SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang and Djamila Batache, Bär & Karrer Ltd
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation Swiss healthcare regulation is spread over various statutes, ordinances and guidelines, including self- regulatory instruments such as best practice codes and references to international provisions. This makes navigating the life sciences landscape depend in large part on legal and regulatory expertise, as well as extensive practical industry experience. The following key acts provide the principles of the national regulation of pharmaceuticals and medical devices, whereby the legal terminology in Switzerland refers to “therapeutic products” as the generic term encompassing both “medicinal products” (pharma- ceuticals) and “medical devices”. • Medicinal products – these are regulated by the Therapeutic Products Act (TPA), the Ordinance on Medicinal Products (OMP), the Medicinal Products Licensing Ordinance (MPLO), the Ordinance on the Requirements of Marketing Authorisation of Medicinal Products (OMAMP), the Ordinance on Medicinal Products Advertising (OMPA), and the Ordinance on Integrity and Transparency (OIT). • Medical devices – these are regulated by the TPA, the Medical Devices Ordinance (“MedDO”) and the Ordinance on In Vitro Diagnostic Medical Devices (“IvDO”). Switzerland has revised its medical devic- es law to align it with Regulation (EU) 2017/745 on medical devices (“EU-MDR”) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“EU-IVDR”). Duties and responsibilities for Swiss healthcare are divided among the federal, cantonal and municipal authorities, whereas this Global Practice Guide focus- es on the federal level. As part of the Federal Depart- ment of Home Affairs (FDHA), the Federal Office of Public Health (FOPH) is responsible for public health in Switzerland. The Swiss Agency for Therapeutic Prod- ucts (“Swissmedic”) is the Swiss authority responsible for the authorisation and supervision of therapeutic products. As a federal public law institution, Swiss- medic is autonomous with regard to its organisation and management.
1.2 Challenging Decisions of Regulatory Bodies Administrative decisions of regulatory bodies are usu- ally issued in the form of a ruling and can be chal- lenged in administrative procedures or administra- tive court proceedings. The appropriate legal action depends on whether a federal or a cantonal regulatory body has issued the decision. If issued by a federal authority, decisions can be appealed to the Federal Administrative Court. Decisions of the Federal Admin- istrative Court are subject to further appeal to the Fed- eral Supreme Court. These challenge procedures in general also apply to other regulated products. In certain areas, such as public procurement or social security, special provi- sions may apply. Besides, criminal procedure rules may apply to administrative and criminal sanctions issued by regulatory bodies. 1.3 Categories of Pharmaceuticals and Medical Devices Medicinal products are divided into four dispensing categories: • category A – medicinal products that may be dispensed on a one-time basis on a physician’s prescription (Article 41 of the OMP); • category B – medicinal products that require a prescription and can be obtained several times, whereby medicinal products on list B+ can also be dispensed without a prescription (Article 42 of the OMP); • category D – medicinal products that may be dis- pensed without a prescription, but after specialist advice (Article 43 of the OMP); and • category E – medicinal products that may be dis- pensed without a prescription and without special- ist advice (Article 44 of the OMP). The assignment to a particular category determines who is authorised to dispense, prescribe and use the medicinal product (Articles 24 et seq of the TPA). Non-prescription medicinal products, known as OTC medicinal products, are intended for self-medication. The classification into the different categories is made by Swissmedic (Article 23a of the TPA).
346 CHAMBERS.COM
Powered by FlippingBook