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2001
Human Rights Issues Related to the Patenting of Human Biological Material (disponible en anglais seulement)
Ce document est présenté dans la langue dans
laquelle il a été fourni par l'auteur ou la
source
Prepared For
The Canadian Biotechnology Advisory Committee Project Steering
Committee on Intellectual Property and the Patenting of Higher Life
Forms
By Barbara von Tigerstrom, B.A., M.A., LL.B. 1
February 2001
Table of Contents
Executive Summary
-
Introduction
-
The patent system and patenting of higher life
forms
-
Overview of relevant human rights law
-
Human rights law in Canada
-
International human rights law
-
Human rights and the patenting of human
materials
-
Human rights and human dignity
-
Rights to protection of intellectual
property
-
Rights to health and to benefit from
scientific progress
-
Research subjects, informed consent and
self-determination
-
Privacy and protection from
discrimination
-
Individual autonomy
-
Conclusion
Executive Summary
The patenting of higher life forms and their biological material has
become the focus of concerns about biotechnology and about the patent
system. There has been much discussion of ethical, legal and social
issues relating to genetics, biotechnology and patenting. However,
human rights law analysis as such is strikingly under-represented in
the literature an unfortunate gap given the important issues at stake.
Consideration of human rights is fundamental to any full discussion of
the patenting of human material because they reflect the special
status that human beings have in our legal system, which makes
patenting of human material different from other higher life forms.
Discussions about patenting tend to attract a variety of concerns
about biotechnology generally, some of which are directly related to
patenting, while others are not. Similarly, an attempt must be made to
identify issues which are specifically human rights issues as opposed
to more general concerns about ethics or patent law.
The rationale for the patent system is that by giving inventors a
limited monopoly we provide an incentive for innovation and encourage
the disclosure of information so that society can benefit from
innovation. In Canada, micro-organisms, cell lines, and purified or
isolated genes and proteins are patentable; non-human higher life
forms were recently found to be patentable by the Federal Court of
Appeal. The US and Europe have allowed the patenting of non-human
animals but not humans. European patent law also has a general
exclusion based on public order or morality. International trade law
imposes some requirements on states as to what patents should be
allowed and what protection should be provided.
In Canada human rights are protected by legislation, which generally
deals with discrimination, and the Canadian Charter of Rights and
Freedoms. Some of the rights and freedoms that may be relevant
include: freedom of conscience and religion (section 2(a)); the right
to life, liberty and security of the person and the right not to be
deprived thereof except in accordance with the principles of
fundamental justice (section 7); the right to be secure against
unreasonable search and seizure (section 8); and equality rights
(section 15(1)). Infringements of Charter rights are permitted only if
they meet the test for justification under section 1. Charter rights
are to be interpreted in a purposive manner, and are to be given a
large and liberal interpretation. The Charter applies to government
actions, including legislation or the issuance of a patent. A law is
void to the extent of that it infringes the Charter. Remedies for
Charter violations may include striking down legislative provisions,
reading in or reading down provisions in legislation to make them
consistent with the Charter, or making a declaration or an order.
International human rights law may be contained in treaties, customary
international law or general principles of law, as well as non-binding
soft law documents. Canada is a party to the International Covenant on
Civil and Political Rights and the International Covenant on Economic,
Social and Cultural Rights as well as a number of other major human
rights conventions.
Human materials may refer to human beings, human embryos, and elements
or products of the human body including human organs and tissues, cell
lines, genetic material and proteins. All of these are considered for
the purposes of discussion although human beings are almost certainly
not patentable. In patenting we are not dealing with materials in
their natural form, but with isolated or purified materials or other
products of human intervention.
The concept of human dignity is frequently raised in the context of
biotechnology and especially human genetics research. It is a powerful
and important concept, but difficult to define. There is no right to
dignity as such, but the concept of human dignity can be used to
interpret specific rights and their meaning in a given context.
It would be a mistake to assume that the relationship between
patenting and human rights is necessarily antithetical. The patent
regime plays a role in generating important benefits for individuals.
In addition, international law has recognized rights to the protection
of intellectual property as part of the human rights framework. The
right to protection of intellectual property, like other rights, is
not absolute, and rights may have to be limited to accommodate each
other where there is a conflict.
International law affirms the right to the highest attainable standard
of physical and mental health. The right of everyone to enjoy the
benefits of scientific progress and its applications is also
recognized. Some people have raised concerns about equitable access to
benefits from medical research which may be related to patenting.
First, the granting of patent rights is designed to create incentives
for research, but it may also hamper research that could lead to
beneficial discoveries. Second, there are concerns that the exclusive
rights held by patent owners will result in prohibitive costs for
therapeutic applications of research, and thus lead to serious
inequities of access to the benefits of research. Finally, there is a
concern that reliance on patents as incentives for research will
direct research priorities toward certain types of products (those
which are likely to be patentable and to be commercially lucrative)
and leave gaps in areas which may be of great importance to the
general population or to disadvantaged groups within a nation or in
the international community.
A number of distinct issues are raised with respect to patenting human
material due to the fact that the patented inventions are derived from
material obtained from human beings. The question therefore arises
whether the individuals from whom material is taken are entitled to
some specific benefit or compensation if the material is used to
produce a patented invention. A number of well-known and controversial
cases have highlighted concerns in this area, some of them involving
the alleged exploitation of vulnerable peoples.
To the extent that research subjects claims to benefit are based on
the recognition of property rights in ones own body and biological
material, there is no clear support in human rights law. However,
these claims may also be based in equity. Furthermore, individual
autonomy and bodily integrity are protected in the context of medical
treatment and research by the requirement of informed consent.
Informed consent requires the disclosure of any financial interest or
commercial potential of the research. Groups such as indigenous
peoples may make more extensive claims using the right to
self-determination. This right might entail a greater degree of
control over any research involving a particular population, possibly
including some rights to financial, health or other benefits.
Other human rights issues may be raised by the targeting of certain
ethnic or indigenous populations, where the group is one that is
vulnerable to discrimination, or that holds strong religious or
spiritual beliefs which are inconsistent with the patenting of human
or other biological material.
Modern genetic research has given rise to serious concerns about
personal privacy and the possibility of discrimination based on
genetic heritage. The right to privacy and to protection from
discrimination is recognized both in Canadian and international law.
Possible implications for the patent system need to be further
investigated.
The U.S. Patent and Trade Office has taken the position that patenting
of human beings is contrary to the Constitution which prohibits
slavery. A patent holder does not own the invention, but it must be
determined whether the property interests of a patent holder might
entail sufficient control that the patent offends the prohibition on
slavery or broader rights to liberty and security of the person. In
the Canadian context we must consider whether patent rights might in
some cases offend the Charters guarantees of liberty, security of the
person and equality. This must be undertaken with reference to the
rights that the patent holder would have, i.e. exclusive rights to
make, use or sell the invention. Some have suggested that excluding
others from using or making the invention could interfere with
individual autonomy (e.g. a individuals right to reproduce).
Further questions arise as to the scope of any constitutional
prohibition on patenting humans. First, what patents on human
materials, as opposed to humans per se might give rise to potential of
infringements? Second, assuming that there are some constitutional
barriers to patenting human beings, how would we define human beings
as the subjects of this protection? This question arises with respect
to human embryos and transgenic animals, hybrids and chimaeras which
are part human.
Resolution of the issues raised in this paper is important for
government, individuals, industry, investors and researchers. Various
options have been suggested to modify or supplement the patent regime.
A rigourous analysis of human rights issues can help take the debate
toward a more comprehensive assessment of potential harms and
benefits. This will allow in turn a more precise consideration of
possible responses. Further discussion of human rights issues within
Canada and interntaionally should therefore provide a useful
contribution to policy debate in this area.
-
Introduction
The patenting of higher life forms and their biological material
has become a point of convergence for concerns about
biotechnology and about the patent system. The particular issues
surrounding patenting of genetic material, for example, have
been the subject of much debate2 and there are patent law issues
associated with other controversial topics, such as cloning and
embryonic stem cells. As a result, patent law has become an
important locus of public policy discussion.
The ongoing public debate on these topics has generated a large
body of literature, including discussion of ethical, legal and
social issues (ELSI) relating to genetics, biotechnology and
patenting. Much of this literature discusses ethical concerns
and in that context raises issues of human rights and human
dignity. However, human rights law analysis as such is
strikingly under-represented in the literature an unfortunate
gap given the important issues at stake.
The possibility of obtaining a patent on a living organism
raises novel legal and ethical issues.3 When the potential subject matter
of the patent is human biological material, these issues are
supplemented by others which result from the special status that
human beings (as compared to other animals) have in our society
and our legal system. This status is manifested in the
recognition and enforcement of human rights. Consideration of
human rights is thus fundamental to any full discussion of the
patenting of human material.
