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Home Publications Consultations 2001 Integrated Summary Report: Summary of Consultations on Biotechnological Intellectual Property and the Patenting of Higher Life Forms1.0 A Description of the CBAC Consultation Process
1.1 Purpose of the Consultations
2.0 Identifying Issues and Guiding Principles
1.2 Key Issues for Consultations 1.3 Stakeholders 1.4 Consultation Opportunities 1.5 The Role of this Report 1.6 Topics Addressed
2.1 Overview
3.0 What should be patentable?
4.0 Determining Canada’s International Role
2.2 Should the Patent System Deal with Social and Ethical Issues? 2.3 The Advantages and Disadvantages of Patenting 2.4 Human Health and Environmental Considerations 2.5 Cultural Considerations 2.6 Guiding Principles
4.1 Overview
4.2 Inconsistencies in Approach Among Canada’s Various International Obligations 4.3 Canada’s International Role 5.0 The Rapporteur’s Perspective IntroductionThe Canadian Biotechnology Advisory Committee (CBAC) is an independent expert advisory committee created to assist the Government of Canada in the formulation of public policy on a broad range of biotechnology subjects. Its advice is provided to the Biotechnology Ministerial Coordinating Committee (BMCC), which comprises the federal Ministers of Industry, Agriculture and Agri-Food, Health, Environment, Fisheries and Oceans, Natural Resources and International Trade. CBAC’s Program Plan 2000, describes in detail its program of activities. One component is to provide advice to the Government of Canada on matters pertaining to Biotechnological Intellectual Property and the Patenting of Higher Life Forms. In preparing its advice, CBAC sought the views of a representative cross-section of Canadian stakeholders with an interest in this topic. The purpose of this report is to provide a summary of the views, opinions and advice from all CBAC consultations to date on Biotechnological Intellectual Property and The Patenting of Higher Life Forms. CBAC will solicit more views, opinions and advice from Canadians throughout the summer of 2001. This report is presented in the following sections. 1.0 A Description of the CBAC Consultation Process 2.0 Identifying Issues and Guiding Principles 3.0 What Should be Patentable? 4.0 Canada’s International Role 5.0 The Rapporteur’s Views Additional Input is found on the CBAC web site as follows:
1.0 A Description of the CBAC Consultation Process1.1 Purpose of the ConsultationsThe purpose of the consultations was to engage stakeholders in a dialogue to provide advice to CBAC on possible policy initiatives regarding on Biotechnological Intellectual Property and the Patenting of Higher Life Forms. 1.2 Key Issues for ConsultationsIn order to identify the key consultation issues, CBAC commissioned and published a number of research studies regarding Biotechnological Intellectual Property and the Patenting of Higher Life Forms. The research studies are available from the CBAC website. These research studies were reviewed and assessed and four key consultation issues were identified:
To assist stakeholders in preparing and participating in consultations, CBAC issued two documents:
The Consultation Document 2001, was the primary instrument through which CBAC sought stakeholder input. The document describes the four key issues and poses specific questions for discussion. 1.3 StakeholdersCBAC invited the participation of Canadian stakeholders from a wide range of interests. This included those with an interest in: health, consumers’ interests, environment, social welfare, agriculture, First Nations, religious perspectives, industry, law, research, academics and government. All stakeholders participating in these consultations are listed in the reports found in the additional input noted on page 1 of this document. Based on accepted research methods, CBAC decided to focus on stakeholder input in this phase of its consultations in order to determine the issues that needed to be resolved and to commence discussions among those knowledgeable in the field on how best to address these issues. This input will enable CBAC to prepare an initial report to the BMCC and the public setting out the issues that need to be addressed. The report will contain an educative component that is designed to enable the general public to participate in a discussion that often becomes technical. By proceeding in this way, CBAC hopes that the report can be used as a springboard for Canadians in general to participate in CBAC’s deliberations. 1.4 Consultation OpportunitiesStakeholders were invited to provide input to CBAC in the following ways:
1.5 The Role of this ReportThis report is a consolidation and synthesis of all the input received by CBAC through all consultation activities. CBAC will consider the contents of this report and the commissioned research studies in preparing its advice to the Government of Canada matters pertaining to Biotechnological Intellectual Property and the Patenting of Higher Life Forms. 