Q&A: Nagoya Protocol threatens timely sharing of pathogen sequence data

Photo of Carolina dos S Ribeiro
Carolina dos S Ribeiro

On the agenda at this year’s Convention on Biological Diversity Conference of the Parties, taking place Nov. 17 to 29 in Egypt, will be the issue of including genetic sequencing data in the Nagoya Protocol, an international treaty governing the sharing of genetic resources.

Parties will discuss whether genetic sequencing data fall within the scope of the protocol, which historically has addressed access to physical biological samples, according to Carolina dos S Ribeiro, MSc, senior advisor in the Center for Infectious Disease Control at the Netherlands National Institute for Public Health and the Environment, and colleagues, who addressed the topic in a recently published perspective in Science.

Infectious Disease News spoke with Ribeiro about the Nagoya Protocol and the free sharing of pathogen sequence data, especially as it pertains to the rapid response to and control of infectious diseases. – by Marley Ghizzone

What is the Nagoya Protocol and what does it means for public health?

The Nagoya Protocol is an internationally binding treaty that was adopted in 2010, but only entered into force in 2014. It was developed and agreed under the umbrella of the United Nations’ biodiversity agency known as the Convention on Biological Diversity (CBD). The CBD has three objectives: 1) the conservation of biodiversity; 2) the sustainable use of its components; and 3) the fair and equitable sharing of the benefits arising out of the utilization of genetic resources.

The Nagoya Protocol addresses the third objective, the fair and equitable sharing of benefits of genetic resources. “Genetic resources” is anything that contains genetic material (DNA, RNA) like plants, animals, microbes and human beings; the CBD-NP regulates all of those except the human genome. Briefly, the Nagoya Protocol defined the “rules of the game” for sharing such genetic resources between countries. It determines that the genetic resources in principle are owned by the country where they have been found, or whoever the government decides to grant the ownership, and that the country can set conditions by which they are willing to share the materials.

As the Nagoya Protocol, in its definition of genetic resources, includes microbes (bacteria, parasites, viruses, fungi) that may infect humans, animals and plants, it potentially affects all international sharing of such materials even if they are to be used for public health purposes.

Why is this important for infectious diseases response and control?

This new regulation over the sharing of genetic resources may have important consequences for the functioning of global public health: infectious diseases do not respect borders, and rapid sharing of materials and related information is one of the hallmarks of modern-day infectious disease surveillance, response and control. Public health experts and researchers in infectious diseases are worried that the Nagoya Protocol may hinder this international collaboration that is crucial in the fight against infectious diseases.

What is challenging about the Nagoya Protocol, and why has there only been a partial implementation in some countries?

The main challenge about the Nagoya Protocol is that, depending on the way countries decide to implement it, users will have to negotiate with the government of all countries from which they wish to access the genetic resources, in what we refer to as bilateral negotiations. This means that scientists and experts willing to access and use pathogen genetic resources for outbreak-related research and response will have to negotiate conditions bilaterally with governments for each material needed. Imagine an international scientific consortium willing to validate a diagnostic test for a new pathogen: they would need samples from all affected countries and for that they would have to negotiate access to the pathogen material for all consortium members with each government for each shared sample. This scenario is very worrisome, especially when we are talking about a public health crisis, in which a day saved on the development of a diagnostic test, or the understanding of a transmission route can save many lives.

An extra challenge is that even 4 years after the protocol entered into force, there are still many countries that have not completely implemented it. The implementation of the Nagoya Protocol is a complex and long-term process in which, among other things, countries have to modify or create new laws and policies.

What drawbacks are there to including genome sequence data in the Nagoya Protocol?

Genome sequence data is the digital record of DNA or RNA, obtained through a process called genetic sequencing. Once available, this record can be shared directly with other researchers or public health experts, or by adding it to a shared database. This practice is of outmost importance for responding and controlling outbreaks rapidly, because they serve as input for surveillance systems allowing the tracking of new cases. Public health has benefited a lot from this open science movement. With the inclusion of genome sequence data in the Nagoya Protocol it would no longer be possible to share this data so fast and openly. The process for requesting permission, would lead to a substantial increase of complex administrative mechanisms, both for users and providers, as well as intermediaries such as biobanks and databases.

