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Home Publications Consultations 2001 Highlights of Vancouver Roundtable IP/PHLCBAC Roundtable Consultation on Biotechnological Intellectual Property and Patenting of Higher Life FormsVancouver Session
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Stakeholders | |
Abraham, Sam | BC Cancer Agency |
Bannister, Kelly | Faculty of Law/School of Environmental Studies – Eco Research Chair – Environmental Law and Policy |
Bruce, Caroline | University of British Columbia, – Industry Liaison Office |
Draper, Dale | BC Ministry of Forests |
Hamilton, Tatyanna | Royal Roads University |
Holland, Wil | BC Old Age Pensioners Organization |
Howard, Pat | BC Biotechnology Circle |
Kadonaga, Lisa | University of Victoria, Dept. of Geography |
Kingwell, Brian | Smart Biggar Fetherstonhaugh & Co. |
Lauzon, Patrick | Merck Frost |
Litman, Moe | University of Alberta – Health Law Institute |
Losken, Karl | Earth Save Canada |
Mably, Paul | BC Ministry of Employment and Investment, International Branch |
Mah, Bernadette | Science Council of BC |
Mazo-Gray, Victoria | Research Scientist |
McKellin, William | University of British Columbia, Dept. of Anthropology & Sociology |
Moore, Stephen | University of Alberta - Dept. of Agricultural, Food & Nutritional Science |
Mykle, Anre | BC Chamber of Commerce |
Nield, Jeff | Farm Folk City Folk |
Osinchuk, Myka | Alberta Biotechnology Association |
Phillips, Lesley | Cubist Pharmaceuticals |
Reid, Ron | University of British Columbia, Faculty Of Pharmaceutical Sciences |
Rendina, Charles F. | Lightyear Technologies |
Reynolds, Paul | Simon Fraser University |
Rocheleau, Catherine | Catherine Rocheleau & Associates Inc. |
Sersli, Stephanie | Simon Fraser Public Interest Research Group (SF PIRG) |
Stinson, Paul | BC Biotechnology Alliance |
Sullivan, Bill | Guild, Yule and Company Barristers and Solicitors |
Tees, Susan | Patent Agent |
Technical Resources
Dominique Hussey
Richard Gold
Sanjay Venugoopac – Industry Canada
Gary Hewston – Agricultural and Agri-food Canada
Canadian Biotechnology Advisory Committee
Mary Alton Mackey
Denny Warner
Canadian Biotechnology Secretariat
Norma Burlington
Kelly-Anne Smith
Media Relations
Karl Martin
Facilitation Team
Christina Burns
Peter Homenuck
Jim Micak
Anna Olsson
Francis Rolleston
Raymond Vles
Christel von Engelbrechten
The Canadian Biotechnology Advisory Committee (CBAC), as part of its national consultation process held a roundtable in Vancouver, British Columbia, May 2, 2001, to address matters concerning Biotechnological Intellectual Property and Patenting of Higher Life Forms.
To engage stakeholders in a dialogue to provide advice to CBAC on possible policy initiatives regarding Biotechnological Intellectual Property and the Patenting of Higher Life Forms (IP and HLF).
The roundtable addressed three matters: identifying issues and guiding principles; the types of higher life forms, if any, that should be patentable and subject to patent protection; and determining Canada’s international roles.
The discussion on issues that need to be understood and assessed produced a long list of challenges that must be met to effectively assist in developing the necessary policy.
Participants expressed general concerns on a range of issues: what are the ethical and moral grounds on which choices would be made; who would make the decisions; do we know enough about impacts (health, environmental, economic and cultural) to confidently make decisions; what are the costs and benefits of patenting of higher life forms; how do we monitor and manage biotechnology and the patenting of higher life forms through the existing regulatory system?
These concerns are discussed in greater detail below.
Some participants stressed the benefits of patenting, including the disclosure of information to support new inventions (the alternative being secrecy) and the economic incentives for research. Furthermore, a patent regime that differed too much from that of our trading partners could harm Canada’s competitiveness.
In response it was noted that patents can sometimes slow down innovation by restricting access to an invention for further development by others. Are there alternatives to patents that could achieve the same benefits without this restriction?
Other concerns regarding patenting included:
Some of the issues raised were related to the scope of what should be patentable:
Participants agreed that biotechnology gives rise to many ethical and moral issues. Some participants felt that these issues should be dealt with outside the Patent Act so as to keep the Act focused on the protection of intellectual property. They argued that the Patent Act and patenting process are not equipped to deal with ethical and moral issues, nor should it be. Other participants were less certain that this distinction could be so clearly made.
