Cannabis law and legislation in Spain

Cannabis cultivation for research, medical and scientific purposes is prohibited unless authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS).

Currently, in Spain, medicinal cannabis is not regulated. However, on 27 June 2022, the Spanish Congress approved a report on the analysis of experiences of cannabis regulation for medicinal use (informe sobre el análisis de experiencias de regulación del cannabis para uso medicinal), taking a step forward in the regularisation of Cannabis. The text includes a total of eight conclusions that states, among others, that there are "cannabis preparations that may have therapeutic uses" ". The AEMPS is drafting a report of recommendations for the regulation of cannabis for medical use to fit in with the regulations and guarantee the quality of standardised cannabis extracts of preparations. As a result, and in anticipation of the future legalisation of Cannabis, the Spanish Medical Cannabis Association (AECAME) has been established.

As medicinal cannabis is not regulated in Spain, the cultivation of cannabis or the production of derivatives for commercialisation is only allowed in the case of export to a company duly authorised in its country of origin.

The authorisations that can be obtained from AEMPS in order to enter the cannabis business are:

1. Authorisation for the cultivation of cannabis plants for research purposes for the production of varieties or seeds of cannabis with therapeutic use or for the investigation of the physical and/or pharmacological properties, among others, of cannabis and its products
2. Authorisation for the cultivation of cannabis plants for medical and scientific purposes; and
3. Authorisation for the cultivation of plants likely to produce narcotic drugs in order to obtain the necessary batches for the validation of the manufacturing process of active narcotic drugs for medical purposes.

To date, the AEMPS has granted fourteen authorisations to cultivate Cannabis to eleven entities for research purposes. Additionally, five other companies have been granted with authorisations for the production and/or manufacture of Cannabis and its products for medical and scientific purposes. Also, there are two companies authorised for the cultivation of Cannabis plants to obtain the necessary batches for the validation of the manufacturing process of narcotic active ingredients (cannabis) for medical purposes.

Therefore, certain patients can have access to a cannabis-based drug only on medical prescription (patients with endometriosis, multiple sclerosis, cancer, etc.).

It is prohibited to produce, import or sell recreational cannabis.

Article 368 of the Spanish Criminal Code criminalises the cultivation of cannabis when it promotes, favours or facilitates the illegal consumption of drugs and establishes a prison sentence of three to six years.

Nevertheless, the case law provides that cultivation and possession of narcotic substances that are not intended for trafficking but for one’s own consumption and certain hypotheses of shared consumption in which there is no purpose or risk of diffusion, is unpunished. Consequently, if the cultivation is not intended for the purposes discussed but only for self-consumption or shared use within an organisation, is an act of impunity.

Furthermore, Spanish legislation on security protection establishes that the “consumption or possession” of “toxic drugs, narcotics or psychotropic substances, even if they are not intended for trafficking, in places, roads, establishments public or public transport” is considered as a serious offence, and imposes sanctions ranging from EUR 600 to EUR 30,000.

Notwithstanding this, case law determines that the cultivation of cannabis for self-consumption is not a crime in Spain. Cultivation for lucrative purposes and cultivation in visible places is illegal.

Industrial cultivation of cannabis is legally permitted in Spain as long as it does not exceed the limits for THC content of 0.3% set by the European Union in Regulation (EU) No 2021/2115 of the European Parliament and of the Council of 2 December 2021 establishing rules on support for strategic plants to be drawn up by Member States under the common agricultural policy and financed by the European Agricultural Guarantee Fund and by the European Agricultural Fund for Rural Development and repealing Regulations (EU) 13052013 and (EU) 1307/2013.

Furthermore, it will be compulsory to use certified seed of varieties registered in the common catalogue of varieties of agricultural plant species of the European Union, or of varieties that have been granted a Provisional Marketing Authorisation (PMA) according to the European Commission Decision 2004/842/EC.

In this regard, Royal Decree 1729/1999 of 12 November 1999 laying down the rules for applying for and granting aid for fibre flax and cannabis authorises 25 varieties of industrial cannabis for cultivation in Spain and lays down the rules for granting subsidies for crops intended for fibre production. In order for the crop to be legal, the seeds must be certified by the EU.

Thus, cannabis cultivation can only be used for the production of fibre, grain or seeds.

As for products intended for cosmetic use that contain cannabis, these are subject to specific regulations, under the competence of the AEMPS. Thus, the extract and oil of certain parts of the Cannabis sativa species are allowed in cosmetic products, and the use of cannabidiol (CBD) is also allowed. However, the manufacturer of a cosmetic with CBD has to comply with cosmetic regulations in order to market its products.

In this sense, it is important to emphasize, in the packaging of these products, that they are cosmetic products for external use, and that they are not suitable for human consumption.

CBD does not appear on the EU food list as an audited product. Therefore is “not fit for human consumption”.

A company wishing to market in Spain parts of the plant Cannabis sativa L. (flowers, leaves and stems), extracts and cannabinoids, in the food area, must present an application to the European Commission in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 regarding novel foods and, once the risk has been assessed by the European Food Safety Authority (EFSA), the relevant authorisation or non-authorisation decision will be taken.

In principle it is not forbidden to patent inventions containing cannabis as long as they comply with the patentability requirements. Nevertheless, as this substance is considered illegal in many countries including Spain, the possibility of using it is limited.

The regularisation of Cannabis in Spain is gradually progressing.

On 27 June 2022, the Spanish Congress approved a report on the analysis of experiences of cannabis regulation for medicinal use (informe sobre el análisis de experiencias de regulación del cannabis para uso medicinal), taking a step forward in the regularisation of Cannabis. The text includes a total of eight conclusions that states, among others, that there are “cannabis preparations that may have therapeutic uses”. As a result, and in anticipation of the future legalisation of Cannabis, the Spanish Medical Cannabis Association (AECAME) has been established.

In addition, regarding the recreational use of cannabis, several political groups are proposing laws to the Congress that would provide for its legalisation (the latest such proposal being published on 27 May 2022).