Inalienably Yours? The new case for an inalienable property right in human biological material: Empowerment of sample donors or a recipe for a tragic Anti-Commons?
Jasper A. Bovenberg*
Introduction: Mo(o)re Coming to a Court Near Your Biobank Soon?
The
full scientific and commercial potential of a Biobank, however, may
not be realised if there is uncertainty over the question of who owns
the collected material. In order not to
chill research and investment or the very creation of a Biobank, any
uncertainty about clear title to the collected material must be
resolved prior to its creation. In fact, resolving this uncertainty
is more important for the future of Biobanks than resolving it in any
particular way.7
De novo Biobanks typically address
the ownership issue by requiring sample donors to waive or assign any
property rights in the material they supply to the Biobank. Existing
repositories often lack such a waiver or assignment and they may lack
appropriate consent of the sample donors for novel research
questions. There is a current shift, however, towards acceptance of
simplifying existing specific informed consent requirements for
previously unanticipated research use, which would obviate the need
for re-consent for each new research project and thus ‘unlock’
these repositories for broader research use.8
However,
both property waivers and assignments and the trend towards broad
consent, may be undermined by a countervailing trend. While
courts and legislatures have long been reluctant to recognise
property rights in human biological material, donors and commentators
have recently reacquired a taste for the commodification thereof.
This trend calls for patient empowerment
through the recognition of an ‘inalienable’ personal
property right of a person in his or her biological material.
Property proponents are pleading in courts
and urging legislators to create new property rights in human
biological material as a means to secure ongoing control over their
material after donation and to enable them to share in any benefits
that may result from the research on the material they provide. One
author has even calculated that an individual’s DNA sample is
worth USD 50,000, and has urged everybody to stand up for their
property rights in their samples.9
The fact that individuals supply a Biobank’s base material
seems to justify such a claim. Given the objective to ensure ongoing
control, this property right is claimed to be inalienable.
Under this
‘inalienable property’ model, waivers and assignments of
property rights, as required by de novo Biobanks, are held
void or voidable as against public policy. As a result, property
rights in the collected material would vest in countless individuals.
Also, this approach would render obsolete the trend towards
simplifying consent for research on existing collections. While
researchers would no longer be required to obtain specific re-consent
for each new research project under this simplified consent model,
they would be required to obtain such consent under the proposed
property model.
The
recent call to recognise property rights in samples on the one hand
and the need to promote research on Biobanks on the other hand, urges
a reconsideration of the question of whether individuals indeed have
a personal property right in their collected biological material.10
To do this, Part II will first summarise the present state of the law
in a number of common law jurisdictions, including the inferences
that can be drawn in this respect from the recently enacted UK Human
Tissue Act 2004. Part III will describe the new arguments that are
currently being made for recognising an inalienable property right in
human biological material. Part IV will then revisit the issue of
whether an individual has a property right in his biological material
as such. While most commentators limit their discussion of this issue
to the question of whether bodily material is alienable, this Article
attempts to analyse whether human biological material fits each and
all of the eleven standard incidents of personal property that have
become the commonly accepted bundle of core property rights. This
part also addresses the issue of whether personal property rights may
be extended to encompass human biological material, if and when
processed and cultured.
Part
V will analyse the policy considerations pro and contra the
recognition of property rights in human biological material. Part VI
will examine the implications of recognising inalienable property
rights in the specific context of a Biobank. I will argue that the
recognition of property rights in human biological material in this
context may lead to a proliferation of property rights that could
result in the suboptimal use of this new resource. To articulate the
adverse consequences of the potential proliferation of property
rights, Part VI will apply the anticommons property theory to
existing and de novo Biobanks. Anticommons property is
associated with the ‘tragedy’ that too many
rightholders in a resource may block optimal use of such resource. It
will be examined whether a Biobank could become anticommons property
and if so, whether a Biobank Anticommons will be necessarily tragic.
To put the analysis presented in this Article into context, it will
be preceded by a typology of Biobanks in Part 1.
1. What is a Biobank?
1.1 How can a Biobank be created?
A major difference between de novo
Biobanks and pre-existing collections of human tissue is that the
latter were not originally designed as Biobanks, and they may lack
appropriate consent for previously unanticipated research questions.
In addition, they are much more diverse in terms of the population
included (affected and/or unaffected individuals, specific or general
community), the nature and size of the biological specimens and
related data collected, the context of the collection (clinical or
research settings), the form of storage, and the underlying
scientific purpose (ranging from screening programs, association
studies, genetic epidemiology to pharmaco-genetics).20
1.2 What human biological materials
go into a Biobank?
Pre-existing repositories may contain
a variety of human biological material, such as pathological tissue
or the blood drops on Guthrie cards. By definition, a Biobank cannot
state in advance the complete range of analyses that will be
performed on the collected material. Consequently, the collection,
processing and storage of the samples in de novo Biobanks is
designed so as to ensure the widest possible range of analyses that
can be carried out on the samples in the future. In
principle, a Biobank could be fed with all sorts of human biological
material: hair, nails, and, indeed, blood, sweat and tears. In
practice, the three most advanced de novo Biobanks - Iceland,
Estonia and the UK Biobank - have chosen to take blood samples. The
0.5 million participants in the UK Biobank, for example, will be
asked to contribute 40 mls of blood. The
constituent fractions of blood are plasma, buffy coat, serum and red
cells. Prior to storage, the blood samples will be fractionated and
aliquoted in different storage formats to protect the long term
integrity of the samples. The samples of each participant will also
undergo a default series of biochemical measurements. Whole blood
will be stored for subsequent DNA analysis. In
addition to blood, UK Biobank will also be collecting urine samples
from the participants. Urine contains a number of bodily products,
reflecting the overall metabolic status of an organism and can reveal
important information pertaining to the presence of pathologies or
biological stressors.22
For the avoidance of doubt, the Biobanks that are the subject of this
article are used for biomedical research, and not for transplantation
or therapeutic uses. They typically contain blood and regenerative
tissue (except sperm and ova), i.e. tissue that can be
replaced by the body after removal. They typically do not contain
organs, bone, sperm, ova, embryos or foetal tissue and, therefore,
are not to be confused with organ banks, sperm banks and the like.
1.3 On what basis are samples transferred to a Biobank?
However, ‘property waivers and
assignments’, whether granted in the context of existing
collections or de novo Biobanks, may not work for a number of
reasons. First, property proponents argue that a property right in
human biological material is ‘inalienable’. For them,
‘inalienability’ is a necessary corollary of recognising
personal property rights in human biological material. If human
biological material were alienable, then individuals could transfer
their property rights and thus dispose, rather than retain, on-going
control over their samples. In this vein, any waiver or assignment of
property rights is considered either legally void or voidable as
against public policy, or owing to ‘power asymmetry’
between the sample donor and the recipient institution or ‘undue
influence’ exercised by the institution over the sample donor.24
According to one commentator:
[No] such assignation of rights should be legally permissible. Thus, while individuals or communities might choose not to exercise their (property) rights, they cannot give them away. 25
As to existing collections, many of them do not provide
for ‘property waivers’ in respect of the collected
material. And in the event waivers have been obtained, they are
unlikely to be ‘blanket waivers’; their scope is likely
to be related to the scope of the informed consent given for the
research concerned. In brief, the issue of personal property rights
in the human biological material collected in Biobanks must be
addressed.
2. Who owns human biological material? The present state of the law
The question of whether an individual has a property right in his material collected in a Biobank is, obviously, preceded by the preliminary question of whether an individual has a personal property right in his or her biological material as such. Both legislatures and courts have long been reluctant to recognise such a right.
In the US no federal property right
in human biological material has been adopted, in spite of various
pleas to that effect. While the National Organ Transplant Act
prohibits the sale of any human organs for use in human
transplantation,26
no federal law prohibits the sale of blood for transfusion, research
or manufacturing.27
Similarly, states banning commercial dealings in respect of organs
generally make an exception for regenerative tissue.28
Various states have considered legislative proposals29,
but only one state, Oregon, has adopted legislation explicitly
recognising that ‘an individual’s genetic information and
DNA sample are the property of the individual except when the
information or sample is used in anonymous research’.30
This provision, however, has been repealed and replaced by a more
comprehensive set of privacy rights with regard to the collection and
use of genetic samples.31
In the UK, no legislation exists
which directly addresses the issue of whether a person can claim a
property right in his biological material. The 1961 Human Tissue Act
only makes lawful the use of parts of bodies of a deceased person for
therapeutic or research purposes in the event such person had
consented to such post mortem use.32
The implication of this Act is that the person consenting to the use
of any body parts after death for research donates these parts free
of all claims. On the other hand, it has been argued that the Human
Organ Transplants Act, the Human Fertilisation and Embryology Act
1990 and section 25 of the National Health Services Act (1977) seem
‘implicitly to adopt a property approach’.33
The Human Tissue Act 1961 and the Human Organ Transplants will be
repealed and replaced by the Human Tissue Act 2004 which received
Royal Assent on November 15, 2004.34
The purpose of the Human Tissue Act 2004 is to provide a
comprehensive framework for issues relating to whole body donation
and the taking, storage and use of human organs and tissue. Notably,
the Act makes consent and not personal property rights
the fundamental principle underpinning the lawful storage and use of,
inter alia, human body parts and tissue. The Act is silent on
the issue of whether an individual can claim a property right in
biological material removed from his body. Part 2 of the Act contains
a prohibition of commercial dealings in human material, which appears
to endorse a ‘non-property’ approach. However, the
prohibition is limited to dealings in material which is ‘intended
to be used for the purpose of transplantation’.35
Also, the prohibition does not apply to material ‘which is the
subject of property because of an application of human skill’.36
In this provision, the Act explicitly acknowledges that at least the
person applying skill on human biological material can claim a
property right to the material concerned.
