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Annual Report - 2002
Table of Contents
Message
of the Chair, Canadian Biotechnology Advisory Committee
CBAC Membership
Executive Summary
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Introduction
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Canada's Biotechnology
Sector
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Biotechnology and
Canadian Innovation: Statement on the Occasion of the
National Summit on Innovation and Learning
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Reports and Public
Policy Developments
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Message of the chair,
Canadian Biotechnology Advisory Committee
On behalf of the Canadian Biotechnology
Advisory Committee (CBAC), I am pleased to present CBAC's third
Annual Report, covering the calendar year 2002.
This has been a particularly active year for CBAC. Two major projects
were completed — namely, on the regulation of genetically
modified foods and the patenting of higher life forms — and work
on other projects continued. We expanded our outreach efforts
considerably and established additional productive liaisons with other
bodies engaged in examining the public policy aspects of
biotechnology.
CBAC welcomed several new members to its ranks in 2002. I thank all of
the members of CBAC who were unstinting in their dedication, in the
face of demanding deadlines and heavy workloads to fulfil CBAC's
mandate. I also thank the staff of the Canadian Biotechnology
Secretariat who so ably supported the committee in its endeavours. I
am particularly grateful to Roy Atkinson, who has headed the
Secretariat since CBAC's inception in 1999, for his outstanding
contributions. Kim Elmslie has been appointed to succeed him as
Executive Director. Mr. Atkinson will continue to be associated with
CBAC for some months as Special Adviser to provide continuity on
certain key initiatives.
As CBAC enters its fourth year, we look forward to building on our
achievements and continuing to explore the role of biotechnology in
Canadian society as part of the federal government's Innovation
Strategy.
Sincerely,
Dr. Arnold Naimark
Chair, CBAC.
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CBAC Membership
Chair
Dr. Arnold Naimark
Director, Centre for the Advancement of Medicine
University of Manitoba
Winnipeg, Manitoba
Members
Dr. Mary Alton Mackey
President, Alton Mackey and Associates
Toronto, Ontario
Dr. Lorne Babiuk
Director, Veterinary Infectious Disease Organization
Saskatoon, Saskatchewan
Ms. Gloria Bishop
Communications Consultant
Toronto, Ontario
Dr. Conrad Brunk
Director, Centre for Studies in Religion and Society
University of Victoria
Victoria, British Columbia
Prof. Timothy Caulfield
Associate Professor/Research Director, Health Law Institute
University of Alberta
Edmonton, Alberta
Dr. Pierre Coulombe
President and CEO
Infectio Diagnostic Inc.
Ste-Foy, Québec
Dr. Pete Desai
President
Desai and Desai Inc.
Calgary, Alberta
Dr. Barry Glickman
Professor and Director, Centre for Biomedical Research
University of Victoria
Victoria, British Columbia
Dr. Arthur Hanson
Distinguished Fellow and Senior Scientist
International Institute for Sustainable Development
Winnipeg, Manitoba
Mrs. Suzanne Hendricks
Nutritionist
Ottawa, Ontario
Dr. Douglas Kilburn
Director, Biotechnology Laboratory
University of British Columbia
Vancouver, British Columbia
Dr. Bartha Maria Knoppers
Law Professor and Senior Researcher
Centre for Public Law Research
Université de Montréal
Montréal, Québec
Dr. Lynn Letourneau
Professeure sous octroi
Département des sciences animales
Université Laval
Québec, Québec
Dr. Murray McLaughlin
President & CEO
Foragen Technology Ventures Inc.
Guelph, Ontario
Ms. Anne Mitchell
Executive Director
Canadian Institute for Environmental Law and Policy
Toronto, Ontario
Dr. Peter W.B. Phillips
Professor
College of Agriculture
University of Saskatchewan and NSERC/SSHRC Chair
Saskatoon, Saskatchewan
Dr. Douglas Powell
Assistant Professor, Plant Agriculture
University of Guelph
Guelph, Ontario
Dr. Laura Shanner
Associate Professor, Department of Public Health Sciences
John Dessetor Public Health Ethics Centre
University of Alberta
Edmonton, Alberta
Dr. René Simard
Former Rector
Université de Montréal
Montréal, Québec
Mrs. Denny Warner
Former Manager, Vanderhoof Chamber of Commerce
Cranbrook, British Columbia
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Executive Summary
General Activities
CBAC significantly increased its communications and outreach
activities, particularly with regard to publicizing its reports on the
regulation of genetically modified (GM) foods and the patenting of
higher life forms. We built on CBAC's citizen engagement plan by
expanding its partnership network, augmenting its exhibit program,
participating in special forums such as Parliament's Standing
Committee on Health, and participating in and making written
submissions in connection with major conferences such as the National
Summit on Innovation and Learning.
CBAC recommended that patents not be granted on the human body
at any stage of development, and that higher life forms meeting the
criteria of the Patent Act be patentable subject to certain
limits.
CBAC continued to monitor developments in biotechnology in relation to
genomics and proteomics, stem cells and cloning, agricultural
biotechnology, patenting, genetic information and privacy, transgenic
technologies and xenotransplantation.
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Special Projects
Following almost two years of intensive research and consultation,
CBAC issued its final reports on the patenting of higher life forms
and the regulation of GM foods. CBAC members look forward to receiving
the government's responses to the two reports.
The report Patenting of Higher Life Forms was released on
June 6, 2002. In it, we recommended that patents not be granted on the
human body at any stage of development, and that higher life forms
meeting the criteria of the Patent Act be patentable subject to
certain limits. The report discussed pertinent social and ethical
issues, made recommendations on improving the patent system, and
addressed issues related to the equitable sharing of the benefits of
biotechnological inventions and the recognition of traditional
knowledge. The CBAC report figured prominently in the Supreme
Court's deliberations on the Harvard Mouse case, and there was
substantial congruence between the Court's findings and CBAC's
report. Although the Court concluded that the Harvard Mouse did not
meet the definition of an invention and therefore is not patentable,
the Court did not take a position on whether or not higher life forms
ought to be patentable, leaving this matter for legislators to decide.
The report Improving the Regulation of Genetically Modified Foods was
released on August 26, 2002. CBAC concluded that GM foods approved
under the current regulatory system do not pose any greater health or
environmental risk than their conventional counterparts. The report
identified opportunities to improve the management and coordination of
the regulatory system, enhance communication with the public, support
a voluntary labelling system, strengthen the system's capacity to
deal with more complex GM food products, and incorporate scientific
and technical advances as they emerge. The report also addressed
environmental stewardship, international cooperation and informed
dialogue. In a related endeavour, CBAC initiated work on the
“Acceptability Spectrum,” a tool designed to facilitate
discussion on the acceptability of GM foods or other
biotechnology-based products.
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Developments
In February, the federal government announced Canada's Innovation
Strategy. Several aspects of the Strategy directly or indirectly
involve biotechnology-based innovations. The Strategy includes
regional and sectoral consultations, culminating in a national summit
in which the Chair of CBAC participated.
The rapid pace of advances in acquiring and applying knowledge
concerning the structure and function of the genomes and proteomes of
humans, plants and animals continued throughout the year. These
advances expanded the range of potential benefits for human and animal
health, the environment and the economy to narrow the public health
gap between rich and poor countries. They also extended the range of
concerns about potential harms such as the inappropriate use of
genetic information to discriminate against individuals relative to
employment, credit and insurance or pension eligibility. Calls for
stronger legislation concerning privacy of genetic information have
been issued in both the United States and the United Kingdom. For
example, in a recent Canadian case, it was discovered that DNA samples
donated some 20 years ago by members of a British Columbia First
Nation for rheumatoid arthritis research had also been used for other
types of research without the donors' consent. In Canada, Ontario
Human Rights Chief Commissioner Keith Norton stated that genetic
information should not be used to deny insurance or invoke
exclusionary periods on the basis of a “pre-existing
condition.”
Research continued into the various uses of embryonic and adult stem
cells as well as stem cells derived from primate parthenotes1 for treating diseases and growing
replacement tissues. While research on non-embryonic stem cells
continued apace, a number of studies appeared to refute earlier
findings suggesting that adult stem cells are multipotent and can be
induced to form a variety of cell types. Clearly, additional research
is required to resolve the discrepancy.
Claims that a human baby has been produced through cloning captured
media headlines around the world. While cloning humans for
reproductive purposes is generally deemed to be unacceptable, there is
much less consensus on cloning to obtain stem cells for therapeutic
purposes. Canada, like Australia and France, appears likely to take an
intermediate position, allowing some forms of human embryonic stem
cell research but banning cloning. Canada's proposed legislation
on reproductive technologies as well as the guidelines issued by the
Canadian Institutes for Health Research recommend this approach. Work
on an international treaty on human cloning has been delayed by
differences in viewpoints: should the treaty immediately ban cloning
for any purpose, or should it ban cloning for reproduction only,
leaving the issue of cloning for stem cell research for a later step?
