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INTERNATIONAL LAW ASSOCIATION

THE HAGUE CONFERENCE (2010)

INTERNATIONAL LAW ON BIOTECHNOLOGY

Members of the Committee:

Professor Thomas Cottier (Switzerland): Chair

Professor Mary Footer (Netherlands):Rapporteur

Dr Emmanuel Opoku Awuku (HQ)

Professor Laurence Boisson de Chazournes (France)

Dr Philippe Cullet (UK)

Mr Anil B Divan (India)

Alternate: Mr Vineet Saran

Professor Marsha Echols (USA)

Professor Der-Chin Horng (China (Taiwan))

Professor Naoki Koizumi (Japan)

Mr Mihalis Kritikos (Hellenic)

Dr Federico Lenzerini (Italy)

Dr Christian Lopez-Silva (Mexico)

Ms Ruth Mackenzie (UK)

Dr Marc Markus (Switzerland)

Alternate: Professor Anne Petitpierre

Dr Fabio Morosini (Brazil)

Alternate: Dr Fernando de Faria Tabet

Professor Iulia Motoc (Romania)

Bernard O'Connor (Ireland)

Professor Inger-Johanne Sand (Norway)

Professor Joanne Scott (UK)

Alternate: Dr Aphrodite Smagadi

Professor Han Somsen (Netherlands)

Professor Peter-Tobias Stoll (Germany)

Dr Christopher Ward (Australia)

Dr Susette Biber-Klemm Observer

Mr Sufian Jusoh Observer

Mr Michael Burkard Observer

Mr Sadeq Z Bigdeli ObserverMr Michelangelo Temmerman Observer

Mr Fitzgerald Temmerman Observer

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Draft Final Report and Draft Final Recommendations

Introduction

1. Biotechnology or genetic engineering, producing genetically modified organisms (GMOs), touches upon

many quarters of the law: human rights and property protection, trade regulation and environmental law,

with all these areas being closely interlinked. A great variety of policy areas are affected, from research,

family planning, health care to biodiversity, from environmental degradation to energy, nutrition and

agricultural policies, to name just a few. Most of these policies are primarily matters of domestic law. The

regulation of biotechnology mainly takes place in domestic fora. Yet, countries share common concerns.

Biotechnology has been on the agenda of different international fora and organizations.

2. In 2006, the newly established Committee on the International Law on Biotechnology was called upon to

focus on aspects of international law of biotechnology regulation, and to take national regulations intoaccount to the extent required to understand and further develop rules of international law

1. In its work,

the Committee essentially concentrated on three questions: the potential need for further harmonisation,

the potential need for decentralisation of regulation, and the potential need for changes of current

international law. The Committee sought to make a contribution to bring about greater coherence between

the different areas of application. It examined the issues from a perspective of multilayered governance

and proper vertical allocation of regulatory powers; and gave special consideration to the so-called North-

South divide in the field. Four interlinked areas of regulation have hereby been at the centre of the

investigation: human rights and bioethics, proprietary rights and public goods, market access and

(international) trade regulation, and (international) environmental law. Throughout the investigations, the

Committee has given due consideration to the potential risks as well as to the potential benefits of

biotechnology. It took into account the different levels of development and ethical sensitivities amongstcountries and regions when advising on harmonisation.

3. The needs of developing countries have been one of the central elements in the discussions of the

Committee. They are reflected throughout the report and recommendations. Procedures designed in their

context need to be adapted to the technical, financial and infrastructural limits of the countries involved.

Generally, they are seen as necessary to foster and support the creation of an infrastructure that enables

developing countries to cope with biotechnology and benefit from it. The development of drought resistant

crops for instance should not remain inaccessible to developing countries, especially in view of climate

change and population growth. International law can be an element that contributes to making this

possible. Three elements are hereby central: the issue of access to the relevant technologies (and the

investment into locally adapted innovation); the necessary infrastructure for risk assessment and

management; and the issue of bio-piracy and due reward for the use of genetic resources and traditional

knowledge that originate in developing countries. In this context, the Committee agrees on a number of

specific guidelines, alongside more precise recommendations. First, the Committee advances the theory of

graduation, according to which the strength of IP protection should be aligned to the level of economic

1 INTERNATIONAL LAW ASSOCIATION, Committee on the International Law on Biotechnology, The

International Law on Biotechnology , Toronto Conference Report, 2006, available at: http://www.ila-

hq.org/en/committees/index.cfm/cid/1016, at p. 10.

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development of countries, so as to ensure that local and global technology development coincide. Second,

the Committee suggests the creation of an international network of laboratories responsible for risk

assessments while leaving the policy decision on how to use this information (risk management) to the

countries domestic authorities. Finally, in relation to traditional knowledge and bio-piracy sui generis

traditional intellectual property or TIP rights are being advanced for inclusion in the reform of WTO

intellectual property disciplines, in addition to a more prominent use of Art. 10bis of the Paris Convention

on unfair competition. Rights of farmers and breeders, developers of non-biotechnological plants and

animals, must be recognised in this context as well so that biotechnology may develop those efforts.

4. The final report and the recommendations of the Committee build upon the extensive interim report

submitted to ILA in Rio de Janeiro in 20082. The present report essentially summarises the interim report

which should be read as an integral part of the overall result of the Committees effort and work. In

addition, the final report reflects the outcome of the debates from the last Rio conference and the special

Committee meeting held in Bern, Switzerland, at the World Trade Institute in June 2009. The present

report further incorporates the developments that occurred since the publication of the interim report and

brings a number of new elements in this light. Finally, it brings a large set of recommendations uponwhich agreement has been found amongst the Committee members.

5. A number of developments have taken place in the international debate, in the law and in the technology

itself since the 2008 Rio interim report. The insertion of an artificial genome into a cell (popularly

nicknamed Synthia the first realization of what is called synthetic life), exemplifies the increasing

impact and possibilities of biotechnology in what is called bionanotechnology.3

In parallel, a larger

acceptance of agricultural biotechnology is emerging, in particular in light of the challenges of global

warming and climate change. The potential of drought resistant plants has induced the need for a review of

risks and the potential of biotechnology in many countries. The European Union, until recently skeptical

about biotechnology in food and agriculture has, after 13 years, allowed the cultivation of Amflora potato

within its territory, as well as the use of the Amflora's starch by-products as feed. In return, the debate onsafety issues in this context appears to be moving towards a more careful examination of the impact of

non-biotechnological products and processes which are not subject to the Cartagena Protocol on

2 INTERNATIONAL LAW ASSOCIATION, Committee on the International Law on Biotechnology, The

International Law on Biotechnology, Rio Conference Report, 2008, available at: http://www.ila-

hq.org/en/committees/index.cfm/cid/1016.

3 D.G. GIBSON (et al.), Creation of a Bacterial Cell Controlled by a Chemically Synthesized Genome, Science

Magazine, 20 Mai 2010, published online at: http://www.sciencemag.org/cgi/content/abstract/science.1190719(last visited 27 Mai 2010).

The abstract of the article reads: We report the design, synthesis, and assembly of the 1.08-MbpMycoplasma

mycoides JCVI-syn1.0 genome starting from digitized genome sequence information and its transplantation into a

Mycoplasma capricolum recipient cell to create newMycoplasma mycoidescells that are controlled only by the

synthetic chromosome.The only DNA in the cells is the designed synthetic DNA sequence, including "watermark"

sequences and other designed gene deletionsand polymorphisms, and mutations acquired during the building

process. The new cells have expected phenotypic properties and are capable of continuous self-replication.

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Biosafety.4 International regulation has undergone some movements as well and yet fundamental decisions

have not been taken since the issuance of the Interim Report in 2008: its conclusions still stand.

6. The final report begins by exploring the relationship of human rights protection and genetic engineering,

mainly focusing on the matter of health. It addresses and summarises the relationship of appropriation and

public goods in the field of intellectual property as well as access and benefit sharing. It turns to issues of

international trade regulation, including market access, non-tariff barriers and subsidies; and concludes

with an assessment from the point of view of international environmental law. In doing so, it essentially

follows the structure adopted for the 2008 Interim Report with some modifications. At the end of the

report, the Committee submits its recommendations for approval by the International Law Association.

