ANNUAL REPORT 2015

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Pandemic Infl uenza Preparedness Framework

Partnership Contribution

ANNUAL REPORT 2015

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Pandemic Infl uenza Preparedness Framework

Partnership Contribution

ANNUAL REPORT 2015

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© World Health Organization 2016.

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Last updated: 08 July 2016

WHO/OHE/PED/2016.01

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List of Acronyms

AFRO AHI AMRO AOW BSF CDC

CPA EBS ECBS

ECN ECSPP

EID EMP

EMRO

EQAP ERC

EURO GIP GISRS

WHO HQ IATA ICAO

IDP

IHR ILI

Regional Offi ce for Africa Animal human interface Regional Offi ce for the Americas Area of Work

Band Selection Form

Centers for Disease Control and Prevention, Atlanta, Georgia (USA) Critical Path Analysis

Event-based surveillance

WHO Expert Committee on Biological Standardization

Emergency Communications Network Expert Committee on Specifi cations for Pharmaceutical Preparations

Emerging Infectious Disease

WHO’s Essential Medicines and Health Products Department

Regional Offi ce for the Eastern Mediterranean

External Quality Assessment Project Emergency Risk Communication Systems

Regional Offi ce for Europe

WHO’s Global Infl uenza Programme Global Infl uenza Surveillance and Response System

WHO headquarters

International Air Transport Association International Civil Aviation Organization (ICAO)

Institutional Development Plans for regulatory capacity

International Health Regulations (2005) Infl uenza-Like Illness

IPCIRR

ISST IVTM L&S MERS-CoV

MOH MS NIC NRA OIE OIR PCR PSC PHEIC

PIP BM PIP PC

PQ RO RRT RSS SARI SEARO SMTA-2 WHO CC

WPRO

Infection Prevention and Control Infl uenza Reagent Resource

Infectious Substance Shipping Training Infl uenza Virus Tracking Mechanism Laboratory and Surveillance

Middle East Respiratory Syndrome Corona Virus

Ministry of Health WHO Member State National Infl uenza Centre National Regulatory Authority World Organization for Animal Health Outbreak Investigation and Response Polymerase Chain Reaction

WHO Programme Support Costs

Public Health Emergency of International Concern

Pandemic Infl uenza Preparedness Biological Material

Pandemic Infl uenza Preparedness Partnership Contribution

WHO Prequalifi cation WHO Regional Offi ce Rapid Response Training

Regulatory Systems Strengthening Severe Acute Respiratory Infection Regional Offi ce for South-East Asia Standard Material Transfer Agreement-2 World Health Organization Collaborating Centre

Regional Offi ce for the Western Pacifi c

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The Pandemic Infl uenza Preparedness (PIP) Framework for the sharing of infl uenza viruses and access to vaccines and other benefi ts is a broad-based partnership adopted in May 2011 by the 194 Member States of the World Health Organization (WHO) to improve global pandemic infl uenza preparedness and response. The Framework established a PIP Benefi t Sharing System that includes an annual Partnership Contribution (PC) to WHO from infl uenza vaccine, diagnostic and pharmaceutical manufacturers using the WHO Global Infl uenza Surveillance and Response System (GISRS). In accordance with the high-level PC Implementation Plan 2013-2016¹, the PC is distributed across fi ve Areas of Work (AOWs):

Executive summary

1. Laboratory and Surveillance 2. Burden of Disease

3. Regulatory Capacity Building 4. Planning for Deployment 5. Risk Communications

The capacities developed from these AOWs will strengthen overall preparedness and capacity of countries to respond to public health emergencies (see fi gure below).

Vaccine virus development Antivirals Diagnostics

GISRS

Burden of Disease Laboratory

&

Surveillance

Vaccine production

Preparedness for pandemic interventions

Regulatory Capacity Building

Risk Communi-

cations

Planning for Deployment INFORMATION

IMPLEMENTATION of influenza specific interventions

(e.g. vaccination, treatment, etc.) PUBLIC HEALTH

DECISIONS

& STRATEGY

INFLUENZA OUTBREAK

Community

Influenza virus

REDUCTION OF MORTALITY

& MORBIDITY

Pandemic Infl uenza Preparedness Cycle

1 http://www.who.int/infl uenza/pip/pip_pcimpplan_update_31Jan2015.pdf?ua=1

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2 Refers to both seasonal and non-seasonal infl uenza viruses

3 Virus detection is the fi rst step towards vaccine composition, see Critical Path Analysis from detection to protection, World Health Organization 2015

By the end of 2015, approximately US$ 31 million was distributed for activities to prepare countries for pandemic infl uenza across the fi ve AOWs. Of these funds, 70% supported Laboratory and Surveillance capacity-building activities to detect, monitor and share novel infl uenza viruses. The balance supported capacity-building activities in the remaining AOWs. This report summarizes the results of implementing the PC in 2015, providing for the fi rst time Regional and Area of Work profi les.

Progress in 2015

Building upon processes and procedures for work planning developed in 2014, all projects met key milestones in 2015. Highlights are described in the sections below.

Laboratory and Surveillance

This area of work aims to improve country capacity to detect, monitor and share infl uenza viruses for risk assessment and to inform vaccine composition during an infl uenza pandemic. The focus is on expanding the Global Infl uenza Surveillance and Response System (GISRS) so that more laboratories improve the quality of their laboratory testing to better detect novel infl uenza viruses and share these viruses with their networks. In the Regions, 43 priority countries reported data on 21 indicators measuring their capacity to detect, monitor and share novel infl uenza viruses and to sustain these activities over time. Measurements taken for all countries in August 2014 (baseline) compared with subsequent measures made in February 2015 and again in August 2015 showed increasing capacity in all three areas.

Many countries have defi ned country implementation plans for infl uenza virus surveillance, demonstrating a commitment to sustaining pandemic infl uenza preparedness activities into the future. Others are

actively working to establish WHO-recognized National Infl uenza Centres (NICs). WHO offi cially recognized Zambia’s NIC in 2015, increasing the total number of Centres to 143 across 113 countries.

