The last ditch negotiations for the Trans-Pacific Partnership (TPP) trade agreement, which got underway this week in Atlanta, have hit yet another road block, with negotiators failing to make headway on the sticking points of auto parts, dairy access and drug protections.
Australia’s Trade Minister, Andrew Robb, has been quick to shunt blame on the US, claiming that its failure to strike a deal with congressman back home has hamstrung its ability to reach a compromise.
Robb has also blamed the US’ intransigence with regards to pharmaceutical protections on so-called “biologic” drugs, which are an important new class of medicines produced from living organisms and are used to treat cancers and diseases such as rheumatoid arthritis.
Australian patent law currently gives pharmaceuticals 20 years of protection. Rival pharmaceutical companies must then wait another five years to access the clinical data needed to create similar and cheaper versions, known as “biosimilars”.
In the TPP negotiations, the US first pushed for 12 years of data exclusivity before reducing its bid to 8 years, whereas Australia (amongst others) wants to keep protections to 5 years, as applies currently. Any extension of protections beyond five years would delay the entry of generic drugs, raise the cost of drugs in Australia, and would compromise Australia’s Pharmaceutical Benefits Scheme (PBS).
Speaking about the issue of biologic protections, Andrew Robb noted:
“I came to lower protection so I get frustrated if we are talking about increasing protection in the case of biologics or see no reduction in other areas,” Mr Robb told the newspaper in Atlanta. “Something has to give.”
Andrew Robb has previously insisted that he would never agree to any deal that pushed-up the cost of medicines in Australia or compromised the PBS. The Department of Foreign Affairs and Trade (DFAT) has backed this view, stating the following in its fact sheet on the TPP, released in June:
The Government is negotiating intellectual property provisions in the TPP within the framework of Australia’s existing laws and policies and does not support any proposals that would require changes to Australia’s current intellectual property arrangements, including our copyright and enforcement regimes…
The Government has stated clearly that it will not accept an outcome in the TPP which adversely affects the Pharmaceutical Benefits Scheme or our health system more generally, or an outcome that increases the price of medicines for Australians.
While such comments are reassuring, it is disconcerting to read that Andrew Robb is considering a backdoor deal that would effectively raise protections for biologics. From The SMH:
…international trade agreement experts say a new proposal is being floated among US pharmaceutical companies, which, if accepted, would mean biosimilars would not be able to be registered and available for consumers for three more years while they underwent safety tests.
It is believed Australian negotiators are seriously considering such an administrative compromise ahead of the talks, which Mr Robb has said could make or break the deal.
Co-ordinator of the Australian Fair Trade and Investment Network, Dr Patricia Ranald, said safety checks were already required for biosimilars in Australia: “Even if the negotiators come up with a different way to achieve market exclusivity on biologic medicines it would still have the same effect of [keeping] biosimilars out of the market,” she said…
“Our health policy shouldn’t be changed every two years through trade negotiations behind closed doors,” Dr Ranald said. “It should be democratically decided in our normal parliamentary process”…
La Trobe University public health researcher Dr Deborah Gleeson said there was a risk the Pharmaceutical Benefits Scheme would pass on rising costs from pharmaceutical monopoly protections to consumers…
Dr Gleeson has warned that pharmaceutical monopoly protections already cost the Australian health system hundreds of millions of dollars a year.
Clearly, the best thing that could happen is for the TPP negotiations to collapse, as this is the only way to stop copyright and patent protections from being extended, and to stop foreign corporations suing the Australian Government (read taxpayers) via investor-state dispute settlement clauses embedded in the TPP.