7. The work of the Committee was assisted by the individual research project 9 on trade and biotechnology

of the National Centre of Competence and Research (NCCR) Trade Regulation, hosted at the World Trade

Institute of the University of Bern, and funded by the Swiss National Research Foundation.5

Human Rights and Bioethics

A. In General

8. A number of human rights that specifically relate to biotechnology are identified in this section, which

emphasises the primacy of human dignity as a framework based upon which rational decision can be taken

both in legislation and in adjudication. The prohibition of inhuman and degrading treatment; the guarantee

of personal liberty; the right to health, to food, to sustainable development; as well as protection of

property and economic rights are identified as key rights in relation to biotechnology relating to the

treatment of humans. The risk that biotechnological applications may result in violations of human dignityis amplified in developing countries because of the gap that exists between these countries and developed

ones in terms of opportunities to have access to the benefits of biomedicine. In addition, procedural rights

relating to due process and to participatory decision-making as a matter of good governance are considered

essential.

9. Human rights offer a path towards shared understanding and common rules. Their impact, however,

cannot be defined in the abstract. The pros and cons of biotechnology often require a careful assessment in

a particular context and application in the various fields open to genetic engineering. Genetically modified

products and processes are both supported and challenged by human rights claims. The need to assess and

to find an appropriate balance of interests emphasises the importance of procedural rights, in particular due

process and the right to be heard. Human rights guarantees in international law, both in substance and in

4 For instance: K.AMMANN,Biodiversity and Biotechnology: Myths and Good News that shape Trade Regulation ,

presented at the Word Trade Institute, Bern, 17 May 2010: http://www.botanischergarten.ch/WTI/Ammann-WTI-

GMOs-Regulation-Trade-20100517.ppt.

5 The results of IP 9 can be found at www.nccr-trade.org (archives) and are summarized in Thomas Cottier &

Panagiotis Delimininatis (eds.), The Prospects of International Trade Regulation: From Fragmentation to

Coherence, Cambridge University Press 2010 (forthcoming).

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procedural terms, therefore contribute to a proper framework on biotechnology regulation. This is

important and even more so because a specific and comprehensive regime in international law in the field

of human dignity and bioethics does not currently exist, except for the Council of Europes 1997

Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the

Application of Biology and Medicine: Convention of Human Rights and Biomedicine (Oviedo Convention)

and its three protocols (the 1998 Protocol concerning the prohibition of human cloning,6

the 2002 Protocol

concerning transplantation of organs and tissues of human origin,7 and the 2005 Protocol on biomedical

research8). A new additional protocol on bioethics was adopted by the Council of Europe in 2008. The

Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing

for Health Purposes9, primarily seeks to reinforce the principle of human dignity in relation to tests

carried out for health purposes, involving analysis of biological samples of human origin and aiming

specifically to identify the genetic characteristics of a person which are inherited or acquired during early

prenatal development. It brings an absolute prohibition of any form of discrimination against a person,

either as an individual or as a member of a group, on grounds of his or her genetic heritage, and refutes a

utilitarian approach confirming the primacy of human dignity: [t]he interests and welfare of the human

being concerned by genetic tests covered by this Protocol shall prevail over the sole interest of society orscience.

10For the rest of the world, no binding treaties have been enacted yet.

10. The difficulty of finding common ground in specific regulations of biotechnology and genetic engineering,

as applied to humans, suggests that regulations beyond the general guarantees of human rights in

international law need to be sought in domestic, or regional, law. Additional and more specific rules may

6 COUNCIL OF EUROPE,Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the

Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings ,

CETS No. 168, available at: http://conventions.coe.int/treaty/en/treaties/html/168.htm (last visited 11 June 2008).

7 COUNCIL OF EUROPE,Additional Protocol to the Convention on Human Rights and Biomedicine concerning

Transplantation of Organs and Tissues of Human Origin, CETS No. 186, available at:

http://conventions.coe.int/Treaty/En/Reports/Html/186.htm (last visited 11 June 2008).As stated in Article 2, thisProtocol only applies to the transplantation of organs and tissues of human origin carried out for therapeutic

purposes.

8 COUNCIL OF EUROPE,Additional Protocol to the Convention on Human Rights and Biomedicine, concerning

Biomedical Research , CETS No. 195, available at: http://conventions.coe.int/Treaty/en/Treaties/Html/195.htm (last

visited 11 June 2008).

9 COUNCIL OF EUROPE,Additional Protocol to the Convention on Human Rights and Biomedicine, concerning

Genetic Testing for Health Purposes, 27 November 2008, CETS No. 203, available at:

http://conventions.coe.int/Treaty/EN/Treaties/html/203.htm (last visited 27 may 2010).

10 Genetic services must be of appropriate quality (Article 5) as well as of clinical utility (Article 6); in principle,

genetic tests for health purposes may only be performed under individualised medical supervision (Article 7); the

person concerned by a genetic test must be provided with prior appropriate information, concerning especially the

purpose and the nature of the test and the implications of its results, as well as with appropriate genetic counselling

(Article 8); before a genetic test is carried out, the free and informed consent of the person concerned must be

mandatorily obtained (Article 9);10 the rights to respect for ones private life and to information (including the right

not to be informed) must be granted (Article 16)10. When genetic tests are to be carried out on previously removed

biological materials belonging to a person that cannot be contacted, the test can be carried out in accordance with

the principle of proportionality, where the expected benefit cannot be otherwise obtained and where the test cannot

be deferred (Article 14). Last but not least, biological samples shall only be used and stored in such conditions as to

ensure their security and the confidentiality of the information which can be obtained from them (Article 17).

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evolve over time. Some members of the Committee are in favour of a comprehensive instrument based

upon human rights. Others prefer to pursue the matter on an incremental basis, addressing specific

problems as they arise.

B. Substantive Rights

11. An analysis of the most important international legal instruments regulating bioethics11

allows for the

identification of a series of basic principles that, if correctly and effectively applied, are suitable for

minimizing the possible adverse effects of the implementation of human-related applications of

biotechnology and, therefore, for giving concrete realization to the basic dogma of the primacy of human

dignity The Committee suggests that the following principles should be recognised and emphasized as

having general standing and importance in all countries alike:

i) The right to prior, free and informed consent;

ii) The right to privacy and confidentiality;

iii) The right to information and to the right to be protected from disclosure of information;

iv) The prohibition of discrimination based on genetic traits;

v) The prohibition of human reproductive cloning;

vi) The prohibition of non-therapeutic eugenic practices;

vii) The prohibition on using the human body for economic profit;

viii) The right to reparation for harm caused by biotechnology.

12. Depending on the specific circumstances of individual cases, most of these rights and prohibitions referred

to in the previous paragraph are susceptible to derogation in exceptional circumstances for reasons of

ordre public, as well as when required by an urgent need to preserve the health of the person(s) involved

in the operation of genetic engineering. While the concept ofordre public varies from country to country,

the possibility of derogating from these rights, however, is to be interpreted restrictively. Any derogation

requires a strict preventive balance between the value infringed and the interest pursued. Such comparative

evaluation has to be made on the basis of the principle of proportionality, requiring that three conditions

11 The existing international legal framework on bioethics is mainly expressed in terms of soft law instruments,

particularly the United Nations Educational, Scientific and Cultural Organization (UNESCO)s Universal

Declaration on the Human Genome and Human Rights (UDHGHR, 1997), the International Declaration on Human

Genetic Data (IDHGD, 2003), the Universal Declaration on Bioethics and Human Rights (UDBHR, 2005), and the

United Nations Declaration on Human Cloning (UNDHC), adopted by the General Assembly in 2005. The notable

exception as mentioned is the European regional level, where the Council of Europes 1997 Convention on Human

Rights and Biomedicine (Oviedo Convention) and its three protocols (the 1998 Protocol concerning the prohibition

of human cloning, the 2002 Protocol concerning transplantation of organs and tissues of human origin, and the

2005 Protocol on biomedical research) set up a binding and comprehensive legal regime on bioethics.

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are met: 1) the objective pursued must be legitimate; 2) the derogable measure taken must be appropriate

to achieve such objective; 3) there must be no alternative means to achieve the same objective, which is

less onerous in terms of human rights infringement.

