![Table of Cases
European Court of First Instance
A v Commission (Case T-18/10/39) [1994] ECR II-179 ..............................332
Alpharma Inc v Council (Case T-70/99) [2002] ECR II-3305 ..............394, 398
Land Oberösterreich and Austria v Commission (Cases T-366/03 and
T-235/04), 5 Oct 2005, not yet reported...........................31, 200, 391, 400
Pfizer Animal Health SA v Council (Case T-13/99) [2002]
ECR II-3305.................................................................................195, 394, 398
European Court of Human Rights
Pretty v UK, Judgment of 29 Apr 2002 ........................................................374
European Court of Justice
Austria v Commission (Case C-492/03) [2004] OJ C/21/20 ........................31
Case C-292/97, 13 April 2000 ...............................................................372, 382
Commission v CEV
A Santé Animale SA and Pfizer Enterprises Sàrl,
Judgment of 12 July 2005 ...........................................................................19
Commission v Italy (Case C-456/03), Judgment of 16 June 2005,
not yet reported...........................................................................................30
ERT (Case C-260/89) [1991] ECR I-2925 .....................................................372
Glawischnig (Eva) (Case C-316/01) [2003] ECR I-5995 ................................30
Greenpeace France and others v Ministry of Agriculture (Case C-6/99)
[2000] ECR I-1651..................................................................30, 44, 182, 398
Ministero della Salute v Codacons et al, Judgment of 25 May 2005,
not yet reported...................................................................................30, 398
Mlle M v Commission (Case 155/78) [1980] ECR 1797...............................332
Monsanto Agricoltura Italia SpA and Others v Presidenza del
Consiglio dei Ministri and Others (Case C-236/01) [2003]
ECR I-8105....................................................................30, 44–6, 48, 182, 398
National Farmers’ Union (Mad Cow Disease case) (Case C-157/96)
[1998] ECR I-2211.........................................................................................46
Netherlands v Parliament and Council (Case C-377/98) [2001]
ECR I-7079 ............................................................30, 35, 38, 295-6, 375, 380
Norbrook (Case C-127/95) [1998] ECR I-1531 .............................................190
Opinion 2/00 (Cartagena Protocol on Biosafety) [2001] ECR I-9713...............30
Thetford/Fiamma (Case 35/87) [1988] ECR 3585 .........................................205
UK v Commission (Mad Cow Disease case) (Case C-180/96)
[1998] ECR I-2265 ................................................................................46, 190](https://image.slidesharecdn.com/25333700-250509224635-57073c3a/85/Biotechnology-And-International-Law-Francesco-Francioni-Tullio-Scovazzi-Editors-7-320.jpg)
![Wachauf (Case 5/88) [1989] ECR 2609 .........................................................372
X v Commission (Case C-404/92) [1994] ECR I-4737 .................................333
European Patent Office
Antanamid, BPatG, 28 July 1977, [1978] GRUR 238 ...................................204
Onco-Mouse/Harvard III, decision of 3 Apr 1992, [1992] OJ EPO 588........17
Relaxin, 8 Dec 1949, Case V 8/94, [1995] OJ EPO 338C............................204
Schicktkeratotransplantat, 12 Dec 1983, [1985] GRUR 276..........................204
Serotoninrezeptor/Eli Lilly, 14 Jun 2000, Case T 241/95, [2001]
GRUR Int 460 .............................................................................................204
GATT Panel Reports
Japanese Measures on Imports of Leather, BIDS 31S/94, 2 Mar 1984...........248
GERMANY
Red Dove, BGH, 27 Mar 1969, BGHZ 52......................................................204
International Court of Justice
Gabcíkovo-Nagyamros Project, Case Concerning the (Hungary v Slovakia)
[1997] ICJ Rep 7 ...............................................................................18–20, 47
Icelandic Fisheries cases [1974] ICJ Rep 3.........................................................37
Legality of the Threat or Use of Nuclear Weapons, Advisory Opinion
[1996] ICJ Rep 226 .......................................................................................18
International Military Tribunal for the Former Yugoslavia (ICTY)
Prosecutor v Anto Furundzija, Case IT-95-17/1-T, 10 Dec 1998.................336
International Tribunal for the Law of the Sea (ITLOS)
Camouco Case (Panama v France) [2000] ILM 666........................................132
Monte Confurco Case (Seychelles v France), Case No 6 ................................132
MOX Plant (Ireland v UK), Order of 13 Nov 2001..................................18, 20
Southern Bluefin Tuna (New Zealand v Japan; Australia v Japan),
Order of 27 Aug 1999..................................................................................18
United States of America
Buck v Bell 274 US 200 (1927) ........................................................................317
Diamond v Chakrabarty 447 US 303 (1980) ...................................................204
Kewanee Oil v Bicron 416 US 470 (1974) .......................................................208
WTO
Australia – Salmon, WT/DS18/AB/R, 20 Oct 1998 .................49, 190, 193–4
EC – Asbestos, WT/DS135/AB/R, 12 Mar 2001...........................39, 184, 198
x Table of Cases](https://image.slidesharecdn.com/25333700-250509224635-57073c3a/85/Biotechnology-And-International-Law-Francesco-Francioni-Tullio-Scovazzi-Editors-8-320.jpg)
![8 Francesco Francioni
14 See, in particular, GA Res. 1803 (XVII 1962), ‘Permanent Sovereignty over Natural
Resources’, reprinted in [1963] ILM 223 (infra, text corresponding to n 23).
15 See United Nations Convention on the Law of the Sea, 1982 [1982] ILM 1261, Part XI.
16 The Antarctic Treaty System was initiated by the 1959 Antarctic Treaty (402 UNTS 71).
17 For a general evaluation of the Antarctic Treaty system, see Francioni and Scovazzi
(eds.), International Law for Antarctica (The Hague, 1996) and the literature cited therein.
resources ‘beyond national jurisdiction’ were subject to the regime of free-
dom. This entailed equal rights of access to the resources of the high seas
and the freedom to occupy and claim territories and resources that
belonged to no other state. In the course of the twentieth century, this
strict dualism yielded to further models of natural resources allocation
and management. First, the option of enlarging the scope of national sov-
ereignty by way of occupation of territories deemed to be terra nullius was
precluded by the prohibition of the use of force, the elimination of colo-
nialism and the concomitant emergence in the 1960s of the principle of
permanent sovereignty over natural resources.14 Secondly, with respect to
the classical regime of the seas, the principle of freedom has undergone
profound transformation as a consequence of the emergence of the new
customary rules allowing states to establish the exclusive economic zone
(EEZ) and the continental shelf, two legal concepts that are based on the
combination of functional sovereignty of the coastal state with a residual
recognition of community interests involved in their exploitation and of
the traditional principle of freedom of the high seas. Thirdly, as perhaps
the most radical departure from the regime of freedom, the principle of
the common heritage of mankind has made the international community
the title holder of the resources of the deep sea bed. An institution—the
International Sea Bed Authority—has been established by the quasi-uni-
versal Law of the Sea Convention15 and a system of prior authorisation
and management has replaced the primitive principles of free access and
first come, first served. Fourthly, in the second part of the last century
innovative and sophisticated models of international management of
resources, over which national sovereignty is absent or contested were
been developed. The pre-eminent example of this model is the Antarctic
Treaty System,16 which combines freedom of access to the continent with
the preservation of certain sovereignty claims and a system of internation-
al inspection, monitoring and strict environmental protection enacted and
implemented by a parliament-like institution, the Antarctic Treaty
Consultative Meeting.17 Fifthly, in the last decade the new concept of
‘common concern of humankind’ has emerged as a legal tool designed to
safeguard the general interest of the international community in the
preservation of certain components of the global ecosystem, such as bio-
diversity and climate. Unlike the common heritage of mankind, the com-
mon concern does not purport to vest title over relevant resources, but](https://image.slidesharecdn.com/25333700-250509224635-57073c3a/85/Biotechnology-And-International-Law-Francesco-Francioni-Tullio-Scovazzi-Editors-42-320.jpg)
![with an evident oxymoron, that ‘[t]he concept of the common heritage of
mankind, as applied in the International Undertaking on Plant Gene-
tic Resources, is subject to the sovereignty of states over their plant genetic
resources’.20
The adoption of the Biodiversity Convention in 1992 confirms this
return to sovereignty. The preamble to the Convention proclaims that
‘[s]tates have sovereign rights over their biological resources’. The same
concept, in slightly different language, is expressed in Article 15(2). If we
consider that the Biodiversity Convention has been ratified by the vast
majority of the states,21 that its text does not allow reservations (Article
37) capable of diminishing its normative character, and that these provi-
sions reiterate the principle proclaimed by the FAO Conference, the rea-
sonable conclusion is that the legal status of genetic resources cannot
be founded on the common heritage principle, but rather follows the tra-
ditional rule according to which natural resources are subject to the sov-
ereignty of the state in whose territory they are located. It is true that,
following the adoption of the Biodiversity Convention, traces of the com-
mon heritage remained in the Agenda 21 programme of strengthening the
FAO role as trustee of the global common represented by plant genetic
resources through the FAO Global System for the Conservation and
Utilisation of Plant Genetic Resources.22 Yet, however disappointing this
may be, the FAO system never succeeded in becoming the exclusive
mechanism for ensuring the conservation and management of plant
genetic resources. Gene banks and private networks moved in to compete
in the role of collectors and custodians of plant germoplasm, and today
the FAO is only one of the players in the worldwide business of potential
providers of plant genetic resources.
Notwithstanding this failure in making plant genetic resources part of
the common heritage, the regulatory model that emerges from the above
practice significantly departs from the original concept of permanent sov-
ereignty over natural resources as established in the well known GA
Resolution 1803 of 1962.23 First of all, the new model refers to ‘sovereign
rights’ (see the CBD preamble) rather than sovereignty tout court, which
in itself signals a less than absolute power of the territorial state over
genetic resources. But, most important, this model can be qualified as
‘modern’ because it aims at reconciling the sovereignty of the territorial
state with the general interest of the international community in securing
conditions to facilitate access to genetic resources for environmentally
10 Francesco Francioni
20 Res. C 3/91, FAO Conf. 26th Sess. (emphasis added).
21 At 30 Apr 2005 188 states were parties to the Convention; see http://www.biodiv.org/
world/parties.asp.
22 See http://www.fao.org/FOCUS/E/96/06/06-e.htm.
23 See supra n 14.](https://image.slidesharecdn.com/25333700-250509224635-57073c3a/85/Biotechnology-And-International-Law-Francesco-Francioni-Tullio-Scovazzi-Editors-44-320.jpg)
![freedom of the sea.29 However, such analogies with fishing and scientific
research can be quite misleading when it comes to determining the status
of genetic resources beyond national jurisdiction. First, fishing is con-
cerned with harvesting living resources of the sea for human consump-
tion or other commercial uses but has no relation whatsoever with the
activity of identification, collection and possible development of the
intangible patrimony of genetic resources contained in living organisms.
Appropriation of the fish by the fisherman does not entail appropriation
of the wealth of genetic information the catch may yield; any more than
the purchase of a house designed by an architect entails the appropriation
by the buyer of the talent and know-how that the architect bestowed in it.
That talent, although incorporated in the house, is a separate asset with a
continuing vitality and creative potential that the purchaser of the house
cannot own. By the same token, also the application by analogy of the
regime of freedom governing scientific research on the high seas is rather
dubious. In fact, rules relating to marine scientific research are activity
related, in the sense that they establish rights and obligations applicable
to the conduct of science activities at sea, but in no way can such rules,
those contained in Part XIII of the Law of the Sea Convention or the cor-
responding customary rules, be used to establish a legal status of genetic
resources in the high sea and on the international sea bed. This is con-
firmed by Article 241 of the Law of the Sea Convention, which provides
that ‘[m]arine scientific research activities shall not constitute the legal
basis for any claim to any part of the marine environment or its re-
sources’.30
Since the principle of freedom cannot be presumed to govern the legal
status of genetic resources of the high seas and deep sea bed, and since
sovereignty is excluded by definition in these areas, the logical conclusion
is that these resources must be deemed to be subject to the principle of
common heritage. They should therefore be placed under the jurisdiction
of the existing institutional mechanisms established with the LOS
Convention or under a new specialised institution to be created within the
same forum. This conclusion is reinforced by the fact that the most prom-
ising repository of marine genetic material is located in the vicinity of
hydrothermal vents in the sea bed, where extreme environmental condi-
tions linked to scarcity of light and temperature variations provide pre-
cious genetic resources that science and technology are just starting to
identify.31 Since such resources are so closely linked to the physical condi-
tions of the deep sea bed, it is unavoidable that the eventual exploitation
12 Francesco Francioni
29 See Part XIII of the Law of the Sea Convention, supra n 15.
30 Emphasis added.
31 See the chapter by Scovazzi in this volume, as well as the debates in the Vth Meeting
of the UN open-ended informal consultative process on oceans and the law of the sea](https://image.slidesharecdn.com/25333700-250509224635-57073c3a/85/Biotechnology-And-International-Law-Francesco-Francioni-Tullio-Scovazzi-Editors-46-320.jpg)
![human genome. The results, now at an advanced stage, open up unprece-
dented prospects of application in life sciences, medicine, and in relation
to the general goal of improving health and welfare of human beings. At
the same time, the prospects of biotechnological applications to human
genetic material have raised fears that human beings may be reduced to
‘means’ in function of technological experimentation or of commercial
goals. Besides, genetic knowledge is deemed to contain the potential for
conscious discrimination based on genetic patterns of individuals or
groups, and on other violations of human rights. Against this problemat-
ic background, international practice over the past ten years has evolved
toward the extension of the principle of common heritage from the field
of economic resources to the new area of the intangible resources repre-
sented by the human genome. Thanks to the vigorous action of UNESCO,
whose mandate in the field of advancement of science and culture is
linked to the constitutional commitment to guarantee ‘the democratic
principle of the dignity, equality and mutual respect of men’ (UNESCO
Constitution),36 a Universal Declaration on the Human Genome and
Human Rights was adopted in 1997.37 Article 1 of the Declaration states
that ‘[t]he human genome underlies the fundamental unity of all mem-
bers of the human family, as well as the recognition of their inherent dig-
nity and diversity. In a symbolic sense, it is the heritage of humanity’.38
Although the use of the phrase ‘in a symbolic sense’ may appear to weak-
en the legal strength of this article, the general context of the Declaration
clearly confirms its intention to proclaim the human genome the common
heritage of humanity. Article 4 provides that the human genome in its nat-
ural state shall not give rise to financial gains. This precludes its patenting
for commercial purposes. Article 10 subjects scientific genomic research in
such fields as biology and medicine to respect for human dignity and fun-
damental rights of individuals and peoples. Further, the Declaration
requires a commitment to international cooperation in the assessment of
risks and benefits deriving from genomic research and in the promotion
of developing countries’ capacity to carry out such research and to bene-
fit from its technological applications.
Obviously, the Universal Declaration on the Human Genome is not a
binding treaty and its text can at best reflect underlying principles of
emerging international law or, at least, constitute a body of soft law
designed to model the evolution of customary law around its standards.
Yet, it is difficult to deny that the Declaration has affected the opinio iuris
of the international community. Its text emanates from the UNESCO
14 Francesco Francioni
36 See the Preamble to the UNESCO Constitution (third sentence), available at
http://www.unesco.org.
37 See Universal Declaration on the Human Genome and Human Rights, 11 Nov 1997,
available at http://www.unesco.org.
38 Emphasis added.](https://image.slidesharecdn.com/25333700-250509224635-57073c3a/85/Biotechnology-And-International-Law-Francesco-Francioni-Tullio-Scovazzi-Editors-48-320.jpg)
![The first principle of international environmental law that may find
useful application in the field of biotechnology is the due diligence obli-
gation incumbent upon every state to prevent damage to the territory of
other states or to common spaces as a consequence of biotechnology activ-
ities that entail release of genetically modified material into the environ-
ment. This obligation can be traced to the Stockholm Declaration,45
Principle 21, and to the Rio Declaration,46 Principle 2, and now forms an
integral part of the International Law Commission draft articles on trans-
frontier damage resulting from hazardous activities (2001).47 An express
recognition of this principle in the field of biotechnology can be found in
the appellate decision of the Examining Division of the European Patent
Office in the well-known case of the Onco-mouse.48 In this case the appli-
cants were seeking patent registration in Europe for the Harvard ‘Onco-
mouse’, a genetically bioengineered mouse resulting from the introduction
into its genetic make-up of a specific onco gene that would make it acute-
ly prone to develop tumours. Besides the moral considerations involved
in assessing a process that entailed the intentional infliction of acute suf-
fering upon a living creature, the Examining Division expressly referred
to considerations relating to the protection of the environment as a neces-
sary element in striking the balance between the usefulness of the inven-
tion and the protection of public order. The Division affirmed:
There is a basic interest of mankind to remedy widespread and dangerous dis-
eases, on the other hand the environment has to be protected against the uncon-
trolled dissemination of unwanted genes . . . .49
Finally the Division held the granting of the patent compatible with the
protection of the environment on the basis of the finding that in the spe-
cific case:
No release is intended into the general environment. Therefore the risk of an
uncontrolled release is practically limited to intentional misuse or blatant igno-
rance on the part of the laboratory personnel carrying out the tests.50
It is useful to recall that, from a general point of view, the principle of
prevention of transboundary environmental harm has been considered to
International Law for Biotechnology 17
45 See Stockholm Declaration on Environment and Development, 16 June 1972 [1972] ILM
1416.
