# Presentation: 349370

## WHO Activities to Strengthen Global Public Health Diagnostics and BiosafetyBradford A. Kay, MS, MPH, Dr.P.H.CoordinatorWHO Programme for Laboratory Capacity Developmentand Biosafety

**Notes:**
[SOME WORDS OF EXPLANATIONS FOR EACH]:

Brad in pink (Nicoletta docet...) you’ll find our suggestions extra text...

## Global Health Security: Everyone Participates

**Communicable diseases**
- Naturally acquired
- Accidentally acquired
- Deliberately released
**Impacts**
- Mortality and morbidity
- Destabilize disease prevention and control programs
- Disrupt travel, trade and tourism
- Economic consequences
- Social instability
- Political instability

## Disease Early Warning SystemsMust be Address Diverse Needs

**Sporting events**

**International trade, travel**

**Pilgrimage**

## InternationalHealth Regulations

- Re-negotiating a global agreement on how to coordinate the response to disease threats of international concern.

**Notes:**
Unpredictable emergencies will arise 
Will be a problem for all countries not just those initially affected

Co-ordination and global leadership is called for 

The IHR could provide a frame work for joint, coherent action

## Diagnostic Capacities are Essential Elements of Health Security

**Disease Early Warning Systems**
**Notification by health care facilities**

**Epidemic Intelligence**
**Health information from media****and other informal sources**

**Alert****s**

**Response**

**National Control Programmes**
**Known risks**

**Emergency Response Programmes**
**Exceptional risks **

**Laboratory****Verification**

**Laboratory****Validation**

**Reports**

**Rumors**

**Notes:**
This is the context thqt ze qre opeirqtion

## Situation 

**Many countries lack:**
**Epidemiological capacities **
- Structured epidemic intelligence systems
- Action-oriented outbreak indicators and thresholds
- Structured response mechanisms
- Confirmation capabilities
**Public health diagnostics**
- Laboratory involvement in disease surveillance
- Appropriate roles
- Advocacy or resources
- Supporting infrastructures (national and global)
- Biosafety awareness and practices
- Pathogen security practices

## Member States requested WHO to: 

**World Health Assembly Resolution:**
**WHA55.16, **
**18 May 2002**

** ****Strengthen global surveillance **
** ****Assist emergency preparedness and response**
** ****Provide guidance and technical information**
** ****Develop new tools**

**Member States requested WHO to:**** **

**Notes:**
In the current era of bioterrorism, the threat of misuse of dangerous pathogens and toxins is perceived globally.
In May 2002, at the 55th WHA, WHO Member States formally mandated the Secretariat - through resolution 16 -  to address health-related threats induced by accidentally/deliberately released agents (can be chemical, pathogens, toxins etc.)
ergo BIOTERRORISM (!!!) enters formally into the screen of WHO 
two universes that overlap (mutual understanding needed and not TURF BATTLE)
The action of the Secretariat to address this mandate are as follows
 [SOME WORDS OF EXPLANATIONS FOR EACH]:
  - to strengthen global surveillance; 
  - to provide tools and support for Member States, with regard to emergency preparedness and response plans;
  - to continue to issue international guidance and technical information;
  - to examine the possible development of new tools

## WHO: A global network

-  **HQ**

-  **PAHO**

-  **EMRO**

-  **EURO**

** ****WPRO**

-  **SEARO**

-  **AFRO**

- 192 Member States, 6 Regional Offices, 141 Country Offices

**WHO: A global network**
**with privileged access to countries**

**Notes:**
Groups at HQ involved with Communicable Diseases
Regional Offices
	Autonomous
	Different Structures
Member States
	First line reporting to RO

## The WHO CSR* Strategy

**National**
- Strengthen epidemiology
- Strengthen surveillance and reference diagnostics
- Integration of surveillance, reporting
**Regional**
- Regional reference centers
- Information sharing
- Integration of surveillance activities
**Global**
- Disease alert and response
****Communicable Disease Surveillance and Response***** **

