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Новости/Аналитика

Cannabis Therapeutic Market Potential Analysis

27.11.2019

Hemp varieties bred in Ukraine , in which THC is less than 0.05%, and CBD more than 1.5% . The experiments suggest that the use of fresh or dried leaves of industrial hemp therapeutic orientation gives a huge therapeutic effect - significantly reduces pain cures migraines, allergies, various neurodegenerative diseases, and others . In Ukraine , having issued the relevant permits, you can grow the above varieties on a personal plot , heal / heal, or buy juices, smoothies, seasonings, food , cosmeticsdietary supplements, etc. , which already exist and are in great demand in the domestic market . At the same time, the Ukrainian consumer will buy goods for tens of hryvnias, and not for hundreds of dollars, pharmacological preparations based on hemp extracts made abroad.

Recently, a topic has been "gaining momentum" in Ukraine related to the issue of legalizing the possibility of using medical marijuana. On February 1, 2019, the corresponding petition was formed on the Verkhovna Rada website and the collection of signatures began. People’s deputies are urged to change the law by creating appropriate conditions for the full use of marijuana in medical and scientific activities, including with the aim of developing, clinical trials, state registration of effective medicines or treatment protocols involving the use of products with a high content of cannabinoids .

On March 12, the media released information that the petition demanding to legalize the use of cannabis for medical and scientific purposes in Ukraine received 25,000 signatures, the minimum required for further consideration of the document.

Given the relevance of the topic, there is a need to understand the reasons for the urgency of the issue and most importantly the consequences of the adoption or rejection of this regulatory act for Ukrainian realities.

Some terminology

Medical cannabis is a product based on hemp plant (industrial hemp) in the form of its parts (flowers, leaves, inflorescences, seeds and their derivatives - oils , tinctures, capsules, other products). For the use of hemp for medical purposes, both processed and untreated plants are used, as well as extracts of the individual components contained in it. Such products include high cannabidiol (CBD) and low tetrahydrocannabinol (THC), which in a sense puts them on a par with ordinary consumer products .

Pharmaceutical cannabis - refers to drugs that include pure cannabinoids (of plant or synthetic origin) that have undergone complete clinical trials and are licensed as a medicine. Examples of pharmaceuticals of this kind are Sativex, Epidiolex, Cesamet, Marinol and Syndros.

Recreational hemp is a product that is used for non-medical purposes. In the modern market of Ukraine, such a product is distributed illegally. It usually has a higher concentration of THC, which utilizes the psychoactive properties of the plant. This is illegal in many countries of the world . Recreational hemp, as a rule, is smoked (or eaten ), the oils or extracts of such plants are used in the vast majority for relaxation.

International market of hemp products

Canada is currently the largest producer and exporter of plant seed products , including hemp grain , oil, and hemp protein . The share of Canada currently accounts for 60-90% of the total import market of products made from hemp USA . Canadian hemp plant grains are usually of high quality , as farmers are only allowed to use seed varieties that are listed on the Health Canada Approved Variety List. All cannabis seeds from Canada are tested for GMOs, and farmers mostly do not use any pesticides during cultivation. Also, Canadian agricultural producers are certified «Pro-Cert Organic». It should be noted that Canada is today almost the only country in the world where the cultivation, as well as the use of all types of hemp, is legalized. It happened on October 17, 2018.

In Europe, hemp is used for industrial purposes, such as materials for automobiles and construction . Most cannabis in the EU is grown in Eastern Europe , such as Romania , Hungary and Poland . However, many other countries on the continent grow hemp for other tasks. The hemp industry was rebuilt in Europe , as the European Union subsidized its farmers (up to $ 400 / acre) for growing hemp in the 90s of the twentieth century.

Not only in Europe, technical hemp is in great demand. In countries of Asia , South and North America there is a boom in industrial hemp breeding. In particular, in Canada for several consecutive years there has been a positive trend in the development of the food sector of the hemp industry . In 2016, Canada grew 34,000 hectares of hemp, and in 2017 a new record was reached - 56,000 hectares. Starting this year, the cultivation of industrial crops of industrial hemp will begin in the United States , where growth in the next ten years is expected to reach 50,000 hectares.

 

Industrial hemp crops in Europe for the period 1993 - 2017

During the year, serious changes occurred in the territory of individual countries of the European Union related to changes in the status of hemp. The supreme legislative body of Lithuania has amended the current legislation, according to which it has become possible to use medicines based on the therapeutic properties of hemp in the country . Now hemp in the country, according to the prescription of a medical professional, can be used by patients diagnosed with multiple sclerosis, oncological and autoimmune diseases.