In Australia, the Human Tissue Acts
set forth consent conditions for the donation rather that the
sale of human blood, regenerative tissue and non-regenerative
tissue.37
No statute exists addressing the property status of genetic samples.38
The courts in the above common law
jurisdictions have traditionally held that neither a human corpse nor
parts of a corpse can be the subject of property rights.39
This position, however, is subject to a number of exceptions,
especially where courts have found that body parts and bodily
substances, such as urine and blood samples, are capable of being
stolen, thus implying that these samples have property status.40
One early Australian case, Doodeward v Spence,41
concerned an action for recovery of a two headed-foetus preserved in
a jar of alcohol. The ‘owner’ had bought it at an auction
and was subsequently prosecuted for publicly exhibiting the specimen
for gain, ‘to the manifest outrage of public decency’.42
While reaffirming that a corpse could not be the subject of
property, the Australian High Court held that a corpse or a part
thereof could be subject to a right of possession, where it had come
lawfully into someone’s possession, who had subsequently
bestowed some (‘perhaps not much’) work and skill upon
it. In Re v Kelly the same principle was applied to body parts
removed from the body.43
Kelly, an artist, had removed a number of human body parts from the
Royal College of London without its permission and without the
intention of returning them. All the specimens taken had been
preserved or fixed by college staff, and most of them had been the
subject of further dissection so as to reveal the inner workings of
the body. The court dismissed the appeal against the conviction for
theft holding that the parts of a corpse could be "property"
for the purposes of section 4 of the Theft Act 1968, ‘if they
had acquired different attributes by virtue of the application of
skill, such as dissection or preservation techniques, for exhibition
or teaching purposes.’44
Under existing common law, the
following two elements must be established for a person or
institution to acquire a possessory property right in human
biological material. First, the organisation or person using the
biological material must have lawful authority to do so. Second, that
organisation must apply some work or skill to the preservation of the
sample. It is not clear how much work is required. The two-headed
foetus had simply been placed in alcohol, which, by the standards of
the dissenting judge, meant that ‘no skill or labour has been
exercised on it’.45
While the Criminal Court in Re v Kelly recognised anatomical
specimens as the property of the institution because it had
preserved, fixed or dissected them, the preservation of a deceased’s
brain in paraffin wax has been held not to constitute sufficient work
or skill.46
One test to determine whether sufficient skill has been applied could
be whether the work has resulted in the material acquiring an ‘actual
pecuniary value’, as Griffith, J considered in Doodeward v
Spence.47
Another test could be to assess whether the material had acquired, by
virtue of the application of skill, different attributes, as
contemplated by the Criminal Court in Re v Kelly. In general,
it should be noted that most case law to date has dealt with limited
fact situations in which the courts have only recognised a limited,
possessory ownership right for specific purposes.48
In the US, there are only a few reported cases dealing with disputes over property rights to human biological material. They involve disputes between researchers and a corporation over the acquisition and ownership of established cell lines rather than ownership of ‘raw’ human biological material.49 Until recently, the only case squarely addressing the issue whether a tissue donor has a property interests in his excised cells was the landmark decision of the California Supreme Court in Moore. In 1976 John Moore underwent treatment for a rare form of hairy-cell leukemia at the Medical Centre of the University of California at Los Angeles. His physician, Dr Golde, recommended surgical removal of his abnormally large spleen, without, however, disclosing to Moore his ‘prior formed intent’ to obtain portions thereof for research purposes. In a series of postoperative visits, Golde withdrew substantial amounts of blood and other samples, cultured a cell line from Moore’s T-lymphocytes and discovered that the cells had a unique ability to produce a protein that might be used to develop an anti-cancer agent. While the Regents of the University of California filed a patent application for the cell line, Golde, in spite of repeated representations to Moore that there was no commercial value to his bodily substances, negotiated agreements for commercial development thereof, earning him, according to the legend, millions of dollars. When Moore found out what had happened to his excised cells, he filed suit against, inter alia, Dr Golde and the University of California. Moore claimed, inter alia, an interest in the products developed by using his tissue on the basis of a tort of ‘conversion’- an intentional exercise of dominion and control over personal property that so seriously interferes with the right of another to control that property that the tortfeasor may justly be required to pay the other the full value of the property.50 This claim forced the California Supreme Court to consider whether Moore had a property interest in his excised cells.
The California Supreme Court held that Moore had no such property interest. The court first found that there was no case holding that a person retains a sufficient interest in excised cells to support a cause of action for conversion.
It then rejected Moore’s
argument that "[i]f the courts have found a sufficient
proprietary interest in one's persona, how could one not have a right
in one's own genetic material, something far more profoundly the
essence of one's human uniqueness than a name or a face?".
According to the court, this analogy misconceived the nature of the
genetic materials and research involved in the case at hand. The
court pointed out that the goal and the result of the research was to
produce lymphokines, a protein which, unlike a name or a face, has
the same molecular structure and function in every human being. In
addition, the court considered that the particular genetic material
which is reponsible for the natural production of lymphokines ‘is
also the same in every person; it is no more unique to Moore than the
number of vertebrae in the spine or the chemical formula of
hemoglobin’.51
The reason Moore’s cells were unique was that they overproduced
lymphokines, because they were infected by a virus, HTLV-II (Human
T-cell leukemia virus type II).52
Next, the court refused to accept the
argument advanced by the Court of Appeals that ‘[a] patient
must have the ultimate power to control what becomes of his or her
tissues. To hold otherwise would open the door to a massive invasion
of human privacy and dignity in the name of medical progress.53
In retort, the Supreme Court held that it was not ‘necessary to
force the round pegs of "privacy" and "dignity"
into the square hole of "property" in order to protect the
patient, since the fiduciary-duty and informed-consent theories
protect these interests directly by requiring full disclosure.’54
The
next consideration that made Moore’s property claim problematic
for the court was a California statute, which restricted how excised
cells may be used and required their eventual destruction. Thus, the
court reasoned, ‘the statute eliminates so many of the rights
ordinarily attached to property that one cannot simply assume that
what is left amounts to "property" or "ownership"
for purposes of conversion law.’55
The court further argued that the
patented cell line and the products derived from it could not be
Moore’s property ‘because the patented cell line were
both factually and legally distinct from the cells taken from Moore's
body.’56
According to the court, Moore’s claim that ‘he owned the
cell line and the products derived from it were inconsistent with the
patent, which constitutes an authoritative determination that the
cell line is the product of invention.’57
Having found that Moore had no
property rights in his excised cells under existing law, the court
then refused to extend the theory of conversion, for a number of
policy reasons.58
First, the court did not want to impose a strict-liability tort duty
on scientists to investigate the consensual pedigree of each human
cell sample used in research. To impose such a duty would create a
potential obstacle to research stemming from uncertainty about legal
title to biological samples and hinder research by restricting access
to the necessary raw materials. Second, the court considered that
the case made by Moore for a property right in his biological
material was better suited to legislative resolution. Third, the tort
of conversion was deemed unnecessary to protect patients' rights,
because physicians would face liability if they breached existing
disclosure obligations, a mechanism which did not unnecessarily
hinder research.
The court concluded that the use of
excised human cells in medical research did not amount to a
conversion. The court made it clear however, that it was not prepared
to bar any role a property approach could have in the protection of
human beings.59
Moore was shortly followed by the District Court of Florida in
Greenberg v. Miami Children’s Hospital,
60
which decision will be discussed infra.
3. The new case for property rights in human biological material
By establishing an individually identifiable sample as the property of the sample source,the GPA not only serves the interests of those who would want to maintain exclusive control over their DNA, but also enables those who desire to share or transfer such control to do so … Owning one’s DNA sample allows transfer of control of the sample in accordance with property law principles.63
As we have seen, however, to date no such statutory property rights are available. Yet, as Laurie has put it, ‘the voices in support of property in the person are becoming louder and the ears on which they fall will not always be deaf’.64 In his 2002 ‘Genetic Privacy, A Challenge to Medico-Legal Norms’, Laurie made the following case for recognising personal property rights in human biological material:
A personal property
paradigm could, in fact, serve an all-important role in completing
the picture of adequate protection for the personality in tandem with
other protections such as autonomy, confidentiality and privacy.
However, the added value of a property model lies in its ability to
empower individuals and communities and to provide the crucial
continuing control over samples or information through which ongoing
moral and legal influence may be exerted.65
Support for his prediction can be
found with a number of patient groups and commentators66
and can be illustrated by the following examples.67
A recent example of a patient
advocacy group claiming property rights over their tissue is PXE
International, Inc. (‘PXE’). PXE is a non-profit
organisation incorporated by a patient advocacy group, representing
the interests of individuals affected by pseudoxanthoma elasticum
(PXE), a genetic disorder causing calcification of elastic tissue.
PXE is a global organisation that coordinates and funds a consortium
of nineteen research labs, provides patient support, directs a blood
and tissue bank and maintains a database of thousands of
individuals.68
In order to steer researchers toward working on finding the gene
associated with PXE disease, PXE entered into a contract with
researchers. Under the contract, PXE is entitled to retain ownership
rights in any patent application arising from the research, including
a profit share in any revenue to be generated by such inventions, a
right of control ensuring broad and affordable availability of
genetic tests, and a right to influence future licensing of the
intellectual property.69
In essence, the PXE agreement implies that PXE and/or its members
possess a property right in their biological material. To date,
neither party to the contract has challenged its enforceability on
the ground that the individuals do not have a property right in their
excised material pursuant to Moore. PXE’s example has
been followed by patient groups such as Cure Autism Now and the
Juvenile Diabetes Research Foundation.70
On October 30, 2000, another patient
advocacy group, the parents of children with Canavan disease, the
Canavan Foundation and the National Tay-Sachs&Allied Diseases
Association, filed a six-count complaint against Miami Children’s
Hospital Research Institute Inc. and its researcher, Dr Reuben
Matalon, asserting, inter alia, conversion and seeking damages
and equitable and injunctive relief. As Moreno, District Judge, put
it, ‘this case presents an unfortunate dilemma set against the
backdrop of a historic breakthrough in the treatment of a previously
intractable genetic disorder’.71
The plaintiffs had encouraged a team of scientists to pursue research
into Canavan disease, a fatal genetic disorder with no known cure.
Using financial resources, blood, urine and tissue samples, autopsies
and confidential medical information contributed by the patients and
their families, the team identified the Canavan gene mutation and
developed a genetic screening test for the disease. After the team
was recruited by the Miami Children's Hospital Research Institute,
their continued work led the Hospital to file a patent application
for the gene associated with Canavan disease, its various mutations
and related applications, including carrier and prenatal testing.72
According to the plaintiffs the Hospital threatened centers that
offered Canavan testing with possible enforcement actions regarding
the recently-issued patent and restricted public accessibility
through negotiating exclusive licensing agreements and charging
royalty fees.73
In count V of their complaint,
plaintiffs alleged that they had a property interest in their body
tissue and genetic information, and that they owned the Canavan
registry in Illinois which contained contact information, pedigree
information and family information for Canavan families worldwide.
They claimed that the hospital and Matalon had converted their names
and the genetic information by utilising them for the hospitals'
‘exclusive economic benefit’.74
The Florida District Court, however, declined to recognise a property
interest for the body tissue and genetic information voluntarily
given to the Hospital. The court held that these were donations to
research without any contemporaneous expectations of return of the
body tissue and genetic samples. The court approvingly cited the
California’s Supreme Court’s finding in Moore that
a donor has no property interest at stake after he has made his
donation.75
The court also reasoned that limits
to the property rights that attach to body tissue had been recognised
in Florida state courts and that the property right in blood and
tissue samples evaporates once the sample is voluntarily given to a
third party. The court also rejected plaintiff’s reference to
Pioneer Hi-Bred v. Holden Foundation.76
In this case the Southern District Court of Iowa had held that a corn
seed company’s property interest in the genetic message
contained in a corn seed variety is property protected by the laws of
conversion. The Greenberg court pointed out that the Pioneer
court had recognised that, ‘where information is gathered and
arranged at some cost and sold as a commodity on the market, it is
properly protected as property.’77
The Greenberg court saw this reasoning as providing ‘more
support for property rights inherent in the Hospital’s research
rather than the donations of plaintiffs' DNA’.78
The court also distinguished a litany of cases in other jurisdictions
that had recognised that body tissue can be property in some
circumstances on the ground that they did not involve voluntary
donations to medical research.79
Additionally, plaintiffs had cited a
Florida statute on genetic testing in support of their contention
that persons who contribute body tissue for researchers to use in
genetic analysis do not relinquish ownership of the results of the
analysis. The Greenberg court, however, found the statute
inapplicable under a common law theory of conversion, ‘because
by its plain meaning, it only provides penalties for disclosure or
lack of informed consent if a person is being genetically analysed.80
Even assuming, arguendo, that the statute did create a property right
in genetic material donated for medical research purposes, the
Greenberg court found it ‘unclear whether that would
confer a property right for conversion, a common law cause of
action.’81
Finally, the court held that the
facts alleged did not sufficiently allege the elements of a prima
facie case of conversion, as the plaintiffs had not alleged how
the Hospital’s use of the Registry in their research was an
expressly unauthorised act. Plaintiffs had failed to allege the
circumstances or conditions that were attached to the defendants' use
of the Canavan Registry. The court also rejected plaintiffs claim
that the fruits of the research, namely the patented material, was
commercialised, on the following ground:
If adopted, the
expansive theory championed by Plaintiffs would cripple medical
research as it would bestow a continuing right for donors to possess
the results of any research conducted by the hospital. At the core,
these were donations to research without any contemporaneous
expectations of return.82
The court did permit, however, a
cause of action for unjust enrichment, recognising ‘a
continuing research collaboration that involved Plaintiffs also
investing time and significant resources in the race to isolate the
Canavan gene’.83
The apparent inconsistency between
the judicial precedents established in Moore and Greenberg
on the one hand and the PXE agreement on the other hand, recently
caused another commentator to call for the adoption of a property
model. Proposing ‘Federal Recognition of Human Research
Participants’ Property Rights in Their Biological Material’,
this commentator proposes a hybrid property/liability approach.84
The property component of this model would entitle individuals to
invoke property rights in their biological material when they
negotiate in advance over any rights in the use of their
material. The liability component of this model would entitle
individuals who had not negotiated in advance, to bring an
action for conversion when researchers had withheld from them vital
information that would have facilitated their ability to bargain for
such rights. Applied to Biobanks, participants in de novo
Biobanks would be entitled to negotiate with the entity governing the
bank over any rights in the use of their material. Applied to
existing collections of human biological materials, the entities
governing those repositories could face actions for conversion if
they have withheld from them information that might have caused them
to bargain over any rights in the use of their material.
