Last updated: 9 ธ.ค. 2562 |
PUBLISHED : 9 Dec 2019 - 16:14
Will the Polish medical cannabis market set itself ahead of the game in Europe as the medical cannabis industry evolves? The Polish medical cannabis market is becoming more and more open. Does this mean that Poland, step by step will move towards further changes in legal regulations and in the future will become a leader in the medical cannabis market?
In order to answer the aforementioned question, one should consider such issues as how current Polish legal regulations affect the possibilities of placing medical cannabis on the market.
Legal possibilities for the cannabis sativa market – CBD
The Polish legislator allows the cultivation of hemp for nutritional, pharmaceutical, cosmetic, chemical, textile, pulp and paper industries, including the production of building materials and seed production. Similarly, there are no restrictions on its import, export and processing.
Cultivation of cannabis sativa L. hemp, in which the total content of delta-9-tetrahydrocannabinol (-9-THC) and tetrahydrocannabinolic acid (delta-9-THC-2-carboxylic acid in the flowering or fruiting tops of plants from which the resin has not been removed) does not exceed 0.2% of dry mass may be carried out with an appropriate permit, in designated areas of the state, on a strictly defined surface, using seed of the elite or certified category (within the meaning of the seed regulations).1
The cultivation permit is issued by the commune head, mayor or city president competent for the location of cultivation. The condition for obtaining a permit is no criminal record for the offenses referred to in art. 63, 64 or 65 of the Act of July 29, 2005 on counteracting drug addiction. i.e. for:
Growing hemp is only possible:
In the case of processing hemp from their own cultivation for the needs of the textile, chemical, cellulose and paper as well as food, cosmetic, pharmaceutical, building materials or seed industries, the farmer makes an appropriate commitment to the voivodeship marshal competent for the place of cultivation, within 14 days of sowing them.
Currently, there are no regulations in Polish law that could limit the way in which hemp is processed, i.e. those which specify the final product from the cultivation or processing of this type of plant (oil, dried, honey from CBD, etc.), provided that the final intended use will be consistent with the catalogue described above.
It is worth emphasising that CBD cannabinoid can be used in cosmetics. These types of products arouse a particular interest in customers and tend to appear in Poland more and more often. Until now, CBD could not have been used in the food industry. The reason is the lack of recognition of CBD-enriched food as a novel aliment. The Polish Chief Sanitary Inspector has only recently specified the conditions that must be met in order for CBD products to be used for food purposes. These are new legal provisions, and these paths have not yet been practically studied.
The circumstances described above stimulate the Polish hemp market and increase the number of producers of at least CBD oil. Similarly, the interest of Polish farmers in the cultivation of hemp is enhancing. The growing area of hemp cultivation is illustrated in the table below.
The above data were prepared on the basis of agricultural producers declarations and relate only to the area of crops located on registration plots submitted in applications for agricultural subsidies made by the Agency for Restructuring and Modernization of Agriculture.2 However, not all Polish farmers declare their crops to this institution.
Analysing the possibilities of growing and producing products containing CBD, it should be mentioned that no guidelines regarding the quality of such products or their designations were introduced. This means that the producer of CBD oil is not obliged to determine the level of CBD in the product. Such a product can be purchased without medical prescription. Similarly, there are no guidelines on how to use CBD oil, how to calculate its dose depending on body weight and whether special precautions should be taken when consuming it together with other products (e.g. honey, wine, beer).
Legal possibilities for the medical cannabis market – THC
In November 2017, amendments to the Act on counteracting drug addiction entered into force. According to the newly introduced art. 33a (cited in paragraph 1):3
“Herbs other than fibrous hemp and extracts, pharmaceutical tinctures, as well as all other non-fibrous hemp extracts and non-fibrous hemp resin referred to in the provisions issued under Art. 44f, may constitute a pharmaceutical raw material referred to in art. 2 point 40 of the Act of 6 September 2001 – Pharmaceutical Law, intended for the preparation of prescription drugs referred to in art. 3 clause 4 point 1 of the Act of 6 September 2001 – Pharmaceutical Law, after obtaining the marketing authorisation issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, hereinafter referred to as the ‘President of the Office.’
Art. 2 point 40 of the Act of September 6, 2001 – the Pharmaceutical Law Act, gives a definition of pharmaceutical raw material. According to the wording of the aforementioned provision, ‘the pharmaceutical raw material is a substance, or a mixture of substances used in the preparation or manufacture of medicinal products.’” The pharmaceutical raw material, by definition alone, can be used to manufacture more than one medicinal product.4
In accordance with art. 2 points 32) the Pharmaceutical Law Act:
“A medicinal product is a substance or a mixture of substances, presented as having properties for the prevention or treatment of diseases occurring in humans or animals or administered for the purpose of diagnosis or for the restoration, improvement or modification of the physiological functions of the body through pharmacological, immunological or metabolic action.”
Pursuant to Polish law, hemp in a certain form may constitute a pharmaceutical raw material intended for the preparation of prescription drugs (Article 33a in connection with Article 3 (4) point 1 of the Pharmaceutical Law Act), after obtaining a marketing authorisation. This authorisation in the form of a decision is issued for a period of five years by the President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (Article 33a (2) and (3) of the Act).
