Policy responses for Belgium - HSRM

Belgium


Policy responses for Belgium

2. Ensuring sufficient physical infrastructure and workforce capacity

ENSURING SUFFICIENT PHYSICAL INFRASTRUCTURE AND WORKFORCE CAPACITY is crucial for dealing with the COVID-19 outbreak, as there may be both a surge in demand and a decreased availability of health workers. The section considers the physical infrastructure available in a country and where there are shortages, it describes any measures being implemented or planned to address them. It also considers the health workforce, including what countries are doing to maintain or enhance capacity, the responsibilities and skill-mix of the workforce, and any initiatives to train or otherwise support health workers.

2.1 Physical infrastructure

Belgium faces a shortage of protective equipment and medical supplies, including masks, personal protective equipment (PPE) (gowns and glasses), diagnostic tests, and alcohol-based hand gels for health care providers.

Personal protective equipment and masks

In response to these low stocks, the government launched a series of public procurements of PPE, including participation in EU Joint Procurements. The Risk Assessment and the Risk Management Group defined a list of priority beneficiaries for the distribution of protective equipment and recommendations for the rational use of PPE (1, 2).

Furthermore, a working group (3) has been set up to rapidly identify solutions to the shortage of protective equipment and medical supplies. Various avenues have been explored, especially for masks, such as the immediate and massive purchase and confiscation of existing stocks of masks (medical and industrial) in wholesale and retail points of sale, the prohibition of the sale of masks without a medical prescription, the exploration of the purchase of masks abroad (e.g. in China), the manufacturing of masks locally or a call to the European Union to lift export restrictions on the concerned manufacturers (e.g. 3M for mask) in other Member States. An inventory of the medical equipment needs of health care facilities has also been set up, via a specific application that allows requests to be centralised and standardised. Additionally, a generic e-mail address was created where suppliers of medical equipment can send their offers ([email protected]). Guidelines on the re-use of masks were also defined (4).

Out-of-the-box ideas are also being developed, such as the manufacture of masks in textiles by volunteers or the diverted use of diving masks.

Due to the urgency of the situation and the worldwide shortage, it should also be noted that Belgium has to deal with a series of fraud (counterfeit products or changes in the sales conditions) by companies trying to take advantage of the situation, particularly for masks.

Moreover, because the surgical masks obtained did not always met the European or international standards, an Alternative Test Protocol (ATP) was developed on April 23rd to ensure they can still be permitted for use, either as a surgical mask or comfort mask. This ATP can only be applied during the current COVID-19 crisis and only examines the bacterial filtration efficiency and the results of differential pressure tests to determine whether the non-compliant masks are of sufficient quality to be used as surgical masks during the crisis (5). This ATP protocol was refined (concerning the differential pressure parameter) from June 4th (https://www.afmps.be/fr/news/coronavirus_troisieme_version_du_protocole_dessai_alternatif_atp_pour_les_masques_chirurgicaux).

In order to be ready for the exit from the lockdown phase, measures are also taken to increase the number of fabric masks (surgical masks and FFP2-FFP3 masks being restricted for health care professionals) via national and international manufacturers but also voluntary initiatives. The procurement and distribution of these masks to the population is managed by the municipalities.

Additionally, at the interministerial conference of 29 April, Federal authorities and Federated entities agreed on a more intensive coordination between authorities concerning the overall distribution of personal protective equipment to the care sector, for example, by sharing information on reliable suppliers, stock levels, orders, deliveries, etc. They also decided to create a solidarity stock, to which all Federated entities can call on to meet urgent and acute needs in their regions.

Pharmaceuticals and other health products

Legal measures to tackle the shortage of medicines and health products have been enacted through Royal and Ministerial decrees as follows: on March 18th pharmacies have been temporarily authorised to prepare and market hydroalcoholic gels, but can only sell them to health professionals; on March 23rd  restricting the retail sale of several medical devices to be authorised only in licensed pharmacies and if prescribed by a health care professional; and on March 24th temporary measures (up to 31st March 2021 as a maximum) such that the Minister of Public Health can take measures to secure the necessary medicines and raw materials used by community pharmacists (6).

