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Analysis of India et al.’s proposed TRIPS amendment

So I’ve finally had chance to read through India et al.’s proposed Article 29bis amendment to the TRIPS Agreement in document WT/GC/W/564.

It raises some interesting questions, some of which I see have also been raised by countries participating in the discussions (more on this below.)

To start with, the communication contains some introductory remarks that set the context for the proposed text attached to the document. The sponsors of the communication state, in part:

In order to enable the Members to take appropriate action by this date [31 July 2006, from the Hong Kong Ministerial Declaration], a number of Members have proposed moving towards text-based negotiations on the disclosure of origin requirement. Accordingly, this communication presents a proposal for such a text, taking into account the objectives of the requirement as well as the questions, comments and concerns raised by various Members in the negotiations so far. The proposed text will assist the consultations being undertaken by the Director General.

I like how the sponsors have justified their move to introduce proposed text by stating that it will assist in the consultations. What their remarks do not state is that there are a number of countries - the U.S., in particular - that oppose any move to text-based negotiations as they do not believe amendments to TRIPS are necessary. We will have to see if these countries refuse to engage in text-based negotiations or if they concede the point. I would guess that they are inclined to the former position but the pressure is certainly increasing to move to the latter.

Moving to the proposed text itself, para. 1 reads as follows:

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.

I like this explicit recognition of the CBD in text that would be included in a WTO agreement. This would improve the integration of different instruments of international law - and by ‘integration’ I’m thinking in terms of the sustainable development law principle of integration rather than one agreement being ‘integrated’ into the other. This wording could also increase the ability to raise CBD considerations in any dispute settlement proceedings that may arise.

Throughout the proposed text, the co-sponsors refer to ‘biological resources’. I have a few questions in this regard. First, is there an assumption that ‘biological resources’ in this text will have the same meaning and definition as under the CBD? Using the same definition would be important for consistency, clarity and integrative understanding but the CBD definition is itself notoriously vague and unclear so the question could well remain as to what exactly are the ‘biological resources’ being referred to.

Secondly, is using the term ‘biological resources’ a way to get the derivatives of genetic resources included in the scope of the disclosure requirements? I would guess yes and I’ll return to this point below.

Thirdly, will ‘biological resources’ include human biological resources? Human genetic resources have been excluded from the scope of the CBD (see COP decision II/11). Have human biological resources also been excluded from the scope of the CBD? Is there a desire to exclude them from the scope of this proposed text or do countries want them included given the controversy that also surrounds the patenting of human genes and derivatives?

Para. 5 of the proposed text includes the option of a contravention of the disclosure requirements going to the validity of the patent, specifically, the patent could be revoked “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.” I am not surprised that the co-sponsors have included this option but it is a highly controversial one. If there are text-based negotiations, I think this is a point the co-sponsors will likely have to concede as it is generally not favoured by the developed countries that are actually willing to consider disclosure requirements (namely various European countries.)

I also have some broader questions. How do the discussions on certificates of origin/disclosure/legal provenance relate to this proposed amendment? A technical experts group under the CBD is set to discuss certificates later this year or early next year. Does this proposed amendment foreclose some of their discussions, particularly on the debate over origin vs. provider? The proposed text favours disclosure of provider rather than disclosure of origin.

Also, how does the proposed amendment relate to the FAO IT and its multilateral system of access in particular? The IT was created, in part, to bring earlier FAO texts into conformity with the state sovereignty approach of the CBD. Indeed, Article 1 of the IT states:

1.1 The objectives of this Treaty are the conservation and sustainable use of plant genetic resources for food and agriculture and the fair and equitable sharing of the benefits arising out of their use, in harmony with the Convention on Biological Diversity, for sustainable agriculture and food security.
1.2 These objectives will be attained by closely linking this Treaty to the Food and Agriculture Organization of the United Nations and to the Convention on Biological Diversity.

Is the IT thus somehow incorporated by reference into para. 1 of the proposed TRIPS amendment? Perhaps the co-sponsors might consider amending para. 1 of their text to also make explicit reference to the objectives of the IT. This would help to make the text even more integrative and could help to clarify the relationship among this multiplicity of inter-twined agreements. It may. however, go beyond the mandate from the Hong Kong Ministerial Declaration.

I’m thinking there must also be some issues related to the IP provisions in the IT but I haven’t thought these through yet. It is somewhat ironic, though, that it seems as though the IT is being left out of the discussions when the first meeting of the Governing Body of the Treaty is meeting this week as well.

According to IP-Watch, Brazil and India answered questions about their proposed amendments on June 14th. The Philippines and the EC asked why the term ‘biological resources’ is used instead of ‘genetic resources’. The answer focused on two points. First, that the state sovereignty approach of the CBD is over ‘resources’ and is not limited to ‘genetic resources’. Secondly,

the term biological resources, which is broader, is intended to ensure that all possible cases of biopiracy are covered and to keep pace with technological developments especially with respect to biotechnology. This terminology is similar to the term “biological material” which had been used in earlier submissions and which is, for example, used in the EU Biotechnology Directive[.]

This would seem to support my thinking that using the term ‘biological resources’ is a way to get derivatives of genetic resources included in the scope of the amendment. I have trouble believing that this will be successful.

I also like the question by Chinese Taipei asking whether para. 1 of the proposed article means “that non-CBD members will have to comply with CBD requirements”. The answer states, in part:

The amendment does not bind non-CBD Parties to the provisions of the Convention, as the disclosure obligations are acquired exclusively under and in accordance with the TRIPS Agreement.

I also like how Brazil and India go on to say that TRIPS already transposes provisions from a number of other international IP agreements into its requirements so the proposal here is consistent with that practice.

See the full question and response document here (Microsoft Word document courtesy of IP-Watch.)

Japan and Norway have also tabled proposals on the TRIPS-CBD relationship. I haven’t seen the actually texts but it’s worth pointing out that the Norwegian proposal does not include a violation of disclosure requirements going to the validity of a patent as Norway does not support this position.

One final question. What’s happened to the CBD being granted observer status at TRIPS Council? Why is that not being discussed in this context?

Okay, that was two questions.

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