13. Importantly, some of the above principles, especially those relating to bioethics, may form part of the

realm of non-derogable rights and must not be impaired even though requirements of proportionality may

be met. The standards pertinent to the present enquiry, which are characterized by being non-derogable,

are, in particular, the freedom from inhuman and degrading treatment and the worst form of systematic

discrimination, such as apartheid, banned by jus cogens. No justification whatsoever can be found to

introduce genetic manipulation as a weapon in war under the principle of human dignity. The Committee

notes that the 1972 Biological Weapons Convention prohibits the development, manufacture, stockpiling,

and the transfer and use of biological weapons. This is consistent with the principle of non-derogable

rights.

C. Procedural Rights

14. In the context of pluralist societies where different values co-exist, emphasis should be placed on

procedural requirements. Procedural due process, an obligation to argue and justify decisions in a rational

and non-arbitrary manner, a right to appeal and judicial review provide essential elements based upon

which procedures involving genetic engineering should be shaped. In addition, freedom of speech and

information, freedom of the press, freedom of association and the right to obtain information from

governments are of paramount importance with a view to conducting an informed political debate on the

subject.

D. Gender and Non-discrimination

15. Social discrimination based upon genetic discrimination is one of the most important issues. To the extent

that these inherently domestic affairs go beyond internationally recognized human rights standards, the

Committee suggests that these matters should be taken up in non-binding instruments. It is necessary in

this context to draw a clear distinction between genetic discrimination and discrimination on the basis of

general health status. The distinction, however, is difficult to sustain in practice, as the examples of sexual

discrimination, insurance policies and criminal investigation demonstrate. International law has not been

able to address these issues properly and conclusively.

16. In this context, women are particularly likely to suffer from genetic discrimination; especially in relation

to new techniques of reproduction, mostly in terms of pre-natal selection. Freedom of choice and non-

directive genetic counselling is the lynch-pin of the argument that genetics does not essentially lead toeugenics. Freedom from outside coercion is equally an essential principle. Another point that deserves

emphasis is the danger of private life insurance policies, or insurance against injuries or disability, when

genetically-based health risks may tip the balance to the detriment of the individual person concerned. The

law seeks to protect consumers from inappropriate use of private information. It may not sufficiently do so

at this stage. The subject remains to be addressed in international instruments. It also raises the issue as to

what extent this matter can be addressed under domestic regulation in the WTO General Agreement on

Trade in Services.Finally, recourse to genetic engineering in criminal procedures amounts to one of the

most important implications for human rights protection. DNA evidence raises several questions relating

to the protection of genetic privacy.

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17. Given the complexity of the subject matter, and the diversity of values and attitudes involved towards

human related genetic engineering, the Committee recommends to base international law disciplines on

existing human rights guarantees, and to seek harmonization beyond internationally recognized standards

based upon human dignity mainly to the extent necessary for international intercourse and trade, in

particular in pharmaceuticals. It is less required, however, in matters relating to therapies and treatment

where a process of trial and error and international regulatory competition is likely to limit overall risks

and to yield better long-term results.

Proprietary Rights and Public Goods

A. The Patent System

18. The status of biotechnology in patent law so far is essentially defined by domestic law and practice within

the bounds of international minimal standards and regional patent systems. Levels of protection and thescope of rights vary in different jurisdictions, commensurate with levels of social and economic

development. While protection is strong in industrialised countries, in particular the United States (US)

and the European Union (EU), developing countries have been less inclined to create strong systems. The

same holds true for biotechnology.

19. Patent laws are fairly abstract and needthis feature for the proper, smooth functioning of the system. Since

technologies develop very fast, especially in the field of biotechnology, constantly enacting new

technology-specific legislation would substantially hold back the functioning of the patent system.

Moreover, rapidly changing technologies mean that the patent rules cannot be too technical. Otherwise

they would become rapidly outdated.

20. Given the high number of patents granted in the field of biotechnology, and their concentration in the

hands of small groups of enterprises in certain areas, their alleged broad scope, the way they are

used/licensed, and the increasingly stronger enforcement of patents in general, legal scholars argue that

research is likely to be hampered and the technologies underused.12 This theory of anti-commons,

however, lacks strong empirical evidence and may be rooted in the way patents were granted at the

beginning of the technology. In June 2009 the European Commission issued its report on the investigation

of anti-competitive conditions in the pharmaceutical sector. It pointed at an issue of patent thickening in

the field, yet identified filing strategies to be the cause rather than the scope of patents.13

Similarly,

12 Alternative methods of protection and distribution have been proposed in this context. Jerome Reichman for

instance suggests a liability regime to replace patent protection. The essential effect of such a system would be that

one can no longer exclude third parties from access to technologies as is the case with the patent system (An

overview of issues and regimes can be found in: J. REICHMAN and K. MASKUS, The Globalization of Private

Knowledge Goods and the Privatization of Global Public Goods, Cambridge, Cambridge University Press, 2005).

Similarly, the so-called creative commons approach, essentially rooted in copyright law, is increasingly influencing

patent law as well.

13 EUROPEAN COMMISSION, Competition inquiry into the pharmaceutical sector, 8 July 2009, available at:

http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/index.html (last visited 5 August 2009).

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possible links between the use of patents and a certain concentration of companies in specific agricultural

sectors are not well established. Sometimes, concentration is unrelated to patent protection. The market of

genetic supply in animal breeds appears for instance highly concentrated in certain sub sectors such as

poultry and swine.14

And yet the market there was not shaped by IP-based monopolies but instead by the

use of secrecy jointly with hybridisation leading to monopolies unlimited in time and scope. An

assessment is nonetheless required as to whether rules limiting the scope of protection, such as the

research exemption, or a limitation to specific purposes (purpose bound protection) or similar provisions

should be introduced on a mandatory basis in international law. In general, there arises the question of

maximum standards in the TRIPs Agreement: whether next to minimum levels of protection, the TRIPs

Agreement should as well set limits to the extent IP protection can be granted by its member states.

21. It is controversial to what extent additional harmonization in international law is required in the field of

genetic engineering, and whether the possibility to exclude plants and animals under the TRIPS

Agreement can be removed. Essentially three elements come into play and must be balanced. Patents are

intrinsically linked to trade and investment. Therefore, international harmonization of patent rules is

generally advisable at least among developed countries in order to further the establishment of equalconditions for trade as well as to enhance the creation of a level playing field and thereby also to ensure

the legal security and predictability necessary to encourage investment. Common standards should be

sought in particular in relation to research.15 The Committee submits that agreement in international law

should be sought on research exemptions. Such exemptions exist already in a large number of countries,

including developing countries. Furthermore, harmonization should take into account flanking policies,

which are discussed below. It may however be countered by bioethical challenges and regional differences

in relation to biotechnology. International law thus may continue to set minimal standards. It may also set

maximum standards but leave countries an appropriate margin of discretion in allowing them to take into

account specific needs and interests.

22. The Committee also points to a necessity to view these issues in the context of the limited effects of thepatent system and its utilitarian nature. A common basis of perception could be sought in human rights but

a concrete assessment of human rights in patent law, as in other fields discussed above, reveals a

problematic issue. Certain matters such as prior informed consent of human donors of genetic material

might nonetheless be considered necessary in order to respect the human right to privacy or even in certain

interpretations of the concept of human dignity. However, the practicalities of obtaining such prior

informed consent and the utilitarian arguments must be balanced against these human rights arguments. A

human-dignity approach as well as a general need for clarification for the general public might also

support an explicit exclusion of the human body from financial gain and from patentability along with a

14 S. GURA,Livestock Genetic Companies - Concentration and Proprietary Strategies of an Emerging Power in the

Global Food Economy, Ober-Ramstadt: League for Pastoral Peoples and Indigenous Livestock,Development,

2007.

15 See: T. COTTIER, A. DOLOTBAEVA, A. JEVTIC, S. JUSOH and M. TEMMERMAN, The Research Exemption

in Patent Law: At the crossroad of innovation and competition, A Case Study on Biotechnology and International

Law, forthcoming 2010.

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clarification that patent law only applies to isolated human substances and never to the human body as

such.16

23. Plant-related biotechnology faces the problem that protection may be sought by means of patents, plant

variety protection under the UPOV system, and by means ofsui generis systems under Article 27(3)(b) of

the TRIPs Agreement. The Committee encourages efforts to compare, and possibly align, criteria for

obtaining protection for genetically modified plants and to align the scope of rights attached. In particular,

the Committee suggest examining whether the UPOV system should be partly adapted and relaxed to

allow protection of improved farmers varieties that result from controlled on-farm breeding processes.

