Executive Summary of Ethical Issues Associated with the Patenting of Higher Life Forms

I. The United States and European Experiences

The European situation was and is different because of the existence of Green or ecology parties in a number of countries and at the EU level. It was and is different, as well, because of specific provision in the European Patent Convention (EPC), which covers patenting in most EU countries, for denial of patents on public interest grounds. No comparable statutory provision or authority exists in the United States. In addition, the EPC precludes the issuance of patents on "inventions the publication or exploitation of which would be contrary to ordre public or morality".

A draft directive recently adopted by the European Parliament precludes patents on:

a. the human body or parts of the human body per se;
b. processes for modifying the genetic identity of the human body for a non-therapeutic purpose which is contrary to the dignity of man;
c. processes for modifying the genetic identity of animals which are likely to inflict suffering or physical handicaps upon them without any benefit to man or animal.

II. Canadian Policy and Politics

Both the United States and Europe have experienced relatively high-profile public debates about the ethics of patenting higher life forms. This has not happened in Canada. The Canadian Patent Office (CPO) has so far stated a policy of not granting patents on higher life forms, based on an interpretation of existing case law. There is no legislation supporting this position, and court decisions are ambiguous. In the absence of a catalyst like the announcement of a patent on a transgenic animal or the activities of high-profile policy entrepreneurs, debate about the ethical implications of intellectual property rights in higher life forms has been minimal in Canada, with two exceptions.

The first exception is the passage of the Plant Breeders' Rights Act in 1990, and the Parliamentary hearings that preceded it. The second exception is the work of the Royal Commission on New Reproductive Technologies (RCNRT), which actually paid little attention to patenting issues. The absence of such public debate is one of the reasons for the process-based approach proposed in Section XII of the report.

III. Analysing Arguments For and Against Patenting Higher Life Forms

Arguments about patenting higher life forms can be classified based on two factors: the topic of discussion, and the nature of the argument being made. With respect to what is being discussed, patenting higher life forms can be seen either as derivatively wrong or as wrong in itself. The former view is based on the claim that genetic engineering, certain applications of genetic engineering or certain kinds of research in molecular genetics are morally wrong.

Another line of criticism is directed at patenting per se. Even if genetic engineering is morally acceptable and should be allowed to proceed, some of the outcomes ought not to be patentable.

Under each of these headings, arguments assume two forms that correspond to the two main traditions in Western moral philosophy. On the one hand, an activity (such as genetic engineering, or the patenting of all or some higher life forms) is held to be intrinsically wrong, or wrong in principle. Philosophers refer to such arguments as deontological. On the other hand, an activity such as genetic engineering or patenting could be wrong because it causes bad or harmful consequences. Philosophers call such arguments consequentialist. These categories of arguments about genetic engineering and patenting are schematically depicted in Figure 1.

Figure 1

Patenting:

Topic of Discussion: Genetic Engineering

a) Form of Argument: Deontological (arguments dealing with inherent or intrinsic yighthness or wrongness).

Pro: Genetic engineereingis is part of humanity's obligation to ezpand the range of scientific
knowledge andtechnological capability.

Con: Genetic engineering, or certain kindsof human gene therapy, amount to ''Playing God''.

b) Form of Argument:Consequenlialist(arguments dealing with harmful or beneficial consequences).

Pro: Genetic engineering will make new possible a new kinds of therapies foe debilitating
diseases,and substantial increases in farmers' ability to produce more food at the same lower cost.

Con: A slippery slope leads inexorably from such medical techniques as pre-implatation diagnosis and embryo doning to the dire consequences that would follow from a revival of eugenics.

Topic of Disscusion: Pattenting

Form of Argument: Deontologigal(arguements dealing with inherent or intrinsic rightness or wrongness).

Pro: Patenting of higher life forms is justified on grounds of faimess to inventors and investors.

Con: Ownership of life, or property rights in portions of the human genome, are inherently wrong.

Form of Argument:Consequentialist(arguemnts dealing with harmful or beneficid consequences).

Pro: Patenting is neccessary in order to create an incentive for investing research and devellopment that will lead to the various benefits that ca be realized from genetic engineering; without the inccentive provided by patenting that investment will not be made, or will be made at lower levels.

Con: Patenting will have destructive economic effects on family farms; will enable patent holders to reap monopoly profits even from life saving therapies and diagnostic techniques; will lead us to objectify life and living creatures. human and otherwise.

