1. Department of International Health Regulations Coordination
OIE Global Conference on Veterinary Legislation Djerba, Tunisia 7-9 December 2010
Bruce Plotkin
Department of International Health Regulations Coordination
Departments of Food Safety and Zoonoses
and International Health Regulations Coordination
Health Security and Environment Cluster
WHO HQ, Geneva, Switzerland 1

2. Outline of Presentation
Codex Alimentarius:
What is it? What does it do?
Importance for national legislation
International Health Regulations (2005):
Background, overview, scope
Key elements
Importance of intersectoral collaboration
Legislative assessment and revision:
Lessons learned and practical suggestions

3. Codex Alimentarius Commission - what is it? -
Codex Alimentarius Commission (CAC) is an intergovernmental body operating within the United Nations
Joint initiative of FAO and WHO (since 1963)
FAO/WHO Food Standards Programme
180 member governments, including the European Community as a member organization
Approximately 20 technical committees
Product is Codex Alimentarius (Latin for "food code")

4. Codex Alimentarius Commission - what does it do? -
Creates harmonized international food standards with a dual purpose:
“to protect the health of consumers”
“to ensure fair practices in the food trade”
Also promotes coordination of all food standards work undertaken by international governmental and non-governmental organizations
Standards, when introduced into national legislation, contribute to ensure safety of foods
Commission meets annually - discuss and adopt international food standards, guidelines
For examples, at its recent 33rd session, the commission considered:
guidelines on controlling bacteria in seafood throughout the food-chain; and
setting maximum residues level for ractopamine in meat

5. Codex standards for food safety → Codex standards
Voluntary / Non-mandatory
Reference for policy & decision-makers
Since 1995, international standards references under the SPS and TBT Agreements of the World Trade Organization (WTO)
International standards in SPS
for food safety → Codex standards
for animal health → OIE (World Organisation for Animal Health)
for plant health → IPPC (Int'l Plant Protection Convention)

6. FAO/WHO Guidelines for strengthening national food control systems (2003)
ANNEX 6 – Guidelines for Developing a National Food Law
A set of guiding principles as a general approach to the drafting of food legislation
Applicable to different legal systems
Complement an in-depth analysis of the legal and institutional framework that govern food production, import, export, distribution, handling and sale in a particular country
Prompt countries to take full advantage of Codex standards and food safety & quality lessons learned in other countries

7. International Health Regulations (2005) A (very) short history
1969 IHR covered 3 diseases: YF, cholera, plague
Revision started 1995 –adopted by all States in 2005
IHR in force, and implemented, globally since Legally binding on 194 States Parties
Concerns during revision included - EIDs, Zoonoses e.g. Ebola/VHFs, BSE, Nipah, SARS, avian influenza, future serious potentially unknown international risks
Global legal framework against international spread of serious disease
Apply to government as a whole, not just particular ministry, department or agencies
Broad / open disease scope for early warning/response & to catch emerging risks
Overall framework: surveillance, response, support ,information sharing, capacities
Does not replace existing regulatory regimes – Does mandate collaboration

8. Major innovations
From control at borders to containment at source and development of core public health capacities in all countries
From disease list to broad range of serious int'l public health risks
From preset health measures to generalized rules and risk assessment in particular context

9. Purpose and Scope of IHR
"to prevent, protect against, control and respond 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" (Article 2)

10. Broad scope and coverage of IHR (2005)
“Disease”: “an Illness or medical condition, irrespective of origin or source, that presents or could present significant harm to humans”
“Event”: “a manifestation of disease or an occurrence that creates the potential for disease”
"Public health risk": "the likelihood of an event that may adversely affect the health of human populations, …"
Events/risks may be:
Biological/infectious, chemical, radionuclear
Known or unknown, emerging or re-emerging
Transmissible by persons, transport conveyances, cargo/goods food/animals/products), vectors, environment, etc.

11. Government areas and functions affected by International Health Regulations
Public health
Environment
Radio-nuclear and chemical activities / safety
Customs
Food safety
Borders / immigration
Agriculture (and animal health)
International ports, airports, ground crossings
Transportation (including dangerous goods)
Collection, use and disclosure of public health information
Activities of authorities at national, state/provincial/district, local levels.

