HUMAN GENOME WORKSHOP
SUMMARY REPORT
OTTAWA
Executive Summary
Highlights
Social Justice
Human Rights
Health
Canadian Biotechnology
Strategy
Annex I - Health Workshop
Annex II - Social Justice Workshop
Annex III - Human Rights Workshop
EXECUTIVE SUMMARY
Rapid technological changes are occurring in the field of biotechnology.
Advancements in the human genome technology sector could have an impact similar
in magnitude to the information revolution. It stands to be the next critical
issue for policy development on a global scale. Innovations in this field will
affect virtually all policy areas, including privacy, national security, the
economy, health, governmental services, and numerous others. Because there is a
strong potential for these technological advancements to raise issues not
currently being examined, broad thinking and horizontal approaches are required
to address this subject.
In response to this situation, the Department of the Solicitor General
Canada, Health Canada, and the Department of Justice sponsored a Human
Genome Workshop, held on February 24th at the Government Conference Centre
in Ottawa.
The purpose of the workshop was to examine the potential social justice,
human rights, and health policy implications resulting from advancements in
human genome information and technology. The workshop provided a forum where 50
participants, representing an important cross-section of relevant fields,
explored the policy implications of issues that cut across departmental and
disciplinary lines.
Dr. Chrétien, Scientific Director and CEO, Loeb Health Research Institute,
Ottawa Civic Hospital, identified some general conclusions from the
workshop:
- Public engagement and education is crucial - the public must be able
to understand what is occurring, and what may occur in the field.
- Government Collaboration - government departments must work together
and coordinate their activities in order to develop policy initiatives which
respond to developments in human genome technology. The Canadian Biotechnology
Advisory Committee (CBAC) was encouraged to take the lead for Canada, both
domestically and internationally, to coordinate activities across
government.
- Timing - The policy issues surrounding human genome technology must
be dealt with urgently, given the fast pace at which this field is
advancing.
The views, ideas, or thoughts expressed at the workshop and reflected in
this Report do not represent the policy of the Government of Canada, Solicitor
General Canada, the Department of Justice, Health Canada, or any Federal
Government Agency or Department.
Highlights
Social Justice
Professor Bartha Knoppers, Ph.D., Université de Montréal, provided an
overview of potential social justice policy implications of developments in
human genome technology, and examined approaches that may need to be considered
to deal with them. Her conclusion emphasized that policy makers must decide on
the most effective policy approach while keeping in mind that the debate is
international and multi-jurisdictional. As a result, an integrated and
coordinated policy response is required. She asked policy makers to be
transparent about their concerns and hopes, and to engage in open discussions
on these subjects in order to develop policy.
Cross-species Genetic Manipulation
Developments in genetic technology already affect life in Canada. Current
practices include genetically-altered food products that contain medicine for
human consumption, genetically-manipulated cows to ameliorate milk production,
and the production of genetically-manipulated animals whose organs are used for
human transplants (xenotransplantation).
The Commercialization of Genomics
The commercialization of genomics raises many economic and ethical
questions. Pharmacogenomics (the attempt to tailor drugs to individual or group
needs) is a large and booming industry in Canada and around the world. The
private sector has taken the lead in DNA banking for the purposes of
pharmacogenomics, and thus controls both the technology and information related
to genomics.
Patenting of Genetic Information
Whether there is a need for mandatory consent for the patenting of products
derived from human DNA is an important issue. The Council of Europe (an
inter-governmental forum for examining social problems, whose role is to
strengthen democracy, human rights and the rule of law throughout its 41 member
states) and other institutions abroad have already taken steps to require a
person's consent be obtained prior to developing products derived from their
genes. The question of patents raises concerns about how and why research is
carried out. Some researchers may be motivated by economic reasons (in order to
obtain patents) yet others argue that patents are necessary to protect
investment, and stimulate research and development. Canada may learn lessons
from research in other jurisdictions during the last decade. For example,
ambiguities and overlap in the U.S. system for patenting of genes has slowed
down therapeutic research in the United States.
