Why the Irish Medical Cannabis Access Program is interesting for the national market

Why are the officials of the Ministry of Health of Ukraine currently blocking the regulation of the possibility of the widespread use of the therapeutic properties of technical hemp of a therapeutic orientation not for specific patients, the cost of drugs for which in the future will need to be paid from the state budget? What is the reason that government agencies do not want to regulate the possibilities for cultivation, as well as the use of leaves and inflorescences of therapeutic hemp, which have a huge therapeutic potential by individuals, and also do not "launch" the market for using the therapeutic properties of socially safe varieties with a huge range of uses for industrial purposes.

The Irish Ministry of Health announced that a new Medical Cannabis Access Program (MCAP) has been in operation in the country since July 2021, under which patients receiving pharmaceuticals based on the therapeutic properties of the plant, with the approval of the Ministry, will receive compensation for used products directly from the state budget.

As part of the new Medical Cannabis Access Program, Irish patients have several options to determine the legitimacy of using the plant's therapeutic properties:

•  Ministry approval that a patient can theoretically access any hemp product used for medical purposes for any condition with the written permission of the Minister of Health. Applications must be made by the patient's primary care physician, with the approval of the relevant healthcare professional. Currently, in this way they gain access to pharmacological preparations based on the therapeutic properties of hemp in 63 patients;

•  pharmaceuticals Sativex and Epidyolex, approved for the treatment of a limited range of pathological conditions - for example, spasticity in multiple sclerosis, as well as rare childhood forms of epilepsy - and can be prescribed by any doctor. These pharmaceuticals are not recommended for reimbursement by the Irish Health Authority and therefore remain “poorly marketable”;

• a  new MCAP, according to which a patient can be registered with a medical specialist in order to gain access to a set of pharmacological preparations based on the therapeutic properties of cannabis for the treatment of a limited number of diseases.

According to the Minister of Health, doctors can now apply to enroll their patients in the MCAP program. The program has evolved over the years since it was proposed by the Health Products Regulatory Authority (HPRA) in 2016. According to the approved scheme, only doctors with a specialty in their respective fields will be able to register their patients for medical services related to the use of hemp products from a carefully selected list of drugs.

Patients are eligible for the MCAP program only if they have not received relief through conventional treatments, suffering from: 

- spasticity associated with multiple sclerosis;

- intractable nausea and vomiting associated with chemotherapy;

- severe, resistant to treatment epilepsy. 

The limited set of drugs will only eventually be approved by the HPRA for use as part of the proposed treatment regimen. Reimbursement of drug costs is not guaranteed and will only be approved for the specified patient and only for those consumers who receive pharmacological drugs using: a medical record, a long-term disease plan or a drug payment plan. Some details regarding the pricing of medical cannabis dispensing in pharmacies have yet to be agreed.

Once a medicinal product based on the therapeutic properties of cannabis is approved for use under the MCAP, operators wishing to distribute it will need to apply for an annual controlled drug license in addition to the controlled import license for pharmaceuticals for each imported shipment. As of March 2021, three wholesalers were allowed to import hemp-based medical products, with 12 batch import licenses issued, of which only two were used.

On July 20, it was announced that the state will pay for the treatment of 17 patients receiving hemp products with significant therapeutic potential with the approval of the ministry at a pharmacy in the city of Transvaal in the Netherlands. 

Commentary of the specialists of the Association "Ukrainian technical hemp"

The work on the creation of the Program began in March 2017 based on the findings of the expert report of the Office for the Regulation of Medical Products "Hemp for Medical Use - Scientific Review", which was prepared at the request of the Minister of Health. Following the publication of the report, the Minister established an expert group to advise on the development of a medical cannabis access program, which provided clinical guidelines for the program. 

On June 26, 2019, the Minister of Health signed a regulation authorizing the “launch” of the Medical Cannabis Access Program on a pilot basis within five years. The program facilitates access to hemp-based products for medical use in accordance with current regulatory requirements as well as clinical guidelines. Hemp products are added to the Schedule of the Rules only after they are deemed eligible for use under the Medical Cannabis Access Program. It should be borne in mind that the scheme for medical access to cannabis is not subject to revision for 5 years.

Practically everything is instructive in the above information for the national market:

- it is necessary to pay attention to the scanty number of patients who use pharmacological drugs based on the therapeutic properties of cannabis, when they are not reimbursed for their cost and lobbying by pharmacological companies aimed at increasing the number of patients solely by providing the opportunity to compensate the cost of pharmacological drugs for state budget account (a similar trend is observed in all economically developed countries of the world);

- the trend, which can be traced in all countries that regulate the possibilities for the use of the therapeutic properties of hemp for medical purposes - the next stage after the regulation of the possibility of using pharmacological preparations based on the therapeutic properties of hemp raises the question of reimbursing the cost of the above mentioned pharmacological preparations from the state budget;

- in Ireland, as well as in a number of other economically developed countries, before making changes to the current regulatory framework, a corresponding pilot program has been launched, within the framework of which the mechanisms of working with pharmacological preparations based on the therapeutic properties of the hemp plant are being worked out;

- “regulation” of the possibility of using the therapeutic properties of the hemp plant, through the use of a strictly defined number of pharmacological preparations, which must undergo appropriate certification and demonstrate safety in relation to the patient;

- a strictly limited number of diseases for the treatment of which pharmacological preparations made on the basis of the therapeutic properties of cannabis can be used;

- the use of pharmacological preparations based on the therapeutic properties of hemp exclusively in cases where traditional treatment has not brought relief to the patient;

- the lack of own companies that can meet the demand of patients predetermines the import of exclusively foreign pharmaceuticals.

And now an extremely simple question - “How the experience of using the therapeutic properties of cannabis in Ireland should fundamentally differ from what is imposed on the Ukrainian market. Why should the state structures of our country not act according to the logic of the bureaucracy of the rest of the economically developed countries of the world ”. Based on the foregoing, an extremely simple question arises - why are the officials of the Ministry of Health of Ukraine currently blocking the regulation of the possibility of the widespread use of the therapeutic properties of technical hemp of therapeutic orientation not for specific patients, the cost of drugs for which in the future will need to be paid from the state budget. What is the reason that government agencies do not want to regulate the possibilities for cultivation, as well as the use of leaves and inflorescences of therapeutic hemp, which have a huge therapeutic potential by individuals, and also do not "launch" the market for using the therapeutic properties of socially safe varieties with a huge range of uses for industrial purposes.