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
Pakistan
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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
2
3
• International agreement
• Signature and ratification by states
• 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 ] 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 cleanup, 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: Pakistan
• Biological Safety Association of Pakistan (BSAP)
– Participates in the development of national and international
biological safety standards, guidelines, and regulations
• National Guidelines for the Development of Code of Conduct for Life
Scientists (see Slide No. 31)
– Serves as a recognized resource for professionals and scientific
expertise in biological safety and security
• Activities
– Workshops and publications on the issues of biosafety
(BSAP 2008)
Laboratory measures
• Biological Safety Association of Pakistan – (BSAP) is a non- profit
organization that is an affiliate of PSM, the leader in the profession of
biological safety which was established in 1974.
• BSAP aims to:
• Foster and promote professional and public awareness of biological safety
through effective communication.
• Participate in the development of national and international biological
safety Standards, guidelines, and regulations.
• Interact with ABSA to help advance biological safety as a scientific
discipline through education, research and training and to maintain
standards for biological safety professionals.
• Serve as recognized resource for professionals and scientific expertise in
biological safety and security.
(BSAP 2012)
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)
• As of 15 June 2007, Pakistan along with 192 member states is a
signatory to the International Health Regulations of 2005
• it is imperative that all the designated MoH and WHO Pakistan core
technical staff should be sensitized about their responsibilities and
reviewing components of public health emergencies of international
concern (PHEIC).
• Certain additional tasks being undertaken include that the nomination of
a WHO IHR Team comprising of an Epidemiologist, Information Officer
and a Law Officer, maintaining close liaison with the WHO focal point in
WHO‐EMRO, and establishing regular contact with the National Focal
Point (DG Health) and his nominees.
(WHOPAK 2012)
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
Pakistan
• BTWC
– 13 processes of legislation undertaken to implement the scope
of the Convention, including via the criminal code, export control
and anti-money laundering measures
(VERTIC 2012)
• Chemical Weapons Convention (CWC)
– Ordinance of the CWC and statutory notification on CWC
regulations have been introduced
(OPCW)
BTWC Submission of
Confidence Building Measures (CBMs)
1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998
AB
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GE
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PK
TJ
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UKR
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1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
AB
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GE
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√
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√
√
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PK
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TJ
UKR
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AB (Azerbaijan), GE (Georgia), PK (Pakistan), TJ (Tajikistan), UKR (Ukraine)
Table was created based on the database of the UNOG
Evolution of the BTWC:
strengthening national measures
1995-2001
1995-2001 (AHG)
• Major threat
• State offensive programmes
• Security approach
• Compliance
(Organization, verification)
2003-
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
Advisory
board
• Holding interdisciplinary discussions on the definition of risks,
biosecurity measures and strategic recommendations for policy
development in biosecurity
• 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 national action plan
A national biosecurity dual-use action plan model
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
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
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
Monitor consequential growth of sensible codes and oversight systems
Report on progress to BTWC and relevant scientific meetings
Education 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
Legal
criteria of scientific journals
Structural
6
5
4
Autonomous
3
4. Changing evaluation criteria
on higher education institutions
2
1
5. Establishing a national
advisory board
6. Legislating a biosecurity act
Individual
Engagement of scientists in Pakistan
– Background survey
• Investigated the current state of biosecurity education in Pakistan
• Covering 24 universities in the country (students = 448)
• Major findings
– Students that can correctly define the term “dual-use research”
13%
– “Do you know any example of codes of responsible conduct
which apply to life scientists and technologists?”
6% answered YES
(Mancini 2011)
– Ongoing bioescurity education
• Quaid-i-Azam University: Dual use education/biosecurity/bioethics group
(Shinwari 2010)
Engagement of scientists in Pakistan
• National Guidelines for the Development of a Code of
Conduct for Life Scientists
• Adopted in 2010 by the National Focal Point for the BTWC under the
Ministry of Foreign Affairs
• The purpose:
– To constitute a form of commitment of life scientists towards humanity,
so that the life scientists clearly understand:
•
•
•
•
•
Potential risks involved in research
Commitment to human advancement
Ethical responsibility
National and international commitments, laws and regulations
Safeguarding public trust
(Government of Pakistan 2010)
National measures:
Areas of possible improvement
Pakistan
• Laboratory safety measures
– Good efforts have been made
• National legislation of the BTWC
– Good efforts have been made
• Education and Codes of Conduct
– Good efforts have been made
– Opportunities for sharing best practice with regional and
wider communities
References
• The references cited in this presentation
may be found in the Notes section of this
slide.