Trans-Pacific Partnership Transparency for the Big Pharma Wrecking Crew

Professor Brook K. Baker, Senior Policy Analyst

June 11 2015

A new WikiLeak release of the recent draft text of the US-led proposal for the Trans-Pacific Partnership annex on Pharmaceuticals and Medical Devices shows how the fig-leaf of “transparency” and “procedural fairness” is being used to allow transnational pharmaceutical companies to subvert countries’ ability to make decisions about which drugs and medical devices they can afford to cover, in order to expand access for monopoly-priced medicines.

The newly-leaked 2014 draft has facial improvements over an older 2011 draft that was universally panned by other Trans Pacific Partnership (TPP) countries. While the more recent draft no longer directly targets medicines pricing, it includes explicit provisions for Pharma’s direct involvement in government procedures and deliberations for deciding on and listing medicines and devices that will be reimbursed by government health programs, such as PHARMAC in New Zealand, the Pharmaceutical Benefits Advisory Committee in Australia, and Medicare in the United States. Pharma and device applicants will also have input of the level of reimbursement for their products. There are set timelines and requirements that the criteria used to decide which medicines will be included/excluded for reimbursement be fully disclosed and justified. These measures reduce the sovereign autonomy and flexibility of responsible agencies to make difficult assessments regarding value for money in health care. Although a separate appeals process will no longer be required, there are requirements that there be substantive reconsideration processes—appeals in another name. All of these transparency and procedural niceties can be used by pharmaceutical and medical device companies to bully government decision-makers into accepting higher-prices for medical technologies of dubious value.

Even more dangerously, the provisions included in the transparency chapter could give rise to investor claims directly against states, allowing foreign investors to bypass national courts and seek unlimited monetary damages in three-person private arbitration proceedings. For example, according to TPP Investment Chapter rules, if a pharmaceutical or medical device company was dissatisfied with a government decision, it could proceed directly to arbitration claiming that it had been subjected to unfair and inequitable treatment. Even worse, if a country with no existing system for medicine and device formularies adopts this rational system for trying to control medical costs and deter introduction of medicines and devices of dubious medical value, the pharmaceutical investor could claim that its expectations of the profits and of a stable regulatory environment has been unfairly disrupted.

The Annex on Pharmaceuticals and Medical Devices is an unveiled attempt to give drug and device companies access to government's sovereign decision-making on medicines and device formularies and price-setting policies. The provisions, as they stand, allow for endless opportunities for one-sided interventions, lobbying, and reconsideration appeals challenging lack of meaningful participation, failures of evidence-based decision-making, obstruction of introduction of medical innovations brought forward by self-interested companies (not patients). Big Pharma and medical device companies basically want to bully governments into succumbing to their excessive pricing demands for new products, regardless of medical merit or beneficial comparison to alternatives. If they lose in these deliberation, the adoption of this "transparency", fox-in-the-henhouse strategy would allow companies to pursue investor-state dispute resolution, convening biased private arbitration panels to review claims that expectations of profits have been thwarted by the adoption or implementation of formulary or health care coverage and pricing decisions.

This chapter continues to pose a threat to access to affordable medicines, potentially burdening patients, insurers, and governments with bloated prices for the medicines they need, as well as for inferior products they don’t need. It also ties governments' hands to take more serious steps to control these health care costs and to reject medicines and medical devices with marginal or no additional therapeutic benefits. Yesterday, the New York Times reported that the new draft no longer demanded protection for pharmaceutical prices. However, this is somewhat misleading. The truth is the changes are largely cosmetic. The TPP’s transparency chapter still opens the door to the pharmaceutical and device-manufacturing industries to use procedural wrecking balls to destroy the machinery of government that is created to make rational decisions on the medicines and devices that it will reimburse with its limited financial resources and on the level of that reimbursement. It will harm the health interests of patients, insurers, and governments in each and every country involved, all in the relentless drive for monopoly prices and monopoly profits.

Broad Coalition Of AIDS activists, Nurses And Other Advocates Applaud Senate Wall Street Speculation Bills Introduced By Sen. Bernie Sanders

For Immediate Release

May 19, 2015

Contact: Paul Davis, 215-833-4102, Michael Tikili, 347-217-3030

Broad Coalition Welcomes Senate Wall Street Speculation Bills

Washington, D.C. – A broad coalition of AIDS activists, nurses, students, religious and civil rights groups, environmentalists, labor and housing advocates today enthusiastically welcomed plans by Sen. Bernie Sanders to introduce two new Senate bills Tuesday that would impose a small fee on Wall Street speculation to pay for college education for all and other critical community needs.

