Life Sciences & Health Care Law
For many years we have been advising pharmaceutical and medical device companies as well as companies in the field of biotechnology and various health service providers from global corporations to innovative start-ups.
We see ourselves as a partner in all regulatory and strategic issues of our clients, providing them with legal expertise as well as our extensive industry knowledge and network in the healthcare industry and politics.
In this way, we support our ambitious, globally oriented clients in this dynamic and constantly innovating industry through the complex web of legal, economic and regulatory challenges associated with it.
Our Life Sciences & Healthcare team protects the value of our clients’ businesses and enables them to expand globally by providing practical, business-oriented advice on complex legal and strategic issues. As one of the long-standing market leaders in this highly regulated sector, our full-service team provides comprehensive support and representation for all Life Sciences & Healthcare business structures throughout the product lifecycle – from conception and human testing, through approval, launch and price negotiation, to subsequent marketing, as well as compliance and in the case of defense and enforcement of claims.
In addition, we regularly advise in this area on the complex requirements with regard to regulation, competition, compliance and data protection.
We always see ourselves as a strategic partner for our clients in the German, European and international markets.
In addition to legal advice, we support our clients in their strategic objectives. We ask the (right) questions, think and find creative solutions to meet the individual challenges of our clients.
Our Health Care & Life Sciences team is committed to the following issues:
- Regulatory framework conditions (pharmaceutical law, medical device law)
- Market Access (reimbursement of products, pricing, tendering and contracts with health insurers)
- Distribution of products (distribution agreements, distribution law according to AMG) and medicinal advertising law
- Preclinical and clinical studies
- Cooperations and Licensing
- Financing, Mergers and Acquisitions, Stock Option Plans
- Strategic Partnerships, Mergers and Acquisitions
- Questions about distribution and parallel import
- Patenting and patent litigation
- Product liability and process management
- Product Development – Clinical Trials
- Authorisation and certification system in the EU
- Distribution conditions – Competition law – Licensing
- Pharmacovigilance and product liability system in the EU
- System of statutory health insurance (GKV)
- Pricing of medicines and regulation at the expense of the GKV
- Health Technology Assessment – HTA – in the cost-benefit assessment according to SGB V
- Early benefit assessment of medicinal products according to AMNOG
We have successfully built up our expertise in the healthcare sector with well-known clients over more than thirty years and continue to expand it. A good relationship with legislators and associations leads to consistent and efficient support for our clients. The framework conditions for companies and other stakeholders in the healthcare sector are constantly changing.
We mainly advise and represent pharmaceutical companies, but also other players in the healthcare market, such as manufacturers of medical devices or service providers.
Our advice covers all issues relevant to the successful distribution of products, whether pharmaceuticals, medical devices or dietary supplements. We support our clients in all phases of the life cycle – from the development of the product to the expiry of the intellectual property rights.
Whether it’s researching or marketing a new life-saving therapy, regulatory compliance, an international patent litigation, a strategic alliance or a global merger, we know your situation and understand how to help you take the next steps. We anticipate risks and solve problems before they arise.
