SMART CHILD INITIATIVERecording, monitoring and managing vaccine supply, cold chain inventory and vaccination

status of children using block chain technology

Concept Paper prepared by: UNICEF MENA REGIONAL OFFICE

VisionReaching all the unreached children in the world with potent vaccine through tracking,

monitoring and managing vaccine supply from manufacturer to child.

Basic ConceptTracking and monitoring the vaccine throughout its cold chain to ensure adequate supply and potency

using blockchain.

Phase one of the SMART CHILD INITIATVE- 2019-2020Populate Blockchain software with vaccine information and track the vaccine stock and temperature

from manufacture to national and subnational level

Phase two of the SMART CHILD initiative from 2021-2022Populate Blockchain software with vaccine and cold chain equipment information and to add supply

management features in order to manage supply and monitor vaccine potency throughout all national and subnational levels

Phase three of the SMART CHILD initiative from 2023 - 2030Populate Blockchain software with child information to create electronic registry to track, monitor and

manage vaccine supply throughout its journey from manufacture to the child (SMART CHILD) and validate that all children are immunized.

Version 2.1 January 2019

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Introduction United Nations Member States and partners have achieved major progress in reducing vaccine-preventable deaths in recent years; however, every year, more than 19 million children miss out on the benefits of complete vaccinations, and many children receive no vaccines at all. 1 Nearly 30 % of deaths among children under 5 years of age are the result of vaccine preventable diseases. 2 One reason children are not receiving vaccinations is due to vaccine distribution problems, which lead to “stock-outs” or the unavailability of vaccines.3 According to data submitted by 194 countries from 2011 to 2015 a third of these countries reported at least one vaccine stock-out at national level for a month or longer.4 In addition, vaccine exposure to temperatures outside of their recommended ranges is an ongoing issue.5 Therefore, to reduce stockouts and ensure vaccine potency a real time decentralized vaccine monitoring and management solution is required.

Despite vast developments in technology, adaptation of newer and more technologically advanced tools by government partners in cold chain and vaccine management is low.6 One of the major reason for lack adoption is lack of trust in central server based solution.7 Existing adopted technologies are not producing required results for better performance of the immunization programme as the tools do not match current technology.8 This has led to the accumulation and use of multiple tools (mostly excel based) by multiple partners leading to fragmented vaccine management data among different levels preventing an understanding of clear linkages and overall problems in supply chain for better performance.9

Blockchain is the most decentralized, secured and trusted information system the world has ever seen. It provides a profound solution of building transparency in rapidly changing “next generation” supply chains. It has huge potential to decentralize trust in supply chains and bring measurable benefits to the governments and partners who are involved with supply chain management. Blockchain technology offers a streamlined method of maintaining a secure ledger of transactions of vaccine and other cold chain supply compared to a traditional database. The data is fully encrypted in blockchain, which ensures it is available only to trusted parties for their utilization. Available open source block chain platforms can be simply adopted for the purpose of improving the efficiency of immunization programmes.

The SMART CHILD initiative or the adoption of blockchain technology can move us closer to realizing the Sustainable Development Goals (SDGs) and targets set forth in the Global Vaccine Action Plan (GVAP). The GVAP encourages the use of new technologies to improve immunization supply chains and to seek

1 UN News. Vaccines are protecting more children than ever, but millions still miss out on routine immunizations – UN. 24 April 2018. Available at: https://news.un.org/en/story/2018/04/1008162 [accessed January 13, 2019]2 IBID3 Lydon, P, et al. Vaccine stockouts around the world: Are essential vaccines always available when needed? Vaccine. 2017. 35(17): 2121-2126.4 IBID5 Hanson, C M, et al. Is freezing in the vaccine cold chain an ongoing issue? A literature review. Vaccine. 2017. 35(17): 2127-2133.6 WHO UNICEF Supply Chain Hub expert opinion7 Zhang, P, Schmidt DC, White J, and G Lenz. Blockchain Technology Use Cases in Healthcare. 2018. 32. Available at: https://www.dre.vanderbilt.edu/~schmidt/PDF/blockchain-bookchapter-2018.pdf [accessed January 13, 2019]8 IBID9 IBID

