Our team combines extensive knowledge of the Swiss regulatory environment and legal framework with a comprehensive understanding of the global life sciences regulatory landscape encompassing pharmaceuticals, biotech, medical devices, food and cosmetics. Our lawyers are at the forefront of the industry as trusted advisers to both established and emerging life sciences companies conducting business in Switzerland and beyond.
Bringing Cost-effective Excellence and a Global Mindset to all Regulatory, Compliance and Corporate Issues
Our long-established presence in Geneva, at the cutting edge of international trade law, WTO dispute resolution and international arbitration, has laid strong foundations working with global life sciences companies and the international organizations that help shape global and national policies in life sciences. Our regulatory strength is enhanced by our team of former senior officials from Swissmedic, the European Medicines Agency, the European Commission, the FDA and the Ministry of Commerce of China, underpinning our industry perspective as we help clients advance their commercial objectives wherever they do business.
One Cohesive Approach
We bring our multidisciplinary life sciences knowledge to bear in helping our clients make strategic decisions to advance their innovative products and services. The complex issues that life sciences companies face require overlapping skills and experience across multiple legal disciplines, scientific and clinical backgrounds, as well as commercial acumen from first-hand in-house industry experience. Our team comprises a deep bench of highly experienced lawyers advising at every stage of the product life cycle, from clinical trials to post-marketing issues. This includes pharmacovigilance, labeling, promotional and advertising matters.
Our Swiss life sciences practice assists clients in the following areas:
- Market Access: Our regulatory team has a deep understanding of the mechanisms involved in securing an effective market access and the strategies to maintain it. We help clients develop a forward thinking strategy early on to enhance a product’s pathway and gain swift and effective access to key markets. Creative thinking, profound legal and regulatory knowledge and strong connections form the basis of ensuring entry to market.
- Life Cycle Management: Composed of lawyers with a scientific background as well as a former clinician, our regulatory team advises bio pharmaceutical companies on how to navigate the dilemmas arising from the day-to-day running of the business; and advising on the regulatory protections afforded by the legal framework. This includes strategies to maximize a company’s IP regulatory rights (such as SPC, regulatory data protection, marketing protection, orphan exclusivities and pediatric extensions), whilst ensuring compliance with the competition rules.
- Competition: Most, if not all, competition cases in the life sciences sector overlap with regulatory issues such as pricing and reimbursement, or matters arising from life cycle management (including parallel trade). Our counseling and advocacy is market-based rather than theoretical and operates at the interface of IP regulatory law, such as the competition issues arising out of a patent settlement or the assertion of IP regulatory rights.
- Compliance: Leveraging extensive industry experience and global reach, we have advised on numerous compliance matters involving corporate activities in over 100 countries. We partner with life sciences clients to develop and implement tailored compliance programs, taking proactive steps to identify risks and conducting remedial actions where needed.
- Good Manufacturing Practice (GMP): Failing to meet GMP requirements can have drastic and costly consequences for life sciences companies. We are the only law firm with a dedicated team of more than 30 lawyers devoted to GMP and Quality Systems Regulation (QSR) on three continents. Owing to the sheer volume and depth of our experience, clients entrust us with their most complex investigations, conducting audits at manufacturing sites and counseling on interaction with regulatory agencies.
- Privacy and Cybersecurity: Life sciences companies must consider a range of privacy, data protection and cybersecurity rules that apply to the handling of personal data (relating to patients, health care practitioners, employees and vendors) in Switzerland, the EEA and globally. We help mitigate compliance risks by developing comprehensive strategies that take into consideration our clients’ commercial needs.
- International Arbitration: With an integrated team of practitioners on three continents including a deep bench in Switzerland, we help life sciences companies avoid, manage and resolve cross-border disputes. We efficiently collaborate with clients throughout the lifetime of business-critical contracts, giving them the benefit of our results-oriented strategies, innovative tools and long track record of success in high-stakes arbitrations.
- International Trade: Addressing issues at the intersection of international health regulation, market access and IP protection, Sidley is the only international law firm in Switzerland advising life sciences clients on critical international trade matters. Our presence on the ground in Geneva is a key asset in representing clients impacted by the decision-making of the World Health Organization (WHO) and the World Trade Organization (WTO).
- Technology Transactions: Located in key advanced technology hubs, clients turn to us for our in-depth technical and scientific experience to help them maximize the value of strategic relationships and the return on IP investments, including collaborations, joint ventures, licenses, co-promotion agreements, outsourcings and research and supply chain agreements.
- Mergers and Acquisitions: Based in key financial and regulatory hubs our global M&A team helps clients structure and execute transactions across the full spectrum of public and private mergers, drawing on our experience with food, drug and medical device regulation, compliance, GMP, data protection, competition and product liability matters.
- Private Equity: Venture capital funds, corporate funds and foundations, as well as later stage private equity investment houses, value our one-team approach to executing deals. In addition to full-service transactional support, we conduct comprehensive regulatory due diligence through our highly skilled life sciences regulatory team to ensure the most favorable negotiating position.
