Consultant- Development of a National Introduction Plan for Medogen SubQ (DMPA-SC) in Uganda

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PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing health challenges.

1. BACKGROUND

Uganda has extensive experience with subcutaneous depot medroxyprogesterone acetate (DMPA-SC), particularly Sayana Press, which is available through public, private and private-not-for-profit channels. This experience has establishedprovider competencies, client awareness, service-delivery platforms, commodity systemsand reporting arrangements. MedogenSubQis another DMPA-SC product and should therefore be considered for integration as an additionalproduct within the existing DMPA-SC category, rather than as a new contraceptive method.

A structured, government-led introduction plan is required to verify regulatory and policy readiness; clarify product positioning; assess quantification, procurement, pricing, financing and supply implications; protect voluntary informed choice; align service-delivery, health information and logistics systems; and define quality-assurance, pharmacovigilance and post-market surveillance arrangements. The planning process will distinguish systems that can be used unchanged from those requiring limited adaptation or a new decision.

Providers already competent in counseling for and administering Sayana Press will not require broad retraining. Any additionalpreparation will be limited to concise, product-specific orientation where verified differences in presentation, labeling, device operation, storage, waste management, reporting or approved self-injection use require it.

The authoritative status of MedogenSubQin Uganda, including registration, approved indications, labeling and any self-injection claim, will be confirmed with the National Drug Authority during the assignment. National policy, procurementand rollout decisions remainthe responsibility of the Government of Uganda.

PATH is a global nonprofit dedicated to health equity. With more than 40 years of experience forging multisector partnerships, and expertisein science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world's most pressing health challenges.

PATH will engage the Consultant to produce a practical, costed and stakeholder-informed national introduction plan. The assignment comprisesa maximum of eightnon-consecutive working days delivered within a five-week elapsed period. The five-week period allows time for document access, stakeholder scheduling, Ministry review, technical validationand finalization; it does not represent25 billable working days.

2. CONSULTANT ACTIVITIES

The Consultant will perform the following activities and produce the work products specified in Section 3. The Consultant will use independent professional judgment, document evidence sources,and clearly identifyassumptions, information gaps, and matters requiring a national decision.

• Complete inceptionand alignment. Review the assignment brief and available documents; confirm the methodology, priority questions, stakeholder map, consultation approach, document request list, five-week work schedule, review processand decision owners; and submita concise inceptionnote for PATH's written acceptance.

• Conduct a focused desk review and readiness assessment. Review relevant national family planning policies, DMPA-SC guidance and training materials, available product and regulatory documentation, quantification and supply plans, procurement requirements, health management information system and logisticsmanagement information system tools, financing arrangements, and pharmacovigilance procedures. The Consultant will verify the regulatory position with competent authorities and will not present unverified manufacturer or stakeholder statements as regulatory facts.

• Undertake targeted stakeholder consultations and gap analysis. Prepare consultation guides and consult the Ministry of Health, National Drug Authority, procurementand supply agencies, implementing partners, service-delivery representativesand appropriate private-sectoractors. The Consultant will synthesize evidence across stakeholders and classify each planning domain as: existing system can be used unchanged; limited adaptation is required; or a new decision or action is required.

• Analyze introduction scenarios. Assess product positioning within the full contraceptive method mix; the relationship with Sayana Press and intramuscular DMPA; provider and client communication; rights, voluntarism and informed choice; quantification, procurement, pricing, financing and supply resilience; service-delivery adaptations; data and monitoring; quality assurance; pharmacovigilance; public-private alignment; and sustainability. The analysis will explicitly guard against unnecessary provider retraining, parallel systemsand brand-driven promotion.

• Develop the draft national introduction plan. Prepare an editable draft that includes an executive summary; verified regulatory and policy action matrix; programme positioning statement; service-delivery and proportionate product-orientation approach; quantification, procurement and financing scenarios; data and monitoring arrangements; quality and pharmacovigilance measures; governance; stakeholder responsibilities; phased implementation matrix; costed roadmap; indicators; decision gates; risk register; and sustainability measures.

• Support technical validation. Prepare a concise presentation and decision log, facilitateone technical validation session, present key findings and options, guide discussion of unresolved decision points, and document agreed actions and consolidatedcomments. The Consultant will facilitatethe process but will not substitute for Ministry regulatory, policy or procurement decisions.

• Finalize and submitthe complete package. Revise the plan in response to one consolidatedset of comments provided by PATH, prepare a response-to-comments matrix, quality-assure internal consistencyand calculations, and submitclean final versions of the introduction plan, costed implementation roadmap and presentation in editable formats.

Quality and safeguarding requirements. All outputs will be in English, concise, evidence-basedand suitable for national use. The Consultant will apply brand-neutral, rights-based family planning language; protect confidential or commercially sensitive information; cite or identify the source and date of material evidence; avoid unsupported regulatory or cost claims; and maintain a clear distinction between technical recommendations and decisions reserved for national authorities.

3. AGREEMENT DELIVERABLES

Payment will be based on actual working days at the daily rate statedin the Agreement, up to the maximum number of days shown below and a total ceiling of seven working days. The Consultant may invoice after PATH has accepted the corresponding deliverable in writing. Week 1 begins on the Agreement start date. All due dates fall within the five-week period of performance.

TOTAL MAXIMUM PROFESSIONAL INPUT - 8 days

Deliverable acceptance will be based on compliance with this Scope of Work and incorporation of consolidatedtechnical comments. Ministry endorsement, regulatory authorization, procurement approvalor funding decisions are external programme outcomes and are not obligations the Consultant can guarantee.

4. PRIMARY PATH CONTACT

The primary PATH contact is George William Barigye, Regional Technical Advisor, PATH. The primary PATH contact will receive and approve deliverables, provide or coordinate access to available information, facilitatestakeholder engagement, and communicate one consolidatedset of technical comments to the Consultant.

The primary PATH contact may approve in writing minor clarifications to methods or adjustments to due dates that remainwithin the five-week period of performance and do not change the activities, deliverables, maximum level of effort, or total contract value. Any addition or removal of an activity or deliverable requires a written amendment to the Agreement.

The Ministry of Health will provide technical leadership and make national programme decisions. Product manufacturers, local representativesand distributors may provide technical and commercial information but will not determinenational policy, procurementor rollout decisions.

5. TRAVEL

The Consultant may travel within Uganda to complete approved in-person consultations or the technical validation session when such travel is required. All travel and reimbursable travel costs must be approved in writing by PATH before they are incurred. No international travel is anticipatedunder this Scope of Work.