Table of Contents

Preface

Abbreviations

List of Tables

INTRODUCTION: THREE REALMS OF BIOTECHNOLOGY

Purposes and Contribution

The Three Bio-Realms and Related Products and Processes

Main Arguments

Foundational Concepts and Analytical Framework

Structure of the Book

PART I: ANALYTICAL FRAMEWORK AND HISTORICAL POLICY CONTEXT

CHAPTER 1- THE STATE, NETWORKED DEMOCRACY AND SCIENCE-BASED GOVERNANCE

Introduction

Conceptual Foundations

• Governance and Regulation
• Networked Democracy and Interests
• The Nature of Biotechnology and Science-based Governance

The Analytical Framework: Three Core Elements

• The State as Biotech Supporter and Biotech Regulator
• Networked Biotech Governance Interests and Democracy
• Science-based and Precautionary Governance

Conclusions

CHAPTER 2- NATIONAL AND INTERNATIONAL BIOTECHNOLOGY POLICY IN LIBERAL AND CONSERVATIVE GOVERNMENT ERAS

Introduction

Biotech Policy in the Trudeau and Mulroney Eras: Early Support and Major Trade and Patent Policy Impacts

Biotech Policy in the Chretien Liberal Era: Towards Better Balance amidst Extended Trade and Precautionary Norms

Biotech Policy in the Chretien, Martin and Harper Eras Since 2000:

Towards a Genome-Centred Bio-Economy?

The Core Politics Underlying International Biotech Policy

Conclusions

PART II: EMPIRICAL ANALYSIS OF THE CHANGING BIOTECH-GOVERNANCE REGIME

CHAPTER 3: SCIENCE AND SUPPORTIVE GOVERNANCE

Introduction

Federal and Related Biotech Research Agencies: Networked Governance, Support and Research Conduct

• National Research Council (NRC)
• The Granting Councils’ Networks of Centres of Excellence
• Canada Foundation for Innovation
• The Canadian Institutes of Health Research (CIHR)
• Genome Canada

Biotech Policy and Advisory Bodies and Arenas of Partial Support, Debate, Criticism and Engagement

• Industry Canada and Its Innovation and Related Intellectual Policy Agenda
• Engaging Ministers in The Interdepartmental Bio-Policy and Bio-Governance Structure
• CBAC, External Advice and Governance Through Citizen Engagement
• Periodic Parliamentary and Opposition Party Involvement, Criticism and Inquiries.

Biotech Policy and the Search for Technology Assessment Arenas

Conclusions

CHAPTER 4 - THE BIO-FOOD REALM: BUSINESS DOMINATED PLURALISTC POWER

Introduction

Bio-Food Regulation Making: Initial Design and Congealment under Institutionalized Pluralistic Power

Pre-Market Bio-Food Product Assessment and Approvals under Novel Food Concepts and Regulations

Product Regulation on Research on Plants with Novel Traits (PNT) and Potential Unconfined Environmental Release

Bio-Food Post Market Regulatory Monitoring

Conclusions

CHAPTER 5- THE BIO-HEALTH REALM: NETWORKED POWER AND GOVERANCE

Introduction

Changing Bio-Health Regulation and Related Policy Development

Pre-Market Assessment and Approvals of Biologics and Genetic Therapies

Post Market Regulatory Monitoring and Assessment for Funding under Medicare and Health Care Plans

Conclusions

CHAPTER 6- THE BIO-LIFE REALM: PLAYING CATCH-UP WITH SELF-DISCIPLINED POWER RELATIONS

Introduction

Bio-life Civic Regulation, Bio-Power and Bio-Politics

Bio-life Regulation and Rule-Making

Regulating Bio-life Products and Activities: The Case of Assisted Human Reproduction

Inspection, Enforcement and Post- Monitoring Bio-life Activities

Outstanding Issues, Genetic Testing, AHRA Inertia and the Politics of Implementation

Conclusions

CHAPTER 7- POWER, CHANGING BIOTECH GOVERNANCE AND EXTENDING DEMOCRACY

Introduction

Key Arguments and Related Explanations of Biotechnology Governance Regime Change

Biotechnology Governance Challenges and Extending Democracy

REFERENCES

About the Author

G. Bruce Doern is a professor emeritus in the School of Public Policy and Administration, Carleton University. He is the author and co-author of numerous books on Canadian politics and policy, including Faith and Fear: The Free Trade Story, with Brian Tomlin, and Canadian Public Policy: Ideas, Structure, Process, with Richard Phidd.

Michael J. Prince is the Lansdowne professor of Social Policy in the Faculty of Human and Social Development at the University of Victoria.