Sen. Sanders will unveil the legislation at a Capitol Hill press conference Tuesday, May 19 at 11:30 a.m. at the Senate Swamp. Student leaders, as well as nurses, AIDS activities and other long time advocates of the Wall Street fee, also known as the Robin Hood tax, will also attend.What: Press conference with Sen. Bernie Sanders

When: Tuesday, May 19, 11:30 a.m.

Where: Senate Swamp, Capitol Hill (near Constitution Ave. and 1st St.)

(note: in the event of rain check for possible location shift)

Live Stream:

Sanders’ landmark education bill would eliminate undergraduate college tuition fees for students attending public colleges and universities, reform student loans, and expand work-study programs. The bill is a critical step to eradicating student debt, currently pegged at nearly $1.2 trillion and the fastest growing form of consumer debt, as well as expanding educational and employment opportunity.

It also puts the U.S. on a path embraced by other nations that already provide free college education including Brazil, Chile, Finland, France, Germany, Norway, Slovenia, and Sweden.

The second Robin Hood tax bill would help reinvest in American families and communities by providing the resources for jobs and healthcare for all, affordable housing, eradicating HIV/AIDS and fighting poverty, and climate change. It parallels a House bill, HR 1464, the Inclusive Prosperity Act, introduced by Rep. Keith Ellison (D-MN) with 25 House co-sponsors.

“We applaud Sen. Sanders for this bold and far sighted step. Free college education, as many other countries already provide, opens the door for greater economic opportunity, reducing income inequality, and a better life for all Americans,” said RoseAnn DeMoro, executive director of National Nurses United, the largest U.S. organization of nurses, and a leader of the Robin Hood tax campaign, who will be speaking at the press conference.

“Nurses see first hand the irreplaceable bond between good health and economic security and social justice,” DeMoro said. The Robin Hood tax, which can raise hundreds of billions of dollars every year, paid by Wall Street speculators, “is the perfect way to fund this program, as well as providing the resources we need for other vital humanitarian needs, including healthcare and good paying jobs for all, affordable housing, eradicating poverty and environmental justice. It is the hallmark of a civilized society and a more just nation.”

Both bills set a nominal tax – 50 cents on every $100 of stock trades on stock sales, and lesser amounts on transactions involving bonds, derivatives, and other financial instruments. Passage would allow the U.S. to join dozens of other nations – including every other major global financial market – in a growing system of financial transaction taxes.

In the U.S., the Robin Hood Tax embodies a widespread campaign endorsed by 172 national organizations representing millions of members in unions, student, health, clergy, civil rights, environmental and community organizations, and other consumer and activist groups

"Income inequality is now at the center of our national political discourse, with politicians of every stripe recognizing it as a major problem of our time. What too few are willing to say is that we must demand more revenue from corporations and the 1 percent to level the playing field,” said George Goehl, executive director, National People’s Action.

“Experts are saying that we have the science we need to end the global AIDS crisis, yet everyone agrees that this will not be possible without a considerable increase in resources,” said Jamila Headley, managing director of Health GAP (Global Action Project). NPA and Health GAP are, along with NNU, major leaders of the Robin Hood campaign.

The Robin Hood tax would also slow the growth of automated high frequency trading, which makes the stock market more dangerous. A small tax would make risky HFT unprofitable, and help reduce the excess speculation on commodities like food and gas that drives up prices, which will protect the economy from computer-generated collapses and market manipulation.

Forty nations from the United Kingdom to South Korea administer or have administered a financial transaction tax. In addition, 11 nations in the European Union are finalizing details of their own financial transaction tax to be implemented on January 1, 2016.

Time for Parliament to Act—the FY 2015/16 budget must correct the health worker crisis in Uganda

By: Asia Russell

May 3, 2015

Uganda is in the throes of a health workers crisis—there is an absolute shortage of professional health workers, medics are inequitably deployed across the country, and they are paid abysmally low wages, leading to high rates of attrition and poor motivation.

Astonishingly, government is exploring a plan that would only pour fuel on the fire—by exporting 283 qualified Ugandan health workers to Trinidad and Tobago.

