Belgium – Bill regarding Reimbursement of Pharmaceutical Specialties (Van Bael & Bellis)
Publication date: 18/02/2019
On 7 February 2019, the federal government submitted a bill regarding the reimbursement of pharmaceutical specialties to the federal chamber of representatives (Bill 54 3535/001) (the “Bill”). The Bill provides for the following saving measures designed to contain the pharmaceutical budget:
- More significant price decrease on the basis of turnover for medicines that have benefited from reimbursement for 15 years (“volume cliff”) (There will be a staggered system providing for a range of turnover figures between EUR 1.5 million and EUR 70 million).
- Extension of maximum price (“ceiling price”) system from medicines delivered in the community pharmacy to medicines delivered in the hospital pharmacy.
- Start of cheapest prescriptions and prescription quota systems in hospital environment.
- Further limitation of invoicing level open to hospitals to 85% of the official price. This system applies to a segment of the medicines open to competition, namely medicines falling under the reference reimbursement system. It is designed to channel to the public purse part of the savings made by hospitals from discounts obtained from their suppliers.
- Adaptation of definition of “cheap prescription”.
- Medicines in reimbursement category F will now also be made subject to the price cuts applying to “old” medicines (reimbursed for 12 or 15 years). The reimbursement basis of medicines of category F is a flat fee per indication, treatment or analysis.
- Definition of specific compensating levy for 2019 (“compenserende heffing”/”cotisation compensatoire”).
- Limited increase of pricing transparency for medicines subject to Managed Entry Agreements: Members of the General Council (the top body within the Public Institute for Illness and Disability Insurance) and of the Auditing Court (which verifies and oversees the spending of the government) will be given access to aggregated price information (as a rule on the ATC1 level, i.e., the top level of the Anatomical Therapeutic Chemical Classification System of medicines). The qualifying members will be required to sign a non-disclosure agreement.
The government is apparently confident that the Bill will garner a majority in the chamber. The Bill can be found here.