Trade Talk Documents Suggest Access to Medicines May Become Harder
The 77-page document, which was obtained by WikiLeaks and reviewed by The Wall Street Journal, contains proposals made at the last round of talks in May, according to people familiar with the document. The TPP is a trade agreement that is under negotiation to lower tariffs and open markets by 12 countries in the Asia and Pacific regions.
The pharmaceutical industry trade group believes a trade deal should offer “strong intellectual property protections,” and has received backing from members of Congress. Patient advocacy groups have openly fretted the deal may limit access to medicines for people in poor countries.
The revisions address some of the most contentious topics batted around by drug makers and advocates. For instance, the document does not include a specific reference concerning compulsory licensing that appeared in an earlier version of the draft document following TPP talks that were held last year.
Countries may issue compulsory licenses to a generic drug maker allowing it to copy a patented medicine without the consent of the pharmaceutical company that owns the patent. This right was memorialized in a World Trade Organization agreement known as Trade-Related Aspects of Intellectual Property Rights, or TRIPS.
Pharmaceutical industry officials have frequently voiced concern that licenses may be issued inappropriately. Drug makers, in fact, have battled over licenses issued in Thailand and India. Bayer, for instance, lost a legal battle in India last year over a license awarded to a generic drug maker that wanted to make a copy of a cancer medicine.
Following trade talks in August 2013, New Zealand, Canada, Chile and Malaysia proposed a passage that stated “nothing in this chapter shall limit a party’s rights and obligations under Article 31 of TRIPS agreement or any amendment thereto.”
This article spells out various rights and conditions for countries that wish to issue a compulsory license, but the reference was removed from the May document. By removing this passage, the latest draft may leave countries with a more restrictive series of steps before a license can be issued, one patient advocate says.
“This is a pretty big deal, because outside of the U.S., pretty much all compulsory licenses on drug patents have been [issued] under Article 31,” says Jamie Love of Knowledge Ecology International, a non-profit that tracks patent and access issues, who has reviewed the latest document.
A spokesman for U.S. Trade Representative Michael Froman declined to discuss or confirm details of any documents, but notes a report issued earlier this year on intellectual property and health policy includes language supporting the right of countries to issue compulsory licenses. [EDITOR'S NOTE: The spokesman also wants to point out that Froman testified before Congress last May that his office has consistently sought a balance between upholding access to life-saving drugs and protecting innovation.]
It is worth noting that draft versions of trade talks typically change as discussions evolve, which can also make the documents challenging to read as language is massaged and passages come and go.
The May document also contains the first written reference to the amount of marketing exclusivity that may be awarded biologics, which are typically more expensive injectable medicines used for combating such hard-to-treat illnesses as cancer. The document offers a range – from zero to five to eight to 12 years – for negotiation.
The U.S. Trade Rep spokesman says the Affordable Care Act calls for 12 years of exclusivity. And a spokesman for the Pharmaceutical Research and Manufacturers of America, the industry trade group, says “more than half the Congress and a number of governors have written to the Administration that it is important that the U.S. push for the 12-year period, consistent with U.S. law.”
Although the U.S. trade rep never publicly confirmed its negotiating position, the specter of 12 years of exclusivity has riled consumer groups. Last year, more than a dozen groups, including AARP and Consumers Union, wrote the White House over concerns expensive biologics will be out of reach for many Americans.
They also noted the White House budget regularly seeks a 7-year exclusivity period. “This [shorter exclusivity period] would be better than the status quo, but still impose needless costs on the system and suffering on U.S. citizens,” says Peter Maybarduk, who heads the Global Access to Medicines Campaign at Public Citizen, a consumer advocacy group, who has reviewed the document. “But this leak shows us that the White House is playing a dangerous game: in this secretive negotiation, the Administration is pressing for the longer 12-year period and is surrendering that budget pledge.”
[UPDATE: Later, a US Trade Rep spokesman sent us a follow up note: "The intellectual property negotiation in TPP is ongoing and a final text has not been agreed to. We strongly caution anyone from drawing premature conclusions of any kind based on supposed leaked text from unsubstantiated, unnamed sources.
"The U.S. is working to reach an outcome in TPP that upholds our values by balancing the need to promote access to medicines with the need to 'incentivize' the development of life-saving new drugs and to create jobs in innovative American industries."]