Paper series examines key challenges and opportunities for nonprofit product developers

The Global Health Technologies Coalition (GHTC) today released the fifth and final paper and a summary of findings paper in its briefing series examining financing, accessibility, regulatory, and capacity issues facing nonprofits engaged in global health research and development (R&D). The five-part series aims to inform policymakers and other stakeholders with an interest in advancing R&D to meet health needs in low- and middle-income countries (LMICs).

The series focuses on nonprofit product development organizations (NPPDs), or nongovernmental organizations that partner with the public, philanthropic, and private sectors to develop health products specifically targeting poverty-related and neglected diseases in LMICs.NPPDs play a vital role in bringing together the fragmented resources and expertise of the various sectors involved in neglected disease R&D.

The fifth and final paper examines efforts by NPPDs to strengthen the research and manufacturing capacity of academic, nongovernmental, and commercial partners in LMICs. The summary of findings paper provides an overview of the key challenges, lessons, and potential solutions identified by NPPDs in their efforts to advance the development of new vaccines, drugs, diagnostics, microbicides, and other health products for LMICs.

The final paper on capacity-strengthening finds that while the mission of NPPDs is developing new health products, rather than capacity-building, many NPPDs have had to actively invest in improving the capacity and infrastructure of their local product development partners. This is because research and manufacturing infrastructure in LMICs remains weak, and many local partners have limited or no experience in conducting research and manufacturing in line with international safety and quality standards. NPPDs are engaged in capacity-strengthening work such as upgrading research and manufacturing facilitates, providing training across many skill sets, and transferring technological knowledge.

In the capacity paper, NPPDs offer a set of key lessons that they and their partners have learned in trying to strengthen local research and manufacturing capacity to bring new health technologies to those most in need:

• There must be a shared commitment among partners to comply with international technical and ethical standards to ensure volunteers’ safety and rights as well as to facilitate access to high-quality products among those in need.
  
• Capacity-strengthening investments must weigh accelerating the near-term availability of much-needed products against the potential of lengthier timelines to increase capacity. At times, the need to accelerate access to a product may take precedence over local capacity strengthening.
  
• Capacity strengthening should enable home-grown solutions and local product development to be responsive to existing needs and emerging challenges. These efforts should enable local engagement and country ownership of health research, related product development, and manufacturing in endemic countries.
  
• Capacity-strengthening investment needs to be sustainable and enable LMICs to leverage the value of this increased capacity for their continued future growth. Because capacity strengthening can be a time-consuming and complex endeavor, donors and governments in endemic countries must commit to financing and enforcing international research and manufacturing standards to ensure an even playing field for the long-term sustainability of these efforts.
  

The summary paper concludes that NPPDs face a number of challenges including insufficient funding, shortcomings in regulatory systems, and limited local research and manufacturing capacity which hinder progress on R&D for poverty-related and neglected diseases in LMICs. However, NPPDs have identified a number of solutions to address these challenges including working toward securing more predictable, stable, and long-term funding across all phases of product development, diversifying funding sources and improving coordination across funders. As well, NPPDs are seeking policy changes and sustainable funding to improve regulatory capacity and pathways and working to strengthen local partners’ research and manufacturing capacities to meet international standards.

This fifth and final paper—Briefing Paper, Volume 5: Working with partners to strengthen local research and manufacturing capacity—and the summary of findings paper—Advancing research and development to address poverty-related and neglected diseases and conditions—are part of a series from the GHTC that examines financing, accessibility, regulatory, and capacity issues facing NPPDs. The series aims to inform global policy and financing discussions about R&D for neglected and poverty-related diseases affecting LMICs.