Cannabis is one of the oldest medicinal plants in the world. According to the Portuguese Observatory for Medicinal Cannabis (OPCM), the plant was used for many centuries by European and East Asian communities to acquire fibres and to manufacture fabrics due to its resistance. The use of cannabis for medicinal purposes emerged in 2,700 BC and even then the plant was used to treat a wide variety of illnesses, including seizures and epilepsy. Although the psychoactive properties of the plant were identified in the mid-19th century, the use of the millennial plant went into decline in the 20th century due to the prohibition of its cultivation. However, since then, numerous investigations have been carried out by researchers and pharmacologists who have proved the effectiveness of the plant’s properties for various pathologies and symptoms such as epilepsy, convulsions, reducing nausea and vomiting in cancer patients, eating disorders and multiple sclerosis, among others.
The progressive knowledge of the properties of cannabis for medicinal use and the consequent removal of this plant from the UN list of the most dangerous substances, has provided a growing trend of liberalisation regarding the consumption of cannabis throughout the World. In Portugal therapeutic use was legalised in 2018, has been regulated since February 2019 and is beginning to take its first steps since that date. Portugal’s privileged conditions – good climate, hours of sun exposure, available land, skilled and competitively priced labour, in addition to clarity in legislation – are attracting dozens of interested parties to make Portugal the gateway to the European medical cannabis market. According to some specialists in the sector, Portugal could become the largest European producer, and the licensed cannabis farms in our country already have enough capacity to supply the entire European market in the coming years. Israel is already importing Portuguese cannabis.
Thus, the medical cannabis industry has seen exponential growth in recent years with the legalisation of the sale of these products in various European countries. The growth in demand and the associated margins have led several investors to bet on the medical cannabis market. According to various analysts, this market has the potential to reach €3.2 billion by 2025.
How does licensing work in Portugal?
The main challenge lies in the interpretation and compliance with the EU-GACP (Good Agricultural and Collection Practice) and EU-GMP (Good Manufacturing Practice) regulations, of the European Medicines Agency, in order to be able to place on the market, products based on the cannabis plant for medicinal purposes that demonstrate consistency, quality, efficacy and that are safe.
Law no. 33/2018, of 18 July, opened a new path for the medical cannabis business in Portugal, as it established the legal framework for the use of medicines, preparations and substances based on the cannabis plant for medicinal purposes, namely their prescription and dispensing in a pharmacy.
As of 2019, with Decree-Law No. 8/2019 of 15 January, which regulated the aforementioned Law, it became possible to produce medicinal cannabis in Portugal. Thus, the entire production chain, from the cultivation of the plant to its preparation and distribution, is known and controlled, and it is possible to ensure that products are produced in accordance with all good practices and applicable requirements. It is up to INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.) to license, regulate and supervise the cycle from cultivation.
We can divide the cannabis industry into 6 major groups: Cultivation; Manufacturing; Distribution; Import and Export; Transit; Prescription and dispensary.
Cultivation licences must be submitted to INFARMED, which will carry out a documentary assessment and an inspection or survey. After the first documental evaluation, validated by the Ministries and by SICAD (Intervention Service in Addictive Behaviours and Dependencies), an aptitude Decision is issued, which allows the applicant to proceed with the project (for example, constructions, installation of the security system, etc.). The process should mainly follow the Good Agricultural and Crop Practice (GACP) guidelines.
Subsequently, the applicant must request an inspection and a date is set for the inspection. After the inspection, a licence will be issued, which must be renewed annually.
On the other hand, the application for authorisation for the manufacture of medicines, preparations and substances from the cannabis plant for medicinal purposes, must follow mainly the guidelines of good manufacturing practices provided for in the GMP. The licensing process follows mostly the same course as the licensing process for cultivation, but when submitting it, more elements have to be sent. In this case, the appointment of a pharmacist as Technical Director is mandatory. The licence is also valid for one year and has to be renewed annually.
There are also other licensing procedures for Distribution, Import and Export, and Transit. For Prescription and Dispensing: Prescription is limited to preparations with Marketing Authorisation (MA) granted by INFARMED. The therapeutic indications are available on the INFARMED website, and include for example: chronic pain associated with oncological or nervous system diseases; epilepsy; multiple sclerosis, among others. The use of medicinal cannabis-based products depends on a clinical assessment, carried out by a doctor, who, in view of the approved therapeutic indications, prescribes a prescription to be picked up at the pharmacy. Medicinal cannabis can only be prescribed when conventional treatments do not produce the expected effects or have relevant adverse effects.
In Portugal, there are already licensed entities in all the above mentioned economic activities. However, there are still some challenges, particularly at regulatory level, due to the lengthy response times and also the high demand of this sector, which operates not only in the agricultural area, but also and mostly in the area of medicine.
CONSULAI with its qualified and multidisciplinary team has worked to support investors who want to invest in the sector of medical cannabis, both in terms of the licensing process itself with INFARMED as well as in terms of support from EU funds, available for these investments.
According to available data, there is a significant market with much potential that can generate revenue and create jobs. In our opinion, the future will be mainly through the promotion of scientific research and the demystification of legends and dogmas associated with the plant, its production and consumption.