Patient Involvement in Drug Reimbursement in Belgium

Belgium integrates patient voices in drug reimbursement via RIZIV/CTG.

Discover how the new dual-track model aligns with EU practices, EUPATI and GIN.


On 1 April 2025, Belgium officially opened the door for patients to participate in decisions about the reimbursement of medicines. For the first time, the Commission for the Reimbursement of Medicines (CTG/CRM) at the National Institute for Health and Disability Insurance (RIZIV/INAMI/NIHDI) includes patient representatives in its procedures (RIZIV press release, 2025).

A turning point in Belgium

The CTG/CRM advises the Minister of Social Affairs on reimbursement, weighing therapeutic value, cost, safety, and efficiency of medicines. The Minister takes the final decision, informed by the CTG/CRM’s advice and input from other stakeholders (see RIZIV CTG/CRM page). What has long been missing, however, was a structured way to capture the lived experience of patients.

How the new Belgian system works

The reform introduces a dual-track model:
1. Permanent representation of patients in the CTG/CRM, via VPP (Vlaams Patiënten Platform / Flemish Patients’ Platform) and LUSS (Ligue des Usagers des Services de Santé / League of Users of Health Services) as non-voting, consultative members
2. Structured patient questionnaires for innovative medicines, capturing disease burden, treatment experiences, and patient experience with the medicine under review (RIZIV reform page)

The Questionnaire

To better understand the impact of diseases and treatments, patients are invited to complete a structured questionnaire. It is divided into three main parts:

  • Part A – Impact of the Disease. This section explores how the illness affects daily life. For example:
    • Which daily activities are difficult or impossible because of the condition?
    • Do patients need support in daily life, such as physical help or emotional support?
    • What is the impact of the disease on family members or caregivers?
  • Part B – Experience with Existing Treatments. Here, patients share how well current therapies meet their needs. Key questions include:
    • What are the main benefits and drawbacks of the current treatment?
    • Which side effects are hardest to tolerate, and how do they affect quality of life?
    • Does treatment interfere with work, school, or social life?
  • Part C – Experience with the New Medicine (if applicable). If patients have tried the medicine under review, they are asked:
    • Has the medicine improved symptoms or quality of life?
    • Is it easier to take or administer compared to older treatments?
    • What side effects have been experienced, and are they manageable?

Belgium in the European context

Belgium’s reform does not happen in isolation. Across Europe, patient voices are already embedded in reimbursement and Health Technology Assessment (HTA):
– In the UK, patient experts present evidence directly to NICE committees (NICE manual).
– In Germany, the G-BA guarantees seats for Patientenvertretung (patient representatives) with consultative rights (G-BA portal).
– In France, the Haute Autorité de Santé (HAS) systematically integrates patient associations in evaluations.

By comparison, Belgium is catching up with these more established systems. The addition of VPP and LUSS to the CTG/CRM ensures that patients will no longer be absent from the discussion, even if they do not yet have voting rights.

Belgium and international guidance

Looking beyond Europe, there are also international toolkits that define what ‘good’ patient involvement should look like. Two key references are EUPATI and GIN.

– EUPATI (European Patients’ Academy on Therapeutic Innovation): focuses on empowering patients through training, education, and toolkits. Its guidance stresses principles like relevance, fairness, transparency, and capacity building, and recommends structured processes (EUPATI guidance).
– GIN (Guidelines International Network): a global network offering frameworks for HTA bodies and guideline developers. Its toolkit maps how patients can be involved throughout the HTA lifecycle; from topic selection, to committee membership, to patient-friendly summaries of reports (GIN toolkit).

GIN vs. EUPATI: complementary roles

AspectGINEUPATI
ScopeGlobal network improving guidelines & HTA methodsEuropean initiative focused on patient training & advocacy
AudienceAgencies, ministries, professionals, patient repsPatients, carers, patient organisations
ContributionFrameworks & toolkits for how to involve patientsEducation & tools to prepare patients
RelationSets the rulesTrains the players

How Belgium measures up

Best-practice elementEUPATI / GIN expectationBelgium (CTG, 2025)
Patient presence in committeesYes, with clear role✔ CTG/CRM includes VPP & LUSS (non-voting)
Structured inputStandardised submissions✔ Patient questionnaire for innovative medicines
Transparency & feedbackClear reporting on patient impact△ Transparency goal stated; feedback loop evolving
Capacity buildingTraining & support△ VPP/LUSS support available, more development needed
Early involvementInput at topic scoping△ Currently limited to innovative dossiers

Conclusion

Belgium’s reform is a milestone, but also a starting point. With its new dual-track model, the CTG/CRM now integrates both collective patient perspectives and case-specific experiential knowledge into its deliberations. Compared to neighbours like the UK, Germany, and France, Belgium has made a significant leap. Against international guidance from EUPATI and GIN, it shows strong alignment on the basics, but still has room to grow in transparency, feedback, and early engagement. In short: Belgium has caught up and now needs to keep moving forward.


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