Discrimination Based on Genetic Information
DNA databanks (storage of genetic information), coupled with the power of
informatics, has created a new potential danger regarding invasion of privacy
and the potential for discrimination. Employment and insurance are two areas
where decisions, based on genetic information, could lead to unreasonable
discrimination. While other countries have already taken steps to reduce the
potential for genetic discrimination in the areas of employment and insurance,
Canada has not yet advanced to the same level.
Approaches to Policy Making
Policy responses could take many forms, each having advantages and
disadvantages.
- The Constitutional Human Rights approach is far-reaching and relies
on already existing human rights instruments to examine new technologies.
However, it is reactive, ad-hoc in nature, slow, and costly.
- The Statutory-Specific approach provides immediate certainty and
precision. But it may limit public discourse, cause unintended impacts in other
areas, and risk the development of conflicting statutes.
- The Administrative approach allows for internal regulation by
professionals, and external regulation by review agencies through the creation
of professional codes of conduct. This approach allows for greater integration
of policy, but it is slow and incremental, and does not openly address issues
of values and ethics.
- The Liberal-Market Driven approach at first glance, provides the
most flexible options. It allows individual citizens to make decisions, but can
be a double-edged sword, as protests can have a significant impact on the
decisions of companies, and the lack of oversight can create an ethical
vacuum.
Issues and Questions Raised:
- Are researchers and policy makers learning lessons from biotechnological
developments in plants and animals to ensure that similar problems are not
repeated with humans?
- While advancements in human genome technology may save lives and provide
substantial economic benefits, they may also lead to the creation of new
challenges such as cloning. How can policy makers best protect Canadians from
potential new threats while allowing them to benefit from positive
developments?
- What are the best methods to ensure privacy of all medical information? If
existing systems are deemed insufficient, what is the best policy option(s) to
protect privacy?
- Is policy development required to safeguard against the potential for
inadvertent or deliberate abuse of genetic information by government, private
companies and individuals?
- Internationally, governments and institutions have set guidelines regarding
genetic research. Which course should policy makers follow regarding research,
the patenting of genetic information, and the issue of consent?
- Which measures should policy makers adopt to limit the possibilities for
genetic discrimination?
- Policy makers have several options for developing policies, including the
Constitutional Human Rights, Statutory-Specific, Administrative, and
Liberal-Market driven approaches. Which of these options, or combination of
options, would be most effective in relation to human genome technology?
- Human genome information has the potential to provide behavioral clues,
such as demonstrating a genetic pre-disposition for violence. What are the
potential implications for crime prevention, the management and rehabilitation
of inmates, and the selection of national security and law enforcement
representatives (i.e. national security and law enforcement representatives may
be required not only to identify/understand the genetic-based behavioral clues
in individuals, but also to demonstrate they do not posses these genetic
characteristics)?
Human Rights
Virginia McRae, General Counsel, Family, Children and Youth Section,
Department of Justice, focused on policy implications for the family and
children. Human genome technology provides a sharper focus to long-standing
human rights issues, since laws are often viewed as the answer to dilemmas
created by science. The expectation that criminal law will solve some of these
dilemmas may be unrealistic, due to the general nature of criminal law. Laws
are only instruments, which tend to highlight the pace of change and reflect
societal values.
Family Law and Children
Family law protects and fosters relationships by recognizing and enforcing
certain responsibilities. While children are no longer viewed as mere
extensions of their parents, parents still make decisions on their children's
behalf. Developments in human genome technology may increase the magnitude and
depth of parental decisions. The concept of protecting and fostering children,
not as genetic products, but as valued humans and individuals, may need to be
ensured.
Adoption practices and the rights of adopted children may need to be
re-examined as a result of developments in genetic technology. Such a
re-examination may raise a host of issues regarding responsibility,
accountability, disclosure, ethics, the welfare of the individual, and the
desires of the state.
Human Rights Legislation and Agreements
Human Rights articles and legislation currently focus on the protection of
human dignity, both domestically and internationally1. Human Rights, at the level of
individuals and population groups, is important, given the type of information
that may now be available from genome technology.
