Guidelines on Access to
Genetic Resources
For Users in Japan
Second Edition

Japan Bioindustry Association (JBA)
Ministry of Economy, Trade and Industry, Japan (METI)

March 2012

About the Second Edition
Seven years have passed since the first edition of the “Guidelines on Access to Genetic
Resources for Users in Japan” was issued by the Ministry of Economy, Trade and Industry(METI) and Japan Bioindustry Association (JBA) in March, 2005.
In October, 2010, the “Nagoya Protocol on Access to Genetic Resources and the Fair andEquitable Sharing of Benefits Arising from their Utilization to the Convention on Biological
Diversity” (the “Nagoya Protocol”) was adopted at the Tenth Conference of the Parties to theConvention on Biological Diversity held in Nagoya, Japan.
The Nagoya Protocol is characterized by new features including compliance measures
within user countries that are proportionate to the measures taken by countries providing
genetic resources, and the establishment of the Access and Benefit-sharing (ABS)
Clearing-House. Furthermore, under the Protocol, "traditional knowledge associated withgenetic resources" that is held by indigenous and local communities is to be accessed in amanner similar to the manner of accessing genetic resources, in accordance with thedomestic law of the providing country.
Under these circumstances, METI and JBA decided to update the first edition of the
Guidelines to make them reflect key principles of the Nagoya Protocol in addition to those of
the Convention on Biological Diversity and the Bonn Guidelines, replacing that first edition
with this new revised edition. We also decided to update frequently asked Q&As under“Practical Problems and Suggested Solutions” to make them more user-friendly.
The fundamental ABS principles and procedures derived from the Convention on Biological
Diversity (e.g. that States have sovereign rights over their genetic resources and that theauthority to determine access to genetic resources rests with the national governments andis subject to their national legislation), which were fully reflected in the first edition of the
Guidelines are unchanged after the adoption of the Nagoya Protocol.
We hope that the second edition of the Guidelines on Access to Genetic Resources forUsers in Japan will be useful to those who access and use genetic resources and traditional
knowledge associated with genetic resources in foreign nations, including, in the transitional
period before the Nagoya Protocol enters into force.
March 12, 2012
Research Institute of Biological Resources
Japan Bioindustry Association (JBA)Contents

Chapter I

General Information ···························································································· 1

1. Background and Aims ····································································································· 1(1) Background ·············································································································· 1(2) Aims ························································································································· 2
2. Scope ······························································································································ 4
3. Basic Concepts ··············································································································· 5(1) Treatment of Genetic Resources, etc. under the Laws of Providing Countries ········ 5(2) Handling of Genetic Resources, etc. by Contracts ··················································· 5(3) How to Use The Guidelines 2012 ············································································· 5
4. Use of Terms ·················································································································· 6
Chapter II Steps in the Access and Benefit-Sharing Process··········································· 10
1. National Focal Point and Competent National Authorities ············································ 10
Provisions Set Forth in the CBD and the Nagoya Protocol ··········································· 10(1) Explanatory Notes ·································································································· 111) National Focal Point ··························································································· 112) Competent National Authority ············································································ 11(2) National Focal Point in Different Countries ····························································· 12(3) Practical Problems and Suggested Solutions························································· 12
2. Obtaining Prior Informed Consent (PIC) ······································································· 14
Provisions Set Forth in the CBD and the Nagoya Protocol ··········································· 14(1) Explanatory Notes ·································································································· 161) Obtaining Prior Informed Consent (PIC) ···························································· 162) Points to Note ···································································································· 16(2) National / Domestic Laws ······················································································· 17(3) Practical Problems and Suggested Solutions························································· 17
3. Establishing Mutually Agreed Terms ············································································· 22
Provisions Set Forth in the CBD and the Nagoya Protocol ··········································· 22
A. Mutually Agreed Terms (MAT) ··················································································· 26(1) Explanatory Notes ·································································································· 26(2) Practical Problems and Suggested Solutions························································· 27
B. Sharing the Benefits of Utilization ··············································································· 29(1) Explanatory Notes ·································································································· 29

1) Benefit-Sharing ·································································································· 292) Points to Note····································································································· 30(2) Practical Problems and Suggested Solutions························································· 31
4. Compliance ··················································································································· 32
Provisions Set Forth in the Nagoya Protocol and the Bonn Guidelines ························· 32(1) Explanatory Notes ································································································ 34
5. Dispute Resolution ········································································································ 36
Provisions Set Forth in the Nagoya Protocol and the Bonn Guidelines ························· 36(1) Explanatory Notes ·································································································· 37(2) Practical Problems and Suggested Solutions························································· 38
Chapter III Other Issues ··································································································· 39
1. In-House Management Systems for Corporations and Other Organizations ················ 39(1) Explanatory Notes ·································································································· 39
Chapter IV

Roles of the JBA and the Ministry of Economy, Trade and Industry ··············· 40

Reference Materials ············································································································ 41
1. The Convention on Biological Diversity ········································································· 41
2. The Nagoya Protocol ···································································································· 41
3. The Bonn Guidelines····································································································· 41
4. National Laws in Different Countries relating to Access to Genetic Resources
and Benefit-Sharing ······································································································ 41
5. Examples of Agreements and Contracts relating to Access to Genetic
Resources and Benefit-Sharing ···················································································· 41

Acronyms

ABS

Access and Benefit-Sharing

CBD

Convention on Biological Diversity

COP

Conference of the Parties to the CBDIRInternational Regime

ITPGR International Treaty on Plant Genetic Resources for Food and Agriculture
JBA

Japan Bioindustry Association

MAT

Mutually Agreed Terms

METI

Ministry of Economy, Trade and Industry

MTA

Material Transfer Agreement

NGO

Non-Governmental Organization

PIC

Prior Informed Consent

UPOV

Union internationale pour la protection des obtentions végétales(International Union for the Protection of New Varieties of Plants）

Chapter I

General Information

1. Background and Aims
(1) Background
1) The Convention on Biological Diversity (CBD),1 adopted on May 22, 1992, entered into
force on December 29, 1993. The CBD, while recognizing the sovereign rights of Statesover their natural resources, states that the authority to determine access to genetic
resources rests with the national governments and is subject to national legislation.
Access shall be subject to prior informed consent of the Contracting Party providing such
resources, unless otherwise determined by that Party. Benefits arising from the utilizationof the genetic resources shall be shared in a fair and equitable way and upon mutuallyagreed terms.
The Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of
the Benefits Arising out of their Utilization (the “Bonn Guidelines”)2 were adopted at the
Sixth Meeting of the Conference of the Parties to the CBD (COP6) in April 2002. The
Bonn Guidelines are voluntary and intended to serve as a reference when developing
and drafting legislative, administrative, or policy measures and/or contracts and otherarrangements on ABS as described in Article 15 of the CBD.
2) However, following adoption of the Bonn Guidelines, some countries asserted that, giventhat those Guidelines were not legally binding, they were insufficient as a mechanism forthe sharing of the benefits arising from the utilization of genetic resources with thecountries providing those resources.
As a result, a resolution to start new negotiations regarding an “international regime (IR)on ABS” was adopted at the World Summit on Sustainable Development in 2002. Then,following a decision at the Seventh Meeting of the Conference of the Parties to the CBD(COP7) in 2004, negotiations concerning an IR began under the CBD.
3) At COP8 in 2006, the CBD Parties agreed "to continue IR negotiations in accordance with
the COP7 decision, and to complete its work at the earliest possible time before COP10."

1

See the website for the Biodiversity Center of Japan, Nature Conservation Bureau, Ministry of theEnvironment (http://www.biodic.go.jp/biolaw/jo_hon.html), for the official Japanese translation.
2
See the website for the Japan Bioindustry Association (JBA) Research Institute of Biological Resources(http://www.mabs.jp/archives/bonn/index.html), for the Japanese translation by JBA (9/5/2002, withEnglish.)-1-

Nevertheless, discussion of IR did not proceed smoothly due to differences in views
among countries, and an extremely difficult situation ensued.
Then, on the final day of the COP10 in October 2010 in Nagoya, Aichi Prefecture, Japan,
the IR negotiation saw a dramatic development: a political settlement, leading to theadoption of the “Nagoya Protocol on Access to Genetic Resources and the Fair andEquitable Sharing of Benefits Arising from their Utilization to the Convention on
Biological Diversity” (the “Nagoya Protocol.”)34) Countries are currently in the process of preparing to develop their various domestic
measures on ABS to implement the Nagoya Protocol. Therefore, it is reasonable toexpect that the legal certainty, clarity, and transparency of ABS procedures worldwide willremain insufficient for some time for those corporations and researchers that utilize
genetic resources or traditional knowledge associated with genetic resources in or fromother countries.
5) On the other hand, there are expectations that research and development inbiotechnology will produce significant achievements in the 21st century. Bioindustry is an
important and attractive segment of industry that has the potential to solve some of the
global-scale problems that humankind is facing. Japan’s bioindustry is willing to develop
businesses that utilize genetic resources positively and appropriately despite theabove-mentioned conditions worldwide.
(2) Aims
1) It is important that corporations and researchers, as users of genetic resources andtraditional knowledge associated with genetic resources (hereinafter collectively referred
to as “genetic resources, etc.”) understand actively the ABS principles of the CBD and
the Nagoya Protocol, and that they access genetic resources, etc. accordingly, therebybuilding good relationships with providers based on mutual trust. Therefore, it isnecessary for METI and JBA to promote policies that develop an enabling environment
for streamlined access to genetic resources, etc. in a sustainable manner, through which
both the providers and the users of genetic resources, etc. will enjoy fair and equitablebenefit-sharing.

