Law and the regulation of medicines / Emily Jackson.
2012
KD3460 .J33 2012 (Map It)
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Details
Author
Title
Law and the regulation of medicines / Emily Jackson.
Published
Oxford ; Portland, Ore : Hart Pub., 2012.
Call Number
KD3460 .J33 2012
ISBN
9781849461795 (pbk.)
1849461791 (pbk.)
1849461791 (pbk.)
Description
xvi, 292 pages ; 24 cm
System Control No.
(OCoLC)767570762
Bibliography, etc. Note
Includes bibliographical references (pages 267-292).
Record Appears in
Table of Contents
Acknowledgements
vii
Preface
xiii
1.
What are Medicines and why are they Special?
1
I.
Why Medicines are Special
1
II.
The Development of a Special Regulatory Regime for Medicines
4
III.
What is a Medicine?
6
IV.
Complementary and Alternative Medicines
8
A.
Licensing Herbal Medicines
9
B.
Homeopathic Medicines
10
C.
Licensing Complementary and Alternative Medicine
12
D.
Satisfaction with CAM and the Placebo Effect
14
E.
CAM on the NHS
17
V.
Conclusion
19
2.
Clinical Trials
21
I.
What are Clinical Trials?
23
A.
Phase I Trials
24
B.
Phase II and III Trials
25
C.
Phase IV Trials
26
D.
Randomised Controlled Trials
26
E.
Non-inferiority Trials
29
F.
Vaccine Trials
31
II.
Regulating Trials
32
A.
Informed Consent
33
B.
Participants who Lack Capacity
39
III.
Ethical Review
43
IV.
Trials and Industry
47
A.
Conflicts of Interest
47
B.
Results and Publication Bias?
50
C.
Clinical Trials Registration
56
D.
Outsourcing Research and Publications
59
V.
The Global Trials Industry
64
A.
The Standard of Care Debate
65
B.
Informed Consent
67
C.
Community Benefit
69
VI.
Conclusion
70
3.
Licensing
73
I.
The Significance of a Marketing Authorisation
73
II.
Applying for a Marketing Authorisation
73
III.
Grounds for Licensing Decisions
76
A.
Proof of Efficacy, Safety and Quality
76
B.
`Me-too' Drugs
77
C.
`Evergreening'
81
D.
Data Exclusivity
82
E.
Confidentiality of Data
84
F.
Generic Drugs
86
IV.
Relationship between Regulators and Industry
90
V.
Classification of Medicines
92
VI.
Buying Prescription Drugs Online
94
VII.
Conclusion
96
4.
Pharmacovigilance and Liability for Dangerous Drugs
99
I.
Post-marketing Surveillance
99
A.
Adverse Drug Reactions
99
B.
Voluntary Reporting of ADRs
100
C.
A Life-cycle Approach to Medicine's Risk-Benefit Profile
104
D.
The `Weak Link' in Regulation?
104
E.
Off-label Prescription
106
F.
The Suppression of Safety Data
108
II.
The Consequences of Identifying Drug Safety Hazards
111
III.
Liability for Drug Injuries
112
A.
Contract
113
B.
Negligence
114
C.
Regulator's Liability
116
D.
The Consumer Protection Act 1987
116
E.
Long-term Medication and Pregnancy: A Special Case?
121
F.
Liability for Birth Defects
122
G.
Vaccination Injuries
123
IV.
Conclusion
125
5.
Marketing
127
I.
Direct to Consumer Advertising
127
II.
Selling Diseases
132
A.
Sexual Dysfunction
134
B.
Menopause
136
C.
Depression, Anxiety, Shyness and Stress
137
D.
Treating Risk Factors as Diseases
140
E.
Disease Awareness Campaigns
141
III.
Patient Groups
143
IV.
Public Relations
145
V.
The Relationship between Doctors and the Pharmaceutical Industry
146
A.
Advertising
146
B.
Gifts and Sponsorship
150
C.
Continuing Medical Education
152
D.
The Size of the Gift Makes a Difference
153
E.
Doctors' Claims not to be Influenced
155
VI.
Conclusion
157
6.
Funding and Access to Medicines in the UK
159
I.
The Costs of Prescription Medicines
161
II.
The Pharmaceutical Price Regulation Scheme
162
III.
Value-Based Pricing
166
IV.
The National Institute for health and Clinical Excellence (NICE)
170
A.
Comparative Cost-effectiveness and Disinvestment
171
B.
The Process of NICE Appraisal
173
C.
QALYs and Cost-effectiveness Analysis
174
D.
End of Life Medicines
176
E.
Social Values and Consultation
177
F.
Judicial Review of NICE Decisions
178
V.
Exceptional Case Review
180
VI.
Judicial Review
182
VII.
Top-Up Payments
184
VIII.
Conclusion
185
7.
Funding and Access to Medicines: A Global Problem
189
I.
The Problem of Unaffordable Medicines
191
II.
TRIPs, Doha and Generics
193
III.
Incentives to Develop and Supply Treatments in Low-income Countries
198
IV.
Humanitarian, Charitable and Philanthropic Initiatives
204
VI.
Conclusion
208
8.
The Future of Medicines I: Pharmacogenetics
211
I.
The Limitations of Genetic Testing
215
II.
An Expansion in Genetic Testing: Consent and Confidentiality
216
III.
Resource Implications
218
IV.
Cost-effectiveness and Orphan Patients
220
V.
Clinical Trials
223
A.
Safer, Smaller Trials?
223
B.
Routine Testing in Trials
224
C.
Feedback
225
D.
Unprofitable Pharmacogenetic Trials
225
VI.
Licensing
226
VII.
Withdrawn Medicines?
227
VIII.
Improved Post-licensing Surveillance?
228
IX.
Liability for Harm
229
X.
Conclusion
233
9.
The Future of Medicines II: Enhancement
235
I.
The Line between Treatment and Enhancement
237
II.
A Pharmacological Fix?
241
III.
Enhancing Sporting Ability and Cheating
243
IV.
A Parallel with Education?
247
V.
Distributional Justice
248
VI.
Coercion
250
VII.
Prescription Drug Abuse
251
VIII.
Transhumanism and Posthumanism: Utopia or the End of History?
253
A.
Posthumanism
253
B.
Transhumanism
257
IX.
Conclusion
258
Concluding Remarks
261
Bibliography
267