03 August 2020 - Authored by:Tine Carmeliet
Recently, Royal Decree no 34 was published, containing measures to ensure the availability and proper management of medicinal products during the Covid-19 pandemic.
The royal decree enables the Minister of Health to authorise a product from Belgium’s strategic stockpile of medicinal products that is not licensed for the treatment of Covid-19 to be used for its treatment, provided that the authorised medicinal product indicated for the treatment of Covid-19 is unavailable. Only patients hospitalised or patients receiving ambulant care for the treatment of Covid-19 can receive such unlicensed medicinal product. In addition, the Minister can make such alternative product available in a public pharmacy upon specific request from a pharmacy to the Federal Agency for Medicines and Health Products (FAMHP).
The Minister will identify the therapeutic indications for such unlicensed product. Several obligations are included for both the healthcare professional and the public or hospital pharmacy to ensure proper use of the unlicensed product. For example, healthcare professionals and pharmacists are obliged to report any suspected serious or unexpected adverse reactions to the product to the FAMHP.
The measures listed in the royal decree will last until 31 March 2021.
This article was co-authored by Lore Van Espen.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, August 2020 Issue (Thomson Reuters).