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Associate Professor Anne-Maree Farrell, Faculty of Law, Monash University

The Precautionary Principle and the Regulation of Risk Examining The M en-Who-Have-Sex-With-Men (MSM) Blood Donation P olicy. Associate Professor Anne-Maree Farrell, Faculty of Law, Monash University. Overview.

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Associate Professor Anne-Maree Farrell, Faculty of Law, Monash University

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  1. The Precautionary Principle and the Regulation of RiskExamining The Men-Who-Have-Sex-With-Men (MSM) Blood Donation Policy Associate Professor Anne-Maree Farrell, Faculty of Law, Monash University

  2. Overview • 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?

  3. Background 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

  4. The Precautionary Principle • Origins • Public health context • How to deal with (scientific) uncertainty • Political context • Critique

  5. Precaution and Blood Safety • Precautionary approach in HIV blood contamination era – how defined? • Important technique of legitimation – public trust • Precautionary principle = ‘zero risk’ • Implications • Role of science

  6. MSM Blood Donation Policy • Origins • Differing national approaches • Advances in technology • Evidence of risk? • Scientific and regulatory cultures

  7. MSM Blood Donation Policy • 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

  8. MSM Blood Donation Policy • 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

  9. Precautionary Principle and Managing Public Health Risks 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

  10. Precautionary Principle and Managing Public Health Risks What Way Forward? • Enhanced Safety • Individual v Collective Risk • Competing Risks • Evidence Base • Role of Technology

  11. Precautionary Principle and The Regulation of Risk 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?

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