A useful analysis of this subject depends on a precise
definition of the issues. Discussions about patenting tend to
attract a variety of concerns about biotechnology generally,
some of which are directly related to patenting, while others
are not. Similarly, an attempt must be made to identify issues
which are specifically human rights issues as opposed to more
general concerns about ethics or patent law. To a certain extent
these distinctions are artificial: for example, if we accept the
role of patents in encouraging innovation in particular areas,
the availability of patent protection cannot be completely
separated from concerns about the underlying technologies.
However, the scope of this paper will be limited to specifically
considering human rights issues relating to patenting of human
materials.
The first section will briefly review key points of patent law
and the patenting of higher life forms. Next, some background
information on human rights in Canadian and international law
will be provided, and then the third section will identify and
discuss some human rights issues which may be implicated in
patenting human materials. Finally, the concluding section will
offer some suggestions for further research and policy
development.
-
The patent system and patenting of higher
life forms
Any discussion of patenting must consider the rationale for the
patent law system. This rationale has been described thus:
One who has created a novel invention which is of perceived
benefit to the wider community is rewarded by the grant of a
monopoly to exploit his or her creation for a fixed period of
time. In return, the inventor must disclose details of the
invention so that the community can make use of it on the expiry
of the monopoly. In this way it is thought that several
interests are served well. The inventor is rewarded for his or
her industry, while the community is assured of some kind of
benefit albeit in the long term. Furthermore, it is believed
that such a system is a source of encouragement to others to
invent and innovate.4
Society benefits from the disclosure of information that occurs
through the patent system. Without patent protection, it is
argued, researchers would be less willing to disseminate
information. In short, the theory behind the patent system is
that economic growth is advanced by scientific research and that
research flourishes best in an environment where information can
be shared openly.5
In Canada, an invention which is eligible for patent protection
is defined as any new and useful art, process, machine,
manufacture or composition of matter, or any new or useful
improvement in any art, process, machine, manufacture or
composition of matter.6 The
subject matter of the patent must not have been previously
disclosed to the public7 and
must not have been obvious to a person skilled in the art or
science to which it pertains.8 These three basic requirements of
novelty, non-obviousness and utility are fairly uniform from
country to country.
In order to obtain a patent, an application must be filed
including a specification of the invention. The specification
must set out a full description of the invention and the claims
defining precisely the subject matter for which the patent is
claimed.9 This may include a
product, a process for making the product, a novel use for a
known product, and/or an improvement of any of these. If a
patent is granted, the patent holder will have the exclusive
right to make, use and sell the invention for the term of the
patent10 (twenty years from
the date of filing).11
Some biotechnological products and processes were patented even
before the twentieth century, however advances in genetics and
in particular the development of recombinant DNA technology made
the question of patenting living organisms a pressing one.12 In 1980, the United States
Supreme Court decision in Diamond v. Chakrabarty13 allowed the patenting of
genetically engineered bacteria and established a broad
definition of patentable subject matter: anything under the sun
made by man,14 including
living matter produced by human intervention. Canadian law has
permitted the patenting of micro-organisms and cell lines since
1982.15 Elements of the human
body such as proteins and genes which are in isolated and
purified form are also patentable in Canada, as elsewhere,
provided the standard requirements are met.16 Canadian law, however, prohibits
patenting of methods of medical or surgical treatment.17
U.S. law has permitted patents on multicellular life forms since
198718 and the first such
patent was issued in 1988 the now-famous Harvard mouse patent.19 In Canada, however, higher
life forms (multicellular living organisms) were not, until
recently, considered to be patentable. In the summer of 2000,
the Federal Court of Appeal held that transgenic non-human
mammals are patentable.20 The
Court suggested that this holding is limited to non-human
animals.21 However, there is
no specific statutory or judicial prohibition in Canada against
patenting humans or human body elements, human cloning or
modification of human germ line identity.22
In Europe, biotechnology patenting is governed by several levels
of law, including the European Patent Convention (EPC), European
Union (EU) law and national laws. The EPC differs from Canadian
and U.S. law in that it allows an exception to patentability
where exploitation of the invention would be contrary to ordre
public or morality.23 The
morality exclusion has been quite narrowly interpreted24 but has been used to weigh the
benefits and risks of the invention.25 Plant and animal varieties are
also excluded by the EPC, but transgenic plants and animals are
considered patentable provided the claims are not restricted to
a single variety.26
In 1998, the EU approved a Directive on the legal protection of
biotechnological inventions (the EU Directive). 27 The EU Directive states that the
human body, at the various stages of its formation and
development, and the simple discovery of one of its elements,
including the sequence or partial sequence of a gene, cannot
constitute patentable inventions. However, an element isolated
from the human body or otherwise produced by means of a
technical process, including the sequence or partial sequence of
a gene, may constitute a patentable invention, even if the
structure of that element is identical to the natural element. 28 The exception with respect to
ordre public and morality is also confirmed, and the following
are considered to be unpatentable on that basis: 29
-
processes for cloning a human being;
-
processes for modifying the germ line genetic identity of
human beings;
-
uses of human embryos for industrial or commercial purposes;
-
processes for modifying the genetic identity of animals which
are likely to cause them suffering without any substantial
medical benefit to man or animal, and also animals resulting
from such processes.
Finally, a complete picture of the state of patent law
internationally requires consideration of international trade
agreements containing provisions on intellectual property
protection, notably the North American Free Trade Agreement
(NAFTA) and the Agreement on Trade-Related Aspects of
Intellectual Property (TRIPS). Both of these agreements permit
exclusions to patentability where necessary to protect ordre
public or morality, to protect human, animal or plant life or to
prevent serious prejudice to the environment.30 States may also specifically
exclude diagnostic, therapeutic and surgical methods for the
treatment of humans or animals, as well as plants and animals
(other than micro-organisms) and essentially biological
processes for the production of plants and animals.31 Both the NAFTA and TRIPS also
contain provisions on patent protection, which limit, for
example, the circumstances in which compulsory licensing is
permitted.32
-
Overview of relevant human rights law
-
Human rights law in Canada
There are two major sources of human rights law in the
Canadian domestic legal system: the Canadian Charter of
Rights and Freedoms33
and human rights legislation. In Canada, human rights
legislation primarily deals with discrimination in
employment, housing, services, etc. This paper will not
consider human rights legislation in any detail, although
its potential role must be kept in mind when discussing
any discrimination issues raised in the context of
patenting.
For our purposes the most important source of domestic
human rights law is the Charter which is part of the
Canadian Constitution and sets out the fundamental rights
and freedoms of individuals in Canada. Some of the rights
and freedoms that may be relevant include: freedom of
conscience and religion (section 2(a)); the right to life,
liberty and security of the person and the right not to be
deprived thereof except in accordance with the principles
of fundamental justice (section 7); the right to be secure
against unreasonable search and seizure (section 8); and
equality rights (section 15(1)).
The rights and freedoms in the Charter are guaranteed
subject only to such reasonable limits prescribed by law
as can be demonstrably justified in a free and democratic
society. This means that the rights are not absolute;
infringements of Charter rights are permitted as long as
they meet the test in this provision (section 1). The
courts have developed a framework for analysing this test,
which requires the government to show the objective of the
legislation or other action is pressing and substantial,
that the infringement is rationally connected to this
objective, that it impairs rights as little as possible
and that the effect of the infringement is proportional to
the objective.34
Charter rights are to be interpreted in a purposive
manner, that is: [t]he meaning of a right or freedom
guaranteed by the Charter [is] to be ascertained by an
analysis of the purpose of such a guarantee; it [is] to be
understood, in other words, in the light of the interests
it was meant to protect.35 The other basic principle of
Charter interpretation is that constitutional provisions
and human rights guarantees are to be given a large and
liberal interpretation.36 in order that they may have
their full effect.
The Charter applies only to government actions, not the
actions of private individuals or organizations. Section
32(1) states that the Charter applies to Parliament,
provincial legislatures and the provincial and federal
governments in respect of all matters within [their]
authority. Legislation is clearly a government action and
so, for example, the Patent Act is subject to the
Charter. The issuance of a patent is also a government
action.
According to section 52 of the Constitution, the
Constitution ( including the Charter) is the supreme law
of Canada, and any law that is inconsistent with the
provisions of the Constitution is, to the extent of the
inconsistency, of no force or effect. Therefore, a law is
void to the extent of that it infringes the Charter (i.e.
that there is a violation of a Charter right that is not
justified in accordance with section 1).37 Remedies may include
striking down legislative provisions, reading in or
reading down provisions in legislation to make them
consistent with the Charter, or making a declaration or
order. Where Charter rights have allegedly been violated
by any government act, the person whose rights or freedoms
have been infringed or denied may apply, under section
24(1), to a court for a remedy.
