In 2006, Belgium implemented a procedure for the reimbursement of medicinal products that was inspired by the system applicable in New Zealand, known also as the “kiwi model”. The system was implemented by a Royal Decree of 17 May 2006, and provided for, among other measures, a new way of reviewing reimbursement groups of medicinal products with the same active substance which are out of patent. The purpose of the system is to decrease the price of the products and their reimbursement base on a competitive level, by rewarding, through a specific procedure, the cheapest product. It was intended to apply where the revision occurs for budgetary reasons.
It should be noted that the system does not preclude any reimbursement decrease group revision for products protected by a patent. A Royal Decree of 22 December 2005 authorises the Minister of Health or the Commission for the Reimbursement of Medicinal Products (“CRM”) to create new “groups” of medicinal products for identical or analogous indications or with working mechanisms for which a totally new base reimbursement would be imposed.
In practice, the Royal Decree of 17 May 2006 was to provide a specific advantage to the cheapest product, i.e. to grant a greater reimbursement percentage to the cheapest product, as compared to the percentage applicable to the other products. The system was indeed much lighter than the system applicable in New Zealand, where only the cheapest product is reimbursed, the other products not being reimbursed at all.
The proposed model has been subject to litigation by the representative organisation pharma.be and several pharmaceutical companies. The claimants’ main argument alleged that the specific grouped reimbursement revision, as provided for in the Royal Decree, was contrary to the equality principle, as it treated all molecules the same way, without taking essential differences such as dosage, therapeutic indications or pharmaceutical form into consideration. The sole element that was taken into account in the grouped revision procedure was the active substance of the products, although the other elements play a role in the ordinary grouped revision procedure, which is triggered when the CRM decides to revise the reimbursement of products used for identical or analogous therapeutic indications.
The Council of State considered that the other elements (e.g. dosage, amount of units per packaging) should also play a role where the grouped revision occurs for budgetary reasons. Moreover, the Council of State noted that the legal grounds of the annulled Royal Decree had been amended in the meantime (i.e. between the filing of the claims and the annulment decision), providing for a regime in which those elements should have been taken into account in order for the attacked Royal Decree6 to comply with its legal grounds.
The principle of the Belgian kiwi system is thus not completely thrown back into question. However, there is little doubt that the stakeholders, and notably the pharmaceutical industry, will continue to challenge the attempts to implement a kiwi system in Belgium.