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.

Will U.S. create barriers to LDCs' future access to medicines?

Professor Brook K. Baker, Health GAP and Northeastern U. School of Law

September 7, 2015

Earlier this year, WTO Least Developed Country Members requested an unconditional extension of the expiring WTO TRIPS transition period that exempts them from having to implement pharmaceutical patents and other intellectual property protections that constrain their ability to make or procure low-cost generic medicines.  Informed sources indicate that the U.S. is currently opposing the LDC draft extension. While the exact US government position has not yet been made public, it seems likely from past US positions that the US Trade Representative might be opposing several of the most important elements of LDC request that make the extension truly meaningful for access to medicines. 

As the next TRIPS Council meeting is on October 15, it is likely that the USTR has begun bilateral negotiations with LDCs with respect to their request for an unconditional extension from the requirements of the TRIPS Agreements with respect to pharmaceutical patents, data protections, marketing exclusivity, and mailbox requirements.  LDCs are seeking an extension for as long as they remain LDCs.  They ground their request both on the language of the Doha Declaration on the TRIPS Agreement and Public Health and Article 66.1 of the TRIPS Agreement.  These binding, unanimous-consent documents grant LDCs the right to seek further extensions of their TRIPS transition period and require that such extensions "shall" be accorded upon properly motivated request. 

The USTR is continuing its traditional silence on its formal position with regard to the LDC request.  It has reportedly consulted on the request, but has not done so extensively with public health and human rights groups that are on record that the US should accede to the LDC request without conditions.

Reading the tea leaves of past US positions in negotiations on earlier transition periods and their extension and the US position on the August 30 Decision on Paragraph 6 of the Doha Declaration concerning compulsory license supply to countries with insufficient domestic manufacturing practice, it is easy to identify policy positions that the USTR must avoid.

First, the US may but must avoid efforts to shorten the time limit of the proposed extension as short extensions do not allow LDCs the policy space to secure durable sources of lower cost generic medicines nor a sufficient time period to develop sustainable local pharmaceutical capacity.  LDCs made a request two years ago for a transition period from their basic TRIPS-compliance obligations for as long as they remained LDCs.  The US and EU opposed this rational request and instead insisted on no more than the eight year extension granted (2013-2021).  The need for a transition period for pharmaceuticals as long as a country remains an LDC is even clearer than for the general TRIPS compliance, as the health needs of LDC populations requires paying the lowest possible prices for medicines of assured quality.  Surely the US will not once again oppose an extension for countries that remain trapped in an LDC development quagmire and to force them to return every few years for an additional time-limited extension.  

Second, the US may but must not tie the granting of pharmaceutical extension to a declaration, express or implied, that intellectual property protections are unequivocally good for development.  In the 2013 extension process, the USTR insisted on a IP fundamentalist clause genuflecting to the magical development elixir of patent monopolies.  It required a clause from LDCs expressing "their determination to preserve and continue the progress towards implementation of the TRIPS Agreement."  Regrettably, the best evidence is that increased IP protections and continued efforts towards TRIPS compliance do not create favorable conditions for accelerated development in low-income countries and instead that such polices increase prices and thereby reduce access to global public goods like medicines.  Questions about the negative impacts of easily granted and over-enforced patents are growing even in the U.S. where government programs and private insurers cannot afford some of the astronomically over-priced medicines that have recently hit the market.

Third, the US may but must not demand that LDCs restrict their pharmaceutical capacity, if and when they develop it, to non-commercial purposes only and in particular to serving domestic needs only (See, Chairman's Statement to the August 30 Decision requiring non-commercial purpose).  LDC countries like Lesotho, population 2 million, can simply not build viable pharmaceutical capacity that solely serve small and poor populations.  Viable pharmaceutical enterprises in LDCs, especially in the generics context, need to achieve efficient economies-of-scale and should at least reach regional markets.  More to the point, such industries need time and policy space to develop as existing capacities are non-existent or weak.  Finally, to impose export limits on commercially oriented pharmaceuticals would create a perverse carve out for medicines that is totally inconsistent with technological development rights affirmed in the 2013-21 TRIPS-compliance extension.

Fourth, the US may but must not impose conditions that require LDCs to maintain existing degrees of IP protection.  The first general LDC extension 2006-2013 unfortunately contained a stay-put provision that locked LDCs into the levels of IP protection imposed by their colonial masters or unwisely adopted because of flawed technical assistance from WIPO.  Fortunately, LDCs succeeded in reversing this stay put clause in their 2013-2021 extension with the following provision:  "Nothing in this decision shall prevent least developed country Members from making full use of the flexibilities provide by the [TRIPS] Agreement to address their needs, including to create a sound and viable technological base and to overcome their capacity constraints supported by, among other steps, implementation of Article 66.2 by developed country Members [relating to technology transfer]."  This provision grants LDCs the policy space - free from exclusive, monopoly rights - to advance their development project and to fulfill their human rights obligations including the right to health.

The USTR should immediately disclose its LDC pharmaceutical extension negotiation position.  To the extent that its position includes any of the above retrograde policies, they should be reversed.  Instead, the US should join the emerging global consensus, supported even by the European Union, that the LDC pharmaceutical extension should be granted on requested terms.  Allowing LDCs unfettered access to more affordable generic medicines will also advance the US policy objectives of halting and reversing the global AIDS pandemic where the US has saved billions of dollars in its PEPFAR program by purchasing over 90% of its antiretroviral supplies from generic sources.


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