Pharmaceutical and Medical Law
Especially the legal framework governing companies and other organisations involved in healthcare is constantly changing. We principally advise and represent pharmaceutical companies, but also other parties involved in healthcare, such as manufacturers of medical products or care providers, in the following areas of law:
Collaboration between companies and care providers is subject under anti-corruption law to a wide-ranging mesh of legal regulations and codes. We work with our clients in finding solutions to put these regulations into business practice. Along with advice on individual cases, we also offer to draw up compliance systems in the companies concerned.
In pharmaceutical law we advise and represent companies on and in all relevant questions. We concentrate on matters of direct market relevance, such as the licensing and sale of medicines. Along with the German Pharmaceutical Products (Provision) Act (AMG), a large amount of delegated legislation is also applicable here. Regulations under European law are of particular importance. Further, we assess whether advertising is permissible under the German
Medicaments Advertising Act.
The German healthcare system is familiar with many types of joint collaboration. We support our clients in their collaboration with other parties involved in healthcare. A central issue here is the collaboration between pharmaceutical companies and types of medical practitioners’ organisations. The provision of legal advice to care providers is also becoming increasingly important.
Social-security law, particularly German Social Code V, governs the legal relations between social-security insurers, care providers and third parties. We deal particularly with all questions of compulsory benefits payable by statutory health insurers for medications. These include fixed allocations, guidelines on pharmaceutical products, and other prescription limits. Along with purely legal advice and representation, we can also provide our clients with support in strategic product positioning, for example by way of direct contracts between companies and health insurers.
We provide advice on drawing up contracts between pharmaceutical companies and health insurers. Along with the general framework of social-security law, care must be taken here to satisfy the rules of anti-trust law and legislation controlling the award of contracts and procurement. We work with our clients in developing solutions to attain the commercial objectives desired and provide them with support in proceedings for award of contract conducted by health insurers.
