• 3rd National Science and Technology Basic Plan (FY2006〜2010) set “Safest and Most Secure Society in the world” as R&D goal.

- “Biosecurity” became a key agenda

• Development of Biological Detection System

• Sharing knowledge and networking of expertsat Keio Univ. G-SEC (FY2007~FY2010) & Nagasaki Univ. (FY2011~FY2012); - hosted 11 workshops & 15 seminars - Concept: “ linking public

health &security” & “networking experts inpublic &private sectors”

• US-Japan Medical Biodefense Research Symposium （2007〜）

National Security

Tomoya SAITO, MD, MPH, PhD (tsaito@niph.go.jp)Department of Health Crisis Management, National Institute of Public HealthInterdisciplinary Graduate School of Science and Technology ,Tokyo Institute of Technology

ISE-SHIMAG7 Summit

2016

Amendment (2006)

Pandemic Preparedness

First TTX for Bioterrorism(Smallpox) under Civilian Protection Act （2008）

Recognition of attempt at biological attacks e.g. Aum Shinrikyo’s attemptRecognition of threat on biological weapons

Mass gathering & major national events have been

a driving force for reinforcing civilian CBRN defense.

Acknowledgement: This study is funded by the Research Fund from Japan Agency for Medical Research and Development (15fk0108012h0201,15fk0108039h0002) and JSPS KAKENHI Grant Number 15KT0054. © T Saito/NIPH, August 2015

SARS(2003)

Biosecurity Landscape in JapanEfforts of public health & national security last two decades

Infectious Disease Prevention Act (1897)

Amendment (2003)

Pandemic Flu(2009)

Pandemic Flu(2009)

Special Measures Act for Pandemic preparedness (2012)

Review Committee for biodefensein Defense Agency (2000)Budgeting for biodefense capacity in Self Defense Forces (FY2000)Counter-NBC terrorism squad in Police (2000)

Start-up of building biodefense capacity

Amendment(2014)

1st Pandemic flu preparedness action plan (2005)1) & guidelines (2006)2)

1) revised in 2006/2007/2009 2) revised in 2009

Government action planand guidelines (2013)

9/11 & Anthrax attack (2001) Major national event (2000)Mass gathering (2002)

GOJ Basic Principle for Responding Bio&Chem Terrorism (2001) Smallpox preparedness・ Stockpiling smallpox vaccine (2002〜)・ Amendment of Infectious Disease Control Act

and Immunization Act to respond smallpox (2003)・ Development of smallpox response guidelines (2002)

and action plan (2003)Development of Syndromic Surveillance

Civil Protection Act (2004)• NBC attack is included in the

scenario of “Emergency Response Situation”

Terrorist Attack Preparedness Action Plan (2004)• called for early establishment of a

pathogen control system

Stockpiling antivirals & pre-pandemic vaccines (2004〜)

Emerging and Re-emerging Disease Preparedness and Response

Infectious Disease Control Act (1998)

• Establishment of pathogen control scheme

• Category for “Novel Flu”

Amendment (2008)

• SARS and SmallpoxIncluded in Category IInfectious Disease

First TTX for Anthrax attackunder Civilian Protection Act （2009）

• Reinforcementof clinical sample collection

SummaryGOJ started capacity building for biodefense since the end of 1990’s

and enhanced it after 9/11 Attack. Reinforcing public health biopreparedness and preventive measures (pathogen control) were followed by enhancement of R&D and networking for biosecurity as a key agenda under “Safe and Secure Society” initiative. Pandemic

preparedness was significantly improved after 2009 with the Special Measures Act for crisis management. DURC in life science has been

addressed through academic initiatives. Next challenge is a collaboration of public health sectors with security sectors.

