Multimedialna platforma wiedzy medycznej Internetowa Księgarnia Medyczna Kalendarium Konferencji
Nowotwory. Journal of Oncology
MENU
Shortcuts Submit an article Author Guidelines Ahead Of Print Editorial Office Manuscript Submission Reviewers 2023 Best Original Paper Award

open access

Vol 72, No 1 (2022)
Review paper
Published online: 2022-02-09
View PDF Download PDF file
Get Citation

Off-label use of medicinal products in oncology: exercising due diligence or experimental activity?

Justyna Estera Król-Całkowska1, Janusz Jaroszyński2
DOI: 10.5603/NJO.2022.0003
·
Nowotwory. Journal of Oncology 2022;72(1):26-33.
Affiliations
  1. Department of European and International Law, Faculty of Law and Administration, Lazarski University, Warsaw, Poland
  2. Department of Administrative Procedure, Faculty of Law and Administration, Maria Curie-Sklodowska University of Lublin, Lublin, Poland

open access

Vol 72, No 1 (2022)
Review article
Published online: 2022-02-09

Abstract

One of the primary responsibilities of a physician is to diagnose and treat diseases with due diligence. Exercising due diligence in treatment process involves, among others, the use of optimal diagnostic, therapeutic and follow-up mana­gement in accordance with the current state of medical knowledge. Each medicinal product has the Summary of Product Characteristics which defines, among others, registered indications, the age group for which the product is registered, the dosing scheme, and route of administration of the product. Polish law does not refer directly to the admissibility of products that use off-label nor does it include regulations forbidding such activities. Considering a number of problems associated with products which use off-label and, on the other hand, commonness of such activities, it is necessary to introduce legal regulations defining the legitimacy and admissibility of such methods of proceeding.

Abstract

One of the primary responsibilities of a physician is to diagnose and treat diseases with due diligence. Exercising due diligence in treatment process involves, among others, the use of optimal diagnostic, therapeutic and follow-up mana­gement in accordance with the current state of medical knowledge. Each medicinal product has the Summary of Product Characteristics which defines, among others, registered indications, the age group for which the product is registered, the dosing scheme, and route of administration of the product. Polish law does not refer directly to the admissibility of products that use off-label nor does it include regulations forbidding such activities. Considering a number of problems associated with products which use off-label and, on the other hand, commonness of such activities, it is necessary to introduce legal regulations defining the legitimacy and admissibility of such methods of proceeding.

Full Text:

View PDF Download PDF file
Get Citation

Keywords

off-label use; oncology treatment; medical experiment; due diligence; reimbursement of drugs

About this article
Title

Off-label use of medicinal products in oncology: exercising due diligence or experimental activity?

Journal

Nowotwory. Journal of Oncology

Issue

Vol 72, No 1 (2022)

Article type

Review paper

Pages

26-33

Published online

2022-02-09

Page views

5618

Article views/downloads

283

DOI

10.5603/NJO.2022.0003

Bibliographic record

Nowotwory. Journal of Oncology 2022;72(1):26-33.

Keywords

off-label use
oncology treatment
medical experiment
due diligence
reimbursement of drugs

