SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang, Djamila Batache and Christine Schweikard, Bär & Karrer AG
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices Swiss healthcare regulation is spread over vari- ous statutes, ordinances and guidelines, includ- ing self-regulatory instruments such as best practice codes and references to international provisions. This makes navigating the life sci- ences 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 “medic- inal products” (pharmaceuticals) 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 Prod- ucts (OMAMP), the Ordinance on Medicinal Products Advertising (OMPA), and the Ordi- nance 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” ). Switzer- land recently revised its medical devices 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 Prac- tice Guide focuses on the federal level. As part of the Federal Department of Home Affairs (FDHA), the Federal Office of Public Health (FOPH) is responsible for public health in Switzerland. The Swiss Agency for Therapeutic Products ( “Swiss- medic” ) is the Swiss authority responsible for the authorisation and supervision of therapeu- tic products. As a federal public law institution, Swissmedic is autonomous with regard to its organisation and management. 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation Administrative decisions of regulatory bodies are usually issued in the form of a ruling and can be challenged in administrative procedures or administrative court proceedings. The appropri- ate legal action depends on whether a federal or a cantonal regulatory body has issued the deci- sion. If issued by a federal authority, decisions can be appealed to the Federal Administrative Court. Decisions of the Federal Administrative Court are subject to further appeal to the Federal Supreme Court. These challenge procedures in general also apply to other regulated products. In certain areas, such as public procurement or social security, special provisions may apply. Besides, criminal procedure rules may apply to adminis- trative and criminal sanctions issued by regula- tory bodies. 1.3 Different Categories of Pharmaceuticals and Medical Devices Medicinal products are divided into four dis- pensing categories:
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