GENOMICS MONITORIssue No. 9March 2009
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GENOMICS MONITOR - ISSUE 9 - CONTENTSPART I - REGULATORY DEVELOPMENTS 1) Highlights 2) Arms Control 3) Health and Disease Control 4) Environmental Protection 5) Trade 6) Drugs Control - Changes to the Number of States Parties to the Drugs Regulations PART II - INTERACTIONS BETWEEN INDIGENOUS PEOPLES RIGHTS AND INTERNATIONAL REGULATION OF BIOTECHNOLOGY
- Introduction - Definition - Indigenous Peoples Rights - Indigenous Rights with Particular Relevance to the International Regulation of Biotechnology - Implications of these Rights in Relation to Biotechnology - Interaction of these Rights with the International Regulation of Biotechnology - Summary/Conclusions - References PART III - EVENTS AND RECENT PUBLICATIONS |
GENOMICS MONITOR - ISSUE 9Aims of the Monitor
Aims of Issue 9 Issue 9 of the Genomics Monitor provides updated information on the status of the regulations applicable to the control of the biotechnology revolution (summaries of the regulations were provided in Issue 1) and reports on relevant interstate and international organisation meetings and initiatives. In this issue there is also analysis of interactions between indigenous rights and the international regulation of biotechnology. Importance of this Area Current information sources on the international regulation of biotechnology are very limited. Seven years ago a website (www.genomics-gateway.net) was established to bring together, in one central location, information on all the international regulations in this area, with links provided to the official texts. A more thorough study of developments in this area is now provided through the Monitor, to inform all those working in this area of current issues and debates and of the status of the regulations. Its value lies in the range of information it provides on the regulations, its emphasis on the interconnections between the regulations, and highlighting of debates that cut across regulatory areas. It will provide a central authoritative source for anyone interested in this area. Acknowledgements The development and production of the Monitor has been made possible through the support of the Strengthening the Biological Weapons Convention Project based in the Department of Peace Studies, University of Bradford and the Institute for Science, Ethics and Innovation at the University of Manchester. The Institute of Science, Ethics and Innovation aims to examine the ways in which science is used in the 21st Century, to evaluate possible or desirable changes, and to consider the forms of regulation and control of the process that are appropriate or required (www.manchester.ac.uk/isei). Structure of Issue 9 The Issue is divided into three parts: Part I provides information on regulatory developments; Part II covers interactions between indigenous peoples rights and international regulation of biotechnology; and Part III provides information on forthcoming events and recent publications. Figures given on numbers of states parties were accurate on 26th February 2009. |
PART I - REGULATORY DEVELOPMENTS Changes to the numbers of states parties to the regulations are reported in each section (arms control, health and disease control; environmental protection; trade; and drugs control). There are also reports, within the relevant sections, on:
• Biological Weapons Convention – Intersessional Process 2007-2010: Informal Advance Report of the 2008 Meeting of States Parties • 17th/2008 Edition of Terrestrial Animal Health Code • 11th/2008 Edition of the Aquatic Animal Health Code • Codex Alimentarius – Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals • 2008 (amended version) of Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants • International Regime on Access and Benefit-Sharing – Report of the Meeting of the Group of Legal and Technical Experts on Concepts, Terms, Working Definitions and Sectoral Approaches • Workshop on Good Practice in Sanitary and Phytosanitary Related Technical Cooperation • Meeting of the TRIPS (Trade Related Aspects of Intellectual Property Rights Agreement) Council • Optional Supplementary International Search under the Patent Cooperation Treaty • UPOV Council 42nd Session – Report on Decisions • Launch of Capacity-Building Project – Legal and Technical Assistance to Developing Countries on Implementing the International Treaty on Plant Genetic Resources for Food and Agriculture with Particular Reference to the Multilateral System of Access and Benefit-Sharing Links to the texts of the regulations and the associated international organisations can be found in Issue 1 of Genomics Monitor (http://www.brad.ac.uk/acad/sbtwc/gateway/monitor/genomicsmonitorissue1.pdf) or through the summary pages on Genomics Gateway (http://www.genomics-gateway.net). Quick Reference Table of the International Regulations Applicable to the Control of the Biotechnology Revolution
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Biological Weapons Convention – Intersessional Process 2007-2010: Final Report of the 2008 Meeting of Experts The 2008 Meeting of Experts took place from 18th-22nd August in Geneva. It was a one week meeting in preparation for the 2008 Meeting of States Parties, and considered the topics of:
There were participants from 96 states parties, 4 signatory states, and 3 other states, the United Nations Office for Disarmament Affairs, United Nations Institute for Disarmament Research, United Nations Environment Programme, the Security Council’s 1540 Committee, the European Commission, International Council for Genetic Engineering and Biotechnology, International Committee of the Red Cross, Organisation for Economic Cooperation and Development, United Nations Educational, Scientific and Cultural Organisation, World Health Organisation and the World Animal Health Organisation (OIE). Several non-governmental organisations, industry associations, scientific, academic and other groups attended the open sessions. Annex I to the Report contains a table of summaries of Considerations, Lessons, Perspectives, Recommendations, Conclusions and Proposals Drawn from the Presentations, Statements, Working Papers and Interventions on the Topics Under Discussion. The Report can be found at http://daccessdds.un.org/doc/UNDOC/GEN/G08/630/84/PDF/G0863084.pdf?OpenElement.
Biological Weapons Convention – Intersessional Process 2007-2010: Informal Advance Report of the 2008 Meeting of States Parties The 2008 Meeting of States Parties (considering the same topics as the Meeting of Experts – see above) was held 1st-5th December in Geneva. It was attended by 97 states parties, five signatory, and one non-signatory state. Also attending as observers were the United Nations Office of Disarmament Affairs, United Nations Institute of Disarmament Research, the European Commission, International Committee of the Red Cross, Interpol, the World Health Organisation, and the World Animal Health Organisation, plus 17 non-governmental organisations and research institutes. In the Informal Advance Report (available at http://www.unog.ch/80256EDD006B8954/(httpAssets)/C70514F42F7BF072C1257516005B1E7A/$file/BWC+MSP+2008+Advance+Report.pdf) states parties noted the need for: “carefully assessing risks” and “balancing security concerns against the need to avoid hampering the peaceful development of biological science and technology” (pgh.19). Under discussions on the topic of ‘national, regional and international measures to improve biosafety and biosecurity, including laboratory safety and security of pathogens and toxins’, the terms biosafety and biosecurity were given the following definitions within the context of the Convention:
The distinction made in this definition is similar to that made by the World Health Organisation in its Laboratory Biosafety Manual:
The states parties “agreed on the value of:”
Any measures adopted ought to: be “practical, sustainable, enforceable and readily understood”; “avoid unduly restricting the pursuit of biological sciences for peaceful purposes”; be “adapted for local needs” and “appropriate for the agents being handled and the work being undertaken” (pgh.21.v). Some of these points were expanded on. For example in relation to international cooperation:
And in relation to capacity-building:
Under the second topic - oversight, education, awareness raising and adoption and/or development of codes of conduct with the aim of preventing misuse – in relation to oversight some similar points were made on the value of national frameworks of oversight measures, and on the need for such measures to be proportionate, practical and “not unduly restrict permitted biological activities” (pgh.25). Further, States Parties “agreed on the importance of involving national stakeholders in all stages of the design and implementation of oversight frameworks” and “noted the value of harmonizing…national, regional and international oversight mechanisms” (pgh.25). In relation to awareness raising:
They also noted that formal educational requirements (possible mandatory) “could assist raising awareness” (pgh.26). It was felt that education/awareness programmes could usefully:
In relation to codes of conduct, it was seen that they could complement other (e.g. regulatory) frameworks “and help guide science so that it is not misused” and that national stakeholders should be encouraged to “voluntarily develop, adopt and promulgate codes of conduct” (pgh.28). States Parties have been “encouraged to inform the Seventh Review Conference of, inter alia, any actions, measures or other steps that they may have taken on the basis of discussions at the 2008 Meeting of Experts and the outcome of the 2008 Meeting of the States Parties” (pgh.31). An Annex to the Report – Synthesis of Considerations, Lessons, Perspectives, Recommendations, Conclusions and Proposals Drawn from the Presentations, Statements, Working Papers and Interventions on the Topics Under Discussion at the Meeting of Experts – contains some additional suggestions, including that: biosafety and biosecurity measures should “address resources relevant to humans, animals and plants” (pgh.2.iv); and that States Parties should “Ensure that adequate preparedness and response capacity exists in case of failures” (pgh.3.vii), adopt measures to protect whistleblowers (pgh.9.vi), and “Regularly review scientific and technological developments relevant to the Convention and consider creating an international science advisory panel to independently analyze such developments.” (pgh.9.viii). The 2009 Meeting of Experts is scheduled for 24th-28th August, and the 2009 Meeting of States Parties is scheduled for 7th-11th December. These meetings will consider point (v) of the 2007-2010 Intersessional Process – With a view to enhancing international cooperation, assistance and exchange in biological sciences and technology for peaceful purposes, promoting capacity building in the fields of disease surveillance, detection, diagnosis, and containment of infectious diseases: (1) for States Parties in need of assistance, identifying requirements and requests for capacity enhancement; and (2) from States Parties in a position to do so, and international organizations, opportunities for providing assistance related to these fields. CHANGES TO THE NUMBER OF STATES PARTIES TO THE ARMS CONTROL REGULATIONS There are now 163 states parties to the Biological Weapons Convention and 186 states parties to the Chemical Weapons Convention. |
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17th/2008 Edition of Terrestrial Animal Health Code The 2008 version of the Terrestrial Animal Health Code (TAHC) contains amendments, revisions and new information as agreed by OIE (World Organisation for Animal Health) member states in May 2008. It is split into two volumes, the first containing more general guidance, the second containing disease-specific recommendations. The Foreword to the TAHC states that the changes include:
The appendices do not appear in the TAHC’s table of contents, and these topics appear instead to have been incorporated into chapters of the Code. For example ‘Design and implementation of identification systems to achieve animal traceability’ forms Chapter 4.2, and ‘Somatic cell nuclear transfer in production of livestock and horses’ is Chapter 4.12. This chapter provides “a starting point for identifying, characterising and providing a basis for discussion on the animal health risks associated with SCNT cloning technology” (4.12.1). Its initial focus is on “the scientific basis for the risk assessment aspects, prevention measures and guidance”, which currently include:
It specifically notes that the chapter does not address the following issues, which “may be addressed at a later stage by the OIE” or “may be addressed by other bodies or instruments”:
The rest of the chapter outlines general principles for risk analysis, and then specific guidance on managing animal health risks associated with embryos and animal health risks related to the recipients.
