ABS. Access and benefit-sharing

Access and benefit-sharing

The Conference of the Parties,

Recalling its decision VII/19, on access and benefit-sharing,

Recalling also its decision VIII/5 C, on collaboration between the Ad Hoc Open-ended Working Group on Access and Benefit-sharing and the Ad Hoc Open-ended Inter-Sessional Working Group on Article 8(j) and Related Provisions and the participation of indigenous and local communities,

Taking note of the reports of the third and fourth meetings of the Ad Hoc Open ended Working Group on access and benefit-sharing,

A. International regime on access and benefit-sharing

1. Welcomes the progress made in the Ad Hoc Open-ended Working Group on Access and Benefit-sharing to elaborate and negotiate an international regime;

2. Decides to transmit the annex to the present decision to the fifth meeting of the Ad Hoc Open‑ended Working Group on Access and Benefit-sharing for the purposes of continuing to elaborate and negotiate the international regime in accordance with decision VII/19 D, as well as, inter alia, the following inputs for the elaboration and negotiation of an international regime:

(a) The outcomes of the group of technical experts on the certificate of origin/source/legal provenance;

(b) A progress report on the gap analysis, and the matrix, and;

(c) Other inputs submitted by Parties relating to access and benefit-sharing.

The annex reflects the range of views held by Parties at the fourth meeting of the Ad Hoc Open-ended Working Group on Access and Benefit-sharing;

3. Invites Parties, Governments, indigenous and local communities, international organizations and all relevant stakeholders to provide information regarding the inputs on an analysis of existing legal and other instruments at national, regional and international levels relating to access and benefit-sharing to the Secretariat of the Convention four months prior to the fifth meeting of the Working Group on Access and Benefit-sharing;

4. Requests the Secretariat to prepare a compilation of the information provided in accordance with the paragraph above and make it available for the work of the Working Group on Access and Benefit—sharing;

5. Decides to designate Mr. Fernando Casas of Colombia and Mr. Tim Hodges of Canada as Co-Chairs of the Ad Hoc Open-ended Working Group on Access and Benefit-sharing, for the purposes of the elaboration and negotiation of the international regime on access and benefit-sharing in accordance with the mandate of decision VII/19 D;

6. Requests the Ad Hoc Open-ended Working Group on Access and Benefit-sharing to continue the elaboration and negotiation of the international regime in accordance with its terms of reference in decision VII/19D and instructs the Ad Hoc Open-ended Working Group to complete its work at the earliest possible time before the tenth meeting of the Conference of the Parties;

7. Requests the Executive Secretary to make the necessary arrangements for the Ad Hoc Open-ended Working Group on Access and Benefit-sharing to be convened twice before the ninth meeting of the Conference of the Parties;

8. Invites Parties, Governments, indigenous and local communities, international organizations and all relevant stakeholders to submit to the Secretariat further information relevant to the gap analysis;

9. Requests the Executive Secretary to prepare, for the fifth meeting of the Working Group on Access and Benefit-sharing, the final version of the gap analysis referred to in decision VII/19 D, annex, paragraph (a) (i), bearing in mind that this work will proceed in parallel and not hold up the work relating to the elaboration and negotiation of the international regime;

10. Invites Parties to submit to the Executive Secretary information on the legal status of genetic resources in their national law, including their property law where applicable, and requests the Executive Secretary to submit a report to the fifth meeting of the Working Group.

Annex

INTERNATIONAL REGIME ON ACCESS AND BENEFIT-SHARING

In accordance with the Convention on Biological Diversity,

Nature

The international regime could be composed of one or more instruments within a set of principles, norms, rules and decision-making procedures legally-binding and/or non-binding.

[Potential] Objectives

To endeavour to create conditions to [facilitate] [regulate] access to genetic resources for environmentally sound uses by other Parties and not to impose restrictions that run counter to the objectives of this Convention.

To ensure the fair and equitable sharing of the monetary and non‑monetary benefits arising from the use of [such] [genetic] resources and associated traditional knowledge, taking into account that the three objectives of the Convention are interlinked.

[To establish a mechanism providing certainty about the [legal provenance] [origin] [source] of genetic resources].

