UNICEF Update IPC Meeting - PowerPoint Presentation

Slide1

UNICEF Update

IPC Meeting

Washington, 6-7 June 2016Slide2

UNICEF expenditure by material groups, 2015Slide3

Global & local warehousing & transport

Kit-packing targets

Reduce

lead-timeHealth

kit-packing in Africa & IndiaInventory- as of 31 Dec

$199 M Globally

$44 M by SD

SD Managed Warehouses- 2015

$130 M Value of throughput

319,173 kits packed and shipped

Copenhagen:

highly automated, largest humanitarian warehouse; all hazards & GDP certified

Dubai:

nutrition, natural disasters

Shanghai:

Education kits

Panama:

serves LAC, natural disasters

Djibouti:

serves YemenSlide4

ACCESS TO HEALTH TECHNOLOGIES: UNICEF STRENGHTS

FIT FOR

PURPOSE: Government programmatic needs, policy, qualitySCALABILITY: network, experience and capacity in procurement for new and large scale programmesADDRESSING MARKET

NEEDS: Suppliers-users, funding.Slide5

Medicines and Nutrition: Procurement

>120 suppliers in 35 countries

Delivery to >110 countriesSlide6

MNC: some figures

Iron Folic Acid

2014: 400 M tabs (98% bottle 1,000 tabs)2015: 935 M (100% pack of 100 tabs) Antiretrovirals (ARVs)2015: 5.63

million packs of ARVs procured. Equivalent treatment for an estimated 403,500 adult patients for one year of first-line therapy in 37 countries (52 per cent decrease).ORS-Zinc Co-Pack

2014: 1.8 M packs2015: 10 M packs (sources in India, Bangladesh, Kenya and Nigeria)Amoxicillin DT2014: 8.5 M pneumonia treatments2015: 17.2 M pneumonia treatments. Supply to 33 countries

Ready to Use Therapeutic Food (RUTF)

2015: 34,817 MT procured (2.35 M cartons). Half of manufacturers and 38%of procurement in

programme

countries.

Development of

a Codex guideline for

RUTF to

facilitate the regulation and inclusion of quality RUTF into government programmes including adaptation to local formulas. Slide7

Amoxicillin DT – UNICEF engagement with Manufacturers

2007- 2009Better medicines for children project

2010Inclusion of Amoxicillin Dispersible tablets in priority list of Essential medicines1st UNICEF tender to explore market (REOI). Only 2 suppliers participated. 1 LTA established.20122nd UNICEF tender to expand supplier base. 5 Suppliers participated. 2 LTAs established.

Product shelf life established as main barrier UNICEF proactively worked with unsuccessful suppliers to establish shelf life2013 UNICEF engagement with 13 potential suppliers in India, Bangladesh and Africa

Number of LTAs increased to 3UN Commission funding to conduct ERP. 1st ERP REOI published with requirement for BE studies (9 manufacturers participated). Amox

DT from 2 manufacturers received ERP risk category 3

UNICEF feedback to unsuccessful manufacturers and active engagement to meet ERP requirements especially BE studies

2014

UNICEF increase number of LTAs to

4

2015

2

nd

UNICEF ERP REOI published (11 suppliers participated)

1 manufacturer from Africa (barriers for African suppliers; GMP, BE, product development)

2016

ERP 2 finalized. Total of 4 manufacturers attained ERP risk category 3.

More work needed to engage with suppliers to complete recommendations of ERP 2 and to enter market.Slide8

Technical Barriers to product developmentSlide9

Enablers to product developmentSlide10

Source:

UNICEF Supply Division

UNICEF’s QUALITY Assurance system

WHO “Model

Q

uality

A

ssurance

S

ystem

for

Procurement Agencies MQAS” - TRS

986 Annex

3

Pharmaceutical Inspection Cooperation Scheme (PIC/S)

principles on

Quality System

Requirements

for GMP

Inspectorates

European Union - Good Distribution Practice Guidelines

Documentation

system

in place

Quality manual

Division procedures

Centre

procedures

All procurement activities are centralized in UNICEF Supply Division (procurement by UNICEF country offices requires authorization)Slide11

Source:

UNICEF Supply Division

Pre-qualification

ACTIVITIES

Medicinal Products

Product

Questionnaire

as in WHO

“Model Quality Assurance System for

Procurement

Agencies MQAS” - TRS 986 Annex 3

Nutrition Products

Interagency Food Product Questionnaire

Manufacturers/ Suppliers

Review

of Good Manufacturing Practice

information:

