(Cth) Exempt New Antimicrobials from Registration and HTA Fees
- Devathri Nanayakkara, Shrikaavya Karthikeyan & Elaine Qiao
- Apr 21
- 7 min read
Author: Devathri Nanayakkara, Shrikaavya Karthikeyan & Elaine Qiao | Publish date: 21/4/2026
P: Manufacturers of new antimicrobials are required to pay registration fees for market entry and Health Technology Assessment (HTA) fees for PBS listing.
S: The Minister of Health should amend Part 3 of Therapeutic Goods Regulation 1990 and Section 67 of the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022, to exempt new antimicrobials from registration and HTA fees, respectively.
E: Dr Nadine Hillock: ‘Exempt new antimicrobials from registration and HTA fees.’
Problem Identification:
Part 3 of the Therapeutic Goods Regulation 1990 and Section 67 of the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022 provide fee exemptions for certain therapeutics for market entry and PBS listing. However, no fee exemption is applied to new antimicrobials.
According to Medicines Australia, this disincentivises the introduction of new antimicrobials, resulting in fewer market launches. They argued that this reduces patient access to effective medicines in Australia and the WHO noted it promotes inappropriate usage, increasing the risk of antimicrobial resistance.
Context:
Antimicrobials refer to medicines used to treat infections and include antibiotics, antivirals, antifungals and antiparasitics.
Antimicrobial resistance (AMR) refers to the non-response of bacteria, viruses, fungi and parasites to antimicrobial medicines. According to the Australian Centre for Disease Control, AMR ‘can lead to longer hospital stays, higher medical costs and, in severe cases, death.’ The WHO highlighted that AMR is one of the top 10 global public health and development threats.
In Australia, prescription medicines must undergo pre-market evaluation and be registered by the Therapeutic Goods Administration before being supplied to the market. The Pharmaceutical Benefit Scheme (PBS) lists all of the medicines that are available to patients at a Federal Government-subsidised price. Health Technology Assessment (HTA) fees apply when submitting an application for PBS listing.
Registration fees for market entry are known to be around $300,000, in addition to annual fees to maintain market approval. For PBS listing, HTA fees are known to be around $270,000 for the main submission, with separate charges for pre-submission meetings and post-recommendation pricing processes. Each resubmission can cost the manufacturer between $44,000 to $290,000.
Arguments:
According to the 2021 New Frontier Parliamentary Inquiry, ‘despite the…urgent need for antimicrobials, there is no viable market’ for novel antimicrobials in Australia, causing limited access for patients. The Antimicrobial Resistance Pricing and Reimbursement Scoping Study report stated that this is due to Australia’s relatively small human market size. It explained that Australia’s small market size limits antimicrobial usage, and when weighed against registration fees, firms find market entry unattractive. Andrew Bowskill, co-chair of the Australian Antimicrobial Resistance Network (AAMRNet), noted that of 25 new antimicrobials registered in the EU/USA since 2011, ‘only 3 are registered in Australia’. He further added that of those registered ones, ‘none are reimbursed through PBS.’ AAMRNet stated that the absence of reliable access to the latest antimicrobials sometimes makes ‘the difference between life and death.’
Further, Hillock et al. (2020) observed that the lack of PBS-listed new antimicrobials may lead to the use of alternative, less-appropriate drugs, contributing to the risk of AMR. They noted that private hospitals in particular would give ‘preference to PBS-listed antimicrobials over non-PBS antimicrobials’ due to cost concerns. Their study also found that even when the right choice of antimicrobial is known, if ‘it’s too highly priced then they will look for another option.’ The Access to Medicine Foundation highlighted that using sub-optimal treatments ‘gives pathogens an opportunity to develop resistance.’ They explained that this was because unsuitable antimicrobials kill only some pathogens and allow non-susceptible pathogens to survive and spread unchecked. According to Hillock et al. (2020), inappropriate use of antimicrobials ‘is the leading cause of worsening antimicrobial resistance’.
Advice/Solution Identification:
The HTA Review Reference Committee, the AAMRNet, Dr Nadine Hillock, and Medicines Australia have all called for the exemption of antimicrobial technologies from HTA fee requirements. Dr Nadine Hillock from Adelaide University also called for registration fee exemption. She stated that, ‘as part of a broader package of incentives, this will improve access to the new antimicrobials in Australia.’
Precedent:
There is domestic precedent for exempting medicines with a limited use from registration and HTA fees. In Australia, orphan drugs used to treat rare medical conditions affecting a small population of patients are eligible for a fee waiver for registration and PBS listing (first submission).