Consequentialist arguments need not be strictly utilitarian in form or content. The consequences taken into account need not be solely economic ones. They may be environmental, social or even spiritual, depending upon how harms are defined and identi fied. As this observation suggests, basing decision-making on consequentialist arguments does not mean decisions should be made simply by aggregating individuals' preferences. What we want as individual consumers may differ from what we consider, as citizens, to be a desirable social policy choice. Finally, when we decide what is to count as a beneficial or a harmful consequence of a particular policy, such as allowing patents on genetically engineered laboratory animals or on a particular animal, we rely on pre-existing values or ethical commitments. Simply pointing to a particular set of consequences of that policy does not itself constitute an ethical argument.

IV. Of Slippery Slopes and Accumulated Consequences

Claims about "slippery slopes" are often encountered in discussions of biotechnology policy and intellectual property rights. The "thin edge of the wedge" is another image that communicates the same idea. Among several frameworks for assessing slippery slope arguments, political theorist Richard Vernon provides one of the clearest and simplest: such arguments must "contain a genuine causal element linking the top of the slope with the bottom," or in other words they must specify the lubricant that makes the slope slippery.

One such lubricant is "precedential force." A second is involved where "previous expenditures of effort are regarded as an investment which it would be costly to abandon." A third type of lubricant can be identified in situations where particular actions or policies either create altogether new actors, or strengthen the commitment and expand the resources of existing ones. Finally, there is what Vernon calls "cumulative effects on our political culture." The key questions with respect to slippery slope arguments of all kinds are: what is the lubricant? how slippery will the lubricant in fact make the slope? how sure are we about the preceding answer? It is also useful to ask whether the effects of the lubricant can be offset, for example by spreading sand, ashes, or some other traction aid on the slippery slope at a particular point.

Slippery slope arguments must be distinguished from claims about the cumulative effects of large numbers of seemingly insignificant or isolated decisions. Decisions that are defensible viewed in a local or small-scale context may be indefensible and even irrational when the system-wide consequences of large numbers of similar decisions are taken into account., which may be unanticipated and/or perverse. The discipline of economics and the domain of environmental policy provide a number of useful and cautionary examples.

V. Generic Arguments About Patenting Higher Life Forms

At least three distinct arguments in favour of patenting higher life forms can be identified. First, patenting is viewed as an incentive necessary to motivate the profit-motivated private sector to meet public needs like the provision of increased agricultural yields and life-saving therapies and diagnostic techniques. This argument has been prominent in the U.S. debates about patenting, especially as they relate to patents on portions of the human genome. Second, countries that offer weak or limited patent protection can expect to suffer economic losses as investors in the biotechnology industry simply look elsewhere. The power of this claim depends both on the overall economic significance of biotechnology and on the intra-national distribution of its benefits. A third argument is based on considerations of fairness: people deserve the fruits of their intellectual work. Fairness or justice is valued in and of itself, apart from socially beneficial consequences.

It seems hard to argue against patenting if, for instance, it will actually provide an incentive for major medical breakthroughs. However, some commentators view the accumulation of scientific knowledge through genetic research as a mixed blessing, and argue that will in the end be socially destructive. If one regards genetic engineering and its applications as ethically troubling to begin with, then patenting becomes ethically suspect in direct proportion to the strength of the incentive it provides for such research and development. Further, some recent developments suggest that patenting may in fact hinder the pursuit of lines of inquiry with potentially lifesaving results, by substituting self-interested preservation of confidentiality for the norm of open and immediate sharing of results that supposedly governs scientific communication.

The national income and employment possibilities associated with a thriving biotechnology industry are themselves desirable, and provide an argument for expansive patent protection if the economic benefits are as substantial as claimed by promoters of the industry. However, there are reasons to take a sceptical view of those claims. Jobs and income are not the only relevant ethical considerations; claims about economic benefits may be driven by the interests of industry promoters, and deserve more careful examination.

VI. On Playing God

A familiar objection to genetic engineering is that genetic engineers are playing God. Although some argue that genetic engineering is not fundamentally different from the natural process of selective breeding, there are abundant reasons to treat genetic engineering as a special and distinctive kind of phenomenon. These reasons, however, do not make explicit the basis of the claim by opponents that it is wrong to exercise the control over biological processes represented by genetic engineering.