From April 1st 2020, export outside the European Economic Area (EEA) of a list of medicines and raw materials defined by the FAMHP is prohibited. Exports within the EEA are permitted but must be notified in advance to the FAMHP via e-mail ([email protected]) and these medicines and raw materials must be intended to be placed on the market in the EEA. Compulsory quotas for wholesalers are also defined for these products (maximum 50% increase compared to last year's sales volume) and hospitals and pharmacies (hospital and community pharmacies) must report their large stock volumes (> +50% of their usual volume) for possible redistribution. Strategic stocks are also being distributed to hospitals for certain products used to treat patients with COVID-19 or used in intensive care, e.g. to put a patient on a ventilator (such as hydroxychloroquine, Kaletra, Rocuronium (curare), Sufentanyl, etc.).

Other measures to tackle the shortage of these pharmaceuticals concern extending an invitation to Belgian manufacturers to increase their production and speed up delivery, the finding of additional manufacturers, the supply of raw materials in order to start up local production, the purchase of stocks aboard, or the use of pharmaceutical products for veterinary use that have been made available for human use after having checked their full compatibility and safety. An identification system has also been set up for all Belgian stocks of pharmaceutical products used to treat COVID-19 patients (5).

On April 8st 2020, nevertheless, because the ban on exports outside the EEA (European Economic Area) could result in other countries not having access to medicines, the export ban has been replaced by an obligation to notify the export to the FAMHP. The FAMHP can nevertheless always prohibit these exports in the interest of Belgian patients (5). This notification requirement has been removed since May 29th.

Measures are also taken to guarantee the oxygen supply (see https://www.famhp.be/en/news/coronavirus_measures_taken_by_the_famhp_and_relevant_partners_to_continue_to_guarantee_oxygen). The FAMPH has also published guidelines on changing consumables (filters, etc.) used for ventilation of COVID-19 patients and on 3D printing of respirator accessories.

Testing capacity

The PCR-testing capacity for COVID-19 was originally limited to one national reference lab (UZ Leuven). Rapidly, other clinical laboratories developed the technique on their own initiative, which led to a national network of clinical labs (mostly hospital labs, and some private labs). The list of participating labs is updated daily (https://epidemio.wiv-isp.be/ID/Documents/Covid19/COVID-19_Diagnostic_Labs_FR.pdf). University research units also joined the effort by using an ‘old’ technique requiring less reagents but more workforce. These laboratories essentially carry out tests for their usual local hospitals and clients, as well as for some humanitarian initiatives for homeless people, migrants, etc. These tests are paid for by the NIHDI (and some local funding for the humanitarian tests).

A governmental working group (task force) was created to increase the testing capacity. This working group set up a parallel platform gathering some biotech/pharma industries and two universities (KU Leuven and ULiège). By the end of April, this platform was essentially devoted to a large campaign of testing in homes for older people and nursing homes, launched by the federal and federated entities (7).

The following tests are considered (8-9):

1. The reference test remains the PCR test performed on nasopharyngeal swabs or other biological material (this test shows the presence of the virus itself). The PCR test is the most sensitive and can test patients very accurately but the current Belgian capacity is limited. In order to increase the number of PCR tests, universities have been called upon to develop new testing methods requiring fewer reagents. A new method has rapidly been deployed in the university laboratories. Biotechnology companies have worked on the automation of processes. Pharmaceutical companies and suppliers have made laboratory space, people, reagents and machines available. Various machines from different companies were brought together in order to increase the number of tests as much as possible. This is a unique collaboration involving the entire health and biotechnology ecosystem. On April 6th, university research labs joined the effort and also made themselves available for testing.

2. A rapid antigen test (COVID-19 Ag Respi-Strip of the Belgian company Coris Bioconcepts) received approval for distribution from the Federal Agency for Medicines and Health Products (FAMHP). This test shows the presence of viral molecules (antigens) in the nasal swab. Given its high cost price and limited sensitivity, its indications are limited, and all negative results have to be confirmed by PCR. It is only distributed to hospitals and laboratories.

3. In preparation for the exit from the lockdown phase, antibody tests (serological tests showing the presence of antibodies in the blood, indicating that the person is (getting) immunised) are also being considered for continuous and larger scale testing. Antibody tests are being purchased as well as developed, including multiplex tests for research. Antibody tests will be useful in determining if COVID-19 was passed or not (determination of individual and group immunity). No test is currently approved in Belgium but studies are in progress: collection of samples in blood donors (cross sectional studies) and health care workers (longitudinal studies) have started. Alternatives solutions are also been sought.