4. Can human biological material be
owned? Legal analysis
In order to be able to answer the
first question, the concept of property will be defined. In the past,
personal property has been defined as the relationship between a
person and an object and described as the ‘sole and despotic
dominion which one man claims and exercises over the external things
of the world, in total exclusion of the right of any other individual
in the universe’.86
In less hyperbolic terms, property has nowadays come to be
characterised as a ‘bundle of rights’, governing the
infinite number of potential relations and non relations that people
may have with each other over any given resource.87
The bundle of rights is not fixed. There is however, a core list of
standard incidents proposed by Honoré that is commonly
accepted as making up the bundle of personal property rights or ‘full
ownership’. According to Honoré this concept is common
to all ‘mature’ legal systems, and he draws his examples
from both common law and civil law jurisdictions. Generally, if a
person controls all or most of these rights in respect of an object,
he is considered the owner of that object.88
The core bundle that constitutes ownership includes the following
incidents or ‘sticks’:89
the right to exclusive possession;
the right to personal use and enjoyment:
the right to manage use by others;
the right to the income from use by others;
the right to the capital value, including alienation, consumption, waste, or destruction;
the rights to security (that is, immunity from expropriation)
the power of transmissibility by gift, devise, or descent;
the lack of any term on these rights;
the duty to refrain from using the object in ways that harm others;
the liability to execution for repayment of debts; and
residual rights on the reversion of lapsed ownership rights held by others.
4.1 Applying the sticks to human
biological material
Most commentators discussing property rights in human biological material are content to discuss the question of whether such material is alienable, i.e. whether it can be sold. However, the most obvious avenue of inquiry to assess whether an individual can have property rights in his biological materials seems to be to analyse whether human biological material fits each and all of the eleven standard incidents of property. The advantage of this approach is that, once the standard case of full ownership has been analysed, all contradictions and implications are easier to identify and assess.
(i) The right to exclusive possession. The right to possess is ‘the right to have exclusive physical control of a thing, or to have such control as the nature of the thing admits’.90 The remedies available to the owner are designed to enable the plaintiff either to retain or get back the thing owned. One characteristic of human biological material seems to render the application of the right of possession illusory. At least some human material is ubiquitous: we scatter millions of samples around us every day; when we get a haircut, when we shed skin cells, when we lick a stamp on an envelope, and so on. In practice, exclusive physical control of these types of biological material thus scattered around seems nearly impossible. Yet, while the remedy available to exercise the right to possession may not secure effective ‘control’ for at least some types of material, there seems to be no reason as to why human biological material could not be subject to a right of exclusive physical control. For example, such remedy would empower an individual to bring an action for recovery of the drops of ‘his’ blood stored on a Guthrie card in a newborn screening card collection- that is assuming this possessory right has not accrued to the institution holding the collection.
(ii) The right to use. The right to use refers to ‘personal use and enjoyment’, excluding the rights to management and income discussed below.91 The permissible types of use constitute an open list and, moral objections aside, there seems to be no reason why an individual could not exercise this right in respect of his biological material. In fact, this right seems to co-incide with a person’s right to autonomy over his body. To be sure, any harmful use could be prohibited, as discussed infra. In practice, only a limited number of individuals may have the requisite knowledge and technology to actually use their sample personally for research purposes in any meaningful way. Craig Venter for example, was probably unique in that he was able to use his own DNA sample in his successful effort to sequence the human genome.92
(iii)
The right to management. The right to manage is the right to
decide how and by whom the thing owned shall be used.93
The right implies the power to license acts which, without such
authorisation, would otherwise be unlawful. The right also implies
the power to permit others to use one’s things, to define the
limits of such permission and to contract in respect of the
exploitation of the thing. Thus, the right to management indeed
provides a basis for an individual to exercise on-going control over
the use of his biological material by third parties. It allows
individuals to decide whether or not to license research acts and to
define the terms of such permission. In practice, the fact that human
biological material can be used for an infinite number of research
purposes, and the fact that researchers are unable to state in
advance what uses they will make of the material may make the
exercise of the right to management problematic. Yet, conceptually
that is no reason why this right could not apply and is, perhaps,
even an additional reason why it should apply to human biological
material.
(iv)
The right to the income. ‘Income may be thought of as a
surrogate of use, a benefit derived from forgoing personal use of a
thing and allowing others to use it for reward’.94
Practically, a person who supplies a drop of blood for research does
not really forego personal use of his biological material; he will
continue to produce a life-time supply of genetically identical
material. Yet, conceptually, the fact that an individual is his own
continuous supply of her biological material is not, per se, a
reason to deny her the right to exploit her materials. Statutory
prohibitions aside, there is no reason why an individual could not
exact a reward from a researcher willing to use his biological
material. In practice, however, absent rare genes or a rare disorder
as in Moore, researchers allowed to use the material are
unlikely to be willing to pay any reward for such a right to use for
the reasons set forth below, under (v).
(v)
The right to the capital. ‘The right to the capital
consists in the power to alienate (i.e. ‘sell’)
the thing and the liberty to consume, waste or destroy the whole or
part of it’.95
Prima facie there are no reasons why an individual could not
alienate his biological material.96
However, alienation of an object implies the transfer of the full
bundle of rights to the new owner, including the right to the
capital. So, while alienation would enable an individual to exercise
his right to the capital value of his biological material, the
logical consequence thereof is that he can no longer exercise
on-going control over his material.
Obviously,
a person alienating his biological material could seek to impose
limitations on the use of the material by the new owner. However, if
you demand consideration in exchange for your sample, can you expect
those paying such consideration to accept your on-going control over
that sample? Why should a researcher who has paid for certain
biological material, accept that the seller retains the right to
claim it back or have it destroyed at will? Anyone who is required to
pay ‘quids’ for material will want to receive a proper
‘quo’. If an individual chooses to ‘commodify’
his biological material, the logical extension thereof is that he
‘has to deliver’; he cannot have his cake and eat it. As
a result then, in the words of Thomas Murray, ‘Putting a price
on the priceless, even a high price, actually cheapens it’.97
Compounding this issue is that the transfer
of exclusive rights to human biological material is
problematic, if not impossible to enforce. Any individual ‘possesses’
or, indeed, ‘is’ his own life-time supply of biological
material, which enables him to ‘sell’ genetically
identical material not just to one, but to an infinite number of new
‘owners’.
Another complication triggered by the
right to the capital is that the use of most human biological
material as such is unlikely to generate any income and, hence, the
proper consideration will be hard to assess. Typically, property
proponents claim a share of the profits to be made with the sale of
any products derived from the research on their material. In doing
so, they equate the value of a person’s sample to a percentage
of future profits to be made by the company marketing the end
product.98
Such an equation, however, is flawed because the only way to
determine the market value of a commodity is in the market place, as
a result of supply and demand.99
That could, indeed, mean that someone having ‘unique’
genes, like John Moore or the community of PXE patients, could
negotiate a monopoly price. However, the invisible hand of the market
will most likely bring down the price of ‘common material’
to a minimum. Also, some donors might be willing to donate their
samples for free, whether for altruistic reasons or in expectation of
other, more indirect benefits such as better health care for their
(grand-) children. Recognition of a property right in human
biological material would not provide for any mechanisms to exclude
such a ‘coalition of the willing’ from the market place
for human biological material. Notwithstanding this complication,
however, the fact that the material may have only limited or even no
commercial value does not, per se, mean that it cannot be
subject of a property right.
(vi)
The right to security. The right to security or immunity from
expropriation reflects the notion that the owner ‘should be
able to look forward to remaining owner indefinitely if he so chooses
and he remains solvent’.100
There seems to be sufficient reason to grant an individual the
‘security stick’ in his biological material. This right
reinforces the principle of autonomy and informed consent in that any
transmission of material should be consensual. What’s more, the
right to security is, unlike the consensual right to informed
consent, a general right, availing not only against a contractual
counterpart but also against others. Yet, it may have an adverse
implication. The right to security is consistent with ‘the
existence of a power to expropriate or divest in the state or public
authorities’.101
This is not a general power to expropriate any property for any
purposes. Such a general power would, even when subject to paying
adequate compensation, be fatal to ownership.102
However, when limited to certain classes of objects, and to specific
limited purposes, in the public interest, expropriation is possible,
subject to the state or said authorities paying adequate
compensation. In other words, if human biological material is private
property, the State could expropriate such property, for example for
purposes of research in the general interest, provided adequate
compensation is paid. Needless to say, such power of expropriation
does not promote the exercise of on-going control of a person over
his biological material.103
(vii) The incident of transmissibility. Transmissibility means that an interest does not stop with the death of the owner, but can be transmitted to the owner’s successors, whether by gift, devise or descent. An interest which is transmissible to the holder’s successors enables them to enjoy the thing after the holder’s death. Although transmissibility can stop short at the first, second or third generation, an owner’s interest is characterised by indefinite transmissibility. There is no limit on the possible number of transmissions, though the nature of the resource in question may well limit the actual number.104 There seems to be no reason why human biological material could not be subject to the incident of transmissibility. Upon the death of an individual, any property interests in his biological material would pass on to his heirs or any persons designated by him. The fact that both outside and within the dead body, human biological material only has a limited life span, if any, does not seem to make that any different. In deceased form, it can still be preserved and used.
(viii) The incident of absence of term. The absence of term means ‘unlimited’ duration in that it is not certain to determine on a fixed date or on the occurrence of a contingency. Ownership is considered an ‘indeterminate’ interest to which no term is set, unlike, for example, copyright which lapses 70 years after the death of the holder. Should the owner live for ever, he would continue in the enjoyment of his property right for as long as the thing remains in existence. As Honoré points out, however, even indeterminate interests are determinable, because the owner or his successor may lose their interest in the event of bankruptcy or execution sale.105 There seems to be no reason why human biological material could not be subject to the incident of absence of term, as there seems to be no fixed date or contingency the occurrence of which would call for the determination of a property right in human biological material, apart from the events of bankruptcy or execution sale.
