The omnibus appropriations passed this morning in a vote of 310 to 112, and the FY 16 budget bill is sure to be signed by the President. Health GAP and our fellow global AIDS activists are very disappointed that the mega spending bill fails to restore the $300 million in funding cuts that PEPFAR, the U.S.-funded global AIDS program, has seen since 2011. Instead, funding for global AIDS treatment and prevention remained level to FY 2015 at $4.32 billion for the President’s Emergency Plan for AIDS Relief (PEPFAR), and $1.35 billion for the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
This is a pivotal moment in the history of the most devastating epidemic in modern history. We have the opportunity to end the HIV pandemic in the coming decade, but without enough funding for treatment and prevention, President Obama and Congress are betraying their promise to end AIDS.Read more
Big Pharma’s Monopolies Strengthen and Multiply in
Trans Pacific Partnership Trade Agreement
After five years of secret negotiations directed and controlled by pharmaceutical lobbyists and drug-company-dominated trade advisory groups, the official text of the Trans Pacific Partnership negotiated by the Obama administration has been released. The text confirms critics’ worst fears – pharmaceutical behemoths like Pfizer, Bristol-Myers Squibb, Merck, Glaxo-Smith Kline, and Abbot Laboratories have gained expanded monopoly protections and greatly enhanced enforcement rights. Patients, both domestically and abroad, will suffer delayed access to more affordable medicines and biologics. In the U.S., resulting prices increases will lead to even more rationing and burgeoning out-of-pocket payments. In low- and middle-income TPP partners, excessive prices that neither patients nor governments can afford can and will result in death.
In the mind-numbing blur of thousands of pages, killer text can be found. There are express mandates requiring patent term extensions beyond the twenty years required by international law. There are mandatory monopolies on new uses of known medicines and provisions that make it easier to get secondary patents that are only weakly inventive and that also lengthen patent monopolies. There are additional monopolies on the regulatory data submitted by Big Pharma on small molecule medicines, monopolies blocking generic competition that start at five years but can be extended for successive three-year periods. And there are new monopolies on biologic regulatory data that effectively forestall the marketing of biosimilars for at least eight years.
To guard against the risk of price controls and non-listing of their newest high-priced medicines, the drug companies have also gained privileged access to government bodies that make decisions on product listing and reimbursement rates. The pharma-fox is in the cost-cutting hen house.
Ever attentive to the details of profiteering, Big Pharma and Big Bio have also expanded their repertoire of enforcement rights. Mandatory injunctions, expanded damages, and enhanced border measures will be required. Even more dangerously, biopharmaceutical monopolists have now gained unprecedented powers in the DTPP’s Investment Chapter to directly sue governments when their expectations of monopoly profits are thwarted by a government’s patent, data-related, and pricing decisions and rules.
Drug companies are hiding their glee at new monopoly rights by complaining that they didn’t get everything they wanted, especially 12-years of monopoly protection on biologic regulatory data. Every time Big Pharma fails to get every last drop of blood money it wants, it complains that its future research and development projects will wither and die. This is an industry that is consistently one of the top three most profitable in the world. Company valuation and annual sales each exceed a trillion dollars. One out of every five health care dollars in rich countries is spent on medicines and annual price escalation of medicines is consistently many multiples of inflation rates. And in developing country TPP partners like Vietnam, Peru, Chile, Mexico, and Malaysia, government health budgets will be strained and people living with preventable, treatable, and curable illnesses will do without. People living with HIV, hepatitis c, and other diseases will simply not have affordable access to newer medicines embargoed by the TPP’s monopoly protections.
The Obama administration has claimed that the TPP represents a new gold standard trade agreement – a trade agreement for the 21st century and for all countries. The TPP is a gold standard ... for the hugely profitable and profiteering pharmaceutical industry. But it is a budget buster for governments, insurers, and patients and a disaster for the right to health domestically and abroad.
