POLAND Trends and Developments Contributed by: Barbara Kiełtyka, Jakub Gładkowski and Małgorzata Kiełtyka, Kieltyka Gladkowski KG Legal
Laws of 2024 , item 146, as amended). Another example is the requirement for more informa- tion about the drug use amount associated with long-term (eg, annual) prescriptions, effec- tive from August 2024. These examples reflect a clear trend towards greater control over the amount of a drug that a patient takes, partly attributable to problems with target and parallel imports in Poland. Tetrahydrocannabinol There is a trend towards greater patient access to consciousness-altering substances. Atti- tudes regarding whether psychoactive sub- stances should be restricted vary within the EU. As an example, tetrahydrocannabinol (THC) is available in Poland on prescription as medical cannabis, in line with a national procedure for introducing pharmaceutical raw materials to the market, compliance with GMP documentation requirements and an amendment to the Pharma- ceutical Law excepting medical cannabis from anti-drug laws (primarily Article 33a of the Act of 29 July 2005 on Counteracting Drug Addiction). The Pharmaceutical Law is currently aimed at limiting access to medical cannabis to physical pharmacies and tightening the requirements for issuing prescriptions thereof. This is because the Polish government views the popularity of online platforms combining medical advice with prescription services as an undesirable attempt to circumvent the law on medical cannabis, such that THC can be used for purposes other than pain management. As the problem of abuse of narcotic and psychotropic drugs is growing, the Polish Ministry of Health has decided to intro- duce further restrictions to significantly reduce the over-prescription of drugs subject to spe- cial controls. The latest Regulation of 30 October 2024 specifies substances for which prescrip- tions can no longer be obtained in Poland as part of an online service – ie, via so-called prescrip-
tion machines/platforms and private telecon- sultations. In accordance with this Regulation, from 7 November 2024, a doctor is obliged to consult with their patient in person before writ- ing a prescription for fentanyl, morphine, oxyco- done, non-fibrous hemp (including dried herbs and medical cannabis extracts) or pharmaceu- tical tinctures. The Regulation provides for one exception, where these drugs can be prescribed via a teleconsultation only as a continuation of treatment by a primary care physician (excluding The sale of over-the-counter (OTC) drugs in places other than pharmacies (eg, large gro- cery stores, multi-sector stores, railway sta- tions, petrol stations) is supervised by the Polish authorities, requiring restrictions and constant supervision. According to publicly available data, OTC sales are worth PLN9 billion gross for pharmacies, versus PLN0.5 billion outside of pharmacies (ratio of 1:18). The Pharmaceuti- cal Inspector makes the decisions regarding the OTC (without prescription) sale of specific drugs outside of pharmacies. This can be very com- plicated for manufacturers, with the procedure being administrative in nature and depending on arguments that do not necessarily have a legal basis, instead being related to distribution and GMP. night and holiday care). Over-the-counter drugs Another problem related to the distribution of OTC drugs outside of pharmacies concerns the classification of suspensions not as drugs, but rather as dietary supplements or medical devic- es. Distributors and manufacturers are looking for easy and legal sales models, and the clas- sification of a product as a drug, supplement or medical device gives rise to frequent disputes between manufacturers and pharmaceutical market supervisory authorities.
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