Issues and Questions Raised:
- Human Rights legislation and agreements currently focus primarily on
individual rights. Should the emphasis on group rights be increased given the
potential for genetic discrimination of groups? If so, how can policy makers
ensure that individual rights are still protected?
- What are the best policy options to ensure that certain groups are not
discriminated against based on their genetic make-up?
- Should the government regulate advancements in human genome technology? If
so, what is the best method to generate appropriate policy responses?
- Should the law recognize the right to know one's genetic background? What
will be the impact on the family?
- What are the best ways to deal with issues involving children (including
genetics, privacy, and human rights)? What are the best means to ensure that
policy makers explore all options prior to the development of policies dealing
with children?
Health
Dr. Francis Rolleston, Director, Ethics and International Relations, Medical
Research Council, indicated that genetic sequencing poses opportunities and
challenges to health research. Scientists are attempting to link specific gene
sequences to health, in order to use this knowledge to advance health services.
The potential uses of human genome technology and information are numerous,
including prediction, diagnosis, treatment (e.g. drug design, pharmacogenomics,
gene alteration, xenotransplantation) and prevention of diseases.
Genohype (dreams exceeding current abilities) raises further issues. At
present, we are only beginning to understand the complexities of the
inter-relationship amongst health, diseases, and genes. For example, there
are:
- diseases related to single genes; and
- multi-factorial health issues/diseases.
Single gene diseases are easier to understand, diagnose, and predict.
However, the vast majority of diseases are multi-factorial and predictability
for these is low and uncertain. Geneticization (genetic reductionism -
attributing personal health only to genes) is a potential danger.
Genomic Research
Research in this field is imperative for national, ethical, health, social,
economic, and cultural reasons. Research is key to the foundation of the health
system, and genetics and genomics are essential components. Canada is a leader
in the biotechnological field. Policy makers and practitioners must be aware of
the potential for Canada's intellectual, genetic, and entrepreneurial resources
to be the heightened target of foreign intelligence organizations.
Genomics will have a significant impact on the health care system by opening
up new possibilities, imposing new burdens, and running new risks. There is a
risk that new methods may be applied before they are properly understood and
tested. The government, in consultation with the public, should establish
policies that protect Canadians and ensures appropriate access to new
technologies. Dr. Rolleston cautioned that existing councils and organizations,
which guide research on human genomics, have an uneven influence because they
do not monitor or collaborate with all research organizations.
Other Policy Issues
Numerous other policy issues are raised by genomics. Genomics adds a sense
of focus and urgency to a range of issues, including privacy, consent, use of
databases, genetic screening, use of genetic information, children, and the
individual's relationship to family. Genetics may have unique impacts on the
prediction and treatment of disease relating to families, use of tissue samples
for DNA analysis and access to information for research purposes.
Issues and Questions Raised:
- The scientific, bureaucratic, and political communities should collectively
assess the potential socio-economic implications of advancements in human
genome technology.
- What role does government have in ensuring that empirical and scientifical
research forms the basis of health policy decisions?
- How can policy makers best protect and encourage the Canadian Biotech
industry?
- What are the real impacts of developments in human genome technology and
information on the health care system?
- Of the new medical genetic services soon to be available, which costs
should be covered by the public health system?
- What trade-offs need to be made given the potential advantages and
disadvantages of developments in human genome technology coupled with the need
for policy makers to balance Canadians' access to new technologies and their
protection from health-related threats?
- Should the government develop a global ethical policy that would be
applicable and enforceable on all genetic research conducted in Canada?
- In order for biotechnology to be developed, private industry, academia, and
the government must access genetic information. What mechanisms should policy
makers develop to prevent abuses (including the misuse of information) while
balancing the need for information?
Canadian Biotechnology
Strategy
Roy Atkinson, Executive Director, Canadian Biotechnology Strategy
Secretariat, explained biotechnology's potential to improve the quality of life
of Canadians, particularly by providing opportunities for health benefits. At
present, most of the biotechnology research and development is occurring in the
health field. As a result, more than 90% of advanced biotech products available
on the world market today are related to health. Biotechnology is a huge
economic venture that will continue to grow. Recent government initiatives
(such as the Science and Technology Strategy, the Jobs and Growth
Strategy, and the 1997 Speech from the Throne) reflect the Federal
government's interest in ensuring Canadian leadership in biotechnology.
