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Table 2 Expectations and predictable actions of the key stakeholders in the medical cannabis market in Ukraine

From: Perspectives on formation of medical cannabis market in Ukraine based on holistic approach

Expected results Predictable actions after legalization Notes
Stakeholders: high interest / high power
Public organizations (activists): patients, healthcare professionals, lawyers, politicians, scientists, business representatives and other concerned parties
  Ensuring the interests of patients in obtaining economically and physically available, high-quality, effective, safe medical and pharmaceutical care when using medical cannabis. Monitoring patients’ rights to receive appropriate medical and pharmaceutical care, cooperation with state regulatory bodies, health professionals, patients and other stakeholders. Creation and support of the stakeholders network to inform and exchange ideas and experience. Carrying out activities for better social awareness of medical cannabis, advantages and risks of its use including activities participated by opinion-leaders (PR-actions, operation of various societies and voluntary organizations). These stakeholders are a ‘driving force’ at the stage of preparation to the process of medical cannabis legalization, especially concerning stakeholders having a high power but low interest.
They possess high power due to their leadership qualities, charisma, the ability of inspiring and uniting people with similar values.
Stakeholders: low interest / high power
Legislative and regulatory authorities
  Development and adequate performance of the system that provides affordable and effective medical and pharmaceutical care by using medical cannabis through various tools, such as the Health Technology Assessment (HTA), under the international Conventions’ requirements, the WHO’s recommendations, reports and alerts of the INCB and other international documents. Creation of legal framework regulating the medical cannabis turnover, also as a component of the general strategy of state narcotic drugs policy, which may include legalization of other drug containing plants and decriminalization of their use. Introduction of amendments and changes to various normative legal documents, for instance, to the Law of Ukraine “On Narcotic Drugs, Psychotropic Substances and Precursors” (Law of Ukraine 1995), as well as to subordinate laws, such as the Decree of CMU №770 (Decree of CMU 2000) and others. Establishing conditions to create new herbal medicinal products or herbal preparations by developing monographs in the State Pharmacopoeia of Ukraine (SPhU). Introducing the mechanisms of cannabis traffic regulation for medical and scientific purposes according to Art. 23 and Art. 28 of the 1961 Convention (United Nations 1961). The medical cannabis market is new for Ukraine, yet the existing legal and regulatory system can provide regulating instruments, according to the requirements of International Conventions (licensing, quoting, needs assessment, harvest control, etc.). For this reason, it requires some amendments to be introduced on behalf of government, in particular the Ministry of Health of Ukraine (MHU) and the State Service of Ukraine on Medicines and Drugs Control.
Law enforcement authorities
  The presence of a legal framework to regulate and prevent the illicit trafficking of cannabis-based preparations, containing narcotic drugs and psychotropic substances. Providing preventive mechanisms for illicit turnover of medical cannabis containing narcotic drugs and psychotropic substances (herbal substances, herbal preparations or medicinal preparations of herbal origin, both registered and prepared in pharmacy conditions) in accordance with the current legislation of Ukraine. The lack of decriminalization of cannabis and corruption element in Ukraine may reduce the effectiveness of regulating its illicit trafficking.
Stakeholders: high interest/ low power
Patients
  Obtaining physically and economically available, effective and safe medical and pharmaceutical care with the application of CBMP to improve the health and life quality. Monitoring additional information on cannabis-based preparations for treatment and their official status: cooperation with health specialists (physicians, licensed pharmacists), association into public organizations (groups) for self-assertion as to obtaining accessible medical and pharmaceutical care. Negative tendencies in Ukraine should be taken into consideration: the average availability level of the ‘golden pain management standard’ – morphine – was between 11.2 and 14.3% during 2012–2016, even despite the liberalization of legislation (Institute of Analysis and Advocacy 2018).
Growers of cannabis
  Possibility of official cultivation and growing of cannabis plant, both of outdoor (hemp) and indoor (medical marijuana), with various THC and CBD content, within the legislative environment framework. Legislation liberalization as concerns the growing of hemp. The purpose is to create a sustainable business (investment promotion, gaining a market share, profitability). Cultivation and growing of cannabis strains with various THC and CBD content for industrial and medical purposes, depending on the requirements of the current legal and regulatory framework. Investment promotion for creating relevant conditions for growing cannabis, especially indoor, personnel preparation and training, safety provision, automation of the process, as well as formation and support of sales markets considering competition, etc. Additional advantages: new job opportunities, development of business activity, including small businesses, investments promotion, encouraging ‘illicit’ growers to come out of the shadow, etc.
