Regulating autologous stem cell interventions in Australia: updated review of the direct-to-consumer advertising restrictions
Chris Rudge
A D , Narcyz Ghinea B , Megan Munsie A and Cameron Stewart C
+ Author Affiliations
- Author Affiliations
A Department of Anatomy and Neuroscience, The University of Melbourne, Victoria 3010, Australia. Email: megan.munsie@unimelb.edu.au
B School of Public Health, Faculty of Medicine and Health, University of Sydney, NSW 2006, Australia. Email: narcyz.ghinea@sydney.edu.au
C Faculty of Law, Rm No 337, New Law Building, University of Sydney, NSW 2006, Australia. Email: cameron.stewart@sydney.edu.au
D Corresponding author. Email: christopher.rudge@unimelb.edu.au
Australian Health Review 45(4) 507-515 https://doi.org/10.1071/AH20217
Submitted: 21 August 2020 Accepted: 11 November 2020 Published: 6 May 2021
Abstract
Objective This paper provides an update and overview of the law governing direct-to-consumer (DTC) advertising of autologous stem cell interventions (ASCIs) in Australia. It follows significant changes to the advertising regulations made in 2018.
Methods The paper reviews the three primary sources or ‘centres’ of law regulating ASCIs in Australia, together with the relevant guidance documents that supplement these sources. It provides analysis of how the post-2018 advertising regulations, contained in the Therapeutic Goods Act 1989 (Cwlth), apply to all ‘biologicals’, including ASCIs. It demonstrates how these three sources of law interact with one another and outlines the new tiered offence regime that applies to contraventions of these prohibitions.
Results The analysis demonstrates that DTC advertising of ASCIs in Australia is strictly controlled, with primary legislation prohibiting the advertising of biologicals altogether.
Conclusions The polycentric legal regime regulating biologicals in Australia clearly makes DTC advertising of ASCIs unlawful. Health practitioners who promote ASCIs, either online, in print or in other media forms, may be penalised in different ways and by different authorities.
What is known about the topic? Although several analyses have examined the regulation of ASCIs in Australia, no analysis has studied the reforms made in 2018 relating to the advertising of biologicals. As such, this analysis contributes a fresh examination of these relatively recent reforms.
What does this paper add? This analysis clarifies the effects of these new advertising regulations, providing clear guidance on the relevant legal provisions for the benefit of health practitioners and health professionals more generally.
What are the implications for practitioners? Health practitioners, especially those who offer ASCIs, should be aware that civil and criminal penalties are likely to be imposed on individuals who promote biologicals in Australia by any means.
Keywords: autologous, biologicals, direct-to-consumer advertising, stem cells, therapeutic goods regulation.
References
[1] Sipp D, Caulfield T, Kaye J, Barfoot J, Blackburn C, Chan S, De Luca M, Kent A, McCabe C, Munsie M, Sleeboom-Faulkner M, Sugarman J, van Zimmeren E, Zarzeczny A, Rasko JEJ. Marketing of unproven stem cell-based interventions: a call to action. Sci Transl Med 2017; 9 eaag0426| Marketing of unproven stem cell-based interventions: a call to action.Crossref | GoogleScholarGoogle Scholar | 28679655PubMed |
[2] Bauer G, Elsallab M, Abou-El-Enein M. Concise review: a comprehensive analysis of reported adverse events in patients receiving unproven stem cell-based interventions. Stem Cells Transl Med 2018; 7 676–85.
| Concise review: a comprehensive analysis of reported adverse events in patients receiving unproven stem cell-based interventions.Crossref | GoogleScholarGoogle Scholar | 30063299PubMed |
[3] Berger I, Ahmad A, Bansal A, Kapoor T, Sipp D, Rasko JEJ. Global distribution of businesses marketing stem cell-based interventions. Cell Stem Cell 2016; 19 158–62.
| Global distribution of businesses marketing stem cell-based interventions.Crossref | GoogleScholarGoogle Scholar | 27494673PubMed |
[4] Turner L. The US direct-to-consumer marketplace for autologous stem cell interventions. Perspect Biol Med 2018; 61 7–24.
