UN Commission on Life-saving Commodities: Concept Note (March 2012)

Publication date: 2012

March 2012 1 Establishing a UN Commission on Life-Saving Commodities for Women and Children Background The Global Strategy for Women’s and Children’s Health highlighted the inequities suffered by women and children around the world and set out a common agenda to save 16 million lives by 2015. It advocated strongly for universal access to basic healthcare for all women and children. It identified the need for increased access to and the appropriate use of essential medicines and other commodities that are necessary to achieve the health-related MDGs, particularly MDGs 4, 5 and 6. Too often, cost-effective, high-impact health commodities do not reach the women and children who need them. Some of the barriers to access include the lack of affordable products, lack of age-appropriate formulations- especially for children, weak supply chains, inadequate regulatory capacity at the country level to protect the public from sub-standard or counterfeit medicines that cause harm, and lack of awareness of how, why and when to use these commodities. Recent experience shows that it is possible to overcome many of the barriers associated with underutilised commodities, even in the most deprived communities. Successes include the development of new products and technologies, such as vaccines to prevent diarrhoea, meningitis and pneumonia, therapeutic foods to treat severely malnourished children, and increased coverage of HIV/AIDS, TB and malaria programmes. Efforts to promote a robust supply of quality products and advocacy for fair pricing for these commodities have contributed to price reductions, greater market efficiencies, and higher returns on investments in public health. To apply the lessons learned from this successful work to other essential but hitherto overlooked health commodities, the United Nations is establishing a Commission to address this issue. As part of the Every Woman, Every Child initiative, the Commission will champion the effort to reduce the barriers that obstruct access to essential health commodities. Rationale In 2011, a series of informal meetings and consultations with many stakeholders explored the idea of a Commission as a strategy to examine and overcome the critical gaps in essential health commodities. There was widespread consensus that a Commission could serve as a catalyst for the increased availability and affordability of relevant commodities. Some of the cross-cutting issues that the Commission could address include:  Creating incentives for manufacturers to produce and innovatively package overlooked commodities, including fostering opportunities to strengthen local production and packaging;  Identifying fast-track regulatory activities to accelerate registration and reduce registration investment for a special list of products to encourage a focus on quality medicines; March 2012 2  Addressing financial barriers to access through social protection mechanisms, such as fee waivers, vouchers and social insurance, and global financial mechanisms, such as pooled procurement. The Commission will convene stakeholders and experts, bring together a wide range of on-going but fragmented technical work, and launch further analysis in order to assess production gaps, funding gaps, financing mechanisms, social determinants and knowledge gaps. It will also identify opportunities for efficiency gains through technical innovation, strengthening commodity procurement, distribution systems, and predictable financing- all with the aim to increase prevention and treatment coverage to prevent the avoidable causes of premature death and disease among women and children under five years old. Proposed Objectives The Commission will advocate at the highest levels to build consensus around priority actions for increasing the availability, affordability, accessibility and rational use of selected commodities for women’s and child health, with the following objectives:  Identify opportunities to increase the production and supply of affordable, high-quality, high- impact commodities for women’s and children’s health, including through shaping the market, strengthening the quality of local production capacity, promoting innovative technologies and new product development, strengthening regulatory frameworks, supporting effective supply chain mechanisms, and enhancing innovative financing mechanisms at both the global and local levels.  Propose innovative strategies to support high-burden countries in increasing access to overlooked commodities through proven, private and public sector market shaping interventions.  