Free Standard AU & NZ Shipping For All Book Orders Over $80!
Register      Login
Australian Health Review Australian Health Review Society
Journal of the Australian Healthcare & Hospitals Association
RESEARCH ARTICLE (Open Access)

Physicians’ legal duty to disclose more cost-effective treatment options: an examination of Australian civil law applied to personal importation

Narcyz Ghinea https://orcid.org/0000-0002-1457-7252 A *
+ Author Affiliations
- Author Affiliations

A Philosophy Department, Faculty of Arts, Centre for Agency, Values and Ethics, Macquarie University, North Ryde, NSW 2109, Australia.

* Correspondence to: narcyz.ghinea@mq.edu.au

Australian Health Review 47(3) 314-321 https://doi.org/10.1071/AH23008
Submitted: 16 January 2023  Accepted: 29 March 2023   Published: 24 April 2023

© 2023 The Author(s) (or their employer(s)). Published by CSIRO Publishing on behalf of AHHA. This is an open access article distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND)

Abstract

Objective A significant proportion of Australians defer or do not fill prescriptions they require due to cost. This article explores whether, and under what circumstances, physicians have a duty to assist these patients by disclosing how they can access more affordable medicines via personal importation.

Methods This study involved a critical examination of Australian statutory and case law pertaining to physicians’ duty to disclose material information to identify key principles applicable to the context of cost-motivated personal importation.

Results There are several legal principles that suggest that physicians have a duty to advise patients of options for accessing more affordable medicines, including via personal importation. These include a duty to warn of inherent and non-inherent risks, a duty to disclose treatments that offer clear advantages, and a duty to facilitate access to the means for achieving patients’ health goals. However, it is unclear whether, and on what grounds, responsibility for harm arising from a patient's inability to afford prescribed medicines should be attributed to the prescribing physician. Arguments supporting attribution of such a responsibility are proposed to motivate further legal, policy and ethical debate.

Conclusions Physicians have a duty to take reasonable steps to mitigate foreseeable harm to their patients, however the law is silent on whether this duty extends to taking steps to help patients access medicines that they can afford. This investigation provides a framework to guide the development of sound policy and law on informed financial consent and economically motivated prescribing.

Keywords: affordability, clinical ethics, duty of care, informed consent, legal duty, negligence, pharmaceuticals, Personal Importation Scheme.


References

[1]  Healthengine and Australian Patients Association. Australian Healthcare Index. Report 2. October. 2021. Available at https://australianhealthcareindex.com.au/wp-content/uploads/2021/10/Australian-Healthcare-Index-Report-2-October-2021.pdf

[2]  Van Alsten SC, Harris JK. Cost-Related Nonadherence and Mortality in Patients With Chronic Disease: A Multiyear Investigation, National Health Interview Survey, 2000–2014. Prev Chronic Dis 2020; 17 200244
Cost-Related Nonadherence and Mortality in Patients With Chronic Disease: A Multiyear Investigation, National Health Interview Survey, 2000–2014.Crossref | GoogleScholarGoogle Scholar |

[3]  Seaman K, Sanfilippo F, Bulsara M, Roughead L, Kemp-Casey A, Bulsara C, Watts GF, Preen D. Predictors of ceasing or reducing statin medication following a large increase in the consumer copayment for medications: a retrospective observational study. Public Health Res Pract 2020; 30 e29121905
Predictors of ceasing or reducing statin medication following a large increase in the consumer copayment for medications: a retrospective observational study.Crossref | GoogleScholarGoogle Scholar |

[4]  Ghinea N. Do doctors have a responsibility to help patients import medicines from abroad? J Med Ethics 2023; 49 131–5.
Do doctors have a responsibility to help patients import medicines from abroad?Crossref | GoogleScholarGoogle Scholar |

[5]  Ghinea N. Personal Importation and the law: protecting patients who import medicines for legitimate health care needs. J Law Med 2022; 29 829–46.

[6]  Ghinea N, Lipworth W, Day R, Hill A, Dore GJ, Danta M. Importation of generic hepatitis C therapies: bridging the gap between price and access in high-income countries. Lancet 2017; 389 1268–72.
Importation of generic hepatitis C therapies: bridging the gap between price and access in high-income countries.Crossref | GoogleScholarGoogle Scholar |

[7]  Cohen D. NHS England explores funding options for cystic fibrosis drug. BMJ 2019; 366 l5600
NHS England explores funding options for cystic fibrosis drug.Crossref | GoogleScholarGoogle Scholar |

[8]  PharmacyChecker.com. Drug Price Comparisons & Online Pharmacy Safety. Available at https://www.pharmacychecker.com/verification-portal/[cited 14 February 2023].

