Fourth law amending the law on drugs and other regulations was passed by the German Bundestag. The Research (studies), which has only a benefit for the affected patient group, is to be permitted in the future, provided that the person concerned expressly permits this after comprehensive medical education in the full possession of his mental powers, and the legal representative on the basis of the disposition and after comprehensive medical examination Clarification in the concrete clinical examination. As a result, far more stringent regulations for…Continue Reading “Non-profit research on dementia (studies)”

Germany has 82 million inhabitants. 80 percent insured in statutory health insurance. This means that the cost-bearer is not the patient, but the health insurance fund (except for pro rata patient payments). Only CE certification for medical products is almost the same in Europe. However, this does not apply to the later financing of health services (diagnostics and therapy) by means of new, innovative medical devices.

The Federal Joint Committee, the Institute for Quality and Efficiency in Health Care, thus play an increasingly important role in the evaluation of applications. Thus, validated studies are becoming an increasingly important component. These studies are evaluated with regard to a possible patient benefit (Federal Joint Committee, the Institute for Quality and Efficiency in Health Care).
Here is an currant example for this (extracorporeal shockwave therapy in heel pain).
Doctors use extracorporeal shockwave therapy for heel pain. A current preliminary benefit assessment has shown that there is no significant benefit from the current study. It is therefore to be expected that due to the provisional evaluation, remuneration of this therapy has little prospect of success. Summary: The statutory health insurance will not pay for such therapy. It is hardly to be expectedthat patients will then appear as self-payers.
For the last validation of extracorporeal shockwave therapy in heel pain, the institute has published a preliminary benefit assessment for quality and cost-effectiveness in the health care system. Until 18 December 2016, doctors, manufacturers, patients, self-help groups, ... are required to issue further opinions.

The aim of this procedure is to show that Germany's health care system is a highly regulated market. Without a positive benefit assessment of new diagnostic and therapeutic approaches (with the help of innovative medical technology or new applications in other indications) placement will be extremely difficult. Other hurdles may include Guidelines of professional associations (example S3 Guidelines Cancer) as well as quality assurance Agreements (example Spatial and organizational prerequisites for the execution of cardiorespiratory polysomnography). 

Of course there is still the way to new methods of examination and treatment over the inpatient care route. 

However, there are also considerable hurdles. Before you build up an extensive, own sales system as an international medical technology manufacturer, you should talk to us. Even if you have done everything right, you need the right contacts. We also make the right contacts for you. VIGORIS HEALTHCARE has the market overview and market access. We can support you or show you alternative ways. Also we are also happy to train yours employees.

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Continue Reading "Without proven patient use (studies) everything is nothing."