The High Court in the United Kingdom ruled that the Human
Fertilisation and Embryology Authority does not have the right to
license the tissue typing and selection of test tube embryos to save
the lives of their siblings. Also in the U.K., where cloning to obtain
stem cells is allowed under strict conditions, scientists plan to
apply for a licence to experiment on human embryos for medical
purposes, and for another to conduct research on parthenogenesis of
humans.
Canada, like Australia and France, appears likely to take an
intermediate position, allowing some forms of human embryonic stem
cell research but banning cloning.
There were significant developments on the food labelling front this
year. The U.S. issued voluntary country-of-origin information
guidelines in October, scheduled to become mandatory in September
2004. Canada's department of Agriculture and Agri-Food will review
the guidelines and consult with stakeholders to determine a course of
action. The European Parliament backed a proposal to increase
labelling requirements for food and to set more stringent rules for
testing and identifying the amount of material traceable to genetic
modification in foods and animal feed. In Canada, CBAC's report on
Improving the Regulation of Genetically Modified Foods called for a
voluntary labelling regime once an effective standard has been
developed. The Canadian Council of Grocery Distributors and the
Canadian General Standards Board continued their work on developing a
Canadian standard for voluntary labelling, and two parliamentary
standing committees examined the issue.
Most of the news concerning agricultural biotechnology and the
environment this year emanated from the U.S., much of it concerning GM
crops. Traces of StarLink corn were found in an American shipment
headed for Tokyo and its food supply. Zambia refused food aid in the
form of GM corn from the U.S. The U.S. National Research Council
called on the government to review the potential environmental effects
of new transgenic plants more rigorously before approving them for
commercial use and to monitor transgenic plants after they enter the
marketplace. A U.S. poll found that respondents, when given basic
information on risks and benefits, were evenly divided over whether GM
food and other agricultural biotechnology products hurt or help the
environment.
The impact of genetic patents on access to gene-based diagnostic tests
was a prominent issue in Canada and the U.K. In Canada, a U.S. company
demanded that all screening tests for breast cancer based on two genes
on which it holds patents — BRCA 1 and 2 — must be done
through its own laboratories and threatened to sue any provincial
agency that covered the cost of the tests done in other laboratories.
In the U.K., laboratories claimed that the ability to diagnose and
study haemochromatosis is being hampered by restrictions caused by the
patenting of a key gene, with the result that 30 per cent fewer of
them are able to offer the test.
An Ontario report called for a comprehensive review of Canada's
Patent Act to consider a range of concrete proposals for dealing with
problems associated with gene patenting. The U.K. Nuffield Council on
Bioethics proposed an ethical framework for gene patenting. It also
recommended that patents on DNA sequences be the exception rather than
the rule and that the tests of inventiveness and usefulness be more
rigorously applied to applications for genetic patents.
Advances in transgenic technologies and xenotransplantation included
the development of pigs genetically engineered so the human immune
system will not reject a transplanted pig organ. This could result in
more successful pig-to-human transplants.
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Introduction
This is the third Annual Report of the Canadian Biotechnology
Advisory Committee (CBAC). The report contains two main
sections. The first deals with the committee's activities
during the past year. The second presents an overview of
biotechnology developments relevant to CBAC's mandate.
In 2002, CBAC reached an important milestone as it completed two
major projects and released its final reports on the regulation
of GM foods and the patenting of higher life forms. CBAC then
turned to the development of its work program for the next three
years. The overarching theme for its work program is
“Biotechnology in Canadian Society.” It has begun to
explore projects related to biotechnological innovation and
their impacts. CBAC now looks forward to undertaking new special
projects, concentrating on biotechnology and innovation. This
project more specifically involves examining Canadian
institutions to assess how they might be transformed to enable
them to better capture the benefits of biotechnology while
managing risks and facing social and ethical challenges. This
project dovetails with and supports Canada's Innovation
Strategy, announced by the Government of Canada in February
2002.
The push for new scientific discoveries and technological
innovations continued unabated in 2002. While claims of cloning
human babies captured the greatest media attention, a host of
lower-profile advances occurred in genomics and proteomics as
well as in cellbased technologies such as stem cells and
non-human cloning.
Canada, like other countries, continued its efforts to come to
grips with the ever-widening horizons created by
biotechnological advances and by the social and ethical
challenges inherent in them. Substantial additional investments
were made in biological sciences and the development of
biotechnologies while increasing attention was given to
formulating appropriate policies in areas such as patents,
health care, privacy of genetic information, GM food labelling,
and transgenic technologies such as xenotransplantation and
molecular farming.
CBAC, a body of external experts, was established in 1999 to
advise the Government of Canada on the policy issues associated
with the ethical, social, regulatory, economic, scientific,
environmental and health aspects of biotechnology. We also
provide Canadians with easy-to-understand information on
biotechnology issues as well as opportunities to voice their
views on the matters on which we are advising the government.
CBAC reports through the Biotechnology Ministerial Coordinating
Committee (BMCC). Readers are encouraged to visit our web site
at (Canadian
Biotechnology Advisory Committee).
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CBAC Activities
The year 2002 marked considerable progress for CBAC in both our
general activities and our special projects. The committee
continued its monitoring and reporting functions, and prepared
an advisory memorandum to the Biotechnology Ministerial
Coordinating Committee (BMCC) on the Patent Act and
higher life forms. It also increased its communications and
outreach endeavours, particularly with regard to the release of
two major reports. The committee also supported work on an
“Acceptability Spectrum,” a tool designed to
facilitate discussion on the acceptability of GM foods or other
biotechnologybased products, and developed a new work plan for
the next three to five years.
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2A) CBAC Membership
Six new members were appointed to CBAC for three-year
terms. Fourteen members were reappointed, seven for
one-year terms and seven for two-year terms. The list of
CBAC members appears at the beginning of this report, and
biographical information about them may be found on the
CBAC web site.
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2B) General Activities
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Monitoring and Reporting
Developments
A key aspect of CBAC's mandate is to monitor and
report developments in biotechnology and to provide
advice to Ministers on emerging issues the committee
believes require the government's early
attention. Our report on the patenting of higher
life forms was quoted extensively in the Supreme
Court of Canada's December 5, 2002, decision in
the “Harvard Mouse” case. However, the
Court concluded that the Harvard Mouse did not meet
the definition of an invention and therefore is not
patentable. Following the decision, we began
preparing an advisory memorandum to Ministers that
will recommend how the Government of Canada should
respond to the Supreme Court ruling.
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Communications and Outreach
Activities
CBAC significantly increased its communications and
outreach activities in 2002 as part of its mandate
to make CBAC and its work more visible by
stimulating debate and dialogue among Canadians.
These endeavours included issuing news releases,
posting items on the web site, participating in
regional, national and international forums and
major conferences, and expanding the exhibit
program. In addition, CBAC members continued to be
active in their own right as commentators on major
issues of public interest related to biotechnology.
Communications:
Much of CBAC's communications effort this past
year centred on eliciting views from stakeholders
and the public on the committee's two interim
reports released in 2001, and on publicizing the
release of the final reports last June and August.
The reports concerned the two special projects on
which CBAC has been focussing its attention since
its inception: the regulation of GM Foods, and the
patenting of higher life forms.
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Comments on Interim Reports:
To reach as many people as possible, the interim
reports were posted on CBAC's web site.
Announcements were placed in specialized journals
and magazines, and media releases were issued to
tell Canadians about the reports and how to submit
their opinions, and copies were also distributed
through the partnership network.2 All interested
individuals and organizations were invited to send
their views via CBAC's tollfree telephone number
or web site as well as by fax or regular mail. In
all, 196 submissions were received from
organizations, associations and individual
Canadians. These inputs were considered by CBAC as
it developed the recommendations contained in the
final reports.
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Wide Publication of Final Reports:
The report Patenting of Higher Life Forms
was released in June. The report Improving the
Regulation of Genetically Modified Foods
followed in August. Both were posted on the web site
and distributed through CBAC's partnership
network to some 800 recipients, including all
Members of Parliament and Senators. The reports were
also displayed at several exhibits across the
country. Announcements were placed in specialized
journals and magazines. News releases advised of
their availability. Altogether, some 1,400 GM food
reports and 1,200 patenting reports were
distributed. As well, several thousand visits were
made to the reports on the web site. CBAC responded
to several hundred enquiries from the public and the
media regarding the two reports and other
developments in biotechnology. Media analysis
indicated that the GM foods report generated
prominent and widespread media coverage following
its release.3
A key aspect of CBAC's mandate is to
monitor and report developments in biotechnology and
to provide advice to Ministers on emerging issues
the committee believes require the government's
early attention.
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Ongoing Communications Endeavours:
CBAC also continued its regular communications
activities involving the issuing of news releases
and posting of web site material regarding committee
activities. A significant overhaul of the web site
was undertaken to improve its general functionality,
including features to encourage Canadians to use the
Public Forum more actively. The enhanced web site
will be launched in the first half of 2003.