46 See Rio Declaration on Environment and Development, 14 June 1992 [1992] ILM 874.
47 See Draft Articles on Prevention of transboundary harm from hazardous activities, 2001,
available at http://www.un.org/law/ilc/texts/prevention/preventionfra.htm.
48 Onco-Mouse/Harvard III, Examining Division, decision of 3 Apr 1992 [1992] OJ EPO, 588
ff.
49 Para. 4.
50 Para. 4(iv).](https://image.slidesharecdn.com/25333700-250509224635-57073c3a/85/Biotechnology-And-International-Law-Francesco-Francioni-Tullio-Scovazzi-Editors-51-320.jpg)
![be part of customary international law by the International Court of
Justice. In its 1996 advisory opinion on the Legality of the Threat or Use of
Nuclear Weapons the Court affirmed that ‘[t]he general obligation of states
to ensure that activities within their jurisdiction and control respect the
environment of other states or of areas beyond national control is now
part of the corpus of international law relating to the environment’.51 Just
a year after this Advisory Opinion, the International Court of Justice
confirmed this finding in the well known judgment or the Gabcikovo-
Nagymaros litigation between Hungary and Slovakia.52
Besides the principle of prevention, another substantive principle of
international environmental law is particularly suitable for application in
relation to biotechnology: that is the so-called ‘precautionary approach’.
In its substantive dimension, the precautionary approach requires states
to adopt or tolerate the adoption of legislation or administrative measures
that are necessary to forestall foreseeable risks for the environment. A rad-
ical interpretation of this principle—although still a controversial one—
would entail the setting aside or cessation of an economic or technologi-
cal activity that entailed a serious risk for which no reliable assessment or
management method was available. In the field of biotechnology, where
the implications of the release into the environment of bio-engineered
organisms is still surrounded by great uncertainty, this principle can have
a wide scope of application. The Bio-safety Protocol additional to the
Biodiversity Convention has been inspired by the precautionary
approach.53 As we shall see in the following section, the Protocol has insti-
tuted a procedure of prior informed consent for the trade in ‘living mod-
ified organisms’ and permits the adoption of precautionary measures to
restrict imports of such organisms when the risk they pose for the envi-
ronment or health is deemed to be incompatible with the level of environ-
mental protection and safety set by the importing state. In the case law,
the reception of the precautionary approach is still patchy and rather ten-
uous. While specific reference was made to it by the International
Tribunal for the Law of the Sea in the Southern Bluefin Tuna case54 and by
some individual opinions of judges of the same Tribunal in the recent
MOX Plant case,55 other jurisdictions have refrained from pronouncing
18 Francesco Francioni
51 [1996] ICJ Rep 226, 241–242, para. 29.
52 [1997] ICJ Rep 7 41, para. 53.
53 See Cartagena Protocol on Biosafety to the Convention on Biological Diversity, 2000
[2000] ILM 1027.
54 Southern Bluefin Tuna (New Zelanda v. Japan; Australia v. Japan), Order of 27 Aug 1999,
available at http://www.itlos.org, part, para. 77 (see also the individual opinions of judges
Treves and Laing).
55 MOX Plant (Ireland v. United Kingdom) case, Order of 13 Nov 2001, available at
http://www.itlos.org, espec. para. 84.](https://image.slidesharecdn.com/25333700-250509224635-57073c3a/85/Biotechnology-And-International-Law-Francesco-Francioni-Tullio-Scovazzi-Editors-52-320.jpg)
![on the legally binding nature of the approach (Hormones case56 and
Gabcikovo-Nagymaros57) as either a custom or a general principle. On the
other hand, this principle is well entrenched in European Union law and
has been given a robust interpretation in the European judicial practice in
the recent Pfizer case.58 Be it as it may, it is easy to imagine that this prin-
ciple, as a soft law approach or as hard law creating binding obligations,
is bound to play two very important roles in relation to biotechnology.
The first is a complementary role in relation to the principle of prevention
examined above. Where the effect of the release of new genes into the
environment can escape full scientific assessment, the precautionary
approach is part and parcel of every state’s due diligence obligation to see
that activities within its jurisdiction or under its control do not result in
environmental damage.59 The second role is rather procedural, in the
sense that it entails the appropriate use of available practices and scientif-
ic knowledge to ensure that the environmental impact of bioengineered
products or services is fully evaluated before they are released into the
environment. But this leads us to the procedural dimension of interna-
tional environmental law.
When I speak of the ‘procedural dimension’ of environmental norms, I
refer especially to the set of procedural obligations arising from the gen-
eral principle of inter-state cooperation in preventing and minimising
environmental risks. This principle entails a number of duties: the duty to
provide information related to the risk posed by genetically modified
organisms; the duty to consult whenever differences arise as to the nature
and extent of the risk; the duty to allow civil society participation in deci-
sions involving difficult choices between the social advantages offered by
technological innovations and the risks posed by such advances; and,
most important, the duty to provide an environmental impact study of
the specific biotechnology upon the environment and health of the peo-
ple. These different faces of the principle of cooperation have already
International Law for Biotechnology 19
56 European Communities—Measures Concerning Meat and Meat Products (EC—Hormones),
Report of the Appellate Body, doc. WT/DS26/AB/R-WT/DS48/AB/R of 16 Jan 1998, para.
123.
57 See Gabcikovo-Nagymaros Project (Hungary v. Slovakia), [1997] ICJ Rep 7, part. at 42, para.
54.
58 See Commission of the European Communities v. CEV
A Santé Animale SA and Pfizer
Enterprises Sàrl, Judgement of 12 July 2005, available at http://www.europa.eu.int/eur-lex.
59 On the issue of liability for damage caused by deliberate release of genetically modified
organisms, see McGarity, ‘International Regulation of Deliberate Release Biotechnologies’, in
Francioni and Scovazzi (eds.), International Responsibility for Environmental Harm
(London/Dordrecht/Boston, 1991), 319 ff.; Mackenzie, ‘Environmental Damage and
Genetically Modified Organisms’, in Bowman and Boyle (eds.), Environmental Damage in
International and Comparative Law: Problems of Definition and Valuation (Oxford, 2002), 63 ff.](https://image.slidesharecdn.com/25333700-250509224635-57073c3a/85/Biotechnology-And-International-Law-Francesco-Francioni-Tullio-Scovazzi-Editors-53-320.jpg)
![received ample recognition in international practice. In the already men-
tioned MOX Plant case,60 the Law of the Sea Tribunal has formally recog-
nised this principle in relation to the protection of its marine environment.
In the Gabcikovo-Nagymaros case the International Court of Justice, in spite
of its rather shy interpretation of existing norms of international environ-
mental law, did not hesitate to consider the duty to cooperate and to pro-
vide a continuous impact assessment of technological risks as a funda-
mental principle binding upon the parties.61 This practice reinforces the
normative character of the principle of cooperation as enunciated in the
Stockholm and Rio Declarations (Principles 24 and 7, respectively).62
There are other emerging principles of international environmental law
that may have certain relevance to biotechnology. I am thinking particu-
larly of sustainable development and the concept of intergenerational
equity. However, these principles still remain too tenuous to be able to
yield any norm-creating effects.63 In any event, their possible relevance
can be best appreciated in the context of international economic law,
which is the subject of the following section.
IV. BIOTECHNOLOGIES, JUSTICE AND THE EQUITABLE
SHARING OF BENEFITS
If one can speak of an ‘economic constitution’ of the world today, it may
be defined on the basis of the post-World War II liberal project that culmi-
nated in the establishment of the WTO, following the end of the Cold War,
in the development of a worldwide network of bilateral investment
treaties, and the linking to intellectual property protection of the commer-
cial advantages guaranteed by WTO. Such basic system is founded on the
progressive realisation of the freedom of movement of goods and servic-
es, of capital, and to a much more limited extent, of persons seeking eco-
nomic opportunities.
In relation to such framework of principles the problems raised by the
application of biotechnology to economic activities can fall in a variety of
legal categories as large and diverse as the multiplicity of treaty regimes
ranging from trade, intellectual property rights, investments, biodiversity
protections and development assistance, to mention just some examples.
The issues arising in the relationship between biotechnologies and these
20 Francesco Francioni
60 See supra n 55, para. 82.
61 See supra n 57, 68, para. 112 and 78, para. 140. See also the individual opinion of Vice-
President Weeramantry [1997] ICJ Rep 88, at 111–113
62 See supra n 45 and 46 respectively.
63 In this sense, see Lowe, ‘Sustainable Development and Unsustainable Arguments’, in
Boyle and Freestone (eds.), International Law and Sustainable Development (Oxford, 1999), 19 ff.](https://image.slidesharecdn.com/25333700-250509224635-57073c3a/85/Biotechnology-And-International-Law-Francesco-Francioni-Tullio-Scovazzi-Editors-54-320.jpg)
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Biotechnology And International Law Francesco Francioni Tullio Scovazzi Editors
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- 5. Preface This book isthe product of a collective research project organised by the Editors at the University of Siena, the European University Institute of Florence and the University of Milano Bicocca in the period between 2003 and 2005. The basic question it tries to address is how international law is responding, or should be responding, to the new challenges and risks posed by the development and application of modern biotechnology. How scientific and technological progress impacts on the law is not a new problem. Also in the past, international law has faced the challenge of its adaptation to new realities and needs posed by advances in science and technology. Its evolution in the area of the law of the sea, outer space and the control of the offensive use of weapons—to mention just a few—is witness to its capacity of timely and progressive development. In the field of biotechnology, however, the process of adaptation of the law to scientific and technological advances seems particularly problematic. First, although there is general agreement over the need for regulation in the different fields of biotechnology application such as agriculture, life sciences and forensic practices, domestic law remains deeply divided over the approach to take. Should regulation be of the ‘command and control’ type, or be based on flexible codes of conduct, or even left to self- regulation by relevant stakeholders? Second, ethical standards play a fundamental role in determining the limits of the permissible scope of scientific research and in directing scientific progress toward socially and morally acceptable goals, but the diversity of such standards hinder a common understanding of such limits and goals. Third, biotechnology activities are not carried out by the traditional subjects of international law, the states, but rather by private actors in science and business who are not readily amenable within the scope of application of the tradition- al categories of international norms which are designed to regulate state action. These are elements of a new complexity that compound the diffi- culty in building consensus at the international level on the development of new norms along the traditional lines of customary practice and treaty making. This volume is an attempt at covering the most pressing legal issues raised by the impact of biotechnologies on different categories of interna- tional norms. The approach we have chosen is pluralistic in the sense of being based on critical reflections developed in the contributions of a
- 6. diverse group oflegal scholars and experts, with different professional and cultural backgrounds and including academics, practitioners and officials of international organisations. The contributions address: 1) the international status of genetic resources, both in areas of national jurisdic- tion and in common spaces, such as the international sea, the sea bed area and Antarctica; 2) the relevance of environmental principles in the gover- nance of modern biotechnologies; 3) the impact of biotechnology prod- ucts and services on trade rules, including intellectual property law; 4) the human rights implications, especially in the field of human genetics; and 5) the intersection between general international law and regional sys- tems, especially those developed in Europe and Latin America. The overall objective of the book is to provide an up-to-date picture of international law as it stands today and to stimulate a critical reflection and further research on the possible normative solutions that will be required in the years to come. Francesco Francioni European University Institute, Florence Tullio Scovazzi University of Milano Bicocca This book would not have been published without the financial support of various institutions. The Editors wish to express their gratitude espe- cially to the Italian Ministry of the University and Research for the fund- ing of Research Project COFIN 2002 - prot. 2002121574, the European University Institute as well as Universities of Siena and Milano Bicocca, which cofinanced the research and provided support and facilities for the meetings of the participants. vi Preface
- 7. Table of Cases EuropeanCourt of First Instance A v Commission (Case T-18/10/39) [1994] ECR II-179 ..............................332 Alpharma Inc v Council (Case T-70/99) [2002] ECR II-3305 ..............394, 398 Land Oberösterreich and Austria v Commission (Cases T-366/03 and T-235/04), 5 Oct 2005, not yet reported...........................31, 200, 391, 400 Pfizer Animal Health SA v Council (Case T-13/99) [2002] ECR II-3305.................................................................................195, 394, 398 European Court of Human Rights Pretty v UK, Judgment of 29 Apr 2002 ........................................................374 European Court of Justice Austria v Commission (Case C-492/03) [2004] OJ C/21/20 ........................31 Case C-292/97, 13 April 2000 ...............................................................372, 382 Commission v CEV A Santé Animale SA and Pfizer Enterprises Sàrl, Judgment of 12 July 2005 ...........................................................................19 Commission v Italy (Case C-456/03), Judgment of 16 June 2005, not yet reported...........................................................................................30 ERT (Case C-260/89) [1991] ECR I-2925 .....................................................372 Glawischnig (Eva) (Case C-316/01) [2003] ECR I-5995 ................................30 Greenpeace France and others v Ministry of Agriculture (Case C-6/99) [2000] ECR I-1651..................................................................30, 44, 182, 398 Ministero della Salute v Codacons et al, Judgment of 25 May 2005, not yet reported...................................................................................30, 398 Mlle M v Commission (Case 155/78) [1980] ECR 1797...............................332 Monsanto Agricoltura Italia SpA and Others v Presidenza del Consiglio dei Ministri and Others (Case C-236/01) [2003] ECR I-8105....................................................................30, 44–6, 48, 182, 398 National Farmers’ Union (Mad Cow Disease case) (Case C-157/96) [1998] ECR I-2211.........................................................................................46 Netherlands v Parliament and Council (Case C-377/98) [2001] ECR I-7079 ............................................................30, 35, 38, 295-6, 375, 380 Norbrook (Case C-127/95) [1998] ECR I-1531 .............................................190 Opinion 2/00 (Cartagena Protocol on Biosafety) [2001] ECR I-9713...............30 Thetford/Fiamma (Case 35/87) [1988] ECR 3585 .........................................205 UK v Commission (Mad Cow Disease case) (Case C-180/96) [1998] ECR I-2265 ................................................................................46, 190
- 8. Wachauf (Case 5/88)[1989] ECR 2609 .........................................................372 X v Commission (Case C-404/92) [1994] ECR I-4737 .................................333 European Patent Office Antanamid, BPatG, 28 July 1977, [1978] GRUR 238 ...................................204 Onco-Mouse/Harvard III, decision of 3 Apr 1992, [1992] OJ EPO 588........17 Relaxin, 8 Dec 1949, Case V 8/94, [1995] OJ EPO 338C............................204 Schicktkeratotransplantat, 12 Dec 1983, [1985] GRUR 276..........................204 Serotoninrezeptor/Eli Lilly, 14 Jun 2000, Case T 241/95, [2001] GRUR Int 460 .............................................................................................204 GATT Panel Reports Japanese Measures on Imports of Leather, BIDS 31S/94, 2 Mar 1984...........248 GERMANY Red Dove, BGH, 27 Mar 1969, BGHZ 52......................................................204 International Court of Justice Gabcíkovo-Nagyamros Project, Case Concerning the (Hungary v Slovakia) [1997] ICJ Rep 7 ...............................................................................18–20, 47 Icelandic Fisheries cases [1974] ICJ Rep 3.........................................................37 Legality of the Threat or Use of Nuclear Weapons, Advisory Opinion [1996] ICJ Rep 226 .......................................................................................18 International Military Tribunal for the Former Yugoslavia (ICTY) Prosecutor v Anto Furundzija, Case IT-95-17/1-T, 10 Dec 1998.................336 International Tribunal for the Law of the Sea (ITLOS) Camouco Case (Panama v France) [2000] ILM 666........................................132 Monte Confurco Case (Seychelles v France), Case No 6 ................................132 MOX Plant (Ireland v UK), Order of 13 Nov 2001..................................18, 20 Southern Bluefin Tuna (New Zealand v Japan; Australia v Japan), Order of 27 Aug 1999..................................................................................18 United States of America Buck v Bell 274 US 200 (1927) ........................................................................317 Diamond v Chakrabarty 447 US 303 (1980) ...................................................204 Kewanee Oil v Bicron 416 US 470 (1974) .......................................................208 WTO Australia – Salmon, WT/DS18/AB/R, 20 Oct 1998 .................49, 190, 193–4 EC – Asbestos, WT/DS135/AB/R, 12 Mar 2001...........................39, 184, 198 x Table of Cases
- 9. EC – BiotechProducts, Complaints by the US, Canada and Argentina, WT/DS291, WT/DS292 and WT/DS293, 21 Apr 2004, 17 May 2004 and 19 July 2004..................................25, 31, 44, 49, 53, 199, 236, 387, 389 EC – Hormones, WT/DS26/R/USA, 18 Aug 1997; WT/DS26/AB/R and WT/DS48/AB/R, 16 Jan 1998............19, 45–6, 49, 189–94, 234, 395, 402 EC – Sardines....................................................................................................402 Guatemala – Antidumping Investigation Regarding Portland Cement from Mexico, WT/DS60/AB/R, 25 Nov 1998.................................................191 Japan – Apples, WT/DS245/AB/R, 26 Nov 2003.........44, 190, 192, 194, 246 Japan – Measures Affecting Agricultural Products (Japan varietals), T/DS76/R, 27 Oct 1998; WT/DS76/AB/R, 22 Feb 1999 .....................192, 194–5, 245 Korea – Beef, WT/DS161/AB/R-WT/DS169/AB/R, 11 Dec 2000 ............39 Korea – Dairy Safeguards, WT/DS98/AB/R, 12 Jan 2000..................179, 189 Korea – Government Procurement, WT/DS163, 19 Jun 2000.......................250 US – British Steel, WT/DS138/AB/R, 10 May 2000..................................184 US – Shrimp I (Shrimp/Turtle case), WT/DS58/AB/R, 12 Oct 1998 ....................................................38, 55, 76-77, 183-84, 198, 250 US – Shrimp II, WST/DS58/AB/RW, 22 Oct 2001 ......................................55 US – Standards for Reformulated and Conventional Gasoline, WT/DS2/R, 29 Jan 1996; WT/DS2/AB/R, 29 Apr 1996............191, 250 US – Transitional Safeguard Measures on Combed Cotton Yarn from Pakistan, WT/DS192/AB/R, Nov 2001..................................................................190 Table of Cases xi
- 11. Table of Legislation BOLIVIA Constitution1994............................................................................................431 Supreme Decree No 24676 – Regulations on Decision 391, 21 Jun 1997 .........................................................................................431, 436 Arts 2–3 ............................................................................................................436 Art 40................................................................................................................431 Supreme Decree No 24679 ............................................................................416 Art 2..................................................................................................................416 Art 6..................................................................................................................416 Art 17................................................................................................................416 Art 22................................................................................................................431 Art 36................................................................................................................416 BRAZIL Charter of Indigenous People 1973 .................................................354–6, 365 Art 2..................................................................................................................365 Art 3(1) .............................................................................................................354 Art 4..................................................................................................................356 Art 9..................................................................................................................354 Art 11 ................................................................................................................354 Art 20................................................................................................................355 Art 65................................................................................................................355 Title IV..............................................................................................................356 Constitution 1988................................................................................354–6, 365 Art 20................................................................................................................356 Art 67................................................................................................................355 Art 225..............................................................................................................357 Art 225(I)..........................................................................................................357 Art 225(I)(2) .....................................................................................................357 Art 225(IV)...................................................................................................357–8 Art 231..........................................................................................................354–6 Art 231(1) .........................................................................................................354 Art 231(2)–(4)...................................................................................................355 Art 232......................................................................................................354, 356 Decree-Law No 3.551 of 4 Aug 2000............................................................365 Provisional Measure (PM) 2186–16 of 23 Aug 2001......................357–8, 361 Art 1(3) .............................................................................................................358
- 12. Art 8..........................................................................................................357, 362 Art8(1)–(2).......................................................................................................357 Art 8(4) .............................................................................................................357 Art 9..................................................................................................................357 Ch 3...................................................................................................................357 CHINA Law on Maternal and Infant Health Care ..................................................317 COLOMBIA ICA Resolution C 3492, 22 Dec 1998............................................................436 Arts 1–2 ............................................................................................................436 Art 5..................................................................................................................436 Arts 12–14 ........................................................................................................436 Arts 23–24 ........................................................................................................436 ICA Resolution on agricultural biosecurity................................................435 ICA Resolution on fish farming biosecurity...............................................435 Ministry of the Environment Resolution 0620 of 7 July 1997..................516 Art 1..................................................................................................................416 Art 2..................................................................................................................417 Proposal for the Protection of Collective Knowledge 2000 .....................431 Art 5 point 3...............................................................................................................431 points 6–7.........................................................................................................431 ECUADOR Political Constitution 1998 ............................................................................431 Art 84, point 9 .................................................................................................431 Proposed Law on Conservation and Sustainable Use of Biodiversity...437 Regulations Project on Decision 391............................................................431 Art 22................................................................................................................431 EUROPEAN COMMUNITY/EUROPEAN UNION Charter of Fundamental Rights of the European Union..................................................319, 369–74, 376–7, 380–5 Preamble ......................................................................................371, 373–4, 382 Art 1..............................................................................................................373–5 Art 2..................................................................................................................382 Art 3 .................................................294, 311, 319, 321, 325, 373, 375–6, 382–4 Art 3(1) .............................................................................................................375 Art 3(2) ...............................................................................................375–80, 384 xiv Table of Legislation
- 13. Art 13................................................................................................................378 Art 15(3)...........................................................................................................373 Art 18................................................................................................................373 Art 19(2) ...........................................................................................................373 Art 21................................................................................................................325 Art 21(1) ...................................................................................................376, 378 Art 35................................................................................................................376 Arts 39–40 ........................................................................................................373 Arts 42–44 ........................................................................................................373 Art 46................................................................................................................373 Art 51................................................................................................................372 Art 51(1) ...................................................................................................372, 374 Art 51(2) ...........................................................................................................372 Art 52....................................................................................................372, 382–3 Art 52(1)–(2).....................................................................................................382 Art 52(3) ...................................................................................................376, 382 Art 53........................................................................................................372, 383 Art 54................................................................................................................372 Ch I ...................................................................................................................374 Ch VII.......................................................................................................371, 382 Charter of Fundamental Workers’ Social Rights 1989..............................370 EC Treaty .................................................................................373, 382, 391, 399 Arts 12–13 ........................................................................................................370 Art 28................................................................................................................370 Art 30................................................................................................................382 Art 39................................................................................................................370 Art 39(2) ...........................................................................................................382 Art 43................................................................................................................370 Art 49................................................................................................................370 Art 95(5)...........................................................................391, 394, 397, 399–401 Art 136..........................................................................................................370–1 Art 141..............................................................................................................370 Pt II ...................................................................................................................370 European Convention for the Protection of Human Rights and Fundamental Freedoms 1950 (ECHR) .......................323, 370, 373, 382–4 Preamble ..........................................................................................................373 Art 2..................................................................................................................383 Art 3..................................................................................................373, 378, 383 Art 8..................................................................................................373, 378, 383 Art 14................................................................................................................323 Additional Protocols ......................................................................................373 European Social Charter................................................................................371 Treaty of Amsterdam 1997 ....................................................................370, 373 Protocol on granting asylum to nationals of Member States ..................373 Table of Legislation xv