Authors

Justyna Estera Król-Całkowska
Janusz Jaroszyński

References (47)
  1. The Act on the Profession of Doctor and Dentist of 5.12.1996., ie. DzU 2021 r., pos. 719.
  2. The Pharmaceutical Law of 06.09.2001, ie. DzU 2021 r., pos. 974, with changes.
  3. Dal Pan GJ. Monitoring the safety of off label medicine use. WHO Drug Information 2009: 21–22.
  4. Stafford RS. Regulating off-label drug use--rethinking the role of the FDA. N Engl J Med. 2008; 358(14): 1427–1429.
    CrossRefPubMed
  5. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. OJ L 311/67. https://eur-lex.europa.eu/legal-content/PL/TXT/PDF/?uri=CELEX:32001L0083&from=EN (01.08.2021).
  6. https://rejestrymedyczne.ezdrowie.gov.pl/rpl/search/public (01.08.2021).
  7. Matusewicz W. Stosowanie leków w onkologii i hematologii w zakresie wskazań do stosowania lub dawkowania, lub sposobu podawania odmiennych niż określone w Charakterystyce Produktu Leczniczego, Warszawa 2012. http://www.korektorzdrowia.pl/wp-content/uploads/prezes-aotm-wojciech-matusewicz-stosowanie-lekow.pdf (01.08.2021).
  8. Saiyed MM, Ong PS, Chew L. Off-label drug use in oncology: a systematic review of literature. J Clin Pharm Ther. 2017; 42(3): 251–258.
    CrossRefPubMed
  9. Herbrand AK, Schmitt AM, Briel M, et al. Association of Supporting Trial Evidence and Reimbursement for Off-Label Use of Cancer Drugs. JAMA Netw Open. 2021; 4(3): e210380.
    CrossRefPubMed
  10. Bun S, Yonemori K, Sunadoi H, et al. Safety and Evidence of Off-Label Use of Approved Drugs at the National Cancer Center Hospital in Japan. JCO Oncol Pract. 2021; 17(3): e416–e425.
    CrossRefPubMed
  11. Poole SG, Dooley MJ. Off-label prescribing in oncology. Support Care Cancer. 2004; 12(5): 302–305.
    CrossRefPubMed
  12. Rückeshäuser P. Off label use: the legal problems of drug application beyond the licensed use. , Hamburg 2011: 1–386.
  13. Emmerich J, Dumarcet N, Lorence A. France's new framework for regulating off-label drug use. N Engl J Med. 2012; 367(14): 1279–1281.
    CrossRefPubMed
  14. Choonara I, Conroy S. Unlicensed and off-label drug use in children: implications for safety. Drug Saf. 2002; 25(1): 1–5.
    CrossRefPubMed
  15. Masełbas W, Członkowski A. Stosowanie produktów leczniczych poza wskazaniami rejestracyjnymi. Przewodnik Lekarza. 2008; 3: 81–87.
  16. Vrancken I. Off-label Prescription of Medication. European Journal of Health Law. 2015; 22(2): 165–186.
  17. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Archives of Internal Medicine. 2006; 9: 1021–1026.
  18. Kapko M. In: Zielińska E. ed. Ustawa o zawodach lekarza i lekarza dentysty. Comment. Wolters Kluwer Polska 2008: 528.
  19. The Judgment of the Court of Appeal in Warsaw of 14.02.2014, no, VI ACa 1000/13, LEX nr 1469448.
  20. The Judgment of the Supreme Court of 24.11.2011, no, I CSK 69/11, OSNC 2012/5/63 2012.
  21. The Resolution of the Supreme Court of 26.10.2011, no, III CZP 58/11, OSNC 2012/5, pos. 59.
  22. Widłak T. nterpretacja klauzuli ,,aktualna wiedza medyczna” w polskim prawie — zarys zagadnień epistemologicznych i metodologicznych. Gdańskie Studia Prawnicze. 2017; 38.
  23. Luty O. Zaniechanie zlecenia produktu leczniczego poza zarejestrowanym wskazaniem a odpowiedzialność cywilna lekarza. PiM. 2014; 2: 132–150.
  24. American Society of Clinical Oncology. Reimbursement for cancer treatment: coverage of off-label drug indications. J Clin Oncol. 2006; 24(19): 3206–3208.
    CrossRefPubMed
