National SeriesLecture 4

National MeasuresUkraine

Bradford Disarmament Research CentreDivision of Peace Studies, University of Bradford, UK

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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 ] essential safety practices and procedures.

(WHO 2004)

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) 3BSL 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) 4BSL 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

A member of the European Bosafety Association (EBSA)• Sets standards for professional biosafety competence

– The Laboratory Biorisk Management Standard (CWA 15793)

EU-Ukraine common foreign and security policy• “..[European Union and Ukraine] …cooperate in the enhancement of

bio-security and bio-safety standards in laboratories… in particular in light of the ongoing dialogue on possible cooperation on bio-safety and bio-security in the Ukrainian Anti-plague station (AR Crimea, Simferopol)”

(European Commission 2009)

Laboratory measures: Ukraine

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).

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 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 toxinsEach 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

8 Core capacities required of States:

1. National legislation, policy and financing, 2. Coordination and NFP communications, 3. Surveillance, 4. Response, 5. Preparedness, 6. Risk communication, 7. Human resource, and 8. 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)

IHR Reports• On 30 May 2011, the National International Health Regulations (IHR) Focal Point (NFP)

for Ukraine reported to WHO three laboratory confirmed cases of cholera from the Mariupol area. As of 6 June, 11 additional cases have been reported. Thus, the total figure reported to WHO now stands at 14 laboratory confirmed cases of cholera – in 13 adults and 1 child aged one-and-a-half.

Responses• In light of the cholera cases, the Ukrainian authorities have enhanced surveillance.

Water and sanitation conditions are being improved by detecting unauthorized sewages, as well as through cleaning and disinfection of drainage ditches. Public information campaigns on hygiene and appropriate care for people infected with cholera are being organized. Local authorities have prohibited swimming and fishing in the surrounding Kal’chyk and Kalmius Rivers, as well as the Sea of Azov. Healthcare professionals have been asked to test all cases of diarrhoea coming to healthcare facilities.

(WHO 2012c)

Public health measures (IHR)

2. Arms control

National implementation of an international legal agreement

Biological and Toxin Weapons ConventionArticle 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.”

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)

“in accordance with its constitutional process”= No one size fits all

National implementation of an international legal agreement

Ukraine

• BTWC– More than 35 processes of legislation, decree and ordinance to

implement the scope of the Convention, including via the Constitution, the criminal code, export controls, environment and public health measures

(VERTIC 2012)

• Chemical Weapons Convention (CWC)– No legislation is registered with the CWC website

(OPCW)

National implementation of an international legal agreement

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

GE √ √ √ √ √

PK

TJ √ √ √ √ √UKR √ √ √ √ √ √

BTWC Submission of Confidence Building Measures (CBMs)

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011AB √ √ √ √GE √ √ √ √ √ √ √ √ √ √ √PK

TJ √

UKR √ √ √ √ √ √ √ √ √ √ √ √

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 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)

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)

Evolution of the BTWC: strengthening national measures

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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Committee

• 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.

A possible policy process for oversight

E.g. USA - The National Science Advisory Board for Biosecurity (NSABB) Israel - Steering Committee on Issues in Biotechnological Research in the Age of Terrorism

Oversight of Research

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)

A national biosecurity dual-use action plan model

1. Identify what is currently taught (a survey)2. Develop a network of interested lecturers3. Develop appropriate content for courses4. Implement pilot courses5. Monitor and evaluate pilot courses6. Identify and elucidate best practice7. Institute clear, active links between industrial partners/associates, defence

agencies and academic institutions teaching biosecurity 8. Develop or participate in an international network to share best practice9. Make dual-use/biosecurity education mandatory10. Monitor consequential growth of sensible codes and oversight systems11. Report on progress to BTWC and relevant scientific meetings

Education national action plan

Structural

Individual

AutonomousLegal

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

4. Changing evaluation criteria on higher education institutions 5. Establishing a national advisory board

6. Legislating a biosecurity act

6

3

5

4

2

1

Education national action plan

Engagement of scientists in Ukraine

– Background survey • A national survey has been planned

– International seminars on biosecurity and biosafety• Have been held between 2007-2010

– Biosecurity education• National Taras Shevchenko University in Kyiv is planning to

introduce a biosecurity education module (higher education)

(Kysil and Komisarenko 2010)

National measures: Areas of possible improvement

Ukraine• Laboratory safety measures

– Efforts have been made

• National legislation of the BTWC– Efforts have been made, the legislative information to the OPCW can

be considered

• Education and Codes of Conduct – Good efforts have been made,– Implementation of the survey and the development of a national code

of conduct for biosecurity can be good agendas

References

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