HESA Committee Report

POST-MARKET SURVEILLANCE OF PHARMACEUTICALS

SECTION ONE: BACKGROUND

SECTION TWO: HEALTH CANADA’S PROPOSED NEW APPROACH

A.     Risk,Benefit and Context for Use

B.     Progressive Licensing in the Post-market Phase of the Life-cycle

C.     Distancing Post-market from Pre-market

section three: Post-market Safety

A.     Adverse Drug Reactions and Serious Adverse Drug Reactions

B.     Current Adverse Reaction Reporting

C.     Data Quantity and Quality

D.     Proposed Mandatory Reporting for Hospitals

E.     Spontaneous/Voluntary Reporting by Health Professionals

Section four: Post-market Effectiveness

A.     Efficacy to Utilization Effectiveness

B.     Clinical Trials and Additional Studies

C.     Databases Assessing Effectiveness

D.     Drug Effectiveness and Safety Network

section five: Post-market Quality

A.     Packaging, Labelling and Other Quality Issues

B.     Warnings, Advisories and Recalls

SECTION SIX: ADDITIONAL POST-MARKET COMPONENTS

A.     Direct-To-Consumer Advertising

B.     Privacy and Confidentiality.

C.     Off-label Use of Pharmaceuticals

D.     Consumer Participation

E.     Vaccines

SECTION SEVEN: Committee Observations and Conclusions

A.     Adverse Drug Reaction Reporting

1. Key Elements for Effective Adverse Reaction Reporting

2. Hospitals and Adverse Drug Reaction Reportin

3. Conclusions

B.     Effectiveness and Safety Research

1. Key Elements for a Research Network

2. Conclusions

C.     Electronic Databases

1. Key Elements for Effective Electronic Databases

2. Conclusions.

D.     Regulatory Resources

1. Key Elements for Post-Market Regulatory Resources

2. Conclusions

LIST OF RECOMMENDATIONS

APPENDIX A: LIST OF WITNESSES

APPENDIX B: LIST OF BRIEFS

REQUEST FOR GOVERNMENT RESPONSE

SUPPLEMENTARY OPINION OF THE BLOC QUÉBÉCOIS

SUPPLEMENTARY OPINION OF THE NEW DEMOCRATIC PARTY