[9]  Harper C, Ghinea N, Lipworth W. The right to health: Implications for the funding of medicines in Australia. J Law Med 2017; 24 640–55.

[10]  Sparks v Hobson; Gray v Hobson. 2018. Available at http://www.austlii.edu.au/cgi-bin/viewdoc/au/cases/nsw/NSWCA/2018/29.html?context=1;query=Sparks%20v%20Hobson%20;mask_path= [cited 12 January 2023].

[11]  Chappel v Hart [1998] HCA 55; 195 CLR 232; 156 ALR 517; 72 ALJR 1344 (2 September 1998). Available at http://classic.austlii.edu.au/cgi-bin/sinodisp/au/cases/cth/HCA/1998/55.html?stem=0&synonyms=0&query=title(Chappel% 20and% 20Hart% 20) [cited 26 July 2022].

[12]  Rogers v Whitaker [1992] HCA 58; (1992) 175 CLR 479 (19 November 1992). Available at http://classic.austlii.edu.au/au/cases/cth/HCA/1992/58.html [cited 26 July 2022].

[13]  Carver T. Informed consent, Montgomery and the duty to discuss alternative treatments in England and Australia. J Patient Saf Risk Manag 2020; 25 187–93.
Informed consent, Montgomery and the duty to discuss alternative treatments in England and Australia.Crossref | GoogleScholarGoogle Scholar |

[14]  Jambrovic v Day; Jambrovic v Day. 2017. Available at http://www.austlii.edu.au/cgi-bin/viewdoc/au/cases/nsw/NSWSC/2017/1468.html?context=1;query=Jambrovic%20v%20Day%20;mask_path= [cited 12 January 2023].

[15]  McWhirter R. Informed Consent and Performance Data: Clinician Experience as a Material Risk. UNSWLJ 2017; 40 566
Informed Consent and Performance Data: Clinician Experience as a Material Risk.Crossref | GoogleScholarGoogle Scholar |

[16]  UNSW Law Journal. Medical Negligence, Causation and Liability for Non-disclosure of Risk: A Post-Wallace Framework and Critique. 2014. Available at https://www.unswlawjournal.unsw.edu.au/article/medical-negligence-causation-and-liability-for-non-disclosure-of-risk-a-post-wallace-framework-and-critique [cited 12 January 2023].

[17]  Richards and Ors v Rahilly and Anor. 2005. Available at http://www.austlii.edu.au/cgi-bin/viewdoc/au/cases/nsw/NSWSC/2005/352.html?context=1;query=Richards%20and%20Ors%20v%20Rahilly%20and%20Anor;mask_path= [cited 12 January 2023].

[18]  Bester J, Cole CM, Kodish E. The Limits of Informed Consent for an Overwhelmed Patient: Clinicians’ Role in Protecting Patients and Preventing Overwhelm. AMA J Ethics 2016; 18 869–86.
The Limits of Informed Consent for an Overwhelmed Patient: Clinicians’ Role in Protecting Patients and Preventing Overwhelm.Crossref | GoogleScholarGoogle Scholar |

[19]  ACT v Gillan; Gillan v ACT. 2018. Available at http://www.austlii.edu.au/cgi-bin/viewdoc/au/cases/act/ACTSC/2018/223.html?context=1;query=Gillan%20v%20ACT%20;mask_path= [cited 12 January 2023].

[20]  Rufo v Hosking [2004] NSWCA 391 (1 November 2004). Available at http://classic.austlii.edu.au/au/cases/nsw/NSWCA/2004/391.html [cited 26 July 2022].

[21]  Varipatis v Almario. 2013. Available at http://www.austlii.edu.au/cgi-bin/viewdoc/au/cases/nsw/NSWCA/2013/76.html?context=1;query=Varipatis%20v%20Almario%20;mask_path= [cited 12 January 2023].

[22]  Rubino v Ziaee. 2021. Available at http://www.austlii.edu.au/cgi-bin/viewdoc/au/cases/act/ACTSC/2021/331.html?context=1;query=Ziaee% 20;mask_path= [cited 12 January 2023].

[23]  Tai v Hatzistavrou. 1999. Available at http://www.austlii.edu.au/cgi-bin/viewdoc/au/cases/nsw/NSWCA/1999/306.html [cited 12 January 2023].

