HEAL Seminar Sept 2009

8/14/2019 HEAL Seminar Sept 2009

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Principles of Good

Regulation in Bioethics

HEAL Workshop

28 September 2009


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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/assets/www.brc.gov.uk/prin

DH Arms Length Bodies Review (2004)

http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/
http://www.berr.gov.uk/files/file14498.pdfhttp://archive.cabinetoffice.gov.uk/brc/upload/assets/www.brc.gov.uk/principlesleaflet.pdfhttp://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4098155.pdfhttp://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4098155.pdfhttp://archive.cabinetoffice.gov.uk/brc/upload/assets/www.brc.gov.uk/principlesleaflet.pdfhttp://www.berr.gov.uk/files/file14498.pdf


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Biotechnology

ReviewSummary of questions:

1. Existing gaps inregulatory coverage of

biotechnology?

2. Overlaps? Justified?

3. Simpler structurepossible?

4. More transparentsystem of providingadvice to Govt?

5. Ethical issues addressedfully?

6. Stakeholders givenopportunity to makeviews known?

7. Framework flexible enoughto cope with rapid

developments?8. Public confidence in

current system?


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Better RegulationCommission

Summary of principles:

1. Proportionality2. Accountabilty

3. Consistency

4. Transparency5. Targeting


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DoH ALB

ReviewArms Length Bodies Review (2004) Focus on practical & compliance issues

Regulation of Providers and services

Professionals

Medicines

Including - controversial and ultimatelyunsuccessful - 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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Why do we have bio-ethical regulatoryauthorities?

Historical explanations

Justifications On what bases might their authority rest?

How might we establish whether that authorityis well-founded?

Initial questions


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A map of currentbodies

NCoB,

HGC,

Advisory Bodies

Professional

Associations

ProfessionalRegulatory

Bodies

HTA

Regulation of

processes

e.g. tissue

NRES etc,

ICH, GCPClinical

Ethics

Committees

Funding

Councils, UKCRC,

Big charities

MHRA

HPC

GTAC, RSAc

PCT/NICE

liaison

NICE

HFEA

No

National Ethics

Committee


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Why Have Regulatory

Authorities Emerged?

Hypotheses for testing


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History

Research1. The product of a chain of ethical

reasoning; Nuremburg Helsinki etc.

2. The demands of a globalpharmaceutical market

3. Response to scandal

4. Policy based research


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History

Professions Hypotheses UK tradition informs shape ofregulatory system. Compare e.g. France,Germany, post-dissolution Russia

Protection of staff from service (e.g.students)

Geopolitics (e.g. status under GenevaConvention, rank)

Networks of powerful people, e.g. spouses,parents current Georgian Presidentswife 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 andnational)

Lobbying processes


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How might wejustify thecontinued existence ofRegulatory Authorities?

Hypotheses for testing


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Research

Risk and proportionality

Processes Simplicity, consistency, compatibility

(overlap), single approval routesTransparency, methodological integrity,

audit trails (fraud)

Authority of decision makers Involvement of researchers, committeeor 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, fromprofessionals in their regulators)

Subsidiarity are levels right? Respective roles with professional associations Councils to Boards? Self-regulation?


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Justifications?

On what might the claims of theauthority to resolve issues inbiomedical ethics depend?

How would we determine whetherlegitimacy in this sense existed?


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Next steps?

To explore further, during lunchtimeseminars, the following:

Justifications

Legitimacy

Membership of bodies

Processes: what characterises goodregulation?


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Acronyms Usedin this slideshow

ACRONYMS ACHRE Advisory Committee on Human Radiation Experiments ACGM Advisory Committee on Genetic Modification ACGT Advisory Committee on Genetic Testing ACNFP Advisory Committee on Novel Foods and Processes ACP Advisory Committee on Pesticides ACRE Advisory Committee on Releases into the Environment AGSAG Advisory Group on Scientific Advances in Genetics APC Animal Procedures Committee BMA British Medical Association BMJ British Medical Journal CIOMS Council for International Organisations of Medical Sciences COREC Central Office for Research Ethics Committees

CQC Quality Care Commission CRO Contract Research Organisation CSM Committee on the Safety of Medicines CTA Clinical Trials Administrator CTIMP Clinical Trial of Investigational Medicinal Product DoH Department of Health FDA Food and Drug Administration (US) FAWC Farm Animal Welfare Council GAfREC Governance Arrangements for Research Ethics Committees GAIC Genetics and Insurance Committee GCP Good Clinical Practice GDC General Dental Council GLP Good Laboratory Practice GMC General Medical Council GTAC Gene Therapy Advisory Committee HFEA Human Fertilisation and Embryology Authority

ACRONYMS HGAC Human Genetic Advisory Commission HPC Health Professions Council HTA Human Tissue Authority ICH GCP International Conference for Harmonisation of GCP IEC Independent Ethics Committee IRB Institutional Review Board (US) IVF In vitro fertilisation MCA Medicines Control Agency MHRA Medicines and Healthcare Products

Regulatory Agency MRC Medical Research council NHS National Health Service

NIGB National Information Governance Board for Health andSocial Care

NICE National Institute for Health and ClinicalExcellence

NIGB National Information Governance Board NMC Nursing and Midwifery Council NPSA National Patient Safety Agency NRES National Research Ethics Service NRR National Research Register PIAG Patient Information Advisory Group PICTF Pharmaceutical Industry

Competitiveness Task Force RCOG Royal College of Obstetricians and

Gynaecologists RCP Royal College of Physicians RCS Royal College of Surgeons RCT Randomized Controlled Trial REC Research Ethics Committee RGF Research Governance Framework for

Health and Social Care UKXIRA UK Xenotransplantation Interim

Regulatory Authority VPC Veterinary Procedures Committee WMA World Medical Association

HEAL Seminar Sept 2009

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