11th/2008 Edition of the Aquatic Animal Health Code The 11th Edition of the Aquatic Animal Health Code (AAHC) incorporates changes agreed by the OIE member states in May 2008. “These include new and revised chapters on the following subjects: definitions, diseases listed by the OIE, obligations and ethics in international trade, import risk analysis, recommendations for safe transport of aquatic animals and aquatic animal products” as well as to some of the disease specific chapters, and also “three new appendices on welfare of farmed fish, control of aquatic animal health hazards in aquatic animal feed and aquatic animal health surveillance” (http://www.oie.int/eng/normes/fcode/en_preface.htm#sous-chapitre-0).
International Plant Protection Convention – Draft Report of the Open-Ended Working Group on Building National Phytosanitary Capacity At the December 2008 meeting of the Open-Ended Working Group on Building National Phytosanitary Capacity, several discussion papers were presented and their main points are summarised in the Report. The meeting produced a draft concept paper, draft strategy document and an indicative operational plan (reproduced in Annexes 4, 5, and 6 of the Report respectively), and agreed a definition of ‘phytosanitary capacity’ – “The ability of individuals, organizations and systems of a country to perform functions effectively and sustainably in order to protect plants and plant products from pests and to facilitate trade, in accordance with the IPPC.” (pgh.101). The Concept Paper (Annex 4) further expands on the definition. For example it explains that:
The Draft Strategy (Annex 5) contains six strategic areas which it was felt the IPPC should work on. Some of these areas have two parts:
The Annex contains a table which for each strategic area lists activities and how they should be undertaken. There is also a column labelled ‘who’, but at present this is blank. The Indicative Operational Plan (Annex 6) contains a table linked to the six strategic areas, providing information for each area on ‘activity’, ‘who’, ‘timeframe’, ‘resources’, and ‘assumptions’. The assumptions column is blank.
Codex Alimentarius – Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals This new Codex Guideline supplements the Guidelines for Foods Produced Using Recombinant-DNA Microorganisms and Foods Derived from Recombinant-DNA Plant, and it uses the risk analysis base of the Codex Principles for the Risk Analysis of Foods Derived from Modern Biotechnology. Summaries of these three documents can be found on pages 20-22 of Genomics Monitor Issue 1 (www.brad.ac.uk/acad/sbtwc/gateway/monitor/genomicsmonitorissue1.pdf). The Guideline specifically states that, although they might be connected issues, it does not address animal welfare; ethical, moral and socioeconomic aspects; environmental risks; the safety of recombinant-DNA animals used as feed; or the safety of animals fed with feed derived from recombinant-DNA animals, plants and microorganisms (pgh.2). The approach to food safety assessment recommended in the Guideline assesses the new animal (line) relative to a “conventional counterpart having a history of safe use”, covering “intended and unintended effects” in order to “identify new or altered hazards relative to the conventional counterpart” (pgh.4). The assessment is to include consideration of:
The Guideline uses the following definition of a recombinant-DNA animal:
A particular requirement of the food safety assessment is that it pick up any “unexpected, adverse effect on human health” (pgh.15). The Guideline sets up a “stepwise process” including:
The overall aim of conducting the food safety assessment “is to provide assurance, in the light of the best available scientific knowledge, that the food does not cause harm when prepared, used and/or eaten according to its intended use.” (pgh.22) It will include, in regard to expressed substances, assessment of potential toxicity, bioactivity, or allergenicity (pp.7-8). It should also include consideration of “potential altered accumulation or distribution of substances or microorganisms significant to human health” and the appropriateness of using antibiotic resistance marker genes (p.9). In particular it advises that “The transfer of genes from commonly allergenic foods should be avoided unless it is documented that the transferred gene does not code for an allergen.” (pgh.53) and that “Antibiotic resistance genes used in food production that encode resistance to clinically used antibiotics should not be present in foods.” (pgh.67). There is also an annex on Assessment of Possible Allergenicity. It is recommended that food safety assessments “be reviewed in the light of new scientific information that calls into question the conclusions of the original safety assessment”.
