Health GAP Applauds New Pediatric Drug Deal with Patent Pool, and Condemns GlaxoSmithKline’s Threats to Obstruct Access to Critical New HIV Medicine
Activists from Health GAP (Global Access Project) welcomed a new voluntary license agreement on pediatric formulations of the antiretroviral medicine abacavir (ABC). The group welcomed improvements of the license between the drug company ViiV (a venture between Pfizer, GlaxoSmithKline and Shiongoni) and the Medicines Patent Pool (MPP) compared with a deal previously negotiated between MPP and Gilead, which contained more onerous restrictions. The terms and conditions of the new agreement will extend unfettered generic competition to more than 99% of children with HIV in low- and middle-income countries--an improvement in geographic coverage over Gilead medicines for adults. The license also comes without harmful restrictions on the physical location of manufacturers, sourcing of active pharmaceutical ingredients (APIs), use of compulsory licenses, or data exclusivity. The agreement directly covers 118 countries with 98.7% of the developing world's children with HIV. In addition, explicit provisions in the agreement allow sale in additional countries where there are no policy blocks in place to extend generic coverage to 99.4% of the pediatric epidemic. Health GAP asserts that, unless similar provisions are agreed by ViiV’s shareholders in upcoming license agreements, these improvements will appear to be merely a calculated public relations move, given the shrinking pediatric HIV market.
MPP is still in negotiations with ViiV on dolutegravir (DTG)--an even more important medicine that is part of entirely new class of anti-AIDS drug called integrase inhibitors. In spite of the step forward on ABC, drug giant and 76.5% majority ViiV shareholder, GlaxoSmithKline currently limits ViiV’s adult voluntary licenses to only 69 least developed, low-income, and sub-Saharan African countries.
"The agreement on pediatric ABC is a significant step up over previous MPP licenses, but the children's antiretroviral market is small and fragmented. A license on the small children's ARV market with low commercial value cannot be used by ViiV or GSK as PR cover for restrictive licensing on critical newer drugs for adults like dolutegravir," said Health GAP's Senior Policy Analyst Brook Baker, a professor of law at Northeastern University. "Glaxo must back away from its current geographical limitations on adult ARV voluntary licenses, or they will expose the new ViiV license as a public relations gesture that is good for children but deadly for their parents."
Health GAP strongly cautioned against any deadly limitations on access to DTG. "Glaxo is threatening to profoundly restrict adult access to critically needed newer medications," said Health GAP's Nairobi-based Paul Davis. "This improved voluntary license on abacavir must be the floor for GSK, not the ceiling. We need integrase inhibitors here and everywhere in the developing world, and GSK must cease its efforts to gouge monopoly profits out of people with AIDS."
"The improvements in the pediatric ABC license over the Gilead license show that we can improve over the flaws of previous licenses ," said Asia Russell from Health GAP in Kampala. "We call on the Patent Pool, ViiV and GSK to replicate and expand the terms and conditions of the pediatric ABC license for adult and pediatric dolutegravir."
As you know, the sequester, those automatic across-the-board budget cuts that will kill 36,000 people living with AIDS this year who would have otherwise survived, have taken effect because Speaker Boehner and Congress decided to protect Wall Street and the wealthiest 1% instead of poor and people living with HIV/AIDS. This will have a devastating direct effect on the global AIDS pandemic.
To stand up against these draconian cuts, members of Health GAP, Queerocracy, ACT UP NY and ACT UP Philly stripped naked in the House Speaker Boehner’s office in the Longworth Building in Washington D.C. on November 27th, 2012, in an act of civil disobedience. Our goal was to expose the “naked truth” about what sequestration cuts will mean to AIDS programs. We must remember that this demonstration was not primarily about nudity, but was intended to be a smart tactic that would bring media attention to these deadly cuts.
We have been told that all seven of us will be found guilty of a misdemeanor. We will have to continue to make trips to DC from NYC, Providence, Tampa and Philadelphia to attend court and potentially perform community service. Our fines will be several hundred dollars each.
We are asking you to do 2 things:
1. Call Senator Mikulski, 202-224-4654 and demand that she restore cuts to programs that will end AIDS in the FY13 and 14 budget processes. Call him at (202) 224‐3542
Students from Columbia University's Student Global AIDS Campaign chapter have been trying to meet with Senator Schumer for months to discuss the looming, deadly, budget cuts called "sequestration". Even though he is their elected official, no one from his office would set up a meeting. So, they went down to his office, joined by ACT UP NY and QUEEROCRACY, to meet with him anyway. After chanting and picketing out in front, the group entered the lobby, holding up signs that said, "Senator Schumer, 37,000 people living with AIDS will die from budget cuts." The group negotiated to have 2 leaders, SGAC's Mel Meder and Health GAP's Michael Tikili wait in the lobby, while the rest of the group returned to the streets, telling passersby about the effects of the budget cuts.