- 14. Treaty Establishing aConstitution for Europe ..............369, 371–2, 375, 383 Pt II ...................................................................................................................294 Treaty on European Union 1992 (TEU/Maastricht Treaty) .............370, 382 Pre-Amsterdam article numbers Art F(1)–(2) ......................................................................................................370 Post-Amsterdam article numbers Art 6..........................................................................................................370, 372 Decisions Dec 97/98.........................................................................................................389 Dec 182/1999/EC concerning the 5th framework programme of the EC for research, technological development and demonstration activities...........................................................................296 Art 6..................................................................................................................297 Art 7..................................................................................................................296 Annex II ...........................................................................................................297 Dec 1999/167/EC supplementing and implementing Dec 182/1999/EC......................................................................................296 Dec 549/2003...................................................................................................398 Dec 2003/653 rejecting draft legislation aimed at establishing a GMO-free area in Upper Austria..............................................31, 391, 394 para 61..............................................................................................................394 paras 72–73 ......................................................................................................398 Dec 2004/1.......................................................................................................398 Dec 2004/643 authorising the placing on the market of maize NK 603....390 Dec 2004/657 authorising the placing on the market of sweetcorn Bt-11 .....................................................................................390 Directives Dir 90/220/EEC on the deliberate release into the environment of genetically modified organisms.........174, 177, 181, 199, 235, 389, 398 Art 16........................................................................................................236, 389 Dir 98/44/EC on the Legal Protection of Biotechnological Inventions ..........................................31, 38, 291, 294, 295–6, 335, 375, 379 Recital 18..........................................................................................................223 Recital 27..........................................................................................................218 Recital 38......................................................................................................295–6 Art 5..................................................................................................................294 Art 5(1) .....................................................................................................296, 379 Art 5(2) .....................................................................................................295, 379 Art 5(3) .............................................................................................................296 Art 6..............................................................................................................295–6 Art 6(2) .............................................................................................................379 Art 11 ................................................................................................................208 xvi Table of Legislation
- 15. Dir 98/79/EC onin vitro diagnostic medical devices .............................296 Art 1(4) .............................................................................................................296 Art 19................................................................................................................296 Dir 2001/18 Deliberate Release Directive .............31, 71, 174, 177, 181, 196, 199, 235, 238, 388–91, 394, 401 Art 2(2) .............................................................................................................232 Art 4(2) ...............................................................................................................42 Art 23................................................................................................236, 390, 393 Art 30................................................................................................................390 Art 35................................................................................................................181 Dir 2001/20/EC on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use .......297 Art 1(2) .............................................................................................................297 Art 3(2) .............................................................................................................297 Arts 4–6 ............................................................................................................297 Dir 2001/83/EC on the Community code relating to medicinal products for human use...........................................................................297 Dir 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells...............297, 380–1 Preamble Recital 12..........................................................................................................298 Recital 22..................................................................................................297, 381 Art 4..................................................................................................................381 Art 4(2)–(4).......................................................................................................381 Art 12................................................................................................................380 Arts 13–14 ........................................................................................................297 Regulations Reg 2081/92 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs.........203 Reg 40/94 on the Community Mark (as amended) Art 64................................................................................................................209 Reg 2100/94 on Community Protection of Plant Varieties (as amended) Art 14................................................................................................................208 Reg 258/97 Novel Foods Regulation........174, 177, 180, 199, 236–7, 389–90 Art 12........................................................................................................389, 393 Reg 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety................................47 Art 7..............................................................................................................45, 47 Art 7(2) ...............................................................................................................47 Reg 692/2003 amending Reg 2081/92 ........................................................203 Table of Legislation xvii
- 16. Reg 1829/2003 GMFood and Feed Regulation .........................71, 180, 195, 237, 388–90, 392 Reg 1830/2003 on the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Dir 2001/18.....................................................235, 237, 390, 392 FRANCE Civil Code........................................................................................................290 Code of Public Health....................................................................................289 Art L665-11 ......................................................................................................290 Art L672-4 ........................................................................................................289 Law No 76-1181 of 22 Dec 1976....................................................................289 Law No 94-653 relative au respect du corps humain of 29 July 1994 ..........290 Law No 94-654 ................................................................................................289 Art 2..................................................................................................................290 Art 6..................................................................................................................289 Art 14................................................................................................................289 GERMANY Embryonenschutzgesetz, 13 Dec 1990.............................................................290 Gebrauchsmustegesetz, 28 Aug 1986, BGBI I 1456 Sect 3.................................................................................................................205 Law on Eugenics in the service of public welfare 1933............................317 Patent Act s 11(2)................................................................................................................226 s 12 ....................................................................................................................208 INDIA Biodiversity Related Community Intellectual Rights Act........................353 Biological Diversity Act 2002..........................................................................41 s 21 ......................................................................................................................41 INTERNATIONAL Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice on Environmental Matters 1998...........................................................................................72, 74 Preamble ..........................................................................................................175 Art 6............................................................................................................73, 175 ACP-EEC Convention 1989 (Lomé IV) .......................................................274 xviii Table of Legislation
- 17. African Charter onHuman and Peoples’ Rights 1981 Preamble ..........................................................................................................323 African Model Legislation for the Protection of the Rights of Local Communities, Farmers, Breeders and for the Regulation of Access to Biological Resources 1998...........................................266, 353–4 Agreement on Agriculture (AG Agreement).......76, 176, 185, 187, 237, 264 Art 13................................................................................................................185 Art 21(1) ...........................................................................................................185 Agreement on the Application of Sanitary and Phytosanitary Measures 1994 (SPS Agreement) .................................25, 44, 47–8, 50, 62, 74–6, 173, 176, 178–9, 181–3, 185–93, 195, 197–200, 237, 242, 245, 247, 264, 395–6, 398–400, 434 Preamble ..........................................................................................................186 Art 1(1) .............................................................................................................177 Art 1(4) .............................................................................................................186 Art 2(2).............................................................................177–8, 181, 191–3, 200 Art 2(3).............................................................................................178, 181, 194 Art 2(4) .................................................................................................186, 190–1 Art 3..................................................................................................................193 Art 3(2) .....................................................................................................186, 190 Art 3(3)...........................................................................................49, 191–2, 401 Art 3(5) .............................................................................................................186 Art 5..........................................................................................................181, 193 Art 5(1).........................................177–8, 181–2, 191, 193–4, 198, 200, 234, 246 Art 5(2).....................................................................................181, 191, 194, 234 Art 5(3).............................................................................................181, 194, 248 Art 5(4) .............................................................................................................247 Art 5(5).................................................................................178, 181–2, 194, 198 Art 5(6).........................................................................................181, 194–5, 198 Art 5(7)........................................................47, 74, 178, 181–3, 185, 191, 193–4, 198, 200, 234, 245–6, 396–7, 401 Art 7..............................................................................................................177–8 Art 8..............................................................................177–8, 181, 199–200, 395 Art 12(1) ...........................................................................................................186 Art 12(4) ...........................................................................................................186 Annex A...........................................................................187, 189, 193, 197, 246 para 1(a)–(b) ....................................................................................................177 para 1(d)...........................................................................................................177 para 4................................................................................................................193 para 5..................................................................................................................49 Annex B............................................................................................................177 Annex C ...........................................................................................177, 181, 199 para 1(a)...........................................................................................180, 200, 395 Table of Legislation xix
- 18. Agreement Relating tothe Implementation of Part XI of UNCLOS 1994 (Implementing Agreement)........................88, 130–1, 163 Sect 5, para 1(a)...............................................................................................131 Annex, Sect 1 para 5(g).............................................................................................................88 para 6(a)(i) .......................................................................................................130 para 7..................................................................................................................88 Agreement on Straddling Fish Stocks and Highly Migratory Species 1995 (Fish Stocks Agreement) .....................................99–100, 129 Art 5(k).............................................................................................................129 Annex I.............................................................................................................129 Agreement on Technical Barriers to Trade (TBT Agreement)......................................................25, 50, 62, 76, 176, 179, 182, 185–9, 200, 237, 242, 264, 396, 399 Preamble ..........................................................................................................186 Art 1(5) .....................................................................................................187, 189 Art 2(1) .....................................................................................................179, 248 Art 2(2) .....................................................................................................179, 182 Art 2(4)–(6).......................................................................................................187 Art 2(9) .............................................................................................................179 Art 5..................................................................................................................179 Art 5(2)(1).........................................................................................................181 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement/ADPIC) ......................21–2, 42, 50, 52–5, 101, 201, 208, 227–8, 246, 269, 279, 334, 346–8, 428–9 Art 1..........................................................................................................223, 430 Art 3..................................................................................................................223 Art 27................................................................................................................204 Art 27(1).............................................................................................21, 343, 350 Art 27(2) .......................................................................................................22, 54 Art 27(3)(b)............................................................22, 341, 347–9, 353, 427, 429 Art 29................................................................................................................209 Art 30................................................................................................................208 Art 39................................................................................................................207 Agreement Establishing the World Trade Organisation 1994 (WTO Agreement) ................................30, 76, 101, 179, 189, 197, 251, 342 Preamble ............................................................................................................76 Art II(2).............................................................................................................185 Art XVI(3) ........................................................................................................185 Annex 1 ............................................................................................................185 Annex 1A...................................................................................62, 179, 185, 190 Annex 2 – DSU...........................................75, 77, 176, 183, 185, 188, 195, 197 Art 3..........................................................................................................196, 198 xx Table of Legislation
- 19. Art 3(2) .......................................................................................................77,179 Art 7..........................................................................................................188, 196 Art 11..........................................................................................180, 188–90, 196 Art 13................................................................................................................184 Art 13(2) ...................................................................................................192, 195 Art 17(9) ...........................................................................................................184 Art 19................................................................................................................198 Art 19(1) ...........................................................................................................200 Art 23................................................................................................................250 Annex 3 ............................................................................................................185 Annex 9 ............................................................................................................196 Annex 10 ..........................................................................................................196 Appellate Body Working Procedures..........................................................184 r 16(1)................................................................................................................184 Andean Pact Decision 345 – Common Set of Regulations for the Protection of Rights of Acquirers of Vegetable Varieties 1993 ...........429 Art 8..................................................................................................................429 Andean Pact Decision 391 on Common Regime on Access to Genetic Resources 1996..........................266, 411, 413–21, 428–9, 432, 435 Art 1..................................................................................................410, 414, 421 Art 5............................................................................................................413–14 Art 6(2) .............................................................................................................414 Art 7..................................................................................................................424 Arts 8–9 ............................................................................................................419 Art 16..........................................................................................................414–15 Arts 17–25 ........................................................................................................414 Arts 26–30 ..................................................................................................414–15 Art 31................................................................................................................414 Art 32..........................................................................................................414–15 Arts 33–34 ........................................................................................................414 Art 35..........................................................................................................414–15 Arts 36–38 ........................................................................................................414 Art 39..........................................................................................................414–15 Art 40................................................................................................................414 Art 41..........................................................................................................414–15 Art 42................................................................................................................414 Arts 43–47 ........................................................................................................414 Andean Pact Decision 435 on the creation of CAAAM 1998 ..................429 Andean Pact Decision 486.............................................................................427 Andean Pact Decision 487 – Common Set of Regulations on Industrial Property 2000...........................................................................428 Art 3..................................................................................................................428 Art 75(h)...........................................................................................................428 Table of Legislation xxi
- 20. Andean Pact Decision523 on Regional Biodiversity Strategy for the Tropical Andean Countries 2002.........................266, 412–13, 419–20, 429, 433, 435, 438 Annex...............................................................................................405, 433, 435 Andean Pact Decision 524 institutionalising the Table on the Rights of Indigenous People in the Andean countries 2002................................429 Antarctic Treaty 1959 (AT/Washington Treaty)................8, 11, 13, 103, 111, 113–14, 116–19, 121–2, 128, 130–1, 135, 138, 140–1, 143, 149–52, 154–5, 157–61 Preamble................................................................................13, 151, 154–6, 168 Art I...................................................................................................................156 Art II .........................................................................................117, 149, 154, 156 Art III....................................................................117, 119, 149, 152–4, 156, 161 Art III(1)...............................................................................................153, 161–2 Art III(1)(a)–(b)................................................................................................153 Art III(1)(c).......................................................................................119, 153, 161 Art III(2) ...........................................................................................................153 Art III(3) ...........................................................................................................152 Art IV...............................................................121, 128, 134, 150, 153, 156, 167 Art VI................................................................................................................130 Art IX................................................................................................................161 Madrid Protocol on Environmental Protection 1991 (PEPAT)........................................13, 31, 66, 113–15, 117–18, 125, 135, 143, 149, 152, 156–8, 160–2, 167–8 Preamble ..........................................................................................................156 Art 2........................................................................................13, 114, 156, 161–2 Art 3..................................................................................................125, 156, 161 Art 3(1) .............................................................................................................114 Art 3(2)(c)(iv)...................................................................................................136 Art 3(3) .............................................................................................................117 Art 7 ............................................................................................................116–17 Art 8..........................................................................................................125, 156 Art 8(a)–(c).......................................................................................................157 Arts 11–12 ........................................................................................................160 Annex I.................................................................................................125, 156–7 Annex II Art 3..................................................................................................................122 Art 4..................................................................................................................125 Basel Convention on the Transboundary Movement of Hazardous Wastes and their Disposal 1989.........................................................69, 108 Izmir Protocol 1996 ........................................................................................108 Bilbao Declaration 1993 .................................................................................305 Budapest Treaty. See Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure 1977 xxii Table of Legislation
- 21. Canberra Convention. SeeConvention on the Conservation of Marine Living Resources 1980 (CCAMLR) Cancun Declaration 2002...............................................................................407 CGIAR..............................................................................................................279 Codex Alimentarius.......................................................................6, 62, 77, 401 Convention on Biological Diversity 1992 (CBD)......................7, 9–10, 25, 29, 33–6, 38–9, 41–2, 50, 52–6, 62–8, 71–2, 75–6, 78, 82, 91–4, 96–7, 99–102, 106–7, 111, 132–9, 144, 147, 149, 163, 166–8, 173, 175, 188–9, 197, 212–13, 215, 218, 220–2, 228, 231, 242–3, 259, 262, 265–72, 275–6, 278, 347, 403, 412–14, 417, 419, 424, 428, 433–5 Preamble........................................................................10, 33, 78, 100, 223, 413 para 3..............................................................................................................31–2 Art 1..................................................................................................64–5, 91, 265 Art 2 .................................................................................29, 61, 65, 91, 267, 410 Art 2(2) .............................................................................................................132 Art 3............................................................................................................92, 213 Art 4............................................................................................................67, 167 Art 4(a) .............................................................................................................167 Art 4(b)...............................................................................................91, 134, 167 Arts 6–7......................................................................................................65, 213 Art 8..............................................................................................65, 67, 107, 213 Art 8(a) .......................................................................................................91, 107 Art 8(g).............................................................................................67–8, 77, 433 Art 8(j)......................................................................215, 266, 269, 278, 344, 347 Art 8(l)..............................................................................................................424 Arts 9–11 ..........................................................................................................213 Art 12........................................................................................................213, 419 Arts 13–14 ........................................................................................................213 Art 15 .........................................................106, 133–34, 136, 166, 213, 265, 414 Art 15(1) ...........................................................................................................166 Art 15(2) .................................................................................................9–10, 213 Art 15(3) ...........................................................................................................267 Art 15(4) ...........................................................................................................213 Art 15(5)...........................................................................................106, 213, 414 Art 15(7).............................................................................41, 106, 133, 213, 417 Art 16 ...............................................................23, 72, 106, 135–7, 166, 221, 266 Art 16(1)–(2).....................................................................................................419 Art 16(3) ...................................................................................................221, 419 Art 16(5) ...........................................................................................................166 Art 17........................................................................................................166, 266 Art 18..................................................................................................72, 166, 266 Art 19............................................................................................23, 67, 137, 166 Table of Legislation xxiii