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increased synergies with other sectors.10 Indeed, blockchain can help increase the quality of pharmaceuticals by decreasing counterfeits in circulation and in realizing SDG 3 or to achieve Universal Health Care (UHC), by tracking progress across national populations and within different groups like income level, sex, age, place of residence, migrant status, and ethnic origin.11

The SMART CHILD initiative is a solution to challenges that government and partners face to reach unreached children with potent vaccine and validate the process using blockchain technology. It will help governments build transparency. Furthermore, it improves the integrity of data and drives efficiencies for government and partners. It will avoid stock outs and effectively trace the vaccine from manufacturer to the child. It will remove major delays and cost to manage the vaccine and will reduce stockout and vaccine wastage through real time monitoring solutions and allow the use of other advance technologies like radio-frequency identification (RFID) and the Internet of Things (IoT) to interact with the blockchain and improve vaccine management practices.

10 World Health Organization. Global vaccine action plan. 2011–2020. 2013.11 Drury, P, Roth S, Jones T, Stahl M and Medeiros D, 2018. Guidance for Investing in Digital Health.

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Problem statement Fragmentation of data at different levels in different servers with limited access was the primary reason for not getting real-time data. Because of low interoperability of data and other technical hurdles (e.g., different security policies, separate infrastructures and environments of the manufacturers and governments), useful real-time knowledge on cold chain and vaccine supply chain products have not been available to interested stakeholders (e.g. National decision makers, maintenance contractors, vaccine suppliers, partners and operating companies in the supply chain). In other words, there is a lot of data stored in systems that are not able to communicate with other systems effectively. This leads to major inefficiencies and inaccuracies.

Inefficient, inaccurate and delayed immunization information and stock management systems make the goal of vaccinating all children more difficult. Though efficient web-based solutions are available, countries are reluctant to adopt these systems instead preferring data in a secured server owned by the government or using basic excel-based tools. Existing tools are limited in their potential to scale beyond national and subnational level. Therefore, countries are currently using simple paper-based excel solutions with limited capacity and lack scalability beyond national or subnational levels.

The following questions must be answered in real-time to ensure efficient vaccine stock management:

Questions Can be answered in real-time in current paper/Excel -based systems (yes/no)

Can be answered in real-time in current web-based systems (yes/no)

Can be answered in real-time in a blockchain system (yes/no)

1. How many vaccines are available at each level?

No No- Not at all levels Yes

2. Which cold stores have a low amount of vaccine with upcoming expiry?

No Yes- Only limited to national level Yes

3. Which facilities have vaccine with a specific batch number?

No Yes- Only limited to national level Yes

4. Which facilities are reporting vaccine wastage?

No No Yes

5. Which facilities are reporting vaccine wastage due to expiry?

No No Yes

6. How long does a supplier take to deliver vaccine to the country or a facility within a country?

No No Yes

7. Which facilities may have a stockout in the

No Yes- Only limited to national level

Yes

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near future? 8. How many vaccines

have been wasted in the last month?

No Yes- Only limited to national level Yes

9. How many children have been immunized in a particular facility in the last month?

No No Yes

10. What vaccines did a particular child receive and when?

No No Yes

11. Can the origin and status of vaccines each child received be determined?

No No Yes

12. Which vaccines are causing more adverse events following immunization?

No No Yes

Phases of the SMART CHILD initiative The SMART CHILD initiative will be rolled out in three phases while implementing learnings from each phase along the way.

Phase one is simply inputting the vaccine into the blockchain. This phase allows the government and partners to learn about Blockchain technology and improve existing cold chain and vaccine management system. During this phase, vaccine data will be tracked only at the national and subnational levels, and in some pilot countries the system will be used to monitor the vaccine beyond the subnational level.