| The US direct-to-consumer marketplace for autologous stem cell interventions.Crossref | GoogleScholarGoogle Scholar | 29805145PubMed |
[5] Munsie M, Lysaght T, Hendl T, Tan HL, Kerridge I, Stewart C. Open for business: a comparative study of websites selling autologous stem cells in Australia and Japan. Regen Med 2017; 12 777–90.
| Open for business: a comparative study of websites selling autologous stem cells in Australia and Japan.Crossref | GoogleScholarGoogle Scholar | 29125016PubMed |
[6] Waldby C, Hendl T, Kerridge I, Lipworth W, Lysaght T, Munsie M, Stewart C. The direct-to-consumer market for stem cell-based interventions in Australia: exploring the experiences of patients. Regen Med 2020; 15 1238–49.
| The direct-to-consumer market for stem cell-based interventions in Australia: exploring the experiences of patients.Crossref | GoogleScholarGoogle Scholar | 32009513PubMed |
[7] Lysaght T, Lipworth W, Hendl T, Keridge I, Lee T-L, Munsie M, Waldby C, Stewart C. The deadly business of an unregulated global stem cell industry. J Med Ethics 2017; 43 744–6.
| The deadly business of an unregulated global stem cell industry.Crossref | GoogleScholarGoogle Scholar | 28356490PubMed |
[8] Petersen A, Tanner C, Munsie M. Navigating the cartographies of trust: how patients and carers establish the credibility of online treatment claims. Sociol Health Illn 2019; 41 50–64.
| Navigating the cartographies of trust: how patients and carers establish the credibility of online treatment claims.Crossref | GoogleScholarGoogle Scholar | 31599982PubMed |
[9] Australian Government. Therapeutic Goods Amendment. (2009 Measures No. 3) Bill 2009, Revised Explanatory Memorandum. 2009. Available at: https://www.legislation.gov.au/Details/C2009B00241/Revised%20Explanatory%20Memorandum/Text [verified 20 July 2020].
[10] See Therapeutic Goods Act 1989 (Cwlth) s 32EA(9), inserted by the Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010 (Cwlth). Available at: https://www.legislation.gov.au/Series/C2004A03952 [verified 15 March 2021].
[11] Therapeutic Goods Act 42DL(11), inserted by the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 (Cwlth) s. 35. Available at: https://www.legislation.gov.au/Series/C2004A03952 [verified 15 March 2021].
[12] Therapeutic Goods Administration. Regulation of autologous cell and tissue products: including so called ‘autologous stem cell’ therapies. [Media release] 24 October 2017. Available at: https://www.tga.gov.au/media-release/regulation-autologous-cell-and-tissue-products [verified 10 August 2020].
[13] Munsie M. Open for business: selling stem cell therapy down under. Paper presented at the International Legal and Regulatory Context for Clinical Translation of Autologous Cellular Therapies Legal Workshop, 12 November 2019; Queensland University of Technology, Brisbane; 2019.
[14] Bennett B, Carney T, Chiarella M, Walton M, Kelly P, Satchell C, Beaupert F. Australia’s national registration and accreditation scheme for health practitioners: a national approach to polycentric regulation? Syd Law Rvw 2018; 40 159–81.
[15] See Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018. Available at: https://www.legislation.gov.au/Details/C2018A00007 [verified 15 March 2021].
[16] Therapeutic Goods Administration. Australian Regulatory Guidelines for Biologicals: Part 1: Introduction to the Australian Regulatory Guidelines for Biologicals. Version 1.0. 2011. Available at: https://www.abc.net.au/cm/lb/4058676/data/australian-regulatory-guidelines-for-biologicals-data.pdf [verified 10 August 2020].
[17] Therapeutic Goods (Excluded Goods) Order No. 1 of 2011, item 4(q).
[18] Coroners Court New South Wales. Inquest into the death of Sheila Drysdale. 15 July 2016. Available at: https://coroners.nsw.gov.au/documents/findings/2016/Findings%20Drysdale.pdf [verified 22 October 2020].