(ix) The prohibition of harmful
use. An owner’s liberty to use the thing he owns as he
chooses is subject to the limitation that such use does not harm
others. No matter how freely you may use your car, you are not
allowed, for one thing, to ‘drink and drive’. Although
most limitations are familiar and obvious, what use qualifies as
‘harm’ is open to debate. In the case of human biological
material, it is hard to conceive of any use by its ‘owner’
that would be harmful to anybody else, except for cases involving the
intentional transmission of diseases, such as having unsafe sex when
diagnosed HIV-positive. Rather, in certain circumstances it is a
refusal to use one’s material that may be harmful to
others. A PXE patient who refuses to hand over his tissue to PXE
Inc., may not act in the interests of the community of PXE patients
and, in a way, cause them harm. As Becker has noted, ‘[H]armful
use may shade into a requirement for productive use.’106
It would probably go too far, however, to qualify such a refusal to use as an
infliction of harm. Most likely, the principle of autonomy would prevail in that
no one could be forced to participate in scientific research. To the extent,
however, that harmful use could be made of human biological material, there
seems to be no reason why no prohibitions could be imposed on the use of those
materials. Thus, there is no reason why this incident could not apply to human
biological material.
(x)
The liability to execution. Liability to execution means that an
owner’s interest can be taken away from him to satisfy any
overdue debts owed third parties, whether by execution of a judgement
debt or on insolvency.107
According to Honoré, executability constitutes one of the
standard ingredients of the liberal idea of ownership.108
It is a question, though, whether human biological material could be
subject to executability. Conceptually, in essence, this liability is
only an extension of the right to the capital and the income. If an
individual has the right to the capital and the income in respect of
his biological material, then his material is inherently liable to
execution. Technically, it would also be feasible to take a tissue
sample from an insolvent and put it on the auction block or
‘liquidate’ it by way of trade sale, under any legally
required supervision. However, the ubiquity and the potential for
lifetime supply of human biological material trigger some serious and
thorny practical and conceptual questions. Absent unique features
such as Moore’s lymphocytes, the taking of one blood sample is
unlikely to satisfy any material debts. Could then a debtor be forced
to have his blood taken and sold until all debts have been paid or
until he dies? To what extent and in which way, should this execution
take into account the state of health of the debtor involved? These
questions seem to rule out the application of executability to human
biological material. Yet this application would not be totally
absurd, as illustrated by a US tax case. The case concerned a donor
who earned her living by repeatedly selling her rare blood.109
The tax court determined that the payments received by the donor for
the sale of her blood were taxable as income, subject to ordinary
business expenses incurred by her creating this product. In this way,
payments received or receivable in exchange for donations of blood
for other purposes, such as research, would be subject to the
incident of executability.
(xi)
The residual right. The residual right is the right on the
reversion of lapsed rights held by others. This characteristic of
ownership means that the owner is the ultimate residuary. When the
rights of holders of lesser interests lapse, the ‘owner’
acquires these rights. This seems an appropriate right in the context
of human biological material. It enables individuals to retain
residual rights in their material after any ‘lesser’
rights, such as a right to use it for research purposes, have lapsed.
However, the impact of this characteristic should not be overstated.
It only applies in the situation that the owner has allowed lesser
rights in his materials. It does not provide for any residual rights
in human biological materials after alienation, transmission,
expropriation or execution.
4.2 Have Your Stick?
For various reasons, however, this
eclectic approach is not satisfactory. First, as a result of imposing
all desirable limitations, the bundle of
property rights would be stripped of a number of core rights. Just
how many of the standard incidents may be removed from the bundle
before we stop calling it property, is a contentious issue. According
to Honoré, while all incidents are necessary for full
ownership; none of them is a necessary constituent of ownership per
se.112
People may own objects in various restricted senses, for example when
one has the right to management and income of one’s house, but
only a restricted right to use and capital, due to leasing and
mortgage agreements. Also, each of the sticks is subject to differing
scopes, restrictions and definitions. It has been argued that a
number of subsets of the eleven incidents may constitute a
variety of what may reasonably be called ownership: the right to
capital alone, as it is the most fundamental of the standard
incidents; any subset including the right to capital, the right to
security, possession, use, income or management plus any other
element or set of elements.113
Thus, ‘property law is capable of modifying the bundle of
rights, including the fundamental right of alienation, so as to
accommodate moral and policy concerns.114
And as Radin has pointed out, some things may be given away but not
sold (e.g. organs). She has labelled this category of things
‘market-inalienable’.115
In fact, that is precisely what the courts did in Moore and
Greenberg.
Categorising human biological
material as ‘market-inalienable’ property would simply
eradicate the problem that, otherwise, alienation would result in
loss of control. If you would have all standard property rights in
your biological material without, however, the right to alienate it,
you could indeed exercise ongoing control. But solving one problem,
market-inalienability creates another. By precluding the sale of
human biological material, it would inhibit the achievement of the
other goal property proponents aim to achieve, i.e. to invoke
property rights as the underpinning of the claims for profit-sharing.
Somehow, the twin goals of ‘ongoing control’ on the one
hand and ‘profit-share’ on the other hand, are
contradictory, if not mutually exclusive.
A
second objection to the eclectic approach would be that the extension
of only a limited subset of property rights to human biological
material will obscure rather than clarify the legal status thereof.116
Absent clear statutory provisions, there will be uncertainty as to
which incidents of property are removed from the bundle. Any clear
legislation in this respect will require consensus as to what exactly
is considered an inappropriate incident; the notion that there are
‘ethical concerns’ about granting full ownership does not
help very much as it does not specify those concerns.
4.3 Property rights in human
biological material if and when cultured?
The
above triggers the question of whether, and under what conditions,
the standard property incidents, jointly or separately, extend
automatically to human biological material, if and when processed or
cultured by others. While mere processing of biological material
might not be sufficient to confer (limited) property rights, their
artificial culture most likely is. This applies a fortiori to
cell cultures and cells from which an immortal cell line has been
derived. Such cell line, can hardly be considered to ‘be’
the original cell; the longer the sample is in culture, the less it
is like the original specimen.120
It is equally hard to consider the cell culture or a cell line as
‘the fruits’ of the original material, to which fruits
the owner of that material would be entitled under the theory of
accession.121
Rather, a subset of accession theory- specification- would apply,
vesting full title in the person who added the most value to the
final product.122
In brief, property rights do not automatically extend to any
derivative products produced by others. If such extension were to be
accepted, then John Moore would have title to the cell line produced
from his excised cells. Such entitlement, however, seems only
justified if Dr Golde and the Regents would be paid for the value
they added to the original cells by producing the cell line.
As we have seen, the present state of
the law tends towards the opposite position; if an organisation or
person uses human biological material with lawful authority, he will
obtain a possessory right if he applies some work or skill to the
preservation of the sample. It is not clear how much work is
required. Applying the ‘alcohol’ threshold set forth in
Doodeward v Spence, the storage proceedings for blood and
urine proposed by, for example, the UK Biobank, seem to pass both the
‘skill or labour test’, as would the techniques enabling
the immortalisation of peripheral blood
lymphocytes. In line with this case law, under the UK Human Tissue
Act 2004 human biological material is not regarded ‘as from a
human body if it is created outside the human body’. According
to the Explanatory Notes to the Act, this includes cell lines.123
5. Should human biological material
be owned? Policy arguments in support of a property model
First, the doctrines currently
protecting a person’s interest in his tissue are considered
inadequate. Privacy rights are said to only confer ‘negative’
rights and not to amount to ’a right of positive entitlement’.124
Recognising a property right in human material is considered to
facilitate the exercise of continuing, indeed positive control by an
individual over what happens to his tissue after donation. The
concepts of informed consent and breach of fiduciary duty, relied
upon by the court in Moore, are also held to be inadequate.
The rights and remedies provided under these doctrines do not avail
against those outside the scope of the patient-physician
relationship. As we have seen, an essential characteristic of a
property right is that it can be asserted, not only against the
original recipient of the material, but also against any subsequent
users who have never been in a (contractual, informed consent)
relationship with the donor. In addition, it is argued that the
amount of damages available under these theories will not motivate
physicians to disclose any financial interests.125
Absent a property right in biological material, courts and juries are
expected to award relatively low compensatory and punitive damages.
Also, under these theories, ‘research participants will be left
without a remedy, because the harm they suffered affected not their
medical interests but rather their dignity and autonomy’.126
The second factor relates to
considerations of equity and justice. It is considered ‘unprincipled’
that intellectual property rights on ‘genetic inventions’
allow commercial companies to make six-digit profits, while the
individual, as the supplier of the raw material, is denied a piece of
the cake.127
Because the contribution of human biological material is just as
indispensable in the research process as the use of other supplies,
such as reagents and equipment, it is claimed to be unjust to deny
research participants compensation, where the suppliers of other
materials are being paid for their deliveries. One commentator
suggests that such compensation should not only be due upon
commercialisation of any derived biological product, but from the
moment the researchers begin to use that material.128
The ‘but for’ argument supporting equitable claims for
compensation was also put forward by Mosk J in his dissenting opinion
in Moore:
[N]o one can question Moore’s
crucial contribution to the invention-an invention named, ironically,
after him: but for [emphasis added] the cells of Moore’s
body taken by defendants, there would have been no Mo cell line…[F]or
all their expertise, defendants do not claim they could have
extracted the Mo cell line out of thin air.129
Recognising
property rights in human biological material would allow individuals
to share in the profits that may be generated by the use of their
samples.
The
third factor is that the recognition of a property right would
reinforce the trust that the participants must have in biomedical
research and without which such research is doomed to fail. The facts
in Moore painfully illustrate how this trust could be lost
when a patient finds out that his repeat visits to the hospital did
not serve his well being but the disguised commercial interests of
his physician. A property right in their materials would provide
donors with clear and enforceable legal remedies to redress any
abuse, misuse or underuse of their samples.
A
fourth argument has been formulated by one commentator as follows:
[R]esearch participants also merit property rights in their genetic material because… participants face risks associated with biomedical research... [R]esearch participants must contend for the potential harm resulting from the medical procedures they undergo in the experimentation process, the loss of privacy, the dangers of negative consequences from the release of their medical information, and the risk of learning emotionally disturbing information about their health.130
The
fifth argument advanced by several property proponents is that a
property right in human biological material will not chill but rather
stimulate research. It has been submitted that those previously
reluctant to come forward with their material, would have an
incentive to do so if they would be financially rewarded for their
contribution.131
Thus, property rights would enable the allocation of human biological
material to the highest bidder.132
The sixth factor is clarification. Proponents of property rights in human biological materials claim that these rights will clarify the legal status of those materials, which they claim is presently unclear. Property rights define the relationship between donors and recipients and provide for clear remedies in the event they have been violated, such as an action for return or destruction of samples, injunctive relief or damages.133
5.1 Should human biological material
be owned? Policy arguments against a property model
A
number of countervailing arguments can be made against the case for
property rights in human biological material. First, historically,
property rights in the human body and its parts have been considered
inappropriate, as articulated in the principle of ‘non
commerciality’ of the human body and its parts, and set forth
in various international instruments.134
The idea, for example, that an individual could offer his tissue for
sale on eBay, is regarded by some as an infringement on human
dignity. Similarly, the application of related incidents of property
rights as seizure and foreclosure are considered by some an affront
to human dignity.
Second, recognising a property right in human biological material would undermine the traditional notion of altruistic participation in research for the benefit of society at large. Neither the traditional, ‘pre-biotech’ pharmaceutical industry nor the medical devices industry could have sold a single product without the involvement of hundreds of thousands of healthy volunteers and patients in the trials that are legally required to obtain and maintain market authorisations for these products. Yet, to date, research participants typically neither demand a share of any profits nor claim control rights over the sale of products. It is easy to imagine scenarios that would occur were this tradition abandoned. John Moore, by way of a speculative example, could have been charged for the use of any diagnostics by Hairy Cell Leukemia (HCL) Inc., and/or other groups of former research participants involved in the testing of the device, or the use of the diagnostic might have been denied, pending the outcome of the negotiations of such groups over control rights and benefit sharing.
