Conclusions: On Process and Substance

XII. - Conclusions: On Process and Substance

A distinguishing characteristic of democratic institutions is that their acceptability is determined as much by how they make decisions (process) as by the nature of the decisions they produce (outcome). At least as important as the outcome of policy decisions about patenting higher life forms is the process by which such decisions are reached. Indeed, democracy is largely about process, and about the willingness of all parties involved to live with the uncertainty of the outcome in any particular case.⁽²⁷¹⁾

How should societies and governments make choices about technologies that are unfamiliar and incompletely understood? One approach is to leave such decisions up to the experts: those who "know best." However, democratic societies appear increasingly unwilling to do this with respect to choices involving science and technology, whether those choices concern the siting of hazardous waste disposal facilities or the environmental hazards of genetically engineered plants.⁽²⁷²⁾ The controversies that have surrounded the marketing of food preserved using irradiation and milk from cows given bovine growth hormone provide two apt examples. Such mistrust is fuelled in part by experts'(as well as so-called laypersons') often incomplete enumeration of technological risks,⁽²⁷³⁾ and in part by straightforward misuses of the authority that accompanies the specialized knowledge of experts. Brian Wynne argues, in this regard, that "the heart of risk perceptions and risk conflicts [is] not the issue of technical risk magnitudes, but rather trust in institutions."⁽²⁷⁴⁾ The nature of trust has also changed. Whether in the clinical or the political context, trust based on status, power and expertise has been replaced by a more egalitarian conception of earned trust. By definition the latter cannot be demanded; it must be continually earned and justified.

Questions of trust and appropriate mandate are especially important in the context of genetic engineering and its products. Because of, for instance, the uncertainty associated with the environmental health and safety impacts of the release of genetically engineered organisms, biotechnologies are at best imperfectly amenable to conventional techniques of risk assessment. According to Nancy Davis, because new biotechnologies "may radically change the way people can and will live their lives, some of the risks they pose are special. It is not clear that such risks can be adequately assessed, or even properly understood, within the confines of a consequentialist framework."⁽²⁷⁵⁾ The definition of a consequentialist framework used by Davis is narrower than ours, and excludes some effects of biotechnological advances on human attitudes that we have included. Nevertheless, her warning should be heeded.

Many of the points made in the preceding paragraphs are reflected in the findings of a 1993 survey on public attitudes toward biotechnology in Canada conducted by Decima Research for the Canadian Institute of Biotechnology. A summary of that survey is worth quoting at length:

First, there is recognition that biotechnology is extremely powerful, and that while two-thirds of respondents believe that it offers "some/a lot of benefit", two-thirds also believe that biotech poses "some/a lot" of danger to society. Two global domains of public concern were identified: first, that there is potential for the misuse of biotechnology, and secondly, that biotechnology amounts to tampering with nature.

Finally, the survey indicated that public confidence in biotechnology companies is moderately low, and trust in government to ensure the safety of biotechnology is only moderate. A majority of respondents do not believe that the established [industrial biotechnology] sector takes account of the human consequences of biotechnology.⁽²⁷⁶⁾

The survey results are broadly consistent with those from similar surveys in a number of other jurisdictions.⁽²⁷⁷⁾

Gillian Turner and Brian Wynne have identified as a key element of so-called cultural theories of risk the insistence that "risk definition ... is a social process, and no framework can claim a privileged status over others. Risk definitions have to be negotiated."⁽²⁷⁸⁾ This point is extremely important, as are the questions it leads us to ask. With specific reference to human germ line modification, Krimsky has argued:

The implications of genetically modifying germ cells are far from understood. Many agree that there are profound consequences associated with initiating such experiments, but few can even begin to anticipate the scope of these consequences. Therefore, to begin such a process without understanding its broader implications, without a reasonable idea about whether it is possible to control the process once it is begun, and without a strong consensus from an informed electorate would be socially irresponsible.⁽²⁷⁹⁾

Viewed this way, the argument against patenting is an instance of a more general argument for the social control of technology, and perhaps even of a mistrust of technology. How relevant is this position to patenting? Why should consensus about patenting be required when a variety of other human activities are permitted despite bitter conflicts that do not appear amenable to easy or rapid resolution (e.g. clearcutting the forests of British Columbia's Clayoquot Sound, raising and trapping animals for fur, building nuclear power stations)? An answer to this hypothetical challenge depends crucially on just how special the potential hazards associated with genetic engineering and patenting higher life forms really are ... and this, in turn, depends on the resolution of any number of factual questions that can only be answered as the technology develops and as social scientific research into its implications continues.

