US may reverse reforms that promoted access to drugs, leaked documents show

BMJ 2011; 343 doi: (Published 25 October 2011) Cite this as: BMJ 2011;343:d6948
  1. Jeanne Lenzer
  1. 1New York

Twenty two US labour, consumer, religious, environmental, and human rights organisations have charged the Obama administration with reversing modest free trade reforms passed by the Bush administration that enhanced access to drugs.

The organisations sent a letter to the US trade representative, Ron Kirk, last week, citing leaked documents from the US proposals for the Trans-Pacific Free Trade Agreement and calling on the US government to publicly release the full draft negotiating texts. The leaked documents have been posted online by the Citizen’s Trade Campaign, a non-profit fair trade coalition that is based in Washington, DC (

Public Citizen, a non-profit watchdog organisation also based in Washington, DC, said in a news release on 22 October that the leaked documents show support for “extreme pharmaceutical corporation demands that would undermine consumers’ access to affordable medicine.”

Lori Wallach, director of Public Citizen’s Global Trade Watch, said in the news release, “The roll back of the modest Bush-era reforms is shocking, but what is truly stunning is the proposal to empower pharmaceutical firms to attack the medicine formulary systems that New Zealand, Australia, and other developed countries have used so successfully to achieve what is ostensibly an Obama administration goal of reducing sky-high drug prices.”

One of the provisions in the proposal is an “access window” that obliges companies to make lifesaving drugs available in participating countries within a certain period of time. In exchange, patent owners are given enhanced intellectual property protections. But Judit Rius Sanjuan, of Médecins Sans Frontières, said in a statement posted online by the Citizen’s Trade Campaign that the access window is actually about “getting brand-name drugs to market faster, and giving their producers longer monopoly rights that prevent price-lowering competition and keeping medicines out of the hands of the millions of people who need them.”

Peter Maybarduk, director of Public Citizen’s access to medicines programme, told the BMJ that the proposed scheme will “simply shore up pharmaceutical company monopolies and limit competition.”

He added, “This will limit access to affordable medicines, and access depends in no small part on generic competition and on countries’ ability to keep costs contained.” For example, he said, “Generic competition in first line HIV medicines reduced global costs by 99%, from $12 000 [£7500; €8600] per person per year to under $100, and six million people are now taking these cheaper drugs. Market competition produced a major difference in that area, but we need to do the same for heart disease, cancer, and other illnesses.”

The Pharmaceutical Research and Manufacturers of America, an industry trade group, responded to the charges by Public Citizen in a statement released to the BMJ. It states, “Both the generic and research based pharmaceutical industry have supported efforts to improve transparency and due process in trade agreements. From what we know the [proposals] represent a new approach by the Obama Administration to respecting innovation and promoting access.”

The organisation said that the proposals are “designed to deploy the tools of policy to promote trade in, and reduce obstacles to, access to both innovative and generic medicines, while supporting the innovation and intellectual property protection that is vital to developing new medicines and achieving other medical breakthroughs.”


Cite this as: BMJ 2011;343:d6948

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