handling regulatory issues of off-patent gm...
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biosafety and biotechnology regulatory services
Handling regulatory issues of off-patent GM crops
2015 IIBN Forum
Ghent, 19 June 2015
Dr. Patrick Rüdelsheim
• BVBA, founded in 2003
• Service provider for:
• biosafety management
• compliance with biotech legislation
• Combining biosafety and
regulatory expertise for diverse
fields of application
Perseus
Off-Patent GM crops
Develop Co Seed Co
Organizations Individuals
Tech Co
Off-Patent GM crops
Develop Co Seed Co
Organizations Individuals
Tech Co
Basic Regulatory timeline
“Product
Discontinuation” “Proof of
Concept”
Elite Event
Phase 0 Phase 1 Phase 2 Phase 3 Phase 5
“Product
Launch”
Model species Target
species
Phase 4
Research Commercial Development
S P
S A
C L
Safety Package
Submission &
Approvals
Conditions & Liability
Regulatory elements
Material
• The “correct” event
• Genealogy
Study
• Design
• Competence
Report
• Proprietary/ Confidential/ Copyright
• Important to know content
Regulatory elements
Safety Package
Submission &
Approvals
Conditions & Liability
Identification of “Applicant”
Complexity
• Forms
• Reports
• Supplementary information
Data protection
• CBI
• Data protection
• Copyright
Regulatory elements
Safety Package
Submission &
Approvals
Conditions & Liability
Global strategy
• Primary markets
• Export markets
Regulatory elements
Safety Package
Submission &
Approvals
Conditions & Liability
0
5
10
15
20
25
95 96 97 98 99 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Mon 810 Authorizations
Cultivation Food Feed
Identification of “Authorization holder”
Type
• deregulation, authorization, registration
Scope
• Material (stacks), uses, territory
Validity
• Unlimited, fixed period
Regulatory elements
Safety Package
Submission &
Approvals
Conditions & Liability
• GMO related conditions
• Authorization specific conditions
• Reporting
• Renewals / discontinuation
Regulatory elements
Safety Package
Submission &
Approvals
Conditions & Liability
Authorization specific conditions Mandatory elements of the growers’ IRM programme: Structured refuge requirements Signed Growers agreements Annual affirmation by Growers that they will follow
the IRM requirements Grower compliance program (conducted by
registrants) o Anonymous telephone surveys o On-farm assessments o Growers can report violations of the structured refuge
requirements as “tips and complaints” to the seed company
o Remedial actions are required of growers who have deviations from the structured refuge requirements
Resistance monitoring programs for Cry1Ab and Cry1F Bt corn (European corn borer, corn earworm, southwestern corn borer) and for Cry3Bb1, Cry34Ab1/35Ab1, mCry3Aa1 Bt corn (western corn rootworm) o Bioassays (conducted by registrants) o Growers are encouraged to report incidents of
“unexpected damage” in the field
Regulatory elements
Safety Package
Submission &
Approvals
Conditions & Liability
Renewals
• Data requirements for renewal applications,
which should contain a copy of the authorisation, post-market monitoring and post-market environmental monitoring reports, systematic search and evaluation of literature, updated bioinformatics and any additional documents or studies performed by or on behalf of the applicant during the authorisation period.
• The applicant is requested to assess the collected information and conclude whether the previous risk assessment remains valid.
• The applicant can also propose amending or complementing the original conditions of the authorisation, including the monitoring plan(s).
Regulatory elements
Safety Package
Submission &
Approvals
Conditions & Liability
Emerging regulatory systems
Which elements are in place?
Are they properly defined?
Data acceptability, protection, access?
Liability
Regulatory elements
Safety Package
Submission &
Approvals
Conditions & Liability
Real Regulatory timeline
“Product
Discontinuation” “Proof of
Concept”
Elite Event
Phase 0 Phase 1 Phase 2 Phase 3 Phase 5
“Product
Launch”
Model species Target
species
Phase 4
Research Commercial Development
S P
S A
C L
Who will
• Update safety package?
• Defend product?
• Obtain/maintain authorizations?
• Ensure compliance with conditions?
• Interact with authorities?
• Be liable in case of damage?
Challenges
Safety Package
Submission &
Approvals
Conditions & Liability
Develop Co Seed Co
Organizations Individuals
Tech Co
Options
Develop Co
Independently maintain regulatory responsibility
Share regulatory responsibility
Discontinue regulatory responsibility
Consequences
Independently maintain regulatory responsibility
Develop Co Seed Co Organizations Individuals Tech Co
S P
S A
C L
S P
S A
C L
S P
S A
C L
S P
S A
C L
S P
S A
C L
Consequences
Share regulatory responsibility
Develop Co Seed Co Organizations Individuals Tech Co
S P
S A
C L
S P
S A
C L
S P
S A
C L
S P
S A
C L
S P
S A
C L
Consequences
Discontinue regulatory responsibility
Develop Co Seed Co Organizations Individuals Tech Co
S P
S A
C L
S P
S A
C L
S P
S A
C L
S P
S A
C L
S P
S A
C L
The AgAccord
A unique private sector solution to address the transition of regulatory and stewardship responsibilities for biotech events as patents expire.
Generic Event Marketability and Access Agreement (GEMAA)
The Data Use and Compensation Agreement (DUCA)
Initiatives
www.agaccord.org
• Nature of “off-patent” products requires specific regulatory approach
• GM crops regulatory systems are not ready for this
• Pioneers can set the track for orderly settlement at this last frontier
Conclusion
Technologiepark 3
B-9830 Zwijnaarde
Belgium
M +32 475 45 72 04
F +32 9 321 07 05
www.perseus.eu
Special thanks to Sue MacIntosh & Vickie Foster