[[Subject to national legislation] To [protect] [respect, preserve and maintain the traditional knowledge of] the [rights] of indigenous and local communities to their traditional knowledge, innovations and practices [associated to genetic resources and derivatives] [related to the conservation and sustainable use of biological diversity] and to [encourage] [ensure] the fair and equitable sharing of the monetary and non-monetary benefits arising from the utilization of their knowledge, [consistent with human rights obligations] [subject to national legislation of the countries where these communities are located] [and applicable international law]].

[To ensure compliance with PIC in the context of MAT of countries of origin and of indigenous and local communities.]

To contribute to the effective implementation of articles 15, 8(j) [and 16 to 19] and the three objectives of the convention.

The conservation and sustainable use of biological diversity.

[To prevent the misappropriation and misuse of genetic resources, their derivatives and associated traditional knowledge]

[To ensure that fair and equitable sharing of benefits flow to the countries of origin of the genetic resources]

[[Promote] [Ensure] compliance with prior informed consent of the providing countries and of indigenous and local communities and mutually agreed terms;]

[Ensure and enforce the rights and obligations of users of genetic resources;]

[Ensure mutual supportiveness with relevant existing international instruments and processes] [and that they are supportive of and do not run counter to the objectives of the convention].

[Contribute or promote capacity-building and [to ensure] technology transfer to developing countries, in particular least developed countries and small island developing States]

Scope

1. The international regime applies to, [in accordance with national legislation and other international obligations]:

(a) Access to genetic resources [and derivatives and products] [subject to the national legislation of the country of origin];

(b) [[Conditions to facilitate access to and] transboundary [movement] [utilization] of genetic resources [and derivatives and products] [or associated traditional knowledge]];

(c) Fair and equitable sharing of the monetary and non-monetary benefits arising out the utilization of genetic resources [and their derivatives and/or] associated traditional knowledge [and, where appropriate, their derivatives and products], in the context of mutually agreed terms [based on prior informed consent] [in accordance with the national legislation of the country of origin];

(d) [[Protection of] [Respect, preserve and maintain] traditional knowledge, innovations and practices of indigenous and local communities [embodying traditional lifestyles relevant for the conservation and sustainable use of biodiversity] [associated to genetic resources] [and their derivatives and products] in accordance with national legislation].

2. [The international regime applies to all genetic resources and associated traditional knowledge, innovations and practices and benefits arising from the utilization of such resources.]

3. [The international regime will not apply to the plant genetic resources [of those plant species] that are considered by [under annex 1 of] the International Treaty on Plant Genetic Resources for Food and Agriculture [or by the Commission on Genetic Resources for Food and Agriculture], [when those resources are used for the purposes of that Treaty].

4. [The international regime is without prejudice to the FAO International Treaty on Plant Genetic Resources for Food and Agriculture and will take into account the work of the WIPO/IGC on the intellectual property aspects of sui generis systems for the protection of traditional knowledge and folklore against misappropriation and misuse].

5. [The international regime ensures mutual supportiveness and complementarity with relevant existing international instruments and processes] [and that they are supportive of and do not run counter to the objectives of the Convention].

6. [The international regime will not apply to human genetic resources].

7. [The scope of the regime would be in compliance with national access and benefit-sharing regimes relating to the genetic resources within national jurisdictions [, in the context of the international trade and exchange of these genetic resources]].

[Potential] Elements [to be considered for inclusion in the international regime]

Access to genetic resources [and derivatives and products]

1. [States have sovereign rights over their own genetic resources, and the authority to determine access rests with national Governments and is subject to national legislation.]

2. [[Subject to national legislation,] conditions for access to genetic resources [derivatives and products] shall be [dependent upon] [related to] benefit sharing arrangements].

3. Access procedures shall be clear, simple and transparent and provide legal certainty to different kinds of users and providers of genetic resources with a view to the effective implementation of Article 15, [paragraph 2], of the Convention on Biological Diversity.

4. [Parties] [Countries of origin] providing genetic resources, [derivatives and products][, including countries of origin,] in accordance with Article 2 and Article 15 of the Convention [may] [shall] establish measures requiring that access to such genetic resources [derivatives and products] [for specific uses] shall be subject to prior informed consent.