3

See the website for the JBA Research Institute of Biological Resources, for the Japanese translation by
JBA (1/31/2011) (http://www.mabs.jp/archives/nagoya/index.html).

-2-2) Based on this thinking, we developed the first edition of Guidelines on Access to Genetic
Resources for Users in Japan in 2005. In the preparation of those guidelines, weconsulted experts in academia and industry, in Japan and in other countries.
Now, with the adoption of the Nagoya Protocol, we have updated the 2005 edition toincorporate important principles contained in the Protocol into the present second edition of
the Guidelines on Access to Genetic Resources for Users in Japan 2012 (hereinafterreferred to as “The Guidelines 2012.”)3) The specific aims of The Guidelines 2012 are as follows:- To help both providers and users to enjoy benefits and build win-win relationships,
through streamlined access to genetic resources according to the relevant legislation or
regulatory requirements of the providing countries and by fair and equitable sharing of
the benefits arising from these uses.
- To minimize the risk to users of getting involved in problems when they seek to utilize
genetic resources for commercial purposes; and to promote business flexibility in those
activities.
- To facilitate users’ understanding by providing concrete explanations and examples
about the relevant provisions and terminology of the CBD, the Nagoya Protocol, and theBonn Guidelines.
4) The Guidelines 2012 are voluntary and should not be interpreted as making any change
in the existing legal rights and obligations of providers and users of genetic resources.

-3-2. Scope1) The scope of The Guidelines 2012 is based on that of the Nagoya Protocol (Article 3).
Namely, it applies to “genetic resources within the scope of Article 15 of the Convention
and to the benefits arising from the utilization of such resources, and also to traditional
knowledge associated with genetic resources within the scope of the Convention and tothe benefits arising from the utilization of such knowledge." (In addition, human genetic
resources are excluded from the scope of The Guidelines 2012.)
Furthermore, there are countries that have already put in place domestic laws or regulatory
requirements on the utilization of genetic resources, etc. In these cases, the scope of thedomestic laws or regulatory requirements of those countries will of course prevail,regardless of the scope of The Guidelines 2012. Therefore, please ascertain the specificsituation of the country where you wish to access genetic resources, etc.
2) Genetic resources covered by the International Treaty on Plant Genetic Resources for
Food and Agriculture, adopted in 2001 by the Conference of the Food and Agriculture
Organization of the United Nations, are exempt from The Guidelines 2012.
3) The Guidelines 2012 address all access to foreign genetic resources, whether in aforeign nation or in Japan. With regard to the laws, regulatory procedures, etc. related toJapanese genetic resources within Japan, please refer to the relevant national laws, etc.
(e.g., the Plant Variety Protection and Seed Act, the Plant Protection Act, the Act on
Domestic Animal Infectious Diseases Control, the Invasive Alien Species Act, the Law for
the Conservation of Endangered Species of Wild Fauna and Flora, etc.)-4-3. Basic Concepts(1) Treatment of Genetic Resources, etc. under the Laws of Providing Countries
1) According to the CBD, “recognizing the sovereign rights of States over their natural
resources, the authority to determine access to genetic resources rests with national
governments and is subject to national legislation.” (Article 15, Paragraph 1 of the CBD.)
2) Consequently, when accessing genetic resources of a foreign country, the basic premise
is for a user to conform to the domestic laws and administrative measures stipulated bythat country.
To determine which laws and measures apply, please check by contacting that country’s
National Focal Point for the CBD (see infra Chapter II, Part1 “National Focal Point andCompetent National Authorities”) or by consulting a legal expert in that country in case youneed information in greater depth.
(2) Handling of Genetic Resources, etc. by Contracts
In some countries, there are no laws or administrative measures governing access togenetic resources. In such cases, business will be conducted in accordance with a contractthat you will develop with your counterpart. When negotiating a contract in such a situation,please bear in mind that the relevant provisions of the CBD and the Nagoya Protocol andrules recommended in the Bonn Guidelines have important implications as references.
(3) How to Use The Guidelines 2012
1) The Guidelines 2012 present and discuss relevant provisions of the CBD, the Nagoya
Protocol and the Bonn Guidelines, and also touch on some of major points underdiscussion at international forums. The Questions and Answers shown below present
types of problems that you may encounter in actual situations, and give suggested
solutions to them for your reference.
2) If you are still unclear about key points or encounter problems in checking the regulatory
system of a country, as part of your preparations for doing business or research there,
please contact JBA or the METI. (See Chapter IV, infra, for the contact points.)-5-

4. Use of Terms(1) Genetic resources“Genetic resources” means genetic material (any material of plant, animal, microbial orother origin containing functional units of heredity) of actual or potential value. (Article 2 of
the CBD.)(2) “Country of origin of genetic resources” and “country providing genetic
resources”
1) "Country of origin of genetic resources" means the country which possesses thosegenetic resources in in-situ conditions4. (Article 2 of the CBD.)
2) “Country providing genetic resources" means the country supplying genetic resources
collected from in-situ sources, including populations of both wild and domesticatedspecies, or taken from ex-situ sources, which may or may not have originated in thatcountry. (Article 2 of the CBD.)(3) In-situ conditions"In-situ conditions" means conditions where genetic resources exist within ecosystems andnatural habitats, and in the case of domesticated or cultivated species, in the surroundings
where they have developed their distinctive properties. (Article 2 of the CBD.)(4) Utilization of genetic resources“Utilization of genetic resources” means to conduct research and development on thegenetic and/or biochemical composition of genetic resources, including through theapplication of biotechnology as defined in Article 2 of the CBD. (Article 2(c) of the Nagoya
Protocol.)(5) Biotechnology“Biotechnology” means any technological application that uses biological systems, livingorganisms, or derivatives thereof, to make or modify products or processes for specific use.
(Article 2 of the CBD and Article 2(d) of the Nagoya Protocol.)4

It must be noted that the definition of "country of origin" in the CBD is not the same as that used in abiology text book.

-6-(6) Derivative“Derivative” means a naturally occurring biochemical compound resulting from the genetic
expression or metabolism of biological or genetic resources, even if it does not containfunctional units of heredity. (Article 2(e) of the Nagoya Protocol.)(7) Traditional knowledge associated with genetic resources“Traditional knowledge” is not defined in the CBD and the Nagoya Protocol, but a relevant
description is found in the Article 8(j)5 of the CBD. Under the Nagoya Protocol, traditional
knowledge associated with genetic resources is also subject to the ABS, and is to be treatedin accordance with the domestic laws (Articles 7 and 12 of the Nagoya Protocol) or
regulatory requirements (Article 16 of the Nagoya Protocol) of the providing countries.
(8) Benefits
For the purpose of The Guidelines 2012, “benefits” refer to the benefits that the provider
and/or the user of genetic resources, etc. gain as a result of utilization of those resources.
Benefits may include monetary and non-monetary benefits. (Annex to the Nagoya Protocol.)(9) Prior informed consent (PIC)
When a user wishes to access genetic resources, etc. in a foreign country, the user isobliged to submit specific information to the government of the country providing such
resources and to acquire its prior informed consent, if required by the law of that country.
(Article 15, Paragraph 5 of the CBD; and Article 6, Paragraph 2 and Article 7 of the Nagoya
Protocol.)It may also be necessary, if required by the domestic law, to obtain similar prior informed
consent from the relevant indigenous and local communities. (Article 6, Paragraph 2 andArticle 7 of the Nagoya Protocol.)(10) Mutually agreed terms (MAT)
Sharing of benefits arising from the access and utilization of genetic resources, etc. must
be conducted on the basis of a mutual agreement between the provider and the user of such
resources. Specific terms and conditions of such an agreement are to be negotiated5

