Belgium – Federal Governmental Agreement Defines Pharmaceutical Policies for Coming Years

04/02/2025
News

The incoming federal government which became operational on Monday 3 February 2025 will spend considerable resources, time, and effort on healthcare. This is apparent from the governmental agreement of 31 January 2025 (the GA – see attached Dutch and French versions) which the federal government is now committed to implementing. Remarkably, the GA features many policies that already formed part of the healthcare and pharmaceutical objectives of the previous government, but this is no coincidence: the outgoing Minister of Social Affairs and Healthcare (the Minister), Frank Vandenbroucke, has kept his position and continues to face the same budgetary constraints and a similar set of societal and technological challenges.

Here are the most striking aspects of the GA from the perspective of the pharmaceutical industry (page references are to the Dutch version):

Shortages – The GA identifies shortages as a priority concern in healthcare (p. 107). It envisages actions at both the European level (where Belgium has played a prominent role in helping to create the Critical Medicines Alliance and pushing for the soon to be adopted Critical Medicines Act) and the Belgian level (p. 117). The government will (i) pursue transparency; (ii) assess pricing mechanisms; (iii) give the public service obligations at various levels of the supply chain more teeth; and (iv) establish a list of critical medicines (p. 117).
Incentives for generic medicines and biosimilars – Even though the possibilities for market entry of generics and biosimilars have been greatly enhanced in recent years, the GA contemplates creating further incentives (p. 117).
Roadmap reimbursement medicines – While the Roadmap for the reform of medicine reimbursement procedures (here and here) dates back to March 2023, the government will continue its implementation. This dovetails with the GA’s often repeated objective to accelerate access to innovative medicines (pp. 117 - 119).
Cost reduction of medicines – Keeping the budget for medicines in check continues to be a challenge, especially given the need for patient access to innovative medicines and the requirement to maintain a pharmaceutical-friendly business environment. The GA again provides for cost-cutting measures by curbing excess medicine consumption (p. 124); and focusing on small or treatment-specific packages (p. 117).
Assessment of the Federal Agency of Medicines and Health Products (FAMHP) – During the past few years, there have been many calls in the federal Parliament for a thorough evaluation of the FAMHP, which the Minister has seemingly resisted. If the GA is observed (p. 117), this should change and may actually play in the hands of the agency’s new senior management.
Hospitalisation at home – The GA contemplates regulatory changes that will expand the possibility of hospitalised treatment at home (p. 117 and p. 118). One aspect is the greater involvement of municipal pharmacies, rather than hospital pharmacies, in securing the delivery of medicines to patients (p. 117).
Biopharma Research & Development Concertation – The GA envisages the creation of a “Biopharma R&D Concertation Platform” (p. 118), but also expressly supports, more broadly, a “structural dialogue” between the government and the pharmaceutical industry (p. 117).
Clinical trials – The GA renews earlier calls for regulatory changes in support of clinical trials (p. 118), including measures governing advanced therapy medicinal products, ethical committees, and a national Clinical Trial Network.
Intellectual property – The GA contains a welcome and explicit endorsement of a “very strong intellectual property policy that creates the requisite incentives for developers” (p. 118) and promises an industry-friendly position of Belgium in the pending negotiations regarding the new pharmaceutical regulatory framework.
Radiopharmaceuticals – The government will support research into radiopharmaceuticals and medical radioactive isotopes (p. 92).
Gender focus – The GA offers specific attention for differences in symptoms, prevention, and treatments between men and women and will also bring that sensitivity to bear in scientific research, clinical trials, and the commercialisation of medicines. The GA also promises for this year the implementation of the action plan to tackle endometriosis, which has been long in the making.
Prevention – The GA focuses on prevention while it is mindful of the need to cooperate with the regional governments which bear the primary responsibility (see, for example, pp. 120-121).

Data sharing – While this is an area which is in full development at EU level (as is evidenced by the recently enacted European Health Data Space Regulation), the GA focuses on its implementation in Belgium where the data universe is still highly fragmented and multi-sourced (pp. 121-122).