Amendment of the Therapeutic Products Act: The Federal Act on Medicinal Products and Medical Devices ("TPA") aims to protect human and animal health by ensuring that only high-quality, safe and effective therapeutic products are placed on the market.
In December 2023, the Federal Council launched the consultation procedure on the third partial revision of the TPA. The proposed changes aim to advance the digitalization of key processes in the healthcare system, clarify the use of new technologies, and improve the quality of care. Specifically, the draft revision addresses the following areas:
- Ensuring access to innovative therapies: Advances in biomedicine have led to a variety of new therapeutic options, which in the EU are referred to as advanced therapy medicinal products ("ATMP"). These are regulated by Regulation (EC) No. 2007/1394 and include gene therapy medicinal products, somatic cell therapy medicinal products, bioengineered tissue products and a combination of ATMPs and medical devices. Switzerland intends to adopt the EU legislation to a large extent in order to ensure that the population has access to innovative and high-quality therapies and to create a comparable level of safety.
- Electronic prescriptions for therapeutic products: Electronic prescriptions for therapeutic products are to become mandatory. The electronic issuance, transmission and redemption of prescriptions is intended to improve readability, thus increase patient safety. It is also intended to prevent counterfeiting and unauthorized multiple redemptions. However, patient autonomy and the freedom to choose a pharmacy will continue to be guaranteed.
- Electronic medication plan: Healthcare professionals will be required to draw up an electronic medication plan when prescribing, dispensing, or administering medication and to provide it to the patient electronically or in print on request. The aim is to increase information transparency and improve medication safety, acceptance, and adherence to treatment.
- Medication safety in pediatrics: The use of electronic systems for calculating drug dosages is to be made mandatory in institutions providing inpatient treatment for children in order to increase safety in pediatric medication.
- Supply security in the field of veterinary medicine: The EU has updated and modernized its regulation on veterinary medicinal products (Regulation (EU) 2019/619 on veterinary medicinal products, Regulation (EU) 2019/420 on medicated feed). As more than 80% of the medicinal products authorized in Switzerland are manufactured in the EU, Switzerland is dependent on the supply of veterinary medicines from the European market. In order to ensure the supply and exportability of animals and animal products, the revision aims to make the Swiss veterinary medicinal products legislation as equivalent as possible to that of the EU and to impose as few additional requirements as possible on authorization holders for a Swiss authorization.
Amendment to the Epidemics Act: The Federal Act on Controlling Communicable Human Diseases ("EpidA") regulates the protection of humans against communicable diseases.
At the end of last year, the Federal Council launched the consultation procedure on the partial revision of the EpidA to improve the framework for dealing with future pandemics. The amendments aim to strengthen cooperation between the cantons and the federal government in strategies to combat communicable diseases. The proposed amendments are based in particular on the experience gained from the COVID-19 pandemic and relate to the following points:
- Refinement of the escalation model: The existing three-stage escalation model with the normal, special, and extraordinary situation will be refined. The aim is to clearly allocate responsibilities between the federal government and the cantons in the event of a specific health risk and to provide for appropriate measures depending on the epidemiological situation. In particular, the criteria and regulations that are considered when assessing a health risk situation are to be formulated more precisely and the cantons and parliament are to be better involved.
- Binding provisions: The draft revision specifies the conditions under which the Federal Council can take over the responsibilities of the cantons and what it can mandate. Provisions for future pandemics are to be strengthened and made more binding. Certain measures, including regulations for home office, compulsory masks, certificates and protection concepts, will also be specified in detail.
- Enhanced monitoring: Systems and methods for monitoring communicable diseases will be better interconnected, strengthened, and digitalized. This includes the national reporting system, wastewater monitoring, and the implementation of genetic sequencing.
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