CBD meeting ends with draft elements of Access and Benefit Sharing Regime

The main ingredients of an international agreement on access and benefit sharing (ABS) under the Convention on Biological Diversity (CBD) have been set out in a document at the end of a week-long meeting of the CBD's working group on access and benefit sharing held in Granada on 30 Jan to 3 Feb..

The draft elements of the international regime were formulated after strenuous efforts by developing countries and despite objections and resistance by most developed countries at the end of the ad hoc open-ended working group's meeting on Friday (3 February).

Agreement was reached on a recommendation to be forwarded to the 8th meeting of the Conference of the Parties (COP8) in March in Curitiba, Brazil for the next phase of work, and on a draft that will be the basis for future negotiations. This draft entitled "International Regime on Access and Benefit Sharing" and annexed to the recommendation, is entirely bracketed reflecting lack of consensus over the notion of one instrument.

However, the draft contains a structure and core issues in 6 pages, compared to an unwieldy and lengthy document that arrived in Granada. Developing countries are hopeful that this will set the stage for formal negotiations towards a single instrument within a time-frame to be decided at COP8.

The contentious issues that keep countries deeply divided include: the need for a new instrument and whether it should be legally binding; the inclusion of derivatives and products of genetic resources and associated traditional knowledge; disclosure requirements in applications for intellectual property rights; and enhanced participation of indigenous and local communities in the ABS negotiations.

The disclosure requirements relate to the country of origin or source of genetic resources, derivatives and products and/or associated traditional knowledge, evidence of prior informed consent, as well as evidence of fair and equitable benefit sharing according to national law.

With a large majority of countries wanting to start work on a negotiation text, and the major developed countries resisting and delaying, Chairperson Prof. Margarita Clemente of Spain steered the week's debate with a firm hand. Though the resulting three documents are heavy with brackets, reflecting lack of consensus, a significant turning point in the negotiations has been reached.

The Granada meeting was the second session following the decision of the CBD's 7th meeting of the Conference of Parties (COP7) in February 2004 to authorize 2 meetings to "elaborate and negotiate" an international regime on access and benefit sharing (ABS).

On 3 February, the Working Group adopted three recommendations to be forwarded to the COP8 for final decision. These were on the international regime on access and benefit-sharing, issues related to an international certificate of origin/source/legal provenance, and measures to ensure compliance with prior informed consent (PIC) and mutually agreed terms.

A "Friends of the Chair" group held intensive negotiations on the international regime document from Thursday lunchtime, while a parallel open-ended Contact Group met on the other 2 documents, in marathon sessions that ended at about 2.30 am on 3 February. The contact group was co-chaired by Francois Pythoud of Switzerland and Consolata Kiragu of Kenya.

Developed countries, apart from Norway, tried to delay work on a negotiating text by insisting on a "gap analysis" to determine what is lacking in existing national and international instruments relating to access and benefit sharing. According to some observers, this was a tactic to make a case that there is no need for a legally binding instrument to prevent bio-piracy and ensure fair and equitable sharing of benefits between the providers and users of genetic resources and traditional knowledge.

Eventually, the week's discussions produced a text on the nature, objectives and elements of an international regime. According to the Chairperson, Prof. Clemente, there had been fruitful discussions, and while the text is bracketed, it is useful to highlight options that need further reflection. Importantly, a path has been set and Parties now can walk that path to an international regime on ABS.

Brazil's head of delegation, Hadil Fontes Da Rocha Vianna, said the meeting produced a well-organized and structured basis to fulfill the Group's mandate to negotiate an international ABS regime. India, on behalf of the group of Like Minded Mega-diverse Countries, welcomed the outcome document that could be used as a basis for negotiations. Mongolia, on behalf of the Asia-Pacific group, expressed disappointment with those parties who questioned the appropriateness of the Group's mandate to negotiate an international ABS regime. Venezuela, on behalf of GRULAC, said that the adoption of a draft document was a major step forward to an international ABS regime.