2008 (amended version) of Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants Two main amendments have been adopted to the Recombinant-DNA Plant Guideline: a new annex (Annex 3) on Food Safety Assessment in Situations of Low-Level Presence of Recombinant-DNA Plant Material in Food; and a new annex (Annex 2) on Food Safety Assessment of Foods Derived from Recombinant-DNA Plants Modified for Nutritional or Health Benefits. Annex 3 applies to situations where recombinant-DNA plant material which has passed a Codex food safety assessment in one country is present in low-levels in food imported to other countries which have not yet completed the food safety assessment. This can occur because of different rates of authorisation, and is likely to occur in two main ways. The first may occur during the processing stages for grains, beans and oil seeds, and in these cases the recombinant-DNA material “would be present only at a low level in any individual serving of food.” (pgh.4). The second relates to fruit and vegetables, and in these cases “exposure would be rare but could be to an undiluted form of the unauthorized recombinant-DNA plant material.” (pgh.4). In either case the exposure level is lower than that which would be assessed in the Codex food safety assessment and therefore “only certain elements of the Codex Plant Guideline will be relevant” and these are indicated in the annex (pgh.5). Where provisions have been amended for the purposes of the annex these are reproduced in full, otherwise the relevant paragraphs in the main text are listed. The annex specifically does not: address risk management; “preclude national authorities” from undertaking the full food safety assessment; or affect obligations to meet import requirements (pgh.6). Nor does it apply where the importing country has already conducted the food safety assessment and decided against authorisation (footnote 24). Annex 2 details additional considerations that need to be taken into account in safety assessment of foods modified for nutritional or health benefits. It specifically does not extend into assessment of the benefits. Provisions of both the Plant Guideline and the Codex General Principles for the Addition of Essential Nutrients to Foods are also generally applicable to these foods. A recombinant-DNA plant modified for nutritional or health benefits is defined as one which:
A nutrient is defined as:
CHANGES TO THE NUMBER OF STATES PARTIES TO THE HEALTH AND DISEASE CONTROL REGULATIONS There are now 170 states parties to the International Plant Protection Convention. The Codex Alimentarius Commission now has 179 member states plus the European Community. |
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International Regime on Access and Benefit-Sharing – Report of the Meeting of the Group of Legal and Technical Experts on Concepts, Terms, Working Definitions and Sectoral Approaches This Working Group was established by Decision IX/12 of the 9th Conference of the Parties to the Convention on Biodiversity, which instructed it to:
Its meeting, held in December 2008, was attended by 21 experts nominated by member states and the European Community, and 13 expert observers from organisations, including from the Commission on Genetic Resources for Food and Agriculture and the secretariat of the International Treaty on Plant Genetic Resources. An annex to the Report – Outcome of the Meeting of the Group of Legal and Technical Experts on Concepts, Terms, Working Definitions and Sectoral Approaches – provides details on the discussions that took place (https://www.cbd.int/doc/meetings/abs/absgtle-01/official/absgtle-01-abswg-07-02-en.pdf). Under point a. the experts discussed biological resources, genetic resources, derivatives and products in turn. In most cases finding that further clarification is needed on these terms. A non-exhaustive list was established of activities in which genetic resources are used, their use in such cases indicating actual or potential value. (Genetic resources are defined in the Convention as “genetic material of actual or potential value”.) These activities were listed under the broad headings of:
In relation to biological resources, the Group recognised “that biological resources used as commodities are subject to a separate set of international norms and rules and there was general agreement that commodities should be outside the scope of the international regime for purposes of prior informed consent” while acknowledging that “the scope of the regime was outside the mandate of the group.” (pgh.10.) The terms biological resources and genetic resources are both defined in the Convention. The terms derivatives and products are not. A list of 11 ways of understanding the term derivatives was elaborated by the Group. They agreed that these could generally be grouped into:
The scope of the regime in relation to naturally occurring derivatives that can be accessed “without also accessing the genetic resource at the same time” was questioned (pgh.21). The Group noted that “all products are derivatives but not all derivatives are products” and provided a set of potential indicators that allow judgement of when a derivative is a product, which include: “(i) commercialization and availability on the open market/for sale to the public; (ii) seeking marketing or other approvals such as product registration; (iii) submission of applications for intellectual property protection; and (iv) the identification of a specific use for a derivative.” (pgh.23). For discussion of points b. and c. the experts divided into four groups looking at:
The sub-groups each considered the topics of:
The sub-groups reported back to the main group and these reports are summarised later in the annex. This includes: paragraph 43 summarising genetic resources for each sector and how they are used; paragraph 44 containing listings of benefit-sharing mechanisms by sector; and paragraph 45 containing listings of specific characteristics of each sector. After the subgroups had reported the experts discussed “differences between sectoral ABS approaches” based on the subgroup characterisations (in paragraphs 46-55). In particular, it was noted that “the agricultural sector is unique due to a number of factors, including the following:
General differences identified between sectors included:
Overall “The experts therefore considered that a ‘one size fits all’ approach would not be suitable under the international regime” (pgh.53). Under point d. the experts looked at options and approaches and particularly the issue of bringing coherence to the regime, noting that this could have some negative as well as positive aspects, for example possible loss of flexibility. It was also felt that: “The international regime could provide for minimal access and benefit-sharing requirements that apply across sectors if no specific system is in place.” (pgh.57.g.) Examples are listed in the annex of national and international voluntary codes of conduct and best practice that the subgroups highlighted (pgh.59).
CHANGES TO THE NUMBER OF STATES PARTIES TO THE ENVIRONMENTAL PROTECTION REGULATIONS There are now 153 states parties to the Cartagena Protocol on Biosafety. |
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Workshop on Good Practice in Sanitary and Phytosanitary Related Technical Cooperation This workshop was held in Geneva in October 2008 with the cooperation of the Standards and Trade Development Facility and the Organisation for Economic Cooperation and Development. Its aims were:
The work of the meeting and the report it produced were based on surveys and interviews on good practice undertaken by STDF and OECD. The meeting’s report (Summary Report of the Good Practice Workshop, http://docsonline.wto.org/DDFDocuments/t/G/SPS/R52.doc) gave suggestions for follow up work to focus on:
The research findings highlighted the following areas of good practice for SPS-related technical assistance:
But also noted that there are continuing problems, including “fragmented, supply-driven assistance, insufficient attention to ownership or absorptive capacity, a cursory approach to assessing and prioritizing needs, inadequate coordination, limited focus on and involvement of the private sector, not enough focus on developing local capacity to build capacity, and limited complementary investments in infrastructure.” (pgh.17) along with poor integration “into broader development assistance” (pgh.25).
Meeting of the TRIPS (Trade Related Aspects of Intellectual Property Rights Agreement) Council The TRIPS Council meeting, held in October 2008, discussed a range of topics including: biodiversity, pharmaceutical patents, technology transfer, technical assistance, and intellectual property and public health. In relation to ongoing negotiations on TRIPS and the Convention on Biodiversity (TRIPS/CBD) it was noted that some member states want to link these negotiations (particularly the disclosure aspect) with negotiations on the issue of extending the multilateral register for geographical indications for wines and spirits to other geographical indications (http://www.wto.org/english/news_e/news08_e/trips_28oct08_e.htm). There was disagreement both on whether the issues should be linked in negotiations, and on whether the negotiations with TRIPS Council have reached an appropriate stage to be included in the Doha Round Negotiations. The Secretariat of the Convention on Biodiversity continues to be refused observer status in the TRIPS Council due to member state disagreement on this matter (http://www.wto.org/english/news_e/news08_e/trips_28oct08_e.htm). In regard to the issue of TRIPS and public health, implementation of the 2003 Decision on TRIPS and Public Health was reviewed. It was noted that the amendment to the TRIPS Agreement that makes the 2003 Decision permanent, had only been accepted by a limited number of member states “leaving just over a year for the number of accepting members to reach the required two thirds” (http://www.wto.org/english/news_e/news08_e/trips_28oct08_e.htm). The amendment will not come into force until two thirds of members have accepted it. Forty-five member states have accepted the amendment and “Switzerland and the EU said their legislation is in place, so eligible importing countries can seek supplies under the new rules from them as well.” (http://www.wto.org/english/news_e/news08_e/trips_28oct08_e.htm). The amendment allows exporting member states to manufacture patented pharmaceutical products under compulsory licence at the request of an eligible importing member state (generally a least-developed country) that requires the products for public health reasons, but lacks the capacity to undertake production domestically. The text of the amendment is available at http://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm. In discussions on technical cooperation and technology transfer, member states “stressed that providing incentives is not enough to ensure technology transfer. The receiving countries’ investment and intellectual property framework and their ability to absorb the technology is also important” (http://www.wto.org/english/news_e/news08_e/trips_28oct08_e.htm). There was disagreement about whether consideration of technical cooperation with the TRIPS Council should “take into account the cluster of 14 proposals on the subject of World Intellectual Property Organisation’s Committee on Development and Intellectual Property” or whether these should only be applied to WIPO activities (http://www.wto.org/english/news_e/news08_e/trips_28oct08_e.htm).
Optional Supplementary International Search under the Patent Cooperation Treaty As of the 1st January 2009 there is an optional supplementary international search service available to applicants using the Patent Cooperation Treaty (PCT) system. It is offered due to the possibility that because some international search authorities may lack skill in some languages, not all prior art might be identified in the main international search. The WIPO explains that “it is not expected that SIS [supplementary international search] will be requested routinely, but rather as a strategic decision by the applicant, taken after consideration of the results of the main international search.” (http://www.wipo.int/pct/en/newslett/2008/12/article_0002.html). SIS is currently offered by three international search authorities details of which are provided in a table in the article referenced above and in an annex to the PCT Applicant’s Guide (http://www.wipo.int/guide/en/gdvol1/annexes/annexsisa/ax_sisa_ru.pdf). There is also a powerpoint presentation available at http://www.wipo.int/pct/en/texts/ppt/sis.ppt. However, requests for SIS should be made to the International Bureau not to directly to the international search authorities.
UPOV Council 42nd Session – Report on Decisions This report is available at http://www.upov.int/export/sites/upov/en/documents/c/42/c_42_20.pdf. Inter alia, the meeting noted a decision of the 76th Session of the UPOV Consultative Committee, that:
Launch of Capacity-Building Project – Legal and Technical Assistance to Developing Countries on Implementing the International Treaty on Plant Genetic Resources for Food and Agriculture with Particular Reference to the Multilateral System of Access and Benefit-Sharing This project, launched in November 2008, is to designed to help countries to “develop improved national laws and regulations as well as administrative and information technology arrangements for the operation of the Multilateral System” and to “improve knowledge among national stakeholders of issues underlying the implementation of the Treaty and… Multilateral System.” (ftp://ftp.fao.org/ag/agp/planttreaty/noti/NCP_GB3_JIPI_e.pdf). It will do this through provision of technical assistance. CHANGES TO THE NUMBER OF STATES PARTIES TO THE TRADE REGULATIONS The Patent Law Treaty now has 19 states parties, the Budapest Treaty on the Deposit of Microorganisms for the Purpose of Patent Procedure now has 72 states parties, the Convention for the Protection of New Varieties of Plants now has 67 states parties, and the International Treaty on Plant Genetic Resources now has 119 states parties.