During the second phase, additional vaccine information will be added to the system (manufacturer, storage temperature, etc.) as well as cold chain equipment (manufacturer, type, functional status, storage capacity, etc.).

In phase three, registry or health card information will be added for each child in the target study population. SMART Child will use a trusted Blockchain and build the application on well-established industry standards and provides a necessary foundation to build new value - increased trust, optimized supply chain efficiencies, automated compliance and enforce quality assurance processes.

SMART CHILD INNOVATION

Phase 1 Phase 2 Phase 3

Duration 2019-2020 2020-2022 2023-2030Implementation strategy Manufacture to national

and subnational level From manufacture to facility level

Manufacture to child

Type of Data Inputted Vaccine names Vaccine names, vaccine attributes and cold chain equipment

Plus child information

Blockchain Platform Ethereum or any other Based on lessons learned 6 | P a g e

open source blockchain a different cost-effective blockchain platform may be selected

IoT Limited integration with IoT

Integration with IoT Blockchain based solution will be incorporated to monitor the potency of the vaccine

Integration Integration of Blockchain is not required as the solution is only on Ethereum blockchain

As the manufactures and transportation are involved, interoperability of the blockchain will be considered

More interconnectivity between different blockchains

Purpose and remarks To convene stakeholders on this technology and to study the feasibility for scaling Blockchain based solution to improve the immunization vaccine management system

This phase may be further divided into further phases based on the lessons learned from phase one

Interoperability

Phase one 2019-2020 of the SMART CHILD initiative - Ready to be implemented

Phase one of the SMART CHILD initiative will be implemented only at national and subnational levels. This will allow the country to manage and monitor the vaccine from the National level to subnational level. UNICEF will support a number of countries to pilot this tool.

Vaccine names are inputted in the blockchain platform. The open source mobile application is used to manage the vaccine at various levels.

The opensource blockchain platform was chosen in this first phase as it is a decentralized system and the country owns the data in an encrypted form. Data is entered into the blockchain platform using a secret code (private key) and analysis may be visualized through a public address (public key). Anyone issued the public addresses with the permission of the government will be able to monitor vaccine movement in real-time.

The system may be used at any level and only requires a mobile phone with internet connection. Cold chain managers would be the primary user, but UNICEF or any interested partner can visualize the stock level of data if the cold chain manager agrees to share the public address of the electronic ledger in blockchain.

The following questions will be answered during phase one in real-time:

1. How many vaccines are available at each level in any period?2. What is the total value of the vaccine in a certain location?

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3. How many vaccines are in the pipeline? 4. Which facility may have a potential stock out in the near future? 5. How many vaccines are considered wastage?6. What is the value of the vaccine wasted during a period at any level?7. Alert system during each transaction and near stock out and overstock.

Phase two 2021-2022 of the SMART CHILD initiativeBased on the lesson learned from phase one, the phase two plan may be revised accordingly. It may be in the same blockchain or in different blockchain like EOS, VeChain, BSV, etc. or even our own blockchain based on the lesson learned. Phase two will expand from National and subnational levels to healthy facilities.

In addition to inputting vaccine data, cold chain equipment information will also be inputted, which will ensure a real-time cold chain inventory system. Certain IoT features will be added to update the vaccine situation automatically in real-time in the blockchain such as temperature, humidity, VVM status, etc. The addition of offline and SMS based data management features may also be considered.

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Display Screen: name and amount of vaccines

Sending or receiving vaccine

Accepting a shipment of vaccine

Inputting cold chain equipment - This feature will allow updated real-time inventory. The functionality of the cold chain equipment will be monitored in a decentralized approach including the temperature monitoring, storage capacity and functionality (repairs, spare parts, etc.) and it will be linked the health workers mobile phones to monitor the status in real-time. If any refrigerator or any equipment needs repairs, the maintenance team would be alerted to the in real-time and the inventory can be moved back to facility again once it is repaired. Faulty equipment can be reported in block chain, which will help identify superior quality and durable equipment for better performance.

