Introduction of human papillomavirus vaccines into developing countries - international strategies for funding and procurement.

This paper explores different international vaccine financing and procurement strategies used by the Pan American Health Organization, United Nation's Children's Fund, the Global Alliance for Vaccines and Immunization, the Gulf Cooperation Model, and the Advanced Market Commitments. The aim is to identify lessons learned to help ensure equitable distribution of life-saving vaccines for cervical cancer prevention, with particular emphasis on sustainability. A critical first step in the cascade of activities necessary for Human papillomavirus (HPV) vaccine introduction should be the creation of an informed policy decision making process that is grounded in the best available information at a national level. This process will help ensure that decisions are financially sustainable. Any vaccine purchasing mechanisms should address the following essential points: 1) prioritization of cost-saving interventions; 2) flexible participation; 3) sufficient support to confront in-country challenges for managing vaccine procurement mechanisms; 4) a definite time-line for country ownership of vaccine purchases; 5) accuracy of vaccine demand forecasting; 6) maintenance of vaccine supply chains; and 7) well-functioning surveillance and regulatory bodies. In mapping the way forward, using the lessons learned and maintaining flexibility of financing and procurement mechanisms remain critical issues.

PATH's approach to product introduction in developing countries.

Health interventions developed for wealthy nations are difficult to introduce in developing countries due to a lack of sufficient technological, financial, political, or infrastructural resources. Increasingly, however, product developers are creating new technologies that meet the needs of low-resource settings. Experience has shown that many activities must be undertaken to prepare health systems to accept and embrace new, improved, or under-utilized health technologies. This article describes three health technologies--a diagnostic test for vitamin A deficiency, new cervical cancer vaccines, and the vaccine vial monitor--that PATH, a global health organization, has helped advance for developing-country markets.

Chapter 15: HPV vaccine use in the developing world.

Human papillomavirus (HPV)-related morbidity and mortality from cervical cancer primarily occurs in the developing world, where, unfortunately, access to vaccines in general, and expensive newer vaccines in particular, is often more limited than in the industrialized world. In addition, secondary prevention methods such as HPV screening, Pap testing, or visual inspection are uncommon in the developing world. The HPV vaccine will be first introduced into the industrialized countries and it will then, over the course of time, become used in the developing countries. HPV vaccine should be introduced in the framework of comprehensive cervical cancer control, and offers an opportunity to bring together a wide range of constituents who have not to date worked closely on vaccination. Ultimately, the decision of whether and when a vaccine will be introduced will depend on individual countries. To prepare for decisions on HPV vaccine use, the sexual and reproductive health (SRH; including adolescent health), immunization, and cancer control communities need to work together to analyze the appropriate data and build international and national consensus. The timeframe for other newer vaccines, such as hepatitis B and Hib, has been measured in decades, and the challenge to the public sector is to greatly shorten the time needed to make HPV vaccines available and affordable for the developing world, where their impact will be greatest.

Chapter 25: Education, training, and communication for HPV vaccines.

As human papillomavirus (HPV) vaccines come to market, they will face education and training challenges similar to those of other new vaccines, along with HPV-specific issues. Recent studies document stark knowledge gaps about HPV at all levels--among policy makers, healthcare providers, parents, and teens--in both the industrialized and developing worlds. Pharmaceutical companies, public health advocates, medical trainers, and health educators need to understand their diverse audiences and respond appropriately to the needs of each. They also must use research-based communication strategies and materials to most effectively, and accurately, convey the need for an HPV vaccine and to manage expectations about how the vaccine can, and cannot, protect women and men.

Cervical dysplasia treatment: key issues for developing countries

Many developing countries face serious obstacles that have hindered establishent of successful cervical cancer contrl programs. Various countries are now seeking to strenthen cytology services and identify simple low-cost screening strategies; but any real gains in reducing cervical cancer incidence and mortality will also require effective treatment of women with preinvasive disease. Despite a trend toward conservative outpatient approaches for treating cervical dysplasia in industrialized countries, clinicians in many developing countries still rely primarily on invasive inpatient methods such as cone biopsy and hysterectomy. For woment who could be treated with less invasive methods, these procedures tend to pose unnecessary risks and entail high costs that put them beyond the reach of may patients. Outpatient therapy, employing methods such as cryotherapy and the loop electrosurgical excision procedure (LEEP), combined with proper follow-up, is appropriate for dealing with visible lesions on the ectocervix when invasive cancer and endocervical involvement have been ruled out. Cryotherapy and LEEP hold out particular promise for developing countries because of their effectiveness, lack of side-effects, simplicity, and low cost. Cure rates range form 80 percent to 95 percent, depending on the method used and the severity of the lesions. However, each method has advantages and disadvantages that demand consideration. Various ways of reducing the number of follow-up visits, including the two-visit see and treat approach, are also available for use in areas where women's access to health services may be limited. A recent survey by the Program for Appropriate Technology in Health (PATH) affirmed the tendency to rely on cone biopsy and hysterectomy. It also found that in many places all degrees of preinvasive disease were treated, rather than only high-grade or severe conditions; that respondents in Latin America, the Caribbean, and Asia tended to use cryotherapy and LEEP more widely than other low-cost methods; the LEEP was preferred over cryotherapy in Latin America; and the colposcopes and other basic equipment needed to provide treatment were nto consistently or widely available in some settings (AU)