Such
scenarios are not purely hypothetical and there is no reason why such
groups would act any differently than commercial entities in their
licensing policies. As Gitter points out, patient groups might
exercise control over ‘their’ research results in such a
way as to maximise the group’s benefit, while limiting access
to these results to people suffering from other disorders.135
For example, there is, according to Gitter, ‘evidence that the
gene associated with PXE might also relate to hypertension and
cardiovascular disease’.136
PXE reportedly realises that it could “make a killing (sic)
because who cares if we’re making the costs of cardiovascular
treatment huge”.137
PXE Inc. has, however, asserted that the group would resists
bettering their own fortunes at the expense of patients suffering
from other diseases, claiming that it did ‘not just represent
people with PXE, we represent anybody who has anything’.138
Such a statement, however, does not amount to a binding and
enforceable access policy. In fact, PXE Inc. does acknowledge that,
in practice, ‘the group would insist upon licensing deals that
would maximise the access of PXE patients to a future diagnostic or
test or treatment’.139
The irony of this position, of course, is the fact that PXE patients
are, most likely, not immune from other diseases, for which yet other
groups could claim property rights. In brief, if the property rights
model were to be adopted, we might all end up having to swap licenses
and set off royalty payments before consulting our physician.
Third,
the long standing tradition of altruistic donation evokes the
fundamental question of whether the donation of a tissue sample is so
inherently different from other, traditional forms of participating
in ‘non genetic’ research, as to justify special
compensation and control rights? A closer analysis of the argument
set forth above may illustrate this point:
[R]esearch participants also merit property rights in their genetic material because… participants face risks associated with biomedical research... [R]esearch participants must contend for the potential harm resulting from the medical procedures they undergo in the experimentation process, the loss of privacy, the dangers of negative consequences from the release of their medical information, and the risk of learning emotionally disturbing information about their health140.
There can be no denying that each of these risks applies equally, if not, a fortiori, to those participants in ‘non-genetic’, traditional clinical research. The trouble ‘traditional’ trial subjects have to go through may well exceed the trouble of donating 40 mls of blood and a jar of urine to a Biobank. As a practical matter, the distinction between the contribution of human biological material and other forms of participation in research will be hard to implement, since biomedical research typically involves not just analysis of human biological material, but a whole range of other investigations as well.
Fourth, the ‘but for’
argument per se does not and cannot provide an inherent
justification of a property claim. Using this argument, anyone
involved in the research and development process of a drug could
stake a claim to the end results; the supplier of the chemical
reagents, the secretary posting the patent application, all trial
subjects involved in the various phases of clinical safety tests and
post-marketing surveillance and the regulator issuing the market
authorisation. And here too, the ‘but for’ argument could
easily spill over into other areas of research participation and
healthcare. Using the argument, every patient could claim a portion
of their physician’s income since ‘but for’ their
visit and ‘but for’ their condition, the physician could
not have earned his income. Again, this is not a hypothetical
scenario. The plaintiffs in Greenberg alleged that Dr. Matalon
had personally profited from his research on their biological
material by receiving a substantial federal grant to undertake
further research on the gene patent.141
Fifth,
recognising property rights to enable patients to claim part of the
benefits resulting from any derived products could undermine the
solidarity which underpins systems of health care in countries having
national health-insurance systems. Under these systems, the costs of
medical care, including prescription drugs, are largely reimbursable.
So, eventually, any profits in the biomedical sector are paid for out
of the collective premiums. Any profits payable to a subset of
patients with a specific disorder goes at the expense of those who
are paying the premiums. In the final analysis, the most equitable
and just solution may be for the government to simply levy taxes on
the corporate income generated by industry and redistribute the
proceeds, subject to democratic control.
Sixth,
a number of commentators are willing to ignore the fundamental
difference between property rights and patents, when they use the
patentability of biological inventions as an argument to support
property rights in human biological material. Their reasoning is
motivated by the alleged ‘unprincipledness’, which
allegedly allows biotechnology companies to make a profit while
denying a property interest to the supplier of the base material.
Intuitively, one can only sympathise with such an observation. A
patent however, is not property but a reward for an invention in the
form of a limited and temporary monopoly to exploit the invention.142
In the long run, to ignore the fundamental differences between the
concepts of personal property and patents and their built-in checks
and balances, may prove counterproductive.
Seventh, the concern that the doctrines of informed consent and autonomy are inadequate may be better addressed at a more appropriate level. Most of the interests that a property right is claimed to more adequately protect are actually better served by the laws specifically designed to serve those interests; data protection laws and clinical trial legislation, for example, contain adequate and enforceable remedies to protect individuals against abuse of the personal information derivable from their material. The Australian Law Reform Commission, for example, concluded that the preferred starting point for any comprehensive reform of the law relating to the collection, storage, use of, and access to, genetic samples was to build on existing information and health privacy legislation. The Australian Inquiry recommended that this could be done by ensuring that privacy laws cover the handling of genetic samples, as well as the genetic information derived from them.143 Most recently, the UK Human Tissue Act 2004 has made consent and not personal property rights the fundamental principle underpinning of the lawful storage and use of, inter alia, human body parts and tissue.
In
brief, both legal and policy concerns caution against the recognition
of property rights in human biological material as such. The
next question then is whether an individual should be able to claim a
property right in his material in the specific context of a Biobank
and, particularly in respect of de novo biobanks, and whether
a waiver of any property right in human material is valid, binding
and enforceable.
6. Property rights in human
biological material in Biobanks
As we
have seen, a Biobank is based on the collection, storage and use of
hundreds of thousands of samples. These samples will be used in
hundreds of future research projects. Some of these projects may, in
turn, lead to the formulation of yet other research projects. Let us
just imagine what would happen if the participating individuals could
exercise property rights in their samples. Imagine research project X
proposed to be conducted using all the samples of Biobank Y. Seeking
‘ongoing control’, donors will exercise their right to
the management of their samples, which may lead to the following: x
thousand donors say yes; x thousand others say no; x thousand others
say only if we get feedback; x thousand donors say only if we don’t
get feedback; and/or x thousand donors claim back their material.
Similarly, seeking to share in the benefits, donors will exercise their right to the capital value of their samples, which could easily lead to the following. X thousand donors accept a 5 % profit share; x thousand donors do not settle for less than 10%; x hundred donors claim to have lucky genes or to exhibit special conditions so they claim joint ownership of any related patents; x thousand donors insist on free genetic counselling; and/or x thousand others prefer free personalised medicine. A practical illustration can be found in the debate over the proper benefits due to the population in exchange for the creation of the Icelandic Biobank.144 Another example is the failure of the stakeholders in a US Biobank (the Framingheart Study) to reach agreement on the terms and conditions for the digitisation and exploitation of the collected data by a private company, which was willing to fund an ethics advisory board and a science education program in Framingham schools, as well as a separate fund to benefit the city.145
The
above complications only relate to two of the eleven standard
incidents of property. And they relate to only one research project.
Now imagine the implications of the exercise, in one way or the
other, of the other nine incidents for multiple projects. UK Biobank,
for example, expects some hundreds of projects to be conducted on the
UK Biobank per year. Even if, as has been proposed,146
the projects would be announced on a website maintained by the
operator of the Biobank in question, any meaningful exercise of
property rights by a participant faced with, let’s say, 250
announcements per year (5 per week), seems unlikely.
At best, it would provide an illusory perception of ‘ongoing
control’. On top of this, Biobanks could conceivably be faced
with the prospect of a bailiff foreclosing either material or
contractual rights to future royalties, which donors may have pledged
to secure their debts.
Recognising
property rights, even only a limited subset of the standard
incidents, for the owners of biological material in the context of a Biobank is likely to create a proliferation of property
rights.147
A Biobank would face the prospect of hundreds or more ‘Moore’
cases for each of the hundreds of projects each year. Assuming that
this prospect does not prevent the Biobank from being funded and
created in the first place, this proliferation of property rights
would inevitably require costly transactions to acquire
those rights, preceded by countless negotiations about the terms of
the collection, storage and use of the samples. The transactions
would have to address a wide array of issues: the purpose of the
transfer or donation, the right to use the biological material, a
specification of use, the consideration due, the term of the
agreement, breach, compensation, expiration, events of default, the
right to modify the sample, use and access thereto by third parties,
the production of derivative products such as cell lines,
intellectual property rights and so on. And even if a sufficient
number of sample suppliers would agree to the use of their samples
for project X, such an agreement is unlikely to be considered a ‘done
deal’. As we have seen, property proponents have argued that
either waivers or assignments of property rights in human biological
material would either be void, due to asymmetries of power between
the donor and the recipient or due to undue influence exerted by the
institution on the donor, and has to be prohibited by statute.148
6.1 Property rights in Biobanks: reversing the trend towards simplified consent
A
second drawback resulting from recognising property rights in human
biological material in a Biobank is that it would effectively
undercut the current trend towards accepting general consent for
(population-based) research on existing large-scale collections.
Under this model, existing specific
informed consent requirements for previously unanticipated research
uses would be replaced by a more general consent, which would obviate
the need for re-consent for each new research project. This
would enable researchers to ‘unlock’ these repositories
that would otherwise be prone to underuse.149
This trend is fortified by the proposed
ethical Guidelines for Access to Banked DNA, issued by the World
Health Organisation.150
These guidelines provide that existing stored specimens, such as
those in hospital departments or collections of blood spots on
newborn screening cards, should not be subject to new rules for
consent or re-contact. The guidelines also state that a blanket
informed consent, which would allow use of a sample in future
projects, is the most efficient approach. This trend has been
reinforced by the recent opinion of the German National Ethics
Council in its Opinion on ‘Biobanks for Research’.151
The opinion has been heralded as an ‘enlightened, pragmatic and
practical approach, still respecting basic ethical principles’.152
However, the gains from this trend- unlocking existing collections
for biobank research- may be short-lived if the call for personal
property rights in the samples concerned is heeded. While researchers
would no longer be required to obtain specific re-consent for each
new research project under this simplified consent model, they would
be required to obtain such consent under the proposed property model.
6.2 The Tragedy of the Anticommons
To
gain further insights into the adverse effects of property rights in
human biological material in the context of a Biobank, it may be
helpful to turn to Heller’s theory of anticommons property.
The theory is a useful tool in understanding the widespread intuition
that when too many holders have an exclusive right in a resource, the
use of the resource is likely to be suboptimal. As Heller notes,
anticommons property can best be understood as the mirror
image of commons property. Commons property has been defined
as the situation in which multiple owners are each endowed with the
privilege to use a given resource and no one has the right to exclude
another. This situation may lead to a ‘Tragedy of the Commons’
in that the resource will be overused to the point of exhaustion. The
metaphor of the Tragedy of the Commons was introduced by Garrett
Hardin who gave the following example.153
Multiple herdsmen enjoy the privilege to graze their sheep on a
pasture open to all of them. Each herdsman will try to maximise his
number of sheep, with each extra sheep earning him +1. While each
extra sheep will lead to overgrazing the pasture, the effects of
overgrazing are shared among the herdsmen. As a result, the actual
loss to an individual herdsman of adding one more sheep on the
pasture is not -1 but a fraction of -1. Since, as we saw, each
herdsman will seek to maximise his number of sheep, while not
suffering the full adverse consequences thereof, the pasture will
inevitably be overgrazed. In other words, people often overuse
commonly-held resources, because they have no incentive to conserve
them if no one has the right to exclude others from using such
resources. Other examples given by Hardin include depleted fisheries
and pollution. The metaphor of the Tragedy of the Commons has been a
powerful argument for the privatisation of commons property, in the
form of creating private property rights which create incentives for
conservation of the resource.
