Shifting Connections
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Shifting Connections A Report on Emerging Federal Policy Relating to Women’s Health, the New Genetics and Biotechnology Report Author: Constance MacIntosh Prepared for: Working Group on Women, Health and the New Genetics Delivery Date: January 31, 1999 This document, Shifting Connections: A Report on Emerging Federal Policy Relating to Women’s Health, the New Genetics, and Biotechnology, was commissioned by the Working Group on Women, Health and the New Genetics, with funding obtained from the National Network on Environments and Women’s Health (NNEWH). NNEWH is one of Canada’s five centres of Excellence for Women’s Health, all of which operate through funding provided by the Women’s Health Bureau of Health Canada. This report is intended to provide a broad overview of the current federal policy environment as it relates to the interconnections between women’s health, the new genetics, and biotechnology. The views herein do not necessarily represent the official policy of the sponsors. Table of Contents PART I. INTRODUCTION AND SYNTHESIS OF FINDINGS............................ 1 Introduction..................................................................................................... 1 Synthesis and Overview of Findings.............................................................. 1 1) Health System Reform.................................................................. 3 2) Biotechnology Initiatives.............................................................. 4 3) Ownership and the New Genetics – National and International Legislation and Obligations ................................................... 6 4) The New Genetics – From Basic Research to Society............... 8 Acknowledgments........................................................................................... 9 PART II. HEALTH SYSTEM REFORM................................................................. 10 The Health Protection Branch Transition Programme................................ 10 1) Background – The Health Protection Branch.............................. 10 2) The Health Protection Branch Transition Programme............... 11 3) The Five Core Transition Areas .................................................... 12 a) The Science Core................................................................ 12 b) The Surveillance Core........................................................ 16 c) Risk Management ............................................................... 17 d) Program Development ....................................................... 19 e) Legislative Renewal ........................................................... 20 4) The Science Advisory Board......................................................... 24 5) Public Involvement/Consultations................................................ 26 6) Commentary................................................................................... 26 Appendix One – Working Group for Public Involvement. Membership List..................................................................... 28 The Women’s Health Bureau......................................................................... 29 1) Introduction.................................................................................... 29 2) Health Canada’s “Women’s Health Strategy”.............................. 30 3) Information on the “Women’s Health Strategy” Initiatives ....... 30 a) Applying a department-wide gender-based analysis process to new activities and policies..................................... 30 b) Developing tools and methodologies to implement gender based analysis.............................................................. 31 c) Producing a ‘Status Report on the Health of Canadian Women’ which uses a health determinants approach 31 d) Monitoring and assessing the impact of the health reform process on women’s health........................................ 31 e) Implementing joint Canada-USA initiatives in women’s health............................................................................ 32 f) Developing a women’s health research agenda to help co-ordinate policy-setting among federally-funded research programs....................................................... 33 4) Commentary................................................................................... 35 PART III. BIOTECHNOLOGY INITIATIVES ....................................................... 37 The Canadian Biotechnology Strategy.......................................................... 37 1) Introduction to Biotechnology ..................................................... 37 2) The Predecessor to the 1998 Canadian Biotechnology Strategy 37 3) The 1998 Canadian Biotechnology Strategy ............................... 38 4) Biotechnology Ministerial Coordinating Committee (BMCC) 39 5) The Canadian Biotechnology Advisory Committee (CBAC)..... 39 6) Current Federal Regulatory System for Biotechnology............. 41 7) Sector Consultation Documents................................................... 42 a) Sector Overview of Health and Health Industries............ 42 b) Sector Overview of Agriculture and Agri-Food............... 43 c) Environment and the Environment Industries Overview. 44 8) Commentary................................................................................... 45 Appendix One – A Reproduction of “Annex A – Ten Key Themes in the CBS Workplan”.............................................. 47 Legislation on New Reproductive and Genetic Technologies.................... 52 1) Introduction.................................................................................... 52 2) The Royal Commission on Reproductive Technologies............ 52 2) The Human Reproductive and Genetic Technologies Act.......... 53 3) The Proposed New Human Reproductive and Genetic Technologies Act.................................................................... 54 a) Timing for Release of the New Bill.................................. 54 b) The Content of the New Bill.............................................. 55 Appendix One – Members of the Advisory Committee on Reproductive and Genetic Technologies.............................. 57 Xenotransplantation........................................................................................ 58 1) Background..................................................................................... 58 2) Current status ................................................................................. 58 3) Federal Activity – Developing National Standards for All Transplantations ...................................................................... 58 4) The Xenotransplantation Expert Working Group........................ 59 5) The Public Review Process........................................................... 60 6) The Canadian Biotechnology Strategy ......................................... 60 Appendix 1 – Members of the Xenotransplantation Working Group61 PART IV. OWNERSHIP AND THE NEW GENETICS – NATIONAL AND INTERNATIONAL LEGISLATION AND OBLIGATIONS...................... 62 Intellectual Property Activities..................................................................... 62 1) Background..................................................................................... 62 2) The Patenting of Genetically Altered Higher Life Forms and Plants 63 3) The Patenting of Genetically Altered Mammals......................... 64 4) Ethics and Patenting....................................................................... 66 5) The Canadian Biotechnology Strategy ......................................... 66 6) International Instruments............................................................... 67 a) The Trade Treaties .............................................................. 67 7) Commentary................................................................................... 68 Appendix One – Excerpts from Part V (Patents) and Part VII (Institutional Arrangements) of the WTO - TRIPs Agreement69 Appendix Two – Excerpts from Part 6, Chapter 17 (Intellectual Property) of NAFTA............................................................... 71 International Instruments on ‘Genetic Resources’...................................... 72 1) The United Nations Convention on Biological Diversity........... 72 2) Universal Declaration on the Human Genome and Human Rights73 3) Commentary................................................................................... 75 PART V. NEW GENETICS – FROM BASIC RESEARCH TO SOCIETY........... 76 Genome Research........................................................................................... 76 1) Introduction.................................................................................... 76 2) The Canadian Genome Analysis and Technology Program ........ 76 3) Genome Research Centres and the Genome Task Force ........... 77 4) Genome Canada.............................................................................. 78 a) The Proposed Project......................................................... 78 b) The Interim Project............................................................ 79 Appendix One – Members of the MELSI Advisory Committee for CGAT....................................................................................... 81 Appendix Two – Research Projects Funded by MELSI................... 82 Appendix Three – Research Contracts Commissioned by MELSI. 83 Appendix Four – Members of the MRC Subcommittee to the Standing Committee on Ethics