[Ip-health] PhRMA falls short on explaining Trans-Pacific FTA: LTE in The Hill

Peter Maybarduk pmaybarduk at citizen.org
Wed Nov 16 09:47:57 PST 2011

Thanks to Judit at MSF for pointing out an op-ed by PhRMA in The Hill on the Trans-Pacific FTA.  The Hill published our Letter to the Editor in response on Monday: 

PhRMA falls short on explaining trade pact
Nov. 14

PhRMA’s John J. Castellani fails completely to answer serious concerns from health groups that U.S. proposals to the Trans-Pacific Partnership Agreement would compromise access to medicines in the Asia-Pacific region and increase legal barriers to cost efficiency for the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) in Vietnam (“The global battle against HIV/AIDS,” Nov. 3).

Newly leaked negotiating texts reveal that the Office of the U.S. Trade Representative (USTR) is demanding that Trans-Pacific countries radically expand monopoly privileges for Big Pharma and eliminate safeguards against patent abuse. The U.S. proposal to the Trans-Pacific free-trade agreement guts the 2007 congressional New Trade Policy, which provided limited safeguards for access to medicines. It is the most aggressive, pro-Big Pharma proposal the United States has ever brought to a trade negotiation. Who will pay the price? Patients.

The U.S. proposal would extend patent protection to new uses for and minor variations on old drugs, even in the absence of any therapeutic advance. It would mandate patent extensions and new, exclusive controls over clinical trial data, and link regulatory approval to patent status. These measures, among many others proposed across several chapters of leaked U.S. text, facilitate abuse and are already controversial in the United States. They could be disastrous if applied to developing countries throughout the Asia-Pacific.

While most medicines PEPFAR purchases for Vietnam are generics, the remaining patented medicines impose a vastly disproportionate cost burden and reduce the program’s ability to scale up treatment. U.S. proposals at the Trans-Pacific FTA would expand monopoly protections for AIDS drugs in developing countries including Vietnam.

Mr. Castellani claims too much credit for Big Pharma in developing today’s HIV/AIDS treatments. PhRMA has long promoted commercial monopoly privileges as a proxy for future innovation in drug development. But the world’s largest funder of medical research and development is actually the taxpayer-funded National Institutes of Health (NIH). For example, NIH grants led directly to the discovery of ritonavir, the basis for HIV/AIDS products Norvir, Kaletra and Aluvia. Abbott now sells these products in the U.S. and around the world at a high, monopolist price. PEPFAR specifically cites high Aluvia prices in Vietnam as a significant constraint on the program’s cost efficiency. U.S. taxpayers pay exorbitant prices to buy through PEPFAR the AIDS medicine that, ironically, their taxpayer money helped finance in the first place. PhRMA would like to see these monopolies lengthened, strengthened and applied much more broadly through the Trans-Pacific FTA, no matter the public investment or cost to public health.

PhRMA’s definition of “appropriate intellectual property protection” has increased year by year, ever further in excess of World Trade Organization standards. USTR pressures other countries to adopt PHrMA demands — and there are no rational limits to what PhRMA will demand. The proposed measures at the Trans-Pacific FTA are not specifically or rationally related to improved pharmaceutical innovation — only to Big Pharma profit maximization. It falls to Congress to set limits, stand up for taxpayers and stand for public health.

>From Peter Maybarduk and Burcu Kilic, Public Citizen’s Global Access to Medicines Program, Washington, D.C.


Here the John Castellani op-ed our letter answers: 

The global battle against HIV/AIDS
By John J. Castellani - 11/02/11 06:23 PM ET

In 1981 the first cases of AIDS in America were detected in California and New York. Over the past three decades, more than 30 treatments have been approved to treat HIV/AIDS. While this is remarkable progress, it’s not enough. The biopharmaceutical research industry remains deeply committed to developing new treatments — and eventually a cure.

HIV/AIDS and other opportunistic infections often take a greater toll on those who don’t live on our shores. But millions of lives around the globe have been eased and even saved thanks to more than 115 antiretroviral (ARV) therapies for opportunistic infections that have been brought to market.

In order for scientific progress in these areas to continue, the substantial financial investments in medicines created in America’s biopharmaceutical labs — medicines that take years and billions of dollars to develop — must be protected by international patent laws. It’s important, however, to underscore that such protection need not inhibit government programs from obtaining medications for patients overseas who desperately need treatment. Specifically, the proposed intellectual property provisions in the Trans-Pacific Partnership (TPP) trade agreement will not hinder the ability of the U.S. government to procure medicines for the President’s Emergency Plan for AIDS Relief (PEPFAR).

Pharmaceutical Research and Manufacturers of America’s (PhRMA) member companies have supported PEPFAR since its inception, and the TPP agreement does nothing to alter that support. So far, the FDA has “approved” for the purposes of PEPFAR more than 265 generic versions of patented drugs now being produced outside of the United States. The vast majority of the medicines purchased by PEPFAR, in fact, are generic versions of medicines created by biopharmaceutical research companies and still under patent protections.

We believe the TPP negotiators are fully committed to maintaining the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The bottom line is that if governments and international agencies wish to purchase safe and effective drugs through the PEPFAR mechanism, the proposed TPP plan does nothing to change this. But what is certain is that without appropriate intellectual property protection, further innovations and needed research, progress could be slowed and in some areas stopped — and it is patients who will lose out.

Our scientists are hard at work in labs each day to develop the next revolutionary treatment that could save patients’ lives. But we all must recognize that the problem with fighting these brutal diseases in developing countries is not simply a lack of accessible treatment. Insufficient infrastructure — weak healthcare systems, lack of transportation, lack of trained healthcare personnel — is an enormous roadblock to any significant progress. Recognizing these multi-dimension problems requires broad-based solutions. 

The biopharmaceutical sector acts as a partner in health in these countries. In both 2007 and 2008, for example, U.S. biopharmaceutical companies contributed more than the combined health budgets of USAID, the World Bank and the World Health Organization. In addition, companies including Pfizer, Bristol Myer-Squibb and Abbott Laboratories have constructed hospitals, clinics and an infectious disease institute to help train Africa’s AIDS cadres.

The biopharmaceutical research industry remains steadfast in combating HIV/AIDS: The industry is currently developing around 100 new medicines and vaccines to help treat HIV. Further, more than 10 of the top research-based pharmaceutical organizations have issued voluntary licenses to developing countries for local production of ARV drugs so patients can access treatments more swiftly.

For every two patients who begin HIV treatment, five more are infected. The HIV/AIDS epidemic is a complex problem, and we in the biopharmaceutical research industry know as well as anyone that it will require a complex solution. We will find a cure eventually, but in the meantime, we must work together to ensure that progress continues across the healthcare system so the millions of patients suffering today have a hope of a better tomorrow.

Castellani is CEO and president of Pharmaceutical Research and Manufacturers of America.

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