-
International human rights law
International human rights law has a much broader scope
than Canadian domestic law, in terms of both the number
and diversity of sources and the rights explicitly
protected. There are three main sources of international
law: international conventions or treaties, customary
international law and general principles of law.38 A state which is a party to
a convention is bound by its provisions,39 and customary international
law is generally binding on all states. There is also a
large body of what is sometimes called soft law:
resolutions, declarations and other documents of
international legal bodies (e.g. the UN General Assembly)
which are not binding as such but may be persuasive, may
be used to interpret binding legal obligations and may,
over time, be codified in conventions or solidify into
customary law.
The analysis in this paper will focus on what is sometimes
referred to as the International Bill of Rights: the
Universal Declaration of Human Rights (UDHR),40 the International Covenant
on Civil and Political Rights (ICCPR)41 and the International
Covenant on Economic, Social and Cultural Rights
(ICESCR).42 The UDHR
was originally a resolution of the UN General Assembly and
therefore not binding, but it is generally accepted that
at least some of its content has gained the status of
customary international law.43 In any event, most of the
rights recognized in the UDHR were later codified in the
ICCPR and ICESCR, to which Canada is a party. Canada is
also a party to a number of other major human rights
conventions, which may be relevant to specific issues in
this paper.
International law obligations are primarily binding on
states. The extent to which international law may apply
directly to individuals and other private entities such as
corporations is a subject of debate, although at least
some norms, in the area of international criminal and
humanitarian law, apply directly to individuals actions.
In Canada, international treaty obligations are not
automatically part of domestic law. The provisions of a
treaty to which Canada is a party must be given effect by
the enactment of legislation (federal or provincial,
depending on which has jurisdiction over the particular
subject matter). However, international law may be, and
is, also used to interpret Canadian law and in particular
international human rights law is used by Canadian courts
in interpreting the Charter.44 This paper will consider
generally international human rights law applicable to
Canada, not only those obligations which have been
incorporated into Canadian law, since any acceptable
government policy must respect international obligations.
-
Human rights and the patenting of human
materials
In this section we will consider human rights issues which may
be raised by, or in the context of, the patenting of human
materials. Human materials will be used generally to refer to
human beings, human embryos, and elements or products of the
human body including human organs and tissues, cell lines,
genetic material and proteins. Some of these are unquestionably
patentable under current Canadian law (e.g. cell lines, genes,
proteins) while others are almost certainly not (e.g. human
beings). For the purposes of this section we will assume that
any of these or related processes may potentially be patentable
inventions provided they meet the standard criteria for
patentability. We are therefore not dealing with materials in
their natural form, but with isolated or purified materials or
other products of human intervention.
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Human rights and human dignity
The concept of human dignity is frequently raised in the
context of biotechnology and especially human genetics
research.45 Human
dignity is explicitly invoked in the EU Directive46 and the UNESCO Universal
Declaration on the Human Genome and Human Rights (UNESCO
Declaration).47 The
Vienna Declaration and Programme of Action notes that
certain advances, notably in the biomedical and life
sciences may have potentially adverse consequences for the
integrity, dignity and human rights of the individual, and
calls for international cooperation to ensure that human
rights and dignity are fully respected in this area of
universal concern.48
Dignity is a powerful and centrally important concept,49 although its
application is often difficult given the lack of any clear
agreement on its meaning and how to recognize and prevent
its violation.50 One
suggestion is that it means respect for the intrinsic
worth of every person, which prohibits treating
individuals merely as instruments or objects of the will
of others.51
From a human rights perspective, there is no right to
dignity as such; rather, the concept of human dignity can
be seen as the foundation of human rights, and specific
rights as manifestations of or means of protecting
dignity.52 The
preambles to the ICCPR and ICESCR state that human rights
derive from the inherent dignity of the human person.
Therefore, the concept of human dignity can be used to
interpret specific rights and their meaning in a given
context, and to extend and strengthen human rights by
formulating new rights or construing existing rights to
apply to new situations.53
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Rights to protection of
intellectual property
It would be a mistake to assume that the relationship
between patenting and human rights is necessarily
antithetical. The role that the patent regime is presumed
play in generating benefits for individuals is significant
from a human rights point of view, as will be seen in the
next section. In addition, international law has
recognized rights to the protection of intellectual
property as part of the human rights framework. The ICESCR
in article 15(1)(c) recognizes the right of everyone to
benefit from the protection of the moral and material
interests resulting from any scientific, literary or
artistic production of which he is the author. Article 27
of the UDHR contains a similar guarantee. Interestingly, a
strong argument in favour of including this right in the
UDHR drew on an example of contributions to medical
research.54 The
inclusion of this right in international human rights law
instruments has not gone without criticism,55 but its recognition and the
justifications offered for intellectual property as a
right56 must be
considered in any analysis. The right to protection of
intellectual property, like other rights, is not absolute,
and rights may have to be limited to accommodate each
other where there is a conflict.
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Rights to health and to benefit from
scientific progress
Human research subjects may claim particular benefits or
compensation, where materials obtained from them are used
to generate a patented invention. These issues will be
considered in the next section. This section will deal
with the rights of all people to health and to benefit
from scientific progress, regardless of any involvement as
research subjects or sources of material.
The ICESCR affirms the right to health57 in the following terms: The
States Parties to the present Covenant recognize the right
of everyone to the enjoyment of the highest attainable
standard of physical and mental health.58 Certain specific obligations
are also set out, including steps necessary for the
prevention, treatment and control of epidemic, endemic,
occupational and other diseases and the creation of
conditions which would assure to all medical service and
medical attention in the event of sickness.59 The right of everyone to
enjoy the benefits of scientific progress and its
applications is also recognized.60
The concerns raised in this area are not unique to the
patenting of human materials but are especially important
in this context given that the types of inventions under
consideration are likely to be related to health and
medical treatment. They have been discussed in more
general terms as concerns relating to distributive
justice,61 but the
existence of rights to health and to benefits of research
allows them to be properly considered as human rights
issues.
There are essentially three related concerns. First, the
granting of patent rights may hamper research that could
lead to beneficial discoveries, because scientists may not
be able to conduct research without the risk of infringing
on others patent rights or the cost of obtaining rights
under a license. Purely experimental use of inventions is
not an infringement, but the scope of this exemption may
be too limited to address these concerns.62 This concern has been raised
particularly in the context of gene patents where it is
feared that patents on genes may result in a chilling
effect on further research.63 The counter-argument is that
without the incentive that patents create, research would
be even more seriously impaired by a lack of financial
support. The resolution of this issue is difficult because
it depends in part on the actual operation of patents as
incentives for or barriers to research, which as a factual
question is the subject of considerable debate.64
Second, there are concerns that the exclusive rights held
by patent owners will result in prohibitive costs for
therapeutic applications of research, and thus lead to
serious inequities of access to the benefits of
research.65 This is not
a concern unique to patents on human material but has
arisen also in the case of pharmaceuticals, for example.66 The rights to health
and to benefit from scientific progress and its
applications are to be guaranteed equally to all
persons,67 and this
equality is threatened if the patent regime indirectly
prevents equitable access. However, it could also be
argued that in the absence of the patent regime, products
might not be marketed and no one would receive concrete
benefits from research.68
Finally, there is a concern that reliance on patents as
incentives for research will direct research priorities
toward certain types of products (those which are likely
to be patentable and to be commercially lucrative)69 and leave gaps in areas
which may be of great importance to the general population
or to disadvantaged groups within a nation or in the
international community. This has led to calls for
government funding in areas likely to be neglected by
commercial interests.70
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Research subjects, informed consent
and self-determination
A number of distinct issues are raised with respect to
patenting human material due to the fact that the patented
inventions are derived from material obtained from human
beings. The patented invention will not consist of
material from an individuals body in its natural state
because of the requirements for patentability, but in
virtually every case there will be one or more source
individuals to whom the material can be directly or
indirectly traced. The right to receive some benefit from
research therefore takes on a particular importance and
different dimension in respect of these individuals or
groups. Claims to benefit may arise in other circumstances
indeed in any case where an individual feels she has
contributed to the invention, through labour,
participation in an experiment, etc. but in this case we
are dealing with material actually taken from individuals
bodies, which raises additional issues of bodily
integrity.
A number of well-known and controversial cases have
highlighted concerns in this area. In Moore v.
Regents of the University of California,71 John Moore sued his doctor
after discovering that the doctor had, without his
knowledge or consent, used some of his tissue removed for
treatment purposes to develop, patent and commercialize a
cell line. Moore unsuccessfully argued that he had
property interests in his own biological material which
entitled him to a share of the profits. The court held
instead that Moore would be entitled to compensation for
the doctors breach of his fiduciary duties.
