The international trade deal between 12 countries decided behind closed doors is expected to become public soon, but many experts worry it will restrict access and raise prices on needed medicines.
Global health depends on more than access to healthcare. It also requires that treatments are affordable to those who need them.
One of the largest trade agreements in history — the Trans-Pacific Partnership Agreement, or TPP — governs trade between the United States and 11 other Pacific Rim nations. It has been widely criticized for having been negotiated in secret, and leaked specifics have raised concerns that the deal will drastically inflate the cost of pharmaceutical drugs around the world.
Those familiar with the agreement say it will create or extend pharmaceutical monopolies. That, they say, will lead to increased drug costs and undue suffering.
Peter Maybarduk, director of Public Citizen’s global access to medicines program, said that corporations influence these types of trade agreements to further their own interests, not those of consumers and patients.
“It’s clear the TPP will be harmful to people by eliminating people’s access to medicine,” he told Healthline.
Zahara Heckscher, a breast cancer patient and activist, was arrested on September 30 outside of the TPP negotiations in Atlanta.
She was protesting a potential “death sentence clause” in the agreement that would extend patents on biological medicines for eight years. That, she said, would limit the number of companies making these drugs and keep their prices artificially high.
“I am here on behalf of women and men around the world with cancer who are fighting to stay alive,” she said as she was led away in handcuffs.
The TPP is a proposed trade agreement between 12 countries: Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the United States, and Vietnam.
It is the largest regional trade agreement to date, governing 37 percent of the world’s gross domestic product, 11 percent of the world’s population, and 25 percent of all global trade, according to Australia’s Department of Foreign Affairs and Trade.
The TPP’s 30 chapters cover an array of trade issues, including customs, e-commerce, investment, labor, and telecommunications. Its goal is to eliminate tariffs and reduce member nations’ costs of importing and exporting goods to and from each other. Sticking points in the negotiations have centered on the automobile, agriculture, and pharmaceutical industries.
The Office of the United States Trade Representative touts the TPP as a win for U.S. companies that want to sell made-in-America goods abroad because it eliminates more than 18,000 taxes and trade barriers.
“My approach to trade has been guided by a unifying principle: leveling the playing field for American workers and businesses, so we can export more products stamped ‘Made in America’ all over the world that support higher-paying American jobs here at home,” President Obama said, after the agreement was reached.
The 12 nations agreed to the pact on October 5, but its details have not been made public. The full text of the finalized version of the TPP is expected to be released in the first week of November when the president presents it to Congress.
On the same day the agreement was reached, the whistleblower website WikiLeaks released the 60-page final version of the intellectual property chapter of the TPP, which deals with trademarks, copyrights, and patents.
The intellectual property chapter is crucial in terms of global health, as it may provide “longer and broader monopolies on medicines and other health technologies,” preventing needed drugs from gaining generic status sooner, according to a report from Australia’s Centre for Health Equity Training Research and Evaluation.
“There may be a lot of consequences to health that we don’t know about yet because we haven’t seen the text yet,” said Public Citizen’s Maybarduk.
The humanitarian aid group Médecins Sans Frontières (Doctors Without Borders or MSF) depends on low-cost generic medicines to treat patients, primarily in places where access to pharmaceuticals is limited by conflict or poverty.
The TPP would impart protections for drug manufacturers, in some cases extending the length of exclusive rights to manufacture and market new drugs before they are eligible to be made and sold in generic form globally.
MSF reports that 80 percent of antiretroviral drugs used to treat epidemics like AIDS are generics produced in India, but that could be interrupted by the TPP.
“But many newer medicines are locked up by patent monopolies that protect high prices for manufacturers and keep vitally important medicines out of reach for people in developing countries,” MSF said in their report opposing the TPP.
In the United States, where 80 percent of all prescription medicines are generics, patent and marketing protections range from five to 12 years depending on the drug, according to the
The United States argued for longer and stronger protections like these for pharmaceutical companies in TPP negotiations. In current drafts of the TPP, drug exclusivity would last eight years with potential extensions.
“This is kind of a threshold, and you can always increase that threshold,” Kevin Noonan, Ph.D., a biotechnology patent attorney in Chicago, told Healthline. “It doesn’t change much in the U.S.”
The TPP does include a provision similar to the now-expired Doha Declaration, which allows countries to manufacture their own drugs in response to an epidemic or other threat to public health, Noonan said.
Another clause of concern is the chapter on “investor-state dispute settlement” (ISDS), which was released in March. This allows corporations to sue countries in private tribunals when they feel future profits have been jeopardized, even if those losses are due to stricter regulations in that country.
“Under their auspices, policies covering a wide range of issues, from food and tobacco labeling, to patent law, to drug pricing rules, to environmental protection could be challenged in participating countries — including, of course, the United States,” Amy Kapczynski, J.D., a law professor at Yale Law School, wrote in the New England Journal of Medicine.
Overall, Maybarduk said these and other aspects of the TPP “expand the scope of monopoly power” of the pharmaceutical industry, which is “pulling every lever it can.”
“This TPP keeps going further because that’s what the pharmaceutical industry wants,” he said.
Noonan said pharmaceutical companies have every right to try to protect their investments.
According to the Tufts Center for the Study of Drug Development, developing a new prescription medicine in the United States costs, on average, $2.5 billion, up 145 percent from 2003.
“It’s foolish to expect a company to invest a billion or more dollars and then have the government come in and say it’s too expensive,” he said. “This is capitalism: high risk and high reward.”
While the agreement has to be ratified by the governments of each participant country, it’s primarily been negotiated in secret, creating mistrust over its scope and purpose.
Many U.S. lawmakers have shown opposition to the deal, even those who aspire to occupy the Oval Office next. Some feel it goes too far, some not far enough.
U.S. business owner and leading Republican presidential candidate Donald Trump is no fan of the TPP, repeatedly denouncing it during speeches and calling it “a terrible deal” on Twitter.
Sen. Bernie Sanders (D-Vt.), who is also running for president, opposes the deal, too.
“This would expand the profits of big drug companies, keep drug prices artificially high, and leave millions of people around the world without access to life-saving drugs,” he said in a statement against the TPP.
In June, the U.S. Senate gave President Obama fast-track authority to negotiate the pact, which restricts Congress’s ability to amend or filibuster the deal. Lawmakers can only approve or reject it with a straight yes-no vote.
Maybarduk encourages concerned voters to contact their Congressional representatives to show support or opposition to the TPP.
Observers don’t expect Congress to deliberate on ratification until after the current Presidential election cycle.
“We should be more critical of U.S. trade agreements,” Maybarduk said. “It sounds boring, but it’s important.”