Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Die Auswirkungen der Arzneimittelrabattverträge nach dem GKV-Wettbewerbsstärkungsgesetz auf den deutschen Generikamarkt

Michael Hahn (Abschlußjahr: 2009)

The German health care system faces enormous financial pressure. Two of the fundamental problems are: an increasing life expectancy causing the need for more money by more elder people. The second problem, if medical treatment improves it then becomes more expensive.

About 90 % of the German population are covered by the statutory health insurance. In order to reduce expenditure by introducing elements of competition the recent healthcare reforms granted the statutory health insurance funds the right to negotiate discounts with individual manufacturers of medicinal products. Germany´s most recent "Statutory Health Insurance Competition Strengthening Act" (Gesetz zur Stärkung des Wettbewerbs in der gesetzlichen Krankenversicherung - GKV-WSG), which came into effect on 01 April 2007, includes various incentives for such agreements.

Prior to this date, rebate contracts were of minor importance in Germany because neither physicians nor pharmacists had any motivation to prefer rebated drugs.

Since the GKV-WSG came into force, pharmacists are obliged to replace prescribed non-rebated drugs by equivalent rebated drugs according to the so-called aut-idem regulation unless the physician has excluded substitution. Drugs subject to rebate contracts are also exempt from certain prescribing restrictions.

Rebate contracts awarded to pharmaceutical manufacturers by the statutory health insurance funds are public contracts within the meaning of Section 130a (8) of the German Code of Social Law (Book V). Accordingly, the statutory health insurance funds must observe the public procurement provisions of the Act against Restraints of Competition as well as the contracting rules for the award of service contracts when concluding rebate contracts for pharmaceuticals in excess of the thresholds stipulated by law.

The "Statutory Health Insurance Competition Strengthening Act" influences physicians and pharmacists as well as patients and affects particularly the German Generic Pharmaceutical Industry.

The scope of this thesis is to demonstrate the impact on the Market, the reactions of the involved parties and the opportunities for the generic pharmaceutical companies.

Furthermore it discusses under which circumstances for drug substitution is possible and evaluates under which circumstances substitution may have a negative influence on therapy outcome, duration or cost of therapy.

Pages: 50