Hearing procedure

The results of hearing procedures are also incorporated into the consultation process. Hearings are always required by law when the interests of third parties are affected. Depending on the directive and/or topic, examples of those entitled to a hearing (German only) include organizations of service providers, healthcare professionals associations, medical device manufacturers, pharmaceutical companies, the federal commissioner for data protection and freedom of information, the Robert Koch Institute, the Commission on Radiological Protection, and scientific associations.

According to the Rules of Procedure, the statutory hearing procedure normally commences upon resolution by the competent subcommittee when it nears the end of its deliberations. The organizations and experts entitled to a hearing receive a draft resolution and the substantiating documents. The deadline for submitting a statement must not be shorter than four weeks. Each person or organization that is entitled to a hearing and has submitted a written statement is normally entitled to an oral hearing as well (Rules of Procedure, chapter 1, sections 8-14).

After evaluating the written and oral statements, the subcommittee drafts a resolution document for the plenum showing

• which changes to the draft resolution the subcommittee recommends based on the statements received, and stating
• the rationale for rejecting any changes requested.

The timing and course of the hearing procedure can vary depending on the field the G-BA is addressing, for example medicinal products, methods assessment, disease management programmes, or others. In addition to the statutory hearing procedure on draft resolutions, there is another possibility to submit a preliminary estimation on the subject of a consultation, for example, in the assessment of examination and treatment methods. When the assessment process is initiated, the topic of the consultation is published in the Federal Gazette and on the G-BA website. This gives experts in medical science and practice, umbrella organizations of self-help groups and patient representatives, and umbrella organizations of manufacturers of medical devices and equipment in particular the opportunity to submit their opinions based on a questionnaire. Furthermore, the organizations and experts the G-BA has determined to be entitled to a hearing, as well as other persons and organizations legally defined as entitled to a hearing (e.g. healthcare professionals associations) for the respective topics, are informed in writing about the publication and their option to submit an initial estimation (Rules of Procedure, chapter 2, section 6).

In the benefit assessment of medicinal products in accordance with SGB V, section 35a, pharmaceutical companies, federations, and experts are given the opportunity to submit written and oral statements, for example on the result of a benefit assessment conducted by the IQWiG.