„Cannabis in …”
„Cannabis in …” is a series of articles devoted to the subject of legalization and admission of medical cannabis for sale in selected countries of the world. They focus on the laws in a given country, details of the entry of a new product on individual markets and raises legal issues and difficulties related to the admission and marketing of cannabis-based medicines.
Each article will be divided into 4 sections:
1. General information,
2. Law and admission,
3. Market opportunities,
4. Summary.
Cannabis in … Poland
General information
November 1, 2017 the amendment to the act on counteracting drug addiction and reimbursement of medicines and medical devices entered into force. In this way, access to cannabis as a raw material was legalized, which is used to prepare or manufacture cannabis-based medicines. At that time, Poland joined the group of 12 European countries that legalized cannabis for medicinal purposes. The market of medical cannabis in Poland has just started. Due to the fact that the cultivation of cannabis in Poland is still prohibited, the only option is to import it. In Poland, medical cannabis is still poorly known to patients and doctors, and there are many myths about it. Most people do not see the difference between cannabis as a medical drug and as a narcotic. The problem is its availability. Many patients with prescriptions complain that it’s hard to obtain medical cannabis. There is almost no point in searching for it in pharmacies. If it appears, it usually disappears within a few days, due to the fact that its cultivation in Poland is prohibited. The only way to deliver medical cannabis to wholesalers and pharmacies is to import it from abroad, which results in a deficit of availability, and additionally complicated regulations and a long waiting time for authorization significantly extends the time.
Law and admission
The statutory regulations of 2017 paved the way for legal trade in medical cannabis in Poland. However, it was only in January 2019 that it became possible prescribe it to patients. Shortly after the legislation was adopted, medical cannabis producers began to apply for registration and admission to trading in Poland.
Unfortunately the process of registering a cannabis-based drugin Poland is difficult and complicated mainly because of the procedures and the necessary waiting time for a response from the ministry, and this is only the first step to be able to sell medical cannabis in Poland. The steps of registering a medical drug based on cannabis containing more than 0.2% THC can be done in two different ways. The first way to register the medical drug is possible only when the drug has already been registered in the European Union. It takes place on the basis of mutual recognition of permits covering all member countries.
Registration procedure for a medical drug in Poland, if the device has been registered in the European Union (Mutual recognition of permits).
The second way is to register a drug in Poland, which is new for the entire European Union.
Registration procedure for a medical drug in Poland.
After accepting one of the stages presented and entering the drug in the register of medicinal products, you can apply for a marketing authorization. Unfortunately, as in the case of drug registration, in the case of sales, a number of conditions must be met. One of the most important is having a GMP certificate, which opens the way of selling cannabis in Europe to producers from around the world. The marketing authorization application is another very important document. It contains a number of detailed data to be provided. If the drug meets all of the standards, it receives a marketing authorization. The waiting time for a decision can be up to 200 days, and the consent is issued for a period of 5 years, after which it must be renewed.
Requirements for selling medicinal cannabis products.
A problematic tax on the sale of medicinal cannabis.
It could be assumed that the VAT (tax) rate for medicinal cannabis is a simple matter. In particular, as a medicinal product authorized on the territory of the Republic of Poland (in accordance with the provisions of pharmaceutical law) it may be taxed at a rate of 8%, exactly like other basic pharmaceutical substances, medicines and other pharmaceutical products. However, this is not the case with cannabis. It turns out that the company introducing cannabis to the Polish market receives an individual interpretation, which shows that cannabis in the form it imports is not a medicine but a pharmaceutical raw material. According to published interpretation of the director of the National Tax Information made by the importer of pharmaceutical raw material sales to pharmaceutical wholesalers or pharmacies should be subject to 23% VAT rate. It is only from this raw material that chemists prepare prescription drugs at the pharmacy. From this interpretation it can be concluded that only their sale to patients will be subject to an 8% VAT rate as the sale of a medicine authorized on the Polish territory. In this connection it can be noted that the issue of tax on the sale of medical cannabis is not so obvious.
Market opportunities
The medical cannabis market in Poland will grow. For a long time, there has been an increased interest in legal access to high-quality cannabis flowers. It is estimated that up to 300,000 Polish patients could benefit from its medical use. The problem in Poland is not only the availability but also the price. For the time being three companies have permission to sell medical cannabis in Poland, and several others have applied for admission.
In 2019, the total sales of cannabis flowers amounted to over 70 kilograms, and in 2020 it could be even several times more. The price of medical cannabis is approximately PLN 70 gross. In Poland, according to the estimates of Prohibition Partners, the size of the cannabis-based medical market in 2028 will be 2 billion euro. According to a survey, 22% of Poles once tried smoking cannabis and admitted to buying it from a dealer or darknet, and over 30% believe that smoking cannabis does not harm health as much as other stimulants. There is a lot of space on the cannabis map of Poland for producers of „ganja”, mainly due to negligible competition and a deficit of goods. It is certainly a good opportunity for new companies to introduce their products, contributing to the popularization of cannabis as a medicine, thus improving the opinion of this wonderful plant.
Summary
„Difficult Polish market” – this is how you can describe the medical cannabis market in Poland in 3 words. Existing laws make it difficult for the release of medical cannabis for sale. The ignorance of the rulers in the subject of cannabis treatment effectively prevents the law from being loosened, and cannabis is still treated as a heavy drug, which is addictive. Poles still have little or no knowledge in the field of medical treatment of cannabis. Many people declare that they have tried or continue to consume cannabis but treat it as a drug for relaxing, and not for healing. Complicated regulations that interrupt sales in Poland and a niche on the market means that the medical trade of cannabis can bring producers profits in millions of dollars, as well as open new opportunities for the emerging and previously unknown in Poland industry of cannabis cultivation and sale.