COVID-19: Healthcare products regulation - Belgian law recap

In recent weeks, the Belgian government has taken measures leading healthcare and life sciences businesses to adapt the way in which they produce or distribute healthcare products on the local market. This article provides an overview of measures taken until 15 April 2020 and their impact on the pharmaceutical and medical devices industries.

Pharma

Exceptional measures to combat medicine shortages resulting from the COVID-19 pandemic

Since 25 March 2020, the Federal Agency for Medicines and Health Products (FAMHP) has been granted powers, via royal decree, for a period of one year (until 31 March 2021 at the latest) to take the following special measures to address drug shortages:

• Restrict or prohibit export of medicinal products or raw materials;
• Temporarily restrict the supply of medicinal products (including magistral or officinal formulae) to a maximum quantity per patient;
• Temporarily limit the supply of medicinal products or raw materials to pharmacies to a fixed quantity per pharmacy;
• Temporarily limit the supply of medicinal products (including magistral or officinal formulae) to hospital pharmacies;
• Order the redistribution of stocks of medicinal products or raw materials, by requesting that they be returned to the wholesaler or redistributed among pharmacies; Notably, such requests can also come from the Federal Public Service (FPS) for Economy services, upon request of the FAMHP;
• Requisition stocks of medicinal products or raw materials to redistribute them;
• Authorise and regulate the supply of medicinal products by physicians or other healthcare professionals;
• Order that wholesalers’ stocks of medicinal products be exclusively sold or delivered in accordance with the instructions of the FAMHP.

The above measures can only be taken if it can be demonstrated that they are necessary, proportionate and adequate. They should always be limited in time and may be imposed for a one-month (renewable) period. The Belgian State must compensate the damage resulting from any measures taken, subject to conditions.

Further measures taken against drug shortages due to the COVID-19 crisis

The pandemic has resulted in a sudden increase in demand for certain medicines used to treat COVID-19 patients. Some medicinal products or raw materials intended for the preparation of magistral or officinal formulae are no longer available in pharmacies, hospitals or at certain wholesalers. Others may be at risk of no longer being available in the short term if urgent measures are not taken.

In this context, and following the measures described above, the FAMHP adopted a Decision on 1 April 2020 to prevent shortages and ensure that some medicinal products are subject to:

• the prohibition of export outside the European Economic Area (EEA);
• mandatory quotas for wholesalers;
• the identification of large stocks by hospitals and pharmacies for redistribution.

The medicinal products concerned are included in Annex I (medicinal products with a single active substance), Annex II (medicinal products with several active substances) and Annex III (raw materials) to the Decision.Exemptions to the Decision are listed in Annex IV.

Urgent measures have been taken for a (renewable) period of one month. They have been updated on 8 April 2020, in a consolidated version of the Decision which clarifies the following:

• As Belgium acts as a logistical platform for certain medicinal products, the export ban outside the EEA could result in other countries unnecessarily having no access to these products. The export ban has therefore been replaced by an obligation to notify exports to the FAMHP (coronashortages@fagg-afmps.be). For exports outside the EEA, the FAMHP can still oppose export within three working days of receipt of a notification if this is in the interest of Belgian patients.
• The list of medicines and raw materials that are considered essential and critical has also been revised, with new Annexes. As the situation is constantly evolving, the FAMHP expects to adapt the list accordingly.

Management of clinical trials during the COVID-19 pandemic

In collaboration with research industry associations, the FAMHP issued guidelines to assist clinical trial sponsors with ongoing clinical trials and clinical trials conducted for the prevention or treatment of COVID-19.

The Belgian guidance supplements the EU-wide guidelines on clinical trials published on 20 March 2020 by the European Medicines Agency (EMA)and is expected to be regularly updated.

The following points may be of interest for pharmaceutical companies conducting clinical trials in Belgium or with Belgian patients:

• Priority will be given to any (new) clinical trial application related to the treatment or prevention of COVID-19 infections. For multi-country COVID-19-related trials, the accelerated Voluntary Harmonisation Procedure (VHP) should be considered. For national COVID-19 trials, the FAMHP recommends sponsors to use the accelerated Clinical Trial Regulation (CTR) pilot procedure.

• As trial subjects may be quarantined or subject to similar restrictions during the pandemic, access to investigator sites may be forbidden or restricted. In this situation, home-based nursing and contacts via phone may be required to identify adverse events and ensure continuous medical care and oversight, which should take place in accordance with the European guidance.

• Although the direct shipment of investigational medicinal products (IMPs) from sponsors to patients is still not allowed in Belgium, the FAHMP clarifies that in exceptional circumstances such as the coronavirus pandemic, IMPs could be shipped directly from the trial site to the participant under the responsibility of the principal investigator. This is only possible provided that the product is suitable for “transport, storage at home and administration at home use”. Furthermore, special training must be provided to the participant, caregiver, nurse or physician on the home administration of the trial medication. The Belgian guidance further explains how direct shipment of IMPs may result in a substantial change to the clinical trial protocol, which should be submitted to the FAMHP and the ethics committee in accordance with European Good Clinical Practice principles.

‘Clock-stop’ for reimbursement procedures involving medicinal products

The coronavirus outbreak has made it impossible to guarantee the organisation of meetings and regular consultation among decision-making bodies and, ultimately, it has become increasingly difficult to respect the binding deadlines provided by reimbursement legislation.

In this context, to avoid jeopardising reimbursement dossiers which are being reviewed by the Commission for the Reimbursement of Medicines (CRM) of the National Institute for Health and Disability Insurance (NIHDI), Belgium introduced a ‘clock-stop’ suspending reimbursement procedures involving medicinal products.

