BioPortal | Report on Biotechnology

If anyone had told Canadians in the 1960s or '70s that scientists would one day identify genes that cause cystic fibrosis and muscular dystrophy, or manipulate stem cells to regenerate tissues and organs, it would have seemed an impossible dream.

Yet the world witnessed an explosion of extraordinary advances in molecular biology, genetics, cell biology and biochemistry in the final days of the 20th century that have revolutionized the way we live and think about life itself. The biotechnology innovations resulting from these scientific breakthroughs bring everything from vaccines to prevent disease, to healthier foods, to bio-fuels to replace non-renewable energy sources, to treatments enabling infertile couples to start a family.

Biotechnology is expanding the frontiers of knowledge with discoveries in fields as diverse as agriculture, energy, health care, the environment and the sustainable development of natural resources. Its impact on this century is predicted to be more dramatic and far-reaching than that of telecommunications and computers in the last, because it deals with life and living things which permeate all aspects of our own lives.

Biotechnology is viewed by most industrialized nations as a critically important engine of economic growth and social progress. However, due to its ability to manipulate life forms, biotechnology has generated controversy as well as excitement in many countries, including Canada. This transformative technology has sparked a society-wide debate about whether we should interfere with nature and potentially alter or create life. Some biotechnology innovations challenge the values and beliefs that underpin society, forcing Canadians to confront complex ethical questions never before faced.

In the late 1990s, the Government of Canada undertook consultations to gauge Canadians' concerns and priorities for this rapidly-growing field with the potential to profoundly change everything from their health care to their children's career choices. The Canadian Biotechnology Strategy Task Force was struck in 1997 to take a measure of Canadians' values, as well as to review and build on the accomplishments of the original National Biotechnology Strategy (NBS), launched in 1983. The unprecedented rate of discovery had outpaced the earlier Strategy's capacity to respond to new developments.

Since 1999, the Canadian Biotechnology Secretariat and its partners have maintained a large-scale tracking program of public opinion research. In the intervening years, 10 public opinion surveys have been commissioned and more than 75 focus groups conducted. This research has generated more than 17,000 data points in what is now North America's largest and most comprehensive investigation into attitudes about biotechnology and the public policy that surrounds it.

The polling program was designed to produce two waves of research each year, with a large tracking component as well as more intensive inquiry into specific issues such as genetic privacy, genetically modified food and stem cell research. The most recent wave of research, completed in March 2003, carried out a cross-national comparative study of attitudes towards biotechnology in Canada and the United States.

In the spring of 1998, the Task Force conducted consultations with provincial officials, industry, non-governmental organizations (NGOs), scientists, academics and other stakeholders concerning the Strategy's vision, goals and principles, impacts on Canada's main biotechnology industries, as well as on research and development (R&D). The Task Force also sought feedback from Canadians on how best to address their interests in the policy development process. Finally, it conducted extensive public opinion polling to learn Canadians' views about biotechnology and their need for ongoing information.

More than 5,000 individuals and organizations participated in the deliberations and in the shaping of a renewed federal policy framework. The result of this exhaustive process was the 1998 Canadian Biotechnology Strategy (CBS), a blueprint to enhance the quality of life of Canadians in terms of health, safety, the environment and social and economic development by positioning Canada as a responsible world leader in biotechnology.

Fulfilling the promise:

The Canadian Biotechnology Strategy

Biotechnology Statistics Program

Knowledge is the foundation of sound decision making. To maintain and enhance the significant knowledge base created over 1999-2003, the Biotechnology Statistical Program has been strengthened to provide an accurate estimate of the magnitude of biotechnology activities in Canada.

The enhanced statistical measurement and analysis project, carried out by Statistics Canada, now includes more data on the use and development of biotechnology by business, as well as new analysis from the existing "Biotechnology Use and Development" survey to assess trends in biopharmaceuticals, bio-products and emerging technologies such as genomics and proteomics. It also covers new international initiatives to ensure compatibility of statistical measures among countries over time. An important component of this work is ensuring the research findings are shared with specialists and generalists, practitioners and policy makers, as well as funders and evaluators.

The Canadian Biotechnology Strategy aims to ensure that all aspects of the development and application of biotechnology are responsibly managed, striking a balance between the detection and management of risk, and the development of new discoveries, in order to capture the technology's long-term health, environmental and economic benefits.

