Humanitarian groups blast trade deal

Doctors Without Borders became the latest group to speak out against the impending agreement, complaining that it could hinder public health by granting drug makers longer monopolies on their products.

The group is afraid of several leaked provisions in the nascent deal, which is still being ironed out.

Governments that sign on to the trade deal could be forced to grant pharmaceutical companies additional patents for changes to their products, even if a change doesn’t do anything, the group said.

The process is called evergreening and is a way to delay entry of much cheaper generic copycat versions of a brand name drug.

All countries have an obligation to grant patents but aren’t obligated to grant patents on modifications to existing drugs, said Judit Rius, U.S. access campaign manager for the group.

Another patent issue irks the group, this one involving exclusivity for biologics, which are a new class of medicines made up of living organisms. Vaccines and several cancer treatments are biologics.

The deal would focus on giving drug makers data exclusivity for 12 years for biologics. Data exclusivity means that a generic competitor can’t use clinical trial data to help get a copycat version approved, thus delaying generic entry, Doctors Without Borders President Deane Marchbein said in a column in the journal Health Affairs.

Proponents say the exclusivity would help promote innovation and allow companies to recoup their investments, but Marchbein is skeptical.

“This simply isn’t supported by the evidence,” she wrote. “On the contrary, the Federal Trade Commission finds that no years of data exclusivity were necessary to promote innovation in biologic drugs.”

Rius said the main problem with the provisions is they could raise prices and stifle access to these treatments, especially in poor countries.

The anti-poverty group Oxfam agreed that the policies could hamper access and is inconsistent with Obama’s efforts on global development.

“A change in course away from the current design … is needed in order for U.S. trade policy to truly serve development outcomes,” reads a letter from Oxfam America and 16 other groups, including several religious organizations.

However, the pharmaceutical industry believes stronger patent protections are needed.

“This is a forward-looking agreement and you need to protect innovation if you want to have medicines to be available,” said Mark Grayson, spokesman for the Pharmaceutical Research and Manufacturers of America.

The pharmaceutical industry and several countries have engaged in battles over patent protections. Take India, which isn’t included in the 12-nation Pacific trade deal but has lax protections for patents.

A 2014 study found that half of new drugs over a nine-year period were copied in India within a year of their introduction. That makes India unattractive to pharmaceutical manufacturers, the study said.

The White House and pro-trade congressional Republicans are seeking to give the president “Fast Track” authority, which would allow him to submit any trade deal to Congress for an up-or-down vote without amendments and is widely thought to be necessary to get the Pacific deal approved.

The White House sparred with influential progressive Sen. Elizabeth Warren, D-Mass., on Monday, saying the lawmaker’s criticism of the deal was false.

Warren has argued the trade deal could end banking reforms and ship U.S. jobs overseas. She echoes criticisms from other traditional allies such as labor and environmental groups.

The Obama administration said Warren was distorting the legislation.