Biopharma industry representatives are criticizing the recently reached Trans-Pacific Partnership (TPP) final agreement, which calls for a shorter exclusivity period for new biologics than the U.S. standard of 12 years that drug developers sought to duplicate in the trade accord.

In hammering out TPP, the U.S., Japan, Australia, and nine Asia-Pacific countries agreed to allow nations bound by the agreement two exclusivity options. One would allow five years of data exclusivity, followed by three years of semi-exclusivity. The other option entails eight years of full exclusivity.

The exclusivity provisions represented a compromise between the U.S. position and the stance of Australia and Peru, which sought up to five years of protection. Nations seeking the shorter exclusivity period argued that preventing drug developers from producing their own versions of competitors’ biologics would hurt people in poorer countries by driving up the prices of prescription drugs.

“We do think we have a balanced result,” Magali Silva Velarde Alvarez, Peru’s minister of commerce, foreign trade, and tourism, told The New York Times.

The compromise followed five straight days of near-continuous negotiations, according to the Times and other news outlets.

The exclusivity provisions and the rest of TPP are expected to face opposition from both parties in Congress—and have already drawn rhetorical fire from the two U.S. biopharma industry groups.

“While we await the final details, it appears that the Ministers missed the opportunity to encourage innovation that will lead to more important, life-saving medicines that would improve patients’ lives,” Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO, John Castellani said in a statement yesterday.

“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,” Castellani added. “This term 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.”

Expressing similar sentiments was Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO).

“While the TPP agreement will not impact the U.S. data protection period, we believe the failure of our Asian-Pacific partners to agree to a similar length of protection is remarkably short-sighted and has the potential to chill global investment and slow development of new breakthrough treatments for suffering patients,” Greenwood said in a BIO statement. “BIO strongly believes that 12 years of data exclusivity is a prerequisite to attract the investment required to continue medical innovation and develop new biological cures and therapies.”

However, groups seeking shorter exclusivity periods also criticized the TPP, arguing that negotiators went too far in accommodating biopharma industry concerns.

“Although the text has improved over the initial demands, the TPP will still go down in history as the worst trade agreement for access to medicines in developing countries, which will be forced to change their laws to incorporate abusive intellectual property protections for pharmaceutical companies,” declared Judit Rius Sanjuan, U.S. manager & legal policy adviser for Doctors Without Borders.

The compromise “fell short of Big Pharma’s most extreme demands but will contribute to preventable suffering and death,” agreed Peter Maybarduk, director of Public Citizen’s Access to Medicines Program.

TPP’s exclusivity compromise was welcomed, though, by a trade group representing manufacturers and distributors of finished generic pharmaceuticals, bulk pharmaceutical chemicals, and other goods and services to the generic industry.

“Trade provisions that facilitate both the development of innovative, life-saving medicines and the availability of affordable generic medicines are a win for patients. We applaud the United States Trade Representative and negotiating countries for working diligently in an effort to strike this balance,” stated Chip Davis, President and CEO of the Generic Pharmaceutical Association (GPhA).

The exclusivity provisions were not addressed specifically in a statement released yesterday by President Barack Obama. Mindful of resistance to new trade agreements—resistance likely to intensify as presidential and Congressional election campaigns take shape for 2016—Obama hailed TPP as “an agreement that reflects America’s values and gives our workers the air shot at success they deserve.”

“When more than 95% of our potential customers live outside our borders, we can’t let countries like China write the rules of the global economy. We should write those rules, opening new markets to American products while setting high standards for protecting workers and preserving our environment,” President Obama stated.

But Sen. Orrin Hatch (R-UT), chairman of the Senate Finance Committee, has promised to oppose the agreement absent a 12-year biologics exclusivity period.

“While the details are still emerging, unfortunately I am afraid this deal appears to fall woefully short,” Sen. Hatch said in a statement yesterday. “Closing a deal is an achievement for our nation only if it works for the American people and can pass Congress by meeting the high-standard objectives laid out in bipartisan Trade Promotion Authority.”








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