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Outreach:
CBAC built on the citizen engagement plan it
initiated last year to increase awareness of the
committee and its work and of biotechnology in
general to encourage participation in CBAC
activities and to expand the partnership network. We
also augmented the exhibit program at selected
venues across the country as a means of encouraging
debate and dialogue.
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Forums and Conferences:
On March 12, CBAC Chair Dr. Arnold Naimark and the
co-chairs of CBAC's GM foods project, Dr. Peter
Phillips and Suzanne Hendricks, appeared before the
Standing Committee on Health, which was examining
issues related to the labelling of GM foods.
Outlines of their comments and a copy of CBAC's
written statement to the Standing Committee are
available on CBAC's web site.
CBAC attended BIO 2002, the annual conference of the
Biotechnology Industry Organization, in Toronto on
June 9–12, where Dr. Bartha Maria Knoppers,
chair of CBAC's Intellectual Property Project
Steering Committee, was a guest speaker. This event
is the largest biotechnology gathering in the world,
this year attracting more than 15,000 participants
from 52 countries.
In 2002, two years of extensive research and
consultation culminated in the release of CBAC's
final reports on improving the regulation of GM
foods and on the patenting of higher life
forms.
Dr. Peter Phillips was also a guest speaker at the
2002 Agricultural Biotechnology International
Conference (ABIC) in Saskatoon, September
16–18, attended by more than 900 participants
from 22 countries. The gathering focussed on the
convergence of agricultural biotechnology with life
sciences, bioinformatics, health care and nutrition.
Dr. Mary Alton Mackey was a panelist at a public
forum co-sponsored by Greenpeace and Council of
Canadians at the St. Lawrence Centre in Toronto in
October to discuss the GM foods report. The
discussion centred primarily on the labelling of GM
foods.
CBAC Chair Dr. Arnold Naimark presented a written
statement at the Government of Canada's National
Summit on Innovation and Learning, held November
18–19 in Toronto. More than 450 decision
makers from the private, public and voluntary
sectors met to discuss Canada's Innovation
Strategy, a long-term vision to make Canada more
competitive in a knowledge-based economy. The
statement appears in this report as Appendix A.
Other events at which CBAC displayed a booth were
BioNorth 2002, a biotechnology and life sciences
conference, held November 4–6 in Ottawa,
Health Canada's International Conference on
Post-Market Surveillance of GM Food on October
18–19 in Ottawa, the National Policy Research
Conference on October 23–25 in Ottawa, the
Annual Ontario Public Health Association Conference
on November 18–20 in Richmond Hill, Ontario,
and BioFuture 2002 on November 21–22 in
Vancouver.
CBAC interacted with the Institute on Governance as
the latter proceeded with its program on governance
issues related to biotechnology. Dr. Naimark and
other CBAC representatives participated in the
Institute's December Forum on patenting of
higher life forms.
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2C) Special Projects
In 2002, two years of extensive research and consultation
culminated in the release of CBAC's final reports on
improving the regulation of GM foods and on the patenting
of higher life forms. We hope to receive responses to
these reports from the government early in 2003. While the
completion of these reports effectively marks the
conclusion of these special projects, CBAC undertook to
monitor developments in these areas and may provide
further advice if the need arises. Following the
conclusion of these two projects, CBAC developed a new
work plan, which is outlined below in the subsection on
Continuing Projects.
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Improving the Regulation of GM
Foods: CBAC concluded that GM foods
approved under the current regulatory system do not
pose any greater health or environmental risk thantheir conventional counterparts in the marketplace.
However, the committee did identify important
opportunities to improve the management and
coordination of the system, to enhance communication
with the public, and to strengthen the system's
capacity for dealing with the more complex GM food
products now in development and for incorporating
scientific and technical advances as they emerge. In
the report, CBAC recommends ways to improve the
management and coordination of Canada's food
regulatory system, calls for the introduction of a
system of voluntary labelling once a standard has
been developed, and advises on creating a
centralized information service on GM and other
novel foods. The report, available on CBAC's web
site, also addresses issues relevant to
environmental stewardship, international cooperation
and informed dialogue.
Patenting of Higher Life Forms:
CBAC recommended that patents should not be granted
on the human body at any stage of development, and
that non-human higher life forms (seeds, plants and
non-human animals) meeting the criteria in the
Patent Act should only be patentable subject to
certain limits. The report discusses the key social
and ethical issues involved in deciding whether
higher life forms should be patentable in Canada. It
discusses and makes recommendations for improving
the patent system, sharing the benefits of
biotechnological inventions equitably, and
respecting traditional knowledge in relation to
intellectual property. The recommendations reflect
social and ethical concerns related to biotechnology
and the need to maintain balance between the rights
of patent holders and of those seeking access to the
benefits of biotechnology inventions. Now that the
Supreme Court of Canada has made its ruling on the
patentability of the Harvard Mouse, the federal
government is considering its implications.
CBAC's report provides advice on policy issues
to be addressed by the government.
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“Acceptability Spectrum” Pilot
Project: In 2002, CBAC initiated a
three-phase pilot project to examine an
“Acceptability Spectrum” for GM food and
to assess its viability and usefulness. The
Acceptability Spectrum is a tool designed to
facilitate discussion among those with divergent
views on the acceptability of GM foods and feeds.4 The first phase of
the project involved the creation of an Exploratory
Committee, consisting of nongovernment members who
reflect a wide range of interests, to develop and
steward the tool through an extensive consultation
process. Phase 2 involved six stakeholder sessions,
held in March and April in Montréal, Ottawa,
Hamilton, Toronto and Vancouver, to review and
improve the dialogue tool. The results of the
sessions were compiled in a summary report,
available on CBAC's web site. Several federal
government departments contributed supplementary
funding to allow completion of this phase of the
project.
Privacy and Genetic Information:
The objective of this project is to examine the
mechanisms currently in place in Canada to protect
the privacy of genetic information. Access to
genetic information is a matter of increasing
importance to the public and to governments around
the world, and CBAC continues to monitor
developments. Among the initiatives undertaken in
this area in 2002 was the preparation of a session
titled Biobanks: Overview and Issues for a Genome
Canada symposium to be held in February 2003. The
committee commissioned four papers for the session,
each describing current practices in a specific area
and identifying any gaps or questions that need to
be addressed. The purpose of the papers is to
identify and describe the relevant laws, policy and
data for future policy analyses and development in
Canada concerning large-scale collections of genetic
information.
Incorporating Social and Ethical
Considerations into Biotechnology:
CBAC's original work plan included a special
project on incorporating social and ethical
considerations into decision making about
biotechnology. As a first step, CBAC developed a
statement of principles and values. These principles
and values were discussed during the consultations
surrounding the GM food and the patenting of higher
life forms projects. The statement was made
available to the public for additional comments. The
lessons learned during this initial phase are to be
assessed early in 2003, and a decision will be taken
on the focus of future work in this area.
Following completion of its two special
projects in 2002, CBAC developed a new articulation
of the general theme of its ongoing work; namely,
Biotechnology in Canadian Society.
Institutional Transformation: CBAC
will examine how Canadian institutions, both within
and outside government, might be transformed to
enable them to best capture the benefits of
biotechnology while managing risks and facing social
and ethical challenges. These transformations may
involve changes in how institutions are organized
and perform their functions, the development of new
organizations, and/or the cultivation of new
partnerships, alliances and networks. The
institutional transformations fall into two
categories: those that focus on social and economic
development (e.g., education, research, knowledge
transfer, risk capital) and those that focus on
regulatory matters (e.g., risk assessment,
management and communication, health, environment
and respect for core social values). The exploration
of this topic will involve research to determine its
parameters, examination of the short-term issues and
opportunities associated with biotechnological
innovations, and assessment of the pathways for
longer-term institutional transformation.
New Work Plan: Following completion
of its two special projects in 2002, CBAC developed
a new articulation of the general theme of its
ongoing work; namely, Biotechnology in Canadian
Society. As noted earlier, a statement on this
matter (see Appendix A) was presented at the
Government of Canada's National Summit on
Innovation and Learning held November 18–19 in
Toronto.
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Recent Developments in Biotechnology
This section briefly summarizes some of the significant
developments during the reporting period that are particularly
relevant to CBAC's work or that may influence its activities
in the future.
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3A) Canada's Innovation Strategy
In February, the federal government announced Canada's
Innovation Strategy, which outlines a long-term vision to
make Canada more competitive in a knowledge-based economy.
Supporting development of Canada's biotechnology
sector while protecting the public interest is a key
component of the Strategy. Biotechnology has the potential
to fundamentally transform innovative economies. In the
context of the Strategy, the government reiterated its
commitment to achieving the full scope of benefits that
biotechnology has to offer and to identifying areas where
challenges exist and improvements are required.
Among the Strategy's “early-action” target
areas that impact on biotechnology are: the advancement of
the target dates for key regulatory reviews from 2010 to
2005, including early action on the drug approval process,
an agreement with universities and colleges to double
research and triple commercialization, and continued
funding for research and development and indirect costs.
