The GOVERNANCE of the health system with regard to COVID-19 relates to pandemic response plans and the steering of the health system to ensure its continued functioning. It includes emergency response mechanisms, as well as how information is being communicated, and the regulation of health service provision to patients affected by the virus.
Before the COVID-19 crisis
Belgium has a monitoring and risk management system based on the National focal point for the International Health Regulations (WHO, 2005) (https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/protocole_daccord_entre_les_autorites_sanitaires_belges.pdf). The national focal point is composed of two pillars:
• A Risk Assessment Group (RAG) which analyses the risk for the population on the basis of epidemiological and scientific data. This group is composed of medical epidemiologists (Sciensano - formerly the Scientific Institute of Public Health), representatives of the health authorities of the federal state and the federated entities, and experts with specific knowledge of the health risk.
• A Risk Management Group (RMG) which relies on the advice of the former to decide what measures need to be taken to protect public health. The RMG is composed of representatives of the health authorities and is chaired by the Belgian National Focal Point. In the event of a serious crisis, the RMG meets regularly to manage all health-related aspects of the crisis. If this crisis requires coordination between different sectors and administrations, a crisis cell is set up at the crisis centre of the FPS Interior.
From January 2020
In January 2020, a Scientific Committee on COVID-19 was set up to provide a sharper scientific opinion on the evolution of the virus and to help optimise Belgium’s preparation for the arrival of this new respiratory virus.
At the start of the epidemic (in early March), various initiatives were taken at different levels without consultation or consistency (some regions closed nursing homes, while others did not; some mayors decided to ban people who had returned from the regions at risk from going to public places and schools, etc.) Consequently, the Prime Minister decided (on March 12th) to call a ‘federal phase’. The National Security Council (NSC), which consists of the Prime Minister and the Deputy Prime Ministers, was extended to include the Ministers-President of the Regions and Communities. From then on, this collegiate body took all policy decisions for managing the crisis. It is in this context that all mandatory measures of physical distancing have been taken. The various interministerial, interdepartmental and interregional crisis units supported these decisions, coordinated by the Federal Coordination Committee.
Three additional national bodies were launched at the level of the National Crisis Centre (NCCN): the "Evaluation Unit" (CELEVAL), the Federal Coordination Committee (COFECO), and the “INFOCEL”. The role of the RMG changed and became responsible for governing the crisis at the level of the health system and to translate and implement the decisions of COFECO at the level of the health system. The "Evaluation Unit" (CELEVAL) is composed of representatives of Sciensano, the Scientific Committee on COVID-19, the High Council for Health, the administrations in charge of health within the Regions and Communities as well as the FPS Interior and Mobility, and chaired by the FPS Public Health. The evaluation cell advises the authorities in taking decisions to combat the pandemic.
The COFECO is chaired by the NCCN and bring together the Chair of the RMG and representatives of the Prime Minister, the Federal Ministers for Home Affairs, Justice, Finance, Foreign Affairs, Public Health, Budget, Mobility, Defence, Employment and Labour, as well as the Ministers-President of the Regions and Communities. The following administrations are also represented: the FPSs Public Health, Mobility, Economy and Defence as well as the regional crisis centres and the federal police. The COFECO prepares and coordinates the implementation of the policy decisions of the NSC at the strategic level. Management of the medical aspects is specifically coordinated by the FPS Public Health (including hospital capacity, personal protective equipment, testing, etc.)
On March 27th, the federal government was given special powers to act without going through the usual legislative procedures to respond to the emergency related to the exceptional circumstances. The scope of these special powers is limited to urgent provisions relating to public health, public order, social provisions, and the safeguarding of the economy and citizens.
Regulation and licensing of drugs and medical devices
As the market for protective and other medical equipment is currently under global pressure, the federal government has decided to set up a temporary Task Force to implement economic, logistical and legal actions and propose solutions to support care providers. The working group is also working on outside-the-box solutions, as the normal procedures through public contracts were often taking too long. It has fostered collaboration within the whole Belgian biomedical ecosystem, between laboratories, universities and the pharmaceutical sector in order to improve testing capacity (see also section 1.5 and 2.1 on Testing).
Accelerated homologation procedures have been set up by the FAMHP (federal drug agency). One rapid antigen testing has already been approved but because of limited sensitivity, negative results must still be confirmed by a PCR (April 6th).
The normal procedure for assessment and approval of new clinical trials (of 28 days) has been reduced to 4 days for trials on COVID-19, and the fee has been waved.
Furthermore, some extra-ordinary legal measures have been taken to rapidly counter the shortages of protective equipment, medical supplies and diagnostic tests.
• Hydroalcoholic gels: by Royal decree of March 18th 2020, pharmacies (outpatient and hospital pharmacies) have been temporarily authorised by the FPS Public Health to prepare and market these products themselves. However, products prepared on the basis of this exception can only be sold to health professionals (home nurses, doctors, etc.)
