The Therapeutic Products Act, which has been in force since 2002, is currently being revised for the third time. The Federal Council opened the consultation on 8 December 2023. You can find out which topics are affected on this page.
Following various previous revisions to the Therapeutic Products Act (TPA), Parliament and the Federal Council have once again identified a need for action in relation to drug safety for patients, electronic prescribing using e-prescriptions and drug safety in paediatrics.
Advanced therapy medicinal products (ATMPs) are now also 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, as far as possible equivalence to the new EU veterinary medicinal products legislation is to be created to prevent trade barriers and the development of antibiotic resistance, and ensure market access to innovative therapies in veterinary medicine.
These points are to be addressed as part of the present draft 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 in a single regulation (Regulation (EC) No. 2007/1394), they include gene therapy medicinal products, somatic cell therapy medicinal products, bioengineered tissue products and a combination of ATMPs and medical devices.
In the present regulation, Switzerland is adopting EU law as far as possible to guarantee the population’s access to innovative and high-quality therapies and new products.
This will also create a comparable level of safety and increase 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 stepped up. Parliament has referred corresponding initiatives to the Federal Council. The implementation of these initiatives is intended to 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
This draft revision is intended to create the legal basis for prescriptions for therapeutic products to be issued electronically and transmitted digitally. This 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 the e-prescription guarantees better legibility and thus helps increase patient safety. In future, it should be possible to prevent counterfeit prescriptions and unauthorised multiple prescriptions by means of electronic prescriptions. The bill defines the framework within which the e-prescription will be used. However, patient self-determination and the free choice of pharmacy should continue to be guaranteed.
Medication plan
A further aim of this revision is to create a legal basis for a mandatory electronic medication plan and for carrying out medication reconciliation when prescribing, dispensing or using medicinal products. According to the draft law, patients are to receive the medication plan electronically or in printed form on request. The aim is to increase drug safety, acceptance and adherence to treatment as well as to create more transparency and a better exchange of information between all healthcare professionals providing treatment. This revision objective implements the Stöckli 18.3512 Right to a medication plan to improve patient safety and 21.3294 Creation and management of medication plans to improve medication quality and patient safety for polymorbid patients motions.
Drug safety in paediatrics
Medication is also a major challenge in the treatment of children. On the one hand, there are only a few medicinal products 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.
As part of the implementation of Article 67a TPA, the federal government has already created a national register with harmonised dosage recommendations for the use of medicinal products in paediatrics throughout Switzerland. 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 drugs used for children, the use of electronic systems for calculating drug dosages is to be made mandatory. 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 modernised its regulation governing veterinary medicinal products. It came into force on 27 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. In addition to adjusting the duration of authorisation for veterinary medicinal products, these also include adjustments in relation to antimicrobials and, in this context, measures to reduce resistance. In addition, market access to novel and innovative therapies in veterinary medicine is to be guaranteed.
Documents
All following documents are available in French, German and Italian only
Links
Legislation
Last modification 29.04.2024
Contact
Federal Office of Public Health FOPH
Division of Biomedicine
Therapeutic Products Law Section
Schwarzenburgstrasse 157
3003
Bern
Switzerland
Tel.
+41 58 463 51 54