United States trade policy undermines access to anti-retroviral medicines

Published: 23rd July 2012

International AIDS Conference 2012 Washington D.C. – Despite commitment to end AIDS, the US government is introducing stronger intellectual property rules through trade agreements and bilateral pressure that will undermine the fight against AIDS by devastating the ability of developing countries to access affordable anti-retroviral medicines, international agency Oxfam said today.

“Under the influence of the multinational pharmaceutical industry, the US is pushing for enhanced monopoly protection on new medicines, including medicines to treat HIV and AIDS, thus driving up the cost for people living in poverty,” said Dr. Mohga Kamal-Yanni, senior health advisor for Oxfam.  “Neither patients nor governments will be able to pay for anti-retroviral medicines urgently needed to address the pandemic.”

Low cost generic medicines are critical

Strict intellectual property rules prevent low-cost generic versions of medicines from entering the market. Generic competition is the only proven mechanism for lowering prices. The US has pushed for stricter intellectual property rules especially via a new trade agreement – the Trans Pacific Partnership, which is currently being negotiated between the United States and eight other countries in the Asia-Pacific region and Latin America, with Mexico and Canada projected to join soon. 

The US has also sought to push other countries to implement enhanced monopoly protection via its annual Special 301 Report, which harshly criticizes countries that use legal measures under global trade rules to reduce unaffordable medicine prices – a critical pre-requisite to providing treatment.

Without low-cost generics, it would not have been possible to initiate over eight million people on anti-retroviral therapy. Until generics entered the market over a decade ago, anti-retroviral therapy cost $10,000 per patient per year. Thanks to generic competition, the price for first-line medicines in preferred fixed-dose combinations now costs under $80 per patient per year. 

Donors, including the United States Government, have relied heavily upon low-cost generic medicines to meet ambitious treatment goals.

US trade policy threathening gains

“Despite all the successes – including of the US – to address the pandemic, narrow commercial interests are threatening to undue the recent gains,” said Kamal-Yanni. “It is stranger than fiction that the US is pursuing strict IP rules in developing countries such as Vietnam, which is one of 16 countries that receives assistance under the US Global AIDS Program.”

The renewed US drive for strict IP rules through trade agreements is coming at an especially inopportune moment. Scientific consensus has pointed to treatment as a great route to prevention of HIV and AIDS. Yet donor financing for HIV and AIDS, in the aftermath of the global financial crisis, is leveling off even as the challenges remain enormous. In particular, the costs of new and more effective treatments for HIV, many of which remain under monopoly patent protection, are as much as 10 or even 50 times the cost of first-line treatments. These high costs not only threaten to undermine the ongoing treatment of over eight million people, some of whom must switch to these new medicines as they develop resistance to first line medicines, but will hinder governments and funding agencies from expanding treatment to millions of others who desperately need it. At a time when more must be done with less, US trade policy threatens to put the drive for universal access into reverse.

“To end AIDS,  countries need to scale up access to affordable medicines,” said Kamal-Yanni. “The US must stop demanding new intellectual property rules through trade agreements and direct pressure.”

Despite all the successes – including of the US – to address the pandemic, narrow commercial interests are threatening to undue the recent gains.
Dr. Mohga Kamal-Yanni
Senior Health Advisor for Oxfam

Notes to editors

For more information, or to arrange an interview with an Oxfam spokesperson, please use contact above or Mohga Kamal-Yanni, on mkamalyanni@oxfam.org.uk   +44 77 76 25 58 84.

Download the Oxfam Media Brief, International AIDS Conference, July 2012

The Trans-Pacific Partnership is a pluri-lateral trade agreement currently under negotiation between the United States and eight other countries – Australia, New Zealand, Chile, Peru, Vietnam, Malaysia, Singapore and Brunei – with Mexico and Canada expected to join soon.  Negotiations started in 2009 and have not yet been completed.

Some of the strict intellectual property rules the US has pursued under the Trans Pacific Partnership include:

  1. Scope of patentability: Expanded scope of pharmaceutical patents to include new indications, new formulations and other minor changes
  2. Patent-term extensions: Extended patent monopolies for administrative delays
  3. Enhanced protections for clinical trial data by providing data exclusivity 
  4. Patent linkage: Linking drug registration rights to patent status
  5. Enforcement rules: Expands enforcement of IP via customs and border officers, which could lead to unwarranted seizures of generic medicines
  6. Pre-grant oppositions: Eliminates right of other countries to use opposition system to curb frivolous patent applications and patent abuse.

The US is also negotiating a chapter on pharmaceutical pricing and reimbursement that would disable the ability of Governments, including the US Government, to effectively set prices for medicines.
The May 10th (2007) Agreement was a new trade policy, agreed upon by the Bush Administration and the US Congress, to rewrite environment, labor and intellectual property rules in free trade agreements with Peru, Colombia and Panama.  New IP provisions included in the May 10th Agreement scaled back many of the worst elements in those agreements that would have undermined access to affordable medicines.

Contact information

For further inquiry:
Laura Rusu in Washington, DC +1 202-459-3739 lrusu@oxfamamerica.org

Related links

Oxfam's work on HIV/AIDS