However, while under-assignment
of property rights for a commonly-held resource will lead to
over-utilisation of the resource, over-assignment of
property rights in a resource may result in under-use of such
resource. Unbridled privatisation in the form of granting rights to
multiple owners may lead to a proliferation of fractional property
rights. Such a proliferation would leave no one with an effective
privilege to use the resource. One of the examples discussed by
Heller is the ‘Post-Earthquake Reconstruction of Kobe Japan’.
Although $30 billion had flowed into the city to rebuild it after the
earthquake, much of the city lay in rubble for a long time, because
“a single angry tenant can block urban renewal. And does”.154
Under Japanese post-war property laws, land in Kobe had been divided
to the point where there are thousands of parcels the size of a US
garage and a building ‘can be based on a plot that is actually
dozens of smaller parcels thrown together by developers.’155
In one block of Kobe, over 300 renters, lessees, landowners, and
subletters owned often overlapping claims, and each one had to agree
before rebuilding could go forward. According to a city official, it
was ‘like trying to get thousands of little corporate
presidents to agree on one plan’.156
An obvious solution would have been for the government to intervene
and buy the land under laws of eminent domain. However,
as Heller points out, Japanese authorities frequently decline to
seize property because this would violate the nation’s
historical and cultural preference for harmony and consensus.157
This mirror image of the Tragedy of
the Commons has been named, naturally, the Tragedy of the
Anticommons. Anticommons property has been defined as ‘a
property regime in which multiple owners hold effective rights of
exclusion in a scarce resource’.158
The anticommons can also be expressed in terms of the
bundle-of-rights metaphor. According to Heller, ‘an object is
held as anticommons property if one owner holds one of Honoré’s
core rights in an object and a second owner holds the same or another
core right in the object, and so on, with no hierarchy among these
owners’ rights or clear rules for conflict resolution’.159
The ‘tragedy’ is that ‘rational
individuals acting separately may collectively waste the resource by
underconsuming it compared with a social optimum.’160
Anticommons property can appear whenever governments create new
property rights, in particular when they create too many rights and
too many decision-makers who can block use.161
As Heller demonstrated, a powerful application of anticommons
appeared in transition economies, where store-fronts remained empty
in spite of privatisation, due to the proliferation of property
rights. Another example is land use, when parcels may become
uneconomically small after successive partitions.162
The Anticommons property model has also been used to gain insights
into the effects of privatisation of upstream biomedical research in
the US. Privatisation of fundamental biomedical research, in
combination with over-assignment of patent rights on gene fragments,
threatens to enable everyone involved in the product development
process to set up a ‘tollbooth’ on the road towards the
production of life-saving innovations.163
As a result, such production is slowed down or may become
prohibitively expensive. The metaphor has also been used to
articulate the adverse implications of unrestricted recognition of
database rights in genomic databases.164
6.3 Property rights in material
stored in Biobanks: creating another Anticommons?
6.4 Will a Biobank Anticommons be
Tragic?
It is important to note that an
anticommons is ‘not necessarily tragic’.167
Anticommons property is only tragic if it endures once it has
emerged. For a variety of reasons, most Anticommons are transient
since most Anticommons property will normally be rebundled into
useful private property. This rebundling can be brought about by
market mechanisms, informal institutions or government intervention.
As regards market mechanisms, people usually start trading their
initial endowments and rearrange them until resources are put to
their highest-valued uses.168
For example, as Heller and Eisenberg have put it, ‘copyright
collectives have evolved to facilitate licensing transactions
so that broadcasters and other producers may readily obtain
permission to use numerous copyrighted works held by different
owners. Similarly, in the automobile, aircraft manufacturing,
and synthetic rubber industries, patent pools have emerged,
sometimes with the help of government, when licences under
multiple patent rights have been necessary to develop
important new products.’169
Informal institutions may evolve
because Anticommons property theory is partly based on the assumption
of rational-self interested persons. This assumption may not reflect
the motives of people in the real world.170
In practice, ‘close-knit communities’ may develop
informal norms and institutions to manage resources and avoid
tragedies, for example, co-operation among multiple tenants of an
apartment block. 171
Finally, Anticommons property could be rebundled into useful private
property by government intervention, e.g. when the governments
redefines, abolishes or confiscates previously granted property
rights.
However, these solutions may not work
in the context of human biological material, for a number of reasons.
The market mechanism may fail because sample donors are unlikely to
start trading their property rights in their samples, as long as they
do not want to give up ‘ongoing control and perceive their
rights as inalienable. Also, the number of parties to deal with, - up
to half a million or more, as well as the number of deals, - up to a
few hundred per year, would drive up transaction costs beyond the
financial capacity of public or even private research. Adding to the
transaction costs would be the costs of administering the agreements
over time. In addition, the actual compensation payable to the
participants is likely to add significant costs, even if it were
assumed that your DNA sample is worth only a fraction of USD 50,000.
Moreover, bargaining may fail due to ‘holdouts’. Just
like the angry tenant in Kobe could, by himself, block the
reconstruction of the entire block, an angry individual or group of
individuals could potentially paralyse sensible use of the Biobank.
Furthermore, the emergence of standard license terms would be hard to achieve, due to the heterogeneity of participants. While members of a copyright collective will primarily seek to maximise royalties, participants in a biological material collective will have a wider array of interests. And these interests will diverge widely among participants, since they all have divergent economic and healthcare needs, divergent moral opinions and religious convictions, and divergent ethical and cultural backgrounds. This heterogeneity will require costly case-by-case negotiations on the terms and conditions of use of their collected material. Worse, these negotiations could lead to different terms for different groups for the storage of their biological material in one and the same Biobank. This would undermine the very purpose of a Biobank, i.e. to create a large enough resource to do statistically meaningful research. The emergence of standard licensing terms will also be impeded by participants’ cognitive bias; individuals may be prone to overvalue their biological material. This is not merely a hypothetical problem. We have already seen claims, right or wrong, that any individual’s DNA sample is worth USD 50, 000. And, with hindsight, even the action brought by John Moore for a share in the proceeds of his rare cells, may have been motivated by an overvaluation of his rare cells. Notably, many a commentator of Moore has misrepresented some of the highly emotive facts in this case. Although it is true that some drug companies were initially interested in the cells because of their association with cytokines, they eventually pursued other avenues. And while Dr Golde is reported to have sold a patent over the cell-line for USD 15 million, the patent in fact was issued to the University of California which, according to Professor Henry Greely of Stanford Law School, decided not to maintain it. The cell line is still offered for sale, for USD 425, by the American Type Culture Collection (ATCC), a global not for profit bioresource institution. While it is true that Dr. Golde had some financial interests in the cell lines, according to Greely ‘no one ever made a dime off the patent’.172
The mechanism of government intervention may fail as
well. As we have seen, one implication of recognising personal
property rights in human biological material would be that it becomes
subject to expropriation. Yet, the taking by the government of
property rights in human biological material is unlikely. It would
require the establishment of ‘adequate compensation’.
Even assuming this could be done, the government is unlikely to be
prepared to compensate hundreds of thousands of sample donors, if
only for lack of resources. As a matter of principle, governments may
be declined to expropriate human biological material, in view of
considerations of personal autonomy, just as the Japanese government
frequently declines to expropriate for the sake of harmony and
consensus.
Informal
institutions, finally, may work, precisely because the individuals
concerned might not act as ‘rational-self interested’
persons. Irrational behavior may particularly
occur in the area of research participation, where it has long been
the norm to participate and donate material for free. In this
perspective, participants in a Biobank do not exercise their property
rights for altruistic reasons. Paradoxically, then, it would be the
tradition of altruistic participation that would prevent a Biobank
Anticommons, - which is caused by the replacement of that tradition
by a property rights model, from turning into a tragedy. However, the
formation of such a coalition of willing participants would require
their waiving or their assigning their property interest in their
biological material. As we have seen such waiver or assignment would
run counter to the proposed ‘inalienability’ of these
interests. In a sense, the sample collection formed by PXE
Inc. may form an example of such an informal institution.
Theoretically, the group faced its own Anticommons, in that
individual PXE patients could have claimed property rights in their
material. Apparently, they have resolved the issue. Yet, while
informal institutions may arise in the context of dedicated special
interest groups, they are unlikely to evolve in the context of
large-scale Biobanks. By definition, these banks comprise material
from a very large and a very diverse ‘constituency’, from
which material is assembled not for hypothesis driven research into a
specific, genetic disorder, but for the broad purpose of
population-based research into the causes of multiple common
diseases.
6.5 How to avoid a tragic Biobank Anticommons?
When market mechanisms, governmental intervention and informal institutions fail, it is unclear what other mechanisms are available to convert Anticommons property into a useful resource. As Heller notes, this question is underdeveloped in the literature on the economics of property rights.173 One obvious solution advanced by Heller is for governments ‘to convey a core bundle of property rights to a single owner, rather than rights of exclusion to multiple owners’.174 This single owner would be the entity operating the Biobank. Obviously, no one could be forced to donate his or her biological material to a Biobank, ever. Individuals contemplating to participate in a de novo Biobank could even be given the opportunity to have themselves tested and, in the event they have rare and potentially commercially valuable material, they could decide not to participate and try to sell or transfer their materials to somebody else, an option John Moore and the Greenbergs was denied. However, once a donation is made, upon informed consent, it should be unconditional, for free and for as long as the Biobank exists; any residual individual property interests in the material in the Biobank should be denied. A Biobank would thus earn clean title, unaffected by any individual residual property interests, to store and use the collection of material, in accordance with its terms and mission, and in the interests of all involved, including, but not limited to, the individuals donating material. Obviously, the unconditional donation of a sample would not prevent an individual or a group of patients, from donating, selling or transferring his material, on whatever basis, to anyone else, for any conceivable purpose.
This option is less radical than it
may appear. As we have seen, existing case law hints in the same
direction. A similar approach has been proposed by Skene, be it that
his proposal to reject a general principle that people have a
property interest in their body parts and tissues seems to permit
conditions to be imposed on the initial consent.175
Notably, the rejection of any individual property rights would not
affect the exercise by research participants of any ‘non-property’
protections offered by law against the abuse of samples or the
information contained therein, such as privacy rights. Given the
particularly sensitive nature of this collection of nature and
nurture data, these laws could even be enhanced. The Estonian
legislation establishing the Estonian Gene Bank, for example,
contains an express prohibition against genetic discrimination. In
addition, donors could be given specific rights in respect of their
material, such as the right to know or not to know the results of any
analysis.176
The prime general interest to be served by the Biobank would be the
promotion of research. To that end, Biobanks should be subject to
principles of good governance, including, but not limited to, the
following: they should be accessible for research purposes only; all
research must pass ethical and scientific review; and any benefits
must flow back to the resource. In essence, this approach aims to
solve the adverse implications of individual ongoing control and
‘individual claims for a benefit share by providing for
‘collective’ ongoing control and ‘collective’
benefit-sharing.
6.6 Anticommons and Common heritage
Denying property rights, even in a
watered down version, in human biological material in the context of
a Biobank would thwart the emerging pleas in favour of an inalienable
property model for human biological material to enable ongoing
control and a profit-share. However, the arguments against a property
model are not limited to the metaphor of the Tragedy of the
Anticommons. Additional support can be found in the notion, set forth
in a number of international declarations, that the human genome is,
in a symbolic sense, the heritage of mankind178
and that Biobanks are a global public good.179
These proclamations are commonly understood to serve as an argument
against misappropriation of the human genome, genetic samples and
associated genetic data by industry.
