1. T HE P RECAUTIONARY P RINCIPLE AND THE R EGULATION OF R ISK E XAMINING T HE M EN -W HO -H AVE -S EX -W ITH - M EN (MSM) B LOOD D ONATION P OLICY Associate Professor Anne-Maree Farrell, Faculty of Law, Monash University

2. O VERVIEW Politicisation of risk : what happens when risk becomes politicised in the wake of failure to manage (public health) risks? Case study : MSM Blood Donation Policy Precautionary Principle : shift towards highly precautionary approach – ‘zero risk’ mindset Loss of public trust = highly precautionary approach How does this play out in practice? What can we learn from this case study? 2

3. B ACKGROUND HIV blood contamination episodes in 1980s Political fallout and scandals in 1990s (and beyond) Adverse media Protracted litigation Government-sponsored inquiries Criminalization of those in charge of blood services (eg France & Canada) Institutional and regulatory reform 3

4. T HE P RECAUTIONARY P RINCIPLE Origins Public health context How to deal with (scientific) uncertainty Political context Critique 4

5. P RECAUTION AND B LOOD S AFETY Precautionary approach in HIV blood contamination era – how defined? Important technique of legitimation – public trust Precautionary principle = ‘zero risk’ Implications Role of science 5

6. MSM B LOOD D ONATION P OLICY Origins Differing national approaches Advances in technology Evidence of risk? Scientific and regulatory cultures 6

7. MSM B LOOD D ONATION P OLICY USA as ‘outlier’ FDA position Considered policy on several occasions Evidence base Legacy of failed leadership – HIV blood contamination episode Precaution as reputational risk management 7

8. MSM B LOOD D ONATION P OLICY History of challenges to permanent MSM deferral Differing positions Key issue: non-compliance rather than deferral Evidence: compliance more likely if rationale for (1 year) deferral explained Gaps in evidence base Changes in Law 8

9. P RECAUTIONARY P RINCIPLE AND M ANAGING P UBLIC H EALTH R ISKS Politics of Risk Alteration of ‘set point’ for risk tolerance Subordination of scientific risk assessment and cost-benefit analysis Problems in getting the balance right: individual v collective risk Heightened sensitivity on part of regulators to adverse public or media reaction 9

10. P RECAUTIONARY P RINCIPLE AND M ANAGING P UBLIC H EALTH R ISKS What Way Forward? Enhanced Safety Individual v Collective Risk Competing Risks Evidence Base Role of Technology 10

11. P RECAUTIONARY P RINCIPLE AND T HE R EGULATION OF R ISK Some Final Thoughts…. Role of Regulation Needed at all? Legitimacy: query effectiveness? Political context Regulatory Design: Risk: narrow v expansive Approach: hard v soft Technology-driven? Rights Risk v rights? 11