Why Australia Approves Medicines Patients Still Cannot Access

By Steve Holmes

On January 28 2026 I attended the first Bridging Funding Coalition meeting for 2026.

Bridging funding Australia (Coalition) exists to address the growing gap between medicine approval and patient access. The average delay between approval and funded access is now 466 days.

My role in this work is simple.
To listen carefully.
To understand what is real.
And to ensure patients and caregivers are informed, represented, and not left behind by process.

What follows is a clear explanation of why bridging funding matters, written for people navigating illness under pressure.

What Patients and Caregivers Need to Know First

Bridging Funding in Australia

If you read nothing else, read this:

Australia often approves medicines that patients cannot access in time.

The average delay between approval and funded access is 466 days.

That delay is systemic. It is built into the system.

During that time, some patients deteriorate or die.

This outcome is known, measured, and largely accepted by default.

That last point matters.
It removes moral ambiguity and replaces confusion with clarity.

What Is Actually Happening

In Australia, medicines are approved by the Therapeutic Goods Administration.

Approval means a medicine is safe and effective.

It does not mean patients can receive it.

After approval, medicines enter a separate funding process before they become accessible through the Pharmaceutical Benefits Scheme.

That process commonly takes well over a year.

For patients with aggressive or time-critical disease, waiting 466 days is not neutral.
It changes outcomes.

Medicines in Australia are approved by the Therapeutic Goods Administration.

More information on the approval process is available here:
https://www.tga.gov.au

Why the Delay Exists

To understand why this happens, four things must be clear.

Approval is not access
Regulatory approval and funded access are separate decisions.

The funding system is built for certainty, not urgency
Health Technology Assessment processes are rigorous and necessary.
They are not designed to move at the pace illness demands.

There is no built-in pathway for time-sensitive need
The system has no native mechanism to respond when patients need access sooner.

Bridging funding exists because of this gap
It is designed specifically to sit between approval and funding.

This is a system design issue, not a failure of clinicians or regulators.

What Bridging Funding Does

In practical terms, bridging funding Australia provides a temporary pathway for eligible patients to access approved medicines while formal funding decisions are completed.

It allows access after regulatory approval but before PBS listing, under defined rules and clinical oversight.

It does not bypass safety.
It does not weaken evidence standards.
It does not replace assessment.

It recognises a simple reality.

Human time and system time are not the same.

Where the Access Gap Appears

The current sequence looks like this:

  1. A medicine is approved
  2. Funding assessment begins
  3. Negotiation occurs
  4. PBS listing is finalised
  5. Patients gain access

The delay sits between step one and step five.

With bridging funding, the sequence becomes:

  1. A medicine is approved
  2. Bridging access begins for eligible patients
  3. Funding assessment continues
  4. PBS listing is finalised

Nothing is skipped.
Access begins earlier where time matters most.

Why This Matters to Real People

Imagine being told a medicine exists that could help you.

Imagine learning it is approved.

Then imagine being told you must wait more than a year because funding has not caught up.

For some people, that wait changes everything.

Bridging funding exists to reduce that harm where possible.

What Was Discussed at the January 28 Meeting

The meeting focused on practical progress rather than slogans.

The meeting brought together patient groups, clinicians and policy contributors working on practical solutions to improve access to approved medicines.

More information about the coalition and its work is available at https://www.bridgingfundingaustralia.com.au/.

Key points included:

Approved medicines that remain unfunded long after accelerated approval.

Ongoing work to define clear eligibility criteria for bridging funding.

Continued policy signals that bridging funding remains part of broader health technology assessment reform.

Development of clear communication tools so organisations explain bridging funding consistently.

Discussion of horizon scanning to anticipate medicines earlier and reduce future delays.

Continued international comparison showing Australia lags peer countries in time to access.

Key talking points

  1. Australians currently can wait more than 466 days for reimbursed access to registered medicines to
    treat their disease. Patients do not have this time to wait for reimbursed access to medicines to treat a
    time-critical diagnosis.
  2. The Cholangiocarcinoma Foundation Australia has supported the coalition partners alongside patient advocacy groups, clinicians, researchers, and pharmaceutical industry representatives to highlight the need for faster patient access to medicines with a high added therapeutic value OR that address a high unmet clinical need, by calling for the introduction of bridging funding – an interim government funding mechanism that bridges the gap between a medicine’s approval by the TGA and its reimbursement on the Pharmaceutical Benefits Scheme (PBS).
  3. Bridging funding is one of the recommendations made to the Government in the Health Technology assessment (HTA) Review, which was released in September 2024. Bridging Funding should be implemented within the next 12 months given the significant stakeholder support and consideration of options put by the Bridging Funding Coalition to the HTA Implementation Advisory Group, who are responsible for guiding HTA reform.
  4. More than 25 organisations that make up the Bridging Funding Coalition are now calling on the Government to ensure Australian patients get faster access to medicines by committing to establishing bridging funding for medicines in the 2026/27 Budget and establishing an Independent Expert Implementation Group to rapidly co-design a bridging funding mechanism.
  5. 5. The Bridging Funding Coalition have supported disease agnostic bridging funding and have instead focused on patient access to medicines with a high added therapeutic value OR that address a high unmet clinical need.
  6. An investment in bridging funding represents an earlier government investment in a reimbursed therapy that may prevent a patient’s condition from advancing to a more serious or incurable stage.

