The draft intellectual property text from the Trans Pacific Partnership Agreement negotiations, released by Wikileaks last week, confirms many of the fears of Australian public health advocates.
The leaked text, dated August 30, 2013, shows that the United States is continuing to push for extreme intellectual property privileges that would expand and prolong patent monopolies at the expense of affordable access to medicines.
Keeping medicines under patent for longer means paying more for drugs. But who would bear this cost? In Australia, medicines are subsidised through the Pharmaceutical Benefits Scheme, which has an uncapped budget. Increasing expenditure on pharmaceuticals might initially be absorbed by allocating a bigger share of the health budget to the PBS, but in the longer term this would be unsustainable. At least part of the extra cost - perhaps all - would have to eventually be passed on to consumers.
Concession card holders currently pay $5.90 per prescription for a PBS-listed drug. This is already a significant burden for people on low incomes, particularly those with chronic illnesses who need to fill several prescriptions each month. With even a small increase in the patient contribution for PBS medicines, many pensioners and disadvantaged Australians may find they need to postpone purchasing much-needed medicines, or go without.
Developing countries in our region will also pay a heavy price if the US proposals for the trade deal are agreed to by the other countries. Humanitarian organisation Medecins Sans Frontieres has warned [PDF 720KB] that the TPP could become ‘the most harmful trade pact ever for access to medicines in developing countries’.
But will Australia join the US as perpetrator, or support the efforts of other countries to strike a better balance between intellectual property privileges and the public interest? The leaked text provides few answers. The text shows the negotiating positions of all twelve parties, and it is clear that the previous Australian Government opposed many of the worst American proposals for pharmaceutical patents.
For example, the text indicates that before the election, Australia was rejecting proposals to extend patent periods to compensate for delays in regulatory approval and to extend the length of time before generic manufacturers can use clinical trial data produced by the original manufacturer to register their products for sale.
This is not surprising given that the previous government had undertaken not to accept provisions in trade agreements that would undermine the Pharmaceutical Benefits Scheme or restrict access to generic drugs in Australia. But there are many parts of the leaked text where Australia's position is not clear, and it is also not clear to what extent the previous Government was supporting a counter-proposal put forward by several other countries - a more flexible approach that would largely protect access to affordable medicines.
Australia's silence on key elements of the counter-proposal may be due, at least in part, to the caretaker period in the lead up to the election. But Australia appears to have supported a US proposal to require countries to allow patents for new uses and new methods of using existing products.
This calls into question even the previous Government's commitment to preserving access to medicines in the region. The US proposal for patents for new uses and new methods is consistent with current Australian patent law, but would encourage evergreening of patents in other TPP countries, including Vietnam, which already has significant problems providing access to medicines for much of its population.
On Thursday, Andrew Robb, the Minister for Trade and Investment, issued a statement re-iterating the previous government's commitment to maintaining the PBS. This is encouraging. But the lack of documented commitment by the previous government to the more moderate counter-proposal leaves a great deal of wriggle room for the Coalition.
The US proposals for the TPP are far more extreme than the intellectual property provisions Australia accepted in its bilateral trade agreement with the US. We would hope, particularly given Robb's statement affirming the PBS last week, that the government would reject all provisions that would add significantly to pharmaceutical expenditure in Australia.
But Australia's intellectual property standards are already closer to those of the US than many of the other countries negotiating the TPP. And the success of the counter-proposal may well depend on what position Australia ultimately takes.
With two very distinct proposals on the table, which will Australia support? The ultimate outcome for low-income Australians and the hundreds of thousands of people in the region who struggle to pay for medicines - or die for the lack of them - may to a large degree depend on which direction Australia takes from this point on.
But due to the secrecy of the negotiations, we may still be guessing until after the agreement is signed.
First published on The Drum on 20 November 2013.