Public Engagement in Policy Decisions
Canadians, and others around the world, have concerns related to
biotechnology that may be classified under four broad categories:
- health and environment;
- ethics;
- social impacts (domestic and international); and
- public awareness and engagement.
The Canadian Biotechnology Strategy (CBS) is viewed by many in government,
industry, and academia, as the first step in establishing a guiding policy
framework for biotechnology. The establishment of the Canadian Biotechnology
Advisory Committee (CBAC) is central to the future development of a policy
strategy on biotechnology. This Committee will provide broad-based advice that
integrates issues from economic to ethical. It is a new mechanism to facilitate
a "National Conversation", strengthen coordination across departments on key
social and ethical issues, and help integrate stewardship with economics,
public engagement, and partnerships. The government has an evolving vision and
strategy for biotechnology and is putting the appropriate machinery in place to
support its development2.
Issues and Question Raised:
- Policy makers must think carefully about the role and functions of
institutions responsible for issues relating to biotechnology, particularly in
the area of ethics.
- Which mechanisms should policy makers use to provide the public with
accurate information and engage them in the policy development process?
Annex
I
HEALTH WORKSHOP
To address the potential health policy implications of advancements in human
genome technology, the following issues require further deliberation:
- Develop a shared and clear understanding of the meaning of 'health' so as
to provide accurate and responsible information, and educate the public
and professional population.
- The policy process should be transparent and include public education.
- The discussion on genetics needs to proceed within the broader health
context so as to avoid genetic reductionism (health attributed only to
genes).
- Researchers need to realize the social and/or ethical implications of their
scientific achievements.
Genetics will have a significant impact on the
operation of the health care system, particularly on the use of genetic
information.
- Use of genetic information requires a balanced policy approach.
- Recognize genetics as a positive tool, without over-emphasizing its
importance or usefulness.
- Link expenditures to effectiveness.
- Privacy and disclosure of genetic information are central to the
discussion of genetics and health care.
- The health care system must have access to genetic information, but the
potential for its improper use is a concern.
- Transparent systems would increase public confidence in genetic
databases.
- Quality control mechanisms need to evolve in step with emerging
biotechnological needs.
- Are policies needed to guide how and when the health system informs family
members of a genetic problem?
Annex
II
SOCIAL JUSTICE
WORKSHOP
Participants noted that a definition of 'social justice' is a prerequisite
for any evaluation of the social justice policy implications of advancements in
human genome technology. Definitions of social justice varied among
participants. The concept of achieving a balance within society was agreed upon
(however, the definition of 'balance' was elusive). Discussion focused on fair
opportunity for all and the need to balance individual rights and societal
interests.
The following issues were identified:
The government should deal with the issues of
privacy and access to information regarding DNA/genetic information.
- The application of DNA information and its impact on privacy and
confidentiality should be gauged.
- Balancing society's need to access information and the individual's right
to privacy is a challenge given genetic testing and information obtained. This
challenge represents a crucial policy issue that may require modification of
existing standards, regulations, and accreditation systems.
- Different types of testing should be distinguished to identify the level of
information required, and the corresponding oversight or security needed to
protect that information.
- Specific accountability structures are needed to ensure the proper use of
DNA information; centralized or decentralized DNA databanks will have different
affects on the accountability structure.
- A risk assessment should be undertaken to determine the level of
restriction needed for different types of DNA databanks (e.g. medical,
criminal, etc.).
- What international literature and models are available for study in
Canadian policy formulation?
- Economic cost/benefit of processes may need to be examined.
- Potential high costs of new technologies demands that the government acts
to ensure accessibility to quality health care for all Canadians.
- Government's role in developing new technologies should be clarified.
There is the need to inform the public and make
the policy-making process inclusive and transparent.
- Government has the responsibility to lead policy development in this
area.
- Public engagement is key; accurate information will reduce fears and
facilitate productive discussion.