At the global level, improvement in virus detection was demonstrated by the results of the 174 laboratories from 137 countries around the world that participated in the WHO External Quality Assessment Programme (EQAP). A total of 103 countries reported 100% correct results on the assessment panels. Virus-sharing has been facilitated by better infl uenza detection capacity at the national level, coupled with training to ship infectious substances. In fact, 128 countries shared viruses² with WHO Collaborating Centres (CCs) for characterization in 2015. These national eff orts to detect and share infl uenza viruses strengthen GISRS and provide concrete evidence of improvements towards global pandemic infl uenza preparedness.³

Burden of Disease

Preparation for the next pandemic will require increased global vaccine production capacity. This can only be achieved if global seasonal vaccine demand increases in parts of the world where it is not widely used. The introduction of seasonal vaccine in new countries will require disease and economic burden data to allow policy-makers to compare the burden of infl uenza with other health priorities. WHO is convening the countries that are doing Burden of Disease studies so that they can share their results and increase the overall picture of burden of infl uenza in diff erent country setting. Forty countries, including the 19 PIP PC priority countries, are currently engaged in estimating the burden of infl uenza using WHO methodology and technical support. These national estimates will be used to produce a robust global estimate for the burden of infl uenza by the end of 2016.

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4 http://www.who.int/risk-communication/pandemic-infl uenza-preparedness/en/

Regulatory Capacity-Building

Rigorous regulatory processes and practices are essential to ensuring the approval and use of safe and eff ective infl uenza vaccines and related products in the event of a pandemic. 2015 saw regulatory capacity assessments performed in 14 out of 16 PIP priority countries. These assessments help countries develop the standards necessary for eff ective regulatory systems, market authorization processes and pharmacovigilance. In 2015, 14 national regulatory authorities (NRAs) adopted the Collaborative procedure between WHO Prequalifi cation of Medicines Programme and National Regulatory Authorities for the assessment and accelerated national registration of WHO-prequalifi ed pharmaceuticals and vaccines. This agreement between WHO and national governments accelerates regulatory approval of infl uenza vaccines and related products in a public health emergency.

Planning for Deployment

Vaccines and anti-viral treatments need to be deployed quickly to where they are needed from manufacturers, global stockpiles or donating countries in order to save lives during an infl uenza pandemic. The PIPDEPLOY simulation tool was developed in 2015 to measure and improve the time it takes to deploy vital infl uenza products into countries during a pandemic. The fi rst simulation will take place in 2016, paving the way for improvement in response time by making sure that national supply chain and regulatory systems together work effi ciently and eff ectively during a pandemic.

Risk Communications

Risk communication during a crisis can prevent the spread of rumours and false information that create panic and hamper eff ective public health measures.

New guidelines, tools, resources, curricula and materials were developed to disseminate pandemic infl uenza skills and knowledge and build capacity in pandemic infl uenza risk communication globally.⁴Last year alone, 1500 people from 122 countries were trained in Risk Communications.

Preparing for pandemic infl uenza has stimulated the need for specialized training in emergency communication and helped to develop the Emergency Communication Network (ECN). The ECN now has a roster of 150 trained communicators who can be deployed to emergency situations to provide advice and support for protecting populations at risk.

Next steps toward preparedness for pandemic infl uenza

The Regions and AOW Programmes have defi ned activities for 2016 that build upon the achievements of 2015. A third round of data collection on the 21 indicators of laboratory and surveillance capacity for the 43 PIP priority countries was collected in the fi rst quarter of 2016. This collection will help measure the impact of the PIP PC funds over time and track improvements in laboratories globally to detect, monitor and share infl uenza viruses with human pandemic potential.

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Overview of the PIP Framework

Background

Novel infl uenza viruses with human pandemic potential can emerge anywhere in the world at any time. All countries, therefore, need the capacity to detect, monitor and share these viruses so that response measures can rapidly be developed and global populations protected in the event of a pandemic. The PIP Framework, which grew out of the re-emergence of A(H5N1) infl uenza in 2004, is a broad-based partnership adopted by the 194 Member States of WHO on 24 May 2011 to improve global pandemic infl uenza preparedness and response. The Framework brings together public and private partners, recognizing that “Member States have a commitment to share on an equal footing H5N1 and other infl uenza viruses of human pandemic potential and the benefi ts, considering these as equally important parts of the collective action for global public health”

(PIP Framework, section 1, Principle 3).

For over 50 years, WHO has been at the forefront of infl uenza virus monitoring and risk assessment through the work of a global alert mechanism for the emergence of infl uenza viruses with human pandemic potential known as the Global Infl uenza Surveillance and Response System (GISRS). This international network of public health laboratories specialized in infl uenza, coordinated by WHO, and provides year-round surveillance of infl uenza through its 143 laboratories in 113 countries.

Under the PIP Framework, countries are expected to share viruses with human pandemic potential in a rapid, timely and systematic manner with GISRS.

Likewise, manufacturers are expected to provide funds and real-time access to essential infl uenza products at the time of a pandemic. This arrangement is called the PIP Framework Benefi t Sharing System. It has two operational tools that ensure that manufacturers which use GISRS share the benefi ts that arise from such use.

These two tools are:

1. The annual Partnership Contribution (PC), and 2. Standard Material Transfer Agreements-2 (SMTA2)

which ensure that at the time of the next pandemic, WHO will have real-time access to specifi c quantities of response supplies, notably vaccines, antiviral medicines and diagnostics, that will be deployed to countries in need.

The objective of the Benefi t Sharing System is, on the one hand, to increase global health security by strengthening capacities where they are weakest, and on the other, to ensure equity of access to pandemic response products by all countries, regardless of income level. PIP PC funds support the capacity-building eff orts that are underway.

Key principles of the PIP Framework

In the PIP Framework, Members States affi rmed the fundamental principle that virus-sharing and benefi t- sharing are equally important parts of collective action of global public health. Intrinsic to this are several other principles which guide implementation of the PIP Framework. They are transparency, equity, collaboration and partnership.