[24]  Gould v South Western Sydney Local Health District. 2017. Available at http://www.austlii.edu.au/cgi-bin/viewdoc/au/cases/nsw/NSWDC/2017/67.html?context=1;query=Novus%20actus%20interveniens;mask_path=#_Ref478109736 [cited 8 March 2023].

[25]  Medical Board of Australia. Good medical practice: a code of conduct for doctors in Australia. October. 2020. Available at https://www.medicalboard.gov.au/Codes-Guidelines-Policies/Code-of-conduct.aspx

[26]  Dickson N. The GMC’s stance on Avastin. BMJ 2015; 350 h2043
The GMC’s stance on Avastin.Crossref | GoogleScholarGoogle Scholar |

[27]  Lipworth W. Wendy Lipworth: Counting the cost of off-label prescribing. InSight+; 2011. Available at https://insightplus.mja.com.au/2011/23/wendy-lipworth-counting-cost-label-prescribing/ [cited 6 March 2023].

[28]  Cancer Council. Informed financial consent. 2023. Available at https://www.cancer.org.au/health-professionals/resources/informed-financial-consent [cited 26 July 2022].

[29]  Australian Medical Association. Informed Financial Consent. 2020. Available at https://www.ama.com.au/articles/informed-financial-consent [cited 6 March 2023].

[30]  Australian Commission on Safety and Quality in Health Care. AS18/10: Informed financial consent. 2021. Available at https://www.safetyandquality.gov.au/publications-and-resources/resource-library/as1810-informed-financial-consent [cited 6 March 2023].

[31]  Richman B, Hall M, Schulman K. The No Surprises Act and Informed Financial Consent. N Engl J Med 2021; 385 1348–51.
The No Surprises Act and Informed Financial Consent.Crossref | GoogleScholarGoogle Scholar |

[32]  Pisu M, Martin MY. Financial toxicity: a common problem affecting patient care and health. Nat Rev Dis Primers 2022; 8 7
Financial toxicity: a common problem affecting patient care and health.Crossref | GoogleScholarGoogle Scholar |

[33]  Altomare I, Irwin B, Zafar SY, Houck K, Maloney B, Greenup R, et al. ReCAP: Physician Experience and Attitudes Toward Addressing the Cost of Cancer Care. J Oncol Pract 2016; 12 247–8.
ReCAP: Physician Experience and Attitudes Toward Addressing the Cost of Cancer Care.Crossref | GoogleScholarGoogle Scholar |

[34]  Mahase E. FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway. BMJ 2021; 374 n1898
FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway.Crossref | GoogleScholarGoogle Scholar |

[35]  Mostaghim SR, Gagne JJ, Kesselheim AS. Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study. BMJ 2017; 358 j3837
Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study.Crossref | GoogleScholarGoogle Scholar |

[36]  Australian Institute of Health and Welfare. Health expenditure Australia 2020-21, Non-government sources. 2022. Available at https://www.aihw.gov.au/reports/health-welfare-expenditure/health-expenditure-australia-2020-21/contents/spending-trends-by-sources/non-government-sources [cited 25 January 2023].

[37]  Beasley D. U.S. new drug price exceeds $200,000 median in 2022. Reuters; 2023. Available at https://www.reuters.com/business/healthcare-pharmaceuticals/us-new-drug-price-exceeds-200000-median-2022-2023-01-05/ [cited 8 March 2023].

[38]  Levy MS. Big Pharma Monopoly: Why Consumers Keep Landing on “Park Place” and How the Game is Rigged. Am Univ Law Rev 2016; 66 247–303.

[39]  Fox E. How Pharma Companies Game the System to Keep Drugs Expensive. Harvard Business Review, 6 April 2017. Available at https://hbr.org/2017/04/how-pharma-companies-game-the-system-to-keep-drugs-expensive [cited 2023 Jan 13].

[40]  Becker DJ, Lin D, Lee S, Levy BP, Makarov DV, Gold HT, et al. Exploration of the ASCO and ESMO Value Frameworks for Antineoplastic Drugs. J Oncol Pract 2017; 13 e653–65.
Exploration of the ASCO and ESMO Value Frameworks for Antineoplastic Drugs.Crossref | GoogleScholarGoogle Scholar |

[41]  Warsame R, Kennedy CC, Kumbamu A, Branda M, Fernandez C, Kimball B, et al. Conversations About Financial Issues in Routine Oncology Practices: A Multicenter Study. J Oncol Pract 2019; 15 e690–703.
Conversations About Financial Issues in Routine Oncology Practices: A Multicenter Study.Crossref | GoogleScholarGoogle Scholar |