Current strategies, initiatives and challenges to mitigate biorisk: Indonesia s experience

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Current strategies, initiatives and challenges to mitigate biorisk: Indonesia s experience Head of Delegation HERAWATI SUDOYO MD, PHD Eijkman Institute for Molecular Biology Ministry for Research and Technology Members PRETTY SASONO PhD National Institute of Health Research and Development, Ministry of Health SRI MUHARSINI DVM, PhD Indonesian Research Center for Veterinary Science, Ministry of Agriculture YULI SUBIAKTO MSc Directorate of Health, Ministry of Defense

Indonesia and Infectious Diseases a Great Challenge to Mitigate Biorisk Problems with emerging and reemerging infectious diseases Most caused mainly by environmental, ecological or demographic factors spread by travel and trade Indonesia is a maritime country with 17.504 islands, 700 languages, 33 provinces, 220 million population Problems with people movement Recognize the need to develop, strengthen and maintained the capacity to detect, report and respond to public health events

Indonesia A rapidly developing country with serious problems in Infectious disease Malaria: 15 million cases and 42,000 deaths/year (2005) - highest case number and fatality rate in the world; increasing drug resistant parasites Tuberculosis: ranked third in TB burden following India and China - TB is third major causes of mortality Estimation: 269 TB cases/100,000 Dengue: Most important viral borne disease In 2004: 78,690 cases (CFR- 1.2%) In 2007: 123,174 cases,1,251 deaths Hepatitis B: 10% of population are carriers Moderate-to-high endemic (WHO) Avian Influenza: 133 positive cases (CFR: 80%) - highest case number and fatality rate in the world Anthrax, Chickenpox, HIV-AIDS, Meningitis, Plaque, Hantaan and Nipah, Ricketsiosis

National actions to promote capacity building WHAT ARE WE FACING? Indonesia A very diverse populations vast genome diversity disease management complex Indonesia - A rapidly developing country with serious challenges in infectious (emerging and re-emerging) and zoonotic diseases

National strategy and initiative to mitigate biorisk I. Development of BSL-3 facilities II. Establishment of BSL-3 Networking Group III. Formation of Indonesian Biorisk Association IV. Human capacity development in biorisk management V. Development of Code of Conduct on biosecurity and introduction on Dual Use of dangerous pathogens

I. Building BSL3 to combat emerging infectious diseases Capacity, Quality and Safety Laboratory services are essential to identify and confirm the causes of outbreaks infectious disease outbreaks can be contained and suppressed through early detection, immediate response and cooperation and support at the nationa level

BSL3 facilities location and function 2010 seven BSL3 facilities built; three animal BSL3 (2 Bogor and 1 Surabaya) and human specimen (3 Jakarta, 1 Surabaya), others on going Institutions: MOH National Institute of Health, Research and Development MOA Indonesian Research Center for Veterinary Science Universities UI Institute of Human Virus and Cell Biology (IHVCB), UNAIR Institute for Tropical Diseases (TDC) MRT Eijkman Institute for Molecular Biology BSL3 facilities Jakarta, Bogor Surabaya Functions diagnostics and research including challenge test

Improvement of capacity for disease surveillance, detection and diagnosis 44 Reference laboratories for emerging infectious diseases were developed to increase national capacity in detection and diagnostic response to emerging infectious diseases Serological and molecular diagnostic were established RT - PCR assay for molecular identification DNA Sequencing analysis also used for confirmation Detection of viral sequence changes will indicate possibility of outbreaks

Challenges to Sustainable Operations The Way Ahead (presented by Indonesia) - Summary on Important Issues from International Workshop on BWC Supporting Global Health, Oslo, 18-19 June 2009 Strengthening laboratory biosafety and biosecurity to protect laboratory capacity and safely combat infectious diseases best practices on biological safety and biosecurity (Biosafety guidelines and SOPs developed will be disseminated Ensure the sustainability of maintenance and management - Build effective and sustainable partnership between developed and developing countries Maximize existing resources and facilities to enhance effectiveness and efficiencies Ensure a suitable infrastructure - certification

II. Establishment of Indonesian BSL3 networking First BSL3 seminar and round table discussion held at the Eijkman Institute on August 2 nd, 2010 Purpose: To establish networking between laboratories to share knowledge, experiences, endorsement and provide expertise when needed Participants: 12 different institutions - Universities (2), Research Institutes (2) Research Center for Veterinary Science/IRCVS (1), Primate Research Center (1), Agricultural Quarantine Center (1), Veterinary Drug Assay laboratory/vdal (1) and Vaccine companies (4) 10

