Integrated Summary Report: Summary of Consultations on Biotechnological Intellectual Property and the Patenting of Higher Life Forms

Introduction

5.0 The Rapporteur’s Perspective

Introduction

The 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:

• Highlight Documents – Roundtable Consultations
• Summary Report of the President/CEO Industry Hearing to CBAC September 2000
• Summary Report of the Non-Governmental Organization (NGO) Hearing to CBAC November 2000

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1.0 A Description of the CBAC Consultation Process

1.1 Purpose of the Consultations

The 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 Consultations

In 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:

• What should and should not be patentable?
• What are the mechanisms of governance available for change?
• How should social and ethical issues be addressed?
• Canada’s intellectual obligations and competitiveness.

To assist stakeholders in preparing and participating in consultations, CBAC issued two documents:

• Biotechnological Intellectual Property and The Patenting of Higher Life Forms – Consultation Document 2001
• Summary Document – A Summary of Proposed Ideas arising from Research Papers not addressed in on Biotechnological Intellectual Property and The Patenting of Higher Life Forms – Consultation Document 2001

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 Stakeholders

CBAC 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 Opportunities

Stakeholders were invited to provide input to CBAC in the following ways:

• Participation in Roundtable Consultations
  - Halifax - April 23, 2001
  - Montreal - April 25, 2001
  - Toronto - April 27, 2001
  - Vancouver - May 2, 2001
  - Saskatoon - May 4, 2001
  In total 156 stakeholders participated in the roundtable consultations
  
  
• Participation in CEO/President Briefing
  - Ottawa, September 29, 2000
  In total 16 stakeholders participated
  
  
• Participation in Non-Governmental Organization Hearing
  - Ottawa, November 23, 2000
  In total 17 stakeholders participated
  
  
• Scientific Researcher E-Forum – February 2001
  In total 13 participants
  
  
• Submission of Comments to CBAC – February to May 2001
  - Website submission
  - Written submission
  - Toll free telephone
  In total 10 submissions were received

1.5 The Role of this Report

This 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 Addressed

The 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.

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2.0 Identifying Issues and Guiding Principles

2.1 Overview

Developing 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:

• Does humanity have the right to manipulate life for its benefit?
• Is it wise for society to undertake modification of life if we do not know and understand the long-term risks of our actions?
• Who should be held accountable if something goes wrong with a biotechnological innovation?
• Does anyone have the right to prevent or stifle innovation that leads to societal benefits?
• Who decides what is right? What is the basis for such a decision?
• Does the public good override the rights of individuals or vulnerable groups?

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:

• Finding the proper balance between economic and research benefits on the one hand and health and environmental concerns on the other.
• Defining “safe” and “equitable” is important and necessary.
• Emphasis should be placed on accountability and enduring liability – mechanisms are required.
• The review process must be open and transparent and publicly available.
• Biotechnology encompasses many inventions that have different effects on humans, animals and the environment and raise different issues than more traditional technology. The review should deal with each form of technology separately.
• Science has overtaken public understanding. Informed people must make the effort to communicate with the public and build awareness.

Obtaining the Public Perspective on Social and Ethical Issues

Participants 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:

• The potential impacts of biotechnology are such that consideration of bioethics must be global.
• What should belong to all of society and therefore should not be patentable?
• A process is needed to determine costs, risks and benefits. How should we deal with uncertainties of unforeseen risks that may arise from biotechnology? We need to build in safety criteria.
• How do we achieve transparency in the decision-making process?
• What is the risk to environment/society of releases that may escape and affect the gene pool and biodiversity?

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:

• Education to inform participants.
• Formulation of questions that the public and experts can discuss productively.
• A clear understanding of what is important to Canadians, for example what values should guide Canadian approach to health care as opposed to American or European approaches?
• A means to capture the public consensus.
• A way to monitor the evolution of values.
• Different forms of biotechnology should be discussed separately. The issues and the public concerns with respect to food biotechnology are very different from those associated with medical or industrial applications. Treating these separately will make it easier to have a productive discussion.

2.3 The Advantages and Disadvantages of Patenting

The 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:

• Patenting may increase the amount of research undertaken in Canada resulting in societal benefits.
• Patenting may provide those who invest in research and development with a way to recover their costs, in turn resulting in further beneficial research.
• A patent requires disclosure, and disclosure aids research. The alternative to patents, namely, trade secrets, restricts the transfer of knowledge.
• If companies are forced to do research with no return for their efforts, Canada will lose its biotechnology industry to other, more receptive countries.
• Patent law is a vehicle that facilitates economic development and wealth generation.
• Patents enhance Canada’s international reputation as a country supportive of biotechnological research.
• Venture capitalists often depend on patented inventions when considering whether to invest.

