Before medical marijuana was legalized, the law made it illegal.
Art. 33a of the Act of July 29, 2005. on counteracting drug addiction: Non-fibrous hemp herb and extracts, pharmaceutical tinctures, as well as all other extracts [...] may be a pharmaceutical raw material [...] after obtaining a marketing authorization issued by the President of the Office for Registration of Medicinal Products, Products Medical and Biocidal Products.
Waiting for raw material (2017-2019)
The process of medical marijuana legalization in Poland.In the period from July 2017 to January 2019, the legal status of medical marijuana allowed doctors to prescribe a raw material that was not available in Poland. During this period, target imports of dried cannabis continued through pharmacies from foreign producers. Only in 2018, the Main Pharmaceutical Inspectorate received applications for a license to import the following products: Bediol, Bedrocan, Bedrolite, Bedrobinol, Bedica iPedanios as part of target import. The total amount of imported products was then 3.85 kg. The remaining patients waited for the introduction of new pharmacy products or used cannabis purchased on the black market at that time.
Patients' knowledge of the effects of medical marijuana and its side effects is very often based on experiences of buying cannabis on the black market. The lack of adequate availability of the raw material in pharmacies and the low level of information so far make patients reach for droughts of unknown origin, containing heavy metals and pesticides, which were not subject to any supervision of the cultivation, storage or sale process.. The unknown cannabinoid spectrum of black market marijuana and the lack of medical supervision have left many patients discouraged from cannabis therapy.
Problems in the way of medical marijuana producersThe reasons for the lack of medical marijuana in Polish pharmacies were discussed in detail during the international cannabis conference. An expert panel devoted to the medical marijuana supply chain brought us closer to the problems faced by producers of medical marijuana when trying to introduce a new product to pharmacies. First of all, solutions have been proposed to improve the availability of medical marijuana in Poland.
The producers agree that the problems in the registration process are mainly due to the lack of administrative experience and the fact that it is a completely new product. Each link in the medical marijuana supply chain "learns it on a living organism, i.e. by submitting an application, each element of which is carefully checked.. [...] We hope that this is due to the fact that we are one of the first to register this product and it is from us that officials learn. Hopefully after these first registration products, [...] officials will become proficient with this product and it will be much easier. However, now the procedures are unfortunately very long ”- summarized the representative of PharmaCann.
A significant problem so far encountered by producers turned out to be the time of obtaining GIF permits. A psychotropic product requires an import license in each case, which the GIF issues usually within 4 weeks for a 90-day period as part of the standard narcotic drug regime.. "Laboratories must apply for appropriate GIF Inspections, and we must also apply for an import permit when introducing a product.. The time of obtaining such import permits from our side, as well as the waiting time by laboratories for the GIF Inspections is quite long, ”said Tomasz Krześniak, chief lawyer of PharmaCann, which is the registration of new hemp products.
There is also a gap in the medical marijuana supply chain to pharmacies related to the laboratories themselves responsible for issuing certificates. “All these laboratories are only in the process of acquiring know-how, appropriate permits and licenses. We are dealing with a 1N group product, i.e. a narcotic one, which requires the extension of the permits and licenses held by the laboratories "- summarizes the PharmaCann representative. Tomasz Nawrocki, representing SynoptisIndustrial (Neuca Group), adds: "I agree that Polish laboratories prepared for this process are not. [...] Here is the issue of obtaining authorizations for psychotropic products for research into psychotropic production and extending the scope of authorization for drug research, as well as equipment competences and methodological development. As of today, based on my knowledge, 100% prepared laboratories are exactly zero ”.
Tomasz Nawrocki has a different opinion. "We have economic units that have permits to import psychotropic products, qualified people who are competent to certify these products depending on which part of the world it comes from. [...] In terms of registration, the greater problem is the awareness of the preparation of appropriate documentation, accuracy of preparation, understanding what it means to test stability, understanding that the product cannot be stable at the time of its certification, but when declaring the expiry date, the product must be stable , declared under the specification for the entire period of validity, ”we learn from a Synoptis Industrial representative.
Medical marijuana from the point of view of pharmacies and pharmacistsThe initial lack of pharmaceutical raw material turned into a problem related to its limited availability and irregular deliveries from producers.. Medicover pharmacist notes that "we continue to observe social resistance, which means that [cannabis] therapy is still perceived as inappropriate. Medical cannabis is available only for therapeutic purposes, any use - whether prophylactic, or any other use beyond medical indications, is illegal with us. Therefore, it causes many difficulties and unnecessary prejudices "
Due to the fact that medical marijuana is a pharmaceutical raw material, the pharmacy is obliged to process the product before delivering it to the patient. The simplest action is packing, i.e. repacking a 5-gram package into smaller units. Pharmacies, however, have been further trained in this direction and are afraid of the consequences of improper handling of raw materials.. This means that the dispensing by the pharmacy of the full, e.g.. The 5-gram package without opening is against applicable law.
Interesting insights are provided by Bartłomiej Sasin, a representative of Pharma NET. He points to barriers at the level of legal regulations relating to pharmacies or pharmacy outlets: "It is an element of a wider systemic issue, i.e. the failure to adapt some regulations concerning the functioning of pharmacies to the present day.. The first barrier that exists is the fact that there are pharmacies based on old licenses that only sell ready-made drugs. [...] There are a lot of pharmacies that still operate under the old rules, but do not have the so-called. the prescription room, i.e. the one where the mortar and all the equipment for the pharmacist to create the drug is located in the pharmacy. This is the first legal problem. [...] The second aspect is the fact that even if we have pharmacies that have a prescription chamber in accordance with the obligations arising from the pharmaceutical law, in practice they often fulfill the obligation to manufacture drugs "
After the introduction of raw material to pharmacies (2019-2021)
Introduction of medical marijuana to Polish pharmaciesThe first milestone since the legalization of medical marijuana in July 2017 was the registration of the first pharmaceutical raw material by Spectrum Cannabis. test batch. In January 2019, medical marijuana first appeared in pharmacies.
Registration of pharmaceutical raw material is much simpler than drug registration, which requires many years of clinical research, which has its advantages and disadvantages.. Joanna Jakóbczyk notes that "registration as a pharmaceutical raw material of medical cannabis causes that they do not have the characteristics of a medicinal product. Therefore, this is another difficulty and, to some extent, justified resistance on the part of doctors who want to be responsible, want to conduct therapies based on knowledge. [...] The resistance is somewhat justified, because there is no knowledge, there is no product characteristics that represent the indications, side effects, dosage. [...] There is no leaflet intended for the patient, because it is a pharmaceutical raw material ". On the other hand, qualifying medical marijuana to the group of pharmaceutical raw materials significantly accelerated the initiation of treatment by pain, oncology and palliative medicine patients who most expected products with a high concentration of delta-9-THC.
The first batch of dried cannabis, which reached Poland, consisted of only 6 kg of dried Red No. 2Lemon Skunkod by Spectrum Cannabis. The cannabinoid concentration of this product is a relation approx. 19% THC to 1% CBD. The second delivery of the only product available by the end of 2019 took place in March and covered the largest number of flowers. Unfortunately, patients complained about the low quality and improper conditions of drying and storing the product, which resulted in an exceptionally low score. The next batch arrived in Poland at the turn of July / August, while the next delivery was expected by October 2019.. Then, patients faced a break in access to medical marijuana, which lasted until March 2020
In March 2020, patients were given the opportunity to choose between Red No. 2 and the products offered by the new manufacturer. Aurora Deutschland has started its activity with the registration of 4 products. Two of them with the content of 22% and 20% THC in relation to 1% of CBD, differing in terpene environment, went to pharmacies as part of a test batch in the amount of 6 kg. Next, the manufacturer also introduced a CBD-rich product of 12% with an extremely low THC content of less than 1%, but we still expect medical marijuana from Aurora Deutschland to have an equivalent THC to CBD ratio of 8%. In June 2020, Canopy Growth known previously as Spectrum Cannabis introduced its new product in Poland. Cannabis flowers with a relatively balanced concentration of 10% THC to 7% CBD turned out to be an excellent response to the health problems of patients with low tolerance to the psychoactive ingredient delta-9-tetrahydrocannabinol (THC).
Target importThe Main Pharmaceutical Inspector issues documents enabling the import or export of narcotic drugs, psychotropic substances or category 1 precursors for personal medical needs based on a prescription or medical documentation regarding the recommended intake of a given medicinal product. In 2019, however, patients continued to use other methods of purchasing raw material in the form of medical marijuana. In 2019, the Main Pharmaceutical Inspectorate received. applications for the total amount of the pharmaceutical raw material Cannabis flos of 153.53 kg. At the same time, an additional 211 kg of cannabis was delivered to Poland as part of target import
Patients who decide to buy medical marijuana from other producers show a dynamically growing interest in target imports. By February 26, 2020. The Minister of Health received applications for the import of Cannabis Flos for a total amount of 85.6 kg.
