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Cannabis for Medical Use: CEE Regulatory Update

June 2019 – A growing number of countries around the world are gradually legalising the use of cannabis for medical purposes.

It can be said that governments are now generally taking a more liberal approach to this product, which could significantly benefit many patients suffering from serious illnesses. This trend is also opening up many interesting business opportunities. Below, we present a summary of recent changes related to the national regulation of cannabis for medical use in some Central and Eastern European countries:


Czech Republic

The use of cannabis for medical treatment has been allowed in the Czech Republic since April 2013, although it is strictly regulated. There are certain restrictions on the prescription of cannabis for medical use: (i) the strains of cannabis that can be prescribed, i.e. Cannabis indica and Cannabis sativa L.; (ii) the types of medical problems it can be used for (mainly chronic illnesses, interminable pain, oncological diseases and treatment of HIV symptoms); (iii) the amount that can be prescribed (180 grams of dried cannabis for medical use per person per month); and (iv) the areas of expertise required from physicians authorised to prescribe medical cannabis.

Growing medical cannabis is only possible on the basis of a licence granted by the State Institute for Drug Control (the “Institute”). That said, licence holders may only begin cultivation after they have been granted a permit to handle addictive substances. Once harvested, producers are obliged to sell the medical cannabis to the Institute, which further resells it to authorised operators of a pharmacy for the preparation of medicinal products. There is only one company in the Czech Republic authorised to grow cannabis for medical use – Elkoplast Slušovice, which won a tender for the licence. Their first delivery of cannabis to the Institute took place in March 2016. Medical cannabis is also imported into the Czech Republic, mainly from the Netherlands.

Although medicinal products containing cannabis are not reimbursed by the public health insurance in the Czech Republic, this is currently being reconsidered. In early 2019 the Ministry of Health proposed allowing public health insurance to cover 90 per cent of the cost of an individually prepared medicinal product containing medical cannabis. The proposal is currently being discussed in Parliament and seems to have wide support by the main political parties. However, there is an ongoing discussion whether certain restrictions should be imposed on the reimbursement in order to control the overall cost of reimbursement from the budgets of health insurers.

Recently there have also been attempts to further soften the current regulation of cannabis use in general. Some MPs have suggested allowing private cultivation of a certain number of cannabis plants, the possibility of holding or donating up to 30 grams of cannabis to another person and having one and a quarter kilograms of dry matter at home. However, the proposal was rejected by the government.

It is likely that similar proposals will continue to emerge, and it will be interesting to see whether the current government will change its position in the future.


Bulgaria

Cannabis is classified in Bulgaria as a plant constituting a high risk to public health due to the harmful effect of its abuse, and it is prohibited for use in human and veterinary medicine.

More specifically, the Act on Narcotic Substances and Their Precursors has also banned the cultivation, production, processing, trade, storage, import, export, re-export, transit, transfer, transport, supply, acquisition, use and possession of cannabis. However, this is subject to two notable exceptions. In particular, the above prohibition does not apply when:

(i) the cultivation of cannabis is intended for fibre, seeds for animal feed and sowing, provided the plants contain less than 0.2 per cent of THC; or

(ii) limited quantities of cannabis are used for medical, scientific or laboratory research, for educational purposes, as well as for maintaining the ability of dogs uncovering narcotic substances.

The activities under (i) and (ii) above are subject to separate licences, which are issued by the Minister of Agriculture, Food and Forests and the Minister of Health, respectively. The maximum cannabis quantity allowed for the purposes under item (ii) is 30,000 grams.

Otherwise, interest is increasing in Bulgaria in industrial cannabis. At the end of 2018 it was reported that the Canada-based International Cannabis Corp (ICC) entered into a partnership agreement with Balkan Cannabis Corp (which claims to have operations in both Bulgaria and Macedonia) for a large cannabis-related project in Bulgaria, although there has been no official confirmation of this project.


Hungary

Hungary only allows processing of industrial cannabis for CBD oil, subject to notification and license requirements.

There have recently been some discussions and proposals related to the regulation of cannabis for medical purposes. However, no specific steps have been taken yet. In any event, interest is growing for industrial cannabis in Hungary.


Romania

The use of cannabis for medical purposes is legal in Romania. The cultivation of cannabis for medical use is possible with a permit issued by the Ministry of Agriculture, Forests and Rural Development. In addition, the Ministry of Health issues authorisations for the purchase, distribution and use of cannabis products. However, these authorisations are limited to specific needs. As regards imports of cannabis to Romania, every individual import activity has to be authorised by the Romanian Ministry of Health. In practice, these authorities have been reluctant to issue the respective authorisations.