24. In relation to developing countries the theory of graduation might reveal itself to be particularly useful in

order to take into account evolving levels of social and economic development in shaping the obligations

in the field of biotechnology patents. Also, the question arises whether exceptions, such as the research

exemption, implemented at the international level, would favour developing countries in their access to

technologies and development and hence are also, or especially, needed. In relation to developing

countries in a broader context, attention should be given to the eventual adaptation of the TRIPSAgreement in order to favour international technology transfer in a more effective way than is done today.

This would also involve the further scrutiny and establishment of a legal framework for publicprivate

partnerships.

25. Finally, it should be noted that harmonizing patent law is not only a matter of creating new and additional

provisions in international law but also of cooperation between judicial authorities and harmonization of

patent examiners guidelines.

B. Flanking Measures Sui Generis Rights

26. The Committee is of the view that a balance must be found between the system of intellectual propertyrights to biotechnological invention and the recognition of prior art in access to genetic resources (GR) and

related traditional knowledge (TK) in the areas of agricultural and pharmaceutical grassroots innovation

and breeding. Modern biotechnology often is instrumentally based upon the previously existing

knowledge of local communities and individuals as to the use of plants and substances for the benefit of

humankind. These contributions are to be respected and must obtain adequate rewards, firstly for reasons

of equity, but secondly in order to create incentives for the maintenance of the biological diversity inherent

in these systems. In order to create a level playing field, the specific needs of the developing countries

should be taken into account: the rights to prior art need to be strengthened. Special attention should be

paid to the particular needs of indigenous peoples.

1. ACCESS AND BENEFIT SHARING

27. The system of access and benefit sharing (ABS) under the CBD endeavours to balance the rights and

duties for providers and users of genetic resources and traditional knowledge.

16 See: S. BIBER-KLEMM, D. BOCHNEAK, D. JANKOWSKI and M.TEMMERMAN, Patenting Human Genetic

Inventions: At the crossroad of ethics and innovation - selected issues in view of international law , forthcoming

2010.

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Firstly, regarding the subject matter and scope of the ABS system, there are open questions as to the

interpretation of terms and some specific resources to be included.17

Many key terms of the CBD remain

contentious. The question of the implications of the ABS system for access to animal genetic resources,

particularly to domesticated breeds, has not been dealt with until now.18

Furthermore, as the access and

benefit sharing regime of the CBD is not applicable to marine genetic resources in the High Seas beyond

national jurisdiction, the question of access to these resources is largely open and in need of scientific

assessment.

Secondly, with regard to the control over use made of genetic resources and TK, two concepts are at the

forefront of the debate: a) the certificate of origin; and b) the disclosure of origin in the patent procedures. 19

The Committee advises that that the TRIPS Agreement is the appropriate forum to harmonise such

requirements.20

The Committee does not take a view as to whether disclosure should be constitutive or

17 See J.CABRERA, C. LOPEZ-SILVA,Addressing the Problems of Access: Protecting Sources, While Giving Users

Certainty. ABS Series No. 1. IUCN Environmental Policy and Law Paper No. 67/1. Gland, Switzerland and

Cambridge (2007) , http://data.iucn.org/dbtw-

wpd/commande/downpdf.aspx?id=11172&url=http://www.iucn.org/dbtw-wpd/edocs/EPLP-067-1.pdf.

18 See S. BIBER-KLEMM and M. TEMMERMAN (eds.),Rights to Animal Genetic Resources for Food and

Agriculture, NCCR Trade Regulation Working Paper No 2010/05, 2010, available at: http://www.nccr-

trade.org/publication/rights-to-animal-genetic-resources-for-food-and-agriculture/; M. IVANKOVIC,Analysis of

applicability of Access an Benefit-Sharing (ABS) principles on Animal Genetic Resources (AnGR), Centre for

Genetic Resources, the Netherlands (CGN), MSc Studies Report: June 2008; HIEMSTRA, S.J., DRUCKER, A.G.,

TVEDT M.W. (et. al),Exchange, Use and Conservation of Animal Genetic Resources, Policy and regulatory

options, Centre for Genetic Resources, the Netherlands, 2007.

19 In a communication dated 18 July 2008, Albania, Brazil, China, Colombia, Ecuador, the European Communities,

Iceland, India, Indonesia, the Kyrgyz Republic, Liechtenstein, the Former Yugoslav Republic of Macedonia,

Pakistan, Peru, Sri Lanka, Switzerland, Thailand, Turkey, the ACP Group and the African Group have agreed to

pursue the matter in the Doha negotiations round and declared:

4. Members agree to amend the TRIPS Agreement to include a mandatory requirement for the disclosure of the

country providing/source of genetic resources, and/or associated traditional knowledge for which a definition will

be agreed, in patent applications. Patent applications will not be processed without completion of the disclosure

requirement.

5. Members agree to define the nature and extent of a reference to Prior Informed Consent and Access and Benefit

Sharing.

6. Text based negotiations shall be undertaken, in Special Sessions of the TRIPS Council, and as an integral part of

the Single Undertaking, to implement the above. Additional elements contained in members' proposals, such as PIC

and ABS as an integral part of the disclosure requirement and post grant sanctions, may also be raised and shall

be considered in these negotiations. (WORLD TRADE ORGANISATION, Trade Negotiations Committee, Draft

Modalities for TRIPs Related Issues, 19 July 2008, TN/C/W/52, available at:

http://trade.ec.europa.eu/doclib/docs/2008/september/tradoc_140562.pdf).

20 There are various arguments to this end: first, the TRIPS Agreement owes a duty to developing countries. Second,

the TRIPS Agreement is obliged to address the relationship to the CBD under the Doha Declaration; and within the

framework of the WTO to develop an integrated, coordinated approach to issues regarding conservation and

sustainable use of GR and TK is possible. This is relevant for the negotiating process, where trade-offs with other

than intellectual property rights and a balanced package of rights and obligations can be envisaged. Furthermore,

the TRIPS Agreement offers a broad coverage of Members, and disputes arising fall under the jurisdiction of the

WTO dispute settlement mechanisms.

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informational for the purpose of bringing about effective benefit-sharing. In securing appropriate means to

achieve benefit sharing, it also must be taken into account that there is a significant number of traditional

products in the life-style, wellness and food additive sector that make use of TK but which are not patented

and for which alternate legal avenues for benefit sharing need to be developed.

Thirdly, regarding the implementation of the ABS system, it is recommended that the issue of registration of

the information and instruments to assure the sharing of benefits should be further explored. Documentation

of TK is discussed in its defensive function to prove prior art in the patenting processes, or in the context of

positive legal protection.

28. The sharing of benefits resulting from the use of GRs and TK is based on a purely contractual relationship

between the ABS parties. More stringent solutions ought to be evaluated, in particular at the interface with

technology transfer, such as voluntary licensing, the option of compulsory licensing for products resulting

from the accessed information, or the pooling of patents, joint ownership of rights and creation of joint

ventures. Fourthly, as regards the legal protection of TK, we propose to further assess the development of

specific sui-generis intellectual property rights (traditional intellectual property rights; TIP-Rights). Art.10bis of the Paris Convention, forming part of the WTO TRIPs Agreement, offers a foundation in place on

unfair competition rules. Even if that provision, in principle, is sufficient to prevent so-called bio-piracy, a

specific sui-generis right would clarify conditions and rights, including their potential registration.

29. Negotiations are still ongoing. The plan is to adopt an ABS protocol to the Convention on Biological

Diversity at COP 10, in the fall of 2010. Here, debates are moving among others into discussing the

temporal scope of the ABS system.21

2. ACCESS TO PLANT VARIETIES AND ANIMAL BREEDS

30. From the perspectives of equitable recognition of prior art, and of the creation of incentives for

smallholders for conservation of genetic diversity, the Committee recommends to examine on the one

hand options to strengthen the position of farmers and small breeders, and on the other had to assess the

impact of intellectual property rights for animal and plant breeding on access to genetic resources by

smallholders.

