PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, finance, technology, advocacy, and dozens of other specialties, PATH develops and scales innovative solutions—including vaccines, drugs, devices, diagnostics, and approaches to strengthening health systems worldwide.

The global community including the scientific society, private sector, civil society, governments, United Nations, and philanthropists among others have formed the Access to COVID 19 Tools-Accelerator (ACT-A) aimed at reducing mortality and severe diseases through accelerated development, equitable allocation and scaled up delivery of vaccines, Therapeutics, and diagnostics. The downstream effort is to support efficient delivery of the ACT-A products to people (through health systems) thereby protecting health systems, restoring societies and economies.

In furtherance of the ACT-A vaccination goal; GAVI, WHO, CEPI and UNICEF have established the Covax facility to ensure accelerated development, equitable allocation and scaled up delivery of 2 billion doses of COVID-19 vaccines globally by the end of year 2021. The COVID-19 Global Vaccine Access Facility (Covax Facility) pools resources and shares vaccine development risk.

In line with these developments, a time-frame for vaccine deployment has been proposed to guide country preparedness. Overall guidance for phased vaccination of target populations at-risk has been provided together with readiness assessment tools. The baseline assessment for Uganda stands at 36% on the strength of its institutional mechanisms for mass vaccine deployment accrued over time.

Against this background, PATH would like to hire the services of a consultant to undertake a short-term assignment of developing a regulatory framework for the introduction of COVID-19 vaccine in Uganda. The consultancy will last for a period of 48 days between January 15, 2021 and March 30, 2021 and will be executed in Uganda.

General objective:

The general objective of this consultancy is to: Ensure the national regulator or authority has clarified the requirements and documents needed for regulatory approvals of COVID-19 vaccines

Responsibilities:

The specific responsibilities of the consultancy will include the following;

1. Develop a clear and succinct roadmap for the regulatory process for COVID-19 vaccine.
2. Generate a checklist for all indemnification requirements in close consultation with Ministry of Health, Ministry of Justice and Ministry of Finance.

• Initiate planning meetings with regulatory sub-committee of the national coordination committee (NCC) at Ministry of Health.

1. Support both in-person and virtual bi-weekly meetings for the regulatory sub-committee to provide progress on the regulatory process.
2. Organise and lead consultative meetings with key players in the regulatory process to obtain the necessary information, regulatory reviews and approvals. The players include, but are not limited to, department heads at National Drug Authority, Ministry of Health, Uganda Revenue Authority/Customs, among others.
3. Organise both in-person and virtual engagements with local technical representatives (LTR) of the vaccine manufacturers to expedite the process of inspection at source and eventual issuance of import certificates by the local regulator.

• Engage with the office of the Minister of Health to obtain a letter for expedited approval for COVID-19 vaccine introduction
• Participate and represent PATH in regular in-person and virtual meetings of relevant sub-committees under the NCC with a bias to regulatory issues.

Deliverables:

1. A roadmap to guide the regulatory process for COVID-19 vaccine introduction in Uganda
2. Milestone reports aligned to agreed outputs in the roadmap.