<html><head><meta http-equiv="Content-Type" content="text/html charset=utf-8"></head><body style="word-wrap: break-word; -webkit-nbsp-mode: space; -webkit-line-break: after-white-space;" class=""><i class="">Republicans are lining up their cover to flip back pro-TPP immediately post-election...<br class=""></i><div class=""><br class=""></div><div class=""><br class=""></div><div class=""><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class="">INSIDE US TRADE<o:p class=""></o:p></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><o:p class=""> </o:p></div><h1 style="margin-right: 0in; margin-left: 0in; font-size: 24pt; font-family: 'Times New Roman', serif;" class="">Hatch: Biologics Commitments From TPP Countries Would Not Require Side Letters<o:p class=""></o:p></h1><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class="">September 08, 2016 <o:p class=""></o:p></div><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">Senate Finance Committee Chairman Orrin Hatch (R-UT) this week said commitments from Trans-Pacific Partnership countries on his demand for 12 years of market exclusivity for biologic drugs would not have to be framed in a contract or a side agreement – but rather as a “methodology” he believes “honorable” countries will follow.<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">“We have to come up with a methodology where they agree to 12 years,” Hatch told <em class="">Inside U.S. Trade</em> 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.”<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">Hatch said his “specific demand” can be achieved by “finding a way of having the countries agree to change that terminology in the TPP to 12 years, or come up with something that would be acceptable.”<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">The Obama administration, Hatch and the pharmaceutical industry have been discussing how to reaffirm that the 12 year-period – as provided under U.S. law – will not be affected by TPP.<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">Hatch said the issue “is not resolved yet,” but noted that the administration is aware that “12 years is a serious time language I've got to have.”<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">“They know that I'm sincere; they know I'm not asking for outrageous things,” Hatch said. “I'm asking for U.S. law. What we want to do is make sure that [the other countries] have to meet those terms too.”<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">Sources told <em class="">Inside U.S. Trade</em> that one path to a potential solution discussed by Hatch and the administration would be to include 12 years of market exclusivity in the TPP implementing bill that the Congress will vote on.<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">Nailing down that time frame in the implementing legislation would ensure a future administration could not propose a shorter exclusivity period, as has been attempted in previous budgets by President Obama.<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">While emphasizing that a final deal on a fix has not yet been struck, Hatch said the administration, in its attempt to meet his demand, may be looking at the possibility of side letters, which -- according to Hatch – a number of countries would be willing to commit to.<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">“I suspect they are looking at side agreements,” Hatch said. “I understand there are a number of [TPP countries] willing to do this. But that's up to the administration to bring that along.”<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">When asked which countries have expressed willingness to enter into any form of side agreement on biologics, Hatch said “that's not up to me to say. I know which countries are willing to go to 12 years but that's up to [the administration] to determine.”<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">As for the timing of a vote, Hatch said he “would favor a vote anytime we get one, if they get it fixed,” while characterizing progress on the biologics issue to date as “not enough.”<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">“We're not going to get this done before the end of this fiscal year, it seems to me,” he added.<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">Even if the biologics fix is achieved, Hatch said the deal won't easily pass Congress.<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">“Without [a biologics fix], TPP is not going to pass; and with it, it's going have a rough time passing,” Hatch told <em class="">Inside U.S. Trade</em>, noting additional issues lawmakers have raised in opposition to the deal.<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">“There's some other things wrong with this; the services section is wrong, the labor section has some problems,” Hatch said. “But I think if we could solve this one problem, they're a long way towards getting TPP passed.”<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">While he hasn't spent a lot of time on the financial services data fix because he's “been worried more” about biologics, Hatch said, “I hear we made strides, I put it that way,” he added.<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">Casting doubt on the possibility that the deal will garner sufficient support to pass in a lame-duck session, Hatch said the agreement would have a chance in the next administration.<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">“If they don't solve this problem on TPP, let's face it, first of all there won't be a TPP and secondly, I mean we got five years more to work on TPP, so the next president is gonna have a crack at this if we don't do it now,” he said.<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">The same point was made recently by Senate Majority Leader Mitch McConnell (R-KY), who said <a href="http://insidetrade.com/node/155609" style="color: purple;" class="">the deal will be around for the next administration and Congress to “massage.</a>”<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">When asked how he thinks TPP might a Clinton or Trump administration given the anti-trade rhetoric emanating from both campaigns, Hatch stressed the general importance of trade for the U.S.<o:p class=""></o:p></p><p style="margin-right: 0in; margin-left: 0in; font-size: 12pt; font-family: 'Times New Roman', serif;" class="">“I think it has to happen,” he said. “That just makes good sense. It's international trade and we need to be involved more on international trade.” – <em class="">Jenny Leonard</em>(<a href="mailto:jleonard@iwpnews.com" style="color: purple;" class="">jleonard@iwpnews.com</a>)<o:p class=""></o:p></p><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><o:p class=""> </o:p></div></div></body></html>