2. Recent reviews and agreements

The Therapeutic Goods Administration and updates to the Health Technology Assessment process

The Committee was aware that there has been a number of reviews and reforms of Australia’s different health programs undertaken since 2013, including the Expert Panel Review of Medicines and Medical Devices Regulation (Sansom Review).
The Sansom Review was engaged to assess the current regulatory framework and make recommendations on options to improve the way in which therapeutic goods are regulated in Australia.1
In response to the Sansom Review, the Government provided $20.4 million over four years (including $9.5 million in capital funding) from 2016–17 to improve the regulation of therapeutic goods in Australia. The ongoing cost of the measure from 2017–18 is to be met by the TGA’s cost recovery arrangements.2
The Department of Health (the Department) emphasised that Australia’s regulatory and HTA processes continue to deliver good outcomes for Australians because they are subject to continuing review and improvement. Recent improvements to HTA processes include:
greater collaboration across HTA committees and the Department to align regulatory and reimbursement processes
improved mechanisms for consumer involvement and engagement in HTA
a Strategic Agreement with Medicines Australia that has streamlined medicines listing processes and reduced the time to listing by an average of 3.5 months
the development of a Health Products Portal to reduce duplication and red tape through a digital solution for applicants engaging with both regulatory and reimbursement processes
the 2020‐25 National Health Reform Agreement which provides specific arrangements to ensure Australians with some of the rarest conditions have access to new, life‐saving highly specialised therapies in public hospitals
the use of Managed Access Programs to provide early access to clinically important medicines
post‐market reviews to inform optimal and sustainable use of listed medicines.3

National Medicines Policy Review

The Department describes Australia's National Medicines Policy (NMP) as a ‘cooperative endeavour to bring about better health outcomes for all Australians, focusing especially on people’s access to, and wise use of, medicines.’4
The NMP was published in 2000 and aims to deliver positive health outcomes for all Australians through their access to and appropriate use of medicines. It has four main pillars:
timely access to the medicines that Australians need, at a cost that individuals and the community can afford
medicines meeting appropriate standards of quality, safety and efficacy
quality use of medicines
maintaining a responsible and viable medicines industry.5
In recognition of the changing medicines landscape over the past 20 years, the Minister for Health made an election commitment in 2019 to review the NMP. The aim of the review is to identify any gaps in the policy’s objectives, partnership approach and accountabilities.
The review of the NMP was delayed due to the COVID‐19 pandemic.6 The Department informed the Committee that the Review of the NMP will re-commence in August 2021.7
The Minister for Health has established an Expert Advisory Committee to lead the Review of the NMP for the Department. The Committee is chaired by Deputy Chief Medical Officer, Professor Michael Kidd AM. Its members include Professor Lloyd Sansom AO; Mrs Janette Donovan; Dr Sarah Dineen-Griffin and Mr David Herd.
This review will support a refresh of the NMP as a high-level policy framework, to ensure that the changes in the health system environment are addressed, and where applicable, the policy updated to take account of these changes.8

Post-market review of the Life Saving Drugs Program

The Australian Government’s Life Saving Drugs Program (LSDP) provides subsidised access for eligible patients with rare and life-threatening diseases to essential and very expensive medicines. Persons with these rare diseases often require medicines that have a very high cost per patient. These medicines often fail to meet the comparative cost effectiveness criteria required for Pharmaceutical Benefits Scheme (PBS) funding. The LSDP provides eligible patients with access to these life-saving medicines at no expense to the patients or their families.9
In April 2014, the then Minister for Health announced the Post-market Review of the Life Saving Drugs Program (LSDP Review), providing an opportunity to review the program to ensure that Australians with very rare conditions continue to have subsidised access to much-needed, expensive medicines. The LSDP Review examined important issues such as access and equity, value for money and the future administration of the program.10
A number of recommendations were made including that consideration be given to the value of medicines for rare diseases to consider matters beyond cost-effectiveness – ‘these principles are already embedded in the approach used by the PBAC (Pharmaceutical Benefits Advisory Committee) in its decision making but this would benefit from being more transparent.’ Further, ‘consideration should be given to enhancing the medicines submission process for rare disease therapies by adopting a collaborative multi-stakeholder approach early in the assessment cycle, before the medicine submission is formally submitted for consideration by the PBAC.’11
In response to the LSDP Review, the Australian Government agreed to ensure that eligible patients retain ongoing access to medicines currently available through the LSDP; a pathway to consider new medicines which includes fit-for-purpose clinical effectiveness and cost effectiveness assessment; and the future integrity and sustainability of the program.12

Strategic Agreement 2022 – 2027 with Medicines Australia

In early September 2021, Medicines Australia signed a new, five-year Strategic Agreement with the Australian Government (MA Strategic Agreement) to deliver greater long-term policy certainty for patients, industry and the Government. The Committee was pleased to note that the MA Strategic Agreement will ensure that this report and the review into the NMP will play a role in improving the HTA processes.
Aims for the MA Strategic Agreement are as follows:
Provide timely access to new medicines and vaccines.
Ensure patients have greater involvement in decision making for medicines access.
Modernise processes to keep pace with advancing science and innovative technologies.
Address the changing international policy environment on access.
Keep Australia as a global priority for the launch of new and innovative medical treatments.13
Key measures for the MA Strategic Agreement include:
An independent review of HTA processes will ensure Australia’s HTA system evolves to keep pace with advancements in medical technologies. The Review will run from July 2022 – June 2023, with recommendations to be implemented by July 2024.
The HTA Review will elevate the patient voice by including a patient representative on the Review Committee.
An enhanced Patient Engagement Process will be created to incorporate patient views early in the PBAC system.
The House Standing Committee on Health, Aged Care and Sport’s inquiry and the review of the National Medicines Policy will play a role in improving Australia’s HTA processes.
Pricing reforms will provide clear purchasing and pricing arrangements with innovative medicines and vaccines manufacturers to ensure Australia has a viable supply of medicines.
The New Medicines Funding Guarantee, agreed in 2020, will deliver $2.8 billion of PBS funding for new and amended listings over the forward estimates without the need for offsets.
Medicines Australia will run an annual Horizon Scanning Forum from 2022 to identify major advances in healthcare over the next 3-5 years.
Security of supply measures will help to reduce medicine shortages.
Hospital price disclosure will support ongoing sustainability and supply.
A pharmaceutical industry representative will be appointed to the Medical Services Advisory Committee.14

Strategic Agreement 2022 – 2027 with the Generic and Biosimilars Medicines Association

In early September 2021, the Australian Government and the Generic and Biosimilar Medicines Association (GBMA) signed off on a new five year strategic agreement (GBMA Strategic Agreement), brought forward by one year out of concern for patients who are struggling to access vital medicines during to the global pandemic disrupting international supply of medicines.
In essence, the GBMA Strategic Agreement will strengthen the PBS for patients and ensure improved stability and viability for the medicines industry. It will also ensure pharmacy shelves across Australia are stocked and that some Australians will have early access to new life changing medicines regardless of where they live.
The generic and biosimilar industry contributes more than two thirds of all medicines dispensed on the PBS each year.
The GBMA has reconfirmed its commitment to working with Government on the ‘Repurposing of Medicines’ initiative in order to expand patient access to some medicines.15

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