Second statement of the joint Diagnostics Commission of the DVV and the GfV on the Pharmacy Reform Act (ApoRG)

Second statement of the joint Diagnostics Commission of the German Association for the Control of Viral Diseases (DVV) and the Society of Virology (GfV) on the Pharmacy Reform Act (ApoRG)

Background: On June 25, 2024, the Federal Ministry of Health (BMG) invited to an oral hearing on the draft bill of the Pharmacy Reform Act (ApoRG). The GfV already submitted a statement on this on June 27, 2024 at the same time as other participating associations. The overriding aim is to provide quality-assured and evidence-based diagnostics under the responsibility of doctors. These requirements are not met in the current draft.

The Federal Minister of Health, Ms. Warken, recently presented the planned pharmacy reform. From the point of view of the joint Diagnostics Commission of the GfV and DVV, there are still considerable concerns regarding the following points, among others.

1. medical indication and assessment of findings

Diagnostic testing for infectious agents is not a purely technical process, but requires a medical indication, interpretation of findings and derivation of therapeutic consequences. Transferring these tasks to pharmacies would only be conceivable on the basis of binding additional qualifications, clear quality standards and defined medical interfaces. However, the current draft bill does not contain such regulations. This means that central requirements for targeted, quality-assured and economical diagnostics are currently not met. Nor can it be assumed that further fragmentation of diagnostics with unclear interfaces will lead to an improvement in patient care. This harbors the risk of incomplete or misguided diagnostics and thus delayed treatment decisions.

2. regulatory quality requirements and infection control

Binding legal requirements apply to the performance of virological-microbiological diagnostics, including, among others

• Guideline of the German Medical Association (RiliBÄK) - external and internal quality assurance, interlaboratory comparisons
• EU In Vitro Diagnostic Medical Devices Regulation (IVDR) - Requirements for the selection, validation and performance evaluation of test systems
• Biological Substances Ordinance (BioStoffV) & TRBA 100/250 - occupational safety, hygiene concepts, disposal of infectious samples
• Infection Protection Act (IfSG) - reporting obligations, transmission of findings to health authorities

These regulations serve both patient safety and the protection of healthcare workers. Implementation of these regulations requires quality-assured diagnostic structures, trained personnel, suitable premises and standardized reporting processes. As things stand, such quality-assured structures are neither planned nor operationalized in pharmacies.

3. technical and diagnostic limitations

The draft is limited to the use of rapid antigen tests. These tests have limited diagnostic value and require further confirmatory diagnostics in the event of unclear results, which is not provided for in pharmacy structures. This results in potential gaps in care and delays in the diagnostic process.

In summary, the Joint Diagnostics Commission sees the following problem areas in particular:

• Patient safety: Diagnostic testing without a medical indication and assessment of findings carries the risk of incorrect or delayed treatment decisions.
• Protection against infection: The quality, hygiene and reporting requirements prescribed by law in laboratory diagnostics are currently neither planned nor feasible in pharmacy structures.
• Quality of care: The draft leads to additional diagnostic interfaces without a defined link to medical treatment pathways, the public health service and specialist confirmatory diagnostics, thus contributing to further fragmentation of care.

The Joint Diagnostics Commission recognizes the fundamental benefits of low-threshold diagnostic services. However, these can only make a contribution to care if they are embedded in a medically responsible, quality-assured and infection protection-compliant overall concept.

The Joint Diagnostics Commission therefore once again calls on the BMG to revise the draft bill accordingly so that diagnostic services are only provided within the framework of medically responsible, quality-assured and infection protection-compliant structures. As long as these requirements are not met, there is a risk of jeopardizing patient safety, inadequate infection control measures, unclear follow-up costs and further fragmentation of diagnostic care.

For the Joint Diagnostics Commission on November 7, 2025,

PD Dr. Nadine Lübke & Prof. Dr. Marcus Panning, Düsseldorf and Freiburg

Click here to read the statement of the joint Diagnostics Commission of the German Association for the Control of Viral Diseases (DVV) and the Society of Virology (GfV) on the planned Pharmacy Reform Act (ApoRG) of June 27, 2024.