Other cases have been if anything more controversial
because they involved the alleged exploitation of
vulnerable peoples. For example, a cell line was developed
using blood taken from a member of the Hagahai tribe in
Papua New Guinea and patented by the National Institutes
of Health (NIH) in the United States. The NIH subsequently
abandoned the patent, apparently in part because of the
international controversy which ensued (although it also
had minimal commercial value).72 There have been other
examples of controversial research involving populations
around the world.73
Such cases have sparked opposition to the Human Genome
Diversity Project74 and
raised concerns about the exploitation of individuals and
populations.
As noted above there is a general right to the highest
attainable standard of health and to benefit from the
applications of scientific research which must be
guaranteed without discrimination. The idea that
individuals and/or groups who participate as research
subjects and as sources of biological material are
entitled by virtue of that participation to some
additional or specific benefit is increasingly well
accepted, at least in theory, as an ethical obligation of
researchers.75 To the
extent that claims to benefit are based on the recognition
of property rights in ones own body and biological
material, there is no clear support in human rights law.76 However, these claims
are also based in equity, and rights to bodily integrity
and self-determination may also be relevant.
Individual autonomy and bodily integrity are protected in
the context of medical treatment and research by the
requirement of informed consent. This requirement is based
on the principle that every competent person has the right
to determine what is done with his or her own body.77 In Canada, this right
is considered to be coextensive with an individuals rights
under section 7 of the Charter (liberty and security of
the person).78 Informed
consent requires the disclosure of any financial interest
or commercial potential79 of the research. However,
recognition of individual rights in the consent process
will ensure only that subjects are aware of commercial
interests, but does not extend to a right to receive
benefit or compensation.
More extensive claims might be made using the right to
self-determination. In its current formulation, however,
this is a right that is recognized to belong only to
peoples under international law.80 There is as yet little
consensus regarding the definition of peoples or the exact
content of the right.81
However, such collective rights may be especially relevant
to indigenous peoples, given the emerging norms regarding
the right to self-determination of indigenous peoples in
international law82 and the recognition of aboriginal
rights in Canadian constitutional law.83 For those who can claim this
right, it might permit a greater degree of control over
any research involving a particular population,84 possibly including some
rights to financial, health or other benefits. The right
to self-determination of all peoples including indigenous
peoples might also be understood to include the right to
make collective decisions about participation in research.
However, it is important to remember that the individual
members of such groups would also have individual rights
to autonomy which could not necessarily be overridden by
collective decisions.
Other human rights issues may be raised by the targeting
of certain ethnic or indigenous populations. For example,
where the group is one that is subject to pre-existing
disadvantage or vulnerable to discrimination, the
possibility of discrimination claims should be considered.
In addition, where the group is one that holds strong
religious or spiritual beliefs that are inconsistent with
the patenting of human or other biological material,85 there might be
allegations that patents on material derived from the
group infringe their freedom of religion86 or aboriginal rights.
-
Privacy and protection from
discrimination
Modern genetic research has given rise to serious concerns
about personal privacy. Genetic information is especially
problematic from a privacy perspective because it may
reveal otherwise hidden characteristics such as propensity
to develop a certain disease, which may be the basis for
discrimination.87 The
association of certain genetic traits with identifiable
groups also raises concerns regarding group privacy and
discrimination.
The right to privacy is recognized both in Canadian and
international law. Although there is no specific right to
privacy set out in the Canadian Charter, courts have
recognized a right to privacy based on section 7 (liberty
and security of the person) and section 8 (freedom from
unreasonable search and seizure) which may apply in some
situations.88 This
right receives special protection when the personal
information at issue relates to an individuals health.89 In international law,
the ICCPR recognizes the right of everyone to protection
of the law against arbitrary or unlawful interference with
ones privacy.90
Equality rights are also protected in Canadian law by the
Charter and human rights legislation, as well as in
various international law documents.91
There are clearly some serious concerns with respect to
genetic privacy and the potential for discrimination based
on genetic information. It is less clear, however, to what
extent these concerns are related to patenting per se.
Patents may play a role in encouraging the development of
certain technologies, for example for genetic tests,92 and thus may be
indirectly implicated in any misuse of information which
might result. The other potential area of concern is the
disclosure of genetic or other personal information in
patent documents, which will become public. Information
disclosed would not be directly identified with any
individual, but might in some circumstances be traceable
to individuals or groups, and therefore violate their
privacy and leave them vulnerable to discrimination. There
may also be potential conflicts between those who agree to
the use of their material (either as an individual or as a
group), and those (e.g. certain members of a group) who
may wish to prevent disclosure to protect privacy or other
interests. We need to examine what measures are required
to adequately protect privacy and how privacy protection
may be reconciled with respecting the autonomy of research
subjects and the need to have an open patent application
process.
-
Individual autonomy93
The EU Directive explicitly provides that the human body
and processes for cloning human beings or modifying the
germ line identify of human beings are not patentable.94 Neither Canada nor the
U.S. has any specific statutory provision excluding human
beings from patentability.95 Despite the absence of a
statutory exclusion, the U.S. Patent and Trademark Office
(USPTO) has taken the position that it will not accept a
claim directed to or containing within its scope a human
being because a the grant of a limited, but exclusive
property right in a human being is prohibited by the
Constitution.96 The
specific constitutional basis for this position is
presumed to be the Thirteenth Amendment of the U.S.
Constitution which prohibits slavery.97 One possible response to
this is that a patent holder does not own the invention,
and thus patent rights in a human being are not equivalent
to slavery.98 However,
this argument cannot be dismissed without determining
whether the property interests of a patent holder might,
although not amounting to ownership, entail sufficient
control that the patent offends the prohibition on slavery
or broader rights to liberty and security of the person.
The prohibition on slavery is well-established in
international law,99
and includes institutions and practices similar to slavery
such as debt bondage and forced marriage100 as well as contemporary
forms of slavery such as traffic in women and children,
use of children in armed conflicts and sale of organs.101 Slavery is defined as
the status or condition of a person over whom any or all
of the powers attaching to the right of ownership are
exercised.102
Canada is a party to relevant conventions, and although
our domestic law contains no specific prohibition on
slavery, it would surely violate rights to liberty and
security of the person and equality rights protected in
the Charter. These Charter guarantees (and equivalent
rights in international law) also cover a broader scope,
proscribing infringements which might not be caught by the
definition slavery. In the Canadian context, therefore, it
is more useful to refer to these rights to determine what
type or degree of control might offend the Charter.
The question, then, is whether and to what extent patent
rights in a human being (or human material) would infringe
the Charter. While this might seem a somewhat speculative
question, in fact its resolution would be both important
and useful. The Patent Acts provisions on
patentability and patent rights could be read down to
limit patents and patent rights to those consistent with
the Charter. However, if the grant of patent rights does
not infringe the Charter but we want to exclude certain
materials from patentability or prohibit the exercise of
certain patent rights, a specific prohibition will be
required. In any case, a specific prohibition might be
favoured to avoid uncertainty and proactively establish
desired limits.
It is not the goal of this paper to attempt to
conclusively determine the scope of potentially
unconstitutional patents. For each potential subject
matter, it must be considered whether the exercise of the
usual rights of the patent holder in the absence of any
other regulation or prohibition would infringe Charter
rights. The patent holder has the exclusive right to make,
use and sell the invention,103 but it must be remembered
that in reality what this means is the right to prevent
others from making, using or selling the invention, not
necessarily an affirmative right to do those things. It
has been suggested that an attempt to enforce the right to
exclude others from using the invention could interfere
with the patented individuals right to use him- or herself
or associate with others;104 this could be the case only
if we take a very broad view of what it means to use an
invention. Concerns have also been raised that the
exclusive right to make the invention could interfere with
individuals rights to reproductive freedom.105 Essentially, the individual
would be infringing the patent by reproducing and thus the
patent holders rights would in theory prohibit
reproduction. This may seem unlikely, especially given the
limited term of patents, but the potential for such
conflicts should be examined.
Further questions arise as to the scope of any
constitutional prohibition on patenting humans. First,
what patents on human materials, as opposed to humans per
se might give rise to these types of infringements? 106 In a European case
involving a patent on a gene encoding a protein called
relaxin, which had been isolated from tissue taken from a
pregnant woman, opponents to the patent argued that the
patent and its exploitation constituted slavery and would
involve the dismemberment and piecemeal sale of women.
