Draft Of Global Regime On Genetic Resources Emerges At CBD

GRANADA, Spain – A draft version of international regulations on the use of genetic resources has been put forward by the chairwoman of a United Nations conference here.

The draft was welcomed by developing countries and a few developed countries but met with deep scepticism from many developed countries, the pharmaceutical industry, and some inter-governmental organisations when presented on 1 February.

The “open-ended draft” text is called an “international [legally binding] regime on access and benefit-sharing within the framework of the Convention on Biological Diversity,” with the brackets indicating a lack of agreement.

The text is intended to reflect the “main thrust” of the debate on the use of genetic resources that took place on 31 January, the chairwoman said on 1 February. Thus one developed country observer argued that at this point, the entire text should have been in brackets.

It is not clear what the status of the draft is but one delegate indicated that it “smells like a protocol.” Another draft is expected to be presented on 2 February.

The 30 January to 3 February meeting is the fourth gathering of the CBD ad hoc open-ended working group on access and benefit-sharing, and is being held by the United Nations Environment Programme (UNEP) and the UN Convention on Biological Diversity (CBD). Whatever suggestions this working group may make will be forwarded to the CBD Conference of Parties, which will meet in Curitiba, Brazil on 20-31 March. The conference of parties includes all the countries that have ratified the CBD, the observer said.

Two years ago the conference of parties met in Kuala Lumpur and gave this working group the mandate to set up an international regime for genetic resources.

At issue is a possible international regulation of biological resources, such as plants that may be used for the development of medicines, and how the users of these resources should share the benefits with the providers (often indigenous communities). This is referred to as an access and benefit-sharing regime.

Ahmed Djoghlaf, executive secretary of the CBD, urged the working group to make progress. “The serious divergence of views on the suggested international regime on access and benefit-sharing are generating a level of uncertainty that is detrimental to the convention and to all parties concerned,” he said in prepared remarks. “This uncertainty is compounded by the variety of measures taken by parties at the national level and the challenges facing their effective implementation.”

One source said that the working group on 30 January discussed the issue of whether the instrument would be legally binding. A text on an alternative international regime on biodiversity tabled by Ethiopia on behalf of the African Group was not discussed as it was considered premature, and the parties did not want to focus the discussion on the Ethiopian paper only, the observer said. On 1 February, when the countries voiced their comments on the draft from the chairwoman, Ethiopia asked to have its text be taken into consideration.

A number of developed countries expressed concern about the draft, which proposed the setting up of a certificate of origin. It also ties the certificates in with patent applications, stating: “Such certificates of legal provenance or utilisation and, if existing, evidence of prior informed consent and mutually agreed terms related to arrangements should be a precondition for patentability and other intellectual property applications.” This paragraph was later proposed by at least one developed country to be dropped, according to a participant.

In plenary sessions that lasted into the night on 1 February, delegates discussed the draft and the secretariat said it wanted to come up with a new draft on 2 February reflecting the changes. One source said that the chair had to come up with a proposal for the conference of parties as that was the mandate of this meeting.

A number of mainly developing countries, including Brazil, Costa Rica, Ethiopia, India, Mexico, Norway, Peru and South Africa said they were happy with the document as a starting point for further discussion.

But a number of developed country and intergovernmental sources expressed concern about the draft and the manner in which the chairwoman had presented the draft, which states it is a “draft submitted by the chair.”

Drafting Moving Too Fast or Too Slow?

The Australian delegate said Australia was “very concerned” about the document as well as the process and said it did not reflect the discussions of the previous day. This was a draft protocol, she said, and it was “moving parties too quickly in one direction towards a legally binding regime.”

Countries such as Austria (speaking on behalf of the European Union), Canada, Korea and New Zealand echoed this concern, saying that further “gap studies” should be carried out before a regime could be considered. These studies look at existing regulations for biodiversity and identify what is there and what is lacking (thus the term “gap”).

The CBD published a gap study on 17 November, but one source said this was just a compilation and lacks an analysis.

The delegate from Malaysia, however, said that the issue of access and benefit-sharing had been discussed for some 13 years now so one could not say that the process was moving too quickly. He noted that access had always been there but regulation should be set up for “those who remove the resources.” He said the issue of disclosure in patent applications should be moved to the front of the text.

On 1 February, Brazil proposed two new paragraphs on “disclosure of legal provenance,” after the title “benefit-sharing” and before “certificate of origin.”

Henrique Choer Moraes, one of the Brazilian negotiators at the World Intellectual Property Organisation, told Intellectual Property Watch that in terms of disclosure, the country of origin should be indicated in intellectual property applications and this should be applied together with prior informed consent and benefit sharing. He said that Brazil wanted the issue of disclosure and certificate of origin to go forward in discussions individually.

US Industry Front and Center

The pharmaceutical industry is well represented at the meeting. Jacques Gorlin, president of the American BioIndustry Alliance, told Intellectual Property Watch that the ABIA was not opposed to an access and benefit-sharing regime but said this should not go through the patent system. The best approach was contracts with up-front benefits to provider countries, he said.

Gorlin also said that the chair’s draft had “whetted the appetite” of those who wanted a protocol on the issue.

One IGO representative said the three-page draft was useless as the chair had not even attended the last CBD meeting, which took place in Bangkok in February 2005 She said that the draft thus went backwards and did not even reflect the progress made in the meantime.

Another source said the draft was forced and only reflected the needs of the Latin American region. The draft was entirely based upon the chair’s understanding, he noted.

The developed country observer noted that it was not usual that the chair came up with a draft in this way, but rather reflected what the participant of the conference had agreed to. There was some industry speculation in the corridors as to who had influenced the chairwoman in preparing the draft, given that industry was pushing hard to have the draft dropped.