Nagoya Protocol: Analysis and implementation options for developing countries

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TWN Info Service on Intellectual Property Issues (Apr11/04)
25 April 2011
Third World Network

Dear friends and colleagues,

We are pleased to share with you a new research paper that was issued by South Centre in April 2011, an inter-governmental think tank of developing countries, entitled "Nagoya Protocol on Access and Benefit Sharing of Genetic Resources: Analysis and Implementation Options for Developing Countries". The author is Professor Gurdial Nijar, Director of the Centre of Excellence for Biodiversity Law (FAculty of Lw, University of Malaya, Malaysia) and one of the lead ABS negotiators of developing countries. We reproduce below the Summary and Conclusion, and the full document is available on:

http://www.southcentre.org/index.php?option=com_content&view=article&id=1558%3Athe-nagoya-protocol-on-access-and-benefit-sharing-of-genetic-resources-analysis-and-implementation-options-for-developing-countries&catid=154%3Aintellectual-property-and-biological-diversity&Itemid=364&lang=en

The Nagoya Protocol on ABS was adopted by the 10th meeting of the Conference of Parties (COP10) to the Convention on Biological Diversity in November 2010. The paper concludes as follows:

"As is common knowledge, the Nagoya Protocol was rushed through in the final hours of COP10 in an attempt to secure a binding instrument on ABS. As a result the Protocol represents, at best, a partially negotiated instrument. In the process, transparency, legal certainty and balance seem to have been sacrificed. The silver lining, however, is that the generalised provisions, crafted in an attempt to accommodate seemingly polarised positions, provide considerable flexibility. It is for developing countries to exercise the options open to them as a result, as outlined in this article, through national law as well as through COP/MOP at the crucial implementation stage after the Protocol is ratified. Hopefully, this will finally provide the world with an instrument truly supportive of national ABS laws and policies to end biopiracy and restore fairness and equity in the exchange of genetic resources across the globe. For, ultimately, only on the basis of fair and equitable sharing of benefits can the conservation and sustainable use objectives of the CBD be finally realized."

Thank you.

With best wishes,
Third World Network

Nagoya Protocol on Access and Benefit Sharing of Genetic Resources: Analysis and Implementation Options for Developing Countries.

Research Paper 36, April 2011

A SUMMARY

The various options with regard to some key components may be summarised as follows.

3.1 Scope

Derivatives. The term 'utilisation of genetic resources' provides a clear basis for extending the scope of the Protocol to biochemical components of genetic resources. This includes derivatives that no longer are part of the genetic resource and therefore do not have functional units of heredity. This term also appears in the provisions on access, benefit sharing and compliance. Hence these provisions also extend to derivatives. Importantly, access provisions apply to stand alone biochemical components of genetic resources. Finally, the research and development aspect in the definition of ‘‘utilisation of genetic resources’’ covers the whole chain - from research on the genetic resource and/or the biochemical component right up to their commercialization. This would also include the genetic resource, its modification and the results of any R&D including any information and know-how.

Temporal scope. The inclusion of new and continuing uses of genetic resources and derivatives accessed before the coming into force of the Protocol does not violate the retroactivity principle. This interpretation is consonant with international law. Hence countries may provide for such uses in their national law.

Pathogens. Pathogens, which are a subset of genetic resources, are clearly within the scope of the Protocol, as evidenced by a specific reference in preamble 16, and the benefit sharing provisions apply for any access. A cumulative reading of paragraphs 3 and 4 of Article 4 and Article 8(b) suggests the following conclusions:

a. A country can develop a national law that deals with pathogens as a genetic resource and subject it to the ABS requirements.

b. Countries may also collectively enter into any obligation - including a standard material transfer agreement in international fora such as the WHO -- that reflects the ABS objective of the Protocol. The agreement must therefore include fair and equitable sharing of benefits arising from the utilisation of the viruses, (which should be expeditious if access to the viruses is expeditious), access and the transfer of relevant technologies in relation to developing vaccines for pathogens. The vaccines must be made available to developing countries at affordable prices.

c. Parties to the Protocol in developing their national law or administrative or policy measures are not bound to take into account any ongoing work or practice in the WHO relating to pathogens. They need only to consider taking into account any such work or practices.

3.2 Benefit Sharing

Article 5 of the Protocol provides for benefit sharing arising from the utilization of genetic resources as well as subsequent applications and commercialisation. This is no more than an amplification of ‘‘utilisation’’ as referred to earlier. The sharing must be fair and equitable. Parties are at liberty to determine what constitutes such sharing according to their needs through mutually agreed terms. Countries may stipulate minimum terms that ought to be included to fulfill the fair and equitable criteria in their national ABS law. Some of these terms are indicated in Article 6 paragraph 3(g) of the Protocol. Developing countries could consider drawing up a menu of model clauses for easy reference. This may be particularly helpful where genetic resources are endemic to a region so as to avoid any downward spiralling of such terms.