(See above subsection 2.C.ii on
Institutional Transformation as well as Appendix A for
CBAC's statement issued in conjunction with the
National Summit on Innovation and Learning.)
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3B) Genomics, Proteomics and Related
Developments
Advances in genomics and proteomics are pervading life
sciences research. They have the potential not only to
expand our understanding of fundamental biological
phenomena but also to generate technological innovations
with significant economic impact.
Canada has committed itself to being at the forefront of
this important field. Genome Canada to date has received
$300 million from the government to develop and implement
a national strategy in genomics research. The agency has
invested more than $293 million in 56 large-scale projects
across Canada. With funding from other partners, this
amounts to $586 million invested in innovative genomics
and proteomics research. Important investments in genomics
research have also been made through the National Research
Council and the Canadian Institutes of Health Research
(CIHR).
The Pan Canadian Proteomics Meeting held in Toronto on
November 26–27 attracted more than 100
representatives of the scientific, industry, government
and funding agency communities. A decision was made to
create the Canadian Proteomics Network.5 The network will include all
Canadian scientists working on proteomics and will be
supported through a partnership among Genome Canada, CIHR
and industry.
In December, Genome Canada and the Danish Ministry of
Science, Technology and Innovation signed a Memorandum of
Understanding on Co-operation in Genomics to support
initiatives to increase scientific and industrial
exchanges and to identify areas of joint research such as
population genomics, agriculture and food genomics, and
drug discovery. This is the fourth such international
agreement for Genome Canada in the last 18 months.6
The Canadian Museum of Nature, Genome Canada and CIHR
announced in January that the country's first national
exhibition on genomics will start a three-year,
cross-Canada tour in spring 2003. “Putting the Gee!
in Genome” will celebrate Canadian genomic
discoveries and encourage public discussion of genomics
and its impact.
The Human Genome: A new type of genome
map, called the haplotype map, has been developed.7 Some researchers believe the
haplotype map may be a more efficient way to find the
genes involved in complex diseases and may offer insight
into human evolution and migration. The International Hap
Map Project builds on the results of the Human Genome
Project. In another development, geneticists at deCODE
Genetics in Iceland created a new genome map using their
database of genetic information from Icelandic families
and the sequence of the Human Genome Project to increase
the accuracy of the original genetic map fivefold and
correct 104 mistakes in the draft human genome sequence.
Craig Venter, renowned for his role in mapping the human
genome, announced plans to offer a service in which a
person's entire genetic code would be mapped for about
US$621,500. Other researchers say the service would be of
little use, because the scientific community can currently
test for only a few dozen diseases, and so the client
would not receive substantial information. Dr. Neil Risch,
a leading population geneticist, stated in a paper that
race can be useful in understanding disease and drug
response among different ethnic groups. This statement
challenges the emerging view that race is a biologically
meaningless concept, as the Human Genome Project has
revealed human beings have more than 98 per cent of their
genetic makeup in common.
Impact on Human Health: Advances in
genomics and proteomics are expected to have highly
significant impacts on human health. The sidebar
illustrates some of the advances in the field of genetic
testing and improved pharmaceuticals. Gene therapy has
proven to be more difficult than anticipated. While some
limited success has been achieved in certain
circumstances, much work remains to be done. Clinical
trials conducted on humans continue to be closely
monitored and, in some cases, have been cancelled.8
Some of the research in gene therapy has focussed on
finding ways to deliver genes other than through a viral
vector. One method being tested on cystic fibrosis
patients involves condensing the DNA molecule into a tiny
ball shape that can pass through the nuclear membrane.
Another method used in gene therapy aimed at shrinking
tumors in mice involves delivering a gene via an injected
nanoparticle that targets only new blood vessels that have
formed to feed the growing tumor, thus starving the tumor.
Another new type of gene therapy, called RNA
trans-splicing, has been used to treat mice with a form of
haemophilia.
The World Health Organization stated in a major report
that developments in genetics could bridge the public
health gap between rich and poor countries. It recommended
creation of a US$1.5 billion fund for genetic research
aimed at ameliorating health problems in poor countries.
In response to this report, the University of
Toronto's Joint Centre for Bioethics undertook a study
that identified the top 10 biotechnologies that could
improve global health within the next few years. The list
included the development of cheap vaccines, ways to ensure
clean drinking water and methods to genetically modify
foods to enhance nutritional value.9
Non-human Genomic Developments: The genomes of the
parasite that causes malaria and the mosquito that
transmits it have been sequenced. This means research may
now be able to develop effective prevention and treatment
methods. Dogs and cows joined the high-priority list for
genomic sequencing because of their respective medical and
agricultural importance. A single-celled organism called
Oxytricha trifallax also appears on the list
because of its compact genome, which could help speed up
the search for genes in humans. Already on the list are
chickens, chimpanzees, honeybees, sea urchins,
Tetrahymena and 15 species of fungi. Craig Venter
is working on a synthetic chromosome to replace the
genetic material of a bacterium. The ultimate goal is to
create bacteria that can remove excess carbon dioxide from
the air or produce cheap hydrogen fuel.
In April, two research groups published draft sequences of
the genome of two different rice varieties. Rice is the
first food crop to be sequenced and this significant
development could help in the sequencing of other cereal
crops. Because rice is the staple food of two-thirds of
the world's population, this information could help
increase food production and enhance nutrition.
Sampling of Gene Discoveries in 2002
-
The Health Network in Toronto identified two genes that
play a role in heart disease, one that protects against
heart disease and one that contributes to it.
-
Several projects turned up genes that could lead to
better screening and treatment for various types of
cancer such as liver, breast and bowel cancer.
-
People with a particular genetic pattern tend to
develop AIDS more slowly.
-
Six genes related to Fanconi anemia, a rare childhood
cancer syndrome, were found to be linked also to BRCA 1
and 2.
-
People with facioscapulohumeral muscular dystrophy have
fewer copies of the DNA sequence D4Z4.
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3C) Stem Cells and Cloning
Stem Cell Research: Researchers are
working toward using stem cells as possible new treatments
for common diseases such as diabetes and Parkinson's
as well as for growing many types of replacement tissues
from a patient's own cells. The controversy in this
area primarily concerns the fact that the most useful type
of stem cells is obtained from human embryos. While
research over the past two years has made several advances
in non-embryonic stem cells — that is, stem cells
from human adults as well as umbilical cords and placentas
from live births — a number of studies appeared to
refute earlier research demonstrating that adult stem
cells are multipotent and can repair other tissues in the
body.10 Research
continued in 2002 into the various uses of embryonic and
adult stem cells as well as stem cells derived from
primate parthenotes.
Cloning Research: Much recent media
coverage concerning cloning has focussed on the
possibility of cloning humans and claims that this had
been accomplished.11
Meanwhile, research continued on animal cloning as a means
of one day treating human disorders and illnesses and, in
some cases, even protecting against biological warfare.12 Advances in animal
cloning included extending the species to be cloned,13 developing organs and
tissues from cloned cells, and gaining insight into the
health status of cloned animals.
Policies Regarding Cloning for Human Reproductive and
Therapeutic Purposes: While cloning for human reproduction
is generally regarded as unacceptable, there is much less
consensus on cloning for therapeutic purposes. Few nations
have specific cloning laws. Those that do have chosen to
ban cloning for reproductive purposes while their
legislation respecting cloning for therapeutic purposes is
much less consistent. California,14 U.K., China and Japan, for
example, allow cloning to obtain stem cells. Canada,
Australia, France and some U.S. states appear likely to
take an intermediate position, allowing some forms of
embryonic stem cell research but banning cloning for
therapeutic purposes. Canada's draft legislation on
reproductive technologies as well as the guidelines issued
by the Canadian Institutes of Health Research in March
both recommend allowing some forms of embryonic stem cell
research but banning cloning for therapeutic purposes.15 Germany approved strict
regulations prohibiting scientists from deriving human
embryonic stem cell lines and banning the import of these
cells without evidence that no other feasible way exists
to conduct the research. The approval of imports would be
subject to the establishment of a national commission to
review all import proposals.
Work on an international treaty banning human cloning was
delayed for at least a year because of differing views
among some nations as to the extent of the treaty. The
U.S. and the Vatican want the treaty to prohibit all forms
of human cloning. France and Germany want a treaty that
would immediately ban cloning for reproductive purposes.
Given the mixed views on cloning for therapeutic purposes,
France and Germany want to proceed now with a ban on
cloning for reproductive purposes only, without waiting
for a consensus to be reached on cloning for therapeutic
purposes.
While cloning for human reproduction is generally
regarded as unacceptable, there is much less consensus on
cloning for therapeutic purposes.
In the U.S., Senator Sam Brownback announced in June that
he was abandoning efforts to persuade the Senate to pass a
bill banning all human cloning, including cloning for
therapeutic purposes, and would instead work on approval
of a two-year moratorium on cloning. The U.S. has
patchwork legislation among many states. Some people
believe this will create confusion over how to regulate
cloning, while others believe it could help stimulate
national action.
