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
Shopping Cart: ( empty )
You are here: Home > Journals > AH > AH22209
RESEARCH ARTICLE
Contents Vol 47(2)

Promoting the personal importation of therapeutic goods: recent legislative amendments to advertising regulations may impact consumer access and understanding

Christopher Rudge https://orcid.org/0000-0001-6629-8485 A * and Narcyz Ghinea https://orcid.org/0000-0002-1457-7252 B
+ Author Affiliations
- Author Affiliations

A Faculty of Law, Sydney Law School, University of Sydney, Rm No 523, New Law Building, NSW 2006, Australia.

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

* Correspondence to: christopher.rudge@sydney.edu.au

Australian Health Review 47(2) 182-191 https://doi.org/10.1071/AH22209
Submitted: 10 October 2022  Accepted: 23 January 2023   Published: 13 February 2023

© 2023 The Author(s) (or their employer(s)). Published by CSIRO Publishing on behalf of AHHA.

Abstract

Objective The personal importation scheme is a legislative mechanism that allows health consumers to import unapproved medicines under certain conditions. This article analyses the legal and policy basis for the scheme and considers how reforms to advertising laws for therapeutic goods may restrict communications about it. The article represents the first published analysis of the personal importation scheme’s interaction with the communications of health professionals and buyer’s clubs. It considers how these communications may be affected by legal amendments, particularly where unapproved medicines may be accessed through the scheme.

Methods An examination of Australian therapeutic goods law concerning the personal importation scheme was conducted, including both the historical law and recent regulatory reforms. Illustrative tables were prepared to identify scheme-related advertising that may contravene therapeutic goods law. Risk estimates were allocated to several new legal rules to indicate whether health professionals or buyer’s clubs would contravene these laws when promoting the scheme to health consumers for unapproved medicines.

Results Representations made directly to the public by health practitioners or on buyer’s clubs websites about accessing unapproved therapeutic goods through the personal importation scheme are likely to contravene one or more advertising laws.

Conclusions The Therapeutic Goods Administration has very strong powers to initiate compliance or enforcement action for advertising breaches in Australia for many promotional practices. Arguably, in the age of the internet and in the context of emerging expensive medicines, these powers should not be used to restrict health practitioners or buyer’s clubs from sharing information about the lawful personal importation scheme to health consumers in need. Nevertheless, the study finds that health practitioners who promote or refer to the availability of unapproved medicines through the personal importation scheme outside of a consultation are likely to contravene the law and may be subject to disciplinary or enforcement action.

Keywords: access to medicines, advertising, buyers’ clubs, health regulation, medical practitioner law, personal importation, unapproved medicines.


References

[1]  Lybrand S, Wonder M. Analysis of PBAC submissions and outcomes for medicines (2010–2018). Intl J Tech Assess in Health Care 2020; 36 224–231.
| Analysis of PBAC submissions and outcomes for medicines (2010–2018).Crossref | GoogleScholarGoogle Scholar |

[2]  Donovan P. Access to unregistered drugs in Australia. Aust Prescr 2017; 40 194–196.
| Access to unregistered drugs in Australia.Crossref | GoogleScholarGoogle Scholar |

[3]  Therapeutic Goods Administration. Accessing unapproved products. 2022. Available at https://www.tga.gov.au/accessing-unapproved-products [verified 8 July 2022].

[4]  Therapeutic Goods Administration. Authorised Prescriber Scheme. 7 February 2022. Available at https://www.tga.gov.au/resources/resource/guidance/authorised-prescriber-scheme [verified 8 July 2022].

[5]  Therapeutic Goods Administration. Special Access Scheme. 29 June 2022. Available at https://www.tga.gov.au/form/special-access-scheme [verified 8 July 2022].

[6]  Therapeutic Goods Administration. Personal Importation Scheme. 18 March 2015. Available at https://www.tga.gov.au/products/unapproved-therapeutic-goods/personal-importation-scheme [verified 8 July 2022].