However, other participants expressed concerns about possible detrimental aspects of patenting such as the following:

• Corporate financing may skew the research undertaken to commercial ends rather than what is best for society.
• To whom do benefits of research go? Should they accrue only to those who can afford to pay for research? How is the public interest served?
• Biotechnology research on animals is currently being conducted even without a clear position on the availability in Canada of patent protection over animals. Thus, patents may not provide a significant incentive for research.
• There may be no need to patent plants or animals. There are alternatives to patent protection, such as plant breeders’ rights, that can be effective.
• In the area of health, there is a need to ensure that patents do not have an impact on healthcare accessibility and cost. Several participants stated that this was of particular importance in the area of genetic diagnostic procedures.
• If a company controls the production of donor animals for human transplant, how is the public interest served?
• Patents restrict the use of research and enabling technologies, acting as a barrier to additional research.
• Onerous conditions on use of research for patents can stifle further innovation. These conditions may also block research or the examination of safety.
• Royalty payments may restrict access to inventions for use.
• Patents only support industry. Patents are not required if there is no desire to develop a particular industry. Does Canada want a biotechnology industry? There is a need to balance the negative effects of development of a biotechnology industry with the betterment of humankind.
• Innovation is driven by curiosity, not money. Therefore, the absence of patents might not get in the way of innovation and research.

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 Considerations

One 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:

• Should we develop and commercialize technologies that include life forms just because we can? In some cases moral and ethical considerations need to be taken into account in assessing the merits of the technology.
• Should something that can reproduce without assistance be patentable? Who has the right to make this determination?
• Do life forms have a special significance that requires a new decision-making process to determine patentability?
• We need to consider the ethics of manipulating natural life forms. Do humans have the right to modify life for our benefit?
• We need to assign responsibility, accountability and liability for unforeseen consequences if we allow patenting of biotechnology and higher life forms. Developers and implementers of life form based technology ought to be responsible for adverse effects that may result from patented animals and plants.
• Patenting of life forms increases the commodification of life.
• Patenting the products of biotechnology can adversely affect health care delivery if it makes diagnostic tools prohibitively expensive. In the United Kingdom, a publicly funded research foundation licensed its technology to industry on the condition that the technology be provided free of charge to the UK health care system.
• The need to conserve biodiversity by ensuring that the original organisms or strains of organisms are not lost due to the introduction of engineered organisms.
• Should there be a right to patent higher life forms derived from ecosystems in other countries without the approval of that country?

2.5 Cultural Considerations

Some 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 Principles

The 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 Consider

The following were suggested by participants as principles that CBAC may wish to add to the Ethical Context:

• Bio-diversity
  - the ability of nations to have control over their biological resources
  
  
• Environmental Protection
  - the maintenance of genetic diversity and promotion of sustainable development
  
  
• Non-malfeasance
  - to do no harm, to ensure that there is no potential for misuse of biotechnology
  
  
• Ecosystem Perspective
  - all principles should not be solely written from an anthropogenic perspective, but should include a broader ecosystem perspective
  
  
• Freedom to Explore, Investigate and Expand Knowledge
  - this principle should encourage learning more and not stifling human curiosity
  
  
• Respect for Human Rights and Dignity
  - add a principle that recognizes and protects human rights and the dignity of humanity and of all life
  
  
• Responsible Stewards of Life
  - Define humanity’s obligations to other forms of life

(c) Comments on the Proposed Principles

The following is specific advice on the wording of the principles as set out in the Consultation 2001 document:

1. Justice
   • It was suggested by some that this principle as written is a political statement because it deals with the distribution of benefits and burdens but does not address whether these benefits and burdens should be allowed to occur.
   • In addition to oppression, add a reference to avoiding exploitation of vulnerable groups.
   • Justice should also be considered in the context of developing countries. At present, the distribution of benefits of biotechnology is unfairly weighted in favour of developed countries. The emphasis of benefits should be shifted to developing countries.
   • There is a need to provide a definition of Justice. What is meant by “fair”, who are the vulnerable groups, and who determines who they are?
   
   
   
2. Accountability
   • The definition of accountability must describe who is answerable should something go wrong.
   • Add the concept that those who engage in biotechnology ought to have enduring liability for harm.
   • Consider combining accountability and autonomy so they can be balanced against each other.
   