Introduction of IoT devices- IoT devices like RFID technology will be used to monitor the temperature status during storage and transportation of the vaccine

The following additional questions will be answered during phase two in real-time:

1. Which cold stores have a low amount of vaccine with upcoming expiry?2. Which facilities have vaccine with a specific batch number?3. Which facilities are reporting vaccine wastage due to expiry?4. How long does a supplier take to deliver vaccine to the country or a facility within a country?5. Which facilities are experiencing temperature monitoring issues?6. How long does it take to repair a certain cold chain equipment?7. Which cold chain equipment requires repairs?8. Which health facilities are reaching cold chain capacity?

Phase three 2023-2030 of the SMART CHILD initiativeTracking of vaccine will expand from manufacturer, National, subnational, health facility levels to the child in this phase. A SMART CHILD wallet will be prepared for children in the target study population to track the vaccine from manufacturer to child. Integration with other blockchain based solutions in health and other relevant sectors will be considered

It was previously impractical to monitor a child’s vaccination status and trace a vaccine from manufacturer to a child with the existing paper-based excel systems. SMART CHILD Wallet is an important feature during this phase to validate vaccination of children. SMART CHILD Wallet is a blockchain-based child health record including immunization status in an encrypted form. Using public key anyone can monitor the immunization status of the children at any time through mobile. It also will allow to enter other relevant information such as adverse events following immunization and even other health related information in the same SMART CHILD wallet. While having a copy of a SMART CHILD wallet in health center the health workers can easily identify defaulted children by scanning the copy of the wallet.

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SMART CHILD Wallet

The following additional questions will be answered during phase three in real-time:

1. How many children have been immunized in a particular facility in the last month?2. What vaccines did a particular child receive and when? 3. Can the origin and status of vaccines each child received be determined?4. Which vaccines are causing more adverse events following immunization?

Additional benefit beyond vaccine management – Future considerations Smart Child credit Once the child fully immunized the system could generate some form of credit in their wallet, which can be used for any programs in future as bonus points. The child could even can convert these points into real cryptocurrency in the future as a savings account. The child may collect these bonus points for each vaccine dose they receive (or other health service if expanded) and could motivate parents to immunize children without defaulting.

Managing other supply The SMART Child block chain can facilitate the management of other supplies in health (medicines, biologicals, etc.) using the same blockchain as a platform.

Timeline Status

Sep 2018 Presenting the white-paper to UNICEF audience (only limited members through web)

Presented during the hub meeting

Oct 2018 Presenting the concept to the donors /innovation team Done Oct-Dec 2018

Finalization of the Whitepaper with the support of different experts on blockchain within UNICEF and WHO.

Presented in the Hub meeting, where feedback is collated

Jan-Feb Formulation of the task team: the task force will conduct Syria, Iraq, Libya and Tunisia have

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Mast. Job boss

2019 the feasibility study and discussion at different levels (manufacturer, government, health workers, ICT people of the countries) and select an appropriate vendor.

agreed to test this tool. It will be presented to the PPM HQ to get their approval by end of January.

Feb- March 2019

Further discussion with selected blockchain experts /partners beyond UNICEF and WHO and select vendors.

Already discussed with the Innovation team and further guidance will be obtained

March-Nov 2019

Testing in a number of countries and presenting the way forward to supply experts and other partners

Nov – Dec 2019

Brainstorming of the government on the innovative technology and prepare them for the implementation in additional countries.

2020 Scaling 2020-2030 Based on the lesson learned the phase two of the

SMART CHILD initiative will be planned and implemented

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ANNEX A: Mock ups of proposed blockchain smartphone display

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Mock up – Cold chain inventory and temperature monitoring

Web-based display of Vaccine management

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ANNEX B: Step-by-step guide to tracking vaccine on prototype

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