Bioethics as a Governance Practice Health Ethics and Law Annual Lecture 2015 Jonathan Montgomery Professor of Health Care Law, UCL Chair, Nuffield Council on Bioethics Chair, Health Research Authority

Some Current Bioethical Issues

What is Bioethics? Subject? –Scope? Discipline? –Methods? Expertise? Field? –Who plays? Enterprise?

What is Bioethics Governance? Independent, multidisciplinary and pluralist ethics committees should be established, promoted and supported at the appropriate level in order to: (a)assess the relevant ethical, legal, scientific and social issues related to research projects involving human beings; (b)provide advice on ethical problems in clinical settings; (c)assess scientific and technological developments, formulate recommendations and contribute to the preparation of guidelines on issues within the scope of this Declaration; (d)foster debate, education and public awareness of, and engagement in, bioethics. UNESCO Universal Declaration on Bioethics (2005). Article 19

A Brief History of Bioethics Governance in the UK Professional ethics (Royal Colleges, BMA) –‘Club regulation’ (Wilson ch 1) –Church of England (Wilson ch 2) –Contrast with theologians & bioethicists in the USA as ‘outsiders’ Ian Kennedy’s Reith Lectures The Unmasking of Medicine (lectures 1979, book 1983) –Bioethics, Thatcherism & The Audit Society (Wilson ch 3) –national ethics committee? Duncan Wilson, The Making of British Bioethics (Manchester UP 2014)

A brief history; UK bioethics governance Nuffield Council on Bioethics (1991-) –Wilson ch 6 Cabinet Office, The Advisory and Regulatory Framework for Biotechnology: Report from the Government’s Review (London: OST 1999) –Human Genetics Commission ( ) Emerging Science and Bioethics Advisory Committee (ESBAC) ( )

But not so simple… Assisted Reproduction; Warnock (1984), the HFE Acts (1990 & 2008), HFE Authority Organs…. Alder Hey (2001), Human Tissue Act 2004, Human Tissue Authority, Organ Donation Taskforce (2008) Committee on the Ethical Aspects of Pandemic Influenza (CEAPI) (2006-?) Advisory Group on Ethics to CMO on 100,000 genomes project (2013, Chair Mike Parker)

The Bonfire of the Quangos The evils of Quangos –(a) Expensive, (b) Undemocratic The HGC strategy –Reduce costs but keep brand alive –Bioethics governance as a luxury –Disestablishment as democracy at work The HFEA strategy –Newsnight The HFEA survives; the HGC is long gone Gov Response to the Public Administration Select Ctte Report, “Smaller Government: Shrinking the Quango State” (London: TSO, 2011) Cm 8044

Some Observations General governance v specialist inquiries Deliberation v regulation Scope for overlap –Mitochondrial DNA Limits to national differentiation? –Uses of Health Data, Clinical Trials are EU issues –UK & the international bioethics community The UK as a rogue bioethical state?

Bioethics Governance as a Response to Scientific ‘Advance’

Bioethics Governance as a Response to Scandal From Nuremberg to Helsinki – Governance by Principle Beecher & Pappworth – Governance by Gatekeeping Griffiths on Mid-Staffs - Research Governance Framework

Bioethics Governance as a Response to Pluralism Closure –May be temporary or provisional Mediation –Inclusionary processes Authority and Accountability

Bioethics Governance as a Response to Relativism Distinguishing Democracy and Bioethics Governance ‘Public Reason’ Qualities of Deliberation

Key Challenges for Bioethics Governance Understanding Contingency –History –Context Legitimation & Power Regulatory Effectiveness, Efficiency, Proportionality

What is Bioethics? Subject Discipline Field Enterprise Governance Practice

Bioethics as a Governance Practice Health Ethics and Law Annual Lecture 2015 Jonathan Montgomery Professor of Health Care Law, UCL Chair, Nuffield Council on Bioethics Chair, Health Research Authority