Transparency guides all facets of the implementation of the Framework. Thus, program and fi nancial information is freely shared with collaborators and partners: the internet-based PIP PC implementation portal and the PIP webpage enable regular access to up-to-date facts, fi gures and reports on the use of funds and indicators measure progress towards meeting milestones and targets.

Equity refers to the commitment that WHO Member States make to ensure that at the time of the next pandemic, all countries will have real-time access to life-saving pandemic infl uenza vaccines, diagnostic tests and anti-viral medicines. The conclusion of SMTA2s embodies the work that is being carried out to achieve greater equity.

Collaboration on preparedness activities brings together the three levels of WHO (headquarters, regional and country offi ces) that work closely with GISRS laboratories, industry and civil society to implement capacity-strengthening projects in priority countries.

PIP aims to build a partnership with its broad stakeholder base to promote shared ownership and support of the PIP objectives and coherence on the implementation of its strategies.

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Overview of achievements

The PIP PC funds are used to implement activities in the fi ve AOWs defi ned in the PIP Partnership Contribution Implementation Plan 2013-2016⁵, approved by the Director-General in January 2014 and updated in January 2015.

These AOWs are:

1. Laboratory and Surveillance 2. Burden of Disease

3. Regulatory Capacity-Building 4. Planning for Deployment 5. Risk Communication

Activities identifi ed for support under each AOW are directly linked to the fi ndings of the Gap Analyses conducted in 2013⁶.

Figure 1: The fi ve Areas of Work (AOWs) supported through PIP PC

5 http://www.who.int/infl uenza/pip/pip_pcimpplan_update_31Jan2015.pdf?ua=1 6 http://www.who.int/infl uenza/pip/pip_pc_ga.pdf?ua=1

This report presents an overview of the achievements and challenges in 2015. It provides technical descrip- tions of the work undertaken as well as fi nancial accounting of the funds for each AOW through Regional and AOW profi les. Summaries of the achievements of 2014 are presented side-by-side with those of 2015 to highlight that adequate preparation in 2014 led to the improvements in preparedness in the WHO regions reported here for 2015.

PREPAREDNESS

Regulatory Capacity Building

Burden of Disease Laboratory

& Surveillance

Risk Communications

Planning for Deployment

RESPONSE

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Summary of 2014 Achievements

During 2014, the PIP Secretariat developed key processes and procedures to enable effi cient, eff ective and transparent management of funds, and implementation of activities using standard approaches to monitor and report on technical and fi nancial progress. During this time, 54 work plans were developed across the three levels of WHO. Starting in April 2014, funds were distributed against approved 2014 work plans and by August 2014, US$ 17.4 million had been distributed across headquarters, Regional Offi ces and Country Offi ces to implement activities in the fi ve AOWs. These actions provide a fi rm foundation for the results of 2015.

The highlights of 2014 are presented in the table below.

Table 1: Highlights from 2014⁷

Laboratory and Surveillance capacity-building

Burden of Disease

Regulatory capacity-building

Planning for Deployment

Risk

Communications

21 capacity indicators were defi ned to measure progress towards outputs and outcomes.

Baseline data were collected in the 43 countries prioritized for support in this area.

Seven countries participated in a training to learn how to develop national disease burden estimates using a new WHO manual.

Work started to revise the expedited review procedure to facilitate licensing of pre-qualifi ed antivirals and vaccines.

The new Collaborative procedure to address assessment and accelerated national registration of WHO-prequalifi ed pharmaceutical products and vaccines was developed and endorsed by the Expert Committee on Specifi cations for Pharmaceutical

Preparations (ECSPP) in October 2014.

Model agreements between WHO and recipient countries of pandemic products were drafted.

Signifi cant training materials were developed, translated and published online.

AREA OF WORK ACTIONS

Table 2: Highlights from 2015 (See Regional and AOW profi les for complete results)

Laboratory and Surveillance capacity- building^8,9

Burden of Disease

Regulatory capacity- building

RiskCommuni- cations

Established and functioning event-based surveillance for infl uenza in 12 of the 43 PIP priority countries.

128 countries worldwide shared virus¹⁰ with WHO CCs, H5 Reference Laboratories and Essential Regulatory Laboratories.

66 countries consistently

reported epidemiological data to regional or global platforms.

114 countries consistently reported virological data to a regional or global platform.

103 countries participated in EQAP and scored 100%.

40 countries, including 19 PIP PC priority countries, are estimating the burden of infl uenza using WHO methodology and technical support.

3 PIP priority countries completed robust national burden of

infl uenza estimates.

6 countries are piloting the WHO economic burden tool.

WHO collaborative procedure for accelerated regulatory approval of infl uenza products adopted by 14 countries¹¹.

14 of 16 priority countries assessed for regulatory capacity.

PIPDEPLOY tool to improve deployment of infl uenza products to countries was developed. The fi rst simulation will start mid- 2016.

17 target countries¹² had specifi c risk communication training and/

or workshops.

The ECN has a roster of 150 people able to be deployed to health emergencies worldwide.

7 See Pandemic Infl uenza Preparedness Framework Partnership Contribution 2013-2016:

Annual Report 2014. World Health Organization 2015 for complete 2014 results.

8 Data from regional and global data bases (see Annex 1)

9 Achievements for L&S at WHO HQ level were made with funds from PIP PC and other donors

10

Refers to seasonal and pandemic potential infl uenza viruses 11

United Rep. of Tanzania, Uganda, Ethiopia, Ghana, Kenya, Mozambique, Burkina Faso, Cameroon, Benin, Mali, Armenia, Sri Lanka, Bhutan, and Myanmar 12 Barbados, Cambodia, Dominica, Egypt, Kazakhstan, Kenya, Republic of Moldova,

Mongolia, Nepal, Saint Lucia, Saint Vincent and the Grenadines, Senegal, Sudan,

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Summary of 2015 Achievements

While 2014 focused on developing foundational processes and procedures for the PC implementation across all AOWs, by 2015 work was well underway to ramp up the implementation pace of preparedness projects in PIP priority countries. In 2015, WHO had available US$ 13.3 million for Preparedness work. The activities supported with these funds are starting to show concrete improvements in pandemic infl uenza preparedness as shown in Table 2.

