The Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) has published its Stellungnahme des IQWiG zum Medizinregistergesetz (IQWiG statement on the Medical Register Act). This document responds to a Referentenentwurf (draft bill) that seeks to create a unified legal framework for German medical registers, acting as a bridge to the European Health Data Space.
While the institute welcomes the legislation, it warns that the current draft focuses too heavily on data infrastructure rather than research utility. To address this, the IQWiG (Institute for Quality and Efficiency in Health Care) proposes a ‘pool financing’ model. Under this plan, all companies with patent-protected medicines that exceed an annual turnover of €1 million would contribute 1 per cent of their revenue into a central fund.
This levy could be reduced to 0.5 per cent for manufacturers that have already conducted independent comparative studies during the Arzneimittelmarktneuordnungsgesetz (Medicinal Product Market Reform Act) process. The institute argues that these funds are essential to transform registers from mere data silos into active research tools.
Furthermore, the statement emphasizes that if such registers are to improve care, the research findings must be made public. The institute recommends that any authorization to process these data should be strictly tied to a mandatory publication of results. It also notes that the current lack of high-quality data often forces the health system to make decisions based on incomplete evidence at the time of a drug's launch.
The likely impact includes a mandatory financial contribution for manufacturers of patent-protected medicines. However, the resulting infrastructure could provide more reliable pathways for post-authorisation safety and efficacy studies, potentially reducing long-term regulatory uncertainty for the sector.
Source: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG
Link: IQWiG statement on the Medical Register Act
Date: 20 November 2025