The head of the British Ministry of Internal Affairs gave the go-ahead to research aimed at exploring the possibility of legal sale of products containing hemp extracts in the country. In turn, the Minister of Health examined in detail the issue related to the use of the therapeutic properties of hemp and came to the conclusion that the government should enable citizens of the country to be treated with cannabisa . The introduction of appropriate changes to the current legislation of the country should take place before the end of this year, which will allow patients with insomnia, various neurodegenerative diseases or people who suffer from chronic pain to use the plant for medical purposes.

A government scientific committee has been set up in France , composed of experts in the field of neurology, sociology, the fight against HIV / AIDS and government drug policies, whose main task is to determine the possibility of legalizing the use of hemp's therapeutic properties for medical use . The above government agency should publish conclusions on the advisability of using hemp for medical purposes only at the end of 2019.

With regard to the vision for the use of hemp plants, there have been global changes. The United Nations adopted the Declaration, which obliges countries to support the development of backward agrarian regions, which clearly describes the trend of the need to stimulate effective agricultural policies. A separate paragraph determines the need for a positive attitude of government structures of the international community to such a highly profitable agricultural crop as hemp .

The declaration, in particular, is intended to be used in policymaking in developing countries with a rich history of cannabis cultivation. This refers to countries such as Morocco, South Africa , and India, in which depressed agricultural areas are the main producers of hemp plants and more than others lose from the global ban on its cultivation, as indicated in the UN Development Program.

Germany shows a positive trend in enhancing the use of hemp plants in various fields of production. In the first half of 2018, Germany imported 1.8 tons of psychoactive hemp. About 60% of the raw materials came from Canada and 40% from the Netherlands , and in the summer of 2018, the Dutch government agreed to increase the annual export of medical hemp to Germany from 700 to 1,500 kg. At a time when Germany is on the path to becoming one of the world's largest markets for the use of plants for medical purposes , the lack of publicly available data on the consumption of hemp raw materials makes it difficult for potential investors to assess the real market potential of the industry. Unlike Canada , German authorities do not centrally publish statistics on the number of patients or on the volume of therapeutic cannabis sold . However, the German National Association of Statutory Health Insurance Funds published data on insurance claims for the use of therapeutic hemp in the amount of € 30.8 million. And this is to “pay off” almost 80 thousand prescriptions only in the first half of 2018. These data can already serve as certain indicators of market demand for the legal need to use medical cannabis .

In France , more than 1 thousand employees work in the seed sector , and the financial turnover exceeds the mark of 500 million euros. The leader of the French seed market today is Hauts-de-France, which is the most successful enterprise not only in its homeland, but also has international business experience . The cultivation of any crop begins with the acquisition of high-quality seed material . French producers of seed material , including hemp seed , have merged into an intersectoral group under the auspices of GNIS (national interprofessional group of seed production ), where they jointly conduct research in the direction of creating new plant varieties , marketing and marketing of seed products . Seven companies belonging to the GNIS association (5 of which include Hauts-de-France) in 2017 produced 21% of the seeds of grain crops, 12% - seeds of fodder crops and lawn grass, 91% - flax and hemp seeds , 11% - oilseeds.

Growing seed in France is a strictly controlled process. For the cultivation of seeds, farmers enter into contracts with seed companies , which indicate the scope of supply, timing and quality indicators of the product . The Official Inspection and Certification Service (SOC), which is part of GNIS and has the status of a government body, monitors and certifies produced seed .

The rapid development of the hemp products market is forcing members of the European Parliament to pay a lot of attention to the settlement of the “legislative field” for hemp business . The Committee on Ecology, Social Security and Sanitary Control of Food at the European Parliament was tasked with developing a bill that could take into account the interests of both producers of hemp products and its potential consumers . At the same time, one of the main goals of the future legislative act is to provide equal opportunities for the production of hemp goods and products throughout the European Union , as well as uniform production standards that simplify quality control and create a competitive environment. It should be noted that the adoption of a unified legislative framework for the hemp industry will help to separate the legal conduct of the hemp business from the illicit market, and will also support the development of research programs aimed at studying the therapeutic properties of the plant , which must be introduced to use it more effectively .

So, in the world there is a gradual expansion of hemp sown areas, and liberalization of the attitude towards the aforementioned agricultural crop both at the national (official) level and directly in society. The figure shows the geographical distribution of hemp plants, as a culture that is increasingly grown and used as raw material for processing and manufacturing new products . According to analytical data, countries that grow hemp for commercial purposes (indicated on the map in green): Africa , Egypt , North and South America , Canada , Chile , Asia and the Pacific , Australia , China , India, Nepal, South Korea, Thailand, Europe , Austria , Denmark , Finland , France , Germany , Great Britain , Hungary , Poland , Portugal , Romania , Russia , Slovenia , Spain , Switzerland , Ukraine .