5. [Parties that are not countries of origin of genetic resources or their derivatives they hold shall not give access to those genetic resources without the prior informed consent of the countries of origin of those genetic resources.]

6. [Where the countries of origin of genetic resources or derivatives can not be identified, the Parties in whose territories those genetic resources or derivatives are found will grant access to users on behalf of the international community.]

7. Mutually agreed terms for access to and specific uses of genetic resources [or derivatives], in accordance with Article 15, paragraph 4 of the Convention on Biological Diversity[, may include conditions for transfer of such genetic resources [or derivatives] to third parties, subject to national legislation of countries of origin].

[Recognition and protection of] traditional knowledge associated with genetic resources [derivatives and products]

The elements of the international regime should be developed and implemented in accordance with Article 8(j) of the Convention on Biological Diversity:

(a) [Parties may consider developing, adopting and/or recognizing, as appropriate, [international,] national and local sui generis [models] [systems] for the protection of traditional knowledge, innovations and practices associated to genetic resources, [derivatives and products;]]

(b) [Subject to its national legislation,] Parties [should] [recognize and protect the rights] [respect, preserve and maintain knowledge, innovations and practices] of indigenous and local communities and [ensure] [encourage] the equitable sharing of benefits arising from the utilization of such knowledge, innovations and practices [regarding benefit-sharing derived from their traditional knowledge associated with genetic resources, [derivatives and products,] subject to the national legislation of the countries where these communities are located [and to applicable international law];

(c) [[Users [Parties] should comply with the prior informed consent of indigenous and local communities holding traditional knowledge associated with genetic resources, [derivatives and products] in accordance with Article 8(j) of the Convention on Biological Diversity, subject to national legislation of the country where these communities are located [and to applicable international law]].

(d) [Access and benefit sharing arrangements relating to traditional knowledge should be implemented in the context of national access and benefit-sharing regimes.]

Fair and equitable benefit-sharing

1. [Minimum conditions for the fair and equitable sharing of the benefits arising out of the use of genetic resources, derivatives or products shall be stipulated in relevant national [access] legislations [or] [and] under the international regime] and [shall] [may] be taken into consideration in mutually agreed terms [shall] [may] be based on prior informed consent between the provider and user of given resources.]

2. [Mutually agreed terms conditions may stipulate benefit‑sharing arrangements regarding derivatives and products of genetic resources.]

3. The conditions for the sharing of the benefits arising out of the use of traditional knowledge, innovations or practices and associated [with] genetic resources [derivatives and products] [will] [may] be stipulated in mutually agreed terms [between users and the competent national authority of the provider country with active involvement of concerned indigenous and local communities] [between the indigenous or local communities and the users, and where appropriate with the involvement of the provider country].

4. [Mutually agreed terms may contain provisions on whether intellectual property rights may be sought and if so under what conditions.]

5. Mutually agreed terms may stipulate monetary and/or non-monetary conditions for the use of genetic resources, [their derivatives and/or products] and associated traditional knowledge, innovations and practices.

6. [The international regime should establish basic benefit-sharing [obligations] [conditions], including the distribution of benefits through the financial mechanism, to be applicable in the absence of specific provisions in access arrangements.]

7. [Where the country of origin of the genetic resources or derivatives accessed cannot be identified, the monetary benefits there from shall accrue to the financial mechanism and the non-monetary benefits shall be made available to those Parties that need them.]

8. [Parties should establish, taking into account Article 20, paragraph 4 of the Convention, measures to ensure the fair and equitable sharing of benefits from the results of research and development, including through facilitating access to the results of such research and development and through technology transfer, and other utilization of genetic resources, [derivatives and products] and associated traditional knowledge, taking into account prior informed consent and mutually agreed terms and respecting national legislations of the country providing genetic resources.]

9. [Parties that develop technologies making use of genetic resources, derivatives and product should establish national legislation to facilitate access to and transfer of those technologies to developing countries that are the origin of such resources under mutually agreed terms.]

10. [Clarification of the actual nature of benefit sharing, emphasizing the need for differentiation of commercial versus non-commercial uses of genetic resources with resulting differentiated obligations/expectations.]

11. [Practical and enforceable benefit sharing clauses in material transfer agreements as agreed to between the providers and the users.]