## CSR Capacity Strengthening Activities

**Epidemiology**

**    ****Disease prioritization**

**Epidemic intelligence systems**

**Early warning systems**

**Data management, analysis, and information dissemination, training, partnerships, evaluation**

**Response activities**

**Standard diagnostic tools**

**Lab infrastructure, resources**

**Management**

**Quality assurance/quality control**

**Biosafety **

**Public health laboratories**

**Advocacy and development of political commitment**

**Assessment of national capacities**

**   ****Monitoring and evaluation**

## Laboratory Capacity Strengthening Unit

- Lyon-based personnel
-             Programme activities

**Biosafety**

- Geneva-based personnel
-                   Programme activities

**Preparedness**
**For ****Deliberate **
**Epidemics**

**External**
**Quality**
**Assessment**

**Training**

**Country**
**Infrastructure**
**Development**

**Partnership**
**Development**

**Distance**
** ****Learning and **
**Follow-up**

## Programme Targets                                                                               

**Development of globally relevant programmes and tools that strengthen:**
**Public health and national referral laboratories **
**Biological safety and pathogen security**
**National health security  **

## Consensus standards, guidelines and practical tools

**Notes:**
[BRAD, SOME EXAMPLE OF HOW PROLIFIC THE DOCTORS ARE WHEN THEY WRITE...]

To be kept in mind are the (i) advisory role for member states and (ii) JUST recommendations 

Again on the (i) nature of the mandate & (ii) credibility of WHO’s scientific actions

## Strengthening Epidemiological Practices 

**Surveillance standards**
**National Assessments **
**Instructional case studies**
**Training modules**
**Field epidemiology training **(TEPHINET,EPIET,FETP)
**Identify national surveillance priorities**
**Monitor and evaluate **

## Global Outbreak Alert and Response Network 

- Daily assessment of disease outbreaks (Global Public Health Information Network)
- Rapid assistance (identification, verification and communication)
- Global outbreak preparedness and
-      response strategies

**Global Outbreak Alert and Response Network **
**A “network of networks”**

## A goal for national public health laboratories

**Sustainable support for health security through good laboratory practices**

## Summary of Core Diagnostic Functions

**Identification/characterization of priority agents**
**	**Timely, scalable, with adequate collection and transport ** **
**Microbiology of food and water**
**	**Routine and outbreak-associated specimens
**Quality assurance/quality assessment**
**	**Internal and external with performance indicators and feedback
**Information management and communications**
**	**Regular, timely reporting to and from all levels
**Training and continuing laboratory education**
**	**Continuing education in technical and managerial issues
**Policy and advocacy for public health labs**
- 	Needs and evidence-based, integration of lab with epidemiology
**Biosafety and biosecurity practices**

## Distance Learning and Information Resources 

**Distance learning**
**On-line networks **
**E-learning materials**
**Information resources**
**CD-ROM training materials**
**Help desk functions**
**Internet resource center**
- Documents
- Links
- User groups

## EQA as Part of Strengthening National Referral Labs

- 46 national labs
- 3 programs
-  plague
-  enterics
-  bacterial meningitis
- 3 languages
- 3 shipments/year

## Regionally-based Two-year Programme for National Laboratory Specialists

- Technical methods
- Management principles
- Applied epidemiology
- Quality assurance
- Access to on-line resources
- Biosafety/biosecurity
- Advocacy materials

## Twinning National Laboratories and Specialized Institutions

**Establish strong professional relationships**
**Strengthen laboratory functions through:**
**Exchange of information**
**Mentoring  **
**Joint research **
**WHO follow-up and assistance**
**Networking potential**

## Successes with Lab Capacity Programme

**Document on Core Capacities of National Referral Laboratories**
**Laboratory assessment tool keyed to core diagnostic capacities **
**Lab training modules **
**Workshops “in a box” (SARS, cholera, meningitis, antibiograms, EQA...)**
**Regional EQA model programs (AFRO, EMRO) **
**Functional lab networks in AFRO, EMRO, EURO**
**Electronic communications capabilities**
**Web-based resources and distance learning tools through Internet **
**Expanding partner base for sustainability**

