Although in recent years various elements to control the expenditure for medicines have been established in Germany, it still represents a massive problem for the statutory health insurances. Above all it had to be noted that the savings from the rebate contracts remained distinctly below the expectations. So there was a need for further restructuring of the pharmaceutical market in order to exploit new savings and avoid ongoing cost increase.

This took place on 11 November 2010 with the adoption of the “Law on Reorganization of the Pharmaceutical Market in the Statutory Health Insurance” (Arzneimittelmarktneuordnungsgesetz - AMNOG). This law includes a package of measures with sustainable effective structural changes, increased competition and the elimination of over-regulation, which relates to patented drugs as well as generics.

A particular element of the new law is an article to amend the “Regulation on the Designation and Marking of Pack Sizes for Medicines in the Health Care Contract” (Packungsgrößenverordnung - PackungsV). Contrary to its original purpose, this change provides the PackungsV with a new meaning in relation to the control of pharmaceutical expenditure.

As part of this thesis, the historical development of the PackungsV will be demonstrated to then have a look on the influence as a management tool in the pharmaceutical market newly acquired by the AMNOG. Particular attention is paid to the effects that the changes to the PackungsV cause in relation to the rebate contracts between the health insurances and drug manufacturers. Even the far-reaching consequences for other stakeholders in the German health care system are outlined in detail and critically scrutinized.

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