Canna Reporter isn’t getting much information from Tilray
The first cannabis flowers approved by Infarmed have been available in Portuguese pharmacies since the beginning of April, but Tilray does not reveal the cultivar or chemovar of the THC18 flowers it is selling in Portugal, nor has it yet asked for your contribution. In the information leaflet, provided by Infarmed, only the THC (18%) and CBD (<1%) content are included, but for many doctors and patients it is important to know the profile of cannabinoids and terpenes of this substance, to better adapt the treatment the different pathologies and the way to consume it.
Portugal follows the same line as Germany, where only the levels of THC and CBD are revealed.
The user is not provided with information about the other compounds in the plant. In Canada, Tilray sells seed genetics.
Cannareporter sent questions to Tilray, transcribed with the respective answers below, and also to Infarmed, which as of the date of this publication has not answered.
Tilray’s responses were sent via email by Rita Barata, Head of Marketing EMEA & Country Manager Iberia at Tilray.
1 – What is the chemovar or cultivar of the THC18 flowers?
Tilray, as a company in the pharmaceutical industry, in compliance with the law and the current APIFARMA code of ethics, cannot provide specific information about products to the general public.
2 – Where can the certificate of analysis of these flowers be consulted? What other cannabinoids and terpenes are present?
Preparations and substances based on the cannabis plant, require the submission of a dossier and subsequent approval by INFARMED, IP The quality dossier is the submission of module 3, of the CTD (Common Technical Document) format, characteristic of medication submission. It is commonly referred to as the pharmaceutical module, which contains all the information on production and quality control. The information that can be provided to patients is found in the information leaflet, which is available on the appropriate channels.
3 – Has Tilray already requested the participation of these flowers from Infarmed?
We believe that reimbursement is a fundamental step towards achieving equitable access and we will work for that as soon as possible. However, it is still necessary to make the existing co-payment scheme – naturally designed for medicines – compatible with the new reality of preparations and substances based on the cannabis plant.
4 – How many doctors has Tilray visited to provide training on this new therapy? In which hospitals?
Tilray develops its promotional and educational activity under the terms of the law in force and considers this strategic information to be confidential.
5 – How many patients do you think may benefit from this new product?
The epidemiology of uncontrolled patients, with conventional therapies in the approved indications, is uncertain. However, the available evidence points to still high numbers, for example in chronic cancer pain and chronic neuropathic pain. For this substance based on the cannabis plant for medicinal purposes, INFARMED approved the following therapeutic indications, in cases where conventional treatments did not produce the expected effects or caused relevant adverse effects:
- Spasticity associated with multiple sclerosis or spinal cord injuries;
- Nausea, vomiting (resulting from chemotherapy, radiation therapy and combined HIV therapy and medication for hepatitis C);
- Stimulation of appetite in palliative care of patients undergoing cancer treatments or with AIDS;
- Chronic pain (associated with oncological diseases or the nervous system, such as neuropathic pain caused by nerve damage, phantom limb pain, trigeminal neuralgia or after herpes zoster);
- Gilles de la Tourette syndrome
- Therapeutic-resistant glaucoma
It is up to the attending physician to assess the patient’s situation and, depending on the characteristics of the preparation and / or substance, decides on its use and under what conditions, determining whether or not the patient at home will be able to benefit from this therapeutic alternative. We hope to guarantee access to this therapy to the largest number of patients who need it, according to the defined medical criteria.