1.6 Topics AddressedThe report summarizes the comments received from stakeholders through the consultations. Section 2.0 is a synthesis of the key issues identified by participants as being important and that need to be understood and assessed in developing any policy advice regarding Biotechnological Intellectual Property and the Patenting of Higher Life Forms. Included in this discussion are participants’ views of the principles and ethical context that CBAC proposed for developing policy in the biotechnology field. Section 3.0 summarizes comments received regarding what should be patentable, and what safeguards, exclusions and exemptions that Canada should consider. Section 4.0 addresses Canada’s International Role, with specific suggestions regarding Canadian actions for compliance with current treaty obligations, as well as advice on a future role for Canada in discussions and negotiations regarding Biotechnological Intellectual Property and the Patenting of Higher Life Forms. Section 5.0 – The Rapporteur’s Perspective is a summary of the observations of Dr. Francis Rolleston. Dr. Rolleston attended all roundtable consultations and provided his perspective of the key issues and suggestions from the stakeholders. It should be noted that Dr. Rolleston is presenting his own views on what he heard and they do not necessarily reflect the views of any particular participant or of CBAC. 2.0 Identifying Issues and Guiding Principles2.1 OverviewDeveloping public policy advice on Biotechnological Intellectual Property and the Patenting of Higher Life Forms raises many issues that require careful consideration. Of primary concern are the social and ethical considerations surrounding the patenting of life forms; the contribution of biotechnology to Canadian society, the significance of the biotechnological industry to Canada’s economy and uncertainty regarding the environmental and health effects of biotechnological innovation. This section summarizes the views and opinions of stakeholders on these issues. In addition, other more specific issues were identified by participants. These are summarized and presented in Section 3.0 – What is patentable? And Section 4.0 – Canada’s International Role. 2.2 Should the Patent System Deal with Social and Ethical Issues?The dominant concern during the consultations was the role that social and ethical considerations should play in Biotechnological Intellectual Property and the Patenting of Higher Life Forms. Many significant questions were raised:
While most participants agreed that these issues need to be debated and addressed, there were different opinions as to whether the Patent Act and the patent process is the appropriate forum through which to do so. Some participants maintained that while social and ethical issues pertaining to biotechnological innovation are important and must be addressed, patent law and the patent process is not the appropriate vehicle for such considerations. Some participants were of the view that, as a statute dealing with property rights, the Patent Act is not the place to deal with social and ethical issues. These participants suggested that Canada create a separate regulatory review mechanism to address ethical and social issues arising out of biotechnology innovation in much the same way that pharmaceuticals are currently reviewed for safety. This view was re-enforced by some who felt that the Canadian Intellectual Property Office (CIPO) staff should not be making ethical decisions because they lack the knowledge and skills to do so and have no appropriate mandate to allow for such decisions. If a separate regulatory system were to be devised, participants felt that there was a need to clearly define the relationship between patenting and the assessment of social and ethical concerns. Some felt that the system should combine flexibility with security so as to respect ethical considerations without slowing research and delaying the creation of innovations. A central aspect of this system would be mechanisms to balance the benefits of biotechnology to society against the costs of this innovation to society. A third view suggests that ethical considerations should take precedence over commercial interests within the patenting process. Similar to an old provision in the Patent Act that an illicit invention could not be patented, a provision could be developed for biotechnological innovations that prohibits the issuance of patents because of ethical concern or the fear of unknown risk to humans or the environment posed by the invention. What Form of Ethical Review?Participants provided considerable advice as to the form of the ethical review of biotechnological innovations. It was suggested that there is a need for prior review of ethical concerns arising from a biotechnological invention as is now done with respect to research involving human subjects or animals. There may be a role for an ethics review body to decide whether a proposed patent should be refused on moral grounds. Another approach would be a process that links prior “ethical audits” to patenting. An independent body could look at ethical considerations and decide jointly with CIPO whether to grant a patent in particular circumstances. As a counterpoint to this line of reasoning, some participants maintained that compulsory ethical review may not work because inventors may decide to avoid patenting their innovations, at least in Canada, and may opt for other mechanisms, including trade secret protection. This would prevent inventions from being publicized, as they would have been under the patent system. There was broad agreement that a thorough review of the social and ethical aspects of biotechnology needs to be undertaken in the form of “ethical due diligence”. The result of this exercise would be a policy framework in which clear Canadian positions on IP and PHL are developed. Rules that try to anticipate future risks and future societal values would not be effective because risks and values change quickly. A more flexible mechanism in the form of a policy framework is preferred. Some additional comments on an ethical review process include the following:
Obtaining the Public Perspective on Social and Ethical IssuesParticipants in all groups stressed the importance of understanding and assessing the social and ethical issues related to biotechnology from the Canadian public perspective. These are important issues of concern to Canadians and require a thorough and open discussion. The reasons for making social and ethical issues paramount is underscored when the following questions and statements from the participants are considered:
While participants had no specific answers to these questions, it was frequently mentioned that informed public debate was required to resolve them. These issues affect all Canadians, and should not be left to “the experts” to decide. Some of the conditions proposed for a constructive public debate on the ethics of biotechnology are as follows:
2.3 The Advantages and Disadvantages of PatentingThe second major concern focused on the merits of the patenting of higher life forms. Some participants strongly expressed the opinion that the benefits of the patent system needed to be considered and weighed in determining policy on patenting biotechnological innovation involving life forms. Of paramount importance is understanding the value of the patent system to encourage innovation resulting in many benefits including:
However, other participants expressed concerns about possible detrimental aspects of patenting such as the following:
Many patentees indicated that they far prefer a U.S. patent to Canadian one for reasons both of market size and also of accessibility and cost of the patenting process. Their primary focus is not on the Canadian patent system but on that of the U.S. and the market in the U.S. Some participants noted the need to make the patenting process less expensive for smaller companies. If the cost is prohibitive, large industry will dominate. As patenting becomes more expensive, there is an increase in market consolidation, limiting access and competitiveness. The Patent Act can be improved to make it more responsive to the needs of small companies. One specific suggestion was to add a tax to the patent-processing fee that could then be used to assist small companies in paying for the costs of patenting. In order to maintain the benefits of patenting, some participants felt that it was important to keep Canada’s patenting process in conformity with our international obligations. Canada can choose to be out of step with our trading partners, but only at the risk of being internationally uncompetitive. Doing things differently from our trading partners could harm the biotechnology industry in Canada. 2.4 Human Health and Environmental ConsiderationsOne of the greatest concerns expressed by participants centered on whether humans have the right to assume control over other life forms. While many suggested that plants and animals are already regarded as property and have already been greatly changed by humans through directed breeding, there were several participants that suggested that this does not mean that humans have the right to manipulate or alter life. This is especially so if the inventor of new life forms cannot guarantee that modified life forms can be confined and controlled with no possibility of escape into the environment. Some asked how can one assure that the spread of engineered genes will not result in risk to human health or the environment? If there is no guarantee, how can society permit biotechnological products to enter markets? The patenting of gene sequences blurs the distinction that we have traditionally maintained between life forms and material objects. The manipulation of life should not be allowed, not only on moral grounds, but also from an ecological perspective since we may not understand the long term implications to our ecosystem from modified life forms. Other issues include:
2.5 Cultural ConsiderationsSome participants raised concerns about the unequal distribution of the benefits of patents and infringing on cultural norms. Patents were described as protecting developed economies, but may disadvantage other cultures in less developed countries. Indigenous cultures whose traditional knowledge is being used as part of an invention over which patent protection is being sought do not obtain the benefits of the patent or the invention. Some countries (e.g., Kenya) are establishing procedures to protect indigenous knowledge. Some research centres (e.g., the Danforth Centre, St. Louis) have a requirement that use of a patent is to be given without charge to developing countries. The issue of the protection of aboriginal collective rights within the patent system was often raised. Certain populations have unique genetic profiles that have value for research. Instead of encouraging “Bio-prospecting and Bio-privacy”, there is a need for partnership and for sharing of these research benefits. There is also a moral obligation to share profits resulting from the use of traditional knowledge; compensation or royalties must be provided if traditional knowledge is used in research leading to a patentable invention. The effect of patenting of life forms on aboriginal peoples was expressed from another perspective. If a patent is granted on a chemical or a gene sequence that is found in a wild plant, then that plant will have monetary value. There will then be an incentive to harvest it, which may result in over-harvesting to the point where the plant becomes an endangered species. If aboriginal communities make use of this same plant, its scarcity will have adverse affects on culture since the plant will no longer be available for traditional uses. 2.6 Guiding PrinciplesThe Canadian Biotechnology Advisory Committee has identified and proposed principles to develop a framework for assessing proposals for public policy related to biotechnology matters. The principles are presented on page three – Box One, in CBAC’s Biotechnological Intellectual