   
   
3. Autonomy
   • The reference to informed choice may require elaboration. The principle should define how to properly engage people who may lack the knowledge or understanding of what is proposed in a way that ensures an “informed” decision.
   • Consider breaking this principle into two parts – (a) being informed (b) ability to act independently – define both.
   • The definition should include a reference to non-coercion, ensure the ability to make independent choice and decisions.
   
   
   
4. Beneficence
   • Define as a commitment to pursue “ALL” benefits.
   • Include in the definition the concept of the benefits of investment.
   
   
   
5. Respect for Diversity
   • Definition should specify bio-diversity in its broadest sense.
   • Extend the concept to specifically include plants, animals and the environment.
   
   
   
6. Knowledge
   • As currently written, the principle is not clear – define what is meant by knowledge.
   
   
   
7. Caution
   • It was proposed that this principle should simply be “a commitment to adopt a precautionary approach” and that the phrase “when knowledge is incomplete” is unnecessary. Where there is uncertainty, the “safest choice” should be made. The document must clearly define this principle.
   • It was suggested that the intent of this principle should be to avoid rushing into things without serious prior consideration but should also be concerned with being so cautious that any progress is not possible – must be balanced.
   • It was noted that biotechnology requires a ‘lot of caution’ because even experts are not clear about potential risks.
   • The precautionary principle, upon which the caution principle is based, is controversial, and there are several different interpretations. Does CBAC mean “if you don’t know, don’t do it” or does it mean “anticipate, go slowly and ensure you have an escape strategy”? This needs to be clarified.
   • Is the concept of “substantial equivalence” used in some regulatory mechanisms consistent with this principle?

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3.0 What should be patentable?

3.1 Overview

All 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 Plants

While 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 plants

Economic incentives to foster innovation
Among those in favour of patenting invented plants, most believed that the Patent Act is needed to provide protection of inventions and thereby foster innovation. The economic benefits to the patentee would provide incentives for creativity and promote further research and development. Patenting, it was argued, would provide some assurance to investors that they will receive compensation for the research and development they funded. It was expressed by some that this is particularly important for small companies that need to raise money to fund their research in a competitive North American market.

Funding for research
Some also noted that public sector funding for research and development is limited and that public policy needs to consider the dependence of research on funding from the private sector. Industry involvement and funding of research, in part raised by marketing patented products, would enable increased research in universities to take place and reward researchers for their efforts.

Disclosure of information
The disclosure of patented inventions, as required by the Patent Act, was also expressed as important for encouraging further innovation and beneficial developments. Several participants expressed the opinion that the availability of information on inventions resulting through the Patent Act makes patenting a preferred alternative to other mechanisms, in particular trade secrets. Some participants felt that, without allowing patenting, large corporations will still continue to develop and innovate, but with no obligation to make information about their invention public, thus stifling future research. Disclosure of information through patenting was also seen by some as a way to help build public understanding of the benefits of biotechnology.

Societal benefits
Among those favouring patenting of plants, recognition of broader societal benefits were discussed. It was suggested that patenting has the potential to enhance and change plants to meet the needs of humans. This could bring about increased quantity and quality of food production and reduce pesticide and herbicide use. Some argued that patenting could be a way to encourage development of a greater number of plant varieties, thereby enhancing biodiversity. Some participants also suggested that, because genetic modification is conducted in controlled environments, it is safer than traditional methods of breeding and selection. The Halifax consultation discussion focused particularly on the patenting of higher life forms for medicinal purposes. In this regard, participants were generally supportive of the patenting of plants for this specific purpose.

International competitiveness
Some participants agreed that the requirements for patentability (novelty, utility, nonobviousness) are sufficient and correctly interpreted in today’s laws. The work and ingenuity involved in modifying a plant by inserting a new gene are seen as justifying the award of a patent. Several of the participants supporting the current definition of invention and interpretation of the criteria for patentability also felt that making the criteria more stringent would put Canada at a disadvantage vis-à-vis the rest of the world. In this respect, it was felt that “going slowly”, as argued by some of those opposing patenting, will reduce Canada’s ability to compete internationally, and cause significant economic costs and harm to domestic industry.

Perspectives against allowing the patenting of plants, or in favour of patenting with conditions.

Unknown risks
Some participants were firmly against patenting of plants on the basis that we do not know the risks involved in biotechnology. It was suggested that we need to “stop the clock” while we undertake more research about the potential benefits and risks of biotechnological innovation. Many participants stated that, once patents are allowed for genetically modified plants, it will be too late to implement safeguards. Further, some felt that allowing patents on plants sends a signal to the public that the patented product is socially acceptable.

