Pharmaceutical Law – l▷ in Switzerland | Zurich Bern Basel Geneva Lausanne Lugano St.Gallen Zug | Divorce Lawyers / Tax, Banking, Inheritance, Patent, Property Law Attorneys

Pharmaceutical Law

Therapeutic Products Act
Life Sciences Law
Pharma Compliance and Licenses
Biomedicine ethics and social responsibility
Principal areas: Digital Health, Genomics, Medtech, Computer aided Surgery

Therapeutic Products Act

The legal framework for therapeutic products in Switzerland

The Therapeutic Products Act mandates comprehensive implementational legislation. Important enactments referring to the Therapeutic Products Act are listed below.

Federal Law on Medicinal Products and Medical Devices (Therapeutic Products  Act, HMG; SR 812.21)
Federal Law on the Transplantation of Organs, Tissues and Cells  (Transplantation Law)
Federal Law on Narcotics and Psychotropic Substances (Narcotics Law,  BetmG)
Federal law on research involving humans (Human Research Act, HFG)
Federal Law on the Control of Communicable Human Diseases (Epidemics Act, EpG)

Swissmedic and the pharmaceutical industry routinely engage in an exchange of thoughts on matters pertaining to the regulation of medicinal  products within the context of the Regulatory Affairs Roundtable (hereinafter referred to as the Roundtable).

The Roundtable enables the two sides to make their positions heard so that, if deemed necessary, they can promptly and appropriately respond to regulatory and technical signals. On the side of Swissmedic, there is a specific need to discuss modifications to the regulation of medicinal products with representatives of the pharmaceutical industry prior to implementation, in order to take appropriate measures with regard to practical aspects of operational implementation and to communicate these in a way that is  meaningful to the target audience.

Life Sciences Law
Various areas of law work together in the field of life sciences to provide a framework that promotes the development and dissemination of  new technologies, makes their use as low-risk as possible – and, where necessary, also defines their limits.
It ensures that knowledge becomes fungible. For technology transfer, the law also provides other necessary regulations, in particular  contract law and antitrust law, which prevents restrictions on intracompetitive activities.
The life sciences industry, which is constantly evolving, brings together a variety of legal fields and also raises new legal challenges. Clients in the life sciences, health care and veterinary industries need attorneys who understand the urge to find ever more cutting-edge  and sophisticated solutions to healthcare related challenges.
The crucial role that the life sciences industry plays in Switzerland is apparent from the value added generated in the sector.
The life sciences industry includes pharmaceuticals, biotechnology and medical technology. Due to the presence of companies such as Syngenta, agrochemicals also have an important contribution to Switzerland’s economy.
The two best-known Swiss life sciences companies are Roche and Novartis. They rank among the top three pharmaceutical companies worldwide. Also of  crucial importance for Switzerland as a business location are the many smaller life sciences companies. All these companies achieve a very high degree of hourly productivity and make Switzerland one of the world’s leading life science locations.
Pharma Compliance and Licenses
Pharmaceutical law regulates the approval, manufacture, dispensing and advertising of medicinal products and medical devices as well as market  surveillance based on the Therapeutic Products Act and its ordinances. It furthermore oversees competition law, data protection, the setting of prices, as well as patent and trademark protection.
Under Swiss pharmaceutical and compliance law, all manufacturers and wholesalers of drugs and medicines must obtain a license from Swissmedic. Medical devices (e.g. cardiac pacemakers, dental custom-made devices, condoms, blood pressure monitors, injection equipment, catheters, acupuncture needles) are not subject to an approval procedure and the distributors do not require explicit authorization from the competent authority. However, they must fulfill the basic requirements according to the Medical Devices Ordinance (MepV, part of the HMG).
HMG: In the medical technology sector, Swiss medical device law is relevant, notably the Federal Law on Medicinal Products and Medical Devices  (Heilmittelgesetz, HMG) in conjunction with the related ordinances. Furthermore, there are legal enactments on such topics as innovation, research, transparency, quality, tariffs and trade.
Medical Product: In the context of a medical product, any instrument, apparatus, device, software, substance, accessory or other medical device, whether used alone or in conjunction with one another, including software specifically intended for use for diagnostic or therapeutic
purposes, shall be defined as a medical product.
Biomedicine ethics and social responsibility
In the field of biomedicine, the development, structure and functioning of the human body as a complex biological system are researched and taught. The focus is on the processes in the both healthy and diseased human organism at the level of cells and molecules. Biomedical research investigates the underlying biological mechanisms at the interfaces of natural sciences, medicine and mathematics.
During the past few years, human and stem cell research, reproductive and transplantation medicine, genetic diagnostics and pharmacogenetics, as well as innovative drugs and medical devices have revolutionized the field of biomedicine.
While these developments present opportunities, they also raise questions about biosafety, ethics and social responsibility.
An important measure to be able to use the opportunities for the health of the population and to reduce or avoid the risks is the legislative work in the fields concerned. The Swiss Federal Office of Public Health FOPH Biomedicine Division drafts, enforces and reviews the relevant laws. In doing so, it focuses on transparency, coherence,  appropriateness and compatibility with international standards.
Principal areas: Digital Health, Genomics, Medtech, Computer aided Surgery
1. Providing representation to pharmaceutical companies involved in the process of developing and delivering medicines, including advising on clinical trials and parallel trade.
2. Medtech, medical devices and the convergence of information technology with Pharma, Life Sciences and Healthcare, encompassing the world of digital health.
3. Emerging life sciences – Computer aided surgery, new genomics and personalized medicine niche sectors, and the deployment of artificial intelligence (AI) with pharma to facilitate better medical outcomes.


Kaffeevelo / Kaffeemobil mieten    Coffee Bike mieten Zürich    Kaffeemobil mieten Zürich