But Parliament has the chance to help stop this ill-advised proposal and to ensure the Financial Year 2015/16 budget corrects the factors that are pushing health workers to leave Uganda in the first place. The 2015 budget will be the final budget before the 2016 elections—no better time for Parliament to show it is responsive to citizens’ priorities. A large national public opinion poll recently conducted by Columbia University in 2014 showed Ugandan voters reported healthcare as the most important issue for the 9th Parliament to address. 25% of Ugandans report it is the most important issue for Parliament—an increase from 17% of voters polled in 2011.

But for too long, the health worker emergency has triggered virtually no intervention by government. This changed in 2012 when civil society attempted to make the health worker crisis a political priority. A prolonged advocacy campaign, led by civil society alongside Parliamentarians, ensured that the national budget was not passed until the health worker crisis was prioritized. Eventually the Financial Year 2012/13 budget committed 49.5 billion shillings to recruit 6,321 additional health workers and deploy them to Local Government clinics, while more than doubling the wages of doctors working at HCIVs.

Parliament also committed itself to prioritize health worker motivation in the Financial Year 2013/14 budget—through wage enhancement, in particular for midwives, who are the backbone of the health system. But this promise was not kept—and up to today health workers continue to toil without adequate pay, with non functioning equipment, and with poor training and support. Parliament is passing budget after budget without addressing this grave injustice.

Meanwhile, Uganda could lose another 283 of its scarce health workers thanks to a government plan to export them to Trinidad and Tobago to work in an elite medical facility. This move would deplete Uganda of midwives, nurses, doctors, psychiatrists, and other highly sought-after cadres of health workers. This move is being challenged in High Court; many Parliamentarians have also spoken out, recently joining civil society to petition the Speaker of Parliament to halt the deal. The Rt. Hon. Speaker herself told civil society that exporting health workers ‘did not make sense’ when women are dying in childbirth in clinics in Uganda.

Rather than correcting the factors that push Ugandan health workers to migrate in search of better pay and better working conditions, government wants to help health workers leave the country—further undermining a health system that is already failing to deliver essential services. Trinidad and Tobago, unlike Uganda, has no health worker crisis. The tiny, oil rich nation has a maternal mortality ratio of 84 per 100,000 live births (compared with 438 for Uganda) and a skilled birth attendance rate of 97.8% (compared with Uganda’s rate of 41.9%). Ugandan women are four times more likely to die during childbirth than women in Trinidad, and three times as many Ugandan children die before the age of five. Exporting 100 midwives effectively denies maternal health services from 900,000 pregnant women and mothers. The transfer of highly qualified doctors deprives care to 1.2 million patients.

Compared to Uganda, Trinidad and Tobago has 10 times as many doctors, 3 times as many nurses, 22 times the per capita health spending, and 32 times the per capita gross domestic product.

If implemented, this plan will mean more suffering and preventable death in Ugandan communities, particularly among pregnant women, newborns, people with HIV, tuberculosis and malaria, and other leading causes of preventable death in Uganda.

Moreover, Uganda stands to suffer an estimated 80.2 billion shillings in lost return on investment from the proposed export deal.

The Budget Framework Paper for the Health Sector 2015/16 describes poor wages of health workers and insufficient numbers as causing a ‘persistent service delivery gap.’ The Ministry of Health estimates that 129 billion shillings is required for salary enhancement for all staff in the sector annually. This is just a fraction of the estimated 377 billion shillings being spent on health care abroad for Ugandan VIPs.

The evidence is clear—Uganda’s acute shortage of health workers can only be fixed through investing in better pay, better working conditions, and better management. All people should be free to travel to seek employment as they please, but government should be prioritizing efforts to increase health worker motivation and retention—instead of developing schemes that would make suffering worse.

Importantly, public outcry has so far helped stall the export of health workers—the medics were meant to have departed more than 3 months ago. Foreign aid to the health sector is also at risk—the Belgian government recently announced 6 million euros in health sector aid would be suspended as a result of the government plan. And while the Minister of Health, Hon. Dr. Elioda Tumwesigye, recently told media that government was ‘rethinking’ the export of health workers, there is no solid evidence that the plan has been stopped.

Meanwhile, the clock is ticking: everyday 16 pregnant women die while giving birth and everyday countless disgruntled medics loose hope that government will enhance their wages and give them the tools they need to save lives. Alongside a halt to this scandalous export plan, civil society calls on Parliament not to pass the 2015/16 budget until it delivers what voters deserve: a) recruitment of an additional 3000 health with a focus on deployment in underserved Districts; b) an increase in wage by at least 50% for midwives and other priority cadres of health workers at HCIVs and IIIs; and 3) an increase in primary health care (PHC) funding for facilities at Local Government level so clinics have the medical equipment health workers require to deliver life saving services to their patients.

