Policy Analysis: An Essential Research Tool for the Introduction of Vaccines in Developing Countries

Article excerpt

INTRODUCTION

Despite enormous advances in the prevention and treatment of disease in developed countries and among the rich in developing countries, the poor in developing countries continue to face the ravages of respiratory and diarrhoeal diseases, malaria, HIV, and many other causes of death and illness (1). The private for-profit sector does not allocate significant resources to develop products for these neglected individuals because the potential for profits is dim. The public sector must, thus, take the lead in developing these products. Not since the 19th century, when development of most health products, such as Pasteur's work, took place in the public sector, has the public sector taken an effective leading role in health-technology research and development. For most of the 20th century, the public sector focused on supporting basic scientific research and relied on private industry to develop new preventive and therapeutic modalities.

With the advent of the 21st century, some leaders in the public-health sector began to realize that products for the poor would not be developed or provided, if decisions were based on market forces. These individuals recognized that the public sector must be involved in virtually all aspects of product development from basic studies to post-licensure surveillance. We call this comprehensive effort 'translational research'. [The term 'translational research' has been prominently used in cancer research and refers to a more limited activity of taking various treatments from clinical research to clinical application. In this document, we use translational research in the broader sense of translating laboratory findings into products used by people in health programmes, especially in developing countries] (2-4).

This paper deals with an essential component of translational research, i.e. policy analysis. The paper also focuses on the role of policy analysis to support the introduction of new and improved vaccines to poor populations--policy analysis for introduction. Policy analysis for introduction is similar to private-sector market research. This component of policy analysis consists of a systematic scientific effort to identify and understand the critical policy issues that will affect the introduction of new and improved health technologies and to identify the means to overcome barriers to successful introduction.

In recognition of the need of the public sector to take a leadership role in translational research, several new donors have begun to support research and development programmes for diseases of importance in poor countries. Of prime importance, the Bill and Melinda Gates Foundation has contributed more than US$ 700 million to research programmes on health technologies. These product-specific programmes are often referred to as public-private partnerships because much of their work is carried out through collaborative arrangements with for-profit companies. Also funded by the Rockefeller Foundation, the Wellcome Trust, and other donors, such as World Bank and bilateral aid agencies, these partnerships are run by international non-profit groups located in Asia, Europe, and the United States (5). Although the nature of the individual programmes differs, most serve as secretariats that orchestrate a translational research strategy under which they distribute R&D sub-contracts to other groups. Sometimes referred to as virtual R&D programmes (6), they typically do not undertake research on their own. A few have in-house programmes that are complemented by contracts with outside groups for work that cannot be done internally. Examples are the work of the International Vaccine Institute (IVI) on diarrhoeal diseases, the research of the Program for Appropriate Technology in Health (PATH) in diagnostics, and the efforts of the Population Council in contraceptive research and development. These latter partnerships function similarly to biotechnology companies. …