Pharmaceutical Wholesalers Call for Increased Funding and Stricter Oversight of Medicine Shippers

The German Association of Pharmaceutical Wholesalers (Phagro) is advocating for stronger regulatory measures and enhanced compensation within the framework of the proposed Pharmacy Care Advancement Act (ApoVWG). Central to Phagro's position is the recommendation that oversight of logistics companies involved in the distribution of prescription medicines be formally established under the German Medicines Act (AMG).

Phagro supports the extension of the Medicines Trade Regulation (AM-HandelsV) to include logistics firms contracted by pharmacies for the shipment of prescription drugs. According to the association, this extension would clarify that logistics providers are also required to comply with Good Distribution Practice (GDP) standards, thereby increasing transparency and ensuring the safe handling of pharmaceuticals.

However, Phagro contends that these requirements must be explicitly anchored in the German Medicines Act to eliminate ambiguity regarding regulatory responsibilities and notification obligations. The association highlights that the exact assignment of supervisory authority and mandatory reporting processes, as defined in sections 64 and 67 of the AMG, would benefit from such legislative clarity.

The German Federal Council (Bundesrat) had previously suggested incorporating these changes into the AMG to address gaps in oversight. While this proposal was not adopted by the federal government, Phagro maintains that clear legal guidelines are essential, referencing judicial decisions that distinguish the roles of logistics companies from those of pharmacies in medicine distribution. The association asserts that logistics providers act solely on behalf of pharmacies and are not directly involved in the dispensing of medications, underscoring the need for precise legal definitions to avoid regulatory uncertainty.

In addition to regulatory concerns, Phagro is seeking a revision of the current compensation model for pharmaceutical wholesalers. The association argues that the fixed fee per medicine package should be increased by at least 30 cents to ensure fair remuneration for distribution services. Currently, wholesalers receive a fixed amount of 73 cents per package and an additional percentage-based markup, which is capped at a maximum of 37.80 euros per package.

Another key issue raised by Phagro relates to the proposed rights of health insurance funds to request detailed information on the purchasing conditions of pharmacies. The draft legislation would allow insurers to require pharmacies to provide evidence of their sources, quantities, and actual purchase prices for ready-to-use parenteral medicines. Manufacturers, in turn, would have to disclose information on their customers, transaction volumes, and pricing structures to insurers.

Phagro is critical of the mandatory participation in a planned electronic reporting system, arguing that it infringes upon the professional autonomy of pharmaceutical wholesalers. The association points out that wholesalers are not contractually tied to the National Association of Statutory Health Insurance Funds (GKV-SV), and mandatory reporting could impose unnecessary administrative burdens.

Similarly, the Association of Cytostatic Drug-Manufacturing Pharmacists (VZA) has called for a more limited and clearly structured approach to the reporting rights of health insurers. The VZA suggests that the parameters for price inquiries should be jointly negotiated by the GKV-SV and the German Pharmacists Association (DAV), and that individual health insurance funds should not have unrestricted access to such information. Instead, the VZA states that transparency at the level of the central association would suffice to minimize bureaucracy.

Phagro's recommendations reflect broader concerns within the pharmaceutical supply chain about regulatory clarity, fair compensation, and the balance between transparency and professional independence. As legislative discussions continue, stakeholders are urging policymakers to consider the practical implications of new regulations for wholesalers, pharmacies, and logistics providers alike.