Healthcare and Life Sciences
Gleiss Lutz has an excellent reputation in advising on healthcare and life sciences issues. Our lawyers are not only recognised legal experts, but also have extensive industry experience and the necessary scientific and medical background. Our full service approach allows us to draw on relevant specialists from across the firm to provide clients with seamless advice on all matters with implications for their healthcare projects. As a result we are not only well-versed in handling complex transactions, but are also experts when it comes to the ins and outs of the statutory health insurance system, public procurement and regulatory issues as well as enforcing and defending IP rights.
“Leading Healthcare […] practice.”
Transactions
Gleiss Lutz is one of Germany’s leading M&A law firms, with decades of experience in advising on complex national and international transactions. Our clients include international groups and major listed stock corporations, as well as family-owned companies and medium-sized businesses.
Our advice covers the entire range of M&A topics, from transactions in pharmaceuticals and medical devices, the hospital or rehabilitation sectors, to all other areas of the healthcare industry, such as counselling providers of outpatient services, e.g. on the purchase of practices and establishment of ambulatory healthcare centres. As one of Germany’s largest law firms, we have the necessary resources to handle even the most complex transactions. Our full service approach allows us to call on recognised experts from other practice areas key to any given transaction (e.g. antitrust, tax, employment, IP etc.). In established teams, our advisers draw on their comprehensive expertise and experience to offer clients seamless service and individually tailored solutions.
Regulatory requirements
Virtually all areas of the healthcare market are highly regulated. Thanks to our substantial expertise and experience in this area, we are able to cover all aspects of regulatory advice.
From developing and implementing new healthcare concepts, assisting with accreditation and other administrative procedures, structuring medical sector cooperation as well as advising on public permits, all the way to drafting agreements with medical staff – we help clients overcome the many challenges they face in the healthcare industry. Gleiss Lutz counsels manufacturers of medicinal products and medical devices, for example, during the early stages of product development, on drafting contracts for R&D cooperations, in- and outlicensing arrangements and the purchase of licenses, as well as on their subsequent product development and marketing strategy, and the conclusion of manufacturing agreements and procedures for licensing installations. We advise statutory health insurance funds extensively on all relevant aspects of their business, including social security issues. Hospital operators can bank on our strength in the area of privatisation as well as in disputes on inclusion in hospital funding by the federal states, the negotiation and conclusion of agreements for the provision of medical services and advice on the legal aspects of hospital financing as well as new health service delivery models.
Compliance
Market players in the healthcare industry face a myriad of legal requirements deriving from complex existing and new legislation, as well as continuous legislative reforms.
We develop and review customised compliance programmes to help clients avoid intervention by public authorities – ranging from the revocation of licences and accreditations to even criminal sanctions. Clients confronted with suspected violations can rely on us to assist with internal investigations and benefit from our prowess in court and experience in dealing with competition and criminal authorities.
Procurement of healthcare services
When it comes to healthcare tenders, Gleiss Lutz offers clients comprehensive legal advice. We have hands-on experience gained from our regular involvement in countless invitations to tender by statutory health insurance funds and other contracting entities – something bidders that we represent in tender procedures also benefit from.
What’s more, we put together effective and efficient teams to assist clients in designing and implementing tender procedures and to represent bidders in judicial review proceedings.
IP and industry-specific contract drafting
Gleiss Lutz has decades of experience in successfully advising on the infringement, validity and exploitation of patents and utility models as well as the protection of inventions and know-how in biotechnology, medical products and pharmaceuticals.
Over the past ten years we have worked on virtually all major pharmaceutical patent infringement cases. And our involvement in numerous product launches means we have substantial experience in handling drug advertising disputes. Apart from patent litigation, another focus of our practice is on the licensing and transfer of patents and know-how as well as R&D cooperations. Our lawyers also have extensive experience in drafting and negotiating sector-specific agreements. We advise clients both during the product development phase (such as on in- and outlicensing contracts, agreements with CROs regarding clinical trials, R&D contracts, etc.), as well as during the commercialisation phase (e.g. contract manufacturing agreements, technical agreements, co-marketing and co-promotion contracts, the assignment of product rights, etc.).
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