Principles of medical law / edited by Judith M. Laing, Jean V. McHale ; consultant editors, Professor Sir Ian Kennedy, Dr. Andrew Grubb.
2017
KD3395 .P75 2017 (Map It)
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Title
Principles of medical law / edited by Judith M. Laing, Jean V. McHale ; consultant editors, Professor Sir Ian Kennedy, Dr. Andrew Grubb.
Published
Oxford, United Kingdom : Oxford University Press, 2017.
Call Number
KD3395 .P75 2017
Edition
Fourth edition.
ISBN
9780198732518 (hbk)
0198732511 (hbk)
0198732511 (hbk)
Description
cxvi, 1,225 pages : forms ; 26 cm
System Control No.
(OCoLC)980245916
Bibliography, etc. Note
Includes bibliographical references and index.
Other Editions
Revision of: Principles of medical law. 3rd ed. Oxford ; New York : Oxford University Press, 2010 9780199544400 (OCoLC)467748628
Record Appears in
Table of Contents
Table of Cases
xxvii
Table of Legislation
lxxix
Table of Statutory Instruments
xcix
Table of Treaties and Conventions
cvii
Table of European Law
cix
Table of Legislation from Other Jurisdictions
cxv
Part I
1.
Organization of Health Care
3
A.
Structure of the NHS
1.
General duties of Secretary of State
2.
commissioning of NHS services
3.
provision of NHS services
4.
NHS Constitution
B.
NHS 'Governance'
1.
NHS priority setting
2.
Public and patient involvement in the NHS
3.
Governance of standards and performance
C.
Conclusion
2.
Regulating Health Care Professions
54
A.
Health Care Professions and Regulation
1.
Introduction
2.
health care 'professions'
3.
Self-regulation and the medical profession
4.
Trust in the medical profession
5.
Impact of the trust agenda on regulation
B.
Fitness to Practise Framework
1.
Registration and licensing
2.
Codes of conduct
3.
Auditing doctors' fitness to practise: revalidation
4.
Medical Practitioner Tribunal Service and fitness to practise adjudication
C.
Fitness to Practise Decision-making
1.
Investigating complaints
2.
Registrar stage
3.
Case examiners
4.
Investigation Committee
5.
Interim Orders Tribunals
6.
Grounds for imposing interim orders: Section 41A Medical Act 1983
7.
When is an interim order in the public interest?
8.
Endorsement of a narrow construction of 'the public interest'
9.
Medical Practitioners Tribunals
D.
Meaning of 'Impairment'
1.
Taking action on registration: When is fitness to practise 'impaired'?
2.
'Impairment' and the 'redemption model' of fitness to practise
3.
'heads' of impairment
4.
'Misconduct': Section 35C(2)(a)
5.
Misconduct: Sexual relationships with patients
6.
Misconduct: Dishonesty
7.
Dishonesty and the burden of proof
8.
Sanctions for proven dishonesty
9.
Misconduct in the private sphere
10.
Reporting/not reporting concerns about patient safety
11.
Deficient professional performance: Section 35C(2)(b)
12.
Criminal cautions and convictions: Section 35C(2)(c)
13.
Sexual abuse/offences
14.
Adverse health: Section 35C(2)(d)
15.
Language competence: Section 35C(2)(da)
16.
Fitness to practise sanctions: Section 35D
17.
Appeals: Section 40
18.
Voluntary erasure
19.
right to a fair hearing and disciplinary proceedings
20.
When is Article 6 'engaged'?
E.
Making Professional Regulation More Accountable
1.
Annual accountability hearings
2.
Professional Standards Authority and the Section 29 Public Interest Appeal
3.
Section 29-a power of last resort?
F.
Culture of 'Open and Honest Care'
1.
Being honest about mistakes
2.
professional and statutory duty of candour
3.
'Freedom to Speak Up: Protections for whistleblowers
4.
Transparency-published mortality rates
G.
Conclusion
Part II
3.
Duties in Contract and Tort
101
A.
Introduction
B.
Breach of Contract
1.
Treatment under the National Health Service
2.
Private treatment
3.
Contracts with third parties generally
C.
Negligence: Duty of Care
1.
To patients
2.
To third parties
3.
Doctors engaged by others
D.
Conclusion
4.
Breach of Duty
163
A.
Reasonableness
1.
reasonable person
2.
reasonable doctor
3.
Reasonable care
B.
Standard of Care Required
1.
Common professional practice
2.
Departures from common practice
3.
Keeping up to date
4.
Assessing degrees of risk
5.
Specialists and the inexperienced
6.
