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Email this article Legal Aspects of Off-Label Treatment with “Medical Marijuana” in Terminally Ill Patients – a Medical Experiment or an Embodiment of the Patient’s Right to Receive Services in Accordance with Current Medical Knowledge?
Abstract
The subject of the use of medicinal products containing “medical marijuana” during the therapy of terminal patients has been the subject of extensive discussion until recently. Currently, such action is legal, but questions still arise not so much about the possibility of using medical marijuana in the treatment of terminally ill patients, but about the implementation of off-label use treatment. The analysis of the applicable legal provisions, views of scholars in the field, and the case law allow us to conclude that treatment involving medical marijuana inconsistently with the SmPC (Summary of Product Characteristics) is an acceptable action that should not be equated with a therapeutic experiment in the strict sense. The above is confirmed by the admissibility of using marijuana raw materials as the basis for the preparation of a pharmacy-compounded (prescription) medicine. The production of pharmacy-compounded drugs requires the use of pharmaceutical raw materials, the amount and composition of which depend on an independent decision of the person prescribing the medicine. The admissibility of any composition of the contents of a pharmacy-compounded drug containing medical marijuana speaks for the admissibility of its use in any way. The above leads to adoption of similar requirements in relation to pre-made drugs containing marijuana. Regardless of the admissibility of using medical marijuana outside the SmPC or in the form of a compounded drug, medical marijuana treatment is the implementation of the patient’s right to treat pain and receive health services in accordance with the current state of medical knowledge.
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LEGAL ACTS
Act of 31 January 1985 on preventing drug addiction (Journal of Laws 1985, no. 4, item 15, as amended).
Act of 5 December 1996 on the professions of medical practitioner and dentist (consolidated text, Journal of Laws 2022, item 1731, as amended).
Act of 24 April 1997 on counteracting drug addiction (Journal of Laws 1997, no. 75, item 468, as amended).
Act of 6 September 2001 – Pharmaceutical Law (consolidated text, Journal of Laws 2022, item 2301).
Act of 29 July 2005 on counteracting drug addiction (Journal of Laws 2005, no. 179, item 1485, as amended; consolidated text, Journal of Laws 2022, item 2050, as amended).
Act of 6 November 2008 on the rights of patients and the Commissioner for Patients’ Rights (consolidated text, Journal of Laws 2020, item 849).
Act of 7 July 2017 amending the Act on counteracting drug addiction and the Act on the reimbursement of medicines, foodstuffs intended for particular nutritional uses and medical devices (Journal of Laws 2017, item 1458).
Act of 20 July 2018 amending the Act on counteracting drug addiction and the Act on the State Sanitary Inspectorate (Journal of Laws 2018, item 1490).
Regulation of the Minister of Health of 5 December 2017 on the model application for marketing authorisation of pharmaceutical raw materials for the preparation of prescription drugs in the form of plant of cannabis other than fibrous and extracts, pharmaceutical tinctures, as well as all other extracts of non -fibrous cannabis and resin of non- fibrous cannabis and the detailed scope of data and list of documents covered by this application (Journal of Laws 2017, item 2337).
Single Convention on Narcotic Drugs, New York, 30 March 1961, United Nations Treaty Series, vol. 520.
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CASE LAW
Decision of the Constitutional Tribunal of 17 March 2015, SK 3/15, OTK-A 2015, no. 3, item 39.
Judgment of the Court of Appeal in Warsaw of 14 February 2014, VI ACa 1000/13, LEX no. 1469448.
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Judgment of the Supreme Court of 24 November 2011, I CSK 69/11, OSNC 2012, no. 5, item 63.
Judgment of the Voivodeship Administrative Court in Warsaw of 26 February 2018, VI SA/Wa 2179/18, LEX no. 2689804.
Resolution of the Supreme Court of 26 October 2011, III CZP 58/11, OSNC 2012, no. 5, item 59.
DOI: http://dx.doi.org/10.17951/sil.2023.32.1.213-230
Date of publication: 2023-03-28 11:24:08
Date of submission: 2023-02-20 18:14:16
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