Principles of Good Regulation in Bioethics

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Principles of Good Regulation in Bioethics

• HEAL Workshop
• 28 September 2009

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Principles of Good Regulation

• Workshop content
• The focus is on regulatory bodies and matters
  around the appraisal of existing bodies with
  regard to
•             (i)   membership (independence,
  expertise),
•         (ii)   processes (participation and
  openness),
•       (iii)  authority (to ensure compliance).
  
• However, the overarching interest is in
  questioning whether we can identify what provides
  regulatory bodies with their legitimacy.  

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Relevant sources

• Biotechnology Review (1999)
• http//www.berr.gov.uk/files/file14498.pdf
• Better Regulation Commission (previously
  Taskforce)
• http//archive.cabinetoffice.gov.uk/brc/upload/as
  sets/www.brc.gov.uk/principlesleaflet.pdf
• DH Arms Length Bodies Review (2004)
• http//www.dh.gov.uk/prod_consum_dh/groups/dh_dig
  italassets/_at_dh/_at_en/documents/digitalasset/dh_40981
  55.pdf

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Biotechnology Review

• Summary of questions
• Existing gaps in regulatory coverage of
  biotechnology?
• Overlaps? Justified?
• Simpler structure possible?
• More transparent system of providing advice to
  Govt?

• 5. Ethical issues addressed fully?
• 6. Stakeholders given opportunity to make views
  known?
• 7. Framework flexible enough to cope with rapid
  developments?
• 8. Public confidence in current system?

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Better Regulation Commission

• Summary of principles
• Proportionality
• Accountabilty
• Consistency
• Transparency
• Targeting

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DoH ALB Review

• Arms Length Bodies Review (2004)
• Focus on practical compliance issues
• Regulation of
• Providers and services
• Professionals
• Medicines
• Including - controversial and ultimately
  unsuccessful - proposals for a new regulatory
  body RAFT (Regulatory Authority for Fertility and
  Tissue later known as RATE, c/f Tissue and
  Embryos).

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Initial questions

• Why do we have bio-ethical regulatory
  authorities?
• Historical explanations
• Justifications
• On what bases might their authority rest?
• How might we establish whether that authority is
  well-founded?

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A map of current bodies
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Why Have Regulatory Authorities Emerged?

• Hypotheses for testing

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HistoryResearch

• The product of a chain of ethical reasoning
  Nuremburg Helsinki etc.
• The demands of a global pharmaceutical market
• Response to scandal
• Policy based research

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History Professions

• UK occupational power, with/without concerns for
  patient care history of Guild tradition
  industrialisation Vocational ethic.
• Self-regulation, with medicine dominant. Impact
  of WW, especially gender (VAD post WWI, men to
  health care WWII, enrolled nurse during WWII
  acquired rights).
• Deprofessionalisation issues ? 1960s
• EU, established self-regulation
• Failure (perceived or otherwise) of
  self-regulation UK 1980s conflicts
  professionals governments

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History Professions

• Hypotheses UK tradition informs shape of
  regulatory system. Compare e.g. France, Germany,
  post-dissolution Russia
• Protection of staff from service (e.g. students)
• Geopolitics (e.g. status under Geneva Convention,
  rank)
• Networks of powerful people, e.g. spouses,
  parents current Georgian Presidents wife is a
  nurse.

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History Big Ethical Issues!

• Risk avoidance and management
• Accountability not just self-regulation, buck
  passing by Governments?
• Reassurance (NB metaphors for debates)
• Keeping pace with technological innovation?
• Tentative conclusions/judgments
• Decision making imperatives moral standpoints
  or
• Can regulation be flexible, anticipatory
  (prohibitive or permissive), proactive?
• Why were things left out when known about?

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Ethical issues contd.

• Deliberative Democracy
• Public interest
• Authors and Receivers
• Who sets agenda? What goes unheard
• Accountability and delegation (local and
  national)
• Lobbying processes

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How might we justify the continued existence of
Regulatory Authorities?

• Hypotheses for testing

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Research

• Risk and proportionality
• Processes
• Simplicity, consistency, compatibility (overlap),
  single approval routes
• Transparency, methodological integrity, audit
  trails (fraud)
• Authority of decision makers
• Involvement of researchers, committee or expert,
  independence

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Big Ethics

• Accountability
• Need to have a decision maker
• Expectations need to be fixed (known). No
  surprises in contested areas
• Limitations of public involvement (may depend on
  nature of role)
• Consultations (difficult to change questions)
• Are lay people lay for these purposes or
  alternative experts
• Procedural legitimacy limitations thereof
• Trust - Creating possibilities for
  self-regulation
• Move from knee jerk to
• NOW Random accumulation of bodies
• THEN grouped - Patients rights, Transparency,
  Clinical Standards, Ethics possibly with
  super-ethics regulator?
• Pendulum issues (can we swing it back?)
• May be conditioned by resources HTA and
  self-declaration of compliance? Is this more that
  the Retained Organs Commission?
• Risk of putting in stone

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Professions

• Somebody has to do it Safeguarding, ensuring
  Levels of care.
• Who decides standards (e.g. assault while
  unconscious) judges compliance?
• Expected professional behaviours (which other
  occupations have this) character
• Unprofessional and illegal conduct
• Database of people licensed to practise (NB
  global movements)
• Clarity of mission(s)
• Hold government to account on behalf of client
  groups (regulators or professions)
• Establish key principles ethical values, codes
  of conduct,
• Recognition of multi-cultural dimensions,
  possibility of lack of consensus
• Trust (individual clients, public confidence in
  profession, from professionals in their
  regulators)
• Subsidiarity are levels right?
• Respective roles with professional associations
• Councils to Boards? Self-regulation?

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A Typology?

• Inspectorate ensuring compliance
• Policy makers
• Explicit - resolving substantive conflicts
• Hidden controllers
• Advisory
• Promoting debate
• Access control rights to practise
• Types weights of evidence required
• Rights to command resource on behalf of society
  e.g. to access training, commit funds

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Justifications?

• On what might the claims of the authority to
  resolve issues in biomedical ethics depend?
• How would we determine whether legitimacy in this
  sense existed?

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Next steps?

• To explore further, during lunchtime seminars,
  the following
• Justifications
• Legitimacy
• Membership of bodies
• Processes what characterises good regulation?