The modifications following the revision of the TPA (Stage 2), which have been in force since 2019, improve access to medicinal products and the conditions for research and industry.
The Federal Council resolved to implement the revised Therapeutic Products Act (TPA) with effect from 1 January 2019.
In view of the numerous legislative changes, the corresponding right of enforcement had to be comprehensively modified. Certain provisions (national recommendations on dosages of paediatric medicinal products, definitive arrangements for medicinal products approved by cantons) were already brought into force at the beginning of 2018.
The Federal Council also resolved to postpone the entry into force of the provisions with regard to integrity, transparency and the obligation to pass on discounts, because the consultation on the corresponding implementation provisions had revealed the need for a major overhaul of the ordinances concerned (the Ordinance on Integrity and Transparency in the Field of Therapeutic Products [OITTP] and the adaptation of the Ordinance on Health Insurance). These provisions entered into force in January 2020.
The modifications implemented are aimed in particular at:
- Facilitating market access:
Providing new and simpler approval opportunities for certain categories of medicinal products (especially medicinal products approved in an EU or an EFTA country, medicinal products with traditional uses and medicinal products already approved in a canton, as well as various medicinal products used in complementary medicine);
simplifying self-medication by modifying the allocation of medicinal products to the various supply categories and easing supply requirements.
- Improving drug safety:
Strengthening and updating market supervision (introducing the Pharmacovigilance Plan, applying Good Vigilance Practice and expanding the scope of and more precisely defining reporting obligations);
improving the use of medicinal products in paediatrics (publishing a register of off-label dosage recommendations for the medicinal products used in paediatrics, and establishing new obligations and incentives for the pharmaceutical industry to promote the development of paediatric medicinal products);
defining minimum requirements for prescribing medicinal products.
- Increasing transparency:
Expanding the scope of the information published by Swissmedic about the medicinal products submitted to it for assessment and their authorisation holders (in particular, publishing the reports which are crucial to the approvals of medicinal products for humans with new active ingredients [SwissPAR]);
publishing the results of clinical trials;
creating an information system to monitor the issue and use of antibiotics and the antibiotic resistance situation in veterinary medicine.
The Ordinary Revision of the Therapeutic Products Act (Stage 2) is part of the master plan of the Confederation for strengthening biomedical research and technology.
Enactment competencies of the Federal Council:
(all documents are only available in French, German and Italian)
- Explanations on the Ordinance on Medicines (PDF, 684 kB, 26.01.2023)
- Explanatory report on the revision of the Ordinance on Medicine Advertising (PDF, 449 kB, 26.01.2023)
- Explanatory report on the Ordinance on Swissmedic Supervisory Fees (PDF, 148 kB, 26.01.2023)
- Report on consultation results (PDF, 1 MB, 26.01.2023)
Last modification 01.12.2023