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.

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.

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.