In our Belgian Pharma Law Summer Blog Series, we examine recent developments in Belgian pharmaceutical law. Whether you are looking for an informative summer read or a concise overview of the latest legal developments to catch up on after the holidays, our series has you covered. Our third and final part examines the ‘Bill containing various provisions on health' (the “Bill”), adopted without amendments by the federal Chamber of Representatives on 16 July 2026. Of particular relevance is Chapter 2 of the Bill, which introduces a broad set of measures affecting, among other things, the reimbursement framework for medicinal products and certain financial contributions owed by the pharmaceutical industry.

Simplified track for low(er)-impact reimbursements

Currently, every amendment to the list of reimbursable pharmaceutical specialities (the “List”) requires a full procedure, regardless of budgetary significance. The Bill introduces a simplified track delegating reimbursement decisions to the Medical Care Service of the National Institute for Health and Disability Insurance (NIHDI) for:

• applications concerning generics, biosimilars, hybrids, or cases of well-established use, where there is already a speciality with identical reimbursement modalities; or
• applications where the annual gross expenditure for the relevant speciality (or specialities, in the case of a combination treatment) does not exceed 7 million EUR and the annual gross cost per beneficiary does not exceed 100.000 EUR.

This delegation – subject to review after two years – is intended to free up capacity for files with a significant budgetary impact. The Minister of Health (“MoH”) estimates that the 7 million EUR threshold will allow approximately one third of applications to be processed via this simplified procedure.

Set-up for combination therapy reimbursement rules

Combination therapies – where two or more specialities from different companies are used together as a single treatment – expose a gap in the current reimbursement framework: each speciality is assessed independently, creating a risk of deadlock where one component is reimbursed before another, or where de-reimbursement of one component renders the combination clinically non-viable but the other remains on the List.

In response, the Bill envisages the adoption of a Royal Decree to set procedural rules for combination treatments, e.g. parallel, mirrored procedures for the various specialities; automatic reimbursement of the other specialities as soon as one speciality in the combination is reimbursed; and automatic de-reimbursement when the combination is no longer reimbursable. This ensures that decisions regarding the components of the same treatment remain consistent, thus improving transparency.

Delegation of continuity-of-care confirmations

Under the (bio-)reference reimbursement system, a brand speciality manufacturer facing generic/biosimilar market entry following loss of exclusivity must either accept a significant price reduction or opt for de-reimbursement. Where de-reimbursement is chosen, it may be delayed by up to three months, provided the company demonstrates – and the Administrator-General of the Federal Agency for Medicines and Health Products (FAMHP) confirms – that immediate de-reimbursement would endanger the continuity of care for patients. The Bill extends this confirmation power to the Administrator-General’s delegate, enabling more timely confirmations in time-sensitive situations – such as where no readily available alternative exists.

Expanding the use of English in reimbursement files

The Bill permits applicants to also submit reimbursement files and supporting documents in English for the new Early and Equitable Fast Access (EEFA) procedure and for “small” reimbursement commissions (e.g. radiopharmaceuticals), in line with the ordinary reimbursement procedure. The MoH notes that this reflects the reality of clinical studies mostly being published in English and growing European cooperation on health technology assessments. Formal reports will, however, continue to be issued in one of the national languages.

Unavailabilities and definitive market withdrawal

For specialities reimbursable exclusively in a hospital setting, the possibility of deferring automatic de-reimbursement until after five years – instead of three – following an unavailability is reintroduced. In a hospital setting, tenders have a duration of five years. If a speciality is not on the List, it is not eligible for a tender. In the event of de-reimbursement after three years of unavailability, companies would, where applicable, need to submit a new reimbursement application to participate in the tender, which is considered undesirable.

The Bill furthermore aims to centralise notifications of definitive market withdrawal by pharmaceutical companies on the FAMHP’s online PharmaStatus platform.

