THE PRECAUTIONARY PRINCIPLE AND THE

REGULATION OF RISK

EXAMINING THE MEN-WHO-HAVE-SEX-WITH-MEN (MSM) BLOOD DONATION

POLICY

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

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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?

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BACKGROUNDHIV 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

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THE PRECAUTIONARY PRINCIPLE

Origins

Public health context

How to deal with (scientific) uncertainty

Political context

Critique

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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

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MSM BLOOD DONATION POLICY

Origins

Differing national approaches

Advances in technology

Evidence of risk?

Scientific and regulatory cultures

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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

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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

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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

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PRECAUTIONARY PRINCIPLE AND MANAGING PUBLIC HEALTH RISKSWhat Way Forward?

Enhanced Safety

Individual v Collective Risk

Competing Risks

Evidence Base

Role of Technology

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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?