I would argue, however, that the notion of the human
genome and Biobanks as a ‘common heritage’, a global
public good, should also serve as a barrier to the recognition of
personal property rights for the individual suppliers of the ‘raw
material’, at least in the context of the large-scale
collection, storage and use of human biological material. The idea of
a common or global public good is a two-edged sword in that it both
wards off overly broad patent claims on ‘genetic inventions’,
and a proliferation of proprietary claims by individuals to their
biological material, each of which would hinder reaping the full
fruits of this resource.
Conclusion
Nevertheless, recognising property rights in human biological material may be appropriate in certain contexts, for example to enable specific patient groups to negotiate the terms and conditions of research into their specific disorder. In the final analysis, courts are likely to adopt a contextual approach and the way they will resolve the issue in a particular case will be influenced by the manner in which it is framed. To inquire whether PXE patients should be able to dictate the terms of use of the tissue repository they set up, is likely to evoke a positive response, as is the inquiry of whether the Greenbergs are entitled to compensation for their ‘blood, sweat and tears’.
To inquire, however, whether each individual research participant should be able to block or profit from each use of the biological material he has provided to a Biobank, should invite at least a mixed and qualified response. The potential of a tragic anticommons in both existing sample collections and de novo Biobanks cautions against the granting of unqualified and inalienable property rights in human biological material in that context. For both existing, large-scale repositories of human material and de novo Biobanks, the Tragedy would be that they cannot be converted into respectively cannot be used as a Biobank and that they will be prone to underuse. A second drawback of adopting an unqualified property approach would be that it would effectively undercut the current trend towards simplifying existing informed consent requirements for (populations-based) research on existing large-scale collections. To avoid uncertainty over the issue of who owns collected human biological material, the principle that the property rights in such material vest in the entity that has lawfully collected and stored the material, should be implemented in legislation. This approach would also coincide with the widespread notion that these collections are a global public good. As the steward of the collection, the entity operating the Biobank is to act in accordance with provisions of good governance, in the interest of its beneficiaries, including not only the community of sample donors but also the public at large and future generations. This way most individuals and their offspring will benefit more than when they heed the call to stand up for their property rights in their samples.
* J.D. University of Leiden, LL.M, University of Michigan. Bovenberg is a member of the Amsterdam and New York Bar and currently on sabbatical as a Ph.D. fellow at the University of Leiden, Faculty of Law, E.M. Meijers Institute. His research is sponsored by a grant form the NetherlandsGenomicsInitiative and forms part of the Society and Genomics Program of the Netherlands Centre for Medical Systems Biology. The author is most grateful to William W. Lowrance, Ph.D., consultant in Health Policy and Ethics and chair of the Interim Advisory Group on Ethics and Governance of the UK Biobank and professor David Weisbrot, President of the Australian Law Reform Commission, for their most valuable comments on an earlier draft of this article.
1 Moore v. Regents of the University of California, 793 P.2d 479 (Cal.1990), cert denied 499 U.S. 936 (1991).
2 According to a 1998 estimate of the U.S. National Bioethics Advisory Commission “at least 282 millions specimens (from more than 176 million individuals cases) are stored in the United States, and the collections are growing at a rate of over 20 million cases per year”. National Bioethics Advisory Commission (NBAC), Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Rockville, Maryland, August 1999.
3 Aka “large-scale human genetic research databases”, “gene banks” or “population databases”.
4 E.g. Icelandic Biobank, the Estonian Gene Bank, the UK Biobank, the International HapMap project including populations from Nigeria, China, Japan and the USA. For an overview see: M A Austin, S Harding and C McElroy, “Genebanks: A Comparison of Eight Proposed International Genetic Databases”, (2003) 6 Community Genetics 37-45. For the US initiative see the NIH Request for Information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-046.html
5 See http://www.p3gconsortium.org/
6 F S Collins, E D Green, A E Gutmacher and M S Guyer, (2003) “A vision for the future of genomics research”, 422 Nature, 840.
7 U.S. Congress, Office of Technology Assessment, “New Developments in Biotechnology: Ownership of Human Tissues and Cells-Special Report”, OTA-BA-337 (Washington, DC: U.S. Government Printing Office, March 1987) (hereinafter “OTA”), at 4.
8 B M Knoppers, “Biobanks: simplifying consent”, 5 Nature Reviews Genetics, (2004), 485.
9 J C Bear, “What is a person’s DNA worth? Fair compensation for DNA Access”, (2001) paper presented at 10th International Congress of Human Genetics in Vienna.
10 This article will not discuss the question of who owns the information contained in a biobank, i.e. the medical and genetic information that can be derived from the materials and the associated health data. For an analysis of the multiple parties that could claim a database-right in the data contained in genomic databases see: J A Bovenberg, “Should Genomics Companies Set Up Database in Europe?”, 18 Nature Biotechnology, 907, September 2000. Likewise, this article will not discuss privacy rights with respect to the information tha may be contained in biological material. As will be explained, the question whether or not to recognise property rights in human biological material does not affect the existence and exercise of privacy rights.
11 UK Biobank, http://www.ukbiobank.ac.uk/why.htm, “Why is this needed and what are the benefits?” (2004)
12 F S Collins, “The case for a US prospective cohort study of genes and environment”, 429 Nature 475, 476.
13 J A Bovenberg, “Ownership and Commercialisation of Large-scale Human Genetic Databases”, OECD report on Biobanks, forthcoming.
14 For a description, see http://www.decode.com. This biobank is not to be confused with the Icelandic Health Sector Database, which is currently on hold.
15 See http://www.geenivaramu.ee/.
16 See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-046.html
17 The Scientist, May 26, 2004, available at http://www.biomedcentral.com/news/20040526/04/
18 See http://www.p3gconsortium.org/
19 M J Khoury, “The case for a global human genome epidemiology initiative”, 36 Nature Genetics (2004) 1027, see also http://www.cdc.gov/genomics/hugenet/default.htm.
20 C Sallée and B M Knoppers, “Existing Human Genetic Research Databases”, OECD report on HGRD’s, forthcoming.
21 National Bioethics Advisory Commission, “Research Involving Human Biological Materials: Ethical Issues and Policy Guidance”, Rockville, Maryland, August 1999, Volume, Report and Recommendations, at 22.
22 UK Biobank, “Sample Handling and Storage Subgroup Protocol and Recommendations, version 1.0, 7 July 2004, for comment (hereinafter UK Biobank Sample Protocol), at 21.
23 Estonian Gene Donor Consent Form, Annex 1 Regulation No 125, Dec 17, 2001, Minister of Social Affairs, section 3.
24 D E Winickoff and R N Winickoff, “The Charitable Trust as a model for Genomic Biobanks”, N Engl J Med (2003) 349;12, 1181.
25 G Laurie, Genetic Privacy, a Challenge to Medico-Legal Norms, (2002) (hereafter referred to as Laurie, Genetic Privacy, at 318.
26 National Organ Transplant Act, 42 U.S.C.A. paragraph 274e(a) 2000.
27 R Rao, “Property, Privacy, and the Human Body”, 80 B.U.L.Rev. (2000), 359 at 373.
28 D M Gitter “Ownership of human Tissue: A Proposal for federal Recognition of Human Research Participants’ property Rights in Their Biological Material”, (2004) 61 Washington and Lee Law Review, 257 and M A Shields, “Liability for conversion and misappropriation of genetic material” , at 267, fn. 34.
29 M M Lin, “Conferring a Federal Property Right in Genetic Material: Stepping into the Future with the Genetic Privacy Act”, (1996) 22 American Journal of Law and Medicine 109, at 112-118, (“hereafter referred to as: Lin”).
30 ORS 659.715.
31 Senate Bill 114, s. 15, passed by the Senate on May 22, 2001, available at: http://pub.das.state.or.us/LEG_BILLS/PDFs_2001/ESB114.pdf.
32 Human Tissue Act 1961, as amended by Anatomy Act 1984 (c.14), s.13(2)(c) and Statute Law (Repeals) Act 1974 (c.22), Sch. Pt. XI.
33 Nuffield Council of Bioethics, Human Tissue Ethical and Legal Issues, 1995, at 70.
34 Human Tissue Act 2004; the substantive provisions of the Act will come into force on days appointed by the Secretary of State by order. Full implementation is not expected to be before April 2006 (Human Tissue Act 2004, Explanatory Notes, 69).
35 Human Tissue Act 2004, s. 32 subsection (1) and subsection (8).
36 Human Tissue Act 2004, s. 32(9).
37 Australian Law Reform Commission “Essentially yours” (2003), available at http://www.austlii.edu.au/au/other/alrc/publications/reports/96/ (hereinafter: “ALRC”), at 5478.
38 ALRC, at 527.
39 A Campbell-Tiech, A corpse in law, British Journal of Haematology (2002) 117, at 809.
40 ALRC, at 528.
41 Doodeward vs Spence (1908, 6 CLR 406), 415.
42 Doodeward vs Spence (1908, 6 CLR 406). See also P Skegg, Human corpses, Medical Specimens and the Law of Property, (1976) 4 Anglo-American Law Review 412.
43 R v Kelly [1999] QB 621
44 R v Kelly [1999] QB 621, 631.
45 Doodeward vs Spence (1908, 6 CLR 406), Higgins, J, 417.
46 Dobson v North Tyneside HA, [1996] 4 All ER 474. Also see Skene, “Proprietary rights in human bodies, body parts and tissue: regulatory contexts and proposals for new laws”, 22 Legal Studies: the Journal of the Society of Public Teachers of Law, (2002) 103, at 125, fn 120.
47 Doodeward vs Spence (1908, 6 CLR 406), 415.
48 ALRC, 527-529 and Skene, “Proprietary rights in human bodies, body parts and tissue: regulatory contexts and proposals for new laws”, 22 Legal Studies: the Journal of the Society of Public Teachers of Law, (2002) 103, 105-110.
49 Miles, Inc. v Scripps Clinic and Research Foundation, 810 F. Supp1. 1092 and United States v. Arora, 860 F. Supp. 1091. For a survey of the current state of US case law see M M Lin, “Conferring a Federal Property right in Genetic Material: Stepping into the Future with the Genetic Privacy Act”, (1996) 22 American Journal of Law and Medicine 109, at 112-118, D M Gitter “Ownership of human Tissue: A Proposal for federal Recognition of Human Research Participants’ property Rights in Their Biological Material”, (2004) 61 Washington and Lee Law Review, 257 and M A Shields, “Liability for conversion and misappropriation of genetic material”, Annotation of Greenberg v. Miami Children’s Hospital, 121 A.L.R.5th 315. In addition to the reported cases, there are a few reported instances in the US which have been settled out of court. For a description of these case histories, see OTA, at 24.
50 18 Am. Jur. 2nd Conversion § 1.
51 Moore v. Regents of the University of California, 793 P.2d 479 (Cal.1990), 490.
52 Moore v. Regents of the University of California, 793 P.2d 479 (Cal.1990), 491, and n. 30.
53 Moore v. Regents of University of California, 249 Cal. Rptr., 494, 508.
54 Moore v. Regents of the University of California, 793 P.2d 479 (Cal.1990), 491.
55 Moore v. Regents of the University of California, 793 P.2d 479 (Cal.1990), 492.
56 Moore v. Regents of the University of California, 793 P.2d 479 (Cal.1990), 492.
57 Moore v. Regents of the University of California, 793 P.2d 479 (Cal.1990), 493.
58 Moore v. Regents of the University of California, 793 P.2d 479 (Cal.1990), 493-497.
59 Moore v. Regents of the University of California, 793 P.2d 479 (Cal.1990) 493. The court did rule however, that Moore’s third amended complaint stated a cause of action for breach of fiduciary duty or lack of informed consent.
