National Series Lecture 5. National Measures

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Transcript National Series Lecture 5. National Measures

Bradford Disarmament Research Centre Division of Peace Studies, University of Bradford, UK

National Series

Lecture 4 National Measures

Jordan

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Outline

• Public health – WHO Biosafety/Biosecurity Guidelines (2004) – International Health Regulations (2005) – Laboratory Biorisk Management Standard (2008) • Arms control – BTWC (1972) – Chemical Weapons Convention (1993) • Engagement of life scientists – Oversight – Codes of conduct – Education

National implementation

1 • International agreement 2 • Signature and ratification by states 3 • National measures in states • Legislation, regulation order or other forms

1. Public health

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Laboratory measures

Objective • The

WHO Laboratory Biosafety Manual

is a helpful reference for states that accept the challenge to develop and establish national codes of practice for securing their microbiological assets, yet ensuring their availability for clinical, research and epidemiological purposes.

• Codes of practice = a codified list [or guideline or standard of required] of essential safety practices and procedures.

(WHO 2004)

Laboratory measures

Biosafety level (BSL) 1-2 • Access – Authorizing access, hazard signs, and gates/doors closed • Personal protection – Uniforms (coveralls, glasses, and footwear), washing hands • Procedures – No pipetting by mouth, limited and written procedures for clean up, and procedures minimizing the formation of aerosols and droplets • Laboratory working areas – keeping neat, clean and free of potentially dangerous material at the end of the working day • Biosafety management – This is the responsibility of the laboratory director – Training, evaluation, surveillance and treatment should be provided when necessary

Laboratory measures

Biosafety level (BSL) 3 BSL 1-2 applies except where modified as follows: • Biohazard symbol must include the name of the laboratory supervisor • Laboratory protective clothing upgrade • Open manipulations of all potentially infectious material contained • Respiratory protective equipment may be necessary Biosafety level (BSL) 4 BSL 3 applies except where modified as follows: • The two-person rule should apply, whereby no individual ever works alone • A complete change of clothing and shoes is required prior to entering the laboratory • Personnel must be trained in emergency extraction procedures • A method of communication for routine and emergency contacts

Laboratory measures

The Biosafety and Biosecurity International Conference Process (BBIC) took another important step forward with the successful conduct of the BBIC-2011 regional conference in Amman, Jordan in collaboration with the Royal Scientific Society and El Hassan Science City from 13 to 15 September. There were nearly 130 participants from 23 countries. • Third BBIC in Amman, Jordan in 2011 • Create Four Working Groups, agreed upon developing: – Human Capital – Physical Infrastructure – Preparedness and Prevention – Policy Making and Legal – Asess feasibility of Regional Training Centres – Establish a MENA region Biosafety and Biosecurity – Association (ICLS 2011)

Exercise 1

Laboratory safety/security: whose responsibility?

• Who should be responsible for laboratory safety and security measures (scientists, PI, managers of the institutions or government)?. How should such processes be implemented?

• Read the document (the case of Thomas Bulter - Texas Tech University ) and report to the class (10 min).

Laboratory measures

Is physical protection enough for laboratory safety and security?

Laboratory Biorisk Management Standard (CWA-15793:2008) Flexible risk assessment approach = not based on an assumed static level of risk agents but

situational

• Timing and scope – when to review practices? (e.g.) – Commencement of new work or changes to the programme of work including the introduction of new biological agents – New construction / modifications to laboratories, plant and equipment or its operation; – When considering emergency response and contingency planning requirements;

Laboratory measures

Laboratory Biorisk Management Standard (CWA-15793:2008) Highlighting the role of the top manager “Top management shall take ultimate responsibility for the organization’s biorisk management system.” Top management includes Officers (Director General, Chief Executive Officer, Chief Operating Officer, Chief Financial Officer, etc.) and Directors of the organization.

Laboratory measures

Laboratory Biorisk Management Standard (CWA-15793:2008) • Planning for hazard identification, risk assessment and risk control • Identifying roles, responsibilities and authorities of actors • Personnel training, awareness and competence • Operational control (physical and technical procedures) • Emergency response and contingency plans =

Wider

than the

physical protection

of agents and toxins Each element is detailed and instructions provided in the document

Public health measures

• The stated purpose of the International Health Regulations (IHR) 2005 are: "to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.” (WHO 2012a) “3 top priorities of the IHR” (WHO 2012) - States should: • Establish a functioning National IHR Focal Point • Ensure adherence to reporting requirements and verification of public health events.

• Assess and strengthen national capacities

Public health measures (IHR)

8 Core capacities required of States: 1.

2.

3.

4.

5.

6.

7.

8.

National legislation, policy and financing, Coordination and NFP communications, Surveillance, Response, Preparedness, Risk communication, Human resource, and Laboratory. See

Checklist and Indicators for Monitoring Progress in the Development of IHR Core Capacities in States Parties

(WHO/HSE/IHR/2010.1.Rev.1)

Public health measures (IHR)

• Concern The IHRs do not have an enforcement mechanism (no teeth!) against non-compliance • Rationale Non-compliance risks run by States: – – – – – tarnished international image increased morbidity/mortality of affected populations, unilateral travel and trade restrictions economic and social disruption and public outrage (WHO 2012b)

Public health measures (IHR)

Jordan • A mission for the assessment of IHR core capacities took place in Jordan from 22 to 26 January 2012. The main objectives of the meeting were to: – Identify the core capacities required to support IHR implementation at the local/community level and/or primary public health response, and at the intermediate and national levels; – Provide guidance on the use of assessment tools; – Identify ways to integrate the IHR requirements into existing public health laws in Jordan; – Agree on IHR core capacity requirements for points of entry in the country.

