Session IV The Nagoya Protocol on Access and Benefit sharing is an international agreement that became effective in 2014, whose objective is "the fair and equitable sharing of the benefits arising from the utilization of genetic resources". It requires users to obtain authorization from the country of origin before accessing a genetic resource and to negotiate the terms and conditions of its use. While the intention of the Protocol is to contribute to the sustainable use of biodiversity, its application to the field of infectious pathogens has resulted in increased bureaucracy, which makes it difficult to share strains and sequences. This red tape hampers innovation in the field of vaccines against FMD and other transboundary diseases (FAST) and it is ultimately detrimental for disease control and pandemic preparedness. The Pandemic Influenza Preparedness (PIP) framework could be used as example of a framework that facilitates rapid sharing of virus strains, sequences and information. The veterinary scientific community and the international organizations needs to come together to define a similar innovative framework for FAST animal pathogens and ultimately exclude them from the scope of the Nagoya Protocol.

1. EuFMD
OS22
The need for
an innovative framework
for access and benefit sharing
of FAST pathogens
Pascal Hudelet

2. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22 2
Claude Hamers 1962 - 2022

3. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
Introduction
SARS-CoV-2: a vaccine in less than a year
● Sequence published 10 days after 1st report
● Vaccine development initiated 3 days after
sequence is published
A breach of the Nagoya protocol!
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From: SARS-CoV-2 mRNA Vaccine Development Enabled by Prototype Pathogen
Preparedness, Corbett et al., bioRxiv 2020.06.11.145920

4. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22 4
Introduction
Reminder – The Nagoya Protocol
● The Nagoya Protocol to the Convention on Biological Diversity is an international agreement whose
objective is the fair and equitable sharing of the benefits arising from the utilization of genetic resources
● The genetic resources are owned by the country where they have been found
• Genetic Material coming from living organisms : plants, animals, micro‐organisms
• Some countries (Brazil, South Africa…) also apply ABS to digital sequence information (“DSI”)
● Genetic resources may be accessed subject to:
○ The “prior informed consent” of the country (PIC)
○ “Mutually agreed terms” (MAT) have been reached that include the fair and equitable sharing of the
benefits arising from the utilization of the concerned resources
○ A “Material Transfer Agreement” (MTA) must be in place to transfer material
● All parties must agree on the terms before the transfer of the material

5. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22 5

6. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22 6
The intent

7. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22 7
The resulting impact on
vaccine development

8. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
FMD: 2 case studies New strain from African country
○ BI in contact with Nagoya focal point to source strain (available at WRL)
○ National ABS law being voted => uncertainties on scope and
retroactivity
○ Conditions for PIC proposed that are not compliant with BI’s policies
 Unable to start R&D for 4 years
 Strain now abandoned because no agreement
 Need to start from scratch with new country, new strain
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New strain from Sth East Asian country
○ BI sent request to Nagoya focal point (from Ministry of Environment)
to allow us to work on strain sourced from WRL under MTA
 No response in 2 years; Unable to start R&D for 2 years.
○ Very complex permitting process with 2 ministries, a lab and a local
partner needed to be involved
○ Needs a local project team with legal and scientific advisors > 1yr
 Strain now abandoned because no agreement
 Need to start from scratch with new country, new strain

9. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
Impacts for FMD
The specific problem of FMD new vaccine strains
● A priority for Animal health, but focal points are often part of the Ministry of Environment
(focus on Biodiversity)
● Unrealistic expectations from countries
○ Mostly developing countries vs. wealthy countries & ‘’Big Pharma’’
○ Overestimation of actual business value of 1 strain
○ Dynamic virus evolution vs. more than 3 years of ‘negotiation’ and 2-3 years development
 7 years after Nagoya implementation, we have had no success with any ABS agreement for
new vaccine development
 Standstill of development of new FMDV vaccines
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10. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
Similar knock-on effects for other transboundary diseases
Influenza
○ Since 2018: sharing of over 30 influenza virus strains has
been delayed from 3 to 5 months because of a lack of
clarity over national Nagoya Protocol/ABS legislation
○ Influenza vaccine development is on a strict 6-month
schedule. Any delay  vaccines not available in time
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Covid-19
○ ‘’It is estimated with SARS-CoV-2, a delay in one
month of sharing the virus samples could have led to
an additional loss of 400,000 lives’’
Burci, Gian Luca, and Frederic Perron-Welch. 2021. “International Sharing of
Human Pathogens to Promote Global Health Security—Still a Work in
Progress.” Insights 25 (13).
The Yearly Race for an Influenza Vaccine and the Role of Reagents – The Native Antigen Company
Adapted from the World Health Organization’s Pandemic influenza vaccine manufacturing process and timeline

11. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
Impacts for Innovation on FAST diseases
Complex, uncertain environment
 A challenge to keep up with 137 national ABS
laws, which are sometimes unclear and keep
changing
 Unclear accountabilities
 Huge administrative delays
Loopholes
 The ‘returning traveller’ bringing a germ with
him and making it a national resource
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A threat for innovation
 Jeopardizing the timely development of candidate vaccine
viruses and access to vaccines
 Dramatically restricting the data available in public
databanks
Disincentive to invest in FAST diseases
 Excessive obligations deter potential users
 Companies hate uncertainty
 Shifting investments from FAST/pandemic preparedness
programs to safer, more ‘certain’ developments
Undermining the CBD’s benefit sharing objective
 More advantageous for companies to work with countries not
party to the NP / no ABS law

12. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
Innovative frameworks exist
Pandemic Influenza Preparedness (PIP) framework
● Global approach to pandemic influenza preparedness and response
● Key goals: to improve the sharing of influenza viruses with human
pandemic potential; and to increase the access of developing countries
to vaccines and other pandemic related supplies
● Does not apply to seasonal influenza
● Coordinated by the WHO Global Influenza Surveillance and Response
System (GISRS), an international network of influenza laboratories
● Sharing of biological materials governed by Standard Material Transfer
Agreement (SMTA)
● Rapid sharing of data on the Global Initiative on Sharing All Influenza
Data (GISAID) database – now open to SARS-CoV-2
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13. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
I. Recommendations for Users of FAST genetic resources
Agree to share the benefits of their use in a fair and equitable way
● We will comply with the Nagoya Protocol
● We will share benefits in monetary and non-monetary forms
○ Joint research programs
○ Training
○ Technology transfers
○ Supply of vaccine
○ …
● Yet, needs to be
○ Fair to both sides
○ Clarity on process upfront
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14. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
II. Recommendations for the international scientific community
1. Officially agree on the following principles:
● Timely sharing of pathogens, sequences and metadata is essential for surveillance
and development of diagnostics, vaccines and therapeutics
● Therefore FAST pathogens isolates are a common good
● Pathogens should be excluded from the scope of the Nagoya protocol
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15. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
II. Recommendations for the international scientific community
2. Advocacy
We need you as local advocates with your authorities, to facilitate access to strains and sequences
○ Raising awareness on the importance of strain sharing
○ Raising awareness on the importance of vaccines
○ Raising awareness on the existence of NP/ABS
○ Support joined international effort to exclude FAST pathogens from the NP
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16. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
II. Recommendations for the international scientific community
3. Specialized international instrument
Creating exceptions to the Nagoya Protocol will be a long-term effort
We will still have to comply with local laws and regulations
We need an international instrument to cover the sharing of FAST pathogens strains and
sequences
○ Template MTA
○ Provide models for benefit sharing
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17. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
Conclusions
● The Nagoya Protocol was designed to support the fair and equitable sharing of
benefits arising from the utilization of genetic resources
● However, it has created a set of constraints that hinder innovation in FAST diseases
● We need the support of international organizations to exclude FAST pathogens from
the scope of the Nagoya Protocol
● A new innovate framework for FAST diseases is needed that will encourage
countries to promptly share their material while guaranteeing them a fair share of the
benefits
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18. Thank you !..
www.boehringer-ingelheim.com
pascal.hudelet@boehringer-ingelheim.com