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

info@perseus.eu

www.perseus.eu

Special thanks to Sue MacIntosh & Vickie Foster