Cannabis law and legislation in Portugal

Medical use

In July 2018, Portugal published Law no. 33/2018, of 18 July, which legalised cannabis use for medicinal purposes. Decree-Law no. 8/2019 of 15 January sets forth the parameters of Law no. 33/2018, which establishes the legal framework for the use of medicines, preparations, and substances based on the cannabis plant for medicinal purposes, determining its principles and objectives, as well as the regulation and supervision of activities related to the use of the cannabis plant for medicinal purposes.

Law 33/2018 establishes that the National Authority of Medicines and Health Products, I.P. (INFARMED) is the national administrative body with competence to define conditions and to grant authorisations for the following activities: cultivation, production, manufacture, wholesale, trade, distribution, import, export, introduction, dispatch, transit, possession, and use of plants, substances and preparations using controlled substances (narcotics and psychotropics). 

Before assessing any application for authorisation, INFARMED shall forward a copy of the request to the Ministry of Justice's Office for the Fight Against Drugs; the latter shall give an opinion within 30 days and, if appropriate, shall consult with the relevant departments within the Ministries of Agriculture and Economics. It should be noted that while the requirement for cannabis cultivation and production is the authorisation from INFARMED, to build the facility where the cultivation and production will take place it will be necessary to apply to Instituto de Apoio às Pequenas e Médias Empresas e à Inovação (IAPMEI) for a licence for the industrial production of cannabis.

The entity (natural or legal person) that has facilities dedicated to the manufacture of medicines for human use and/or experimental medicines before the beginning of the exploitation of the industrial activity, is subject to industrial licensing under the terms of the applicable legislation (the System of Responsible Industry (SIR), approved in the annex to Decree-Law 169/2012, of 1 August, amended by Decree-Law 165/2014, of 5 November and 73/2015, of 11 May).

Regarding the INFARMED authorisation, INFARMED will decide on the request within 90 days from the date of admission of the application.

The prescription of cannabis-based medicinal products, preparations, and substances is a special medical prescription made in accordance with a special form approved by the Ministry of Health. The prescription must identify the patient, the prescribing doctor, the medicinal product, preparation or substance, respective quantity, dosage, and mode of application. The prescription of cannabis-based medicinal products, preparations, and substances can only take place when conventional treatments are not efficient or cause relevant adverse effects and the therapeutic indication of the cannabis-based medicinal products, preparations and substances have been approved by INFARMED. Prescriptions of cannabis-based medicinal products, preparations, and substances can only be used once.

Dispensation of cannabis-based medicinal products, preparations, and substances for medical purposes can only be made in pharmacies by pharmacists upon provision of the respective prescription and verification of the purchaser’s identity.
The holder of a special prescription for cannabis-based medicinal products, preparations, and substances can hold and transport cannabis-based medicinal products, preparations, and substances for their own consumption, according to the prescription and up to the quantity prescribed.

Non-compliance with the rules set forth in Regulatory Act no. 61/94 constitutes administrative offences sanctioned with a fine between EUR 50 to EUR 3,740.98 for a natural person and between EUR 100 and EUR 24,940 for a legal person, depending on the relevant illicit conduct. In case of misuse of authorisation, the prohibition to conduct the authorised activities for a period of one to three years may also be imposed as an ancillary sanction.

Recreational use

Producing, importing, and selling recreational hemp is prohibited in Portugal.

However, it is not considered a crime to possess plants, substances, or preparations in quantities which do not exceed that required for average individual consumption during a 10-day period.

Industrial use

In respect of the cultivation of hemp for industrial purposes, for food or feed use, or the manufacture of food or compound feed, of varieties of cannabis sativa for the production of fibre and seeds not intended for sowing, the control functions are carried out by the Institute for the Financing of Agriculture and Fisheries, I.P., together with the Judiciary Police, the National Republican Guard (GNR) and the Public Security Police (PSP) under terms to be defined by order of the members of the government responsible for the areas of internal administration, justice, and agriculture. There are no uses permitted other than the ones mentioned above.

Notwithstanding, the cultivation of cannabis plants for industrial ends (non-medicinal purposes) is subject to some restrictions and conditions. The applicable rules are set forth in separate statutes and regulatory acts.

The main applicable restrictions and conditions are as follows:

  • The only cannabis variety allowed to be cultivated for industrial purposes is Cannabis sativa L. (hemp);
  • The seeds used must be certified and cannot contain more than 0.2% of THC content;
  • The seed varieties must be approved by Direção-Geral da Alimentação e Veterinária (DGAV), the competent body of the Ministry of Agriculture, and registered in the National Catalogue of Varieties, maintained and published by DGAV; and
  • The cultivation of hemp must be previously approved by DGAV.

Hemp seeds and their derivatives are allowed in Portugal, but the legal status of cannabidiol (CBD) is more complex. Although products with a tetrahydrocannabinol (THC) content of less than 0.2% are allowed, it is prohibited by law to exploit cannabis extracts generally, which is listed in the table of substances controlled by INFARMED.

The hemp seeds that can be found in any supermarket (often referred to as “industrial hemp”) are exploited in seed form. CBD, on the other hand, is largely extracted from the hemp plant and is therefore considered a cannabis extract. In other words, the regulation of the use of CBD operates in a legal vacuum.

