Australians forced to wait 15 months for new drugs vs US & Europe: Report

Australian patients are being forced to wait up to 15 months longer to access the latest breakthrough medicines than in the US or Europe because drug companies are delaying bringing them down under, a new landmark report has revealed.

Page last updated: 25 June 2015

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25 June 2015

Australian patients are being forced to wait up to 15 months longer to access the latest breakthrough medicines than in the US or Europe because drug companies are delaying bringing them down under, a new landmark report has revealed.

The independent review of the Therapeutic Goods Administration’s (TGA) medicines and medical devices regulatory framework – released today – finds Australia’s safety regulator had one of the most efficient and consistent approval processes in the developed world.

This includes Australia being on average 90 days – or three months – faster than world-leaders Europe to approve new medicines as safe.

However, the review has also confirmed Australia is being unfairly categorised as ‘slow’ when compared to the rest of the world because some drug companies were making Australians wait for medicines while they first tested them in bigger markets like the US and Europe.

For example, the review found Australia waiting on average about six months longer than the US and Europe for drug companies to apply to list new medicines here. This includes:

    • 148 days (or about five months) for anti-cancer medicines
    • 231 days (or about seven months) for cardiovascular medicines
    • 467 days (or about 15 months) for nervous system medicines
Minister for Health Sussan Ley said Australia continued to list drugs as quickly and efficiently as possible and was committed, through this review, to working with medicines manufacturers to improve approval process times, and cut red tape, without compromising quality.

“The Abbott Government continues to demonstrate our commitment to listing new drugs as fast as possible on the Pharmaceutical Benefits Scheme by doubling Labor’s effort in half the time.

“To continue to achieve this – and encourage even greater access to new drugs for patients - we want to ensure Australia’s drug safety approval system is even faster and more-efficient while maintaining our high safety standards.

“This review proposes a number of ways to achieve this, including cutting red tape and reducing international duplication of drug approvals, and we are considering it closely.

“However, this independent expert review also debunks the myth that Australia is slow at approving new medicines when compared to the rest of the world.

“For example, it finds Australia has one of the most consistent and reliable approval system of key developed countries and on average was about three months faster than world-leader Europe.

“Yet, the review also finds Australians are being delayed access to new innovative and potentially life-saving medicines by drug companies by an average six months longer than the US or Europe.

“This is a trend I want to turn around because it’s important Australians get fast access to new breakthrough medicines and I’m committed to working closely with medicines manufacturers to make our world-best approval system even better.”

For example, the review finds that when comparing drug safety approval systems like for like, Australia is on average 90 days faster than Europe:
    • Australia (TGA) – takes an average of 391 days to approve a new drug as safe
    • Europe (European Medicines Agency or EMA) – takes an average of 481 days to approve a new drug as safe
However, the review also finds Australia receives drug applications on average six months after the US, compared to just 20 days on average for Europe. Therefore, when factored in, this leads to a significant blow out in Australia’s approval times for new drugs when compared to the rest of the world.
    • Australia (TGA) – total approval times of 572 days (lag-time of 181 days compared to US)
    • Europe (EMA) – total approval times of 501 days (lag-time of 20 days compared to US)
The TGA Review makes a total of 32 recommendations, including new ways to expedite drug approvals through a multi-tiered approval system that will potentially include allowing drugs approved in other countries with similar health and safety standards as Australia to be considered for fast tracked approval if the evidence stacks up.

In Australia, medicines must be approved as safe by the Therapeutic Goods Administration before they can be considered for listing on Australia’s Pharmaceutical Benefits Scheme.

Ms Ley said Australia in addition to the strong performance of the TGA on the world stage, Australia also had one of the fastest turnarounds for listing drugs for government subsidisation once approved as safe in the world, with the nation’s independent expert Pharmaceutical Benefits Advisory Committee averaging just 17 weeks from submission to recommendation.

The Abbott Government has more-than-doubled the number of new and amended drug listings on the PBS to over 660 – worth a total of almost $3 billion since September 2013 – when compared to Labor’s 331 listings during their last three-year term in office.

This includes $1.3 billion worth of new listings in our 2015/16 Budget to treat melanoma, breast cancer, blindness and the debilitating shingles virus.

Key Quotes from the Review
    • The TGA outperforms the EMA (European Medicines Agency) and a number of medium sized regulators in terms of its median approval time.
    • In terms of predictability of approval times, the TGA, along with the EMA, is setting the benchmark for other NRAs (National Regulatory Authorities for Drug Safety & Approvals).
    • Availability of a new medicine on the Australian market is determined by both the time that it takes a sponsor to submit a data dossier to the TGA seeking registration, and the time that it takes the TGA to undertake an assessment of the medicine for safety, quality and efficacy.
    • This ‘submission gap’ contributes to the time it takes for new medicines to become available on the Australian market when compared to overseas markets (such as the US and Europe) whose regulators tend to be the first point of submission of data dossiers.
    • The median submission gap between the FDA (US) and the TGA was 181 days.
    • These submission gaps may be contributing to a perception that the TGA is slow to approve new drugs for market, as observers will not necessarily be aware the dossier was not submitted in Australia at the same time as it was submitted in, for example, the US.
A copy of the review can be found on the TGA website.


Media Contact: Troy Bilsborough 0427 063 150

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