The Product Development Partnership (PDP) Access Steering Committee commissioned this paper to explore the optimal timing and sequencing of access-related activities for drugs and vaccines, the underlying rationale for this sequencing, and the dependencies between activities. The paper accompanies two generic Gantt charts—one for drugs and one for vaccines—that capture the timing and sequencing of access activities. Semi-structured telephone interviews were conducted with sixteen respondents in donor organizations, pharmaceutical companies with experience of drug and vaccine development and commercialization in low- and middle-income countries (LMICs), and PDPs working on drug and vaccine projects.
The time period prior to stringent regulatory authority (SRA) or twinned product approval is referred to as “upstream” within the paper. The earliest access activities, which begin prior to Phase 2b trials, usually between nine and ten years prior to product approval by an SRA, are conducted to establish the disease context, the intellectual property context, and the key relationships with regulators and key opinion leaders that will be required throughout the following years. The second phase of upstream activities runs from between nine and six years prior to SRA product approval and occurs in parallel with Phase 2b clinical studies. These activities focus on gaining a better understanding of the value proposition of the new intervention and establishing draft strategies in areas such as regulatory affairs, manufacturing, and financing. In the period between six and three years prior to SRA product approval, around the same time that Phase 3 studies are being carried out, there are four groups of access activities for PDP consideration, which focus on building a stronger constituency of support at the global and national level and at financing agencies. Market and stakeholder studies can also continue during this time and be used as part of the relationship-building approach. In the final upstream time period from three years prior to SRA product approval, the PDP provides necessary support to manufacturing partners to ensure that the product will be ready for shipment by the time of launch in the first wave of countries. In addition, PDPs and their partners will engage in various financing activities, file an SRA regulatory package, and establish and/or refine an evidence package for both country decision makers and WHO.
In the downstream period, which refers to the time after a product receives approval from an SRA or via a twinned regulatory filing, the PDP’s role becomes less active and one of supporting, informing, and building capacity for existing country-level decision-making and implementation processes. PDPs and their partners file WHO prequalification and endemic country dossiers, provide support to country policy review and pilot/demonstration studies, and support the conduct of monitoring and evaluation activities.
These timelines reveal a progression from initial scoping of value proposition and strategy, through early engagement and collection of evidence, to an intensification of engagement and assembly of evidence into formal packages to support global and country decision making, and finally to more variable involvement in roll-out and surveillance activities. This discussion paper highlights those activities identified by stakeholders as taking longer than anticipated (including manufacturing,
registration, adoption, and financing issues) and causing delays (including inaccurate demand forecasts, failure to anticipate post-marketing commitments, and inability to obtain intellectual property clearance). The paper also points to some key tactics that, if implemented appropriately and in a timely manner, have the potential to accelerate access timelines (such as early country studies, financing scoping, and consultations with regulators). These considerations, plus the sample timelines, may be used by PDPs and their partners to plan access activities in a way that minimizes delays and maximizes