IFBA 1 st International Conference Global Biosafety & Biosecurity: Taking Action Bangkok, Thailand, 15-17 Feb 2011 WHO 5-Year Strategic Work Plan for Biosafety Dr Nicoletta Previsani Laboratory Alliances and Biosafety World Health Organization 1
A Strategic Work Plan for 2010-2014 In the beginning we called it: '193 Ways to Implement Biosafety' 193 Member States And this is how it all began 2
A sad trigger for safety awareness: Laboratory Acquired Infections (LAIs): the risk of sparking an epidemic FMD Pirbright, 2007 Taipei Airport '03 The SARS outbreak was over, the Region was coming out of a huge economic crisis The viruses were still available in laboratories 3 SARS Singapore, 2003 Taipei, 2003 Beijing, 2004 $$$ Strengthen BIOSAFETY! Reduce RISKS of infection! It should not have happened, even in these extraordinary circumstances and it must not happen again Hilary Benn Environment Secretary
4 WHO s public health mandate for biosafety and laboratory biosecurity WHO Constitution of 1948 "Attainment by all people of highest possible levels of health World Health Assembly resolution 55.16 (2002) "Global public health response to natural occurrence, accidental release or deliberate use of biological and chemical agents or radionuclear material that affect health International Health Regulations, resolution 58.3 (2005) "Prevention and control of the international spread of disease and public health risks" World Health Assembly resolution 58.29 (2005) "Enhancement of laboratory biosafety"
International Health Regulations IHR (2005) 194 countries are signatories Purpose: "prevent, protect against, control and provide a public health response to the international spread of disease" Requires countries to develop minimum core national and international surveillance and reporting capacities 5 May 2005 http://www.who.int/csr/ihr/en/index.html
Core capacity requirements for surveillance and response IHR (2005) Annex I 6 Countries shall develop, strengthen and maintain the capacity to prevent, detect, assess, notify and report public health emergencies of international concern respond promptly and efficiently to public health risks and public health emergencies of international concern and provide support for the above through specialized staff laboratory analysis of samples (domestically or through collaborating centres) logistical assistance (equipment, supplies and transport)
Transport and handling of biological substances, reagents and materials for diagnostic purposes Article 46: Countries shall facilitate the transport, entry, exit, processing and disposal of biological substances and diagnostic specimens, reagents and other diagnostic materials for verification and public health response purposes 7
Laboratory support to outbreak response Laboratory capacity needs can be met supranationally Laboratory services are essential to identify and confirm the infectious agents likely to cause public health emergencies of international concern (PHAIC) Clear role and responsibility within national surveillance & response system Quality Assurance Biorisk Management Specimen collection, transfer and transport Laboratory services cannot be switched on just for outbreak investigation WHA 2006: immediate and voluntary compliance with IHR (2005): WHO is requested to "expand and accelerate training efforts in the areas of laboratory capacity, including regional networking of laboratories, biosafety, and quality control " 8
IHR Timeframe 2005 World Health Assembly approved the revised IHR 2007 Entry into force assess existing national structures and resources to meet minimum core requirements 2009 Each State Party has 3 years to meet the core capacity requirements 2012 All countries have reached a minimum required level of core capacities 9
WHA 58.29: Enhancement of laboratory biosafety May 2005 Member States to: 1. review safety of labs and protocols, follow WHO guidance 2. implement specific progs, follow WHO guidance 3. enhance compliance of labs with bs guidelines 4. mobilize human and financial resources to reduce LAIs 5. cooperate with other MS to facilitate access to lab equipment 6. encourage dev of bs training progs and competency stds for lab workers WHO to: 1. play an active role 2. support other programmes and partners 3. update relevant guidelines 4. provide technical support 5. report to EB 10
IHR and biosafety can WHO certify my lab? 11
Biosafety and Laboratory Biosecurity CWA 15793:2008 Laboratory Biorisk Management Standard 16 points action plan ftp://ftp.cenorm.be/public/cwas/wokrshop31/ WHO publications Implementation 12
Six years later: Where are we now? Enhancement of laboratory biosafety May 2005 Through engagement, communication, meetings, workshops, consultations, training, coordination of global efforts by various stakeholders: 2011: 1. development / revision of legislation (e.g. Singapore / China / Canada) 2. construction / renovation of laboratories (e.g. Brazil: 12 new BSL3) 3. growing commitment to implement BRM systems (CWA15793) 4. bench worker / lab manager / regulators: shift in responsibilities 5. need for education and competency based training 13
How do biosafety and laboratory biosecurity translate into practice? 14
Strengthening biosafety and lab biosecurity programmes: 'CWA 15793: Laboratory Biorisk Management Standard' Scope of CWA 15793: To set requirements necessary to control risks associated with the handling or storage and disposal of biological agents and toxins in laboratories and facilities. PDCA! 22 March 2011 Slide 15 15
What are biorisks? How are biorisks 'managed'? Biorisk: Combination of the probability of occurrence and severity of the harm where the source of harm is a biological agents or toxins The Management of Biorisks has 3 basic components: Biorisk Assessment: what are the risks associated with specific agents, specific work, individual facilities? Biorisk Mitigation: what are the measures adopted to reduce these risks? why? how is the decision made? what are the considerations? 16 Performance: are the adopted mitigation steps giving the expected and wished results? are they valid with time? reviewed regularly?
