Strengthening National Implementation

Siripan WongwanichDepartment of Medical Sciences,

Ministry of Public Health, Thailand

• Implementation of BWC

• Legislation : Pathogens and Animal Toxins Act

of the Kingdom of Thailand

• Implementation of biosafety, biosecurity and bioethics

Scope

Translation into Thai language (EU Pilot Project 253485)Workshop on “Introduction of Biological and Toxin Weapon

Convention and Thai legislation for implementation of BTWC”- 2nd April 2012 in Bangkok. - 150 participants from ministries (public health, military,

interior, foreign affairs, science & technology, agriculture, transportation, justice), academia, and other private and government sectors.

- Key Legal Expert for EU Pilot Project 253485

Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriology (Biological)

and Toxin Weapons and on Their Destruction • April 1972

• December 2011

Pathogen and Animal Toxin ActB.E. 2525 (1982), amended 2544 (2001)

• superseded Act B.E. 2475 (1932)• In charge by the Minister of Ministry of Public Health• The Director-General of the Department of Medical Sciences is

responsible for issuing permits for the possess (use, storage) production, distribution, sale, import, export, transport/trans-shipment of pathogens and animal toxins.

Pathogens and animal toxins capable of causing disease in humans, livestock, animal carriers, or other animals specified by ministerial regulation.

Application form indicated pathogens list, equipment,

SOPs, personnel, etc.

Organisation/Agency

‐ Produce

‐ Possession, use, storage

‐ Dispose/distribute

‐ Import

‐ Export

‐ Transit/trans‐shipment

Inspection

Licencing/Registration

Licencing annually(private= 546)

Registration(Gov. = 109)

Pathogens (bacteria, virus, fungi, rickettsia, parasite, prion)Animal toxins

20%14%

2%

4%

3%

1%

56%

Total = 655Public health services,Academia, Research institutes, Pharmaceutics,Food and Agriculture Industries, Other private sectors

Canada USA Australia Singapore Thailand

Human Pathogen and Toxins Act

Purpose

H.R. 3448, January 2002. HHR Final Rule: 42CFR Part 72 (1997).

Purpose

Biological Control Act 1984

The Biological Agents and Toxins Act 2005

Pathogen and Animal Toxins Act 1982, 2001

Health Minister

มี Advisory Committee*

CDC, Department of Health and Human Service (HHS) and United States Department of Agriculture (USDA)

Minister of State Director of Medical Service

Public Health Minister

Director General, DMSc

Pathogen and toxin list**

Selected Agentsand Toxins

Target organisms

Pathogen and toxin list

No Pathogens List in the Act

Safety Officer Safety Officer Safety Officer Safety Committee

No

List of Personnel access to Pathogen and Toxins

List of Personnel access to Pathogen and Toxins

List of Personnel access to Pathogen and Toxins

No

Comparative study: identify gaps

Sharing & Learning

IFBA

Institute for Biological Science

Public Health Agency Canada

Biosafety, Biosecurity & Bioethics Measures

Engineering control

Bio-Waste Treatment

- Including of 12 chapters and 95 sections - specified authority of minister of MOPH- authority of advisory committee- issue criteria, requirements, conditions for a permition- category of pathogens (Toxins) and animal toxins- code of conduct, procedures (routine and S&T research)- safety/security/bioethics management

(CWA 15793:2011 Lab biorisk management standard)

Thailand is currently developing amendments to the Pathogens and Animal Toxins Act (B.E. 2525 (1982) and amended by B.E. 2544 (2001)....will be reviewed by the Cabinet next Tuesday 24th July 2012.

establishes a very comprehensive system to authorize the

production, import, export, sale, transport and possession

(use, storage) of pathogens and animal toxins.

requires permit holders to adopt some accountability measures

over pathogens and animal toxins; requiring the adoption of

biosafety and biosecurity measures.

strengthening its enforcement mechanism with a system for

co-operation and co-ordination between law enforcement and

public health officials.

criminalizes the intended use of pathogens and animal toxins in bad faith

THAILAND BIORISK MANAGEMENT CHAMPIONS

1. Involve in production, possession, distribution, import, export and trans-shipment of pathogens & animal toxins

2. Private or public organisations (legally identificafiable)

3. Contain Biosafety level 2 /or 2+/or 3 facilities4. The design, environment, instrument is suitable for the tasks5. Sufficient qualified personnel6. Qualified Biosafety Professional7. Biosafety and biosecurity management system is established and

implemented at all time8. Being inspect by DMSc’s inspector9. Renew annually a license or registration certificate10. Submit a report of pathogens and animal toxins regulary to DMSc

Onsite–visit BSL 2, BSL 3Mahidol Oxford Research Unit

2nd module of Biosafety Professionals: 29 Feb-2 Mar 2012, Bangkok

Biosafety Professionals, Bangkok

A4.21 st batch A = 36 

2nd batch B=25 

36x2= 72

1st training module 

2nd training module 

Biosafety Professionals

B1

B1.1

B1.2

25x2=50

Total =183 แหง

Guideline of Biosecurity

in Laboratory

Risk group of pathogens

Guidelines

The International Federation of Biosafety Associations (IFBA) 2nd Annual Conference Biosafety and Biosecurity:

Building Sustainable Capacity

“IFBA Biosafety Hero 2012”

• Promote awareness of the obligations under the Convention

• Review and update the national act related to biosafety and biosecurity

• Clear policy and requirements of legislation program

• Support the public and private sectors

• Educate and communicate with stakeholders, i.e. research organisations, academia, manufacturers, distributors, publisher, media and public.

• Sharing knowledge and collaborate with local and international organisations

Summary of activities

Conclusion: sharing for prevention & peaceful

Policy maker

ManagementScientistEngineerArchitech

GovernmentOfficer

PublishersMediaPublicAssociations