Emergencies
7.
Defensive medicine
C.
Common Types of Error
1.
Failure to obtain consent
2.
Failure to attend or treat
3.
Diagnostic errors
4.
Failures of communication
5.
Treatment errors
D.
Psychiatric Patients
1.
Self-harm
2.
Harm to third parties
3.
Negligent certification
4.
Procedural bars
E.
Evidence and Proof
1.
Proof of negligence
2.
Res ipso loquitur
3.
Standard of proof
F.
Breach of Convention Rights
1.
Article 2
2.
Article 3
3.
Article 8
5.
Actions Arising from Birth
236
B.
Claims by Living Children for Injuries Caused Before Birth
1.
Claims for injuries at common law
2.
Claims for injuries under the Congenital Disabilities (Civil Liability) Act 1976
C.
Claims by Living Children for 'Wrongful Life'
1.
'Wrongful life' claims at common law
2.
'Wrongful life' claims under the Congenital Disabilities (Civil Liability) Act 1976
D.
Claims by Parents of Children Born Alive
1.
Claims by parents for wrongful conception or birth
2.
Claims by parents for physical and psychiatric injury
E.
Claims on Behalf of the Estate in Cases of Stillbirth and Neonatal Death
1.
Stillbirths
2.
Neonatal deaths
F.
Claims for Injuries Preventing the Conception of Children
6.
Causation and Defences
297
A.
Causation
2.
Factual causation
3.
place of Bolam in causation
4.
Causation and the duty to inform
5.
Legal causation
B.
Defences
1.
Contributory negligence
2.
Valenti non fit injuria
3.
Ex turpi causa non oritur actin and other policy factors
4.
Limitation Act 1980
7.
Institutional Liability
371
B.
Liability in Private Law
1.
Vicarious liability
2.
Direct liability
C.
Liability in Public Law
1.
Failure to provide a service
2.
Blanket bans and exceptionality
3.
Withdrawal of service
4.
Departure from evidence
5.
Waiting lists
D.
Remedy and Redress
1.
Private law
2.
Public law
E.
Conclusion
Part III
8.
Consent to Treatment: The Competent Patient
419
A.
Consent to Treatment
2.
Burden of proof
3.
Withdrawal of consent
4.
Limits to consent
B.
Nature of Consent
1.
Forms of consent
2.
Scope of consent
C.
Elements of Consent
1.
Capacity
2.
Information
9.
Tests for Incapacity
452
A.
Introduction to the Common Law Position
1.
How does the common law start to assess capacity?
2.
Children and consent
B.
Three Stages of Childhood
1.
child of tender years
2.
Gillick competent child
3.
16- and 17-year old
C.
Test for Determining an Adult's Capacity at Common Law
1.
Ability to understand versus actual understanding
2.
What did the patient need to understand?
D.
Capacity Under the Mental Capacity Act 2005
1.
Introduction to the 2005 Act
2.
Who comes under the Mental Capacity Act?
3.
role of the Code of Practice
4.
Capacity as a decision-specific test
5.
statutory principles of empowerment
6.
statutory test for determining incapacity
7.
Understanding the information relevant to a decision
8.
Retaining the information
9.
Using or weighing that information as part of the process of making the decision
10.
ability to communicate the decision
11.
causative nexus
E.
Specific Areas Concerning Assessments of Capacity
1.
Beliefs and value systems
2.
Misperception of reality
3.
Compulsive or driven behaviour
4.
External factors
F.
Conclusion
10.
Care and Treatment of Those Lacking Decision-making Capacity
484
A.
Sources of the Law
1.
Parens patriae
2.
Statute
3.
Human Rights Act 1998
4.
Common law
B.
Foetus
1.
status of the foetus
2.
Medical treatment and the foetus
C.
Children
1.
Who can determine welfare?
2.
ambit of parental consent
3.
court
D.
Adults Who Lack Mental Capacity
1.
General principles
2.
Advance directives and the adult who lacks capacity
3.
jurisdiction of the Court of Protection
4.
jurisdiction of the High Court
E.
Best Interests
1.
Best interests or substituted judgment?
2.
In whose best interests?
3.
statutory checklist
4.
Factors in the best interests equation
5.
Independent Mental Capacity Advocates
F.
Particular Cases
1.
Sterilization
2.
Abortion
3.
Blood testing
4.
Organ and tissue donation
5.
Life and death
6.
Deprivation of liberty
G.
Conclusions
11.
Mental Health Law
563
B.
Background
2.
reform process
C.
