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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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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

overview
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?
background
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
the precautionary principle
The Precautionary Principle
  • Origins
  • Public health context
  • How to deal with (scientific) uncertainty
  • Political context
  • Critique
precaution and blood safety
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
msm blood donation policy
MSM Blood Donation Policy
  • Origins
  • Differing national approaches
  • Advances in technology
  • Evidence of risk?
  • Scientific and regulatory cultures
msm blood donation policy1
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
msm blood donation policy2
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
precautionary principle and managing public health risks
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
precautionary principle and managing public health risks1
Precautionary Principle and Managing Public Health Risks

What Way Forward?

  • Enhanced Safety
  • Individual v Collective Risk
  • Competing Risks
  • Evidence Base
  • Role of Technology
precautionary principle and the regulation of risk
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?