Countries that research hemp and develop a regulatory framework for its full involvement in agricultural production (the map is marked in blue) Japan , the Netherlands , and the United States . The United States has lagged behind other countries in the field of research and processing cannabis for decades , providing an opportunity for neighboring Canada to earn money on the export of hemp products to the United States .

World hemp plant growing geography as of 2018

In China, hemp is again used in the textile industry in order to reduce cotton production and possibly even replace it in the future almost completely. In the northeast of China, there are large programs for introducing enzymatically processed hemp fibers into the textile industry . The Chinese auto industry also uses hemp fiber for lightweight construction. The total area of ​​cultivated land increased from 40,000 ha (2016) to 47,000 ha (2017).

After hemp almost completely disappeared after the Second World War and with the worldwide ban on cannabis as a plant that is cultivated, as of today in Canada , China and the European Union, the plant is grown on an area of ​​about 150,000 ha.

Regulatory support in the field of "medical" hemp breeding

At a conference of the European Industrial Hemp Association (EIHA), a map of the EU countries was presented where the use of the low-drug (therapeutic) cannabisa is allowed. Now 21 of the 28 countries that are part of the EU have adopted regulatory acts regulating the legality of the use of hemp or medicines made on the basis of the plant.

EU countries where cannabis is used for medical purposes 

Normative legal acts regulating the legality of the use of hemp for medical purposes have been adopted by the following EU states :

However, it is worth noting that in countries where the use of hemp for medical purposes is not currently regulated, work is underway to create a regulatory framework that will allow the therapeutic properties of the plant to be used .

The most rapidly growing hemp market is in China . China is the largest exporter of hemp paper and textile . Most clothing brands are made in factories in China . Although it’s hard to say how big the cannabis industry is actually in China , a recent analysis showed that it is around $ 200 million.

Cannabidiol (CBD) is approved as a medicine in almost all European countries and is grown in greenhouses for the needs of the pharmaceutical industry. Last year's International Conference in Harbin ( China ) was one of the largest events that have ever been held. 300 delegates from China , Australia , Europe and Canada presented success stories from around the world and discussed future production and marketing strategies for even better cannabis products . The conference demonstrated the importance and versatility of ecological products from plants .

The cultivation area in Heilongjiang Province of China alone increased to 74,000 acres (30,000 ha) last year alone - an area comparable to the total hemp cultivation area in Canada or Europe . And the plans of provincial officials to double the area of ​​cultivation of the plant next year.

Over 500 patents have been granted in the hemp industry in China . They include sowing , processing , textiles , food , oil , paper production, medicine , etc. Most of them are owned by Chinese companies and private entrepreneurs, and some by foreign enterprises.

In recent years , research , sowing and processing of hemp has been rapidly developing in China . The industrial hemp sowing area in China in 2017 was about 50 thousand hectares. There are more than 20 companies producing CBD.

Universities from Heilongjiang, Ukraine and Canada have launched a comprehensive research program to develop new hemp varieties , more versatile and efficient combines and new technologies for the production of hemp fibers, seeds and inflorescences . Berlin-based HANF FARM GmbH has developed the unique Multicombine HC 3400 combine.

The leadership of Heilongjiang Province is convinced that it is on the right track and is looking for partners in Europe and North America for international cooperation. They have the resources to create a modern industry and provide subsidies, as well as effective infrastructure.

And what about hemp crops in Ukraine ? Analyzing the dynamics of changes in hemp sowing areas in Ukraine over the period since 2000, it can be noted that growth from 0.3 thousand ha in the worst year (2009) to a relative peak (3.47 thousand ha) in the last period was the result of painstaking the work of the Bast Institute and the Ukrainian Technical Hemp Association in the direction of popularizing culture and changes in the regulatory framework.

The decline in sown areas (2.7 thousand ha - 2017, 1.3 thousand ha - 2018) is primarily due to the unstable demand for hemp products (raw materials - fiber , seeds ; finished products - processed food , textile  and construction products) products, energy products ). The development of the hemp breeding processing industry will positively affect the development of the industry , which will make it possible to obtain not only raw materials for sale, but also a finished product at affordable prices. The medical use of hemp for Ukraine can become not only an incentive for the development of the hemp industry, but also for the development of related processing sectors of production.

