Belgium – Covid-19 coronavirus: measures affecting the life sciences sector

Relaxation of Ministerial Decree restricting the sale of certain medical devices and personal protective equipment

On 23 March 2020, the Belgian government adopted a Ministerial Decree (Decree) regulating the sale of certain medical devices and personal protective equipment (PPE) that can be used in the fight against Covid-19 coronavirus (Dutch/French). The decree provides that only authorised pharmacies may sell certain medical devices (such as screening material, disinfection wipes for medical use, respirators and devices used for brocho alveolar lavage) and PPE (such as FFP2 and FFP3 masks, (im)permeable protective gowns, protective goggles and masks), however only if they have been prescribed by a healthcare professional. On 7 April 2020, the Decree was amended (Amendment) (Dutch/French), providing that hydro alcoholic gels and hand alcohol no longer require a prescription from a health care professional as there is no longer a risk of biocide shortages. In addition, manufacturers and wholesalers are now allowed to offer PPE to companies that, by virtue of legal or regulatory provisions, require such products in the exercise of their activities.

Guideline for the reuse of surgical masks and FFP2/FFP3 masks

On 7 April 2020, a guideline with regard to the reprocessing of surgical masks and FFP2/FFP3 masks has been published (Guideline) (English). The Guideline intends to manage the different initiatives on the reuse of surgical masks and personal facial protection. In order to increase the availability of surgical masks and filtering face piece respirators, the Guideline prescribes a reprocessing policy for as long as the shortages continue. In case of choice, new surgical masks, FFP2 or FFP3 are preferred. The Guideline stipulates inter alia that (i) the selected method(s) used for cleaning, disinfection and sterilisation must be justified; (ii) the performance of the surgical masks and respirators may not be reduced; and (iii) a clear statement specifying that the mask has been reprocessed, must be provided. With regard to the liability related to the reprocessed masks, the Guideline provides that the initial manufacturer is exempted from liability, whereas the reprocessing requester shall be legally responsible for the reprocessing requested.

FAHMP communication on how Covid-19 tests should be made available

On 30 April 2020, the FAMHP issued a communication on how Covid-19 tests should be made available in Belgium (Dutch/French). In case Belgian manufacturers (and Belgian authorised representatives of foreign manufacturers) of Covid-19 tests want to place their tests on the Belgian market, they should notify the FAMHP. Such notification is to be distinguished from an approval as tests for use by healthcare professionals are not subject to an approval from the FAMHP. Prior to this notification, such manufacturers and representatives should complete a self-certification process, confirming their compliance with European Directive 98/79/EC, and add CE marking to their product. Self-tests are still prohibited in Belgium.

A short version of this post was originally published by the same authors in Practical Law – Life Sciences, June 2020 Issue (Thomson Reuters).