This distinction is important because our ethical intuitions are often in conflict. A basic antagonism toward biotechnology, expressed in the argument from playing God, conflict with a equally strong conviction that everything possible should be done to find cures or palliative measures for debilitating and fatal diseases, including (for instance) the creation of transgenic animals that serve as laboratory models for the study of such diseases. A number of similar instances of conflicting intuitions can be found in debates about the ethics of biotechnology; their existence strengthens the case made in this report for emphasizing procedure rather than "right answers" in resolving ethical conflicts about biotechnology.

Three variants of the playing god argument deserve separate attention. The first appeals to the notion of species integrity, which some observers see as problematic. Second, there is the claim that patenting tends to reduce the value of life to that assigned to it by the economic system. Third, it can be argued that a loss of a sense of the mystery of life may accompany the scientific ability to define life in terms of genetic information. Here again, however, a counterargument can be made that such an ability actually enhances our sense of wonder with respect to life and living things.

VII. Some Distributional Implications of the Ownership of Genetic Resources

The prospect of patents on genetic resources raises a number of distributional questions that emerge most immediately as they affect agriculture. Patents on the genetic makeup of crops and livestock could exacerbate the concentration of economic power in the global agri-food industry. Advocacy groups are concerned that this is already happening as large firms develop plant varieties resistant to the particular herbicides they market. They are further concerned that "species patents" on genetically engineered crops will hasten the corporate domination of global agriculture, perhaps impairing the economic viability of agriculture in poorer countries. The chance that such patents will survive legal challenges, and the implications if they do, are flagged as an area of high priority for further research.

In addition, the extension of the intellectual property regimes of developed countries to cover genetic resources could allow scientists and investors in those countries to appropriate both genetic resources and indigenous knowledge from the Third World. This phenomenon has been termed "bio-piracy" by critics, especially when human genetic materials are involved. In this context, the Rio Convention on Biodiversity raises complex issues involving not only the ownership of genetic resources already in depository collections, but also the meaning and implications of the concept of national sovereignty over genetic resources.

Finally, there is the potential for monopoly profits associated with the ownership of intellectual property rights. Arguably, this potential is inherent in the nature of a patent system, but it becomes ethically troubling when it involves access to lifesaving diagnosis and therapy. If the benefits of genetic research in terms of diagnosis and treatment are as dramatic as some enthusiasts believe, the question of excessive profits will invariably arise.

VIII. The Control of Environmental Hazards

In North America, public concern about the negative consequences of biotechnology began with environmental effects, including those of genetically modified organisms (GMOs). The relevance of environmental concerns to the issue of patenting is not immediately obvious. However, opponents of patenting might respond by arguing that the regulatory regime is either (a) inherently incapable of dealing with the hazards posed by GMOs, or (b) incapable of dealing with them at present. In either instance, the potential hazards may be serious enough that the incentive provided by patenting should not be provided.

This argument has been made with reference to characteristics of GMOs, such as the ability to reproduce and interbreed with native, unmodified species, which make them unlike other environmental hazards. A further concern is the possibility of unanti cipated gene transfer among organisms. These issues exacerbate the scientific disagreements and uncertainties that are already part of environmental regulation. If people's views on how uncertainty about environmental risks should be dealt with reflect competing attitudes toward technology, the social system and social interactions as a whole, as some social theorists claim, then conflicts about the environmental risks associated with biotechnology are likely to be both ethically and politically intractable.

IX. Animal Welfare

At least since the early nineteenth century, the public has become less willing to tolerate the infliction of suffering on animals. Genetic engineering of animals for agricultural or laboratory purposes could be harmful to them in a variety of ways, some of which have already been documented. According to both opponents and supporters of patenting, if patents on genetically engineered animals were not available, it would be less likely that such creatures would be developed for commercial purposes.

There are existing regulatory controls on the use of animals in laboratories and (to some extent) in agriculture, but critics might challenge both their ethical adequacy and their effectiveness. Further, regulatory controls may not be adequate where the patented characteristics or traits are in and of themselves likely to cause suffering, or where the suffering produced by the engineering of particular reproducible traits into animals is different in kind from that dealt with under current controls.

