Life Sciences & Healthcare
The life sciences sector and the healthcare industry are characterized by a dense regulatory framework, high levels of innovation, complex technological processes, and challenging ethical and economic considerations. At the same time, companies, institutions, and healthcare providers operate under close scrutiny from policymakers, regulatory authorities, and society.
With profound legal expertise, industry-specific knowledge, and an interdisciplinary approach, we support our clients in successfully navigating this challenging and dynamic environment.
We advise pharmaceutical, biotechnology and MedTech companies, manufacturers, suppliers, distributors, healthcare providers, and other stakeholders in all regulatory and commercial matters along the entire value chain. Additionally, we represent our clients in regulatory proceedings before authorities and in court.
Our core competencies include comprehensive regulatory advice on the handling of therapeutic products. We support our clients in the pharmaceutical, biotechnology & MedTech sector in particular with regard to:
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Regulated activities (manufacturing, import/export, wholesale/retail trade, international trade, dispensing, etc.) and marketing authorizations for medicinal products
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Regulatory issues relating to classification, manufacturing, placing on the market, labeling, distribution, and use of medical devices
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Advertising for medicinal products and medical devices
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Integrity and transparency/price discounts, including compliance with industry codes and discount regulations
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Good Practice frameworks (GxP)
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Clinical trials involving pharmaceuticals and medical devices
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Market surveillance and vigilance
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Our team regularly drafts, negotiates, and reviews industry-specific agreements for clients in the pharmaceutical, biotechnology & MedTech sector (distribution and supply agreements, contract manufacturing agreements, research & development agreements, licensing agreements, collaboration agreements, NDAs, consultancy agreements, sponsorship agreements).
Additionally, we advise on related general contract law matters.
We have extensive experience with the legal requirements regarding pricing and reimbursement of pharmaceuticals and medical devices covered by the Swiss mandatory health insurance. Our services include advising clients on all matters related to the Specialty List (Spezialitätenliste, SL) and reimbursement in individual cases pursuant to art. 71a et seqq. of the Health Insurance Ordinance (KVV). In addition, we represent clients in these matters before the Federal Office of Public Health (FOPH), vis-à-vis insurers, and in court.
Furthermore, we provide comprehensive support regarding discounts and rebates under art. 56 of the Health Insurance Act (KVG), including legal requirements and admissibility, agreements on the partial passing on of discounts, and regulatory oversight and compliance.
Our team has extensive experience in handling complex administrative proceedings and representing clients before authorities and in court.
In particular, we represent clients in regulatory proceedings regarding handling of therapeutic products (such as marketing authorizations, operating permits, advertising, import and export, distribution, and market surveillance) as well as health insurance issues such as the Specialty List (Spezialitätenliste, SL).
We advise healthcare providers such as physicians, dentists, laboratories, pharmacies, drugstores, and health insurers, on regulatory requirements for professional practice, operating licenses, health insurance accreditation, professional regulations, public personnel law, advertising, tariff regulation, hospital planning, and state liability.