<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=""><div class=""><i class="">Three articles below…</i></div><div class=""><i class=""><br class=""></i></div><div class=""><a href="https://www.bgov.com/news_item/IIbROK33ALtps5QzYD5Zww?ni_source=AlertEmail&ni_name=NewsAlert" target="_BLANK" style="font-family: Arial, sans-serif; font-size: 15pt;" class="">White House Says No Renegotiation of TPP</a></div><div class=""><div class="WordSection1"><p class="MsoNormal"><span style="font-size: 10pt; font-family: Arial, sans-serif; color: rgb(136, 136, 136);" class="">November 6, 2015 02:50PM ET | Bloomberg First Word</span><span style="font-size: 9pt; font-family: Arial, sans-serif;" class=""></span></p><p class=""><span style="font-size: 9pt; font-family: Arial, sans-serif;" class="">(Bloomberg) -- “It would not be wise after five years of negotiations with 12 different countries to try to renegotiate the agreement,” White House spokesman <span class="person">Josh Earnest</span> says regarding criticism of Trans-Pacific Partnership trade deal.</span></p><ul type="disc" class=""><li class="MsoNormal"><span style="font-size: 9pt; font-family: Arial, sans-serif;" class="">Earnest responds in news briefing to Senate Finance Cmte Chairman <a href="http://www.bgov.com/us_legislators/BB1804" target="_BLANK" class="">Orrin Hatch</a> saying Obama administration may have to renegotiate parts of TPP</span></li><li class="MsoNormal"><span style="font-size: 9pt; font-family: Arial, sans-serif;" class="">NOTE: Hatch, R-Utah, earlier today said failure to secure 12 years’ protection for next-generation biological drugs may drive cos. out of the industry, leave U.S. consumers subsidizing less expensive medication in other nations, Reuters <a href="http://www.reuters.com/article/2015/11/06/us-trade-tpp-hatch-idUSKCN0SV1XV20151106" target="_BLANK" class="">reported</a></span></li><li class="MsoNormal"><span style="font-size: 9pt; font-family: Arial, sans-serif;" class="">Earnest contends Hatch is doing bidding of drug lobby, though at same time says pharmaceutical cos. have a point</span><ul type="circle" class=""><li class="MsoNormal"><span style="font-size: 9pt; font-family: Arial, sans-serif;" class="">“They do have a legitimate argument in terms of making the case that there should be some protection that they’re afforded so they continue to have an incentive to invest in the kind of research and development” that results in “new lifesaving medications”</span></li></ul></li><li class="MsoNormal"><span style="font-size: 9pt; font-family: Arial, sans-serif;" class="">TPP gives 8-year guarantee for exclusivity for new drugs while U.S. gives 12; 8 still an improvement from zero that many TPP countries now have: Earnest</span><ul type="circle" class=""><li class="MsoNormal"><span style="font-size: 9pt; font-family: Arial, sans-serif;" class="">Cos. “need to acknowledge that a previously empty glass is now almost full”</span></li></ul></li></ul><p class="MsoNormal"><span style="font-size: 9pt; font-family: Arial, sans-serif;" class="">Related: <a href="http://www.bgov.com/news_item/mIICinusAzpbVsMlB5w9aw" target="_BLANK" class="">Pacific Nations Release Text of Landmark TPP Trade Agreement</a></span></p></div></div><b class=""><div class=""><b class=""><br class=""></b></div><div class=""><b class=""><br class=""></b></div>Hatch Doubts TPP Vote In 2016, Says GOP Would Get Better Deal On Drugs<br class=""></b>Posted: November 06, 2015, Inside US Trade<div class=""><br class="">Senate Finance Committee Chairman Orrin Hatch (R-UT) on Friday (Nov. 6) expressed doubt that Congress will take up legislation to implement the Trans-Pacific Partnership (TPP) during the Obama administration and argued that a future Republican administration would negotiate a better deal on intellectual property protections for drugs.</div><div class=""><br class="">After delivering an address to the U.S. Chamber of Commerce's 2015 Global IP Summit, Hatch told reporters that “it will be difficult for congress to take [TPP] up during an election year.” He added that prospects for consideration immediately after the elections were also dim, saying “a lot of people on something this important don't want it passed or rejected by a lame-duck Congress.”</div><div class=""><br class="">Hatch also said there is “no question” that an administration under a Republican president would get a better deal on the issue of IP protections for biologic drugs, in a sign that he may see holding out as a better strategy.</div><div class=""><br class="">The chairman, at the same time, said in clearer terms than he has before that he will push the current administration to renegotiate the biologics exclusivity period in TPP -- one of the thorniest IP issues in the talks -- even while voicing doubts that the administration was ever committed to striking a deal reflecting the 12 years in U.S. law.</div><div class=""><br class="">He further contended that the TPP biologics outcome is only one problem that could erode support for the deal in Congress, citing other unnamed market access issues and the carveout on tobacco control measures from investor-state dispute settlement. He warned that failure to improve the deal could mean that it is never ratified.</div><div class=""><br class="">“At the end of the day, USTR may need to go back to the negotiating table and try again. It's certainly not unprecedented,” Hatch said in his speech. “I understand that renegotiation can be difficult, but at the end of the day the alternative to renegotiation may be no TPP.”</div><div class=""><br class="">Both in his speech and remarks to reporters, Hatch noted that Obama opposed granting 12 years of exclusivity for biologics while in the Senate, and that his administration has proposed shortening that period to seven years. In light of this, he said the administration will “have to forgive those of us who doubt their commitment to get 12 years of protection for U.S. companies.”</div><div class=""><br class="">The nearly final version of the TPP's IP chapter requires that countries grant a minimum market exclusivity period of five years for new biologics drugs, with a possibility to go to as high as eight years.</div><div class=""><br class="">Hatch argued that a deal that does not reflect U.S. law would fail to meet the objectives laid out in the Trade Promotion Authority law. That, however, is not a clear-cut issue. The fast-track legislation makes it a principal negotiating objective of the U.S. that “the provisions of any trade agreement governing intellectual property rights ... reflect a standard of protection similar to that found in United States law.”</div><div class=""><br class="">“TPA standards are not mere suggestions, they are the law. If Congress determines that the agreement does not satisfy the demands of the law, the agreement is not going to pass,” Hatch stressed.