Partnership Contribution Collection Process

PIP Framework Section 6.14.3 establishes an annual Partnership Contribution (PC) to be paid to WHO by infl uenza vaccine, diagnostic and pharmaceutical manufacturers using the WHO GISRS. Section 6.14.3 specifi es that the sum of the annual PC is equivalent to 50% of the running costs of GISRS, which in 2010 were estimated to be US$ 56.5 million, setting the annual amount to be collected at US$ 28 million. The collection process begins in January/February each calendar year with the publication of the PC questionnaire. This starts the process of collecting the contribution that funds the work plans for the following calendar year. The process is fully described in the following sections.

Questionnaire & Contributor identifi cation

Every year, WHO issues the Partnership Contribution Questionnaire in order to identify potential Contributors.

The purpose of this annual Questionnaire is to determine if an entity is an infl uenza vaccine, diagnostic [or]

pharmaceutical manufacturer using the GISRS. The PIP Framework considers a Contributor to be a company/

institution that meets the following criteria:

1. is an infl uenza vaccine, diagnostic and pharmaceutical manufacturer (currently or in the past 15 years);

2. uses (or has used in the past 15 years) the WHO GISRS;

and

3. has developed or produced a human infl uenza vaccine, antiviral, diagnostic or other product to

13 As of 02 March 2016

prevent, treat or diagnose infections from H5N1 or other infl uenza viruses with human pandemic potential and such product has obtained provisional or fi nal licensure, registration or market authorization.

“Use of GISRS” means a company/institution has used or received:

•

Materials (e.g. virus materials, such as candidate vaccine viruses, wild-type viruses, cDNA, plasmids, or reagents); and/or

•

Services (e.g. antigenic and genetic characterization of candidate vaccine viruses/seed material, antiviral susceptibility assays); and/or

•

Information (e.g. sequence information, epidemiological data, antiviral susceptibility data, pre and post-vaccine composition meeting reports);

developed and/or provided by or through GISRS.

Potential Contributors are identifi ed by the PIP Secretariat using information from manufacturer associations, internet searches and the Infl uenza Virus Traceability Mechanism (IVTM) which identifi es non- GISRS recipients of PIP Biological Materials (PIP BM).

A broad range of organizations including academic institutions, government agencies, non-profi t organizations and manufacturers of infl uenza products are identifi ed. A link to the Questionnaire is sent by email to all identifi ed entities.

Companies/institutions are identifi ed as Contributors through their answers to the Questionnaire. Those so identifi ed are sent a “Band Selection and Certifi cation Form” (BSF) which requests them to calculate their year average annual infl uenza product sales for 4 years and to use that fi gure to place themselves into one of 23

“sales bands”. WHO enters each company’s sales band into a weighted formula to determine how much each contributor will pay. Once the formula is applied, each contributor is sent an invoice which is payable within 30 days.

Table 3: PC Collection (2013-2016)

Entities contacted Questionnaire Responses Contributors identifi ed Funds received¹³

194 89 32

$27,538,586

250 102 42

$26,964,062

256 90 39

$18,813,522

2013 2014 2015

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Results of the Partnership Collection in 2014

Based on answers to 2014 Questionnaire, 42 contributors were identifi ed and US$ 26,964,062 was collected to support activities implemented in 2015.

Results of the Partnership Collection in 2015

Funds from the 2015 PC Collection process will support activities in work plans approved for 2016 implementation. Collection of 2015 funds is still underway. Detailed results of the PC collection are found in Annex 2.

Use of PC funds

PIP PC funds were used in 73 countries in 2015. (See Figure 2)

Why fi ve Areas of Work?

The infl uenza A(H1N1) pandemic of 2009 highlighted weaknesses in preparedness at the global, regional and country levels. Two systemic reviews¹⁴ were performed in its immediate aftermath that identifi ed areas where global action was needed to strengthen the world’s capacity to eff ectively and effi ciently respond to a pandemic event. Lessons learnt from these reviews and the PIP Framework’s Gap Analyses¹⁵ led the PIP Advisory Group to recommend that the PIP PC preparedness funds be used to strengthen capacity in fi ve critical areas: laboratory and surveillance capacity, knowledge of disease burden, regulatory aff airs, planning for deployment of pandemic response supplies and risk communications. These recommendations were

Figure 2: Countries using funds from PIP PC, 2015

14 These reviews were 1) a review of the International Health Regulations (2005) (http://apps.who.int/gb/ebwha/pdf_fi les/WHA64/A64_10-en.pdf) and 2) a review of the deployment of A(H1N1) vaccine(http://www.who.int/infl uenza_vaccines_plan/

resources/h1n1_vaccine_deployment_initiative_moll.pdf).

15 Pandemic Preparedness Partnership Contribution, 2013-2016: Gap Analyses (November 2013)

The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement.

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16 Critical Path Analysis: From detection to protection, World Health Organization 2015.

accepted by the Director-General. Each AOW developed specifi c goals to improve pandemic infl uenza preparedness. These are highlighted below in Table 4.

Expected Outcomes

Based on guidance from the Advisory Group, lessons learned, the Gap Analyses and interactions with stakeholders; the Secretariat developed a high-level Partnership Contribution Implementation Plan 2013- 2016. The Plan specifi es that in a decade’s time the allocation of the PC resources should result in the following improvements in pandemic preparedness:

•

All countries should have in place well established core capacities for surveillance, risk assessment and response at the local, intermediate and national level, as required by the IHR.

