by Michael Stumo
Senate Finance Committee Chair Orrin Hatch is predictably relaxing his TPP demands for Big Pharma data exclusivity stating he doesn’t need a side agreement but some other agreement that “honorable countries” will live up to.
According to Inside US Trade (subscription require):
“We have to come up with a methodology where they agree to 12 years,” Hatch told Inside U.S. Trade on Sept. 7. “That doesn’t have to be a contract; it doesn’t have to be an agreement; there are a number of ways they can do that. And honorable countries will live up to it.”
Hatch is not concerned about US trade deficits, offshoring or job losses from trade deals. He is concerned that Big Pharma is not getting 12 years of data exclusivity for biologics. Biologics are a new class of drugs. When a pharmaceutical company seeks approval for a biologic, it submits data (studies) to show it is safe and effective. Other companies seeking to achieve approval for similar drugs want to avoid re-doing those studies and want to rely on data already submitted by others. On one hand the first company to submit data spent a lot of money on the research and does not want potential competitors to free ride on their data. On the other hand, there is a public interest in bringing effective drugs to market and increasing competition without re-inventing the wheel.
Hatch is going to bat for the pharmaceutical companies who want all TPP countries to extend the data exclusivity period – the period by which competitors cannot rely upon the original data for competing drug approvals – to 12 years. But I’ve never been comfortable that this objection would stick. The administration will be hard pressed to meet Hatch’s demand because Australia and others are opposed to 12 years. But Hatch and Big Pharma want the TPP and have been playing “gettable” the whole time.
There have also been rumors that Big Pharma would later decide that, on net, the TPP without 12 years of exclusivity is better than no TPP because of all the other globalist goodies in the deal. This Hatch statement could be a move towards agreeing to move TPP in the Senate Finance Committee in the lame duck session while “saving face” by receiving vague and unenforceable statements of intention by other countries.
Ultimately, trade policy needs to eliminate trade deficits, grow good paying jobs on net, and grow our manufacturing and agriculture supply chains. That’s why we need a national goal of balanced trade.
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