Innovative medicines are evolving one after another at an accelerating pace, yet for patients, access can still feel slow and unequal. Across the BeNeLux countries, different systems exist to bridge this gap, each with its own logic, rules, and pitfalls.

In this blog, we take you through Belgium, the Netherlands, and Luxembourg, and explain how early access to medicines is organized, on regulatory and financial bases. Not a legal deep dive, but a clear overview of what truly matters for patients, healthcare professionals, and companies.

1. Belgium – from exception to system

The Belgian approach is built on two well-aligned pillars that enable earlier access to innovative treatments for patients with a high unmet medical need, free of charge. The medicines are provided by pharmaceutical companies, with possible financial compensation from the government:

1.1. Can the medicine be placed on the market? → The regulatory pillar for a cohort of patients: Compassionate Use Program (CUP) & Medical Need Program (MNP)

In general, medicines must first obtain marketing authorization (MA) to enter the market in Belgium, either via the central EMA procedure or other routes (e.g. national procedures via FAMHP). And once the marketing authorisatin is granted, a procedure can start to obtain a price and in most cases also reimbursement. The time between MA and patient access can be very long. Therefore alternative pathways are installed to allow access for the patient before being commercialised.

During the registration process, a CUP can be requested to the FAMHP.

Once authorized, and during the period before price and/or reimbursement for the relevant indication(s), an MNP can be requested. An MNP allows treatment of patients without price and/or reimbursement by the government (and therefore at the expense of the developer). The MNP runs until formal launch of the concerned speciality for the concerned indication.

Both CUPs and MNPs are managed by FAMHP. These programs ensure legal access to medicines for patients but do not provide financial compensation:

• CUP: According to Article 83 of European Regulation (EC) No. 726/2004, meaning it can be applied across EU countries. These programs are used before marketing authorization. Each EU Member State sets its own rules and procedures for compassionate use.
• MNP: used after marketing authorization (national procedure).

1.2. What is the financial compensation? → The financial pillar for a cohort of patients: Early and Equitable Fast Access (EEFA)

This is where Belgium truly differentiates itself. With the introduction of Early and Equitable Fast Access (EEFA), which came into force on March 1, 2026, Belgium has developed a structured and transparent system that combines both regulatory access and financial intervention. This system is explicitly designed to provide patients with faster access to innovative medicines addressing a high unmet medical need (UMN).

Through NIHDI (CATT), the health insurance system provides temporary (and limited) financial support to developers/distributors via:

• Early Access (EA): Applies to medicines that do not have a marketing authorization, no possibility of submitting a reimbursement file, and that are listed on the UMN list. These medicines have a CUP or MNP program at the FAMHP, and the procedure takes approximately 55 days. The request is submitted either by the company responsible for the medicine or by the Minister of Social Affairs or Public Health.
• Fast Access (FA): Applies after marketing authorization (moment when you can submit a reimbursement application) to medicines listed on the UMN list, and those that have obtained marketing authorization following Early Access, or,  have been designated as a priority by the EMA (PRIME), or have been assessed via an accelerated procedure. The process takes approximately 90 days. The application is submitted either by the company responsible for the medicine or by the Minister of Social Affairs or Public Health.

1.3. Regulatory and financial pillar for individual patients: Named Patient Program (NPP)

• NPP: The physician submits an Individual Patient Request via the new NIHDI application. This procedure replaces the Special Solidarity Fund and follows a 30-day processing timeline. Can be compensated retroactively.

A crucial condition for financial compensation in Belgium is the recognition of unmet medical need (UMN) and inclusion of the indication on the official UMN list created by NIHDI. This list is established annually and acts as a strict gatekeeper: without UMN status, EEFA is not possible.

If your indication is not on the list, the process stops. The deadline to apply for UMN recognition is May 15. Once approved, the indication is included in the list in the following calendar year. If you need support, HEBIAS is ready to assist. Each indication is ultimately evaluated and ranked based on a priority score.

UMN definition depends on 5 criteria: Impact on quality of life and life expectancy, effectiveness and accessibility, burden and inconvenience and societal impact.

What makes EEFA unique?

• Fixed lump sums per patient depending on the drug class and program, paid by NIHDI to developers/distributors. These amounts vary significantly: in 2026, from €140 for non-orphan small molecules up to €120 000 for cell and gene therapies.
• Uniquely, Belgian health insurance contributes via fixed per-patient payments, while the medicine itself is provided free of charge to the patient.
• Strict but clear timelines.
• Mandatory data collection and follow-up (data owned by NIHDI, not the company), used for monitoring and potential future reimbursement decisions.

