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TWN Info Service on Intellectual Property Issues (Mar07/02) 5 March 2007
THE OUTCOME OF THE MEETING AS REPORTED BY THE CBD SECRETARIAT (in doc. UNEP/CBD/WG-ABS/5/2) IS IN AN ANNEX BELOW. The report is also available at: http://www.biodiv.org/doc/meetings/abs/abswg-05/official/abswg-05-02-en.doc The outcome of this Expert Group discussion is a technical input to the Ad Hoc Open-ended Working Group on Access and Benefit-Sharing (ABS Working Group), when it meets next on 8 – 12 October, in Canada to continue negotiations on an international regime on access and benefit-sharing. The terms of reference of the Working Group were: “(a) Consider the possible rationale, objectives and the need for an internationally recognised 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.” This
issue that is being discussed at the CBD is closely linked to discussions
on the Amendment of the TRIPS Agreement to include a disclosure requirement
in patent applications proposed by a group of developing countries ( The proposal also requires that “Members shall put in place effective enforcement procedures so as to ensure compliance with the obligations set out in paragraphs 2 and 3 of this Article. In particular, Members shall ensure that administrative and/or judicial authorities have the authority to prevent the further processing of an application or the grant of a patent and to revoke, subject to the provisions of Article 32 of this Agreement, or render unenforceable a patent when the applicant has, knowingly or with reasonable grounds to know, failed to comply with the obligations in paragraphs 2 and 3 of this Article or provided false or fraudulent information.” This proposal at the WTO TRIPS Council is made by the group of developing countries “For the purposes of establishing a mutually supportive relationship between this Agreement and the Convention on Biological Diversity, in implementing their obligations, Members shall have regard to the objectives and principles of this Agreement and the objectives of the Convention on Biological Diversity.” (See WTO doc. WT/GC/W/564/Rev.2, TN/C/W/41/Rev.2, IP/C/W/474). GENERAL BACKGROUND The CBD ABS Working Group was established by COP 5 in 2000 and was mandated to develop guidelines and other approaches to assist Parties and stakeholders in addressing access and benefit-sharing. The Working Group successfully negotiated the voluntary Bonn Guidelines on access and benefit-sharing, which were adopted by COP 6 in 2002. The issue of an international certificate of origin was first considered within the framework of the CBD at the second meeting of the ABS Working Group in December 2003, as another potential approach to assist with the implementation of the access and benefit-sharing provisions of the Convention. At COP 7, the need to further examine other approaches including an international certificate of origin/source/legal provenance, in particular the operational functionality and cost effectiveness of such an international certificate, was emphasized. Most importantly, the COP 7 mandated the Working Group to negotiate an international regime on access and benefit-sharing. Developing countries at the CBD had successfully argued that the voluntary Bonn Guidelines are inadequate to fulfill the CBD objective of fair and equitable benefit-sharing. In the terms of reference of the Working group, the list of elements to be considered for inclusion in the international regime includes an “internationally recognised certificate of origin/source/legal provenance of genetic resources and associated traditional knowledge”. It should be noted that at the last (8th) COP meeting held in Curitiba, Brazil it was decided that the ABS Working Group would 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 COP in 2010. OTHER RELEVANT DOCUMENTS a) background document prepared by the Secretariat for discussion during the Lima Expert Group meeting is available at: http://www.biodiv.org/doc/meetings/abs/absgte-01/official/absgte-01-02-en.doc b) The Compilation of Submissions Provided by Parties, Governments, Indigenous and Local Communities, International Organizations and Relevant Stakeholders Regarding an Internationally Recognized Certificate of Origin/Source/Legal Provenance is available at: http://www.biodiv.org/doc/meetings/abs/absgte-01/official/absgte-01-03-en.doc c) Other documents are available at: http://www.biodiv.org/doc/meeting.aspx?mtg=ABSGTE-01 Best
Wishes Annex OUTCOME OF THE MEETING OF THE GROUP OF TECHNICAL EXPERTS ON AN INTERNATIONALLY RECOGNIZED CERTIFICATE OF ORIGIN/SOURCE/LEGAL PROVENANCE 1. The Group of Technical Experts attempted to provide information and guidance in response to each of the elements contained in decisionVIII/4 C, paragraph 1, of the Conference of the Parties. The following reflects the outcome of discussions without prejudice to the desirability of the options or agreement on any specific option. A. POSSIBLE RATIONALE, OBJECTIVES AND THE NEED FOR AN INTERNATIONALLY RECOGNIZED CERTIFICATE OF ORIGIN/SOURCE/LEGAL PROVENANCE 1. Any option considered should contribute to achieving the objectives of the Convention. The group was aware that all countries are both providers and users of genetic resources. 2. National legal systems alone are not sufficient to guarantee benefit-sharing once genetic resources have left the provider country. In this respect, the certificate as part of a broader access and benefit-sharing regime, could be an important tool to reduce this limitation. 