Regulatory, Administrative Procedures & Compliance

Regulation and compliance play a vital role for most of our clients.

Working within Swiss, EU and global frameworks, we regularly advise on research, approvals, clinical trials, quality agreements, pricing, reimbursement and marketing, drug advertising, trans-border trade, compliance, investigations, regulatory due diligence and material benefits in the drug market.

Regulatory, Administrative Procedures and Compliance
The regulatory framework governing the life sciences sectors is complex and constantly evolving. Our specialised lawyers closely monitor the continuing regulatory developments and case law in this area.

Research and Development. Research and Development is a core issue in the life sciences sector. Our lawyers have extensive expertise in advising our clients in matters relating to their research and development projects. Swiss regulatory law is constantly changing. Our lawyers keep you up to date.

Approvals. Our regulatory experts are familiar with the modalities of the different types of approvals relevant in the life sciences sector and the particularities of the corresponding procedures. We assist our clients in the evaluation of the appropriate regulatory strategy and in the approval proceedings before the competent authorities (e.g. Swissmedic, Federal Office for Health, cantonal laboratories). We also represent our clients in procedures before the federal and cantonal administrative courts.

Clinical Trials. The regulation of clinical trials in Switzerland is somewhat different compared to that of the European Union. We have extensive experience in all legal issues pertaining to the conduct of clinical trials in Switzerland, including the drafting of the respective contractual arrangements.

Pricing and Reimbursement. We protect our clients' interests in administrative proceedings in pricing and re-imbursement matters before the Swiss regulatory authorities and represent our clients in court.

Drug Advertising. We are familiar with the restrictions applicable to drug advertising in Switzerland and assist companies in complying with the respective rules and represent companies in respective investigations by the regulator.

Transborder Trade. Transborder trade of pharmaceuticals into Switzerland is not only an issue under Swiss patent law but also under Swiss regulatory law. Transborder trade of food and near-food products into Switzerland as well is highly regulated and involves detailed knowledge of relevant law and practice. We are familiar with the legal modalities and closely observe the political and administrative developments in this field.

Compliance. Compliance is a challenge in the fast changing regulatory environment of the life sciences sector. We can help companies to produce and implement policies and processes to ensure that they follow the numerous laws, rules and regulations.

Material Benefits and Transparency in the Drug Market. We are familiar with the rules and regulator's practice regarding the restrictions  applicable to promises and acceptance of material benefits as well as the transparency requirements in the Drug market. We advise companies in respective compliance issues and support and represent them in investigations by the regulator.

Investigations. Our attorneys specializing in public law assist in regulatory proceedings. An important focus here is administrative procedures relating to the marketing of health care and food products. Our attorneys also assist in criminal proceedings against companies and individuals.

Recent matters include where:

• We assisted Biogen (NASDAQ: BIIB) in the land purchase required for the one billion franc investment for a new biological manufacturing facility in Luterbach (Canton of Solothurn) expected to create 400 jobs. 
• We advised a major international pharma company on setting up its phase III clinical trial for a vaccine candidate with Swiss investigators, and on regulatory matters in order to set up an international research project. 
• We acted on behalf of a Swiss pharmaceutical company in administrative proceedings and in the subsequent court appeal concerning the listing of a medicinal product on the list of pharmaceutical specialties. 
• We advised a major medical devices organisation in restructuring its business unit as a consequence of new regulatory laws. 
• We reviewed a foreign energy drink on its compatibility with Swiss regulation laws and advised the manufacturer on regulatory issues regarding the import of the product into Switzerland. 
• We advised a leading research company and analysed regulatory risks linked to extraction of bone cells from donors. 
• We advise a major supermarket chain in implementing a new law in order to be able to sell low risk pharmaceuticals. 
• We advise a major supermarket chain on regulatory issues regarding parallel imports of food and near-food products. 
• We repeatedly provide advice regarding the labelling and advertising of food products with pharmaceutical-like ingredients. 
• We act on behalf of individuals from a pharmaceutical company in administrative criminal and criminal proceedings. 
• We have conducted an internal investigation concerning compliance issues for a major biotech company relating to a phase IV study. 
• We represented the University of Zurich and the Swiss Federal Institute for Technology Zurich in their administrative proceedings and litigation concerning field trials with genetically modified wheat. 
• We represented a leading European chain of institutes for assisted reproductive technology in implementing a new business case in the field of long-term storage of women’s egg cells for fertility precaution. 
• We advised a major Swiss pharmaceutical company on regulatory matters in order to set up an international research project. 
• We advised an international clinical services provider on securing compliance with Swiss laws when offering the services of study nurses to sponsoring pharmaceutical companies. 
• We provide permanent advice to a major biotech company on its marketing practices and the marketing practices of its competitors. 
• We provide advice to pharmacies relating to the permits for distributing traditional Chinese medicine products.