The new Belgian federal government has outlined its vision for public health in a policy paper under the slogan “More money for health, more health for our money”. Public health is a high-priority sector with a significant budget, and the policy paper introduces several key measures that will shape the pharmaceutical industry in the coming years. For pharma companies operating in Belgium, these developments bring both new regulatory challenges and strategic opportunities. Here is a focused analysis of ten key changes and their potential impact on the pharma industry.
10 key pharmaceutical policy measures & their impact
1. Strengthening of Health Technology Assessment (HTA) processes
What? Given the EU’s Health Technology Assessment (HTA) Regulation applies since 12 January 2025, the National Institute for Health and Disability Insurance (NIHDI) will improve its expertise regarding HTAs and integrate this into decision-making processes for medicines, medical devices and emerging health technologies.
Industry Impact? Pharma companies should anticipate increased scrutiny in HTA evaluations, potentially influencing reimbursement decisions and market access timelines.
2. Ensuring affordable and accessible medicines
What? A commitment has been made to European initiatives such as the Critical Medicines Act, the Biotech Act and the ongoing reform of the EU’s pharmaceutical legislation. There will be continued cooperation with the EU and its Member States on pricing, reimbursement, joint negotiation and procurement.
Industry Impact? Pharma companies should prepare for a continuation of tougher price negotiations and an expansion of EU-level regulatory alignment, which could affect pricing strategies and market exclusivity periods.
3. Preventing and addressing medicine shortages
What? At the national level, there will be a strengthening of the framework to prevent and address shortages, including sharper measures that ensure the proper enforcement of public service obligations. To increase transparency, a stock monitoring tool will be introduced and refined following the pilot project, and a Belgian list of critical medicines will also be published.
Industry Impact? Pharma companies can be expected to likely face stricter compliance requirements, particularly around stock management and supply chain transparency.
4. Evaluation & reform of the FAMHP
What? The functioning of the Federal Agency for Medicines and Health Products (FAMHP) will be evaluated, with potential reforms within a delineated budgetary framework.
Industry Impact? While reforms could enhance efficiency, pharma companies should stay alert for potential changes that could impact regulatory and compliance obligations.
5. Continued rollout of the pharmaceutical ‘roadmap’ & multi-year framework
What? The earlier ‘roadmap’ for pharmaceutical policy will continue to be executed, with special consideration for the implementation of the European HTA-procedure and the goal to operationalise the fast and early access procedure and have it evaluated by the end of 2027. Alongside the roadmap, a multi-year pharmaceutical framework will be introduced to ensure a more predictable budget and provide more transparency to the pharmaceutical industry and the public. The framework will also introduce financial flexibility and incentives to boost the market for generics and biosimilars, developed in close dialogue with the industry.
Industry Impact? For innovative pharma companies, this could provide a more predictable investment environment, enabling clearer long-term planning. However, the financial flexibility measures might also introduce budgetary constraints on high-cost innovative therapies, requiring companies to proactively engage with policymakers to ensure sustainable reimbursement models. Finally, the further incentivisation of generics and biosimilars can be expected to increase competition in the off-patent market, requiring pharma companies to adapt pricing and market positioning strategies.
6. Reviewing the functioning of Ethics Committees
What? To safeguard Belgium’s position as a global leader in medicines research and innovation, a review of the functioning of Ethics Committees will take place.
Industry Impact? Pharma companies involved in R&D in Belgium should stay engaged in, and updated on, discussions on potential reforms, which could impact the handling and timelines of clinical trial approval.
7. Balancing IP protection & societal interests
What? The Minister reaffirmed its commitment to a balanced IP policy that incentivises developers while safeguarding societal interests, advocating this approach in debates on Regulatory Data Protection (RDP), Market Protection, Supplementary Protection Certificates (SPC), molecule patents, and the orphan drug exception regime.
Industry Impact? The innovative pharma industry should stay engaged in ongoing policy discussions, as changes in IP protections could impact investment in R&D, commercial strategies and the availability of new therapies to Belgian patients.
8. Expanding pharmacy distribution & digital information tools
What? It will be explored whether public pharmacies should be allowed to dispense certain medicines that are currently available only through hospital pharmacies. Additionally, since the FAMHP has the key task of providing clear and accurate information on medicines, it will further develop the FarmaInfo platform launched in 2023. There will be an implementation of the electronic patient information leaflet. To proactively identify opportunities and challenges at the national level, the Minister plans to launch a pilot project.
Industry Impact? This could present new distribution opportunities for pharma companies while requiring adaptations to digital health communication strategies.
9. Addressing PFAS in the medic(in)al sector
What? The federal level is working with the regions to phase out PFAS. In the medical sector, it will be assessed where PFAS can be replaced. However, where no alternative exists, temporary exemptions might be needed for the production of medicines and medical devices to ensure their availability.
Industry Impact? Companies using PFAS in manufacturing should prepare for regulatory scrutiny and explore alternative materials where feasible.
10. Legal framework for medicine donations & reform of the medical devices Regulations
What? A legal framework will be created to donate medicines, vaccines and other medical material within the context of humanitarian crises or development cooperation. Additionally, Belgium will advocate for a swift review and adaptation of the Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVDR) Regulations to avoid the risk of critical medical devices disappearing from the market.
Industry Impact? Pharma companies engaging in humanitarian efforts might benefit from clearer donation guidelines. Meanwhile, potential reforms to the MD/IVDR regulations could impact market availability and regulatory compliance requirements.
Conclusion: impact on the innovative pharma industry in a nutshell
(i) Increased scrutiny of, and EU-level cooperation on, pricing, reimbursement, and market access.
(ii) Tighter compliance on medicine shortages and supply chain transparency.
(iii) Potentially greater competition in generics and biosimilars.
(iv) Regulatory shifts affecting IP protection, market exclusivity, and medical device availability.
(v) New opportunities in distribution, sustainability measures, and digital health communication.