This argument was dismissed by the Opposition Division of
the EPO in the following terms:
As for the opponents assertions concerning slavery and the
dismemberment of women, these are considered to betray a
fundamental misunderstanding of the nature of a patent. It
cannot be overemphasised that patents covering DNA
encoding human H2-relaxin, or any other human gene do not
confer on their proprietors any rights whatever to
individual human beings, any more than do patents directed
to other human products such as proteins, including human
H2-relaxin. No woman is affected in any way by the present
patent she is free to live her life as she wishes and has
the same right to selfdetermination as she had before the
patent was granted. Furthermore, the exploitation of the
invention does not involve dismemberment and piecemeal
sale of women. The whole point about gene cloning is that
the protein encoded by the cloned gene in this case human
H2-relaxin is produced in a technical manner from
unicellular hosts containing the corresponding DNA; there
is therefore no need to use human beings as the source for
the proteins.107
Although some perceive serious ethical problems with
patents on human materials,108 from a human rights law
point of view we need to consider in each case whether the
nature of the invention is such that its exploitation
would infringe legally recognized rights of individuals.
The second question is, assuming that there are some
constitutional barriers to patenting human beings, how
would we define human beings as the subjects of this
protection? This question has been raised in the context
of embryos109 and
anencephalic infants.110 A human embryo or fetus is
not a person in Canadian law,111 but if it was determined
that there was or should be a prohibition on patenting
human beings or relevant processes, such a prohibition
might have to extend to embryos in order to have any real
effect. The EU Directives exclusion specifically refers to
the human body at the various stages of its formation and
development.112
The development of technology for creating transgenic
animals, hybrids and chimaeras113 raises another definitional
question: if an animal is part human and part non-human,
at what point is it to be considered a human being and
entitled to legal protection as such?114 The question is not a
serious one when dealing with transgenic animals such as
the Harvard mouse with a very limited amount of human
genetic material, but it would be quite another matter if
we are faced with, for example, a human/chimpanzee
chimaera.115 A patent
application in the United States has sought to test these
limits. Jeremy Rifkin and Dr. Stuart Newman filed a patent
application at the USPTO covering the production of
human-animal chimaeras that could be up to 50% human. The
aim of the application was to test the rules on patenting
life forms and to use patent rights to prevent anyone from
attempting to produce these animals.116 The application was
rejected in part on the basis that it included a human
being within its scope and human beings are not
patentable.117
-
Conclusion
Further analysis will be required to resolve some of the
questions raised in this paper. Resolution of these issues is
important for all concerned: for government, in order to
identify and comply with relevant human rights obligations;
individuals, to know what rights are protected and how; and
industry, investors and researchers, to have some certainty as
to what activities are permissible and what patents may be
obtained and exploited. A more comprehensive and detailed
examination of the issues dealt with here, as well as some of
those which were set aside concerning human rights implications
of the technologies themselves, can lead us to the next step,
which is to identify measures which may be required to protect
human rights.
These measures may include modifications to the patent law
regime: various options have been proposed for law reform which
would alleviate some of the concerns identified here. These
might include exclusions to patentability but also broader
exemptions for research use, compulsory licensing, and limiting
the scope or term of patents,118 or the application of principles
such as common heritage119 or
public trust.120 We should
also consider various regulatory measures that could either
prevent the development of technologies in the first place or
regulate the exploitation of certain types of inventions.121 We may be able to identify
areas in which development of human rights law is required to
address novel situations or ensure effective protection.122 Finally, some concerns may
require non-legal solutions such as public education or
encouraging dialogue between stakeholders. A rigorous analysis
of human rights issues can help take the debate beyond should we
patent or not toward a more comprehensive assessment of
potential harms and benefits. This will allow a more precise
consideration of possible responses.
Further examination and discussion of human rights issues
relating to patenting of human biological material should
therefore provide a useful contribution to policy debate in this
area. This discussion would best be pursued at both a national
and international level, since international cooperation and
consensus in this area will be important for Canada.123
Index
-
1 Martin Kratz (Bennett Jones, Calgary) and Edward Yoo
(Bennett Jones, Edmonton) provided valuable assistance with the
patent law aspects of this paper. The author would also like to
thank Timothy Caulfield, Glenn Rivard and Lori Golberg, and
numerous other individuals who provided comments on earlier drafts.
The opinions expressed in this paper and any remaining errors or
omissions are the authors. The paper was written in March 2000 and
revised in June 2000 and February 2001.
-
2 See e.g. B. Evenson, Gene Map Belongs to All: Clinton
National Post (15 March 2000 ) A1. The USPTO responded with a
statement that its policy was unaffected by the announcement:
United States Patent and Trademark Office, Press Release #00-17, US
Patent Policy Unaffected by US/UK Statement on Human Gene Sequence
Data (16 March 2000 ).
-
3 The U.S. Office of Technology Assessment has suggested
that patenting of living organisms is novel for three reasons: the
invention itself is alive, the invention can in some instances
reproduce itself, and a deposit of the invention may be required
because it cannot be adequately explained in words; see Kevin O
.Connor, Patenting Animals and Other Living Things (1991) 65 S.
California L. Rev. 597 at 598.
-
4 G. T. Laurie, Biotechnology and Intellectual Property:
A Marriage of Inconvenience? in S.A.M. McLean, Contemporary Issues
in Law, Medicine and Ethics (Aldershot, U.K.: Dartmouth,
1996) 237 at 241 [footnotes omitted].
-
5 S. R. Avisar, The Ethics of Biotechnology. The Argument in Favour
of Patents (1993) 10 C.I.P.R. 209 at 209.
-
6 Patent Act, R.S.C. 1985, c. P-4, s. 2.
-
7 Ibid., s. 28.2 (1).
-
8 Ibid., s. 28.3.
-
9 Ibid., s. 27. The description provided is the
quid pro quo for which the inv entor is given the monopoly
and thus this requirement is central to the patent system:
Consolboard v. MacMillan Bloedel (Sask.) Ltd., [1981] 1
S.C.R. 504 at 517.
-
10 Ibid., s. 42.
-
11 Ibid., s. 44.
-
12 O Connor, supra note 3 at 602. The U.S.
Patent Office had granted a patent for yeast in 1873, but later,
until the decision in Diamond v. Chakra barty (infra note
13), took the position that living matter could not be patented.
See P. A. Rae, Patentability of Living Subject Matter (1993) 10
C.I.P.R. 41 at 41-42.
-
13 447 U.S. 303.
-
14 Ibid. at 309.
-
15 Re Application of Abitibi Co., (1982) 62
C.P.R. (2d) 81 (Patent Appeal Bd.). See J. D. Morrow, Patentable
Subject-Matter: Emerging Technologies in G. F. Henderson e t al.,
eds., Patent Law of Canada (Toronto: Carswell, 1994) 23 at
26.
-
16 Morrow, ibid. at 25. See also
Kirin-Amgen Inc. v. Hoffmann-La Roche Ltd., [1999] F.C.J.
No. 203.
-
17 Tennes see Eastman Co. et al. v. Commissioner of
Patents (1972), 8 C.P.R. (2d) 202 (S.C.C.).
-
18 Ex parte Allen, 2 U.S.P.Q. (2d) 1425
(U.S.P.T.O. Bd. Pat. App. & Int.).
-
19 U.S. Patent 4,736,866.
-
20 President and Fellows of Harvard College v.
Canada (Commissioner of Patents), [2000] F.C.J. No. 1213
(F.C.A.) (QL) [hereinafter Harvard College], rev .g
Harvard College v. Canada (Commissioner of Patents), [1998
] F.C.J. No . 500 (T .D.). On October 2, 2000, the Commissioner of
Patents applied for leave to appeal this decision to the Supreme
Court of Canada : Supreme Court of Canada, Bulletin of
Proceedings, 13 October 2000 at 1747.
-
21 Ibid. at para. 127: . the Patent
Act cannot be extended to cover human beings.
-
22 Similarly, in the U.S., there is no prohibition
against patenting humans, although it is generally accepted that
patents on human beings would not be granted: see infra note 96 and
accompanying text. Specific statutory prohibitions do exist,
however, for example in Australia: Patents Act 1990, s.
18(2).
-
23 European Patent Convention, 5 October 1973,
U.K.T .S. 1978 No. 20 [hereinafter EPC], article 53(a).
-
24 The exception applies only in rare and extreme cases
where the invention would universally be regarded as outrageous:
Howard Florey / Relaxin , [1995] EPOR 541, para. 6.2.1.
-
25 Harvard / Onco-mouse, [1990] EPOR 4, para.
5. It is not clear to what extent this approach has survived the
later interpretation articulated in Howard Florey / Relaxin,
ibid.
-
26 Ibid., para. 4.1-4.8.
-
27 Directive 98/44/EC, O.J. L 213, 30/07/1998 p .
0013-0021 [hereinafter EU Directive]. National laws were
required to be in compliance with the Directive by July 30, 2000.
The government of the Netherlands initiated a challenge in the
European Court of Justice seeking to have the Directive an nulled
on various grounds, mainly procedural but also including
allegations that the Directive breaches fundamental rights. Case
C-377/98, Netherlands v. Parliament [1998] O.J. C378/13.