- Technical Questionnaire

- Manufacturing license

- GMP or ISO certificates

- Site Master File

- Recent Inspection Reports

Contract

Manufacture

is

accepted if

both the manufacturer and the sub-contractor are approved

by UNICEF

Slide12

Source:

UNICEF Supply Division

inspections – KEY FACTS

145

GMP inspections carried

out 2010

-

2015

24 manufacturers found GMP non-compliant

Re- inspection based on a risk based approach (frequency 2-5 years)

Annual inspection plan establishedSlide13

Source:

UNICEF Supply Division

INTERNATIONAL Collaboration

ON INSPECTIONS

UNICEF relies

on WHO PQ of vaccines, HIV,

Malaria

and

TB

products

Joint

inspections with WHO PQ, ICRC,

MSF

UNICEF

is a Partner to the Pharmaceutical Inspection Cooperation Scheme (

PIC/S)

UNICEF shares inspection reports and information with international partners and vice versa

GMP reports and information from partners is used to prioritize and in some cases to

waive

GMP inspections

Good Manufacturing / Good Distribution

Practice

- Training

It is expected that manufacturers that are found GMP non-compliant by UNICEF partners inform UNICEF immediately.Slide14

Source:

UNICEF Supply Division

UNICEF Supply Division warehouse

UNICEF SUPPLY DIVISION

holds an Emergency Relief Authorization issued by the Danish Health and Medicines Agency

is legally authorized to procure, hold, supply and export medicinal products including narcotics and

psychotropics

has to comply with Danish and EU Pharmaceutical Legislation – Compliance with EU Good Distribution Practice Guidelines

operations subject to repeated inspection by the

Danish

Health

and

Medicines AgencySlide15

UNICEF Ideation for BMGF Pediatrics Initiative

Purpose:

Take stock

of previous work, pull together

existing data

, and identify

key experts

within UNICEF

Brainstorm current

challenges & opportunities

related to drug platforms or delivery technologies

“Rank” potential solutions according to

Impact + Chance of Success

Participants:

Technical specialists from Medicine & Nutrition;

Health Technology procurement

centres

;

Programme

specialist from Health

Programme

Division (NYHQ);

Ideation leads from Innovation Unit

Outcomes

Priority technology areas

identified

Challenges

(tech, manufacturing, implementation)

identified

Basis for

further elaboration with WHOSlide16

Priorities for Exploration

Idea

Specific

Benefits

Technology HurdlesHeat stability:

Zone

IVb

Eliminate

r

equirement for

mechanized ventilation for warehouses temperature control

Improved supply chain and better access

Difficult

to have

heat

stable

Long Term (Not less than 3 years)

Zone

IVb

formulations

Development of stable bases for Rectal suppositories

Dose optimization:

Concentrated doses (e.g. Vitamin A, or

efavirenz

600mg down to 400mg)

Reduced

liquid volume burden to children (Both oral and injectable)

Reduced

exposure to unnecessary quantities of drugs

Reduced toxicity and side effects

Reduced cost

Solubility of

large amount of API in small volume of liquid

Clinical studies for optimized doses

Development of optimized

formulations

Formulations

: ORS, azithromycin,

cefixime

, paracetamol dispersible; Rectal formulations/suppositories (

artesunate

); pro-drugs

Taste

masked ORS(

i.e not flavoured) to improved uptakeNew FSOD forms needed for these medicines for leading childhood illnessesTaste masking for bitter potassium salt in ORS a challenge

Dispersible tablet technology exists, but need to apply

it to these drugs

Dosing Flexibility:

A

cross weight and age bands; No need for precise measurements – minimal use of oral liquids.

Improved

supply chains

Prescribing flexibility

Addresses users with low literacy levels (No precise measurements)- better compliance

Review

existing clinical data

,

mainly of older drugs for possible dosing based on AGE and/or WEIGHT BANDS ( and not specific weight or BSA)-Therapeutic index?

Improving existing medicines:

Gentamicin injection packaging & presentation; Alternative zinc salts to improve taste. Current Zn PQ is sulfate.