3.3 Compliance

There is a clear obligation for countries with users in their jurisdiction to establish 'effective, appropriate and proportionate' measures for compliance. Developing countries can, through national law and a COP/MOP decision, establish clear and objective criteria for what constitutes 'effective, appropriate and proportionate' measures. Further national law could provide for the denial of access to users where their countries have not established measures that match the criteria.

The Protocol obliges countries to establish one or more checkpoints to monitor compliance. The choice of the checkpoint is in the discretion of Parties. Developing countries could seek to secure the following decisions at COP/MOP:

a. that the checkpoints be those that are effective for purposes of monitoring compliance;

b. that Parties inform the Secretariat of their designated checkpoints within a prescribed timeline;

c. the COP/MOP will evaluate whether the checkpoints are effective for purposes of monitoring and transparency in relation to the utilization of the genetic resources including derivatives, bearing in mind the criteria specified in paragraph 1(a)(iv) of Article 17;

d. if the check points are considered not to meet the said criteria, the Party will be required to re-designate an appropriate checkpoint;

e. if a Party fails to designate an acceptable checkpoint, it will be deemed to be in non- compliance;

f. countries that already require disclosure requirements at intellectual property rights offices must be obliged to name such offices as a checkpoint;

g. other countries should be required to endeavour to designate such offices as a checkpoint;

h. there must be mandatory disclosure requirements at the checkpoints by the production of the international certificate.

Parties may also prescribe in their national law that access will be denied to users unless and until their countries have designated checkpoint(s) acceptable to COP/MOP. Until such a decision is made by COP/MOP, Parties may deny access to users in countries that have no effective checkpoints.

3.4 Access to Justice

Developing countries should, through decisions of COP/MOP and their national law, elaborate on the content of 'access to justice' in Article 18 of the Protocol. This Article requires user countries to take effective measures to ensure that provider countries have recourse to their legal system to obtain redress when there has been a breach of the mutually agreed terms for the grant of access. The concept 'access to justice' encompasses several facets as the Aarhus Convention instructs. It includes an obligation to provide access to administrative or judicial procedures to challenge breaches of national law as is provided for by Article 18.2 of the Protocol. The concept also envisages giving the right to a wide category of persons to challenge any violation of national law in court or any other independent and impartial body, such as an ombudsman. This would include NGOs and indigenous and local communities. Importantly, the term also obliges a State to ensure that costs in bringing an action are not prohibitively expensive. States must therefore provide an inexpensive and accessible forum.

3.5 Traditional Knowledge

The Protocol advances the CBD provisions on TK. However, these provisions are made subject to national law. It should be clarified that this is to allow countries to reflect the diversity of the ways in which TK is held and treated in different countries. A preamble to the Protocol recognizes 'the unique circumstances where traditional knowledge associated with genetic resources is held in countries'. The qualifier should not be construed to thwart the rights of indigenous and local communities. Further, it should be clarified through COP/MOP decisions and national law, that nothing in the Protocol allows for access to publicly available TK or TK that is diffused and has no identifiable holders (and that is consequently held by the State) without PIC and MAT. Work in other fora - such as WIPO - should not be allowed to undermine this requirement as this would clearly run counter to the objectives of the CBD and the Protocol.

3.6 Technology Transfer

The Protocol subtracts from the provisions of the CBD on technology transfer. It is of crucial importance for COP/MOP to restate that the provisions in the Protocol are built upon the existing obligations in Article 16 of the CBD. This should include, inter alia, a clear obligation by Parties to provide incentives to the private sector within their jurisdiction to promote and encourage access to and transfer of technology to developing countries to help them establish a sound and viable technological and scientific base. This will be operationalising Article 16.4 of the CBD.

CONCLUSION

As is common knowledge, the Nagoya Protocol was rushed through in the final hours of COP10 in an attempt to secure a binding instrument on ABS. As a result the Protocol represents, at best, a partially negotiated instrument. In the process, transparency, legal certainty and balance seem to have been sacrificed. The silver lining, however, is that the generalised provisions, crafted in an attempt to accommodate seemingly polarised positions, provide considerable flexibility. It is for developing countries to exercise the options open to them as a result, as outlined in this article, through national law as well as through COP/MOP at the crucial implementation stage after the Protocol is ratified. Hopefully, this will finally provide the world with an instrument truly supportive of national ABS laws and policies to end biopiracy and restore fairness and equity in the exchange of genetic resources across the globe. For, ultimately, only on the basis of fair and equitable sharing of benefits can the conservation and sustainable use objectives of the CBD be finally realized.

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