The EU was disappointed with the rejection of its proposal on indigenous peoples' participation. The International Indigenous Forum on Bio-diversity had requested at the Bangkok Working Group meeting for more procedural rights in the Group along the lines of the Working Group on Article 8(j). The Forum's spokesperson expressed deep disappointment at their limited participation, and said that the outcome document does not reflect the recognition of indigenous peoples' rights over their lands, natural resources and traditional knowledge.

Throughout the week, industry representatives were present in large numbers, including those from the International Chamber of Commerce, Pharmaceutical Research and Manufacturers of America and American Bio-industry Alliance. A representative of the Japan Bio-industry Alliance was a key spokesperson in the delegation of Japan.

In the first outcome document, the Working Group decided to transmit to COP8 in Brazil the annex containing the international regime text, and the "gap analysis" matrix developed by the CBD Secretariat. Parties are recommended to review the Working Group's progress to elaborate and negotiate the international regime; and to reconvene the Group to continue its work and establish a work schedule "so as to expedite and facilitate the early elaboration, negotiation and conclusion" of the international regime on ABS.

The Group also recommended that COP8 requests the Secretariat "to prepare a final version of the gap analysis ... 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". This qualification is an important recommendation welcomed by developing countries that did not want the gap analysis to be a stumbling block. A final recommendation is a call for funds from all Parties to enable the Working Group to meet.

Lack of consensus in the nature of the regime resulted in a reiteration of the mandate from COP7, i. e. "The international regime could be composed of one or more instruments within a set of principles, norms, rules and decision-making procedures legally and/or non-binding".

Accordingly, the title of the Working Group decision is "International Regime on Access and Benefit Sharing" and contrasted with the original Chair's draft that was entitled "International [legally binding] Regime on Access and Benefit Sharing" within the CBD Framework.

On the Objectives, developing countries maintain that regulation of access to genetic resources is a sovereign right under the CBD. They reject the notion of "facilitated access" that major developed countries want to include in the international regime, reflecting the interests of the biotechnology, pharmaceutical and agribusiness sectors.

Thus, any access should be subject to national legislation, with prior informed consent (including the right to say No) as a fundamental component. This lack of consensus led to the first objective being framed as: "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 the Convention". There are 12 other objectives listed, with 9 totally in brackets.

There is a section on Scope, with "derivatives and products" bracketed. Regarding traditional knowledge, innovations and practices of indigenous and local communities, many Parties wanted to use the term "protect" while others wanted to stick with the CBD language of "respect, preserve and maintain". The inclusion of human genetic resources is also contested.

The relationship with other international agreements and processes such as the FAO International Treaty on Plant and Genetic Resources for Food and Agriculture, WTO TRIPS Agreement (especially on the disclosure requirements in patent applications), and WIPO is also contentious and the 2 relevant paragraphs are bracketed.

Elements (with brackets) for the international regime include: Access to genetic resources [and derivatives and products]; [Recognition and protection of] traditional knowledge associated with genetic resources [derivatives and products]; Fair and equitable benefit-sharing; [Disclosure of legal provenance/origin/prior informed consent and benefit sharing]; [Certificate of origin] [International certificate of origin/source/legal provenance]; Implementation, monitoring and reporting; [Compliance and enforcement]; Access to justice; [Dispute settlement mechanism]; Capacity building [and technology transfer]; [Institutional support]; [Non-Parties].

The element concerning Non-Parties does not have any specific provisions yet. This is expected to be a heated topic as the US houses the major bio-prospectors of genetic resources and has the world's broadest scope of patent law resulting in many cases of misappropriation.

While developing countries consider the title of this section to be "Elements" identified for the regime, developed countries still argue that these are "Potential elements to be considered for inclusion in the international regime". The text is bracketed accordingly to reflect this.

Brazil has been taking the lead in insisting that the international regime must provide for compliance with national access and benefit sharing legislation, and require the disclosure of country of origin or source, evidence of prior informed consent, and evidence of fair and equitable benefit sharing in IPR applications. Compliance and enforcement of prior informed consent and mutually agreed terms for granting access are priorities for developing countries.