Stanford University stated that it intends to experiment
with cloning technology. This has further fuelled the
debate over the use of stem cells. Researchers at the
university will use cloning to develop stem cell lines for
cancer and other health research, which they will share
with outside researchers. This could benefit stem cell
research in general, as many scientists in the U.S.
complain of inadequate access to the currently approved
stem cell lines.
The Massachusetts Medical Society, which owns and
publishes The New England Journal of Medicine,
approved a resolution supporting stem cell research. The
society favours federal funding for ethically conducted
medical research involving embryonic stem cells derived
from cloning. It also encourages the state congressional
delegation to support federal funding of this research.
The Pew Initiative on Food and Biotechnology released a
poll of U.S. citizens in December that found respondents
were both fearful and hopeful about the advance in genetic
technologies. They tended to distinguish between health
and non-health applications of the technologies. For
example, two-thirds approved of using genetic testing to
help parents avoid producing offspring with genetic
diseases, but more than 70 per cent opposed using these
technologies to select traits such as intelligence.
Seventy-six per cent opposed human cloning and 22 per cent
believed that a human has already been cloned.16 Respondents believed that
government needs to regulate genetic technologies,
particularly human reproductive cloning.
In the U.K., where cloning for therapeutic purposes is
allowed under strict conditions, scientists from the
Roslin Institute, where the sheep Dolly was cloned,
announced plans to apply for a licence to experiment on
human embryos for medical purposes. The Institute's
Professor Ian Wilmut has also applied for a licence to
conduct research on parthenogenesis17 of human embryos. Meanwhile,
the U.K. Medical Research Council announced in September
that the National Institute for Biological Standards and
Control will be responsible for setting up the previously
announced U.K. Stem Cell Bank.
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3D) Agricultural Biotechnology
Labelling of GM Food: Many countries
either have introduced labelling requirements for GM foods
or are in the process of doing so. Several nations
including Canada are working within the Codex Alimentarius
Commission to develop an international voluntary standard
for labelling. Developments in this area continued to
unfold in 2002, notably in Canada, the U.S. and Europe.
CBAC's report Improving the Regulation of Genetically
Modified Foods, issued in August, recommended introducing
a voluntary labelling regime but only after an effective
standard with broad support has been developed. It also
recommended that Canada enhance its efforts, in concert
with other nations, to develop a harmonized approach to
labelling with special emphasis on developing an
internationally accepted labelling standard.
Pre-implantation Genetic Diagnosis (PGD)
-
In the U.K., the Human Fertilisation and Embryology
Authority (HFEA) decided in February that a British
couple could use the embryo screening technique
called PGD to test for an embryo that matches their
two-year-old son, Zain. Zain has a rare inherited
blood condition, thalassaemia, and needs a bone
marrow transplant to survive. The parents planned to
use cells from the umbilical cord of the new baby
for the bone marrow transplant. However, in
December, Britain's High Court ruled that the
HFEA does not have the right to license the tissue
typing and selection of test tube embryos to save
the lives of their siblings. The HFEA may appeal the
Court's decision. The court case was initiated
by a pro-life campaigner on behalf of a group called
Comment on Reproductive Ethics.
The Canadian Council of Grocery Distributors and the
Canadian General Standards Board (CGSB) continued their
work on developing a standard for the voluntary labelling
of GM foods. The most recent draft of the standard was
published in December 2001. Through 2002, this draft was
being revised before going to final ballot. Two
parliamentary standing committees also addressed the
issue. The Standing Committee on Health, whose mandate
includes consideration of the best ways to meet
consumers' needs for food information, suspended its
hearings in April 2002 and may resume in the first half of
2003. The Standing Committee on Agriculture studied the
impact of voluntary and mandatory labelling on
agricultural producers and the agri-food industry. It
issued its report in June. Among its recommendations, it
called on the government to continue developing a
voluntary standard for labelling foods according to
whether or not they were derived from biotechnology; the
standard would apply only to genetically engineered
organisms, as proposed in the CGSB draft standard.18
NGO Consumer Information Initiatives
-
The Canadian Institute for Environmental Law and Policy
released a report in March 2002 titled A Citizens'
Guide to Biotechnology: Helping Citizens Have a Real
Say in the Development of Biotechnology in Canada.
-
In October, Greenpeace released its Shoppers Guide
telling consumers which of some 1,000 products commonly
found in Canadian supermarkets do or do not contain
genetically engineered ingredients.
In October, the U.S. issued voluntary guidelines,
scheduled to become mandatory in September 2004, requiring
U.S. retailers to display country-of-origin information to
consumers at the final point of sale for imported and
domestic fresh beef, pork and lamb, fish and seafood, and
fruit and vegetables. Exemptions are granted if the item
is an ingredient in a processed food item or sold in a
food service establishment. Canadian and American food
companies, packers and processors protested the
guidelines, calling them costly and unnecessary.
Agriculture and Agri-Food Minister Lyle Vanclief called
U.S. guidelines flawed and unworkable, and said they run
counter to the long-term interests of both countries. The
Minister said his department would review the guidelines
and consult with stakeholders to determine an appropriate
course of action.
In the U.S. in November, Oregon voters roundly rejected an
initiative that would have required labels on food
containing genetically engineered material. The measure
was defeated by 73 per cent of those voting in a state
plebiscite.
The European Parliament backed a proposal that would
increase labelling requirements for food and lead to more
stringent rules for testing and identifying foods and
animal feed for genetically engineered (GE) content. The
proposal would decrease the threshold for GE content from
1 per cent to 0.5 per cent and require manufacturers to
trace foods to their place of origin.
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Agricultural Biotechnology and the
Environment: Most of the news concerning
agricultural biotechnology and the environment in 2002
emanated from the U.S. Much of it concerned unapproved
mixing of GM with non-GM crops. Traces of StarLink corn
were found in an American shipment headed for Tokyo and
its food supply, and Zambia refused food aid in the form
of GM corn from the U.S.
Two teams of government researchers confirmed University
of California–Berkeley biologist Ignacio
Chapela's findings that GM corn was growing in Mexico.
The alleged presence of transgenic corn in traditional
strains of maize has caused much controversy. Some
scientists claim that Chapela's methodology was flawed
and that the results are therefore not conclusive. It is
still unclear whether transgenic corn has actually invaded
Mexico. In June, the Secretariat of the Commission for
Environmental Cooperation (CEC), part of NAFTA, announced
that it would prepare a special report on the potential
effects of transgenic corn on traditional maize varieties
in Mexico. An international advisory group was named in
October, which included two CBAC members, Dr. Conrad Brunk
and Dr. Peter Phillips. The report is expected to be
released early in 2004.
CBAC's report Improving the Regulation of
Genetically Modified Foods, issued in August, recommended
introducing a voluntary labelling regime but only after an
effective standard with broad support has been
developed.
Three companies were fined for not following proper
procedures. Two did not follow proper isolation procedures
for their experimental crops. A third was fined under the
Plant Protection Act, 2000 and ordered to pay
approximately $2.8 million to buy and destroy soybeans
grown on land previously used to grow GM corn.
The U.S. National Research Council called on the
government to review the potential environmental effects
of new transgenic plants more rigorously before approving
them for commercial use, and to monitor GM plants after
they enter the marketplace to confirm premarket
assessments. A U.S. poll found that respondents were
evenly divided over whether GM crops and other
agricultural biotechnology products hurt or help the
environment when given basic information on risks and
benefits.
In another development, Australian researchers found that
the pollen from non-GM oilseed rape (canola) can spread
long distances but only in small amounts. The same would
likely be true of GM canola pollen, which will make it
difficult to achieve perfect isolation between GM and
non-GM crops involving plants such as canola.
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Scientific Developments: Among the
scientific developments in 2002 were several concerning
rice, the staple food of two-thirds of the world's
population. In April, two research groups published draft
sequences of the genome of two different rice varieties.
Other advances included rice plants that require less
water and others that carry a gene for a human breast milk
protein. Japanese scientists developed a technique that
allows them to more efficiently render specific genes in
rice inactive. This could help scientists discover the
function of plant genes and result in more accurate
genetic modification.19
These developments and others could help to increase
global food production and enhance nutrition.
The Food and Agriculture Organization and the Consultative
Group on International Agricultural Research requested
donations from national governments, foundations and
corporate sponsors to establish a fund to help secure the
genetic information contained in the world's major
crops.
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3E) Patents and Access to Health Care
The issue of gene patents came to the fore in Canada in
2001 and 2002 when an American company invoked a patent
claim to block laboratories in Canada from using a test
for detecting a genetic predisposition to the development
of certain types of inherited breast cancer. The
U.S.-based Myriad Genetics Laboratories demanded that all
breast cancer screening tests based on two genes on which
it holds patents — BRCA 1 and 2 — must be done
through its own laboratories.20 The company threatened to
sue any provincial agency that permitted the tests to be
done in any other laboratories. British Columbia stopped
funding of the test. Ontario has refused to do so.
