LDCs be damned: USTR and Big Pharma seeks to eviscerate Least Developed Countries' insulation from pharmaceutical monopolies

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?

Obama's USTR Wins Big for Big Pharma in the Trans Pacific Partnership Deal

Big Pharma will secretly love the TPP outcomes of longer, broader, and stronger intellectual property monopolies, but will cry crocodile tears that Obama's USTR did not bring all the bacon home - yet.  Late stages of TTP negotiations concluded this morning in Atlanta focused significantly on monopoly protections on biologics' regulatory data where industry wanted 12 years of ironclad protections but only achieved five years of hard protection and another three years of soft protection.  And industry lost its efforts to outlaw patent opposition procedures and to make it easier to gain patents on minor tweaks of known medicines.  But, the USTR delivered big time for the obscenely profitable multinational pharmaceutical industry, which achieved patent term extensions to compensate for regulatory and patenting delays, mandatory patents of new uses of known medicines, data-related monopolies on both small molecule medicines and biologics, opportunities to prevent registration of generics and bio-similars if patent rights are asserted, and enhanced enforcement powers, including investor-state-dispute-settlement before prior arbiters whenever Pharma's expectations of profits from their IP "investments" are frustrated.

Stories of major pharmaceutical companies abusing their monopoly positions to over-price medicines are sadly nothing new, but the real impact of Pharma's extortionate pricing will be felt on the ground, in hospitals, clinics, and communities around the Pacific rim where patients, insurers, and governments will be priced out of the market or forced to forego other needed services simply to stay alive. Once again, we have a trade deal that puts profits over human lives.

The global effort to end the HIV/AIDS pandemic is dependent on continuing access to affordable medicines, 90% of which globally are generic, but the terms of the TPP threaten to delay access to newer generic HIV medicines for many years.  

It is paradoxical – or criminal – that at the same time that the US is verbally committing to expand the number of people living with HIV, tuberculosis and malaria to treatment and prevention, they are undermining affordability via secret trade agreements where only industry representatives have had full and regular access to negotiation text. A close reading of the final agreement will show how closely it tracks the industry's wish list submitted several years ago.

Although brow-beaten negotiators finally caved in to US pressure, there is still opportunity to fight the passage of the TPP and its dangerous IP provisions in Congress and in the court of public opinion.  People in the US don't want to pay high prices for a longer period of time for needed medicines nor do they think that people in other countries should do so either.  But unless people demand that Congress stand up to longer and more burdensome pharmaceutical monopolies, Big Pharma will have succeeded in ratcheting up IP protections a couple new notches and will seek even stronger and longer monopolies in future agreements.

Health GAP and Ugandan partners launch civil society election platform calling for defeat of HIV, maternal mortality, the health worker crisis and other leading causes of preventable death in Uganda

Health GAP and a coalition of more than 50 Ugandan civil society organizations launched a Health Manifesto at a press conference today demanding politicians aspiring to political office in the 2016 general elections in Uganda commit to bold demands around ending AIDS and other leading causes of preventable death in Uganda. The 2016 Civil Society Health Manifesto lists 10 points regarding funding the health sector, equipping facilities with medicines and health workers, and delivering accountability and political will that has been sorely lacking up to now. Civil society will train grassroots organizations and equip them with skills to hold candidates accountable during election season. 

Health GAP, PATH, UNASO, AGHA Uganda, HEPS Uganda, TASO and many other partners are spearheading this effort--civil society will transform political debate in Uganda at a critical moment, when health service delivery is failing communities and election season is just kicking off. According to Health GAP partner Joshua Wamboga, Executive Director of UNASO: "Access to prevention and treatment are literally life-and-death political issues that should be taking center stage during our 2016 elections. As voters we will not stand by and allow candidates and political parties to be silent about the most vital issue facing our country—our health and our health rights. Using this Health Manifesto, we are demanding that all candidates commit themselves to investing in sufficient medicines, health workers, and in the political required to stop the epidemic of preventable death and disease in our communities.”