3rd gen. Smallpox Vaccine LC16m8

Great Tohoku Earth quake & Fukushima NP accident(2011)

Proposal: Dual Use Issues in Pathogen ResearchScience Council of Japan(23 January, 2014)

Code of Conduct Regarding Dual Usead hoc committee on dual-use issuesin science and technology (2012)

Code of Conduct for Scientists Science Council of Japan(2011)

Code of Conductfor Scientists: revisedScience Council of Japan(2013)

Dual use concept to be included

For all science disciplines For individual science fields

“Life Science and Biosecurity”-Dual use dilemma

&countermeasures (2013)Ed. Prof. Shinomiya& Dr. Kawahara (in Japanese)

Japan-UK Joint Seminarby Keio G-SEC/NDMC“Biosecurity, Dual Use Dilemma and Education for Life Scientists”(2011)

Keio G-SEC Biosecurity Workshop“Ethics for Science & Technology and Risk Management for Sensitive Technologies” (2010)

1st dual-use seminar in Keio G-SEC/JST RISTEX“Biosecurity: Current and Future Concerns and Response” (2008)

“Predawn Stage” at motivated institutes Basis for interdisciplinary discussion for dual-use issues in life

science in Japan was established with the efforts of 3 institutions: ・ National Defense Medical College・ Research Institute of Science and Technology for Society,

Japan Science and Technology Agency (JST RISTEX)・ Keio University Global Security Research Institute (Keio G-SEC)

Activities by the Science Council of Japan

Translations ofA Code of Conduct for BiosecurityExecutive Summaryof Fink Report(2010)T.Saito, Keio G-SEC

Education

R&D for biodefense for“Safe and Secure Society”

• Tiered measures • Surveillance &active investigation• Medical preparedness• Control measures for zoonosis

Infectious Disease Surveillance (1981~)

1st intensive syndromicsurveillance with an automated system

1st intensive syndromicsurveillance with an automated system

1st Operation of Syndromic

surveillance

1st Operation of Syndromic

surveillance

H5N1 GOFResearch

(2011)

Dual-use Education in Life-Science Degree Courses at Universitiesin Japan Survey Report (2009)National Defense Medical College/Bradford Disarmament Research Centre Project Team

Activities in life science communitiesSpecial symposiums/workshops on dual-use in annual meetings of academic societies (2012) - Japanese Society for Virology - Japanese Society for Cell Synthesis Research- Japan Association for Bioethics- Molecular Biology Society of Japan

Strategic Proposal: Preparedness Framework and Its Governance of Dual Use Research of Concern for Promising Progress of Life Sciences (2013)Center fore R&D strategy, Japan Science and Technology Agency

Development of Educational Module Resource (2010)National Defense Medical College/Bradford Disarmament Research Centre Project Team

DURC and Biosecurity

Approach to DURC in life science from scientists in Japan started from the institutional level and reached the higher

organizational level. Science Council of Japan has addressed the dual issue by revising code of conduct for scientists and

proposed a guideline for pathogen research.

Next ChallengeCloser collaboration of public health sectors with intelligence sectors for risk assessment and with police departments for criminal investigation is expected.

H7N9(2013)

Response to recent major outbreaks gave GOJ the opportunity to improve the medical and public health

capacity for highly-contagious diseases. Especially, interdepartmental collaboration is reinforced through

whole-of-government approach e.g. police, fire defense and public health, which will be

an asset for biodefense.

MERS(2012)

Ebola(2014)

Next ChallengeCapacity building for international response for major outbreaks is under consideration. • Program for Infectious Disease Crisis

Management Experts by MHLW(2014~)• Team of experts and its dispatching capacity

is in consideration. Legal preparedness has been reinforced through several amendment of

Infectious Disease Control Act guided by lessons through major outbreaks.

Special Measures Act enforced in 2013 giveslegal basis for crisis management in pandemic e.g. prioritized vaccination, social distancing, business continuity planning, mobilization of medical resources, etc. Development of mass vaccination plan is now underway.

Procurement of NBC Reconnaissance Vehiclein JGSDF （2010~）

Bio BulwarkTM (Mobile detection system w/DNA chip)by TOSHIBA, National Research Institute of Police Science and

Obihiro Univ. of Agriculture and Veterinary Medicine