About Vitamin Angels

Founded in 1994, Vitamin Angels is a public health nonprofit working to improve nutrition and health outcomes in low-resource settings worldwide. We strengthen, extend, and amplify the impact of our partner organizations working to reach the most nutritionally vulnerable groups – pregnant women, infants, and children – who are underserved by existing systems. We do this by delivering evidence-based interventions and offering technical assistance, including ongoing monitoring and evaluation, to ensure program quality, scale, and impact. Vitamin Angels works with over 2,000 local organizations, including governments, to reach more than 60 million women and children in 65 countries annually.

VA also provides technical advisory services to national governments intended to introduce or strengthen national health services focusing on improved nutrition. Unfortunately, more than three billion people globally, primarily those situated in low-resource settings, continue to face some form of malnutrition – especially micronutrient deficiencies and the adverse consequences that derive from micronutrient deficiency. Addressing this inequity requires expanding access to evidence-based nutrition interventions, particularly for underserved and nutritionally vulnerable populations.

Multiple micronutrient deficiencies during pregnancy are a major public health problem, especially for women in low- and middle-income countries (LMICs). Micronutrient deficiency among pregnant women leads to poor maternal health and adverse pregnancy outcomes including low birth weight, pre-term birth, still birth, and poor child growth and development. Antenatal supplementation with iron and folic acid (IFAS) has been the global standard of antenatal care (ANC) for decades. However, in LMICs, there is a shift in antenatal supplementation to transition from IFAS to the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) of a multiple micronutrient supplement (hereafter MMS means UNIMMAP MMS). MMS was developed by the World Health Organization (WHO), UNICEF, and the United Nations University in 1999 [1] to contain iron, folic acid, and 13 other vitamins and minerals. MMS is more eQective than IFAS in addressing micronutrient deficiency and its adverse consequences for the health of 2 pregnant women and pregnancy outcomes [2,3]. The WHO revised its guidelines for a positive pregnancy experience in 2020, and revised MMS use from “not recommended” to “recommended in the context of rigorous research”, including implementation research [4], and added MMS to the WHO Model List of Essential Medicines in 2021 [5]. Today, use of UNIMMAP MMS during pregnancy is one of the most important interventions to address micronutrient deficiency and its adverse consequences for the health of women and pregnancy outcomes.

VA serves in a leadership role, internationally, in collaboration with the Kirk Humanitarian foundation to introduce and scale the use of MMS in antenatal care (ANC) practice in lowand middle-income countries (LMICs).

Role or Purpose of Position

The Pharmaceutical Product (UNIMMAP MMS) Policy and Regulatory Specialist (Consultant) will provide support to the Philippines Department of Health (DOH) to secure supplies of MMS, manufactured as a pharmaceutical product, for short- and longterm needs of antenatal care services offered by the Philippine national health services. A key need for this consultant derives from a change sought by the DOH to re-classify MMS from a dietary supplement to a pharmaceutical product.

The objectives of this consultancy are to:

• Assist the DOH to landscape the supply context and raise awareness among key stakeholders to the challenges and limitations of existing supply policies, the regulatory framework, selected supply support systems (e.g., budget, procurement, and distribution) that must be overcome to achieve a re-classification of MMS, •
• Gain consensus on the specific issues and actions needed to achieve reclassification, appropriate supply policies, and a regulatory framework for MMS that provides guidance to manufacturers seeking to obtain a certification of product registration for an MMS product, •
• Develop and help the DOH execute a short-term supply strategy, and •
• Assist the DOH to create a scaling transition plan and secure a sustainable supply of MMS for long-term needs.
• Key interventions include vitamin A supplementation, multiple micronutrient supplementation (MMS), and deworming.