Table 4: Pandemic infl uenza preparedness goals by AOW

Laboratory and Surveillance capacity-building Burden of Disease

Regulatory capacity-building

Risk

Communications

Improve national ability to detect, monitor and share novel infl uenza viruses

Provide training and support for burden of infl uenza estimates which will contribute to the development of a global burden of infl uenza estimate Build national regulatory capacity so that vaccines, diagnostic tests and antiviral medicines for infl uenza can be deployed quickly

Plan for effi cient and equitable deployment of vital supplies for pandemic infl uenza Build national capacity to provide accurate public health information during emergencies

•

All countries should have access to a NIC laboratory - the backbone of GISRS.

•

A clearer picture of the health burden that infl uenza imposes on diff erent populations should be established.

•

All countries should have access to pandemic infl uenza vaccines and antiviral medicines to help reduce pandemic-related morbidity and mortality.

•

All countries should have improved capacities to carry out eff ective risk communications at the time of a pandemic.

An analysis of the full scope of preparedness work that will be required from the time of detection of a novel virus to the protection of the global population was developed in the Critical Path Analysis (CPA)¹⁶. This analysis showed that additional areas will require PC resources to achieve the improvements in pandemic preparedness foreseen by the PC Implementation Plan 2013-2016.

How are results measured across Areas of Work?

The PC Implementation Plan 2013-2016 sets out the expected outcomes and outputs for the 5 AOWs currently supported. Each AOW has a set of performance indicators that measure progress towards delivery of defi ned outputs (deliverables) and expected changes (outcomes) in levels of preparedness for an infl uenza pandemic. These outcomes and outputs are measured biannually using defi ned indicators. Baselines and targets are set and reviewed regularly for each indicator.

Analysis of progress towards these targets is performed every six months in order to ensure activities are appropriate or draw attention to specifi c areas that need corrective action. In the following section, progress is presented by outputs and outcome in each AOW profi le.

The profi les focus on the achievements of 2015 and preview work underway for 2016.

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The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement.

Laboratory and Surveillance Profi le

Following the 2009 A(H1N1) pandemic, strengthening laboratory and surveillance (L&S) capacities were identifi ed as key to improving national capacities to conduct risk assessment and thereby increasing global preparedness. Early in the process to distribute resources among AOWs, it was recommended that L&S receive the largest proportion of funds. Thus, 70% of preparedness funds are allocated to strengthening L&S capacities in countries.

All activities funded with the PC aim to achieve the following outcome: “The capacity to detect and monitor infl uenza epidemics is strengthened in developing countries that have weak or no capacity.” The majority of activities are under the responsibility of Regional Offi ces that work through Country Offi ces to strengthen capacities where they are most needed – in the laboratories and at the fi eld level. Thus, at the regional

level, emphasis is placed on: 1) strengthening national capacities to detect respiratory disease outbreaks due to a novel virus (Output 1); and 2) strengthening national capacities to monitor trends in circulating infl uenza viruses (Output 2). Tying this together at the global level is an emphasis on strengthening collaboration, through the sharing of information and viruses, with a view to improving the quality of the GISRS system (Output 3). The focus is on strengthening data sharing, enhancing laboratory capacities for infl uenza diagnosis by polymerase chain reaction (PCR), improving quality of viruses shared from countries, and strengthening capacities to ship infectious substances (dangerous goods).

This section will provide an overview of achievements in each region (Regional Profi les) followed by the achievements at the global level.

Improve national ability to detect, monitor and share novel infl uenza viruses

Target countries: Afghanistan, Algeria, Armenia, Bangladesh, Bolivia, Burundi, Cambodia, Cameroon, Chile, Congo (Republic of ), Costa Rica, Djibouti, Dominican Republic, Ecuador, Egypt, Fiji, Ghana, Haiti, Indonesia, Jordan, Korea DPR, Kyrgyzstan, Lao PDR, Lebanon, Madagascar, Mongolia, Morocco, Mozambique, Myanmar, Nepal, Nicaragua, Sierra Leone, South Africa, Suriname, Tajikistan, The United Republic of Tanzania, Timor-Leste, Turkmenistan, Ukraine, Uzbekistan, Viet Nam, Yemen, Zambia

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Building Laboratory and Surveillance Capacity in 43 PIP priority countries

Since 2013, PIP PC funds have been directed to build or strengthen laboratory and surveillance in countries across all WHO regions to improve global pandemic infl uenza preparedness.¹⁸ Gap assessments were conducted and countries were prioritized¹⁹ according to pre-defi ned criteria²⁰ and taking into account the following factors identifi ed by the PIP Advisory Group²¹:

•

Fairness, equity and public health risk, particularly vulnerability to infl uenza A(H5N1);

•

Be evidenced-based and consider indicators such as core capacities under the IHR, income, disease burden and epidemiology;

•

Consider the need for countries to have the critical foundation of epidemiology and laboratory surveillance;

•

Take into account the modest amount of PC resources;

•

andEnsure the involvement of at least on country from each region while maintaining the focus on countries with the highest need.

The focus for the 43 PIP PC priority countries is on improving laboratory and surveillance capacities so that in a decade’s time, all countries are able to detect and monitor infl uenza epidemics²². Twenty-one indicators were developed to measure progress (See Table 5). The indicators are grouped into four categories and data are collected every six months against each indicator. These indicators measure a country’s ability to detect, monitor and share novel infl uenza viruses, as well as the ability to sustain these practices into the future. Each indicator is scored for each target country according to three levels of capacity²³ as provided by country representatives and confi rmed through appropriate documentation. An average of these scores across the indicator categories is presented in the profi les for three data collection periods:

•

Baseline (August 2014),

•

Period from September 2014 to February 2015,

•

Period from March 2015 to August 2015.

17 31 August 2014

18 The African Regional Offi ce (AFRO), the Regional Offi ce for the Americas (AMRO/

PAHO), The European Regional Offi ce (EURO), The Eastern Mediterranean Regional Offi ce (EMRO), The South-East Asia Regional Offi ce (SEARO), and The Western Pacifi c Regional Offi ce (WPRO).