The World Health Organization (WHO) has recently recommended that pure CBD should not be subjected to strict international controls. In a preliminary report published in December 2020, the WHO advanced that suggestion according to tests conducted on humans and animals It asserted that: "cannabidiol is not likely to be over-consumed or addictive like other cannabinoids, such as THC." In response to this WHO guidance, INFARMED affirmed that CBD is not classified as a controlled substance in the United Nations tables, and is not included in the tables attached to Decree-Law no. 15/93, of 22 January.

But what is certain is that there are several physical stores in Portugal, including cosmetic stores, supermarkets, and organic and health stores, that sell products with CBD as a component. There are also a wide range of options available online for consumers to purchase CBD.

Given this legal void, the Food and Economic Security Authority (ASAE) has published a memorandum on the subject stating that the European Commission considers that foodstuffs with extracts of any part of the Cannabis sativa L. plant as well as foodstuffs to which Cannabis sativa L. extracts have been added (e.g. oil from the seeds) are authorised novel foods provided that the THC content of the surfaces of the plant varieties used (e.g. stems and seeds) does not exceed 0.2%, as laid down in Regulation (EU) No. 1307/2013 of 17 December. However, the European Commission considers that other specific legislation of each Member State relating to restrictions on the placing on the market of cannabis as a food or food ingredient should be taken into account.

In Portugal, Decree-Law No. 15/93, 22 January is in force and defines the legal framework for the trafficking and consumption of narcotics and psychotropic substances, and Regulatory Decree No. 61/94, 12 October establishes the rules for controlling the licit market in narcotics, psychotropic substances, precursors and other chemical products that can be used in the manufacture of drugs included in Tables I to VI attached to Decree-Law No. 15/93, 22 January. These laws prohibit the cultivation of hemp (Cannabis sativa L.) without making an exception for the cultivation of varieties intended for industrial purposes. However, the recent Law No. 8/2019, the 23rd amendment to Decree-Law No. 15/93 of 22 January, which approves the legal regime applicable to the trafficking and consumption of narcotic drugs and psychotropic substances, and which transposes Directive (EU) 2017/2103, of the European Parliament and of the Council, of 15 November, provides for the use of the cannabis plant only for medicinal purposes, in medicines, preparations, and substances, with a medical prescription.

The foods derived from the plant Cannabis sativa L. which are authorized to be marketed in the European Union and which have a history of safe and meaningful consumption, are those derived exclusively from hemp seeds, namely seed oil, hemp protein, and hemp flour. They always come from varieties of Cannabis sativa L. containing less than 0.2% THC and do not present health claims and therapeutic properties in their labelling/advertising.

According to Regulation (EU) No. 2015/2283 on Novel Foods and Novel Food Ingredients, the flowers, leaves, and extracts of any part of the Cannabis sativa L. plant (as well as foods to which such parts and/or extracts have been added) are considered to be novel foods and to be placed on the market they will have to go through the authorization procedure as set out in Regulation (EU) No. 2015/2283. This involves a risk analysis performed by the European Food Safety Authority (EFSA).

In ASAE’s view, the use of cannabinoids (such as CBD, THC, cannabigerol (CBG), and cannabinol (CBN), in food will mean that such foods are considered unauthorized novel foods, similar to plant parts and their extracts. Thus, the commercialization of foods containing these substances is not authorized.

The DGAV has also commented on this, stating that CBD is one of the different cannabinoids found in cannabis plants. Unlike THC, CBD has no psychoactive properties and is not addictive. CBD has no history of consumption as a food or food ingredient in the EU prior to 1997, and it cannot be used in food as it does not meet the requirements of the Novel Foods and Food Ingredients Regulation (EU) 2015-2283. Therefore, to be placed on the market, CBD will have to undergo a risk assessment by EFSA. Regarding the possibility of commercializing food supplements containing Cannabis sativa L., it states that this is possible with some restrictions. It clarifies that cannabis varieties that are in the Catalogue of Varieties and that have a THC content of less than 0.2% may be used in foodstuffs. Not all parts of the plant can be used - only the seeds, cold pressed seed oil, and flour from milled seeds have a history of being consumed as food.

ASAE, as the national administrative authority specialised in food safety and economic supervision and with powers of a criminal investigation, has directed its efforts to reassuring consumers that the foodstuffs placed on the market do not endanger their safety and health and that their interests are protected, thus guaranteeing healthy and fair competition between economic operators. The ASAE, acting within the scope of the Official Control of Foodstuffs and in the execution of the National Plan for Food Inspection, has been developing several inspection actions regarding the use of Cannabis sativa L. and cannabinoids in food.

Patentability

There is no general prohibition on patenting cannabis-based products, according to Código da Propriedade Industrial (the Industrial Property Code Decree no. 110/2018). However, it is important to note that any commercial exploitation which is contrary to public order or morality shall not be patentable. 

Pursuant to this principle, if the invention is not contrary to the public order, then it is possible to obtain a patent.

Latest developments

The latest Regulatory Decree no. 2/2020 of 4 August, establishes the authorisation system for the cultivation and industrial exploitation of hemp varieties.

Amended Regulatory Decree no. 61/94 establishes the rules for the control of the illicit market for narcotic drugs and psychotropic substances, included in tables I to IV annexed to Decree-Law no. 15/93 of 22 January, and for precursors and other chemical products susceptible to use in the manufacture of drugs.

Under the terms of this Regulatory Decree, control functions are assigned to entities in the governing areas of agriculture and justice in respect of hemp grown for industrial purposes.

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