12. [Benefits should be directed in such a way as to promote conservation and sustainable use of biological diversity [in countries of origin of genetic resources.]]

13. [Benefit-sharing arrangements should not be limited to mutually agreed terms when these arrangements are supporting prior informed consent.]

[Disclosure [of [legal provenance] [origin] [prior informed consent and benefit-sharing].

1. Intellectual property rights applications whose subject matter [concerns or makes use of] [is directly based on] genetic resources [and/or derivatives and products] and/or associated traditional knowledge should disclose the country of origin or source of such genetic resources, [derivatives and products] or associated traditional knowledge[, as well as evidence that provisions regarding prior informed consent and benefit sharing have been complied with, in accordance with the national legislation of the country providing the resources].

2. [National legislation shall provide for remedies to sanction lack of compliance with the requirements set out in the above paragraph which must include inter alia revocation of the intellectual property rights in question, as well as co-ownership of the IPR and its transfer.]

3. [If the disclosed information is incorrect or incomplete, effective, proportionate and dissuasive sanctions should be envisaged outside the field of patent law.]]

[[Certificate of origin] [International certificate of [origin/source/]legal provenance]

1. The international regime may establish an international certificate of origin/source/legal provenance of genetic resources, [derivatives and/or products] to be issued by the [provider country] [country of origin].

2. The international regime [may] [shall] establish a system to certify the [origin/source/legal provenance of genetic resources] [legal utilization of traditional knowledge, innovations or practices of indigenous and local communities associated to genetic resources].

3. Such certificates of origin/source/legal provenance [or utilization] may be [an integral part] [evidence] of PIC and MAT arrangements.

[4. Such certificates of origin/source/legal provenance [or utilization] and, if existing, evidence of PIC and MAT related arrangements may be a precondition for patentability and other intellectually property applications.]

[5. An international certificate of origin/source/legal provenance could be an element of an international regime.]

[6. The potential needs, objectives, desirable characteristics/features, implementation, challenges, including costs and legislative implications of such an international certificate, are to be further explored.]

[7. The certificate of origin/source/legal provenance may be used as a means of complying with the disclosure requirements according to national legislation.]]

Implementation, monitoring and reporting

1. [Parties shall establish] mechanisms for monitoring implementation as well as reporting procedures [may be considered] for the international regime.

2. [Parties [may] [shall] develop national legislation[, as appropriate,] for the implementation of the international regime.]

[Compliance and enforcement]

1. [Recipients of genetic material, [derivatives and products] shall make no applications for patents related to such genetic materials, [derivatives or products] without the prior informed consent of the [provider country] [country of origin.] [Non compliance of this provision shall, inter alia, result in the rejection of the patent application and where necessary the revocation of such patent.]

2. [Parties [may] [shall] develop national legislation[, as appropriate,] for the implementation of the international regime.]

3. [Each Party must comply with national legislation of the [countries providing genetic resources, derivatives and products] [country of origin], [including countries of origin], regarding access and benefit-sharing when accessing and/or using genetic resources, [derivatives and products] and associated traditional knowledge.]

4. [The international regime [may] [shall] ensure that whatever terms and conditions that may be stipulated under mutually agreed terms are complied with and enforced.]

5. [The international regime [may] [shall] contain] cooperative procedures and institutional mechanisms to [[promote] and [ensure]] compliance [may be considered for the international regime].

6. [International regime [shall] [may] contain measures to ensure compliance with the prior informed consent of [Parties] [indigenous and local communities regarding access to their traditional knowledge, innovations and practices associated with genetic resources [, derivatives and products].]]

7. [International regime [shall] [may] contain measures to [[promote] and [ensure]] compliance with the prior informed consent of the country providing genetic resources, [derivatives and products] including countries of origin, in accordance with Article 15, paragraph 3, of the Convention on Biological Diversity.]

8. [International regime [shall] [may] contain measures to prevent misappropriation and unauthorized access and use of genetic resources [, their derivatives and products] and associated traditional knowledge, innovations and practices.]

9. [Parties should take measures to ensure that genetic resources utilized within their jurisdiction comply with the Convention on Biological Diversity and the conditions under which access was granted.]