CBD Article 8 (“In-situ Conservation”): “Each Contracting Party shall, as far as possible and as
appropriate: … (j) Subject to its national legislation, respect, preserve and maintain knowledge, innovations
and practices of indigenous and local communities embodying traditional lifestyles relevant for theconservation and sustainable use of biological diversity and promote their wider application with theapproval and involvement of the holders of such knowledge, innovations and practices and encourage theequitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices.”-7-

between the parties concerned in compliance with the law and administrative measures of
the country providing such resources. (Article 15, Paragraphs 4 and 7 of the CBD; andArticle 5, Paragraphs 1, 2, and 5 of the Nagoya Protocol.)(11) ABS Clearing-House
An Access and Benefit-sharing Clearing-House is to be established as part of theclearing-house mechanism under Article 18, paragraph 3, of the CBD. It shall serve as ameans for sharing of information related to access and benefit-sharing. In particular, it shallprovide access to information made available by each Party relevant to the implementationof the Nagoya Protocol. (Article 14, Paragraph 1 of the Nagoya Protocol.)Information provided through the ABS Clearing-House shall include the following (Article
14, Paragraph 2 of the Nagoya Protocol):(a) Legislative, administrative and policy measures on access and benefit-sharing;(b) Information on the national focal point and competent national authority or authorities;
and(c) Permits or their equivalent issued at the time of access as evidence of the decision to
grant prior informed consent and of the establishment of mutually agreed terms.
Additional information, if available and as appropriate, may include the following (Article 14,
Paragraph 3 of the Nagoya Protocol):(a) Relevant competent authorities of indigenous and local communities, and information
as so decided;(b) Model contractual clauses;(c) Methods and tools developed to monitor genetic resources; and(d) Codes of conduct and best practices.

-8-

-9-

practices, etc.

trade

involved
Contract execution

i.e. contract) conclusion

parties

Mutually Agreed Terms (MAT,

providers andSeeking prior informed consent (PIC)

Resource(central, provincial)

regulatory measures

National laws,

Government

National laws,

Country Providing Genetic Resources

The Convention on Biological Diversity

Access and Benefit-Sharing Frameworketc.

universities,

Companies,

Japan

Supportfrom JBA
and METIChapter II

Steps in the Access and Benefit-Sharing Process

1. National Focal Point and Competent National Authorities
Provisions Set Forth in the CBD and the Nagoya Protocol[Article 15, Paragraph 1 of the CBD; Article 13, Paragraphs 1 and 2 of the Nagoya Protocol;
Paragraphs 13 and 14 of the Bonn Guidelines][CBD]
Article 15, Paragraph 1
Recognizing the sovereign rights of States over their natural resources, the authority todetermine access to genetic resources rests with the national governments and is subject tonational legislation.

[Nagoya Protocol]
Article 13. National Focal Points and Competent National Authorities
Article 13, Paragraph 1
Each Party shall designate a national focal point on access and benefit-sharing. The
national focal point shall make information available as follows:(a) For applicants seeking access to genetic resources, information on procedures for
obtaining prior informed consent and establishing mutually agreed terms, including
benefit-sharing;(b) For applicants seeking access to traditional knowledge associated with genetic
resources, where possible, information on procedures for obtaining prior informed
consent or approval and involvement, as appropriate, of indigenous and local
communities and establishing mutually agreed terms including benefit-sharing; and(c) Information on competent national authorities, relevant indigenous and local
communities and relevant stakeholders.
The national focal point shall be responsible for liaison with the Secretariat.
Article 13, Paragraph 2
Each Party shall designate one or more competent national authorities on access andbenefit-sharing. Competent national authorities shall, in accordance with applicable national
legislative, administrative or policy measures, be responsible for granting access or, as
applicable, issuing written evidence that access requirements have been met and be
responsible for advising on applicable procedures and requirements for obtaining priorinformed consent and entering into mutually agreed terms.

- 10 -

(1) Explanatory Notes
It is the principle of the CBD that the authority to determine access to genetic resources
rests with the national governments and is subject to national legislation.
Thus, when accessing genetic resources, etc., the domestic laws, administrative measures,etc. of the country providing the resources must first be checked. For that purpose, you caninquire through the national focal point and competent national authorities of the providing
country.
Note that you need to exercise caution, when you obtain genetic resources from foreignsources via intermediaries, for example. (see infra, Chapter III, Part 2(3) “Practical Problems
and Suggested Solutions,” Question 6.)1) National Focal Point
Under the CBD, a Contracting Party designates a single national focal point and makes
this information available through sources such as the ABS Clearing-House of theSecretariat to the CBD (http://www.biodiv.org/world/map.asp).6
Under the Nagoya Protocol, the national focal point is to provide information on competent
national authorities, relevant indigenous and local communities, and relevant
stakeholders through the ABS Clearing-House. (Article 13, paragraph 1(c) of the Nagoya
Protocol.)2) Competent National Authority
Article 13, Paragraph 2 "National Focal Points and Competent National Authorities" in the
Nagoya Protocol describes "competent national authority" as follows:"Each Party shall designate one or more competent national authorities on access andbenefit-sharing. Competent national authorities shall, in accordance with applicablenational legislative, administrative or policy measures, be responsible for granting accessor, as applicable, issuing written evidence that access requirements have been met andbe responsible for advising on applicable procedures and requirements for obtaining priorinformed consent and entering into mutually agreed terms.”
Furthermore, the role of competent national authorities is described as follows inparagraph 14 of the Bonn Guidelines:
6

The comprehensive name for the CBD’s information disclosure systems is “clearing-house mechanism.”
This mechanism provides information, such as documentation, to people all over the world. The
comparable system in the Nagoya Protocol is called the “Access and Benefit-sharing Clearing-House” (seeArticle 14 of the Nagoya Protocol.)- 11 -

“Competent national authorities, where they are established, may, in accordance withapplicable national legislative, administrative or policy measures, be responsible for
granting access and be responsible for advising on:(a) The negotiating process;(b) Requirements for obtaining prior informed consent and entering into mutually agreed
terms;(c) Monitoring and evaluation of access and benefit-sharing agreements;(d) Implementation/enforcement of access and benefit-sharing agreements;(e) Processing of applications and approval of agreements;(f) The conservation and sustainable use of the genetic resources accessed;(g) Mechanisms for the effective participation of different stakeholders, as appropriate forthe different steps in the process of access and benefit-sharing, in particular,
indigenous and local communities; and(h) Mechanisms for the effective participation of indigenous and local communities while
promoting the objective of having decisions and processes available in a language
understandable to relevant indigenous and local communities.”
See "Lists of National Focal Points" on the website of the Secretariat to the CBD(http://www.cbd.int/information/nfp.shtml) for information regarding competent national
authorities.
(2) National Focal Point in Different Countries
The national focal points and competent national authorities of Contracting Parties to the
CBD are available on the CBD Secretariat website, as mentioned above. It should be noted
that, in some countries, the entities with actual responsibility for granting access may bedifferent from the national focal points or competent national authorities designated on the
CBD Secretariat website.
(3) Practical Problems and Suggested Solutions
Question 1: What should I do if there is no information given in the CBD Secretariat website
about the national focal point or competent national authority of a country?
Answer 1: You may be able to get the necessary information by consulting with JBA or METI.
(Please refer to Chapter IV, infra, for the contact point at JBA or METI that handles suchinquiries.)- 12 -

At paragraph 3(a) of Article 6 "Access to Genetic Resources," the Nagoya Protocol
stipulates that a Party requiring prior informed consent must "provide for legal certainty,
clarity and transparency of their domestic access and benefit-sharing legislation or
regulatory requirements." Furthermore, paragraph 2(a) of Article 14 "The Access andBenefit-sharing Clearing-House and Information Sharing" obligates each Party to makeavailable to the ABS Clearing-House information related to "legislative, administrative andpolicy measures on access and benefit-sharing."
Accordingly, this type of problem will be resolved as the Nagoya Protocol enters into force
and the CBD Secretariat’s ABS Clearing-House becomes operationally advanced.
Question 2: What should I do when I do not get a prompt reply after contacting the national
focal point, or when, with only a preliminary reply given by the national focal point, I findmyself being referred to a variety of different departments within that country’s government
without meaningful progress?
Answer 2: While you should keep trying to get in touch with the most appropriate entity ofthat government by all available communication means, you may consult with JBA or METI
which may have useful information. (Please refer to Chapter IV, infra, for the contact point at
JBA or METI that handles such inquiries.)
Question 3: Is there a way to check which countries have an ABS national law and which do
not?
Answer 3: You can check using the "ABS Measures Search Page" on the CBD Secretariat’s
website (https://www.cbd.int/abs/measures/), but the listing may not be comprehensive.