X. Patenting and Human Beings

Private firms in the United States are now applying for patents on human gene sequences. Ethical disputes about patenting a portion of the human genome are inextricably linked with conflicting views about the entire enterprise of genetic research involving human beings. With specific reference to patenting, the key questions are:

1. Should human beings themselves be patentable? It is taken for granted that they should not be, but the line between the human and the non-human may not be clear for purposes of patent law. In addition, there is not an explicit legal prohibition of patents on human beings. An argument can therefore be made that Canada should both adopt a specific statutory prevention on patenting human beings, and attempt to arrive at a definition of a human being for purposes of this exclusion.
2. What about patents on portions of the human genome? Despite the argument that patents are necessary incentives for private investment in research, many people are uncomfortable with the idea that someone might have the right to exclude others from using a portion of the human genome covered by a patent.
3. What about the conditions under which human genetic material is obtained? This issue was brought to public attention by the Moore case, in which a hospital patient unsuccessfully tried to collect a share of the royalties from a cell line obtained from his spleen. In another case, a patent application on a cell line "collected" from an indigenous Panamanian woman by U.S. researchers was eventually dropped after an international outcry. There should be a basic presumption that informed consent and equitable arrangements for distributing returns are essential ethical conditions for commercialization or patenting of genetic materials of human origin.

XI. Commodification and Objectification

Among the most potent objections both to genetic engineering itself and to patenting higher life forms is the diminished moral respect for life and living organisms that either or both might engender. This could occur by way of "commodification," the set of attitudes that ordinarily accompany commercial transactions, or "objectification". To objectify something is related to treating it as a market commodity, but what is disturbing about objectifying a person or organism is not the exchange of money but rather the notion that a subject, a moral agent with autonomy and dignity, is treated like an object.

The charge of commodification or objectification captures one of the most widely voiced criticisms of patenting: the failure of patent law to distinguish between living and non-living things. We need to ask precisely how patenting is likely to diminish respect for life, for example through commodification or objectification, and whether that diminished respect is of enough significance to justify restrictions on the patentability of living organisms. One of the key questions is that of people's ability to make the appropriate ethical distinctions in situations where commodification and objectification might occur. There are reasons to believe both that people can make these distinctions much of the time; there are also reasons to believe they cannot. Here even more than in other situations involving ethics and patenting of higher life forms, there are no easy answers.

XII. Conclusions: On Process and Substance

For this reason, we have taken a process-based approach to our recommendations. One approach to public policy choices about technologies that are unfamiliar and incompletely understood is to leave them up to the experts. However, societies are increasingly unwilling to do this, for a variety of reasons. Failing to have an informed public debate about the ethics of patenting higher life forms effectively prejudges the questions raised in this report in favour of a point of view that is relatively sanguine about potential hazards, and in favour of an incremental approach to dealing with those hazards. More particularly, with respect to matters such as the patenting of transgenic animals or of human cell lines and the products derived from them, any pretence to moral neutrality is itself not neutral because it predisposes public policy toward accepting the status quo and an incremental approach to policy formation that may not be justified. "Patent now, deal with the ethical questions later" is simply not a defensible approach, yet the Canadian Patent Office as presently constituted has neither the statutory mandate nor the capacity to deal with them.

Any effort adequately to address the ethical questions outlined in this paper will involve two institutional stages. The first stage should involve hearings by a Parliamentary committee given a mandate specifically to examine the ethical issues associated with the patenting of higher life forms and to recommend legislative, regulatory and policy changes. A key ethical question addressed should be whether the baseline or starting point for decisions about patenting higher life forms should be a presumption in favour of patenting or a presumption against it.

Until the public debate we envision has occurred, Canada should preserve the viability of as many policy options as possible, and should therefore resist pressure to adopt policies on intellectual property that might create additional restrictions on the ability to deny patents on higher life forms.

Assuming that some ethical constraints on the patentability of higher life forms are recognized and embodied in legislation, the application of general principles to specific cases will not be self-evident. Indeed, some ethical issues probably can be decided only on a case-by-case basis. There will therefore be a need for some institution to make those determinations. Our preferred option is that of an appointed ethical review board or panel that would operate at arm's-length from the CPO, but the options of requiring certification of ethical review by patent applicants and of leaving the meaning of statutory exclusions from patentability to the courts to resolve are also outlined. Many further details of course remain to be considered.

Finally, at present there is no provision in Canadian patent law for a challenge to patents on public interest grounds. We recommend attention to this matter if exclusions from patentability are adopted.