Medical cannabis in Greece: legalisation and regulation

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The Greek Ministries of Development and Investments and Rural Development and Food tell MCN about the future of Greece’s medical cannabis industry.

In 2018, the government of Greece approved the legalisation of cannabis for medical use. Representatives of the Greek Ministry of Development and Investments and the Ministry of Rural Development and Food tell MCN about the decision to legalise, the complexities of implementing regulatory standards; and the future of Greece’s cannabis industry.

What decisions and policy developments led to the legalisation of medical cannabis in Greece in 2018?

The provisions of no. 1 of Law 4523/2018, which added Article 2A to Law 4139/2013, laid out exemptions for the production, possession, transportation, storage, supply; as well as the installation and operation of a plant for the processing and production of finished medicinal cannabis products, within a single and enclosed area. In accordance with this law, the relevant ministerial decisions were adopted which set out both the authorisation process for these processing plants and the terms and conditions for the production and marketing of fin

What criteria will companies have to meet in order to obtain a cultivation licence for medical cannabis in Greece?

In accordance with the legislation currently in force, companies may be exceptionally permitted to install and operate medical cannabis processing and production plants for the sole purpose of either supplying the state monopoly on the provision of cannabis for medical purposes, or for the export of these products. In order to receive these permits, companies must meet the following conditions:

  • The area within which all the activities for which authorisation is granted must be a single space measuring at least four acres;
  • The single area of activity and the area in which cultivation takes place must both be enclosed;
  • Specific safety and security requirements must be observed for the protection of the perimeter;
  • The Public Security Directorate of the Greek police (SDS/AEA) will supervise the operation to ensure its security provision is compliant with the above requirements. Further checks will also be conducted by the relevant police departments;
  • In the event of a breach in safeguarding conditions, authorisation may be withdrawn at any time;
  • Applicants will not be approved for a permit if they or any of their employees – including transport drivers – have been convicted or indicted of any felony. Applicants who have been convicted of certain misdemeanours, as well as those who have been placed under judicial support such as curatorship, will also not be eligible to receive a permit; and
  • Approval will only be granted for single installations in designated areas and regions where cannabis and hemp processing and production are permitted under land use regulations.

Once an installation has been approved and a company has been granted the requisite operating permits for the units concerned, the company should apply to the Greek National Medicines Agency (EEA) for further authorisation to produce and market their product.

How will the legalisation of cannabis for medicinal use aid the progress of Greek healthcare and what economic benefits can it have?

According to the European Parliament’s resolution 2018/2775, there is already convincing evidence that cannabinoid use has significant effects on treatment of a number of serious diseases. The potential use of medical cannabis will therefore be an additional and dynamic alternative treatment for people suffering from serious illnesses and in need of holistic healthcare. In addition, in line with its above-mentioned resolution, the European Parliament has urged Member States to study and promote the prescription of cannabis for medical purposes.

Regarding the consequences for the Greek economy of legalising medicinal cannabis cultivation and production, consideration of worldwide and pan-European data on the cannabis industry leads to the conclusion that our country can, indeed, act as an investment attraction for cannabis-related activities; and that this will undoubtedly have a positive impact on domestic financial figures. To date, analysing the investment proposals already submitted, it is estimated that there will be 8,716 employees in this productive sector and the estimated size of the investments is €1,681,068,794.

How can Greece’s embracing the medical cannabis industry stimulate its position in the global economy?

The legalisation of the production of cannabis-based medicinal products in Greece may boost the country’s position in the world economy, as the commissioning and operation of industry units will lead to increased exports. In particular, it is estimated that the world market for medicinal cannabis will continue to grow; while the German market – which is currently the largest cannabis market in the European Union – is estimated so see a commensurate increase. Therefore, to meet these needs, imports of medicinal cannabis products from countries which already have a defined and secure legislative framework in place will further increase.

Given this, and because:

  • Greece is one of the first European countries to have a legislative framework already in place for the operation of processing plants for the production of medicinal cannabis products;
  • The prevailing climate in our country favours this particular production process; and
  • In Greece there is a skilled workforce and the cost of meeting the energy needs of cannabis production facilities in this sector is relatively low.

It is therefore estimated that our country offers positive investment prospects for the industrial production of medicinal cannabis products, which can contribute to a positive picture of the Greek economy through increased exports.

