Planning for new health interventions for developing countries : an integrated strategy to prepare for malaria vaccines and lessons for future interventions

Historically, new health interventions have been developed primarily to address the needs of the wealthy in developed countries. Where drugs, vaccines, diagnostic tests and other interventions happened to address diseases prevalent in the developing world, they would eventually trickle down. Such new interventions were relatively rare, often separated by years or decades for a single disease area (e.g. malaria) or delivery strategy (e.g. routine immunization programs).
Since 2000 when the GAVI Alliance was established, it and the Global Fund to Fight Aids, TB and Malaria and have committed over US$20 billion to implementing existing interventions in developing countries. Partially as a result, countries have considered and will consider implementation of many new interventions. Multiple new malaria medicines and rapid diagnostic tests are now available and bednets have been improved over approximately the past decade. Challenges may be even greater for immunizations programs as countries consider four or more new vaccines for implementation, all becoming available to the poorest countries over approximately a five year period.
It is likely that there will be even more interventions to address public health problems of the developing world in the future. An estimated $3.2 billion was spent on research and development for new interventions for the developing world in 2009 alone, up 8.2% from 2008.
Given this environment, this thesis considers two questions:
1) Have there been, and do there continue to be, delays accessing (i.e. implementing) new health interventions through national health systems in developing countries? When will they begin to prevent disease and save lives?
2) If so, are the causes of delays predictable and what additional can be done to address the causes and accelerate access?
Methods
Chapter two addresses the first question and proposes a new strategy to address the major aspects of the second question. It uses literature review, statistical analysis and descriptive analyses of temporal patterns. Frost and Reich (2008) propose an “access framework” which appears to capture the major themes identified in the literature and analysis. The framework suggests that access is the product of activities to address the availability, affordability, and adoption of new interventions, as well as the architecture (i.e. coordination) facilitating these activities. The chapter also uses descriptive and statistical methods to analyze the time from regulatory approval to the beginning of implementation of four vaccines and three malaria interventions. It concludes by applying the results of the literature review and analyses to propose modifications to Frost and Reich’s framework.
Thesis chapters consider aspects of the transition of health interventions from research and development to implementation, in light of the modified framework. Many of the chapters draw upon the experience of, or research related to, the most advance malaria vaccine candidate. It is being developed by GlaxoSmithKline and the PATH Malaria Vaccine Initiative, in partnership with the Swiss Tropical and Public Health Institute and many other organizations. The final chapter synthesizes the findings of the previous chapters, suggests considerations for those who wish to operationalize the framework, and proposes future research questions.
Results
The analyses suggest that there have been delays implementing new health interventions. Generally, a decade after each studied vaccine or malaria intervention was approved by regulators, less than 30% of developing countries, and in most cases less than 15%, had begun to implement it. The pace of implementing new health interventions in developing countries has not changed significantly since the 1980’s.
In order to accelerate implementation, activities must begin earlier, during research and development, which build the foundation for later access activities. The modified access framework (Figure 1) proposes architecture (i.e. coordination), availability, affordability, and adoption activities which should be considered for each intervention prior to regulatory approval. Individual chapters report on research into or analyses of concrete strategies and examples of activities to be undertaken during research and development:
* Chapter 3. Aligning new interventions with developing country health systems: Target product profiles, presentation, and clinical trial design;
* Chapter 4. Roles of international organizations and implementation of the new health interventions in developing counties: The RTS,S/AS01 malaria vaccine;
* Chapter 5. Adoption of new health products in low and middle income settings: How product development partnerships can support country decision making;
* Chapter 6. Country planning for health interventions under development: Lesson from the malaria vaccine decision-making framework and implications for other new interventions;
* Chapter 7. Modeling the public health impact of malaria vaccines for developers and policy-makers; and
* Chapter 8. Simulated impact of RTS,S/AS01 vaccination programs in the context of changing malaria transmission.
Limitations & discussion themes
The perspective of the analysis was primarily that of not-for profit organizations and governments. It is likely that the analysis of timelines tend to understate the delays. There are reasons to assume that the experience for malaria and immunization interventions has been faster than that seen for other interventions, again suggesting that delays may have been longer than found. Finally, while many of the chapters describe evaluation approaches, it is too early to determine if the access strategies have accelerated the transition of malaria vaccines, or the other health interventions considered.