- ANNA SFETSIOU
Industrial and Medical Cannabis: A New Legal Framework Established In Greece
One of the most innovative scientific discoveries in the industrial and pharmaceutical field was the cultivation and use of cannabis or else marijuana, for the production of goods. Even though many countries have been and still are, reluctant to the legal cultivation and production of cannabis products, there is no doubt on the multiple benefits of the utilization of cannabis from an economical, industrial and medicinal point of view.
In particular, there are two types of legal uses of cannabis namely, the industrial and the medical use. As far as it concerns the first type of use, hemp, or industrial hemp, is a strain of the Cannabis sativa plant species that is grown particularly for the industrial uses of products deriving from it. Hemp is used to make a variety of commercial and industrial products such as textiles, clothing, paper, food etc. On the other hand, medical cannabis, or medical marijuana (MMJ), is cannabis and cannabinoids that are prescribed by doctors for their patients. Medical cannabis has several beneficial effects. Scientific researches proved that it helps in chronic pain and muscle spasms while others suggested its use for reducing nausea during chemotherapy, improving appetite in HIV/AIDS, improving sleep, and improving tics in Tourette syndrome.
Cannabis plants produce a unique family of terpeno-phenolic compounds called cannabinoids, the two cannabinoids frequently produced are cannabidiol (CBD) and/or D9-tetrahydrocannabinol (THC). CBD is a non-psychotropic cannabinoid claimed to have antiepileptic and anti-inflammatory properties. Also it has many therapeutic uses in neurological disorders, anxiety, cognition, movement disorders, and pain. CBD is produced by three different ways, either pharmaceutically or derived from hemp or marijuana. CBD products are manufactured in a wide range of product forms available from tobacco shops and vape stores, to supermarkets, and online retailers.
Nowadays, the production and trading of cannabis products is considered to be one of the fastest growing industries. More than 30 countries produce industrial hemp including Australia, Denmark, Canada, United Kingdom, Russia etc. In a global scale, China is the world-leading producer of hemp which produces more than 70% of the world output while France is Europe's biggest producer (and the world's second largest producer) with 8,000 hectares (20,000 acres) cultivated. As for the medical use of cannabis, the legislation differs from country to country. Countries such as Canada, Chile, Australia, Finland, Germany etc. have legalized the use of medical cannabis while others have more restrictive laws. Prescription of cannabis is already legal in Canada, Israel, 16 European countries and 30 US states, with the world cannabis market today reaching 30 billion dollars.
Lately the ratification and enforcement of the Law 4523/2018 (Government Gazette A 41/07.03.2018) for the Cultivation, Production, Procession and Extraction of Medical Cannabis, has brought into light a promising legislative development in Greece. Under the new provisions, the production, possession, transport, storage and supply of raw materials and substances of cannabis varieties of Cannabis Sativa L with a THC content of more than 0.2% is permitted under certain terms and conditions, as well as the establishment and operation of a processing unit for the manufacturing and production of medicinal cannabis products for the purpose of either trading within the borders of the State or exporting. According to the Ministerial Decision No 51483/700/F.15 (Government Gazette B 1692 / 15.05.18) on the cultivation and processing of medicinal cannabis and No D3 (c) 52588 (Government Gazette B 2840 / 16.07.18) decision of the Minister of Health on the production and circulation of finished medicinal cannabis products, a number of different licenses and a Market Authorization needs to be obtained for the purpose of producing and supplying cannabis end products for medical use. In particular, natural persons or legal entities, residing either in Greece or abroad, must submit an application accompanied by the required supporting documents for a License for the establishment of facilities processing and producing finished medical hemp products. The Facilities Approval is granted following a decision by the Ministers of Economy and Development, Health, and Rural Development and Food, within 30 days after filing a complete application and is valid for 5 years. Moreover, the interested parties must obtain a License for the operation of facilities processing and producing medical cannabis. After the granting of the previously mentioned licenses, follows the Common License for the approval of production, possession, transport, storage, supply of raw materials and substances of cannabis varieties of THC content exceeding 0,2%, as well as the installation and operation of a processing plant. Lastly, a transfer approval and a specific Market Authorization has to be granted from National Organization for Medicines (E.O.F.). The Market Authorization is given within 90 days after validly filling the Application.
Regarding the industrial use of cannabis, in spring 2013, Greek Parliament voted for the legalization of cultivating certain varieties of industrial cannabis namely, Cannabis sativa L, and the production of raw hemp products. In particular, according to Law 4139/2013 (Government Gazette 74/vol. Α’/20-03-2013), the raw harvested products resulting from the cultivation of cannabis varieties which belong in Cannabis Sativa L genre and are low in Tetrahydrocannabinol (THC) content, up to 0,2%, are legalized in Greece and do not fall under the scope of Law 4139/2013 for drugs. Today, two Ministerial Decisions (982/88573/24.04.2019, 981/88525/24.04.2019) implementing the EU Regulations No. 1307/2013, No. 809/2014 and No. 639/2014, provided grounds for the flourishing and expansion of the production of hemp products in the country. The Ministerial Decisions regulated, according to the EU Regulations, the terms and conditions under which cultivation and production of hemp is permitted. As above, the interested parties must obtain a License for cultivating and producing hemp. After the submission of the application consisting of all the supplementary documentation and the completion of administrative control among 15 days, The Department of Rural Development and Control (TAAE), accepts or rejects the Application.
Greece is aiming to create new business and job opportunities in the new cannabis market generated after the recent legislative developments which legalized the use of medical cannabis and the production of industrial cannabis. The new legislation is also expected to create around €360 million of investment and up to 2,250 job openings. By 2028, the domestic medicinal cannabis industry could be worth €2 billion to the Greek economy, according to facts compiled for The European Cannabis Report™. Up till now, 7 licenses have already been provided for hemp cultivation from a total number of 57 applications. On the other hand, a total number of 80 applications for a License for the establishment of facilities processing and producing finished medical hemp products, have been submitted while 15 companies already obtained the License. So far, no firm has succeeded on granting all three licenses required to begin production. In an attempt to support and encourage companies to proceed with cannabis cultivation and production of cannabis goods, Greece’s Agricultural Development and Food Ministry released a set of guidelines for the cultivation of cannabis for industrial and medical use. As the production of medical and industrial cannabis products is a work in progress for the country, the legislative framework is expected to be formulated and developed in the next few years, filling the gaps and providing effective solutions for the companies who wish to engage this revolutionary industrial sector. A lot is still to be seen not only from a legislative but also from a scientific point of view but one thing can be stated with certainty and that is the indisputable impact and prospect on Greece’s economic future.
About the Author:
Anna Sfetsiou is a Greek lawyer, at the Bar Association of Athens, specialized in IP Law. In 2018 she graduated with honors from the Democritus University of Thrace Law School. Subsequently, in 2019 she obtained an LL.M in European Intellectual Property Law from Stockholm University. She has been actively writing articles with a focus on Intellectual Property law, GDPR legislation and in general commercial law. Nowadays, she is working as a lawyer in HLaw Legal Services.