Property and the Patenting of Higher Life Forms, Consultation Document 2001. As part of the consultation, CBAC was interested in obtaining comments on these principles. Specifically, CBAC was interested in knowing whether the participants felt that the proposed principles are appropriate and whether there are additional principles that should be considered. (a) Comments on the Principles – Are they Appropriate?Almost all participants agreed that the principles presented were appropriate, representing a good starting point for biotechnological policy development. Stating the principles in broad terms was also considered appropriate since the nature of principles is to be over-arching and directional. Some, however, suggested that the framework as presented is too outcome oriented. Before assuming an outcome, CBAC should conduct an assessment of the outcomes to determine whether or not these are desired for Canada. The assessment of outcome should be conducted in a way that probes at the underlying moral and philosophical issues raised by biotechnology in general and intellectual property and patenting of higher life forms in particular. This should include Canada’s positions on such matters as the nature of life, the ownership of life, and whether humanity has the right to manipulate life. However, many participants suggested that while the principles provide a reasonable framework, the real challenge is in the interpretation and application of the principles. It was felt that CBAC needed to continue to identify, understand and describe Canadian values and ensure that these values are reflected in the definition of the principles. It was viewed as essential to clearly define what these principles mean since as currently described, some of the principles are open to various interpretations. It was also noted by several participants that there might be an inherent conflict between and among the principles. For example, how does this framework reconcile the economic benefits of biotechnology on the one hand with the principle of Justice and Beneficence on the other? Some suggested that citing ethical principles is not helpful if their applicability is not demonstrated. CBAC was therefore urged to provide clarification demonstrating how these principles could be applied. (b) Additional Principles to ConsiderThe following were suggested by participants as principles that CBAC may wish to add to the Ethical Context:
(c) Comments on the Proposed PrinciplesThe following is specific advice on the wording of the principles as set out in the Consultation 2001 document:
3.0 What should be patentable?3.1 OverviewAll consultation activities asked participants to consider whether plants and animals should be patentable and, if so, under what conditions. The discussions reflected a wide range of views and perspectives. While some participants were firmly in favour of patenting plants, and others were just as firmly against, most participants called for approaches somewhere between these opposites. There was generally greater support for the patenting of invented plants than the patenting of invented animals. It was widely agreed in all consultations that Canada’s current Patent Act does not adequately accommodate the issues surrounding biotechnological development. A range of possible amendments to the existing patenting process was suggested. In particular, many felt that there is a need to clearly identify which higher life forms can and cannot be patented; where to “draw the line” between those higher life forms that should be patentable and those that should not; whether humans have the moral right to control other living things; possible economic implications for Canada of patenting or not patenting higher life forms; and whether the Patent Act should differ substantially from the patent processes of our major trading partners. The importance of establishing ethical and/or moral safeguards, within and/or external to the patenting process, was stressed by several participants in all consultation sessions. Further, many participants strongly expressed the need to improve the regulatory systems surrounding biotechnology research and use to ensure that there exist appropriate checks and balances prior to or in parallel with the patenting process. Many felt that adequate processes for monitoring the use of patented higher life forms also needs to be put in place. The following section outlines the arguments expressed for and against the patenting of plants and animals, and the recommendations for actions suggested. Major questions that remained unresolved in the consultation discussions, but which were expressed as key concerns by the participants, are also presented. 3.2 PlantsWhile many participants were favourably disposed to the patenting of plants and their component parts, this support was frequently expressed as conditional upon changes to the current Patent Act and to accompanying regulatory systems. On the other hand, some participants strongly opposed the patenting of plants altogether. Perspectives in favour of allowing the patenting of plantsEconomic incentives to foster innovation Funding for research Disclosure of information Societal benefits International competitiveness Perspectives against allowing the patenting of plants, or in favour of patenting with conditions.Unknown risks Access to benefits Impacts on biodiversity Impact on agricultural policies Commercializing research Restrictions on research Plant Breeders Rights has a proven track record that has encouraged investment in research and development of plant species. As a result, today there are more varieties available to farmers with improved agronomies and quality