Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Case Study: Impact of a new German law ("AMNOG") to restructure the pharmaceutical market on a Generic Company

Kristina Tripp (Abschlußjahr: 2011)

Language: English

After introduction of the first legal health insurance in Germany in 1883 by Bismarck modifications have been implemented continuously to restructure the health system. These modifications had quite often a deep impact on the stakeholders of the health market.

To oversimplify there are two phases of health policy, which differ in the ways of handling. Between the middle of the 1970ies and 1992 the focus was set on cost reduction programs. Thereby the structure of the legal health insurance has hardly been changed. A change came in 1992, due to the so called "Gesundheitsstrukturgesetz", which was a law to modify the structure of the health system. Since that time policy tries to change the relationship between health insurances, patients, physicians, pharmacies, wholesales etc. in terms of a regulated market.

The latest change in the health insurance-system came on 1st January 2011 with the so called AMNOG - a law to restructure the pharmaceutical market in the legal health insurance. Central point is the introduction of a cost-benefit-analysis for new medicinal products. Additionally the payment for the wholesales has been changed to reduce the cost of distribution for medicinal products. Furthermore the discount contracts had been remodeled in a more patient-friendly way.

The new regulation has not only an impact on the pharmaceutical industry but also on wholesale, pharmacies, health insurance and all the other stakeholders on the health market like physicians and patients.

This thesis wants to show the impact of the AMNOG on a big generic company to find the best way to act, based on a decision analysis to reach companies goals.