Belgium - Publication and Presentation of Policy Note Public Health - Impact on Pharmaceutical and Medical Devices Sectors

• 12/11/2021
• Articles

The Minister of Social Affairs and Public Health (the Minister) just published his policy note (beleidsnota/note de politique générale) which he is scheduled to present to the Committee for Health and Equal Opportunities of the federal Chamber of Representatives on 16 November 2021 (the Policy Note – see, attachment). The Policy Note goes in tandem with the healthcare budget (estimated to reach EUR 31,755,422,000,000 in 2022).
 
The Policy Note discusses the full range of public health policy aspects, including financing, managing health crises, reorganising public healthcare, access, quality control, care efficacy, evidence-based care, healthcare professions, preventive measures, addictions, digitisation of care, related policies, international relations and financial control of payers (sick funds) and healthcare practitioners.
 
Unsurprisingly, the Policy Note deals extensively with pharmaceuticals and medical devices as well. The following points stand out: 

• Industry cooperation - As was the case for his predecessor, the Minister will again conclude agreements with the pharmaceutical and medical devices sectors to “define the priorities of each stakeholder in the interest of public health and specifically the patient” (p. 54).
• Shortages - The Minister will complete the regulatory framework governing medicine shortages (p. 54) and promises to publish “very soon” a first implementing decree in relation to the transparency of wholesaler-distributors. Other implementing decrees will follow and Belgium will also advocate for the expansion of the existing joint procurement and emergency stock measures at EU level (p. 55 and p. 77).
• Regulatory reorganisation and efficacy-enhancing measures for in vitro diagnostics and personalised medicine – The Minister will streamline and accelerate procedures by reorganising the various authorities involved in authorising and reimbursing care. An example is that of the joint contributions towards one specific form of treatment by clinical biology, companion diagnostics and medicines (p. 55 and p. 56).
• Unmet medical need – The Minister announces a range of initiatives with regard to clinical trials, access and financing of innovative therapies, and medicine repurposing (p. 40, p. 41, p. 58, and p. 59).
• Reimbursement of medicines – The Policy Note repeats an earlier promise that the procedure governing the reimbursement of medicines, including Managed Entry Agreements, will be assessed and revised (p. 57). 

Contrary to earlier indications, the Policy Note does not tackle the role of the pharmaceutical sector in financing hospitals, even though hospital financing is addressed extensively (p. 5, p. 22, p. 23, p. 24, p. 25, p. 31, and p. 32).