Covid-19 coronavirus: Measures affecting the Belgium life sciences sector
16 May 2020
In the fight against Covid-19 coronavirus, the Belgian government has taken several exceptional measures, including:
- Banning the use of rapid Covid-19 diagnostic tests for six months.
- Regulating the supply and distribution of essential medicines.
- Issuing guidelines for checking the compliance and suitability of surgical face masks.
First, in order to avoid a misinterpretation of results, the FAMHP has imposed a ban on the use of rapid Covid-19 diagnostic tests from the Belgian market for six months starting from 18 March 2020. Such tests are defined as a group of medical devices for in vitro diagnostics allowing rapid measurement or detection of antibodies linked to SARS-CoV-2, such as IgG, IgM and IgA.
Second, a shortage of medicines essential for treating Covid-19 coronavirus patients poses a significant risk to public health. In the absence of medicine that can adequately treat Covid-19, any drug potentially effective against the SARS-CoV-2 virus is considered a therapeutically essential drug. In order to safeguard the regular availability and optimal distribution of these medicines, the Belgian government has taken measures to address the supply and distribution of these medicines, including, inter alia: (i) limiting or prohibiting the export of medicine or raw material; (ii) temporarily limiting the delivery of medicine to a maximum amount per patient; and (iii) temporarily restricting the supply of certain medicine or raw material to pharmacies to a fixed quantity per pharmacy. Furthermore, rules on the delivery of medicines (for example, to hospitals, care institutions and doctors) and on the redistribution of stocked medicines from wholesalers have been introduced. The FAMHP has also issued concrete guidelines that contain an annex that lists the specific medicines currently limited for supply and distribution. Some of these medicines are also essential for patients with chronic diseases (for example, lupus, rheumatoid arthritis, HIV and so on) and the FAMHP has taken certain measures to guarantee the continuity of treatment for those patients.
Last, the FAMHP has issued Guidelines to verify the conformity and suitability of surgical masks. The guidelines are mainly intended for companies that do not produce masks according to EU standards to ensure quality, safety and effectiveness. Given the exceptional circumstances, masks for which a level of safety and performance that is equivalent to EU standards can be demonstrated can now be marketed in Belgium.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, May 2020 Issue (Thomson Reuters).