In Portugal, more than 10 kg of cannabis have already been prescribed, but there are only 5 requests for ACM at Infarmed

Sales of cannabis for medicinal purposes in Portugal are still insignificant, but show signs of growth, according to the data revealed yesterday by Infarmed. With just one product (dry flower with 18% THC) and one drug (Sativex) in pharmacies, patients in Portugal say there is still a long way to go. There are only 5 requests for ACM (Marketing Authorization) awaiting evaluation by the Portuguese regulator, which does not meet the needs of patients, warns Paula Mota, from the Mothers for Cannabis Movement.

Cannabis for medicinal purposes in Portugal was legalized in 2018, however, it was only in 2021 that the first cannabis-based preparation was authorized in Portugal. The prescriptions for this preparation, under the legislation that provides for the ACM, have shown signs of growth, even though only one product is approved under this regime (Tilray Flor Seca THC 18).

In the first half of 2021, 126 packages of Tilray flowers were prescribed, a value that almost tripled in the second half, with 334 packages prescribed by doctors. From 2021 to June 2022, the product has already been prescribed 823 times, having almost tripled its homologous value in the first half of this year, to 326 prescriptions.

In total, in 2021, approximately 0 kg of cannabis were prescribed, a value that in the first half of 5 rose to 2022 kg and which can reach 10 kg of annual consumption at home. The therapy, which is not reimbursed by the state, although it can only be used as a last resort, has already cost patients more than 20 thousand euros.

Cannabis prescriptions in Portugal since 2019

Regulator is analyzing only 5 ACM requests

The Marketing Authorization (MCA) applications, advocated in the medical cannabis legislation, have established a set of mechanisms that allow companies to produce cannabis-based preparations and substances for medical purposes. These procedures aim to allow companies to place their products on the Portuguese market without having to resort to the Marketing Authorization (MA) procedure at European level.

Thirteen ACM requests have been made since 2019. However, only one has been approved and 5 are under analysis, with the other 7 having been invalidated, rejected or cancelled.

Table with information on requests for ACM for cannabis-based preparations and substances, since 2019. Report “Medical Cannabis – Evolution of activity” by Infarmed, IP.

Patients dissatisfied with slow process

To CannaReporter, Paula Mota, who heads the Mothers for Cannabis Movement, states that the product in question does not meet the needs of many patients, as it is “indicated for patients over 25 years of age and prohibited for those under 18. In addition, its prescription is only for some pathologies, namely chronic pain, nausea , spasticity, glaucoma, which leaves out epilepsy, for example”. The jurist, who has a 13-year-old daughter with refractory epilepsy, warns that there is no product with ACM “suitable for children and adults with epilepsy, this being the pathology where we have seen the most demand for this type of cannabis-based preparations”. On the other hand, the founder of the Movement warns that the “cost of the product is impractical for the majority of Portuguese patients”, stressing that “the fact that some doctors do not prescribe is due to the lack of analytical information regarding the content of the flower or even because they consider that vaping is not the best way to use this plant.”

Paula Mota recalls that “the products that Portuguese patients most need are preparations of oils based on the cannabis plant, with a predominance of CBD and lower THC levels, since most of these preparations are also used by children and by patients in whom vaporization is not advised.

CannaReporter sent several requests for additional statements that at the time of publication of the article had not yet been answered. Thus, the article will be updated as statements are made by the various players in the industry.