12. Animals / products
References to animals in the IHR arise in mainly 2 contexts:
"Goods" – part of provisions throughout the IHR
Defined as: "tangible products, including animals and plants, transported on an international journey, including for utilization aboard a conveyance"
"Animals" – additionally referenced separately (examples):
Definitions: infection/disinfection, contamination/decontamination, reservoir/vector
Port/airport authorities responsible for removal and safe disposal of animal dejecta and other contaminated items on conveyances
Designated ports/airports must have capacities to assess and care for affected animals by arrangements with local veterinary facilities for isolation, treatment
Ship Sanitation Inspections / certificates include animal reservoirs
Maritime Declaration of Health includes disclosure of sick animals

13. Key structures & mechanism
National IHR Focal Point
In all countries available 24/7 for urgent communications with WHO IHR Contact Point on urgent events under the IHR (for e.g. notification/verification/follow-up) involving any covered risks
Responsible for obtaining information from all government sectors on IHR-covered events (should include animal health), and for disseminating information to them.
Potential focus for intersectoral collaboration
Has access to restricted IHR Event Information Site – information on selected (also OIE/FAO)
Environment
Radio-nuclear and chemical activities / safety
Customs
Food safety
Borders / immigration
WHO IHR Contact Point
Located in each of WHO’s 6 regional offices – for communications with the National IHR Focal Points
Works with WHO HQ, Country office and National government – on IHR events, technical support, capacity building

14. Key IHR elements for veterinary health sector & legislation: Public Health Operations (potentially zoonoses, animals)
WHO: Global surveillance, assessment, support / response
States: Notification/reporting/verification of urgent health events to WHO
States: Collaboration with National IHR Focal Points
WHO: Information sharing with States on selected urgent events with potential international implications
States: Regulation of application of health measures to int'l trade, transport and travelers and sanitary requirements at international ports/airports, crossings
Keys for implementation by veterinary health sector: Awareness of IHR requirements, and
Timely collaboration with IHR unit, including information sharing, through NFP or other mechanism

15. Development of core public health capacities for surveillance and response
All States Parties must develop/maintain national minimum public health capacities, including surveillance, assessment & response
Required capacities: Detect, assess, control and report internally on public health events – according to specified criteria
At all levels and throughout national territory
Deadline for development: 2012/2014
Efforts to achieve these capacities ongoing worldwide
Development monitored with States and WHO support
Report on progress to the WHO World Health Assembly
Includes your areas: Zoonoses and food-related risks
Critical area for intersectoral collaboration

16. National IHR Core Public Health Capacities: Monitoring and reporting
8 Core capacities
Legislation and Policy
Coordination
Surveillance
Response
Preparedness
Risk Communications
Human Resources
Laboratory
3 levels
National
Intermediate
Peripheral/Community
Potential Hazards
Biological
Infectious
Zoonosis
Food safety
Chemical
Radio nuclear
Events at Points of Entry

17. The requirements for intersectoral collaboration
Required directly, and effectively indirectly under IHR (2005)
Relevant mechanisms and provisions under the IHR (2005):
National IHR Focal Point in all countries:
Veterinary health sector a key authority with relevant public health information
May also be other IHR coordinating authority
National programme for meeting IHR Core capacity requirements – including zoonoses and food safety
These are subjects of national/WHO monitoring & reporting to World Health Assembly
Coordination with National IHR authorities:
National veterinary legislation should be consistent with national organization for IHR implementation
Ongoing legislative assessment and revision process regarding IHR (2005) rights and obligations – presents an opportunity for synergies and efficiencies

18. Assessment and revision of legislation
Potential benefits:
Enable veterinary health sector to carry out its necessary specific tasks
Facilitate more efficient and effective functioning to achieve objectives
Enable or facilitate implementation of country’s rights and obligations under the range of relevant international laws
Empower the veterinary health sector
Institutionalize the role and activities of the sector within the government
Facilitate important inter-sectoral collaboration within government in activities relevant to veterinary health sector’s
Good governance
Potential challenges include: institutional, technical, informational, resource

19. Lessons learned in context of public health legislative assessment and revision
Others in your government are probably also doing assessments / revision of legislation, some of which may relate to your intended legislation
Legislation must be specific to domestic legal and governance systems, socio- political context
Prioritize:
What may need to be done most urgently
What are most important elements for each State
Consider options to expedite the legislative process if urgently needed
Process needs to involve all relevant sectors, offices, levels
May well save time / avoid obstacles later
Process needs to involve not only options for high level legislation, but also regulations, rules, procedures that implement legislation operationally

20. Practical suggestions – Preparations
Contact relevant government legal advisors for appropriate procedures – if needed
Consider developing awareness materials such as cabinet papers to facilitate support
Start early to identify / mobilize governmental, technical, financial, other resources
Contact other States (particularly those with similar national contexts) who are doing, or have done, similar assessments and revisions for their lessons learned, collaboration
Contact your country's national authorities concerned with implementing the IHR (2005) rights and obligations and other relevant national/international obligations (e.g. WTO/Trade):
Facilitates awareness of full legislative landscape relevant to veterinary legislation
Can ensure consistency and effective implementation in areas of mutual concern
Start early to identify existing legislation, regulations, rules relating to your proposed legislation - can take surprising time, and if are problems better to know early

21. Resources: Guidance for full assessment
Detailed, step by step guidance materials on WHO Website (IHR context)
Most relevant: Brief Introduction: Considerations of Why, What, Who and How of legislative assessment and revision – as applied to IHR (2005) but much of it is generally applicable (and brief!)

22. w w w . w h o . i n t / i h r
Thank you