Frequently asked questions

  1. What has been the response from government stakeholders in the push for bridging funding for
    Australian patients?
    As bridging funding is one of the recommendations of the ongoing HTA review, a variety of government
    stakeholders have been engaged on the need and potential design for bridging funding – from MPs to
    Department of Health officials. The significant stakeholder support for bridging funding has been a crucial point
    of interest for all these stakeholders.
  2. Why is this being led by industry/by AstraZeneca?
    Bridging funding to enable faster access to medicines for patients is not a new concept, however it is
    recognised by AstraZeneca as a crucial area of health system reform. It is one of the recommendations of the
    ongoing HTA review could contribute tangible impacts to patient outcomes. The work of the Bridging Funding Coalition, who represents patient advocacy groups, clinicians, researchers, and pharmaceutical industry representatives are aligned on the need for faster access to medicines, to address the gap in access for Australian patients.
  3. Isn’t Bridging Funding just good for industry? Bridging funding is a form of temporary funding that enables eligible Australian patients to access medicines at the time of Therapeutic Goods Administration (TGA) registration, where the medicine is an improvement in treatment – providing high added therapeutic value OR addresses high unmet clinical need. It would help more Australians access medicines who may have received a prognosis where they need access to time-critical treatment, where there are no other equivalent options. The work of the Bridging Funding Coalition, who represents patient advocacy groups, clinicians, researchers, and pharmaceutical industry representatives are aligned on the need for faster access to medicines, to address the gap in access for Australian patients. There is strong broad stakeholder support to address this gap to help improve patient outcomes who have collaborated to provide options on how bridging funding could be set up and funded to the IAG. Furthermore, bridging funding and the financial arrangements that underpin this access mechanism have not yet been determined by Government. The final design of a bridging fund is ultimately a decision for government, not industry.
  4. Is bridging funding focused on cancer patients only? What about other types of diseases? The Bridging Funding Coalition is advocating for faster access to medicines with a high added therapeutic value OR that address a high unmet clinical need. This criteria supports access to medicines beyond cancer therapies, and the final eligibility criteria will be determined by Government.
  5. How much would the fund cost the government? A retrospective analysis revealed that if bridging funding had been available between 2022 – 2025: 7,200 patients per year could have had faster access to time critical treatment at a cost of $334m to Government per year. This equates to approximately a government investment of $46,000 per year per patient to provide faster access to eligible time-critical therapies that may save or significantly extend a patient’s life.
  6. Is there a risk that bridging funding would become another HTA process? Bridging funding for medicines should be available in parallel to the reimbursement evaluation process and at the time of TGA registration to provide faster patient access to medicines. Bridging funding should not be designed to bypass or impact the HTA process for long term government reimbursement; nor prolong pricing negotiations or reimbursement implementation.
  7. How will patients with rare disease or rare cancers benefit from bridging funding? The Bridging Funding Coalition is developing an eligibility criteria that reflects the need to address faster patient access where there is a high added therapeutic value OR that address a high unmet clinical need, where there is no other treatment option available and where the patient has a time critical illness or prognosis, to name a few examples. Initial analysis against this criteria showed that bridging funding could support medicines for some types of rare cancers, new medicines for common cancers, and some types of rare diseases.
  8. What about medicines that are not yet registered with the TGA? The Bridging Funding Coalition is proposing that this mechanism supports access to medicines that are deemed safe and effective to use by the TGA, supported by robust clinical evidence and are registered for use in Australia. The access gap that exists for Australian patients is 466 days from the date of TGA registration to the time a medicine is reimbursed on the PBS. Bridging funding is a mechanism to enable faster access to patients who do not have the time to wait for a registered medicine to be listed on the PBS.

In Closing

The January 28 meeting reinforced a simple reality.

Approval without access is not enough.

When systems move slower than disease, patients pay the price.

Bridging funding is a way to align system design with human need.

Understanding that is the first step toward changing it.

This work aligns with how we approach patient access and system response across disease areas.
Learn more about our broader approach here:
How We Win

What This Means for You

If you are a patient or caregiver:

Approval does not guarantee access.
Delays are structural, not personal.
Bridging funding is an active effort to address this gap.

If you are a clinician:

Patients may ask why approved treatments are unavailable.
Bridging funding offers a framework aligned with urgency and care.

If you are part of the wider community:

This affects many diseases, not just one.
Access delays are a system issue, not a niche problem.

Where This Leaves Me

I will continue to attend these meetings, contribute where I can, and translate progress clearly for our community.

Not through advocacy.
Through understanding, sequence, and execution.

That is how progress holds under pressure.