Schalast | “Healthcare & Life Sciences” Practice Group
Our era of “new health” is distinguished by health optimization and digitalization. Innovations are defining factors, including novel approaches to medication production, such as mRNA technology, that pave the way for personalized medicine, the application of biotechnology, genetic engineering, AI, and robotics.
Aspects of the “new health” era
Ever more people are making efforts to improve their physical and mental health (the “well-being trend”) as a result of the pressures they face at work and in their daily lives. The goals are to avoid illness as long as possible (disease prevention) and maintain or improve one’s current level of physical fitness.
As a result, businesses are investing more resources into creating sustainably sourced, (nutrient-)optimized foods (such as regenerative, plant-based options). Personal health management (“biohacking”) is rapidly expanding to include the use of digital health (eHealth) applications and wearables such as smartwatches and fitness trackers. These kinds of digital applications are also anticipated to help the medical industry develop better treatments and medicines.
As these changes occur, the necessary legal framework also grows in breadth and complexity. Legislative efforts are underway in Europe, for example the European Health Data Space (EHDS) and the AI Regulation. On the other hand, however, the German Pharmaceutical Market Reorganization Act that had already been the topic of discussions in the past appears to be countered by national legislation such as the Financial Stabilization Act.
We keep an eye out for hot issues and are familiar with industry requirements. Based on this expertise, we create ideas and plans for our clients and support them over time. Our ability to provide comprehensive and individualized solutions is a direct result of our interdisciplinary advisory strategy, which involves lawyers from various legal fields, such as IT law, competition law, and corporate law, at an early stage.
Advertising and competition in Healthcare & Life Sciences
Advertising in the healthcare sector, especially for drugs, medical devices, dietary supplements, or cosmetics, is subject to a wide range of regulatory and legal requirements, such as the Unfair Competition Act, the Therapeutic Products Advertising Act, the Health Claims Regulation, and compliance codes, to ensure that new products are introduced to the market in a safe and effective manner. The Green Claims Directive proposed by the EU Commission would increase scrutiny on the verifiability of environmental product claims, leading to stricter regulations for food labeling and communication. Therefore, we work with our clients to analyze and enhance labeling and marketing concepts, defend them in the event of injunction claims, and formulate legal strategies to combat competitors.
Additionally, we have years of experience serving as legal counsel for medical and laboratory practices, medical care centers, and their liability insurers, as well as hospitals and hospital owners.
Medical professionals & hospital administrators
In addition to organizational duties, medical professionals and hospital administrators may be held personally liable for damages caused by negligence in patient care, diagnosis, and education. Transparent regulation of patients’ rights became a reality with the passage of the Patients’ Rights Act. Since then, the value of risk management has skyrocketed. Our advisory services are geared towards minimizing such risks. To that purpose, we collaborate with our clients to conduct a gap analysis of their processes and set up the appropriate norms and controls at the onset. This allows us to avoid costly liability and recourse proceedings. We also act as our clients’ counsel in and out of court.
We advise all players in the Healthcare & Life Science sector, in particular:
- on regulatory issues relating to product classification (differentiating between medicinal product, medical device, food, cosmetics),
- on issues regarding product approval (market access) and product certification, including the certification of AI as a medical device, as well as on market entry
- on product safety issues (preventive advice and, where necessary, judicial enforcement of and defense against claims)
- on complex industry-specific contracts and M&A projects
- on drafting legally compliant marketing concepts, labeling or in the context of competition law proceedings
- in defending medical liability claims (out of court and in court)
- on the acquisition and sale of health care facilities; (partial) privatizations, in restructuring projects and hospital mergers; equity investments and joint ventures as well as due diligence
- in all matters pertaining to employment law (employment contracts with physicians, disputes with the works council, collective bargaining agreements, and works agreements)
- in connection with digitalization, data protection, and compliance (drafting digitalization and compliance concepts)
- in remuneration and billing issues
- in matters of licensing and professional law