19 See List of PIP PC Implementation target countries for Regional Offi ce in Annex 1.

20 See http://www.who.int/infl uenza/pip/pip_pcimpplan_update_31Jan2015.pdf?ua=1 at pages 9-10.

21 See http://www.who.int/infl uenza/pip/pip_pcimpplan_update_31Jan2015.pdf?ua=1 at page 8, Section 5 “Methodology”

22 See www.who.int/infl uenza/pip/pip_pcimpplan_update_31Jan2015.pdf?ua=1 at page 12 “Outcome”

23 1= no capacity, 2= partial capacity, 3= full capacity

Detection capacity (43 PIP priority countries)

Number of countries with an established and functioning event-based surveillance system

Monitoring capacity (43 PIP priority countries)

Number of countries able to consistently report and analyse virological data

Number of countries able to consistently report and analyse epidemiological data

8 43 12

26 5

35 17

30 9

Output indicators

Support to WHO Regions and Countries

BASELINE ¹⁷ TARGET STATUS

(18)

Measuring progress in 2015

Indicators of performance

Laboratory and Surveillance indicators have been grouped across four categories (see Table 5 below) to measure the capacity of target countries to detect, monitor and share novel viruses with human pandemic potential and to sustain these actions into the future.

The Regional Profi les presented here highlight pre- PIP PC gaps in Laboratory and Surveillance. They also integrate the ongoing work of the four other AOWs into regional profi les to show how all areas are working together through the WHO Regional Offi ces to strengthen national pandemic infl uenza preparedness.

Tracking capacity development over time

Capacity-building needs continuous eff orts over a signifi cant period of time, especially in light of changing country political situations or laboratory staff turnover.

WHO will monitor these country-level indicators over time to track the progress of priority countries towards improved national ability to detect, monitor and share novel infl uenza viruses.

This remainder of this section will provide an overview of achievements by region (Outputs 1 and 2) followed by the achievements at the global level (Output 3).

Table 5: Laboratory and Surveillance capacity indicators measured for each of the 43 PIP priority countries.

See Annex 1 for details of indicator rationale and scoring criteria

Algorithm for laboratory detection of unusual infl uenza viruses

Registration in IRR or receiving testing kits from WHO CCs

PCR Testing ability

PCR Quality for non-seasonal infl uenza viruses

PCR Quality for seasonal infl uenza viruses

Sequencing ability

National “Early Warning” systems or Event-Based Surveillance (EBS)

National surveillance for ILI

National surveillance for SARI

Integration of laboratory and epidemiological data

Regular infl uenza surveillance reports/bulletins

Coordination at the Human Animal Interface

Reporting lab surveillance data to WHO through FluNet and/or regional databases Reporting epidemiologic surveillance data to WHO through FluID and/or regional databases

Shipping capacity for infectious substances Sharing samples with WHO CCs

Sharing sequence data

Country Implementation Plan developed

Rapid Response Team Training

Evidence of sustainability (integration in national plan) WHO-recognized National Infl uenza Centre

DETECTION MONITORING SHARING SUSTAINABILITY

(19)

Algeria

Burundi Cameroon

Ghana

Madagascar Mozambique Republic of Congo

Sierra Leone

South Africa Tanzania Zambia

Regional Offi ce for Africa (AFRO)

PIP PC Achievements 2015

In 2015, the region experienced several major infectious disease outbreaks including Ebola, Cholera, and Meningitis, making it diffi cult to manage competing disease priorities, often with the same staff responsible at the national levels for sentinel surveillance of all infectious diseases. The Regional Offi ce for Africa (AFRO) focused on supporting Ghana and the United Republic of Tanzania with PIP PC implementation funds. These funds allowed AFRO to provide training and technical support to these PIP target countries to improve submission of weekly surveillance information to WHO’s Collaborating Centre (US CDC) and GISRS laboratories via FluNet and weekly epidemiological bulletins. Provisional data analysed shows the results for all 11 countries that are the target of PIP PC funds for Laboratory and Surveillance capacity-building, even though only two countries (Ghana and the United Republic of Tanzania) have achievements that can be directly attributed to PIP funds in 2015.

Detection capacity

Sharing Capacity

Number of countries sharing infl uenza virus with WHO CCs, H5 Reference Laboratories and Essential Regulatory Laboratories at least once a year in the past two years

Monitoring capacity

1

NA²⁸

11

NA²⁹

3²⁵

8³⁰ 8

1

11 11

8²⁶ 0²⁷

Output indicators for priority countries:

Algeria, Burundi, Cameroon, Congo, Ghana, Madagascar, Mozambique, Sierra Leone, South Africa, The United Republic of Tanzania and Zambia

27 Lower capacity due to Ebola outbreak 28 No regional baseline, global baseline is 90 29 No regional target, global target is 108

30 Algeria, Cameroon, Ghana, Madagascar, Mozambique, South Africa, United Republic of Tanzania, Zambia

24 31 August 2014

25 Ghana, Mozambique, South Africa

26 Algeria, Cameroon, Ghana, Madagascar, Mozambique, South Africa, the United Republic of Tanzania, Zambia

2015 Laboratory & Surveillance programmatic results for PIP target countries

BASELINE ²⁴ TARGET STATUS

The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement.

(20)

AFRO Detection Capacity AFRO Sharing Capacity

AFRO Monitoring Capacity

AFRO Sustaining Capacity All countries have demonstrated capacity in PCR testing.

Laboratory algorithms and reagents are in place in most priority countries. Event-based surveillance for infl uenza is still a gap in AFRO with only three countries having full capacity for EBS.

Countries still need support for shipping viruses to WHO Collaborating Centres. Nonetheless, Ghana benefi ted from training at a WHO Collaborating Centre (United Kingdom) and provided training to neighbouring countries (Nigeria, Côte D’Ivoire) in infl uenza virus isolation techniques, thereby improving ability in the region to isolate infl uenza viruses for shipping to GISRS laboratories.

Monitoring capacity continues to improve from the baseline level (31 August 2014). One of the biggest challenges in this region is assisting countries to develop and update their plans for national infl uenza sentinel surveillance. Guidelines, protocols for investigation of respiratory illness outbreaks and training were produced by the Regional Offi ce through PIP PC funds.