As of the date of writing the outcome of this case had not been
determined. For a discussion see A. Scott, . The Dutch Challenge to
the Bio-Patenting Directive [1999] 4 E.I.P.R. 212.
-
28 Ibid., article 5.
-
29 Ibid., article 6. For a critical examination
of this article, see R. B. Skarstad, . The European Unions Self-
Defeating Policy: Patent Harmonization and the Ban on Human Cloning
(1999) 20 U. Pa. J. Intl Econ. L. 353.
-
30 North American Free Trade Agreement Between the
Government of Canada, the Government of Mexico and the Government
of the United States, 17 December 1992, Can. T.S. 1994 No.2,
32 I.L.M. 289 [hereinafter NAFTA], Article 1 709(2 ); Final Act
Em bodying the Results of the Uruguay Round of the Multilateral
Negotiations, Marrakesh Agreement Establishing the World Trade
Organization, signed at Marrakesh (Morocco), April 15, 1994, Annex
1C, Agreement on Trade-Related Aspects of Intellectual Property
Rights, GATT, Doc.MTN/FA/Add.1 (15 December 1993 ); reprinted
in 33 I.L.M. 1197, 1200 [hereinafter TRIPS], Article 27(2).
-
31 NAFTA, ibid., Article 170 9(3); TRIPS,
ibid., Article 27(3). States are required to provide some
form of protection for plant varieties. The provision in the TRIPS
Agreement allowing exclusions for plants and animals was to be
reviewed four years after its entry into force (TRIPS came into
force 1 January 1995).
-
32 NAFTA, ibid., Article 170 9(10); TRIPS,
ibid., Article 31.
-
33 Part I of the Constitution Act, 1982, being
Schedule B to the Canada Act 1982 (U.K.), 1982, c. 11. The
province of Quebec also has the Charter of Human Rights and
Freedoms, R.S.Q. c. C-12.
-
34 This test was first set o ut in the case of R. v.
Oakes, [1986] 1 S.C.R. 1 03. It was sub sequently summarized in
e.g. Egan v. Canada, [1995] 2 S.C.R. 513 at para. 182.
Depending on the nature of the alleged infringment, at the first
stage of the test it may be appropriate to examine the objective of
the legislation generally, or of the specific impugned provision,
omission, or other action, or both: Vriend v. Alberta,
[1998] 1 S.C.R. 493 at para. 109-11.
-
35 R. v. Big M Drug Mart Ltd., [1985] 1 S.C.R.
295 at 344.
-
36 Edwards v. Attorney General of Canada,
[1930] 1 D.L.R . 98 at 107 ; Canadian National Railway Co. v.
Canada (Canadian Human Rights Commission), [1987] 1 S.C.R.
1114 at 1134.
-
37 The exception to this is where a government invokes
the notwithstanding clause in section 33, which allows the
enactment of a law which is expressly declared to operate
notwithstanding any violation of the Charter.
-
38 Statute of the International Court of
Justice, 26 June 1945, 3 Bevans 117 9, Article 38. Judicial
decisions and academic writing may be considered as subsidiary
sources.
-
39 Accord ing to the principle of pacta sunt
servanda, parties to a treaty must perform their treaty
obligations in good faith: Vienna Convention on the Law of
Treaties, 23 May 1969, 1155 U.N.T.S. 331, article 26.
-
40 10 December 1948, UN G.A. Res. 3/217A.
-
41 16 December 1966, Can. T.S. 1976 No. 47, 999 U.N.T.S.
171.
-
42 16 December 1966, Can. T.S. 1976 No. 46, 993 U.N.T.S.
3.
-
43 See e.g. H. Hannum, . The Status of the Universal
Declaration of Human Rights in National and Internationa l Law .
(1995) 25 Georgia J. Intl & Comp. L. 289 at 317ff;
Filartiga v . Pena-Irala, 630 F. 2d 876 (2d Cir. 1980).
-
44 See e.g. W . A. Schabas, International Human
Rights Law and the Canadian Charter, 2d ed. (Toronto:
Carswell, 1996).
-
45 See e.g. B . M. Knoppers, Human Dignity and
Genetic Heritage (Ottawa: Law Reform Commission of Canada,
1991); D. Beyleveld & R. Brownsword, Human Dignity, Human
Rights, and Human Genetics (1998) 61 Modern L. Rev. 661.
-
46 Supra note 27, para. 16.
-
47 Universal Declaration on the Human Genome and
Human Rights, UNESCO Gen. Conf., 29th Sess., 29 C/Resolution
19 (19 97). The UNESCO Declaration has been endorsed by the UN
General Assembly: The human genome and human rights, 9
December 1998, UN GA Res. 53/152. Dignity is mentioned in articles
1, 2, 6, 10, 11, 12, 15, 21, 24.
-
48 Vienna Declaration and Programme of Action,
25 June 1993, UN Doc. A/CONF.157/24, para. 11.
-
49 No other ideal seems so clearly accepted as a
universal social good. O. Schachter, Human Dignity as a Normative
Concept (1983) 77 Am. J. Intl L. 848 at 849.
-
50 Schachter, ibid., suggests: Without a
reasonably clear general idea of its meaning, we cannot easily
reject a specious use of the concept, nor can we without
understanding its meaning draw specific implications for relevant
conduct.
-
51 Schachter, ibid. Schachters article contains
a useful elaboration of this definition and its implications. See
also Beyleveld & Browns word, supra note 45 at 665-66.
-
52 The Proclamation of Teheran issued at the
Teheran International Conference on Human Rights, 13 May 1968, U N
Do c. A/CO NF.32 /41 states that the primary aim of the United
Nations in the sphere of human rights is the achievement by each
individual of the maximum freedom and dignity (para. 5).
-
53 Schachter , supra note 49 at 853.
-
54 See R. P. Claude & B. W. Issel, Health, Medicine
and Science in the Universal Declaration of Human Rights (1998) 3
Health and Human Rights 127 at 138. The Dutch representative
apparently supported the need for protection of intellectual
property rights by using the example of Marie Curie, who had
devoted her whole life to the progress of science for the good of
humanity, not for a commercial venture.
-
55 R. L. Ostergard, Intellectual Property: A Universal
Human Right? (1999) 21 Human Rights Q. 156.
-
56 See Ibid. at 157-65 .
-
57 The phrase right to health is used to refer to the health
related rights recognized in this article of the Covenant and other
sources (on the use of this phrase, see e.g. V. A. Leary,
.Implications of a Right to Health in K. E. Mah oney & P.
Mahoney, eds., Human Rights in the Twenty-first Century
(Dordrecht: Martinus Nijhoff, 1993) 481 at 4 84-86; B. C. A.
Toebes, The Right to Health as a Human Right in International
Law (Antwerp: Intersentia, 1999) at 16-24). The recognition of
the right to health does not require states to guarantee a state of
health (see e.g. Committee on Economic, Social and Cultural Rights,
CESCR General Comment 14 : The right to the highest attainable
standard of health, 22nd Sess., UN Doc.
E/C.12/2000/4 (2000) at para. 8-9), but does entail a set of
obligations, some of which are set out explicitly in the Covenant,
and others which have been identified through interpretation of the
relevan t provisions. See e.g. Leary, ibid.; Toebe s,
ibid.; Economic and Social Rights and the Right to Health
(Cambridge, Mass.: Harvard Law School Human Rights Program, 1995);
Committee on Economic, Social and Cultural Rights, ibid.
-
58 ICESCR, supra note 42, article 12(1). The
UDHR, supra note 40, also affirms the right to a standard
of living adequate for ... health..., including ... medical care
(article 25(1)).
-
59 Ibid., article 12(2)(c), (d).
-
60 Ibid., article 15(1)(b). Article 27(2) of
the UDHR states that everyo ne has the right to share in scien
tific advance ment and its benefits. For a discussion of the
drafting of this article see Claude & Issel, supra note 54 at
137. Other UN documents also add ress the question of benefit from
scientific progress, e.g. Declaration on the Use of Scientific
and Technological Progress in the Interests of Peace and for the
Benefit of Mankind, 10 November 1975, UN G .A. Res. 3384(XXX).
-
61 See e.g. B. Looney, Should Genes be Patented? The
Gene Patenting Controversy: Legal, Ethical and Policy Foundations
of an International Agreement (1994) 26 L. & Poly Intl Bus. 231
at 239-40.
-
62 Traditionally, the exemption has covered only
experiments for purely philosophical motives or for amusement, and
with no commercial purpose. The Patent Act, supra note 6,
does not create any exemption for research but the common law
exemption is preserved by s.55.2(6): For greater certainty,
subsection (1) does not affect any exception to the exclusive
property or privilege granted by a patent that exists at law ... in
respect of any use, manufacture, construction or sale of the
patented invention solely for the purpose of experiments that
relate to the subject-matter of the patent. For discussions of the
scope of the exemption, see E. R. Gold, Making Room: Reintegrating
Basic Research, Health Policy, and Ethics into Patent Law in T.