The decision-making processes respecting biotechnology in general and patenting higher life forms in particular were topics of considerable discussion. Who should make the decisions on biotechnology: Parliament or the courts? Can court decisions be changed through legislation? How can transparency and adequate consultation be assured? What is the role of moral or ethical review in patenting? How can ethical issues be introduced into a regulatory process where science dominates? Can government be trusted to make the right decisions on these issues? Whose perception of risk is paramount, that of the public, or the experts?
Some participants felt that there was a need to find the right balance between risks and benefits; between ethical and environmental considerations on the one hand, and the benefits of technological progress on the other.
It was suggested that the experience of other countries with these issues would be useful to Canada, for example the Royal Commission on Biotechnology in New Zealand.
Some participants believed that patenting could have environmental and cultural impacts. If a patent is granted on 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.
It was noted that through the use of traditional knowledge, for example, medicinal plants are used to facilitate creation of new substances. Some participants felt that the people possessing this traditional knowledge should be given compensation when it is used in biotechnology research.
While aboriginal people do not do “research” in the modern, empirical sense of the term, they developed traditional knowledge through a process of trial and error. Those who use the knowledge to create new products from which they profit should share some of the profit with those who provided the traditional knowledge used to create the product. This revenue will help maintain aboriginal communities and traditional culture.
In response, it was noted that if the compensation to be paid for the use of traditional knowledge were too high, then researchers would use other methods to achieve their goals.
A participant noted that both English common law and aboriginal cultures favour the sharing and distribution of information and knowledge without charge. How then do we determine the value of traditional knowledge? Should aboriginal people who contribute toward an invention be direct beneficiaries, or indirect, as part of the general public who benefit from the invention?
It was suggested that those wanting to use traditional knowledge should follow aboriginal customs and tradition in the sharing of knowledge. This might serve as a bridge between the two cultures. For example, in order to successfully create a National Park in the Queen Charlotte Islands, Parks Canada was asked to become an official Haida clan. They agreed and participated in the traditional native ceremonies. This act greatly facilitated the introduction of the park and the creation of good relations with the native people. It was noted that the absence of aboriginal representation made it difficult to discuss these issues. It was suggested that is important to ensure that Aboriginal interests participate in any future consultation process.
Some participants expressed the following concerns about biotechnology in general:
Participants agreed that the principles listed in the Consultation Paper (page 3) were good. Nobody disagreed with them. The principles are stated in broad terms, but he nature of principles is that they should be over-arching. The difficulty will be to operationalise them. For example it was pointed out that there might be a conflict between these principles and the economic benefits of biotechnology. How is this to be reconciled?
It was noted that the principles were not explicitly referred to in the subsequent discussion in the remainder of the consultation document. This was unfortunate, because principles should serve as a touchstone in the discussion of patenting issues.
It was suggested that two principles in the UN Convention on Biological Diversity should be added: the ethical distribution of benefits and the control of nations over their biological resources. Canada is a signatory to the convention which therefore needs to be reflected in the principles.
There were numerous questions as to the words used in this principle: What is meant by “fair”? Distribution among whom? Who are vulnerable groups? How would these determinations be made and by whom?
There were some concerns that this principle might give rise to unrealistic expectations or result in over-legislation that would be a disincentive to innovation.
It was suggested that this principle be broken down into two parts: being informed and acting independently. The idea of being non-coercive should be included; having autonomy does not necessarily mean ability to make a free choice.
Some participants asked whether accountability is different from the responsibility to prevent negative outcomes? It was suggested that this principle be expanded to describe how people should be answerable and to whom.
It was noted that biotechnology requires a ‘lot of caution’ because even experts are not clear about potential risks. It is difficult to determine where the line should be drawn, since there is always a risk.
The precautionary principle, upon which the caution principle is based, is controversial, and there are several different interpretations of it. 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”?
Is the concept of ”substantial equivalence” used in regulation development consistent with this principle?
Participants were asked to consider whether plants and animals should be patentable, and if so, under what conditions. The discussions were wide-ranging and highlighted a variety of perspectives. Further, the discussions identified a number of concerns that will need to be addressed to put in place the checks and balances necessary to deal with social and ethical concerns if patenting of plants and animals is to be permitted.
Many participants agreed that the simple act of patenting by itself, within existing legal parameters, may not be a problem. However, patenting raises significant societal issues and concerns about use and effects of biotechnology.
Many participants agreed that a thorough discussion on patenting higher life forms must be preceded by an open, transparent public process to obtain broad public opinion that will set the basis for Canada’s public policy position. Participants also felt strongly that an improved regulatory system must be put into place to monitor any implementation and use of patented higher life forms. While some participants felt Canada has a good regulatory system, many noted that the existing system was not set up to deal with biotechnology. Other checks and balances need to be implemented before or in parallel with the patenting process.