## WHO Biosafety Programme

**Coordination of global WHO biosafety activities**
- Biosafety Advisory Group (BAG) and Regional focal points
- Coordination with international agencies, organizations and programmes
**Technical assistance**
- Biosafety collaborating centres
- Global biosafety issues (SARS, smallpox, polio, etc.)
**Publications**
- Laboratory Biosafety Manual, 3rd ed.
- Transport Guidelines for Infectious Substances
**Biosafety training materials**** **
- Train-the-trainer materials
**Regulatory issues**
- UN model regulations for transport of infectious substances
- Coordination with regulatory and industry organizations

**Notes:**
Towards the achievement of our goal, WHO Biosafety activities include 
- the development of biosafety publications 
- the provision of biosafety information 
- the provision of technical assistance to Member States on containment 
- the provision of technical advice on regulatory issues
- the collaboration with specific WHO Programmes (polio, smallpox, blood safety, waste management)
trying to achieve global implementation of biosafety standards and practices and harmonization of biosafety procedures and practices 

## Preparedness for Deliberate Epidemics 

**Strengthening national preparedness**
- Policy guidance
- National preparedness assessment
- Informal networks
- Disease-specific networks (Anthrax, *Brucella*, Tularemia, smallpox, plague...)
- Coordination (FAO, OIE, OPCW, UN, BWC...)

**Notes:**
In addition there are networks of experts that support and peer review the above-mentioned activities
High importance is given to equal geographical distribution
Many scientific fields are merged together
Consensus is searched for among scientists working for both health and security ‘universes’

## Public Health and security activities have

**Public Health and security activities have**
** ****traditionally had minimal overlap**

**Public Health**
**issues**

**Security**
**issues**

## Challenges to health and security 

**Challenges to health and security**** **

**Public **
**Health **

**Security**

**Intentional misuse of **
**biological agent**** **

## Biosecurity issues for public health

**Diseases (natural) continue to dominate global health, social, political and economic structures**
**Strong public health structures for disease surveillance and response are the foundation of biosecurity **
**Biosafety ****(working safely with pathogens)**** is an essential component of biosecurity ****(keeping pathogens from misuse)****  **
**Developing countries have few resources for biosafety or biosecurity issues**
**Sustainable, global biosecurity measures must be developed through consensus with clear advantages to participants   **

## Biosecurity issues for public health

- Bioscience facilities are potential sources of pathogens and toxins
- Health care and public health laboratories
- Research universities
- Pharmaceutical and industry laboratories
- Bioscience community not uniformly accustomed to security issues
- Global norms and standards for professional conduct do not exist
- Global regulatory mechanisms for biological materials do not exist
- Control of certain biological materials is necessary
- Security measures must be in balance with other priority public goods

## Access to pathogens is necessary for global health security

- Education
- Evaluation
- Internal quality
- External assessment
- Basic research

- Applied research
- Culture collections
- Pharmaceutical and manufacturing

## Control of biological agents

- Microbes are ubiquitous, naturally occurring
- Traditional security measures  (gates, guards and guns), can be ineffective
- Minute amounts are significant
- Origin can be difficult to trace
- Travel and trade promote ease and speed of spread
- No international means to control pathogens or to monitor distribution
- Uncertainty about forum to address global issues of biological security

## Needed: Norms and Standards

- Consensus standards for professional conduct
- Protection from theft and loss
- Transfer and/or export mechanism

- Recognition of facilities (registration/licensing?)
- Uniform procedures for screening laboratory personnel
- Uniform procedures for threat and risk assessments

## Desired outcomes

- “Bottom up” security oversight and regulatory mechanisms
- Common national benchmarks for the security of biological materials
- Consensus on research standards and code of professional conduct
- Harmonization of national approaches to biosecurity

- Facilitation of research and collaboration
- Common mechanisms for exchange of sensitive biological materials to authorized users
- Continued access to basic and applied scientific information
- Improved global biosecurity through proactive involvement of scientific community

## Strengthening Labs 

**Sustainable**
**National Diagnostic**
**Capacities**

- Strengthening Labs

**Thank you**