Life Sciences & Health

Our experienced team at SKW Schwarz will gladly advise you on drafting and concluding commercial contracts in the healthcare sector, always keeping an eye on privacy and supporting you with the following requirements:

• Drafting contracts for clinical studies
• Licensing agreements
• Commercial agent/authorized dealer agreements
• Drafting commercial and cooperation agreements
• Legal advice on all aspects of research and development
• Data protection/data security

The healthcare market has been one of the economy’s fastest growing sectors, not only since the COVID-19 pandemic. This also applies to corporate finance and M&A transactions. The number of investments in digital health and AI-related applications is growing particularly strongly (Corporate Finance, 2020). Similarly, venture capital and private equity transactions in biopharmaceuticals and health tech are on the rise, both in terms of the number and size of deals. (Deloitte, 2020).

In corporate law (Corporate/M&A), we advise German and international groups, SMEs, financial investors, securities issuers, investment platforms, as well as fast-growing young companies in the following areas:

• Corporate Finance
• M&A
• Venture Capital/Private Equity
• Capital market law including digital investments

In the area of venture capital as well as capital markets law:

• Prospectus law (EU Securities Prospectus Regulation)
• German Capital Investment Act
• Law governing financial investment brokerage and investment advice (Section 1 German Banking Act, Financial Investment Brokerage Ordinance)
• Crowdfunding (e.g., proposal for the adoption of an EU Regulation for European Crowdfunding Service Providers (ECSP)).

In addition, we have been providing pro bono support for numerous start-up topics for years and are acting as lecturers for various university and government-funded incubators and accelerators.

The increased use of modern information and communication technologies (ICTs) in healthcare is important and helpful on many levels. It can serve efficient healthcare in times of demographic change, enables better access to medical expertise for a large part of the population, leads to cost savings, and networks patients, physicians, and payers. In parallel, of course, the corresponding laws are also changing and create a more complex legal framework (e.g., Appointment Service and Care Act, Digital Care Act and Digital Health Applications Ordinance, Patient Data Protection Act).

The field of eHealth is also growing. Therefore, electronic patient records (ePA), health cards (eGK), e-prescriptions, telediagnostics, data security for wearables (fitness trackers), and medical apps will play increasingly important roles in our lives in the coming years. This leads to enormous business opportunities.

To take advantage of these opportunities, it is important to process the sensitive health data of your customers in a legally compliant manner. SKW Schwarz advises your company with a holistic and innovation-oriented view on all issues related to eHealth, including the following topics:

• Use of information and communication technologies (ICTs) in healthcare: What legal requirements must innovative "eHealth" business models meet? Which telemedical services are compatible with the professional code of conduct for physicians and dentists? How can services be provided in legally compliant manner?
• Data protection/data security: What data protection requirements must be observed when processing sensitive health data? May collected data also be processed for other purposes - and if so, which ones? What are the requirements for privacy and IT security? How are concepts for data protection/data security specifically created and implemented in the company?
• Medical Apps/Medical Device Law: Can your app be certified as a medical device? What are the legal requirements? Does a conformity assessment or CE certification have to be obtained?
• Property rights: How can innovative business models be protected against imitation, for example, by acquiring property rights (e.g., patents, utility models, designs or trademarks)?
• German Drug Advertising Act: What requirements, e.g., for the sale or use of medical apps or other mHealth applications, must be observed with regard to the Drug Advertising Act?

Another trend is also clearly emerging: medical cannabis products will continue to grow in the German healthcare market. From the patient's point of view, this is welcome, as many therapies have been proven to benefit from medical cannabis. And as demand increases, so does the number of providers. The use of medical cannabis is tied to many legal and regulatory issues, however, which manufacturers, distributors and users should address.

One aspect that is becoming increasingly important in our advisory range is the compliance of medical and pharmaceutical products with the Medical Devices Act or with the European Medical Device Regulation (MDR).

We support you in matters of product regulation around the topics:

• Management of product liability litigation
• Regulatory notification procedures
• Control of international product recalls
• Product safety consulting

Our experts ensure that the results of your work, research, and product development are optimally protected and usable. To this end, in addition to our experience in intellectual property, we also have industry-specific knowledge and scientific expertise.

We advise you in trademark law and competition law as well as in patent law in cooperation with renowned patent attorneys.

This includes:

• Advertising and competition violations
• Licensing and transfer of patents and know-how
• Support of research and development cooperations
• Design of customized protection strategies and development of property rights portfolios
• Support during lawsuits and warnings

New and innovative health technologies require constant legal protection. Many mobile health applications can only comply with medical law regulations and be certified with sound legal expertise. Our experts will gladly assist and advise you in the areas of:

• Approval procedures and review of legal requirements of medical products and applications
• Medical Apps/Medical Device Law
• Therapeutic Products Advertising Law: Changes in advertising measures and intellectual property rights
• Procurement law procedures and antitrust considerations in healthcare