It is now possible to produce medicinal cannabis products in Greece by virtue of the recent Law 4523/2018 (Government Gazette A 41/07.03.2018). Prescription of medical cannabis is already legal in Canada, Israel, 16 European countries and 30 US states, with the world cannabis market today reaching 30 billion dollars. Following the scientific advice that accepts the medicinal properties of cannabis and the international tendency to institutionalize the access of patients to pharmaceutical products of cannabis, this growing industry is now introduced in Greece as well.
The purpose of the present newsletter is to present the key points of the new legislation on the process, terms and conditions of medicinal cannabis cultivation and production in our country. More specifically:
I. Law 4523/2018 – Introductory notes
Taking into account the resemblance or differentiation of cannabis compared to other substances, as well as the relevant international guidelines for the classification of narcotic drugs, article 1 of Law 4523/2018 introduces an exception to paragraph 2 of article 2 of Law 4139/2013 “on addictive substances and other provisions”, for cannabis varieties of Cannabis Sativa L containing more than 0.2% of tetrahydrocannabinol (THC). With this exception, it is possible, under strict conditions, for natural and legal persons to produce cannabis of the Cannabis Sativa L type with a tetrahydrocannabinol (THC) content of more than 0.2%, with the sole purpose of producing end-products of medicinal cannabis, that shall be either supplied to the State monopoly with the aim of being available to patients or exported for medical purposes. Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of up to 0.2% are outside the scope of this regulation, since, according to paragraph 3 of Article 1 of Law 4139/2013, these are not considered as narcotic drugs.
The legislation at issue is necessary in so far as cannabis, due to its pharmacological properties and the high risk of abuse, remains classified as a drug under Law 4139/2013 and is therefore under the control of the State monopoly. However, the specificities of the production of cannabis and end-products of medicinal cannabis do not allow the State to take any relevant activities through the State monopoly.
In this context, under the new rules, the production, possession, transport, storage and supply of raw materials and substances of cannabis varieties of Cannabis Sativa L with a tetrahydrocannabinol (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 finished medicinal cannabis products for the exclusive purpose of either supplying the State monopoly and disposing for medical purposes or exporting.
II. The content of the legislation – Terms and conditions for the cultivation, processing, production and circulation of medicinal cannabis products
Pursuant to the provisions of Law 4523/2018, the Joint 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, the following are stipulated:
- For the production, possession, transport, storage and supply of raw materials and substances of cannabis varieties of Cannabis Sativa L with a tetrahydrocannabinol (THC) content of more than 0.2% and the establishment and operation of a processing unit for the manufacturing and production of medicinal cannabis products, a relevant authorization is required, which is provided by joint decision of the Ministers of Economy and Development, Health and Rural Development and Food for all activities.
- The authorization is unified, that is to say, an authorization for an integrated production unit, which must compulsorily include both the production, through the cultivation of cannabis varieties, and the processing for the production of the finished product. The ‘raw material’ (flowers, inflorescences, leaves, etc.) for the manufacturing of the finished medicinal product of cannabis must be contrasted to the propagating material of the cannabis plant, and in this case to the seed and/or seedlings for planting. The product to be marketed may be only the finished medicinal product of cannabis, while the disposal of any propagating material (seeds and/or seedlings for planting), raw materials and generally of any other product that may be obtained from an intermediate stage of the processing, is not permitted.
- The authorization is non-transferable and the assignment of any activity, at any stage, to third parties is also prohibited.
- The authorization is granted to natural or legal persons upon submission of an application accompanied by the required supporting documents, including a certificate of land use by the competent Building Service, Environmental Impact Assessment Study (MPE), Decision approving the Environmental Terms (EPO) and a technical report ascertaining that the capacity of the processing unit is sufficient to exploit/manage the output quantities of the cannabis cultivated in the establishment. If a legal person is domiciled abroad, it is required to declare a tax representative and an agent in Greece. In any case, persons from non-EU countries are required to reside permanently in Greece or have their registered office in Greece. Any change in the ownership of a legal entity must be notified in writing to the Licensing Office of the General Secretariat for Industry (GSI).
- The persons concerned must initially acquire an authorization for the establishment of the unit and afterwards for its operation. The establishment authorization is granted within 30 days of submission of a full dossier and is valid for five (5) years.
