The modifications following the Ordinary Revision of the TPA (Stage 2) and its right of enforcement entered into force on 1 January 2019. This will simplify the population's access to medicinal products and improve the conditions for biomedical research and industry.
The Federal Council has decided to implement the modifications to the Therapeutic Products Act (TPA) as of 1 January 2019. The Council transferred the dispatch on the amendment of the TPA to Parliament on 7 November 2012. The National Council and Council of States accepted the core elements of the Federal Council's draft, amended them in part and adopted the revised TPA in the final vote on 18 March 2016.
Owing to the numerous legislative changes, the 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 early in 2018. The Federal Council also decided to postpone the entry into force of the provisions in regard to the integrity, transparency and the obligation to pass on discounts. In fact, the public consultation of the implementation provisions revealed the need for a major overhaul of these ordinances (Ordinance on the integrity and transparency in the field of therapeutic products [OITTP] and adaptation of the Ordinance on Health Insurance). These provisions should enter into force probably in early 2020.
The modifications planned are aimed specifically at the following:
- Facilitating market access:
creating new and simpler access opportunities for certain medicinal product categories (especially medicinal products approved in an EU or 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 modified allocation of the medicinal products to the different supply categories, and an easing of the supply requirements.
- Improved drug safety:
tightening up and modernising market supervision (introduction of the pharmacovigilance plan, application of Good Vigilance Practice, increased scope and more detailed definition of reporting obligations);
improving the safety of medicinal products used in paediatrics (publication of a register for off-label dosage recommendations for the medicinal products used in paediatrics, establishment of new obligations and incentives for the pharmaceutical industry to promote the development of paediatric medicinal products);
defining minimum requirements for the prescription of medicinal products.
- Increasing transparency:
increasing the scope of the information published by Swissmedic about the medicinal products submitted to it for assessment and their authorisation holders (in particular, publication of the assessment reports for human medicinal products with new active ingredients on which the authorisation decisions are based [SwissPAR]);
publication of a summary report of the results of clinical trials;
creating an information system for monitoring the distribution 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.
Documents
Enactment competencies of the Federal Council:
(all documents are only available in French, German and Italian)
- Rapport explicatif relatif à l’ordonnance sur les médicaments (OMéd) (PDF, 684 kB, 11.05.2017)
- Rapport explicatif concernant la révision de l’ordonnance sur la publicité pour les médicaments (OPuM) (PDF, 449 kB, 20.06.2017)
- Rapport explicatif concernant l'ordonnance sur la taxe de surveillance versée à l’Institut suisse des produits thérapeutiques (PDF, 148 kB, 09.05.2017)
- Rapport sur les résultats de la consultation (PDF, 1 MB, 21.09.2018)
Regulatory impact of TPA revision (Complementary and herbal medicines) (PDF, 1 MB, 06.11.2012)Summary (in French and German)
Links
Legislation
Last modification 05.04.2019
Contact
Federal Office of Public Health FOPH
Division of Biomedicine
Therapeutic Products Law Section
Schwarzenburgstrasse 157
3003
Berne
Switzerland
Tel.
+41 58 463 51 54