Ghana benefi tted from the guidance and began to actively send samples to the National Infl uenza Centre for testing during 2015. Weekly epidemiological bulletins are regularly being produced in all but two target countries in the region.

Countries are working to develop national plans for infl uenza surveillance. In 2015, Zambia obtained WHO certifi cation as a National Infl uenza Centre³¹, increasing regional capacity to detect and monitor viruses with human pandemic potential.

31 Tanzania obtained WHO certifi cation in 2014

Average score

Baseline March 2015 September 2015

Target 3

2

1

0

Average score

Target 3

2

1

0

Average score

Target 3

2

1

0

Average score

Target 3

2

1

0

(21)

0

0 0

0

2

6 6

NA³⁸ 18

NA³⁹

0³²

Pending tools

0^{33, 34}

3 0^{35, 36}

2⁴⁰ Burden of Disease

Regionally representative estimates

Number of countries supported by the Partnership Contribution with infl uenza disease burden estimates by 2016

Planning for Deployment Country readiness

Countries and partners accessing web-based planning tools Regulatory Capacity Building

Targeted training

Number of countries which developed regulatory capacity to oversee infl uenza products including vaccines, antivirals and diagnostics in case of a pandemic

Common approach for accelerated approval

Number of countries with a common approach for accelerated regulatory approval of infl uenza products in a public health emergency

Training on risk communications

Number of trainings completed on IHR risk communications training website³⁷

Support to priority countries

Targeted Member States will have benefi ted from IHR risk communications programme by end of 2016

Actions for 2016

AFRO plans to provide PIP Partnership Contribution funds to Burundi, Cameroon, Congo, Ghana, Madagascar, Mozambique, Sierra Leone, the United Republic of Tanzania and Zambia. AFRO will work to support and maintain existing sentinel sites and laboratory surveillance systems so that:

•

Health care facilities/laboratories in the region have equipment and reagent supplies;

•

Detected infl uenza viruses can be transported from districts to the national infl uenza laboratories and to WHO Collaborating Centers;

•

Laboratory technicians and data managers develop and maintain their skill levels; and

•

Existing surveillance sites are supervised for optimal reporting of results locally and internationally.

32 Senegal and Madagascar are collecting data for burden of disease analysis 33 Marketing authorization is ongoing in Ghana and Nigeria

34 Pharmacovigilance training/meetings ongoing in Ghana, Ethiopia, Gambia, Kenya, the United Republic of Tanzania and DR Congo

35 Agreements signed in the United Republic of Tanzania, Uganda, Ethiopia, Ghana, Kenya, Mozambique

36 Joint reviews of capacity in preparation to sign Burkina Faso, Cameroon, Benin and Mali

37

WHO iLearn platform was used in 2015 38

No regional target, global target is 200 39

No regional target, global target is 30 40

Kenya and Senegal

Results from other Areas of Work that help the region to prepare for pandemic infl uenza (2015)

BASELINE TARGET STATUS

(22)

Bolivia (Plurinational State of)

Chile Costa Rica

Dominican Republic

Ecuador Haiti Nicaragua

Suriname

Regional Offi ce for the Americas (AMRO/PAHO)

PIP PC Achievements 2015

In 2015, the Region for the Americas (AMRO) supported Chile, Costa Rica, Ecuador, Nicaragua and Suriname with PIP PC implementation funds. These funds allowed AMRO to provide training and technical support to these PIP priority countries to improve epidemiology and virology data collection. The Regional Offi ce worked with countries to develop standard data reporting formats that could be shared directly with the global data reporting platform, WHO’s FluID. Funds were also used to build human-animal interface surveillance in the region. Provisional data analysed and presented below shows that country capacity to monitor and detect infl uenza viruses with pandemic potential is improving in target countries and throughout the region as a result of these eff orts.

0

NA⁴⁴

8

NA⁴⁵

0

6⁴⁶ 7

0

8 8

7⁴² 4⁴³

Output indicators for priority countries:

Bolivia (Plurinational State of), Chile, Costa Rica, Dominican Republic, Ecuador, Haiti, Nicaragua and Suriname

2015 Laboratory & Surveillance programmatic results for PIP target countries

BASELINE ⁴¹ TARGET STATUS

44 No regional baseline, global baseline is 90 45 No regional target, global target is 108

46 Bolivia, (Plurinational State of), Chile, Costa Rica, Dominican Republic, Ecuador and Nicaragua

41 31 August 2014

42 Bolivia, (Plurinational State of), Chile, Costa Rica, Dominican Republic, Ecuador, Nicaragua, and Suriname

43 Bolivia, (Plurinational State of), Chile, Ecuador, Suriname

(23)

AMRO Detection Capacity AMRO Sharing Capacity

AMRO Monitoring Capacity

AMRO Sustaining Capacity Prior to PIP PC funding, AMRO/PAHO identifi ed there was

a gap in event-based surveillance in priority countries in the region. The average scores for detection refl ected the need for support in this area. PIP PC funds supported trainings in EBS for infl uenza and data management in the region in 2015 and we expect to see an increase in country capacity for detection in the next round of data collection as a result of this investment.

AMRO/PAHO has worked to enhance reporting of epidemiological and virological data on infl uenza into PAHO FluID to allow real-time ability to monitor infl uenza spread throughout the region. In 2015, Chile, Ecuador and Suriname reported data for the fi rst time using this platform. A total of 783 virus samples were submitted to WHO Collaborating Centre (CDC) for viral characterization. PIP funds have facilitated a training course targeting sample conservation and timely submission to WHO Collaborating Centres to improve sample submission. Fifty laboratory technicians participated in this course in 2015.

The interactive PAHO FluID website launched in 2015 allows transparent access to monitoring and surveillance data across the region (www.paho.org/reportesinfl uenza).

Bolivia (Plurinational State of ), Chile, Costa Rica and Ecuador report full capacity for surveillance of patients hospitalized with severe acute respiratory illness (SARI) with samples routinely tested for infl uenza. PIP PC funds are also supporting a landscape analysis of regional activities being done to improve human-animal interface surveillance in the region to identify gaps and provide guidance to Member States on what is working in countries.