III. Increasing biorisk awareness leading to the formation of Indonesian Biorisk Association Preliminary gathering started on 2009, leading by MOH (will be launched end 2010) Enhance the knowledge of biorisk, issues throughout Indonesia Establish best practices amongst its members Providing advocacy and support to national, regional and international policies, standard and guidelines Develop national capability for biosafety accreditation/certification system (in the future) Develop a quality control (QC) and quality assurance (QA) of the laboratory ISO 17025 Develop a strong networking and partnership

IV. Increasing human capacity development in biorisk management through international and domestic training program Workshop on CEN Laboratory Biorisk Management Standard CWA 15793:2008 was held on 2008 to introduce the implementation of biosafety, laboratory biosecurity and biorisk management Indonesia has 7 trainers for Biosafety (Recent workshop in Singapore, 16 27 August, 2010 organised by NIH, REDI and WHO Regional Office for the Western Pacific) National Biorisk Training Program for BSL3 staff by our certified trainers

Development of a pool of qualified biosafety officers as trainers for local and national laboratories Routine training with significance topics was attended and has to be continued financial support needed : Training for BSL3 Manager and Staff: The Science and Safety BSL3 Program, Emory University; Atlanta, USA (2009); Introduction to Practices and Principles of Containment level 3 Design, Working Practices and Management; Porton Down, Salisbury, UK (2009); APBA< Manila (2010); Behavior-based Trainer Preparation Program at Emory University; Atlanta, USA (2010) APBA, Korea (2010) Infectious Substances Shipping Training Course, Biorisk Assessment Training Course, Train the Trainer Course in Laboratory Biosafety Principles and Practices, Singapore, 2010 Training for Engineer: Operations and Maintenance Workshop, Winnipeg, Canada (2008, 2010)

Indonesia project on life science research the importance of fundamental research Raising awareness and inform on the importance of life science research the early detection of outbreaks is closely related to the ability of laboratories to conduct early diagnosis of diseases Message: Accurate diagnosis and pathogen characterization is a cornerstone in the control of disease. Improvements to detection and diagnostic capabilities are important.

V. Development of Code of Conduct on Biosecurity and introduction on dual use of dangerous pathogens Raising awareness and education on risk management for the accidental or potential misuse of the outputs of life science research: - new technology i.e. the use of DNA based technology and molecular methods - dual use and code of conduct will be introduced to academicians, researcher, laboratory staff, and the future generation (Project of Indonesian Academy of Sciences)

Higher education programs in Indonesia who are involve in teaching life sciences spread, diverse in quality and culture Academy need a good strategy Public Universities 110 Accredited Institutions of higher education 69 Faculty Medicine (microbiology as one curricula)

Other tools to mitigate biorisk Regulations on handling pathogens or dangerous hazardous materials to prevent risk and promote safety: MOH Regulation security hazardous materials for health (1996); MIT Decree on procedures for import of certain dangerous materials (2000), Government Regulations on hazardous material management (2001) and others. To prevent plant and animal disease: Government Regulations on biosafety of genetically engineered product (2005); on veterinary community health (1983), Act on animal quarantine, fishes, and plants (1992) followed by Government Decree on animals quarantine (2000); Agriculture Minister Decree on animal quarantine regulation (2001) Decree on classification of the animal quarantine pest, grouping and its carrier (2008) and others.

Laws, Regulations, Awareness and Acceptance of Life Scientists associated with biosafety and biosecurity To prevent the proliferation of biological weapons BWC signed on 20 June 1972 and ratified by Presidential Decree on 1991 To prevent risk and promote safety of hazardeous materials (GMO, recombinant DNA) To prevent plant and animal disease To publish permit on research and development and application on high risk and dangerous science and technology

Conclusion Strategies, initiatives and challenges Ensure the sustainability of maintenance and management Continuous funding support, maximize existing resources and facilities to enhance effectiveness and efficiencies Strengthening and improving laboratory biosafety practices and biosecurity long term commitment Ensuring quality performance of laboratory QA/QC Expand the use of safe and modern diagnostics need to build national capacity in fundamental and translational research through joint activity Raise awareness of biologically threats globally - introduce Dual Use and Code of Conduct through academic curricula

Thank you for your attention Picture taken from Flores Island