The draft predates the most recent negotiation round held in Hawaii at the end of July. But Deborah Gleeson, a professor of public health at La Trobe University, said it nonetheless provided a strong indication of the status of the international trade deal, which is now in its final stages.
“The US was initially seeking 12 years of data exclusivity on biologics, and they have now backed down to eight years in this draft, which they’re selling as a big concession and as a new flexibility,” said Gleeson, who is also a spokeswoman for the Public Health Association of Australia.
“But eight years is much longer than the current protection period in all TPP countries except for Japan, Canada and the US.”
When a new biologic was produced, the manufacturer usually obtained data exclusivity to protect the clinical trial data for the medicine, including safety and efficacy data.
It meant that competitors hoping to produce cheaper, generic versions of the biologic could not use the original company’s data to prove the safety and efficacy of their drug version while seeking approval from drug regulators.
Biologics sometimes cost hundreds of thousands of dollars, and are used to treat serious illnesses including cancers and rheumatic diseases. The delay in allowing cheaper versions to enter the market was costing the Pharmaceutical Benefits Scheme hundreds of millions of dollars each year, Gleeson said.
The footnotes of the draft also revealed disagreement between the negotiating countries as to the definition of biologics. An approach proposed by Australia and New Zealand and supported by Chile would leave it to each country to determine what constituted a biologic product under its domestic law.
Gleeson said she was disheartened to see solidarity between countries in standing up to demands from the US appeared to be disintegrating.
“Each country is trying to get enough qualifications into the text that they can accede to the US demands without changing very much about how their system works,” she said.
“This is a dangerous approach, it would be much better to see the countries sticking together and rejecting the US demands outright.”
The decade-long trade deal negotiations were supposed to wrap up in Hawaii last month, but the stalemate over biologics and data protection periods on drugs meant negotiations remained deadlocked. A date has yet to be set for further talks.
Other outstanding issues revolve around investor-state dispute settlement rules, with Australia trying to protect its health institutions, including the Therapeutic Goods Administration, Medicare and the Pharmaceutical Benefits Scheme from being sued by overseas companies.
Associate Professor Adrian Hearn, an international relations researcher with the University of Melbourne, said the matters under negotiation represented an evolution of the global trade and investment agenda.
“We’re moving away from the old issues of tariffs and customs, and into behind-the-border issues of intellectual property and investor-state dispute settlement issues, and what they’re about is setting the rules for the future,” Hearn said.
“Any agreement is not going to change the present or past – it’s about new investments, developments and products … and that’s why this agreement is important. This is the next phase of facilitating the movement of money around the world.”