Improved

and safe dosing of gentamicin (Narrow therapeutic Index)

Improved taste of Zinc

Gentamicin requires TDM

Alternative, better tasting Zn salts

Benzathine

Benzyl Penicillin:

move to more modern options for syphilis treatment

More

options for treatment

Limited sources of BBP API-

explore other possible single dose antibiotics

for Syphilis treatment, such as oral.

Review existing clinical evidence

Elimination of potentially harmful excipients:

(artificial sweeteners, colors, alcohol) especially for long term Rx

Safer medicines

(

no long term exposure)

Elimination

of

colorants

Good evidence for approved excipients, especially

on long term exposureSlide17

VACCINES- Appropriate

emergency and outbreak

response

OPV

Switch

Globally synchronized replacement of

tOPV

with

bOPV

within a two week window (17

th

April to 1

st

May 2016). Involving 155 countries and territories, 77 of them received their

bOPV

supply through UNICEF-SD.

Planning

Two years of planning with partners , manufacturers, regions and countries

The challenge of vaccine supply management was unprecedented for UNICEF, manufacturers and Countries

Switch Implementation

Close collaboration with all partners at the global , regional and country level to mitigate all potential risks and challenges to the Switch

Internal UNICEF Supply Division cross-center switch project team

Bridge financing mechanisms to support countries that had delayed funding for

bOPV

.

Impact

Timely delivery of

bOPV

to 76 countries. Ukraine received

bOPV

after Switch due to regulatory delays

18M doses ($2.5M) of

tOPV

that would have been wasted were saved through coordination and advice to countries on

tOPV

order cancellations and conversion to

bOPV

Future Cessation

Post switch surveys and lessons learnt are being documented for a successful cessation by 2020Slide18

Innovation and Process Improvement –

Pentavalent

tender 2017-2019: a multi-phased tender

Context:

Mature supply and demand market:

Vaccines: have high barriers to entry for new

mfrs

, 10years to establish new vaccine and plan and long production lead time for already pre-qualified vaccines (6-24 months)

Predictable

demand

: All countries fully introduced. A flat 150 million dose annual forecast through

Unicef

Competitive

supply

: 7 manufacturers with WHO pre-qualified products, estimated 2-300 % overcapacity in the market.

Tender

scope:

Covering 3 years: 2017-2019

RFP covering total forecasted demand in 2017 through 2019, including MICs not supported by Gavi.

Modality

and structure:

Multi-phased tender to enable to establish longer term visibility for production. but at the same time benefit from the market to relate to an reposition based on pricing/award information from phase 1.

All

phases pursue the tender objectives, but expect these can only be partially achieved in each phase, with focus on enabling price discovery in the first phase. Slide19

Innovation and Process Improvement –

Pentavalent

tender 2017-2019: a multi-phased tender

The lessons learned that incentivized a new approach; shared with industry in the procurement strategy development

Experience has shown that:

We need multiple suppliers, to ensure security of supply and to maintain long-term competition.

The major price shifts have been associated with

- competition

- market production capacity

- price transparency

- catalytic contracting incentives

Limited or no price incentive to have long duration tenders

Suppliers are different; in motivation, strategies, objectives, dependencies, cost structure

There is industry and partner desire for greater transparency on the trade off considerations in the award decision makingSlide20

Innovation and Process Improvement –

Pentavalent

tender 2017-2019: a multi-phased tender

Description of the multi-round tender Mechanics

2016

PHASE I:

January: Issuance of the RFP for supply of Pentavalent vaccines demand in 2017 through 2019.

April: Conclusion of the first awards for

up to 80%

of the demand in 2017 and 2018 supply years.

May: UNICEF publication of PHASE I awarded prices.

PHASE

II:

June: Bidders will be invited to confirm or amend offers for remaining quantities;

September: Finalization of awards for

up to 100% demand

in 2017 and 2018 supply years and intend to award

up to 20%

of 2019 supply year.

October: UNICEF publication of PHASE II awarded prices.

2017

Commencement of supply to countries from awarded suppliers.

2018

PHASE III: If decided that this will be pursued, then timing would be Q1 2018 (possibly following new GOI tender)

January: Bidders will be invited to confirm or submit amended offers for the remaining quantities;

March: Finalization of awards,

up to

100% of 2019 supply year.