Then why would genome sequence data be considered as part of the Nagoya Protocol?

The reason why this is considered is that — with the advances of science — genome sequence data can also be used in downstream phases of research and development, for instance in the development of diagnostic tests, drugs or vaccines, without the need of accessing the originating (physical) material. These products can lead to revenues, of which countries may want to claim a fair share in the benefits generated.

What are some other options that would allow timely sharing while also respecting ownerships and rights?

There are other options for the timely sharing of pathogen genetic resources without compromising providers’ ownerships and rights; in our paper we describe two. The first option is replacing the multiple bilateral negotiations with governments by a unified multilateral system. By this we mean creating a standardized set of terms and conditions that countries formally agree on, so everyone knows what to expect when sharing genetic resources. The second option is an exemption, within the Nagoya Protocol, for sharing pathogens and pathogen genome sequences during a public health emergency without the formal permissions and certificates. These formal permissions and certificates would be negotiated and established retrospectively after the crisis is gone. Still, it is also pointed out in the paper possible drawbacks and complications that are inherent to these options, so details and implementation strategies still have to be worked out.

What is the take home message?

The take home message of the paper is that, while the Nagoya Protocol promotes in essence a fair and transparent process for sharing resources, the way it is being implemented can have serious impact on public health.

The Nagoya Protocol was developed primarily for the objectives of environmental and biodiversity protection, fair development and reciprocity among countries, and respect for ownership and rights. These are, without a doubt, important objectives, but we cannot ignore the impact that it can have on global health and our capacity to rapidly respond and control outbreaks and epidemics. The scientific community, public health agencies and policy makers have to be aware of such impact and consider a way to address ownership and rights in times of crisis, or preferably ahead of time.

Reference:

Ribeiro CDS, et al. Science. 2018;doi:10.1126/science.aau5229.

Disclosures: The authors report no relevant financial disclosures.

Photo of Carolina dos S Ribeiro
Carolina dos S Ribeiro

On the agenda at this year’s Convention on Biological Diversity Conference of the Parties, taking place Nov. 17 to 29 in Egypt, will be the issue of including genetic sequencing data in the Nagoya Protocol, an international treaty governing the sharing of genetic resources.

Parties will discuss whether genetic sequencing data fall within the scope of the protocol, which historically has addressed access to physical biological samples, according to Carolina dos S Ribeiro, MSc, senior advisor in the Center for Infectious Disease Control at the Netherlands National Institute for Public Health and the Environment, and colleagues, who addressed the topic in a recently published perspective in Science.

Infectious Disease News spoke with Ribeiro about the Nagoya Protocol and the free sharing of pathogen sequence data, especially as it pertains to the rapid response to and control of infectious diseases. – by Marley Ghizzone

What is the Nagoya Protocol and what does it means for public health?

The Nagoya Protocol is an internationally binding treaty that was adopted in 2010, but only entered into force in 2014. It was developed and agreed under the umbrella of the United Nations’ biodiversity agency known as the Convention on Biological Diversity (CBD). The CBD has three objectives: 1) the conservation of biodiversity; 2) the sustainable use of its components; and 3) the fair and equitable sharing of the benefits arising out of the utilization of genetic resources.

The Nagoya Protocol addresses the third objective, the fair and equitable sharing of benefits of genetic resources. “Genetic resources” is anything that contains genetic material (DNA, RNA) like plants, animals, microbes and human beings; the CBD-NP regulates all of those except the human genome. Briefly, the Nagoya Protocol defined the “rules of the game” for sharing such genetic resources between countries. It determines that the genetic resources in principle are owned by the country where they have been found, or whoever the government decides to grant the ownership, and that the country can set conditions by which they are willing to share the materials.

As the Nagoya Protocol, in its definition of genetic resources, includes microbes (bacteria, parasites, viruses, fungi) that may infect humans, animals and plants, it potentially affects all international sharing of such materials even if they are to be used for public health purposes.

