Trial regulation for medtech innovations

The trial regulation for new medical examination and treatment methods with medical devices provided by the new German Law on the Stabilization and Structural Reform of the Statutory Health Insurance (Health Reform 2012) should be seen and used as an opportunity, said Dr. Ulrich Orlowski of the German Federal Ministry of Health and Dr. Rainer Hess of the Joint Federal Committee (JFC) at a BVMed conference held in Berlin in the end of January 2012. The medtech companies are confronting the topic of assessment of benefit. But due to the heterogeneity of medical devices, the industry lobbies for distinctions to be made according to risk class and degree of modification.

New instrument for the JFC
If the benefit of a new method is not sufficiently proven but there is a „potential“ for a required treatment alternative, the JFC can commission an independent scientific institute to conduct a trial of this method. Aside from the participation of hospitals, SHI physicians can also be involved in the trial if the particular treatment does not require hospitalization. If the new method is chiefly based on the use of a new medical device, the relevant medical device manufacturer is to contribute a suitable amount to the costs. Hess says that suitability will also be assessed according to the economic capacity of the company. The manufacturer may be the one to submit the trial application if the medical device is an essential component of a new method.

JFC code of procedure to stipulate the details
According to JFC head Dr. Rainer Hess, the regulation offers the opportunity of producing representative studies on new methods when there is not sufficient evidence and no studies on the topic are expected. A code of procedure will determine what a method „with potential“ actually is. Hess interprets „potential“ as „additional benefit“ of a necessary treatment alternative or a „benefit“ of a new method. Regarding medical studies, Hess added that the JFC is „not devoutly RCT“: „We recognize the best possible evidence and are well aware that randomized controlled studies are not always possible for medical devices.“

It is a positive development for medtech companies that the law has maintained the innovation friendly principle of „permission with the reservation of prohibition“ in hospitals. It is also good that the new trial regulation provides for a more rapid introduction of new methods in the inpatient sector. However, it still remains to be seen how the Central Federal Association of the health insurance funds will deal with the new instrument. If there is a SHI application for a trial which the JFC approves, the manufacturer will feel a certain amount of pressure: if the manufacturer refuses to participate in the cost investment, the method can also be excluded for use in the hospital.

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