- 22. Art 19(1) ...........................................................................................................266 Art19(2)...................................................................................106, 137, 266, 417 Art 19(3) .......................................................................................................67–68 Art 19(4) .............................................................................................................67 Art 20................................................................................................................166 Art 20(2) ...........................................................................................................214 Art 20(4) ...........................................................................................................214 Art 21................................................................................................................166 Art 22....................................................................................................52, 92, 102 Art 22(1).......................................................................................52, 92, 102, 347 Art 22(2)...............................................................................................52, 92, 102 Art 23................................................................................................................214 Art 25................................................................................................................134 Art 27..........................................................................................................75, 249 Art 37..................................................................................................................10 Cartagena Protocol on Biosafety 2000 (BSP/CPB) ......................................7, 18, 25, 33, 35, 42, 44–6, 48–9, 51, 53, 61–2, 65, 67–9, 71–9, 107–8, 173, 175, 179–80, 183, 188–9, 196–8, 236, 243–4, 246–54, 264, 270, 281, 399, 433–4 Preamble..........................................................................51, 74–5, 175, 242, 249 para 6..................................................................................................................33 para 9..................................................................................................................51 Recitals 9–11 ......................................................................................................51 Art 1..............................................................................................69, 74, 197, 433 Art 2(4) .........................................................................................................49, 70 Art 3............................................................................................................61, 197 Art 3(f)................................................................................................................68 Art 3(g).............................................................................................................243 Art 5..................................................................................................................197 Art 7......................................................................................................69–70, 197 Art 8......................................................................................................69–70, 241 Art 8(g).............................................................................................................183 Art 9..............................................................................................................69–70 Art 9(4) ...............................................................................................................70 Art 10............................................................................................69–70, 198, 244 Art 10(3) .............................................................................................................70 Art 10(6).....................................................................35, 42, 46, 70, 74, 198, 246 Art 11........................................................................................68–9, 72, 198, 244 Art 11(4) .............................................................................................................49 Art 11(8)...................................................................................35, 42, 46, 74, 198 Art 12..........................................................................................................70, 198 Art 12(2)–(3).....................................................................................................245 Art 14..................................................................................................................70 xxiv Table of Legislation
- 23. Art 15..........................................................................................47, 63,70–1, 246 Art 16............................................................................................................47, 63 Art 18................................................................................................................248 Art 18(2)(a) ......................................................................................198, 243, 248 Art 20..................................................................................................................72 Art 20(2) .............................................................................................................72 Art 21..................................................................................................................70 Art 21(6) .............................................................................................................73 Art 22..................................................................................................................72 Art 23..................................................................................................................74 Art 24..................................................................................................................70 Art 26....................................................................................................70, 74, 248 Art 28..................................................................................................................72 Art 32................................................................................................................249 Annexes I–II ....................................................................................................414 Annex III............................................................................................42, 48, 70–1 Convention for the Conservation of Antarctic Marine Living Resources .........................................................................149 Convention on the Conservation of Antarctic Seals ...........................149–50 Convention on the Conservation of Marine Living Resources 1980 (CCAMLR/Canberra Convention).......113, 119–20, 122–26, 131–3, 135, 138, 141, 143, 157–8, 160 Art 1(1) .............................................................................................................157 Art 1(3) .............................................................................................................126 Art 2..................................................................................................................157 Art 2(1) .............................................................................................................157 Art 2(2) .............................................................................................................125 Art 2(3) .............................................................................................................157 Art 20....................................................................................................119, 157–8 Art 20(1) ...................................................................................................119, 157 Art 20(2)–(4).....................................................................................................158 Art 23(2) ...........................................................................................................141 Art 24(2)(b) ......................................................................................................120 Convention for the Grant of European Patents (European Patent Convention)................................................................................................220 Art 54................................................................................................................205 Art 54(1)–(2).....................................................................................................205 Art 60................................................................................................................207 Convention on Human Rights and Biomedicine 1997 (Oviedo Convention) ....................26, 293, 296, 312, 319, 322, 327, 337–8, 374, 376–7, 380–1, 384 Preamble ......................................................................................293–4, 327, 336 Art 1..........................................................................................................293, 336 Art 1(1) .............................................................................................................374 Table of Legislation xxv
- 24. Art 2..........................................................................................................293, 336 Art3..................................................................................................................376 Art 3(2) .............................................................................................................376 Art 5..............................................................................................325, 327–8, 377 Art 5(1) .............................................................................................................376 Arts 6–8....................................................................................................327, 377 Art 9..................................................................................................................377 Art 10................................................................................................................328 Art 10(2) ...........................................................................................................329 Art 11................................................................................................325, 376, 378 Art 12................................................................................................................378 Art 15................................................................................................................327 Art 16................................................................................................................325 Art 16(v)...........................................................................................................377 Art 17................................................................................................................377 Art 18................................................................................................................312 Art 18(2) ...........................................................................................................381 Art 19................................................................................................................322 Art 19(2) ...........................................................................................................377 Art 20........................................................................................................322, 377 Art 21........................................................................................................321, 379 Art 22................................................................................................................379 Art 26................................................................................................................308 Art 29................................................................................................................384 Art 34................................................................................................................293 Additional Protocol on the Prohibition of Cloning Human Beings 1998 (Paris Protocol) ........................26, 293, 311–12, 376, 380, 384 Art 1..........................................................................................................312, 381 Art 1(1)–(2).......................................................................................................311 Additional Protocol on Transplantation of Organs and Tissues of Human Origin 2002................................................294, 376, 384 Art 13................................................................................................................377 Art 17................................................................................................................377 Art 21............................................................................................................321–2 Art 22................................................................................................................379 Art 23................................................................................................................328 Additional Protocol on Biomedical Research 2005.............43, 294, 327, 384 Preamble ..........................................................................................................325 Art 3..................................................................................................................336 Arts 9–12 ..........................................................................................................338 Art 13................................................................................................................329 Art 14................................................................................................................325 Art 17..................................................................................................................43 Art 17(1)–(2).......................................................................................................43 xxvi Table of Legislation
- 25. Art 25................................................................................................................328 Art 26................................................................................................................329 ChIII.................................................................................................................338 Convention on International Trade in Endangered Species of Wild Fauna and Flora 1973 (CITES) ..........................................76, 101, 104, 198, 433–4 Convention for the Protection of World Cultural and Natural Heritage .......................................................................................433 Convention on the Regulation of Antarctic Mineral Resources Activities (CRAMRA/Wellington Convention) .........116–18, 149, 158–9 Art 2..................................................................................................................158 Art 2(a)–(d) ......................................................................................................158 Art 2(e)–(g) ......................................................................................................159 Art 16................................................................................................................159 Art 16(b)...........................................................................................................159 Art 29(1)–(2).....................................................................................................159 Art 37........................................................................................................118, 159 Art 37(2) ...........................................................................................................159 Art 37(12) .........................................................................................................118 Art 49................................................................................................................159 Ch III...........................................................................................................117–18 Convention on the Suppression and Punishment of the Crime of Apartheid 1973 ..........................................................................................324 Cuzco Declaration on Access to Genetic Resources, Traditional Knowledge and Intellectual Property Rights of the Likeminded Mega-diverse Countries 2002....................................................417, 429–30 Declaration on Race and Racial Prejudice 1978.........................................301 Art 1(1) .............................................................................................................301 Art 1(5) .............................................................................................................301 Art 2(1) .............................................................................................................301 Declaration on the Use of Scientific and Technological Progress in the Interests of Peace and for the Benefit of Mankind 1975........40, 299, 301 Preamble ..........................................................................................................299 Desertification Convention .............................................................................31 Doha Ministerial Declaration 2001 para 6..................................................................................................................51 para 19........................................................................................................53, 219 para 31..........................................................................................................51, 75 para 31(i)............................................................................................................53 Espoo Convention on Environmental Impact Assessment in a Transboundary Context 1991.....................................................................69 European Patent Convention. See Convention for the Grant of European Patents FAO Constitution Preamble ..........................................................................................................279 Table of Legislation xxvii
- 26. Recital 5............................................................................................................279 Art VI:4.............................................................................................................263 FAOGeneral Rules Rule XXXV.......................................................................................................263 FAO International Undertaking on Plant Genetic Resources 1983 (International Undertaking/IU)..............................................................270 FAO Treaty. See International Treaty on Plant Genetic Resources for Food and Agriculture 2001 Fish Stocks Agreement. See Agreement on Straddling Fish Stocks and Highly Migratory Species 1995 Framework Convention on Climate Change ...............................................31 GATS Agreement..........................................................................................24–5 Art XIV...............................................................................................................24 General Agreement on Tariffs and Trade (GATT 1947)..............................30 General Agreement on Tariffs and Trade (GATT 1994) .....................25, 50, 62, 76, 101, 104, 176, 179, 182–3, 185–6, 188–92, 197, 237, 242, 250, 264, 396, 399, 434 Art I...................................................................................................................248 Art III..........................................................................................................25, 248 Art III(4)...................................................................................179, 198, 200, 396 Art XI(1) ...........................................................................................................179 Art XX..................................................................25, 38–9, 182, 191, 198, 250–1 Art XX(a)............................................................................................................24 Art XX(b)..................................................................................................186, 198 Art XX(g)............................................................................................................76 Art XXI ...............................................................................................................24 Marrakesh Protocol........................................................................................185 Hague Ministerial Declaration of the Conference of the Parties to the CBD 2002 ......................................................................................................66 ILC Articles on State Responsibility 2001.....................................................34 Art 42..................................................................................................................34 Art 42(a)(ii) ........................................................................................................34 Art 48..................................................................................................................34 Art 48(1)(a).........................................................................................................34 ILO Convention No 169 on Indigenous and Tribal Peoples in Independent Countries 1989 ...........................................................344, 347 Arts 4–5 ............................................................................................................344 Art 13................................................................................................................344 Art 15................................................................................................................344 Art 15(2) ...........................................................................................................344 Pt II ...................................................................................................................344 Implementing Agreement. See Agreement Relating to the Implementation of Part XI of UNCLOS 1994 xxviii Table of Legislation
- 27. International Convention onthe Elimination of All Forms of Racial Discrimination 1966 ......................................................................324, 346–7 International Convention on Phitosanitary Protection.............................433 International Convention for the Protection of New Vegetable Varieties...........................................................................433 International Convention for the Protection of Plants .............................433 International Convention for the Regulation of Whaling..........................66 International Convention on the Rights of the Child 1989......................373 Preamble ..........................................................................................................373 Art 27................................................................................................................261 International Covenant on Civil and Political Rights 1966 (ICCPR) Preamble ..........................................................................................................373 Art 1..................................................................................................................346 Art 2..................................................................................................................323 Art 6..................................................................................................................279 Art 7..........................................................................................................326, 378 Art 17................................................................................................................328 Art 23................................................................................................................378 Art 23(3) ...........................................................................................................378 Art 27................................................................................................................345 International Covenant on Economic, Social and Cultural Rights 1966 (ICESCR) .......................................................261, 279 Preamble ..........................................................................................................373 Art 1..................................................................................................................345 Art 1(b).............................................................................................................305 Art 2(1) .............................................................................................................280 Art 6..................................................................................................................332 Art 9..................................................................................................................331 Art 11........................................................................................................261, 279 Art 12(1) ...........................................................................................................304 Art 15(1)(b) ........................................................................................................40 Art 15(2) .............................................................................................................40 International Declaration on Human Genetic Data 2003 (IDHGD/DHGD)..........................................4, 15, 26, 40, 52, 299, 304, 327 Preamble ....................................................................................................52, 340 Art 1..................................................................................................................340 Art 3..................................................................................................................337 Art 7..................................................................................................................325 Art 7(a)–(b) ......................................................................................................325 Art 8..........................................................................................................325, 327 Art 8(b).............................................................................................................327 Art 9..............................................................................................................327–8 Art 10................................................................................................................329 Art 12................................................................................................................307 Table of Legislation xxix
- 28. Art 14................................................................................................................328 Art 16................................................................................................................327 Art18................................................................................................................339 Art 18(a) .............................................................................................................52 Art 19..........................................................................................................40, 304 Art 22................................................................................................................327 Art 25................................................................................................................338 Art 27................................................................................................................337 International Plant Protection Convention 1951 (IPPC).....................62, 264 International Treaty on Plant Genetic Resources for Food and Agriculture 2001 (FAO/ITPGRFA/ Seed Treaty) ....................................11, 26, 34–5, 37, 39, 51, 56, 141–2, 144, 220, 262, 265, 270–3, 275–8, 281 Preamble para 3..............................................................................................................31–2 para 9..................................................................................................................51 para 14................................................................................................................37 Recital 4............................................................................................................271 Recitals 9–11 ......................................................................................................51 Art 1..................................................................................................................271 Art 1(1) .............................................................................................................141 Art 2..................................................................................................................141 Art 9..........................................................................................................220, 272 Art 9(1) .............................................................................................................276 Art 9(2) .............................................................................................................277 Art 10..........................................................................................................37, 220 Art 11........................................................................................................141, 271 Art 11(1)–(2).....................................................................................................272 Art 12................................................................................................................271 Art 12(3)(a)–(c) ................................................................................................272 Art 12(3)(d)......................................................................................142, 220, 273 Art 12(3)(e).......................................................................................................272 Art 12(3)(f)–(g) ................................................................................................273 Art 13..........................................................................................................23, 271 Art 13(2) ...........................................................................................................142 Art 13(2)(a)–(c) ................................................................................................274 Art 13(2)(d) ................................................................................................274–75 Art 13(2)(d)(i) ..................................................................................................277 Art 13(2)(d)(ii).........................................................................................142, 275 Art 13(4)–(5).....................................................................................................274 Art 14................................................................................................................274 Art 15(1) ...........................................................................................................276 Art 15(1)(a).......................................................................................................276 Art 15(1)(b)(iii) ................................................................................................276 xxx Table of Legislation