PAGE BREAK

Why is this important for infectious diseases response and control?

This new regulation over the sharing of genetic resources may have important consequences for the functioning of global public health: infectious diseases do not respect borders, and rapid sharing of materials and related information is one of the hallmarks of modern-day infectious disease surveillance, response and control. Public health experts and researchers in infectious diseases are worried that the Nagoya Protocol may hinder this international collaboration that is crucial in the fight against infectious diseases.

What is challenging about the Nagoya Protocol, and why has there only been a partial implementation in some countries?

The main challenge about the Nagoya Protocol is that, depending on the way countries decide to implement it, users will have to negotiate with the government of all countries from which they wish to access the genetic resources, in what we refer to as bilateral negotiations. This means that scientists and experts willing to access and use pathogen genetic resources for outbreak-related research and response will have to negotiate conditions bilaterally with governments for each material needed. Imagine an international scientific consortium willing to validate a diagnostic test for a new pathogen: they would need samples from all affected countries and for that they would have to negotiate access to the pathogen material for all consortium members with each government for each shared sample. This scenario is very worrisome, especially when we are talking about a public health crisis, in which a day saved on the development of a diagnostic test, or the understanding of a transmission route can save many lives.

An extra challenge is that even 4 years after the protocol entered into force, there are still many countries that have not completely implemented it. The implementation of the Nagoya Protocol is a complex and long-term process in which, among other things, countries have to modify or create new laws and policies.

What drawbacks are there to including genome sequence data in the Nagoya Protocol?

Genome sequence data is the digital record of DNA or RNA, obtained through a process called genetic sequencing. Once available, this record can be shared directly with other researchers or public health experts, or by adding it to a shared database. This practice is of outmost importance for responding and controlling outbreaks rapidly, because they serve as input for surveillance systems allowing the tracking of new cases. Public health has benefited a lot from this open science movement. With the inclusion of genome sequence data in the Nagoya Protocol it would no longer be possible to share this data so fast and openly. The process for requesting permission, would lead to a substantial increase of complex administrative mechanisms, both for users and providers, as well as intermediaries such as biobanks and databases.

PAGE BREAK

Then why would genome sequence data be considered as part of the Nagoya Protocol?

The reason why this is considered is that — with the advances of science — genome sequence data can also be used in downstream phases of research and development, for instance in the development of diagnostic tests, drugs or vaccines, without the need of accessing the originating (physical) material. These products can lead to revenues, of which countries may want to claim a fair share in the benefits generated.

What are some other options that would allow timely sharing while also respecting ownerships and rights?

There are other options for the timely sharing of pathogen genetic resources without compromising providers’ ownerships and rights; in our paper we describe two. The first option is replacing the multiple bilateral negotiations with governments by a unified multilateral system. By this we mean creating a standardized set of terms and conditions that countries formally agree on, so everyone knows what to expect when sharing genetic resources. The second option is an exemption, within the Nagoya Protocol, for sharing pathogens and pathogen genome sequences during a public health emergency without the formal permissions and certificates. These formal permissions and certificates would be negotiated and established retrospectively after the crisis is gone. Still, it is also pointed out in the paper possible drawbacks and complications that are inherent to these options, so details and implementation strategies still have to be worked out.

What is the take home message?

The take home message of the paper is that, while the Nagoya Protocol promotes in essence a fair and transparent process for sharing resources, the way it is being implemented can have serious impact on public health.

The Nagoya Protocol was developed primarily for the objectives of environmental and biodiversity protection, fair development and reciprocity among countries, and respect for ownership and rights. These are, without a doubt, important objectives, but we cannot ignore the impact that it can have on global health and our capacity to rapidly respond and control outbreaks and epidemics. The scientific community, public health agencies and policy makers have to be aware of such impact and consider a way to address ownership and rights in times of crisis, or preferably ahead of time.

Reference:

Ribeiro CDS, et al. Science. 2018;doi:10.1126/science.aau5229.

Disclosures: The authors report no relevant financial disclosures.