It fully reflects and responds to Canadians' demands that biotechnology be developed in ways that do not pose a danger to humans, the environment or animals, and which address the social and ethical challenges these technologies pose. At the same time, it advances their overarching objective - to encourage innovations that improve health, protect the environment and stimulate economic growth - to fulfill biotechnology's promise to build a higher standard of living and quality of life for all Canadians.

The CBS does so by providing a policy framework that integrates social, ethical, health, economic, environmental and regulatory considerations into biotechnology development decisions. The Strategy's guiding principles centre on: reflecting Canadian values; engaging citizens in open, ongoing, transparent dialogue; promoting an innovative economy, sustainable development, competitiveness, public health and scientific excellence; and ensuring responsible action and cooperation domestically and internationally.

The Strategy draws together federal departments and agencies engaged in regulatory activities, R&D, technology transfer, as well as investment and trade in biotechnology products and services, both in Canada and abroad.

Rapid advances in the field of genomics have made it possible to conclusively diagnose some hereditary diseases and to predict predispositions to others. In light of the growing accuracy of genetic testing, public concerns have been raised about the possibility that people with certain genetic predispositions might be discriminated against. Also, the highly personal nature of human genetic data, combined with its ability to confirm or refute family lineage, identify people or be used for various research purposes, has raised questions about the potential unauthorized uses of such information. Despite these concerns, Canadians do support genetic research so long as safeguards are in place.

Understanding these risks and developing responsible approaches to protect genetic information and privacy are public policy imperatives as they are prerequisites to public acceptance of biotechnology. Recognizing this, the Genetic Information and Privacy Working Group was created in the fall of 2001. Led by Justice Canada, the Working Group is taking a multidisciplinary and interdepartmental approach to policy considerations surrounding privacy and human rights, to anticipate and develop appropriate responses before problems surface. It has undertaken a research program to identify the challenges and to recommend any changes to federal laws, regulations, programs and policies that may be needed to address these concerns.

Together, the partners identified the nine overarching goals of the CBS, which guide their respective activities on this file:

Made-in-Canada approach

Maximizing the benefits, managing the risks

The Government of Canada understands that the relentless rate of development in this fast-changing field demands that it makes sure these technologies are used wisely and safely to protect the health and safety of Canadians and the environment. Yet, it also recognizes this country's enormous potential to be a responsible world leader in biotechnology.

The Canadian Biotechnology Strategy reflects and carefully integrates these dual roles.

It creates the conditions for innovation to maximize the benefits that flow from biotechnology breakthroughs, while making sure government is a vigilant regulator, assessing, managing and communicating potential risks associated with these technologies to safeguard public and environmental health.

One of the challenges biotechnology presents to government decision makers is its broad scope and complexity. It requires an in-depth understanding of basic science, health and environmental impacts, technological adaptation, industrial applications, as well as sensitivity to social and ethical values, in order to make sound decisions. Consequently, the Canadian Biotechnology Strategy is not simply a Government of Canada initiative but complements the efforts of others, including provincial and territorial governments, the scientific community, NGOs, industry, consumer groups and interested Canadians whose differing views, priorities and expertise collectively bring a balanced focus to the issue.

The CBS acts as a catalyst in advancing the efforts of all these essential players, encouraging national discourse, nurturing partnerships and fostering strategic investments to responsibly advance Canada's biotechnology capability.

While realizing the full potential of biotechnology is a shared responsibility, there are several areas where the federal government plays a leadership role:

Guided by expert advice

The departments and agencies advancing the Strategy undertake activities in each of these areas, relative to their spheres of responsibility. In addition to their contributions, federal decision makers also benefit from impartial expert advice.

During the 1998 CBS Task Force consultations, Canadians called for an independent advisory body that would operate at arm's length from government, to provide independent and comprehensive advice on crucial policy questions surrounding biotechnology. The Canadian Biotechnology Advisory Committee (CBAC) was created to meet this need. The Advisory Committee is composed of experts from the science, business, nutrition, legal, environmental, public advocacy, philosophy and ethics fields, as well as public interest representatives. Members serve on a volunteer basis.

CBAC advises the Biotechnology Ministerial Co-ordinating Committee, which is made up of the ministers responsible for Agriculture and Agri-Food, Environment, Fisheries and Oceans, Foreign Affairs and International Trade, Health, Industry, and Natural Resources. CBAC identifies and assesses emerging and strategic policy requirements on issues associated with the ethical, social, regulatory, economic, scientific, environmental and health aspects of biotechnology. It also conducts research in support of its advisory role and consults with Canadians to reflect their views when offering policy advice.

