MMV delivers statements at 76th World Health Assembly
MMV joined countries and organizations in giving statements on prioritizing strengthening clinical trials and local manufacturing initiatives as well as women’s, children’s and adolescents’ health
The 76th World Health Assembly took place from 21 to 30 May in Geneva, Switzerland. The meeting convenes representatives from World Health Organization (WHO) Member States as well as organizations to determine upcoming global health priorities.
Medicines for Malaria Venture gave three statements at the assembly: a joint statement on strengthening clinical trials to include pregnant and lactating people as well as individual statements on prioritizing malaria prevention and treatment in at-risk populations and supporting local manufacturing of medical products in Africa, where over 95% of malaria cases take place.
23 May 2023
Agenda item 15.1: “Strengthening WHO preparedness for and response to health emergencies”
Subitem “Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination”
Our constituency includes the Global Health Council, the International AIDS Society, The International Union of Tuberculosis and Lung Disease, Medicines for Malaria Venture, PATH and Women in Global Health.
As a group of non-profit innovators, product development partnerships, advocacy and convening organizations whose mission is to accelerate R&D for diseases of poverty, we commend Resolution 75.8 on strengthening clinical trials, and the actions undertaken by WHO secretariat so far to implement this resolution.
Women, girls and other gender-diverse persons of childbearing potential remain vastly under-represented in research and clinical trials, particularly during pregnancy and lactation. At a time of rapid medical innovations, this limits data, prevents understanding of sex and gender-based differences in health outcomes and restricts the availability of therapeutic options for more than half the global population. We must urgently change this.
To fill gender-equity gaps in research, we look forward to WHO’s guidance on best practices for clinical trials specifically focused on pregnant and lactating women, girls and other gender-diverse persons of childbearing potential. Data collection in these populations should be encouraged through existing pharmacovigilance programmes and active pregnancy registries spanning all diseases. Clinical research programmes should be designed to intentionally recruit these populations in trials and disaggregate data by sex, age and gender.
The anticipated release of guidelines on the Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use will certainly help move this agenda forward and speed progress towards addressing the health needs of these underrepresented populations across countries and diseases.
Our organizations are committed to continue working with WHO and the Member States to include specific measures concerning women, girls and other gender-diverse persons of childbearing potential during pregnancy and lactation in the upcoming guidance on best practices for clinical trials, anticipated to be available by the 77th World Health Assembly. Understanding the burden of disease in these important populations is critical to estimate maternal morbidity and mortality, evaluate and implement effective programmatic interventions, and advocate for sufficient resources. Together, we can help address this major historic blind spot in public health.
24 May 2023
Agenda Item 12: “Global Strategy for Women’s, Children’s and Adolescents’ Health (2016–2030)”
Medicines for Malaria Venture welcomes progress in the Global Strategy for Women’s, Children’s and Adolescents’ Health, and stresses the importance of addressing malaria in this agenda.
Over 600,000 people die of malaria every year, mostly children, women and girls. Infection during pregnancy causes disease and death and is associated with maternal anaemia, stillbirth and preterm birth, low birthweight, retardation of child growth and poor cognitive outcomes for newborns.
Innovative chemoprevention and treatment of severe and relapsing malaria, in addition to diagnostics, vector control and bednets, have helped save millions of lives, and a robust portfolio of tools, including vaccines, is ready or in development.
We need continued support for innovation to address inequities and better respond to the needs of children, women and girls. And we need much stronger health systems to fully realize the potential of this innovation.
26 May 2023
Agenda Item Group 4.1
Medicines for Malaria Venture (MMV) welcomes WHO’s updates on antimicrobial resistance and on strengthening local production of medicines.
Africa imports over 70% of its pharmaceuticals, which makes it vulnerable to supply chain disruptions, as was made dramatically clear during the COVID-19 pandemic.
MMV is proud of its partnerships with manufacturers on the African continent, which are currently helping strengthen the supply of antimalarials used to prevent infection in pregnant women and children. This experience shows that the production of local, quality-assured medicines can make a difference, and requires coordinated efforts to upgrade equipment, skills and regulatory procedures.
Scaling up local manufacturing capacity is crucial for ensuring greater supply chain security, expanding access, reducing the use of sub-standard medicines, and therefore slowing resistance against antimalarials and other drugs, and is a catalytic step to making progress towards universal health coverage.