- 13 -

2. Obtaining Prior Informed Consent (PIC)
Provisions Set Forth in the CBD and the Nagoya Protocol[Article 15, Paragraphs 1, 2, 3 and 5 of the CBD; Articles 6, 7, 13, 14 and 17 of the Nagoya
Protocol; Paragraphs 26, 27, 28, 33, 34, 36, 38, 39 and 40 of the Bonn Guidelines][CBD]
Article 15, Paragraph 1
Recognizing the sovereign rights of States over their natural resources, the authority todetermine access to genetic resources rests with the national governments and is subject tonational legislation.
Article 15, Paragraph 2
Each Contracting Party shall endeavor to create conditions to facilitate access to genetic
resources for environmentally sound uses by other Contracting Parties and not to impose
restrictions that run counter to the objectives of this Convention.
Article 15, Paragraph 3
For the purpose of this Convention, the genetic resources being provided by a Contracting
Party, as referred to in this Article and Articles 16 and 19, are only those that are provided byContracting Parties that are countries of origin of such resources or by the Parties that haveacquired the genetic resources in accordance with this Convention.
Article 15, Paragraph 5
Access to genetic resources shall be subject to prior informed consent of the Contracting
Party providing such resources, unless otherwise determined by that Party.

[Nagoya Protocol]
Article 6, Access to Genetic Resources
1. In the exercise of sovereign rights over natural resources, and subject to domestic accessand benefit-sharing legislation or regulatory requirements, access to genetic resources fortheir utilization shall be subject to the prior informed consent of the Party providing such
resources that is the country of origin of such resources or a Party that has acquired thegenetic resources in accordance with the Convention, unless otherwise determined by that
Party.

- 14 -

2. In accordance with domestic law, each Party shall take measures, as appropriate,with the aim of ensuring that the prior informed consent or approval and involvement ofindigenous and local communities is obtained for access to genetic resources where they
have the established right to grant access to such resources.
3. Pursuant to paragraph 1 above, each Party requiring prior informed consent shall take thenecessary legislative, administrative or policy measures, as appropriate, to:(a) Provide for legal certainty, clarity and transparency of their domestic access andbenefit-sharing legislation or regulatory requirements;(b) Provide for fair and non-arbitrary rules and procedures on accessing genetic
resources;(c) Provide information on how to apply for prior informed consent;(d) Provide for a clear and transparent written decision by a competent national authority,
in a cost-effective manner and within a reasonable period of time;(e) Provide for the issuance at the time of access of a permit or its equivalent as evidenceof the decision to grant prior informed consent and of the establishment of mutuallyagreed terms, and notify the Access and Benefit-sharing Clearing-House accordingly;(f) Where applicable, and subject to domestic legislation, set out criteria and/or
processes for obtaining prior informed consent or approval and involvement ofindigenous and local communities for access to genetic resources; and(g) Establish clear rules and procedures for requiring and establishing mutually agreed
terms. Such terms shall be set out in writing and may include, inter alia:(i) A dispute settlement clause;(ii) Terms on benefit-sharing, including in relation to intellectual property rights;(iii) Terms on subsequent third-party use, if any; and(iv) Terms on changes of intent, where applicable.
Article 7, Traditional Knowledge Associated with Genetic Resources
In accordance with domestic law, each Party shall take measures, as appropriate, with theaim of ensuring that traditional knowledge associated with genetic resources that is held byindigenous and local communities is accessed with the prior and informed consent orapproval and involvement of these indigenous and local communities, and that mutuallyagreed terms have been established.

- 15 -

(1) Explanatory Notes
In ordinary contracts, it is sufficient that the parties directly involved agree on the content of
the contract; under the CBD and the Nagoya Protocol, however, when accessing genetic
resources, etc., prior informed consent is to be obtained through the competent authorities
in compliance with the domestic laws or regulatory requirements of that country.
1) Obtaining Prior Informed Consent (PIC)
When accessing genetic resources, etc., you are required to go through the procedure forsubmitting specified information and to obtain permission in accordance with the domestic
laws or regulatory requirements of the country providing genetic resources, etc.7
Note that, depending on the country or region, it may also be necessary to obtain priorinformed consent from other stakeholders, such as indigenous and local communities of
the country providing genetic resources, etc., in accordance with the domestic laws or
regulatory requirements of the country.
2) Points to Note
You need to study the procedure for obtaining PIC in the country or region where you wish
to access genetic resources, etc. In doing so, you should find answers to the following
questions:i) Entity issuing PIC- At what level of government should PIC be obtained, e.g., from the central government
or provincial government?
- Is prior informed consent or approval required from indigenous and local communities
concerned with the genetic resources, etc., in accordance with domestic laws oradministrative measures?
- In accordance with domestic laws or administrative measures, are there any
procedures of customary law, community protocol, and/or other structures that are
unique to the community?

7

As a practical matter, it is necessary, of course, to first obtain informal consent for access from yourcounterpart (the party who has the rights regarding the genetic resources, etc., with whom the contract is tobe negotiated.)- 16 -

ii) Procedure for obtaining PIC- What are the requirements of the domestic laws or administrative measures for
obtaining PIC?
- Specific procedures:(a) Where should inquiries be addressed and applications submitted?
(b) Is there a specified application format and, if so, what items of information (such as
purpose, duration, targeted genetic resources, and fees) are then required?
(c) Are there any other conditions?
- For what use is the PIC granted? What kind of procedure is required for change in use,or transferring genetic resources to a third party?
- Is the PIC to be issued as a written document?
- How many days will it take for PIC to be issued, after filing of application?
- Will the permit be made available to the ABS Clearing-House of the CBD Secretariat as
an internationally recognized certificate of compliance?
(2) National / Domestic Laws
Concerning national / domestic laws of countries, refer to the following websites:- CBD Secretariat website:“ABS Measures Search Page” (http://www.cbd.int/abs/measures/)- JBA website:
Access to Biological Resources and Benefit Sharing under the Convention on Biological
Diversity (CBD): A Corporate Guide"CBD-related Information by Country" (http://www.mabs.jp/countries/index.html)(3) Practical Problems and Suggested Solutions
Question 4: Are activities for academic purposes subject to the CBD?
Answer 4: Accessing genetic resources, etc. for academic purposes is not excluded fromthe scope of the CBD and the Nagoya Protocol. Therefore, academic activities are
considered subject to the CBD and the Nagoya Protocol, unless otherwise determined by
the countries providing the genetic resources, etc.

- 17 -

Question 5: Does one need to seek PIC for genetic resources, etc. that were obtained
before the CBD entered into force (December 29, 1993)?
Answer 5: It is generally accepted that there is no obligation under the CBD to obtain PIC for
genetic resources that had been accessed before the CBD entered into force. Furthermore,
if a country providing genetic resources ratified the CBD after December 29, 1993, there isalso no obligation under the CBD to obtain PIC from that country prior to the date when the
CBD entered into force in that country, unless otherwise determined by the domestic laws oradministrative measures of the providing country.
Question 6: How can a user verify that PIC has been obtained when a commercial
intermediary provides genetic resources, etc. to the user?
Answer 6: We recommend that you use one or more of the following steps to verify whether
the commercial intermediary has obtained the genetic resources according to the procedurein compliance with the domestic laws or administrative measures of the country providing
the genetic resources and whether the intermediary has been authorized by that country totransfer those genetic resources, etc. to a third party user:a) obtain from the intermediary a copy of the documentation to confirm that PIC was
granted;b) obtain a letter of confirmation from the intermediary stating that the intermediaryobtained PIC; and/orc) include a clause in the contract explicitly stating that the intermediary warrants that it
has obtained the genetic resources, etc. in compliance with the domestic laws oradministrative measures of the country providing the genetic resources.
In order to manage risk, it is further recommended that you independently verify compliancewith the procedure required by the particular providing country for PIC under its domestic
laws and/or administrative measures.
Note that commercial intermediaries may range from agents for accessing genetic
resources to general retailers.
When the ABS Clearing-House becomes fully operational after the Nagoya Protocol enters
into force, you are supposed to be able to confirm whether or not the commercial
intermediary has properly obtained PIC, by checking the section of the "internationallyrecognized certificates of compliance” (Article 17, Paragraph 3 of the Nagoya Protocol) ofthat country on the ABS Clearing-House.