3. A certificate could assist to address a number of concerns of the Parties and therefore cover several other objectives. The Group identified the following: (a) Legal certainty; (b) Transparency; (c) Predictability; (d) Benefit-sharing facilitation; (e) Facilitation of legal access with minimal transaction costs and delay; (f) Technology transfer; (g) Preventing misappropriation; (h) Minimizing bureaucracy ; (i) Supporting compliance with national law and mutually agreed terms; (j) Enabling and facilitating cooperation in monitoring and enforcement of access and benefit-sharing arrangements; (k) Facilitating development of national access and benefit-sharing frameworks; (l) Protection of traditional knowledge. 4. Depending on the model, advantages of adopting a certificate could include, in addition, ensuring greater compliance with requirements of the Convention, assisting the fair and equitable sharing of the monetary and non-monetary benefits from the utilization of genetic resources and associated traditional knowledge, and facilitating cooperation among different jurisdictions. Another advantage could arise from simplifying access processes to genetic resources. 5 Achievement of these objectives will depend on the specific characteristics of the model. B DISTINCTIONS BETWEEN THE OPTIONS OF CERTIFICATE OF ORIGIN/SOURCE/LEGAL PROVENANCE AND THE IMPLICATIONS FOR ARTICLES 15 AND 8(J) OF THE CONVENTION 6. After due deliberations, the Group discussed further the definitions, similarities and differences between a certificate of origin/source/legal provenance. The Group recognized that the basic role of the certificate is to provide evidence of compliance with national access and benefit-sharing regimes. Thus, it found it practical to refer to the certificate as a certificate of compliance with national law, in accordance with the Convention. 7. The certificate of compliance would support the effective implementation of Article 15 and Article 8(j) of the Convention, given the appropriate national framework. C. POTENTIAL CHARACTERISTICS AND FEATURES OF DIFFERENT OPTIONS OF SUCH AN INTERNATIONALLY RECOGNIZED CERTIFICATE 8. The Group identified potential features and characteristics of the certificate, as well as various options with respect to the obligations of users and providers of genetic resources. 9. The Group considered that the sovereign rights of Parties over their natural resources allowed them to regulate access and to determine the range of genetic resources and associated traditional knowledge that could be covered, providing flexibility to the Parties and avoiding the need to harmonize national access legislation and thereby significantly reducing implementation costs. This may also allow Parties to include derivatives in the national system if they so wish. It was felt that some harmonization of user measures and checkpoints may be necessary. 10. In order to facilitate and ensure the fair and equitable sharing of benefits, there was a need to provide greater transparency regarding the access to and use of genetic resources and associated traditional knowledge and to ensure compliance with access and benefit-sharing requirements in both user and provider countries. It was agreed that a national certificate, with standard features to allow its international recognition, in combination with control points to be established in the user countries to monitor the use of genetic resources and associated traditional knowledge in accordance with national laws, including prior informed consent and mutually agreed terms, was a possible way to meet these goals. This would require an implementation effort on the part of both providers and users. 11. Considering that there is a conceptual link between the sharing of benefits and conservation and sustainable use, it is important to ensure that countries and relevant indigenous and local communities that conserve and sustainably use biological diversity should be beneficiaries of this system. 12. In accordance with its mandate, the group assessed the practicality, feasibility, costs and benefits of such a system and examined various options for the implementation of the certificate. These options were: Option 1 Provider : All provider countries required to provide a certificate User: All user countries required to request a certificate
Option 2 Provider: National discretion to provide a certificate User: All user countries required to request a certificate
Option 3 Provider: All provider countries required to provide a certificate User: National discretion to request a certificate
Option 4 Provider: National discretion to provide a certificate User: National discretion to request a certificate
13.The combination of these options could lead to several models ranging from models based on purely voluntary instruments to mandatory ones and those having a mixture of voluntary and mandatory instruments. Nature 14. In all the options presented, the certificate of compliance with national access and benefit‑sharing legislation is considered to be a public document to be issued by a competent national authority appointed in accordance with national law, to be reviewed as appropriate at checkpoints by user countries. Scope 15. Under all models considered, in principle, all types of genetic resources could be covered by the system, in accordance with national law. In a system providing for the mandatory issuance of a certificate in all provider countries, such a system should be in accordance with the scope of the Convention. However in a voluntary mechanism in which the issuance and request of the certificate is discretional, the scope could even go beyond that of the Convention on Biological Diversity. 16. It was considered that providers may establish general or specific exemptions [1]/ for specific purposes, limited to matters of public interest, such as health. 