Director : Dr Donald Bruce
1997 General Assembly Report - Ethical Concerns about Patenting in relation to Living Organisms
from the Society, Religion and Technology Project, Board of National Mission
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Accepted by the General Assembly on 22 May 1997, together with the following motion :
That the General Assembly urge the European Commission and European Parliament to amend the draft Directive on the Legal Protection of Biotechnological Inventions, to ensure that living organisms and genetic material of human origin are in themselves unpatentable, as parts of God's creation, and to set up, in parallel with the patenting process, an appropriate European system by which the ethical acceptability of biotechnological inventions can be decided, with statutory rights for the public to present their views.
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SRT 1997 Report to General Assembly
Ethical Concerns about Patenting in relation to Living Organisms
A Summary of a Submission to the European Commission and the
European Parliament on the EC draft Patenting Directive
Introduction
In October 1996, the Bioethics working group of the European
Ecumenical Commission for Church and Society (EECCS) presented a
submission to the European Commission (EC) and European
Parliament (EP) on the question of the patenting of living
organisms. [1] The issue is one of the most controversial in
biotechnology, and is currently under debate within the EP, as
well as in many wider circles. The submission was made in
response to a draft EC Directive which seeks to produce a
harmonised legislation allowing, amongst other things, the
patenting of transgenic animals, plants and micro-organisms, and
also sections of the human genome. The EECCS submission has
attracted strong reactions from the bio-industry, the EC, some
MEP's and some patients' representatives, and fruitful ongoing
dialogue has opened up with all four groups.
It was written on behalf of the working group by the Director of
the Society, Religion and Technology Project. The SRT Project
now wishes to present to the General Assembly the following
summary of the basis of the submission, which also takes account
also of the subsequent discussions with the EC.
The submission represented an informed view from an official
working group of EECCS, comprising scientific, ethical and
theological experts, nominated by Councils of Churches and
churches which are members of EECCS. It was not presented as
"The Official View" of the relevant churches, recognising that
views differ on this issue, but it is believed the opinions
expressed would be accepted by a large number of members of the
churches. The group contained two geneticists who have done
research in the medical application of genetics, a biochemist
and a chemist, as well as theologians and ethicists. It was
therefore not opposed to biotechnology or genetic engineering or
medical research. It also shared many of the concerns of
patient support groups, and counts among its own families some
who have suffered the consequences of genetic disease.
The EECCS submission, however, gave a critical view of the draft
Directive. While it approved of the notion of a directive to
harmonise the laws of EU member states in the area of patenting,
it was considered to contain serious flaws. In order to be
acceptable, it would need to be amended on a number of
significant points, and to address a number of issues it had
failed to address.
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- The context in which patenting is presented in the draft Directive does not properly reflect the range and complexity of the issues involved, but sees them primarily in a narrow economic light, tending to marginalise other factors also important for European society.
Once the scope of patenting is extended to biological systems, the ethical dimension becomes a central issue and no longer something peripheral.
Animate material presents a radical discontinuity from mechanical and chemical inventions, which may require a different way of thinking about intellectual property. Merely to extend patents to include animate material is to approach the question in the wrong way. The possibility of a new system of intellectual property rights for animate matter should be considered.
There is an urgent need for a proper forum for public objection or approval on ethical matters in biotechnology, in order to be accountable to the people of Europe.
The draft Directive generally fails to lay down its ethical presuppositions or engage with the ethical objections which are expressed over patenting animate matter. As such it does not give an adequate basis for legislation on such sensitive issues as these.
There is an ethical basis for the general notion of patenting, but this does not imply that every aspect or application of patenting is ethically acceptable.
On ethical grounds, living organisms of any kind should not in themselves be patentable
The process to produce the genetically modified organism could be patentable, or their application to make specific medical, agricultural or industrial products.
On ethical grounds, genetic material of human origin should not in itself be patentable.