The discussion relating to an international certificate of origin/source/legal provenance of genetic resources saw developing countries stressing the importance of such a certificate to ensure transparency in the trans-boundary movement of such resources. It would also help ensure that those who access genetic materials have done so legally, in full respect of the national legislation of the country of origin/source.

Developing countries also wanted derivatives of genetic resources to be included in the scope of the international regime, as data emerging from bio-prospecting activities and numerous cases of misappropriation relate to derivatives. However, developed countries reject this inclusion.

"If there are no derivatives included, we may as well stop talking, as there will be no benefits to share," said Uganda in one of the mid-week discussions. The African Group in its draft protocol includes derivatives and products in the scope.

The outcome document is a significant step forward as COP8 will now consider a 6-page document containing key issues, compared to the much longer and unstructured documents that arrived in Granada. Despite the numerous brackets (and brackets within brackets).

The second set of recommendations related to a more detailed examination of an international certificate of origin/source/legal provenance that could be an element of an international regime on ABS.

In the contact group discussions, Mexico was a key player in providing details on an international certificate. Supported by many developing countries, it argued that a certificate would be an instrument to track genetic resources and ensure compliance with CBD obligations, and have clear triggers to activate disclosure requirements.

Brazil supported a certificate of legal provenance of genetic resources, derivatives and traditional knowledge issued by the country of origin, in accordance with nationally defined requirements, internationally recognized by the international ABS regime. Norway said a certificate should verify compliance with the CBD and national legislation on access.

While the EU said an international certificate could be a key component of an international regime, it cautioned against a "one size fits all" certificate, preferring the term "internationally recognized" certificate rather than "international certificates," as agreed in the Group's Bangkok meeting in 2005. The US and industry spoke in favour of voluntary certification schemes.

After protracted discussions, the contact group agreed to retain references to an "international certificate."

The Granada Working Group finally recommended that COP8 establishes "a regionally balanced ad hoc technical expert group, consisting of Party-nominated experts, to elaborate possible options for form and intent, practicality, feasibility and costs of an international certificate of origin/source/legal provenance , for achieving the objectives of Article 15 and 8(j) of the CBD." Article 15 deals with access and benefit sharing, and Article 8(j) deals with traditional knowledge, practices and innovations of indigenous and local communities. COP8 will provide terms of reference for this expert group, which will submit a report of its work to the 5th meeting of the Working Group on ABS.

Attached to the recommendation is an annex containing a "list of potential rationale, needs and objectives, desirable characteristics/features, implementation challenges, including costs and legislative implications of an international certificate of origin/source/legal provenance as a possible element of the international regime on access and benefit-sharing".

Reflecting the polarised positions on key aspects of the international regime, the following parts of the list are bracketed:

• whether the international certificate may be one means, if required/applicable under national legislation, to comply with disclosure requirements in IPRs applications, or if national legislation so requires, it could be one means to comply with disclosure requirements in IPRs applications;
• "minimum checkpoints" as a potential characteristic/feature of an international certificate;
• the need for an international legal framework that recognizes internationally the certificates issued by countries of origin or provider countries including countries of origin to certify compliance with national access legislation;
• limits of "one size fits all" approaches;
• challenges associated with extracts/derivatives of genetic resources;
• existence of national access and use legislation as a precondition for the operation and enforcement of the certificate system;
• need for practical implementation studies in different countries and in different sectors; and
• the interface with or the exclusion from the proposed certificate requirements of the standard material transfer agreement under the multilateral system of the FAO International Treaty on Plant Genetic Resources for Food and Agriculture.

The third recommendation of the Group was on measures to ensure compliance with prior informed consent (PIC) and mutually agreed terms for access (MAT) which are obligations under the CBD.

Many developing countries called for international measures to guarantee compliance with PIC, MAT, national ABS laws and CBD provisions, transparency in patent applications and disclosure requirements. Several GRULAC countries such as Brazil, Colombia and Ecuador called for binding compliance measures; periodic monitoring; and user measures to prevent misappropriation and ensure compliance with PIC of countries of origin as well as PIC of indigenous and local communities.