When security called up to his office - lo and behold! - one of his leading staff members came downstairs to hear them out. The staffer even took a sign to show Senator Schumer. She told the group how Sen. Schumer supports the "cause" and was "fighting for us". Mel asked him for a "Dear Colleague" letter to support global AIDS funding. We are watching and waiting @ChuckSchumer! Do the right thing.
Promoting health, development, education, and environmental consideration
Haiti recently submitted, on behalf of the Least Developed Country (LDC) members of the World Trade Organization (WTO), a request to extend the transition period for LDCs to implement the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement.The TRIPS Agreement sets out minimum standards for intellectual property (IP) protection and enforcement that all WTO Members must implement in their national laws. When it was signed TRIPS granted transition periods for both developing and Least Developed Countries. LDCs initial transition period was to have expired in 2005, but an extension was granted in 2005 until June 30, 2013. The Haiti proposal would simply extend this transition period until countries “graduate” from LDC status—a proposal the TRIPS Council is obliged to pass according to WTO rules.
The “Least Developed Country” Category
LDCs are the most impoverished and economically vulnerable countries—officially classified by the United Nations based on three factors: lowest income (GNI $ 1,190 per capita); poor human development indicators of nutrition, health, and literacy; and economic vulnerability. LDCs include countries such as Haiti, Bangladesh, and Zambia. While they comprise 880 million people, one eighth of the world’s population, they subsist on 0.9% of the world total GDP. The transition period in the TRIPS Agreement was to protect LDCs in need of increased assistance, investment, and technology transfer from the burdens of granting and enforcing IP monopolies in order to enable them to “graduate” (as Botswana and Cape Verde have); the global goal is for at least half of LDCs to graduate in the next 10 years.
TRIPS & LDCs
The adoption of Intellectual Property Rules (IPRs) by developing countries means that they are no longer free to make use of technologies developed in wealthy countries without the permission of right holders. Nevertheless, developing countries were convinced to join the WTO because they were promised “special and differential treatment” that included increased investment and technology transfer from rich countries to LDCs under TRIPS. Article 66.1 of TRIPS provided for an initial ten-year extendable timeframe for them to implement TRIPS. It further provided that LDCs would be accorded extensions to this original transition period upon a “duly motivated request.” Article 66.2 requires rich countries to support LDCs in obtaining technologies they need for development and economic growth—an obligation that most observers say has not been met.
In 2002, the LDCs were granted an extended waiver based on the “Doha Declaration on TRIPS and Public Health” saying they were not obliged to implement or to enforce patents and test data for pharmaceutical products until January 2016. Recognizing that LDCs were still likely to be negatively impacted by the full scope of TRIPS, a waiver for the full TRIPS agreement was granted in 2005 that extends throughJune 2013. If it is not extended, LDCs will be under an immediate obligation to implement TRIPS (pharmaceuticals in a few years). The short term and long-term impacts of such an obligation would be harmful to development.
The New LDC Request
LDCs submitted a proposal at the November 2012 TRIPS Council meeting, requesting that all LDCs be provided with a full waiver on TRIPS implementation until they graduate from the LDC status. This would include giving LDCs the right to eliminate any IP provisions that had already been implemented, which is important for countries that find that old IP rules—some dating from the colonial era—are inhibiting development. If agreed, the proposal would also extend the waiver issued to LDCs with regard to pharmaceutical-related provisions.
Wealthy countries have not taken a public position on the LDC request, though there are signs that certain developed countries will refuse to agree with the LDC request or may require onerous conditions, limited timeframe, etc.. In March 2013, the TRIPS Council will meet to take up the LDC group proposal. Civil society groups from across the world including Oxfam, Health GAP, Doctors Without Borders, Knowledge Ecology Intl., Public Citizen, and Third World Network have called on WTO Members to approve the LDC request in its current form.
KEY ISSUES AT STAKE
Access to affordable medicines. LDCs, by definition, face substantial health problems—often high rates of HIV and malaria, weak health systems, and massively insufficient health budgets. Implementation of TRIPS IP rules, as well as of rules that exceed TRIPS (“TRIPS-plus”) drives up the price of medicines by allowing key medicines to be patented—putting life-saving technology out of the reach of patients and national health programs. IP rules could also undermine nascent industries in LDCs. Some LDCs are working with foreign partners to upgrade their domestic pharmaceutical capacities; in Bangladesh and Uganda, for example, the Indian generics firm Cipla has set up manufacturing facilities for quality, low-cost medicines that could be used domestically, or exported to other developing countries. Such activities could be interrupted if patents can be filed in those countries.
