Belgium – Parliament Reviews Health Crisis Bill

• 28/04/2021
• Articles

The federal government submitted last week to the federal Chamber of Representatives (the Chamber) a bill “providing for measures to contain the Covid-19 pandemic and other urgent measures in the realm of healthcare” (55K1929) (the Bill – see, attachment). When adopted, the Bill will introduce a series of rules governing the supply of medicines, medical devices and other health products. Some of these measures are specific to Covid-19, but others have a general scope of application. A Royal Decree may declare several rules that target the Covid-19 pandemic applicable to future pandemics as well. The federal government will have that power until 31 December 2025 (Bill, Article 66).
 
Additionally, the Bill will tackle further health-related subjects as diverse as the financing of hospitals; testing strategies, pricing and funding; information technology and technological instruments for healthcare; and the reimbursement of combined medication which consists of several active substances.
 
As regards the supply of medicines, medical devices and other health products, the Bill establishes a statutory basis for the following measures:
 

• Creating a government-run strategic stock of medicines, raw ingredients, medical devices, blood, human tissue and cells, and personal protective equipment. The strategic stock will not only be designed to deal with the Covid-19 pandemic but is supposed to ensure the continuity of care generally (Bill, Articles 4 and following).
• Making a range of members of the supply chain subject to a reporting obligation for designated products in order to help the government manage its strategic stock (Bill, Article 7).
• Making it possible to have the government import, distribute and supply unauthorised medicines to tackle the Covid-19 pandemic during a limited period of time (Bill, Article 8).
• Creating the possibility, subject to strict conditions, to make an unauthorised alternative for an authorised medicine available, regardless of the medical condition at issue (Bill, Articles 10 and following).
• Allowing hospitals to subcontract work involving home made (“in house”) medical devices (Bill, Articles 20 and following).
• Allowing non-compliant medical devices on the market (Bill, Article 25).
• Creating an export control system that applies to both essential and critical, Covid-19 related, medicines and raw materials (Bill, Article 26). The Bill lists several requirements to make the new regime unassailable under the EU free movement of goods rules.
• Making it possible for the Minister responsible for public health or his representative to interfere with the supply chain in various ways by (i) limiting patient supplies; (ii) reducing pharmacy supplies; (iii) favouring supplies to hospital pharmacies; (iv) redistributing existing stocks; (v) allowing hospital pharmacies to redistribute stocks; (vi) regulating the distribution of Covid-19 vaccines; and (vii) directing the sale of wholesaler stocks (Bill, Article 27).      

At the request of the federal government, the Chamber will review the Bill on an expedited basis. As a result, the Chamber’s Committee for Health and Equal Opportunities has already begun discussing the Bill on Tuesday 27 April 2021 in hopes of having a vote still this week.