10. [Create mechanisms to facilitate collaboration among relevant enforcement agencies in both provider and user countries.]

11. [Without prejudice to specific remedies concerning IPR applications, national legislations shall provide for sanctions to prevent the use of genetic resources, derivatives and associated traditional knowledge without compliance with provisions of the international regime, in particular those related to access and benefit-sharing legislations from countries of origin.]

12. [The following are considered acts or cases of misappropriation:

(a) Use of genetic resources, their derivatives and products and/or associated traditional knowledge without compliance with the provisions of the international regime;

(b) Any acquisition, appropriation or utilization of genetic resources, their derivatives and products and/or associated traditional knowledge by unfair or illicit means;

(c) Deriving commercial benefits from the acquisition, appropriation or utilization of genetic resource, derivatives and products and/or associated traditional knowledge when the person, using genetic resource, derivatives and products, knows, or is negligent in failing to know, that these were acquired or appropriated by unfair means;

(d) Other commercial activities contrary to honest practices that gain in equitable benefit from the genetic resource, derivatives and product and/or associated traditional knowledge.]

[(e) Use of genetic resources, their derivatives and products and/or associated traditional knowledge for purposes other than for which it was accessed; and]

[(f) Obtaining unauthorized information that can be used for the reconstitution of genetic resources, derivatives or products or traditional knowledge.]

[Access to justice

1. Measures to [facilitate] [ensure] access to justice and redress.

2. Measures to [guarantee and] facilitate access to justice and redress, including administrative and judicial remedies, as well as alternative dispute resolution mechanisms [by providers and users].]

[Dispute settlement mechanism]

1. [Parties [shall] [may] establish a dispute settlement mechanism for the international regime.]

2. [Provisions of Article 27 of the Convention on Biological Diversity shall apply with respect to the settlement of disputes under the international regime.]

[Financial mechanism

Parties [shall] [may] establish a financial mechanism for the international regime including for benefit-sharing arrangements.]

Capacity-building [and technology transfer]

1. The international regime should include provisions for the building and enhancement of capacity in developing countries, least developed countries and small-island developing states, as well as countries with economies in transition, for the implementation of the international regime at national, regional and international levels.

2. [Measures for effective technology transfer and cooperation so as to support the generation of social, economic and environmental benefits.]

3. [Building of human, institutional and scientific capacities including for putting in place a legal mechanism, taking into account Articles 18, 19 and 20.4 of the Convention.]

[Institutional support]

[1. Existing non-legislative international measures that support or promote the effective implementation of Articles 15, 8(j) and the three objectives of the Convention are identified and recognized.]

2. Environmentally sound research utilizing genetic resources and associated traditional knowledge is promoted, and commercial and non-commercial scientific research, including taxonomic research, are distinguished.

[Non-Parties]

 

B. Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising out of their Utilization

The Conference of the Parties

1. Notes the progress already accomplished and urges Parties to continue implementing the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising out of their Utilization and to share experiences and lessons learned in their implementation as well as in the development and implementation of national and sub-national measures ;

2. Invites Parties to submit reports on their experiences in developing and implementing Article 15 of the Convention at the national level, including obstacles encountered and lessons learned, four months prior to the fifth meeting of the Working Group on Access and Benefit-sharing;

3. Requests the Secretariat to prepare a compilation of the information provided in accordance with the paragraph above and make it available for the work of the Working Group on Access and Benefit-sharing at its fifth meeting.

 

C. Other approaches, as set out in decision VI/24 B, including consideration of an international certificate of origin/source/legal provenance

The Conference of the Parties

1. Decides to establish a group of technical experts to explore and elaborate possible options, without prejudging their desirability, for the form, intent and functioning of an internationally recognised certificate of origin/source/legal provenance and analyse its practicality, feasibility, costs and benefits, with a view to achieving the objectives of Articles 15 and 8(j) of the Convention. The Expert Group shall provide technical input to the Ad Hoc Open-ended Working Group on Access and Benefit‑sharing and will operate in accordance with the following terms of reference:

(a) Consider the possible rationale, objectives and the need for an internationally recognized certificate of origin/source/legal provenance;

(b) Define the potential characteristics and features of different options of such an internationally recognised certificate;