As the reliability of these tests is not always clearly proven and documented, especially for antigen and antibody tests, the FAMHP and Sciensano have decided to draw up a list of tests that meet minimum criteria and have defined the procedure to be followed by the manufacturers of these tests to be included on this list as well as their qualification criteria (5).

On 23 September 2020, the following decisions were announced to increase the testing capacity and to relieve the current burden on general practitioners:

• Increasing the testing capacity of existing triage centres and setting up of new testing points and triage centres;
• The creation of a call-centre which to concentrate all requests towards a single information point;
• Setting up an appointment platform to dispatch requests to the available centres.
• The creation of a "Corona prescription" for specific asymptomatic cases (close contacts,  people returning from red zones), to be prescribed by people other than physicians
• Encouraging patients to use the available online portals to directly obtain their test results.

Hospitals

Before the COVID-19 crisis, Belgium had an average of about 16.5 operational beds in intensive care units (ICUs) per 100,000 population (about 1,900 operational beds for about 11,500,000 people). Precise data on the number of ICU beds and their occupancy rates during the crisis are not available but on March 22nd 2020, the Federal Minister of Social Affairs and Public Health announced that an extra 759 intensive care beds have been created since the start of the COVID-19 crisis. Hospitals are working to increase this number even further. At the beginning of April, the total number of ICU beds was estimated at around 24 per 100,000 population and hospitals were not yet considered as overcrowded (10-11). The maximum number of patients with COVID-19 in intensive care unit was reached on April 9th, with a total of 1,285 patients (12).

The rapid increase of hospital capacity was due to the fact that each hospital already has in place a predefined emergency plan for such situation, which received considerable attention in 2016 during joint work between federal and federated entities towards optimising hospital emergency planning (10-11).

Sources:
(1) Sciensano (2020). COVID-19 : Communication au sujet de l’avis 9577 datant du 16 mars 2020 du Conseil supérieur de la Santé et des consignes du Risk Assessment Group sur l’utilisation des masques. Brussels : Sciensano (https://epidemio.wiv-isp.be/ID/Documents/Covid19/COVID-19_RMG_Brief_MondMaskers_FR.pdf, Accessed April 2020);
(2) Personal communication with the FPS Public Health: De Raedt Lieven;
(3) FAMHP (2020). A working group (Task Force) should come up with immediate solutions to remedy the shortage of protective equipment and medical equipment on the Belgian market. Brussels: Federal Agency for Medicines and Health Products (https://www.famhp.be/en/news/a_working_group_task_force_should_come_up_with_immediate_solutions_to_remedy_the_shortage_of, Accessed March 2020);
(4) FAMHP (2020). Coronavirus : directive belge pour la réutilisation de masques chirurgicaux et FFP2/FFP3 dans le cadre de l’épidémie de COVID-19. Brussels: Federal Agency for Medicines and Health Products (https://www.afmps.be/fr/news/coronavirus_directive_belge_pour_la_reutilisation_de_masques_chirurgicaux_et_ffp2ffp3_dans_le, Accessed March 2020);
(5) 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);
(6) Droit Belge (2020). Crise du coronavirus: inventaire des mesures normatives (mis à jour). Brussels : Droit Belge (http://www.droitbelge.be/news_detail.asp?id=1013, Accessed March 2020) ;
(7) Personal communication with the “Cliniques Universitaires de Bruxelles”: Pr Frédéric Cotton ;
(8) Personal communication with Sciensano and KCE: Goossens Maria and Hulstaert Frank;
(9) RTBF (2020). Bientôt 10.000 tests de dépistage du coronavirus par jour en Belgique. Brussels : RTBF (https://www.rtbf.be/info/dossier/epidemie-de-coronavirus/detail_bientot-10-000-tests-de-depistage-du-coronavirus-par-jour-en-belgique?id=10467440, Accessed April 2020);
(10) Personal communication with the FPS Public Health: Tom Van Renterghem;
(11) VRT (2020). Health Minister says that an additional 759 intensive care beds have been created in Belgian hospitals. Brussels: VRT ( https://www.vrt.be/vrtnws/en/2020/03/22/health-minister-says-that-an-additional-759-intensive-care-beds/, Accessed April 2020).
(12) FPS Public Health (2020). Coronavirus Covid-19. Brussels: Federal Public Service Health, Food chain safety and Environment (www.info-coronavirus.be, Accessed April 2020).