31. Firstly, in order to strengthen the rights of farmers in the framework of the International Treaty on Plant

Genetic Resources for Food and Agriculture (ITPRGFA), mechanisms to facilitate access to the

Multilateral System for smallholders ought to be created, as well as specific criteria for the allocation of

funds. Secondly, with regard to the rights of farmers to their breeds, it will be necessary to examinewhether the DSU criteria in the UPOV system could be partly adapted and relaxed to allow protection of

improved farmers varieties that result from controlled on-farm breeding processes. Thirdly, the impact of

biotechnology patents for innovation in the area of plant and animal breeding need to be assessed, as well

as the effects of TRIPS-plus treaties on the farmers privilege. Fourthly, regarding animal genetic

resources, by analogy to the investigations on plants and plant breeding, the basic processes in animal

21 There is a strong claim by biodiversity rich countries that benefits arising from the continuing and new utilization

of genetic resources and associated traditional knowledge acquired before the date of entry into force of the CBD

(ex-situ resources) are to be shared too.

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breeding and the instruments used to protect animal breeds should be further investigated, and the

interface with biotechnological methods analysed. On this basis, possible solutions for defining animal

breeders rights and livestock keepers rights could be assessed and the ABS system of the CBD tested for

its application to animal genetic resources for food and agriculture.

32. Ideas forwarded by stakeholder groups are to create an International Treaty on Animal Genetic Resources

analogous to the ITPGRFA and/or to create Animal Breeders Rights analogous to Plant Breeders Rights.

The matter must hereby be placed in the light of what is called the erosion of animal genetic resources,

as documented by the FAO in its State of the Worlds Animal Genetic Resources for Food and

Agriculture.22

Market Access and International Trade Regulation

A. General Provisions and Technical Barriers to Trade

1. GATT

33. The question arises whether biotech products may be treated as like or equivalent to conventionally

made products under the GATT. Another important issue concerning biotechnology is the possible

justification of trade restrictions set out in GATT Article XX (GATT Article XX (b) on health

considerations and GATT Article XX (g) on biodiversity conservation). The Committee holds that Article

XX (b) and (g) GATT could be successfully invoked if there is compelling proof of the negative impact of

biotech products on human health or biodiversity respectively.

34. Concerning the issue of Production and Process Methods (PPMs), jurisprudence has become increasinglyresponsive to non-trade concerns and it has been clarified that the interpretation of WTO rules should be

carried out in a way that allows for taking into account the goal of sustainable development. The

Committee sees two well-founded reasons why such a method of differentiation of like products may

should become practice under WTO trade law jurisdiction. Firstly, consumer tastes perceptions and habits

are recognized as a criterion for the determination of like products. Secondly, it is submitted that PPMs

may have a greater influence on the environment than the end-product itself. At the same time, the

Committee recognises the concerns in particular of developing countries that the like product analysis

within Article III GATT or within Art. XX(b) and (g) GATT must not widen the scope for green and

social protectionism.

2. TBT AND SPS AGREEMENTS

35. Genetically modified products fall either under the WTO TBT or SPS Agreement, the latter specifically

addressing food stuffs (sanitary and phytosanitary measures). The panel inEC Measures affecting the

22 FOOD AND AGRICULTURE ORGANISATION OF THE UNITED NATIONS, The State of the Worlds Animal

Genetic Resources for Food and Agriculture, Commission on Genetic Resources for Food and Agriculture, Rome,

2007, available at: ftp://ftp.fao.org/docrep/fao/010/a1250e/a1250e.pdf(last visited 7 February 2009).

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approval and marketing of biotech products23

found that genetically modified foodstuffs lived up to the

definitions in Annex A of the SPS Agreement, albeit it may be doubted that biotechnology matches the

disease and pest related definitions. While SPS measures may be imposed only to the extent necessary to

protect human, animal or plant health from food-borne risks or from pests or diseases, WTO Members

may enact TBT regulations when necessary to meet a number of legitimate objectives.

36. The TBT Agreement, like the GATT, states that trade restrictive measures should not discriminate

between imported products and like products of domestic or foreign origin. A non-exclusive list of

objectives is given in Article 2.2 of the TBT Agreement and includes the prevention of deceptive

practices, the protection of human health or safety, animal or plant life or health, or the environment.

37. The SPS Agreement obliges Members to base food standards on existing international standards, but also

to have recourse to stricter requirements provided there is sufficient scientific evidence that the level of

appropriate risk, as defined by a government, cannot be met on the basis of the international standard.

Where the science is uncertain, Article 5.7 SPS permits the provisional adoption of precautionary

measures on the basis of available pertinent information. A WTO Member may provisionally adopt anSPS measure if this measure is: (1) imposed in respect of a situation where relevant scientific evidence is

insufficient; and (2) adopted on the basis of available pertinent information. Such a measure may not be

maintained unless the Member that adopted it: (3) seeks to obtain the additional information necessary for

a more objective assessment of risk; and (4) reviews the measure accordingly within a reasonable period

of time.

38. The current SPS Agreement is ill-suited to deal effectively with increasing scientific requirements in

assessing risks deriving from the application of new technologies in food production and agriculture, e.g.

biotechnology and nanotechnology. Problems relating to an unclear or missing functional separation of

risk assessment and risk management as identified by the Codex Alimentarius Commission, i.e. corruption

of scientific integrity, confusion over the role of risk assessors and risk managers, and conflicts of interestscan be observed in SPS case law. In the case Australia Salmon, scientific integrity was corrupted by the

Australian Department of Primary Industries and Energy reversing the scientific findings of its Quarantine

and Inspection Service for protectionist motives.24 Confusion over the functions of risk assessors and risk

managers became apparent in the EC Hormones case.25 Conflicts of interests were found by the

Appellate Body in the Continued Suspension cases, which considered that institutional affiliations of

scientific experts with the Joint FAO/WHO Expert Committee on Food Additives (JECFA) had

"compromised the adjudicative independence and impartiality of the Panel".26

The finding implies that the

best experts in the field cannot be employed both in JEFCA and in assessing national standards in WTO

dispute settlement.

23 WTO PANEL REPORT,European Communities Measures Affecting the Approval and Marketing of Biotech

Products, WT/DS291/R, WT/DS292/R, WT/DS293/R, 21 November 2006.

24 WTO PANEL REPORT,Australia Salmon, [0][0]para 8.154; finding upheld by the Appellate Body, WTO

APPELLATE BODY REPORT,Australia Salmon, WT/DS18/AB/R, 20 October 1998, paras. 170, 173.

25 WTO APPELLATE BODY REPORT,EC Hormones, para. 206.

26 WTO APPELLATE BODY REPORT, US/Canada Continued Suspension, paras. 456-482, in particular para. 481;

reversing Panel's findings in US Continued Suspension, paras. 6.22, 6.62-6.63 and 7.85 /Canada Continued

Suspension, paras. 6.21, 6.57-6.58 and 7.83.

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39. The Committee therefore recommends to review the SPS Agreement, and to base it, commensurate with

the Protocol on Biosafety, on a clear distinction between risk assessment, risk management and risk

communication. In doing so, it recommends placing scientific risk assessment on the level of international

cooperation, while leaving risk management under the responsibility of national authorities.

a) Risk Assessment

40. Biotechnology risk assessments are a complex task. It is proposed that risk assessments, especially for

complex and new risks, e.g., risks deriving from the application of biotechnology, should be administered

at the international level. A risk assessment body and network of scientific institutions should be created

accessible to risk managers from developed countries as well as from developing countries and LDCs. It

would enable in particular the latter, to overcome the threshold of article 5.1 SPS requiring SPS measures

to be based upon an assessment of the risks to human, animal or plant life or health, taking into account

risk assessment techniques developed by the relevant international organizations. The burden of

(biotechnology) risk assessment should be shifted to international organizations.

b) Risk Management

41. While scientific risk assessment falls under international responsibility, risk management belongs to the

realm of national authorities in determining appropriate levels of risk, taking into account economic and

socio-economic factors, which may vary from country to country. A risk assessment may range from zero

risk to high risk, depending upon the assessment of all pertinent factors at stake. The determination of the

appropriate level of sanitary or phytosanitary protection in article 5 SPS in general and article 5.7 SPS in

particular should thus fall under the definition of risk management. In support of developing countries, it is

proposed that the reference to international organizations in article 5.7 SPS should be reinforced. It is

recommended that in the second sentence of article 5.7 SPS, WTO Members and, especially developing

countries and LDCs, should be able to rely on additional information provided by the relevantinternational organizations instead of being urged to provide the additional scientific data themselves.

c) Risk Communication and Consumer Protection

42. Finally, it is appropriate to introduce disciplines relating to risk communication into the SPS Agreement.

Inspired by information principles developed by the Convention on Access to Information, Public

Participation in Decision-Making and Access to Justice in Environmental Matters (Aarhus Convention,

discussed below), the SPS Agreement should enable consumers to secure access to information necessary

for making informed judgements.