Meanwhile, Ontario released a report titled Genetics,
Testing and Gene Patenting: Charting New Territory in
Healthcare, which calls for a comprehensive review of
Canada's Patent Act and provides a range of
concrete proposals to deal with the problems associated
with gene patents. This report was discussed at the
January meeting of the provincial and territorial
premiers.
In the U.K., the ability to diagnose and study
haemochromatosis, a debilitating disease caused by iron
overload in the body, is being hampered by the patenting
of a key gene. The patent gives the holder a monopoly on
testing for the mutations that cause haemochromatosis.
According to a study in the February edition of Nature,
this monopoly on testing has resulted in 30 per cent fewer
laboratories being able to offer the test.
On July 23, the Nuffield Council on Bioethics released The
Ethics of Patenting DNA, which proposed an
ethical framework for gene patenting. It recommended that
granting patents on DNA sequences should be the exception
rather than the rule. It suggested that the tests of
inventiveness and usefulness should be more rigorously
applied to applications for genetic patents and that
patents for a DNA sequence as a diagnostic test or gene
therapy should rarely be granted.
The U.S. is attempting to create a legal framework for the
regulation of biotechnologically based medications
produced by generic drug manufacturers. Several such
medicines no longer have patent protection. It is unclear
what procedures the new generic versions of these
medicines will be required to undergo to be approved by
the Food and Drug Administration. These products, which
are typically composed of proteins, enzymes or antibodies,
are much more complex to replicate than drugs that are
merely chemical compounds. It is not known if their safety
can be assured using the same standard. The Biotechnology
Industry Organization believes such products are so
complex that generics would have to undergo the same
approval process that the medication originally did in
order to prove their safety and efficacy.
GM Animals and the Environment
-
At the University of Guelph, the carcasses of 11
genetically engineered “enviropigs” were
mistakenly taken to a rendering plant and made into
animal feed. Environmental groups felt the animal feed
should have been recalled, but government officials
decided the risk was minuscule.
-
The U.K. Agriculture and Environment Biotechnology
Commission issued a report stating that GM fish should
not be farmed in offshore aquatic net pens due to the
potential for escape. It called for creation of an
advisory body on GM and cloned animals to monitor
developments and advise the government.
The European Patent Office (EPO) decided in July that the
“Edinburgh”21 patent should be maintained
in an amended form so that it does not include human or
animal embryonic stem cells. The Opposition Division of
the EPO decided that the previously granted patent did not
comply with the requirements of the European Patent
Convention.
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3F) Privacy and Genetic Information
There are two areas of particular concern related to the
inappropriate use or release of genetic information. One
is whether stored samples of biological materials should
be the property of the research institution, the
researcher or the person from whose body they came. The
other is the potential use of genetic information to
discriminate against individuals in matters such as
employment, credit, insurance or pension eligibility. Both
of these areas manifested themselves this year, the first
one most notably in Canada and the second primarily in the
U.S. and U.K. While few countries have legislation dealing
specifically with genetic information and discrimination,
this situation is gradually changing.
Members of the Nuu-chah-nulth (Nootka) First Nation on
Vancouver Island discovered that DNA samples they had
donated almost 20 years ago for rheumatoid arthritis
research have been used for other types of research
without their consent. The geneticist who originally
collected the samples moved from the University of British
Columbia to the University of Utah and then to Oxford,
taking the samples with him and using them for other
research projects. The geneticist acknowledges that he did
not obtain renewed consent, and UBC officials acknowledge
that the participants consented only to arthritis
research. The situation has led to the introduction of
policies at the British Columbia and Utah universities
that researchers must obtain consent for each new use of a
stored sample for research. The University of Utah also
introduced the policy that study samples are university
property.
Federal Funding for Plant Research
In October, the Government of Canada announced funding
totalling $10 million over the next five years to the
National Research Council's Plant Biotechnology
Institute in Saskatoon for a program aimed at developing
crops for enhanced human health. The project aims to
develop and improve plants that produce natural health
products as well as to produce pharmaceutical products in
plants through molecular farming technologies.
With regard to genetic testing and possible
discrimination, the Ontario Human Rights Commission
released a report in February on consultations it had
conducted concerning human rights issues in insurance. In
announcing the report, Ontario Human Rights Chief
Commissioner Keith Norton stated that genetic testing and
related information should not be used to deny insurance
or invoke exclusionary periods on the basis of a
“pre-existing condition.”
In the U.S., senior officials of the Bush administration
called on Congress to pass legislation to bar employment
and insurance discrimination based on genetic information,
as the current laws are seen to offer insufficient
protection. Meanwhile, a U.S. railroad company, Burlington
Northern Santa Fe Corp., agreed to pay $2.2 million to
workers it had tested for genetic defects in order to
settle charges that it had illegally tested these workers.
While the information was not actually used to screen out
employees, the collection of the information was seen as
discriminatory. In the end, the DNA test that was
performed (to determine a genetic predisposition to carpal
tunnel syndrome) was found not to provide any useful
information about the employees
In the U.K., the Human Genetics Commission issued two
documents regarding genetic information and privacy. In
May, it released a report recommending that stricter
controls should be placed on the use of DNA data, and that
independent bodies should oversee the management of DNA
collections. The commission also issued a consultation
document concerning the supply of genetic tests directly
to the public. Because genetic testing does not offer
simple yes or no answers, some believe the test results
need to be interpreted by qualified individuals. Others
argue that home tests should be available over the counter
so that people who would not go to the doctor can get
tested. Also in the U.K., GeneWatch warned doctors that
they should be sure the necessary safeguards are in place
before their patients submit samples to the new, national
genetic collection, Biobank UK.
In August, after 18 months of investigation and wide
public consultation, the Australian Law Reform Commission
(ALRC) and the Australian Health Ethics Committee (AHEC)
released a wide range of recommendations that would allow
employers to fulfil their legal obligations while
protecting Australian employees from potential misuse of
genetic testing and information. The Nuffield Council
report mentioned earlier also touched on these issues.
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3G) Transgenic Technologies and
Xenotransplantation
A new method was developed to increase the efficiency of
creating transgenic mammals. Tosk, a biotechnology company
in San Francisco, said it is able to add genes to
mammalian cells with unprecedented efficiency because of
the use of transposons.22 This finding could also have
implications for conducting gene therapy on humans.
Researchers are planning to genetically modify an invasive
European species of carp in order to eradicate it from
several Australian rivers and streams where it has taken
over. Multiple copies of a gene called
“daughterless” will be introduced into the
carp, which will then be released into the waterways. The
genetic modification will prevent the fish from producing
female offspring. The process has not yet been approved.
Scientists are adding a gene to mosquitoes in the hopes of
halting the transmission of malaria. The added gene
prevents the malaria parasite from moving into the
mosquito's salivary gland and therefore from entering
any humans that the mosquito bites. It is hoped that GM
mosquitoes would gradually replace wild mosquitoes, thus
reducing malaria in developing countries.
Nexia Biotechnologies Inc. and the U.S. Army Soldier
Biological Chemical Command reported that they have
produced spider silk proteins via cell culture techniques.
This recombinant spider silk may have medical, military
and industrial applications, as spider silk has a unique
combination of high-performance properties including
toughness, strength, lightness and biodegradability.
PPL Therapeutics, the Scottish firm that owns the Roslin
Institute where Dolly was cloned, announced it has cloned
pigs that have been genetically engineered so that the
human immune system would not reject a transplanted pig
organ. It has been suggested that pig-to-human transplants
may be feasible within four years.
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Canada's Biotechnology Sector23
Canada's biotechnology sector consists of more than 400
companies, employing 62,000 individuals. Canada ranks second in
the world, after the U.S., in terms of number of firms, and
third after the U.S. and the U.K. in generating revenues.
The greatest concentration of biotechnology companies in Canada
lies in the therapeutics sector (57 per cent), followed by
agriculture (15 per cent), diagnostics (10 per cent), genomics
(9 per cent), environment (8 per cent) and medical devices (1
per cent).
Canada's biotechnology sector is distributed across the
country. The dominant players are Quebec with 133 biotechnology
firms (32 per cent), Ontario with 119 firms (29 per cent) and
British Columbia with 81 firms (20 per cent). Quebec, Ontario,
Alberta and British Columbia are particularly strong in the
health care sector. Saskatchewan is a global leader in
agricultural biotechnology. Atlantic Canada excels in
aquaculture, forestry and biodiversity.
In 2001, annual revenues reported by Canada's publicly
traded biotechnology firms exceeded $1.5 billion, a 300-per cent
increase over 1997 levels. More than 400 biotechnology products
are in the research pipeline. Canada's growing R&D
capacity in biopharmaceuticals is a natural evolution from a
research base that has won an international reputation in fields
such as genomics, proteomics, bio-informatics, immunotherapies,
protein engineering and new drug delivery systems. Canada has
established the fastest rate of growth in the number of workers
devoted to R&D, in external patent applications and in
business expenditures on R&D among G7 countries.