- 18 -

Question 7: Is it necessary to obtain PIC when acquiring genetic resources from ex-situ
collections (such as microbial culture collections)?
Answer 7: Ex-situ collections are also subject to the CBD. If the law of a country, where aculture collection, a botanical garden, or other type of BRC8 is located, requires PIC, then,you must obtain PIC. Furthermore, if the ex situ collection obtains a genetic resource from aforeign country and provides this resource to a user in another country, then the ex-situ
collection is considered as a type of intermediary. Therefore, our suggestion, given under
Question 6 above, would apply.
Question 8: What should I do to access a plant species if that species is found in situ within
the territory of more than one country?
Answer 8: In the CBD, a "country of origin of genetic resources" is a "country which
possesses those genetic resources in in-situ conditions." According to this definition, if agenetic resource has been moved to country A from country B before the CBD came into
force and exists in in-situ conditions, then country A is also a country of origin.
When there are several countries of origin in that sense, you can choose a single country
from among them and access the genetic resource there, in compliance with the law of thatcountry.
However, there are some points to be noted when there is a regional agreement among thecountries of origin. For example, there are plants common to Bolivia, Colombia, Ecuador,and other countries along the Andes, and these countries have concluded a regional pact(the Andean Pact). The principles of such a regional pact must also be noted.
Question 9: Is it necessary to obtain a separate governmental PIC of a country even when I
have the approval of the owner of, for example the property on which the genetic resource islocated?
Answer 9: Prior approval of the owner and a governmental PIC are two different things. In acase where the domestic law of that country stipulates that a governmental PIC is required,
you must obtain a separate governmental PIC even when the owner of the genetic resource
has given you prior approval.

8

Biological Resource Center- 19 -

Question 10: In Country A, at a public market, I bought an endemic species of a plant forornamental purposes. After returning to my country, I used it by chance for my research, andI discovered a component specific to that endemic species that has potential forcommercialization. Is it necessary for me to obtain PIC from Country A if I wish to develop acommercial product using this component?
Answer 10: As in some cases, the law of Country A may require you to obtain PIC evenwhen you use the plant purchased at a public market in Country A as a genetic resource forcommercialization. If that is the case, you must follow the procedure in accordance with thelaw of Country A. On the other hand, there may be other cases where the country does nothave such a law in place. In such cases, there is no legal obligation for you to obtain PIC,
but “change of use” issue could arise; commercialization of the genetic resource of thatcountry without notifying the government could be criticized as improper by citizens,non-governmental organizations and others in that country, which could result in damage toyour corporate image9.
Question 11: What do I need to do in order to bring seeds or crops that are indigenous to aforeign country that were purchased at a local market or were kindly provided to me by alocal farmer, to my country to be used as a genetic resource?
Answer 11: In order to bring such seeds, which were purchased at a local market or
received as a gift, back to your country, you need to obtain PIC for accessing andtransferring those genetic resources in accordance with that country's domestic laws oradministrative measures, if the country has such a system in place.
Note that if the country is a member of the International Convention for the Protection of
New Varieties of Plants (UPOV), registered species in general distribution can be used inbreeding as far as plant breeders' rights are concerned; however, we recommend that you
verify beforehand how that country handles the relation between the CBD and the UPOV
and whether there is any regulation about taking seeds out of the country, etc.
(Genetic resources covered by ITPGR are excluded from the scope of The Guidelines
2012.)

9

UNEP/CBD/WG-ABS/4/INF/6 (22 December 2005)- 20 -

Question 12: I have applied to the relevant authorities of the providing country for PIC, incompliance with that country’s law, but even after a number of months passed I still have notbeen informed whether or not my application was approved. What should I do?
Answer 12: First, you need to make an inquiry or request to the authorities in the providing
country, preferably using the services of local legal professionals. If there is still no progress,
you may consult with JBA or METI which may have useful information. (Please refer to
Chapter IV, infra, for the contact point at JBA or METI that handles such inquiries.)
Question 13: I hear that there is no ABS law in Japan. So what should I keep in mind, in theevent that I should wish to provide Japanese genetic resources to a foreign country?
Answer 13: Even though there is no specific law related to ABS, there are laws andregulations that can be partially or indirectly related, such as laws and regulations in the fieldof agriculture, forestry, and fisheries; intellectual property rights; various types of zoning;
import and export laws and regulations; commercial law concerning various rights; andcriminal laws. Therefore, you need to take these laws and regulations into consideration.
Also as mentioned below, it is important to set mutually agreed terms (MAT) and to secure areasonable sharing of benefits.

- 21 -

3. Establishing Mutually Agreed Terms
Provisions Set Forth in the CBD and the Nagoya Protocol[Article 1, and Article 15, Paragraphs 2, 4 and 7 of the CBD; Article 5, Paragraphs 1, 2 and 5,
Article 6, Article 13, Paragraphs 1 and 2, Article 14, Article 18, Paragraph 1, Article 19,
Paragraph 1 of the Nagoya Protocol; Paragraphs 41, 42, 43, 45 and 49 of the Bonn
Guidelines][CBD]
Article 1
The objectives of this Convention, to be pursued in accordance with its relevant provisions,
are the conservation of biological diversity, the sustainable use of its components and thefair and equitable sharing of the benefits arising out of the utilization of genetic resources,[The rest of the Article is here omitted.]
Article 15, Paragraph 2
Each Contracting Party shall endeavor to create conditions to facilitate access to genetic
resources for environmentally sound uses by other Contracting Parties and not to impose
restrictions that run counter to the objectives of this Convention.
Article 15, Paragraph 4
Access, where granted, shall be on mutually agreed terms and subject to the provisions of
this Article.
Article 15, Paragraph 7
Each Contracting Party shall take legislative, administrative or policy measures, as
appropriate, and in accordance with Articles 16 and 19…with the aim of sharing in a fair andequitable way the results of research and development and the benefits arising from thecommercial and other utilization of genetic resources with the Contracting Party providing
such resources. Such sharing shall be upon mutually agreed terms.

[Nagoya Protocol]
Article 5, Fair and Equitable Benefit-sharing
Article 5, Paragraph 1
In accordance with Article 15, paragraphs 3 and 7 of the Convention, benefits arising fromthe utilization of genetic resources as well as subsequent applications andcommercialization shall be shared in a fair and equitable way with the Party providing such

- 22 -

resources that is the country of origin of such resources or a Party that has acquired thegenetic resources in accordance with the Convention. Such sharing shall be upon mutuallyagreed terms.
Article 5, Paragraph 2
Each Party shall take legislative, administrative or policy measures, as appropriate, with theaim of ensuring that benefits arising from the utilization of genetic resources that are held byindigenous and local communities, in accordance with domestic legislation regarding theestablished rights of these indigenous and local communities over these genetic resources,
are shared in a fair and equitable way with the communities concerned, based on mutuallyagreed terms.
Article 5, Paragraph 5
Each Party shall take legislative, administrative or policy measures, as appropriate, in orderthat the benefits arising from the utilization of traditional knowledge associated with genetic
resources are shared in a fair and equitable way with indigenous and local communities
holding such knowledge. Such sharing shall be upon mutually agreed terms.
Article 6, Access to Genetic Resources
1. In the exercise of sovereign rights over natural resources, and subject to domestic accessand benefit-sharing legislation or regulatory requirements, access to genetic resources
for their utilization shall be subject to the prior informed consent of the Party providing
such resources that is the country of origin of such resources or a Party that has acquired
the genetic resources in accordance with the Convention, unless otherwise determinedby that Party.
2. In accordance with domestic law, each Party shall take measures, as appropriate, withthe aim of ensuring that the prior informed consent or approval and involvement ofindigenous and local communities is obtained for access to genetic resources where they
have the established right to grant access to such resources.
3. Pursuant to paragraph 1 above, each Party requiring prior informed consent shall takethe necessary legislative, administrative or policy measures, as appropriate, to:(a) Provide for legal certainty, clarity and transparency of their domestic access andbenefit-sharing legislation or regulatory requirements;(b) Provide for fair and non-arbitrary rules and procedures on accessing genetic resources;- 23 -