[7]  Pearce A, van Gool K, Haywood P, et al. Delays in access to affordable medicines: putting policy into perspective. Aust Health Rev 2012; 36 412–418.
| Delays in access to affordable medicines: putting policy into perspective.Crossref | GoogleScholarGoogle Scholar |

[8]  Bin Sawad A, Aissaoui A. Oncology drugs lag between Europe and other countries: Comparaison between EMA and others agencies (FDA, health canada, TGA, and Swissmedic). Value Health 2016; 19 A164–A165.
| Oncology drugs lag between Europe and other countries: Comparaison between EMA and others agencies (FDA, health canada, TGA, and Swissmedic).Crossref | GoogleScholarGoogle Scholar |

[9]  Australian Federation of AIDS Organisations. Submission to the inquiry into approval processes for new drugs and novel medical technologies in Australia. 2020 (submission 196), p. 5. Available at https://www.aph.gov.au/Parliamentary_Business/Committees/House/Health_Aged_Care_and_Sport/Newdrugs/Submissions [verified 8 July 2022].

[10]  Migraine Australia. Submission to the inquiry into approval processes for new drugs and novel medical technologies in Australia. 2020 (submission 24); pp. 22–23. Available at https://www.aph.gov.au/Parliamentary_Business/Committees/House/Health_Aged_Care_and_Sport/Newdrugs/Submissions [verified 8 July 2022].

[11]  Quilty S. Medicines shortages in Australia—the reality. Australas Med J 2014; 7 240–242.
| Medicines shortages in Australia—the reality.Crossref | GoogleScholarGoogle Scholar |

[12]  Australian Government House of Representatives Standing Committee on Health, Aged Care and Sport. The New Frontier - Delivering Better Health for all Australians. November 2021. 57 [4.19], 212[8.60], 243 [9.60], 265 [9.124]. Available at https://www.aph.gov.au/Parliamentary_Business/Committees/House/Health_Aged_Care_and_Sport/Newdrugs/Report [verified 8 July 2022].

[13]  Commonwealth of Australia. Official Committee Hansard Senate Community Affairs Legislation Committee. Susan Adler (Therapeutic Goods Administration), Senate, Monday, 7 February 2000, CA 66. Available at https://parlinfo.aph.gov.au/parlInfo/download/committees/estimate/712/toc_pdf/115-3437.pdf;fileType=application%2Fpdf#search=%22committees/estimate/712/0000%22

[14]  Therapeutic Goods Administration. Orphan drug designation: A step-by-step guide for prescription medicines. August 2018 [1.1]. Available at https://www.tga.gov.au/sites/default/files/orphan-drug-designation.pdf [verified 8 July 2022].

[15]  Therapeutic Goods Regulations 1990 (Cwlth) r. 16J. Available at https://www.legislation.gov.au/Details/F2023C00011.

[16]  Therapeutic Goods Regulations 1990 (Cwlth) r. 16J(3)(d)(i). Available at https://www.legislation.gov.au/Details/F2023C00011.

[17]  Parliament of the Commonwealth of Australia. National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021 (Explanatory Memorandum). October 2021. Available at https://parlinfo.aph.gov.au/parlInfo/search/display/display.w3p;query=Id%3A%22legislation%2Fems%2Fr6799_ems_8812668a-6b85-4028-8a69-034fe4858fad%22 [verified 9 September 2022].

[18]  Special arrangement may be made under the National Health Act 1953 (Cwlth) s. 100. Available at https://www.legislation.gov.au/Details/C2023C00012

[19]  Australian Government Department of Health and Aged Care. Repatriation Schedule of Pharmaceutical Benefits (RPBS) Items. 2022. Available at https://www.pbs.gov.au/browse/rpbs [verified 9 September 2022].

[20]  Australian Government Department of Health and Aged Care. Life Saving Drugs Program. 2022. Available at https://www.health.gov.au/initiatives-and-programs/life-saving-drugs-program [verified 9 September 2022].

[21]  Willis S. Medicine prices in Australia among the cheapest in the world, research shows. ABC News (Health and Wellbeing), 25 November 2019. Available at https://www.abc.net.au/news/health/2019-11-25/medicine-costs-australia-cheaper-than-overseas/11728422 [verified 13 July 2022].