(WHO 2012c)

2. Arms control

National implementation of an international legal agreement

Biological and Toxin Weapons Convention Article IV “Each State Party to this Convention shall,

in accordance with its constitutional processes

, take any necessary measures to prohibit and prevent the development, production, stockpiling, acquisition, or retention of the agents, toxins, weapons, equipment and means of delivery specified in article I of the Convention.” Chemical Weapons Convention Article VII “Each State Party shall,

in accordance with its constitutional processes

, adopt the necessary measures to implement its obligations under this Convention.”

National implementation of an international legal agreement

in accordance with its constitutional process

” = No one size fits all Case of the BTWC – options for States • Existing national regulations are enough to achieve the scope of the BTWC and no further legislation is necessary • Certain amendments of existing laws and regulations are necessary • An act is newly enacted specifically for the BTWC, and • Broader legislation is enacted not only for the BTWC but generally for anti-terrorism acts (ROK 2003)

National implementation of an international legal agreement

Jordan • BTWC – National legislation of the BTWC in Jordan has been implemented though the development of penal code, export control and environmental laws. (VERTIC 2012) • Chemical Weapons Convention (CWC) – No legislation is registered with the CWC website.

(OPCW)

BTWC: Jordan’s Submission of Confidence Building Measures (CBMs)

1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999

√ √ √

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

√ √ Jordan has submitted its CBM return occasionally, but not in a consistent manner. Table was created based on the database of the UNOG

Evolution of the BTWC: strengthening national measures

1995-2001 2003-

1995-2001 (AHG) • Major threat • State offensive programmes • Security approach • Compliance (Organization, verification) 03-2005/07-2010 (ISP) • Major threat • Primarily non-state level • Terrorism, crimes • Security measures – a national approach • Legislation, laboratory measures, codes, oversight, public health (e.g. surveillance)

Evolution of the BTWC: strengthening national measures From a traditional disarmament regime to a security architecture

1995-2001 2003/06 2011-

Extending threat spectrum > Manmade, safety and natural threats/risks = All hazard approach Institutional evolution > terrorism, crime and public health sectors (e.g. UNSCR1540, Interpol, WHO, OIE, FAO, IFBA)

Exercise2

Are legal obligations sufficient to ensure an effective security culture?

• Discuss what kind of other national measures (in parallel to laboratory security/safety at institutions and legal obligations) should or could be developed in order to prevent the misuse of the life sciences in society • What kind of other social actors can play a biosecurity role?

(10 min) • Report to the class

3. Engagement of life scientists

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Oversight of Research

A possible policy process for oversight Committee • Holding interdisciplinary discussions on the definition of risks, biosecurity measures and strategic recommendations for policy development in biosecurity Advisory board • Providing guidelines for the oversight of scientific research, laboratory management measures, and awareness raising of scientists.

E.g. USA -

The National Science Advisory Board for Biosecurity

(NSABB) Israel -

Steering Committee on Issues in Biotechnological Research in the Age of Terrorism

Codes of Conduct

InterAcademy Panel (IAP) Statement on Biosecurity (2005) – Endorsed by over 60 national science academies – Defines five fundamental policies: 1. Awareness; 2. Safety and security; 3. Education and information; 4. Accountability; 5. Oversight. National example – Royal Netherlands Academy of Arts and Sciences (2005) •

A Code of Conduct for Biosecurity

– Indonesian Academy of Sciences (forthcoming) (Sudoyo 2011)

Education: a national action plan

A national biosecurity dual-use action plan model 1.

2.

3.

4.

5.

Identify what is currently taught (a survey) Develop a network of interested lecturers Develop appropriate content for courses Implement pilot courses Monitor and evaluate pilot courses 6.

7.

8.

9.

Identify and elucidate best practice Institute clear, active links between industrial partners/associates, defence agencies and academic institutions teaching biosecurity Develop or participate in an international network to share best practice Make dual-use/biosecurity education mandatory 10. Monitor consequential growth of sensible codes and oversight systems 11. Report on progress to BTWC and relevant scientific meetings

Education: a national action plan

1. Developing an educational resource for codes of conduct; 2. Developing capacity building programmes 3. Changing evaluation criteria of funding bodies or review criteria of scientific journals Legal 4. Changing evaluation criteria on higher education institutions 5. Establishing a national advisory board 6. Legislating a biosecurity act 6 5 4 Structural 3 Individual 2 1 Autonomous

National measures: Areas of possible improvement Jordan • Laboratory safety measures

– Efforts have been made and need to continue alongside development of a biosecurity framework

• National legislation of the BTWC

– Efforts have been made, the legislative information to the OPCW can be considered

• Education and Codes of Conduct

– Implementation of the survey and the development of a national code of conduct for biosecurity will strengthen efforts

References • The references cited in this presentation may be found in the Notes section of this slide.