Although consensus may never be achieved, failing to have an informed public debate about such questions effectively prejudges them in favour of a point of view that is relatively sanguine about potential hazards, and in favour of an incremental approach that cannot accommodate long-term, sweeping and unique hazards. To repeat Radin's observation, the effect is to "take the status quo as given morally, not just empirically." Patent lawyers who opposed the temporary 1987 moratorium in the United States argued that the PTO should be "morally neutral" and should not function "...as a forum for assessing the consequences of introducing new technology."⁽²⁸¹⁾ A similar argument has been made in Europe:

The ethical concerns currently raised in conjunction with biotechnology patents are misplaced because they stem from a lack of understanding of the patent system. A patent system is not a means of safeguarding the public interest. It is primarily a commercial and industrial tool that encourages innovation, divorced from social and ethical concerns.⁽²⁸²⁾

This line of reasoning is elaborated in a landmark article on constitutional decision- making by the judiciary in which Cass Sunstein argues that the concept of neutrality is unintelligible except when understood with reference to a set of socially and culturally specific baseline assumptions that together define the natural, the good and (perhaps most importantly) the normal.⁽²⁸³⁾ At least in North America, the basic principles of patent law can be traced historically to an underlying, not always explicit, equation of the public interest with the furtherance of commercial and industrial innovation. Once we accept, even provisionally or for purposes of argument, the claim that advances in biotechnology might create serious tensions between the public interest and the furtherance of commercial and industrial innovation, the patent system's claim to moral neutrality is called into question. This is particularly true if there are intrinsic ethical problems with granting patents on certain higher life forms. In this situation "patent now, deal with the ethical repercussions later" is simply not a defensible approach. Patent offices, as presently constituted, cannot deal with those ethical repercussions and should not be expected to. They lack both the statutory mandate (at least in Canada and the United States) and the requisite institutional capacity.

Any effort to address the ethical questions outlined in this paper adequately will involve two institutional stages or "tiers". Given the potentially far-reaching consequences of patents on higher life forms, particularly if the claims of promoters about the role of patenting as an incentive to research and development are accurate, there has been remarkably little public debate in Canada about when such patents are ethically acceptable. The first stage should therefore involve a forum for public debate about the general principles that should guide policy responses to this question. There are several institutional options for conducting such a debate. One is to establish a Royal Commission, analogous to the RCNRT, but this approach has the obvious disadvantages of being both costly and time-consuming. These are serious drawbacks given the financial constraints on government and the pace of developments in biotechnology. Another option is a process of informal consultations analogous to the one that will shortly begin on the federal discussion paper on Improving Social Security in Canada. However, these consultations involve issues that already have a very high profile, rather than issues about which the level of public information and awareness needs to be raised. Further, unless it is eventually concluded that no further change or elaboration of current public policy with respect to patenting higher life forms is necessary (a conclusion with which we would strongly disagree), the ethical issues will ultimately have to be addressed within a legislative framework specifically designed by Parliament to deal with those issues. The exclusions contained in the EU Directive constitute one example of such a framework, although it is possible to envision a framework that would be more specific as well as one that would be even more general. In Canada, this would take the form of amendments to the Patent Act, and quite possibly to other statutes and regulations as well. The two sets of changes might well be interdependent. For instance, it might be concluded that the ethical acceptability of patenting certain kinds of genetically engineered organisms depends on the strengthening of existing regulatory controls on such matters as the treatment of laboratory animals or the use of genetically modified plants in agriculture.

Both for this reason and because of the public profile often associated with such proceedings, we recommend that hearings be held 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. Obviously, such a committee will have considerable latitude in choosing its own approach to the issues. However, as suggested at several points in this report, a key question (perhaps the key question) is whether the baseline or starting-point for purposes of making decisions about patenting higher life forms, both at a policy level and in specific cases, should be a presumption in favour of patenting or a presumption against patenting. The former presumption is implicit in Canadian intellectual property law, and manifests itself in the absence of any statutory authority to deny a patent on what might be called public-interest grounds. The latter presumption is similar to that which operates (at least in theory) with respect to the regulatory screening of prescription drugs and pesticides, where demonstrations both of safety and of efficacy are required before approval is granted. In other words, under the latter presumption patent applicants would need not only to meet the conventional tests of novelty, utility and innovation, but also a variety of other tests designed to reflect the ethical issues distinctive to intellectual property rights in higher life forms. Beyond and apart from this initial choice of baselines, the analytical framework presented in this paper should provide a useful basis for framing questions, if not for arriving at easy, uncontroversial answers.