traits. The ability to protect these varieties through Breeders Right has been the cornerstone of these new developments. Some participants suggested that the Patent Act should be amended to make Plant Breeders Rights compliant with 1991 UPOV. This will further increase research and development. Inadequacies of the patenting and regulatory frameworks RecommendationsIt was generally agreed among most participants that mechanisms for examining the environmental and social effects of patenting plants would be needed. A call for establishing moral and ethical safeguards was also frequently made. The recommendations put forth varied, however, with the participants’ perspectives on the extent to which they felt plants should be made patentable in the first place. Among those who felt that, overall, plants should not be patentable; the following recommendations were expressed:
Among those who felt patenting of plants would be acceptable, a range of suggestions was made, including various conditions under which patenting should occur. It was very strongly expressed by most participants that the development and implementation of a sound, effective regulatory system is essential. Such a safeguard system could be instituted both within the patenting process and in the broader regulatory framework. Regarding safeguards within the Patent Act and patenting process itself, the following was suggested:
Many participants felt that the social, environmental and moral issues need to be dealt with primarily outside the patenting process. Suggestions for safeguards to be established external to the Patent Act, included:
In addition to the safeguard measures within and external to the patenting process, other broad recommendations were made to CBAC regarding the patenting of plants:
Governance 3.3 AnimalsThe discussion on patenting of animals elicited a wide range of views, and participants were quite divided in their opinions. On one end of the spectrum were those who see patenting of higher life forms as immoral and unethical. On the other end of the spectrum were those who see no difference between patenting animals or plants or inanimate objects. In between these stances were participants who were somewhat supportive of patenting animals but only on condition that clear guidelines and constraints exist as to their use. Some of these participants stated that only in certain circumstances may patenting of a limited type be acceptable. However, these participants stated that humans and other primates should clearly be excluded from patentability. A number of participants had difficulty coming to a firm opinion on whether animals should be patentable or not. The central question appeared to be where the line should be drawn between those animals that ought to be patentable and those that ought not. Perspectives in favour of allowing the patenting of animalsSocietal benefits Stimulate innovation and research, support industry Medical research benefits International Competitiveness Moral stance on patenting animals Perspectives against allowing the patenting of animalsMoral/Ethical objections Unknown risks Lack of adequate safeguards Recommendations If patenting were to be allowed for animals, participants recommended that exclusions be made for patenting of particular inventions or higher life forms. The following exclusions were suggested by different participants:
Participants suggested that moral and ethical safeguards for the patenting of animals could be established both within the patenting process and external to the Patent Act. In comparison to the discussion on patenting of plants, however, participants were more adamant about the need to establish external mechanisms for safeguarding and monitoring ethical and moral issues concerning the patenting of animals. Many expressed strongly that animal welfare and human risk issues should be dealt with in a separate framework, outside the patenting process. Ethics reviews, it was suggested, should not be the responsibility of CIPO. Some participants felt that patenting of animals ought to be clearly subordinate to legislation on human rights and animal welfare legislation. Some felt that legislation should also clearly define the limit of how far patenting over animals should go. The following recommendations were made in this regard:
In addition to the safeguard measures within and external to the patenting process, other broad recommendations were made to CBAC regarding the patenting of animals:
3.4 Questions unansweredThe discussions on whether or not plants and animals should be made patentable gave rise to many complex questions, most for which the participants had no clear answers or which fell outside the scope of the consultation sessions. The questions left unanswered to a great extent reflect the discussions on principles and issues of patenting and the difficulty in defining moral and ethical parameters, both for individuals and for society as a whole, to guide the answers. Many of the questions raised concern moral definitions and “drawing lines”, such as:
Other questions by the participants concern the control of resources and political decision making:
Participants also expressed concern with issues of access to knowledge and how to deal with risk:
Other questions concerne the difficulty in finding practical solutions to some of the recommendations that had been suggested:
4.0 Determining Canada’s International Role4.1 OverviewThe final topic of the consultations addressed Canada’s international obligations and role concerning biotechnological intellectual property and the patenting of higher life forms. The participants noted that the patenting systems vary considerably between countries, especially between our major trading partners, the United States and the European Union. Most participants recognized that Canada is bound by treaties to specific actions in patenting, but also has some flexibility to chart its own course. In addition to addressing its own sovereign interests, participants suggested that Canada has an opportunity to provide international moral leadership in a new approach to patenting. Many participants suggested that Canada needs to identify what actions are in its best interests and consider how it can implement these actions within the existing requirements of treaties and obligations. The discussion on Canada’s international role focused on these themes:
4.2 Inconsistencies in Approach Among Canada’s Various International ObligationsParticipants acknowledged that there were inconsistencies in the approach taken by trading partners with respect to patentability of higher life forms. The inconsistencies included variations in the subject matter patentability; different approaches to exemptions from infringement, and differences regarding exclusions such as the ordre public and morality clauses. With respect to fulfilling Canada’s current treaty and agreement obligations regarding the patenting of higher life forms, some were of the opinion that Canada has no choice but to comply; not only must Canada fulfill its current obligations, it makes economic sense to comply. Several reasons were provided supporting this position:
Not all participants shared the view that Canada must harmonize its patent process for higher life forms as prescribed by treaties and agreements. Reasons for this included:
The third view that was expressed by roundtable participants is that Canada needs to assess its approach to patenting of higher life forms in a way that best meets the needs of Canada. While it was acknowledged that existing treaties and agreements place some requirements on Canada, there is sufficient flexibility to define a preferred Canadian approach, charting its own course with respect to what’s patentable, and the nature of exclusions and exemptions. Many participants felt strongly that this is what Canada must do. Considerable advice was also provided regarding whether Canada should establish its approach to patenting of higher life forms to align specifically with either the United States or European Union approach. Some participants suggested that it is desirable for Canada to adopt the patenting approach practiced by the United States. The U. S. is Canada’s largest trading partner and the two economies are becoming highly integrated. Further, the North American Free Trade Agreement requires specific actions by Canada. To ignore these obligations may result in Canada experiencing sanctions and/or penalties. For the Canadian biotechnological industry to prosper and remain competitive there is a clear advantage to adopting patenting of higher life form policies consistent with the U. S. From an investment and trade perspective it was felt that being consistent with the U. S. would maximize benefits for Canada by:
Other participants expressed a preference for adopting the European Union approach since ethical and societal considerations seem to play a more significant role in the patent process. It was felt by these participants that the Canadian view of ethical and societal issues was more consistent with that in the European Union. Many other participants felt strongly that Canada need not harmonize its patent process with that of any one country. Canada rather should be selective in adopting what it feels is most appropriate. It was suggested that Canada should develop its policy and patent process in a way that reflects Canada’s values and interests. In particular, there was a strong expression of support by all roundtable sessions urging the adoption of an ordre public and morality clause by Canada; a clear definition of an experimental exclusion provision; and a prohibition on any patents respecting human and other primates. All the treaties and obligations allow for exemptions and exclusions, these need to be assessed for application to Canada. Some participants felt that Canada needed to develop a comprehensive biotechnology strategy. The strategy should be guided by future public policy consultations. The public policy development should be supported by a comprehensive evidence based assessment of the implications of any treaty compliance action. The assessment should address a broad range of ethical, social, economic, human rights and environmental considerations, clearly describing the advantages and disadvantages of compliance actions for Canada. The assessment should be presented in a way to better inform Canadians about the implications of intellectual property and patenting of higher life forms, treaty obligations. It was proposed through one submission that CBAC should review and assess the African model legislation for Protection of Rights of Local Communities, Farmers and Breeders, and the Regulation of Access to Biological Resources, prepared by the Organization for African Unity. The principles and perspectives presented in these documents may provide value to CBAC in formulating specific advice regarding Canada’s Patent Act and biotechnology. It was felt that these documents provide example of how to change the Patent Act to address issues of concern and meet the requirements of the current WTO TRIPS Agreement, the Convention on Biological Diversity and the International Undertaking on Plant Genetic Resources. 