AMC COVAX

At the Global Vaccine Summit on 4 June 2020, Gavi launched the Gavi COVAX AMC as the first building block of the COVAX Facility. Building on past Gavi innovative finance instruments such as the Pneumococcal AMC, the Gavi COVAX AMC leveraged the comparative advantages of the Alliance to link funding and procurement with catalytic investments in delivery, in support of low- and lower middle-income countries. To date, Gavi has raised more than US$ 12 billion in donor funding for the AMC.

Gavi’s COVID-19 vaccine Delivery Support (CDS) was the way in which funding for COVAX and COVID-19 Vaccine Delivery Partnership (CoVDP) activities was channelled to governments and partners. Through CDS, Gavi provided more than US$ 1.1 billion in financial grants to countries; cold chain and ultra-cold chain (UCC) equipment; technical assistance; and support for management capacity enhancement, scale-up, and demand-generation and confidence activities. The goal of CDS funding was to help countries reach national coverage rates, with a specific focus on accelerating protection of high-risk groups, and to integrate COVID-19 vaccinations into regular programmes to achieve sustainable benefits for both.

In addition to negotiating model indemnity agreements with vaccine manufacturers, to further minimise barriers to access, COVAX supported AMC92 countries to access pro bono legal support. COVAX engaged:

• The International Senior Lawyers Project (ISLP) contacted a number of global legal experts on issues of indemnification and compensation who provided pro bono services to AMC92 countries that required it.
• The O’Neill Institute for National and Global Health Law at Georgetown University in the United States of America developed a preliminary (and non-exclusive) list of consultants around the world with relevant experience who could provide technical legal support to select countries in drafting the enabling legislation/regulation, and taking it through the relevant parliamentary or other necessary approvals.

A first of its kind pandemic innovation, the COVAX AMC No-Fault Compensation (NFC) Programme was designed to protect patients and lower-income countries in the novel liability climate created by the pandemic.

The NFC was designed to be fast, robust and transparent, making it easier for any individual affected by a serious adverse event from any vaccine procured or distributed through the COVAX Facility to get fair compensation – without having to go through a lengthy, expensive and uncertain legal process. The compensation was funded by donor contributions to the Gavi COVAX AMC.

ACCESS THE AMC COVAX NFC CLAIMS WEBSITE

The COVAX No-Fault Compensation Programme: Explained

Indemnity and liability was one of the thorniest problems COVAX had to solve to successfully roll out COVID-19 vaccines in lower-income countries. The solution is a world first, which could offer a model for future pandemics.

Authorizations for Vaccine Procurement from 20 Governments

In order to receive vaccines through the COVAX Facility, participating governments must legally authorize one or more actions in order to comply with the COVAX template indemnity agreement. Not all governments desiring to procure vaccines through COVAX will have current or past experience identifying, applying, or amending laws or regulations that will satisfy the indemnity agreement provisions. In order to provide assistance to those governments wishing to consider legal alternatives, the COVAX Facility has partnered with the O’Neill Institute for National and Global Health Law at Georgetown University, which has analyzed legal authorizations used by governments representing diverse legal and constitutional traditions to facilitate procurement of vaccines generally and, in some cases, COVAX specifically.

Authorizations for indemnity to vaccine manufacturers, distributors, and administrators has been enacted through three primary legal channels: public procurement laws, public health emergency laws, and laws specific to immunization. Legal precedents from 20 jurisdictions are included. Nine were adopted pursuant to COVID-19 specifically: Argentina, Brazil, Colombia, Costa Rica, Guatemala, EU, Malawi, Philippines, UK. Eleven were enacted previously: Ghana, Lao DPR, Liberia, Malawi, Malaysia, Nepal, New Zealand, Sierra Leone, Uganda, Vietnam, and Zambia.

The relevant clauses are listed following the designation of each statutory or administrative authorization. These statutes, regulations, rules, and decrees do not constitute legal advice, nor are these legal precedents maintained for day-to-day accuracy as some are subject to ministerial review and amendment on a daily, weekly, or monthly basis. They are intended only to provide guidance as to how governments procuring vaccines through COVAX may take the necessary legal steps to satisfy COVAX requirements.

Checklist of Key Principles for Ensuring Legislative, Regulatory, or Ministerial Authority to Implement COVID-19 Vaccine Related Indemnity

Governments choosing to receive vaccines through COVAX must be able to show that they may legally indemnify COVAX partners, that is, accept legal and financial responsibility, for serious adverse reactions following immunization (SAEFI) with vaccines procured through the COVAX Facility.

This checklist is intended to assist countries identify the legal authorizations that may be used to fulfill these requirements. These legal authorities may be found in the constitutional text, in legislation, in regulations that may be issued by a proper authority, or by decree of the executive or authorized ministry. The checklist is supported by, and may be cross-referenced with, the accompanying resource, Authorizations for Vaccine Procurement from 20 Governments.

The checklist below provides steps for legal review that may be taken to ensure that proper authority exists to enter into agreements with COVAX Facility partners. Relevant laws may be found in more than one of these general areas, and proper authority may be codified in more general laws like those authorizing the president or executive to act during an emergency. Laws identified should still be reviewed against the national constitution, which may impose limits on borrowing, public finance, or relinquishment of legal claims by individual citizens.