</div><div class=""><br class="">Despite all his strong criticism of the TPP deal, the chairman ultimately stopped short of saying he opposes what exists now. He also acknowledged the size and economic significance of the deal, in a hint that he may be wary of doing something to completely derail it.</div><div class=""><br class="">Still, he left no doubt that he currently sees the deal's provisions on biologics as a non-starter. “I haven't read it yet. I reserve my judgment, but I don't see how we can accept that type of failure in protecting intellectual property,” Hatch said. “I'm not one who thinks we have to win on everything but there are some things we have to win on or else we're crazy.”</div><div class=""><br class="">More broadly, the chairman said that whatever the shape of the final deal may be, he will also press for the administration to lay out in clear terms how each party will bring into force all of the obligations contained in the deal -- including for IP -- akin to the “consistency plans” that the administration negotiated with Brunei, Vietnam and Malaysia on labor. He said members of Congress should have these details before voting on the deal.</div><div class=""><br class="">“I think the administration should provide details to Congress on how each TPP country intends to implement the agreement and how the agreement is implemented to ensure those countries follow through. Those details should be provided before Congress votes on the deal,” Hatch said.</div><div class=""><br class="">He did not specify in what form he would like to receive these detailed assurances. When asked whether he will seek to hold hearings on the TPP deal with administration officials, Hatch said he had not decided.</div><div class=""><br class="">He added that, before the agreement enters into force, the U.S. “maintains significant leverage to ensure that our trading partners will live up to the terms they agreed to, with TPP the administration needs to use that leverage with regards to all commitments under the agreement, including intellectual property commitments.”</div><div class=""><br class="">One of the substantive arguments that Hatch made against TPP containing less than 12 years of market exclusivity for biologics is that, by doing so, U.S. drug companies would need to further increase prices domestically to offset the fact that they would not be recouping their investment costs as much from sales in other TPP markets.</div><div class=""><br class="">“So, in essence, it appears this agreement would once again require the American public to pay higher costs at home in order to subsidize socialized medicine in other countries,” Hatch said. “Something tells me that the administration will downplay that particular side effect when it tries to sell this agreement in Congress.”</div><div class=""><br class="">But Peter Maybarduk, director of the access to medicines program at advocacy group Public Citizen, rejected the premise of Hatch's argument. Maybarduk contended that U.S. drug companies generally have no problem recouping research and development costs and are simply charging prices that are as high as they feel the market will bear.</div><div class=""><br class="">He said that these prices are not linked to actual investment costs of developing a product, let alone the need to recoup the cost of marketing the same products overseas.</div><div class=""><br class="">“Prices are not based on research and development costs. They're based on maximizing revenue under monopolist conditions,” Maybarduk said. “Prices are whatever we will pay to care for the ones we love. And in an environment with no competition and no price negotiation, that's a heck of a lot of money.”</div><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=""><b class=""><span style="font-size: 24pt; font-family: 'Times New Roman', serif;" class="">Dems To Hold TPP Hearings; Levin Raises Possibility Of Changes<o:p class=""></o:p></span></b></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">Posted: November 05, 2015, Inside US Trade<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">House Ways & Means Committee Democrats will hold a series of weekly hearings on Capitol Hill to examine specific issues within the Trans-Pacific Partnership (TPP) during the agreement's 90-day congressional review period, Ranking Member Sander Levin (D-MI) announced Wednesday (Nov. 4).<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt;" class=""><font face="Times New Roman, serif" size="3" class="">In a press release announcing the hearings, Levin also raised the possibility that Congress could seek changes to the TPP deal if lawmakers do not like what they see during the 90-day review period. </font></div><div style="margin: 0in 0in 0.0001pt;" class=""><font face="Times New Roman, serif" size="3" class=""><br class=""></font></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-family: 'Times New Roman', serif; font-size: 12pt;" class="">"The upcoming 90-day period was established to facilitate an intensive and informed debate over the merits of TPP as negotiated, as well as the necessity for any modifications to the agreement, before the agreement is signed," Levin said.</span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-family: 'Times New Roman', serif; font-size: 12pt;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">The hearings will deal individually with TPP disciplines on the environment, labor, investment, automotive and agricultural market access, rules of origin, state-owned enterprises, access to medicines, currency manipulation, and the "potential impact on American jobs and the economy," according to a Levin spokeswoman.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">The hearings will begin the week of Nov. 16, Levin's office said in a press release.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">They will offer a "review of the pros and cons of the agreement" with testimony from experts and stakeholders on opposing sides of each issue within TPP, the release said. The hearings will be held almost every week during the 12-week review period that begins when President Obama notifies Congress of his intent to enter into a trade agreement.<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class=""><br class=""></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: 'Times New Roman', serif;" class="">"[We] are organizing a series of in-depth public hearings to assess the merits of the proposed agreement, zeroing in on those issues that are of particular importance or concern to us and our fellow Democratic colleagues," Levin said. "These sessions will help to build a full foundation of information and transparency before Congress votes on the agreement."<o:p class=""></o:p></span></div><div style="margin: 0in 0in 0.0001pt; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><o:p class=""> </o:p></div><br class=""></div></body></html>