43. There is a need to give serious consideration to consumer interests in international biotechnology law.

With regard to consumer welfare and public health, food safety is the most important aspect, and to that

end biotech products in many countries are often subject to mandatory pre-marketing authorization

procedures involving a scientific assessment of potential risks. Regarding biotech trade, many countries

have by and large adopted the following measures for consumer protection: (1) pre-marketing approval

procedures; and (2) post-marketing labelling and information requirements. These measures are deemed

critical to risk assessment and the management of food safety and are grounded in the principle that

informed choice is a consumer right.

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44. The WTO Agreements include some provisions and agreements directly or indirectly addressing consumer

protection. The approval of biotech products should be subject to Article 8 and Annex C (1) (a) of the SPS

Agreement. Furthermore, a labelling requirement designed to avoid adverse effects or risks to the

consumer as a result of the presence of a biotech product may be considered an SPS measure, which is

covered by Annex A (1) of the SPS Agreement.

45. Labelling is recognized in many countries as a necessary component of the consumers right to

information, and as a tool for making an informed choice. As a whole, the general purpose of labelling is

to ensure that accurate information is available to consumers to enable them to exercise their freedom of

choice in an effective manner. International standards on food safety developed under the Codex

Alimentarius are officially recognized international guidelines for ensuring food safety and fair trade

practices. So far, however, the Codex Alimentarius has not adopted any GMO labelling standards. The

Committee suggests that this gap be filled, which would considerably enhance legal certainty for the use of

GMO labelling under the WTO. WTO philosophy should gradually shift its focus from the supply-side

interests of industry to the demand, welfare-side of the general consumer. However, a legislative change,

incorporating a consumer clause in the WTO Agreement, will be necessary in order to achieve this

B. The Subsidy Agreements

46. Disciplines on subsidies are of importance in assessing governmental support, either direct or indirect, to

the development of biotechnology. With the extension of biotechnology into the field of energy

production, subsidies no longer are limited essentially to agricultural biotechnology but extend to biofuels.

Therefore, the respective agreements of the WTO are of particular importance to the field of

biotechnology regulation.

1. INDUSTRIAL SUBSIDIES

47. Government subsidies on the application of biotechnology in industrial as well as marine and aquatic

processes are covered by the Agreement on Subsidies and Countervailing Measures. Under the ASCM,

two types of subsidies are prohibited: export subsidies or subsidies contingent on export performance

(Article 3.1 (a)); and import-substitution subsidies or subsidies contingent upon the use of domestic over

imported products (Article 3.1 (b)). Other types of subsidies are actionable under the ASCM and can be

successfully challenged only if they are specific within the meaning of the ASCM Article 2 and their

adverse effects on trade are demonstrated according to Chapter III of the Agreement. If a subsidy

programme of a WTO Member for biotech research has a trade-distortive effect (if for instance it has a

depressive effect on prices), the subsidies could be countervailed or a request made for them to be

withdrawn through the WTO dispute settlement system.

2. AGRICULTURAL SUBSIDIES

48. The Agreement on Agriculture (AoA) applies to the biotechnology for agricultural applications, including

production of and trade in GM crops. If the Doha Round negotiations conclude successfully, it may be

expected that amber box subsidies (highly trade-distortive) will be subject to further cuts. This would

include all subsidies granted to farm production and any other subsidy that has a distortive effect on trade

or production in the agriculture sector.

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49. Only the subsidies granted for R&D (for instance relating to research on a certain GM crop) may qualify

as green box measures (not or minimally trade distorting) as part of government service programmes.

This is subject to a precondition that they do not involve direct payments to producers and processors.

Annex 2 provides exemptions for crucial government spending for R&D in the field of biotechnology.

This includes for example research projects being undertaken by some biotech firms aimed at turning

cellulosic materials into transport fuels, which are expected to offer more environmental benefits than

biofuels produced from food crops such as corn or sugarcane while having less impact on food prices.

3. BIOTECHNOLOGY FOR BIOFUELS

50. The classification of biofuels has an important impact on determining the rules applicable to them and on

import tariffs applied to them at borders. It is moreover a decisive element in determining how the WTO

negotiations on market access will lead to liberalization of biofuels markets. In the HS, bio diesel, as one

of the two important biofuels, is classified under Chapter 38 and is clearly defined in the World Customs

Organization (WCO) Explanatory Notes, with specific reference to its composition, production process

and end-use as a fuel for diesel engines. Yet it is argued that this definition may not cover bio dieselproduced with the second-generation technology.

51. The current classification of bio-ethanol is more problematic. Ethanol as a biofuel is not specifically

referred to in the HS system. This leaves ethanol to be classified merely according to its chemical

composition making it subject to a more general categorization as undenatured (HS 220710) or denatured

alcohol (HS 220720). The classification of ethanol under Chapter 22 would make the rules of the AoA

applicable to this biofuel in addition to the general rules of the ACSM. It is also proposed that biofuels

should be classified as environmental goods and their related services as environmental services in order

for them to benefit from the ongoing negotiations at the WTO on environmental goods and services

liberalization.

52. The Committee suggests reviewing existing disciplines on subsidies and the interface with industrial and

agricultural subsidies in the field of biotechnology. The classification of biofuels for purposes of customs

needs revision and adaptation within the Harmonized System.

International Environmental Law

A. The CBD Convention

53. Advances in biotechnology have prompted debate and development in the field of internationalenvironmental law. Biotechnology often entails the release of the resulting GMOs into the environment.

The potential impact of such releases on other species and ecosystems has not yet been considered to be

fully explored or understood. The main area of environmental concern has been the potential effect of

intentional or unintentional releases of genetically modified organisms (GMOs). Such releases are

specifically addressed, albeit rather briefly, by the CBD, and the transboundary movement of GMOs is

addressed in more detail by the Biosafety Protocol. Notwithstanding the adoption of the Protocol in 2000,

in 2004, the World Conservation Union (IUCN) World Conservation Congress adopted a resolution

calling for a moratorium on further environmental releases of GMOs until they could be demonstrated to

be safe for biodiversity and for human and animal health beyond reasonable doubt. In addition to efforts

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on global scale, some rules and procedures of regional application have been developed or have been

proposed.

54. Article 8 of the CBD addresses the regulation of risks associated with GMOs by calling on Parties to (g)

establish or maintain means to regulate, manage or control the risks associated with the use and release of

living modified organisms resulting from biotechnology which are likely to have adverse environmental

impacts that could affect the conservation and sustainable use of biological diversity, taking also into

account the risks to human health. The Biosafety Protocol supplements the provisions of the CBD on

regulating risks associated with GMOs. It specifically focuses on transboundary movements of living

modified organisms and envisages a system of an advanced informed agreement (AIA) in this regard. The

AIA procedure only applies to the first transboundary movement of a particular GMO into a country for

intentional introduction into the environment (for example, seeds for open field trials or for commercial

growing). The Protocol does not prohibit trade in GMOs between Parties and non-Parties, but it requires

that such transboundary movements be carried out in a manner consistent with the objective of the

Protocol. Since major exporters of GMOs remain non-Parties, this provision is of enormous potential

significance.

B. The Quest for Good Governance in Open Field Biotechnology

55. In the framework of this report the need for good governance in open-field biotechnology is stressed.

Good governance is approached as a form of administrating public decision-making characterized by

public accessibility and participation, consensus orientation, transparency and responsiveness. By these

means, it effectively serves to increase the social legitimacy of those regulatory frameworks that deal with

issues under a high level of public scrutiny, such as biotechnology.

