Costs and Benefit of Pharmaceuticals
Innovations within the pharmaceutical sector contribute significantly to the progress of medicine, and therefore to increasing life expectancy and life quality. At the same time these innovations present a substantial cost factor for modern health care systems. The (institutional) design of the pharmaceutical supply system is therefore of vital importance, politically as well as scientifically, for all modern health care systems.
In many countries, the safety assessment of medicinal products with regards to granting marketing authorisation is followed by a mechanism which regulates funding and access to medicines. What all these regulatory systems have in common is, that they rate a drug’s innovative content and value, which surpasses the previous evaluation of the responsible licensing authority. The economic consequences of the introduction of a medicinal product will also be investigated. Furthermore, an evaluation of the cost effectiveness according to the cost-benefit relation will be carried out, either explicitly by means of defined deciding factors (so-called „value-based pricing“) or implicitly, e.g. in negotiation mechanisms.
Considering these points, the dissertation analyses the evidence-based evaluation of medicinal products in the German “Gesetzliche Krankenversicherung” (GKV) compared to the assessment system of the English National Health Service (NHS). Following research questions will be central to the analysis:
1. How do the GKV and NHS, respectively, implement the benefits or cost-benefits evaluation methodically and in procedural terms?
2. Do these systems of medicinal product evaluation have to be measured against a normative standard? Joint normative measurements and principles for the English NHS and German GKV can be derived, for example, from the Charter of Fundamental Rights of the European Union.