knowledgeable about the many laws and regula-
tions that directly affect pharmaceutical manufac-
turers and their employees. Sanctions for failing to
comply with these requirements, may be severe,
both for the manufacturer and for the individual.
Consequently, pharmaceutical corporations need
to develop, implement and maintain effective com-
pliance programs and related training and pharma-
ceutical physicians should stay informed of the
regulations and laws relevant to the industry in
order to ensure compliance. Regulatory compli-
ance and effective internal communication can
avert potential problems and potential legal liabi-
lity for both the manufacturer and its employees.
References
‘...a manufacturer of products which he sells in such a
form as to show that he intends them to reach the
ultimate consumer in the form in which they have
left him with no possibility of intermediate exam-
ination and with the knowledge that the absence of
reasonable care in the preparation or putting up of
the products will result in an injury to the consumer’s
life or property, owes a duty to the consumer to take
that reasonable care’ (per Lord Atkin at p. 599).
Donoghue v. Stevenson(1932). A.C. 562.
Pfizer Corp. v. Ministry of Health(1965). 1 All ER 450,
HL.
U.S. v. Dotterweich, 320 U.S. 277 (1943) (finding
president of company individually guilty for ship-
ping misbranded and adulterated drugs).
U.S. v. Park, 421 U.S. 658, 672 (1975).
Zubulake v. UBS Warburg LLC, 220 F.R.D. 212
(S.D.N.Y. 2003); andStevenson v. Union Pacific
Railroad Company, 354 F.3d 739 (8th Cir. 2004).
Zubulake v. UBS Warburg LLC, 220 F.R.D. 212
(S.D.N.Y. 2003); andStevenson v. Union Pacific
Railroad Company, 354 F.3d 739 (8th Cir. 2004).
21 CFR Section 1.3(a).
21 CFR Section 201.57(e).
21 USC Section 331.
21 USC Section 353(c)(1).
21 USC Section 353(c)(3)(A).
21 USC Sections 301–393.
21 USC Sections 301–393.
21 USC Sections 331(t) and 333(b).
21 USC Sections 355(d) and 393(b)(2)(B).
31 USC Section 3729et seq.
31 USC Section 3730(d)(1)–(2).
42 USC Section 1320a–7b(b) (remuneration includes
discounts, gifts, free supplies, equipment or any item
of value).
50 Federal Register 7452-01, 7470 (22 February 1985).
Article 17 of Directive 2001/20/EC; Schedule 1 Part 2 of
the Medicines for Human Use (Clinical Trials) Reg-
ulations 2004 SI 2004/1031 implementing the Direc-
tive; and Schedule 60(6) of Health and Social Care
Act 2001 through the Health Service (Control of
Patient Information) Regulations 2002 SI 2002/1438.
By Council Reg. 2309/93 and formerly known as the
European Medicines Evaluation Agency but shor-
tened to the European Medicines Agency by Reg.
726/2004 (see following footnote).
Council Reg. 2309/93 since replaced by Reg. 726/2004.
Council Reg. 2309/93.
Council Reg. 726/2004.
EC Directive 2001/83/EC.
EC Directive 2004/27/EC.
EC Directive 65/65/EEC now codified into Community
Code 2001/83/EC.
EC Directive 85/374/EEC.
For definition of ‘sensitive personal data’ see Schedule- The extra safeguards relating to the First Principle
are contained in Schedule 3.
For example, in the UK the government was a defendant
in actions brought by haemophiliacs alleging con-
tamination with the HIV virus through use of blood
products.
Implemented in the UK by the Medicines for Human
Use (Clinical Trials) Regulations 2004 SI 2004/
See ‘Guidance Notes for Health Professionals. Under-
standing the ABPI Code of Practice for the Pharma-
ceutical Industry’ published by the ABPI February
SeeAhles v. Tabor, 34 P.3d 1076, 1078 (Idaho 2001).
SeeOverstreet v. Norden Labs., Inc., 669 F.2d 1286,
1289–90 (6thCir. 1982);Morris v. Parke Davis &
Co., 667 F. Supp. 1332, 1347–48 (CD Cal. 1987);
Tinnerhorlm v. Parke Davis & Co., 285 F. Supp. 432,
442–43 (SDNY 1968).
SeeStaples v. Merck & Co., Inc., et al., 270 F. Supp. 2d
833 (N.D. Tex. 2003) (consumers sued clinical
researcher and research facility for strategic proce-
dural purposes in lawsuit against manufacturer).
Although originally sued, the clinical researcher
and facility were eventually dismissed from the case.
See 42 CFR Part 93 ‘Public Health Service Policies on
Research Misconduct’ (2005) (sanctions can include
imprisonment).
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