2. The Netherlands – strong regulatory framework, limited financial support before reimbursement

In the Netherlands, the principle is that only care meeting established standards of science and practice is eligible for reimbursement. The National Health Care Institute (Zorginstituut Nederland, ZiN) evaluates therapeutic value and cost-effectiveness after market authorization and advises the Minister of Health.

There are two main reimbursement routes:

• intramural hospital funding (not applicable to oral medicines)
• extramural reimbursement via the Medicines Reimbursement System (‘Geneesmiddelenvergoedingssysteem’, GVS), relevant for oral small molecules

The Medicines Act (Geneesmiddelenwet, Gnw) prohibits the dispensing of a medicinal product for which no marketing authorization has been granted in the Netherlands. In specific situations, however, the ‘Gnw’ allows for exceptions to this rule.

• CUP (European Regulation (EC) No. 726/2004): For groups of patients with a high medical need and no approved treatment alternatives. A manufacturer may submit a CUP request to the ‘College ter Beoordeling van Geneesmiddelen (CBG)’.
• ‘Levering op artsenverklaring’ / Individual patient program / Named Patient Program (NPP):  If, according to the treating physician, a patient cannot be treated with the currently available medicines, the physician documents this in a medical declaration (‘artsenverklaring’). Based on this declaration, a pharmacy, wholesaler, manufacturer, or dispensing general practitioner can apply to the IGJ (Inspectorate for Health and Youth Care) for an exemption (authorization) to supply a medicinal product that is not authorized in the Netherlands.
• Magistral and officinal preparations: these are medicines that are prepared by a pharmacy in small quantities and supplied to its own patients.
• Medicines used in clinical trials.
• In cases of temporary shortages, the IGJ may issue an exemption decision.

These routes allow legal access but do not create any right to reimbursement or compensation. Typically, the company provides the medicine free of charge to the patient, without financial compensation from the government.

The Netherlands remains strict. There is no legal framework for temporary reimbursement/compensation between EMA approval and formal inclusion in the GVS. Retroactive payments are not possible.

Individual exceptions via insurers may exist but are uncertain and highly patient-specific.

3. Luxembourg – case-by-case

Luxembourg follows a third approach. Unlike Belgium, it does not have an integrated system for financial compensation, but at the same time there is less need for extensive early access programmes because access to medicines is relatively fast. In this respect, Luxembourg mostly aligns with the pace of Germany, where access is also quite rapid.

Regarding access to medicines that are already on the market in Luxembourg, the organisation of access and reimbursement is characterised by a relatively flexible system. For hospital products that are commercialised in Luxembourg, there is no strict control over the indication for which they are used within hospitals, which facilitates access when a patient requires treatment for an indication other than the reimbursed one.

When a medicinal product does not have a marketing authorisation in Luxembourg, or is authorised but not available or not reimbursed for the relevant indication for specific patients, Luxembourg hospitals can order medicines from other countries, which further facilitates access to treatment. In such cases, an exceptional request can be submitted for individual patients, known as an Autorisation d’Usage Exceptionnel (AUE). The request is made on a per-patient basis and, if the company does not intervene and the product is not available in Luxembourg for that patient, the costs can be covered by the CNS. In case of import, for example from Germany, the Luxembourg hospital initially pays for the medicine, after which the invoice can be submitted to the CNS for reimbursement for specific patients, provided that an AUE request has been submitted and approved. This requires a clear medical need and sufficient scientific evidence, and the application is submitted directly to the Division de la Pharmacie et des Médicaments (DPM) without involvement of the Comité National d’Éthique de Recherche (CNER).

For patient cohorts, there is in theory the possibility of early access via regulatory pathways such as the Compassionate Use Programme (CUP) and the Medical Need Programme (MNP), although these are rarely, if ever, used in Luxembourg due to the limited need. These programmes require submission to the CNER and the DPM, as well as the appointment of a coordinating physician for Luxembourg.

References:

BE:

FAMHP Guidance v1.17 [famhp.be] ; FAMHP page (legal basis + fee approach) [famhp.be]

Snellere toegang tot innovatieve geneesmiddelen dankzij de procedure Early and Equitable Fast Access (EEFA) | RIZIV. (z.d.).

Hervorming terugbetalingsprocedures geneesmiddelen  | RIZIV. (z.d.).

Onbeantwoorde medische noden – Unmet Medical Need  | RIZIV. (z.d.).

NL:

Ministerie van Volksgezondheid, Welzijn en Sport. (2025, 3 oktober). Vragen over afleveren geneesmiddelen zonder handelsvergunning.

Ministerie van Volksgezondheid, Welzijn en Sport. (2026, 6 februari). Leveren op artsenverklaring.

LUX:

Demande d’avis pour programme d’usage compassionnel (CUP, MNP). (z.d.). Comité National D’Ethique de Recherche (CNER) – Le Gouvernement Luxembourgeois.