Caulfield & B. Williams-Jones, eds., The Commercialization
of Genetic Research: Ethical, Legal, and Policy Issues (New
York: Kluwer Academic/Plenum, 1999) 63 at 71 [hereinafter Making
Room . ]; L. M. Kurdydyk & S. S. McDiarmid, Patent Infringement
Issues Relating to Biotechnology . (1993) 10 C.I.P .R. 175 a t
179-88 ; I. P. Cooper, Biotechnology and the Law (St.
Paul, M innesota: West Group , 1982, revised 199 9), vol. 1 at
§ 5A.12; Micro Chemicals Ltd. v. Smith Kline & French
Laboratories Ltd., [1972] S.C.R. 506.
-
63 M. A. Heller & R. S. Eisenberg, Can Patents Deter
Innovation? The Anticomons in Biomedical Research (1998) 280
Science 698; Making Room, ibid. at 65-66. A related
concern is the effect of patenting on disclosure of research
results; see e.g. D. Blumenthal et al., Withholding
research results in academic life science: Evidence from a national
survey of faculty (1997) 277 JAMA 1224.
-
64 See Making Room , ibid. at 64-65, 68.
-
65 See e.g. A. L. Taylor, Globalization and
Biotechnology: UNESCO and an International Strategy to Advance
Human Rights and Public Health (1999) 25 Am. J. L. & Med. 479
at 488-89, 495-96; M. L. Bouguerra, Genes of inequality (September
1999) 52 UNESCO Courier 35.
-
66 See e.g. P. Boulet, J. Perriens & F.
Renaud-Théry, Patent situation of HIV/AIDS-related drugs
in 80 countries (Geneva: UNAIDS/WHO , 2000). In some
countries, including Canada, there are means by which patentees can
be prevented from charging excessive prices for medicines: see
Patent Act, supra note 6, s. 83.
-
67 ICESCR, supra note 42, article 1(2).
-
68 On the role of industry in making products available
to the public, see T. Caulfield, .The Commercialization of Human
Genetics (1998) 21 J. Consumer Poly 125 at 126.
-
69 Ibid. at 147ff.
-
70 A. Attaran, Human Rights and Biomedical Research
Funding for the Developing World: Discovering State Obligations
under the Right to Health (1999) 4 Health and Human Rights 27; A.
R. Chapman, M. S. Frankel & M. S. Garfinkel, Stem Cell
Research and Applications: Monitoring the Frontiers of Biomedical
Research (American Association for the Advancement of Science
& Institute for Civil Society, 1999) at 20-22. I have argued
elsewhere that the tendency to view government funding for research
as an investment for which commercial return is expected is
inimical to the fulfillment of government obligations in this
regard: B. von Tigerstrom, Pharmaceutical Research, Testing and the
Scientific Process: Human Rights Perspectives, Parkland Institute
Fall Research Conference, Edmonton, 26 November 1999.
-
71 Moore v. Regents of the University of
California, 793 P.2d 479 (Cal. 1990 ).
-
72 For a discussion of this case, see A. Pottage, The
Inscription of Life in Law: Genes, Patents, and Biopolitics (1998)
61 Modern L. Rev. 740 at 740-42; K. H. Ching, Indigenous
Self-Determination in an Age of Genetic Patenting: Recognizing an
Emerging Human Rights Norm (1997) 66 Fordham L. Rev. 687 at
701-702.
-
73 For discussion of several other examples, see Ching,
ibid. at 687, 699-702. Genetic research in Iceland has
also been somewhat controversial: see L. Nielsen, The Icelandic
Health Sector Database: Legal and Ethical Conside rations in
Caulfield & Williams-Jones, supra note 62, 111; O. M.
Arnardóttir, D. T. Björgvinsson & V. M.
Matthíasson, The Icelandic Health Sector Database (1999) 6
Eur. J. Health L. 307.
-
74 The Human Genome Diversity Project (HGDP) is an
international effort to document human genetic variation by
collecting and analysing genetic data from around the world. It has
been widely criticised by indigenous peoples. See e.g.
Declaration of Indigenous Peoples of the Western Hemisphere
Regarding the Human Genome Diversity Project, 19 February
1995, online: (http://www.ankn.uaf.edu/declaration.html).
These concerns have led to the formulation of ethical guidelines
for the project including provisions on patenting and commercial
use: Human Genome Diversity Project North American Regional
Committee, Model Ethical Protocol for Collecting DNA
Samples, online: (http://www.stanford.edu/group/morrinst/hgdp/protocol.html).
-
75 See B.M. Knoppers, Status, sale and patenting of
human genetic material: an international survey (1999) 22 Nature
Genetics 23 at 24; L. H. Glantz et al., Research in
Developing Countries: Taking Benefit Seriously (1998) 28 Hastings
Center Report 38.
-
76 The question of whe ther individuals do or should
have property rights in their bodies and body parts is a complex
one which is beyond the scope of this paper, but has been explored
elsewhere. See e.g. E. R. Gold, Body Parts: Property Rights and
the Ownership of Human Biological Materials (Washington, D.C.:
Georgetown University Press, 1996); B. M. Dickens, Living tissue
and organ donors and property law: More on Moore (1992) 8 J.
Contemp. Health L. & Poly 73.
-
77 Schloendorff v. Society of New York Hospital
(1914), 105 N.E. 92 (N.Y.C.A.) at 93.
-
78 Fleming v. Reid (1991), 4 O.R. (3d) 74 (Ont.
C.A.) at 88.
-
79 Moore, supra note 71 at 483. B. M. Dickens,
Informed Consent in J. Downie & T. Caulfield, eds.,
Canadian Health Law and Policy (Toronto: Butterworths,
1999) 117 at 134.
-
80 The ICCPR, supra note 41 and ICESCR,
supra note 42 both state as article 1(1): All peoples have
the right to self-determination. By virtue of that right they
freely determine their political status and freely pursue their
economic, social and cultural development. Article 1(2) of the UN
Charter refers to self-determination of peoples: Charter of the
United Nations, 26 June 1945, Can. T.S. 1945 No.7 Regarding
the restriction of the right to peop les and the difficulties of
defining peoples, see e.g. Reference re Secession of
Quebec, [1998] 2 S.C.R. 217 at para. 123; S. J. Anaya, A
Contemporary Definition of the International Norm of
Self-Determination (1993) 3 J. Transnat l L. & Contemp. Probs.
131.
-
81 In particular, it is important to distinguish between
external self-determination which may include secession or other
changes to state structures, which has a much more limited scope
(and would not be at issue in this context), and internal
self-determination which concerns the exercise of rights within
existing state structures. See Reference re Secession of
Quebec, ibid., at para. 126 ; A. Cassese,
Self-determination of peoples: A legal reappraisal
(Cambridge: Cambridge University Press, 1995), c. 4, 5.
-
82 See e.g. E.-I. A. Daes, The Right of Indigenous
Peoples to Self-Determination in the Contemporary World Order in D.
Clark & R. William son, eds., Self-Determination:
International Perspectives (Hound mills, U.K.: Macmillan
Press, 19 96, 47; S. J. Anaya, Indigenous Peoples in
International Law (New Y ork: Oxford University Press, 19 96);
Draft United Nations Declaration on the rights of indigenous
peoples, UN Doc. E/CN.4/Sub.2/1994/56.
-
83 Section 35 of the Constitution recognizes and affirms
the existing aboriginal and treaty rights of the aboriginal peoples
of Canada.
-
84 Ching, supra note 72 at 7 16ff.
-
85 For example, the Beijing Declaration of
Indigenous Women, 7 September 1995, online: (http://www.ipcb.org/resolutions/htmls/dec_beijing.html),
article 40 calls for a stop to the patenting of life forms, which
is the ultimate commodification of life which we hold sacred. See
also M. J. Hanson, Religious voices in biotechnology: the case of
gene patenting (1997) 27:6 Hastings Center Report 1.
-
86 Freedom of religion is protected by s. 2(a) of the
Charter and article 18 of the ICCPR.
-
87 The privacy issues raised by genetic testing and
research have been extensively discussed in the literature. See
e.g. I. J. Brown & P. Gannon, Confidentiality and the Human
Genome Project: A Prophecy for Conflict in McLean, supra
note 4, 215; M. A. Rothstein, Genetic privacy and confidentiality:
why they are so hard to protect (1998) 26 J. L. Med. & Ethics
198; L. O. Gostin, Genetic privacy (1995) 23 J. L. Med. &
Ethics 320.
