In recent years, it has become increasingly clear that medical innovation is not only a technical or economic issue. It is also a social and ethical one. New treatments, ranging from well-known drugs to advanced therapies such as ATMPs, are reshaping expectations for patients and healthcare providers. Yet these innovations continue to face complex market access pathways.

Belgium has made progress. Since 2025, patient representatives are formally included in some reimbursement committees, and the new European health technology assessment (HTA) regulation has entered into force with direct implications for national processes. These are valuable steps. However, they do not yet guarantee that patients are effectively, early, and representatively involved.

This blog explains why patient participation is essential for market access, outlines the current limitations in the Belgian system, and proposes concrete solutions to strengthen patient engagement with practical recommendations for policymakers, healthcare institutions, industry, and patient organizations.

1. Why Patient Participation Is a Necessity, not a Luxury

Healthcare systems ultimately exist to serve patients. Decisions about which innovations get reimbursed, which indications are prioritized, and how payment models are structured have direct impacts on people’s lives and wellbeing. Patients bring unique, experiential knowledge as they live with the consequences of diseases, side effects, and quality‑of‑life issues that clinical trials alone cannot fully capture.

When patients help inform what matters, HTA bodies can better assess true value. HTAs balance clinical effectiveness, cost‑effectiveness, and social value. Patients can help define which outcomes truly matter, for example symptom reduction, mobility, or ability to work, making decisions more aligned with what patient’s value.

Patient participation also improves legitimacy. Decisions about scarce healthcare resources are inherently political and ethical. Meaningful patient input increases the legitimacy of those decisions and can reduce social resistance when difficult prioritization choices must be made. Early involvement can even make access faster because it ensures that dossiers align better with real-world needs. This creates a stronger foundation for managed entry agreements (MEAs) and outcome-based models.

In short: patient involvement enhances relevance, quality, acceptance, and ultimately access.

2. The Belgian Context: Progress, but Persistent Challenges

Belgium has not stood still. The 2024 reimbursement law reform reshaped procedures, and since 1 April 2025, patient representatives have been formally included in the Reimbursement Commission for Medicines (CTG/CRM). Moreover, Belgium began implementing the European HTA Regulation in January 2025, initially covering oncology drugs and ATMPs, with the NIHDI taking a coordinating role in joint European assessments.

These are major milestones, but several structural challenges remain:

Lengthy timelines and partial availability continue to be an issue. Studies show that average times to reimbursement remain long (often hundreds of days), and a significant share of new medicines never reach patients in certain countries, Belgium included, due to complex negotiations or the absence of company submissions.

The timing of patient involvement is a concern. Input often comes too late, once dossiers and trial designs are already finalized. At that stage, patients can no longer meaningfully influence endpoints or the type of real-world data being collected.

Capacity and representativeness pose difficulties. Many patient organizations lack the resources, time, or expertise to analyze technical HTA reports. This risks over-representation of a few well-funded or visible groups, rather than a balanced patient voice across diseases and demographics.

Data gaps add to these challenges. Reliable patient-centered evidence (especially real-world data) is often fragmented or missing, limiting the ability to support experiential insights with quantifiable outcomes.

Finally, confidential pricing and MEAs complicate transparency. Belgium frequently uses MEAs with confidential discounts. While this can accelerate access, it also limits transparency and makes it difficult for patient groups to understand whether deals are equitable and sustainable.

3. What Patients Bring to the Table: Concrete Examples

Prioritizing meaningful outcomes is essential. In conditions such as breast cancer or multiple sclerosis, patients may value quality of life, cognitive function, or fatigue reduction more than sheer survival statistics. Including these preferences in HTA leads to assessments that reflect what truly matters to patients.

Risk-benefit tolerance varies across patient groups. For severe or life-limiting conditions, some patient groups accept higher risks in exchange for potential clinical gains. Their voices help regulators and payers calibrate acceptable uncertainty.

Patients play a key role in identifying implementation barriers. Patients often flag practical challenges such as travel burden, hospital access, or treatment adherence and this affects real-world effectiveness. Addressing these early can make innovations more successful after approval.

4. Current Structural Limitations in Belgium: A Closer Look

Low institutional capacity among patient organizations remains a significant barrier. Many operate on small budgets, often relying on volunteers. Without resources to interpret technical data, participation remains symbolic rather than substantive.

There is a lack of structured early engagement. While the EU HTA framework promotes early scientific advice, Belgium has yet to institutionalize systematic “early dialogues” with patient representatives at pre-submission stages.

Confidential pricing practices add another layer of complexity. As mentioned, confidential discounts help manage budgets but undermine transparency, leaving patients and the public unsure how reimbursement decisions are justified.

The data landscape is fragmented. Real-world data is scattered across hospitals, insurers, and registries. Technical and privacy barriers make it difficult to aggregate and analyze information effectively.

Finally, there are Insufficient incentives for patient-centred evidence. If market access remains uncertain, industry may hesitate to invest in long-term patient registries or outcomes research ultimately perpetuating the evidence gap.

5. How to Strengthen Patient Participation: Policy and Practice Solutions

Below are complementary measures Belgium could implement to create a robust, inclusive patient engagement ecosystem.

A. Institutionalize Early and Structured Involvement

Belgium can begin by institutionalizing early and structured involvement of patients throughout the market access process. This would require mandatory early dialogues in which developers, HTA bodies, regulators, and patient representatives meet during pre-submission stages, ideally before Phase III trials or during dossier preparation. Such early consultations ensure that patient priorities are integrated from the outset. Alongside these dialogues, Belgium would benefit from standardized inclusion mechanisms that define clear roles, procedures, and timelines for patient participation. This approach would help avoid ad hoc invitations and provide consistent, equitable treatment across dossiers.