Major Duties and Responsibilities

In collaboration with the DOH, the consultant will:

1. Map and examine existing supply policies and the regulatory framework for MMS by conducting appropriate modules of VA’s supply context assessment to understand what aspects of policy and the regulatory framework require adjustments. •
2. Convene stakeholders to identify the most important adjustments impeding formation of a revised supply policy; gain consensus on the actions required to bring about adjustments to policy; and follow-up with the appropriate DOH officials 3 and other relevant stakeholders to support implementation of actions as appropriate. •
3. Convene stakeholders to Identify the most important adjustments impeding formation of a revised regulatory framework that permits registration of UNIMMAP MMS products classified as a pharmaceutical product; gain consensus on the actions required to bring about adjustments to the regulatory framework; and follow-up with the appropriate DOH oQicials and other relevant stakeholders (e.g., Philippines FDA) to support implementation of actions as appropriate. •
4. Facilitate examination and documentation of the acceptability of the Harmonized Expert Consensus Specification (ECS) in the Philippines as it applies to: –
   • Daily nutritional intake values (for pregnant and lactating women) and the upper tolerable intake value limits, including the maximum allowable levels for product classification for all active ingredients in the UNIMMAP MMS formula,
   • Philippine pharmacopeial standards, and
   • Philippine GMP standards.
5. Conduct interviews with DOH program and procurement staQ (and any other relevant stakeholders) to identify any issues that might anticipate challenges to budgeting and procurement staQ from carrying out eQective and eQicient procurement. [Note: This consultation is intended, in part, to assist the DOH to develop a transition plan for securing long-term MMS supplies. This objective may require a budget impact analysis and a cost-eDectiveness analysis to be done to support a transition plan. If the consultant needs to call on the services of additional experts to conduct a budget impact analysis or a cost-eDectiveness analysis or other specialized services, VA will help to identify the appropriate individuals to assist with such analyses.] •
6. Record all activities/events performed to secure MMS supplies and conduct one or more stakeholder meetings in which stakeholders rank the relative strength of that event’s contribution to the increased progress towards supply enablement. (Details of each event, including date, participants, written description, and images, should be documented prospectively, and ratings should be assigned retrospectively by event participants). •
7. Undertake other actions to support the DOH as directed by the VA country director.

Deliverables

• Written report on the result of the Supply Context Assessment (Policy and Regulatory Modules).
• Written report(s) on the convening of supply and regulatory stakeholder meetings that identify the most important supply/regulatory issues and memorialize the consensus statements pinpointing the issues to be addressed, and consensus on the specific actions to be taken and by whom.
• Aggregation of the outputs of official actions taken (e.g., a copy of the laws, rules, regulations, circulars, decrees, or any other legally enforcement documents)
• A copy of the final technical specification that become part of the Philippines regulatory framework (adapted from the internationally accepted Harmonized Expert Consensus Specification) adopted for Philippines UNIMMAP MMS, including accepted pharmacopeial (quality standards) and good manufacturing practice (GMP) standards.
• Interview reports from engagement with DOH program and procurement staff, or other relevant stakeholders.
• An enablement graph that tracks each event (and its relative importance) taken to achieve DOH access to sustainable short- and long-term supply of MMS.

Knowledge, Skills and Abilities

Minimum:

Applied knowledge and experience with:

• Philippines FDA
• Public law and policy pertaining to the adoption and use of new pharmaceutical products in the context of the Philippines national health service
• Pharmaceutical regulations as distinct from dietary supplement regulations
• Review and interpretation of relevant laws and regulations
• Drafting policy proposals or regulatory frameworks
• Engaging government agencies and stakeholders
• Conducting supply context assessments or elements thereof
• Translating regulatory frameworks into standard operating procedures for procurement staff
• Budget impact analysis/cost-effectiveness analysis or the ability to oversee others who conduct such an analysis

Necessary:

• Knowledge of policy-making and processes within the Philippines Department of Health, including the FDA, Policy and Strategy Cluster, Public Health Services Cluster, and Supply Chain Management Cluster
• Analytical thinking
• Clear writing (policy briefs, reports)
• Stakeholder communication & negotiation
• Attention to detail (compliance matters are precise)