What specific benefits can Greece provide for companies hoping to cultivate cannabis in the country?

As we noted in the previous question, Greece is one of the first European countries to have a legislative framework in place which governs the operation of processing plants for the production of medicinal cannabis. In fact, as the current licensing framework is already being implemented by the relevant agency, there is relevant licensing experience; and the process required to obtain authorisation to build a medical cannabis processing unit is relatively fast: it is estimated that it only takes three months on average to obtain the relevant installation permit. As Greece also boasts a skilled workforce and favourable climate, it will form an appropriate base for the effective development of the medical cannabis industry.

What challenges has the Greek government faced in implementing policy on medical cannabis? Do you anticipate any future challenges stemming from the new and largely unregulated industry?

As the cannabis industry is a new and dynamic manufacturing sector, the challenges that Greece will face in implementing this legal framework will be significant and significant. On the one hand, Greece should maintain its comparative advantage over other countries which could potentially compete as host countries for investment in the cannabis industry – such as Cyprus, Malta and Portugal – and on the other hand, it must ensure that the legislative framework is complied with smoothly and effectively, so that all relevant security and control requirements enshrined in law can be met. In addition, the prospect of developing synergies between universities and the market in research and development is a critical factor in the future growth of the industry.

How can the government ensure that the medical cannabis products consumers are exposed to are safe and effective?

The current legal framework permits exclusively only the manufacturing of finished medical cannabis products. Therefore – in principle – the safety and efficacy of these products concerned are implied, due to the fact that they are considered medicinal products under Greek law and are therefore licensed and controlled by the competent Greek agency, the National Organisation for Medicines (EOF). In any case, as there is no legislative harmonisation between the EU Member States on the implementation of an institutional framework within this sector, Greece should contribute dynamically to the dialogue in order to  ensure that EU-wide guidelines, such as those contained in European Parliament resolution 2018/2775, are followed. In particular, this resolution states that Member States must work together to ensure that cannabis-derived products used for medical purposes are safe, controlled and have undergone clinical trials in order to meet the standards for regulatory evaluation and approval.

How do you see the medical cannabis industry evolving in Greece in the future? How can the government aid its development?

The evolution of this sector in our country is undoubtedly linked to the overall trajectory of the global medical cannabis industry. Current projections indicate that the global medical cannabis market will grow from €7.2bn in 2017 to €55bn in 2024, with a compound annual growth rate (CAGR) of 36%; and corresponding estimates for the German medical cannabis market alone suggest a CAGR of 49.5% between 2017 and 2024 – if these predictions are correct, then the outlook for the investment framework is optimistic. Combined with the fact that Greece is a country with a clear legal licensing framework already in place, the market predictions suggest a favourable assessment.

Of course, there are still issues which must be regulated so that nationwide legislation can be made complete. These issues include establishing a clear definition of the type of greenhouses needed for a particular crop and the specific type of finished medicinal products that will eventually be allowed to circulate commercially.

Cannabis law in Greece

Medical use of cannabis is legal in Greece since a relevant law was passed in the Greek Parliament and published in the Government Gazette in 2018. The details of this law and its implementation law were determined by a joint Ministerial Decision, which also set the criteria that companies will have to meet in order to be authorised.

Under the new law, authorisation for the cultivation and processing of medical cannabis in Greece takes the form of a common licence on an integrated production system; meaning that authorisation is completed in two steps: one licence for the initial establishment of a facility; and another for its operation. Licences are issued by the General Secretariat of Industry within the Ministry of Development and Investments. Over 100 companies have applied for these licences, of which 57 have so far been authorised for installation only. Consequently, at present no cannabis strains with tetrahydrocannabinol (THC) content exceeding 0.2% are cultivated for medical use in Greece.

Medical cannabis cultivation is definitely a challenging field: presently there is no specific common European legal framework, and each Member State has to set its own. There has been increasing interest from 2018 up to today; the final medical cannabis products are strictly intended for pharmaceutical use, with the exclusive function of supplying the government’s monopoly or for international export. Consumer safety is protected by the relevant EU legislation on drugs.

You may find the relevant legal framework in English on the website of Ministry of Rural Development and Food, at the following link: www.minagric.gr/index.php/en/farmer-menu-2/medical-cannabis

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