New paper outlines regulatory challenges for diseases of poverty

The Global Health Technologies Coalition (GHTC) today released a new paper shedding new light on issues surrounding access to global health products. The paper examines how organizations that advance the development of new vaccines, drugs, diagnostics, microbicides, and other health products for low- and middle-income countries (LMICs) ensure access to the tools and technologies they develop. The paper focuses on nonprofit product development organizations (NPPDs), or nongovernmental organizations that partner with the public, philanthropic, and private sectors to develop health products specifically targeted for HIV/AIDS, tuberculosis, malaria, neglected tropical diseases, maternal health, and other needs in LMICs. Previous research has found that NPPDs play a vital role in bringing together the fragmented resources and expertise of the various sectors involved in neglected disease R&D. The new GHTC paper finds that NPPDs employ a range of strategies to ensure that the products they develop are accessible to those most in need in LMICs. The paper defines access as a set of activities needed to ensure that products are available, affordable, and acceptable to end-users, and adopted into developing country health systems. The strategies and activities employed by NPPDs include: Starting to plan for access at the beginning of the product development process. Establishing a product’s value, which must be defined by end users and the countries that will use the product. Working closely with manufacturing partners to guarantee that consistent supplies of high-quality products are available to target populations. Engaging end users and beneficiaries in the design and the development of the product. Negotiating collaborations with partners from the public and private sectors that are designed to ensure products are available, affordable, and acceptable. NPPDs also shared a set of key lessons that they and their partners have learned in trying to improve the affordability, availability, and acceptability of new health technologies for those most in need: Defining the value of a technology must be driven by the local communities and countries that will use the product. Product developers must understand and address the needs and wants of those who will ultimately be implementing and benefiting from the product. Achieving global access does not guarantee local access. NPPDs and partners may achieve global access targets (such as receiving World Health Organization prequalification), but this does not guarantee that the technology will be accessible at the national or subnational level. Relying on national average income status can undermine access for the poorest populations. In many middle-income countries, the burden of disease is among poorer populations who have not benefitted from strengthening economies. Therefore, the poorest populations, often the most at risk, are unable to access new technologies. Securing donor recognition that access activities need to be initiated early is critical. In order to ensure there is not a lag between licensing a product and making it available in the health system, NPPDs and partners must start planning for access from the beginning of the development process. Support from donors for these activities is critical. Demonstrating a niche in the market for manufacturers is essential to incentivize their investment. Manufacturing partners must understand the value that they bring to a market to enable them to invest time, effort, and expense to developing products for poverty-related and neglected diseases and conditions. This paper—Briefing Paper, Volume 3: Improving the affordability, availability, and acceptability of health technologies—is the third in 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 research and development for neglected and poverty-related diseases affecting LMICs.