B. Build Capacity Within Patient Organizations

Strengthening patient engagement also depends on building capacity within patient organizations. Many patients do not have the resources require to participate in HTA processes. A national co-funding mechanism involving public and private partners could provide sustainable funding and allow organizations to be compensated for the time and expertise they invest. Belgium could also develop training and certification programs in partnership with KCE, universities, and EU HTA networks. These programs would cover HTA methodology, data interpretation, and policy advocacy, ensuring patient representatives are equipped to engage effectively.

C. Strengthen Data Infrastructure and Patient-Centered Outcomes

Belgium can further enhance engagement by improving its data infrastructure and focusing on patients-centered outcomes. A national real-world data platform would allow for secure, interoperable pooling of anonymized patient outcomes. With clear governance rules, such a platform could support post-market evaluation and facilitate outcome-based contracts. In addition, Belgium would benefit from standardized set of Patient-Reported Outcome Measures (PROMs) across major disease areas. Consistent PROMs would make it easier to integrate patient perspectives directly into HTA and reimbursement processes.

D. Increase Transparency and Payment Flexibility

Greater transparency and more flexible payment models are also essential. Encouraging outcome-based reimbursement would require simplifying the legal and technical framework that governs performance-based agreements. Shared-risk models can accelerate access while still protecting the sustainability of the healthcare budget. Belgium can also clarify confidentiality frameworks. Even if prices remain confidential, authorities can still publish summary information on budget impact, criteria, and evaluation timelines. This level of transparency would improve understanding and foster trust among patient groups.

E. Ensure Representation and Inclusivity

Finally, Belgium must ensure patient representation is both diverse and inclusive. Fair compensation and accessible meeting formats, including virtual participation and scheduling outside regular working hours, would allow a wider range of patients to take part. This includes people who are employed, elderly, living in rural areas, or part of vulnerable communities. Transparent selection criteria and rotation mechanisms can help prevent over-representation of the same small group of advocates, ensuring diverse patient recruitment.

6. Stakeholder-Specific Recommendations

The Federal Government and NIHDI have an important role to play in strengthening patient involvement. They can begin by codifying patient involvement in law or through quality standards for HTA and reimbursement. They should finance a national patient capacity-building program that provides sustainable support for patient organizations. In addition, the creation of formal “early dialogue” structures, paired with investments in real-world data platforms, would help ensure that patient involvement is integrated well before reimbursement.

HTA Institutions such as KCE and NIHDI carry key responsibilities. They can develop and publish national PROM frameworks and offer guidance on how patient perspectives should be incorporated into assessments. These institutions can further require that patient insights are explicitly reflected in HTA reports and recommendations, ensuring that experiential knowledge becomes part of the formal evidence base.

Patient organizations themselves play a central role in this ecosystem. They can build alliances across disease areas, share training resources, and produce concise “evidence briefs” that connect lived experience with measurable outcomes. Strengthening advocacy capacity through EU and national networks, including initiatives such as EUPATI Belgium, can further enhance their ability to contribute to HTA processes.

Industry partners can support this evolution by engaging patients as co-creators during study design and dossier development. They can also make greater use of hybrid MEAs, combining temporary reimbursement with real-world data follow-up, to enable earlier access under monitored uncertainty.

Sickness funds and healthcare providers can contribute as well. They can partner with patients and industry to pilot outcome-based payment schemes, testing approaches that link reimbursement to real-world performance. They can also facilitate data sharing and outcome tracking across hospitals and registries, helping to build the evidence needed for patient-centered decision-making.

7. Addressing Common Concerns

“Patients lack the technical expertise.”

True in some cases but solvable. With targeted training, patients can rapidly become credible partners capable of interpreting complex evidence.

“Confidential prices prevent transparency.”

Transparency is multidimensional. Authorities can maintain commercial confidentiality while still disclosing evaluation principles, budget impact ranges, and decision criteria.

“Participation will slow down decisions.”

The opposite is often true. Early involvement prevents later bottlenecks, incomplete dossiers, or public resistance. Structured processes can ensure participation without delay.

8. Quick Wins: Feasible Within 6–12 Months

1. Launch an early dialogue pilot. Select 2–3 disease areas to test structured meetings between developers, HTA bodies, clinicians, and patient groups to define key outcomes and data needs.
2. Create a small patient participation fund. Provide modest but direct compensation for patient input during HTA or reimbursement meetings.
3. Develop a standardized patient input template. A short, user-friendly form could capture patient priorities, for example top five treatment goals, side‑effect burden, and daily life challenges, in a consistent format.

9. Conclusion: A Call for Shared Responsibility

Patient participation is not an administrative burden, it is a catalyst for smarter, fairer, and faster access to innovation. Belgium is moving in the right direction with the 2024 reimbursement reform, the inclusion of patient representatives in the CTG/CRM since April 2025, and the rollout of the EU HTA Regulation, However, true impact will come only when these reforms are matched by investments in capacity, data, and structure.

If we want medical innovation to truly serve patients, we must go beyond symbolic inclusion: we must equip, empower, and compensate patients for their essential contributions. This requires sustained investment, clear governance, and political will.

The reward is worth it. A healthcare system that makes scientifically sound, socially legitimate decisions and delivers faster access to the innovations that matter most to the people they are designed to help.

Selected References

• Belgian reimbursement procedure reform (2024 legislative updates).
• Inclusion of patient representatives in the Reimbursement Commission for Medicines (CTG/CRM) as of April 2025.
• Implementation of the EU Health Technology Assessment Regulation (January 2025).
• NIHDI press release on Belgium’s role in joint European HTA assessments (January 2025).
• EFPIA / CRA reports on access delays and availability of innovative medicines across Europe.