BEL GVT issued law of May 12, 2024 amending law relating to compulsory health care and compensation insurance coordinated on Jul. 14, 1994, with regard to the modernization of reimbursement procedures with a view to rapid and sustainable access to medication.
Purpose
Modernization to the procedures re medication reimbursement, early and rapid access.
Organization and operations of the Committee that makes early access decisions.
And formulates proposals for modification of the list of medicines for which intervention by compulsory health care insurance is planned within the framework of rapid access.
Rapid access program is limited to pharmaceutical specialties which have been the subject of an early access decision, to medicines which have obtained PRIME eligibility.
From the European Medicines Agency or to medicines, subject to an accelerated evaluation procedure by the European Medicines Agency; the King may set conditions.
The exclusion and the rapid access decisions are both time-limited framework decisions which are based on the available medical data; the King establishes those time limits.
The amount of the flat-rate intervention per early access decision and the amount of the flat-rate intervention per beneficiary re early access are established by the King.
The amount of the flat-rate intervention per beneficiary in the context of early access depends on the nature of the active ingredient and the size of the patient target group.
To set the amount of the intervention for the company, the prescribing doctor submits to the Committee a request for inclusion of the patient in the Early Access Program.
Effectiveness
The law enters into force on Jan. 1, 2025; the King may decide on a different date for the entry into force of each of the law's provisions; it can't be later than Jan. 1, 2027.
The law doesn't apply to procedures that started before Jan. 1, 2025.
Regulators
BEL GVT
Entity Types
CNSM; Corp; Ins
Reference
OG 2024004567, 5/21/2024; Law 5/12/2024; Law 7/14/1994 conso.; ESG
Functions
Claims/Accelerated Benefits; Financial; Legal; Operations; Product Administration; Social
