Pharmaceutical law
The Pharmaceutical Law is an interdisciplinary field of law, which are essentially identical to the pharmaceutical and medical device law is concerned. Pharmaceutical law is not only assigned to one of the “classic” legal areas of private law , administrative law or criminal law , but contains provisions from all three areas, depending on the regulatory material.
There is no generally applicable definition. Nevertheless, the term has found its way into the legal specialist literature. The most important publication organ is the journal “ Pharma Recht ” ( PharmR ) , which has been published since 1978 . The publisher also organizes the German Pharma Law Day , which takes place once a year in Frankfurt am Main .
The basics of drug and medical device law belong in Germany according to § 14b Specialist Lawyer Regulations (FAO) on the special knowledge to be proven for the specialist lawyer for medical law .
Areas of law belonging to pharmaceutical law
The area of pharmaceutical law includes the following areas of law:
- Pharmacy law
- Drug liability law
- Drug safety law
- Drug criminal law
- Drug approval law
- Doctor and hospital liability law
- State aid law
- Medicines advertising law
- Food law
- Trademark law
- Medical device law
- Patent law
- Private insurance law
- Right of special therapy directions ( phytotherapy , homeopathy etc.)
- Law of the clinical trial
- Social law , especially SGB V
- Contract doctor law
The expanded area of pharmaceutical law also includes basic knowledge of pharmacy , the economics of the pharmaceutical market and the ethics of pharmaceutical research .
Training in pharmaceutical law
Since the 2002/2003 winter semester, the University of Marburg has had an additional three-semester qualification in pharmaceutical law that is geared towards the needs of the pharmaceutical industry and is aimed not only at law students and trainee lawyers , but also at students from other faculties such as pharmacy or medicine . In addition to participating in the events, an internship must be completed. In addition, at least two of the three exams offered must be passed per semester and a seminar must be attended. A certificate is awarded after successful participation in the additional qualification.
Research in pharmaceutical law
A research center for pharmaceutical law has existed in Marburg since 1997, which was founded by representatives from universities, industry and legal practice with the aim of bringing practice and science together for a permanent exchange of experience. The research center regularly offers discussions and workshops several times a year and publishes various specialist publications.
Fields of work for pharmaceutical lawyers
Pharmaceutical lawyers work in large and medium-sized law firms , in companies in the pharmaceutical industry and their associations . Knowledge of pharmaceutical law is also useful for lawyers who work in health insurance companies , hospitals , medical associations or clinical ethics committees .
literature
- Peter Dieners, Ulrich Reese: Handbuch des Pharmarechts: Basics and Practice , 1st edition 2010, Munich, Beck Verlag, ISBN 978-3406584718
- Peter Hettich, Stefan Kohler: Pharmarecht, Developments 2010 , 1st edition 2011, Stämpfli Verlag, ISBN 978-3727280771
- Tilo Mandry: The agents in pharmaceutical law , 1st edition 2004, Wissenschaftliche Verlagsgesellschaft, ISBN 978-3804721432
Individual evidence
- ↑ Beck-Verlag website
- ↑ Specialist Lawyers Regulations in the version dated January 1, 2015, website of the Federal Bar Association
- ↑ Standards on pharmaceutical law collection in the database at beck-online.de, accessed on March 21, 2016
- ↑ Additional qualification in pharmaceutical law
- ^ Website of the Research Center for Pharmaceutical Law