(c) Provide information on how to apply for prior informed consent;(d) Provide for a clear and transparent written decision by a competent national authority,
in a cost-effective manner and within a reasonable period of time;(e) Provide for the issuance at the time of access of a permit or its equivalent as evidenceof the decision to grant prior informed consent and of the establishment of mutuallyagreed terms, and notify the Access and Benefit-sharing Clearing-House accordingly;(f) Where applicable, and subject to domestic legislation, set out criteria and/or
processes for obtaining prior informed consent or approval and involvement ofindigenous and local communities for access to genetic resources; and(g) Establish clear rules and procedures for requiring and establishing mutually agreed
terms. Such terms shall be set out in writing and may include, inter alia:(i) A dispute settlement clause;(ii) Terms on benefit-sharing, including in relation to intellectual property rights;(iii) Terms on subsequent third-party use, if any; and(iv) Terms on changes of intent, where applicable.
Article 13, National Focal Points and Competent National Authorities
Article 13, Paragraph 1
Each Party shall designate a national focal point on access and benefit-sharing. The
national focal point shall make information available as follows:(a) For applicants seeking access to genetic resources, information on procedures for
obtaining prior informed consent and establishing mutually agreed terms, including
benefit-sharing;(b) For applicants seeking access to traditional knowledge associated with genetic
resources, where possible, information on procedures for obtaining prior informed
consent or approval and involvement, as appropriate, of indigenous and local
communities and establishing mutually agreed terms including benefit-sharing; and(c) Information on competent national authorities, relevant indigenous and local
communities and relevant stakeholders.
The national focal point shall be responsible for liaison with the Secretariat.
Article 13, Paragraph 2
Each Party shall designate one or more competent national authorities on access andbenefit-sharing. Competent national authorities shall, in accordance with applicable national
legislative, administrative or policy measures, be responsible for granting access or, as
applicable, issuing written evidence that access requirements have been met and be- 24 -

responsible for advising on applicable procedures and requirements for obtaining priorinformed consent and entering into mutually agreed terms.
Article 14, Access and Benefit-sharing Clearing-House and Information-Sharing
1. An Access and Benefit-sharing Clearing-House is hereby established as part of theclearing-house mechanism under Article 18, paragraph 3, of the Convention. It shallserve as a means for sharing of information related to access and benefit-sharing. In
particular, it shall provide access to information made available by each Party relevant to
the implementation of this Protocol.
2. Without prejudice to the protection of confidential information, each Party shall makeavailable to the Access and Benefit-sharing Clearing-House any information required bythis Protocol, as well as information required pursuant to the decisions taken by the
Conference of the Parties serving as the meeting of the Parties to this Protocol. The
information shall include:(a) Legislative, administrative and policy measures on access and benefit-sharing;(b) Information on the national focal point and competent national authority or authorities;
and(c) Permits or their equivalent issued at the time of access as evidence of the decision to
grant prior informed consent and of the establishment of mutually agreed terms.
3. Additional information, if available and as appropriate, may include:(a) Relevant competent authorities of indigenous and local communities, and information
as so decided;(b) Model contractual clauses;(c) Methods and tools developed to monitor genetic resources; and(d) Codes of conduct and best practices.
4. The modalities of the operation of the Access and Benefit-sharing Clearing-House,
including reports on its activities, shall be considered and decided upon by the
Conference of the Parties serving as the meeting of the Parties to this Protocol at its firstmeeting, and kept under review thereafter.
Article 18, Compliance with Mutually Agreed Terms
Article 18, Paragraph 1
In the implementation of Article 6, paragraph 3 (g) (i) and Article 7, each Party shall- 25 -

encourage providers and users of genetic resources and/or traditional knowledge
associated with genetic resources to include provisions in mutually agreed terms to cover,where appropriate, dispute resolution including:(a) The jurisdiction to which they will subject any dispute resolution processes;(b) The applicable law; and/or(c) Options for alternative dispute resolution, such as mediation or arbitration.
Article 19, Model Contractual Clauses
Article 19, Paragraph 1
Each Party shall encourage, as appropriate, the development, update and use of sectoraland cross-sectoral model contractual clauses for mutually agreed terms.
A. Mutually Agreed Terms (MAT)(1) Explanatory Notes
1) As in the case of other ordinary transactions, access to genetic resources, etc. andbenefit-sharing should take place in accordance with MAT. This is explicitly stated in
Article 15, Paragraphs 4 and 7 of the CBD and Article 5 of the Nagoya Protocol.
2) Accordingly, the parties first negotiate MAT. Paragraph 44 of the Bonn Guidelines
provides an "indicative list of typical mutually agreed terms."3) When negotiating MAT with your counterpart, you need to study their country’s domestic
laws and administrative measures regarding access to genetic resources, etc. It is also
advisable for you to investigate their trade laws and business customs. Careful
investigation may be necessary about their country’s traditional knowledge associatedwith genetic resources, because there is often a high level of uncertainty about it.
4) Furthermore, some providing countries will have set clear rules and procedures forrequiring and establishing MAT based on Article 6, Paragraph 3(g) of the Nagoya
Protocol. Therefore, you will need to pay attention to those rules and procedures.
5) Handling of the transfer of genetic resources, etc. involves the use of another type of
document, the "Material Transfer Agreement (MTA)."In the cases involving the transfer of genetic resources, etc., an MTA will need to beconcluded between the provider and the user of the genetic resources, etc.

- 26 -

The MTA is intended as a contract to establish the terms and conditions for the transfer
of materials, such as the following:- The type and quantity of material to be transferred;- The timing of the transfer;- The intended use of the transferred material (to be specified as necessary, including,e.g., for non-commercial use, or for commercial use); and- Whether or not the material can be transferred to a third party and, if yes, theprocedure for doing so.
In some countries, domestic laws and/or administrative measures may stipulate content
requirements for the material transfer agreement. Accordingly, you need to carefully
investigate the domestic laws and/or administrative measures of the country providing
the genetic resources, etc.
In addition, refer to the Suggested Elements for Material Transfer Agreements describedin Appendix I of the Bonn Guidelines which lists elements that should be specificallyagreed upon in the MTA.
6) If there are any concerns or problems, you may consult with JBA or METI which may
have useful information. (Please refer to Chapter IV, infra, for the contact point at JBA or
METI that handles such inquiries.)(2) Practical Problems and Suggested Solutions
Question 14: What type of issues should I keep in mind for the MAT?
Answer 14: Refer to the Bonn Guidelines for examples in “Indicative list of typical mutuallyagreed terms," in Paragraph 44, or for those in Appendix I, "Suggested Elements forMaterial Transfer Agreements."

Also refer to Article 6, Paragraph 3(g) of the Nagoya

Protocol for items to be included in mutually agreed terms. Note that Article 19 of the
Nagoya Protocol calls upon each Contracting Party to the Protocol to encourage, as
appropriate, the development, update and use of model contractual clauses.
Question 15: Our MAT negotiation has been consuming a lot of time. What should I do?
Answer 15: It is not uncommon for negotiations on contract terms to take a long time. Judgefor yourself whether to continue or terminate the negotiation.
If there are any concerns or problems, you may consult with JBA or METI which may haveuseful information. (Please refer to Chapter IV, infra, for the contact point at JBA or METI
that handles such inquiries.)- 27 -

Question 16: We are interested in conducting a research and development project using
traditional knowledge associated with genetic resources. How do we identify the
stakeholders concerning that kind of knowledge?
Answer 16: "Traditional knowledge" is not defined under the CBD or the Nagoya Protocol;
although the Nagoya Protocol includes provisions related to access and benefit-sharing withregard to traditional knowledge associated with genetic resources (see, for example, Articles
5, 6, 12, and 16 of the Nagoya Protocol). Users must abide by the domestic laws and/or
administrative measures of the country providing the resources. Accordingly, you need to
study the domestic laws, administrative measures, customary laws and other procedures of
the relevant indigenous and local communities of that country.
In practice, however, there may be cases where it is not easy to clearly identify the entity
responsible for prior informed consent or approval and for negotiation of MAT, because
traditional knowledge is held collectively by indigenous or local communities and because
several different communities often hold the same traditional knowledge. We recommendthat you closely consult with the competent national authority of the country underconsideration.
If there are any concerns or problems, you may consult with JBA or METI which may haveuseful information. (Please refer to Chapter IV, infra, for the contact point at JBA or METI
that handles such inquiries.)
Question 17: Does a user have to accept the MAT proposed by the provider of genetic
resources?
Answer 17: If you find that all the provisions of the MAT proposed by the provider are
identical to those stipulated by the domestic laws and/or administrative measures of thecountry providing the resources, then, you must comply with the proposed MAT.
On the other hand, your counterpart in the negotiation may propose his/her own terms andconditions which are not based on the domestic laws and/or administrative measures ofhis/her government. In such cases, you are not obligated to agree to these parts of the terms
and conditions.
It is important for you to verify which part of the proposed terms and conditions are based on
the domestic laws and/or administrative measures of the country. You should conduct yournegotiation on the basis of this clarification.