[22]  Moon S, Erickson E. Universal medicine access through lump-sum remuneration — Australia’s approach to hepatitis C. N Engl J Med 2019; 380 607–610.
| Universal medicine access through lump-sum remuneration — Australia’s approach to hepatitis C.Crossref | GoogleScholarGoogle Scholar |

[23]  Toy M, Hutton D, McCulloch K, et al. The price tag of a potential cure for chronic hepatitis B infection: a cost threshold analysis for USA, China and Australia. Liver Int 2022; 42 16–25.
| The price tag of a potential cure for chronic hepatitis B infection: a cost threshold analysis for USA, China and Australia.Crossref | GoogleScholarGoogle Scholar |

[24]  Duckett S. Australia’s bad drug deal: High pharmaceutical prices. Grattan Institute; 2013. Available at https://grattan.edu.au/wp-content/uploads/2014/04/Australias_Bad_Drug_Deal_FINAL.pdf [verified 9 September 2022].

[25]  Australian Government Department of Health and Aged Care. Information about the new Hepatitis C treatments from 1 March 2016. 2016. Available at https://www.pbs.gov.au/pbs/news/2016/02/info-about-new-hep-c-treatments [verified 9 September 2022].

[26]  Douglass CH, Pedrana A, Lazarus JV, et al. Pathways to Ensure Universal and Affordable Access to Hepatitis C Treatment. BMC Med 2018; 16 175
| Pathways to Ensure Universal and Affordable Access to Hepatitis C Treatment.Crossref | GoogleScholarGoogle Scholar |

[27]  Callander E, Corscadden L, Levesque J-F. Out-of-pocket healthcare expenditure and chronic disease – do Australians forgo care because of the cost? Aust J Prim Health 2017; 23 15–22.
| Out-of-pocket healthcare expenditure and chronic disease – do Australians forgo care because of the cost?Crossref | GoogleScholarGoogle Scholar |

[28]  Eczema Australia. Submission to the inquiry into approval processes for new drugs and novel medical technologies in Australia. 2020 (submission 39); 18. Available at https://www.aph.gov.au/Parliamentary_Business/Committees/House/Health_Aged_Care_and_Sport/Newdrugs/Submissions [verified 9 September 2022].

[29]  Gleeson DH, Moir H, Lopert R. Costs to Australian taxpayers of pharmaceutical monopolies and proposals to extend them in the trans-pacific partnership agreement. Med J Aust 2015; 202 306–308.
| Costs to Australian taxpayers of pharmaceutical monopolies and proposals to extend them in the trans-pacific partnership agreement.Crossref | GoogleScholarGoogle Scholar |

[30]  The experiences of implementing generic medicine policy in eight countries: A review and recommendations for a successful promotion of generic medicine. Saudi Pharm J 2014; 22 491–503.
| The experiences of implementing generic medicine policy in eight countries: A review and recommendations for a successful promotion of generic medicine.Crossref | GoogleScholarGoogle Scholar |

[31]  New South Wales Therapeutic Advisory Group Inc. Off-label use of registered medicines and use of medicines under the personal importation scheme in NSW public hospitals. September 2003. Available at https://www.nswtag.org.au/wp-content/uploads/2017/07/off-label-use-sept-2003.pdf [verified 9 September 2022].

[32]  McEwan J. A history of therapeutic goods regulation in Australia. Woden, ACT: Australian Government, Department of Health, TGA; 2007. pp. 101–102, 138, 143.

[33]  Commonwealth of Australia. Parliamentary Paper No 191, Director-General of Health, Annual Report (1970-71). 1972. Available at https://nla.gov.au/nla.obj-2772522617/view?partId=nla.obj-2782775518#page/n0/mode/1up [verified 9 September 2022].

[34]  Therapeutic Goods Act 1989 (Cwlth) s. 18. Available at https://www.legislation.gov.au/Details/C2021C00376.

[35]  Therapeutic Goods Regulations 1990 (Cwlth) r. 12(1), sch. 5, item 1. Available at https://www.legislation.gov.au/Details/F2023C00011.

[36]  Customs Act 1901 (Cwlth) s. 50; Customs (Prohibited Imports) Regulations 1956 (Cwlth), r. 5 and sch. 5. Available at https://www.legislation.gov.au/Details/C2023C00015.

[37]  Biosecurity Act 2015 (Cwlth) s. 173. Available at https://www.legislation.gov.au/Details/C2022C00371.

