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.
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