The Bill modifies several statutory provisions in areas within the purview of the Federal Agency for Medicines and Health Products (FAMHP). The principal features of the Bill are as follows:

Shortages

The Bill labels medicine shortages as “one of the most important public health challenges” (p.4) and confers significant new powers on the Minister of Social Affairs and Public Health (the Minister) both to address such shortages and to preclude them from happening. Accordingly, it will be possible for the Minister to

• limit or prohibit the export of medicines in a range of circumstances, including the case of healthcare risks that have not yet materialised (the Minister already had similar powers before, but these were limited to the narrow situation in which the commercialisation of a specific medicine had been stopped);
• re-allocate remaining stocks of a medicine, regardless of their location, in the hands of marketing authorisation holders, wholesalers, or pharmacists;
• prioritise specific hospitals, healthcare professionals, or patient categories; and
• authorise the limitation of supplies to wholesaler-distributors and pharmacists.

The fresh Ministerial powers only apply to medicines destined for the Belgian market or unregistered medicines used to cater for special needs; including compassionate use and medical need. Operators that are found in breach of their contractual obligations as a result of the Ministerial measures will be shielded from damage claims.

Therapeutic Magistral Form

The Therapeutic Magistral Form (TMF) is a reference book for magistral preparation which is currently managed by FAMHP and is composed of both a general part with norms and specifications of wide application and an applied part with specific formulas. FAMHP will transfer the responsibility and management of the second part to APB, the association of pharmacists, which, according to the explanation given in the Bill, is in keeping with practice in other Member States.

Blood and blood derivatives

The Bill replaces the requisite cardiovascular examination prior to the blood donation with a limited clinical check-up that will no longer involve verifying heart rhythm and blood pressure. These verifications are now considered redundant and often unreliable. As a result, specific temporary criteria for the exclusion of prospective donors will also be removed.

Additionally, the Bill will increase the collected volume of blood by excluding from the maximum volume of a given donation the blood dedicated for the sample pouch.

Human experiments

The Bill reduces the regulatory burden for non-interventional trials involving medicines which are governed by the Law of 7 May 2004 regarding experiments on the human person. It places players outside the pharmaceutical sector, including non-commercial sponsors, on the same footing and creates a level playing field for specific requirements regardless of the applicable regulatory framework (which differs depending on the nature of the study as an experiment, a clinical trial or a clinical investigation).

Clinical trials

The Bill modifies the Law of 7 May 2017 on clinical trials in several respects:

• The representative of the Minister is given the authority to manage the recognition of ethical committees.
• It will be possible to supply investigational and auxiliary medicinal products from a distance. The new provisions should make it easier to run decentralised clinical trials.
• There is a reform of the appeals procedure with the Minister against decisions taken by the Minister in relation to clinical trials.

Veterinary medicines  

Even though the Law of 5 May 2022 governing veterinary medicinal products has been in place for quite a while (and Regulation 2019/6 on veterinary medicinal products even longer), the Bill seeks to address lacunas in the statutory framework by regulating a quality system for inspections of good manufacturing practices of veterinary products, the trade in medicated premixes and medicated feedingstuffs, the supply of non-prescription veterinary medicines, sales at a distance, added elements of the veterinary prescription, and the penalties for the delivery of prescription medicines without a prescription.
The Bill also contains new rules that govern FAMHP, clinical laboratories, the professional rules governing pharmacists and the raw materials used by that group, and medical devices.

The Bill has already been reviewed a first time during the session of the Committee for Health and Equal Opportunities of the CR on 28 April 2026