Washington – As negotiators for a massive Pacific Rim trade pact meet in Maui for a final round of talks, Connecticut lawmakers are pressing for changes they say would improve availability and prevent unaffordably high prices for medicines needed overseas and in the United States.
Last week, Rep. Jim Himes, D-4th District — along with 10 other Democrats who voted to give President Obama “fast track” authority to negotiate the Trans-Pacific Partnership — warned the administration they would not vote for a final agreement if it failed to allow for “timely access to affordable medicines in developing countries.”
The lawmakers had broken from most members of their party in giving Obama the authority to negotiate a trade pact that could not be changed by Congress, only voted up or down. But they said their loyalties to the administration might only go so far.
“At the conclusion of negotiations we will consider whether our constituents and country are better off with, or without, an agreement,” the lawmakers wrote U.S. Trade Representative Michael Froman.
Rep. Rosa DeLauro, D-3rd District, who joined organized labor, environmental groups and most Democrats in opposing the proposed TPP, has also been severely critical of the pharmaceutical provisions under discussion in this last round of talks.
She said they “confirm the worst fears of health care advocates” by restricting access to cheaper, generic prescription drugs in the dozen Pacific Rim countries that would sign on to the TPP.
“It is the U.S. (trade) representatives who have sided over and over again with the big pharmaceutical companies, in the face of opposition from other TPP countries,” DeLauro said at a press conference earlier this month.
American pharmaceuticals say they are trying to protect investments that result in lifesaving drugs.
“These protections allow our member companies to continue to develop and supply cutting-edge medicines that improve the health and quality of life of people around the globe,” said PhARMA, the trade association for the nation’s pharmaceuticals.
Under U.S. law, the U.S. pharmaceutical industry has 12 years of “data exclusivity,” the period during which generic versions of a drug manufactured using data generated by the original maker cannot be approved for sale by the Food and Drug Administration.
Supporters of a shorter timeline argue that it can take companies that make “biosimilars,” copies of complex, and usually very expensive biological drugs, six or seven years to make a generic. 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.
There are no biosimilar drugs on the market in the United States today, but several are available in Asia.
The 11 Pacific Rim nations that would join the United States in the TPP have periods of exclusivity that range from zero to 12 years. The exclusivity period in Japan and Canada is eight years. The exclusivity period in Australia, which is pushing back the hardest in the latest round of trade talks, is five years.
The AARP and others want that period of exclusivity to be seven years or less in the United States, as does the generic drug industry. President Obama says he does, too, even as his administration’s negotiators are pushing for the 12-year timetable.
So has Connecticut Gov. Dannel Malloy, putting him at odds with other Democrats like DeLauro and Himes who are trying to give other TPP countries more flexibility.
In 2011, Malloy and a group of elected officials that included five other governors, asked Obama to insist U.S. trading partners under the TPP adopt the 12-year U.S. standard, which is longer than in Canada and Mexico and most countries in Europe and Asia. They said the biopharmaceutical sector supports more than three million U.S. jobs.
AARP, Doctors Without Borders (Medicines Sans Frontieres) and other patient advocates are pressing TPP negotiators to allow other countries to develop their own timelines.
AARP lobbyist Nancy LeaMond says the “anticompetitive provision” under discussion in Hawaii includes extending brand drug patent protections through “evergreening,” or creating a new drug from a slightly modified older drug to extend intellectual property protections.
As biosimilars become available in the United States, LeMond said, it’s critical Congress not be tied into 12 years by a trade pact that prevents it from considering policy changes that would allow these less expensive follow-on biologics to come to market sooner.
LeaMond also said she is concerned about the TPP’s adoption of “patent linkage,” which would block a nation’s regulatory agency from granting marketing approval to a generic drug if it is alleged there is a patent in another country for a similar drug.
“These provisions are all designed to ensure monopoly control by brand-name drug companies,” LeaMond said.
Pharma lobbies on the TPP
Himes said there should be a “balance” between the interests of pharmaceuticals and the protection of access to live-saving drugs for those in developing countries who need them.
The letter he and his Democratic colleagues sent the USTR last week urged negotiators to change course and adjust the pharmaceutical provisions by making them consistent with a trade pact negotiated with Peru, Panama and Colombia that gave those companies flexibilities with their timelines.
“Big pharmaceuticals need to recuperate their investment or they won’t incur the expense of research and development of creating new drugs,” Himes said. “But there’s also a flip side. It’s also critical that we have life-saving medicines available to people who can’t afford expensive drugs.”
The USTR did not respond to several requests for comment on the lawmaker’s concerns.
Himes said he’s hoping for a “good set of standards.”
But, according to a Sunlight Foundation study, the U.S. pharmaceutical industry has been lobbying for their interest in the Trans Pacific Partnership for years.
The report said that as early as 2009, years before the Trans-Pacific Partnership began to be widely debated, 28 organizations filed 59 lobbying reports mentioning the then far-off trade agreement. Almost half of those organizations were pharmaceutical companies or associations, the report said.
“It was an early clue as to which industry would take the most active role in trying to shape the trade agreement while it was still secret from the public,” Sunlight said.
The report listed Pfizer as the most active company lobbying on the TPP, at least measured by the number of lobbying reports filed between 2009 and 2013 that mentioned the proposed trade pact — more than 40.
“Our lobbying efforts are guided by two main principles — maintaining and improving incentives for innovation as well as protecting and expanding access to medicines,” said Pfizer spokeswoman Sharon Castillo.
Meanwhile, the Obama administration hopes the agreement, which would cover 40 percent of the global economy, will be completed in the next few days or weeks to give Congress enough time to act on it before the end of the year — and before the Trans Pacific Partnership gets mired in 2016 presidential election year politics.