- 29. Art 15(2)–(3).....................................................................................................276 Art 18................................................................................................................274 Art19................................................................................................................142 Art 19(3)(f) .......................................................................................................275 Art 20................................................................................................................142 Pt IV..............................................................................................................141–2 Annex I.........................................................................................141, 220, 271–2 Jakarta Mandate................................................................................................97 Johannesburg Declaration on Conservation and Sustainable Use of Biodiversity 2002...........................................................413, 421, 429 para 3........................................................................................................414, 417 para 4................................................................................................................429 para 5........................................................................................................419, 421 para 6................................................................................................................421 Kuwait Convention on Pollution 1978 Teheran Protocol 1998....................................................................................108 Leipzig Declaration 1996...............................................................................274 Lomé IV Convention. See ACP-EEC Convention 1989 London Declaration 1987 ..............................................................................100 Preamble ..........................................................................................................100 Art XVI.............................................................................................................100 OSPAR Convention for the Protection of the Marine Environment of the North East Atlantic 1992.........................................69 Oviedo Convention. See Convention on Human Rights and Biomedicine 1997 Ozone Convention ...........................................................................................31 Montreal Protocol.............................................................................................31 Paris Convention for the Protection of Industrial Property Art 2..................................................................................................................210 Art 4..........................................................................................................209, 217 Patent Cooperation Treaty ............................................................................220 Patent Law Treaty...........................................................................................220 Presidential Declaration of Guayaquil related to the World Summit on Sustainable Development of the South American Countries 2002........419 para 4................................................................................................................419 Ramsar Wetlands Convention........................................................................31 Rio Declaration on Environment and Development 1992.......17, 20, 45, 77 Principle 2..........................................................................................................17 Principle 5........................................................................................................433 Principle 7..........................................................................................................20 Principle 12..................................................................................................75, 77 Principle 15............................................................................................45, 47, 69 Rome Declaration on World Food Security and World Food Summit Plan of Action 1996..............................262, 271, 279 Table of Legislation xxxi
- 30. Rome Declaration ofthe World Food Summit: Five Years Later 2002 ....................................................................262–3, 282 Rome Statute of the International Criminal Court 1998 ..................318, 378 Art 7..........................................................................................................318, 378 Art 7(1)(g) ........................................................................................................378 Art 8..................................................................................................................318 Rotterdam Convention on Prior Informed Consent 1998....................69, 75 Preamble, para 8 ...............................................................................................51 Seed Treaty. See International Treaty on Plant Genetic Resources for Food and Agriculture 2001 (FAO/ITPGRFA) SPS Agreement. See Agreement on the Application of Sanitary and Phytosanitary Measures 1994 Statute of the International Court of Justice Art 38................................................................................................................310 Stockholm Declaration on Environment and Development 1972 ......17, 20 Principle 2..........................................................................................................63 Principle 4..........................................................................................................63 Principle 21........................................................................................................17 Principle 24........................................................................................................20 Stockholm POPS Convention 2001 Preamble, para 9 ...............................................................................................51 TBT Agreement. See Agreement on Technical Barriers to Trade Teheran Declaration 1968 ..............................................................................299 Point 18 ............................................................................................................299 Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure 1977 (Budapest Treaty).....139–40 Art 1..................................................................................................................140 Art 6..................................................................................................................140 Art 12................................................................................................................140 Regulations, Reg 6(4)(iii) ...............................................................................140 TRIPS Agreement. See Agreement on Trade-Related Aspects of Intellectual Property Rights UN Charter....................................................................................6, 26, 301, 348 Art 1(2) .............................................................................................................346 Art 55................................................................................................................346 Art 103..............................................................................................................348 UN Convention on the Law of the Sea 1982 (UNCLOS) ........................8, 11–12, 35, 37, 50, 52, 76, 82–8, 91–7, 99–104, 106–9, 126–32, 144, 148, 163, 165–6, 168 Art 19(2)(j)........................................................................................................127 Art 40................................................................................................................127 Art 54................................................................................................................127 Art 56(1)(b)(ii) .................................................................................................127 Art 56(2) ...........................................................................................................132 xxxii Table of Legislation
- 31. Art 62..................................................................................................................37 Art 62(4)(f).......................................................................................................127 Art 76..................................................................................................................82 Art 77(4) .........................................................................................................83–4 Art 87........................................................................................................105, 128 Art 87(2) .....................................................................................................95, 166 Arts 116–20 ................................................................................................83, 105 Art 123..............................................................................................................108 Art 133................................................................................................................86 Art 136........................................................................................................87, 163 Art 137..............................................................................................................163 Art 140(2) ...........................................................................................................39 Art 143....................................................................................................86–7, 130 Art 143(1) .................................................................................................85, 87–8 Art 143(2)–(3).....................................................................................................86 Art 143(3)(a)–(b)................................................................................................86 Art 143(3)(b)(i)–(iii) ..........................................................................................86 Art 143(3)(c).......................................................................................................86 Art 143(2)–(3).....................................................................................................86 Art 143(3)(a).......................................................................................................86 Art 144................................................................................................................39 Art 145................................................................................................................88 Art 153(1) .........................................................................................................163 Art 153(3) .........................................................................................................163 Arts 156–157 ....................................................................................................163 Art 162(2)(x).......................................................................................................90 Art 165(2)(e).......................................................................................................88 Art 192........................................................................................35, 100, 105, 108 Art 193........................................................................................................35, 105 Art 194..............................................................................................................105 Art 194(5) ...................................................................................................90, 108 Arts 195–196 ....................................................................................................105 Art 209(2) ...........................................................................................................91 Art 237(2) ...........................................................................................................92 Art 238..............................................................................................................164 Art 241............................................................................................12, 103, 128–9 Art 242..............................................................................................................164 Art 243................................................................................................................85 Art 244..............................................................................................................164 Art 245......................................................................................................103, 164 Art 246 ...............................................................................85, 103, 123, 127, 164 Art 246(2) .........................................................................................................103 Art 246(3)...........................................................................................85, 104, 127 Art 246(5)(a) ................................................................................37, 85, 104, 127 Table of Legislation xxxiii
- 32. Art 246(5)(d) ....................................................................................................106 Art248......................................................................................................104, 127 Art 249..........................................................................................37, 39, 104, 128 Art 249(2) .........................................................................................................106 Art 252..............................................................................................................104 Art 253......................................................................................................104, 128 Art 256........................................................................................................86, 164 Art 257......................................................................................................105, 164 Art 266..............................................................................................................164 Art 267..............................................................................................................165 Art 269..............................................................................................................165 Art 274..............................................................................................................164 Art 311 ..............................................................................................................101 Art 311(2) ...................................................................................................52, 102 Art 311(3)–(4)...................................................................................................102 Art 312................................................................................................................96 Pt XI ...............................................8, 86, 91, 96, 105, 126, 130–1, 155, 163, 165 Pt XII.................................................................................................................128 Pt XIII ...............................................................................................12, 84–6, 164 Pt XIV .................................................................................................129–30, 164 Annex III, Art 17(1)(b)(xii) ..............................................................................88 Regulations on Prospecting and Exploration for Polymetallic Nodules in the Area 2000 (Mining Code) .................................88, 90, 165 Reg 2(1)–(2)......................................................................................................165 Reg 2(4) ............................................................................................................165 Reg 31, para 7....................................................................................................90 Reg 35...............................................................................................................165 UN Declaration on Human Cloning 2004........................................4, 26, 335 UN Millennium Declaration.....................................................................305–6 UNESCO Constitution.....................................................................................14 Preamble ............................................................................................................14 Art 1(1) .............................................................................................................301 UNESCO Convention for the Safeguarding of Intangible Cultural Heritage 2003..........................................345, 347, 365 Art 2..........................................................................................................345, 365 Art 2(d).............................................................................................................345 Art 3(b).............................................................................................................347 Art 13(ii)...........................................................................................................345 Art 14................................................................................................................366 Art 15........................................................................................................345, 366 Universal Declaration on Bioethics and Human Rights 2005 (UDBHR) ................................................................................................4, 340 Art 3..................................................................................................................340 Art 7..................................................................................................................340 xxxiv Table of Legislation
- 33. Art 9..................................................................................................................340 Art 24(1)...........................................................................................................340 Universal Declaration on Cultural Diversity 2001 Art 1....................................................................................................................32 Universal Declaration on the Human Genome and Human Rights 1997 (UDHG/UDHGHR).......................4, 14–15, 26, 31–2, 35, 40, 43, 51, 299–302, 304, 308, 318, 325, 335 Preamble ..............................................................................................300–1, 337 para 3..................................................................................................................51 para 6..................................................................................................................33 Art 1..................................................................................................14, 32, 302–3 Art 2..................................................................................................................337 Art 2(b).....................................................................................................319, 337 Art 3..........................................................................................................319, 337 Art 4 .....................................................................................14, 35, 303, 321, 334 Art 5(b).........................................................................................................325–6 Art 5(c) .............................................................................................................329 Art 5(e) .......................................................................................................43, 326 Art 6..........................................................................................................319, 325 Art 7..................................................................................................................328 Art 8..................................................................................................................337 Art 9......................................................................................................307–8, 327 Art 10..........................................................................................................14, 336 Art 11 ................................................................................................303, 311, 337 Art 12................................................................................................................319 Art 12(a) .....................................................................................................40, 303 Art 12(b)...........................................................................................................340 Art 13........................................................................................................319, 339 Art 14........................................................................................................303, 319 Arts 15–16 ........................................................................................................338 Art 18..............................................................................................40, 303–4, 338 Art 19......................................................................................................40, 303–4 Art 19(ii)-(iv) ...................................................................................................304 Art 24................................................................................................................338 Pt E....................................................................................................................303 Universal Declaration of Human Rights 1948 (UDHR) ...................261, 373 Preamble ..................................................................................................325, 373 Art 1..........................................................................................................323, 373 Art 7..................................................................................................................323 Art 12................................................................................................................328 Art 25........................................................................................................261, 304 Art 25(1) ...........................................................................................................279 Art 27................................................................................................................305 Art 27(1) .............................................................................................................40 Table of Legislation xxxv
- 34. UPOV ...............................................................................................................279 Vienna Conventionon the Law of Treaties 1969...............................101, 191 Art 30........................................................................................................101, 348 Art 30(2) .............................................................................................................51 Art 30(3) ...........................................................................................................347 Art 31................................................................................................................101 Art 31(1)...............................................................................................77, 85, 319 Art 53................................................................................................................348 Art 64................................................................................................................348 World Charter for Nature 1982 ......................................................................63 Washington Treaty. See Antarctic Treaty 1959 Wellington Convention. See Convention on the Regulation of Antarctic Mineral Resources Activities (CRAMRA) WTO Agreement. See Agreement Establishing the World Trade Organisation 1994 ITALY Law No 40/2004 Norme in material di procreazione medicalmente assistita..................................................................................290 JAPAN Law No 104 of 1997........................................................................................290 PERU Decree Law No 26017 – General Law on Industrial Property 1996 ..........428 Forestry Law regulations ..............................................................................417 Law No 26821 – Organic Law for the Sustainable Exploitation of Natural Resources 1997.........................................421, 428 Art 9..................................................................................................................421 Law No 27811 on the Regulations on the Protection of the Collective Knowledge of the Indigenous Peoples in relation with biological resources in Peru 2002..................................................................428, 431–2 Art 1..................................................................................................................432 Arts 7–8 ............................................................................................................432 Art 10................................................................................................................432 Arts 15–20 ........................................................................................................432 Art 37................................................................................................................432 National Regulations on the Protection of the Rights of the Acquirers of Vegetables............................................................................428 Prevention of Risks Derived from the Use of Biotechnology 1999.........437 Arts 2–3 ............................................................................................................437 Supreme Decree No 008–96-ITNCI of 3 May 1996....................................432 xxxvi Table of Legislation
- 35. Supreme Decree No039–2003-AG of 5 Dec 2003 regulating Dec 345 ............................................................................426, 432 Art 15................................................................................................................432 PHILIPPINES Executive Order 247.......................................................................................148 SPAIN Ley 35/1988, sobre técnicas de reproducción asistida of 22 Nov...................290 THAILAND Traditional Thai Medicinal Intelligence Act...............................................212 UNITED KINGDOM Human Fertilisation and Embryology Act 1990................................290, 312 Statutory Instruments Human Fertilisation and Embryology (Research Purposes) Regulations 2001........................................................................................312 UNITED STATES OF AMERICA American Convention on Human Rights 1969..........................................323 Art 1..................................................................................................................323 Constitution Art 1, Sect 8, Cl 8 ............................................................................................202 Federal Food, Drug, and Cosmetic Act (FFDCA) .....................................238 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) ................238 Plant Protection Act (PPA) ............................................................................238 Toxic Substances Control Act (TSCA) .........................................................238 35 USC 102...............................................................................................205, 209 35 USC 115.......................................................................................................209 35 USC 135.......................................................................................................209 35 USC 271(a) (e) ............................................................................................226 VENEZUELA Constitution 1999............................................................................................432 Art 124..............................................................................................................432 Law on Biological Diversity 2000 ................................................................436 Art 82................................................................................................................432 Table of Legislation xxxvii
- 37. 1 International Law forBiotechnology: Basic Principles FRANCESCO FRANCIONI* I. INTRODUCTION M ORE THAN FOUR centuries ago, in the famous monologue of the Shakespearean drama, Hamlet pondered ‘Whether ‘tis nobler in the mind to suffer The slings and arrows of outrageous fortune, Or take arms against a sea of troubles, And by opposing end them. To die, to sleep—no more’.1 Four centuries later, the tormenting doubts of the prince of Denmark mirror the anxieties and conflicting attitudes of the international community with regard to the regulation of modern biotech- nology. Should we use, to the utmost of our ability, the power and resources of science and technology to ‘take arms against a sea of troubles’ and fight the unfavourable conditions of human existence, such as dis- ease, physical disabilities, poverty, environmental degradation? Or is it ‘nobler’ to suffer ‘the slings and arrows of outrageous fortune’ and thus accept the supreme design of nature, in the name of divine providence or in the hope of a superior intelligence of the natural selection process? As in any case of rapid and disturbing advances in science, the response to this type of questions is less than certain. At the moral level, the ques- tion of how far bio-science should be allowed to tamper with the intimate essence of nature pits the fundamental value of freedom of research against the ethical claim that application of scientific advances through specific man-made techniques must not ignore the fundamental distinc- tion between right and wrong or between good and evil. Even if the separation between the pure ‘cognitive’ dimension of science and its ‘technological’ application is not easy to maintain, in a world where * Professor of Law, European University Institute, Florence, and University of Siena. 1 Hamlet, Act III, scene I.
- 38. economic and commercialinterests exercise ever-growing pressure over the financing and orientation of scientific research,2 this conceptual sepa- ration has become fertile ground for the development of the discipline of bioethics. Far from remaining confined to the value systems of national or regional legal orders, this discipline has been fully brought within the remit of universal institutions such as the UN and UNESCO, now direct- ly engaged on the issues of human cloning3 and the preparation of an international code of bio-ethics.4 At the policy level, the biotechnology revolution has generated consid- erable strains in the relationship between science and policy-making. A crisis of trust is currently emerging as to who should make the decisions and set the standards with regard to the application of new scientific knowledge through the use of bio-engineering techniques. Should scien- tists have the last word? Or should the decision be left to democratically elected officials? Should religious considerations play a role also in a sec- ular state? How can we balance the influence of industry against the opin- ion and preferences of the people, as expressed through the manifold manifestations of civil society? In recent times these question have pro- voked very discordant answers with an increasing radicalisation of extreme positions, on either the permissive or the prohibitionist side of the issue. The result is the difficulty of dialogue between opposing camps and the consequent elusion of consensus over who has, or should have, ‘authority’ to set standards in the controversial uses of modern biotech- nology.5 4 Francesco Francioni 2 See Krimsky, Science in the Private Interest. Has the Lure of Profits Corrupted Biomedical Research? (Lanham, 2003). 3 See UN GA Declaration on Human Cloning of 17 Nov 2004 (UN doc. A.C.6/59/L.26), calling upon Member States to prohibit ‘any attempt to create human life through cloning processes and any research intended to achieve that aim’. 4 See UNESCO Universal Declaration on the Human Genome and Human Rights of 11 Nov 1997 (infra n 37), the UNESCO Guidelines for the Implementation of the Declaration on the Human Genome and Human Rights of 16 Nov 1999 (infra n 40) and the International Declaration on Human Genetic Data of 16 Oct 2003 (infra n 41). On 19 October 2005 UNESCO adopted the Universal Declaration on Bioethics and Human Rights, www.UNESCO.ORG/SH5/bioethics. For the work of the UN in this field, see especially: Report of the Secretary General submitted pursuant to the UN Commission on Human Rights resolution 2001/71, doc. E/CN.4/2003/98, 10 Feb 2003, with Annex; Report of the Expert Consultation on Human Rights and Biotechnology, Geneva, 24–25 Jan 2002); UN Commission on Human Rights, Sub-Commission in Prevention of discrimination and Protection of Minotities, Working Group on Indigenous Population, Human Genome Diversity Research and Indigenous Peoples, 4 June1998, doc. E/CN.4/Sub.2/AC.4/1998/4. 5 For a balanced approach, advocating national and international regulation of biotech- nologies, although within a liberal perspective, see Fukuyama, Our Posthuman Future (New York, 2002), especially ch 10, 11 and 12.