- 28 -

B. Sharing the Benefits of Utilization(1) Explanatory Notes
When you utilize genetic resources, etc. of another country, you should share benefits fairly
and equitably based on MAT, in compliance with the domestic laws or administrative
measures of the providing country. If there is no such law or measure in place in theproviding country, you should negotiate a MAT with the individual or entity that is providing
the genetic resources, bearing in mind the principles of the CBD and the Nagoya Protocol.
In the negotiation, It is important that both you and the provider discuss and understandwhat each other needs to achieve, and make a “win-win” agreement.
1) Benefit-Sharingi) Meaning of “benefit”
The term “benefit,” as used in the phrase “benefits arising out of the utilization of genetic
resources, etc.,” does not necessarily refer to net monetary profit that remains after
expenses have been deducted from the revenue generated from the product that has
used the genetic resources, etc.; rather, the word is used in a broader sense to mean
“what the provider and/or the user of genetic resources obtain” as a result of using thoseresources.
ii) Methods for benefit-sharing
As shown below, "benefits arising from the utilization of genetic resources" can be divided
into two major categories: "monetary benefits" and "non-monetary benefits."(a) Monetary benefits: These include, for example, fees for obtained samples, milestone
payments, and royalties.
(b) Non-monetary benefits: These include, for example, training of staff of the providing
country in joint research or technology transfer, and sharing the results of research.
Refer to the Annex in the Nagoya Protocol for examples of "Monetary and Non-monetary
Benefits."- 29 -

2) Points to Notei) Domestic laws or administrative measures of the providing country:
Note in MAT negotiations that, under some countries’ domestic ABS law or administrative
measures, a specific rule is stated for sharing benefits arising from the utilization ofgenetic resources, etc. Also pay attention to the trade laws and business customs in theproviding country.
ii) Points to bear in mind in negotiations:- Common understanding regarding benefit-sharing:
In negotiations, it is important for both sides to have a common understanding of what“benefits to be shared” means. In the case of monetary benefit-sharing, for example, it
may be that you assume that the benefit is the amount remaining after R&D costs andother expenses are deducted from product sales, while your counterpart may have a
different understanding. You should explain and make sure that both sides have acommon understanding.
If your counterpart is not experienced in R&D processes, you need to explain about thesteps involved in research, development and commercialization, indicating that it usuallytake a considerable length of time before monetary benefit can be generated from theutilization of genetic resources.
Furthermore, it is important that you explain to your counterpart that benefit-sharing
patterns vary, depending on the business sector involved (e.g., food, cosmetics,
pharmaceuticals, etc.), because profit margins vary considerably from one sector toanother.
- Sharing of benefits in proportion to the degree of contribution:
Although some providers are not aware of it, “fair and equitable sharing of benefits” does
not mean that benefits will be shared on a fifty-fifty basis. It is important for thenegotiating parties to agree on the principle they will apply in order to share benefits inproportion to the degree of each party’s contribution to the overall achievement.
If there are any concerns or problems, you may consult with JBA or METI which may
have useful information. (Please refer to Chapter IV, infra, for the contact point at JBA or
METI that handles such inquiries.)- 30 -

(2) Practical Problems and Suggested Solutions
Question 18: How should I handle derivatives obtained from the utilization of genetic
resources?
Answer 18: On the basis of mutually agreed terms, derivatives can be made subject tobenefit-sharing. It is important that the provider and the user negotiate to confirm the specificdefinition of “derivative” that will apply within the framework of their contract and how it willbe treated thereunder.
Note that, in some cases, the definition of “derivatives” and their treatment are stipulated in
the domestic laws and/or administrative measures of the country providing genetic
resources. Therefore, you should check them before starting negotiation.

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4. Compliance
Provisions Set Forth in the Nagoya Protocol and the Bonn Guidelines[Article 15, Paragraphs 1, 2 and 3, Article 16, Paragraphs 1, 2 and 3, Article 17, Paragraphs
1, 2 and 3 of the Nagoya Protocol; Paragraph 16 of the Bonn Guidelines][Nagoya Protocol]
Article 15, Compliance with Domestic Legislation or Regulatory Requirements on
Access and Benefit-sharing
Article 15, Paragraph 1
Each Party shall take appropriate, effective and proportionate legislative, administrative or
policy measures to provide that genetic resources utilized within its jurisdiction have beenaccessed in accordance with prior informed consent and that mutually agreed terms havebeen established, as required by the domestic access and benefit-sharing legislation or
regulatory requirements of the other Party.
Article 15, Paragraph 2
Parties shall take appropriate, effective and proportionate measures to address situations of
non-compliance with measures adopted in accordance with paragraph 1 above.
Article 15, Paragraph 3
Parties shall, as far as possible and as appropriate, cooperate in cases of alleged violationof domestic access and benefit-sharing legislation or regulatory requirements referred to inparagraph 1 above.
Article 16, Compliance with Domestic Legislation or Regulatory Requirements on
Access and Benefit-sharing for Traditional Knowledge Associated with Genetic
Resources
Article 16, Paragraph 1
Each Party shall take appropriate, effective and proportionate legislative, administrative or
policy measures, as appropriate, to provide that traditional knowledge associated withgenetic resources utilized within their jurisdiction has been accessed in accordance withprior informed consent or approval and involvement of indigenous and local communities
and that mutually agreed terms have been established, as required by domestic access andbenefit-sharing legislation or regulatory requirements of the other Party where suchindigenous and local communities are located.

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Article 16, Paragraph 2
Each Party shall take appropriate, effective and proportionate measures to address
situations of non-compliance with measures adopted in accordance with paragraph 1 above.
Article 16, Paragraph 3
Parties shall, as far as possible and as appropriate, cooperate in cases of alleged violationof domestic access and benefit-sharing legislation or regulatory requirements referred to inparagraph 1 above.
Article 17, Monitoring the Utilization of Genetic Resources
Article 17, Paragraph 1
To support compliance, each Party shall take measures, as appropriate, to monitor and toenhance transparency about the utilization of genetic resources. Such measures shall
include:(a) The designation of one or more checkpoints, as follows:(i) Designated checkpoints would collect or receive, as appropriate, relevant
information related to prior informed consent, to the source of the genetic
resource, to the establishment of mutually agreed terms, and/or to the utilization ofgenetic resources, as appropriate;[The rest of Article 17, Paragraph 1, omitted.]
Article 17, Paragraph 2
A permit or its equivalent issued in accordance with Article 6, paragraph 3 (e) and madeavailable to the Access and Benefit-sharing Clearing-House, shall constitute aninternationally recognized certificate of compliance.
Article 17, Paragraph 3
An internationally recognized certificate of compliance shall serve as evidence that thegenetic resource which it covers has been accessed in accordance with prior informed
consent and that mutually agreed terms have been established, as required by the domestic
access and benefit-sharing legislation or regulatory requirements of the Party providing priorinformed consent.
[The Article 17, Paragraph 4, omitted.]- 33 -

(1) Explanatory Notes
The Nagoya Protocol contains compliance provisions in Article 15 "Compliance with
Domestic Legislation or Regulatory Requirements on Access and Benefit-sharing";

Article16 "Compliance with Domestic Legislation or Regulatory Requirements on Access andBenefit-sharing for Traditional Knowledge Associated with Genetic Resources"; and, Article
17 "Monitoring the Utilization of Genetic Resources" provides measures to supportcompliance. The Nagoya Protocol assumes that every country is both a user and a provider
of genetic resources.
1) Measures in the User Country
Each Contracting Party is obligated to take measures to provide that the genetic resources
utilized within its jurisdiction have been accessed in compliance with the ABS legislation or
regulatory requirements of the other Party (Article 15 of the Nagoya Protocol). EachContracting Party is obligated to designate at least one checkpoint to monitor the utilizationof genetic resources. (Article 17 of the Nagoya Protocol.)2) Measures in the Providing Country
The obligations of Articles 15, 16 and 17 of the Nagoya Protocol are balanced by the
obligation of the country providing the resources to implement the provisions in the Article 6"Access to Genetic Resources." For example, in Article 6, Paragraph 3, each Party requiring
PIC is obligated to take the necessary measures to provide for legal certainty, clarity andtransparency of their domestic access and benefit sharing legislation or regulatory
requirements. Furthermore, there is an obligation for the providing Party to make available
to the ABS Clearing-House the information concerning its ABS measures (see Article 6.3(e)and Article 14 of the Nagoya Protocol).
3) Certificate of Compliance
To implement Article 17 "Monitoring the Utilization of Genetic Resources," the internationallyrecognized certificate of compliance” system shall serve as evidence (Article 17, Paragraph3), for which the ABS Clearing-House will play a critical role as an information source.
Effective operation of the ABS Clearing-House will be the key for the implementation of the
Nagoya Protocol in general, and the Articles 6, 15, 16 and 17 in particular.

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As outlined above, the Nagoya Protocol is characterized by imposing obligations on both thecountry providing genetic resources and the country using genetic resources 10 . Eachcountry is allowed to exercise considerable discretion in implementing of the Nagoya
Protocol. It remains to be seen at this point of time what kind of domestic ABS legislation
and regulatory requirements will emerge and what kind of impact they will have on countries.
Particularly in the months before the Nagoya Protocol enters into force, we strongly
recommend that the users of genetic resources conduct ABS activities according to the
Guidelines on Access to Genetic Resources for Users in Japan 2012 which have beendeveloped on the basis of the CBD, the Bonn Guidelines and the Nagoya Protocol.