(c) Analyse the distinctions between the options of certificate of origin/source/legal provenance and the implications of each of the options for achieving the objectives of Articles 15 and 8(j) of the Convention;

(d) Identify associated implementation challenges, including the practicality, feasibility, costs and benefits of the different options, including mutual supportiveness and compatibility with the Convention and other international agreements;

2. Also decides that the group of experts shall be regionally balanced and composed of 25 experts nominated by Parties and 7 observers from, inter alia, indigenous and local communities, industry, research institutions/academia, botanical gardens, other ex situ collection holders and representatives from relevant international organizations and agreements, and requests the Executive Secretary to recommend the list of selected experts and observers for the approval of the Bureau;

3. Encourages Parties to take into consideration the need for technical expertise in the Expert Group from, inter alia, indigenous and local communities, industry, research institutions/academia, botanical gardens and other ex situ collection holders when nominating their experts;

4. Further decides that the Group shall meet at least six months prior to the fifth meeting of the Working Group on Access and Benefit-sharing and submit the report of its work to the Working Group at its fifth meeting.

5. Invites Parties, Governments, relevant international organizations, indigenous and local communities and all relevant stakeholders including the private sector to undertake further work, including through research and submission of views, on the possible options for the form, intent and functioning of an international certificate of origin/source/legal provenance and on its practicality, feasibility, costs and benefits, with a view to achieving the objectives of Articles 15 and 8(j), including consideration of certificate models as an input for the work of the Expert Group.

D. Measures, including consideration of their feasibility, practicality and costs, to support compliance with prior informed consent of the contracting Party providing genetic resources and mutually agreed terms on which access was granted in contracting Parties with users of such resources under their jurisdiction

The Conference of the Parties

Reaffirming that disclosure of origin/source/legal provenance of genetic resources in intellectual property rights application is one element in the Terms of Reference in the Annex to Decision VII/19 D for the elaboration and negotiation of an international regime on access and benefit-sharing;

Noting discussions regarding disclosure of origin/source/legal provenance in intellectual property rights applications in the World Intellectual Property Organization and in the Doha Work Programme of the World Trade Organization;

Further noting that there is a diversity of views on the possible measures to support compliance with prior informed consent and mutually agreed terms;

1. Invites relevant forums to address and/or continue their work on disclosure requirements in intellectual-property-rights applications taking into account the need to ensure that this work is supportive of and does not run counter to the objectives of the Convention, in accordance with Article 16, paragraph 5;

2. Urges Parties, Governments and relevant stakeholders to continue taking appropriate and practical measures to support compliance with prior informed consent in cases where there is utilization of genetic resources or associated traditional knowledge, in accordance with article 15 of the Convention and national legislation, and with mutually agreed terms on which access was granted;

3. Requests the Ad Hoc Open-ended Working Group on Access and Benefit-sharing at its fifth and sixth meetings to further consider measures to ensure compliance with prior informed consent in cases where there is utilization of genetic resources or associated traditional knowledge, in accordance with Article 15 of the Convention and national legislation, and with the mutually agreed terms on which access was granted;

4. Requests the Executive Secretary to renew the application for accreditation of the Convention on Biological Diversity as an observer at the Council on Trade-related Aspects of Intellectual Property Rights of the World Trade Organization.

E. Strategic Plan: Future evaluation of progress – the need and possible options for indicators for access to genetic resources and in particular for the fair and equitable sharing of benefits arising from the utilization of genetic resources

The Conference of the Parties

1. Requests the Ad Hoc Open-ended Working Group on Access and Benefit-sharing at its fifth meeting to further address this issue of the need and possible options for indicators for access to genetic resources and the fair and equitable sharing of benefits arising from the utilization of genetic resources;

2. Invites Parties, Governments, relevant international organizations, indigenous and local communities and all relevant stakeholders to submit their views and information to the Executive Secretary in accordance with recommendation 3/5 of the third meeting of the Ad Hoc Open-ended Working Group on Access and Benefit-sharing;

3. Requests the Executive Secretary to compile the views and information referred to above and make such compilation available to the Ad Hoc Open-ended Working Group on Access and Benefit-sharing at its fifth meeting.