Back to the Strategic Work Plan WHO Biosafety and Laboratory Biosecurity programme's Vision (the goal): Safe and secure handling of biological agents in the world Mission (how we reach the goal): Guide, inform, provide expertise and tools, and develop recommendations to support WHO's 193 Member States protect the health of people in and around laboratory environments, in collaboration with partners Participate and collaborate in advancing the science of biorisk management, including biosafety and laboratory biosecurity Establish a biosafety and laboratory biosecurity culture worldwide 17
'Help people help themselves' 'Stimulate local economies and capabilities' 1. Develop guidance and guidelines, web-advisories (pandemic flu) cross-cutting activities, support disease-specific programmes 2. Develop tools to help and support countries achieve their goals 3. Develop and organize Regional / sub-regional training courses 4. Develop a strategic work plan and engage the global community 5. Raise funds to sustain team and activities FUNDING RESOURCES: Regular budget: 0 International funding agencies: 100% 18
WHO's contributions to global biorisk management ONGOING ACTIVITIES: Regional Biosafety Awareness Raising Meetings for animal and public health communities (3 days) develop regional action plan for follow up Strengthen biosafety interface between animal and human health (OIE/FAO/WHO) biosafety is of mutual concern: harmonize guidance CWA 15793 Laboratory Biorisk Management Awareness Training (2 days) help countries adopt and implement the standard WHO Biorisk Management Advanced Trainer Programme (10 days) create expert trainers: associate technical knowledge to adult learning techniques 19 WHO Biorisk Management (AMP model) (3 days) address users
WHO's contributions to global biorisk management (cont'd) WHO Infectious Substances Shipping Training (2 days) help develop the regulations, support their compliance In-country project (Oman) (2 years) strengthen all hazard preparedness under IHR WHO Sustainable Laboratory Design Project low-cost refit of the lab in Lianping County, China DREAMS: CEN CWA 53 Biosafety Professional Competence education: introduce biosafety into undergraduate curriculum Appropriate use, operation and maintenance of biosafety cabinets and other equipment (planned) engineering: address global needs 20
Extended Biosafety Advisory Group (BAG) Meeting 7-9 September 2010, Montreux, Switzerland Develop a 5-year strategic work plan to coordinate global laboratory biorisk management efforts: Present the plan to: 6 WHO Regional Offices, 5 WHO biosafety CCs, OIE, FAO, 6 International Biosafety Associations, vertical WHO disease-specific programmes, other stakeholders and donor agencies Outcomes, along the following lines: 1. Enhance sustainable competencies in biosafety, laboratory biosecurity and biorisk management 2. Develop and support a framework for legislation, standards and guidelines 3. Appropriate selection, operation, and maintenance of facilities and equipment 21 4. Develop an evidence based biosafety and laboratory biosecurity information platform
Conclusions We heard it yesterday, the global needs are great There is room for many to contribute Identify global / regional / local partners to support WHO's efforts and, ultimately, countries Reduce duplication of efforts Identify areas where investment (human and financial) has most impact We certainly need support to achieve the goals and meet the expectations of countries 22
The Dream Team in Geneva Piero Kaz Neda Magdi 23
Thank you http://www.who.int/ihr/biosafety/publications/en/index.html previsanin@who.int 24