The clock-stop started on 13 March 2020 and will end on a date yet to be determined by the Ministry of Health, depending on the evolution of the COVID-19 crisis.

In practice, this means that:

• The NIHDI’s CRM continues working on ongoing drug reimbursement dossiers, but each procedure is temporarily suspended during the clock-stop (ie timelines for each dossier are being postponed until further notice).
• During the clock-stop, all performable tasks will be performed by the NIHDI services (including eg sending reimbursement decisions or examining the admissibility of files submitted to the NIHDI).
• During this period, the NIHDI discourages that applicants send registered letters with acknowledgment of receipt. Although electronically submitted files will be processed by the NIHDI, the legally provided timeframes for each file are suspended from the moment the file is received (until further notice).

Medtech

Prohibition to make available, put into service and use quick antibody measurement or detection tests linked to the SARS-CoV-2 virus.

The ban applies to quick tests for measuring or detecting antibodies linked to SARS-CoV-2, which are defined as a “group of in vitro diagnostic medical devices allowing the rapid measurement or detection of antibodies linked to SARS-CoV-2, such as [Immunoglobulin G], [Immunoglobulin M] and [Immunoglobulin A]”.

The purpose of this prohibition, which applies from 18 March 2020 to 17 September 2020, is to avoid misinterpretations of results generated by certain self-tests.

According to the Belgian government, the tests covered by the ban may provide false negative results if they are used too soon after the patient has had a risky contact or right after the appearance of symptoms. Reassurance from a false negative result bears the risk that patients pass or continue passing the virus instead of being quarantined or hospitalised. Inexperienced users could also misinterpret the result of self-diagnosis tests due to a lack of scientific knowledge. In addition, some IgM detection tests may give false positive results that can lead healthy patients to take unnecessary measures.

Distribution channels restricted for certain medical devices

The need for a number of specific medical devices used to combat the spread of the coronavirus has drastically increased in the past weeks, while their availability is compromised. The following devices are concerned:

1. Surgical masks;
2. Screening material;
3. Disinfecting wipes for medical use;
4. Respiratory equipment and associated devices and accessories;
5. Single-use arterial blood pressure cuffs;
6. Self-adhesive ECG electrodes;
7. Devices used for bronchoalveolar lavage (BAL);
8. Single-use aerosol chambers and bronchoscopy masks.

To avoid shortages and level the playing field, the distribution of the above products is regulated as follows (as of 23 March 2020, for a duration of three months):

• distributors registered with the FAMHP should only sell to other distributors registered to sell the products concerned, registered pharmacies, hospitals and healthcare professionals;
• retail distribution is only permitted via registered pharmacies and provided that the device has been prescribed by a healthcare professional.

In terms of enforcement, the FPS for Economy is empowered to limit transactions, sales and sales volumes concerning these devices, upon request of the FAMHP, both at retail and wholesale levels. All such restrictions are published on the websites of the FPS for Economy and the FAMHP. If necessary, sales of products may be further restricted to hospitals and patients only. The FPS for Economy services may even requisition the medical devices referred to above, in which case compensation will be paid based on the products’ cost price.

Surgical face masks: Guidelines on compliance and suitability

Guidelines have been drafted to verify the conformity and suitability of surgical face masks in order to help manufacturers which do not follow European standards to meet the minimum requirements in the current context. Public authorities and healthcare institutions ordering these face masks can also use these guidelines.

The FAMHP Guidelines clarify the conditions for delivery of surgical face masks before release is allowed.

In light of the exceptional situation, the FAMHP allows for deviations from the rules on CE marking and conformity assessment, as described in the Recommendation 2020/403 of the European Commission of 13 March 2020 on conformity assessment and market surveillance procedures in the context of the COVID-19 threat.

According to the FAMHP, surgical face masks that do not bear the CE marking may be accepted exceptionally and temporarily, as long as the products are only made available during the current crisis and do not enter regular distribution channels.

Surgical face masks and filtering facepiece respirators: Guideline for the reprocessing during the COVID-19 pandemic

Given the challenges in maintaining the supplies of surgical face masks and FFP2/FFP3 face masks, the Belgian Task Force on shortages has prepared a national Guideline on the reprocessing of these single-use products.

Of note, while surgical or medical masks are medical devices controlled by the FAMHP, respiratory protection masks (such as FFP2 or FFP3 dust masks) qualify as personal protective equipment (PPE) and not as medical devices. The competent authority for PPEs is the FPS for Economy, which has also issued guidelines on their website (in Dutch and French).

Circular for healthcare institutions on the (outsourcing of the) manufacture and reprocessing of medical devices and their accessories

The COVID-19 pandemic poses many challenges to the usual production and distribution channels of medical devices. As a result, healthcare institutions have increased the “in-house” manufacture of medical devices and their accessories and the reprocessing of single-use medical devices.

As these activities are scarcely regulated by law, especially when institutions rely on third party service providers to carry out manufacturing or reprocessing activities, a new FAMHP Circular provides for an emergency framework offering healthcare institutions more certainty when working on alternative solutions to address device shortages with third party companies.

Notably, both ‘in-house’ manufacturing and reprocessing activities must be notified to the FAMHP (coronashortages@fagg-afmps.be) using a notification form.

The Circular is only valid during the COVID-19 crisis period and remains subject to rectifications if it is established that excesses are occurring in practice.

Clock-stop’ for reimbursement procedures involving implants and invasive medical devices

The explanations on the temporary clock-stop system provided above also apply to reimbursement dossiers concerning implantable and invasive medical devices.

Find out more about the European Commission's proposal to postpone the MDR.

See our coronavirus (COVID-19) feature for more information generally on the possible legal implications of COVID-19.