Factors believed to be essential to continued growth of
Canada's biotechnology sector include the country's
strong base of scientific expertise, its continuous investment
in research and development, access to early-stage capital, a
supportive tax environment and government leadership in economic
and innovation policy.
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Appendixes
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Biotechnology and Canadian Innovation
Statement on the Occasion of the National Summit
on Innovation and Learning
November 18–19, 2002
The Institutional Transformation Imperative
Transformative technologies like biotechnology bring
fundamental changes to societies and thus hold important
implications for all Canadian regions, communities and
sectors. Through its capacity to provide important
benefits for health, the environment and our quality of
life, biotechnology is bringing change, as well as
challenging existing institutions and beliefs. Its effects
will be even more profound in the future. The development
and beneficial application of biotechnological innovation
must therefore be a central element in the articulation
and implementation of Canada's Innovation Strategy.
Complex transformative technologies like biotechnology
also carry with them risks, pressures on existing
regulatory and decision-making institutions, and create
tensions and trade-offs that cut across personal and
social values. As Canada moves forward to capture the
benefits of biotechnological developments, we must ensure
that these risks and tension are addressed and managed
through institutional changes in and outside all levels of
government in Canada.
The work of the Canadian Biotechnology Advisory Committee
(CBAC) to date has clearly demonstrated that policies and
programs seeking to promote successful and sustainable
innovation in the broadest sense must focus not only on
the technical aspects of innovation but also on fostering
the social and institutional transformations necessary to
realize the full social and economic benefits of
technological advances and to manage the challenges,
pressures and uncertainties.
CBAC is embarking on a major analysis of this
institutional transformation imperative and, by next
autumn, intends to provide strategic advice to federal
Ministers on the more immediate issues and opportunities.
CBAC will also inform Ministers of the major topics,
background analysis, consultation processes and
partnerships it intends to pursue in developing advice on
the longer-term institutional transformations required to
achieve the goals of:
-
ensuring Canadians capture the economic, social, health
care, environmental, and quality of life benefits from
biotechnology; and
-
addressing and managing the potential challenges,
risks, hazards, tensions and trade-offs associated with
this transformative technology.
Innovation Is Everybody's Business
CBAC will be approaching the foregoing task with the
realization that there is a need for a much broader and
deeper understanding of the individual and institutional
factors that facilitate or hinder responsible and
effective development and assimilation of biotechnological
advances so that innovative ways can be found to:
-
address the development of biotechnology in a manner
that reflects the values of Canadians, protects the
environment, ensures sustainability, and builds social
cohesion and consensus;
-
achieve a fair distribution of benefits including
greater equality of access to useful products and
services for all Canadians and for the citizens of
developing countries; and also to achieve a fair
distribution of exposure to risks; and
-
nurture our intellectual and entrepreneurial resources,
thereby strengthening our economic independence and
sovereignty, boosting employment, stimulating greater
productivity and increasing our standard of living.
Identifying and successfully introducing innovations
requires involvement of all sectors of Canadian society in
the process of institutional transformation. The
transformations may involve changes in how existing
institutions, both within and outside government, are
organized and perform their functions, the development of
new organizations or the development of partnerships,
alliances and networks among institutions and
organizations. The institutional transformations can be
considered to fall into two categories. The first is those
that focus on social and economic development (e.g.,
education, training, research, knowledge transfer, the
search for best practices, risk capital supply, staying
abreast of scientific and technological advances, new
approaches to enhancing access to benefits). The second is
those that focus on regulation (e.g., risk assessment,
management and communication, protection of human and
animal health, the environment, and respect for core
social values). In implementing institutional
transformation, it will be necessary to strike a
sustainable balance between competing objectives and
social values.
Canada seeks to be a responsible world leader in the
development, application, stewardship and governance of
biotechnology and has a firm basis for pursuing that goal.
With the impetus provided by the Innovation Strategy and
sustained commitment, there is every reason to be
confident that we can capitalize on these strengths for
the benefit of all Canadians by matching scientific and
technological ingenuity with social ingenuity.
CBAC supports a strategy for innovation that is more than
simply the invention of new products and processes and
establishing ways of getting them into the hands of
Canadians. It must be seen as creative activity that takes
place within a broader context and that embraces an
imperative to transform our institutions. Our members look
forward to contributing to such a strategy and to an
expanded understanding of both the benefits and unintended
consequences of biotechnological innovation.
Top of Page
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Reports and Public Developments
January
National Academy on Sciences, National Academy of
Engineering, Institute of Medicine, National Research
Council, Scientific and Medical Aspects of Human
Reproductive Cloning,
Washington, DC, January 18, 2002,
( http://www.nap.edu/books/0309076374/html/ )
Ontario Government, Genetics, Testing & Gene
Patenting: Charting New Territory in Healthcare,
Toronto, January 2002,
(
http://www.health.gov.on.ca )
Top of Page
February
Ontario Human Rights Commission, Human Rights Issues
in Insurance: Consultation Report,
February 2002,
(
http://www.ohrc.on.ca )
United Kingdom, House of Lords, Select Committee on
Stem Cell Research Report,
London, February 13, 2002,
(
http://www.parliament.the-stationery-office.co.uk )
Top of Page
March
Canadian Institute for Environmental Law and Policy, A
Citizens' Guide to Biotechnology:
Helping citizens have a real say in the development of
biotechnology in Canada,
March 2002,
( http://www.cielap.org/citizensbiotech.pdf,
PDF Format )
Canadian Institutes of Health Research (CIHR), Human
Pluripotent Stem Cell Research: Guidelines for CIHR-funded
Research,
Ottawa, March 4, 2002,
( http://www.cihr-irsc.gc.ca/e/news/8000.shtml )
National Research Council, Environmental Effects of
Transgenic Plants:
The Scope and Adequacy of Regulation,
Washington, DC, March 2002,
( http://www.nap.edu/books/0309082633/html/ )
Top of Page
April
South African Medical Research Council, Guidelines on
Ethics for Medical Research: Reproductive Biology and
Genetic Research,
Tygerberg, April 2002,
( http://www.sahealthinfo.org/ethics/ethicsbook2.pdf,
PDF Format )
World Health Organization, Genomics and World
Health,
Geneva, May 2002,
(
http://www3.who.int/whosis/genomics/pdf/genomics_report.pdf,
PDF Format )
Top of Page
May
An Act Respecting Assisted Human Genetic
Reproduction was tabled in the House of Commons on
May 9 and had its second reading on May 28 and was
referred to committee. The text can be found at
(
http://www.parl.gc.ca )
European Group on Ethics in Science and New Technologies
to the European Commission, Ethical Aspects of
Patenting Inventions Involving Human Stem Cells,
Brussels, May 7, 2002,
(
http://europa.eu.int/comm/european_group_ethics/docs/avis16_en.pdf,
PDF Format )
Human Genetics Commission, Inside Information: Balancing
interests in the use of personal genetic data,
May 2002,
( http://www.hgc.gov.uk/insideinformation/index.htm )
Top of Page
June
Australian Government, Research Involving Embryos and
Prohibition of Human Cloning Bill 2002,
Canberra, June 27, 2002,
( http://www.aph.gov.au/bills/index.htm )
Bioethics Advisory Committee Singapore, Ethical, Legal
and Social Issues in Human Stem Cell Research,
Reproductive and Therapeutic Cloning,
Singapore, June 21, 2002,
( http://lawgenecentre.org/links/about.php?linkID=1248 )
Canadian Biotechnology Advisory Committee, Patenting
of Higher Life Forms,
Ottawa, June 2002,
( E980_IC_IntelProp_e.pdf, PDF
Format )
Top of Page
July
Human Genetics Commission, The Supply of Genetic Tests
Direct to the Public: A Consultation Document,
London, July 2002,
(
http://www.hgc.gov.uk/testingconsultation/testingconsultation.pdf,
PDF Format )
National Consultative Ethics Committee for Health and Life
Sciences (CCNE), Reflections on an Extension of
Pre-implantation Genetic Diagnosis, Opinion no.
