SWITZERLAND Trends and Developments Contributed by: Tobias Meili and André Berne, Wenger Plattner
advance the digitisation of the healthcare sys- tem – something that plays a central role in cut- ting healthcare costs, as well as meeting patient demands, and must be further strengthened. A priority for this revision is to establish a legal basis for the electronic issuance and digital transmission of prescriptions for medicinal products. The exclusively digital transmission of e-prescriptions aims to guarantee better leg- ibility and thus contribute to increasing patient safety. Electronic prescriptions aim to prevent prescription forgeries and unauthorised dupli- cate prescriptions in the future. The framework conditions under which the e-prescription will be used are specified in the TPA. Nonetheless, patient autonomy and unrestricted pharmacy selection ought to be upheld. The revision also aims to create a legal basis for a mandatory electronic medication plan and for the implementation of medication reconciliation when prescribing, dispensing or using medicinal products. The proposed law empowers patients to request a printed copy of their medication plan or receive it electronically. The objective is to improve medication safety, acceptability, and treatment compliance, in addition to foster- ing greater openness and information sharing among all treating healthcare providers. Children’s medication is another significant challenge. Few medications are specifically approved for use in children; however, dosages must be determined for each child based on age, weight, body size, and other pertinent con- siderations. The Swiss federal government has already issued a national directory with stand- ardised dosage recommendations for the use of pharmaceuticals in paediatrics (Article 67a of the TPA). 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 the use of medicines in children, the revision aims to make the use of electronic systems for calculating drug dosages mandatory. Furthermore, reflecting the high pace in the development of advanced therapy medicinal products (ATMPs) and their importance in med- ical practice, ATMPs are also to be regulated more specifically in the TPA. In the EU, ATMPs are regulated in a separate regulation (Regula- tion (EC) No 2007/1394) and include gene ther- apy medicinal products, somatic cell therapy medicinal products, bioengineered tissue prod- ucts, and combinations of ATMPs and medical devices. Not being a member state of the EU, Switzerland nonetheless seeks to mirror EU law as far as possible in the TPA to guarantee Swiss patients access to novel, high-quality treatments and products. The EU and Swiss markets should become more competitive and compatible as a result, and an equivalent level of safety should be established. Finally, the last area of revision is also due to developments in the EU aimed at avoiding trade barriers, preventing the emergence of antibiotic resistance, and guaranteeing market access to cutting-edge veterinary medicine therapies. The EU has revised and modernised its regula- tion in the area of veterinary medicinal products (Regulation (EU) No 2019/6), which entered into force on 28 January 2022. Thus, amendments to Swiss law are required to preserve the safety of the country’s veterinary medicine supply as well as the ability to export animals and animal prod- ucts to the EU. Amendments include modifica- tions concerning antimicrobial active substanc- es and – in this context – resistance-reducing measures, as well as modifying the duration of the authorisation for veterinary medicinal prod-
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