4.3 Canada’s International RoleParticipants in each of the roundtable discussions suggested that it was important for Canada to assume a leadership role in all ongoing and future international negotiations regarding biotechnological intellectual property and patenting of higher life forms. The primary role that Canada should assume is one that promotes the consideration of ethical, societal, human rights and environmental considerations in any future treaties and agreements. Participants expressed a number of different suggestions as to positions that Canada should articulate in international discussions. Protection for Indigenous Peoples Consultation participants felt that Canada should lead the development of a partnership framework that respects and protects the interests of indigenous peoples. This should include benefit-sharing mechanisms that ensure that any population that contributes to biotechnological research fairly shares in the distribution of benefits derived from that research. The framework should also promote the establishment of clear guidelines for ensuring the informed consent of all who contribute to biotechnological research. Guidelines should address such matters as: the reasons for research, potential outcomes and possible uses of the research; such that indigenous peoples can decide whether they wish to contribute to the research. A suggestion was also put forth at the NGO hearing to establish an ombudsperson. This person would handle complaints by communities that feel that their traditional knowledge or biological material has been taken without their consent or without appropriate compensation. Another suggestion was made that Canada establish a trust into which a determined royalty be paid for those using Canada’s biological resources. This trust could be used to compensate First Nations or other communities for the use of the biological resources to which they are entitled. Comprehensive Assessment of Higher Life Form Patents
Establishment of Biotechnology Safety Laws Support for Others Experimental Use Exclusions Enhancing the Canadian Patent Process Some participants felt that before Canada can assume a leadership role on the international stage, it must first “get its act together” at home. It was suggested that if Canada wants a vibrant and healthy biotechnology industry as part of the Canadian economy, a change in our patent approach is necessary. The following suggestions were provided:
Consultation with Canadians 5.0 The Rapporteur’s PerspectiveCBAC’s roundtable consultations included a rapporteur’s summary of each roundtable and his observations of the discussion. The rapporteur’s perspectives and observations of stakeholder participants at the five roundtable consultations are summarized under five headings:
Ethics and Values in Patenting and Intellectual Property Participants in all sessions welcomed CBAC’s introduction of issues of ethics into considerations of patenting and intellectual property. A common thread in the consultations was whether the concerns of ethics relate more to biotechnology itself than to the patenting of biotechnology. Many of the concerns raised appear to have more to do with whether biotechnological innovations should be developed and used than with whether they should be patentable. Many felt that CBAC should address the broader picture of the development and use of biotechnological innovations before focusing on the question of whether they should be patentable. Participants agreed generally that ethics must inform the processes of innovation and bringing new developments to market. The question is: how? Though participants generally agreed with the broad value and principle commitments enunciated in the Consultation document, they asked what they meant, how they should be applied, and how they can be incorporated into specific decisions in the real world of innovation and patenting and marketing. The principles and values need to be integrated throughout discussions on patenting. CBAC would make a very significant contribution to public understanding by indicating how the balance needed in applying ethics and values might affect practical decisions. Participants also generally agreed that considerations of ethics should influence the patenting process, but there was much less agreement on how this should be done. Patents may often be very important in obtaining investment, but they are an optional step in developing an innovation to the market place. Though this study focuses on patents, the arcane and technical patent process is probably a weak point from which to address social policy objectives. Participants felt that legislation or regulation at steps that occur before an innovation can be patented, or, probably more importantly, when a new invention is brought to the market, are where social policy objectives are inserted most effectively. At best, conditions around patents can reinforce objectives addressed primarily through other means. Hence, CBAC should take a broader view of the innovation process when it considers inserting new requirements that reflect social policy. Despite this view, there may be room for modification of the patent process to reflect ethics. Many participants expressed the need for some kind of filter, audit or review process that would allow ethical values to have some impact. Participants generally agreed that CIPO or the courts should not play this role, since both must work within existing legislation. A publicly accountable body or structure, enabled by legislation to address ethics issues and resolve conflicts in a national context, seems preferable. Possible mechanisms might include a CBAC like body, an ombudsperson, or a commissioner. The objective should be a system that has public trust, reflects the diversity of the Canadian people, is open, transparent, effective and efficient, and