Medicinal Cannabis: The state of the art in Portugal

Fátima Godinho Carvalho, from Laboratory of Pharmaceutical Studies (LEF) and Aldo Vidinha (CEO of Stepwise Pharma & Engineering), the two main organizers of the Medical Cannabis Europe, the conference that takes place in Lisbon next week, on the 16th and 17th of September at the Hotel Ramada, outline the current scenario of medical cannabis in Portugal.

APPROVED CANNABIS-BASED PRODUCTS IN PORTUGAL
Decree-Law nº8 / 2019, of 15 January, in force since 1 February 2019, establishes the legal regime for the cultivation, production and use of cannabis-based medicines, preparations and substances for medicinal purposes, having been complemented by the Ordinance No. 83/2021 of 15 April, which defined the requirements and procedures for granting authorizations for the exercise of activities related to the cultivation, manufacture, wholesale trade, transport, circulation, import and export of medicines, preparations and substances based on the cannabis plant, including for industrial purposes. According to Portuguese legislation, cannabis-based products are divided into “substances”, “preparations” and “medicines” based on cannabis. Cannabis-based products are approved for medicinal purposes only in cases where conventional treatments with authorized drugs do not produce effects or cause relevant adverse effects. Dispensing is only allowed in pharmacies, by the pharmacist, upon presentation of a medical prescription. The use of medical cannabis is also limited to a list of therapeutic indications, as well as a list of substances or preparations based on cannabis approved by INFARMED. To date, there are no restrictions issued by INFARMED regarding the authorized routes of administration of cannabis-based products. Oral, sublingual, topical, rectal and inhalation are all permissible routes of administration. However, smoking is still seen by competent authorities and health professionals as a harmful and disapproved way of administering these products. [1-3]

MARKET AUTHORIZATION FOR CANNABIS-BASED PRODUCTS IN PORTUGAL
The name ACM (Authorization for placing on the market) is a new simplified marketing authorization (AIM) concept, which applies to all cannabis-based preparations / substances to be marketed under Portuguese legislation. The application process must be submitted to the local health authority – INFARMED and consists of the presentation of a set of documents addressed not only to the ACM holder but also to specific details regarding the product to be licensed. Within 90 calendar days, the request is evaluated with a focus mainly on product safety (pharmaceutical form, route of administration, technical and scientific knowledge). The quality and safety of the products are the fundamental pillars to be guaranteed by the competent authorities. All approved products are assigned a reference number and published in a publicly available list of INFARMED-approved cannabis-based preparations and substances for sale in pharmacies. The authorization is valid for five years, during which time it must be updated according to the pharmacovigilance data collected. All cannabis-based substances or preparations growing and manufacturing operations must demonstrate clear compliance with GACP (Good Agricultural and Collection Practices) and GMP (Good Manufacturing Practice) guidelines.

CURRENT SITUATION IN PORTUGAL
Since January 2019, INFARMED has received more than 100 licensing applications from various companies that intend to start operations in the cultivation, production, import and export of cannabis-based substances and preparations. By August 2021, it is public knowledge that fourteen companies had obtained cultivation authorization from INFARMED, namely:
Key Leaves, Mhi, Smc, Rpk Biopharma, Terra Verde, Tilray, Purple Flavors, Clever Leaves, Grovida, Pure Healing, Canna Forest, Vf 1883, Agrivabe and Cannprisma [5]. In addition, two companies already hold the INFARMED license for the manufacture of medical cannabis. Rangel is the first company authorized to distribute cannabis-based products. In April 2021, Tilray obtains ACM for the first cannabis-based drug produced in Portugal. [4] INFARMED has approved seven therapeutic indications for the medicinal use of cannabis. This list, available since February 1st, includes, among others, situations of nausea or vomiting resulting from chemotherapy, chronic pain caused by oncological diseases, spasticity associated with multiple sclerosis, treatment-resistant glaucoma and cases of severe epilepsy in children by Dravet and Lennox-Gastaut syndrome. [6] In June 2019, INFARMED announced the reimbursement (37%) of Sativex (the first cannabis-based drug licensed in Portugal). Reimbursement applies in the indication of moderate to severe spasticity due to multiple sclerosis.

Until now, Tilray Flor seca THC 18 has not yet been reimbursed by the Portuguese State. [7]

Information sources:

1. Decree-Law No. 33/2018, of July 18
2. Decree-Law No. 8/2019, January 15
3. Ordinance No. 83/2021, 15th of April
4. https://tilray.pt/primeira-substancia-a-base-da-planta-da-canabis-para-fins-medicinais-aprovada-em-portugal/
5. List of Entities in the Distribution and Production Circuit and Direct Acquisition
6. Resolution No. 11/CD/2019
7. INFOMED - Database of medicines for human use

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