Others pointed out that the existing patenting process was developed for the industrial age and not the biotechnology age. A separate and different approach to patenting may be appropriate. Still others felt that patenting plants and animals was not appropriate under any circumstance.
While there was not one dominant position on patenting higher life forms, there was generally more support for patenting plants than animals.
The details of the discussions follow.
Four central questions emerged from the discussions as follows:
The benefits of patenting were described as the promotion of research and creativity as well as provision of incentives for developing innovations that would provide economic benefits. Increasing yields and quality and reduced use of herbicides were noted as broader societal benefits. Patenting was also seen as encouraging public disclosure and militating against secrecy.
Disadvantages noted included restrictions on the use of inventions, potential effects on biodiversity, a push for changes in agricultural practices, and tying the agricultural industry to a limited number of farm suppliers.
Participants were unsure as to whether or not the relationships between universities and corporations were beneficial. Some argued that industry involvement and funding of research enables research in universities to take place, partly due to marketing products through patenting, which raises funding. This is positive.
While others agreed that the patenting of plants may provide incentives for further innovation, they were concerned about whether private funding pushes research in certain directions and not others based on what can be commercialized. Do we want to fund that kind of research? One of the consequences of the cooperation between universities and industry is the formers dependence on industry funding and commercialization. As a result, basic research may suffer, and there may be a loss of research in areas that are not commercially funded.
The following points were noted and questions were raised:
Some participants felt that patenting is not the only way to protect intellectual property. They felt that plant breeders’ rights could offer benefits without some of the possible disadvantages.
In this context, other participants felt that traditional breeding/selection may be more dangerous than genetic modification, because genetic modification is smaller and more controlled. Others argued that genetic modification is more dangerous than traditional breeding, because it accelerates the natural processes of evolution. As well, precision in laboratory settings is questionable. Results may only be assessed in the final use of the product, after the laboratory procedure has been done.
Some noted that an innovation can be protected as a trade secret but the fact that it is not disclosed, as a patent application would be, is a disadvantage.
The general concern about patenting plants seemed to be largely rooted in issues of concentration of power and control. However, others felt patenting was a reasonable mechanism as long as there were adequate regulatory procedures to deal with health and environmental issues.
The following comments were also noted:
The concern for monopolies and concentration of control was expressed. Some participants felt that if patenting of plants were permitted, some type of farmers’ privilege needs to be incorporated into the Patent Act.
The concern was expressed that companies may promote monoculture agricultural practices so as to maximize their profits. This was seen as also reducing access to a diversity of agricultural methods, ultimately affecting the distribution of benefits.
Others expressed concern over the increasing research partnership between corporations and universities. There was a sense that the perceived independence of universities was being compromised and research agendas were increasingly being dictated by corporate needs.
Some argued that having research exemptions will aid universities and other research centres to continue pursuit of innovation and this will help to prevent monopolies. It was noted that while a patent may exist for 20 years, its useful economic life is much shorter because of the frequent and rapid advances of biotechnology research.
The following points were also noted:
The discussion focused largely on the regulatory system that governs use of biotechnology after patenting. Concerns were raised about the risk to human health, the effects on biodiversity from “genetic drift” and the potential loss of original species.
Most participants felt that the existing patent system is not properly structured to deal with biotechnology issues and that substantial change is required. Several participants noted examples of ineffective regulatory safeguards. Others pointed out inconsistencies, the fact that some concerns may not have been fully considered and that no mechanisms or procedures have been put in place to address them.
It was generally agreed that the development and implementation of a sound regulatory system is essential.
With respect to the patenting process, some suggested that there should be an “ordre public” provision in the patent law. It was also suggested that some mechanisms to ensure testing for environmental and health effects are required. The question was raised as to whether or not the current system puts the burden of proof of safety on the patent holder or applicant. If not, some felt it should do so.
The following comments were noted:
The discussion on patenting animals elicited a wide range of views. On one end of the spectrum were those who see patenting a higher life form as being immoral and unethical, and on the other end were participants who see no difference between patenting animals or plants or inanimate objects. Others enunciated the need for providing safeguards and setting certain conditions before patenting should be allowed.
The following two perplexing concerns were expressed by most participants.
The following is a summary of the various positions taken and the key points made:
Those holding this view expressed many concerns. Their position rests on the principle that it is not ethical to own and control other living things. The following comments were noted in support of this view.
