TWN Info Service on Intellectual Property Issues (Oct10/05)
18 October 2010
Third World Network

South-North Development Monitor (SUNS) #7020, 18 October 2010
Developed Countries Reject Mandatory Disclosure Requirements

Nagoya, 15 Oct (Christine von Weizsacker and Chee Yoke Ling) -- Developed countries continue to reject a list of mandatory checkpoints to detect potential biopiracy by users of genetic resources and associated traditional knowledge within their jurisdiction.

In a final attempt to forge a new treaty under the Convention on Biological Diversity (CBD) that would implement its third objective of fair and equitable sharing of benefits arising from the utilization of genetic resources, deep divergence remains between developed and developing countries after more than five years of discussion and debate.

The deadline for completion of the "Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization" is the 10th meeting of the CBD Conference of Parties to be held in Nagoya, Japan from 18 to 29 October where adoption of the new treaty is scheduled.

The Inter-regional Negotiating Group (ING) constituted by the CBD Ad Hoc Open-ended Working Group on Access and Benefit-Sharing is meeting for the last time in Nagoya from 13-15 October.

One of the central issues related to the compliance system under the protocol is disclosure requirements at specific checkpoints after materials and traditional knowledge that have been accessed leaves a country of origin or a country that provides such material and knowledge. Such disclosure includes disclosure of prior informed consent and evidence of fair and equitable benefit-sharing arrangements between the user (such as researchers, private enterprises and bio-prospecting brokers) and the community or country from where the materials and knowledge are sourced.

The long-awaited substantive discussion on disclosure requirements took place late Thursday night (14 October), but the interventions of developed countries showed an unwillingness to even consider a mandatory list of various checkpoints, one prominent example of which are intellectual property offices. The exception is Norway that accepts some mandatory checkpoints, though not all in the current draft protocol text. Norway's own national patent law has been amended to require disclosure of source of genetic materials in patent applications.

Co-Chair of the ING, Tim Hodges of Canada, started discussion on this issue by asking the question: would anyone disagree with the inclusion of intellectual property (IP) offices in the list of checkpoints, such list containing the following with the brackets in the list showing lack of consensus in the wording in Article 13.1(a):

ARTICLE 13: MONITORING[, TRACKING] AND REPORTING THE [UTILIZATION] OF GENETIC RESOURCES [AND ASSOCIATED TRADITIONAL KNOWLEDGE]

1. Parties shall take measures, as appropriate, .... Such measures [could][shall] include:

(a) The identification and establishment of [effective][mandatory compliance] check points [[and [mandatory] [transparency][disclosure][information] requirements][to [disclose][provide] pertinent information] [at[, for example]:

(i) Competent national authority in the user country;

(ii) Research institutions subject to public funding;

(iii) Entities publishing research results relating to the [utilization] of genetic resources;

(iv) [Intellectual property examination][Patent and plant variety] offices; and

(v) Authorities providing regulatory or marketing approval of products [derived from genetic resources][resulting from the use of genetic resources or its derivatives];]

(v bis) [Indigenous and local communities, including their relevant competent authorities, that may grant access to traditional associated with genetic resources.]

Australia said it does not support the inclusion of a list of checkpoints. In response to Hodges' question on what checkpoints Australia has in mind, the reply was possibly research institutions subject to public funding, possibly ethics councils, but finally it said that it did not have a mandate for the inclusion of a list.

Hodges said that an indicative list could be used and we may find additional, and even more effective checkpoints in the future as we gain experience, adding that it is important to retain an indicative list.

Australia said that it cannot accept an indicative list at this stage.

Peru, on behalf of the Group of Latin American and Caribbean countries (GRULAC), said it is lost in the discussions, that a "no" would not be acceptable and emphasized that these checkpoints have the tasks to check for the existence of certificates (of compliance), as these are measures to support compliance. Peru said it would like to know from those who oppose this list if they have alternatives and whether there can be a signal that the word "could" introducing the list might become a "shall".

Japan said that the list may be indicative or exhaustive or something where it can be made less prescriptive, but the important thing to do is to examine each checkpoint (to see) if it is feasible and implementable. It said that its government found it especially difficult to implement IP offices (as a checkpoint) but also had difficulty with "research institutions subject to public funding" and "entities publishing research results". Japan said it may be easier to deal with this issue if it is an indicative list.