does not unnecessarily impede what is already an expensive and cumbersome process. Such a process could incorporate the “ordre public” or public morality considerations or mechanisms that are in effect in Europe. Public information, transparency and accountability Bringing these very complex technical issues into the public domain requires setting them out in a manner that is accessible to non-experts. Participants expressed a strong desire for greater precision than they found in the Consultation document on the meanings of words such as caution, precaution, approach, principles, and the various terms used to describe the ethical principles. In particular, many participants sought guidance on the practical implications of the terms used, for example, by illustrating them with realistic scenarios. Though participants in the consultations could generally be thought of as well informed, huge gaps of understanding were evident; scientists, policy makers, public advocacy groups, the media, the general public often showed as much diversity of opinion within their groups as between groups. Some felt that national debate is limited by expressions of extreme positions, and by processes of policy development that tend to suppress diversity of view within organizations in favour of “the party line”. As in almost any area of public policy, openness and transparency in setting out the issues are essential. Participants recognized the ultimate authority of the marketplace in determining commercial success, but also felt that it will function more effectively if it is well informed. However, in addition to information, economic factors are also very important. Powerful industrial interests with economies of scale may be able to deliver new products at significantly lower costs than small organic or non-biotechnological producers; such factors may favour genetically modified products. Patenting of higher life forms Many participants asked whether the patenting process, which was conceived in the 19th century in the context of widgets, is really applicable to life forms that can reproduce and/or hybridize with other organisms, and hence can not be withdrawn once they escape. Self-reproduction raises questions over monopolies over living property that do not apply to devices or chemicals. Concerns were raised over the concentration of power and interests that may arise from patents, and that the very wide range of factors in biotechnology may be too broad for management through one process. Some felt that patenting may be more acceptable for higher life forms that are to be used in human health than for other areas such as agriculture or cosmetics. However, some were concerned about the hype around the impact of biotechnology on human health. Most agreed that biotechnology is moving much faster than the public capacity to understand or manage the issues. Many who were opposed to patenting animals were prepared to accept patents on the technologies to develop genetically modified animals, or the use of such animals. Also, a number of those who were prepared to consider the patenting of animals felt that this right should be limited by consideration of such factors as the suffering imposed on the animals balanced against the uses envisaged for the modified animals, with medical uses having the highest priority. There was generally greater support for patenting genetically modified plants, though similar concerns were expressed as for animals. Balancing rights, benefits, risks and responsibilities The recognition of the contributions of traditional knowledge also raised concerns among participants about the “fair” sharing of benefits. For example, a new medicine may be extracted from an herbal remedy that has been used by indigenous peoples in its natural form for generations. How should Canada identify who has a legitimate claim to the economic or other benefits of an innovation? How should competing claims be divided? Through the patent process or the courts, in which the high costs involved may tend to favour the more wealthy? Is the patenting process uniformly accessible? Some participants feared that the costs of obtaining or protecting patents give significant advantages to large industries. Making patents harder to get, particularly for smaller companies, can be expected to increase incentives to move to other countries, with economic costs to Canada. Self-reproducing life forms can be expected to escape. Some participants asked whether the patent holder should be required to take responsibility for foreseeable and non-foreseeable effects, for example, of contamination of crops that another farmer may want to keep free from biotechnologically modified varieties, or of modification of wild species (e.g. fish) by crossbreeding with biotechnologically modified animals. Canada’s international obligations and opportunities In addition, many participants felt that Canada, with links both to the U.S. and to Europe, is in a position to exercise moral leadership for the whole world in establishing a new international consensus on values and principles and their implementation in patenting of higher life forms. Development of a national position through inclusive, open and transparent processes that reflect Canada’s diversity is necessary before we can go international. Also, the development of Canada’s position probably should not be driven purely by altruism; Canada needs to look after her own interests at the same time as considering the longer term consequences of a new international patenting regime. |
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Created: 2005-07-13 Updated: 2006-07-17 |
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