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The Gemeinsamer Bundesausschuss (Federal Joint Committee) has issued its Stellungnahme zum Referentenentwurf eines Gesetzes zur Zusammenführung von medizinischen Registern (Medizinregistergesetz – MRG) (Statement on the draft bill for a law on the merging of medical registers (Medical Register Act – MRG)). This one-off report responds to the federal government’s plan to centralise the country’s fragmented registry landscape under a new national office.
The G-BA (Federal Joint Committee) argued that the current draft lacks the methodological rigour required to support the Arzneimittelmarktneuordnungsgesetz (Medicinal Product Market Reform Act) process. Under the leadership of the Unparteiischer Vorsitzender (Impartial Chairman), the committee expressed concern that the new Zentrum für Medizinregister (Centre for Medical Registers) – to be based at the federal drug agency – may lack the specific expertise to certify registries for reimbursement purposes.
Previously, the committee has often had to mandate its own independent data collection because existing registries provided insufficient evidence for rare disease treatments. The committee now demands a formal role in defining what constitutes a ‘qualified registry’. They insist that for data to be used in pricing negotiations, they must allow for comparative analysis against existing standards of care.
The committee also highlighted the need for better data linkage between clinical registers and health insurance claims data. This update to the legislative process is intended to reduce the administrative burden on hospitals while improving the quality of real-world evidence.
If the health ministry adopts these recommendations, the measures will likely be integrated into the final statute before its planned implementation in 2025. The likely impact will be a higher bar for data quality; manufacturers will find that registry data are only accepted for benefit assessments if they meet the committee’s strict methodological requirements.
Source: Gemeinsamer Bundesausschuss, G-BA
Link: Statement on the draft bill for a law on the merging of medical registers (Medical Register Act – MRG)
Date: 18 November 2024