- 39. At the legallevel this difficulty is reflected in national attempts to abro- gate by popular referenda laws passed by parliaments on contested aspects of biotechnology applications,6 and, at the international level, in the tensions surrounding attempts at establishing norms and institutions for the regulation of the most controversial aspects of biotechnologies, such as the ownership and control of genetic resources, the marketing of genetically modified seeds and food, the use of stem cells of human embryos in biomedicine. Even in Europe, where an impressive body of Community regulations has developed,7 very different attitudes persist on the part of individual states on some key issues such as the limits of admissibility of stem cell research, genetic diagnostics and therapy, safety of genetically modified food, and environmental protection against the risk of trans-national movement of genetically modified organisms (GMO). At the level of public international law, which is the main focus of this contribution and this book, the search for appropriate methods and regu- latory approaches capable of mediating among conflicting views on biotechnology applications meets even greater difficulties. If it is true that the international legal system has demonstrated in the past the capacity to evolve as a consequence of scientific and technological developments— witness the transformation of the law of the sea as a consequence of new techniques of resource exploitation, the emergence of environmental law following massive industrialization, the development of principles gov- erning human activities in outer space—in the field of biotechnology, the diversity and multicultural nature of the international community hin- ders consensus on a reasonably homogeneous core of ethical values and social interests. One manifestation of this difficulty is the current debate in the UN General Assembly with regard to the adoption of a binding legal instrument on human cloning.8 Besides, unlike domestic law, inter- national law is not able to respond to the challenge of rapid technological progress by way of institutional mechanisms competent to enact timely legislation by way of majority vote. The decentralised structure of the international community still relies on treaties and custom as the avail- able tools for law-making, and at the administrative level, with the ex- ception of some advanced regional organisation, such as the European International Law for Biotechnology 5 6 A recent example is provided by the Italian referendum concerning the law on assisted procreation. See Lenzerini, ‘Law n. 40 of 19 February 2004, in (2004) XIV Italian Yearbook of International Law 442. 7 See Pavoni, Biodiversità e biotecnologie nel diritto internazionale e comunitario (Milan, 2004), Part II; Patterson, ‘Biotechnology, Policy Regulating Risks and Risking Regulation’, in Wallace and Wallace (eds), Policy Making in the EU (Oxford, 2000), 32 ff. See also the chapters in this volume by Poli and Sturma. 8 See the work of the Ad Hoc Committee on an International Convention against the Reproductive Cloning of Human Beings, appointed by the UN General Assembly in 2001
- 40. Union, and ofsome soft law regulatory mechanisms in the field of stan- dardisation, such as the FAO/WHO Codex Alimentarius,9 international law cannot rely on the work of administrative agencies, or on general con- sensus on forms of self-regulation by private actors.10 More fundamentally, treaty and customs, as the typical forms of law- making in international relations, are the product of state-driven interests and have been historically concerned with the delimitation of govern- mental powers and state sovereignty in international relations. But biotechnologies are not directly related to governmental powers. The form of power they embody stems from the human ability to manipulate the structure of life and to develop through bio-engineering techniques new genetically modified organisms and products. This new form of tech- nological power originates in the work of scientists and in the new knowl- edge which, when suitable, is privatised through the instrument of Intellectual Property Rights (IPR) and utilised by economic actors—to meet an increasing variety of market demands. This, of course, does not entail that states are powerless to control biotechnologies when they are perceived to pose unacceptable risks. They can exercise such control by way of national legislation, and, indeed, such legislation is now emerging in many states, although at a different pace and with different approach- es.11 But since national legislation is limited in scope to state jurisdiction, it cannot be very effective in relation to biotechnology activities that are developed and implemented in a transnational context. Most commercial applications of biotechnology occur in the transnational business, such as agriculture, food and pharmaceutical production, and medicine. Thus, it is clear that an international approach is necessarily based on some common understanding of what is the permissible scope of such tech- niques, who controls access to the biological resources necessary to their development, by whom they should be managed and overseen, who should benefit from their commercial use, and how disputes arising from their application should be resolved.12 6 Francesco Francioni (GA Res. 56/93 of 12 Dec 2001) and the draft convention text addressed to the UN Secretary General by the Government of Costa Rica on 2 Apr 2003 (UN doc. A/58/73 of 17 Apr 2003). 9 See http://www.codexalimentarius.net/web/index_en.jsp. 10 Even in the recent initiatives for the reform of the UN Charter on the occasion of its 60th anniversary, this issue has remained at the margin of the debate, which has mainly focused on security, terrorism and the reform of the institution. In the High Level Panel Report on Threats, Challenges and Change Level, ‘A More Secure World: Our Shared Responsibility’ Panel Report only a few pages are devoted to issues of environmental governance and and to issues posed by science and technology: see Francioni, ‘The Role of the EU in Promoting Reform of the UN in the Field of Human Rights and Environmental Protection’, Chaillot Paper n. 78 (Institute for Security Studies EU, Paris, 2005), 31 ff. 11 Several European countries have enacted laws in this sense, including those regulating the possible uses of the human genome; see the chapter by Lenzerini, in this volume. 12 Once the need for international regulation is recognised, the problem we have to face is how to develop specific norms and institutions to meet the new needs. Treaty negotiations
- 41. In the followingdiscussion I will try to identify what role international law can play in providing an answer to such questions and in supporting a system of biotechnology governance that is respectful of established principles and values in international relations, including state sovereign- ty and the general interest of the international community as a whole. Since other contributions in this book will deal with specific treaty regimes, this chapter will address the issue of biotechnology only from the point of view of general international law. The main focus will be on the issues that have attracted most controversy in practice and literature: (1) who owns the patrimony of genetic resources that are the object of biotechnological development and application? (2) What is the relevance of general principles of international environmental law for the develop- ment and commercialisation of bio-engineered products and organisms? (3) Does international economic law provide a concept of justice applica- ble to the equitable sharing of benefits arising from the commercial biotechnological innovations and to trade in related products? (4) Does international law allow a human rights approach to biotechnology?13 II. WHO OWNS THE BIOGENETIC RESOURCES? Available Normative Models Since biotechnologies entail the manipulation of living organisms in order to make new products, the first question to be addressed is who owns the genetic material to which bio-engineering techniques are applied? Classical international law, since its development in the seventeenth cen- tury, has provided a simple dualist model of resource allocation. On the one hand, the physical space and the resources located therein were allo- cated to the spheres of national jurisdiction coinciding with the territorial sovereignty of every independent state. On the other hand, space and International Law for Biotechnology 7 and custom as traditional methods of international law-making both require some form of state consent, either by the express manifestation of the will to be bound in the former, or by the development of a consistent practice and the opinio iuris in the latter. It is hardly neces- sary to point out that these requirements entail a slow and unpredictable process of law cre- ation that can be particularly inadequate to address the phenomenon of rapidly developing new technologies. Further, consent and opinio iuris can be withheld by states which have a stake in safeguarding the freedom of their economic actors in taking advantage of the glob- al market for the commercial exploitation of their biotechnological products or services. This has become apparent in relation to the persistent refusal of some major technological play- ers to join the Biodiversity Convention (see infra n 18) and the Biosafety Protocol (see infra n 53) in spite of the dramatic rate of biodiversity degradation the planet is undergoing. 13 This question is the object of an ongoing research project undertaken by this writer at the European University Institute, which should lead to the preparation and publication of a second volume in 2006.
- 42. 8 Francesco Francioni 14See, in particular, GA Res. 1803 (XVII 1962), ‘Permanent Sovereignty over Natural Resources’, reprinted in [1963] ILM 223 (infra, text corresponding to n 23). 15 See United Nations Convention on the Law of the Sea, 1982 [1982] ILM 1261, Part XI. 16 The Antarctic Treaty System was initiated by the 1959 Antarctic Treaty (402 UNTS 71). 17 For a general evaluation of the Antarctic Treaty system, see Francioni and Scovazzi (eds.), International Law for Antarctica (The Hague, 1996) and the literature cited therein. resources ‘beyond national jurisdiction’ were subject to the regime of free- dom. This entailed equal rights of access to the resources of the high seas and the freedom to occupy and claim territories and resources that belonged to no other state. In the course of the twentieth century, this strict dualism yielded to further models of natural resources allocation and management. First, the option of enlarging the scope of national sov- ereignty by way of occupation of territories deemed to be terra nullius was precluded by the prohibition of the use of force, the elimination of colo- nialism and the concomitant emergence in the 1960s of the principle of permanent sovereignty over natural resources.14 Secondly, with respect to the classical regime of the seas, the principle of freedom has undergone profound transformation as a consequence of the emergence of the new customary rules allowing states to establish the exclusive economic zone (EEZ) and the continental shelf, two legal concepts that are based on the combination of functional sovereignty of the coastal state with a residual recognition of community interests involved in their exploitation and of the traditional principle of freedom of the high seas. Thirdly, as perhaps the most radical departure from the regime of freedom, the principle of the common heritage of mankind has made the international community the title holder of the resources of the deep sea bed. An institution—the International Sea Bed Authority—has been established by the quasi-uni- versal Law of the Sea Convention15 and a system of prior authorisation and management has replaced the primitive principles of free access and first come, first served. Fourthly, in the second part of the last century innovative and sophisticated models of international management of resources, over which national sovereignty is absent or contested were been developed. The pre-eminent example of this model is the Antarctic Treaty System,16 which combines freedom of access to the continent with the preservation of certain sovereignty claims and a system of internation- al inspection, monitoring and strict environmental protection enacted and implemented by a parliament-like institution, the Antarctic Treaty Consultative Meeting.17 Fifthly, in the last decade the new concept of ‘common concern of humankind’ has emerged as a legal tool designed to safeguard the general interest of the international community in the preservation of certain components of the global ecosystem, such as bio- diversity and climate. Unlike the common heritage of mankind, the com- mon concern does not purport to vest title over relevant resources, but
- 43. more modestly signifiesthat the international community as a whole, inclusive of states and peoples, is a stakeholder in the conservation and use of such resources. In view of this complex and quite diversified development of interna- tional law over the past half-century, the question arises which regulato- ry model, if any, among those examined above, is applicable to determine the status of genetic resources which today are the object of biotechnolog- ical investigation and application. Although the state of international law is still far from being settled, it is our opinion that three basic normative models now emerge in international practice. A Modern Permanent Sovereignty Regime The first model is what may be called the modern permanent sovereignty regime. By this expression we mean that biogenetic material contained in plants and animals located in the territory of a state is to be deemed sub- ject to the sovereignty of that state. By virtue of this principle every state is free to regulate access to those resources by private or public firms oper- ating in the field of biotechnology. However, this freedom is counterbal- anced by the basic requirement that it be exercised in a manner so as to facilitate access to genetic resources for sustainable development and environmentally sound use. This rather conservative approach has been followed in Article 15(2) of the Biodiversity Convention18 and is the result of an oscillating practice over the past 20 years. In the field of plant genet- ic resources, we can observe that in the mid-1980s an assertion was made under the impulse of FAO that such resources should constitute the com- mon heritage of mankind.19 Later on, state practice backtracked on this position under the pressure of industrial states and farmers’ and breeders’ associations, which were all concerned that the common heritage would pose an unacceptable threat to proprietary rights over plant varieties and their potential improvement by way of biotechnological manipulation. In parallel, less developed countries with a rich biodiversity in their territo- ry became acutely aware of the need to secure international recognition of their entitlement to obtain some form of remuneration vis-à-vis the wide- spread practice of removal of genetic material from their territory by for- eign firms. These combined pressures led to the progressive erosion of the earlier assertion of the common heritage. The FAO Conference, which had been the champion of this principle, resolved at its 26th Session in 1991, International Law for Biotechnology 9 18 See the 1992 Convention on Biological Diversity, available at http://www.biodiv.org/ doc/legal/cbd-en.pdf. 19 See the 1983 FAO International Undertaking on Plant Genetic Resources, available at ftp://ext-ftp.fao.org/ag/cgrfa/iu/iutextE.pdf (see, in particular, the preambles of annexes I and II).
- 44. with an evidentoxymoron, that ‘[t]he concept of the common heritage of mankind, as applied in the International Undertaking on Plant Gene- tic Resources, is subject to the sovereignty of states over their plant genetic resources’.20 The adoption of the Biodiversity Convention in 1992 confirms this return to sovereignty. The preamble to the Convention proclaims that ‘[s]tates have sovereign rights over their biological resources’. The same concept, in slightly different language, is expressed in Article 15(2). If we consider that the Biodiversity Convention has been ratified by the vast majority of the states,21 that its text does not allow reservations (Article 37) capable of diminishing its normative character, and that these provi- sions reiterate the principle proclaimed by the FAO Conference, the rea- sonable conclusion is that the legal status of genetic resources cannot be founded on the common heritage principle, but rather follows the tra- ditional rule according to which natural resources are subject to the sov- ereignty of the state in whose territory they are located. It is true that, following the adoption of the Biodiversity Convention, traces of the com- mon heritage remained in the Agenda 21 programme of strengthening the FAO role as trustee of the global common represented by plant genetic resources through the FAO Global System for the Conservation and Utilisation of Plant Genetic Resources.22 Yet, however disappointing this may be, the FAO system never succeeded in becoming the exclusive mechanism for ensuring the conservation and management of plant genetic resources. Gene banks and private networks moved in to compete in the role of collectors and custodians of plant germoplasm, and today the FAO is only one of the players in the worldwide business of potential providers of plant genetic resources. Notwithstanding this failure in making plant genetic resources part of the common heritage, the regulatory model that emerges from the above practice significantly departs from the original concept of permanent sov- ereignty over natural resources as established in the well known GA Resolution 1803 of 1962.23 First of all, the new model refers to ‘sovereign rights’ (see the CBD preamble) rather than sovereignty tout court, which in itself signals a less than absolute power of the territorial state over genetic resources. But, most important, this model can be qualified as ‘modern’ because it aims at reconciling the sovereignty of the territorial state with the general interest of the international community in securing conditions to facilitate access to genetic resources for environmentally 10 Francesco Francioni 20 Res. C 3/91, FAO Conf. 26th Sess. (emphasis added). 21 At 30 Apr 2005 188 states were parties to the Convention; see http://www.biodiv.org/ world/parties.asp. 22 See http://www.fao.org/FOCUS/E/96/06/06-e.htm. 23 See supra n 14.
- 45. sound purposes. Themodernity of this approach lies in the recognised need for international cooperation in the identification, collection, evalu- ation and conservation of genetic resources, both in situ and ex situ. Thus, sovereignty in this area must be exercised in such a manner as to avoid unreasonable restrictions that defeat the purpose of biodiversity conser- vation and of sustainable use of biogenetic resources. This conclusion is supported by the recently adopted FAO Treaty on Plant Genetic Resources for Food and Agriculture.24 Other contributions to this volume25 will address the complex technical innovations of this treaty. Here it is sufficient to note that its basic premise is that the recog- nised state’s sovereignty over biological resources is to be made compati- ble with the overarching goal of pursuing international cooperation to ensure access to those resources for their development in the interest of the international community and in conditions of ‘fair and equitable shar- ing of the benefits arising from their use’. The Common Heritage Regime (a) The sea and seabed Although most genetic resources are located in areas subject to state sov- ereignty, today, an increasing variety of such resources is found in organ- isms which live in spaces beyond national jurisdiction. Of particular inter- est in this regard are the organisms which have developed in extreme environmental conditions such as those characterising the deep sea26 and Antarctica.27 Since in these areas there is no state sovereignty or, at least, no generally recognised sovereignty, the question arises as to what is the applicable legal regime to determine the status of genetic resources found therein. No explicit answer is provided to this question in existing treaties, such as the 1982 Law of the Sea Convention or the 1959 Antarctic Treaty.28 However, two legal options can be found in customary interna- tional law. The first option is that of the freedom of the high seas. The sec- ond is the common heritage. At first sight, it might appear logical to consider genetic resources of the high seas and the international seabed as equivalent to any tangible bio- logical resources and to subject them to the regime of freedom in analogy with fishing activities. Further, since activities related to genetic resources of the sea are scientific in nature, it might be plausible to subject them to the regime of scientific research which is also covered by the principle of International Law for Biotechnology 11 24 See the 2001 International Treaty on Plant Genetic Resources for Food and Agriculture, available at ftp://ext-ftp.fao.org/ag/cgrfa/it/ITPGRe.pdf. 25 See in particular, the chapter by Footer, in this volume. 26 See the chapter by Scovazzi, in this volume. 27 See the chapters by Vigni and Guyomard, in this volume. 28 See supra n 16.