 

Location geography of hemp enterprises in Ukraine in 2018

Interesting industry development experience in Uruguay

Uruguay is a country that seeks to regulate the medical cannabis market . The main part of this market in the state was until recently in the shade. According to a published report by the relevant government agencies, despite problems with the supply of legal hemp, Uruguay redirected the sale of cannabisa by about $ 22 million from the illegal sector to a regulated market . In accordance with the policy of the aforementioned South American country, the implementation of the hemp policy of the state was rather slow. From the moment of its adoption in 2013 to the present day, adult citizens of the country have three legal options for using cannabis:

- growing plants in home / private conditions - the mechanism has been working since 2014;

- the use of hemp in social hemp clubs - since 2015;

- sales of products through the pharmacy system - from July 19, 2017.

According to experts from the hemp market, 68% of registered users legally grow a plant in the private sector, 20% are members of hemp clubs, and only 12% of total sales come from pharmacies.

According to a joint official statement issued by the Cannabis Regulatory and Control Institute (IRCCA) and the Uruguayan cannabisa regulatory agency, the current situation is hampering the development of the system and its beneficial effects, such as reduced illegal access to marijuana and the gradual increase in the use of controlled products with hemp regarding their quality and safety, as well as changes in the practice of consumption of products .

Constant problems with the supply of the required amount of legal hemp prevented until recently the normal functioning of this business. The regular acute shortage of the product required by the market led to the start of a new application process in early February to increase the number of manufacturing companies

As part of this process, it was decided to select an additional three companies that will be engaged in the cultivation of hemp. Each of the winning companies must sign a contract with the government for the annual supply of 2000 kg of “green mass” of the plant, and they plan to conclude contracts for 5 years. It is planned to move companies that have lost the competitive selection to an additional “waiting list”, which government structures can bring to the market if a decision is made to further expand this market in the country.

Currently, only two companies have been granted licenses for the legal cultivation and sale of recreational hemp in pharmacies authorized to carry out this activity. The only retail outlets where cannabis can be legally purchased in Uruguay is the ICC Labs pharmacy chain, which was recently acquired by Canadian company Aurora Cannabis and Symbiosis. In the first 500 days of legal sales of psychoactive hemp using the above pharmacy network, a total of 1916 kg was sold (an average of 3.8 kg / day). The total sales in pharmacies amounted to about $ 2.6 million, of which manufacturing companies earned $ 1.8 million.

Cannabis sales in pharmacies in Uruguay

The main conclusion that suggests itself from the experience of Uruguay is that the state should not turn its back on hemp market regulation . An appropriate program should be developed that can regulate in any legal field any hemp market in the country - recreational, medical, therapeutic, industrial . Failure to acknowledge the existence of problems in the field gives rise to the black market and corruption, which is inappropriate in the first place to attract investment .

The nuances of the Ukrainian market of "medical" hemp

Some initiators of the appeal to the Supreme Council on the legalization of medical marijuana categorically argue that in our country about 2 million patients are potentially interested in cannabis preparations. This figure is clearly overstated. In order to confirm or refute these claims, the Ukrainian Technical Hemp Association ordered an analytical study of the medical hemp market in the countries of the European continent from the Hemp Consulting consulting company . Research data showed that, for example, in Israel (8.9 million people, the country constantly wages war), where medical hemp and drugs based on the therapeutic properties of the plant have been actively used for more than 20 years , only about 25-30 thousand patients use cannabinoid therapy . In the EU countries and in Canada, the number of patients using the therapeutic properties of hemp or drugs based on them is comparable with the Israeli figures, but not with the 2 million citizens indicated in the petition. According to the calculations of studies conducted by Hemp Consulting in Ukraine, about 200 thousand potential patients are interested in the need for cannabis preparations or hemp therapy . The development of the domestic regulatory framework and the development of Ukrainian capacities for the production of a closed chain - cultivation - primary processing - the production of therapeutic or pharmaceutical preparations, will expand the circle of potential patients to 500 thousand. It should be noted that the development of the regulatory framework should occur simultaneously with the planned information state policy aimed at creating a positive image of hemp therapy , respectively, is confirmed by clinical and scientific my research. Therefore, it is necessary to develop related high-tech industries - breeding , agricultural technology, the processing industry , etc.