"Copy genes" should not be patentable, because :
- i. The argument that copy genes lose their original "identity" by being cloned is false because the same information is conveyed by the copy genes as the original gene
- ii. No inventive step is involved in obtaining copy genes.
Some exaggerated claims are made for effectiveness of the patenting process.
The exceptions to patentability do not go far enough.
- i. A wider appreciation of animal harm is needed than physical suffering
- ii. The draft Directive shows no awareness of the implications of patenting modified plants and plant products for farmers in developing countries.
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The Detailed Concerns
In setting out the context for patenting, it is not sufficient
to present economic growth as the primary social criterion for
biotechnological innovations. This fails to give adequate
consideration of the many other social, environmental, moral and
religious factors involved in biotechnological developments,
including human welfare, animal welfare, care for creation,
safety, concern for poverty and disease in the developing world,
removing injustice from society, or the quality of life
generally. Inventions should not be viewed primarily with their
value as economic entities, but whether they are worthwhile in
themselves, and whether their impact on society is desirable.
It is not enough to see patenting as a no more than a technical
means towards a solely economic end, as though it were a purely
objective procedure.
2. Animate matter, the ethical dimension and the patent process
The extension of the scope of patenting to include "animate
material" presents a number of ethical problems, with regard to
material of human origin, animals and other living organisms.
Sociologists and ethicists have long pointed out that all
technological activities including patenting involve the ethical
and moral dimension. It might be argued that such issues tended
to be on the periphery of patenting while its scope was
restricted to inanimate objects and processes. As soon as
biotechnological inventions and living organisms are brought
into consideration, the whole situation changes. The ethical
dimension becomes just as central and integral to the patent
process as the more familiar patenting criteria of novelty,
inventiveness and industrial application. It is futile to
argue, as some have, that patenting should not involve ethics;
it cannot avoid doing so where living material is involved. The
EC's Group of Advisors on Bioethics have made a similar point in
their opinion to the EC. [2]
Given that patenting was not designed with living things in
mind, insufficient consideration appears to have been given
whether simply extending the patenting system to include animate
matter is the most appropriate means to address intellectual
property rights. Consideration should be given to developing an
entirely separate intellectual property system for living
organisms, which recognises the fundamental distinction between
living creatures and non-living things.
While the patenting process cannot exclude consideration of the
ethical dimension, it is of concern that much of the debate
about the ethical acceptability of biotechnological inventions
has become focused on the patenting process. This is due to the
absence of suitable European and/or national bodies where this
can be given public debate. The group agrees with many
observers that patenting is not the right forum in which to
decide whether it is ethical acceptable for an invention to be
produced and marketed. There are several reasons for this.
Firstly, patenting does not confer the right to manufacture, but
only to prevent others from marketing the invention as if it was
their own. Secondly, patent lawyers are not normally equipped
in this area, and there is not an adequate system of public
accountability for such a task.
The group has therefore called for the setting up of an
appropriate European body by which the ethical acceptability for
the implementation of an invention can be decided, withstatutory rights for the public to present their views, and for
appeals to be made. In the absence of such a body there are at
present insufficient means for the people of Europe to weigh up
the acceptability of the research being done on its behalf.
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In the draft Directive a proper examination was not given of the
ethical dimension of the issues concerned, nor were its own
ethical assumptions made clear. A number of judgements are made
which have deep ethical implications, but without proper
justification, namely :
- to draw an ethical distinction between genes of human origin and other parts of the human body, by asserting that one may be patentable and the other may not,
- to judge that by copying a piece of genetic material it has lost any identity with the organism it came from, and
- to regard transgenic animals, plants and micro-organisms as products of human invention rather than products of nature.
As discussed below, these are ethically unacceptable. Moreover,
many among the general public and within the scientific
community appear to find them unsatisfactory.