Recommend strategies to raise awareness of and demand for these lifesaving products among health care providers and end-users. These objectives will build on on-going work by the UN, NGOs and private sector partners, with the governments of high-burden countries, to develop comprehensive scale-up plans for an essential set of products to promote the health of newborns, children and women. Proposed Scope The Commission will aim to change the way overlooked commodities are made, distributed and used. To do this, the Commission will need to be focused- in terms of the commodities it selects and the bottlenecks it seeks to tackle. Based on consultations to date, and guided by the WHO Essential Medicines List and List Priority Medicines for Mothers and Children, the following March 2012 3 criteria have been deemed clear and sufficient for selecting an initial list of focus commodities. 1 Selected commodities will be: 1. High-impact, effective commodities. In general, high-impact commodities are those commodities that effectively address the avoidable causes of premature death and disease among children under five years old and women during pregnancy and childbirth. 2 2. Inadequately funded by existing mechanisms such as The Global Fund to Fight AIDS, Tuberculosis and Malaria, Global Alliance for Vaccines and Immunisation (GAVI) and UNITAID. 3. Ready for innovation and rapid scale-up in product development and market shaping, with the potential for price reduction and improved stability of supply. A range of products will be considered and an initial list of essential overlooked commodities identified based on these three criteria. The initial list presented in Table 1 is not comprehensive, but is rather a cross-section of vital products, representing access issues common to many commodities. It will be left to the Commissioners to finalise the selection of commodities included in the Commission’s scope of work. Lessons learned from the selected products may be applied to other essential commodities at a later time. 1 These criteria are informed by the following documents: WHO and UNICEF Priority Medicines for Child Survival (Copenhagen, September 2010); WHO, UNICEF and UNFPA Priority Medicines for Mother and Children (March 2011); UNICEF’s list of Maternal, Newborn and Child Health (MNCH) supplies; Bill & Melinda Gates Foundation (BMGF) and UNICEF “end-to-end approach for Maternal, Newborn and Child Health Commodities” (Seattle, May 2011). It is noted that the WHO Priority Medicines List is currently being revised, and the new version will be considered once available. 2 The main causes of newborn and maternal mortality and the effectiveness of specific interventions and commodities to substantially reduce these has been well documented, including in the Lancet series on child survival (2003), newborn survival (2005), maternal survival (2006) and on reproductive health (2006), and publications by the Child Health Epidemiology Reference Group (CHERG). http://www.thelancet.com/collections/series ; http://cherg.org/publications.html March 2012 4 Table 1: Initial list of overlooked commodities for Women’s and Children’s Health Each of the commodities listed in Table 1 faces a specific set of bottlenecks at different stages of the value chain, such that in order to fully understand the key cross-cutting challenges, they will first need to be considered on a case by case basis. Given the potential range of issues, particularly in relation to country-specific concerns such as health systems capacity and performance, the Commission will need to be strategic in determining the breadth and depth of its inquiry. It is not recommended that the Commission attempt to address country-specific health system bottlenecks. Modalities of Work The UN Commission will use high-level advocacy to translate technical knowledge into political action. Central to this is reaching consensus on a set of key barriers and creating urgency and motivation for practical solutions. To do this, the Commission will look across the specific technical issues present in a subset of commodities to identify a few major shared or cross- cutting issues that could drive change. The Commission will not launch new in-depth studies; rather it will synthesize and prioritize existing knowledge and current work to forge a consensus on bottlenecks that require immediate and sustained actions to resolve. There is a need to link Commodity Supportive reference document Fund Potential for rapid progress Comment Amoxicillin No Yes BMGF-UNICEF end-to-end list Injectable Gentamicin No Yes BMGF-UNICEF end-to-end list Injectable Ampicillin No Injectable Procaine benzylpenicillin No Injectable Ceftriaxone No ARI timer