Darkovska-Serafimovska, Marija (2023) Legal regulation and positioning of cannabis based products. In: Towards the fifth industrial revolution: Pharma 5.0, 29.03 - 01.04, 2023, Hotel M, Belgrade, Serbia. (Unpublished)
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Abstract
The use of cannabis-based preparations in traditional medicine has existed for more than a thousand years and has been documented in many countries around the world for the
treatment of muscle spasticity, convulsions, pain, nausea and vomiting, as well as appetite stimulation. However, the clinical use of cannabinoid substances is limited due to legal and ethical reasons, as well as limited evidence of the benefits of their use. In the European Union, a total of 14 countries have allowed the use of cannabis-based products for medical purposes, namely (in order): the Czech Republic, Finland, Romania, Italy, Spain, the Netherlands, France, Austria, Portugal, Germany, England, Slovenia, Croatia and the last Greece. Each of the mentioned countries is a signatory to the United Nations Convention on Narcotic Drugs from 1961, the United Nations Convention on Psychotropic Substances from 1971, and the United Nations Convention against Traffic in Drugs and Psychotropic Substances from 1988. The regulation covering this area is different in all countries, but the same for all states is the status of these preparations based on the concentration of tetrahydrocannabinol (THC) in the final product. Thus, preparations can be classified as borderline products (according to the new EU regulation Novel food) or medicines, depending on whether the concentration of tetrahydrocannabinol (THC) in the final product is
below or above 0.2%. Since August 2016, patients of the Republic of North Macedonia have had access to these products with strictly controlled composition and quality. What is the therapeutic effect of cannabinoids? Is there sufficient evidence based on evidence-based medicine for the positive effects of cannabinoids? For which indications do we have enough positive experiences based on medical evidence? It is certain that the area is intensively
researched. So far, there is enough evidence and positive experience about the effectiveness of cannabinoids for pain relief in patients with malignant diseases, for the relief
of nausea and vomiting induced by chemotherapy, for the treatment of multiple sclerosis and for the treatment of anorexia associated with extreme weight loss in HIV-positive patients. The European Medicines Agency (EMA) has approved cannabidiol (CBD) for 13 indications under the status of Orphan designation. Also, under the same conditions, the EMA
approved the combination of THC and CBD from Cannabis sativa extract for the treatment of glioma. The good side of cannabinoids is the possibility to combine them as an add-on
therapy with existing conventional therapy.
| Item Type: | Conference or Workshop Item (Lecture) |
|---|---|
| Subjects: | Medical and Health Sciences > Clinical medicine |
| Divisions: | Faculty of Medical Science |
| Depositing User: | Marija Darkovska-Serafimovska |
| Date Deposited: | 10 Apr 2023 10:00 |
| Last Modified: | 10 Apr 2023 10:00 |
| URI: | https://eprints.ugd.edu.mk/id/eprint/31645 |
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