Australia’s trade minister, Andrew Robb, has appeared at the National Press Club in Canberra today, where he admitted that concluding the Trans-Pacific Partnership (TPP) trade deal is looking increasingly unlikely.
According to AAP, Rob said that sugar and dairy access remained key sticking points, along with motor vehicle assess between Mexico, the US, Canada and Japan. He also noted that “the closer we get to a US presidential election, the more prospect (there is) of it falling over”.
I am surprised that Robb did not also mention the issue of enhanced protection for pharmaceuticals, in particular the fight over so-called “biologics,” which are an important new class of medicines produced from living organisms.
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.
As explained in The Conversation on 6 August:
Data exclusivity refers to the protection of clinical trial data submitted to regulatory agencies from use by competitors. It’s a different type of monopoly protection to patents. While a product is covered by data exclusivity, manufacturers of cheaper follow-on versions of the product can’t rely on the clinical trial data produced by the originator of the drug to support the marketing approval of their product.
Section 25a of Australia’s Therapeutic Goods Act provides for five years of data exclusivity for all medicines. It makes no distinction between biologics and other drugs. Data exclusivity provides an absolute monopoly that, unlike a patent, can’t be revoked or challenged in court.
The powerful biopharmaceutical industry lobby in the United States has been seeking 12 years of market exclusivity for biologics.
Facing intense opposition from all other countries, the US trade representative fell back this week to eight years. While this was heralded as a new level of “flexibility” in the US position, in reality it remains a significant extension of intellectual property rights in most of the TPP countries.
Regardless, the stalling of TPP negotiations is good news for Australians, since it means that we will not face rises in medicine costs nor increased litigation from multinational corporations taking action under investor-state dispute settlements clauses imbedded in the agreement.