Current Law
1.
guiding principles in the Code of Practice
2.
definition of mental disorder: 'Any disorder or disability of mind'
3.
Professional roles
4.
Routes to compulsory admission to hospital
5.
Compulsory treatment in hospital
6.
Compulsory powers and treatment in the community
7.
Discharge and tribunal review of the lawfulness of detention
8.
Additional safeguards for patients
12.
Confidentiality and Data Protection
643
B.
Confidentiality and Privacy
1.
Common law
2.
Statutory modifications to the obligation of confidence
3.
Disclosure for the purpose of litigation
4.
Confidentiality, warning, and negligence liability
5.
Remedies
C.
Control of Patient Information
1.
scheme of the Data Protection Act 1998
2.
scope of the Data Protection Act 1998
3.
Data Protection Principles
4.
conditions for lawful processing
D.
Access to Medical Records
1.
General
2.
Data Protection Act 1998
3.
Access to Health Records Act 1990
4.
Access to Medical Reports Act 1988
5.
common law
E.
Overview
13.
Clinical Research
712
B.
Regulation of Clinical Research: Regulatory Structures
1.
Regulation and the Health Research Authority
2.
Role of research ethics committees
C.
Evaluating a Research Protocol: Legal and Ethical Issues
2.
Assessing risk
3.
Consent and the competent adult
4.
Consent and the child participant: Common law
5.
Consent: Adults who lack capacity
6.
Consent and incapacity: Children and adults; the Clinical Trials Directive
D.
Monitoring the Conduct of the Trial: General
E.
Monitoring of Trials Concerning Medicinal Products
2.
Reporting requirements
3.
Amendments to the trial protocol
4.
Infringements of clinical trial protocol requirements
5.
Appeal procedures
6.
end of the trial
7.
Provision of information
8.
Specific criminal offences
F.
Responsibility and Accountability
2.
researchers
3.
sponsor
4.
Universities/organizations employing researchers
5.
Responsibilities of organizations providing care
6.
Responsibilities of care professionals
G.
Confidentiality, Privacy, and Research Participant's Information
2.
Consent and anonymization
3.
Statutory exceptions sanctioning disclosure for research purposes
4.
Feedback of clinical information to participants
5.
Use of information for research purposes after death
H.
Regulating Bad Practice: Fraud in Scientific Research
I.
Accountability to the Research Participant
J.
Conclusions
Part IV
14.
Medically Assisted Reproduction
755
1.
Warnock Report
2.
History of regulation
B.
Human Fertilisation and Embryology Authority
1.
Establishment of the Authority
2.
Functions of HFEA
C.
Licensing
1.
Types of licence
2.
licence committee
3.
Licensing procedure
4.
Licence conditions
5.
Prohibited activities
6.
Directions, regulations, and the Code of Practice
7.
Challenging decisions
D.
Access to Treatment and the Welfare of the Child
E.
Conscientious Objection
F.
Consent to the Use of Genetic Material
G.
Counselling
I.
provision of counselling
2.
provision of information
H.
Control of Gametes and Embryos
I.
Access to Information
J.
Status of Children
K.
Marriage and Civil Partnership
1.
Statutory motherhood
2.
Statutory fatherhood
L.
Surrogacy
1.
Surrogacy agreements
2.
Surrogacy agencies
3.
Parentage and parental responsibility for the child
4.
Acquiring legal parenthood
M.
Future?
15.
Reproductive Genetics
835
B.
Creating Gametes and Embryos
1.
In vitro derived gametes
2.
Creating embryos without consent
3.
Reproductive cloning
4.
Hybrid embryos
C.
Embryo Selection Techniques
1.
Pre-implantation genetic diagnosis
2.
HLA tissue typing
3.
Sex selection
D.
Mitochondrial Donation
16.
Abortion
850
A.
Ethics of Abortion
B.
Abortion and the General Law
C.
Statutory Regulation of Abortion
1.
Abortion Act 1967
2.
Background to the 1967 Act
3.
Northern Ireland
4.
Infant Life (Preservation) Act 1929
5.
Section 37 of the Human Fertilisation and Embryology Act 1990
6.
Abortion and post-coital contraception
D.
Abortion Act 1967
1.
scope of the Act
2.
grounds for abortion
3.
Operation of the Abortion Act
E.
Impact of the Human Rights Act
1.
Article 2-the 'right to life'
2.
Article 8-the 'right to private and family life'
3.
Article 10-the 'right to free speech'
F.
Injunctions to Prevent Abortions
1.
As litigation friend of the foetus
2.
As the progenitor
3.
As guardian of the public interest
G.
