Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Einfluss von DRA auf das Tendergeschäft in Deutschland – Strategien eines mittelständischen Generikaunternehmens

Natalie Lubrich (Abschlußjahr: 2014)

Summary
Language: German
The introduction of rebate discounts (so called “tenders”) in the German health system led to some massive shifts of market shares within the competitors. Since then even small generic companies have the opportunity to enlarge their market shares through discount agreements. Despite some dissenting votes from health care institutions, the discount agreements have established themselves as a highly effective tool for active output control as stated by the health insurances and the Ministry of Health. The pioneer of introducing discount contracts is the AOK, which covers with approximately 24 million insured about one third of the total population in Germany. Especially the small and medium-sized generic companies try to win as much tenders as possible to be competitive on the market. To stand a chance for winning a tender, the generic companies must be able to offer a complete portfolio which covers the requirements of the market. The complete coverage is one of the important decision criteria for the health insurances.
So how can DRA influence the tender business in its interface function?
With the example of a medium-sized generic company and the tenders of AOK it will be shown which requirements have to be fulfilled by the pharmaceutical company, which documents in which format have to be submitted, and how the regulatory strategies and activities can look like in order to offer a complete portfolio accordingly. On the one hand the proactive possibilities well before tender announcements will be described, on the other hand the activities which should be performed when participating on a concrete tender announcement. By means of a decision analysis it will be explained how emergency strategies can look like, when, in spite of all proactive activities, amendments of the portfolio are needed spontaneously in order to keep the chances of a tender. Furthermore the activities after winning a tender are described, as well as the query investigated which requirements the current political tools (discount contracts, fixed prices, early benefit evaluation) for decreasing the pharmaceutical expenditure impose to the documentation and which role DRA might (still) play in this context in future.
Pages: 59