Chile, Costa Rica, Ecuador and Nicaragua all have recognized NICs. Most countries have established country plans for sustaining Laboratory and Surveillance activities. March 2015 data collection saw new country plans reported for Costa Rica, Ecuador and Suriname.

Average score

Target 3

2

1

0

Average score

Target 3

2

1

0

Average score

Target 3

2

1

0

Average score

Target 3

2

1

0

(24)

Actions for 2016

AMRO continues to develop capacity in Chile, Costa Rica, Ecuador, Nicaragua, Suriname and to increase support to the region by working in Bolivia (Plurinational State of ), Dominican Republic and Haiti. Activities to strengthen preparedness in the entire region are being planned. There are plans for a severe acute respiratory infections (SARI-net) meeting, upgrades to regional reporting systems, and training for laboratory logistics both regionally and for larger countries in the region (Brazil and Mexico). Several activities target improving coordination at the human-animal interface, including development of respiratory outbreak training materials and a simulation exercise.

47 Costa Rica and Chile have estimates pending publication in peer-reviewed journal.

48 Bolivia (Plurinational State of) has been assessed. Haiti will be assessed in 2016.

49 Bolivia (Plurinational State of), Haiti, Honduras, Nicaragua, Guyana, and Peru are in process of signing the Collaborative agreement.

50 WHO iLearn platform was used in 2015 51 No regional target, global target is 200 52 No regional target, global target is 30

53 Barbados, Dominica, Saint Lucia, Saint Vincent and the Grenadines.

0

0 0

0

2

6 2

NA⁵¹ 6

NA⁵²

2⁴⁷

Pending tools

0⁴⁸

12 0⁴⁹

4⁵³ Burden of Disease

Regionally representative estimates

Number of countries supported by the Partnership Contribution with infl uenza disease burden estimates by 2016

Planning for Deployment Country readiness

Countries and partners accessing web-based planning tools Regulatory Capacity Building

Targeted training

Number of countries which developed regulatory capacity to oversee infl uenza products including vaccines, antivirals and diagnostics in case of a pandemic

Common approach for accelerated approval

Number of countries with a common approach for accelerated regulatory approval of infl uenza products in a public health emergency

Training on risk communications

Number of trainings completed on IHR risk communications training website⁵⁰

Support to priority countries

Targeted Member States will have benefi ted from IHR risk communications programme by end of 2016

Results from other Areas of Work that help the region to prepare for pandemic infl uenza (2015)

BASELINE TARGET STATUS

(25)

Afghanistan

Djibouti Egypt

Jordan Lebanon Morocco

Yemen

Regional Offi ce for the Eastern Mediterranean (EMRO)

PIP PC Achievements 2015

During 2015, the Regional Offi ce for the Eastern Mediterranean (EMRO) worked in seven countries prioritized for PIP PC preparedness funds (Afghanistan, Djibouti, Egypt, Jordan, Lebanon, Morocco and Yemen).

Complex emergencies are occurring in several of these priority countries (Yemen, Afghanistan and Lebanon).

Nonetheless, infl uenza surveillance has gradually started gaining visibility among public health priorities at country level in the region. A regional database (EMFLU) is being promoted as a key platform for infl uenza surveillance information to link countries to all levels of WHO. Provisional data analysed by indicator type and shown in the charts below indicate that capacity to detect, monitor and share infl uenza viruses with pandemic potential varies widely, although there is progress in countries where capacity has been the weakest.

4

NA⁵⁸

7

NA⁵⁹

5⁵⁵

3⁶⁰ 2

1

7 7

4⁵⁶ 1⁵⁷

Output indicators for priority countries:

Afghanistan, Djibouti, Egypt, Jordan, Lebanon, Morocco and Yemen

54 31 August 2014

55 Afghanistan, Djibouti, Egypt, Morocco, Yemen 56 Afghanistan, Egypt, Jordan and Morocco 57 Morocco

58 No regional baseline, global baseline is 90 59 No regional target, global target is 108 60 Egypt, Jordan, Morocco

2015 Laboratory & Surveillance programmatic results for PIP target countries

BASELINE ⁵⁴ TARGET STATUS

ANNUAL REPORT 2015

Pandemic Infl uenza Preparedness Framework

Partnership Contribution

ANNUAL REPORT 2015

Pandemic Infl uenza Preparedness Framework

Partnership Contribution

ANNUAL REPORT 2015

Table of contents

List of Acronyms

Executive summary

Pandemic Infl uenza Preparedness Cycle

Progress in 2015

Overview of the PIP Framework

Background

Key principles of the PIP Framework

Overview of achievements

PREPAREDNESS

RESPONSE

Partnership Contribution Collection Process

•

•

•

Results of the Partnership Collection in 2014

Results of the Partnership Collection in 2015

Use of PC funds

Why fi ve Areas of Work?

•

•

•

•

•

Laboratory and Surveillance Profi le

Improve national ability to detect, monitor and share novel infl uenza viruses

•

•

•

•

•

•

•

•

Output indicators

Support to WHO Regions and Countries

Measuring progress in 2015

Regional Offi ce for Africa (AFRO)

PIP PC Achievements 2015

Output indicators for priority countries:

2015 Laboratory & Surveillance programmatic results for PIP target countries

Actions for 2016

•

•

•

•

Results from other Areas of Work that help the region to prepare for pandemic infl uenza (2015)

Regional Offi ce for the Americas (AMRO/PAHO)

PIP PC Achievements 2015

Output indicators for priority countries:

2015 Laboratory & Surveillance programmatic results for PIP target countries

Actions for 2016

Results from other Areas of Work that help the region to prepare for pandemic infl uenza (2015)

Regional Offi ce for the Eastern Mediterranean (EMRO)

PIP PC Achievements 2015

Output indicators for priority countries:

2015 Laboratory & Surveillance programmatic results for PIP target countries