Field of Law

Communication between the legal profession and physicians, scientists and marketing specialists is indispensable. It must aim at promoting mutual understanding of the basic medical, commercial and legal parameters that are critical to the development and marketing of medicinal products.

Our activities are not limited to specific legal fields; instead they focus on:

two business sectors:

• manufacturers and distributors of medicinal products
• and medical devices
  

and on two professions:

• physicians
• pharmacists
  

We provide legal advice in the legal fields of relevance to these products and professions.

We accompany the development, marketing authorisation, certification, marketing, advertising and safety evaluation of medicinal products and medical devices.

Based on these objectives, we have chosen to focus on the following legal fields:

• Product development – clinical trials
• Marketing authorisation and the certification system in the EU 
• Property rights for medicinal products - Intellectual Property Rights (IP)
• Marketing conditions – competition law – licences 
• Pharmacovigilance and product liability in the EU
• Statutory health insurance system (GKV)
• Pricing and prescription of medicinal products for reimbursement by the statutory health insurance system
• Health Technology Assessment – HTA – in the cost/benefit assessment in accordance with the German Social Code (SGB V)
  
• Medical devices
  

We focus on the above mentioned subjects as they relate to pubic law, social security law, civil or criminal law. All the lawyers in our law firm have many years of experience in these fields and special qualifications.

Our clients use this know-how as a basis for their strategic planning. Furthermore, we engage in forensic work before administrative, social and civil courts, and we act as defence counsels.