10

Background leading to the adoption of this principle in the Nagoya Protocol: In the Bonn Guidelines,
there is a section (Paragraph 16) entitled "Responsibilities" regarding access and benefit-sharing pursuant
to Article 15 of the Convention on Biological Diversity. The Bonn Guidelines recommend principles such as
the following as "responsibilities" of the Contracting Parties: “1. Recognize that Parties may be both users
and providers of genetic resources. 2. Review national policy, and administrative and legislative measures
to ensure they are fully complying with Article 15 of the Convention. 3. Contracting Parties with users ofgenetic resources under their jurisdiction should take appropriate legal, administrative, or policy measures,
as appropriate, to support compliance with prior informed consent of the Contracting Party providing such
resources and mutually agreed terms on which access was granted.

- 35 -

5. Dispute Resolution
Provisions Set Forth in the Nagoya Protocol and the Bonn Guidelines[Article 6, Paragraph 3 (g) and Article 18 of the Nagoya Protocol; Paragraph 59 of the Bonn
Guidelines][Nagoya Protocol]
Article 6, Access to Genetic Resources
Article 6, Paragraph 3
Pursuant to paragraph 1 above, each Party requiring prior informed consent shall take thenecessary legislative, administrative or policy measures, as appropriate, to:[Sub-paragraphs (a) to (f) are omitted.](g) Establish clear rules and procedures for requiring and establishing mutually agreed
terms. Such terms shall be set out in writing and may include, inter alia:(i) A dispute settlement clause;(ii) Terms on benefit-sharing, including in relation to intellectual property rights;(iii) Terms on subsequent third-party use, if any; and(iv) Terms on changes of intent, where applicable.
Article 18, Compliance with Mutually Agreed Terms
1. In the implementation of Article 6, paragraph 3 (g) (i) and Article 7, each Party shallencourage providers and users of genetic resources and/or traditional knowledge
associated with genetic resources to include provisions in mutually agreed terms tocover, where appropriate, dispute resolution including:(a) The jurisdiction to which they will subject any dispute resolution processes;(b) The applicable law; and/or(c) Options for alternative dispute resolution, such as mediation or arbitration.
2. Each Party shall ensure that an opportunity to seek recourse is available under their legal
systems, consistent with applicable jurisdictional requirements, in cases of disputes
arising from mutually agreed terms.
3. Each Party shall take effective measures, as appropriate, regarding:(a) Access to justice; and(b) The utilization of mechanisms regarding mutual recognition and enforcement offoreign judgments and arbitral awards.

- 36 -

4. The effectiveness of this article shall be reviewed by the Conference of the Parties
serving as the meeting of the Parties to this Protocol in accordance with Article 31 of thisProtocol.
(1) Explanatory Notes
An unexpected situation can sometimes arise in a joint research or business project
conducted with a research institution or corporation in a country with different customs andculture, even if you have enjoyed a good relationship with your collaborators at the outset.
Therefore, it is prudent to establish a risk management system in case of disputes.
Particularly, you need to outline the following points in the contract after thorough discussion
with your counterpart for the purpose of mitigating risk:
1) Determination of Jurisdiction
The contract should clarify in which country the legal action may be taken in the event that adispute arises.
2) Determination of Applicable Law
The contract should clearly define which country’s law is to be applied for judgment withregard to the interpretation of wordings in the contract and its validity.
There can be a number of ways of resolving disputes. The following examples represent
major methods:a) Direct negotiation between the parties involved:
Resolution of disputes through mutual consultation between the parties involved would
minimize the time and cost burden and is the most desirable solution.
b) Mediation, conciliation and arbitration:
If a dispute should arise that the parties cannot resolve through direct negotiation, thenext step would be to seek the involvement of a neutral third party. This step can bebroadly classified as follows: i) the third party recommends a compromise between theparties after listening to their conflicting claims (mediation); ii) the third party presents theparties with a settlement plan (conciliation); and iii) the third party issues a judgment withwhich the parties are bound to comply (arbitration). (Please consult appropriate
professionals with regard to the specific procedures.)- 37 -

c) Litigation:
Dispute resolution through litigation may also be considered. Therefore, you need toclearly stipulate the jurisdiction and governing law when concluding a contract.
(2) Practical Problems and Suggested Solutions
Question 19: What are the advantages of resolving disputes through mediation, conciliation,or arbitration?
Answer 19: These resolution methods can reduce time and cost burdens, when comparedto litigation. In addition, when different stakeholders make diverse claims based on therespective cultures and customs of the countries, the diverse claims may be reconciled.

- 38 -

Chapter III

Other Issues

1. In-House Management Systems for Corporations and Other Organizations(1) Explanatory Notes
To cope with the international situation surrounding the CBD and the Nagoya Protocol, it isincreasingly important for corporations, universities, research institutes, and other relevantorganizations, on their own initiative, to each put in place an appropriate in-house system.
This is also an important element for maintaining and further developing good relations with
providers and countries providing genetic resources.
It is particularly relevant for these in-house systems to strengthen their organizational
management, through actions such as those set out below:
1) Disseminate information about the ABS principles of the CBD and the Nagoya Protocol
throughout the organization;2) Upgrade the in-house structure addressing access to and utilization of genetic resources,
etc.; and3) Upgrade the preservation and recording system for the genetic resources, etc. that havebeen either acquired from or provided to a source or entity outside of Japan.
When preparing such systems within your organization, you may consult with the JBA and
METI, as necessary. They may be able to provide you with useful information.

- 39 -

Chapter IV Roles of the JBA and the Ministry of Economy, Trade and Industry(1) On behalf of the Ministry of Economy, Trade and Industry (METI), Japan
Bioindustry Association (JBA) has been implementing CBD-ABS for two decades. As
a result, the JBA has accumulated many diverse experiences, and developed an
extensive network with diverse countries. With this background, JBA has been offering
advice, as requested, to corporations, universities, research institutes, individuals, etc.
concerning ABS matters.
(2) METI can also be consulted not only for general questions about CBD-ABS but also for
problems difficult for corporations to resolve on their own. The earlier you consult, thebetter, when you feel that there is a problem.
(3) Finally, we recommend that you conduct business or research activities according to The
Guidelines 2012. If you do so, it will be much easier for JBA or METI to provide you withappropriate support.
Below are the contact information on JBA and METI:* Research Institute of Biological Resources, Japan Bioindustry Association (JBA)
Tel: +81-3-5541-2731

FAX: +81-3-5541-2737

From the Web form: https://sec02.alpha-mail.net/jba.or.jp/absinfo.htm* Bio-Business Promotion Office, Bio-Industry Division, Manufacturing Industries Bureau,
Ministry of Economy, Trade and Industry
Tel: +81-3-3501-8625

FAX: +81-3-3501-0197

E-mail: cbd-abs@meti.go.jp- 40 -

Reference Materials
I. The Convention on Biological Diversity(The text of the Convention)

http://www.cbd.int/convention/text/(The official Japanese translation)

http://www.biodic.go.jp/biolaw/jo_hon.html

2. The Nagoya Protocol(English with Japanese translation by JBA,)
http://www.mabs.jp/archives/nagoya/index.html
3. The Bonn Guidelines(The English text)

http://www.cbd.int/doc/publications/cbd-bonn-gdls-en.pdf(Japanese translation by JBA)

http://www.mabs.jp/cbd_kanren/guideline/index.html

4. Information sources for National Laws of Different Countries relating to Access to Genetic
Resources and Benefit-Sharing(1) CBD Secretariat website:“ABS Measures Search Page” (http://www.cbd.int/abs/measures/)(2) JBA website:“Access to Biological Resources and Benefit Sharing based on the Convention on
Biological Diversity (CBD): A Corporate Guide - CBD-related Information by Country”(http://www.mabs.jp/countries/index.html)
5. Examples of Agreements and Contracts relating to Access to Genetic Resources andBenefit-Sharing“Standard Forms and Agreements, the National Cancer Institute, the National Institutes of
Health, the United States”(http://ttc.nci.nih.gov/forms/)- 41 -

Guidelines on Access to Genetic Resources For Users in Japan(2012 Edition)
First Edition: published in March 2005
Second Edition: published in March 2012
Publisher: Japan Bioindustry Association
Grande Bldg., 8F, 26-9, Hatchobori 2-chome,
Chuo-ku, Tokyo 104-0032, Japan
Tel:+81-3-5541-2731

Fax:+81-3-5541-2737- 42 -