This week in the Australian parliament, the Pharmaceutical Patent Review quietly disappeared off the radar. The Minister for Industry, Ian Macfarlane, stated in response to a question from the Opposition that ‘the government has no plans to release the final report at this stage’, and further: ‘the government is not considering the recommendations made by the panel’.
On the 15 October 2012, the then Parliament Secretary for Innovation, Mark Dreyfus, announced a review of pharmaceutical patents in Australia. The report was initiated to evaluate Australia’s current system for pharmaceutical patents and its ability to ‘effectively balance the objectives of securing timely access to competitively priced pharmaceuticals, fostering innovation, and supporting employment in research and industry’. Central to the review was an investigation of the patent extension of term provisions available under section 70 of the Patents Act 1990, specifically the impact of these extensions upon the market entry of new generic pharmaceuticals.
The draft report was released in April 2013, upon which the government invited written responses from the public. The draft detailed several suggestions for reform of the pharmaceutical patent process in Australia, including:
- replacing the extension of pharmaceutical patent term (s 70) with direct subsidies for research and development,
- ensuring Australian patents expire no later than corresponding patents in the US or EU, and
- providing originator pharmaceutical companies with greater time to assess their position by forcing generic companies to advise the originator when they apply for registration of a generic medicine.
The preliminary recommendations evoked a mixed reaction amongst the regulatory bodies. The Generic Medicines Industry Association (GMiA) welcomed the draft findings, stating ‘the granting of weak patents restricts innovation, competition and diffusion of knowledge’. Conversely, Medicines Australia, which represents the research-based pharmaceutical industry, responded to the report explaining they ‘are deeply concerned about the biased nature of its analysis and recommendations’.
As it stands, all formerly publicly available, government sources of the Review have disappeared into the ether. Pointedly, Mr Macfarlane has held that the report was commissioned by the previous government, and it is now clear that the current government has no immediate intentions of pursuing the issue.