Abortion and Homicide
1.
Killing in utero
2.
Killing ex utero
H.
Conclusion
Part V
17.
Regulation of Medicinal Products and Medical Devices
889
A.
Common Principles of Product Regulation
1.
nature of product regulation
2.
Overview of this chapter
3.
Basis in EU law
4.
Major differences between the systems of regulation of medicinal products and medical devices
B.
Medicinal Products
1.
Overview
2.
Products covered
3.
Requirement for a marketing authorization: Data requirements
4.
Authorization of research
5.
Manufacturing authorization
6.
Distribution and sale
7.
Information and promotion
8.
Post-marketing requirements for safety
C.
Human Tissues and Cells
D.
Advanced Therapy Medicinal Products
E.
Medical Devices
2.
Law on specific device categories
3.
Resolution of uncertainties
4.
Competent authorities and notified bodies
5.
Definition of a medical device
6.
drug and device borderline
7.
Products comprising both a drug and a device
8.
Classification
9.
Conformity assessment procedures and CE marking
10.
Registration
11.
Harmonized standards
12.
Custom-made devices
13.
Systems and procedure packs
14.
Essential requirements
15.
Information supplied by the manufacturer
16.
Definition of manufacturer
17.
CE marking: Placing on the market and putting into service
18.
Clinical investigation
19.
In vitro diagnostic medical devices
20.
Adverse event reporting: Vigilance
21.
Recall
22.
Market surveillance
23.
Enforcement and sanctions
F.
Impact of the General Consumer Product Safety Legislation
1.
Complementarity between Community rules
2.
GPS obligations on producers
3.
GPS obligations on distributors
18.
Products Liability
951
B.
Contractual Liability
1.
General principles of liability
2.
Exclusion of liability
3.
Privity and collateral contracts
4.
Contracts involving the supply of products: Supply or services?
5.
Medical products as 'goods'
C.
Tort: Negligence
1.
duty of care
2.
standard of care
3.
Proving causation
4.
Claims against regulatory authorities
5.
Shortcomings of negligence as a remedy for injurious medicinal products
D.
Liability under the Consumer Protection Act 1987
1.
European Directive on Product Liability
2.
Act
3.
To what extent has the CPA enhanced patient protection?
E.
Multi-Party Actions
F.
Compensation for Injured Research Subjects
G.
Concluding Remarks
Part VI
19.
Legal Regulation of Human Material
1005
B.
Regulating the Use of Human Material
1.
Human Tissue Authority
2.
Scope of the Human Tissue Act
3.
Organ transplantation
4.
Criminal offences
C.
Property and Human Material
1.
Property and the corpse
2.
Property rights in excised human material
3.
Acquiring property rights from work done on human material
4.
Consequences of recognizing proprietary rights in human material
5.
Waste property
6.
Actions consequent upon the unauthorized interference with a dead body/unauthorized use of human material from a dead body
D.
Conclusions
20.
Patenting and the Human Body
1048
B.
Obtaining and Exploiting a Patent
1.
Patentability criteria
2.
Concepts of invention and value
C.
Medical and Biotechnological Inventions
1.
Absolute grounds for objection
2.
Relative grounds of objection
D.
Access to Medicines: The International Dimension
Part VII
21.
Ending Life
1101
B.
Terminology
C.
Legal Regulation of Ending Life
1.
Murder
2.
Suicide
3.
duty to prevent suicide
4.
Assisting suicide
D.
Slippery Slopes
1.
Netherlands
2.
Oregon
E.
Vulnerable People
F.
Refusal of Treatment and Death
G.
Reform of the Law
1.
Autonomy
2.
Sanctity of life
3.
Dignity
22.
Death
1142
1.
social perspective
B.
Medical Definition of Death
1.
Contexts of definition
2.
Cellular death
3.
Death of the person
4.
triadic approach to the diagnosis of death
5.
Cardiorespiratory death
6.
Brain death and brain-stem death
C.
Legal Diagnosis of Death
1.
Development of the law
2.
case of Re A
3.
Cognitive death
4.
time of death
D.
Administrative Aspects of Death
1.
Death certification and registration
2.
formalities of death
E.
Disposal of the Dead
1.
Responsibility for disposal
2.
Burial
3.
Cremation
F.
Coroner
1.
Development of the office
2.
coroner's investigation
3.
Exhumation
G.
Post-mortem Examination and the Disposal of Body Parts
1.
Post-mortem examinations
1.
Death and the medico-legal curriculum
2.
ways we die
Appendix A
1187
Appendix B
1190
Index
1193