Until the public debate we envision has occurred, Canada should preserve as much public space as possible for that debate, and protect the viability of as many policy options as possible. This issue arises with some urgency because of the concern that industry and government may seek to limit that space, and the concern that governmental decisions may unintentionally have that effect. Both the final text of the GATT agreement dealing with intellectual property⁽²⁸⁴⁾ and the final text of NAFTA, the North American Free Trade Agreement,⁽²⁸⁵⁾ leave considerable space for national action. Neither appears to preclude exclusions like those in the EU Directive. However, the Clinton administration and its key private-sector advisory committees on trade policy have indicated their intention to seek further entrenchment of intellectual property protection through bilateral trade and investment negotiations.⁽²⁸⁶⁾ This development would preclude the kind of national debate and initiative we see as essential. For this reason, it is important that, for now, Canada not make any commitments in new bilateral or multilateral agreements that would limit our ability to restrict patenting of higher life forms based on non-commercial criteria.

Regardless of the substantive conclusions that are ultimately reached by a Parliamentary committee (or some other body) and eventually embodied in legislation, the application of general principles to subsequent specific patent applications will not be self-evident, and their implementation will not be automatic. Indeed, in many situations it is likely that the ethical acceptability of patenting can and should be decided only on a case-by-case basis, although with reference to a set of general principles. (The EPO's approach to the Harvard mouse patent is an example.) The institutional framework within which that decision-making will take place is itself of considerable importance. Obviously, some of its features will depend on the general principles around which the institution is designed, and our approach is not intended to entail specific decisions or to entrench particular value positions in advance of public debate. As with the public debate that we envision preceding it, though, the institution that makes decisions in specific cases must be as open and public as possible, recognizing patent applicants' legitimate expectation that delays will be minimized and the confidentiality that must be maintained until patent applications are laid open to public inspection.⁽²⁸⁷⁾ We have already argued that the CPO, in its present form, is not an appropriate forum for such debate and decision-making. Three options, which by no means exhaust the range of possibilities and combinations, can be considered as alternative mechanisms for public, accountable review and decision-making.

Option A involves an appointed ethical review board or panel that would operate at arm's-length from the CPO, yet would be called upon for decisions in cases where the denial of a patent might be justified on ethical grounds. A key issue for this option is the composition of the board. How large should it be, and who should be a member? Should such a board or panel contain scientists, business people, laypersons, and ethicists? What about the danger that ethicists may become a new and special category of experts, with their own institutionalized biases? Should an attempt be made to achieve "representation" of the various constituencies with a stake or an interest in patenting policy? If so, what would a search for representativeness imply for the nature of ethical decision making? Would it erode the distinctiveness and the prominence that are generally accorded to ethical issues, by reducing their resolution to a process of lobbying and interest-group accommodation?

Instead of creating a national review body, option B establishes a statutory or regulatory requirement that applications for certain categories of patents on higher life forms be accompanied by a certificate of compliance with ethical criteria analogous to those that must be satisfied by applicants for federal funds to support research involving human subjects. Key issues with this option include: What body would supply such certificates? Do the committees that now provide ethics review for university-based research have the resources and capacity (or, in some instances, the independence) to expand into this new area? How, for instance, would an animal care committee or an institutional review board that reviews research on human subjects deal with some of the far-reaching implications of patenting explored in this report?

Option C takes no further action beyond legislative amendment, leaving to the courts the task of resolving conflicts in specific cases. This alternative has the apparent advantage of minimizing additional costs to government.⁽²⁸⁸⁾ Were this option selected, the parties or groups who have standing to object to the issuance of a patent on ethical or public-interest grounds would have to be clarified. But this will need to happen in any case, for reasons explained later in this section. More basic issues include whether the only mechanism for ethical scrutiny of patenting decisions should be the costly, time-consuming and adversarial path of litigation, and whether courts are really the best forum for resolving the "polycentric" questions associated with patenting higher life forms.⁽²⁸⁹⁾

Among the merits of option A, which lead us cautiously to favour it, are: the probability of a greater degree of consistency in decision-making and interpretation than would be likely if those tasks were left either to a number of separate bodies or to the courts; the fact that it may be easier to make provision for ongoing consultation and public participation when a single national body is responsible for ethical review; and the fact that there are no existing bodies whose mandate is to provide ethical clearance for research carried out in the private sector or (in some cases) under direct contract to governments. The unavailability of ethics review bodies outside universities and hospitals, and the varied composition and effectiveness of these bodies even where they do exist, could create substantial difficulties in implementing Option B.