- The operation authorization is granted within 30 days of the submission of a full dossier and is valid for ten (10) years, with the possibility of renewal. Within two (2) months of the issuance of the operation authorization, the Licensing Office of GSI carries out an on-the-spot check to ascertain whether or not the conditions for granting the authorization have been respected. Throughout the operation of the facility, the Licensing Authority performs on-site inspections at least on a yearly basis to verify compliance with the conditions of establishment and operation authorizations, and in case of detection of infringements, the authorization of establishment and/or operation may be revoked. The applicant is obliged to re-submit annually to the Licensing Office of GSI updated most of the documents required for the establishment and operation authorizations.
- The area for which the authorization of the activity is granted may not be less than four (4) acres and is evidenced by a valid ownership title or lease or free concession agreement.
- The entire cultivation and processing activity is carried out in an enclosed land within which the storage points are located. The cultivated area is closed and specific guarding and safety specifications are imposed on the perimeter protection of the unit.
- The authorization is granted in areas of statutory production facilities and in areas where processing or agricultural activities are permitted.
- Importation of seed from the other Member States or third countries is only allowed for the needs of the approved cultivated area. The export of finished cannabis products of Cannabis sativa L, with a tetrahydrocannabinol (THC) content of more than 0.2%, for medical purposes is also permitted. The quantity of seed imported shall not exceed three (3) kg per hectare, and shall be carried out to cover the sowing needs of the approved cultivated area.
- The import, supply and export of raw materials and substances, as well as the disposal and export of seed of cannabis varieties of Cannabis Sativa L with a tetrahydrocannabinol (THC) content of more than 0.2% are prohibited.
- The export of finished products for medical purposes is made by the Customs Office of Piraeus and the Free Zone of Thessaloniki with the permission of the competent authorities of the country in which they are to be dispatched, endorsed by the Greek consular authorities, stating that importation is allowed in that country, that the products are to be used for medical purposes, the name and address of the consignee, the quantity thereof and the time-limit within which the importation is to be made.
- For all finished medicinal products of cannabis falling within the scope of the provisions of Article 1 of Law 4523/2018, i.e. either intended for disposal on the Greek market under the restrictions of Article 2 (2) of Law 4139/2013, or intended for export, as well as for finished medicinal cannabis products imported in Greece either from another EU Member State or from a third country, a specific marketing authorization is required, which is granted by the National Organization for Medicines (EOF) and is valid for three (3) years at the request of the person concerned and may be renewed every three years, after reassessment of the risk-benefit balance.
- For the production of finished medicinal cannabis products, a production license is required, issued by EOF in the name of the authorization holder pursuant to Law 4523/2018, at his request.
- Any advertising of finished medicinal cannabis products, as well as the administration of their samples, are prohibited.
III. The expected benefits and prospects of the new legislation
According to the explanatory memorandum of Law 4523/2018, the expected benefits of the legislation include the possibility of:
(a) access to the country’s patients to finished medicinal cannabis products, given the therapeutic properties of cannabis in specific cases. Access to the cannabis products shall be done in a clearly identified, controlled manner and in accordance with the specificities of cannabis and the production process of the products;
(b) natural and legal persons to cultivate cannabis varieties for the processing of raw materials and, in general, of these substances for the sole purpose of producing finished medicinal products in Greece, by investing in the land and in the establishment of the cultivation and processing facilities;
(c) creating new jobs that will contribute to the development of the economy, in a cutting-edge sector that exploits the comparative, productive advantages of the country; and
(d) economic benefits to the state from exports of finished medicinal products and the taxation of the economic activities of the sector, given that the world market for the cultivation and processing of medicinal cannabis is in the early stages of development and therefore the supply lags behind of the world demand.
It is a fact that in less than a year since the adoption of Law 4523/2018, great interest has been shown by foreign companies for the cultivation of medicinal cannabis in Greece. In fact, the first two authorizations for the establishment of processing units for the production of medicinal cannabis products intended for export have already been issued and, according to published information, 12 more dossiers are expected to be approved in the near future. The talk is of a total investment of € 185.2 million and an opening of 770 jobs.
Undoubtedly, there are many challenges and perspectives for medicine, economy and employment, and we shall have to see whether this new, alternative and fast-growing industry will contribute to the social and economic reconstruction of our country.