In March 2019, the Romanian Finance Minister publicly stated that Romania might take further steps towards liberalisation of cannabis use in the near future. According to available information, the Romanian Ministry of Health has created a special action group to consider the next steps in the process. However, we will have to see what results this activity will bring, and how far the liberalisation of the use of cannabis for medical purposes will go.


Serbia

The use of cannabis for medical purposes is currently not possible in Serbia. In 2014, several patient organisations initiated a campaign to legalise the use of cannabis and cannabis oil in patient treatments, with a special emphasis on cancer patients. In response to the campaign, the Ministry of Health announced that it would analyse possible uses of cannabis for medical purposes. However, the respective working group ultimately concluded that cannabis had no medical indications. Nevertheless, there are some synthetic cannabis-based medicines that may be prescribed, such as Dronabinol (for the treatment of HIV patients), Nabilone (for the treatment of cancer patients) and Sativex (for the treatment of patients with multiple-sclerosis).

In 2018, a petition was submitted to the Constitutional Court asking it to declare unconstitutional the provisions of the Act on Psychoactive Substances that prohibit the use of cannabis, but the court rejected this petition. Currently, there is a persistent effort by some patients as well as cannabis-promoting organisations to put more effort towards the legalisation of cannabis in Serbia. In particular, Cannabis-promoting organisations in Belgrade and other cities in Serbia have organised occasional rallies of cannabis legalisation supporters as well as seminars on the curative effects of using cannabis for certain medical conditions. In addition, their representatives appear from time to time in Serbian media, advocating cannabis legalisation. However, these activities seem to have not produced any wider effect so far.


Slovakia

Medical treatment involving cannabis is generally not allowed in Slovakia. Cannabinoids – the chemical compounds that give cannabis its medical and psychoactive properties – including cannabidiol are treated as controlled substances. Some medicinal products may contain certain controlled substances that are cannabis compounds. However, these products are only available through prescription and have additional prescription restrictions (e.g. prescribed number of packages cannot exceed quantity required for 30 days of treatment).

Possession of registered medicinal products containing certain cannabis substances (Delta 9-THC or cannabidiol) is allowed only in dosages intended for personal use.


Ukraine

Cannabis treatment is not allowed in Ukraine. Free use and cultivation of cannabis is forbidden. Cannabis is only permitted for (i) analysis by experts; (ii) operational investigations in connection with criminal intelligence and surveillance operations; (iii) academic research and educational purposes (if such purpose is sanctioned by law); and for (iv) licensed cultivation and use of cannabis plants (only low THC-yielding plants (0.08 per cent) for industrial purposes, not medical treatment). This rule does not apply to cannabis resin, cannabis tincture or extract of cannabis.

Ukraine’s Strategy of the State Drug Policy, With Regard to Narcotic Drugs up to 2020, includes among its priorities the research of possibilities for the medical use of cannabis. The respective draft law was submitted to lawmakers in April 2016, but it has never advanced further.

In March 2019 a petition for the legalisation of cannabis for medical purposes gained more than 25,000 signatures, which is enough for it to be considered by Parliament. A number of non-governmental organisations signed the petition, which also has support from the current Healthcare Minister Ulana Suprun. On 20 March 2019, the Parliament’s Committee on Human Rights expressed its support for the petition. The Committee decided to create a working group responsible for preparing a draft law legalising cannabis for medical use. On 21 May 2019, this draft law was registered at the Ukrainian Parliament. It is widely expected that the proposal will be approved.


Summary

There have recently been some positive developments as regards the use of medical cannabis in CEE. The Czech Republic has enabled both its use and cultivation, though it is strictly regulated. Some other countries, such as Bulgaria and Romania, have taken first steps. We have seen some initial transactions and increased cooperation in the sector and this promises to pave the way for others.

Nevertheless, some countries still have a negative view of the use of this product. This applies in particular to Slovakia, Hungary and Serbia, where cannabis cannot be used for medical purposes at all. Ukraine seems to be taking some steps towards enacting relevant legalisation, although there are still many obstacles in the way.

 

For further information please contact Tomáš Čihula, Partner, at

e-mail

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Experts from the following Kinstellar offices contributed to this update: Belgrade, Bratislava, Bucharest, Budapest, Kyiv, Prague, Sofia.