The Life Sciences Law Review - Switzerland
|Author:||Dr. Markus Schott and Markus Wang|
|Profession:||Bär & Karrer|
Switzerland is home to a very significant and diverse life sciences industry with an emphasis on research and production. Apart from the two multinational companies, Novartis and Roche, which both have their headquarters in Basle, a large number of medium‑sized and smaller companies, in both the medicines and the medical devices sectors, are based in different parts of Switzerland.
Approval, distribution and marketing of medicines and medical devices are almost exclusively regulated on the federal level by the Therapeutic Products Act (HMG). Pricing and reimbursement by way of mandatory social health-care insurance is governed by a separate act on the federal level, the Health Insurance Act (KVG). Since 1 January 2014 research on humans is regulated in a separate statute at federal level: the Human Research Act (HFG). The Act primarily aims at protecting human welfare, but also at creating favourable framework conditions for research on humans in Switzerland and ensuring quality and transparency of research on humans. The three Acts are implemented by a number of ordinances that contain more detailed provisions setting out the general rules of the Acts.
While the HMG is enforced mainly by the Federal Agency for Therapeutic Products (Swissmedic), the cantonal health departments have some supervisory powers as well. The competent authority for the enforcement of the KVG is the Federal Office of Public Health. Compliance of research with the HFG is supervised by cantonal ethics commissions and the Federal Office of Public Health.
II THE REGULATORY REGIME
The HMG draws a distinction between medicines and medical devices, which are regulated in separate chapters of the Act. While the rules regarding medicines include licensing obligations for the manufacturing, marketing, import, export and trade of medicines, the rules regarding medical devices are based on the principle of self‑regulation by the person placing the device on the market. The HMG also regulates the prescription, dispensing and advertising of medicines as well as clinical trials.
According to Article 4, Section 1(a) of the HMG, medicines are 'products of chemical or biological origin, which are intended to have or are presented as having a medicinal effect on the human or animal organism, in particular in the diagnosis, prevention or treatment of diseases, injuries and handicaps; blood and blood products are also considered to be medicines', and according to Article 4, Section 1(b), medical devices are 'products, including instruments, apparatus, in vitro diagnostics, software and other goods or substances which are intended to have or are presented as having a medical use and whose principal effect is not obtained with a medicine'.
Foodstuffs, cosmetics and general consumer products are regulated by the Federal Act on Foodstuffs and Utility Articles (LMG). According to Article 3 of the LMG, foodstuffs are defined as nutritional products and luxury foods (alcoholic beverages, tobacco and other smoking products). Nutritional products are products that are intended to develop and maintain the human body and that are not marketed as therapeutic products. The fundamental distinction between foodstuffs and medicines means that the marketing of foodstuffs may not claim any kind of therapeutic or prophylactic effect.1
According to Article 5 of the LMG, utility articles are defined as products that are not marketed as therapeutic products and that fall within one of several categories, among which 'personal hygiene articles and cosmetics, and articles that when used as normally intended come into contact with the mucous membrane of the mouth'.
The handling of chemicals (substances and preparations) is governed by the Federal Act on Protection against Dangerous Substances and Preparations, which is based on the principle of self-regulation. The handling of microorganisms is deemed equivalent to the handling of substances and preparations when they are used in biocidal products or plant protection products.
ii Non-clinical studies
To obtain a marketing licence from Swissmedic with regard to a specific medicine, it is necessary to submit to the authority all results of physical, chemical, galenic and biological or microbiological tests as well as of pharmacological and toxicological tests.2 The application must comply with the requirements of the common technical document of the International Conference on Harmonisation and Technical Requirements for registration of Pharmaceuticals for Human Use (ICH), in particular its Module 4 regarding non-clinical documentation. Consequently, when carrying out the studies, the relevant ICH guidelines must be taken into consideration.
Non-clinical studies must be in line with the requirements of the Federal Act on Animal Protection, according to which testing on animals is subject to a cantonal licence and must be in compliance with strict conditions to limit the impact on animal welfare. In a controversial decision, the Federal Supreme Court has prohibited the use of rhesus monkeys for basic neurological research based on the principle of proportionality, in particular because the clinical benefit of the study was highly uncertain.3
The requirements regarding good laboratory practice are defined in the Ordinance on Good Laboratory Practice.
iii Clinical trials
Clinical trials are governed by the HFG, Articles 53 to 54 of the HMG, and the Ordinance on Clinical Trials (KlinV). All clinical trials of therapeutic products must be carried out in accordance with the recognised principles of good clinical trial practice. According to the KlinV, trials with medicines have to comply with the requirements of the ICH...
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