Health Technology Assessment and the Law

1. Health Technology Assessment and the Law Professor Colleen M. Flood colleen.flood@utoronto.ca ph: + 416 697 4594

2. Values Underlying HTA

3. Conclusions

4. Constitutional/Human Rights • Administrative Law • International Law • Private Law

5. What QALY Calculations Don’t Consider • “A QALY is a QALY is a QALY” – so that means may not value improving the lives of the sickest as compared to the relatively healthy nor value a year of healthy life at the end of life as opposed to a marginal rate of improved health over multiple years • Blind to issues of historical discrimination • Does not account for things like effect on labour market participation • Does not consider impact of disease on family

6. A Balance: Individual Rights and Community Rights • “[I]t is not possible to tailor national policies to an enormous range of individual variations. Nonetheless, a health care system that is not sensitive to those individual variations would neither meet political acceptance nor be likely to pass ethical muster” –Dan Callahan

7. The Upshot?

8. Constitutional and Human Rights Challenges (Canada) • Right to life and security of the person • Right to equal benefit of the law without discrimination • Subject to “reasonable limits…as can be demonstrably justified” (this is the value for money bit!”

9. No right to (public) health care • “[T]he legislature is under no obligation to create a particular benefit. It is free to target the social programs it wishes to fund as a matter of public policy, provided the benefit itself is not conferred in a discriminatory manner.” –Auton v. British Columbia (Supreme Court of Canada, 2004)

10. Discrimination and Emergent Therapies

11. Discrimination EVERYWHERE!!! • Refusing to fund Herceptin • Refusing to fund Prostate Specific Antigen • A decision to close a French language hospital • Refusing to fund in vitro fertilization • Women, Men, Francophones, Infertile, Transsexuals

12. The Upshot • Strong HTA processes are the best security against judicial review • Courts consider “value for money” as part of the assessment BUT the case has to be made by the government/decision-maker • Courts have been wary of intervening and they should continue to be so as this process could easily be hijacked by vested interests

13. Administrative Law: ‘Hard Look’ Judicial Review in the UK Courts demanded fair processes in HTA decision-making A balance between individual impacts and societal benefits

14. Procedural Fairness: HTA in the UK

15. Challenges under International Law

16. Conclusion: