Publication date: June 13, 2023
In recent years, the growing interest in the medical use of cannabis has opened up new opportunities in the pharmaceutical industry. In Poland, where the sale of cannabis only for the medical purposes is strictly regulated, the introduction of medical cannabis to the market is associated with legal and administrative challenges, and at the same time opens up prospects for new solutions for patients with various diseases. This case study analyses the process of introducing the sale of medical cannabis in Poland and its impact on the online pharmaceutical industry. It also points to the legal problems of the medical cannabis sales system from the perspective of the common phenomenon of the need for Polish patients to order medicine online and teleconsultations.
Before 2017, cannabis was illegal in Poland for both medical and non-medical use. However, in 2017, the Polish parliament passed a law that allows the use of medical cannabis under the supervision of a doctor for patients suffering from certain diseases.
The core of the regulation is Article 33a (1) of the Polish Act of 29 July 2005 on counteracting drug addiction introduced into the Polish law of the life science sector at that time (consolidated text: Journal of Laws of 2023, item 172), which states that hemp herb other than fibrous and extracts, tinctures pharmaceutical products, as well as all other non-fibrous hemp extracts and non-fibrous hemp resin, may constitute a pharmaceutical raw material within the meaning of the Polish Pharmaceutical Law, intended for the preparation of prescription drugs referred to in the Pharmaceutical Law, after obtaining a marketing authorization issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
This legalization met with mixed reactions from the conservative Polish society, doctors and the pharmaceutical industry. Both in public awareness and in accordance with the guidelines of the Polish pharmaceutical sector, cannabis is not treated as a common drug, but a medicine (or more precisely, a pharmaceutical raw material), which can be legally sold only to a patient under a special prescription from a Polish doctor by performing a medical procedure.
The pharmacy where the prescription is filled has a special status regarding the storage conditions of the pharmaceutical raw material and the conditions enabling the storage of medical cannabis as a medicine (not every Polish pharmacy can have medical cannabis in its offer). The pharmacist is an entity that appears throughout the patient’s drug access chain as a key entity, because it is the pharmacist who is responsible for the legality of the patient’s access to cannabis, i.e. a drug dispensed on the basis of a valid medical prescription issued by a Polish doctor.
The introduction of medical cannabis to the market required the creation of clear legal regulations. The Polish Ministry of Health has developed regulations for the registration and distribution of medical products containing cannabinoids to ensure patient safety. Manufacturers must obtain a proper permit – the patient buys cannabis (dry smoke or oil) as a medical raw material, the legal status of which is similar to that of a drug. In order to sell dried herbs, it is necessary to obtain a decision from the Polish regulatory office to place a specific batch of medicinal cannabis on the market. What is more, from the perspective of the Polish pharmaceutical law regime, it cannot be a product sold in another country as a stimulant. It relates to a product with the right quality of medical cannabis with the proper documentation that meets the requirements of Good Manufacturing Practice in the pharmaceutical industry. Therefore, the medicinal product sold in Poland has an appropriate and controlled composition of active substances of appropriate microbiological purity, high quality and standardized for the content of cannabinoids – THC and CBD.
At least several types of dried cannabis are registered and available in Poland, differing in the ratio of cannabinoids, i.e. potency. However, they are not commonly available in pharmacies.
With the introduction of medical cannabis to the Polish market, a new demand for producers and suppliers of these products also appeared online. Industry companies have begun to consider the potential of the medical cannabis market and look for ways to implement this product into their portfolio in the most affordable channel. At the same time, new companies specializing in the production and distribution of medical cannabis have also emerged.
The question of whether it is legal to obtain a prescription for medical cannabis through e-consultations is also becoming urgent.
Some companies are going a step further and are looking into whether it is legal to dispense medicinal cannabis outside of the pharmacy, which would be the equivalent of so-called “home delivery of medical cannabis”.
On the Polish market, there are online platforms that facilitate contact between doctors and patients reporting ailments, on which they ask the doctor for a prescription also for medical cannabis. Some of these platforms state that a patient can receive a prescription for medical marijuana in as little as 15 minutes.
It is the speed of the medical procedure that is part of the problem of the legality of the availability of drugs affecting the patient’s awareness, and this ease and speed of access to medical cannabis recently drew attention of the Polish regulatory authorities of the Polish Ministry of Health. According to the Polish Ministry of Health, the process of too quick e-consultations may in the future be severely limited by the Polish legislator in the Internet channel, due to the general reservation that online multimedia tools sometimes cause a lack of control over the proper process of examining a patient, and, consequently, over the control of the dispensing process of psychotropic drugs for medical purposes.
This is due to the flood of online prescriptions for hypnotics and opioids used in psychiatry and palliative treatment. The huge number of drugs prescribed for one patient led some doctors to investigations in the professional self-governments of doctors.
Currently, in the light of Polish regulations, launching an online communication platform for teleconsultations between a patient and a doctor is relatively simple in the sense that in the cooperation of the IT administrator of the Internet platform with an entity already operating in the health system as an actual medical clinic, the functionality of the telemedicine platform can be considered as supplementing the service of already existing permits to perform medical activities, which are held by proper entities (doctors, clinics) that actually provide medical services. Thus, the Internet platform is only a medium (software) for connecting patients with doctors offering specific medical advice, ending with the issuance of the electronic prescription at the doctor’s discretion after online interview with the patient.
However, in order to be a legal provider of medical services in Poland, an entry in the register of entities performing medical activity is required. However, this applies to entities that actually provide such activities. The Internet platform can only be perceived as an application facilitating the activity in the network of a specific doctor who takes responsibility for medical advice and issuing a prescription, as well as an application that facilitates the search for treatment offers and specialists by potential patients.
However, everything depends on the legal status of the telemedicine platform. The structure of the chain of providers of a specific telemedicine service can be complex and consist of many entities. Therefore, a foreign IT company that creates an online communication interface between the patient and the doctor (clinic) is primarily software, the functionality of which is “packaged” in the form of a software license offered to medical entities in Poland.
It is therefore important for the platform administrator to take into account the issue of adequate regulation of the collection, processing and storage of data of persons who register on such a platform and use it.
From the perspective of the problem that telemedicine is a virtual phenomenon, because it replaces the physical place of examination at a distance, an interesting legal problem is also the direct application of Article 22 paragraph 3a of the Polish Act of 15 April 2011 on medical activity (consolidated text, Journal of Laws of 2022, item 633, as amended), which concerns the requirements for the premises and equipment of the entity performing medical activity. Pursuant to this rule, such requirements do not apply to rooms and equipment of entities performing medical activity providing only outpatient health services via ICT systems or communication systems. This is the situation we are dealing with in the case of virtual medical advice.
In addition, Art. 22 of the Polish Act of 15 April 2011 on medical activity states, that “The minister competent for health, in consultation with the minister competent for computerization, may specify, by regulation, detailed requirements to be met by rooms and devices as well as ICT systems or communication systems of an entity conducting medical activity providing only outpatient health services via ICT systems or communication systems, guided by the need to ensure the health safety of patients, as well as the type of activity performed and the scope of provided health services.”.
In Poland, however, there is no new special regulation in this regard, but it can be assumed that the most important aspect of this type of activity via the Internet is, in particular, maintaining up-to-date software, minimizing the risk of information loss due to failure, protection against errors and loss of unauthorized modifications, and as a result, meeting all the conditions contained in the GDPR.
In order to become a medical service provider, an application for entry in the register of entities performing medical activity must be submitted. The application can be submitted after registering an account and logging in to the website of the register of entities conducting medical activity. It is through the website that we submit this application. The authority keeping the register will verify the correctness and completeness of the submitted documents. Then, the authority keeping the register, after verifying the submitted documents, makes an entry in the register of service providers and issues a certificate of entry. The fee for the application for entry in the register of service providers is PLN 666. (10% of the average monthly remuneration in the enterprise sector without the payment of bonuses from the profit for the previous year, announced by the President of the Central Statistical Office in “Monitor Polski”.) The certificate is issued in electronic form and generated from the ICT system .
In conducting such a project, it is very important to understand that according to the regulations, in the performance of medical activities in the abovementioned way, such a platform is treated more like software. Therefore, it is possible for the online platform service provider to collaborate with clinics and doctors, who will in practice be subject to all regulatory obligations related to the online service on the online platform. Therefore, it is required to construct reliable regulations of the platform and regulate b2b contracts with doctors in such a way as to limit any abuse related to issuing online prescriptions. For example, a doctor should be obliged to supervise a patient or, for example, there should be implemented a mechanism for forced termination of cooperation with a doctor in the event of overprescription of drugs for one patient. It is also important to ensure a control mechanism that checks whether the preparation is actually used for treatment. One should also ensure proper contact with software suppliers in order to take care of the data that the patients provide to the doctor via the online platform.
In turn, in order to ensure continuity and reliability of supplies, it is recommended to establish cooperation with either a pharmacist or a company that employs pharmacists as a pharmacy with medicinal cannabis in its assortment.
It has to be kept in mind that work is underway in Poland to tighten the rules for the online sale of drugs affecting the patient’s awareness, and thus also medical cannabis. The amendment obliges the competent minister to issue an appropriate regulation. “The minister competent for health matters shall determine, by way of a regulation, the conditions for the mail-order sale of medicinal products dispensed on prescription“.
The regulation is to specify which products cannot be sold by mail order. It will concern, among others, psychotropic substances, expensive cytostatic drugs, antibiotics or insulin sensitive to storage. This is justified by the argument that improper storage conditions and for example high temperature could dangerously change their properties, which could affect the active substance of the drug and cause its change to a substance dangerous to the human body.
Practice shows that pharmacists generally agree with the individual interpretation of the local Polish Provincial Pharmaceutical Inspector, according to which the purchase and delivery of a drug under prescription via a mobile application violates the provisions of the pharmaceutical law. Issuing a medicine under prescription to a person other than the patient is a common practice in the case of courtesy collection of a prescription (for example by a close relative), but this practice is not used for strictly commercial purposes (although the regulations do not explicitly contradict this).
As a rule, however, delivery of drugs by pharmacists to bedridden patients is allowed. The Polish pharmaceutical law itself regulates the sale of prescription drugs, requiring direct contact between the patient and the pharmacy.
There is currently no legal provision for the full-fledged sale of medical cannabis as prescription drugs electronically. This limitation makes it difficult to deliver medicines online. There is no unified platform or system that would enable the safe and legal delivery of medicines online. Currently, there are no standards in Poland regarding orders, payments, deliveries and returns, which makes it difficult to develop such services commercially.
In addition, the Polish supervisory authority (Wojewódzki Inspektorat Farmaceutyczny) indicated that an application or website under which the user would authorize an assistant (proxy) to purchase medicinal products on his behalf and for his own benefit, and then a third party equipped with the appropriate power of attorney would purchase the products in the pharmacy and deliver the products to the patient with the receipt is an unacceptable activity. This form has been recognized as retail and mail-order sales, which unfortunately contradicts the principle that regulated activity requires a specific permit. Therefore, currently in Poland, the sale of medicinal cannabis is obliged to be carried out in the form directly provided for by the law.
The prospects for the development of medical cannabis sales in Poland seem promising in some respects. As science and technology advance, new innovations can be expected in the production, delivery and formulation of medical products containing cannabinoids. With greater social and political acceptance, an increase in demand for these products and their availability to patients suffering from various conditions can be expected.
From the perspective of the possibilities of the mail order channel on the Internet, trading in medical cannabis is subject to more restrictive rules having in mind the speed and freedom of trading that the functionality of selling on the Internet gives.
However, all activities of the intermediary platform between the patient/doctor/pharmacy must be regulated in detail, especially in terms of potential abuse.