Access to benefits
Underlying many of the arguments against the patenting of plants was a general concern by many participants over the potential for increased power and control through formation of corporate monopolies. This was seen as an issue of limitation to fair distribution of benefits, and restricting access to inventions with public benefits due to too high costs (the AIDS vaccine was suggested as an example). In particular there was considerable concern expressed over the potential of patents on medical tests and products to drive cost significantly higher and potentially placing equal access to health care by all Canadians at risk. Provision must be made to ensure that patents do not undermine Canada’s health care delivery system.

Impacts on biodiversity
Many participants voiced strong concerns about the potential impact of biotechnological innovation on human health and the environment. In particular, there was concern about the potential for contaminating the gene pool as genetically modified plant genomes mingle through cross-breeding over time. In particular there was concern about the potential for unpredictable effects on wild species through cross-breeding with escaped plants that carry biotechnologically added genes. It was stated that we cannot predict the results on the environment should this occur. Some argued that genetic modification presents greater risks than does traditional breeding because it accelerates the natural processes of evolution. Some participants also felt that precision of predictive effects in laboratory settings is questionable and that results of genetic modification may only be assessed in the final use of the product, after the laboratory procedure has been completed.

Impact on agricultural policies
Some participants suggested that the patenting of plants will have negative consequences for agricultural policies and practices. Some stated that they are opposed to legislation that would in any way inhibit or interfere with traditional agricultural practices. Others were concerned with potentially tying the agricultural industry to a limited number of agri-business suppliers. In this respect, the concern is that companies may promote monocultural practices so as to maximize their profits. This was seen as both reducing access to a diversity of agricultural methods and ultimately affecting the distribution of benefits through high costs. At the CEO/Presidents briefing to CBAC, members of the agricultural industry expressed the view that they needed access to patented plants so as not to block access to platform technologies. It was suggested by some that Plant Breeders’ Rights inadequately protect genetic engineering and that, therefore, plant developers have resorted to trade secrets. This prevents open sharing of research and technology.

Commercializing research
In response to the argument that patenting may foster and provide access to research funds, many participants expressed concern with the increased cooperation between universities and industry. One consequence of this cooperation, they suggested, is increased dependence by universities on industry funding and the desire for commercialization of inventions. While private funding may push research in a particular direction (i.e. commercially viable), other beneficial research may suffer from lack of funding or researcher interest.

Restrictions on research
Some participants suggested that patenting of plants, through the current Patent Act, may restrict the use of inventions for further research. Pioneering patents that create a new field of research have greater scope than subsequent patents in the field and could be used to restrict access to new technology. Other participants were concerned that if it were possible to grant a patent for a single phenotype of an organism (an organism with particular characteristics) this would effectively give the patent holder a monopoly on the means to create the phenotype through a number of different processes or methods. This would inhibit others from finding other ways to create the same phenotype. In one discussion, it was noted that patenting a specific gene to improve the output or quality of a plant may be extended by an inventor to the entire plant and the industrial application for which it would be useful. This broad patent protection could also restrict access to technology and hinder further research and development. Other participants thought that the current interpretation of the Patent Act definition of “invention” creates further barriers to research because patented genes would be more costly to access, or the use too restricted. Investors are reluctant to fund research using patented genes for reasons of higher cost and less control. While patenting of plants may inhibit innovation and prevent people from developing better varieties, it was felt by some that the Plant Breeders’ Rights Act is not similarly restrictive.

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
Many participants felt that the existing patent system is not properly structured to deal with biotechnology issues and that substantial change is required. In addition, many were concerned that the regulatory systems that govern use of biotechnology after patenting is sometimes ineffective. Regarding the patent system itself, some felt that the interpretation of the novelty, utility and non-obviousness criteria for patents over genes was too simple a test and allowed mere discoveries of genes, as they exist in nature although isolated, to be patented. They felt that the mere ability to sequence genes should not enable people to obtain a monopoly through a patent.

Recommendations

It 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:

• “Stop the clock” while we undertake more research to gain knowledge of the benefits and risks of patenting plants.
• Place a moratorium on certain kinds of research (as has been done already in some countries), on things that should not be patentable in the first place.
• Adopting the Plant Breeders’ Rights is a preferred option over patenting of plants.

