Belgium – Cannabis for Medical Use – Update

• 19/09/2019
• News

As a follow-up to the Van Bael & Bellis Life Sciences Newsflash of 12 March 2019, please find below the latest on medical cannabis in Belgium. 

 

• Following the publication on 20 May 2019 of the Law of 7 April 2019 “amending the provisions on the provision of scientific and technical advice by the Federal Agency for Medicines and Health Products and on the financing of the Federal Agency for Medicines and Health Products as well as the establishment of a cannabis office’’, which provides the statutory basis for a Cannabis Office and the controlled cultivation and commercialization of cannabis in Belgium, we are still waiting for the publication of detailed implementing rules in the form of (a) Royal Decree(s). This may still take some time as there is yet a coalition to be formed for a new federal government following the national elections of 26 May 2019. The current caretaker government does not have the powers to adopt the requisite Royal Decree(s).
   
• Once operational, the Cannabis Office will oversee and control cannabis activities in Belgium. The Cannabis Office will issue a call for tenders for the cultivation of a certain limited amount of cannabis. Licences will be granted to the successful applicants to cultivate cannabis in specified locations. The Cannabis Office will purchase the harvest and export and/or distribute it.
   
• Since 2015, Belgian pharmacists were allowed to dispense “prepackaged” cannabis-based authorised medicines (e.g., Sativex®) and magisterial preparations on the basis of cannabidiol (“CBD”) powder. However, the pharmacists were prohibited from dispensing magisterial or officinal preparations for human or veterinary use which contain one or more tetrahydrocannabinols (“THC”) (Royal Decree of 11 June 2015). THC is the main psychoactive compound of cannabis. In practice, this meant that no magisterial preparations were dispensed as all CBD can contain trace amounts of THC. Patients therefore travelled abroad to obtain such preparations. However, on 16 July 2019, the Federal Agency for Medicines and Health Products (the “FAMHP”) issued a circular No. 648 (See, attached Dutch and French versions) in which it “interprets” the Royal Decree of 11 June 2015. The FAMHP states that the Royal Decree of 11 June 2015 was not intended to prohibit pharmacists from using CBD powder with trace amounts of THC and lays down criteria to determine whether a pharmacist is allowed to use a raw material contaminated with THC in a magisterial preparation. More particularly, raw material with trace amounts of THC can be used for magisterial preparations if the patient is exposed to maximum 1 microgram Δ9-THC per kilogram of body weight per day. The highest daily dose being 1,500 mg for a person weighing 75 kg, it cannot contain more than 75 micrograms Δ9-THC. This corresponds with a contamination of 0.0005%.
   
• Based on the publicly available information, we understand that, following the adoption of circular No. 648, the FAMHP has already authorised one company (Fagron) to supply CBD powder to pharmacists for use in magisterial preparations.
   
• On 11 September 2019, members of the Christian Democratic party CD&V submitted to the Chamber of Representatives a draft resolution “in favour of the therapeutic use, under strict conditions, of cannabinoids in order to soothe pain in case of specific spasmodic symptoms”. While it is uncertain whether the draft resolution will eventually manage to secure a parliamentary majority, it calls on the federal government to:

o   invest in further clinical research on the efficacy of cannabinoids to control pain and spasmodic symptoms;

o   extend, based on the aforementioned research, the indications for which the therapeutic use of cannabinoids is authorised for patients on whom other medicinal products have no or little effect, and for whom medical cannabis has clinically proven benefits in view of combating pain and spasmodic symptoms;

o   invest in research on the safe and controlled production of CBD oil, composed of 5% CBD and 2% THC;

o   approve, based on the above research, CBD oil as a medicinal product, composed of 5% CBD and 2% THC, so as to authorise its supply by hospital pharmacies, under the strict medical supervision of a physician, to patients on whom other medicinal products have no or little effect, and for whom medical cannabis has scientifically proven benefits, and this at least to patients suffering from multiple sclerosis, amyotrophic lateral sclerosis or epilepsy;

o   extend the therapeutic use of Sativex® to patients suffering from amyotrophic lateral sclerosis; and

o   examine the possibility of authorizing imports of approved and safe CBD oil while the production of CBD oil is not yet legalised in Belgium.