Edward Low, an AIDS activist in Malaysia who is HIV-positive, says treatments to fight the disease in his country cost about $90 a month, down from $1,000 a decade ago before generic drugs became widely available.
Now he’s worried that a trade deal being negotiated by nine Pacific-region nations including the U.S. may curtail access to those cheap drugs in favor of patented pharmaceuticals, raising costs to survive HIV/AIDS in developing nations.
“This agreement is good for the rich countries,” Low, 45, said during an interview in Washington. “It’s not good for the poor countries.”
Protecting the patents of drug makers including Abbott Laboratories, Bristol-Myers Squibb Co. and GlaxoSmithKline Plc as part of the Trans-Pacific Partnership has drawn criticism from groups such as Doctors Without Borders and Public Citizen. The proposed accord has also spurred calls from U.S. lawmakers for greater transparency about the negotiations, while technology companies including Microsoft Corp. and Symantec Corp. are urging fewer restrictions on cross-border data flows.
While the advocacy groups claim the U.S. position in the talks favors patented medicines, not just those for HIV/AIDS, administration officials say affordability and innovation aren’t mutually exclusive goals.
The U.S. cited two goals in the talks: “Preserving the intellectual property protections that spur innovation in the pharmaceutical industry in a way that also drives access to medicines in the developing world,” Carol Guthrie, a spokeswoman for the U.S. Trade Representative’s office, said in an e-mail.
The multilateral talks, the main accord being pursued by President Barack Obama’s administration, would create an economic zone with $20.5 trillion in output, according to a Canadian estimate. Talks that began with Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, the U.S. and Vietnam may expand after the parties invited Canada and Mexico.
A final agreement probably will encompass traditional issues including agriculture and intellectual property, as well investment and protections for businesses that compete against state-owned enterprises, according to the trade office.
The number of people living with HIV in the nine nations varies from a low of 49 in Brunei, or about 0.01 percent of its population last year, to 1.2 million, or 0.39 percent of the U.S. population in 2010, according to reports submitted by the countries to the UNAIDS Secretariat in Geneva.
U.S. negotiators in September proposed eliminating duties on medicines and setting a deadline for drug companies to bring their products to market by giving them access to nations in the pact and creating a “pathway” for generics. The strategy is aimed at promoting access to medicines while protecting intellectual property for the products.
“An effective, transparent and predictable intellectual property system is necessary for both manufacturers of innovative medicines and manufacturers of generic medicines,” according to a U.S. briefing document.
“We’ve gotten a lot of comments and criticism about our proposal that we are reflecting upon very carefully,” Deputy U.S. Trade Representative Demetrios Marantis said today at a conference in Washington.
HIV patients take a daily regimen of at least three antiretroviral medications -- such as Bristol-Myers’ Sustiva, Glaxo’s Ziagen and Abbott’s Kaletra -- from two or more different drug classes to manage the virus, according to the U.S. Department of Health and Human Services.
The price of initial treatments in developing countries has declined about 99 percent, to less than $150 per person a year from $10,000 in 2000 as generic medicines become more prevalent, according to a July analysis by humanitarian organization Doctors Without Borders.
Under a 1995 multilateral agreement, which sets minimum intellectual-property standards, patents are protected for at least 20 years. U.S. Trade Representative Ron Kirk has said the U.S. and the partner nations will implement the agreement in a way that supports public health.
Advocacy and development groups that have seen documents in the negotiations said the U.S. position offers too many protections to existing patent holders, such as letting manufacturers extend their patents by modifying existing brand-name products. The U.S. Trade Representative’s office hasn’t confirmed the authenticity of those documents.
Broader patent protections deter production of generics, and treatment costs rise as patients switch regimens after developing resistance to their original medications, according to Burcu Kilic, legal counsel for Public Citizen’s Global Access to Medicines program in Washington.
“We need the generic companies to enter the market” to bring down the price for HIV/AIDS drugs, she said in a phone interview.
Karl Uhlendorf, a spokesman for the Pharmaceutical Research and Manufacturers of America, the Washington-based industry group for patent holders including Bristol-Myers, Pfizer Inc., Abbott and Merck & Co., said in an e-mail that intellectual-property protection isn’t a barrier to patient access to medicines.
“The negotiations should sustain the high standards on intellectual-property rights that are a hallmark of U.S. law,” Senator Claire McCaskill, a Missouri Democrat, said in an Aug. 6 letter to Obama, echoing statements by Democrats from Massachusetts and Washington state.
Intellectual-property revenue is “one of America’s big strengths in the world economy” and patent protections provide incentives for future medicines, said Edward Gresser, a policy adviser at USTR during President Bill Clinton’s administration.
“You really need to look illness by illness” to determine if there’s an issue with access to medicines, he said in a phone interview. “There’s vastly more income being provided to low-income cases” of HIV/AIDS than 10 years ago, he said.
“Trade policy alone cannot solve the challenges relating to access to medicines,” the agency said in its report dealing with pharmaceuticals in the Pacific talks. Poor drug distribution networks and infrastructure systems in developing countries also limit access to HIV treatments, it said.
The next round of talks is set for Sept. 6-15 in Leesburg, Virginia. The public, industry, health and development experts and federal agencies can attend, as they have in the past, according to the trade representative’s office.
Groups that work with HIV/AIDS patients say it’s important that negotiators get the balance right between access and innovation.
“It’s a matter of life or death,” Low said.