EEFA: How Faster Access to Innovative Medicines Works in Belgium

For patients living with a serious or life-threatening condition, every month of waiting can make a difference. At the same time, pharmaceutical companies often have to wait years before their innovative medicines obtain reimbursement through the standard process. To bridge this gap, the National Institute for Health and Disability Insurance (INAMI/RIZIV) will introduce a new, harmonised procedure on 1 March 2026: Early and Equitable Fast Access (EEFA). But what exactly does this reform entail, and what will it change for patients and companies?

What is EEFA?

EEFA forms part of INAMI/RIZIV’s broader Roadmap 2024 to modernise medicines reimbursement procedures. Its objective is to accelerate the assessment of medicines that address an unmet medical need or provide significant added value, enabling patients to access life-changing—or even life-saving—treatments more quickly.

Which committee evaluates the applications?

Applications are assessed by the Committee for Advice on Temporary Reimbursement for the Use of a Medicinal Product (CATT/CAIT). This committee was legally established through new provisions (Articles 31ter to 31octies) in the Law of 14 July 1994 and further elaborated in the Royal Decree of 14 February 2026.

The CATT/CAIT consists of voting members:

• The Chair of the Orphan Medicinal Products Colleges
• The Chair of the Commission for Medicinal Products for Human Use
• Two representatives of the CRM/CTG
• Two members of the INAMI/RIZIV staff,
• 2 health insurance organisations

As well as non-voting members:

• Two representatives FAMHP
• One pharamceutical industry representative
• One member from FAMHP staff
• Representative of patient organisations.

The committee has a dual mandate:

• to establish and maintain a list of unmet medical needs; and
• to make decisions on both individual and collective applications for early and fast access.

Two pathways: Early Acces and Fast Acces

EEFA operates through a two-track approach, each corresponding to a different stage in a medicine’s lifecycle.

Early Access

Early Access applies before marketing authorisation.

To qualify:

• the indication must be included on the list of unmet medical needs (deadline: 15th of May);
• the medicine must be part of an active CUP or MNP;
• no Fast Access application or reimbursement application may yet be submitted for that indication.

The procedure follows a clearly defined timeline, with a preliminary proposal issued by Day 30 and a final framework decision adopted by Working Day 55.

Fast Access

Fast Access takes over once a CHMP positive opinion or a marketing authorisation has been obtained, bridging the period until the standard reimbursement procedure through the CRM/CTG is completed.

Companies may apply from the moment a CHMP positive opinion is issued until no later than one month after marketing authorisation. Medicines that have received PRIME designation or undergone an accelerated EMA assessment are also eligible.

The Fast Access procedure spans 90 working days, with a preliminary proposal issued on Day 30, a final proposal on Day 60, and a ministerial decision adopted by Day 90.

Importantly, once a medicine has been included under Early Access, the transition to Fast Access is automatic for indications already covered by the Early Access decision.

How is the system funded?

Companies receive a lump-sum compensation per temporary reimbursed medicine under EEFA, structured similarly for both Early Access and Fast Access.

Once a definitive reimbursement decision is reached, the lump-sum system ceases and a retrospective reconciliation is performed. No later than 1 July of the year following the temporary or definitive reimbursement decision, 75% of the difference between the compensation received and the actual net cost is settled.

Patients who have already initiated treatment retain access for as long as clinically necessary, regardless of whether the medicine is ultimately included in the standard reimbursement system.

What are the benefits for the standard reimbursement procedure?

Data collected during Early Access and Fast Access can subsequently be reused to support the regular CRM/CTG reimbursement dossier.

Through a new registration system, hospitals submit data to INAMI/RIZIV, which in turn provides pseudonymised datasets to the company. EEFA therefore does not operate independently from the conventional reimbursement pathway; rather, it serves as a bridge towards it.

Strategic planning remains essential

EEFA creates a practical and time-bound route to faster and more equitable access to innovative medicines. However, eligibility remains conditional: only medicines that demonstrably address an unmet medical need and are supported by either EMA safety confirmation or an ongoing CUP/MNP programme can qualify.

For companies considering an application, early engagement with INAMI/RIZIV and a thorough understanding of timelines, documentation requirements, and the interaction with the conventional reimbursement process will be essential to avoid delays and maximise the opportunities offered by the new framework.