TPP a missed opportunity for the Australian Biopharmaceutical Community

The outcomes of the negotiations for the Trans-Pacific Partnership agreed to in Atlanta overnight are a disappointing outcome and a missed opportunity to stimulate and grow the Australian biopharmaceutical industry.

Just last month, the Prime Minister declared that innovation would be at the centre of the Federal Government; the decision not to support greater data protections for innovation sends the reverse signal.

Data protection is a form of intellectual property which is very limited in its application in Australia and is separate to patent protection. It is nonetheless increasingly important as biological medicines become more complex and uncertain in their patentability.

We are aware of some instances already in which biological medicines were not brought to the Australian market due to Australia’s short data protection period.

Increasing data exclusivity periods would have no negative impact on Australian’s access to the latest medicines and would not increase the prices which patients pay through the Pharmaceutical Benefits Scheme (PBS).

In fact, a globally competitive intellectual property system would:

  • Increase access to new medicines and vaccines for Australian patients (including early access to medicines via increased clinical trial activity),
  • Attract additional global investment in Australia’s research and development efforts,
  • Increase the return on inventions and developments made possible by the significant level of public support for medical research in Australia, and
  • Provide greater incentive and certainty for the commercialisation of local, Australian health technology inventions and developments – supporting Australia’s rapidly developing biotechnology sector.

Medicines Australia has consistently presented modelling to government which shows that any modest, short-term increase in the amount government spends on pharmaceuticals is well and truly offset by the savings being delivered through recent amendments to the PBS.

The increased data protection would support the economic potential of the Australian biotechnology sector, and could help create new investment opportunities in our best research centres, scientists and doctors and encourage earlier access to new, breakthrough medical treatments for Australians.

This view is shared by many notable experts including philanthropist and former Australian of the Year Simon McKeon AO, who was clear in his review of medical research in Australia, that the Federal Government should bolster and harmonise Australia’s data exclusivity laws with global best practice. Medicines Australia strongly supports this recommendation.

Australia cannot harness the full potential of this innovation unless we have laws that make us competitive with growing biotechnology hubs around the world.

Australia’s current five-year data exclusivity provision lags behind our global competitors and collaborators such as the United States (up to twelve years for biologics), Canada (eight years), the EU (up to eleven years), and Japan (eight years). This puts potential investment in Australian innovation at risk and is one reason why our scientists look overseas to get their inventions turned into widely available products for consumers. That means Australia misses out on the economic benefits of the innovation including jobs and the tax streams from these medical breakthroughs.

It is extremely disappointing that an unfounded, misleading scare campaign has had such a critical impact on the TPP outcomes. It has let down the many Australians who want to see the local biotechnology sector able to thrive, so they can invent and deliver the next generation of medical innovation.


James Boyce
Phone: 0423 239 265