How to Formulate Domestic Measures for Implementing the Nagoya Protocol
Consulting Fellow, RIETI
When Company A gains benefits through using genetic resources (living organisms) obtained from Country B (Note 1), for example, is it obliged to share them with Country B? This is a typical argument in the "Access and Benefit Sharing (ABS)" issue which has been debated for more than 20 years in the field of environment and development. The ABS issue started with the Convention on Biological Diversity in 1992. The convention confirmed that "every country has the authority to set regulations on the access to its own genetic resources" and stipulated that "every government shall take measures to ensure benefit sharing" on the premise that "benefit sharing is based on the agreement between parties." However, because of the grievances by the resource providers (mainly developing countries) that the contents of the measures to be taken by the resource users (mainly developed countries) are not sufficiently clear, there has been a conflict between them. The 10th meeting of the Conference of the Parties to the Convention on Biological Diversity held in 2010 in Nagoya adopted the Nagoya Protocol, which specifically defines ABS, and settled this longstanding controversy. There is, however, much to be done before it is implemented.
With the aim of implementing the Nagoya Protocol by 2015, Japan has commenced deliberations on its ratification and the introduction of domestic measures. Although I have no objection to the early ratification of the protocol, I would like to request that the relevant authorities conduct careful consideration to avoid a situation in which the introduction of domestic measures in association with the ratification places unnecessary burden on domestic users, such as companies and universities, and disturbs innovation in the field of biotechnology.
The following are some precautions to be taken for "monitoring the utilization of genetic resources" and "determining access to genetic resources," when introducing domestic measures. Also, let me briefly comment on how to deal with multi-valued issues such as ABS.
Monitoring the utilization of genetic resources from overseas sources (measures to be taken when Japan is a user)
First, benefit sharing should reflect mutually agreed terms (MAT) determined through free negotiation among parties, and unnecessary government involvement is to be avoided. For example, it should be no surprise that the content of MAT for the use of the same resources differs depending on whether they are used for research or commercial purposes, and the decision on the content should be left to the parties and not determined uniformly by laws. It is beneficial, however, to formulate best practices, as they may be of reference to all parties.
Second, the scope of application of the protocol should be defined clearly. For example, "elucidated genetic information" and "synthetic compound having biochemically identical properties with genetic resources" do not exist naturally. Therefore, they are not categorized as genetic resources (Note 2) and are considered as falling outside of the scope of application of the protocol. Meanwhile, general commodities, such as wheat and soybeans, do not fall outside just because they are general commodities. However, since there is an implicit agreement for the mode of utilization of general commodities among parties, the benefit is shared when the payment is made by the user for the purchase, unless the use breaches the agreement (Note 3). This interpretation may differ from country to country, but, whatever the case may be, the Japanese government should inform the public of its interpretation regarding the scope of application of the protocol in line with the "monitoring" to help them clearly understand what will or will not breach the obligations under the protocol.
Third, a system capable of properly dealing with the demand for protection by overseas countries (demand to protect genetic resources from overseas sources and associated traditional knowledge) should be furnished within the government. For example, traditional knowledge refers only to that of "indigenous and local communities" in the convention. However, there is a need to have a system (a responsive system under public-private partnership) that can quickly reject the demand for the protection of traditional knowledge beyond the scope of application of the protocol.
Determining access to genetic resources in Japan (measures to be taken when Japan is a provider)
Under the Nagoya Protocol, every country has the right to demand users of genetic resources from domestic sources to obtain prior informed consent (PIC) from the relevant authorities. Whether or not to introduce the PIC system is to be determined by individual countries. If the PIC system is introduced in Japan, where most of the users of domestic resources are Japanese, the burden to be borne by these users will increase as a whole (obliging the PIC system only for non-resident users is not allowed in light of the principle of national treatment). On the other hand, there is no ground to justify the burden. Accordingly, the government should not make a premature decision on the introduction of the PIC system.
However, as the patent offices in some countries demand the patent applicants to disclose and prove the sources of the genetic resources, Japanese companies using genetic resources from domestic sources are required to obtain a certificate of origin to be issued by the Japanese government. In this sense, the PIC system needs to be introduced in Japan. Attention must also be given to ensure that the PIC system in this case is built as a scheme to fulfill the responsibility of the Japanese government to issue the certificate in response to the request by an applicant, rather than being the responsibility of the applicant.
How to address the ABS issue
The Nagoya Protocol is an environmental convention, in principle, but is closely related with the industry, trade, and agriculture sectors in the protection of inventions in the field of biotechnology. It is also related with public health since human beings are excluded from the scope of application. Furthermore, it is related with the rights of indigenous people in connection with the protection of traditional knowledge.
It is difficult to find, at once, a single universal solution that can satisfy all stakeholders, as this issue involves many different values. It might be reasonable to coordinate various opinions of many different stakeholders, commence the implementation in stages, beginning with what can be agreed upon, and follow the procedures by revising the system in a progressive manner while taking international trends into account.
In developing domestic legislation regarding the implementation of the Nagoya Protocol, clear distinction should be made between the provisions on obligation and those on rights. Introducing domestic measures to manage the provisions on rights, in particular, should follow more careful and progressive procedures, in view of the fact that this is an issue requiring the choice of a policy of a multi-valued nature.
- ^ In the Convention on Biological Diversity, "genetic resources" are defined as any material of plant, animal, microbial, or other origin containing functional units of heredity and have "actual or potential value." It can be roughly said that genetic resources are living organisms or parts thereof. Humans do not fall into the scope of application of the convention.
- ^ The Nagoya Protocol defines "derivatives" of "genetic resources," in which the derivatives are limited to naturally occurring biochemical compounds. This suggests that "genetic resources" are limited to naturally occurring resources, because those occurring naturally could not be derived from what is not present in nature.
- ^ However, if soybeans sold as an edible substance in overseas markets are purchased and used for the development of new drugs, for example, prior informed consent may be required depending on the laws of the country providing them.
May 14, 2013
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