Consultancy: Technical Expert for the development of Traceability Adoption Roadmaps for Health Technologies (Therapeutics & Vaccines) using Global Standards, SCSC, Supply Division, Cph

Consultancy: Technical Expert for the development of Traceability Adoption Roadmaps for Health Technologies (Therapeutics & Vaccines) using Global Standards

Supply Chain Strengthening Centre, UNICEF Supply Division

Location: Home based

Duration: 11 months

Field Missions/Travel: Travel expected to at least two countries depending on COVID-19 travel restrictions. (Nigeria/Ethiopia)

Anticipated Start Date: October 2020

 

BACKGROUND: 

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 fulfill 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.

The pharmaceutical industry and the international development community has 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.

According to a BBC news report, the coronavirus has seen a surge in the production and distribution of falsified and counterfeit medical products, particularly those reported in the media as potential therapies for COVID-19. The anticipated high demand and price point of the new COVID-19 vaccine will only see intensified falsification efforts by criminal syndicates and high incidences of diversion/theft of the authentic vaccine once released. The highest risk is in low- and middle-income countries, where governance systems are not fully mature and tools and technical capacity to ensure good practices in manufacturing, quality control and distribution is limited. WHO estimates the trade in falsified and counterfeit medical products in low- and middle-income countries to be more than 30 billion dollars per year.

UNICEF works with various global partner organisations (including USAID, GAVI, WHO, World Bank, Global Fund) 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. One critical enabler for this goal is the adoption of a set of common coding standards, without which the implementation of traceability capabilities becomes unrealistic. Common coding standards would allow for standardised product identification and verification, thereby reducing inherent risks, complexities and costs. The chosen common coding standard in this instance is the GS1 standard.

While the implementation of traceability solutions in countries is typically a long-term initiative, the coronavirus has brought the need to develop a traceability solution in the near term, which can be scaled into a national system in the future. Because of the commitment to vaccine and pharmaceutical safety UNICEF, together with global partners has embarked on a programme of work to evaluate and explore options for a ‘minimal viable traceability’ model that could be deployed across countries to enable the traceability of health products in the very near term. This initiative would be coordinated through a global expert group comprising manufacturers, distributors, national regulatory authorities, traceability experts from public and private sector, UNICEF, the World Bank and other leading health financing and development organizations. UNICEF will play a co-leadership role including technical contribution towards a viable product.

The role of the Expert Group will include defining a clear strategy and plan which maps out the discrete processes and steps needed for a ‘minimal viable solution’, their impacts, where and when the various investments will be needed, where and when the benefits will be accrued and realised including roadmaps for the implementation of traceability, using GS1 standards. UNICEF therefore requires the services of a technical expert, to provide technical inputs in support of this traceability initiative.

OBJECTIVE:

The broad objective of the assignment is to ensure vaccine and pharmaceutical safety by reducing the risk of falsified and counterfeit products entering national supply chains. This objective would be achieved by providing a tool that enables unique identification, tracing and authentication capabilities at country level.

The specific objective of the assignment is to provide in-depth technical guidance and support to UNICEF and the Traceability Expert Group under the auspices of the WB Global Steering Group on Quality Assurance that leads to the development of a viable generic traceability model for rapid deployment in low- and middle-income countries. It is expected that the guidance provided shapes and culminates into a minimum viable traceability solution that can be presented to stakeholders for adoption.

 

DESCRIPTION OF ASSIGNMENT:

The assignment entails supporting the design from conceptual stage of a high quality scalable generic traceability solution that provides minimum traceability capabilities at country level. The assignment also includes supporting national governments in low- and middle-income countries prepare and deploy the identified minimally viable track and trace solutions for the specifically defined health technologies i.e. vaccines and therapeutics for COVID-19. To execute this assignment, the consultant will primarily work with UNICEF and will be part of Traceability Expert Group hosted by the World Bank and work with other relevant national government agencies such as National Regulatory Authorities, Ministries of Health etc. to complete the assignment.

The consultant will report to the Chief of Supply Chain Strengthening Centre UNICEF Supply Division and perform the following tasks;

i) Provide GS1/track and trace SME expertise and ‘honest brokering’ to assist the development of a generic minimally viable traceability model for supplies (vaccines, therapeutics and medical devices) including support towards development of a clear strategy and plan which maps out the discrete processes and steps needed for a ‘minimal viable solution’

ii) Provide expert guidance on traceability strategy and plan for COVID-19 vaccines and therapeutics clearly articulating;

o the benefits to be gained and how local and international stakeholder in the eco-system can share these benefits
o the risks to acquiring these benefits and mitigation strategies
o Defining the investments needed and when for a traceability solution including who should be investing
o Propose high level architectures of traceability models that should be used for a minimally viable solution
o Facilitate consensus around a generic traceability model by providing technical arguments for proposed solution including regulatory alignment.

iii) Produce a clear set of communication materials to share with countries

iv) To act as GS1 SME within UNICEF and to prepare and deliver communication, briefing and training materials including providing advice on serial number data exchange platforms

v) Work with other organisations such as USAID, GAVI, WHO, GS1 and regulators to communicate the functionality of the proposed model including the relevant processes and capabilities required for the management/distribution of master data at all relevant levels.

vi) Provide subject matter expertise to the implementation network to help clarify requirements the downstream, in market, national operations.

vii) Support pilot initiatives to trial the use of coding and traceability across national supply chains for COVID-19 vaccines and therapeutics in 1-2 countries. Document success and challenges for communication to other countries.

viii) Build an implementation network of key contacts and leads across the supply chain to enable the execution of the implementation roadmaps in pilot countries.

