from the two-edged-sword dept
As Techdirt noted in 2014, by agreeing to the "fast track" procedure for trade deals, Congress has essentially given up its power to change them. That's a two-edged sword. Although it makes the ratification process simpler, because things like TPP and TTIP must be accepted or rejected in their entirety, it also means that political bosses have no ability to tweak the text to make it more likely the deals will be ratified. That's coming back to bite one of the people who introduced the fast track bill, Senate Finance Committee Chairman Orrin Hatch.
He has been trying for a while to get TPP to require the same 12 years' monopoly of drug safety data that the US provides for so-called "biologic drugs," in addition to the normal patent protection they enjoy. The final TPP text specifies eight years, and because of the fast track authority that he worked so hard to put in place, there is no way for Hatch to get the text changed now that it has been finalized. According to a report from Bloomberg, Hatch is apparently hoping that "binding side agreements" with the other TPP nations might do the trick, but there's a problem with that or any similar approach:
Australia, New Zealand and Peru have all indicated at various points during the last six months that they will not change their positions concerning biologics and stand by the agreed-upon language contained in the TPP.
That's really pretty extraordinary. After nearly eight years of tough negotiations, concessions were made and a final text agreed by all the countries involved. And now Hatch says it's not good enough, that the US has some special right to ask for yet more, and that countries refusing to up their protection for biologics data to 12 years won't be part of the TPP deal. Understandably, some in those nations at risk of being thrown out of TPP are unhappy about this threat. For example, Dr. Patricia Ranald, Convener of the Australian Fair Trade and Investment Network, said:
"I don't know what they're going to offer, but they know I'm at 12 years of data exclusivity,” he said of the administration. "They're going to have to find a way of having the countries agree to change that formality in the TPP to 12 years or come up with something that will be acceptable."
"The extra three years of monopoly [beyond current Australian regulations] in the current TPP text is already unacceptable. It is outrageous that the US is demanding an even greater increase from 8 to 12 years. We call on the Australian and other governments to reject this proposal."
In fact, it's even worse than that. As we pointed out a year ago, granting any protection to the clinical trial data used to gain approval for biologics seriously undermines one of the fundamental principles of science: that basic facts cannot be owned, and that progress is made by building on the results of others. Hatch is right that the eight-year term of protection for biologics data in TPP is unacceptable, but he's wrong about what the right term would be: it's not 12 years, but zero.