Agenda item 12: Global Strategy for Women’s, Children’s and Adolescents’ Health (2016–2030)
We welcome progress in the implementation of the strategy. However, research and development of health tools to address the often neglected specific medical needs of women and children requires greater prioritisation.
Children are among the most neglected in drug development and paediatric formulations of drugs are often not developed. Additionally, there are knowledge gaps in understanding impacts of medicines on biological females, especially those of childbearing potential, who are often excluded from clinical trials. Lack of inclusion of women and children in R&D limits understanding of the effects of the disease and delays access to treatments.
We welcome the ongoing work of the Global Accelerator for Paediatric Formulations Network to promote innovation of medicines for children and call for support for its priorities. We urge member states to support and implement strategies for innovation of, and access to, health tools to better meet the needs of children and women.
Agenda item 13.1: Universal Health Coverage
Reorienting health systems to primary health care as a resilient foundation for UHC and preparations for a HLM of the UNGA on UHC (EB152/5)
Access to appropriate affordable health tools is a key component of achieving universal health coverage. For antibiotics and neglected tropical diseases treatment, access remains a major challenge in many regions.
The true test of Universal Health coverage (UHC) is whether it addresses the needs of vulnerable and marginalised populations, such as the 1.7 billion people living with NTDs. Too often existing health tools for these diseases have serious limitations hampering the provision of care, can cause catastrophic health expenditure, and impede disease control.
R&D can support UHC by developing new tools for use at primary care level, reducing the need for specialist intervention in hospital settings. For example, oral treatments, or better diagnostic tests. We urge member states to include monitoring of the development and access to health tools as part of UHC action plans and link UHC innovation needs with investment in PPR infrastructure at the upcoming high-level meetings, ensuring sustainability
Agenda item 15.1 – Strengthening WHO preparedness for and response to health emergencies
- Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination (EB152/13)
- Strengthening the global architecture for health emergency preparedness, response and resilience A76/10
DNDi welcomes the implementation report of the resolution to strengthen clinical trials and commends the Secretariat for organizing the stakeholder consultations. We urge member states to take action on the gaps referenced in the report including:
- Improving coordination between new and existing clinical trial networks
- ensuring investments in clinical trial ecosystems include flexibility to respond to emergencies and existing health priorities
- Supporting coordination for regulatory authorities and ethics committees to expedite and streamline clinical trial approval and review processes.
- Supporting the development of best practices for countries on how to ensure access and benefit-sharing principles are implemented
- Ensure that the links are made to resolution WHA 72.8 on transparency to ensure public availability of clinical trial cost data
In relation to the global architecture for health emergency preparedness and response:
The IHR and INB processes provide an opportunity to agree approaches in advance rather than seek to negotiate during a crisis. For the research, development and access to health tools, greater coordination is needed to ensure equity is operationalized including:
- End-to-end R&D approaches, with access embedded, that include early-stage research and clinical development in addition to manufacturing and distribution
- Surge and at-risk public financing for preparedness and response, as well as agreed conditions on publicly funded research to ensure that new treatments and technologies are accessible and affordable for all.
In relation to the medical countermeasure's platform, it is critical all member states are engaged in its design and that R&D capacity across and within regions is harnessed and increased.