Human Papillomavirus (HPV) is a major cause of morbidity and mortality worldwide, with most of the disease burden concentrated in developing countries. Over 90 percent of cervical cancer deaths, almost all of which are caused by HPV, occur in low- and middle-income countries where access to goods and services for prevention and treatment pose major barriers to intervention. In resource-poor settings lacking the capacity for routine screening for cervical cancer, the HPV vaccines developed by Merck and GlaxoSmithKline are desperately needed to help prevent these unnecessary deaths. The initial development of currently available HPV vaccines took place at a number of universities and other publicly funded institutions, yet there is little low-cost access to the vaccine in developing countries where access would be most critical. This is the rule rather than the exception with most university-discovered medicines. Universities and other publicly-funded institutions can adopt a number of licensing methods to ensure that vaccines discovered on their campuses are available at low-cost in developing countries. Universities Allied for Essential Medicines has proposed that universities adopt Global Access Licensing policies to implement these changes by enabling generic or low-cost production of the end product in developing countries. Generic competition is a critical market force that has, for instance, driven down the price of HIV/AIDS treatments from more than $10,000 to less than $99 per patient per year today. While the central barrier to creation of small molecule generics is patent-protection, there are multiple additional barriers that need to be addressed in order to ensure the efficient production of cost-effective generic vaccines and other biologics. While certain biologics may require generic producers to perform additional clinical trials, vaccines are in a somewhat unique situation with respect to both safety and efficacy. With access to appropriate patents, materials and knowledge, vaccines have the potential to be evaluated efficiently and cost-effectively via a pathway parallel to establishing bioequivalence for generic small molecule drugs. A new paradigm is needed that addresses the additional barriers that exist, outside of simply patent protection, to the generic production of vaccines and other biologics. One possible framework, which builds upon previous work on prize funds and patent pools, is discussed here: a Patents, Materials, and Know-how Pool (PMK Pool), based on the patent pool model such as those outlined in the Essential Medical Inventions Licensing Agency and proposals recently put forth by the governments of Barbados and Bolivia. University approaches to licensing vaccines and other biologics need to ensure access not only to patents, knowledge, and materials covered by intellectual property, but must also address the problem of access to materials and know-how that are often proprietary trade secrets. Universities should actively participate in the creation of this and other novel mechanisms, and in the meantime use currently available technology transfer mechanisms to ensure low-cost access to medicines in developing countries.

Disparities in health outcomes and access to the essential medicines that affect health outcomes are two of the most pressing issues facing the world today. The lack of adequate health care in developing countries is rooted in a number of systemic problems, including insufficient health infrastructure, lack of medical personnel, government corruption and incompetence, and the high price of pharmaceuticals. These problems are not mutually exclusive. Instead, they are mutually reinforcing, particularly in least developed and developing countries.

The high cost of drugs and vaccines is undoubtedly one of the driving forces in disparate health outcomes, and partial solutions to poor health in the developing world rightly focus on lowering the cost of health products, while preserving the financial incentive for innovation. The high cost of many medicines is largely due to the international patent system, codified by the Trade Related Intellectual Property Rights (TRIPS) Agreement, which grants a monopoly to the innovator and allows it to completely control pricing for a period of years. The result is an access gap, whereby patients in low- and middle-income countries (LMI) cannot afford expensive patented drugs, while patients in wealthy countries can afford and do have access to such treatments.

The Revolving Fund of the Pan American Health Organization (PAHO) has an almost 30 year track record of providing access to essential vaccines for the entire population of Latin America and the Caribbean region. The activities of the PAHO Revolving Fund, coupled with the provision of high-quality technical assistance, were crucial to the successful control, elimination, or eradication of most of the region's great childhood killers, including measles and polio. Today, however, the Revolving Fund faces new challenges in the form of procuring a new generation of vaccines for human papillomavirus infection, rotavirus, and pneumococcal disease, which are priced orders of magnitude higher than the traditional childhood vaccines. The high cost of these essential new vaccines may require the PAHO Revolving Fund to establish innovative financial mechanisms for procuring these products at prices affordable for national immunization programs in Latin America and the Caribbean. The alternative, namely to bypass the Revolving Fund, could severely threaten the health of the region, especially Latin America's poorest people.

