The health care sector is one of the most tightly regulated markets. In this environment, companies face a variety of challenges.
We advise and represent leading international pharmaceutical manufacturers, medical device manufacturers, biotech companies, hospitals, nursing homes, health insurance companies and service providers. Our interdisciplinary team supports clients in their day-to-day business, with M&A transactions and venture capital investments, regulatory issues, advertising law and the protection of industrial property rights. In addition, we advise on all labor law issues relating to corporate restructuring and the optimization of work processes, tax structuring, compliance issues, digitalization issues, national and EU-wide proceedings against regulatory measures, product safety issues, product liability cases and other disputes, including litigation before national and EU courts.
Together with our clients, we develop new solutions and business models, such as digitalization of medical products, cultivation of medical cannabis in Germany or cooperations with start-ups. By using Legal Tech, we help to control and accelerate internal processes.
Examples of our advisory services:
Representation of a German pharmaceutical company in a lawsuit before the European Courts (EGC and ECJ) against the EU Commission in the context of the successful challenge of a regulatory measure concerning a drug containing estradiol
- Structuring of clinical studies under the aspect of data protection law, especially in cross-border situations
- Negotiation of cross-border supply agreements including regulatory issues relating to the import and export of medical cannabis
- Reorganization of the field sales force of a pharmaceutical company, in particular advice on the employer's structuring rights in case of changes in the distribution territories and reporting channels as well as on questions regarding the co-determination rights of works councils under industrial constitution law
- Cooperation between international pharmaceutical companies in the production of vaccines against coronavirus
- Solution of regulatory and public law issues in connection with the use of mobile corona test stations at European airports
- Market entry of CBD products in the lifestyle segment, including distribution possibilities in consideration of the regulatory restrictions
- Venture capital investment in a medical device manufacturer, including verification of the business model