An analysis of the definitions of the terms ‘substance’, ‘pharmaceutical raw material’ and ‘medicinal product’ shows that it is not possible to normatively identify the terms substance and medicinal product, even if ultimately the active substance in a given medicinal product is one pharmaceutical raw material consisting of one substance.5
On the other hand, the manufacture of a medicinal product is considered to be any activity leading to the creation of a medicinal product, including the purchase and receipt at the place of manufacture by the manufacturer of materials used for production, production, admission to subsequent stages of manufacture, including packaging or repackaging, and storage and distribution of manufactured medicinal products covered by the application for manufacturing authorisation, as well as control activities related to these activities (Article 2 point 42 of the Pharmaceutical Law Act).
Polish law indicates that it is not possible to grow medical cannabis in which the total content of delta-9-tetrahydrocannabinol and tetrahydrocannabinolic acid (delta-9-THC-2-carboxylic acid content in the flowering or fruiting tops of plants from which the resin has not been removed), exceeds 0.2% of dry mass. This type of product can only be imported into Poland and put on the market based on the permits used.
Permission to import medical cannabis (key legal regulations)
The first step towards introducing medical cannabis to the Polish medical market is obtaining a permit to import medicinal products.
An application for such a permit should be submitted to the Main Pharmaceutical Inspector in paper or electronic form. The application (pursuant to Article 39 of the Pharmaceutical Law Act) must contain:
The application should be accompanied by the Main Documentation of the Business Place prepared in accordance with the Good Manufacturing Practice requirements and a list containing the name, dose and pharmaceutical form of manufactured or imported medicinal products.6
If the conditions for obtaining the permit are met, the Main Pharmaceutical Inspector issues the permit for an indefinite period.
These types of conditions include:
The medical cannabis importer who has obtained the authorisation to import this product is entered in the Register of Manufacturers and Importers of Medicinal Products and has the obligations described in art. 42 of the Pharmaceutical Law.
The most important duties include:
The medical cannabis importer may obtain the active substance:
Medical cannabis marketing authorisation (most important legal regulations)
The next step towards placing medical cannabis on the Polish market is obtaining marketing authorisation from the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (hereinafter the President of the Office).
In order to obtain such permission, the applicant submits an application containing (Article 33c of the Act on counteracting drug addiction):
The President of the Office shall refuse to issue a permit if:
Another important element regarding the introduction of medical cannabis to the market in Poland is that:
The table below presents the current state of the market in relation to legal regulations.7
Currently, the Polish market of medical cannabis (THC) recipients (patients) is estimated at about 300,000 people, and it keeps growing. Some experts also provide data showing that soon this number can reach up to one million patients.
Dried cannabis available in Polish pharmacies has 19% THC and 1% CBD and, as some doctors believe, it is impossible to rationally treat and develop cannabinoid therapy with only one drug of a specific composition from a whole range of different varieties and plant compositions.
In addition, current sales prices for this product are significant (2019). On the Polish market, the cost of buying 1g is currently PLN 60-65 (EUR 12-15). It is estimated that in the standard case of treatment the patient requires receiving up to 30 grams of cannabis per month, which means that the potential cost of treatment per month is about PLN 1,800 (about EUR 412).
Bearing in mind the short experience of the Polish medical cannabis market, it can be stated that there is still not only the matter of limited availability of other products (with a different share of THC and CBD), but also the necessity to provide a proper education in this field for doctors and patients. First of all, providing the right knowledge about the use of medical cannabis, dosage, expected effects, availability, is a significant key to the further development of this market.
“In theory, any doctor can write a prescription for medical cannabis. In practice, few have sufficient knowledge about it. The Ministry of Health is reluctant to help change it, so the medical community is coping”, writes Polityka.pl.
A Polish doctor acquires knowledge about cannabis from conferences and training. They are organised by doctors themselves, as well as by other specialists who deal with the promotion of knowledge about the use of cannabis in medicine. One of such places is the Medical Marijuana Consultation Point, which was launched on July 7, 2015 at the Consulting Point in Pain Management Clinic and is run, among others by Dr Jerzy Jarosz.
It is noteworthy that at present the Polish legislator has begun analyses and consultations towards a potential introduction of a licence to grow medical cannabis in Poland. Such permission is considered to be granted to a public entity.
Analysing the changes that have been introduced to the Polish legal system, as well as looking at the current shaped medical cannabis market in Poland, it is possible to think that it is an extremely flexible and somewhat chaotic world. There are more and more patients waiting for the possibility of medical cannabis treatment. However, there is still too little education on this subject. In addition, despite the submission of many applications for consent to the import and distribution of medical cannabis, there is only one product distributed to Polish pharmacies.
Legal regulations regarding the sale of products containing as a main product CBD (after all, also with medical qualities), with a low THC (up to 0.2%) are quite broad, but also new in terms of time. It is worth noting that the Polish government is currently working on a new common agricultural policy for 2021-2027. One of the tasks of this policy is the processing of hemp inflorescences for pharmaceutical, cosmetic and food purposes, and this opens the path for extensive use of CBD.
The changes in Polish law, which concern the possibility of using THC by Polish patients, are happening faster nowadays. It raises expectations that the Polish medical cannabis market will grow even faster. Using the knowledge and experience of other countries, Poland can avoid many mistakes in this process and can show a dynamic development in this field.