Regulation of Innovative In Vitro Diagnostics
Molecular diagnostics in the form of in vitro diagnostics is becoming ever more significant. This means, in particular, diagnostic laboratory tests that serve to yield molecular biological and genetic information on a patient. Such information is used to customize medical treatment to the individual needs of a patient and to thus achieve better treatment results than by way of standard therapies.
In a public health system, on the one hand, patients should have access to such innovative health care services as quickly as possible. On the other hand, access to these services must be sufficiently monitored and financially feasible. Accordingly, various – and often conflicting – interests need to be reconciled. This in turn requires an appropriate regulatory legal framework, which, in fact, the German statutory health insurance system currently does not have as regards in vitro diagnostics.
The aim of the project is to elaborate, in terms of legal policy, a proposal for improvement that balances any conflicting interests in an adequate way and allows for the integration of novel diagnostic services into the catalogue of services offered by the statutory health insurance. For this purpose, the legal systems of selected countries will be compared and the various solutions obtained will be analysed with a view to whether and how this proposed balance in the field of innovative in vitro diagnostics is realized. The findings obtained shall help improve the legal framework conditions that are crucial for the integration of medical research into health care.
This research project is supported by the Fritz Thyssen Foundation (Fritz Thyssen Stiftung für Wissenschaftsförderung).