Urgent Action NOW: defend AIDS drugs from Fast Track Attack

A deal on Fast Track was reached last Thursday, and it’s a doozy. The agreement was reached between Senators Orrin Hatch (R-UT) and Ron Wyden (D-OR), and Congressman Paul Ryan (R-WA), the Chairs and Ranking Members of Senate Finance and House Ways and Means Committee. The bills will go up for committee votes soon, as early as this week.

Although the bill does contain some nice language we've won together with the late Senator Ted Kennedy on respecting the Doha Declaration on TRIPS and Public Health, it also includes dreadful “TRIPS-plus” policies, including a requirement that US trade negotiators actively work for "accelerated and full implementation” of the TRIPS agreement, as well as even nastier language that makes it a legal negotiating objective of the United States to push other countries to adopt "a standard of [intellectual property] protection similar to that found in United States law” — what a nightmare!

These objectives—even before the TPP is finalized—threaten millions of people with HIV. Some Senators are already talking about trying to amend the bill, and we need to pull out all the stops to halt this bill and make any progress as slow and painful as possible. This flawed Fast Track legislation would allow the TPP and other agreements to skirt ordinary Congressional review, amendment and debate procedures — a rubber-stamping of “NAFTA on Steroids” pacts that denies affordable generic medicines, destroys jobs and drives down wages, and causes dangerous environmental, public health and economic setbacks for people here and abroad.

We’ve stopped Fast Track legislation before and we can do so again. We need you to call Congress now!

1. Call your member of Congress TODAY 
2. Stay tuned for electronic actions in the coming days.

We need you to call Congress now. Its critical that we all make emergency phone calls to your members of congress TODAY. This link will Call congress and give you a calling script to borrow from while you're speaking with your elected officials.

It’s crucial that we continue sending a strong message over the next few days through emails to show that Fast Track is Dead on Arrival. After you've made calls today and tomorrow, this link will send an automatic email to your Senators.

PS for more info: Committee on Ways & Means Ranking Member Sander M. Levin released a very solid blow-by-blow run down on why fast track is horrible and must be stopped.

With your help we can defend access to AIDS drugs from this horrible Fast Track deal.

Ending the AIDS epidemic: ICASO and Health GAP to expand community activism to increase the impact of major global health initiatives

April 1, 2015

 ICASO and the Health Global Access Project (Health GAP) are excited to announce a new partnership. The two organizations are collaborating on a new project to support civi l society-led monitoring efforts and advocacy to ensure that the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) continue to play a strong role in the global AIDS response.

 “Our strength lies in the partnerships we build with civil society organizations, working together to accelerate and intensify the fight against HIV. We are excited about this opportunity to strengthen our partnership with Health GAP—a long-standing ally in the global AIDS response,” said Mary Ann Torres, Executive Director of ICASO. 

 The planned three-year project will involve regional efforts in the Middle East and North Africa, Eastern Europe and Central Asia, Asia and the Pacific, Latin America and the Caribbean and Sub-Saharan Africa. In-depth engagement with civil society partners in Uganda and Malawi will contribute to the regional efforts to ensure that major global health initiatives achieve higher impact, and are more effective and responsive to the needs of the communities most affected by the AIDS epidemic. Through coordinated advocacy at the country-level, as well as in the halls of power in Geneva and Washington, D.C., Health GAP and ICASO will collaborate to secure funding for the Global Fund and PEPFAR.

 Health GAP brings a wealth of knowledge of PEPFAR and the Global Fund’s processes, policies and strategies, as well as extensive experience building the capacity of civil society partners and communities in Uganda, Kenya, and other heavily impacted countries, to support efforts to influence the priorities and practices of the Global Fund and PEPFAR at the country-level—where it matters most.

 “The strides we have made in responding to the global AIDS pandemic over the last decade would not have been possible without strong collaboration among civil society activists. We are at a critical moment where the science suggests that we can actually end the AIDS crisis.  Achieving this target will not be possible without increased funding, policies that are responsive to communities’ needs, and the leadership of mobilized, vigilant, informed activists working across North-South divides. Health GAP is excited to join with ICASO in helping to advance this effort,” said Asia Russell, Executive Director of Health GAP.

 Visit ICASO and Health GAP for updates and information about the project, funded by the Bill & Melinda Gates Foundation.



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