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:

• Establish an “ordre public” provision in the patent law, to serve as a moral filter. This recommendation was favoured by many participants. Many suggested that the Canadian patenting process should follow the European model more closely than the patenting process established in the USA. Examples of how the “ordre public” has been implemented in Europe were discussed and many participants felt strongly that a similar clause in the Canadian Patent Act would be consistent with Canadian values and approaches to decisionmaking. It was considered by many to be a necessary, although not completely sufficient, measure to integrate moral and ethical considerations with the patenting process.
• If patenting of plants is to be permitted, some type of farmers’ privilege should be incorporated into the Patent Process.
• The burden of proof of safety should be placed on the patent holder or applicant. If the patented material cannot be controlled or confined, the patent over the subject matter should not be issued.
• A precautionary principle should be employed throughout the patenting process to assist the government to deal with risk and uncertainty.
• An important principle when dealing with species that are important to Aboriginal peoples is that they be fully involved in the decision making process and understand their implications and be given an opportunity to share in the benefits.
• Rather than patenting plants or genes, only the use of the process or the application should be made patentable.
• Multiple patents over, for example, genes, plants and related processes should be avoided.
• Patents must not prevent others from doing research to seek improvements to a patented innovation. Agreements for the use of patents should be allowed between the patent holder and those who want to use the patent for further research.
• Mechanisms for revoking patents need to be established as a form of safeguard against wrongful use of the patent.

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:

• Establish an “ethics review board” or a “biotechnology advisory board” which would have an oversight responsibility within or over CIPO. The ethical principles proposed by CBAC should be applied by this independent body in the review of patent applications.
• Institute legislative ethical safeguards to address human rights and possibly the rights of other primates – may be affected by modified plants.
• Rather than making broad provisions or prohibitions within the Patent Act, Canada should focus on the use and implementation of the patent on a case by case basis.
• Require a genetic pollution law, so that persons are held accountable for the dissemination of genetic material into the environment.

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:

• In order for the public to be able to make informed choices about whether or not to buy a genetically modified product, provision of information, education and public debate is essential.
• Canada needs to decide on its own domestic approach within the context of our major trading partners. Given the global marketplace, some participants felt that Canada needs to “keep pace”. In light of this, Canada needs, for example, to amend our laws to conform with the 1991 International Convention for the Protection on New Varieties of Plants (UPOV) to catch up with our trading partners. (Currently, Canada is compliant with the 1978 UPOV.)
• It was also suggested at the CEO/President briefing to CBAC that Canada should reintroduce the former Bill C-90 in order to harmonize plant breeders rights laws with those of the USA and the EU. Bill C-90 would permit patenting of plants, define experimental use within the Plant Breeders’ Rights Act and expand protection of genetically modified plant varieties and plants derived from those varieties.
• A thorough review of how the patenting process and Patent Act will interact with the Plant Breeders’ Rights Act is needed. It was suggested by some that patenting should not diminish the rights and protection offered in the existing legislation. Some felt that farmers should be able to re-use seed, but not necessarily have the right to sell the seed. Others suggested that if patented seed is to be re-used, a licensing fee could be paid, which might be cheaper than buying new seed.

Governance
Most participants felt that the Patent Act and CIPO should not have a role in determining the social and ethical considerations regarding biotechnology. Similarly, many felt that the courts should not determine public policy on biotechnology and the patenting of higher life forms. Generally there was agreement that it is the responsibility of Parliament to determine Canada’s policy on biotechnology and to determine the specific exclusions and exemptions. Parliament reflects Canadian values and interests and it was felt is the appropriate institution to formulate policies and to decide on biotechnology matters. It is only through clearly stated regulations that specific direction and guidance as the issues surrounding biotechnology can be addressed. Legislation must be supported by specific policy guidelines and codes of conduct. These guidelines and codes of conduct provide the direction for regulatory processes responsible for biotechnology matters.

3.3 Animals

The 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 animals

Societal benefits
Most of the participants who favoured patenting of animals felt that patenting can contribute to the broader social good and that the concerns raised by those opposing patents can be best addressed through other means. Some expressed the view that patenting of animals should be permitted in Canada since it is not possible to draw a clear line between what is and what is not patentable. Some participants argued that patenting in itself will not encourage undesirable conduct given that humans have “tinkered with genes” for centuries already.

Stimulate innovation and research, support industry
Participants favouring the patenting of animals generally presented arguments similar to those in favour of patenting plants. Benefits of patenting, they argued, include motivation for research and therapeutic discoveries; support of medical and health research; support of Canadian industry; potential for increasing food production; and ensuring disclosure of inventions.

Medical research benefits
While participants generally agreed that unnecessary suffering of animals for the sake of enhancing social “lifestyles” should not be permitted, some felt that suffering of animals may be acceptable for the sake of health and medical research and benefits.