The recommendation that a single national body with a mandate for ethical review be established resembles the far more ambitious proposal of the Royal Commission on New Reproductive Technologies (RCNRT) to establish a National Reproductive Technologies Commission "charged with the primary responsibility of ensuring that new reproductive technologies are developed and applied in the public interest."⁽²⁹⁰⁾ The Commission's own work arguably corresponded to the first tier of the approach we recommend here. The proposed National Commission corresponds to the second tier; it would "permit the creation and implementation of coherent, comprehensive, and effective nation-wide standards and monitoring devices" and could "apply an ethical framework in decision making and ensure that the interests of all concerned groups and individuals are considered in setting policy and standards and assuring adherence to them in practice."⁽²⁹¹⁾ The responsibilities of the National Commission would include licensing practitioners of a variety of new reproductive technologies; developing national guidelines and standards of practice for research and delivery, based on the work of permanent subcommittees; and collecting, evaluating and disseminating information about new reproductive technologies and their use.⁽²⁹²⁾ Our recommendation is also similar to the approach proposed by GROW, which during the debate on Bill C-15 suggested the appointment of a board of public-interest representatives to advise on intellectual property issues as they apply to agriculture.⁽²⁹³⁾

With respect to the composition of its proposed National Commission, RCNRT favoured "diverse representation of interests"⁽²⁹⁴⁾ and recommended that the Commission's subcommittees include, as well as members of the Commission itself, outside members who could represent "the views and interests of governments, professional bodies, consumers, and other groups with particular interest in the area of sub-committee activity in question."⁽²⁹⁵⁾ It is premature to make recommendations on such points; further, although we are concerned with issues of representation at the decision-making level, we are even more concerned with the openness and transparency of the process by which decisions are reached.

One important issue that requires further consideration is accountability. Let us assume for purposes of argument that there will be some form of arm's length ethical review of at least certain categories of patent applications on higher life forms. In deciding whether to issue a patent, should the CPO be bound by the decisions of its ethical advisors, or should those decisions remain advisory in nature? The RCNRT's proposed National Reproductive Technologies Commission would have an explicitly regulatory role, rather than just an advisory one. Another issue is that of standing. Suppose that a patent were granted in Canada on the Harvard mouse, or on a particular genetically modified agricultural animal. Would an individual or organization seeking to challenge this decision on such grounds as the impact on animal welfare or on our attitudes toward life and living beings be granted standing to do so, either in the courts or in some other forum?⁽²⁹⁶⁾

In addition to being an important practical problem, this is also a philosophical and a legal/procedural problem. As noted earlier, independent third parties do have a vehicle for challenging the grant of a patent in Europe, although this mechanism comes into play only after the patent is granted. Under Canada's Patent Act, no express standing is granted to the public or other third parties. Section 10 is the only place where the public is recognized in the patent application process: "... all patents, applications and documents filed in connection with patents or applications for patents shall be open to public inspection at the Patent Office, under such conditions as may be prescribed."⁽²⁹⁷⁾ Current CPO practice is that members of the public may file a protest with the Patent Office. Although there is no specific mention of such protests in the Patent Act, section 15 of the Patent Rules states that "the receipt of a protest against the granting of an application shall be acknowledged by the Office, but no information shall be given as to the action taken thereon," meaning that a protest cannot be followed up meaningfully. Section 2.07 of the Manual of Patent Office Practice expands upon this and states that a protest may develop "as a result of public inspection of an opened application."

These provisions would not appear to preclude a public interest protest. However, CPO has no statutory basis for refusing a patent on public interest or ethical grounds. An extensive search of patent cases at both the administrative and judicial levels fails⁽²⁹⁸⁾ to uncover a single case where a member of the public (or interested third party) has sought standing in the courts to challenge a patent on public interest grounds. Once a patent has been issued, the lack of any statutory basis for refusing a patent application on public interest grounds means the validity of the patent can be challenged only on a technical point of patent law. This would not be the case if exclusions of the type embodied in the EU Directive were added to the Patent Act. The Patent Act's failure to provide any formal mechanism for opposition to the issuance of patents is a particularly serious deficiency given the ethical concerns raised in this paper and the importance of public discussion of ethical issues. Specific attention should be paid to the issue of standing if ethics- or public interest-based exclusions are added to Canadian patent law.

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