Transcript Outcome of the HealthforAnimals 2015 Global Animal Health

Outcome of the 4th Global
Animal Health
Conference (GAHC)
24 -25 June 2015
Bettye K. Walters, DVM
US Food and Drug Administration
[email protected]
:
1
4th Global Animal Health
Conference (GAHC) June 2015
Dar Es Salaam, Tanzania
101 attendees from 36 countries
100% had their expectations met
96% rated the GAHC as excellent – good
98% rated the GAHC as informative and
comprehensive
GAHC presentations can be found at
www.diaglobal.org
2
2
Guiding Principles
Harmonization is important because it also
impacts food security and human health .
Core set of scientific competencies that can
lead to the availability of safe, effective and
quality veterinary medical products
– Reduced animal mortality, disease diagnosis,
prevention, and treatment
– Increased animal health and production leads to more
food production
– Increased food production to keep pace with growing
population
3
Conference Objectives
and Sessions
Promote market control
Improve market access
Promote mutual recognition and the formation
of regional organizations
Implement African regional harmonization
initiatives and discuss local opportunities and
challenges towards the implementation of
harmonized regulatory systems
4
Session 1: Why is Regulatory
Convergence important and
what can it facilitate?
• Regulatory convergence can:
• expand drug and vaccine development and marketing
• eliminate obstacles to trade
• increase access to therapies and vaccines for
emerging diseases (60% of which are zoonotic)
• provide greater certainty in the regulatory process
• reduce the number animals needed for testing
• lend greater legitimacy to regulatory decisions
5
5
Session 1: What is needed for
Regulatory Convergence to
work?
Commitment at political and senior
management level
Shared language
Facilities and human resources required for
coordination
Recognition of the work of other international
bodies such as OIE, Codex, VICH, WHO
Recognition that convergence of preauthorisation activities is only one element of an
authorization and control system for VMPs
6
Session 2: Market Control
EXAMPLE: Malaysia
Comprehensive regulatory system in Malaysia
that evolved from collaboration through ASEAN
The system is complex and has many facets to
be comprehensive.
The system evolved and is kept current by
regular discussion in ASEAN.
Need for benchmarking the competencies of
regulatory authorities with the aim of building
mutual trust
7
Session 2: Market Control
EXAMPLE: PANVAC
Arose out of the lessons learned from Rinderpest
Established a regional laboratory with testing, market
controls and training for personnel in other laboratories,
manufacturers, and regulators serving many African
countries
Became an OIE Collaborating Center in 2013
Demonstrated success in providing controls for the
quality of vaccines in Africa
Demonstrates what is possible through collaboration
and support
8
Session 3: Market Access
and Mutual Recognition
What is needed – industry’s perspective
– Predictability of registration process
– Reliability – consistent criteria
– Simplified process – no repetition / unnecessary
administrative burden
– Appropriate enforcement mechanisms by authorities
– Regional oversight of manufacturing sites
– Recognition of and alignment with appropriate
international standards in relation to manufacturing
and control procedures
9
9
Session 3: Market Access and
Mutual Recognition
EXAMPLE: GALVmed
The value of mutual recognition procedures was noted
and realized for veterinary vaccines in East Africa.
Has the following advantages:
– Accelerates the availability of quality vaccines
– Avoids duplication
– Improves predictability
– Builds trust between regulators
– Allows rapid introduction of vaccines against new
diseases
10
Session 3: What can hinder or
limit Market Access and Mutual
Recognition?
Limiting factors to market access and mutual
recognition
–
–
–
–
–
–
–
–
–
Not respecting WTO rules
Inadequate VMP market control
Lack of harmonization
Lack of acceptance of new technologies
Retroactive action on existing products
Poor control over counterfeit products
Data protection – confidentiality
Lack of visibility of changes in regulatory environment
Unreasonable registration costs
11
11
Session 4: Regional
Organizations
What can Regional Organizations provide?
– Harmonization - harmonized technical requirements
in line with intergovernmental standards
– Flexibility - organizational and procedural - for
marketing authorizations
– Adaptability - regional solutions that can be adapted
to local situations
Examples – VICH, EU, South African, Asian,
South American, US-Canada models
12
Session 4: What is needed for
Regional Organizations to
work?
Characteristics, Benefits and Needs of Regional
Organizations
– Need for technical and regulatory commitment
– Legal basis for mutual recognition
– Structure to bring regulators and industry together on
a regular basis
– Time to build trusting and sustainable relationships
– Confidentiality and transparency
– Networking
– Inclusivity of process
– Common language
13
Breakout Sessions
KEY THEMES
common across Sessions
Must have political will among
government departments
Must have good governance
May need capacity building
Need adequate resources
Communication is a must
Trust among regulators and industry
14
Breakout Sessions
KEY THEMES
common across Sessions
Need for strengthening professional
organizations and ethical standards
Improved marketing infrastructure
Ensure confidentiality of data
Build capacity of leaders in the field, end users,
professionals
Human and veterinary single agencies should
work together so not to compete for resources
15
15
Breakout Sessions
KEY THEMES
common across Sessions
International norms are advantageous with caveats
Regular joint review of guidelines
Convergence offers potential for
• Increased pharmacovigilance
• Increased monitoring of resistance
• Increased access to products
16
Breakout Sessions
KEY THEMES
common across Sessions
What are some perceived potential
disadvantages of regulatory convergence?
– Loss of flexibility to make local decisions and
standards
– Loss of market to local industry
– Need time to develop processes
– Capacity building requires financial, IT, and training
resources
17
17
Pre-Conference
VICH Workshop
June 24, 2015
Introduction to VICH
Role of VICH Guidelines in the product
registration process
Introduction to VICH Outreach Forum
How to get involved in VICH
How to get more information
www.DIAglobal.org
18
18
19
19