International Competitiveness
Several participants expressed the view that, if Canada adopts a different patenting system than its trading partners, it will create an unfavourable climate for innovation and investment domestically. Canada would thus not be considered to be among the nations that pay for innovation, and will be getting a free ride when it receives access to the resulting inventions. It was felt by these participants that Canada must pay its own pay.

Moral stance on patenting animals
In opposition to the view that humans should not have the moral right to control animals, some of the participants in favour of patenting animals argued that the issue is not one of ownership of animals but stewardship, given that society already acknowledges property rights over animals. Some participants suggested that animals are just another life form that exist along a continuum with micro-organisms on one end. The difference between higher and lower life forms is only a matter of complexity, not of principle. If simple life forms are patentable, and no one has an objection to this, “the genie is already out of the bottle”. It was also suggested that patenting of animals would not open the door to patenting humans, since this would be in violation of other principles and laws, especially the Canadian Charter of Rights and Freedoms.

Perspectives against allowing the patenting of animals

Moral/Ethical objections
Many participants felt that animals should not be made patentable on moral and ethical grounds. Many felt that life forms that are able to feel pain and can self-reproduce should not be patented. The position rests on the principle that it is unethical to own and control other living things, and that our own life styles cause unnecessary suffering to other life forms. Many also felt strongly that Aboriginal and other cultural, spiritual, or religious views that diverge from the western concept of ownership over animals must be respected.

Unknown risks
The participants opposed to patenting animals frequently emphasized that biological organisms are distinct from other inventions. They have evolved in concert with their surrounding environment and, as such, should not be altered by humans. Patenting of animals would imply interference in the genetic make-up of animals, and we do not know the implications of such actions. It was also suggested that problems may result if a genetically modified animal escapes into the environment and gives rise to unknown life forms. Some participants suggested that patenting of animals will lead to a reduction in available varieties of animals.

Lack of adequate safeguards
It was expressed by some participants that the patent system itself is an inappropriate tool for dealing with animal welfare issues, given that the Patent Act was designed for industrial processes rather than biotechnology. Some participants also expressed the view that they would have little faith in potential safeguards or decision-making processes to protect humans and the environment from the effects of patenting animals. There was concern as to who would make such choices, and who would design boundaries for the patenting of animals. Some suggested that by promoting the patenting of genes, we are being “blackmailed by industry”. It was felt that, if it is of high enough priority, society has other mechanisms than patenting to advance innovation. Some participants felt that the engineered animal should not be made patentable, but the process or application may be.

Recommendations
Many participants who argued that patenting of animals should be permitted also expressed strongly that ethical guidelines and adequate regulatory processes need to be established. Some stated that it is necessary to make the patenting process more responsive to societal views and to ensure transparency in the process. It was suggested that mechanisms be developed to identify relevant ethical or other issues during the patenting process. As well, many felt that ways of monitoring issues that may come up after a patent has been granted must be established. This was seen as particularly important for the patenting of animals, as unexpected effects are likely to result. A common concern was that issues of humane treatment are regularly reviewed.

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:

• Humans
• Processes or uses in which animals suffer. Some suggested that consistent animal welfare rules are needed to guide both private and public research.
• Pain and suffering by animals for the cause of “ lifestyle” products.
• Human organs (not the process to make or use that organ).
• All primates
• Within the patenting process, participants recommended a morality and “ordre public” clause to deal with environmental harm, harm to human health and animal suffering. As for patenting of plants, participants generally felt that an “ordre public” provision would be desirable if there is a commitment to make moral and ethical considerations a priority in reviewing patents.
• Possibly linked to the morality clause, some participants felt that mechanisms could be established for an opposition process to review patent applications.

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:

• A transparent and open social and ethical review body should be established. It should operate at arms length from the government, and should include expert and lay persons. Some felt that such a body should be empowered to assess patentability on a case-by-case basis and that the ethical review should be more than merely advisory.
• With the purpose of protecting biodiversity, scientific safeguards should be established to ensure that genetically modified species will not escape into the environment and replicate. Some suggested that a “terminator” mechanism be a condition of all plant and animal patents so that genetically modified species will survive only under specific conditions.
• Unlimited liability legislation should be created that would allow for class action suits, claims for damages and collection for damages in cases of environmental harm or injury to health.
• A post-patenting surveillance program should be established.
• Ensure stewardship over the animal. This would require monitoring of the ability to trace the origin of the animal.

