Spotlight: medicine and medical device pricing and reimbursement in Belgium

An extract from The Life Sciences Law Review, 8th Edition

Pricing and reimbursement

Belgium operates strict controls on the prices of certain classes of medicines and medical devices and on their reimbursement status. The controls have a cumulative effect as, for many products, marketing is only viable when they are at least partially reimbursed.

Pricing and reimbursement rules are very complex in Belgium. The competent authority for price determination is the Federal Public Service for Economic Affairs, encompassing two specialised commissions: the Commission for Price Regulation and the Commission for Pricing of Medicinal Products.

The applicable procedure for price determination depends on the type of medicine and whether it is considered new. Price determination will either require notification to the Federal Public Service for Economic Affairs (e.g., for generics) or prior approval from the Minister for Economic Affairs (e.g., for innovative medicines). Price increases are also subject to either authorisation or notification requirements, and price decreases must be communicated. Decisions by the Minister for Economic Affairs can be challenged before the Council of State (see Section IV). The price approval process is based on an application dossier that comprises a justification for the requested price (including production cost, a copy of the company's annual accounts for the past three years and a description of the market). A simplified pricing procedure applies for medicines approved on the basis of an abridged, bibliographical or hybrid application. In addition, margins applied throughout the distribution chain are subject to control and limitations.

Reimbursement is decided upon by the Minister of Social Affairs, following a recommendation by the Medicines Reimbursement Committee, which forms part of the National Institute for Health and Disability Insurance (NIHDI). The decision process and the dossier to be submitted depend on the category of medicine. There are three main categories, depending on whether the medicine represents added therapeutic value over existing products and whether it is innovative or generic. As a rule, the Medicines Reimbursement Committee adopts a proposal based on the elements submitted by the company and the medical and therapeutic value of the product. The proposal is then presented to the Minister of Social Affairs, who takes the final decision. The reimbursement decision fixes the reimbursement price (which may be lower than the price initially approved by the Minister for Economic Affairs) and the category of reimbursement (which determines the level of co-payment required from the patient). Decisions by the Minister of Health can be challenged before the Council of State (see Section IV below). In addition, specific procedures apply for amending the reimbursement modalities of a medicine (or group of medicines), which can be initiated by the marketing authorisation holder, the Medicines Reimbursement Committee or the Minister of Social Affairs.

Since 2010, the rules also allow for managed entry agreements to be concluded between the company and the Federal Health Insurance Service. These are commonly known as Article 81 agreements, although that term is no longer accurate in light of a recent overhaul of the Royal Decree on Reimbursement. The agreements allow for risk-sharing mechanisms between the company and the government. They are used primarily when there are uncertainties (e.g., as to the budgetary impact, the therapeutic value or administration specifics) and typically contain a financial mechanism to address these uncertainties, such as rebate schemes. An Article 81 agreement leads to a temporary reimbursement for three years, possibly renewable. That period of time is typically used to gather further information on the product. An Article 81 agreement must contain a number of elements, including details on the price and reimbursement basis of the product, tools to control the budgetary risks (for instance, by controlling the volume of products prescribed), follow-up measures and details on the financial risk-sharing mechanism.

In addition, since 2014, a system of early temporary reimbursement is in place for products that have not yet obtained a marketing authorisation but that are made available via an early access programme (namely a compassionate use or a medical need programme; see Section II.iv above). This system only applies for products that are used to treat certain diseases that reflect an unmet medical need. The diseases are identified in a list that is regularly updated and published on the website of the NIHDI. We understand that, in practice, the system has not been widely used so far.

Since July 2019, there is a 'linked' reimbursement procedure in place for personalised medicines and companion diagnostics. Under this system, medicinal products and their biomarkers are evaluated jointly as a package, and the Minister of Social Affairs takes a reimbursement decision on both products. This new procedure aims to prevent delays in the reimbursement of a test in comparison with the reimbursement of the related medicinal product.

The pricing and reimbursement of medical devices in Belgium is quite complex, and the applicable reimbursement level and procedures depend on the type of device. Certain implantable devices and hearing instruments require price approval by the Minister for Economic Affairs, on the basis of an opinion from the Commission for Pricing of Medicinal Products. Maximum margins may also apply. Some devices (such as implants) can be reimbursed as such, while others may be covered by the general expenses of the hospitals where they are used. There are also detailed rules on the levels of payment or co-payment by patients.