While the Spanish Government proceeds without regulating access to cannabis for therapeutic purposes, the Spanish Agency of Medicines and Medical Devices (AEMPS), attached to the Ministry of Health, continues to grant licences to cultivate cannabis for the research and manufacture of products for medical purposes.
As stated on the AEMPS agency website, which was updated on June 17, there are currently already fourteen companies with a licence to grow cannabis for research, and eight that have a licence for the production or manufacture of cannabis-derived products for medical purposes. However, all production of these companies is intended solely for export because the only product derived from cannabis that is approved and covered by the Social Security in Spain is Sativex, which is used to treat spasms caused by multiple sclerosis. Manufactured by GW Pharma and marketed in Europe and Mexico by Almirall, this drug costs 400 euros and has become one of this pharmaceutical company’s star products: even in 2016, it earned almost the same from Sativex sales as from sales of Almax, as reported at the time by The Economist.
As outlined by the Government in a parliamentary response, the AEMPS had already received around 160 applications in 2017 to request a licence to grow cannabis for commercial purposes; however, only four companies were able to do so in 2020. According to a report prepared by the European Observatory for the Consumption and Cultivation of Cannabis, it was the first time that the agency had provided information on the stakeholders of these licences, As we published in Kannabia in January 2018, these first companies licensed to work with cannabis were DJT Plants Spain SL (established in 2015 by the British Tiamat Agriculture Limited) and Anglia Salads Ltd (currently without a licence), the Polytechnic University of Valencia, Alcaliber (the only one with a licence for outdoor cultivation), Cordoba-based Phytoplant and the Valencian Cija Preservation.
In 2018, just over a year after obtaining a cannabis cultivation and production licence, Juan Abelló sold Alcaliber to the British investment fund GHO, with which it created a new company called Linneo Health, which currently holds a licence for the “cultivation, production, manufacture, distribution, import and export of cannabis sativa and its products” according to the AEMPS website.
In the same year, Hemp and Natural Fibres S.L. (Cafina), a small start-up based in Callosa de Segura (Alicante), also obtained a licence for the production and manufacture of cannabis for medical purposes. In 2019, it was absorbed by the Canadian giant Canopy Growth.
There are already 14 companies that currently have a licence for the cultivation of cannabis for research. The aforementioned Cija Preservation and Phytoplant Research, which maintain their licences, are joined by the Basque Aleovitro (with various recovery projects for agricultural species), the Malaga Bhalutek Sens (of brothers Francisco Javier and Juan García Gómez, the latter also director of the Cannabis Innova Life and Positronics Seeds), the Dutch Biobizz Worldwide, the Extremadura Scientific and Technological Research Center, the Madrid-based Helicon Medical, the Botanical Institute of Barcelona of the Higher Council for Scientific Research, the Institute for Food Research and Technology, Mifco Biobrands (also from Malaga and established in 2019), Ploidy and Genomics from Valencia, Sovereign Fields from the United States (also established in 2019) the Scientific Unit for Business Innovation of the Valencian Agency for Innovation and Worldpharma Biotech, based in Paterna.
To date, the AEMPS has granted eight licences for the production of cannabis and derived products for medical purposes, including the aforementioned Cafina (with authorisation for the cultivation, production, distribution and export of Cannabis sativa and its products), Linneo Health (for cultivation, production, manufacturing, distribution, import and export) and Bhalutek Sens (for the production of seeds and cuttings). They are joined by the Madrid company Cannabasa Agro and Pharma (which has had authorisation for the cultivation of cannabis for the validation of the cannabis extract manufacturing process since 2021), the Alicante Medalchemy (integrated into the British EMMAC Life Sciences Group, which is dedicated to the production of generic drugs derived from cannabis for sale in several European countries excluding Spain), the Almeria Medical Plants (set up in 2020 by Realza, an investment fund chaired by Javier Benjumea), the Tarragona Naturhemp and the Madrid Oils4cure.