17. With regard to plant genetic resources for food and agriculture, the Group recognized that they fall within the scope of the International Treaty on Plant Genetic Resources for Food and Agriculture of the Food and Agriculture Organization of the United Nations and that duplications with that treaty should be avoided. 18. With respect to traditional knowledge associated with genetic resources, the Group felt that its intangible nature poses practical difficulties in some cases, and distinct implementation challenges hence requiring special consideration. The country of origin should consider including traditional knowledge in the certificate, in accordance with national legislation. Further exploration may be needed in order to determine whether the certificate should be extended to traditional knowledge. 19. In order to determine whether the certificate should apply to genetic resources used for scientific research, it was felt that possible implications should be further assessed in order to avoid impeding such research and promote incentives. Various alternatives could be considered, such as excluding genetic resources used for research purposes, providing clear demarcation between commercial and non‑commercial activities or establishing a simplified procedure for the issuance of the certificate. 20. In all the models presented, it was agreed that the certificate would serve to provide evidence of compliance with national access and benefit-sharing legislation, as may be required at specific checkpoints to be established in user countries. These checkpoints may be established to monitor compliance in relation to a range of possible uses. The certificate, in accordance with national law, could establish specific uses of the resources accessed. Content and format 21. To facilitate international recognition of the national certificates, the certificate identified by a codified unique identifier [2]/ could contain the following minimum information: (a)Issuing national authority; (b) Details of the provider; (c) A codified unique alpha numeric identifier; (d) Details of the rights holders of associated traditional knowledge, as appropriate; (e) Details of the user; (f) Subject‑matter (genetic resources and/or traditional knowledge) covered by the certificate; (g) Geographic location of the access activity; (h) Link to mutually agreed terms; (i) Uses permitted and restrictions of use; (j) Conditions of transfer to third parties; (k) Date of issuance. 22. A standardized internationally recognized format for certificates was considered most appropriate. Certificates, should, where possible, provide a link to a national database providing non confidential information of prior informed consent (PIC) and mutually agreed terms (MAT), as appropriate. 23. In designing the content of certificates and related information on PIC and MAT, information to be provided should be gauged to take into account relevant requirements of the checkpoints. 24. The use of a freely available read-only access system based on a unique identifier (alphanumeric code) that links to national databases for additional information was considered desirable. Nevertheless, differences in the capacities of the countries to implement this system were noted. Any system would need to be flexible enough to allow for a mixture of paper and electronic formats. 25. Use of unique identifiers would enable any subsequent identification of material to relate back to the certificate. Transfers to third parties should require maintenance of the link with the certificate and the mutually agreed terms applying to the resources. 26. It is desirable to have some degree of standardization when there is a sub-identification of genetic resources, although it may not be feasible initially. In addition, measures necessary to ensure security should be considered as well as the costs of establishing such a system and the security measures included. 27. Countries that cannot provide for the mandatory issuance of a certificate may wish to consider its issuance on a discretionary basis in light of the benefits for both providers and users that may derive from standard practice in all countries. Procedure In the provider country 28. A national authority in charge of issuing the certificate should be designated and listed in a common international database. Furthermore, countries should be encouraged to streamline rather than add to current internal mechanisms for access, and issuance of permits, contracts and certificates. 29. The issuance of the certificate will be triggered at the request of a user. Countries will be encouraged to issue a certificate as soon as possible after the request and to establish a simple procedure in order to increase incentives for the use of the certificate. While a certificate should be requested as early as possible, a user should have the possibility to request it at any time or at the request of the checkpoint. Issuance could also be an automatic act triggered by the granting of access or agreement on mutually agreed terms. In the user country 30. One or more national authority or entity identified as checkpoint(s) should be appointed by the competent national authority of the user country and listed in the common international database. It would be desirable that the latter be the same issuing authority as when the country is a provider. 31. Checkpoints identified were: (a) Registration points for commercial applications (e.g. product approval processes); (b) Intellectual property rights offices (in particular patent and plant variety authorities). 32. In the case of non commercial uses, additional checkpoints could be further explored such as entities funding research, publishers and ex situ collections. 33. The designation of a national authority as a focal point could be also considered. 