The is strong ethical case in favour of the principle of
patenting for human inventions. Given the tendency of human
nature to abuse, it is a matter of justice to provide
appropriate protection for the commercial applications of
inventiveness and originality in many circumstances. But this
does not imply that every aspect or application of patenting is
ethically acceptable. In particular there are objections, in
certain circumstances, regarding patenting living organisms,
where the distinction between what is God's creation and what is
human invention is lost or blurred.
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Implicit in the assumptions of the draft Directive is that
living organisms can be regarded as an extension of inanimate
objects, such as chemicals or chemical processes. It focuses
primarily on the ways in which living organisms are like things,
rather than their special characteristics as life. We are used
to distinguishing the categories of "people" and "things", and
our legislation regarding them differs fundamentally as a
result. Non-human living organisms and human genetic material
do not fit either category, however. Patent law addresses
intellectual property in relation to things; simply to extend it
to living organisms automatically evaluates them in the category
of "thing".
According to Christian ethics, and many other ethical systems
which draw a distinction between animate and inanimate matter,
this is morally wrong. The prior relationship is that which
links a genetic sequence or a living organism to what is living,
and to God, taking precedence over any industrial or other
relations it may have. A special respect is due to any living
creature, including humans, because it is ultimately a creation
of God, with its own life. all living organisms have an
inherent significance which sets them apart as "products of
nature" from all "products of industry". All of nature is God's
creation, but this does not make nature "sacred" or untouchable.
On the contrary, God has given us the dual responsibility to
develop and also take care of what he has created. But we are
stewards and companions to nature, not its owners. Consequently
we have no intellectual property over what is merely natural.
It is free to all. Boundaries need therefore to be drawn to
make this distinction clear, to avoid reducing life conceptually
to being merely an economic commodity, and then treating it as
such.
Being God's creations, living organisms have an inherent
significance which sets them apart as "products of nature" from
all "products of industry". This is implicit in the
understanding that plant and animal varieties cannot be
patented, and in the concept of "farmers privilege", which
allows a farmer to resow plant seeds in the next generation,
acknowledging that plants are reproducing organisms, and not
merely industrial components. The draft Directive's intention
to extend this to animal breeding is welcome and long overdue.
Living organisms themselves should therefore not be patentable,
whether genetically modified or not. It is wrong in principle.
An animal, plant or micro-organism owes its creation ultimately
to God, not human endeavour. It cannot be interpreted as an
invention or a process, in the normal sense of either word. It
has a life of its own, which inanimate matter does not. In
genetic engineering, moreover, only a tiny fraction of the
makeup of the organism can be said to be a product of the
scientists. The organism is still essentially a living entity,
not an invention. A genetically modified mouse is in a
completely different category from a mouse trap.
A distinction can be made between various categories relating to "animate matter" :
- a whole organism in its natural state
- a whole organism, such as a sheep, which had undergone a genetic modification,
- genetic material which is essentially unchanged from its natural state in a living organism,
- the novel gene construct, such as would be made by inserting a human gene into a sheep
- the process by which a genetic modification was achieved
- the application of genetic material to the make an industrial, agricultural or medical product.
No intrinsic ethical problem is raised in patenting the last two
categories - that of a biotechnological process to produce the
genetically modified organism, or the application, since the
inventiveness claimed is in the application or the process, not
the gene itself. To patent a novel gene construct is perhaps
more controversial, but may still be ethically acceptable. The
main ethical objections arise with the first three categories -
the idea of patenting the whole organism, whether modified or
not, or genes in themselves. This is especially focused in the
question of patenting genetic sequences of human origin,
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The knowledge of the genetic sequence itself (without any stated
practical application) should not be patentable, but only its
application, say, to produce a new therapeutic drug. The latter
is in principle ethically acceptable, the former is not.[3] It is
abhorrent that the information relating to any aspect of the
human body should be seen as intellectual property. It is
contrary to a Christian understanding of the nature of the human
person, of self respect and respect for others. If such
information "belongs" to anyone, it is the individual concerned,
or else the common property of all humanity equally, and not the
exclusive right of any third party. But it is not so much a
question about ownership, as about not claiming invention over
what God has given as free to all.