Ensuring a smart and secure regulatory framework

Public opinion research conducted by the CBS has consistently found that Canadians are open-minded and supportive of the benefits associated with biotechnology, particularly those related to medical discovery, an improved quality of life and new jobs. Fully two thirds describe themselves as supportive of Canada's focus on biotechnology for the future. However, as receptive as they are, Canadians want assurance that any potential risks are being carefully managed and mitigated.

The Government of Canada recognizes its stewardship role. It fulfills this responsibility through scientific research, good governance, accountability and stringent regulations in the areas of health, safety and the environment that ensure Canadian values are promoted and public and ecosystem health are adequately protected.

Recognizing its unique characteristics, Canada has put into place the Federal Regulatory Framework for Biotechnology. This framework provides a transparent and rigorous system to ensure Canadians have confidence in, and benefit from, safe and effective biotechnology-based products and services. If there are any questions about the safety of a product, it is not approved.

The regulatory framework is led by the Canadian Food Inspection Agency, Environment Canada and Health Canada, and supported by a number of other departments including Agriculture and Agri-Food Canada, Fisheries and Oceans Canada, Industry Canada and Natural Resources Canada.

The 2000 federal budget dedicated $30 million a year to the Canadian Regulatory System for Biotechnology (CRSB) to strengthen technical capacity and address human resource needs, improve public awareness of the regulatory system, increase the overall efficiency of the system and provide research in support of ongoing regulatory activities. This amount was increased in April 2003 to close to $35 million a year, on an ongoing basis, to enhance and improve federal regulatory capacity to keep pace with increasing demand and the explosion of developments in this field.

Creating benefits for Canadians

Biotechnology presents a new paradigm for health and medicine - potentially offering customized prevention strategies from birth, pharmaceutical and genetic treatments tailored to each individual, the replacement or repair of organs, and improved diagnosis and monitoring. Innovations in life sciences and biotechnology hold equal promise to improve the environment by reducing pressure on resources and providing innovative remediation and clean-up processes to help the world community address challenges such as climate change. The technology is also providing solutions to problems facing both farmers and consumers, such as alternatives to weed control that eliminate the need for pesticides and herbicides.

Biotechnology presents an exceptional economic opportunity for Canada in the 21st century. This enabling technology can strengthen Canada's competitiveness and open up export markets by creating valued-added industries in the health, pharmaceuticals, agriculture and natural resources sectors. It holds the key to a productive, prosperous economy that creates sophisticated jobs for today's young knowledge workers and the youth of tomorrow.

To realize this potential, the Government of Canada has formally committed itself to being a world leader in biotechnology - a position already well established with this country's world-class credentials. Canada is internationally renowned for its clusters of R&D excellence: Montréal hosts the world's largest specialized research centre for biotechnology; Saskatoon is the world's leading centre for agricultural biotechnology; and Toronto's medical research community ranks among the top four in North America.

The Government of Canada is building on these advantages through a policy framework and targeted investments that are nurturing and developing biotechnology breakthroughs.

The federal government has made important investments in knowledge development to attract and retain the finest minds in various scientific fields, to build Canada's research capacity and to establish joint research projects among universities, government and industry that lead to commercialization.

Specialized research institutes and agencies have been established to ensure focus, direct funding and to attract the world's most competitive researchers in emerging fields such as proteomics, bio-pharmaceuticals, medical diagnostic technologies and nutraceuticals. All of these efforts are developing the infrastructure to support a critical mass of research talent led by world-class public and private sector investigators.

As well, the government maintains competitive tax rates that make Canada an attractive destination to do business, and provides an array of tax incentives as well as start-up funds for private sector projects. It also helps Canadian businesses to promote their biotechnology products and services, here at home and on the world stage, creating new markets and new jobs.

To further spur excellence and Canadian leadership across all sectors of the economy, the Government of Canada has adopted an ambitious national innovation strategy - that promotes skills and learning, fosters R&D and ensures businesses benefit from the commercial application of new knowledge - to make sure Canada remains on the leading edge in the knowledge age.

While not specific to biotechnology, several goals established in Canada's Innovation Strategy will contribute to the biotechnology research enterprise, including, by 2010:

Meeting expectations and demands

Even though biotechnology has already created unprecedented opportunities and promises even more, it has wrought unparalleled policy challenges for government decision makers. The rapid rate of development in these transformative technologies poses a number of social, regulatory and economic challenges - which can only be expected to escalate in the face of the unrelenting pace of scientific progress.

