1. Legal Issues in Transfusion Medicine Legal Issues in Transfusion Medicine Transfusion Medicine Residents Tutorial Judie Leach Bennett Executive Director, Legal & Risk Management Canadian Blood Services

2. 2 Law 101 Division of Powers Federal Provincial Sources of Law in Canada Constitution, including the Canadian Charter of Rights and Freedoms Statutes and regulations Common law

3. 3 Canadian Charter of Rights and Freedoms Forms part of the Constitution Therefore all laws in Canada must be consistent with it The Charter applies only to state action Does not apply to actions between individuals Ex. Freeman case – Section 15 (discrimination)

4. 4 The Charter and Health Care Several cases have applied the Charter in health related situations. The cases bring up several issues: Do we have a right to health care? Do we have a right to pay for it? When can the government take our DNA, and for what purpose? What does equal access to health care mean?

5. 5 Federal Regulation Perfusable Organs for Transplantation CSA Standard: Tissues for Transplantation CSA Standard: Cells, Tissues & Organs for Transplantation & Assisted Reproductions General Requirements CSA Standard: Blood and Blood Component (Voluntary) Food and Drugs Regulation GMP Guidelines Drugs Directorate Guideline Safety of Cells Tissues and Organs Regulations Draft Guidance Document for Cell, Tissue and Organ Establishments Lymphohematopoietic Cells for Transplant Ocular Tissues for Transplantation Cells, Tissues and OrgansBlood and Blood Components Health Canada Issued Documents Future: Incorporation by reference Health Canada Issued Documents Incorporated by reference Exceptional Distribution Provisions FOOD AND DRUGS ACT

6. 6 Provincial Legislation Privacy Public Health Acts Laboratory Registered Health Professionals Hospital Legislation Health Care Consent Quality of Care Legislation

7. 7 Common Law What is “common law”? Judge-made law System of rules based on precedent It cannot be found in any “code” or “legislation”…only in past decisions Flexible and adaptable to changing circumstances Tort (negligence, duties and standards of care) is developed by common law decisions “Common law” and “Civil Law”

8. 8 Relevant Tort Duties Duty of care - proximity, policy considerations Duties owed to blood donors Duty to inform and to obtain consent Duty of confidentiality and donor privacy Duty to notify of positive test results Duty to refer, follow-up Lawful discrimination Stewardship Duties owed to recipients General duty to avoid harm (physicians, manufacturers) Duty of disclosure / duty to warn Duty of confidentiality

9. 9 Medical-Legal Issues Solicitor-client privilege Record keeping Apology legislation Insurance implications Absence of blood shield/no-fault legislation

10. 10 Blood-related Research Research ethics Consent Access to research material and information Intellectual property law