Benefit Appraisal €36mln earmarked to fund studies for medical device trials
Germany’s Federal Joint Committee (GBA) and the unions are in favour of a fund to finance studies within the scope of the trialling regulations for new therapeutic methods involving medical technologies, as was made clear at a BVMed conference.
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GBA Chairman Dr. Rainer Hess and CDU parliament member Dietrich Monstadt led the speakers at the 23 May conference in Berlin titled “The Correct Trialling of Medical Devices”.
Monstadt talked about the resources amounting to €36 million that are envisaged to support the studies. This corresponds to 0.02% of Germany’s annual healthcare expenditure. The aim of the initiative is to make it possible for smaller companies in particular to get involved in trialling regulations. The corresponding statutory regulation could potentially be set in place with the German pharmaceutical law amendment.
Hess reported that the process specifications concerning the new trialling regulations are likely to be approved in the July session.
BVMed CEO and Executive Board Member Joachim M. Schmitt spoke in favour of an objective benefit appraisal that sets forth a sophisticated procedure for evaluating medical devices according to risk category and degree of modification.
Monstadt additionally clarified that the AMNOG methods for pharmaceuticals will not be transferable to medical devices: the two areas differ too much for this, he said.
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BVMed - Bundesverband Medizintechnologie e.V.