[19] Sansom L, Delaat W, Horvath W. Review of medicines and medical devices regulation: recommendations. 2015. Available at: https://www1.health.gov.au/internet/main/publishing.nsf/Content/8ADFA9CC3204463DCA257D74000EF5A0/$File/Review%20of%20Medicines%20and%20Medical%20Devices%20-%20Recommendations_Accessible.pdf [verified 6 July 2020].
[20] Therapeutic Goods Administration. Consultation: regulation of autologous cell and tissue products and proposed consequential changes to the classification of biologicals. Version 3.0. 2016. Available at: https://www.tga.gov.au/sites/default/files/consultation-regulation-autologous-cell-and-tissue-products.pdf [verified 22 October 2020].
[21] Therapeutic Goods Administration. Biologicals regulatory framework proposed changes to start on 1 July 2018, including changes to regulation of autologous human cell and tissue products and classification of biologicals. Version 1.0. 2018. Available at: https://www.tga.gov.au/sites/default/files/biologicals-regulatory-framework-proposed-changes-start-1-july-2018.pdf [verified 18 August 2020].
[22] Therapeutic Goods Act s. 32DD.
[23] Therapeutic Goods Regulation 1990 (Cwlth) sch. 16. Available at: https://www.legislation.gov.au/Details/F2021C00135 [verified 15 March 2021].
[24] Ghinea N, Munsie M, Rudge C, Stewart C. Australian regulation of autologous human cell and tissue products: implications for commercial stem cell clinics. Regen Med 2020; 15 1361–9.
| Australian regulation of autologous human cell and tissue products: implications for commercial stem cell clinics.Crossref | GoogleScholarGoogle Scholar | 32228372PubMed |
[25] Therapeutic Goods Regulations 1990 sch. 5A item 13.
[26] Therapeutic Goods (Excluded Goods) Determination 2018 (Cwlth). Available at: https://www.legislation.gov.au/Details/F2021C00176 [verified 15 March 2021].
[27] Therapeutic Goods (Excluded Goods) Determination sch. 2 item 4A. Table 2, column 2.
[28] Therapeutic Goods (Things that are not Biologicals) Determination No. 1 of 2011. Available at https://www.legislation.gov.au/Details/F2011L00894 [verified 15 March 2021].
[29] Therapeutic Goods (Things that are not Biologicals) Determination.
[30] Therapeutic Goods Administration. Regulation of autologous stem cell therapies: discussion paper for consultation. Version 1.0, January 2015. Available at: https://www.tga.gov.au/sites/default/files/consult-autologous-stem-cell-150106.pdf [verified 6 July 2020].
[31] Therapeutic Goods Administration. Consultation: regulation of autologous cell and tissue products and proposed consequential changes to the classification of biologicals. Version 3.0, August 2016. Available at: https://www.tga.gov.au/sites/default/files/consult-autologous-stem-cell-150106.pdf [verified 6 July 2020].
[32] Therapeutic Goods Administration. Net Pharmacy fined $214,200 for alleged unlawful advertising. [Media release] 2020. Available at: https://www.tga.gov.au/media-release/net-pharmacy-fined-214200-alleged-unlawful-advertising [verified 10 August 2020].
[33] Therapeutic Goods Act s. 32A.
[34] Therapeutic Goods Act s. 3.
[35] Therapeutic Goods Administration. Australian Regulatory Guidelines for Advertising Therapeutic Goods (‘ARGATG’) (December 2019, version 2.4). Available at: https://www.tga.gov.au/book-page/advertising-different-types-therapeutic-goods [verified 6 July 2020].
[36] Therapeutic Goods Administration. Advertising guidance for businesses involved with stem cells and other human cell or tissue (HCT) products: complying with therapeutic goods advertising restrictions. Version 1.0, November 2019. Available at: https://www.tga.gov.au/sites/default/files/advertising-guidance-businesses-involved-stem-cells-and-other-human-cell-or-tissue-hct-products.pdf [verified 6 July 2020].
[37] Therapeutic Goods Advertising Code. (No. 2) 2018 (Cwlth) s. 6. Available at: https://www.legislation.gov.au/Details/F2019C00618 [verified 15 March 2021].