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CHANGES TO THE NUMBER OF STATES PARTIES TO THE DRUGS CONTROL CONVENTIONS The World Anti-Doping Code now has 634 sporting organisation members and the International Convention Against Doping in Sport has 108 states parties.
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PART II - INTERACTIONS BETWEEN INDIGENOUS PEOPLES RIGHTS AND INTERNATIONAL REGULATION OF BIOTECHNOLOGY |
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Introduction This section of the Genomics Monitor considers interactions between indigenous peoples’ rights and the international regulation of biotechnology. Indigenous rights have received increasing recognition by the international community over the past two decades, this has included, in 2007, the adoption of a Declaration on the Rights of Indigenous Peoples. Some of the rights that have been recognised have direct relevance to two particular areas of biotechnology regulation: rules on genetic resources and rules on intellectual property rights. The relevant principles are outlined here, followed by discussion of how indigenous issues are being taken up in the development / interpretation of the biotechnology regulations. In some cases, international rules are broadly compatible with the protection of indigenous rights, in other cases some adaptation or agreement on interpretation and implementation in the context of these rights will be necessary (and may already be underway). However, many long-standing international laws and declarations protect the rights of states (e.g. sovereign rights) and the rights of individuals (particularly, human rights) and points of conflict between these rights and the collective rights assigned to indigenous groups can be anticipated. To illustrate the UN Development Group Guidelines on Indigenous Peoples’ Issues (2008) state that “the implementation of collective human rights should not adversely affect the implementation of individual rights” – this means that there may be a conflict between the indigenous right to own and control genetic resources and traditional knowledge and the individual right, as stated in Article 27.2 of the Universal Declaration on Human Rights (UNGA, 1948): “to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.” Definition There is no internationally agreed definition of ‘indigenous peoples’, however Article 1 of the Indigenous and Tribal Peoples Convention describes them as, inter alia:
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Indigenous Peoples Rights It is the view of several UN bodies including the General Assembly, Human Rights Council and International Labour Organisation, that – due to indigenous peoples’ historical experiences of oppression and exploitation, and current situations of marginalisation and inequity – their survival, development and flourishing require that their collective rights be recognised and protected. For this reason several separate international declarations/conventions have been created on indigenous peoples’ rights. In its Guidelines on Indigenous Peoples’ Issues, the UN Development Group provides examples of the above arguments:
Two key international sources elaborating indigenous rights are the International Labour Organisation’s Indigenous and Tribal Peoples Convention (ITPC) of 1989 and the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP) of 2007. The ITPC is legally-binding on contracting states, however it has, so far, only 19 contracting states. UNDRIP is an aspirational declaration. The international documents indicate that two main types of rights are assigned to indigenous peoples: - Individual rights – indigenous peoples have the same human rights as everyone else:
- Collective rights – additionally, indigenous peoples have been assigned several collective rights, including rights over land, resources, knowledge, institutions, and of self-determination:
Alongside the ITPC and UNDRIP there are several other international declarations and conventions of relevance to indigenous peoples rights as well as various mechanisms that promote inclusion of indigenous issues in relevant international organisations. These include:
And the:
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Indigenous Rights with Particular Relevance to the International Regulation of Biotechnology Most relevant to the relationship between indigenous rights and the international regulation of biotechnology are collective rights granted over (natural) resources and traditional knowledge. For example the following statements are made in UNDRIP:
And the following clause appears in the ITPC:
Implications of these Rights in Relation to Biotechnology Biotechnology makes use of living organisms, biological materials and other genetic resources. Many of the areas in which indigenous groups are located/over which they have been granted rights, are centres of genetic diversity. The natural biological resources (and associated knowledge) in these areas are frequently of interest to, in particular, the pharmaceutical and agricultural industries and research institutions, for use in the development of biotechnology-based medicines and plants. The stated indigenous rights can be expected to influence access to and use of these resources in biotechnology industries and institutions (both public and private), because they place the resources under the control of the indigenous groups. Among other things, the rights require: free, prior and informed consent; fair, just and equitable compensation or benefit-sharing; and continued control over/participation in the development and use of products based on the resources and/or knowledge.
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Interaction of these Rights with the International Regulation of Biotechnology There are two main, strongly interconnected, areas of international biotechnology regulation that interact with these rights:
Genetic Resources and Traditional Knowledge The Convention on Biodiversity – Article 8(j) and the International Regime on Access and Benefit-Sharing One of the three main objectives of the Convention on Biodiversity (CBD) is:
The CBD does not apply to all genetic resources, traditional knowledge, innovations and practices – its scope is limited to those which can be considered relevant to the conservation and sustainable use of biodiversity. The CBD does not define ‘indigenous and local communities’ or ‘traditional knowledge, innovations and practices’. The CBD Secretariat does, however, describe traditional knowledge on its website as:
Article 15 of the CBD covers the topic of access to genetic resources. It first states that: “Recognizing the sovereign rights of states over their natural resources, the authority to determine access to genetic resources rests with national governments and is subject to national legislation.” (.1, CBD, 1992) This appears to conflict with, and therefore might need to be limited by, the rights of indigenous peoples to “maintain, control, protect and develop their… genetic resources” (Article 30.1 of UNDRIP, UNGA, 2007). The access is to be on mutually agreed terms and subject to prior informed consent – but prior informed consent specifically of the Contracting Party i.e. the state. It is also the state, and not sub-state or transboundary groups, that is to participate in scientific research on the genetic resource and in fair and equitable benefit-sharing. Article 8(j) of the CBD (1992) covers traditional knowledge, innovations and practices, it reads:
To assist in the implementation of Article 8(j) the CBD’s Conference of the Parties (COP) established a working group, in which “indigenous and local communities play a full role” (CBD Sec., 2007). This group is known as the Ad Hoc Working Group on Article 8(j). The Secretariat, in relation to its support of the Working Group, collaborates with the UN Permanent Forum on Indigenous Issues, Food and Agriculture Organisation, World Intellectual Property Organisation, World Trade Organisation, and UN Conference on Trade and Development, on relevant issues (CBD Sec., 2007). The Group’s current work includes:
The work of the Group can be followed on the CBD website at http://www.cbd.int/convention/wg8j.shtml. It closely follows and exchanges information with the work of the CBD’s Working Group on Access and Benefit-Sharing. The Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing was established in 2000. It developed the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization (approved by the Conference of the Parties in 2002). Since 2004 the group has been developing an international regime for access and benefit-sharing. This work is ongoing and details can be found at http://www.cbd.int/abs/regime.shtml. The Bonn Guidelines (CBD Sec., 2002) make several references to indigenous and local communities in relation to genetic resources and traditional knowledge. Its objectives include:
Countries involved in granted access to or receiving genetic resources, users and providers, are requested, inter alia, to:
It is not explicitly stated in the Guidelines who is entitled to supply genetic resources/traditional knowledge, but the authority to agree access and make benefit-sharing arrangements remains with the Contracting Parties (states). The Guidelines provide principles for systems of prior informed consent, which:
The Guidelines do not assign rights directly to indigenous and local communities – it is still the state that has authority to make decisions, give consent, etc. Consultation is required, and consent suggested, but control is not given to the indigenous and local communities. Point c) above seems to indicate that once indigenous rights are incorporated into national law, those rights might count as ‘legal grounds’ for restrictions on access. The Working Group on Access and Benefit-Sharing is expected to finish elaborating and negotiating an international regime in time for the CBD’s 10th Conference of the Parties in 2010. An Annex to the Report of the Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing on the Work of its 6th Meeting (January 2008) contains a draft of the International Regime, setting out options for its objectives, scope, main components, and nature. This Report is available at: http://www.cbd.int/doc/meetings/cop/cop-09/offical/cop-09-06-en.doc. It is not yet clear whether the regime will include a legally-binding instrument or how indigenous rights over genetic resources and traditional knowledge will be framed. States are, however, unlikely to agree to additional legal limitations on sovereign rights over their natural resources. Relevant Work of the Food and Agriculture Organisation and the Commission for Genetic Resources in Food and Agriculture The Food and Agriculture Organisation (FAO) aims to achieve ‘food security for all’ and maintenance and development of diverse plant genetic resources are essential for food security. The FAO has worked on issues relating to plant genetic resources since the 1950s (its history in this area is briefly outlined in pages 44-46 of Genomics Monitor Issue 8). In 2001 the FAO adopted the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR). The Treaty’s scope is limited to “plant genetic resources for food and agriculture”, which it defines as “any genetic material of actual or potential value for food and agriculture” (Articles 3 & 2, FAO, 2001). Indigenous and local communities are mentioned in Article 9 of the Treaty:
However, the rights recognised are those, specifically, of farmers. Farmers rights’ are listed as including:
The article further states that farmers have rights “to save, use, exchange and sell farmed-saved seed/propagating material” (Article 9.3 of ITPGR, FAO, 2001). The responsibility for ensuring farmers’ rights is assigned to national governments. ITPGR thus legally obliges states to ensure farmers’ rights over plant genetic resources for food and agriculture are recognised and protected. This is not extended to indigenous and local communities’ rights, nor does the CBD provide any legal requirement of this kind. It may, however, form part of the International Regime for Access and Benefit-Sharing. While states sovereign rights over their plant genetic resources are recognised by ITPGR, contracting states agree that they will exercise these rights through the Treaty’s Multilateral System of Access and Benefit-Sharing (for more information see http://www.planttreaty.org/mls_en.htm). Benefits from resources accessed through the Multilateral System are specifically to “flow primarily… to farmers” (Article 13.3 of ITPGR, FAO, 2001). Much of FAO’s work on genetic resources is undertaken by the Commission on Genetic Resources for Food and Agriculture (CGRFA – http://www.fao.org/ag/cgrfa). As well as plant genetic resources, FAO and CGRFA are also working on animal genetic resources and FAO member states adopted the Interlaken Declaration on Animal Genetic Resources and a Global Plan of Action for Animal Genetic Resources in September 2007 (see ftp://ftp.fao.org/docrep/fao/010/a1404e/a1404e00.pdf and pages 27 - 30 of Genomics Monitor Issue 5). The Interlaken Declaration (which is not legally-binding) recognises:
Outlines commitment to:
And, affirms:
Among the main aims of the Global Plan of Action are:
If the FAO were to move to develop an international treaty on animal genetic resources, it is likely that it would take a similar form to the ITPGR and protect farmers’ and animal breeders’ rights rather than, specifically indigenous rights. Intellectual Property Rights Indigenous (and other) groups have raised concerns about intellectual property rights (IPRs), particularly patents, being claimed by biotechnology research institutions and industries on natural (particularly genetic) resources and associated traditional knowledge that belong to their group, often without notification, informed consent, recognition, or benefit-sharing. Part of this concern is based on notions of sacredness, interconnection of all living things, traditional forms/concepts of ownership (particularly collective ownership), and fears – based on past experiences – of exploitation. Patent rights granted to inventors allow them to:
Patents are granted to inventors on the basis of a product or process being: new/novel; involving an inventive step/non-obvious; and capable of industrial application (see pgh 27.1 and note 5 of the TRIPS Agreement). Not all national patent systems allow patenting of genetic material, but some internationally significant ones do – notably that of the US. The interpretation of the international agreement that sets minimum IPR standards (TRIPS) on this point is still being discussed by states. In addition to concerns that their resources should not be owned / used by others without their consent, indigenous groups have expressed concerns that such ownership could exclude them from exploiting the resource or accessing resulting products and research. Many current intellectual property systems have little capacity to recognise contributions or check on traditional knowledge in prior art searches, for example. Work in the World Trade Organisation under the Doha Development Agenda: A key international agreement relating to intellectual property rights is the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS) of the World Trade Organisation (WTO). Issues relating to traditional knowledge and traditional cultural expressions have been raised within the WTO. In particular, the 2001 Doha Ministerial Declaration instructed the TRIPS Council (the WTO body which administers the Agreement) to “examine, inter alia, the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore” (pgh 19, WTO, 2001). Discussions in the TRIPS Council have so far focused predominantly on traditional knowledge. There remain significant divisions between member states on: whether there is a need for international action on traditional knowledge; whether it should be dealt with by the WTO; at what point the WTO ought to get involved in the international action on traditional knowledge; and what form any action by WTO should take. In the document The Protection of Traditional Knowledge and Folklore – Summary of Issues Raised and Points Made, the TRIPS Council lists the arguments made by its members for and against international action on protection of traditional knowledge. These include:
Which need to be addressed internationally because:
The counterarguments include:
Another key point of contention has been whether WTO is a suitable forum – particularly at the current stage – for debates on these issues. Some states believe that the TRIPS Council should be addressing the area now (in a way supportive of other fora) and other states argue that the Council should wait until work in the other fora, particularly that within the World Intellectual Property Organisation (WIPO) “has sufficiently clarified conceptual issues and possible options” (pgh.13, WTO/TRIPS Council, 2006). WIPO is argued to have “more expertise and capacity” and experience in the area (pgh.13, WTO/TRIPS Council, 2006). Additionally, some states argue that traditional knowledge ought not be discussed in the WTO at all as it “does not involve trade” (pgh.13, WTO/TRIPS Council, 2006). This is a weak argument since the concerns about protection of traditional knowledge relate to its use in products and processes that are likely to be traded internationally. The document also notes that there are particular concerns and suggested responses in relation to the difficulty of traditional knowledge being found in prior art searches. This relates to both the way in which prior art is defined, and the lack of documentation available to patent examiners on traditional knowledge (pgh.20, WTO/TRIPS Council, 2006). Suggested responses (though this is not yet accepted by all member states as a problem) include: “development of databases” of traditional knowledge that could be searched during patent examinations (pgh.25, WTO/TRIPS Council, 2006); and use of disclosure of traditional knowledge in applications which would raise awareness among both holders and examiners of potential problems (pgh.27, WTO/TRIPS Council, 2006). Disclosure has also been suggested as part of measures to ensure consent and benefit-sharing with a possible requirement for applicants not only to indicate origin of traditional knowledge, but also that “they have obtained any necessary prior informed consent” and “entered into appropriate benefit-sharing arrangements” (pgh.28, WTO/TRIPS Council, 2006). Arguably, there is some scope within the TRIPS Agreement for states to provide national requirements relating to genetic resources and traditional knowledge within their IP systems:
The WTO still appears to be some way from reaching consensus on whether and how to approach issues of intellectual property and traditional knowledge. It is unlikely, in the short-term, that there will be any adaptation of the legal texts on which the international intellectual property system is based in response to indigenous rights. This is not to say that these rights are/will not be recognised within or alongside current intellectual property systems – international awareness of the issues has increased substantially over the past decade, and several international fora are actively debating and/or working on related issues, often collaboratively. Work of the World Intellectual Property Organisation and its Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore: The relationship between intellectual property and genetic resources and traditional knowledge has been raised within the World Intellectual Property Organisation which is responsible for administering several international intellectual property agreements, including the Patent Cooperation Treaty. WIPO established an Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) in 2000 to serve as “an international forum for debate and dialogue concerning the interplay between intellectual property (IP), and traditional knowledge (TK), genetic resources, and traditional cultural expressions (TCEs)/(folklore)” (WIPO, no date given 3). Details of its work can be found through http://www.wipo.int/tk/en/igc. The IGC’s work on genetic resources and intellectual property has covered three main areas:
In this area, WIPO has created “improved search tools and classification systems for patent examiners when they examine patent applications which claim genetic resources” (WIPO, no date given 2);
As part of which, it is creating “an online, searchable database of biodiversity-related Access and Benefit-Sharing Agreements, with a particular emphasis on the intellectual property aspects” (WIPO, no date given 2) (This database can be found at http://www.wipo.int/tk/en/databases/contracts/index.html.); and
This includes a Technical Study on Disclosure Requirements in Patent Systems Related to Genetic Resources and Traditional Knowledge (http://www.wipo.int/export/sites/www/tk/en/publications/technical_study.pdf) and Examination of Issues Relating to the Interrelation of Access to Genetic Resources and Disclosure Requirements in Intellectual Property Rights Applications (http://www.wipo.int/edocs/mdocs/tk/en/wipo_ip_gr_05/wipo_ip_gr_05_01.pdf). (Both these documents were developed in response to requests for information from the Convention on Biodiversity’s Conference of the Parties). The IGC has also drafted Revised Draft Provisions for the Protection of Traditional Knowledge and Revised Draft Provisions for the Protection of Traditional Cultural Expressions (both are available at http://www.wipo.int/tk/en/consultations/draft_provisions/draft_provisions.html). Neither document has legal force. WIPO’s disclaimer states:
For TK the relevant principles include:
It then mentions that “legal means should be provided to prevent”:
Article 2 of the substantive provisions suggests the types of legal protection which may be used including specific traditional knowledge laws, intellectual property laws, contract law, civil liability law, indigenous rights’ laws, environmental laws, etc. and notes that, while such may be made available, it is not necessarily the use of exclusive property rights that need be involved. Article 6 covers fair and equitable benefit-sharing and Article 7 prior informed consent. So far, WIPO has not developed any legally-binding provisions on intellectual property, genetic resources and traditional knowledge and folklore, but it has made and continues to make efforts to improve the recognition/disclosure of sources of genetic resources and traditional knowledge within patent applications, and to set out what actions should be considered misappropriate or misuse. The work of the IGC is supportive of indigenous rights over natural (genetic) resources and traditional knowledge.