Public Support for exempting new antimicrobials from registration and HTA fee requirements:
Dr. Nadine Hillock (see acknowledgements).
Broad support for exempting new antimicrobials from HTA fee requirements:
HTA Review Reference Committee - They recommended exempting new antimicrobials from HTA, but not registration fee requirements.
Australian Antimicrobial Resistance Network (AAMRNet) - They recommended exempting new antimicrobials from HTA, but not registration fee requirements.
Medicines Australia - They recommended exempting new antimicrobials from HTA, but not registration fee requirements.
This list reflects publicly stated positions and should not necessarily be taken as endorsement of this specific brief.
News Coverage:
SBS News - “The ‘vicious cycle’ that could see the most prescribed drugs in Australia become obsolete”. An article on growing resistance to common antimicrobial medications and how it affected the most vulnerable groups in society. By: Cameron Carr | 25 October 2025 - Read the article here.
The Guardian - “Drug-resistant infections are on the rise - so why aren’t we getting new antibiotics?” A report on rising drug-resistant infections and why pharmaceutical companies were failing to discover new antibiotics. By: Kat Lay | 17 September 2024 - Read article here.
ABC News - “Australia ‘losing the war’ against drug-resistant infection, despite drop in use of antibiotics”. An article on growing drug-resistant infections and how it almost took the life of Jacob Dye, a psychology academic and father of two. By: Emily Laurence | 16 November 2023 - Read the article here.
ABC News - “Antibiotic resistance is threatening our health. Will bacterial infection send us back to the medical dark age?” An article on 2 research scientists who worked together to discover new antibiotics and what made their job hard. By: Catherine Taylor | 11 May 2022 - Read the article here.
Where to go to learn more:
(2024) Accelerating Access to the Best Medicines for Australians Now and into the Future | Department of Health, Disability and Ageing - This report reviewed the current HTA processes in Australia, identified areas for improvement, and recommended introducing an HTA fee exemption to improve access to novel antimicrobials. View the report here.
(2019) Australia’s National Antimicrobial Resistance Strategy 2020 & Beyond | Australian Government - This report laid out the Australian government’s strategy for combating the growing threat of AMR. View the report here.
(2022) Antimicrobial Resistance Pricing and Reimbursement Scoping Study, Final Report | ACIL Allen Consulting - This report provided evidence for mechanisms that may be used to incentivise the discovery of novel antimicrobials for human health and bring them to market in Australia. View the report here.
(2024) Horizon Scanning Forum, Medicines of Tomorrow | Medicines Australia - This report highlighted the emerging technologies, including novel antimicrobials, presented at the Horizon Scanning Forum and summarised them into key takeaway messages. Read the report here.
(2022) National Health (Pharmaceuticals and Vaccines–Cost Recovery) Regulations | Australian Government - These regulations establish the legislative framework for recovering costs associated with the assessment and listing of medicines and vaccines under PBS and NIP. Read the regulations here.
Human Perspective:
Trigger Warning: This section contains a brief description of a critically ill infant and hospital treatment.
Emily sat beside her premature baby in the neonatal intensive care unit at a private hospital, as the infant battled life-threatening ventilator-associated pneumonia. The doctors explained that the antibiotics initially administered were not working and recommended a novel, more effective antibiotic that was not listed on the Pharmaceutical Benefits Scheme (PBS). Private insurance did not cover the full cost of the treatment, and the out-of-pocket expenses placed a significant strain on Emily’s family. Due to the hospital’s cost considerations, the clinical team had initially administered an alternative PBS-listed antibiotic, despite knowing the non-PBS option was more suitable. While Emily’s baby ultimately made a full recovery, the experience highlighted to Emily how financial constraints and PBS-driven prescribing decisions can influence treatment choices and potentially compromise patient well-being.
To protect the anonymity of those involved, this is a fictionalised account drawn from an amalgamation of real-life stories, experiences and testimonials gathered during the research process for this brief. Any resemblance to actual individuals is purely coincidental.
Conflict of interest/acknowledgment statement:
Dr. Nadine Hillock (public health researcher from Adelaide University) confirmed her support for this recommendation and consented to her quotes being included in the brief following a meeting with FORE Australia on 18 March 2026.
Support
If your organisation would like to add your support to this paper or suggest amendments, please email Info@foreaustralia.com.
Disclaimers
Please review all FORE disclaimers here.
