Report reveals drug companies 'behind medicine approval delays'

29 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 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 tested them in larger markets like the US and Europe first.

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 systems 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."

The review finds that when comparing drug safety approval systems like for like, Australia is on average 90 days faster than Europe.

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.

The TGA Review makes a total of 32 recommendations, including new ways to expedite drug approvals through a multi-tiered approval system. This system would potentially allow drugs approved in other countries with similar health and safety standards as Australia to be considered for fast tracked approval.

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.

According to Ley, 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. 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.