56. Open-field biotechnology is a unique field of scientific enquiry. In contrast to the existence of broad

databases and of well-established theories on the hazards of physical technologies, the study of the

hazards of biotechnology is as yet in embryonic state and there is no integrated historical biosafety

database on the behaviour of different GMOs in a variety of open-field contexts. A further challenge for

the regulators of genetic engineering is how to balance the range of interests and perspectives and to take

into consideration a mosaic of different social, ethical, and environmental and public health concerns,

interests and risk perceptions. As has been acknowledged, genetic engineering, in addition to its effects on

human health and biodiversity, might pose considerable risks to economic and social structures. There is

thus also a need to address non-environmental risks. International law will need to take into account

diverging views into account and work towards commonly accepted disciplines in international economic

law and international trade regulation.

57. Owing to the absence of sufficient databases with information on the possible effects of GMO releases, the

nascent stage of the relevant scientific research, and the structural difficulties in identifying and

quantifying the various potential long-term impacts, the formulation of an ex-ante risk analysis framework

seems the most appropriate model of organizing the required system of rules on licensing. This model of

authorization would contain an obligation to provide detailed information on the organism in question and

to seek the prior informed consent of the relevant national authority. Furthermore, because plants cannot

be uniformly resistant to specific diseases, pests or other climate conditions, and natural ecosystems are

dynamic in their functioning and unique in their features, each release should be evaluated individually.

Moreover, the formulation of the necessary structures not only for the dissemination of technical

information, but also for the provision of procedural opportunities to the various stakeholders to express

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their ethical and socio-economic views, is to be considered as a necessary element of a framework for the

regulation of genetic engineering.

58. Against this background, risk assessment is seen as a process exclusively based upon scientific evidence.

Risk management, on the other hand, responds to risks scientifically assessed. It allows governments to

define appropriate levels of risks to be incurred (including the option of zero risk). It is here that social and

economic factors may be considered. The philosophy allows applying the precautionary principle

whenever assessments are not conclusive.

1. THE BIOSAFETY PROTOCOL

59. The Biosafety Protocol to the CBD is essentially based upon the philosophy of comprehensive risk

analysis. The particular public participation clause contained in Article 23 of the Protocol is the sole

evidence of the Cartagena Protocols approach towards good governance. In fact, Article 23 establishes a

two-level structure for public participation. Overall, the provision is however minimally prescriptive

although it leaves the choice of means of fulfilment to the parties involved. It fails for instance to indicate

the type of information regarding GMOs that should be made available to the public. It should also be

noted that there is no reference to what might constitute public participation in the process for the

authorization of GMO releases. Public participation and the potential inclusion of socio-economic

considerations moreover constitute two of the least elaborated aspects of the Cartagena Protocol in terms

of their discussion by the Meeting of the Parties and the relevant expert working groups.

In paragraph 2 of Article 26, the Cartagena Protocol seems to encourage Parties to the Cartagena Protocol to

cooperate on research and information exchange on any socio-economic impacts of living modified

organisms (GMOs), especially but not limited to impacts on indigenous and local communities.

However, there is no clear mechanism for introducing such concerns into the central control mechanism of

the risk assessment. Non-scientific issues have not been embodied in a standardized manner within thisparticular licensing framework either as part of its substantive content or of its set of procedural rules.

2. THE AARHUS CONVENTION

60. The development and specification of the terms of operation of the Cartagena Protocols public

participation provision has been taking place within the framework of the GMO Working Group of the

Aarhus Convention. The Convention recognizes that sustainable development can only be achieved

through the involvement of all stakeholders and seeks to promote greater transparency and accountability

in the operation of public decision-making mechanisms through safeguarding the rights of public access to

information on the environment, public participation and public access to justice in matters pertaining to

the environment. It should be noted that despite the innovative and detailed character of the guidelinesadopted, neither the Decision of the Parties nor the Guidelines, as such, refer to the need for taking into

account socio-economic considerations that constitute the bulk of comments submitted by the public on

genetic engineering issues, thereby perpetuating the technical character of the biosafety framework that

effectively prevents a meaningful contribution by those actors who do not possess the required technical

knowledge.

61. The amended Article 6 requires Parties to inform and consult the public when decisions are made

regarding the deliberate release and placing on the market of GMOs. The public should have the right to

submit comments and public authorities should take these into account in the decision-making process.

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The scope of this revision has been the safeguarding of transparency in the dissemination of all

information that relates to the use and environmental impact of GMOs (article 21(6) of the Cartagena

Protocol). The amendment is an important development if one considers that the introduction of these

good governance clauses ensures a minimal standardized approach to how public participation and access

to information should be organized at the international level and the role of the public in making decisions

on GMOs. At the same time it leaves space for national biosafety frameworks to adopt stricter measures

that could enhance public participation and access to information in the field of agricultural biotechnology.

C. General Principles and Customary Rules of International Environmental Law

62. Customary rules and principles of general international law remain relevant, particularly as regards non-

parties to the CBD and/or Cartagena Protocol, to aspects of the regulation of risks associated with GMOs

that are not fully addressed by the Biosafety Protocol. The Committee suggests giving further

consideration to the role of Principle 21 of the Stockholm Declaration on state responsibility, the principle

of cooperation, and the relevance of the precautionary principle to the protection of the environment from

risks associated with biotechnology.

63. The issue of state responsibility is relevant to biotechnology since the international nature of trade in

biotechnology products, such as biotechnological agricultural products, means that the risks attached to it

are also of an international nature. There are a few areas which could still result in the fragmentation of the

state liability rules in biotechnology. First, it has been argued that transboundary injury is a relative and

vague notion, which is arguably compounded by the additional qualification of significant as discussed

in various cases such as Trail Smelterand Corfu Channel. This may make it impossible to formulate a

general rule of international law fixing a level at which the damages produced by transfrontier pollution

can be deemed to be substantial. Second, there is a problem in choosing which standards should apply to

injury caused by biotechnology. They are either to be based on fault liability, on strict liability, on absolute

liability, or on a mixture of these standards. Traditionally, international law has conditioned the imposition

of state responsibility on a showing of negligence. Third, the question whether liability under international

law requires culpability remains disputed. While in the past both academia and jurisprudence, based on

Hugo de Groots qui in culpa non est, natura ad nihil tenetur, required culpability, the lack of any

corresponding rule of treaty law makes one wonder if this is still the case.

64. There are several areas where fragmentation in international civil liability rules exists. First, there are

different international rules governing cross border litigations which could be applicable to biotechnology

civil liability claims. Secondly, there are conflicting rules on applicable law depending on the rule in an

individual country where no single solution may be wholly satisfactory for all torts. Thirdly, rules on the

enforcement of foreign judgment vary from one jurisdiction to another.

65. Contemporary technological and industrial development involving biotechnology has led to the emergence

of the concept of international liability focusing specifically on reparation for harm arising from acts not

prohibited by international law, which carry the risk of transboundary harm. The new concept is more

concerned with reparation of loss or injury that may arise from such activities, than with the wrongfulness

of the conduct of the state causing the damage. This new concept of liability is considered as

complementary to the classic responsibility of states for wrongful acts. International liability rules in

biotechnology, in the form of state responsibility and/or civil and state liability, are fragmented and subject

to national laws, rather than being part of a comprehensive and harmonized system.

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1. HARMONIZATION

66. Harmonization of certain rules such as standards of liability in biotechnology is being influenced by public

perception, which is complex. The main process of harmonization of liability rules in biotechnology is

taking place within the Cartagena Protocol framework and the end result could be limited to the liability

arising from activities and products or materials within the scope of the Protocol. The Parties to theCartagena Protocol established an open-ended Ad Hoc Working Group of Legal and Technical Experts

on Liability andRedressto carry out the process pursuant to Article 27 of the Protocol.

67. During its fifty-eighth session in 2006, the ILC adopted the text of the preamble and a set of eight draft

principles on the allocation of loss in the case of transboundary harm arising from hazardous activities.

The Commission concluded that the form of the instrument, i.e. draft principles, has the advantage of not

requiring a harmonization of national laws and legal systems and that widespread acceptance is more

likely if the outcome is cast as principles. The draft adopts the strict liability approach. In such matters, it

is widely recognized that it would be unjust and inappropriate to make the claimant shoulder a heavy

burden of proof of fault or negligence in respect of highly complex technological activities whose risks

and operation the concerned industry closely guards as a secret. The case for strict liability is strengthened

when the risk has been introduced unilaterally by the defendant.