On the other hand, some developed countries favoured voluntary guidelines and codes of conduct to promote compliance with the voluntary Bonn Guidelines on ABS and PIC. The US added "best practices" of industry as another preferred option.

Australia and Japan said the CBD was not the forum for discussing IPR issues. Switzerland and Thailand also preferred discussing disclosure of origin in other fora. Singapore said that non-compliance with disclosure requirements should not lead to an invalidation of a patent.

Brazil, Colombia and Malaysia were among developing countries that disagreed and said that IPR aspects of bio-diversity were the responsibility of CBD Parties. Malaysia pointed out that Article 16(5) of the CBD clearly recognises that IPRs may have an adverse influence on the implementation of the CBD, and that Parties cannot abdicate from their responsibility to ensure that IPRs "are supportive of and do not run counter to the objectives of the CBD".

The WTO and WIPO secretariats reported on the developments in their institutions relating to disclosure requirements. UNCTAD highlighted its report on disclosure of origin, PIC and MAT.

In the contact group, delegates discussed from mid-night Thursday this controversial item. There was no consensus on whether the CBD is the appropriate forum to address disclosure of origin/source/legal provenance in IPR applications.

Brazil played a key role and proposed text to ensure the primacy of the CBD, reiterating that "since CBD provisions are negatively affected by intellectual property rules, this is an appropriate forum to tackle them". Brazil saw the work of the CBD Parties and the TRIPS Council as complementary, with a group of developing countries at the WTO "deeply engaged to move forward disclosure requirements" in the TRIPS Agreement.

It said IPR applications whose subject matter makes use of derivatives and products should disclose the country of origin, evidence that PIC has been complied with and show evidence of benefit sharing. "There must be sanctions that affect the IPR in question when there is non-compliance, and the international regime should incorporate this binding requirement of disclosure in IPRs applications," said Brazil, adding that the developed countries' proposals would not be effective in dealing with bio-piracy.

Uganda, supported by Malaysia and Ethiopia, stressed that compliance with PIC and MAT is an important component of the international regime. "In the interest and spirit of transparency these measures will show that there is nothing to hide if one is applying for intellectual property protection, and ensures that benefit sharing has taken place with the right people and in accordance with national law. This should be part and parcel of the international regime".

The EU and Switzerland preferred WIPO as the appropriate forum and said that there are proposals to amend the Patent Cooperation Treaty requiring the disclosure of country of origin. Australia, Japan, Canada and the US agreed that WIPO and not the CBD should address IPR issues.

The resulting draft recommendation adopted by the Group contains several bracketed sections. COP8 is asked to "invite parties and relevant stakeholders to continue taking appropriate and practical measures to support compliance with PIC of parties providing genetic resources, including countries of origin, and MAT on which access was granted". Brazil and Ethiopia's proposal to include "derivatives, products and associated traditional knowledge" are in brackets. This aspect of scope is bracketed throughout.

There was also no agreement on the listing of organizations invited to address and/or continue their work on disclosure requirements in IPR applications, taking into account the need to ensure that this work does not run counter to the CBD's objectives. The controversial organisation is the WTO, with developing countries wanting to mention it and most developed countries not wanting this.

Brazil was not in favour of singling out WIPO as there were many other organizations that looked at the inter-relation between the CBD provisions and IPRs. It said the CBD has received an excellent study by UNCTAD. It proposed the following wording: "Invites relevant organizations such as FAO, UNCTAD, UNEP, UPOV, WIPO and WTO..."

Australia insisted that special reference be made to WIPO distinct from others. It was supported by Canada, EU and Japan. Australia proposed the following: "Invites WIPO, UNCTAD and other relevant international organizations". Both formulations are now in brackets.

The next Group meeting is requested to further consider measures to ensure compliance with PIC and MAT, including disclosure of origin/source/legal provenance. Language stating that these measures should be considered "as one of the possible elements... for inclusion in the international regime" is bracketed.