Situation today (April 2021)
Availability of medical marijuana from the producers' sideCurrently, 6 products in the form of dried cannabis are registered in Poland, of which 5 are already available in pharmacies. Three products with 19/1, 20/1, 22/1 chemotypes are characterized by high THC concentration and low CBD content. Balanced THC and CBD at the 10/7 level is found in the variety offered by CanopyGrowth, while the advantage of CBD over THC is characterized by Aurora 1/12
Registered products (March 2021):
- Cannabis Sativa L., Red No 2 (Spectrum Cannabis)
- Cannabis Flos THC 10%, CBD 7% (Conopy Growth)
- Cannabis Flos THC 22% CBD 1% (Aurora)
- Cannabis Flos THC 20% CBD 1% (Aurora)
- Cannabis Flos THC 1% CBD 12% (Aurora)
- Cannabis Flos THC 8% CBD 8% (Aurora)
At a time when free activity is limited by the coronavirus pandemic, we learn about new logistics problems faced by manufacturers. Cannabis is a product that, due to the content of THC, is considered a narcotic product, subject to special supervision. Each, even the smallest batch of goods placed on the market outside Poland requires a special permit from the Main Pharmaceutical Inspectorate. “The process takes even several weeks from submitting the application to obtaining the permit. You have to wait, which generates problems when it comes to logistics. You have to harmonize the moment of receiving this permit with the moment of its production, as well as with the logistics company that will bring this product "- explains Tomasz Krześniak from PharmaCann. “Until now, transport was carried out by air, regular lines, the goods were transported as cargo. Airlines do not fly, you have to look for carriers who will bring such goods ”- he adds.
From the statements of Joanna Jakóbczyk, we learn that the problems also apply to pharmacy outlets. Still “some pharmacies do not want to sell narcotic drugs at all. Taking care of medical marijuana in any aspect is still a taboo subject, which results from the lack of elementary education in this field, the lack of systemic education at the faculties of pharmaceuticals or medicine.. Therefore, a lack of knowledge makes it difficult to work with this product. Remember that this is not just a recipe. A responsible pharmacy that deals with the product, raw material, cannabis [...] therapy must prepare for it, [...] provide the patient with all kinds of information or about the vaporization itself, about possible side effects, about possible drug interactions. There are a lot of these topics, and there is a lack of education "
What problems do medical marijuana patients face today?Despite the fact that products in the form of dried cannabis are registered, medical marijuana is very difficult to obtain in Poland. Irregular deliveries make it impossible for patients to base their therapy on a legal source of medicine, risking the legal consequences of using the black market in times of unavailability of medicines in Polish pharmacies.
Another problem that arises for patients is the insufficient differentiation of the offered products in terms of cannabinoid concentration.. We learn about the high need to differentiate cannabis products from Joanna Jakóbczyk - a pharmacist representing the Medicover pharmacy. “There are products that will typically be used by patients overnight. It will be the so-called. Indica with a high content of myrcene, i.e. varieties that have a more relaxing, sedative and calming effect. However, there is also a group of patients who need a daily adjustment preparation who must be professionally active. For them, concentration, memory processes and action enabling everyday functioning during the day are important. And these are varieties with a high innene content ”.
One of the biggest problems of patients at the moment is also the high cost of medical treatment, which definitely exceeds the price of dried cannabis available on the black market.. Even low doses of 300 milligrams a day are associated with a cost of approx. 700 PLN per month. In the head of Tomasz Dzitko, a representative of the Delfarma company, the question arises "who can spend 700 zlotys a month on chronic, long-term treatment. They are already thousands of zlotys ", for which he quickly presents the solution:" A refund that must eventually come to pass. Even if not from the beginning, these products will be refunded in all indications, at least in the most needed ones, i.e.. pain relief or mild epilepsy. "
Physicians have a huge problem with therapeutic regimens. They do not know what concentrations, what products and in what form should be prescribed for a specific disease. According to the appeals of experts presented at the cannabis conference, the VAT tax on named marijuana was reduced from 23% to 8%. “This reduces the costs of treatment for patients by PLN 100 per month. This is a lot, especially for those who buy other drugs in addition to marijuana. Very often it is co-treatment or supportive treatment with traditional, chemical pharmacotherapy ”- adds the representative of Delfarma.
Problems filling the prescriptionIt turns out that patients encounter an obstacle even after obtaining a prescription and checking the availability of the product in a pharmacy. After getting to the doctor, meeting all the conditions for obtaining a prescription for medical marijuana and confirming the availability of the raw material in a pharmacy, technical problems sometimes arise
"The system is not fully prepared to list the pharmaceutical raw material, which is cannabis, which is a problem that has increased in the time of the pandemic.. At the same time, we confidently made a leap forward - doctors in issuing, and we, pharmacies, in the implementation of such prescriptions. Not all the data that must be included in the prescription for 1N2P raw material, i.e. in the tightening of the RPW prescription, is included in it, because the system does not include them. The patient actually has trouble filling the prescription, bonas, the provisions of the pharmaceutical law apply. That is why it is important that there is someone who is responsible for such systems and applies them properly. For my part, I also try to help and suggest where such data should be completed so that the patient does not have to suffer from it. That is why I am in constant contact with doctors, ”said Joanna Jakóbczyk.
