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The Gemeinsamer Bundesausschuss (Federal Joint Committee, G-BA) has released a new update titled Neu im 5. Kapitel der Verfahrensordnung: Klarstellungen zum Unterlagenschutz (New in Chapter 5 of the Rules of Procedure: Clarifications on Data Protection). This decision incorporates definitions from the recently updated Arzneimittel-Nutzenbewertungsverordnung (Medicinal Product Benefit Assessment Ordinance) directly into the committee’s governing rules.
Under the new doctrine, the status of a ‘drug with a new active ingredient’ is maintained until all regulatory protection rights expire. This includes both traditional data protection and specific market exclusivity for orphan drugs. Crucially, for rare disease treatments, the G-BA (Federal Joint Committee) will now only perform benefit assessments in indications where an active protection right still exists.
The update also changes the criteria for reference medicinal products. To serve as a benchmark for determining ‘new active ingredient’ status, a reference drug must now be authorised within Germany. Substances that are only authorised in other EU member states are no longer valid as reference therapies under these rules.
Furthermore, new authorisations for pediatric use may now trigger a discretionary benefit assessment. This is because such approvals are frequently linked to the granting of new data protection periods. Regarding clinical trials, the committee has clarified how manufacturers must report the proportion of German participants. These data no longer need to include open-label extension studies if the patients involved have already been counted in previous calculations.
These measures will start once the Bundesministerium für Gesundheit (Federal Ministry of Health) approves the changes and they are published in the Bundesanzeiger (Federal Gazette). The likely impact includes more predictable assessment timelines for manufacturers of orphan drugs and a tighter focus on domestic authorisation benchmarks.
Source: Gemeinsamer Bundesausschuss
Link: New in Chapter 5 of the Rules of Procedure: Clarifications on Data Protection
Date: 20 November 2025