Hodges said that indeed the Japanese government has done a study finding out the feasibility of these checkpoints but what is important is some flexibility at the national level to find where these checkpoints may be set up and there may be some validity in indicating a range of options here. Governments may come to different conclusions regarding feasibility in different countries, but they "shall" establish checkpoints with flexibility to choose which ones.

Malaysia said that in Article 12 (on "Compliance with domestic legislation or regulatory requirements on access and benefit-sharing"), it has been agreed that Parties "shall" take effective measures, and checkpoints are a means to implement Article 12.

It said that the criterion is to choose "effective" checkpoints and IP offices are an appropriate checkpoint and the existing system of IP offices can already be used. In any event, there is disclosure already (referring to studies already made), thus there will be no added costs involved. The patent offices of the United States, Europe and Japan cooperate to harmonize their procedures, so they are already harmonizing internationally, Malaysia added.

It also said that for other countries this may not be an effective checkpoint; then they have to consider what other checkpoint would be equally effective. It stressed that we have to find a way that is effective; at the national level, but also to cooperate as a community, and to learn what works and what does not.

India said it is also an importer and it has research and development (in genetic resources). It has already identified four possible and feasible checkpoints and said that checkpoints at patent offices are not against innovation, citing its experiences in establishing a prior art database (Traditional Knowledge Digital Library) that was submitted to the EU and US (under memoranda of understanding). It added that in the past it has litigation but now patents are turned down where there is prior art that can be proved with its database.

It said that there is need to look for several checkpoints and patent offices are the most appropriate and should be mandatory for compliance because patents are at the point of the direct transition into commercialization and benefit generation.

India also said that the whole exercise is about benefit-sharing and if patent offices are not included, then we are saying we are not really serious about compliance.

Canada said a list is not needed and that it wanted flexibility and nothing mandatory. Since the paragraph begins with "as appropriate", it asked why a list is needed. It emphasized that we should try to build in flexibility for certain jurisdictions; for example, in the list on the marketing approval of certain products, this would mean that Canada had to amend various laws relating to the regulatory approval of certain products sold in the market and this will be difficult.

Canada, however, is amenable to the idea of checkpoints and this could be discussed in detail in a smaller group. It said perhaps a review mechanism can be included within the Protocol to make it effective.

At this point, Japan repeated that it supports the identification and establishment of checkpoints but not the list of checkpoints.

The EU said that when we are talking about an indicative list, we are talking of levels since the item in Article 13(1)(a) showing the five items are just part of what may be considered as monitoring mechanisms and there are still other ways of doing it as shown by paragraphs (b) to (d).

It said that ultimately what we may need is experience on how it will work, and what we may be able to do is to send some pertinent information back to the provider and this will enable them to make a judgment if activities in the past would show that their rules on access (prior informed consent and mutually agreed terms) are still respected.

The EU further said that India's citation of the practices in the European Patent Office using the Indian Traditional Knowledge Digital Library may not be on point, as they are trying to establish the "novelty" of the inventions whereas in this case (the ABS Protocol) it is about prior informed consent and mutually agreed terms.

Hodges tried to reflect the discussion in the text and proposed the following: "The identification and establishment of checkpoints (which may include)(including) ..."

As it was already way past 11 pm, co-chair Hodges suspended consideration of this item, to be resumed on Friday (15 October). On the remaining speakers' list were Australia, GRULAC, Malaysia, the Africa Group and Switzerland.

Meanwhile, in the afternoon, a small group worked on the review of the issue of "utilization" of genetic resources across the whole draft protocol text. The main issue causing difficulty is the requirement of prior informed consent for access to "derivatives" of genetic resources whereby developed countries say there is no need for such consent and the developing countries saying that this is key to the entire discussion of benefit-sharing. An observer described the proceedings as "completely stuck".

In his report to the ING, the small group co-chair, Ben Phillips of Australia, said that already at the beginning some Parties said there was no more progress to be made. The contentious issue was "access to derivatives"; some Parties view this as impossible to have under the Protocol and "we came to a stalemate".

On the pathogens small group that also met in the afternoon, a drafting group was formed to discuss a collection of suggested text from the delegates, thus going away from the developing-country position that this issue is already taken care of by Article 3bis on the relationship of the Protocol with other specialized international instruments or in Article 3 on scope. +