It has been widely claimed by the bioindustry that the future of
investment in genetic research depends on the ability to patent
sections of the human genome as such. Failure to do so is even
predicted to lead to the collapse of the biotechnology industry
and of medical research in Europe. This seems to a point of
dogma rather than well established by evidence. On the
contrary, the objectives of promoting and maintaining active and
innovative European research into beneficial and ethical genetic
applications could be achieved by patenting the applications,
without the need to patent sections of the human genome or their
so-called copy genes as such. To patent a human genetic
sequence in itself would amount to all and any applications of
it. A company which had obtained such a patent but only worked
on one application of the gene could effectively hold back
medical progress, because, on the bioindustry's own logic, other
companies are unlikely to invest in expensive research in areas
where they had no prospect of patenting any inventions they
made.
This reflects a wider concern of the abuse of the patenting
system. Patenting was set up to provide protection against one
form of commercial abuse, but it can lead to another. It seems
to be a fact of life that a patent applicant will claim
protection over the maximum possible area of technology. If a
company can get away with protecting more than it is entitled
to, it is in its commercial interests. What was set up to
protect can also, by the same token, become a pretext for basic
greed. A fine line exists between the two. The question of
patenting sections of the human genome steps over the line where
the ethical criteria of just protection and secure investment
claims supremacy above criteria of human dignity and free access
to what is natural.
10. "Copy genes" should not be patentable
i). Copy genes do not lose their human association and identity
At the heart of the case for patenting human genes is the
argument that what a patent applicant seeks protection for is
not the gene as it exists in the human body, but rather millions
of copies of it, which are obtained by multiplying the gene in
the laboratory, for example, by bacterial action. The claim is
that these so-called "copy genes" lose their original "human"
identity by being cloned. This is not accepted, because the
same human genetic information is transferred irrespective of
the how many copies are made. Copy genes do not lose their
original "identity" by being cloned, but have the same moral
status as the originating gene, because they are carriers of the
same information. The reason that the genetic sequence would be
utilised in an industrial application would be in virtue of the
information which it represented in the organism which it came
from. Moreover, regardless of the scientific argument, many
people would regard a copy gene of human origin as remaining
"human" because of the way they understand the notion of
identity - that it is primarily to do with connections and
relationships, not atomised entities.
Indeed, the churches and many others are becoming increasingly
concerned that developments in biotechnology are making it more
and more possible to separate and isolate the functions of
living organisms - both human and non-human - from the organism
as a whole. This reductionist trend may be a useful scientific
tool, but it also carries the danger of losing sight of the
connection of all the separated parts with each other and with
the whole.
The process of obtaining copy genes by bacterial cloning is part
of a standard technique in genetic identification, obvious to
anyone "skilled in the art". It is not an inventive step. The
whole point of copy genes is that they are examined and
characterised as though they were the original gene. They have
the character of discoveries, isolated by means that are
non-inventive. Industry sources have even sought to claim that
the level of intellectual effort involved elevates genetic
sequences "beyond the status of mere discoveries. In this
sense, DNA molecules are inventions that can legitimately be
patented.". [4] The mere fact that intellectual effort is
involved does not, however, turn a discovery into an invention.
If a scientist claims to have identified a genetic sequence,
what is identified is a discovery and unpatentable. If what was
identified is patentable because it is not the same as the
genetic sequence in its natural state, then the scientist cannot
claim to have identified the natural sequence, but only some
derivative of it.
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While the basic notion of patenting is supported, exaggerated
claims are sometimes made for its benefits. It is claimed that
patenting encourages early and beneficial dissemination of
knowledge which, without such protection, might be kept secret.
This is a half truth. In the best circumstances, patenting can
indeed lead to the dissemination of information, but there is
also much which still remains secret - if a company regard
something as too sensitive even for patent protection, or if it
is secret "in the national interest". Patenting can also be
misused as a means to deter rivals from researching for
alternative products.