“There is no complete information as to how such raw material should be listed. We are used to the fact that a drug from the 1N2P category is usually a single-ingredient drug, where we have one active substance, and its content in milligrams must be on such a narcotic prescription. On the other hand, [in hemp] we have over 500 active compounds, and the standardized raw material may also have fluctuations. Not all doctors receive knowledge from producers - and I think that this burden is also on their side - how to properly construct a prescription that in fact, we must write the total amount of active substances in this raw material per cannabis flower, and not in the calculation to single cannabinoids ”- explained the representative of Medicover.
Prescription drugs based on pharmaceutical raw materialThe last aspect that needs to be looked at now is the prescription drugs manufactured by pharmacies for the needs of patients. Pursuant to the Act of September 6, 2001. on pharmaceutical law, pharmacies prepare prescription drugs within 48 hours of submitting the prescription. For a prescription for a prescription drug containing a narcotic drug such as medical marijuana, pharmacies should dispense the prepared prescription drug within 4 hours.
The prospect of medical marijuana development in Poland (after 2021)
When focusing on solutions to defined problems, it is worth referring to the excessively high cost of the raw material. The best way to lower the retail price of medical marijuana is to legalize domestic crops and legally breed cannabis plants by patients. Currently, medical marijuana supplies are imported. The drought price level is maintained at the level of Western Europe, and an extended supply chain causes an increase in the price of the final product. Freeing the medical marijuana market will lead to lower prices as a result of competition between producers who today maintain a high level of margins. Medical marijuana is not only an answer to many diseases, but also a huge business that is starting to flourish around the world. The current legal regulations mean that Polish patients support the development of the economy of other countries in the entire process of cannabis production. Taxes on business and employment of employees also go to the budgets of other countries, leaving Poland without any control over the supply of medical marijuana on the market.
Bartłomiej Sasin perfectly referred to the problems of pharmacies, proposing a two-pronged solution to the problems. "It seems that due to the limitations and de facto necessity of specialization by individual pharmacies in creating drugs based on raw materials containing medical marijuana, two elements are necessary:. The first is to create specialized prescription pharmacies that will create high-quality prescription drugs on an ongoing basis, including medical marijuana. [...] Of course, other pharmacies should conclude appropriate agreements with them so that in these pharmacies it is also possible to get this prescription drug, only made in a different pharmacy, within one or two days. Another thing, due to the specialization of pharmacies, there are changes in communication. At this point, if the pharmacy made a large banner or put a notice in the newspaper that you would get medicines containing medical marijuana, they would be punished with violating the pharmacy advertising ban. Consequently, it is also necessary to amend article 94a of the Pharmaceutical Law, which says that all advertising is prohibited.. Unfortunately, the practice of pharmacies has led to the fact that this does not apply only to advertising in the strict sense, but even to all communication, including informing about services that we will provide pharmaceutical care, we will give you drugs containing medical marijuana. These are the two elements: the specialization of pharmacies in the field of prescription drugs, including medical marijuana, and the change in the advertising law of pharmacies ”.
The solution to the problem of prescription drugs could be the creation of a pharmacy system of entities specialized in the preparation of prescription drugs. “Each pharmacy would decide whether it specializes in creating prescription drugs or not. Why is this important? We then have a specialized team of pharmacists who create prescription drugs on an ongoing basis, including very difficult ones "- proposes Bartłomiej Sasin. In this assumption, pharmacies that resign from their own prescription chamber would be obliged to sign a contract with an entity that specializes in this, thus ensuring the continuity of the raw material availability for the patient.. An interesting observation was also shared by Tomasz Krześniak from PharmaCann, who proposed solutions to problems faced by medical marijuana producers. "In my opinion, certain issues can be solved in a very simple way.. For example, the permits that we, as companies importing from abroad, must apply each time. It is enough for there to be a simple computer system that would allow all these applications and permits to be processed electronically, as it is done in other countries. Our company has a branch in Macedonia and there such permits, based on the same legal regulations, the drug convention, are processed in electronic form, which means that there is a day or two from the moment of submitting the application to obtaining the permit. and facilitated them also on the part of GIF or the Registration Office ”.
Joanna Jakóbczyk, in turn, appeals to medical universities in Poland to introduce into the curriculum knowledge of the endocannabinoid system and the impact of individual cannabinoids on the human body, eliminating one of the basic problems of the lack of education.
"I hope that there will finally be a forum for the exchange of views and experiences between the business side and the administrative side, in order to develop certain mechanisms and instruments that will speed up and facilitate our functioning," added Tomasz Krześniak.
In conclusion, despite the growing public awareness, cannabis education is of key importance in all interested social groups - among doctors, pharmacists, patients, producers as well as legislative entities.
Author: Idea Listka