Oxygen No ORS No Yes BMGF-UNICEF end-to-end list Zinc No Yes BMGF-UNICEF end-to-end list Caffeine citrate No Chlorhexidine solution No Yes BMGF-UNICEF end-to-end list Antenatal Steroids Cochrane; Mwansa et al No Yes Vitamin K No Newborn sepsis Injectable Gentamicin No Yes BMGF-UNICEF end-to-end list Newborn asphyxia Ambu bags, suction material UNICEF MNCH supplies No Yes Oxytocin Yes BMGF-UNICEF end-to-end list Misoprostol Severe pre-eclampsia and eclampsia Magnesium sulfate No Yes Reproductive Health Contraceptives (to consider: implants, female condom and emergency contraception) Yes (UNFPA Fund, RHSC) Artemisin combination therapy (ACT) Yes (GFATM) Artesunate: rectal and injection dosage Yes (GFATM) Fixed-dose combination therapy Yes (GFATM) Nevirapine Yes (GFATM) Zidovudine: dosage form and strength Yes (GFATM) Isoniazid/co‐trimoxazole as a fixed Yes (GFATM) Paracetamol Yes (GFATM) Morphine Yes (GFATM) TB TB fixed‐dose combination Yes (GFATM) Child Survival Vitamin A Yes (CIDA) Post-partum hemorrhage HIV Neonatal care Pneumonia Diarrhoea Malaria Priority medicines for children Priority medicines for children WHO Essential Medicines for Children and Women Priority medicines for children Yes (UNFPA Fund, RHSC) March 2012 5 with initiatives focused on addressing specific country-level health systems issues such as financing, human resource capacity, information systems, regulatory capacity and governance. The Commission will need to convene a diverse group of stakeholders to consult existing evidence and survey country and local level experience including: government ministries (Health and Finance); private sector manufacturers, including generics; technical experts; consumers; academics; regulators; and development partners. Structure The proposed UN-sponsored Commission will build on the success of the Commission on Information and Accountability for Women’s and Children’s Health, which has worked rapidly and effectively to identify new, bold solutions to long-standing problems in the area of global health. The Commissioners will represent key constituencies in both the North and South, and will provide broad policy guidance for the development of a set of strategic recommendations. Commissioners shall show a clear commitment to support the Commission, and shall serve according to their expertise until the delivery of their final recommendations by April 2012. UNICEF and UNFPA will serve as vice-chairs of the Commission. Commissioners will be supported by a working group composed of technical experts and a secretariat, hosted at UNICEF. March 2012 6 Time Schedule with Key Dates h(All dates are 2012.) Activity Responsibility Start Finish Confirmation of Commission Co-Chairs United Nations -- March Confirmation of Commissioners United Nations -- March Agreement of a communications strategy Contact Group -- March Selection of Work Stream Leads Contact Group -- March Selection of Secretariat Staff Secretariat Feb March LAUNCH OF COMMISSION Secretariat 23 March Selection and hiring of consultants Secretariat March April Technical Working Group kick-off Technical working group -- March Completion of commodity case studies Specialists Dec Feb/March Completion of commodity in-country work Specialists Feb April VIRTUAL MEETING OF COMMISSIONERS - via tele or video conference Secretariat/ Commissioners Mid-April Analysis of key barriers and solutions Technical working group March May Formulation of draft recommendations Technical working group April May IN PERSON MEETING OF COMMISSIONERS to agree on proposed commodities and consider draft recommendations Secretariat/ Commissioners -- 22 May Draft of final report with recommendations Commissioners May June Possible Second meeting of Commissioners (during which recommendations are finalised) Commissioners -- June/July TBC Final report sent for translation and publishing Commissioners June July LAUNCH OF FINAL REPORT TBC Meeting to develop implementation workplan July TBC Dissemination of findings and recommendations Secretariat July December Key Upcoming Dissemination/Advocacy Opportunities World Health Assembly: Technical discussion Co-Chairs and Vice Chairs -- 21-26 May UNICEF Executive Board: Presentation and discussion of preliminary recommendations Vice Chairs -- 4-8 June Child Survival Forum - Washington, DC Vice Chairs -- 14-15 June G20 summit: Report on the work, findings and recommendations of the Commission and subsequent progress Co-Chairs and Vice Chairs -- 18-19 June UNFPA Executive Board: Presentation and discussion of recommendations Vice Chairs -- 18-29 June ‘Gold Moment’ Launch Event - London, UK Vice Chairs -- July

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