[38]  Therapeutic Goods Regulations 1990 (Cwlth) r. 12(1), sch. 5, items 1(a) and 1(b).

[39]  Therapeutic Goods Administration. Prescription Medicines: New or Extended Uses, or New Combinations of Registered Medicines, 2016. 2016. Available at https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good-0/supply-prescription-medicine/prescription-medicines-new-or-extended-uses-or-new-combinations-registered-medicines-2016 [verified 6 February 2023].

[40]  Therapeutic Substances Act 1953 (Cwlth) s. 7(1)(c). Available at http://classic.austlii.edu.au/au/legis/cth/num_act/tsa1953721953276/.

[41]  Australian Government, Department of Foreign Affairs and Trade. International Covenant on Economic, Social and Cultural Rights [1976] ATS 5. 2009. Available at https://www.info.dfat.gov.au/Info/Treaties/treaties.nsf/AllDocIDs/CFB1E23A1297FFE8CA256B4C000C26B4 [verified 14 July 2022].

[42]  Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Commission recommendations. Hastings Cent Rep 1975; 5 45–46.

[43]  Darvall L. Autonomy and protectionism: Striking a balance in human subject research policy and regulation. Law in Context 1993; 11: 82–96.

[44]  Department of Health and Human Services. Rules and Regulations Title 45 Code of Federal Regulations Part 46 s. 111(a) (1983). Available at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

[45]  Commonwealth of Australia. Parliamentary Debates. Senate Hansard, 6 June 1991, Senator Vallentine, ‘Aids Drugs’, 4523–4524. 1991. Available at https://parlinfo.aph.gov.au/parlInfo/download/chamber/hansards/1991-06-06/toc_pdf/S%201991-06-06.pdf;fileType=application%2Fpdf#search=%22chamber/hansards/1991-06-06/0000%22

[46]  Baume P. A question of balance: Report on the future of drug evaluation in Australia. AGPS (July); 1991. pp. 127–132.

[47]  Commonwealth of Australia. Review of drug evaluation procedures. Canberra: Public Service Board; 1987.

[48]  Therapeutic Goods Amendment Act 1991 (Cwlth) s. 4. Available at http://www5.austlii.edu.au/au/legis/cth/num_act/tgaa1991271/index.html

[49]  Commonwealth Parliament, Senate Official Hansard. Therapeutic Amendment Bill 1991, Second Reading Speech (Senator Patterson). 12 December 1991. 4709–4729. Available at https://parlinfo.aph.gov.au/parlInfo/download/chamber/hansards/1991-12-12/toc_pdf/S%201991-12-12.pdf;fileType=application%2Fpdf#search=%22chamber/hansards/1991-12-12/0000%22

[50]  Skerritt J. Therapeutic Goods Administration, Senate Community Affairs Legislation Committee, Official Committee Hansard. 10 February 2016. Available at https://parlinfo.aph.gov.au/parlInfo/download/committees/estimate/d4e63ac2-46c0-4422-955d-4b7db9b3b72d/toc_pdf/Community%20Affairs%20Legislation%20Committee_2016_02_10_4113_Official.pdf;fileType=application%2Fpdf [verified 15 September 2022].

[51]  Commonwealth Parliament, Senate Official Hansard. Therapeutic Amendment Bill 1991, Second Reading Speech (Senator Knowles). 12 December 1991. 4721. Available at https://parlinfo.aph.gov.au/parlInfo/download/chamber/hansards/1991-12-12/toc_pdf/S%201991-12-12.pdf;fileType=application%2Fpdf#search=%22chamber/hansards/1991-12-12/0000%22

[52]  Parker L, Bennett A, Mintzes B, et al. “There are ways … drug companies will get into DTC decisions”: how Australian drug and therapeutics committees address pharmaceutical industry influence. Br J Clin Pharmacol 2021; 87 2341–2353.
| “There are ways … drug companies will get into DTC decisions”: how Australian drug and therapeutics committees address pharmaceutical industry influence.Crossref | GoogleScholarGoogle Scholar |

[53]  Therapeutic Goods Administration. Special Access Scheme Guidance for health practitioners and sponsors (September 2017 [1.1]). 2017. Available at https://www.tga.gov.au/sites/default/files/special-access-scheme-guidance-for-health-practitioners-and-sponsors.pdf [verified 15 July 2022].