Reference list:
Access to Medicine Foundation. (2022). Lack of access to medicine is a major driver of drug resistance. How can pharma take action? https://accesstomedicinefoundation.org/medialibrary/62c2f0dcda565_atmf_appropriate_access_to_antimicrobials_2022-1666595298.pdf
ACIL Allen Consulting. (2024). Antimicrobial resistance pricing and reimbursement scoping study. Final Report. Australian Government Department of Health and Aged Care. https://www.amr.gov.au/sites/default/files/2025-03/antimicrobial-resistance-pricing-and-reimbursement-scoping-study-final-report.pdf
Australian Antimicrobial Resistance Network. (2024, February 23). Health Technology Assessment Policy and Methods Review – Consultation 2 [submission]. MTPConnect. https://ohta-consultations.health.gov.au/ohta/hta-review-consultation-2/results/aamrnet_c2response_publishattributed_redacted.pdf
Australian Centre for Disease Control. (n.d). Tackling antimicrobial resistance. Australian Government. https://www.cdc.gov.au/topics/communicable-diseases-prevention-and-control/tackling-antimicrobial-resistance
ABLIS. (n.d). Registration or listing of therapeutic goods - Australian Government. Australian Government. https://ablis.business.gov.au/service/ag/registration-or-listing-of-therapeutic-goods/3
Department of Health and Aged Care. (2024, July 1). Fees and charges: summary. Australian Government. https://www.tga.gov.au/sites/default/files/2024-06/fees-and-charges-summary-1-July-2024.pdf
Department of Health, Disability and Ageing. (2025, November 28). Cost Recovery Fees and Charges. Australian Government. https://www.pbs.gov.au/info/industry/listing/elements/fees-and-charges
Department of Health, Disability and Ageing. (2024). Accelerating access to the best medicines for Australians now and into the Future - final report. https://www.health.gov.au/sites/default/files/2024-09/health-technology-assessment-policy-and-methods-review-final-report
Department of Health, Disability and Ageing. (2026, January 1). About the PBS. Australian Government. https://www.pbs.gov.au/info/about-the-pbs#What_is_the_PBS
Department of Health, Disability and Ageing. (2025, March 13). HTA for Australian government subsidy. Australian Government. https://www.health.gov.au/topics/health-technologies-and-digital-health/health-technology-assessments/for-subsidy?language=en
GlaxoSmithKline. (2026, February 18). Urgent and bold action needed to address accelerating threat of antibiotic resistant ‘super bugs’ [Press release]. https://au.gsk.com/en-au/media/press-releases/urgent-and-bold-action-needed-to-address-accelerating-threat-of-antibiotic-resistant-super-bugs/?utm
Hillock, N. T., Merlin, T. L., Karnon, J., Turnidge, J., & Eliott, J. (2020). Feasibility of de-linking reimbursement of antimicrobials from sales: the Australian perspective as a qualitative case study. Journal of Antimicrobial Chemotherapy - Antimicrobial Resistance, 2(2). https://doi.org/10.1093/jacamr/dlaa023
Medicines Australia (2024). 2024 Horizon scanning forum – Medicines for Tomorrow. https://www.medicinesaustralia.com.au/wp-content/uploads/sites/65/2024/11/Horizon-Scanning-report-Final-Web_19112024.pdf
Medicines Australia. (2020). Australia’s antimicrobial resistance strategy – 2020 and beyond [letter]. https://www.medicinesaustralia.com.au/wp-content/uploads/sites/65/2020/11/Department-of-Health-Australias-Antimicrobial-Resistance-Strategy-2020-and-beyond.pdf
MPTConnect. (2024). Fighting superbugs: The path forward. MPTConnect. https://wpstaq-ap-southeast-2-media.s3.amazonaws.com/mtpconnect-national/wp-content/uploads/media/2025/02/Fighting-Superbugs-A-Path-Forward-Dec24.pdf
National Health (Pharmaceuticals and Vaccines–Cost Recovery) Regulations 2022 (Cth). https://www.legislation.gov.au/F2022L00118/2025-07-01/2025-07-01/text/original/epub/OEBPS/document_1/document_1.html#_Toc202868852
Therapeutic Goods Regulations 1990 (Cth). https://www.legislation.gov.au/F1996B00406/latest/text
World Health Organization. (2023, November 21). Antimicrobial resistance. https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance
World Health Organization. (n.d). Ensuring access to medicines and health products to combat antimicrobial resistance. https://www.who.int/europe/activities/ensuring-access-to-medicines-and-health-products-to-combat-antimicrobial-resistance?utm
Comments