Washington – News that the United States and 11 other Pacific Rim nations had finally reached agreement on a new trade deal was not good for opponents of the pact like Rep. Rosa DeLauro, yet liberals have won a few small victories in the deal.
One such plus was a major concession by the U.S. over how long the makers of expensive biological drugs could keep generic competitors out of their market. Biological drugs are made from living organisms and used to treat a growing number of diseases that now include cancer, AIDS, rheumatoid arthritis and diabetes.
The U.S. pharmaceutical industry has 12 years of “data exclusivity,” the period during which generic versions of the drugs can’t win FDA approval of “biosimilars” made with the help of information from the original producer. The industry, whose supporters include Gov. Dannel Malloy, wanted that 12-year period to be the standard for all dozen nations that sign the Trans-Pacific Partnership, even as most of those countries had shorter periods of data exclusivity.
But negotiators agreed to a 5- to- 8 year time frame. This was a relief for some lawmakers who were concerned that a partnership-wide 12-year standard would make it impossible for them to shrink the exclusivity period in the United States, which they think is too long.
Not everyone shares that view.
“We are disappointed that the ministers failed to secure 12 years of data protection for biologic medicines, which represent the next wave of innovation in our industry,” said John Castellani, president of the Pharmaceutical Research and Manufacturers of America (PhRMA).
Castellani said the 12 years of exclusivity “was not a random number, but the result of a long debate in Congress, which determined that this period of time captured the appropriate balance that stimulated research but gave access to biosimilars in a timely manner.”
Meanwhile, Chip Davis, president of the Generic Pharmaceutical Association said his organization and its Biosimilars Council “strongly support efforts to improve worldwide patient access to affordable medicines.”
“Trade provisions that facilitate both the development of innovative, life-saving medicines and the availability of affordable generic medicines are a win for patients,” he said. “We applaud the United States Trade Representative (USTR) and negotiating countries for working diligently in an effort to strike this balance.”
Another win for liberals is a “carve out” provision for tobacco.
U.S. Trade Representative Michael B. Froman pushed for a measure in the final pact that would exclude tobacco products from industry protection provided under the TPP. That means tobacco companies could not sue countries that have established tough laws aimed at cracking down on smoking.
“This agreement is an historic recognition that tobacco is not just another consumer product – it poses an active threat to global health,” said Sen. Richard Blumenthal, D-Conn.
But lawmakers, who are required to vote on the trade pact, won’t have access to it’s full 30-chapter text for about a month. Consequently, many lawmakers greeted the trade pact’s finalization with ambivalence.
“So much about the Trans-Pacific Partnership remains unknown,” said Blumenthal, who urged Froman to make its text public “immediately.”
“As more information about the TPP becomes available, I will scrutinize the text for elements that could undermine important regulations protecting workers’ health and safety and our ability to keep our air and water free from pollution,” Blumenthal said.
Rip off the Band Aid
The pharmaceutical and tobacco provisions may weaken support for the pact among Republicans, but they are not likely to boost support for the TPP among Democrats, most of whom oppose the deal.
DeLauro, D-3rd District, a leader of the congressional opposition to the TPP, did not wait for the text of the agreement to become available before calling it “a bad deal for U.S. jobs and a bad deal for U.S. wages.”
During a telephone press conference Monday, DeLauro said big corporations were at the negotiating table, but “Congress, labor unions and American families have been locked out.”
Opponents of the TPP said it would lead to “lower U.S. safety standards and environmental protection and a loss of U.S. jobs overseas.”
They also said it would reward “currency cheats,” countries that manipulate their currency against the dollar to make their exports cheaper and more competitive.
DeLauro said President Obama “should rip the Band Aid off and show us the text” of the agreement now.
Obama won a trade victory earlier this year with a narrow victory winning “fast track” trade promotion authority from Congress. That authority guarantees the TPP and other trade pacts will be considered by Congress on an up or down vote. It prohibits Senate filibusters.
Every member of the Connecticut congressional delegation, except Rep. Jim Himes, D-4th District, opposed giving Obama that authority.
DeLauro waged a similar battle against the North American Free Trade Agreement (NAFTA,) which was signed by the United States, Mexico and Canada and approved by Congress in 1994.
On Monday, DeLauro and other Democratic lawmakers said they hoped the TPP would be a major issue in the presidential campaign. Democratic front-runner Hillary Clinton has been critical of the pact, but has not opposed it, prompting labor unions to put her endorsement on hold.
Sen. Bernie Sanders, D-Vt., has called the pact “disastrous.” GOP presidential hopeful Donald Trump has repeatedly called it “a bad deal.”