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