Manufacturers of CBD-products
  Liberalization of growing, processing and manufacturing of CBD-products based on the varieties with a low THC-content (their turnover shall not fall into the scope of the law on narcotic drugs and psychotropic substances). Creating conditions for the development of a sustainable profitable business within the legislative environment. Manufacturing CBD-products in accordance with the legal framework considering the minimum permissible THC level (0.2% in the EU countries, 0.3% in the USA, 1% in Switzerland). Investments promotion: establishing economic and technical conditions for processing cannabis herbal substance, manufacturing and qualified staff training. Creation of identifiable brand, the product portfolio reaching the preferences of target audience, product promotion, formation and realization of a competitive strategy for business development. The CBD-products market is highly competitive: there are fewer legal limitations, high growth and profit rates and, currently, low entry barriers in the Ukrainian market (an attractive factor for foreign companies). Additional advantages: creating new jobs, business promotion,
revenues for local and state budgets, etc.
Pharmaceutical manufacturing companies
  The product portfolio diversification due to development and manufacturing of cannabis-based products, including narcotic and psychotropic products, gaining a new market share, profitability improvement, image creation, brand formation. For foreign companies: entering a new market with goods from their product portfolio. For domestic companies: creation of new medications including narcotic and psychotropic ones (preclinical and clinical trials, formulation of dosage forms and methods of quality control), registration, manufacturing, sales, promotion, pharmacovigilance.
For foreign companies: entering a new medicinal products market, their registration (Epidiolex, Sativex) or entering the standardized products market, for instance, of cannabis flowers, including manufacturing of CBMP under pharmacy conditions.
Foreign companies have an advantage compared to domestic ones, which is the time factor and intangible resources including effective promotion of cannabis-based preparations. Their major disadvantage is the product price and low economic accessibility for the Ukrainians.
Distributors (wholesale pharmaceutical companies)
  An opportunity of purchasing, storing and selling of CBMP to wholesalers (distributors), retailers (drugstores) and for storing (health care institutions) backed up with licensing. Consequently, there is the entrance into a new market, product range enlargement and profitability. Purchasing of cannabis-based preparations from manufacturers (foreign and domestic ones), logistics organization, storing, trading (wholesale pharmaceutical companies, pharmacies, healthcare facilities) in accordance with legal requirements, including those for narcotic and psychotropic substances circulation. These intermediaries are currently interested in the market of registered medicines or of CBMP containing narcotic or psychotropic substances that can be sold only via drugstores.
Pharmacies (with extemporaneous compounding)
  Legal opportunity of CBMP manufacturing under the pharmacy conditions in line with current legislation - for instance, cannabis oil from standardized raw materials or dronabinol. Writing monographs on cannabis plant, cannabinoids (THC, CBD), etc. Entering new markets (patients, health care facilities), brand formation, profitability. Purchasing of cannabis herbal substances for CBMP manufacturing under magistral formulas, establishing economic and technical basis for extemporaneous compounding, drugs form formulations, qualified personnel training, and quality control under the current legislation. Cooperation with physicians, studying of the current legal framework, providing high-quality pharmaceutical care. Cannabis-based preparations made under magistral formulas have a competitive advantage. They are not subject to state registration in Ukraine. Besides, pharmacies can sell finished pharmaceutical products or dietary supplements containing cannabinoids.
Higher education institutions (scientific research institutions)
  Formation of new competencies for students and scientists, adjustment or creation of training programs in accordance with current scientific results (for example, meta-analysis).
Obtaining new knowledge through the science and consequently creating scientific products (dissertations, articles, monographs, patents, etc.) to improve lives and society.
Adjustment of training programs and curricula for medical and pharmaceutical higher education institutions (departments) given the scientific-based results on cannabis and cannabinoids therapeutic properties, their application in medical and pharmaceutical practice, etc. Conducting scientific research, creation of new research products, organization of scientific conferences, regular experience exchange. Development of HTA issues and standards (protocols) of treatment. Higher education institutions are, normally, scientific centers, which allow research results to be integrated into training programs for students. Besides, scientific research institutes can be separately considered as the basis for conducting scientific research.
Stakeholders: low interest / low power
Healthcare professionals (physicians, pharmacists)
  For physicians: availability of CBMP with effectiveness evidence base and safety for treating various diseases, existence of treatment protocols and clinical guidelines, legal framework allowing them to prescribe cannabis-based preparations for medical use.
  For pharmacists (licensed drugstores): existence of legislative framework allowing them to legally purchase, store, produce and sell CBMP, including those with narcotic and psychotropic properties.
Acquiring new knowledge on medical cannabis, modes of action, evidence base, functioning of endocannabinoids system and other information through self-education and training programs. Establishing professional associations, sharing experience and knowledge, studying the legal and regulatory framework on cannabis-based preparations turnover and their availability in various countries. It is important for state bodies, public organizations and professional associations to take necessary adjustment steps in terms of little interest and low motivation shown by many health specialists. This is determined, among other factors, by insufficient awareness of medical cannabis, prejudices and reluctance to change the legal and regulatory framework.
Citizens
  Safety and good order legal protection through the enforcement authorities and prevention of the illicit turnover of CBMP containing narcotic and psychotropic substances. Compliance with national laws regulating the flow of medical cannabis containing narcotic and psychotropic substances. These stakeholders are heterogeneous. For instance, a greater focus should be placed on church representatives, separate local communities, as they can have their special purposes, expectations and values.