72,
Paris, July 4, 2002,
( http://www.ccne-ethique.fr/english/avis/a_072.htm )
Nuffield Council on Bioethics, The Ethics of Patenting
DNA, July 2002,
(
http://www.nuffieldbioethics.org/publications/pp_0000000014.asp )
The President's Council on Bioethics, Human
Cloning and Human Dignity: An Ethical Inquiry,
Washington, July 10, 2002,
( http://www.bioethics.gov/cloningreport/ )
United Kingdom, House of Commons Science and Technology
Committee, Developments in Human Genetics and
Embryology,
London, July 18, 2002,
(
http://www.publications.parliament.uk
)
United Nations, Office of the High Commissioner for Human
Rights, OHCHR Group of Experts, Conclusions on Human
Rights and Biotechnology,
Geneva, July 26, 2002,
( http://www.unhchr.ch/biotech/ )
Top of Page
August
Australian Law Reform Commission, Discussion Paper 66:
Protection of Human Genetic Information,
Sydney, August 28, 2002,
(
http://www.austlii.edu.au/au/other/alrc/publications/dp/66/ )
Canadian Biotechnology Advisory Committee, Improving
the Regulation of Genetically Modified Foods,
Ottawa, August 26, 2002,
( http://strategis.ic.gc.ca/epic/site/cbac-cccb.nsf/en/ah00186e.html )
Top of Page
September
Agriculture and Environmental Biotechnology Commission,
Animals and Biotechnology,
September 2002,
(
http://www.aebc.gov.uk )
Californian Government, An Act to add Article 5
(commencing with Section 125115) to Chapter 1 of Part 5 of
Division 106 of the Health and Safety Code, relating to
medical research,
approved by Governor and chaptered by Secretary of
State,
September 22, 2002,
(
http://www.leginfo.ca.gov,
PDF Format )
Council for International Organizations of Medical
Sciences (CIOMS), International Ethical Guidelines for
Biomedical Research Involving Human Subjects,
September 2002
( http://lawgenecentre.org/links/about.php?linkID=1246 )
Top of Page
October
Nuffield Council on Bioethics, Genetics and Human
Behavior: The Ethical Context,
London, October 2, 2002,
(
http://www.nuffieldbioethics.org,
PDF Format )
Gene Therapy Advisory Committee, Issues Advice on
X-SCID Gene Therapy Trials,
London, October 3, 2002,
( http://www.doh.gov.uk/genetics/gtac/whatsnew.htm )
United Nations Educational Scientific and Cultural
Organization (UNESCO), International Bioethics Committee,
Outline of the International Instrument on Human
Genetic Data, Paris,
October 28, 2002,
(
http://unesdoc.unesco.org/images/0012/001281/128150e.pdf,
PDF Format )
World Medical Association, Ethical Considerations
Regarding Health Databases,
Washington, October 6, 2002,
( http://www.wma.net/e/policy/d1.htm )
Top of Page
November
Nuffield Council on Bioethics, Pharmacogenetics:
Ethical Issues — Consultation Paper,
London, November 19, 2002,
(
http://www.nuffieldbioethics.org, PDF Format )
Nuffield Trust for Research and Policy in Health Services,
Learning from Experience: Privacy and the Secondary Use of
Data in Health Research,
London, November 28, 2002,
(
http://www.nuffieldtrust.org.uk
)
United Nations Educational Scientific and Cultural
Organization (UNESCO), International Bioethics Committee,
Preliminary Report on the Possibility of Elaborating a
Universal Instrument on Bioethics,
Paris, November 15, 2002,
(
http://www.bioethicsanddisability.org,
PDF Format )
Top of Page
December
Australian Office of the Gene Technology Regulator (OGTR),
Gene Technology Ethics Committee, Submission on the
Draft Guidelines on Xenotransplantation Research,
Woden, December 12, 2002,
(
http://www.health.gov.au/ogtr/pdf/committee/gtecxensub.pdf )
Government of Canada, Act respecting assisted human
reproductive technologies and related research Bill
C-13,
Ottawa, December 12, 2002,
(
http://www.parl.gc.ca, PDF Format )
Greece National Bioethics Commission, Comments on the
Draft Bill Concerning Medically Assisted Human
Reproduction, Athens,
October 31, 2002,
( http://www.bioethics.gr/images/draftbillen.pdf,
PDF Format )
Canada (Commissioner of Patents) v. President and
Fellows of Harvard College,
Ottawa, December 5, 2002,
(
http://reports.fja.gc.ca/fc/2000/pub/v4/2000fc27094.html )
Top of Page
1 Parthenotes are embryos grown from unfertilized
eggs, which, in mammals, are not capable of developing into
viable fetuses.
2 CBAC's partnership network is a range of groups
and individuals who have expressed interest in CBAC's
activities and who help distribute the committee's materials
to their members and associates.
3 The media analysis revealed that GM foods dominated
the media coverage during the last half of August 2002 due
primarily to CBAC's GM foods report. The report garnered
prominent coverage over a 24-hour period, but debate concerning
the recommendations quickly subsided. Reaction to the
recommendations, particularly from editorial writers, was evenly
balanced between those urging mandatory labelling and those
advocating voluntary labelling. Attention to GM foods during
this period was also boosted by Zambia's reluctance to
accept food aid that may contain GM material from the U.S.
4 The acceptability framework is based on the premise
that different kinds of GM foods and feeds can be classified
along a four-level spectrum: acceptable, acceptable with certain
conditions, unacceptable at present and until more is known or a
given standard is met, and not acceptable under any
circumstances.
5 The meeting was sponsored by the Canadian
Institutes of Health Research, the Canadian Biotechnology
Strategy Fund, and Genome Canada and its centres.
6 Similar agreements are in place with Sweden, Spain
and the Netherlands.
7 The human genome contains some three billion pairs
of DNA. These are organized into sequence variations or
“haplotype blocks” comprising about 10,000 or more
base pairs. By breaking up the human genome into blocks with
known genetic variations, researchers can go directly to those
blocks and search for disease genes rather than having to search
through all three billion DNA base pairs.
8 In 2002, two toddlers with Severe Combined
Immunodeficiency (SCID) who were treated with gene therapy later
developed an apparent leukemia-like side effect. The first sick
toddler prompted U.S. and French scientists in October to stop
gene therapy experiments for SCID. The second sick child
resulted in the temporary halting of 27 more gene therapy
experiments other than those for SCID. Scientists have long
warned that cancer is a possible risk from gene therapy.
9 The survey of 28 leading scientists from around the
world focussed on the needs of the developing world and how
developments in genomics and biotechnology could benefit the
poorer countries. Overall, the experts gave higher ratings to
simpler technologies than to high-technology treatments that
would likely benefit only those in the western world.
10 Some of the debate centres on whether the stem
cells are naturally multipotent or whether this is brought on by
culturing techniques. While some adult stem cells may indeed be
multipotent, more research is required. Many scientists call for
more rigorous standards for stem cell research.
11 The Raelians, a Quebec-based cult, announced in
December that a human clone had been born on December 26, 2002,
although no proof accompanied the announcement. In terms of
media coverage, this was the biggest single biotechnology story
since tracking for the Biotechnology Assistant Deputy Minister
Coordinating Committee began in September 2000. The extensive
coverage raised concerns that such announcements would undermine
legitimate research involving cloning to obtain stem cells for
therapeutic purposes. Dr. Severino Antinori, an Italian doctor,
also announced that a woman was expected to give birth to a
cloned boy in January 2003.
12 For example, in one project, scientists cloned
cows having functional human antibody genes by using artificial
chromosomes to carry the antibody genes into the cows. Being
able to isolate human antibodies from cows' milk could
someday advance the treatment of hereditary immune deficiencies
and viral infections and could be used to protect against
biological warfare.
13 For example, a kitten has been cloned as part of a
larger, more difficult project to clone a dog. Plans have been
made in Australia to clone an extinct species called the
Tasmanian tiger from preserved male and female specimens.
14 California's new law, adopted in September
2002, permitting embryonic stem cell research, is at odds with
the restrictions on federal funds for embryonic stem cell
research. The new law enables embryos to be both donated and
destroyed for stem cell research but bans the sale of embryos.
15 Canada's proposed legislation on reproductive
technologies was read for the second time in the House of
Commons on May 28, 2002, and referred to committee. The bill is
expected to be passed in the first half of 2003.
16 This survey took place before the Raelian
announcement.
17 Parthenogenesis is a special type of sexual
reproduction in which an egg develops into an embryo without the
involvement of a sperm.
18 This “narrow definition” would include
only organisms produced through recombinant DNA technology and
would exclude products derived from chemical or radiation
mutagenesis.
19 With regard to rendering specific genes inactive,
U.S. researchers knocked out the gene in soybeans that is
responsible for many of the allergic reactions that people have
to soya.
20 New research reported in August demonstrates that
the risk of developing breast cancer due to BRCA 1 and 2 is much
lower than originally thought. The previous estimate was
70–85 per cent of those carrying the mutation by age 70;
the current estimate is 26 per cent.
21 The Edinburgh patent describes a method of using
genetic engineering to isolate stem cells, including embryonic
stem cells, from more differentiated cells in order to obtain
pure stem cell cultures. The granting of the patent led to
protests and triggered a major public debate on the patenting of
stem cell technology. The debate centred on whether the patent
extended to humans. The EPO determined that the previously
granted patent violated Article 83, which stipulates that the
invention be disclosed in a manner that allows it to be carried
out by an expert, and Rule 23d(c), which excludes the use of
human embryos for industrial or commercial purposes.
22 Transposons are units of DNA that can move from
one position to another in the same or a different genome. They
trigger changes in gene expression by shutting off genes or
causing insertion mutations.
23 Information in this section derives from Beyond
Borders: The Canadian Biotechnology Report 2002, Ernst &
Young.
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