Faster reimbursement of imported alternatives in case of unavailabilities

The Bill equally aims to simplify the procedure for reimbursing an imported alternative to an unavailable pharmaceutical speciality. Currently, the procedure requiring an opinion from the Commission for the Reimbursement of Medicines (CRM) must be followed for each alternative. The MoH argues that this takes too long for unavailabilities lasting only a few weeks. Going forward, the Medical Care Service will maintain a list on the NIHDI website, which will be updated automatically. For the alternative, the reimbursement modalities and reimbursement basis of the unavailable speciality are carried over, so that nothing changes for the patient. A future Royal Decree may exempt certain types of unavailabilities, such as temporarily reimbursed specialities, or unavailabilities attributable to extraordinary circumstances or force majeure.

For an automatic reimbursement or modification of the reimbursement modalities, the unavailability must concern a reimbursable speciality that qualifies as an ‘essential medicinal product’ whose alternative(s) are not reimbursable. What is to be considered an essential medicinal product in this context will be determined by Royal Decree.

The new system is set to enter into force on 1 January 2029, though the Royal Decree may provide for an earlier date to align entry into force with implementation. 

Clawforward-replacing industry retribution

From 2026 onwards, companies that realise a turnover on the Belgian market with specialities included on the List shall be liable to pay a total retribution of 80.363.000 EUR. The individual retribution is determined in proportion to a company’s turnover relative to the total turnover figures realised in the preceding year. Specialities reimbursed under category A or B that have either been included in the (bio-)reference reimbursement system for more than ten years or for which the active substances generate a turnover of less than 3 million EUR, are excluded from that calculation. Conversely, turnover figures of specialities reimbursed under a managed entry agreement (MEA) are halved.

During the parliamentary debate, the MoH explained that the 80 million EUR figure represents the conversion of the 2025 clawforward into a structural measure. The industry had been asked to put forward proposals to replace the clawforward, with the understanding that, should those proposals prove unsatisfactory, an equivalent price decrease would be imposed in 2026. The sector did submit proposals; however, the MoH found these were either of insufficient quality or sought to shift the financial burden onto other actors. A retribution was therefore ultimately agreed upon to avert a forced price decrease.

Unavailability contribution for 2026

The Bill also introduces, for 2026, an unavailability contribution, following the annulment by the Constitutional Court of a previous scheme (see our blogpost here). When an essential medicinal product is unavailable, the patient must switch to an alternative, often an imported and more expensive product. Today, the sickness insurance covers that additional cost, so that the patient does not bear it. A solidarity contribution is therefore sought from pharmaceutical companies through an unavailability fund. The provision that was annulled regulated the distribution of the burden according to the number of marketing authorisations held. The unavailability contribution for 2026 is now based on a turnover percentage.

It transpired from the parliamentary debate that, during the preparation of the Bill, some stakeholders pressed for greater individual responsibility. The industry associations have therefore committed to developing an alternative proposal for 2027. In the absence thereof, the government will put forward its own permanent scheme.

Certain reimbursement reforms pushed to 2028

In 2024, certain reforms of the reimbursement procedure were adopted, but a postponement of their entry into force is now provided for in the Bill. This concerns, in particular, the procedure in front of the CRM, based on a new classification of procedures depending on whether or not an applicant invokes an added value, and the introduction of a post-MEA indicative price. The MoH explained that the implementation of these elements requires the adoption of Royal Decrees, the drafting of which, given their complexity, takes considerable time, which is why the entry in force of the aforementioned reforms is postponed until 1 January 2028 at the latest.

Conclusion

It is clear that the Bill introduces a wide-ranging set of measures. While certain provisions may appear relatively modest – such as the delegation of continuity-of-care confirmations or the expanded use of English in reimbursement files – others carry considerable operational or financial implications for the pharmaceutical industry, such as the replacement of the clawforward mechanism by an annual retribution of over 80 million EUR. Yet other measures, such as the framework for combination therapy reimbursement, establish a general architecture that is to be fleshed out through subsequent Royal Decrees. While the Bill was recently adopted it has not yet been published in the Official Gazette at the time of writing. Nevertheless, companies are advised to start assessing how these various changes might impact their business in Belgium.

For those who missed them, read Part 1 and Part 2 of our Belgian Pharma Law Summer Blog Series.

ALTIUS’s Life Sciences team closely monitors regulatory developments in the pharma sector. For more information on this topic, please contact Christophe Ronse ([email protected]), Kirian Claeyé ([email protected]) and Bart Junior Bollen ([email protected]).