- An inclusive and transparent consultation process for policy development
should be established to bring individuals, businesses, and non-governmental
organizations together; this approach will foster cooperation between the
public, private, and voluntary sectors.
- The Canadian Biotechnology Advisory Committee (CBAC) was encouraged to
serve as the organization that facilitates the establishment of overall
guidelines and principles for human genome technology. Governmental departments
and agencies should work together to generate policy initiatives that respond
to developments in human genome technology affecting their jurisdictions. This
would ensure that departments deal with any area not covered by CBAC (such as
national security or law enforcement).
- Government departments need to consistently examine ethical questions that
surround policy decisions.
Annex
III
HUMAN RIGHTS
WORKSHOP
The identification of gaps in current human rights legislation may be the
first step in modifying our legal structure to meet the challenges resulting
from developments in human genome technology. Workshop participants began by
identifying basic human rights issues3, and the extent to which current
laws deal with human rights and genetics.
- The current system of domestic and international laws, covenants, charters,
and codes (such as Canadian DNA legislation and international Data Protection
Laws) already offer a significant level of protection for basic human rights,
and provide a substantial regulatory basis on which to build.
- Other laws and regulations, if updated, could also be used to control these
new technologies.
- Policy makers should identify the gaps in current human rights legislation
and work to 'fill' these gaps.
Current laws and conventions form an important starting point in addressing
the gaps in legislation. The issue of genetic discrimination represents a
primary gap. For example, hypothetically, the insurance industry could try to
deny insurance on the basis of genetic characteristics. Due to the economic and
social implications of insurance, participants identified the following issues
for further deliberation:
- Should every Canadian citizen have the right to obtain a basic level of
insurance?
- Should insurance companies, which may want to use genetic testing as a
means of gathering information, be entitled to use this tool if a person
requests additional insurance?
- What are the best means to develop regulations regarding the insurance
industry?
Access to, and disclosure of, genetic information
will have significant implications for family members.
Participants identified the following issues as key in any debate over
disclosure of genetic information:
- Balance between the right to individual privacy and the potential benefit
of sharing genetic information (disease/problem) with family members.
- As a society, we must come to terms with how to deal with disclosure.
Should disclosure be legislated or be left to the individual based on their
moral and ethical views?
- Should policy makers establish the rights of the individual and the family,
with regard to disclosure of sensitive genetic information?
Participants identified the following concerns related to forensic DNA
Databanks:
- Matching DNA samples of relatives of accused/suspected criminals, as a
result of genetic testing, is a legal question with significant ethical and
human rights implications which may require clarification.
- Governmental agencies should ensure that genetic information collected is
used only for purposes originally specified.
Issues in the area of procreation, cloning, and public education:
- The right to decide to procreate should be protected.
- Policy makers should ensure that commercial eugenics does not develop. In
other words, the government should balance the desire to remove genetic
diseases from future generations, while ensuring the procedures do not create
an intolerant society.
- There should be a moratorium on cloning in Canada; this would give policy
makers the time to examine the legal implications of cloning, the rights of the
children who are cloned, and to educate the public.
- Public education is crucial to any Canadian policy response to developments
in human genome technology.
ENDNOTES
1. Domestically, the Canadian Charter of Rights and
Freedoms and Provincial Codes ensure the rights of Canadians. Internationally,
UNESCO's Universal Declaration on the Human Genome and Human Rights
(balances research with Human Rights) and the Council of Europe's Directives of
1997 (outlaws the selection of sex in children) act as social guiding
principles for advancements in Human Genome technology.
2. For further information regarding the Canadian
Biotechnology Strategy's specific vision, goals, guiding principles, and
themes, please consult The 1998 Canadian Biotechnology Strategy: An Ongoing
Renewal Process on the Industry Canada Strategis web site at: http://strategis.ic.gc.ca/cbs.
3. Some of the human rights identified include:
privacy, equality, liberty, security of person, freedom from search and
seizure, access to health care, social and economic rights, right to procreate,
consent, group rights, "right not to know", substitute consent for children,
etc.
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