World Trade Organization

In June 2009, a paper by Sarah Rimmington and Peter Maybarduk of Essential Action, titled "Compulsory Licenses: A Tool to Improve Global Access to the HPV Vaccine?," was published in the American Journal of Law and Medicine.

Cervical cancer disproportionately affects women in lower- and middle-income countries. But the new vaccines developed to prevent infection with some strains of the human papillomavirus (HPV) that cause cervical cancer are priced beyond the reach of most women and health agencies in these regions, due in part to the monopoly pricing power of brand-name companies that hold the patents on the vaccines.

Maybarduk and Rimmington conclude that compulsory licenses, which authorize generic competition with patented products, could expand access to HPV vaccines under certain circumstances. If high-quality biogeneric HPV vaccines can be produced at low cost and be broadly and efficiently registered, and if Merck and GSK are unwilling to grant licenses on a voluntary basis, compulsory licensing could play a pivotal role in ensuring vaccinations against HPV are available to all, around the world, regardless of ability to pay.

The authors also note that some of the barriers they identify could pose formidable – and perhaps insurmountable – hurdles to the successful use of compulsory licensing of this one particular product (Merck and GSK's HPV vaccines) in the near term. Of particular concern are the possible scientific and regulatory challenges to manufacturing and registering generic HPV vaccines (which are biologic products), and the likelihood manufacturing would in any event be concentrated in very few countries. They point out this last challenge could be eased if more manufacturing countries adopt TRIPS Paragraph 6 legislation, enabling them to export vaccines under compulsory license.

However, though barriers to making and using compulsory licenses to ensure the distribution of low-cost generic HPV vaccines may prove insurmountable in the near term, the analysis provided in their paper can still assist governments, humanitarian organizations and others to evaluate the appropriateness of compulsory licensing as a tool to promote access to other life-saving products. For many products, the hurdles will not be so great. Important examples include the prohibitively expensive newer, second-generation drugs for HIV-AIDS, as well as other traditional, chemical-based drugs aimed at additional diseases, which will not face the manufacturing and registration hurdles unique to biologic products like the HPV vaccine.

The context for every product will necessarily be different. But as brand-name companies intensify global patenting, compulsory licensing as a tool to promote access to affordable medical technology becomes ever more important.


Download a copy of the paper here: Rimmington_Maybardukpaper.pdf

In May 2009, twenty-six U.S. consumer, development, HIV/AIDS, public health and religious groups, including Essential Action, Act UP Philadelphia and New York, Africa Action, CPATH, Forum on Democracy and Trade, Global AIDS Alliance, Health GAP, the Interfaith Center on Corporate Responsibility, Knowledge Ecology International and Oxfam America, released a common platform on trade-related intellectual property and access to medicines issues. The document broadly outlines the common policy agenda these groups are pursuing in the areas of access to medicines, innovation and transparency.

You can download the platform here: IP-MedsPlatformMay2009.pdf

You can download a list describing the organizations that endorsed the platform (including contact persons) here:
OrganizationalDescriptionsofPublicHealthGroupsforUSTR-May13.pdf

Read a text version of the platform in the continuation of this post.
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Essential Action, Knowledge Ecology International (KEI), Oxfam America,
AU Program on Information Justice and Intellectual Property (PIJIP),
Forum on Democracy and Trade, Health GAP (Global Access Project)

FOR IMMEDIATE RELEASE | April 30, 2009
Contact Information for each organization accompanies quotations below

Today, the US Trade Representative (USTR) released its annual "Special 301 Report," identifying countries it views as denying "adequate and effective protection of intellectual property rights." Despite committing to the World Trade Organization's TRIPS flexibilities meant to encourage access to low-cost generic medicines, the United States regularly singles out countries for pro-health policies that are TRIPS compliant in the Special 301 Report. The report is based on comments submitted to USTR, most of which come from businesses holding copyrights and patents. The pharmaceutical industry's trade association submits detailed comments each year, which USTR draws on extensively. (To view all the comments received by USTR for the 2009 report, see www.regulations.gov).

Public health and consumer groups had hoped the Obama administration would turn a new page and recognize the right of countries to take TRIPS-compliant measures that increase access to medicines, and thus are disappointed that this year's report mirrors not only Big Pharma's demands, but the policies previously pursued by the Bush administration.
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An interview with Essential Action's Sarah Rimmington on global access to medicines aired on WRVU 91.1 FM in Nashville Tennessee on January 7, 2008.

In the interview with Project Question’s Lonnie Atkinson, Sarah explains how international trade agreements governing patent rules and the brand-name pharmaceutical industry work to restrict the introduction of low-cost generic copies of life-saving drugs in the developing world. The widespread lack of generic versions of many life-saving treatments is a significant contributing factor to the limited access poor people in developing countries have to them.

You can listen to the entire interview here.

by Ed Silverman
Published at pharmalot.com

More than 100 different organizations - representing consumers, labor, fair trade, health advocacy and religious groups - are banding together to urge Congress to support resolutions calling for the US to reaffirm its commitment to international treaties that promote access to medicines and innovations in new medical technologies in developing countries.

Specifically, the groups (you can see a list below) are referring to the Doha declaration of TRIPS, the trade-related aspects of intellectual property rights. (For a quick primer, look at this). A House resolution was introduced by Tom Allen, a Democrat from Maine, and Sherrod Brown, a Democrat from Ohio, introduced a resolution in the Senate.

“In developing countries, the price of medicines is often a life-and-death matter,” says the letter to Congress. “For example, generic competition for the older first-generation AIDS drugs has reduced their price in developing countries by more than 98 percent, which was critical to the massive scale-up in AIDS treatment seen over the past five years. However, most newer, second-generation treatments are under patent and current treatment levels…will not be sustainable unless much cheaper generic versions become available.”
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Click here to download this fact sheet.

Click here for the html version of the fact sheet.

Click here to download this fact sheet.

Click here for the html version of the fact sheet.

Click here to download this fact sheet.

Click here for the html version of the fact sheet.

Click here to download a fact sheet on Access to Medicines in Thailand: Interference by the United States.

Click here for the html version of the fact sheet on Access to Medicines in Thailand: Interference by the United States.

Click here for a January 2007 letter from 22 Members of the U.S. Congress to USTR, asking for an end to pressure on Thailand for its compulsory license.

Click here for USTR's response to the January 2007 letter from 22 Members of the U.S. Congress.

Click here for a June 2007 letter from 35 Members of the U.S. Congress to USTR, criticizing the placement of Thailand on the "priority watch" list of countries allegedly undermining U.S. intellectual property claims.

by Peter Maybarduk and Robert Weissman
Published at The Hill

Ian Swansons article, “PhRMA takes aim at Thailand for production of generics, hints that it will push for sanctions (May 23),” states, “World Trade Organization (WTO) rules do grant poor countries the right to issue compulsory licenses authorizing the production of generic drugs to deal with public health crises.” While this is true, it is important to note WTO rules do not limit compulsory licensing to public health crises or to poor countries.
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