[54]  Ghinea N. Personal importation and the law: protecting patients who import medicines for legitimate health care needs. J Law Med 2022; 29 829–846.

[55]  Wienicke C. Access to therapeutic drugs: law, personal freedom and public health. J Law Med 1997; 5 155–177.
| Access to therapeutic drugs: law, personal freedom and public health.Crossref | GoogleScholarGoogle Scholar |

[56]  Rudd K, MP. House of Representatives, Main Committee. Parkinson’s Disease. 11 March 1999. Available at https://parlinfo.aph.gov.au/parlInfo/genpdf/chamber/hansardr/1999-03-11/0151/hansard_frag.pdf;fileType=application%2Fpdf [verified 15 September 2022].

[57]  Rhodes N, van de Pas R. Mapping Buyer’s Clubs; what role do they play in achieving equitable access to medicines? Glob Public Health 2022; 17 1842–1853.
| Mapping Buyer’s Clubs; what role do they play in achieving equitable access to medicines?Crossref | GoogleScholarGoogle Scholar |

[58]  Ghinea N. Do doctors have a responsibility to help patients import medicines from abroad? J Med Ethics 2023; 49 131–135.
| Do doctors have a responsibility to help patients import medicines from abroad?Crossref | GoogleScholarGoogle Scholar |

[59]  Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (Cwlth) sch. 1. Available at https://www.legislation.gov.au/Details/F2021L01661

[60]  Therapeutic Goods (Medical Devices) Regulations 2002 (Cwth) Available at https://www.legislation.gov.au/Details/F2023C00032

[61]  Poisons Standard October 2022 (Cwlth) sch. 1 (‘Standard for the Uniform Scheduling of Medicines and Poisons No. 36’). Available at https://www.legislation.gov.au/Details/F2022L01257

[62]  Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 (Cwlth) s. 3; Code s. 6. Available at https://www.legislation.gov.au/Details/C2018A00007

[63]  Act s. 3 (‘advertise’).

[64]  Federal Court of Australia. Secretary, Department of Health v Oxymed Australia Pty Ltd 397 ALR 241 (Rofe J) 255 [78(c)], 256 [93], 272 [200], 274 [213], 276 [242], 281. Available at https://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2021/2021fca1518

[65]  Australian Competition and Consumer Commission v Allergy Pathway Pty Ltd (No 2) (2011) 192 FCR 34.

[66]  Therapeutic Goods Administration. Australian Regulatory Guidelines for Advertising Therapeutic Goods. 2020. Available at https://www.tga.gov.au/book-page/advertising-regulatory-framework#act [verified 25 July 2022].

[67]  Code s. 5(3).

[68]  Act ss. 42AA, 42AB, 42AC.

[69]  Act s. 3 (therapeutic goods).

[70]  Act s. 42B.

[71]  Code s. 6(3).

[72]  Code s. 28.

[73]  Code s. 29.

[74]  Act ss. 42DD, 42DE, 42DF, 42DG, 42DH, 42DI, 42DJ, 42DK.

[75]  Code ss. 27, 28, 29.

[76]  Regulations sch. 2 pt. 1 – Prohibited representations.

[77]  Act s. 42DK.

[78]  Code ss. 8–24.

[79]  Rudge C, Ghinea N, Munsie M, et al. Regulating autologous stem cell interventions in Australia: updated review of the direct-to-consumer advertising restrictions. Aust Health Rev 2021; 45 507–515.
| Regulating autologous stem cell interventions in Australia: updated review of the direct-to-consumer advertising restrictions.Crossref | GoogleScholarGoogle Scholar |

[80]  Secretary, Department of Health v Oxymed Australia Pty Ltd [2021] FCA 1518, available at https://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2021/2021fca1518; Secretary, Department of Health v Evolution Supplements Australia Pty Ltd (No 2) [2021] FCA 872, available at https://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2021/2021fca0872; Secretary, Department of Health v Peptide Clinics Australia Pty Ltd [2019] FCA 1107, available at https://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2019/2019fca1107​

[81]  Therapeutic Goods Administration. Conviction for unlawful advertising of sports supplements. 30 September 2021. Available at https://www.tga.gov.au/media-release/conviction-unlawful-advertising-sports-supplements [verified 25 July 2022]; Therapeutic Goods Administration. Court convicts HealthHub247 Pty Ltd and its Director for sports supplements offences. 30 September 2021. Available at https://www.tga.gov.au/media-release/court-convicts-healthhub247-pty-ltd-and-its-director-sports-supplements-offences [verified 25 July 2022].

