In November of 2001, at the height of the global AIDS pandemic, every WTO member country in the world, including the United States, voted unanimously in the Doha Declaration on the TRIPS Agreement and Public Health that WTO Least Developed Countries members should be granted an unconditional extension of any obligation to grant or enforce patents, data protections, or exclusive marketing rights on pharmaceutical products. These countries desperately needed access to affordable generic medicines and freedom from the pillage of Big Pharma's monopoly pricing. This sensible and humane transition policy was confirmed by votes of the WTO TRIPS Council and General Council in 2002.
Fast forward to 2015, and LDCs are again seeking an extension of that same no-pharmaceutical-monopolies policy, which expires on January 1, 2016. Their request has reportedly received approval in nearly every capital of the world - except Washington D.C. (with some weakening opposition from Australia, Canada, and Switzerland). Nothing in the plight of least developed countries has changed - they remain desperately poor, they continue to lead the world in negative health statistics and early death, and they continue to struggle with development challenges and inadequate capacity in their industrial, technological, and administrative sectors. More to the point, they continue to need access to affordable medicines, and, if possible, new manufacturing capacity and expertise to produce at least some medicines on their own.
What the LDCs seek is simple: rather than another time limited extension (even a relatively long 15 year one like the one they first got), is an extension that lasts as long as they remain an LDC. Once an LDC member transitions to lower-middle income status, its obligation to begin to process, grant, and enforce patents and data protections on medicines would change. But in the meantime, countries that were still LDCs could import cheaper generics legally from abroad or manufacture them locally with no intellectual property restrictions whatsoever.
What does the United States Trade Representative want - what pound of flesh is it seeking from LDCs for an further extension that is guaranteed to them by paragraph 7 of the Doha Declaration and by Article 66.1 of the TRIPS Agreement? After all those documents state that initial TRIPS transition periods, like LDCs had for pharmaceuticals, were granted without prejudice to further extensions and that WTO member "shall, upon duly motivated request by a least-developed country Member, accord extensions [of LDC TRIPS-compliance transition periods]." In this context, "shall" means "must," no "ifs," "ands," or "buts."
Instead of acceding to these clear TRIPS mandates, the USTR is unwilling to discuss an extension for as long as an LDC remains an LDC and instead is demanding a more miserly, time-limited extension. The US has been unwilling to state its position publicly. Instead, it has selectively listened to corporate “stakeholders” at home, namely PhRMA and BIO, who oppose an unlimited extension because … well, because of what they say to back up every IP monopoly demand: “We need more profits, even from the poorest countries in the world, in order to research the next generation of life saving medicines.”
Unfortunately, the USTR has not listened to access-to-medicines advocates who wrote a letter urging US support for the LDC extension over a month ago with no response to date. Nor is the USTR listening to other ‘key” US stakeholders including Senator Sanders, and Representatives Jan Schakowsky (D-Ill.), Rosa DeLauro (D-Conn.), Jim McDermott (D-Wash.), Raúl M. Grijalva (D-Ariz.), Keith Ellison (D-Minn.), Barbara Lee (D-Calif.), and Sam Farr (D-Calif.), elected officials who have all have expressed unequivocal support for the LDC request. Even the European Commission has voted unanimously in favor of the unlimited extension.
At a meeting in Geneva with 15 representatives from the LDC Group on Friday October 9, Ambassador Michael Punke, Deputy United States Trade Representative and U.S. Ambassador and Permanent Representative to the World Trade Organization, and gave a startling, unbelievably craven and subservient justification for the US demand for a short-duration extension. He said that Big Pharma was disappointed with the additional intellectual property and pharmaceutical protections the US secured for it in Trans Pacific Partnership negotiations and thus that the US could not give ground on the LDC extension.
Right, the poorest countries in world should get shortchanged on their desperately needed access to more affordable generic medicines because Big Bio did not get 12 years of data exclusivity monopoly protections on their $100,000-plus per-patient-per-year biologics.
The USTR's policy positions on the LDC extension request are deadly. They cynically safeguard Big Pharma's global monopoly empire with potential catastrophic effects on LDCs ability to strengthen their human and technological well-being. At a time when we see migrants' bodies washing onto European beaches, the USTR wants to make sure that pharmaceutical capacity is stillborn in many of the countries those migrants come from. This dour and ethically demented policy position cannot stand.
Is President Obama's administration so out of touch with humanitarian values and common decency that it wants the US to be the sole country at the WTO to oppose a mandatory, unconditional pharmaceutical extension for LDCs that is their legal right?