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Summary/Conclusions The international organisations responsible for regulations in the areas of access to and benefit-sharing from genetic resources, and of intellectual property rights, all demonstrate awareness, and have at least begun discussing, and in some cases taking action on, issues relating to indigenous rights. The CBD has recognised contributions and rights of indigenous and local communities from the time of its creation, and has undertaken further work on issues of access and benefit sharing, genetic resources, and traditional knowledge. However, there is so far, no legal recognition under the Convention of indigenous rights over natural resources – these rights are clearly assigned to states, and not sub-state or transboundary groups. The CBD continues to work on elaboration of an international regime on access and benefit-sharing which will most likely incorporate indigenous and local communities’ rights in some form. The FAO has over fifty years experience of work relating to plant genetic resources. Its International Treaty on Plant Genetic Resources recognises contributions to the development of these resources by indigenous and local communities, but the rights it recognises are those of farmers. There is no reason to think that this is detrimental to indigenous rights, since it will include indigenous farmers’ rights. The FAO is also working on animal genetic resources, again recognising the contributions of indigenous and local communities, alongside states’ sovereign rights over natural resources. Discussion on the intellectual property aspects of genetic resources and traditional knowledge and folklore is furthest advanced in the World Intellectual Property Organisation through its Intergovernmental Committee on IP and Genetic Resources, Traditional Knowledge and Folklore. The Committee is not currently working to create any legally-binding provisions on these issues, but has drafted substantial guidance/principles that may be used by states in considering the relationship between the IP systems and the recognition of indigenous rights over traditional knowledge and genetic resources. The Committee continues to provide a key international forum for discussion on these issues. Debate within the WTO TRIPS Council on the relationship between TRIPS, the CBD, and traditional knowledge has not progressed to this stage. There remain strong divisions between states on the issues, including on whether traditional knowledge should even be considered within the WTO. This lack of consensus need not, necessarily, preclude states from taking national action to recognise traditional knowledge within intellectual property systems, but they may be reluctant to do so before international agreement is reached (for example, because of potential costs of adapting to comply with any subsequent international standards). Many of the concerns relating to genetic resources and traditional knowledge, their access, use and ownership are not limited to indigenous groups, and while international documents relating to indigenous rights may be useful in promoting rights over genetic resources and traditional knowledge, they are not the only motivation for such efforts. Rights frequently come into conflict when it comes to their application, this is true even when balancing one individual right against another. Since issues relating genetic resources, traditional knowledge and intellectual property involve state rights, individual rights, and collective rights, it is inevitable that there will be some areas of incompatibility and aspects that remain difficult to resolve. The increased international awareness of indigenous rights is a positive sign, as is the discussion of their interaction with existing international rules that are taking place in several international organisations. It is, however, unrealistic to expect that they can always be directly incorporated into these existing rules, as negotiating states will continue to balance competing rights claims.
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References: CBD Secretariat. 2002. Bonn Guidelines on Access to Genetic Resources and the Fair and Equitable Sharing of the Benefits Arising out of their Utilization. COP Decision VI/24, http://www.cbd.int/decisions/?dec=VI/24. CBD Secretariat. 1992. Convention on Biodiversity, http://www.cbd.int/convention/convention.shtml. CBD Secretariat. 2009. International Regime on Access and Benefit-Sharing. http://www.cbd.int/abs/regime.html. CBD Secretariat. 2007. Introduction: Traditional Knowledge and the Convention on Biological Diversity, http://www.cbd.int/traditional/intro.shtml. FAO. 2001. International Treaty on Plant Genetic Resources for Food and Agriculture, ftp://ftp.fao.org/docrep/fao/011/i0510e/i0510e.pdf. FAO/CGRFA. 2007. Global Plan of Action for Animal Genetic Resources and Interlaken Declaration on Animal Genetic Resources, ftp://ftp.fao.org/docrep/fao/010/a1404e/a1404e00.pdf. ILO. 1989. Indigenous and Tribal Peoples Convention, http://www.ilo.org/ilolex/cgi-lex/convde.pl?C169. UN Development Group. 2008. Guidelines on Indigenous Peoples’ Issues, http://www2.ohchr.org/english/issues/indigenous/docs/guidelines.pdf. UNGA. 2007. United Nations Declaration on the Rights of Indigenous Peoples. UNGA Resolution 61/295, http://daccessdds.un.org/doc/UNDOC/GEN/N06/512/07/PDF/N0651207.pdf?OpenElement. UNGA. 1948. Universal Declaration of Human Rights, http://www.un.org/Overview/rights.html. UNGA/Human Rights Council. 2007. Implementation of General Assembly Resolution 60/251 of 15 March 2006 Entitled ‘Human Rights Council’ – Report of the Special Rapporteur on the Situation of Human Rights and Fundamental Freedoms of Indigenous People, Rodolfo Stavenhagen. A/HRC/4/32, http://daccess-ods.un.org/access.nsf/Get?Open&DS=A/HRC/4/32&Lang=E. WIPO. No date given - 1. Draft Provisions on Traditional Cultural Expressions/Folklore and Traditional Knowledge, http://www.wipo.int/tk/en/consultations/draft_provisions/draft_provisions.html. WIPO. No date given - 2. Genetic Resources, http://www.wipo.int/tk/en/genetic. WIPO. No date given - 3. Intergovernmental Committee, http://www.wipo.int/tk/en/igc. WTO. 2001. Doha Ministerial Declaration, http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_e.htm. WTO/TRIPS Council. 2006. The Protection of Traditional Knowledge and Folklore: Summary of Issues Raised and Points Made, http://www.wto.int/english/tratop_e/trips_e/ipcw370r1.doc. WTO. 1994. Trade Related Aspects of Intellectual Property Rights Agreement, http://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm
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PART III - EVENTS AND RECENT PUBLICATIONS Arms Control Official documents of the 2008 Meeting of Experts of the Biological Weapons Convention Intersessional Process, available through http://www.unog.ch/bwc/new_proces/mx2008/mx2008.htm. Final Version – Report of the Meeting of Experts, BWC/MSP/2008/MX/3, available through http://www.unog.ch/80256EE600585943/(httpPages)/8C24E93C19BDC8C4C12574F60031809F?OpenDocument. Informal Advance Report of the 2008 Meeting of States Parties of the Biological Weapons Convention Intersessional Process, http://www.unog.ch/80256EDD006B8954/(httpAssets)/C70514F42F7BF072C1257516005B1E7A/$file/BWC+MSP+2008+Advance+Report.pdf Report of the OPCW on the Implementation of the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and their Destruction in 2007, 03/12/08, http://www.opcw.org/index.php?eID=dam_frontend_download&fileID=12536. Chemical Disarmament Quarterly, September 2008, Vol.6(3), http://www.opcw.org/index.php?eID=dam_frontend_download&fileID=12387. Chemical Disarmament Quarterly, December 2008, Vol.6(4), http://www.opcw.org/news/publications/cdq/cdq-dec-2008/. 24th-28th August 2009, Meeting of Experts, Biological Weapons Convention Intersessional Process, Geneva. 30th November – 4th December 2009, 14th Session Conference of the States Parties to the Chemical Weapons Convention, The Hague. 7th-11th December 2009, Meeting of States Parties, Biological Weapons Convention Intersessional Process, Geneva.