[82]  Federal Court of Australia. Secretary, Department of Health v Evolution Supplements Australia Pty Ltd (No 2) [2021] FCA 74. Available at https://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2021/2021fca0872

[83]  Therapeutic Goods Administration. ‘Pre-approval no longer required for ads in specified media. 1 July 2020. Available at https://www.tga.gov.au/media-release/pre-approval-no-longer-required-ads-specified-media [verified 12 July 2022].

[84]  Sansom L, Delaat W, Horvath J. Review of Medicines and Medical Devices Regulation: Report on the Regulatory Framework for Medicines and Medical Devices. Report. Department of Health; 2015. recommendations 52, 53, 54, 55, 56, 57, 58. Available at https://www.rudge.tv/wp-content/uploads/2022/07/Review-of-Medicines-and-Medical-Devices-Recommendations_Accessible.pdf [verified 25 July 2022].

[85]  Parliament of Australia. Explanatory Memorandum. Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017. Available at https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/Bills_Search_Results/Result?bIdr5977 [verified 27 July 2022].

[86]  Sinclair R. Review of the Therapeutic Goods Advertising Framework Final Report on the impact of advertising reforms from the Expert Panel Review of Medicines and Medical Devices Regulation, and other initiatives. 2020. Available at https://www.tga.gov.au/sites/default/files/review-therapeutic-goods-advertising-framework.pdf [verified 25 July 2022].

[87]  Fittler A, Vida RG, Káplár M, Botz L. Consumers Turning to the Internet Pharmacy Market: Cross-Sectional Study on the Frequency and Attitudes of Hungarian Patients Purchasing Medications Online. J Med Internet Res 2018; 20 e11115
| Consumers Turning to the Internet Pharmacy Market: Cross-Sectional Study on the Frequency and Attitudes of Hungarian Patients Purchasing Medications Online.Crossref | GoogleScholarGoogle Scholar |

[88]  Hong Y-R, Hincapie-Castillo JM, Xie Z, Segal R, Mainous III AG. Socioeconomic and Demographic Characteristics of US Adults Who Purchase Prescription Drugs From Other Countries. JAMA Netw Open 2020; 3 e208968
| Socioeconomic and Demographic Characteristics of US Adults Who Purchase Prescription Drugs From Other Countries.Crossref | GoogleScholarGoogle Scholar |

[89]  Funestrand H, Liu R, Lundin S, Troein M. Substandard and falsified medical products are a global public health threat. A pilot survey of awareness among physicians in Sweden. J Public Health 2019; 41 e95–e102.
| Substandard and falsified medical products are a global public health threat. A pilot survey of awareness among physicians in Sweden.Crossref | GoogleScholarGoogle Scholar |

[90]  Isles M. What’s in a word? Falsified/counterfeit/fake medicines - the definitions debate. Med Access Point Care 2017; 1 maapoc.0000008
| What’s in a word? Falsified/counterfeit/fake medicines - the definitions debate.Crossref | GoogleScholarGoogle Scholar |

[91]  Nayyar GML, Attaran A, Clark JP, et al. Responding to the pandemic of falsified medicines. Am J Trop Med Hyg 2015; 92 113–118.
| Responding to the pandemic of falsified medicines.Crossref | GoogleScholarGoogle Scholar |

[92]  Interpol. Pharmaceutical crime operations. 2021. Available at https://www.interpol.int/en/Crimes/Illicit-goods/Pharmaceutical-crime-operations

[93]  Therapeutic Goods Administration. How we manage advertising compliance: advertising principles and the Therapeutic Goods Administration (TGA) compliance framework for therapeutic goods. 2022. Available at https://www.tga.gov.au/how-we-regulate/advertising/legal-framework/how-we-manage-advertising-compliance [verified 25 July 2022].