 health policy strategy.
Electronic prescriptions for therapeutic products
Prescriptions for therapeutic products can already be issued and transmitted electronically if desired as part of an electronic medication process. The requisite legal basis is provided in the existing Therapeutic Products Act. Further information can be found in the ‘Minimal requirements for the electronic signature of electronic prescriptions for human medicinal products’ factsheet under ‘Documents’.
The purpose of the proposed revision here is to create the legal foundation for prescriptions for therapeutic products to be basically issued electronically and transmitted digitally. This will make the use of electronic prescriptions mandatory for the first time.
The revision thus fulfils the requirements of
- Müller Damian motion 20.3209 Electronic prescriptions for therapeutic products. Better quality and greater patient safety and
- Sauter motion 20.3770 Introduction of an e-prescription.
The exclusively digital transmission of e-prescriptions guarantees better legibility and thus helps increase patient safety. Electronic prescriptions should also make it possible to prevent forged prescriptions and unauthorised multiple refills.
The proposed revision defines the conditions under which e-prescriptions will be used. However, patients’ self-determination and the free choice of pharmacy should continue to be guaranteed.
Medication plan
A further aim of the proposed revision is to provide the legal foundation for a mandatory electronic medication plan that must be created or updated every time a medicinal product is prescribed, dispensed or used.
Patients should receive their medication plan electronically or in printed form on request. The plan is intended to increase drug safety, to promote the acceptance of and adherence to treatments, and to create more transparency and better exchanges of information among all the healthcare professionals providing the treatment concerned.
This revision objective implements
- Stöckli motion 18.3512 Right to a medication plan to improve patient safety and
- Stöckli motion 21.3294 Creation and management of medication plans to improve medication quality and patient safety for polymorbid patients.
Drug safety in paediatrics
Medication is also a major challenge in the treatment of children. On the one hand, there are few medicinal products that are specifically authorised for children; and on the other hand, dosages have to be calculated individually for each child based on age, weight, height and other relevant factors.
To avoid calculation errors as far as possible and thus increase the safety of drugs used for children, the use of electronic systems for calculating drug dosages is to be made mandatory.
Electronic systems for calculating drug dosages must contain data based on current medical and pharmaceutical science.
This implements Stöckli motion 19.4119 Increasing drug safety in paediatrics – reducing medication errors through e-health.
Veterinary medicinal products: largely equivalent to EU law
The EU has revised and updated its regulations governing veterinary medicinal products. The new regulations came into force in January 2019.
Amendments to Swiss law are necessary to ensure the security of supply of veterinary medicinal products in Switzerland and to maintain the exportability of animals and animal products to the EU. These amendments include:
- modifying the duration of authorisations for veterinary medicinal products
- adjustments relating to antimicrobials and
- measures to reduce antimicrobial resistance.
Market access to novel and innovative therapies in veterinary medicine should also be guaranteed.
Further information
Index
Federal Office of Public Health FOPH
Therapeutic Products Law Section
Schwarzenburgstrasse 157
Switzerland - 3003 Bern