Access to educational resources. Although the need for affordable medicines is well known globally, LDCs also need access to other important public goods and technologies that are frequently blocked by IP. For example, students in LDCs need access to affordable educational resources and such access is routinely blocked by copyrights owned by textbook publishers. Similarly, LDC researchers need access to the latest scientific information to adapt new technologies and to pioneer innovations meeting unmet local needs. Software, textbooks, and academic journals are key items where copyright is a determining factor in pricing and access. For instance, a reasonable selection of academic journals is far beyond the purchasing budgets of university libraries in most LDCs.
Access to agricultural goods. The rights of small-scale farmers that dominate LDCs agriculture system can also be hampered as IP can hinder their traditional farming practices by preventing free exchange and use of protected seeds and varieties. IP systems for plant variety protection can also hinder access to affordable agricultural inputs, increase erosion of agro-biodiversity, which in turn affects food security.
Access to Green Technology. Many of the break-through green technologies that are energy-saving and that control or mitigate climate change are unavailable in LDCs. Further, many of them are not adapted for use in low-resource and tropical settings and patents will stand in the way of local companies and non-profits adapting them where they’re needed most. For LDCs to be able to deal with the climate challenges effectively, they will need prompt access to affordable technologies, which requires policy space to overcome IP barriers.
TRIPS hinders development in the case of LDCs. Many economists have documented how pushing LDCs to adopt TRIPS is unlikely to support development—indeed today’s wealthy countries largely built their technological capacity by copying and experimenting with proprietary technologies dev
eloped elsewhere without the barrier of overly broad IPRs. In order for IP regimes to have any role in stimulating investment and R&D, a technological and knowledge base must first be built and there must be a functioning market. Such conditions do not yet exist in most LDCs. LDCs should have policy space to access to the same path to development that was previously used by rich countries including the U.S.
Don’t LDCs already have IP systems? Many LDCs have implemented parts of the TRIPS agreement voluntarily—some as a simple legacy of colonial-era laws and others through conscious choice. Under the exception LDCs remain free to adopt whatever IP provisions they find them appropriate. But LDCs should not be forced to adopt the whole TRIPS system immediately—they need the space to prioritize development. LDCs should also not be forced to keep in place any existing laws that prove to be a barrier to development—which wealthy countries have demanded in the past in exchange for the 2006-2013 extension.
Instituting TRIPS-compliant IP systems would be very expensive for LDCs. TRIPS implementation costs countries an initial outlay of anywhere between USD 250K and USD 1m, plus annual expenditures of as much as USD 1m. LDCs should be directing their scarce economic resources towards more pressing regulatory and other essential needs. For example, LDCs could achieve a greater return on their spending by directing resources towards improvement of the regulatory systems that ensure medicine quality and safety, or the education system.
In his State of the Union address, President Obama layed out his vision for the next four years, and he recognized the importance of realizing an AIDS free generation. Despite this recognition in his SOTU, he is seriously considering slashing funding to fight global AIDS in his Fiscal Year 2014 budget proposal. We need your help to make sure that lifesaving global health programs don't get cut!
Call the White House to demand that AIDS funding for PEPFAR and the Global Fund is increased in the President's budget proposal. President Obama will make final decisions on his fiscal year 2014 budget request in the coming days - including the final numbers for the Presidents Emergency Plan for AIDS Relief and the Global Fund to Fight AIDS, TB, and Malaria.
Call and Tweet the President TODAY!
To call the white house: call the White House switchboard at 202-456-1111
Call In Script:
My name is ---------- and I'm calling to urge President Obama to increase funding for the President's Emergency Plan for AIDS Relief and the Global Fund in his fiscal year 2014 budget. The President needs to protect and expand PEPFAR at $5.027 billion, and contribute to the Global Fund at $2.0 billion in FY 2014. We can end the AIDS pandemic if the President commits to funding global AIDS programs at these levels. I hope that President Obama will choose to be the President who ends AIDS."
To Tweet the White House:
@whitehouse Fund the end of AIDS. Increase funding to PEPFAR and Global Fund. #EndAIDS #dontcutnow
The President's budget will have a critical impact on global health financing this year. With a Global Fund replenishment conference set for fall 2013, the President's request level will send an important signal to other donors. A low budget request from the President for the Global Fund will influence the funding levels of other donor countries for the next three years.
As the largest program focused on beginning to end the AIDS pandemic, PEPFAR plays a vital role in tackling AIDS. The new PEPFAR Blueprint for an AIDS Free Generation calls for rapid scale up of core AIDS services, including treatment, which will lead to accelerated declines in HIV infection and mortality
Both of these programs must be funded adequately for us to begin to end the AIDS pandemic - we cannot cut PEPFAR to fund the Global Fund. Robbing Peter to pay Paul has never done any good.
We cannot turn away from the opportunity to end AIDS now. Global health funding is only one quarter of one percent of the federal budget. We can afford to increase investments in global health even in difficult fiscal times.
Please call the White House today.