The healthcare sector is one of the most densely regulated markets. Market participants face a variety of challenges that require an interdisciplinary approach to legal advice.
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, competition and therapeutic product advertising 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 optimize 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
- Advice to one of the largest healthcare associations, in connection with, inter alia, digitalization issues
- Advice to pharmacies in the acquisition of service providers and a medication tracker app
Investments in the health care sector are very popular since the start of the COVID-19 pandemic. In Germany, there has been a particular interest in the strong German medical technology sector during the last years, not only from strategic but also from private equity investors.
The progressive development of new technologies is also leading to new fields of application and innovations in the healthcare industry. A practice that has been established for decades in seafaring is now also finding its way into doctors’ surgeries: the remote treatment of patients without any physical real contact. In sparsely populated regions in particular, existing gaps in medical care can be closed through telemedicine, and even in urban areas the accessibility of specialist care can also be improved.
Oppenhoff advised tesa SE on the sale of tesa Labtec GmbH, a specialty pharmaceutical contract development and manufacturing organization for transdermal therapeutic systems and oral films, to Adhex Pharma.