The GAVI Alliance (GAVI; formerly the Global Alliance for Vaccines and Immunization) and the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) were established in 2000 and 2002, respectively. Since then, they have committed more than USD 20 billion to address the divergence in health status and access to health interventions between developed and developing countries (DCs). In parallel, the past decade has seen unprecedented investments in research and development (R&D) for new health interventions for use in developing countries; approximately USD 3.2 billion was invested in 2009 alone, an increase of 8.2% from 2008
]. Product development partnerships (PDPs) have grown in number and are focused on developing drugs, rapid diagnostic tests, vaccines and other interventions for developing countries
]. The use of such interventions might eventually be subsidized by GAVI, GFATM, and other financing mechanisms.
It is normal in R&D for a large percentage of candidate interventions to fail during development. However, the investments above will lead to some new interventions being approved by regulators and becoming available for use. A critical step is then how quickly they will begin to be implemented through national health systems of developing countries. Beginning implementation does not guarantee, but is on the critical path to, interventions becoming widely accessible to people in need in developing countries.
The progression from R&D to implementation through national health systems in developing countries can be broken down into a series of stages and parallel activities, although it may vary somewhat by type of intervention (Figure
). An intervention moves from R&D through a series of international and ultimately national policy decisions about use and financing. These decisions lead to the beginning of implementation, scaling-up over months or years to target levels, and ideally access as defined below. Regulatory, manufacturing, and supplemental study activities take place in parallel. The World Health Organization (WHO) plays a critical role, such as reviewing interventions to determine if they are suitable for purchase by agencies of the United Nations (UN)
presents a process following a linear progression for clarity, however this may rarely be the actual case. The process varies according to the unique scientific, policy and other challenges of each intervention.
New interventions: From R&D to implementation (illustrative). *Drugs, Vaccines Diagnostics, Reproductive health supplies. **WHOPES: WHO Pesticide Evaluation Scheme
Access has been defined as the result of a set of coordinated activities needed to ensure that interventions will ultimately have an equitable public health impact
]. A number of authors have studied access independently. Obrist et al.
(2007) proposed an access framework focusing on consumer decisions, livelihood, and the assets of poor populations with regard to health interventions
]. They reviewed five concepts determining access to health interventions: availability, accessibility, affordability, adequacy, and acceptability. Mahoney et al.
(2007) identified four criteria for access to new vaccines: availability; affordability; acceptability; and adoptability
]. They propose an access framework that acknowledges the role of decisions made during the R&D period on later implementation. PDPs generally agree on a similar set of access criteria relevant to many interventions
Frost & Reich (2008) analyzed the history of access to six health interventions in the developing world: praziquantel; hepatitis B vaccine; malaria rapid diagnostic tests; Norplant; vaccine vial monitors; and female condoms
]. They proposed that access depends on activities related to four key factors: architecture, availability, affordability, and adoption. Architecture encompasses the organizational structures and relationships that coordinate activities addressing availability, affordability and adoption (Figure
). They also provide a historical description of the R&D phase of each intervention, noting that developer choices are important for later policy decisions on use and implementation. Each concept Mahoney et al.
(2007), Obrist et al.
(2007), and PDPs use in their access frameworks is consistent with the ones identified by Frost & Reich
]. For example, Obrist’s et al.
concept of acceptability is consistent with Frost and Reich’s “end-user adoption and appropriate use”. The one exception, which is not relevant to national implementation of an intervention and therefore this analysis, is Obrist et al.
’s adequacy concept, matching health service organization with individual client expectations
Figure 2 Frost and Reich’s (2008) access framework. The figure presents access as depending on a coordinating architecture that ensures that availability, affordability and adoption considerations are addressed for an intervention. Architecture: Organizational (more ...)
These analyses of access are complemented by many analyses of strategies for the implementation of single or closely-related interventions
]. Some of the literature focuses on the R&D period, including how clinical trials and regulatory processes impact implementation
]. Much of the literature focuses on the period after regulatory approval, using qualitative
] and quantitative approaches
Considerations affecting access to new interventions
This paper hypothesizes that five high-level milestones, consistent with the research on access above, are associated with developing countries beginning implementation of interventions. If these milestones are associated, it follows that they could be targets of efforts by those developing new interventions in order for implementation to begin, and access to be achieved, more quickly. This paper explores this hypothesis by analyzing how long it took after regulatory approval, or equivalent, for countries to begin implementing each of seven interventions, and related implementation to when each of these five milestones took place for each intervention.