Health and Disease Control CAC, Report of the 31st Session of the Codex Alimentarius Commission, ftp://ftp.fao.org/codex/Alinorm08/al31REPe.pdf. CAC, Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals, CAC/GL 68-2008, http://www.codexalimentarius.net/download/standards/11023/CXG_068e.pdf. CAC, 2008 amended version of Principles for the Risk Analysis of Foods Derived from Modern Biotechnology, CAC/GL 44-2003, available through http://www.codexalimentarius.ent/web/standard_list.do?lang=en. CAC, 2008 amended version of Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants, CAC/GL 45-2003, available through http://www.codexalimentarius.ent/web/standard_list.do?lang=en. FAO, 2008, The State of Food and Agriculture 2008 – Biofuels: Prospects, Risks and Opportunities, ftp://ftp.fao.org/docrep/fao/011/i0100e/i0100e.pdf. FAO, The Role of Agricultural Biotechnologies for Production of Bioenergy in Developing Countries, background paper for the FAO Electronic Forum on Biotechnology in Food and Agriculture, http://www.fao.org/biotech/C15doc.htm. FAO (Alessandro Flammini) to the Global Bioenergy Platform, October 2008, Biofuels and the Underlying Causes of High Food Prices, available through http://www.fao.org/bioenergy/48659/en/. FAO, September 2008, Report: Global Programme for the Prevention and Control of Highly Pathogenic Avian Influenza, ftp://ftp.fao.org/docrep/fao/011/aj135e/aj135e00.pdf. FAO/OIE, October 2008, The Global Strategy for Prevention and Control of H5N1 Highly Pathogenic Avian Influenza, ftp://ftp.fao.org/docrep/fao/011/aj134e/aj134e00.pdf. OIE, 2008, 11th Edition of the Aquatic Animal Health Code, http://www.oie.int/eng/normes/en_acode.htm?e1d10. OIE, 2008, 17th Edition of the Terrestrial Animal Health Code, http://www.oie.int/eng/normes/mcode/en_sommaire.htm. OIE, 25/11/08, Editorial from the Director-General, “Feeding the World Better by Controlling Animal Diseases”, http://www.oie.int/eng/edito/en_lastedito.htm. WHO, IHR [International Health Regulations] News, 15/12/08, including a summary report on implementation activities and information on INFOSAN (International Food Safety Network), http://www.who.int/csr/ihr/ihrnewsissue5/en/index.html. WHO, October 2008 Draft – WHO Interim Guidance for the Use of Annex 2 of the International Health Regulations (2005): Decision Instrument for the Assessment and Notification of Events That May Constitute a Public Health Emergency of International Concern, http://www.who.int/csr/ihr/Annex_2_Guidance_en.pdf. WHO, 2008, The Global Burden of Disease: 2004 Update, http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf. WHO, World Health Report 2008 – Primary Health Care: Now More than Ever, http://www.who.int/whr/2008/en/index.html. WHO Bulletin, Vol.86(8) August 2008, Special Theme Issue: Ethics and Public Health, http://www.who.int/bulletin/volumes/86/8/en/index.html. WHO Bulletin, Vol. 86 (9) September 2008, http://www.who.int/bulletin/volumes/86/9/en/index.html. WHO Bulletin, Vol. 86 (10) October 2008, http://www.who.int/bulletin/volumes/86/10/en/index.html. WHO Bulletin, Vol. 86 (11) November 2008, Special Theme Issue: Health Financing, http://www.who.int/bulletin/volumes/86/11/en/index.html. WHO Bulletin, Vol. 86 (12) December 2008, http://www.who.int/bulletin/volumes/86/12/en/index.html. WHO Bulletin, Vol. 87 (1) January 2009, http://www.who.int/entity/bulletin/volumes/87/en/index.html. WHO, Commission on Social Determinants of Health, Final Report: Closing the Gap in a Generation – Health Equity Through Action on the Social Determinants of Health, http://whqlibdoc.who.int/publications/2008/9789241563703_eng.pdf. WHO Global Malaria Programme, World Malaria Report 2008, http://www.who.int/malaria/wmr2008/malaria2008.pdf. WHO and Partners, published in The Lancet, 01/12/08, “Medicine prices, availability and affordability in 36 developing and middle-income countries: a secondary analysis”, http://www.who.int/medicines/news/MedPrices_Word2.pdf. 17th-19th March 2009, 3rd African Veterinary Congress, Yaounde, Cameroon, http://www.onvc.org. 23rd-25th March 2009, 1st OIE International Conference on Identification and Traceability – From Farm to Fork, Buenos Aires, http://www.oie.int/eng/traceability-2009/index.html. 30th March – 3rd April 2009, International Plant Protection Convention – Commission on Phytosanitary Measures, 4th Session, Rome. 5th-8th April 2009, 7th International Symposium on Avian Influenza, University of Georgia, Athens, Georgia, http://www.georgiacenter.uga.edu/conferences/2009/Apr/05/avian.phtml. 20th-24th April 2009, National Symposium: Biotechnology and the Future Worldwide Scenarios, Rosario, Argentina, http://www.redbio.org/eventos.asp?id=70. 23rd-25th April 2009, The European Veterinary Conference 2009, Amsterdam, http://www.voorjaarsdagen.org/content.php. 24th-29th May 2009, 77th General Session of the OIE International Committee. 8th-11th June 2009, International Symposium on Sustainable Improvement of Animal Production and Health, Vienna, http://www-pub.iaea.org/MTCD/Meetings/Announcements.asp?ConfID=35424. 17th-20th June 2009, XIV International Symposium World Association of Veterinary Laboratory Diagnosticians, Madrid, http://www.walvd2009.com. 16th-18th June 2009, Commission on Genetic Resources for Food and Agriculture, Intergovernmental Technical Working Group on Plant Genetic Resources for Food and Agriculture, Rome. 23rd-26th June, 62nd Session Codex Alimentarius Executive Committee, Rome. 29th June-4th July 2009, 32nd Session of the Codex Alimentarius Commission, Rome. 28th-25th July 2009, 2nd Annual World Summit of Antivirals, Beijing, http://www.bitlifesciences.com/wsa2009. 27th-30th October 2009, World Conference on Biological Invasions and Ecosystem Functioning, Porto, http://www.ciimor.up.pt/biolief. 8th-11th December 2009, 63rd Session Codex Alimentarius Executive Committee, Rome.
Environmental Protection CBD Technical Series No.38 (Sarah Laird and Rachel Wynberg), Access and Benefit-Sharing in Practice: Trends in Partnerships Across Sectors, http://www.cbd.int/doc/publications/cbd-ts-38-en.pdf. CBD, 21/11/08, Report of the Compliance Committee under the Cartagena Protocol on Biosafety on the Work of its Fifth Meeting, UNEP/CBD/BS/CC/5/4, http://www.cbd.int/doc/meetings/bs/bsc-05/official/bscc-05-04-en.pdf. CBD, Biosafety Protocol News, Vol.3(4), 5th Anniversary Edition, http://www.cbd.int/doc/newsletters/bpn/bpn-03-04-high-en.pdf. CBD, Business 2010, December 2008, including a table listing ‘International Organisations that Provide Regulatory Frameworks on Transport of Living Organisms’, http://www.cbd.int/doc/newsletters/news-biz-2008-12-low-en.pdf. CBD (Jane Bulmer), Draft Study on the Relationship Between an International Regime on Access and Benefit-Sharing and Other International Instruments and Fora Which Govern the Use of Genetic Resources – International Treaty on Plant Genetic Resources for Food and Agriculture and Commission on Genetic Resources for Food and Agriculture, http://www.cbd.int/doc/programmes/abs/studies/study-regime-01-en.pdf. CBD (Sam Johnston), The Relationship Between An International Regime on ABS and the ATS and UNCLOS, http://www.cbd.int/doc/programmes/abs/studies/study-regime-02-en.pdf. CBD, International Regime on Access and Benefit-Sharing – Report of the Meeting of the Group of Legal and Technical Experts on Concepts, Terms, Working Definitions and Sectoral Approaches, UNEP/CBD/WG-ABS/7/2, http://www.cbd.int/docs/meetings/abs/absgtle-01/official/absgtle-01-abswg-07-02-en.pdf. CBD (Jorge Cabrera Medaglia), Study on the Relationship Between the ABS International Regime and Other International Instruments which Govern the Use of Genetic Resources: The World Trade Organisation (WTO); the World Intellectual Property Organisation (WIPO), and the Union for the Protection of New Varieties of Plants (UPOV), http://www.cbd.int/doc/programmes/abs/studies/study-regime-04-en.pdf. CBD (Bernard Colas) Comparative Study of the Real and Transactional Costs Involved in the Process of Access to Justice Across Jurisdictions, http://www.cbd.int/doc/programmes/abs/studies/study-regime-03-en.pdf. CBD, 27/11/08, Report of the Expert Meeting for South-South Cooperation on Biodiversity for Development, UNEP/CBD/EM-SSC/1/3, http://www.cbd.int/doc/meetings/ssc/emssc-01/official/emssc-01-03-en.pdf. United Nations General Assembly, 12/12/08, Resolution A/63/414/Add.6, Sustainable Development: Convention on Biological Diversity, http://www.cbd.int/doc/external/ga/ga-2008-12-19-cbd-en.pdf. 2nd-8th April 2009, Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing meeting, UNESCO Headquarters, Paris, http://www.cbd.int/doc/?meeting=ABSWG-07. 4th-22nd May 2009, Genetic Resources and Intellectual Property Rights Advanced International Training Programme, Svalov, Sweden, http://www.svalofconsulting.com/prod01.htm. 16th-9th June 2009 (tentative), Access and Benefit-Sharing: Expert Group on Traditional Knowledge Associated with Genetic Resources meeting. 2nd-6th November 2009 (tentative), 6th Meeting Ad Hoc Open-Ended Working Group on Article 8(j) Related Provisions, Kuala Lumpur. 9th-15th November 2009 (tentative), 8th Meeting Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing, Kuala Lumpur. 18th-24th March 2010 (tentative), 9th Meeting Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing. 13th-21st May 2010 (tentative), 14th Meeting Subsidiary Body on Scientific, Technical and Technological Advice. 11th-15th October 2010, 5th Conference of the Parties serving as the Meeting of the Parties to the Cartagena Protocol on Biodsafety, Nagoya, Aichi Prefecture, Japan. 18th-29th October 2010, 10th Conference of the Parties to the Convention on Biodiversity, Nagoya, Aichi Prefecture, Japan.