  25. Lim M, Shulman DS, Roberts H, et al. Off-label prescribing of targeted anticancer therapy at a large pediatric cancer center. Cancer Med. 2020; 9(18): 6658–6666.
    CrossRefPubMed
  26. The Announcement of the Minister of Health of 21.06.2021, on the list of reimbursed medicines, foods for special medical purposes and medical devices as of 1st July 2021. https://www.gov.pl/web/zdrowie/obwieszczenia-ministra-zdrowia-lista-lekow-refundowanych.
  27. Chromiec Z, Hoffmann E. Stosowanie leków poza wskazaniami — przesłanki oraz refundacja. Folia Cardiologica. 2020; 15(2): 188–191.
    CrossRef
  28. Zajdel. Dopuszczalność stosowania produktów leczniczych poza ChPL w programie lekowym „Leczenie przetoczeniami immunoglobulin w chorobach neurologicznych”. Neuroedu.pl. file:///C:/Users/User/Downloads/neuroedu%202016%20Dopuszczalno%C5%9B%C4%87%20stosowania.pdf (01.08.2021).
  29. Safjan M. Prawo i medycyna. Ochrona praw jednostki a dylematy współczesnej medycyny. , Warszawa 1998: 172.
  30. Kondrat M. (ed.). Prawo farmaceutyczne. Komentarz, ed. II. WKP 2016.
  31. The Regulation of the Minister of Finance, Development Funds and Regional Policy on mandatory liability insurance of the entity conducting medical experiment, DzU 2020, pos. 2412.
  32. Kubiak R. Nowe uwarunkowania prawne przeprowadzania eksperymentów medycznych. PS. 2021; 1: 5–26.
  33. The Judgment of the Court of Appeal in Kraków of 12.10.2007, no., I ACa 920/07, LEX no 570272.
  34. Kwinta P. Stosowanie leków poza rejestracją u dzieci – perspektywa lekarza. Przegląd Lekarski. 2011; 68: 1–3.
  35. Aagaard L, Kristensen K. Off-label and Unlicensed Prescribing in Europe: Implications for Patients’ Informed Consent and Liability. International Journal of Clinical Pharmacy. 2018; 40(3): 509–512.
  36. Gęsicka DK. Odpowiedzialność za szkody wyrządzone przez produkty lecznicze – zagadnienia wybrane. Prawo i Medycyna. 2013(3-4): 189–208.
  37. The Judgment of the Supreme Court of 18.01.2013, no, IV CSK 431/12, Lex no 1275006.
  38. Zajdel J. Prawo medyczne. PZWL, Warszawa 2019.
  39. The Judgment of the Court of Appeal in Warsaw of 9.04.2019, no, akt V ACa 147/18, Lex no 2668829.
  40. The Judgment of the Court of Appeal in Warsaw of 19.02.2019, no, V ACa 119/18, Lex no 2631471.
  41. The Civil Code of 23.04.1964, ie. DzU 2020, pos. 1740.
  42. Kubiak R. Prawo medyczne. C.H.Beck, Warszawa 2017: 291–295.
  43. The Judgment of the Supreme Court of 28.08.1972, no akt II CR 296/72, OSNC, No 5/1973, pos. 86.
  44. The Judgment of the Court of Appeal in Kraków of 06.09.2012 r., no akt I ACa 723/12, LEX no 1236722.
  45. The Judgment of the Supreme Court of 28.09.1999 r., no akt II CKN 511/96, LEX no 453701).
  46. The Judgment of the Court of Appeal in Szczecin of 11.05.2017, no akt I Aca 560/15, LEX no 2376937.
  47. The Judgement of the Court of Appeal in Katowice of 18.01.2017 r., no akt V ACa 146/16, LEX no 2233014.

Regulations

Important: This website uses cookies. More >>

The cookies allow us to identify your computer and find out details about your last visit. They remembering whether you've visited the site before, so that you remain logged in - or to help us work out how many new website visitors we get each month. Most internet browsers accept cookies automatically, but you can change the settings of your browser to erase cookies or prevent automatic acceptance if you prefer.

Wydawcą serwisu jest VM Media Group sp. z o.o., ul. Świętokrzyska 73, 80–180 Gdańsk

tel.:+48 58 320 94 94, faks:+48 58 320 94 60, e-mail: viamedica@viamedica.pl