April: Publication of the PHASE III awarded prices.Slide21

An innovative mechanism to

strengthen and rapidly scale country

cold chain systems; includes a component of installation and training services provided by the manufacturer on-site. Total estimated funding for the Platform USD 240 – 310 million over 5

years (excluding India).June GAVI board allocated USD 50 million to launch the implementation of the Platform. Countries are expected to co-finance 20-50% of investment upfront.

Application windows are aligned with applications for HSS funding; HSS funds may be used for co-financingGAVI COLD CHAIN EQUIPMENT OPTMISATION PLATFORMSlide22

1 Fund re-allocation only possible if either CCE or SC are part of the country HSS objectives

Gavi has established the CCE optimisation platform to support countries to improve their supply chain

What will the platform do?

Cold chain equipment is an essential component

of the vaccine supply chain that suffers serious challenges currently

The platform will

address cold chain equipment challenges

in three ways:

Strengthening the coverage and equity of immunisation

Promoting the right technology for each facility

Incentivizing reliable and robust equipment performance

How will countries apply?

The platform

application is in line with the HSS process

and includes additional information covering the platform

Specific country application process will be

adapted to the country situation

:

Countries applying for a new HSS grant will submit a single application

for HSS and the platform

Countries with an existing HSS grant or countries not using HSS money

will only submit a supplementary document covering the platform

How will it work?

The platform will support the

purchase, delivery, installation and training

of higher-performing CCE devices

Specifically, the platform will support eligible countries using a

tiered co-investment model

depending on a country GNI segment

In addition to providing funding to countries, the platform will

involve all key stakeholders

to improve the CCE market situation

1

2

3Slide23

Benin

Afghanistan

Burkina Faso

Burundi

Cambodia

Central African Rep.

Congo, DRC

Eritrea

Ethiopia

Gambia

Guinea

Guinea-Bissau

Haiti

Mozambique

Sierra Leone

Somalia

Tajikistan

Tanzania

Togo

Uganda

Zimbabwe

Preparatory transition phase countries (excl. India

1

)

–

Country co-investment: at least 50% / platform co-investment up to 50%

Cameroon

Cote d'Ivoire

Djibouti

Lao PDR

Lesotho

Mauritania

Myanmar

Pakistan

Yemen, Rep.

Accelerated transition phase countries with at least 2 full years from date of review by IRC prior to becoming fully self-financing (i.e., until at least 2018

2

)–

Country co-investment: at least 50% / platform co-investment up to 50%

Nigeria

Papua New Guinea

Solomon Islands

Sudan

Uzbekistan

Ghana

Zambia

Vietnam

Korea, Dem. Rep.

Liberia

Madagascar

Malawi

Mali

Kenya

Chad

Comoros

Nepal

Niger

Rwanda

Senegal

South Sudan

Initial self-financing countries –

Country co-investment: at least 20% / platform co-investment up to 80%

Nicaragua

Kyrgyz Republic

Sao Tome & Principe

1 India excluded from the

CCE

platform as it will be considered in the context of the India strategy

2 This period allows at least 2 years from the time of IRC review to allow a minimum of time to complete the grant prior to the end of

Gavi’s

support to a country.

Bangladesh

55 countries are eligible for co-investment from the platformSlide24

Need/Challenge

:

>95% of Zika diagnosis are clinical

Lead-time for lab diagnosis is 4-8 weeks, if lab is availableOutcome:

TPP launched April 13th jointly with WHO, to drive development of a productLab based AND Point of CareViral load & antibody

Prefer differential diagnosis (Zika-Dengue-Chikungunya), but min. is

Zika

Need/Challenge

:

Vector control measures largely ineffective

Epidemic modelled to continue for 2-5 years, spreading further.

Outcome

:

TPP under development with WHO

1

st

target population likely: child-bearing age women (15-39) and their male sexual partners

2

nd

priority target pop: full population catch-up; then part of EPI

programme

.

ZIKA Product

Profiles

Vaccine

Rapid Diagnostic TestSlide25

Timing

Zika Diagnostics Activity

Next few weeksFinalise components (TPP, Demand, APC framework)

3Q-20161st call for offers (RFP)

4Q-2016

1st

tranche of (conditional) awards and/or commitments

2Q-2017

2

nd

call for offers (RFP)

4Q-2017

2

st

tranche of (conditional) awards and/or commitments

Timing

Zika

Vaccine

Activity

~July (approx.) 2016

Webinar

with industry to present and get feedback on

preliminary

strategic components of the forecasted procurement quantities, RFP tender aspects and APC.