The following paragraph proposed by Brazil for COP8 to take note of, is also in brackets: "Notes the progress in international discussions regarding disclosure of origin/source/legal provenance in intellectual property rights applications, in particular in the framework of the Doha round of negotiations of the World Trade Organization, and requests the Executive Secretary to renew the request for accreditations of the CBD as an observer at the WTO TRIPS Council."

Brazil, supported by Malaysia and India, also proposed the inclusion of an additional operative paragraph that recommends that COP8: "Reiterates the terms of Article 16 (5) of the Convention and Decision VII/19 D and notes that the international regime negotiations shall consider disclosure of origin/source/legal provenance in intellectual property rights applications".

Australia objected, and wanted Article 16(2) to be included while bracketing the whole text. Article 16(2) refers to "the adequate and effective protection" of IPRs regarding access and transfer of technology under patents or other IPRs. [Note: Article 16(2) also states that this must be consistent with Article 16(5) on the primacy of the CBD objectives.]

The agenda item on use of terms, definitions and/or glossary is delayed until the negotiation of an ABS regime reaches a more advanced stage. The agenda item on indicators for ABS in the context of the evaluation of progress in the implementation of the Strategic Plan will be considered at the next Working Group meeting, to allow for further submission of information by parties.

Developing countries came to Granada prepared for negotiations, with the intention to streamline the lengthy and unwieldy compilation of proposals and views into a structured draft instrument. There was visible cooperation among the regional groupings (Africa, GRULAC and Asia-Pacific) and the group of Like Minded Mega-diverse Countries (LMMC). Although Japan and The Republic of Korea are part of the Asia-Pacific regional group, they were absent from the coordination meetings chaired by Mongolia. Japan is part of JUSCANZ comprising Japan, the US, Canada, Australia and New Zealand. Although the US is not a CBD Party, it is active in the group and its position was consistently advanced.

From the start, developing countries were concerted in their efforts to make progress. The African Group's draft protocol on ABS received support from a number of other developing countries as a basis for the week's discussions. This was rejected by JUSCANZ countries and the EU.

A Chair's 3-page draft was circulated on 1 February, entitled "International [Legally Binding] Regime on Access and Benefit-Sharing" within the CBD Framework. This was endorsed by the Parties present, except for the JUSCANZ countries.

Developing countries supported the draft as a good starting basis but Norway was the only developed country that supported it. Japan, Australia, The Republic of Korea, Canada and the EU objected to using the Chair's draft. The EU and Switzerland preferred a gap analysis first. It appeared to many observers and developing countries' delegations that these developed countries were not prepared to engage in negotiations.

Australia told the Chair that it was "very concerned with the text and process you have taken". Korea also said it was not ready to discuss the legally binding nature of the regime. Switzerland said the draft did not reflect the discussions. Canada proposed that the Chair's draft be added to the existing compilation of views and submissions on the regime.

The Philippines objected to Canada's proposal, saying that "it would take us back to Bangkok". Colombia stressed that the basic gap had been identified at the World Summit on Sustainable Development, i. e. an international ABS regime. "We have an unavoidable mandate from our Presidents and Heads of States that the gap is benefit sharing," it said. The delegate went further to say that this was an "abyss".

Colombia was concerned that it has been 12 years since the CBD entered into force, where benefit sharing as the Convention's third pillar remains unfulfilled. "More gaps analysis might take us another 12 years," it said.

On some developed countries' worry that the discussions were moving too fast, Colombia said that other fora such as the WTO and WIPO were moving faster. "Here at the CBD some people don't want us to move at all," it said.

It was then agreed that the draft would be a basis for "discussions" and not negotiations.

After another long discussion, a revised Chair's draft was distributed, which again was met with objections from developed countries. Australia said: "We are not prepared to negotiate ... We cannot support this document".

Later, a "Friends of the Chair" group was set up to negotiate this document. The structure and core issues provided by the Working Group Chair essentially provided the basis for developing the final text, heavily bracketed as it was.

(* With contributions from Sangeeta Shashikant.)