Deliverables:

1 Regular participation and contribution to the Traceability Experts Group chaired by the WB and other global level meetings with partners
2 Documented technical guidance to UNICEF/Countries/ Technical Expert Group on deployment of traceability model

3 Technical comments to documents/solutions/proposals issued by global partners

4 Leading, coordinating and participating in technical discussions with stakeholders across UNICEF and with other parties including UN agencies, donors, partners and non-state actors

5 Technical support to pilot initiatives to trial the use of coding and traceability across national supply chains for COVID-19 vaccines and therapeutics including development of country implementation roadmaps; progress reports for mid and end of consultancy period.

 

Requirements

Education:

Advanced, post-graduate degree is required, preferably in relevant field (e.g. computer/data science, statistics, business/public administration, public health, supply chain management, psychology or other quantitative degree).

Work Experience:

At least 10 years work experience working in GS1 trace and trace systems and general supply chain management at country and global level.

Competencies:

1) Core Values

• Commitment
• Diversity and Inclusion
• Integrity

2) Core Competencies

• Communication
• Drive for Results

3) Key Functional Competencies

• Analyzing
• Planning and Organizing

Language:

Fluent English, speaking/reading; French desirable

Technical Knowledge:

 

Knowledge Area	Description
GS1 keys	GS1 one has 12 identification keys which range from the ubiquitous GTIN through to the Global Model Number for Medical devices.  The GS1 keys are at the very core of the GS1 system and architecture.
GS1 GDSN	A GTIN based trade item electronic catalogue. GS1 Global Data Synchronization Network (GDSN) is driven by a system of GS1 certified product data pools.
GS1 EPCIS/CBV	The GS1 Electronic Product Code Information Service (EPCIS) and the companion standard, the Core Business Vocab (CBV), are GS1’s ISO approved standards for traceability for products, logistic units, assets etc.
GS1 AIDC	Automated Information Data Capture (AIDC) is a catch all term that includes several GS1 components: GS1 Application Identifiers, GS1 Data carriers (RFID e.g. UHF gen 2 programmed with GS1 Tag data standards, Barcodes 1D/2D)
GS1 EDI	GS1 Electronic Data Interchange (EDI) standards and guidelines ranging from EDIFACT/EANCOM and GS1 UBL, UN XML, GS1 XML, GS1 EPCIS XML
GS1 Digital Link	The GS1 Digital Link standard is a standard for smartphone use and can enable users to resolve the item’s barcode and retrieve data on a given product: i.e. Product information sheets for medication.
Classification systems	The GS1 Global Product Classification (GPC) which is the GS1 classification system.  United Nations Standard Products and Services Code (UNSPSC) is a taxonomy of products and services for use in eCommerce – this system is maintained by GS1 on behalf of the UN.

 

Evaluation Criteria

Qualified candidates are requested to submit:

1. Cover letter/application.
2. Financial quote at a daily rate in US Dollars including all taxes.
3.P11 form if not applying through UNICEF Employment site

4. At least 3 Reference contacts
5. A technical proposal with proposed methodology/approach to managing the project, showing understanding of tasks.
6. CV

Shortlisted applicants will be invited to a telephone interview and candidate will be selected based on the following criteria:

 

	Applicant
TECHNICAL QUALIFICATION (max. 80 points)
Overall Response (10 points)
Understanding of tasks, objectives and completeness and coherence of response
Overall match between the TOR requirements and proposal
Proposed Methodology and Approach (20 points)
Quality of proposed approach/methodology
Quality of project management methodology
Technical Capacity (50 points)
Relevance of consultant’s experience with similar projects and as per required qualifications
Quality of previous work
Demonstrated Technical Knowledge of GS1 Standards
TECHNICAL QUALIFICATION – Total Points
FINANCIAL PROPOSAL (max. 20 points)
daily rate, lump sum
Economy Air Ticket
Total estimated cost of contract (proposed contract fee only)
FINANCIAL PROPOSAL – Weight Combined Score
TOTAL SCORE (max. 100 points)

 

Applications should be submitted by 9th October 2020 Copenhagen time. Please indicate your availability and daily rate to undertake the terms of reference above. Applications submitted without a daily rate will not be considered.