-
88 See e.g. R. v. Dyment, [1988] 2 S.C.R. 417;
R. v. Plant, [1993] 3 S.C.R. 281; R. v. O Connor,
[1995] 4 S.C.R. 411. For a discussion of Charter rights and privacy
in the context of health information, see B. von Tigerstrom, P.
Nugent & V. Cosco, Albertas Health Information Act and the
Charter: A Discussion Paper, Health Law Review (forthcoming).
-
89 R. v. Mills, [1999] 3 S.C.R. 668.
-
90 ICCPR , supra note 41, article 17. The American
Convention on Human Rights, 22 November 1969, O.A.S. T.S. No.
36, 1144 U.N.T.S. 123, contains a similar provision at article 11.
-
91 E.g. ICESCR, supra note 42, article 2(2);
Convention on the Elimination of All Forms of Racial
Discrimination, 21 December 1965, 660 U.N.T.S. 195.
-
92 See e.g. J. Donahue, Patenting of Human DNA Sequences
Implications for Prenatal Genetic Testing (1997-98) 36 J. Family L.
267, arguing that the number of available tests will grow rapidly
as a result of the availability of patent rights for DNA sequences
(at 268; see also 276ff).
-
93 The issues in this section are discussed in greater
detail in B. von Tige rstrom, . Human Rights Issues in Patenting of
Higher Life Forms - The Role of the Canadian Charter of Rights
and Freedoms, paper prepared for the Canadian Biotechnology
Advisory Committee.
-
94 EU Directive, supra note 27, articles 5(1),
6(2)(a),(b).
-
95 Australia does expressly exclude human beings from
patentability, however; supra note 20. Statutes containing
such an exclusion have been introduced in the U.S . but never en
acted: Life Patenting Moratorium Act of 1993, S. 387, 103d
Congress, 1st Session, s. 3; Transgenic Animal
Patent Reform Act, H.R. 1556, 101st Congress ,
1st Session, s. 4; Patent Competitiveness and
Technological Innovation Act of 1990, H.R. 5598,
101st Congress , 2nd Session, s. 204.
-
96 D. J. Quigg (Commissioner of the United States Patent
and Trademark Office), Statement, Policy Statement on Patentability
of Animals, 1077 Off. Gaz. Pat. Office 24 (7 April 1987).
-
97 K. D. DeBré, Patents on People and the U.S.
Constitution: Creating Slaves or Enslaving Science? (1989) 16
Hastings Const .l L. Q. 221 at 228; R. E. Fishman, Patenting Human
Beings: Do Sub-Human Creatures Deserve Constitutional Protection?
(1989) 15 Am. J. L. & Med. 461 at 462.
-
98 See e.g. Fishman, ibid. at 474.
-
99 UDHR, supra note 40, article 4; ICCPR,
supra note 41, article 8; American Convention on Human
Rights , supra note 90, article 6; Slavery
Convention, 25 September 1926, 60 L.N.T.S. 253; Convention
for the Suppression of the Traffic in Persons and of the
Exploitation of the Prostitution of Others, 21 March 1950, 96
U.N.T.S. 271; Supplementary Convention on the Abolition of
Slavery, the Slave Trade, and Institutions and Practices Similar to
Slavery, 7 September 1956, 226 U.N.T.S. 3 [hereinafter
Supplementary Convention]. Canada is a party to all of
these except the Convention for the Suppression of the Traffic
in Persons and of the Exploitation of the Prostitution of
Others.
-
100 Supplementary Convention, ibid., article 1.
-
101 United Nations High Commissioner for Human Rights,
Fact Sheet No. 14: Contemporary Forms of Slavery (Geneva:
UNHC HR, 1991).
-
102 Slavery Convention, supra note 99, article
1(1) [emphasis added].
-
103 Patent Act, supra note 6, s. 42.
-
104 Fishman, supra note 97 at 475-76.
-
105 Ibid. at 475; DeBré, supra
note 97 at 2 38-39; R. W. Walker, Patent Law Should Genetically
Engineered Human Beings be Patentable? (1991) 22 Memphis State U.
L. Rev. 101 at 110; D. L. Burk, Patenting Transgenic Human Embryos:
A Nonuse Cost Perspective (1993) 30 Houston L. Rev 1597 at 164 9-50
(this last author rejects the argument as untenable for a variety
of practical and doctrinal reasons). The right to make reproductive
decisions is protected in Canada by section 7 of the Charter:
Morgentaler v. R., [198] 1 S.C.R. 30. For a comprehensive
review of human rights law and reproductive freedom, see R. J.
Cook, Human Rights and Reproductive Self-Determination (1995) 44
Am. U. L. Rev. 975.
-
106 For practical purposes, the distinction between a
patent on a human being per se and on certain materials or
processes may not be important. In the Harvard College
case, supra note 20, the Federal Court noted at para. 36 that even
if a mouse were found to be within the realm of patentable
subject-matter it would give the inventor no additional protection
in this instance. The inventor has already received a patent for
the creation of the plasmid and the injection the reof into the
mouse oocyte.
-
107 Howard Florey / Relaxin, supra note 24 at
para. 6.3.3.
-
108 Another controversial example is the patent granted
by the EPO to the US company Biocyte for the use of stem cells from
umbilical cord blood. An opposition to the patent was successful
but on the grounds that it lacked novelty and an inventive step ,
not on ethical grounds. D. Butler, Patent on umbilical-cord cells
rejected in Europe...(1999) 399 Nature 626.
-
109 See e.g. Burk, supra note 105.
-
110 Walker, supra note 105 at 106ff.
-
111 Tremblay v. Daigle, [1989] 2 S.C.R. 5 30;
Winnipeg Child and Family Services (Northwest Area) v. G.
(D.F.), [1997] 3 S.C.R. 925.
-
112 Supra note 27, article 5(1).
-
113 A transgenic animal is one that contains one or more
genes from another sp ecies. A hybrid is a genetic cross between a
male of one species and a female of another. A chimaera (or chimera
) is a mosaic containing cells from more than one species. Unlike a
hybrid which contains material from both species in every cell, the
cells in a chimaera remain distinct. There are various methods for
producing such animals. No one has ever created a human/non-human
chimaera, but there is apparently no technical barrier to doing so.
See T. A. Magnani, The patentability of human-animal chimeras.
(1999) 14 Berkeley Tech. L. J. 443.
-
114 For a discussion of these issues, see Fishman,
supra note 97; T. Schrecker et al., Ethical
Issues Associated with the Patenting of Higher Life Forms (17 May
1997) online: (
http://strategis.ic.gc.ca/epic/site/ippd-dppi.nsf/en/ip00033e.html).
-
115 Increasing knowledge about the genetic and behavioural
similarities between humans and non-human primates is challenging
the exceptional staus of human beings in law. In New Zealand , a
law was introd uced in 1999 which would have conferred the
equivalent of human rights on great apes: NZ bill aims to give apes
same rights as humans (1999) 397 Nature 555.
-
116 E. Marshall, Legal Fight Over Patents on Life (1999)
284 Science 2067 at 2067.
-
117 D. Dickson, ... as US bid to patent human-animal
hybrid fails (1999) 399 Nature 626. The applicants have announced
their intention to appeal the decision. The USPTO had previously
released a statement saying that inventions directed to
human/non-human chimera, could, under certain circumstances, not be
patentable because, among other things, they would fail to meet the
public policy and morality aspects of the utility requirement.
United States Patent and Trademark Office, News Release 98-6, Facts
on Patenting Life Forms Having a Relationship to Humans (1 April
1998).
-
118 Making Room , supra note 62; Timothy
Caulfield and Richard Gold, "Whistling in the Wind: Reframing
the Genetic Patent Debate" (2000) 15 Forum for Applied
Research and Public Policy 75.
-
119 Human Dignity and Genetic Heritage, supra
note 45 at 18-20; B. M. Knoppers, Sovereignty and Sharing in
Caulfield & Williams-Jones, supra note 62, 1 at 3,
9-10.
-
120 For a discussion of the public trust doctrine, see
B. von Tigerstrom, The Public Trust Doctrine in Canada: Potential
and Problems (1998) 7 J. of Envtl L. & Practice 379.
-
121 See J. Black, Regulation as Facilitation:
Negotiating the Genetic Revolution (1998) 61 Modern L. Rev. 621 for
a useful discussion of regulation in this field.
-
122 Some commentators have suggested that the existing
human rights framework is in adequate to deal with concerns raised
by modern biotechnology: see A. T. Iles, The Human Genome Project:
A Challenge to the Human Rights Framework (1996) 9 Harvard Human
Rts. J. 27 ; D. Bell, Human Cloning and International Human Rights
Law (1999) Sydney L. Rev. 202.
-
123 This point was made by Glenn Rivard in a
conversation with the author (23 March 2000).
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