As a law firm cooperating with clients in matters of cross-border investments, KIEŁTYKA GŁADKOWSKI KG LEGAL tries to keep up to date with information on regulatory changes in neighboring jurisdictions for the purposes of the expansion and investment plans of our foreign clients.
In this article, we present general information about legislative changes in Ukraine in the field of medical cannabis.
KIELTYKA GLADKOWSKI KG LEGAL PROVIDES ITS FOREIGN CLIENTS WITH LEGAL SUPPORT IN UNDERTAKINGS RELATED TO MEDICAL CANNABIS LOGISTICS CENTRES IN POLAND FOR DISTRIBUTION TO UKRAINE
Legislative changes in Ukraine.
In Ukraine, on December 22, 2023, a bill on the legalization of cannabis for the production of medicines was passed. It provides for the authorization to use medical cannabis for the prevention and treatment of various diseases. This medicinal product will, of course, be available only on prescription, and its sale will only be carried out by pharmacies that have the required licenses and can offer appropriate storage conditions. Additionally, each plant, batch of processed products, unit of packaged products, and packaging of cannabis-based medicine will be marked with a unique electronic identifier. The project also envisages the creation of a special information database in which data from these identifiers will be entered.
Polish industrial property law provides for the protection of intangible assets that have industrial applications. One of the possible subjective rights that protect the rights of the owner of intangible property is a patent, which is granted for an invention and gives the exclusive right to use it for profit, professionally and as a subject of legal transactions.
Ransomware attacks and their legal consequences: a threat to cybersecurity
Computer Security Day, the international day for raising cybersecurity awareness, falls on November 30, and just a few days ago the largest medical data leak to date occurred in Poland. The victim of this cyberattack was one of the laboratory networks in Poland, which cooperates with many Polish clinics, hospitals and other medical facilities. The company refused to cooperate with cybercriminals, which resulted in the disclosure of medical and personal data of over 50,000 people. Poles. Unfortunately, the group of hackers announced that if the company does not meet their ransom demands, they will publish the full dataset by December 31, 2023. They include information such as names, surnames, Polish National Security Numbers, addresses, dates of orders and examinations, as well as numbers enabling verification in the laboratory systems.
– analysis of the legality of the online supply chain under Polish pharmaceutical law
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.
Market and legal conditions for the product in the online channel
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.
Biosimilar medicines, also known as biosimilars, are used in medicine to treat severe and chronic conditions such as cancer, diabetes and autoimmune diseases. Biosimilars – true to their name, they are similar to existing biological reference drugs. They are produced using living organisms or their cells, such as proteins, antibodies and other biological substances. These pharmaceuticals are also produced using biological processes but are not identical to the original reference medicines.
Biosimilars must meet certain criteria to be approved by the relevant regulatory authorities. They must be similar in quality, efficacy and safety to reference medicines. This means that they must have similar biological properties, such as action, mode of action and side effects, to those of the reference drugs.