• Surgical masks, screening equipment, disinfectant wipes for medical use, etc.: by ministerial decree of March 23rd 2020, the retail sale of various medical devices is only authorised in licensed pharmacies and if prescribed by a health care professional. The selling is restricted to other registered distributors, licensed pharmacies, hospitals, and recognised health care professionals (for more details, see section 2 on Ensuring sufficient physical infrastructure and workforce capacity/medical devices and products).
• Medicines and raw materials used by community pharmacists: by Royal decree of March 24th 2020, the Minister of Public Health may temporarily (up to 31st March 2021 as a maximum) take measures to restrict export, provision (according to a determined quantity per pharmacy), dispensing (definition of a maximum quantity per patient) of some medicines and raw materials, as well as to temporarily reserve their dispensing to hospital pharmacies, to order the redistribution of their stock, and to allow their dispensing by doctors or other health care professionals. The minister can also temporarily order that stocks held by wholesalers may only be sold or delivered in accordance with the instructions of the FAMHP.
Additional measures are described in section 2.1.
Crisis bodies outside the health field
Given the major impact of this pandemic on the entire socio-economic fabric, various crisis units have been put together to operationalise crisis management:
• The Operational Unit, coordinated by the National Crisis Centre (NCCN). Via the on-call service (24/7), this unit facilitates the flow of information between the authorities, ensures that the crisis infrastructure is fully operational, and guarantees that the crisis units will be alerted if necessary.
• The Socio-economic Unit is chaired by the FPS Economy and is made up of representatives of the Ministers for the Economy, Employment and Public Health and for Small and Medium-sized Enterprises, as well as from the FPS Economy, Employment, and Labour, Mobility, Social Security and from the Government Department (POD) Social Integration. It carries out analyses and provides advice on the socio-economic impact of the measures already taken or that will be taken.
• The Information Unit is jointly chaired by the FPS Public Health and the NCCN. It ensures the coordination of all local, regional, community and federal authorities so that the crisis communication strategies and actions are coherent. It provides strategic advice to the competent authorities by basing its actions on the identified information needs of the public.
• The Legal Units are responsible for drafting the legal texts and providing answers to various legal questions raised in the context of this complex crisis management.
• The International Unit facilitates the flow of information at European level between the equivalent crisis management authorities.
• The Task Force Integrated Police coordinates the actions of the police services. Other units have been activated to answer various frequently asked questions, and to verify the translations of the published texts.
• The Economic Risk Management Group (ERMG) was made operational (on March 19th) to manage the economic and macroeconomic risks associated with the spread of COVID-19 in Belgium.
• FPS Public Health (2020). Coronavirus Covid-19. Brussels: Federal Public Service Health, Food chain safety and Environment (www.info-coronavirus.be, Accessed April 2020);
• FAMHP (2020). Coronavirus (COVID-19) : Information from the FAMHP. Brussels: Federal Agency for Medicines and Health Products (https://www.famhp.be/en, Accessed April 2020);
• Personal communication with the FPS Public Health: De Raedt Lieven;
• Personal communication with the FPS Home Affairs: Stasse Marie.
On April 6th, a new expert group was established, the “Group of Experts in charge of the Exit Strategy” (GEES) to prepare for the gradual de-confinement. This group is composed of five scientists (virologists, epidemiologists, biostatistician), three economists (among which is the Governor of the National Bank of Belgium), one jurist, and the Secretary General of the Federation of Social Services.
On April 24th an inter-federal Testing & Contact Tracing Committee was launched. It consists of a group of experts and representatives of the concerned Ministers of Health (tracing being a competence of the federated entities). This Committee will be responsible for the staffing of the call centre and the training of the staff, in close contact with other experts and consultation groups, in particular the Interministerial Conference on Public Health.
The Group of Experts in charge of the Exit Strategy (GEES) advises the National Security Council in defining Belgium's exit strategy from the lockdown. For this, the GEES relies on indicators such as the decrease in the number of daily hospitalisations and the flattening of the curve for deaths linked to the virus. Nevertheless, the authorities insist that the virus is still present in Belgium and that the proposed measures could be reversed at any time. The transition phase began from May 4th (estimated dates are provided in section 1.2 on Transition measures: Physical distancing).
On May 11th, an advisory group for mental health was created to advise the GEES about the necessary measures to be taken with regard to the mental health of the population.
New restrictions: Governance
If outbreaks occur in Belgium, local authorities have received more power take direct action since the end of July. Local authorities can take actions directly. They cannot go against the legislation of Federal and Federated authorities, but they can decide for example to be more restrictive in the case of outbreaks in their municipality without having to wait for approval.