- 46. freedom of thesea.29 However, such analogies with fishing and scientific research can be quite misleading when it comes to determining the status of genetic resources beyond national jurisdiction. First, fishing is con- cerned with harvesting living resources of the sea for human consump- tion or other commercial uses but has no relation whatsoever with the activity of identification, collection and possible development of the intangible patrimony of genetic resources contained in living organisms. Appropriation of the fish by the fisherman does not entail appropriation of the wealth of genetic information the catch may yield; any more than the purchase of a house designed by an architect entails the appropriation by the buyer of the talent and know-how that the architect bestowed in it. That talent, although incorporated in the house, is a separate asset with a continuing vitality and creative potential that the purchaser of the house cannot own. By the same token, also the application by analogy of the regime of freedom governing scientific research on the high seas is rather dubious. In fact, rules relating to marine scientific research are activity related, in the sense that they establish rights and obligations applicable to the conduct of science activities at sea, but in no way can such rules, those contained in Part XIII of the Law of the Sea Convention or the cor- responding customary rules, be used to establish a legal status of genetic resources in the high sea and on the international sea bed. This is con- firmed by Article 241 of the Law of the Sea Convention, which provides that ‘[m]arine scientific research activities shall not constitute the legal basis for any claim to any part of the marine environment or its re- sources’.30 Since the principle of freedom cannot be presumed to govern the legal status of genetic resources of the high seas and deep sea bed, and since sovereignty is excluded by definition in these areas, the logical conclusion is that these resources must be deemed to be subject to the principle of common heritage. They should therefore be placed under the jurisdiction of the existing institutional mechanisms established with the LOS Convention or under a new specialised institution to be created within the same forum. This conclusion is reinforced by the fact that the most prom- ising repository of marine genetic material is located in the vicinity of hydrothermal vents in the sea bed, where extreme environmental condi- tions linked to scarcity of light and temperature variations provide pre- cious genetic resources that science and technology are just starting to identify.31 Since such resources are so closely linked to the physical condi- tions of the deep sea bed, it is unavoidable that the eventual exploitation 12 Francesco Francioni 29 See Part XIII of the Law of the Sea Convention, supra n 15. 30 Emphasis added. 31 See the chapter by Scovazzi in this volume, as well as the debates in the Vth Meeting of the UN open-ended informal consultative process on oceans and the law of the sea
- 47. of sea bedminerals shall have a direct impact on them. This is a further convincing reason for bringing them under the common heritage princi- ple and for ensuring that a unified regime applies to the physical and bio- logical environment of the international sea bed. (b) Antarctica As far as Antarctica is concerned, the problem of bio-prospecting is only beginning to be addressed in the context of the Antarctic Treaty Consultative Meeting (ATCM).32 One of the principles of the Antarctic Treaty, which by way of a long and uncontested practice has acquired the status of general international law, is that activities in Antarctica must be carried out in the interest of ‘all mankind’ and in full respect of Antarctica as a natural reserve devoted to peace and science.33 This principle has so far permitted access to natural resources only for scientific purposes and led in 1991 to the adoption of the well known moratorium on the explo- ration and exploitation of mineral resources. Bio-genetic resources do not fall within the moratorium. However, when their prospecting is carried out for gain, the related activities can be carried out within a legal frame- work of cooperation, exchange of information and collective solidarity of the Antarctic Treaty Consultative Parties. It is up to them to devise, if nec- essary, an appropriate regulatory regime for Antarctic bio-prospecting, perhaps as an annex to the Madrid Protocol on the protection of the Antarctic environment.34 (c) The human genome That of genetic resources located in common spaces is not the only area where the principle of common heritage can play a role. Another important area is that of the human genome.35 Here, it is not so much the location of the resources that makes them a global common, but rather the fact that they constitute the very essence and common patrimony of humanity. In the last decade groundbreaking research has been conducted by private and public entities in order to complete the so-called mapping of the International Law for Biotechnology 13 (UNICPOLOS), 9 June 2004, in particular the intervention by the Italian delegate Scovazzi in the panel discussion on ‘New Sustainable Use of the Oceans, Including the Conservation and Management of Biological Diversity of the Seabed in Areas beyond National Jurisdiction’, reprinted in Italian Yearbook of International Law, vol. XIV(2004), forthcoming. 32 A Resolution was adopted at the ATCM held in Stockholm in June 2005 to the effect of committing Consultative Parties to gather and exchange information and date concerning research carried out in Antarctica by their nationals and related to bio-genetic resources in view of establishing whether such research is susceptible of commercial exploitation (docu- ments on file with the author). 33 See Preamble to the 1959 Antarctic Treaty (supra n 16) and art 2 of the Madrid Proto- col on Environmental Protection to the Antarctic Treaty of 1991 (available at http://www.antarctica.ac.uk/About_Antarctica/Treaty/protocol.htm). 34 Further on this issue, see the chapters by Vigni and Guyomard, in this volume. 35 On this issue, see the chapter by Lenzerini, in this volume.
- 48. human genome. Theresults, now at an advanced stage, open up unprece- dented prospects of application in life sciences, medicine, and in relation to the general goal of improving health and welfare of human beings. At the same time, the prospects of biotechnological applications to human genetic material have raised fears that human beings may be reduced to ‘means’ in function of technological experimentation or of commercial goals. Besides, genetic knowledge is deemed to contain the potential for conscious discrimination based on genetic patterns of individuals or groups, and on other violations of human rights. Against this problemat- ic background, international practice over the past ten years has evolved toward the extension of the principle of common heritage from the field of economic resources to the new area of the intangible resources repre- sented by the human genome. Thanks to the vigorous action of UNESCO, whose mandate in the field of advancement of science and culture is linked to the constitutional commitment to guarantee ‘the democratic principle of the dignity, equality and mutual respect of men’ (UNESCO Constitution),36 a Universal Declaration on the Human Genome and Human Rights was adopted in 1997.37 Article 1 of the Declaration states that ‘[t]he human genome underlies the fundamental unity of all mem- bers of the human family, as well as the recognition of their inherent dig- nity and diversity. In a symbolic sense, it is the heritage of humanity’.38 Although the use of the phrase ‘in a symbolic sense’ may appear to weak- en the legal strength of this article, the general context of the Declaration clearly confirms its intention to proclaim the human genome the common heritage of humanity. Article 4 provides that the human genome in its nat- ural state shall not give rise to financial gains. This precludes its patenting for commercial purposes. Article 10 subjects scientific genomic research in such fields as biology and medicine to respect for human dignity and fun- damental rights of individuals and peoples. Further, the Declaration requires a commitment to international cooperation in the assessment of risks and benefits deriving from genomic research and in the promotion of developing countries’ capacity to carry out such research and to bene- fit from its technological applications. Obviously, the Universal Declaration on the Human Genome is not a binding treaty and its text can at best reflect underlying principles of emerging international law or, at least, constitute a body of soft law designed to model the evolution of customary law around its standards. Yet, it is difficult to deny that the Declaration has affected the opinio iuris of the international community. Its text emanates from the UNESCO 14 Francesco Francioni 36 See the Preamble to the UNESCO Constitution (third sentence), available at http://www.unesco.org. 37 See Universal Declaration on the Human Genome and Human Rights, 11 Nov 1997, available at http://www.unesco.org. 38 Emphasis added.
- 49. General Conference, abody of universal character, where states can express their opinion and cast their votes, positive or negative; its adoption by acclamation was preceded by extensive consultations and technical preparatory work, where all currents of opinion—scientific, legal, ethical— were represented, and no objection was raised or reservation attached. After its adoption, the UN General Assembly endorsed its text by a reso- lution of 9 December 1998.39 Further, the Universal Declaration has not remained an isolated act. UNESCO has followed up on the proclamation of the human genome as heritage of humanity: in 1999 it adopted imple- menting measures in the form of a resolution40 prescribing guidelines for making the Declaration effective in domestic law; in October 2003 the General Conference adopted the International Declaration on Human Genetic Data,41 a document that confirms the status of the human genome as common heritage of humanity. The above documents have received broad support from the interna- tional community and provide principles and criteria which domestic law and regional organisations are drawing upon in developing legislation and codes of ethics for the conservation and proper use of the human genetic patrimony.42 (d) The common concern concept Unlike the common heritage of mankind, the ‘common concern’ concept is a relatively recent development in international law. Its appearance in treaty law and practice dates back to the early 1990s, the time of the adop- tion of the major environmental treaties addressing global environmental problems such as biodiversity degradation and climate change. The under-lying idea of the ‘common concern’ is that resources of the world to which this concept applies are not ‘owned’ by the international com- munity on the basis of an indivisible title, as in the case of the common heritage: on the contrary, they remain subject to the traditional regime of sovereignty or freedom, but their management requires a holistic approach that takes into account the general interest of humanity in their conservation. In this sense, such resources are an element of the general interest of humanity and the common concern serves as a legal basis for legitimising forms of intervention within the sphere of domestic jurisdic- tion of individual states, as well as possible limitations on the principle of International Law for Biotechnology 15 39 See A/RES/53/152 of 9 Dec 1998. 40 See 30 C/Resolution 23 of 16 Nov 1999 endorsing the Guidelines for the implementation of the Universal Declaration on the Human Genome and Human Rights. 41 See International Declaration on Human Genetic Data, 16 Oct 2003, available at http://www.unesco.org. 42 For an overview of domestic law on the scientific use of the human genome, cf. Commission on Human Rights, Report on Human Rights and Bioethics, 10 Feb 2003, UN doc. E/CN.4/2003/98.
- 50. freedom applicable tocommon spaces. The most direct relevance of the common concern concept is in the area of biodiversity. All genetic materi- al, in one way or another, is related to the biological diversity of our plan- et. Wild plants and animals that make up the biological diversity of our planet are distributed in areas subject to sovereignty, to freedom or to the common heritage. In relation to all of them, the common concern princi- ple may play a subsidiary role in safeguarding the general interest of the international community whenever specific regulatory models, such as the common heritage, are not applicable, or whenever the standard regime of permanent sovereignty needs to be bent to accommodate the general interest. If we take this into account, it seems that the concept of the common concern can play a complementary role43 in the definition of the interna- tional status of biogenetic resources. On the one hand, it is capable of rein- forcing the principle of the common heritage applicable to resources locat- ed beyond the limits of national jurisdiction and to the human genome; on the other hand it serves to mitigate the exclusivity of national jurisdic- tion over biogenetic resources that are located within state territory. In this case, although the regime of permanent sovereignty remains applicable, the common concern provides the rational and legal foundation for the duty that every territorial state has to facilitate access to its biogenetic resources and to cooperate in view of their sustainable development. III. BIOTECHNOLOGIES AND ENVIRONMENTAL PROTECTION International environmental law is a relative recent development of the international legal system. Up to the second part of the last century hard- ly any norm could be found in this system that would significantly limit state sovereignty over national territory or state freedom in common spaces in function of the preservation of the environment. The situation has changed over the past 30 years. Now it is generally agreed in legal doctrine and in international practice that the protection of the environ- ment has become the object of an international obligation and that such obligation entails some limits on state sovereignty over the use of natural resources in the national territory and in areas beyond national jurisdic- tion.44 16 Francesco Francioni 43 For a different view, according to which the common concern principle plays a primary role in this respect, see the chapter by Pavoni, in this volume. 44 See Birnie and Boyle, International Law and the Environment (Oxford, 2003); Sands, Principles of International Environmental Law (Manchester and New York, 1995), 183 ff.; Brownlie, Principles of Public International Law (Oxford, 1998), 285 ff.; ‘Siena Forum on the International Law of the Environment’, Siena, 17–21 Apr 1990. reprinted in Vita Italiana, suppl. n. 1. Roma, 1990.
- 51. The first principleof international environmental law that may find useful application in the field of biotechnology is the due diligence obli- gation incumbent upon every state to prevent damage to the territory of other states or to common spaces as a consequence of biotechnology activ- ities that entail release of genetically modified material into the environ- ment. This obligation can be traced to the Stockholm Declaration,45 Principle 21, and to the Rio Declaration,46 Principle 2, and now forms an integral part of the International Law Commission draft articles on trans- frontier damage resulting from hazardous activities (2001).47 An express recognition of this principle in the field of biotechnology can be found in the appellate decision of the Examining Division of the European Patent Office in the well-known case of the Onco-mouse.48 In this case the appli- cants were seeking patent registration in Europe for the Harvard ‘Onco- mouse’, a genetically bioengineered mouse resulting from the introduction into its genetic make-up of a specific onco gene that would make it acute- ly prone to develop tumours. Besides the moral considerations involved in assessing a process that entailed the intentional infliction of acute suf- fering upon a living creature, the Examining Division expressly referred to considerations relating to the protection of the environment as a neces- sary element in striking the balance between the usefulness of the inven- tion and the protection of public order. The Division affirmed: There is a basic interest of mankind to remedy widespread and dangerous dis- eases, on the other hand the environment has to be protected against the uncon- trolled dissemination of unwanted genes . . . .49 Finally the Division held the granting of the patent compatible with the protection of the environment on the basis of the finding that in the spe- cific case: No release is intended into the general environment. Therefore the risk of an uncontrolled release is practically limited to intentional misuse or blatant igno- rance on the part of the laboratory personnel carrying out the tests.50 It is useful to recall that, from a general point of view, the principle of prevention of transboundary environmental harm has been considered to International Law for Biotechnology 17 45 See Stockholm Declaration on Environment and Development, 16 June 1972 [1972] ILM 1416. 46 See Rio Declaration on Environment and Development, 14 June 1992 [1992] ILM 874. 47 See Draft Articles on Prevention of transboundary harm from hazardous activities, 2001, available at http://www.un.org/law/ilc/texts/prevention/preventionfra.htm. 48 Onco-Mouse/Harvard III, Examining Division, decision of 3 Apr 1992 [1992] OJ EPO, 588 ff. 49 Para. 4. 50 Para. 4(iv).
- 52. be part ofcustomary international law by the International Court of Justice. In its 1996 advisory opinion on the Legality of the Threat or Use of Nuclear Weapons the Court affirmed that ‘[t]he general obligation of states to ensure that activities within their jurisdiction and control respect the environment of other states or of areas beyond national control is now part of the corpus of international law relating to the environment’.51 Just a year after this Advisory Opinion, the International Court of Justice confirmed this finding in the well known judgment or the Gabcikovo- Nagymaros litigation between Hungary and Slovakia.52 Besides the principle of prevention, another substantive principle of international environmental law is particularly suitable for application in relation to biotechnology: that is the so-called ‘precautionary approach’. In its substantive dimension, the precautionary approach requires states to adopt or tolerate the adoption of legislation or administrative measures that are necessary to forestall foreseeable risks for the environment. A rad- ical interpretation of this principle—although still a controversial one— would entail the setting aside or cessation of an economic or technologi- cal activity that entailed a serious risk for which no reliable assessment or management method was available. In the field of biotechnology, where the implications of the release into the environment of bio-engineered organisms is still surrounded by great uncertainty, this principle can have a wide scope of application. The Bio-safety Protocol additional to the Biodiversity Convention has been inspired by the precautionary approach.53 As we shall see in the following section, the Protocol has insti- tuted a procedure of prior informed consent for the trade in ‘living mod- ified organisms’ and permits the adoption of precautionary measures to restrict imports of such organisms when the risk they pose for the envi- ronment or health is deemed to be incompatible with the level of environ- mental protection and safety set by the importing state. In the case law, the reception of the precautionary approach is still patchy and rather ten- uous. While specific reference was made to it by the International Tribunal for the Law of the Sea in the Southern Bluefin Tuna case54 and by some individual opinions of judges of the same Tribunal in the recent MOX Plant case,55 other jurisdictions have refrained from pronouncing 18 Francesco Francioni 51 [1996] ICJ Rep 226, 241–242, para. 29. 52 [1997] ICJ Rep 7 41, para. 53. 53 See Cartagena Protocol on Biosafety to the Convention on Biological Diversity, 2000 [2000] ILM 1027. 54 Southern Bluefin Tuna (New Zelanda v. Japan; Australia v. Japan), Order of 27 Aug 1999, available at http://www.itlos.org, part, para. 77 (see also the individual opinions of judges Treves and Laing). 55 MOX Plant (Ireland v. United Kingdom) case, Order of 13 Nov 2001, available at http://www.itlos.org, espec. para. 84.