Uganda_Civil_Society_Health_Manifesto.jpg       Uganda_Civil_Society_group_Manifesto.jpg

Civil Society Calls on Candidates to Put Health Services at the Heart of Uganda’s 2016 Election Campaigns

For Immediate Release: September 15 2015

Contact for more information: Sylvia Nakasi, UNASO: 0703 402 030 or nakasisylvia@gmail.com

 Civil Society Calls on Candidates to Put Health Services at the Heart of Uganda’s 2016 Election Campaigns: No Health No Votes!

Health Sector Manifesto defines 10 Actions Candidates Must Commit to in Order to Rebuild the Health Sector

A nation of sick Ugandans cannot benefit from economic development

(Kampala) A coalition of civil society organizations working for access to essential health services in Uganda today launched the “Uganda Election 2016 Health Manifesto,” a platform demanding all parties and candidates commit to correcting massive failings of the health sector in Uganda to deliver essential, quality prevention and treatment services. This marks the first time civil society organizations will join together to leverage Uganda’s general elections in order to prioritize the health needs and health rights of the Ugandan electorate.  

“Access to prevention and treatment are literally life-and-death political issues that should be taking center stage during our 2016 elections,” said Joshua Wamboga, Executive Director of UNASO. “As voters we will not stand by and allow candidates and political parties to be silent about the most vital issue facing our country—our health and our health rights. Using this Health Manifesto, we are demanding that all candidates commit themselves to investing in sufficient medicines, health workers, and in the political required to stop the epidemic of preventable death and disease in our communities.”

 The demands contained in the Manifesto include a demand to scale up per capita health financing from current levels (only USD 10.50) to the minimum recommended by WHO (USD 44) by 2021. Other priorities include increasing the remuneration of health workers and the budget for essential medicines as well as confronting high-level corruption that robs Ugandans of life saving health service delivery. “Lack of focus on our health needs by politicians is a disgrace, and we are here to say, ‘no more,’ “ said Rachel Nandelenga of the International Community of Women Living with HIV/AIDS Eastern Africa (ICWEA). “All candidates seeking elective positions should pronounce themselves on these 10 points. We commit to empowering citizens to choose leaders whose manifestos speak to these demands—we will hold them accountable from the national level right down to the grassroots.”

The coalition pointed out that the most repeated excuse—lack of funding—is not credible, since other priorities receive funding when considered politically beneficial. For example, Parliament received 2 billion shillings to debate during a recent 2-day special sitting; State House spends more than 600 million shillings each day. “As citizens of Uganda our fate is in our hands—every five years we have a special power to raise the bar on health service delivery by making our demands known and making use of our vote. We pledge to do that now,” said Lilian Mworeko, Executive Director of ICWEA.

“We are tired of politicians prioritizing infrastructure and telling us health must wait,” said William Kidega of PATH. “Health cannot wait—not when our public health facilities routinely report stock outs, pregnant women suffer and die of totally preventable causes, and drug-resistant TB is on the rise. Investing in health service delivery means investing in social infrastructure that is the only path to equitable economic development for ordinary Ugandans. This is non-negotiable.”

A recent poll conducted in August 2014 by Columbia University reported that healthcare is the most important issue for Ugandan voters. Across two large public opinion surveys conducted in 2011 and in 2014, voters said healthcare was the most important issue for Parliament to address of these data showed that health, according to voters, is far more important than joblessness, education, or crime (Source: Columbia University 2014).

Uganda’s general election campaigns start October 25. “Between now and the start of general elections we expect all candidates to adopt these 10 points in their manifestos,” said Dennis Odwe of AGHA Uganda. “We will meet with each party individually as well as Independent candidates to deliver this demand.” Civil society members intend to work in key constituencies to support grassroots health rights activists to demand accountability from political candidates, and engage on health crises that have too long gone ignored.



US Position on LDC Pharmaceutical Extension of TRIPS Transition Period

Health GAP, Public Citizen, KEI, MSF, and Oxfam America sent this letter to the United States Trade Representative and US Patent and Trade Mark Office demanding that the US disclose its position on WTO Least Developed Country Members request that their extension of responsibilities under the TRIPS agreement with respect to medicines be extended unconditionally until they are no longer LDCs.  The letter also criticizes several positions that the US is likely to take.  Unlike the US, the European Commission has publicly announced its support for the LDC request.


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