While the general sentiment of participants holding this view is against patenting of animals, there is acknowledgment that in some circumstances patenting of a limited type might be acceptable. Humans and other primates should clearly be excluded from patentability. Further, participants raised the following points:
Proponents of this view were generally supportive of patenting animals but with clear guidelines and constraints. Of particular concern is the need to ensure ethical treatment of animals as well as to ensure open and transparent decision-making. Monitoring and effective regulation of use of patented animals were also seen as essential. The following points were noted.
Participants holding this view did not see a distinction between plants, animals and other objects that might be patentable. They felt that the patenting of animals can contribute to the broader social good and that the concerns raised by other participants can be addressed through other means. The following points were made in support of this position.
During the third breakout discussion participants were asked to provide advice on Canada’s international role on matters pertaining to biotechnological intellectual property and the patenting of higher life forms.
The discussion centred on two questions:
What actions should Canada take in response to current obligations?
Several specific actions were proposed by the three discussion groups.
It was noted that while the current trade obligations, primarily NAFTA and TRIPS, place specific requirements on Canada, there is considerable scope within which Canada can develop strategy and policies. It was proposed that Canada should take advantage of the exclusions provided by these arguments and develop firm Canadian positions. To determine how Canada should respond to these exclusion provisions, a broad, inclusive and transparent public policy discussion should be undertaken by CBAC or the Government of Canada. The consultation should focus on public policy matters, in particular, determining common Canadian values that could help shape an ordre public or morality clause. This public policy consultation must be open to all and should be completed before Canada takes any further positions on matters concerning biotechnological intellectual property and the patenting of higher life forms.
All three of the discussion groups addressed the issue of harmonizing Canadian policies on patenting of higher life forms with other countries. No clear preference emerged from the discussion. Some suggested that it only makes sense for Canada to adopt the approach practiced by the United States. The US is our largest trading partner and our economies are becoming highly integrated. For the Canadian biotechnology industry to remain competitive there is an advantage to adopt patenting of higher life form policies that are consistent with the US.
Other participants stated a preference for adopting the European Union approach since societal considerations play a significant role in their patent process. It was felt by some that the Canadian view of societal and ethical issues was more consistent with the European model.
Many others felt strongly that Canada need not harmonize its patent policies with any one country. Rather, we should determine what is right for Canada. We need to develop policy positions that reflect Canadian values and Canadian needs. The public policy consultation would define these values and needs.
In addition to the public policy discussion, it was suggested that Canada needs to undertake a comprehensive evidence-based assessment of the implications of Canada’s compliance with current treaty obligations. This assessment should address a broad range of ethical, social, economic, human rights and environmental considerations, clearly describing the advantages and disadvantages of these commitments for Canada. The assessment should be presented in a way that better informs Canadians about out intellectual property treaty obligations. This information will allow Canadians to more effectively participate in public policy discussions.
In addition to international commitments, the Government of Canada also has obligations to Canadians. Of greatest significance is the need for the Government to ensure that the existing regulatory processes and/or an ethical review process is capable of fully assessing biotechnological products to ensure the health and safety of Canadians and our environment. Some participants suggested that Canadians lack confidence in the Government to protect their interests and that the Government would have to demonstrate through both policy and practice that it could be trusted.
It was suggested that another role for the Government of Canada was to increase the commitment of public funds to promote biotechnology research and Canada’s emerging biotechnology industry. In addition there is a need to explain to Canadians the benefits of public investment in research and development of biotechnological inventions.
Finally, many participants expressed the opinion that Canada, through its international agreements, has never signed away its sovereignty or the ability to decide matters of interest to Canadians. Canada should not be afraid to take positions that might be inconsistent with our current commitments. What is of paramount importance is to develop positions that reflect Canadian values and interests. If necessary, Canada should be prepared to withdraw from agreements that are not in the best interests of the country.
Some participants felt that Canada should assume a leadership role in future international discussions. This leadership role should focus on promoting the consistent application of ethical considerations in any further treaty or agreement. Other possible roles could include:
Please note that similar reports from each of the 5 CBAC roundtable consultations on Biotechnology Intellectual Property and the Patenting of Higher Life Forms, conducted across Canada from April 23 to May 4, 2001, are being posted on the CBAC website. As well, results from all 5 roundtables will be integrated into a single roll-up report that will also be available on the CBAC website by the end of May 2001.
Please visit the CBAC website at www.cbac-cccb.ca or call the CBAC toll-free number at 1-866-748-2222 for additional information or document related to this or other CBAC projects.
http://cbac-cccb.ca | ||||
Created: 2005-07-13 Updated: 2006-06-30 |
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