[38] Therapeutic Goods Advertising Code (No. 2) s. 6(3).
[39] Therapeutic Goods Advertising Code (No. 2) s. 6(4).
[40] Therapeutic Goods Administration. Advertising to the public: complying with the Therapeutic Goods Advertising Code (No. 2) 2018. Available at: https://www.tga.gov.au/sites/default/files/advertising-public.pdf [verified 6 July 2020].
[41] Therapeutic Goods Act ss. 42AA, 42AB.
[42] Therapeutic Goods Act s. 42DL.
[43] Therapeutic Goods Act s. 42DL(5).
[44] Therapeutic Goods Act s. 42DL(3).
[45] Therapeutic Goods Act s. 42DM.
[46] Therapeutic Goods Act ss. 42DL(2).
[47] Therapeutic Goods Act ss. 42DL(3), 42DM(3).
[48] Therapeutic Goods Act s. 42DLB.
[49] Health Practitioner Regulation National Law Act 2009 (Qld). Available at: https://www.legislation.qld.gov.au/view/html/inforce/current/act-2009-hprnlq [verified 15 March 2021].
[50] Health Practitioner Regulation National Law Act 2009 (NSW) s. 133. Available at: https://www.legislation.nsw.gov.au/view/html/inforce/current/act-2009-86a [verified 15 March 2021].
[51] Health Practitioner Regulation National Law Act (NSW) s. 39.
[52] Australian Health Practitioners Regulation Agency. Guidelines for advertising regulated health services (May 2014). Available at: https://www.ahpra.gov.au/Publications/Advertising-resources/Legislation-guidelines/Advertising-guidelines.aspx [verified 6 July 2020].
[53] Medical Board of Australia. Good Medical Practice: A Code of Conduct for Doctors in Australia (March 2014). Available at: https://www.medicalboard.gov.au/Codes-Guidelines-Policies/Code-of-conduct.aspx [verified 6 July 2020].
[54] Australian Health Practitioners Regulation Agency. Social Media: How to meet your obligations under the National Law (2019). Available at: https://www.ahpra.gov.au/Publications/Advertising-resources/Social-media-guidance.aspx [verified 6 July 2020].
[55] Creyke R. ‘Soft law’ and administrative law: a new challenge. AIAL Forum 2010; 61 15–22.
[56] Foong P. Stemming the tide of unproven autologous stem cell therapies in Australia. UNSW Law Jrnl Frm 2018; 3 1–9.
[57] Health Practitioner Regulation National Law Act (Qld) s. 155.
[58] Schedule 2 of the Competition and Consumer Act 2010 (Cwlth). Available at: https://www.legislation.gov.au/Details/C2021C00055 [verified 15 March 2021].
[59] ACL s. 4(1).
[60] ACL s. 4(4).
[61] ACL s. 4(2).
[62] ACL sch. 2.
[63] ACL s. 18.
[64] ACL s. 20.
[65] ACL s. 22.
[66] Madden B. Medical claims and the ACL: a few thoughts on exclusion clauses and waivers. Mondaq (5 July 2018). Available at: https://www.mondaq.com/australia/consumer-law/716232/medical-claims-and-the-acl-a-few-thoughts-on-exclusion-clauses-and-waivers [verified 6 July 2020].
[67] ACL s 29(1)(a).
[68] Sipp D, Robey P, Turner L. Clear up this stem-cell mess. Nature 2018; 561 455–7.
| Clear up this stem-cell mess.Crossref | GoogleScholarGoogle Scholar | 30258150PubMed |
[69] ACL s. 29(1)(a)–(n).
[70] ACL ss. 33, 34.
[71] ACL s. 60.
[72] ACL chs. 4 and 5.
[73] ACL s. 267.
[74] Australian Competition and Consumer Commission. Advertising and Selling Guide: A Guide for Business (March 2019). Available at: https://www.accc.gov.au/system/files/Advertising%20and%20selling%20Guide_March%202020.pdf [verified 6 July 2020].
[75] Australian Competition and Consumer Commission v Allergy Pathway Pty Ltd [2009] FCA 960 [1] (Finkelstein J).