68. In assessing liability in biotechnology, the Committee recalls that liability is closely related to levels of

risks adopted in a particular field. Countries welcoming biotechnology and its potential adopt different

standards than countries critical or hostile to biotechnology. The concept of liability adopted mirrors

attitudes of a given society to the technology. The Committee therefore considers that international law

should be limited to adopting a minimal standard of product liability while allowing nations to impose

stricter standards commensurate with their interests. The matter is not suitable for legal harmonization.27

69. The Committee, at the same time, suggest developing a mutual fund where countries suffering damage

from transboundary biotechnology could file a claim for compensation. In addition, private biotechnology

exporters should be encouraged to establish their own compensation mechanism along the lines of the

existing mechanism of the International Oil Pollution Compensation Funds existing in the field of marine

pollution (www.iopcfund.org).

2. OTHER OPEN QUESTIONS

70. The Cartagena Protocol has been in force for just five years, and it remains difficult to assess its

effectiveness. Beyond questions of implementation of existing legal rules, there remain a number of

questions which may require further action of clarification.

71. There is a need to point out that transboundary movements of GMOs may to some extent be the subject of

the customary international rules on preventing transboundary environmental harm, if occurring in relation

to a non-Party. In that context, the principle of precaution and other relevant principles may be applicable.

27 See Sufian Jusoh, Liability rules for harms and losses caused by transboundary movement of biotechnology crops

harmonisation or regulatory competition? PhD, University of Berne 2010.

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72. It is furthermore questionable whether the existing rules provide sufficient protection for sensitive

ecosystems and centres of origin or of diversity. The Committee considers that it should be explored

whether some further specific guidance on this point could be achieved by action taken under the CBD

and/or the Protocol or under other relevant international environmental agreements. The situation in regard

to the marine environment and areas beyond national jurisdiction is also in need of clarification. More

generally, while policy debates have for the most part focused on considerations relating to agricultural

biodiversity, special consideration may need to be given to particular risks posed by GMOs in and to the

marine environment, in particular the High Seas and Antarctica, which since they are global commons

beyond national jurisdiction, call for the appropriate attention of international law.

73. Finally, the Biosafety Protocol does not specifically address specific types of GMOs (e.g. genetically

manipulated fish or genetically manipulated trees) or specific traits associated with certain GMOs.

However, it is noteworthy that the Conference of the Parties (COP) reaffirmed the need for a precautionary

approach and called on parties to authorise the release of genetically manipulated trees only after

completion of studies in containment as well as science-based and transparent risk assessments. It seems

likely that further attention will need to be given to this issue in the future, and possibly to other specifictypes and traits of GMOs.

D. The Relationship to WTO Law

74. Biotechnology, on the international level, is covered by the said Multilateral Environmental Agreements

(MEAs), which build their judicial content upon a precautionary approach. On the other hand, WTO trade

law is deemed to focus on the abolition of trade barriers and the combating of protectionism and

unjustified discrimination. Therefore, there is a potential for conflict between trade law and MEAs,

especially in the field of biotechnology. Most of the public debate centres on the compatibility of the

Cartagena Protocol with the SPS Agreement.

75. The general objective of the Cartagena Protocol, namely the conservation and sustainable use of

biodiversity is built upon the precautionary approach as stated in Article 15 of the Rio Declaration, which

is far less restrictive than the SPS Agreement. In this context, it needs to be determined how general

international law rules on interpretation can be used to create a workable interface between trade law and

MEAs. It should be underlined that such possibilities are in line with the general objective of the

international trade law regime, namely that of contributing to sustainable development and the well-being

of all humans. Similarly, MEAs are not intended to foster protectionism or unjustifiable discrimination

Consequently, it is submitted that MEAs and WTO Agreements on trade law are not deemed to conflict

and that there is enough room for flexibility and negotiations. Therefore, the Committee does not make

any recommendations de lege ferenda. The Committee does, however, recommend de lege lata the

application of general international rules on interpretation and, more specifically, the application of

principles and criteria of coexistence and coherence, i.e. the principle of not adding to or not diminishing

the rights and obligations and the concept of no hierarchy, mutual supportiveness and deference. As to

the question of the extent to which inspiration by the provisions of the Cartagena Protocol is legally

possible when it comes to the settlement of disputes in the field of trade in GMOs, the Committee refers to

the concept of indirect applicability. Moreover, it recalls its findings above relating to PPMs and the

adaptation of WTO law to the theory of risk assessment and risk management of the Cartagena Protocol.

Both allow for bringing about coherence between trade and environmental law.

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Recommendations

DRAFT RESOLUTION No: 5/2010

THE INTERNATIONAL LAW ON BIOTECHNOLOGY

The 74th Conference of the International Law Association, held in The Hague, Netherlands, August 15-20, 2010:

RECOGNISING the importance of modern biotechnology in plant and animal breeding, in health care and for

the supply of renewable forms of energy;

MINDFUL of the benefits and risks introduced by modern biotechnology in relation to human health and humandignity, the life and health of plants and animals, and the environment;

TAKING INTO ACCOUNT the development of international and domestic rules, laws and regulations in

modern biotechnology, being developed in various international fora and international organisations, in

particular the United Nations, the World Health Organization, the Convention on Biodiversity, the World Trade

Organization and the Council of Europe; and

RECOGNISING that domestic and international rules are highly fragmented and efforts to achieve greater

coherence should be made in the process of vertical and horizontal co-ordination of regulation of biotechnology

while taking into account diverging regulatory needs among sectors and among domestic jurisdictions;

HAVING CONSIDERED the Reports of the Committee on International on Biotechnology;

THANKS the Chair, the Rapporteurs and the members of the Committee for the valuable work done;

ADOPTS the following Recommendations prepared by the Committee.

THE HAGUE RECOMMENDATIONS ON INTERNATIONAL LAW ON BIOTECHNOLOGY

In General

1. Regulation of modern biotechnology in international law amounts to a cross-cutting effort. It needs tobe addressed in different fora and instruments. The technology is not suitable for a single and all

encompassing international agreement administered by a single international organization. The

development of international law on biotechnology therefore should be pursued in different fora.

2. Biotechnology, in particular plant biotechnology, plays a different role in different countries as its

prospects and ethics are assessed differently. Accordingly, international law needs to allow for a range

of differing regulations, also taking into account different levels of social and economic development.

3. Particular attention in the field of biotechnology needs to be paid to the interests and conditions of

developing countries. Access to technology, appropriate disciplines on benefit sharing and respect for

traditional knowledge and respect for biodiversity in foreign direct investment are all of paramount

importance in bringing about fair and equitable rules in the field.

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4. Regulation of modern biotechnology requires a carefully balanced allocation of rules both on the

international and the domestic level. The role of international law is limited and should focus on key

and framework issues relevant for the protection of human rights, consumers and the environment ininternational trade of goods and services relating to biotechnology. Allocation of regulatory powers

should take into account the concept of multilayered governance, assigning appropriate tasks to

appropriate layers of governance.

5. The relationship of different international agreements is defined by the rules of customary international

law including those expressed by the Vienna Convention on the Law of Treaties and its Article 31(3)(c)

in particular. It does not presume the priority of one set of rules over another set of rules in different

instruments. All are of equal standing and importance. Application and interpretation of pertinent treaty

rules should seek to bring about coherence and to avoid conflict among different rules. This should also

apply even where the ratifications of the respective treaties are not fully identical.

6. Cooperation and coordination between the competent international institutions (including, but not

limited to UNESCO, UN Human Rights Committee, WHO, FAO, UNCTAD, OECD, WTO, WIPO,

UPOV, UNEP and the World Bank) in the field of biotechnology and human rights should be fostered.Cooperation should also be improved at all levels, i.e. international, regional, national and local.

Human Rights and Bioethics

7. Existing standards of human rights protection fully apply to biotechnology. Human rights need to be

taken into account in shaping rules and regulations of biotechnology on all levels of governance, both

international and domestic. In particular, human rights are of importance in shaping appropriateprocedures in the field of biotechnology. The principle of human digni