Many forces are lining up against the TPP in the U.S., including Members of Congress. Trade, environmental, labor, internet-freedom, health, and other constituencies are trying to get their voices heard. Fortunately, the TPP is not yet a done deal, despite its past secrecy and Fast Track legislation that will limit Congressional debate and amendatory authority. Once again AIDS activists know that “pills cost pennies, but greed costs lives.” It’s time to act-up again.
On 30 October the main courtroom in Uganda’s supreme court was packed with people waiting – spilling into the stairwells and hallways adjoining both sides of the large room. I was sharing half of my seat with a colleague. Civil society outrage at Uganda’s crisis of maternal mortality – chronically ignored by government – was what had filled the courtroom with activists.
After four years, we were finally receiving a ruling in a case that has been hailed as landmark health rights litigation in Uganda, a country where more than 16 pregnant women die every day from preventable complications – mainly due to haemorrhage, sepsis, obstructed labour, and unsafe abortion – all conditions that rarely kill women in developed countries.
The case, petition number 16 of 2011, had been filed at the constitutional court in 2011. The families of two women who had died in childbirth, Sylvia Nalubowa and Jennifer Anguko, and the Centre for Health, Human Rights and Development(CEHURD) along with prominent academics including Makerere University law professor Ben Twinomugisha, sued the government of Uganda, arguing that by not providing the essential health services the women required to save their lives, it was violating constitutionally enshrined health rights.
My organisation, Health GAP, worked with Ugandan activist partners to form the Coalition to Stop Maternal Mortality in Uganda, bringing the full weight of grassroots advocacy to an unnecessary tragedy typically brushed under the carpet by Ugandan policymakers.
The campaign was infectious. Ugandans, often alienated and demoralised by a politics not only rife with scapegoating, intimidation, state violence and corruption but also indifferent to health as a political issue, were emboldened by an opportunity to confront the most powerful Ugandan decision-makers directly – through the judiciary.
Unfortunately the case was dismissed in 2012 in a controversial ruling by the constitutional court. The attorney general argued that the constitutional court had no authority to hear a case that might affect health policy because that is the sole domain of the executive. The justices concurred, and threw out the case. This narrow view of the role of the judiciary in responding to health and human rights issues is particularly galling in Uganda, where despite the public health crisis triggered by preventable maternal deaths, the executive has consistently refused to increase health sector spending or provide other remedies.
CEHURD and the families of the deceased women appealed the ruling to the supreme court, with the support of the Coalition to Stop Maternal Mortality in Uganda. During the intervening period, we also advocated outside the confines of the judiciary, leveraging the attention garnered by the litigation to spur parliamentarians to act. In 2012, for example, we secured an unprecedented 49.5bn Ugandan shillings ($13m) in supplementary funding to recruit and retain 6,172 new health workers – initial progress that would have been impossible without the focus on maternal deaths the constitutional court case had generated.
The supreme court’s ruling on 30 October was a unanimous decision to overturn the constitutional court’s dismissal of the case. In their ruling, the justices concluded that the constitutional court had erred when it argued that it had no mandate to consider the health rights case, and that, according to the remarks of Chief Justice Katureebe, the constitutional court is required to determine whether the Ugandan government took all measures to provide maternal health services.
Now the constitutional court must hear the case on its merits. And not a moment too soon because in February next year Uganda will hold general elections. Civil society has launched a 2016 Health Manifesto – a full court press to challenge candidates, including President Yoweri Museveni, who has ruled for 29 years, to commit to 10 priority demands on the campaign trail. Recent polls show that health service delivery is the highest priority for Ugandan voters, but politicians have largely failed to use their political power to improve access to health services for poor Ugandans.
This court case could help change that for good. Depending on the outcome of the case, the constitutional court will have the opportunity to order the government to implement consequential, life saving remedies for poor Ugandan women and for a public health sector that has virtually collapsed due to neglect. Moreover, the case might be argued against the backdrop of a heated presidential election, with the preventable tragedy of Anguko and Nalubowa’s deaths redirecting the focus of petty and often toxic campaigning.
And while it will come too late for Jennifer Anguko and Sylvia Nalubowa, in a crowded courtroom in the months to come, real justice could finally be delivered by the constitutional court for countless Ugandan women like them.
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?
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.