- 53. on the legallybinding nature of the approach (Hormones case56 and Gabcikovo-Nagymaros57) as either a custom or a general principle. On the other hand, this principle is well entrenched in European Union law and has been given a robust interpretation in the European judicial practice in the recent Pfizer case.58 Be it as it may, it is easy to imagine that this prin- ciple, as a soft law approach or as hard law creating binding obligations, is bound to play two very important roles in relation to biotechnology. The first is a complementary role in relation to the principle of prevention examined above. Where the effect of the release of new genes into the environment can escape full scientific assessment, the precautionary approach is part and parcel of every state’s due diligence obligation to see that activities within its jurisdiction or under its control do not result in environmental damage.59 The second role is rather procedural, in the sense that it entails the appropriate use of available practices and scientif- ic knowledge to ensure that the environmental impact of bioengineered products or services is fully evaluated before they are released into the environment. But this leads us to the procedural dimension of interna- tional environmental law. When I speak of the ‘procedural dimension’ of environmental norms, I refer especially to the set of procedural obligations arising from the gen- eral principle of inter-state cooperation in preventing and minimising environmental risks. This principle entails a number of duties: the duty to provide information related to the risk posed by genetically modified organisms; the duty to consult whenever differences arise as to the nature and extent of the risk; the duty to allow civil society participation in deci- sions involving difficult choices between the social advantages offered by technological innovations and the risks posed by such advances; and, most important, the duty to provide an environmental impact study of the specific biotechnology upon the environment and health of the peo- ple. These different faces of the principle of cooperation have already International Law for Biotechnology 19 56 European Communities—Measures Concerning Meat and Meat Products (EC—Hormones), Report of the Appellate Body, doc. WT/DS26/AB/R-WT/DS48/AB/R of 16 Jan 1998, para. 123. 57 See Gabcikovo-Nagymaros Project (Hungary v. Slovakia), [1997] ICJ Rep 7, part. at 42, para. 54. 58 See Commission of the European Communities v. CEV A Santé Animale SA and Pfizer Enterprises Sàrl, Judgement of 12 July 2005, available at http://www.europa.eu.int/eur-lex. 59 On the issue of liability for damage caused by deliberate release of genetically modified organisms, see McGarity, ‘International Regulation of Deliberate Release Biotechnologies’, in Francioni and Scovazzi (eds.), International Responsibility for Environmental Harm (London/Dordrecht/Boston, 1991), 319 ff.; Mackenzie, ‘Environmental Damage and Genetically Modified Organisms’, in Bowman and Boyle (eds.), Environmental Damage in International and Comparative Law: Problems of Definition and Valuation (Oxford, 2002), 63 ff.
- 54. received ample recognitionin international practice. In the already men- tioned MOX Plant case,60 the Law of the Sea Tribunal has formally recog- nised this principle in relation to the protection of its marine environment. In the Gabcikovo-Nagymaros case the International Court of Justice, in spite of its rather shy interpretation of existing norms of international environ- mental law, did not hesitate to consider the duty to cooperate and to pro- vide a continuous impact assessment of technological risks as a funda- mental principle binding upon the parties.61 This practice reinforces the normative character of the principle of cooperation as enunciated in the Stockholm and Rio Declarations (Principles 24 and 7, respectively).62 There are other emerging principles of international environmental law that may have certain relevance to biotechnology. I am thinking particu- larly of sustainable development and the concept of intergenerational equity. However, these principles still remain too tenuous to be able to yield any norm-creating effects.63 In any event, their possible relevance can be best appreciated in the context of international economic law, which is the subject of the following section. IV. BIOTECHNOLOGIES, JUSTICE AND THE EQUITABLE SHARING OF BENEFITS If one can speak of an ‘economic constitution’ of the world today, it may be defined on the basis of the post-World War II liberal project that culmi- nated in the establishment of the WTO, following the end of the Cold War, in the development of a worldwide network of bilateral investment treaties, and the linking to intellectual property protection of the commer- cial advantages guaranteed by WTO. Such basic system is founded on the progressive realisation of the freedom of movement of goods and servic- es, of capital, and to a much more limited extent, of persons seeking eco- nomic opportunities. In relation to such framework of principles the problems raised by the application of biotechnology to economic activities can fall in a variety of legal categories as large and diverse as the multiplicity of treaty regimes ranging from trade, intellectual property rights, investments, biodiversity protections and development assistance, to mention just some examples. The issues arising in the relationship between biotechnologies and these 20 Francesco Francioni 60 See supra n 55, para. 82. 61 See supra n 57, 68, para. 112 and 78, para. 140. See also the individual opinion of Vice- President Weeramantry [1997] ICJ Rep 88, at 111–113 62 See supra n 45 and 46 respectively. 63 In this sense, see Lowe, ‘Sustainable Development and Unsustainable Arguments’, in Boyle and Freestone (eds.), International Law and Sustainable Development (Oxford, 1999), 19 ff.
- 55. Random documents withunrelated content Scribd suggests to you:
- 59. The Project GutenbergeBook of A Colored Man's Reminiscences of James Madison
- 60. This ebook isfor the use of anyone anywhere in the United States and most other parts of the world at no cost and with almost no restrictions whatsoever. You may copy it, give it away or re-use it under the terms of the Project Gutenberg License included with this ebook or online at www.gutenberg.org. If you are not located in the United States, you will have to check the laws of the country where you are located before using this eBook. Title: A Colored Man's Reminiscences of James Madison Author: Paul Jennings Release date: June 3, 2018 [eBook #57259] Language: English Credits: Produced by MWS, Martin Pettit and the Online Distributed Proofreading Team at http://www.pgdp.net (This file was produced from images generously made available by The Internet Archive/American Libraries.) *** START OF THE PROJECT GUTENBERG EBOOK A COLORED MAN'S REMINISCENCES OF JAMES MADISON ***
- 61. A COLORED MAN'S REMINISCENCES OF JAMESMADISON. A COLORED MAN'S REMINISCENCES OF JAMES MADISON.
- 62. By PAUL JENNINGS. BROOKLYN: GEORGEC. BEADLE. 1865.
- 63. PREFACE. Among the laborersat the Department of the Interior is an intelligent colored man, Paul Jennings, who was born a slave on President Madison's estate, in Montpelier, Va., in 1799. His reputed father was Benj. Jennings, an English trader there; his mother, a slave of Mr. Madison, and the granddaughter of an Indian. Paul was a "body servant" of Mr. Madison, till his death, and afterwards of Daniel Webster, having purchased his freedom of Mrs. Madison. His character for sobriety, truth, and fidelity, is unquestioned; and as he was a daily witness of interesting events, I have thought some of his recollections were worth writing down in almost his own language. On the 10th of January, 1865, at a curious sale of books, coins and autographs belonging to Edward M. Thomas, a colored man, for many years Messenger to the House of Representatives, was sold, among other curious lots, an autograph of Daniel Webster, containing these words: "I have paid $120 for the freedom of Paul Jennings; he agrees to work out the same at $8 per month, to be furnished with board, clothes, washing," &c. J. B. R.
- 65. REMINISCENCES OF MADISON. Aboutten years before Mr. Madison was President, he and Colonel Monroe were rival candidates for the Legislature. Mr. Madison was anxious to be elected, and sent his chariot to bring up a Scotchman to the polls, who lived in the neighborhood. But when brought up, he cried out: "Put me down for Colonel Monroe, for he was the first man that took me by the hand in this country." Colonel Monroe was elected, and his friends joked Mr. Madison pretty hard about his Scotch friend, and I have heard Mr. Madison and Colonel Monroe have many a hearty laugh over the subject, for years after. When Mr. Madison was chosen President, we came on and moved into the White House; the east room was not finished, and Pennsylvania Avenue was not paved, but was always in an awful condition from either mud or dust. The city was a dreary place. Mr. Robert Smith was then Secretary of State, but as he and Mr. Madison could not agree, he was removed, and Colonel Monroe appointed to his place. Dr. Eustis was Secretary of War—rather a rough, blustering man; Mr. Gallatin, a tip-top man, was Secretary of the Treasury; and Mr. Hamilton, of South Carolina, a pleasant gentleman, who thought Mr. Madison could do nothing wrong, and who always concurred in every thing he said, was Secretary of the Navy. Before the war of 1812 was declared, there were frequent consultations at the White House as to the expediency of doing it. Colonel Monroe was always fierce for it, so were Messrs. Lowndes,
- 66. Giles, Poydrass, andPope—all Southerners; all his Secretaries were likewise in favor of it. Soon after war was declared, Mr. Madison made his regular summer visit to his farm in Virginia. We had not been there long before an express reached us one evening, informing Mr. M. of Gen. Hull's surrender. He was astounded at the news, and started back to Washington the next morning. After the war had been going on for a couple of years, the people of Washington began to be alarmed for the safety of the city, as the British held Chesapeake Bay with a powerful fleet and army. Every thing seemed to be left to General Armstrong, then Secretary of war, who ridiculed the idea that there was any danger. But, in August, 1814, the enemy had got so near, there could be no doubt of their intentions. Great alarm existed, and some feeble preparations for defence were made. Com. Barney's flotilla was stripped of men, who were placed in battery, at Bladensburg, where they fought splendidly. A large part of his men were tall, strapping negroes, mixed with white sailors and marines. Mr. Madison reviewed them just before the fight, and asked Com. Barney if his "negroes would not run on the approach of the British?" "No sir," said Barney, "they don't know how to run; they will die by their guns first." They fought till a large part of them were killed or wounded; and Barney himself wounded and taken prisoner. One or two of these negroes are still living here. Well, on the 24th of August, sure enough, the British reached Bladensburg, and the fight began between 11 and 12. Even that very morning General Armstrong assured Mrs. Madison there was no danger. The President, with General Armstrong, General Winder, Colonel Monroe, Richard Rush, Mr. Graham, Tench Ringgold, and Mr. Duvall, rode out on horseback to Bladensburg to see how things looked. Mrs. Madison ordered dinner to be ready at 3, as usual; I set the table myself, and brought up the ale, cider, and wine, and placed them in the coolers, as all the Cabinet and several military gentlemen and strangers were expected. While waiting, at just about
- 67. 3, as Sukey,the house-servant, was lolling out of a chamber window, James Smith, a free colored man who had accompanied Mr. Madison to Bladensburg, gallopped up to the house, waving his hat, and cried out, "Clear out, clear out! General Armstrong has ordered a retreat!" All then was confusion. Mrs. Madison ordered her carriage, and passing through the dining-room, caught up what silver she could crowd into her old-fashioned reticule, and then jumped into the chariot with her servant girl Sukey, and Daniel Carroll, who took charge of them; Jo. Bolin drove them over to Georgetown Heights; the British were expected in a few minutes. Mr. Cutts, her brother-in-law, sent me to a stable on 14th street, for his carriage. People were running in every direction. John Freeman (the colored butler) drove off in the coachee with his wife, child, and servant; also a feather bed lashed on behind the coachee, which was all the furniture saved, except part of the silver and the portrait of Washington (of which I will tell you by-and-by). I will here mention that although the British were expected every minute, they did not arrive for some hours; in the mean time, a rabble, taking advantage of the confusion, ran all over the White House, and stole lots of silver and whatever they could lay their hands on. About sundown I walked over to the Georgetown ferry, and found the President and all hands (the gentlemen named before, who acted as a sort of body-guard for him) waiting for the boat. It soon returned, and we all crossed over, and passed up the road about a mile; they then left us servants to wander about. In a short time several wagons from Bladensburg, drawn by Barney's artillery horses, passed up the road, having crossed the Long Bridge before it was set on fire. As we were cutting up some pranks a white wagoner ordered us away, and told his boy Tommy to reach out his gun, and he would shoot us. I told him "he had better have used it at Bladensburg." Just then we came up with Mr. Madison and his friends, who had been wandering about for some hours, consulting what to do. I walked on to a Methodist minister's, and in the
- 68. evening, while hewas at prayer, I heard a tremendous explosion, and, rushing out, saw that the public buildings, navy yard, ropewalks, &c., were on fire. Mrs. Madison slept that night at Mrs. Love's, two or three miles over the river. After leaving that place she called in at a house, and went up stairs. The lady of the house learning who she was, became furious, and went to the stairs and screamed out, "Miss Madison! if that's you, come down and go out! Your husband has got mine out fighting, and d— you, you shan't stay in my house; so get out!" Mrs. Madison complied, and went to Mrs. Minor's, a few miles further, where she stayed a day or two, and then returned to Washington, where she found Mr. Madison at her brother-in-law's, Richard Cutts, on F street. All the facts about Mrs. M. I learned from her servant Sukey. We moved into the house of Colonel John B. Taylor, corner of 18th street and New York Avenue, where we lived till the news of peace arrived. In two or three weeks after we returned, Congress met in extra session, at Blodgett's old shell of a house on 7th street (where the General Post-office now stands). It was three stories high, and had been used for a theatre, a tavern, an Irish boarding house, &c.; but both Houses of Congress managed to get along in it very well, notwithstanding it had to accommodate the Patent-office, City and General Post-office, committee-rooms, and what was left of the Congressional Library, at the same time. Things are very different now. The next summer, Mr. John Law, a large property-holder about the Capitol, fearing it would not be rebuilt, got up a subscription and built a large brick building (now called the Old Capitol, where the secesh prisoners are confined), and offered it to Congress for their use, till the Capitol could be rebuilt. This coaxed them back, though strong efforts were made to remove the seat of government north; but the southern members kept it here.
- 69. It has oftenbeen stated in print, that when Mrs. Madison escaped from the White House, she cut out from the frame the large portrait of Washington (now in one of the parlors there), and carried it off. This is totally false. She had no time for doing it. It would have required a ladder to get it down. All she carried off was the silver in her reticule, as the British were thought to be but a few squares off, and were expected every moment. John Susé (a Frenchman, then door-keeper, and still living) and Magraw, the President's gardener, took it down and sent it off on a wagon, with some large silver urns and such other valuables as could be hastily got hold of. When the British did arrive, they ate up the very dinner, and drank the wines, &c., that I had prepared for the President's party. When the news of peace arrived, we were crazy with joy. Miss Sally Coles, a cousin of Mrs. Madison, and afterwards wife of Andrew Stevenson, since minister to England, came to the head of the stairs, crying out, "Peace! peace!" and told John Freeman (the butler) to serve out wine liberally to the servants and others. I played the President's March on the violin, John Susé and some others were drunk for two days, and such another joyful time was never seen in Washington. Mr. Madison and all his Cabinet were as pleased as any, but did not show their joy in this manner. Mrs. Madison was a remarkably fine woman. She was beloved by every body in Washington, white and colored. Whenever soldiers marched by, during the war, she always sent out and invited them in to take wine and refreshments, giving them liberally of the best in the house. Madeira wine was better in those days than now, and more freely drank. In the last days of her life, before Congress purchased her husband's papers, she was in a state of absolute poverty, and I think sometimes suffered for the necessaries of life. While I was a servant to Mr. Webster, he often sent me to her with a market-basket full of provisions, and told me whenever I saw anything in the house that I thought she was in need of, to take it to her. I often did this, and occasionally gave her small sums from my own pocket, though I had years before bought my freedom of her.
- 70. Mr. Madison, Ithink, was one of the best men that ever lived. I never saw him in a passion, and never knew him to strike a slave, although he had over one hundred; neither would he allow an overseer to do it. Whenever any slaves were reported to him as stealing or "cutting up" badly, he would send for them and admonish them privately, and never mortify them by doing it before others. They generally served him very faithfully. He was temperate in his habits. I don't think he drank a quart of brandy in his whole life. He ate light breakfasts and no suppers, but rather a hearty dinner, with which he took invariably but one glass of wine. When he had hard drinkers at his table, who had put away his choice Madeira pretty freely, in response to their numerous toasts, he would just touch the glass to his lips, or dilute it with water, as they pushed about the decanters. For the last fifteen years of his life he drank no wine at all. After he retired from the presidency, he amused himself chiefly on his farm. At the election for members of the Virginia Legislature, in 1829 or '30, just after General Jackson's accession, he voted for James Barbour, who had been a strong Adams man. He also presided, I think, over the Convention for amending the Constitution, in 1832. After the news of peace, and of General Jackson's victory at New Orleans, which reached here about the same time, there were great illuminations. We moved into the Seven Buildings, corner of 19th- street and Pennsylvania Avenue, and while there, General Jackson came on with his wife, to whom numerous dinner-parties and levees were given. Mr. Madison also held levees every Wednesday evening, at which wine, punch, coffee, ice-cream, &c., were liberally served, unlike the present custom. While Mr. Jefferson was President, he and Mr. Madison (then his Secretary of State) were extremely intimate; in fact, two brothers could not have been more so. Mr. Jefferson always stopped over night at Mr. Madison's, in going and returning from Washington.
- 71. I have heardMr. Madison say, that when he went to school, he cut his own wood for exercise. He often did it also when at his farm in Virginia. He was very neat, but never extravagant, in his clothes. He always dressed wholly in black—coat, breeches, and silk stockings, with buckles in his shoes and breeches. He never had but one suit at a time. He had some poor relatives that he had to help, and wished to set them an example of economy in the matter of dress. He was very fond of horses, and an excellent judge of them, and no jockey ever cheated him. He never had less than seven horses in his Washington stables while President. He often told the story, that one day riding home from court with old Tom Barbour (father of Governor Barbour), they met a colored man, who took off his hat. Mr. M. raised his, to the surprise of old Tom; to whom Mr. M. replied, "I never allow a negro to excel me in politeness." Though a similar story is told of General Washington, I have often heard this, as above, from Mr. Madison's own lips. After Mr. Madison retired from the presidency, in 1817, he invariably made a visit twice a year to Mr. Jefferson—sometimes stopping two or three weeks—till Mr. Jefferson's death, in 1826. I was always with Mr. Madison till he died, and shaved him every other day for sixteen years. For six months before his death, he was unable to walk, and spent most of his time reclined on a couch; but his mind was bright, and with his numerous visitors he talked with as much animation and strength of voice as I ever heard him in his best days. I was present when he died. That morning Sukey brought him his breakfast, as usual. He could not swallow. His niece, Mrs. Willis, said, "What is the matter, Uncle Jeames?" "Nothing more than a change of mind, my dear." His head instantly dropped, and he ceased breathing as quietly as the snuff of a candle goes out. He was about eighty-four years old, and was followed to the grave by an immense procession of white and colored people. The pall- bearers were Governor Barbour, Philip P. Barbour, Charles P. Howard, and Reuben Conway; the two last were neighboring farmers.
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