The high cost and lengthy timescale of seeking patent protection
favours large organisations, and can often be a deterrent for
research institutes or small and medium enterprises, when
compared with a relatively short market advantage. Once a
patent application is put into the hands of patent lawyers, the
questions asked may well divert a company's effort and
personnel, and set back the company's ongoing research
programmes, to lose its competitive edge in the next potential
area of discovery. The litigation that can result from rival
companies claiming "prior art" can also make patenting a much
more doubtful business than it is made out to be.
12. The exceptions to patentability do not go far enough
There are ethical grounds on which patenting may be refused, but
these are too limited in extent to encompass the concerns
discussed above. In addition, two omissions may be cited.
In relation to animals, the wording of the article implies that
the only thing to ask about animals is "do they suffer?". In
the case of animals, there are many potential uses which are
degrading and uncaring, whether or not the animal suffers pain
or physical handicap.
The draft Directive shows no awareness of the implications of
patenting modified plants and plant products for farmers in
developing countries. Serious ethical concerns are raised if
research organisations and trans-national corporations are
granted patents without due recompense to the farming
communities from whose lands the plant was taken, for the use of
their indigenous knowledge. The breadth of some patents can
also put at a disadvantage the very people who need most
urgently to gain from the benefits which biotechnology can
bring, and widen the gap of rich and poor still further.
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1. Proposal for a European Parliament and Council Directive on
the Legal Protection of Biotechnological Inventions, COM (95)
661 final, 13 December 1995.
2. "Ethical Aspects of Patenting Inventions Involving Elements of
Human Origin", Opinion of the Group of Advisors on Ethical
Implications of Biotechnology of the European Commission, 25
September 1996, para 2.1
3. This position is close to the minority view expressed by
Professor Dietmar Mieth of the EC Group of Advisors on
Bioethics, op cit.
4. From "What is the Case for Patenting DNA?", a brochure
produced by the major pharmaceuticals company SmithKline
Beecham, 1996.
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APPENDIX
Key Articles in the EC draft Directive relevant to the report
Proposal for a European Parliament and Council Directive on the Legal Protection of Biotechnological Inventions
Article 3
1. The human body and its elements in their natural state shall
not be considered patentable inventions.
2. Notwithstanding paragraph 1, the subject of an invention
capable of industrial application which relates to an element
isolated from the human body or otherwise produced by means of a
technical process shall be patentable, even if the structure of
that element is identical to that of a natural element.
Article 4
1. The subject of an invention shall not be considered
unpatentable merely on the grounds that it is composed of, uses
or is applied to biological material.
2. Biological material, including plants and animals, as well
as elements of plants and animals obtained by means of a process
not essentially biological, except plant and animal varieties as
such, shall be patentable.
Article 5
Microbiological processes and products obtained by means of such
processes shall be patentable.
Article 6
Essentially biological processes for the production of plants
and animals shall not be patentable.
Article 7
Uses of plant or animal varieties and processes for their
production, other than essentially biological processes for the
production of plants and animals, shall be patentable.
Article 8
The subject of an invention concerning a biological material
shall not be considered a discovery or lacking in novelty merely
on the grounds that it already formed part of the natural world.
Article 9
1. Inventions shall be considered unpatentable where the
exploitation would be contrary to public policy or morality;
however, exploitation shall not be deemed to be so contrary
merely because it is prohibited by law or regulation.
2. On the basis of paragraph 1, the following shall be
considered unpatentable:
(a) Methods of human treatment involving germ line gene
therapy;
(b) processes for modifying the genetic identity of animals
which are likely to cause them suffering or physical handicaps
without any substantial benefit to man or animal, and also
animals resulting from such processes, whenever the suffering or
physical handicaps inflicted on the animals concerned are
disproportionate to the objective pursued.
Dr Donald Bruce
Director, SRT Project
Church of Scotland
4 April 1997
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