For example, there is the issue of public acceptance and confidence about biotechnology breakthroughs affecting human health. Controversial topics, such as reproductive technologies and the privacy of genetic information, demand public input in order to develop responsive policies that reflect Canadians' values. Citizens' views on the life-altering applications of biotechnology will play a central role in Canada's ongoing approach to the responsible development and regulation of this emerging industry.

Public opinion polling has also highlighted Canadians' concern about any potential longterm impacts of biotechnology innovations that could affect human health and the environment. Public confidence would be boosted by research into the long-term effects of biotechnology innovations and the assurance of appropriate mitigation measures if required.

A further pressure is the capacity of the regulatory systems to cope with new, complex innovations. It will be necessary to continually update the regulatory approaches - both to keep our economy competitive and to provide the public with access to products and services emerging in the global marketplace, while ensuring their health and safety are protected. This will require extensive research as well as training to build the necessary capacity.

Enabling the commercialization of biotechnology innovations, to create trade and investment opportunities that will maintain Canada's leadership in the field, is another challenge confronting policy makers in a competitive global market for risk capital.

This country's small start-up companies, many of them spin-offs from university research, often lack sufficient funding to take their products to market. In addition to inadequate access to capital, these firms must also deal with intellectual property and regulatory issues that can adversely affect investors' perceptions of the Canadian marketplace. Because of their unique nature, biotechnology products are subject to longer and more costly regulatory processes than in any other business. While the government has taken steps to facilitate bringing biotechnology ideas to market, addressing these competitiveness issues will remain a challenge for industry and government alike.

Equally important is the need to account to Canadians for the expenditure of their tax dollars and to demonstrate that their investments in research and development yield satisfactory results.

Reporting on results

This overview, along with more detailed reports contained in the following chapters from the CBS departments and agencies, demonstrates the Government of Canada's commitment to ensure the responsible and ethical development of these revolutionary technologies, and to facilitate dialogue with Canadians.

This report on the first five years of the Canadian Biotechnology Strategy, the period from 1998 to 2003, has been prepared to provide a synopsis of Canada's accomplishments, opportunites and challenges in creating an environment where biotechnology can flourish while, first and foremost, protecting human and animal health and the environment.

At the heart of the Canadian Biotechnology Strategy is the recognition that its primary purpose is to serve Canadians. Its raison d'etre is to provide taxpayers with the high-quality, cost-effective, citizen-centred and results-oriented programs and services they want, expect and deserve. To ensure it meets these expectations, the CBS has developed a Results-based Management and Accountability Framework (RMAF).

The Framework entails a four-step process: identifying key results; establishing performance measurement indicators; developing a reporting framework; and preparing an evaluation plan. The objective of the RMAF is to enable the Government of Canada to measure the success of its horizontal management of the biotechnology file, and to convincingly demonstrate the intention and capacity of member departments and agencies to measure their performance against key results commitments on an ongoing basis and, periodically, through evaluation.

It profiles the range of work being carried out under the CBS Fund, with an annual budget of $9.52 million, the $35 million annual CRSB fund, the $20 million per year Genomics R&D Fund, as well as related investments by the respective departments and agencies involved. It also shows how the accountability, performance measurement and reporting requirements for CBS members are leading to effective spending and, most important, good results for Canadians. It provides a benchmark against which future efforts and results can be measured, and serves as a foundation from which to build as Canada moves forward into the knowledge economy.

Moving forward

As anticipated scientific breakthroughs lead to new bio-based technologies, innovative industrial processes and enhanced environmental understanding, there will inevitably be an ongoing evolution in societal views on biotechnology development. Thus, while important groundwork has been laid, Canadians can expect to see CBS partners continue to work domestically and with the global community to promote better health care, sustainable development, social progress and an innovative economy.

This report acknowledges that all Canadians should have a voice informing decisions regarding biotechnology's ongoing growth. Consultations by CBAC, as well as by the departments and agencies involved in the CBS, provide meaningful opportunities for Canadians to express their priorities and concerns to ensure public policy will continue to respond to their needs and reflect their values - no matter what innovations the future holds.

Français	Contact Us	Help	Search	Canada Site

Home	Site Map	CBAC-CCCB	Science.gc.ca

Evolution of the biotechnology revolution