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. 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.

Over the past several years, new vaccines have become available to prevent serious illnesses and conditions in the adolescent population. Several have already been approved by the FDA for use in this age group; others are still in development. Recently, significant public attention has been focused on the availability of vaccines for several strains of HPV, to prevent both cervical cancer and genital warts. Prior to that, the vaccine for Hepatitis B was approved and recommended for the adolescent age group. Others currently available and recommended include vaccines for pertussis, meningitis, and influenza. In the future, additional vaccines are expected to become available for sexually transmitted and communicable diseases such as herpes simplex virus and HIV. Unfortunately, financial limitations and consent requirements can impede adolescents’ access to the vaccines that are recommended for their age group. However, a variety of policy options exist for overcoming the barriers and expanding access. These policy options are grounded both in international principles of human rights and in the existing framework of laws in the United States, and can be enhanced by attending to variations in age and developmental status among adolescents.

This article seeks to demonstrate that health equity, as an empirical and normative concept, is reflected in the human rights to health and equality under international law. The obligations on government that flow from health equity as a human right are then examined. These include the obligation to act in pursuit of health equity as a policy objective, and the obligation to enact measures to ensure health equity as a policy outcome. These obligations are considered in relation to a promising remedial measure for social disparities in cervical cancer: HPV vaccines.

Of the over 100 types of human papillomavirus (HPV), more than 40 can be sexually transmitted. Genital HPV infection is very common, with a point prevalence among women worldwide of approximately 10 percent. In most cases, HPV infection is either cleared or becomes undetectable and causes no disease; however, persistent HPV infection is causally related to all cervical cancers and genital warts. In addition, a large proportion of other cancers, such as vaginal, vulvar, anal, and penile cancers as well as many cancers of the head and neck, are associated with HPV infection. Moreover, recurrent respiratory papillomatosis (RRP) is a potentially serious disease caused by HPV types typically responsible for genital warts. RRP can lead to severe airways obstructions and may require repeated surgical interventions. HPV types are typically divided into high-risk types, most often associated with cancers, and low-risk types, typically associated with warts. High-risk types 16 and 18 are responsible for approximately 70 percent of cervical cancers worldwide, whereas low-risk types 6 and 11 are responsible for approximately 90 percent of genital warts.

The inequitable burden of cervical cancer falls on women in poorer countries, due primarily to a disparity in access to screening services. To ensure that access to the new human papillomavirus (“HPV”) vaccines is not similarly skewed toward higher-income populations, it is important to understand the appropriate priority group for receiving vaccines, the potential barriers to reaching that group, and the options for overcoming those barriers. Based on vaccine efficacy data, the likelihood of achieving high coverage with various groups, and the resultant cost-effectiveness ratios, it is widely agreed that young adolescent girls should be the primary recipients. Potential barriers include the fact that young adolescents are not currently reached by many health services; that there might be stigma attached to a vaccine for a sexually transmitted infection; that financing for the vaccine must be allocated; and that there is limited political commitment to women's health, to cancer prevention, or to this particular vaccine when so many other new vaccines are also becoming available. Despite these very real challenges, there is reason to be cautiously optimistic that those most in need of an HPV vaccine can receive it in programs that are affordable, effective, and acceptable to girls, their families, and their societies.

Low-income countries experience significant morbidity and mortality from avoidable infectious diseases, but all too often life-saving innovative vaccines are only available in high-income markets. The Generic Open (GO) license proposal posits that an increase in generic entry will lower prices through greater competition and increase vaccine availability in low-income markets. However, the GO proposal, as currently structured, is unlikely to function as envisioned in the vaccine market. Innovator vaccine firms will be unlikely to participate in the program because the payments in the GO license do not adequately compensate firms for all lost profits. Additionally, the price reductions from competitive entry are unlikely because the vaccine market is already characterized by low, and in some cases unsustainable, prices. I propose a potential adaptation where developing world vaccine manufacturers serve as contract suppliers to innovator firms for a given period of time. Donors could also share in the initial costs of capacity with the developing world manufacturers. Sales of developing world manufactured vaccines would be sold solely to UN procurement agencies under a confidential pricing or rebate system. This would increase overall product availability, maintain market separation, and decrease costs to UN agencies.