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:

• There should be no legislative exemptions in the Patent Act that discriminate against biotechnology.
• Some participants suggested there may be potential value in having a farmers’ privilege for animals. Farmers’ role in improving stock should not be restricted.
• Canada should consider allowing research on subject matter as is done in Europe as opposed to the more limited exemption in the USA.
• We should find ways of testing without using animals, except as a last resort.
• A suggestions was made at the NGO hearing that medications produced through biotechnology must be made available at reasonable cost, so as to ensure public access to the use of biotechnology products. Further, financial rewards of biotechnological innovation should be shared with those who participated in the medical research (for example, by donating samples).
• Industry representatives at the CEO/Presidents briefing to CBAC suggested that an orphan drug law be instituted in Canada. The law would provide benefits to industry (including exclusivity in the market and tax incentives) to develop and market medications that affect only a small number of individuals in Canada. Orphan drug laws were seen as a way to particularly encourage small biotechnology companies to conduct research on rare diseases.

3.4 Questions unanswered

The 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:

• How synthetic does an organ need to be to be considered patentable?
• Should we make a distinction between domesticated animals and all animals?
• Should we permit patenting of crops that are sold for purposes other than food?

Other questions by the participants concern the control of resources and political decision making:

• Who will determine what is the public good and make judgements regarding that good?
• If a plant itself is valuable, should it be patentable? Who has the right, if any, to benefit?
• How do we deal with the ownership of indigenous knowledge and traditional ecological knowledge?

Participants also expressed concern with issues of access to knowledge and how to deal with risk:

• Should the lack of knowledge of the effect of biotechnology be the basis for not allowing patenting?
• How do we deal with unknowns and uncertainty?
• Is patenting the best way to make available information on innovation?

Other questions concerne the difficulty in finding practical solutions to some of the recommendations that had been suggested:

• How do we ensure that a public policy discussion occurs?
• Will not having patents prevent people from doing research?
• How do we protect against contaminating the gene pool?
• How can we be sure that animals used in the production of products are not suffering? Who gives the consent for animals?

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4.0 Determining Canada’s International Role

4.1 Overview

The 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:

• Are there any inconsistencies in approach among Canada’s international obligations? What are they? Why are they significant?
• What actions, if any, should Canada take to address its international obligations regarding the patenting of higher life forms and related processes?
• What international role should Canada play?

4.2 Inconsistencies in Approach Among Canada’s Various International Obligations

Participants 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:

• The time required to assess and approve an application for a patent takes too long in Canada when compared to the practices of our major trading partners, the United States and the European Union. This was described as a constraint that not only slows but also discourages innovation in Canada. This results in a perception that Canada is not receptiveto research and innovation in the area of higher life forms and drives both research and investment out of the country.
• Canada’s current position on patent restoration was also discussed as a further deterrent to research. By not providing for patent restoration rights, biotechnological research is not as vibrant as it might otherwise be.
• Canada’s failure to make its approach to patenting of higher life forms consistent with its trading partners provides an opportunity for them to challenge the Canadian patent system, resulting in patent policy for higher life forms being reactive and not proactive. As a result, Canada’s policy is being developed in an ad hoc manner causing Canada’s reputation in the international arena to suffer.
• By complying with these obligations, Canada’s trade relations and economy is positively affected by the international perception that Canada adheres to its obligations and is a hospitable trade environment for foreign investment in biotechnology.

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:

• Current treaties are biased in favour of trade and investment, with little regard for human rights, ethics and the environment. Re-negotiate NAFTA based on a new understanding of the potential impacts of biotechnology.
• Moral issues must take precedence over international obligations.
• Patent restoration can result in negative societal impacts, especially in the health care area. By extending patent rights, the costs of medicine derived from the patenting of plants and animals may remain unnecessarily high for a longer period of time.
• Taking patenting of higher life forms positions consistent with Canada’s trading partners may adversely affect the agricultural economy. The result may be additional cost to Canadian farmers or unfair restrictions on access to new food plants.
• Patenting of plants may not be necessary, other mechanisms like the Plant Breeders Rights and Seed Registration may be adequate.

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:

• helping Canada to maintain its highly qualified research community
• providing a stimulus for research initiative
• establishing a favourable climate for increased capital investment in Canadian biotechnology
• supporting the country’s growing biotechnology industry

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 Role

Participants 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
Some participants argued that Canada should ensure that any future treaties or agreements on biotechnological research and the patenting of higher life forms recognize the rights of indigenous peoples and respect for their traditional knowledge. It was pointed out at the NGO hearing that the current high costs of patent litigation prevent traditional communities and developing countries to challenge patents. This makes it difficult for certain communities to protect their traditional knowledge.

