THE DETAILED RULES OF THE INTEGRATED INSITUTIONAL PHARMACEUTICAL SERVICES HAVE BEEN PUBLISHED

The implementation of the integrated institutional pharmaceutical services was made possible by the amendment of Act XCVIII of 2006 on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products (the “Drug Economy Act”) which entered into force on July 7, 2023.

According to the amended Section 51/A of the Drug Economy Act, the State can provide integrated institutional pharmaceutical services to State-maintained inpatient care institutions through a contract concluded with a so-called project company in a public procurement proceeding. Substantially, the amendment outsourced the operation of institutional pharmacies and the settlement of medicines used in institutional pharmaceutical care to the project company.

The referenced section of the Drug Economy Act also allows non-state-maintained inpatient care institutions to voluntarily join in the provision of integrated institutional pharmaceutical services by entering into a contract.

The detailed rules of the new system were published on February 22, 2024, in the Hungarian Gazette within Government Decree No. 33/2024 (II. 22.) (“Decree”) on the Integrated Institutional Pharmaceutical Services. The Decree defines, inter alia, the rules for authorization, provision, and regulatory control of the integrated institutional pharmaceutical services, as well as including the requirements for voluntary participation in the service.

Under the published Decree and the Drug Economy Act, in state-maintained inpatient care institutions, as well as in non-state-maintained inpatient care institutions that voluntarily participate, the following activities will now fall within the scope of the project company instead of the healthcare institution:

• provision of medicines necessary for inpatient care, including procurement, stocking, availability, monitoring, and dispensing of medicines;
• pharmaceutical care provided by the institutional pharmacy to outpatients;
• developments necessary for the unified image of outpatient pharmaceutical care;
• coordination and logistical tasks related to procured medicines; and
• introduction and operation of a customized medicine dispensing system.

The Decree stipulates that after the conclusion of the public procurement contract with the winning project company, institutions can only ensure institutional pharmaceutical care through the project company.

Additionally, the Decree also states that inpatient care institutions can only acquire medicines for patient care with the approval of the project company, and only if the necessary medicinal products cannot be provided by the project company.

Medicines used in inpatient care will also be accounted for by the project companies based on their contracts concluded with NEAK instead of healthcare institutions. Regulatory oversight of the provision of the integrated institutional pharmaceutical service will be carried out by NNGYK.

Professional organizations expressed their disagreement in a joint statement regarding the integrated institutional pharmaceutical service, expressing their dire concern that during the legislation process the legislator neglected consultation with the interested and affected professional chambers and organizations.

The contents of this document do not constitute legal advice and are not a substitute for expert advice.

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