60 Greenberg vs Miami Children’s Hospital Research Institute, Inc., 264 F. Supp 2nd1064 (S.D. Fla. 2003).
61 G J Annas, L H Glantz, P A Roche, “Drafting the Genetic Privacy Act: Science, Policy and Practical Considerations”, (1995) 23 Journal of Law, Medicine and Ethics 360-66 (“hereafter referred to as: Annas, Glanz & Roche, Genetic Privacy Act”), at 362.
62 Model Genetic Privacy Act and Commentary, Section 104, G J Annas, L H Glantz, P A Roche, Health Law Department; Boston University School of Public Health; 80 East Concord Street; Boston, MA 02118, February 28, 1995.
63Annas, Glanz & Roche, Genetic Privacy Act, at 363.
64 Laurie, Genetic Privacy, at 324.
65 Laurie, Genetic Privacy at 316.
66 See e.g. A D Moore, “Owning Genetic Information and Gene Enhancement Techniques: why privacy and property rules may undermine social control of the human genome”, 14 Bioethics (2000) 2, Lin supra fn 23, Laurie, Genetic Privacy, at 315 and 319.
67 For an in depth analysis of the current movements towards a property model in ourselves, see Laurie, Genetic Privacy, at 319-324.
68 See www.pxe.org.
69 Gitter, at 317, referring to Kolata.
70 Gitter, at 318, referring to Genetic Alliance.
71 Greenberg vs Miami Children’s Hospital Research Institute, Inc., 264 F. Supp 2nd1064 (S.D. Fla. 2003), 1066.
72 US patent No. 5,679,635 issued to the hospital in October 1997.
73 Complaint, paragraph 30.
74 Complaint, paragraph 65.
75 Greenberg vs Miami Children’s Hospital Research Institute, Inc., 264 F. Supp 2nd1064 (S.D. Fla. 2003), 1074-1075..
76 Pioneer Hi-Bred vs. Holden Foundation 1987 WL 341211 (S.D.Iowa, Oct.30, 1987), aff'd, 35 F.3d 1226 (8th Cir.1994),
77 264 F. Supp 2nd1064 (S.D. Fla. 2003).
78 Greenberg vs Miami Children’s Hospital Research Institute, Inc., 264 F. Supp 2nd1064 (S.D. Fla. 2003), 1075.
79 Greenberg vs Miami Children’s Hospital Research Institute, Inc., 264 F. Supp 2nd1064 (S.D. Fla. 2003), 1075.
80 Greenberg vs Miami Children’s Hospital Research Institute, Inc., 264 F. Supp 2nd1064 (S.D. Fla. 2003), 1075.
81 Greenberg vs Miami Children’s Hospital Research Institute, Inc., 264 F. Supp 2nd1064 (S.D. Fla. 2003), 1075.
82 Greenberg vs Miami Children’s Hospital Research Institute, Inc., 264 F. Supp 2nd1064 (S.D. Fla. 2003), 1076.
83 According to a September 29, 2003 joint press release, the parties have reached a settlement which provides for continued royalty-based genetic testing by certain licensed laboratories and royalty-free research by institutions, doctors, and scientists searching for a cure; available at http://www.canavanfoundation.org/news/09-03_miami.php.
84 D M Gitter “Ownership of Human Tissue: A Proposal for federal Recognition of Human Research Participants’ property Rights in Their Biological Material”, (2004) 61 Washington and Lee Law Review, 257 (“hereafter referred to as: Gitter”)
85 E.g. the California Supreme Court in Moore.
86 Attributed to Sir William Blackstone, Commentaries on the Laws of England, Oxford 1775.
87 M A. Heller, “The Tragedy of the Anticommons: Property in the Transition from Marx to Markets”, (1998) 111 Harv. L. Rev. 621, (”hereafter referred to as Heller”), at 662.
88 E.g. Heller, 663-664, referring to L C Becker, Property rights: Philosophical Foundations 7-23 (1977); S R Munzer, A Theory of Property 24 (1990) at 27, n. 14 and A Reeve, Property 14-21 (1986).
89 A M Honoré, “Ownership”, in A.D. Guest (ed), Oxford Essays in Jurisprudence 107-128, (“hereafter referred to as: Honoré”).
90 Honoré, at 113.
91 Honoré, at 116.
92 M Ridley, Nature via Nurture, at 1.
93 Honoré, at 116.
94 Honoré, at 117.
95 Honoré, at 118.
96 Which does not mean that there could be no moral or policy objections against that possibility.
97 Thomas H. Murray, Discover, March 1986, cited in OTA, at 126.
98 E.g. John Moore sought a percentage of the proceeds from the sale of the cell line produced from his cells.
99 Of course, a tissue donor could ask to be paid by way of a profit share. However, the value of such a share can only be based on the value determined by supply and demand for the tissue in question, just like the number of employee share options is not related to the company’s profit, but corresponds to the value of the employee in the market place.
100 Honoré, at 119.
101 Honoré, at 119.
102 Honoré, at 119.
103 This kind of expropriation for public interest research purposes is not to be confused with existing powers to forgo consent to bodily searches for forensic purposes, mandatory vaccination programmes and the like, which do not entail any form of expropriation.
104 Honoré, at 121.
105 Honoré, at 122.
106 L C Becker, Property rights: Philosophical Foundations (1977) at 19.
107 Honoré, at 123.
108 Honoré, at 123.
109 See R Rao, “Property, Privacy and the Human Body”, 80 B.U.L.Rev. 359, 372.
110 S R Munzer, A Theory of Property (1990) at 54-55. See also ALRC, at 535.
111 S R Munzer, A Theory of Property (1990) at 49.
112 Honoré, at 112-113. See also L C Becker, Property rights: Philosophical Foundations (1977) at 19-20.
113 L C Becker, Property rights: Philosophical Foundations (1977) at 19-20.
114 M Litman and G Robertson, “ The Common Law Status of Genetic Material”, in Legal Rights and Human Material, Ed. Bartha Maria Knoppers, Timothy Caulfield, and T. Douglas Kinsella (1996), at 64.
115 M J Radin, Market-Inalienability, 100 Harvard L. Rev. (1987) 1849, at 1853.
116 The clarification claim is somewhat disingenuous anyway. It was the very threat of uncertainty that the recognition of a property interest in human tissue would bring about, which tilted the court in Moore towards denying such interest. Also, it is probably this judicial decision that provided the required certainty, at least in the jurisdiction concerned (California), but probably in other jurisdictions as well: the Florida district court in Greenberg v. Miami Children’s Hospital approvingly cited Moore.
117 UK Biobank Sample Protocol, at 14.
118 OTA, at 5.
119 UK Biobank draft scientific protocol 2003, section 2.3.5.1 and UK Biobank Sample Protocol, section 4.2.6., at 30.
120 OTA, at 33.
121 OTA, at 83.
122 OTA, at 84.
123 Explanatory Notes to the Human Tissue Act 2004, commentary on Part 1, section 1 under 10 and section 32 under 48.
124 Laurie, Genetic Privacy, at 300.
125 Gitter, at 306.
126 Gitter, at 307.
127 Laurie, Genetic Privacy, at 315. Gitter, fn. 40: ‘Moreover, a willing research participant frequently neither rues the fact that commercial products were developed from the tissue nor desires return of the tissue, but simply wishes for a share in the profits”.
128 Gitter, at 296.
129 Moore v. Regents of the University of California, 793 P.2d 479 (Cal.1990), 511.
130 Gitter, at 297.
131 Laurie, at 324.
132 Gitter at 292, Lin at 131-132.
133 ALRC, at 531.
134 E.g. Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Oviedo, 4.IV.1997. Article 21.
135 Gitter, at 323.
136 Gitter, at 323.
137 Gitter, at 323, citing the president of PXE International.
138 Gitter at 323.
139 Gitter, at 323.
140 Gitter, at 297.
141 Greenberg vs Miami Children’s Hospital Research Institute, Inc., 264 F. Supp 2nd1064 (S.D. Fla. 2003).
142 Assuming that patents are not improperly awarded and the invention truly meets the criteria for patentability. A discussion of whether that is currently the case in the area of ‘genetic inventions’ is beyond the scope of this Article.
143 ALRC, Recommendation 8-2 (at 286) and Recommendation 20-2 (at 539).
144 H T Greely, “Iceland’s plan for Genomics Research: Facts and Implications”, 40 Jurimetrics J. 153-191 (2000) and Potts, “An examination of the Bargain Made between Iceland and deCODE Genetics with implications for Global Bioprospecting”, 7 Va. J.L. & Tech. (2002) 8.
145 Rosenberg, R, Questions still linger on Heart Study access Boston Globe, February 1, 2001:D4.
146 D E Winickoff and R N Winickoff, “The Charitable Trust as a Model for Genomic Biobanks, N Engl J Med 349;12, 1181.
147 It is important to realize that this proliferation is not a logistical problem. Biobanks are typically designed in such a way as to be able to trace and communicate with research participants and to honor specific requests for withdrawal of participation. The mere possibility of being able to communicate with research participants in itself cannot resolve the array of issues to be dealt with as a result of the proliferation of rights.
148 D E Winickoff and R N Winickoff, ibid, at 1181 and Laurie, Genetic Privacy, at 318.
149 B M Knoppers, “Biobanks: simplifying consent”, 5 Nature Reviews Genetics, (2004), 485.
150 WHO, Proposed International Guidelines on Ethical Issues in Medical Genetics and Genetic Services, 1998, WHO/HGN/GL/ETH/98.1
151 German National Ethics Committee, ‘Biobanks for Research’, Opinon (2004), available at kontakt@ethikrat.org.
152 B M Knoppers, “Biobanks: simplifying consent”, 5 Nature Reviews Genetics, (2004), 485.
153 G Hardin, “The Tragedy of the Commons”, 162 Science (1968) 1243, 1244-1245.
154 Heller, at 684, quoting Jathon Sapsord, Quake-Hobbled Kobe Shows how Land Law Can Paralyze Japan, Wall St.J., Dec.12, 1996, at A1.
155 Heller, at 684..
156 Heller, at 684.
157 Heller, at 685.
158 Heller, at 668.
159 Heller, at 670.
160 Heller, at 677.
161 Heller, at 624-625.
162 Heller, 665, fn 201.
163 M Heller and R S Eisenberg, “Can Patents Deter Innovation: the Anticommons in Biomedical Research”, 280 Science (1998), 5364, at 698-701.
164 J A Bovenberg, “Should Genomics Companies set up Database in Europe?” 18 Nature Biotechnology (2000), 907.
165 See also C H Harrison, Neither Moore Nor the Market, 28 American Journal of Law and Medicine, (2002) at 86.
166 Heller, at 665, fn 199.
167 Heller, at 673.
168 Heller, at 625.
169 M Heller and R S Eisenberg, “Can Patents Deter Innovation: the Anticommons in Biomedical Research”, 280 Science (1998), 5364, at 698-701.
170 Heller, at 675.
171 Skene, “Proprietary rights in human bodies, body parts and tissue: regulatory contexts and proposals for new laws”, 22 Legal Studies: the Journal of the Society of Public Teachers of Law, (2002) 103, at 117.
172 Venting his spleen, CMAJ 1998;159:1451 © Richard Cairney.
173 Heller, at 678.
174 Heller, 688.
175 Skene, “Proprietary rights in human bodies, body parts and tissue: regulatory contexts and proposals for new laws”, 22 Legal Studies: the Journal of the Society of Public Teachers of Law, (2002) 103, at 118.
176 See, e.g. the enumeration of donor rights in the legislation governing the creation and use of the Estonian Gene Bank, Chapter 2, specifically paragraph 11.
177 See also Skene, at 125.
178 UNESCO, Universal Declaration on the Human Genome and Human Rights, 1997.
179 HUGO, Statement on Genomic Databases, Human Genome Organization 2003.