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
Some participants suggested that, in future treaties and agreements, Canada should aggressively promote new standards for reviewing and approving any higher life forms patent applications. This new standard should require:

• Assessment of the innovations against ethical considerations;
• A full life-cycle assessment of the innovations, to better understand all risks and impacts;
• Assessment of the innovation from an ecosystem perspective rather than a human-centered perspective;
• Assessment of the ability to ensure confinement of the innovation preventing escape into the environment.

Establishment of Biotechnology Safety Laws
Some participants suggested that Canada promote the development of an international law that prohibits genetic pollution. Any review of a patent application must be assessed for compliance with this law. This law should recognize the right to all people to access the biological commons of the Earth.

Support for Others
It was proposed that Canada’s international role should extend beyond the negotiation table. As a country, Canada has an obligation to share its biotechnological expertise and provide capacity development and institutional strengthening support and oversight systems regarding intellectual property and patenting of higher life forms, to countries in need of that support. Canada should develop policies and programs to facilitate the active involvement of Canada’s biotechnology industry as well as publicly funded researchers to participate in information transfer and support.

Experimental Use Exclusions
It was suggested that Canada secure agreement from the international community on a clear and common definition of the experimental use exclusion. Currently different countries define this exclusion in different ways. Canada should promote the acceptance of experimental use of patentable higher life forms research to assist in advancement of knowledge for acceptable and beneficial research proposes.

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:

• Develop policies and procedures to reduce the time required to issue a patent in Canada. The goal should be a timeline comparable to the U.S. and European Union patent system.
• The Government should ensure that CIPO is properly funded with sufficient resources to effectively manage patent applications.
• Adopt a peer review process for biotechnology patent application. Peer reviews will not only ensure a more critical assessment of patents but could also accelerate application processing timelines.
• Canada should become more aggressive in protecting patent holder rights from imported products. An approach similar to the U.S. was proposed.
• It was suggested at the CEO/Presidents briefing to CBAC that improvements are particularly needed in the clarity of the Canadian patent process. It was suggested that CIPO issue clear guidelines on filing applications and provide better assistance to would-be patent applicants, as is currently done by the US Patent and Trademark Office.
• Participants at the CEO/Presidents briefing to CBAC also suggested that some of Canada’s current practices be maintained, including the Patent Act provisions permitting an individual to challenge an issued patent without having to first infringe on the patent.

Consultation with Canadians
Finally, many participants felt that it was important for CBAC and the Government of Canada to continue to consult with stakeholders and the public on emerging biotechnology issues. In particular consultation should occur prior to Canada entering into any treaty negotiations respecting biotechnology. While many participants viewed the CBAC stakeholder consultation process as a good first step, they nevertheless urged CBAC to find ways to include more of the public in future consultation rounds.

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5.0 The Rapporteur’s Perspective

CBAC’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;
• Public information, transparency and accountability;
• Patenting of higher life forms;
• Balancing rights, benefits, risks and responsibilities;
• Canada’s international obligations and opportunities.

Ethics and Values in Patenting and Intellectual Property
As discussed earlier, this section comprises a summary of the observations of Dr. Rolleston during the stakeholder consultations. His views are his own and do not necessarily represent either the views of any particular participant or of CBAC.

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
Participants frequently emphasized the need for fuller public involvement in developing policy and making decisions. Such involvement demands transparency and openness, with twodirectional information flows. Citizens must be informed in language that they can understand about the issues and concerns as they are developing, and their input must be actively sought. Participants felt that these CBAC consultations, though valuable, are only a start; some felt that they were insufficiently inclusive of all interests. The difficulties of demonstrating a broad enough consultation were recognized; how can CBAC determine when there has been sufficient consultation? Though the views of indigenous peoples were often identified as essential to the present discussions, many participants stated that Canada’s many communities need to be involved.

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
Opinions were very divided in all consultation sessions on whether plants or animals should be patentable.

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
Participants generally expressed concerns about the possible negative impact on society as a whole because patents effectively confer monopolies. For example, could patents on an animal source for xenotransplantation, genes for breast cancer, or specific medications impose excessive costs for patients or health care systems? What is a “fair” return on holding a patent on an invention that may mean life or death? How should “fairness” be determined? “Fairness” to whom? Should societal considerations and needs be part of the equation, or should the marketplace determine “fairness?

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
Participants recognized the need to find a balance between following our own “made in Canada” approach, and harmonizing with other countries so that we are seen as responsible trading partners. Some participants saw international agreements as challenges to be modified as needs and opportunities arise. Above all participants felt that a public policy debate is required for Canada to decide what we want to achieve before trying to determine specific policies on how to balance sovereignty with internationalism.

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.