On Oct. 18, BEL GVT issued decree regarding insurance contributions.
BEL GVT published Decree of Oct. 6, 2024, amending the Royal Decree of Feb. 1, 2018 establishing procedures, terms and conditions regarding contribution of compulsory insurance for medical care and benefits towards the cost of pharmaceutical specialties.
Decree Overview
The Decree specifies changes to the list of reimbursable pharmaceutical specialties, which has 6 annexes, namely the list of reimbursable pharmaceutical specialties, the reimbursement groups, the applicable models of the documents and authorizations.
Various changes are made to the original text, based upon changes in understanding.
Article 1 is supplemented by provisions under Para 38 and Para 39, setting biological reference specialty to be referred to in any application for pharmaceutical specialties.
If there is no already reimbursable reference specialty or biological reference specialty, reference specialty or biological reference specialty will be determined by Commission.
Specialty products specifically intended for pediatric use and not identical to another specialty product containing the same active ingredient, classified in class 1 or class 2 and specifically intended for pediatric use can be included subject to some conditions.
The changes also cover the requirements for a use of some sub-classes of medication.
and the text also cover requirements to maintain a list of the relevant medications.
Details are also included of the type of forms of administration of approved medicines, such as Cutaneous, Implantation, Inhalation, Injection, Intestinal and Transdermal.
Effectiveness
The terms of the new Royal Decree are now applicable with effect from Jan. 1, 2024.
Dec. 2024 Ministerial Decree
On Dec. 16, 2024, BEL GVT published a Ministerial Decree of Nov. 24, 2024, amending list attached to Royal Decree of Nov. 23, 2021 establishing the procedures, terms and conditions for the compulsory insurance to cover the costs of pharmaceutical supplies.
The updated pharmaceutical supply list forms part of the text of the Ministerial Decree.
The new Decree enters in force on first day of the month following expiry of a period of ten days starting on day after publication in Belgian Official Gazette, on Dec. 26. 2024.
Regulators
BEL GVT
Entity Types
CNSM; Corp; Ins
Reference
OG 2024010856, 12/16/2024; OG 2024009405, 10/18/2024; Decree 10/6/2024; Decree 2/1/2018
Functions
Claims/Accelerated Benefits; Financial; Legal; Operations; Product Administration; Social