Why are foreign companies interested in developing the medical field of hemp use ? Very often, foreign medical preparations are made either on the basis of synthetic cannabinoids (harmful to health) or on the basis of extracts of specifically taken cannabinoids (in the vast majority - cannabidiol, in much smaller quantities canabinol, canabichromene, cannabigerol, etc.). However, during the extraction, up to 90% of the medicinal properties of the plant are lost and, most importantly, the bonds are broken, on the basis of which the cannabinoids "work in the ensemble" - reinforce each other's work. In addition, in some cases, scientists still do not know which cannabinoids have a therapeutic effect in relation to a particular disease. There is another nuance that is not voiced by manufacturers of cannabis-based drugs. In the event that the drug contains more than 0.8% THC, the drug practically does not work (its therapeutic properties are lost). Nature created the plant in such a way that the effect of THC in hemp is balanced by the counteraction of other cannabinoids, primarily CBD. These properties correspond to varieties of technical hemp of a therapeutic orientation , which are bred on the territory of our country. Therefore, foreign manufacturers of medical cannabis are interested in discovering our market right now, when the domestic industry is weak and underdeveloped. This will give them the opportunity to control the market and establish their own “rules of the game." And with our corrupt officials of all ranks - this is not difficult.

For our consumers of hemp products and potential patients requiring hemp therapy, there is also one interesting observation from scientists and market experts . Why should a person take medicine if it is enough for a patient to eat therapeutic therapeutic hemp leaves and inflorescences ? Today there are hemp varieties bred in Ukraine, in which THC is less than 0.05%, and CBD is more than 1.5% . The experiments show that the use of fresh or dried therapeutic hemp leaves of a therapeutic nature gives a huge therapeutic effect - it significantly reduces pain and cures migraines, allergies, various neurodegenerative diseases, etc. In Ukraine , having issued the appropriate permits, you can grow the above grade Curative / treated or buy juice, smoothie, seasoning, food , cosmetics , Additives supplements , etc.., which already exist and are in great demand on the domestic market . At the same time, the Ukrainian consumer will buy goods for tens of hryvnias, and not for hundreds of dollars, pharmacological preparations based on hemp extracts made abroad.

conclusions

First , the issue of amending the legislative framework in accordance with which the therapeutic properties of hemp will be used not only for industrial, but also for scientific and medical purposes, must be treated positively. But there is no need to change the legislative framework in the interests of foreign companies that are lobbying for the opening of a market for products of dubious quality. In Ukraine, created new technical varieties of cannabis therapy , the use of which gives the best result at more affordable prices than pharmaceuticals, imported from abroad.

The second - if we talk about the national practice of treatment with leaves and inflorescences of technical hemp of a therapeutic orientation , then it is extremely effective . No need to buy very expensive foreign drugs based on hemp extract. You can buy oils , juices, seasonings, cosmetics, or by issuing the appropriate permits to independently grow non-narcotic varieties of a therapeutic orientation and on an ongoing basis to heal or be treated . In addition, Ukraine has experience when appropriate conductors and catalysts are added to the "green mass" of plants and the resulting substance, which excludes extraction (currently prohibited by law), is extremely effective in the treatment of very serious diseases, including chronic ones . There are documented examples in Ukraine of the treatment of inoperable forms of cancer , in particular of persons with the fourth (terminal) stage of cancer.

Third , how to accelerate the legalization of hemp in Ukraine ? You can follow the path that the Ukrainian Technical Hemp Association has been using for a long time. To amend the legislation through the decisions of the CMU. This is a much simpler and more efficient way to use for industrial purposes hemp leaves and inflorescences , in the dried straw of which the THC content does not exceed 0.08%. Experience shows that PKMU undergoes review and is accepted within 4-5 months. In fact, in the case of the adoption of such changes in 2020, patients in Ukraine will be able to be treated with the "green mass" of technical hemp of a therapeutic nature , and from April 2020 , anyone who wants to will be able to grow non-narcotic varieties that have a significant therapeutic effect if if they complete the necessary permits in such cases .

PS Today it is quite difficult to assess the potential market for therapeutic or medical hemp in Ukraine , since its use is not permitted by law. An analysis of similar markets for medical hemp developing in Europe showsthat the potential number of patients who can use cannabis-based medicines is predicted by experts for the next 5 years in the amount of 1 - 2% of the total population. For our country, this is about 500,000 patients. But it should be noted that this figure is possible only if the use of appropriate drugs is legally legalized. In the opposite case, even this number of patients in Ukraine will not be. And one more factor should be taken into account, the psychological readiness of people to use the “new” method for treating medical hemp for them. Not every patient who needs such treatment will be ready to apply it for himself, because in our conservative society, stereotypes regarding hemp plants are still strong.

Author: 
Primakov O.A., Ph.D., Senior Researcher, Head of the Department of Research on Intellectual Property and Innovation Marketing, Institute of Bast Crops, NAAS of Ukraine
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