Trade CGIAR, October 2008, Safeguarding the World’s Agricultural legacy, http://www.cgiar.org/pdf/pub_genebanks_2008.pdf. FAO – Commission on Genetic Resources for Food and Agriculture, documents from the 5th Session of the Intergovernmental Technical Working Group on Animal Genetic Resources for Food and Agriculture available through http://www.fao.org/ag/againfo/programmes/en/genetics/angrvent-5th-docs.html. FAO – International Treaty on Plant Genetic Resources, Launch of Capacity-Building Project: Legal and Technical Assistance to Developing Countries on Implementing the International Treaty on Plant Genetic Resources for Food and Agriculture, 13/11/08, ftp://ftp.fao.org/ag/agp/planttreaty/noti/NCP_GB3_JIP1_e.pdf. UPOV Distance-Learning Training Course DL-205: Introduction to the UPOV System of Plant Variety Protection under the UPOV Convention, Session I 4th May – 7th June 2009 (registration 15th January – 28th February); Session II 2nd November – 6th December 2009 (registration 1st June – 30th July). UPOV Council 42nd Session, 30/10/08, Report on Decisions, http://www.upov.int/export/sites/upov/en/documents/c/42/c_42_20.pdf. WIPO, PCT Applicant’s Guide – Annex on Supplementary International Search, http://www.wipo.int/guide/en/gdvol1/annexes/annexsisa/ax_sisa_ru.pdf. WIPO, World Patent Report – 2008 Edition, http://www.wipo.int/ipstats/en/statistics/patents. WIPO, PCT Assembly, 22nd Extraordinary Session – Report, PCT/A/38/6, http://www.wipo.int/edocs/mdocs/govbody/en/pct_a_38/pct_a_38_6.pdf. WIPO, Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, Decisions of the Thirteenth Session of the Committee, http://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_13/wipo_grtkf_ic_13_decisions.pdf. WIPO, Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, documents from the 13th Session of the Committee available through http://www.wipo.int/meetings/en/details.jsp?meeting_id=16204. WIPO Magazine, 04/2008, August, including article “Shedding Light on the Life Sciences: Patent Landscaping for Public Policy Makers”, http://www.wipo.int/wipo_magazine/en/2008/04. WIPO Magazine, 05/2008, October, http://www.wipo.int/wipo_magazine/en/2008/05. WIPO Magazine, 06/2008, December, http://www.wipo.int/wipo_magazine/en/2008/06. WIPO, PCT Newsletter, September 2008, No.09/2008, http://www.wipo.int/edocs/pctndocs/en/2008/pct_news_2008_9.pdf. WIPO, PCT Newsletter, October 2008, No.10/2008, http://www.wipo.int/edocs/pctndocs/en/2008/pct_news_2008_10.pdf. WIPO, PCT Newsletter, November 2008, No.11/2008, http://www.wipo.int/edocs/pctndocs/en/2008/pct_news_2008_11.pdf. WIPO, PCT Newsletter, December 2008, No.12/2008, including details of the new Supplementary International Search service, http://www.wipo.int/pct/en/newslett/2008/12/article_0002.html. WTO/OECD/STDF, 31/10/08, Summary Report of the Workshop on Good Practice in SPS-Related Technical Cooperation, G/SPS/R/52, http://docsonline.wto.org/DDFDocuments/t/G/SPS/R52.doc. WTO, Presentations and podcast from the Workshop on Good Practice in SPS-Related Technical Cooperation, http://www.wto.org/english/tratop_e/sps_e/wkshop_oct08_e/wkshop_oct08_e.htm. WTO, New Transparency Recommendations and Formats for SPS Enquiry Points and Notification Authorities, http://www.wto.org/english/tratop_e/sps_e/notfication_formats_e.htm. WTO, SPS Committee’s revised Recommended Procedures for Implementing the Transparency Obligations of the SPS Agreement (effective from 01/12/08), available at http://docsonline.wto.org/imrd/directdoc.asp?DDFDocuments/t/G/SPS/7R3.doc. 23rd-27th March 2009, WIPO Standing Committee on the Law of Patents, Geneva. 3rd April 2009, Extraordinary Session of the UPOV Council. 20th April 2009, Special High Level Meeting of the Economic and Social Council, Bretton Woods Institutions, WTO and UN Commission on Trade and Development, New York. April 2009, WTO, Technical Workshop on SPS Measures, Maseru, Lesotho. 27th April – 3rd May 2009, WIPO Committee on Development and Intellectual Property, 3rd Session, Geneva. 27th-28th May 2009, Meeting of the WTO General Council. 28th-29th May 2009, WIPO Workshop for Mediators in Intellectual Property Disputes, Geneva. June 2009, WTO General Council – 2nd Global Review of Aid for Trade, Geneva. 1st-5th June 2009, 3rd Session of the Governing Body of the International Treaty on Plant Genetic Resources for Food and Agriculture. 8th-9th June 2009, Meeting of the TRIPS Council, Geneva. 29th June – 3rd July 2009, WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, 14th Session, http://www.wipo.int/meetings/en/details.jsp?meeting_id=17452. 13th-14th July 2009, WIPO Conference on Intellectual Property and Global Challenges – event open to the public, details of program, fees, etc. forthcoming – Geneva, http://www.wipo.int/meetings/en/2009/ip_gc_ge/. 28th-29th July 2009, Meeting of the WTO General Council. 8th-10th September 2009, Second World Seed Conference: Responding to the Challenges of a Changing World – the Role of New Plant Varieties and High Quality Seed in Agriculture, FAO, Rome, http://www.worldseedconference.org. 13th-14th October 2009, Meeting of the WTO General Council. 22nd October 2009, Ordinary Session of the UPOV Council. 27th-28th October 2009, Meeting of the TRIPS Council, Geneva. 16th-20th November 2009, WIPO Committee on Development and Intellectual Property, 4th Session, Geneva.
Drugs Control International Narcotics Control Board, August 2008, The International Narcotics Control Board – Mandate and Activities, http://www.incb.org/pdf/brochures/ENGLISH.pdf. UNODC, World Drug Report 2008, http://www.unodc.org/unodc/en/data-and-analysis/WDR_2008.html. WADA, 5th Edition of the WADA Athlete Guide now available (reflects the recent revisions to the World Anti-Doping Code), http://www.wada-ama.org/en/dynamic.ch2?pageCategory.id=449. WADA Play True, Issue 3/2008 available through http://www.wada-ama.org/en/dynamic.ch2?pageCategory.id=810. 11th-20th March 2009, 52nd Session of the Commission on Narcotic Drugs, Vienna. 21st-22nd April, Symposium for Anti-Doping Organisations http://www.wada-ama.org/en/event.ch2?event.id=3115554.
Social and Ethical Impacts UNESCO, 19/09/08, Report of the Working Group of IBC on Human Cloning and International Governance, SHS/EST/CIB-15/08/CONF.502.2, http://portal.unesco.org/shs/en/files/12376/12229368791REPORT_IBC-WG_Cloning_en.pdf/REPORT+IBC-WG+Cloning_en.pdf. 16th May 2009, International Bioethics Committee 16th Session, Paris. July 2009, Intergovernmental Bioethics Committee 6th Session, Paris.
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