34.Opinions varied on the requirements for reporting at checkpoints. Options include: (a) No reporting to a central clearing-house mechanism or a national authority required; however the user would be obligated to record the certificate identifier on publication, on applications for patents and commercial product registration; (b) Reporting to the clearing-house mechanism. At the international level 35. An international registry containing electronic copies of the certificate or the unique identifier of the certificate could serve as a clearing house mechanism (CHM). Countries could be required to notify the international registry when they issue a certificate. Checkpoints may be required to notify this registry upon the presentation of a certificate. A simple procedure for notification could be agreed. Opinions varied on the amount of information to be stored in the clearing-house mechanism. It ranged from only the unique identifier with a link to the issuing country database to duplication of the information in the certificate. 36. A committee could be constituted to consider logistical aspects of implementation. 37. Harmonization of processes in both provider and user countries related to the issuing and monitoring of certificates may enhance the efficiency and legal certainty of the whole system. Consequences of infringement 38. Legal consequences will vary depending on the nature of the procedure under which the presentation of the certificate is requested. In cases where the certificate is required but not presented, the consequences may range from the suspension of the procedure until due presentation of the certificate to its withdrawal. In case of false representation or forgery, legal consequences may entail administrative sanctions, including fines; criminal sanctions; and, judicial action on the part of the issuing country. In a voluntary system, legal consequences will not apply. D. IMPLEMENTATION CHALLENGES, INCLUDING THE PRACTICALITY, FEASIBILITY, COSTS AND BENEFITS 39. There will be some implementation costs, particularly in the setting up of national authorities (where they have not yet been established), in capacity building and in the maintenance of the international registry as suggested. Other costs may include opportunity costs, direct costs and transaction costs. The implementation and opportunity costs may escalate if for example the model establishes the need of substantive review of certificates on both sides, considers excessive tracking, reporting and monitoring, generates more bureaucracy than required, slows down procedures unnecessarily or discourages research and product development. 40. Additional implementation challenges or costs may be related to the coexistence of genetic resources inside and outside the certificate system, the setting up and maintenance of checkpoints in user countries and the possibility of enforcing the certificate across various jurisdictions. 41. It should be borne in mind that, to the extent that the international certificate could lower significantly the transaction costs and provide more flexibility (and legal certainty), it could balance the additional costs mentioned above, especially when considered in the long run. The certificate may also avoid the costs resulting from a growing number of uncoordinated national regimes. 42. In addition, a preliminary assessment of options was made in relation to practicality, feasibility, cost, and benefits. Among the key factors in assessment will be the extent to which each option provides the basis for a certificate system which reduces transaction costs, builds trusts between Parties and furthers the effective realization of the access and benefit‑sharing provisions of the Convention. 43. In evaluating options available for a certificate system the group noted that legal certainty may be increased as the level of obligations to provide certificates in provider countries and request certificates in user countries increased. Conversely, the level of legal certainty may decrease as any system becomes more discretionary. 44. Analysis of feasibility requires consideration of political willingness, institutional capacity and changes necessary to make certificates a part of systems for the management and use of resources. 45. With regard to the issue of costs, it was considered necessary to take into account not only transaction costs but also direct costs associated with implementation. In some cases, while it is likely that initial costs would be high in the start up phase of a global regime, the transaction costs (e.g. marginal costs of each additional transaction) may under certain circumstances be relatively low. 46. The potential benefits of a certificate system to achieve the access and benefit-sharing objectives of the Convention are likely to increase with greater participation of parties at both the user and provider end. 47. he Group considers it useful for Governments, industry, the research sector, international institutions, indigenous and local communities to further study these issues. Capacity development 48. The Group noted the important role that capacity development will play in securing the effective implementation of any certificate system. The costs of capacity-building may need to be shared by national authorities and the international community. While institutional costs may in large part be borne by national authorities, building technical expertise and technological capacity will require international support. [1]/ In accordance with decision II/11, paragraph 2, of the Conference of the Parties, human genetic resources are beyond the scope of the Convention. [2]/
For example, code certificate BR 2007
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