Then another webinar pre-RFP

4Q-2016

1

st

call for offers (RFP)

1Q-2017

1

st

tranche of (conditional) awards and/or commitments

2Q-2017

2

nd

call for offers (RFP)

4Q-2017

2

st

tranche of (conditional) awards and/or commitments

Key Next Steps- pulling commercial issues forwardSlide26

Supply

Financing

SolutionsSlide27

Pre-

Financing:

VII

– Throughput and Utilization EfficiencySlide28

Special

ContractingSlide29

Supply chain strengthening projects aim to address critical bottlenecks in collaboration with governments

SD works closely

with

country offices and

Governments

to

strengthen and optimize key supply chains

for

targeted products

to

reduce costs, stock-outs, wastage,

and improve performance –

DEFINITION OF NEED

BUDGETING & PLANNING

PROCUREMENT

DELIVERY & CLEARANCE

INSPECTION

WAREHOUSINGDISTRIBUTION, & REORDER

UTILIZATION BY END USER

MONITORING & EVALUATION

with a focus on sharing UNICEF expertise on markets, products,

procurement, warehousing

, inventory management, transportation,

system design, monitoring

and evaluationSlide30

Sustainable National Supply Chains

DEFINITION OF NEED

BUDGETING & PLANNING

PROCUREMENT

DELIVERY & CLEARANCE

INSPECTION

WAREHOUSINGDISTRIBUTION, & REORDER

UTILIZATION BY END USER

MONITORING & EVALUATION

Capacity Development supports

government initiatives to

achieve long term results

in

Results Areas:

Health

HIV/AIDS

WASH)

Nutrition

EducationSlide31

Share knowledge, experiences, innovative solutions and best practices.

Immunization SC Forum 15 countries : 31 May – 3 June

Nutrition SC Practitioners Forum 9 countries : 21 – 23 JuneCMS CEO Consultation 6 countries : 24 JuneVaccine Procurement Practitioners Forum

May 2015, Q3 2016

Convening countries for horizontal learningSlide32

Key Partnerships

GAVI Alliance

WHO – UNICEF

iSC

HUB

Interagency Supply Group

Global Fund – UNICEF MoUSlide33

Supply in Health Emergencies Preparations 2016

Affirm the Priority and Organise Ourselves:

Part of PD-EMOPS-SD matrixed project team taking the preparation forward

Internal SD Project TeamLiaising with Regional and Country SupplyDisease Specific Preparations: Supplies as a part of the Packages of Support

Review of standards products to revise/expandTop-up pre-positioned inventory at global level and guidance on local inventoryIdentify high risk countries that require health systems strengthening supportR&D pipeline

Institutional Strengthening:

Expand supply surge (IRT) rosters to include Infection Prevention Control and experience in public health outbreaks

HEPI training package for supply & logistics staff

Staff Safety: deployment kits for different disease outbreaks

Cooperation with Partners

WHO-WFP Pandemic Supply Chain work (supportive, but not full partner)

World Bank Pandemic FinancingSlide34

Disease Categories

Category 1 Focus to start: Zika-Dengue-Chikungunya, Coronavirus (SARS

CoV, MERS CoV), Ebola, Marburg & Novel Influenza A (Avian, Swine, Pandemic)However, work is also needed on Yellow Fever and Meningitis Slide35

Disease Specific Preparation- Products as a part of Packages of support

Review of existing

products needed for prevention, diagnosis, treatmentCategory 1 diseasesInclude products for Category 1 in SD’s Emergency Supply List (ESL)Quantify inventory, based on adaptable modelsEstablish commercial arrangements

Provide technical notes on new products as a part of programme packageCategory 2 diseasesEstablish commercial arrangement for Category 2 products, but don’t inventory

Quantification assumptionsAt risk population of population of 250,000 (same as CCCs/ESL)Response for first three months response

Based on actual outbreaks/historical data

Used to estimate patient numbers to determine stock requirements

Patient numbers, staff numbers, population used to calculate supply quantities

Decision-making Steps for increasing Inventory

Identify products

Quantify potential demand scenarios

Cost the demand scenarios

Compare with existing inventory and non-emergency demand

Refine and present scenarios for decision

Inventory increased as appropriate by 3Q

2016