Milestones :: Perspectives :: Research

 

Editor’s Note:
It is unusual to include RFP information in this digest, but this instance is justified insofar as it responds to a strategic imperative in global pandemic response.

RFPS – DEVELOPMENT OF A GLOBAL TRUST REPOSITORY, SOLUTION, IMPLEMENTATION AND OPERATION SERVICES
UNICEF – Deadline 13 Jul 2021
Annex B_Global Trust Repository – ToR.pdf
1 Purpose of the RFPS.
To select a vendor that will provide a traceability solution, initially capable of providing a verification service, for use by low and middle-income countries in the management of vaccines, pharmaceuticals and other products, specifically:
:: Enable low and middle-income countries to manage the risk of falsified COVID 19 vaccines and diversion in their national supply chains, while setting the foundation for the establishment of national traceability systems in the long term.
:: Support COVID-19 vaccine safety efforts by making available (in the very short term) a verification tool that countries can access and use for verifying product and detecting diversion.
:: Establish a Global Trust Repository (outside of UNICEF IT operations) that can host traceability data initially from COVID-19 vaccine manufacturers and in future from any manufacturer; and can be accessed by in-country verification solutions.
:: Develop a solution that is scalable, with capacity to accommodate the verification of a broader range of non COVID-19 products and additional functionality without compromising performance.

 

2 Introduction and Business Need.
UNICEF works in some of the world’s toughest places to reach the world’s most disadvantaged children. To save their lives. To defend their rights. To help them fulfil their potential. Across 190 countries and territories, we work for every child, everywhere, every day, to build a better world for everyone. And we never give up. UNICEF, with its universal mandate, has established effective linkages between humanitarian and development programming and supports countries to strengthen capacities and systems when preparing and responding to emergencies.

As COVID-19 vaccines are being distributed, there has been an upsurge in the production and distribution of falsified and sub-standard vaccines and related COVID-19 supplies, particularly those reported in the media as potential therapies for COVID-19. This trend is expected to continue as COVID-19 vaccines and therapeutics become more available. The development of one of the most valuable vaccines in history has driven the proliferation of falsified COVID-19 vaccines, diversions and theft to degrees not seen before. The highest risk is in low- and middle-income countries national supply chains, where governance structures and traceability systems are non-existent or not fully mature, and tools and technical capacity to ensure good practices in manufacturing, quality control and monitoring of distribution chains is limited. To this end, a solution that provides countries with mechanisms to monitor national supply chains of COVID-19 vaccine is imperative to ensure equitable access, safety, and security – and build the foundation for end-to-end traceability for vaccines and medicines. Proposals should therefore include explanations about scalability options (detailed in section 6.2) and provide pricing structures to accommodate future changes over time.

 

3. Background.
The pharmaceutical industry and the international development community has for some time now promoted the use of global data standards to provide a wider and harmonized framework for supply chain visibility, strengthening anti-counterfeiting measures and sharing of data between parties. In this context, the Inter-Agency Supply Chain Group (ISG), with World Health Organisation (WHO) as the host, issued a note in 2017 supporting recommendations to:
1. Work with countries in creating policy frameworks to support GS1 standards adoption.
2. Align national supply chain policies regarding standards harmonization
3. Support & encourage investment in digital infrastructure in countries to implement
national product traceability systems.

 

UNICEF is currently working with various global partner organisations (including BMGF, GAVI, Global Fund, USAID, WHO, World Bank) as part of a global health community supporting low- and middle-income countries prepare for and implement traceability systems that would significantly reduce the risk of proliferation of falsified pharmaceuticals, vaccines and other health technologies.

In August 2020, UNICEF, Gavi and the World Bank made an urgent call to action for the establishment of a COVID-19 Vaccine and Therapeutics Traceability Expert Advisory Board to advocate for the development and implementation of a traceability solution for the COVID-19 vaccine and related therapeutics. The Expert Advisory Board, drawn from global partners, regulators and members of the Global Steering Committee for Quality Assurance hosted by the World Bank immediately set out to explore options for the development of a minimal viable solution that could be rapidly deployed. The first key activity was the establishment of labeling standards to be applied to vaccine packaging at secondary level that would enable traceability of products along the supply chain. In order to coalesce on a common set of labelling standards, UNICEF hosted a consultation with manufactures, regulators, procurement agents and WHO to help inform the labelling specifications of the COVID-19 vaccine that are necessary to enable traceability and authentication of COVID-19 vaccines and other products across national supply chains in countries.

Many of the vaccines being supplied to the COVAX Facility are now serialised in accordance with these labelling specifications using GS1 Standards. In 2021, UNICEF will procure 2 billion doses of COVID-19 vaccines on behalf of the COVAX facility, the vaccine pillar of the global initiative, ACT-A that aims to ensure equitable access to COVID diagnostics, treatments, and vaccines. Over 170 economies have joined the initiative, which is co-led by WHO, Gavi, the Vaccine Alliance and CEPI, the Coalition for Epidemic Preparedness Initiative. Together with partners, UNICEF is committed to ensure that those doses reach their target population safely and help reduce the risk of falsified COVID vaccines entering national supply chains and diversions.

A traceability initiative has now been set up to drive the establishment of a minimally viable verification solution for COVID-19 vaccines – with a long-term vision toward end-to end traceability. To progress the “Traceability Initiative”, a multi-stakeholder governance mechanism (figure 1) led by a Traceability Initiative Steering Committee has now been established and will act as the primary vehicle for the implementation and roll out of the GTR and verification solution. The steering committee will have an oversight role for the entire project while a Project Management Unit will have oversight of programme execution and implementation. The Steering Committee will leverage the World Bank hosted Global Steering Committee on Quality Assurance of Medical Products for advocacy, independent expertise drawn from public and private sector experts, ongoing linkages to its member National Medical Regulatory Authorities (NMRAs) and to accelerate action to the mutually agreed objective of brining COVID-19 Vaccine verification solutions to scale with a vision toward end-to-end visibility of vaccines and medicines.

 

 

The Steering Committee has recommended and approved UNICEF to be the entity responsible for the procurement and commissioning of the Global Trust Repository, verification solution and associated services on behalf of the traceability initiative.