[CTC] GOP lawmakers lament proposed scale-back of biologics protections in NAFTA

Thu Dec 5 06:53:17 PST 2019

GOP lawmakers lament proposed scale-back of biologics protections in USMCA
December 4, 2019 at 6:00 PM
Republican lawmakers on Wednesday expressed concern about reports the Trump administration is willing to give up language on protections for biologic drugs in the U.S.-Mexico-Canada Agreement, but one ardent supporter of strong data exclusivity provisions in trade deals suggested the move would not affect his support for USMCA.
Rep. George Holding (R-NC), a member of the House Ways & Means trade subcommittee, told Inside U.S. Trade the reports were disappointing. He called strong biologics protections in trade deals critical and pointed to his stance throughout the Trans-Pacific Partnership talks, when he backed 12 years <https://insidetrade.com/node/145755> of protection.
“I have read those press reports and would be very disappointed if that’s the case,” Holding told Inside U.S. Trade. “We fought hard for the data-exclusivity provisions in [Trans-Pacific Partnership] and my arguments for those remain just as valid today in this arrangement.”
Congressional Republicans cited TPP’s too-short data exclusivity term for biologics as one provision the Obama administration had to fix before it submitted a TPP implementing bill. The trade pact was never voted on.
But Holding said he would not withhold his support for USMCA if the biologics protections were cut or removed.
“USMCA is an incredible agreement. I certainly would be disappointed with less data exclusivity, but I anticipate voting for USMCA,” Holding asserted.
The Office of the U.S. Trade Representative has proposed scaling back protections for biologic drugs in the deal, The Wall Street Journal <https://www.wsj.com/articles/u-s-considers-easing-drug-protections-to-break-logjam-over-trade-pact-11575320033>reported this week. Bloomberg later reported <https://www.bloomberg.com/news/articles/2019-12-03/mexico-weighs-u-s-plan-to-strip-biologic-drugs-from-trade-pact> that Mexico was considering a U.S. proposal to remove biologics protections entirely.
The USMCA text approved by the three parties would protect biologic drugs from competition from generic versions for 10 years. U.S. law protects biologic drugs for 12 years. During the Trans-Pacific Partnership negotiations, the 12 parties to the deal -- including the U.S. -- agreed to a data exclusivity period for biologics of at least eight years, or to provide five years of exclusivity while undertaking additional regulatory measures.
Mexican Under Secretary for North America Jesús Seade, in a column in the Mexican newspaper El Universal, on Wednesday said “very high protection” for biologic drugs would be “eased dramatically,” according to reports <https://www.nytimes.com/reuters/2019/12/04/world/americas/04reuters-usa-trade-mexico.html>. Seade met with U.S. Trade Representative Robert Lighthizer on Wednesday to discuss proposed changes to USMCA negotiated between the USTR and a group of House Democrats.
In a July 26 progress report <https://insidetrade.com/sites/insidetrade.com/files/documents/2019/jul/wto2019_0235.pdf> delivered to House Speaker Nancy Pelosi (D-CA) by the USMCA working group, the members proposed improvements to the deal aimed at preserving “Congress’s freedom to legislate to improve access to affordable medicines, particularly for some of the most expensive drugs on the market;” enhancing “standards for access to affordable medicines” established in the so-called May 10 agreement; and improving “opportunities for competition to improve access to affordable medicines.”
Sen. Thom Tillis (R-NC) said on Wednesday that he had been updated by USTR officials this week on the biologics issue, though he declined to provide details.
“We have gotten an update particularly on some of the biologics provisions; there are some proposals on the House side we are sorting through it now but we need to get [USMCA] passed,” he told Inside U.S. Trade. On the biologics move, he said “I’ve got some concerns with it, but I need to look at the bigger package before I make a decision.”
Rep. Dan Kildee (D-MI), a member of the House Ways & Means trade subcommittee, confirmed that the biologics threshold was up for reduction.
“Unfortunately, the way it’s been discussed is nothing is agreed until everything is agreed to, but that seems to be where we are,” he told Inside U.S. Trade. Kildee is a not a member of the USMCA working group.
House Ways & Means Committee Chairman Richard Neal (D-MA) said on Wednesday the USMCA talks were on the two-and-a-half-yard line, according to Bloomberg <https://twitter.com/elwasson/status/1202301512678039553?s=19>.
But House Ways & Means trade subcommittee Chairman Earl Blumenauer (D-OR) said a deal with USTR was unlikely to be reached this week, as some USMCA advocates had hoped. “I don’t know about this week,” he told Inside U.S. Trade on Wednesday. USMCA backers are growing restive about a dwindling number of legislative days in 2019, fearing the deal will founder if pushed into the thick of an election year.
Mexican President Andrés Manuel López Obrador and a key Mexican business group this week gave USMCA backers further cause for concern, pushing back [/node/167756] against a U.S. proposal -- hammered out by House Democrats and USTR officials -- to send inspectors to Mexico to ensure the country complies with labor provisions in the deal.
Asked if USTR, Mexico and the USMCA working group, comprised of House Democrats, would have to further address Mexican concerns, Blumenauer told Inside U.S. Trade “I don’t think they are going to have to.”
Kildee said the objections from officials in Mexico were “coming from the people that we hope are going to object to it.”
“If Mexican business interests actually like the agreement, I would have some real questions about it,” Kildee told Inside U.S. Trade. “They are the ones that are going to have to change their behavior,” he said, calling the reaction an “indication that we are getting close to where we need to be because they have been the problem.” -- Isabelle Icso (iicso at iwpnews.com <mailto:iicso at iwpnews.com>)
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://lists.citizenstrade.org/pipermail/ctcfield-citizenstrade.org/attachments/20191205/f8476a06/attachment.html>