Regulation Under the Medicines Act 1968: A Continuing Prescription for Health
| DOI | http://doi.org/10.1111/j.1468-2230.1984.tb01654.x |
| Published date | 01 May 1984 |
| Date | 01 May 1984 |
| Author | Harvey Teff |
REGULATION UNDER THE MEDICINES ACT
1968:
A CONTINUING PRFSCRIPTION FOR HEALTH
INTRODUCTION
A
QUARTER
of a century has passed since the first thalidomide
children were born. In the wake
of
that disaster stricter governmental
controls were imposed on the development and marketing
of
new
medicines throughout Europe and in the United States. In England
such regulation is now governed by the Medicines Act 1968. The
regulatory structure is elaborate and marketing drugs is an expensive
and time-consuming enterprise. Introducing a single new product
can cost
f40
to
f50
million and take
10
years or more. Fewer than
half as many new drugs are being marketed as in the early 1960s’
and the pharmaceutical industry has predictably criticised the con-
trols as too stringent, prohibitively costly and detrimental to inno-
vation. Patients are said to be unnecessarily deprived
of
effective
new treatments and the costs
of
regulation to outweigh any benefits.
A recent survey
of
major pharmaceutical companies in Britain2
stressed their growing concern about the effects of legal regulation
and bureaucratic attitudes on the industry’s competitive position and
economic performance. The authors concluded that: “In the circum-
stances of mounting criticisms and genuine doubts about the value
of the 1968 Medicines Act
,
. .
now is the time for a serious
reappraisal of the
U.K.’s
regulatory
arrangement^."^
Two broad
policy options were suggested-a degree
of
deregulation within the
framework of the Act, or its replacement by a system of voluntary
self-regulation, backed up perhaps by some form of insurance
arrangement for the victims of drug-induced injury,
Regulatory requirements are undeniably among the factors which
inhibit drug innovation, though to what extent and with what
consequences is far from clear. It is evident, for example, that many
“new” drugs are in fact “close copy” products which do not represent
any genuine therapeutic advance. Also, the drug industry is often
condemned as socially irresponsible and in need
of
increased
control,
Whereas at the beginning
of
the
1y6os
some
50
new chemical entities were reaching the
U.K.
market each year, by 1980 the number was down to about
20.
See
F.
Steward and
G.
Wibberley,
“Drug
Innovation-What
is
slowing it down?” (1980)
284
Nature
118-120.
K.
Hartley and A. Maynard,
The
Costs
and Benefits
of
Regulating
New Product
Development in
the
U.K.
Pharmaceutical Industry
(1982).
This
study
was
produced for the
pharmaceutical industry’s Office
of
Health Economics
and
the authors’ findings were based
on
a postal questionnaire sent
to
25
major
U.K.
and foreign-owned firms. The sample
consisted
of
firms selected by the Association of the British Pharmaceutical Industry,
to
ether with a set of firms chosen by the authors
on
a random sample basis.
303
Ibid.
at p.35.
304
THE
MODERN
LAW
REVIEW
[Vol.
47
both in view of some companies’ activities in the Third World-
where regulation may be either non-existent or unenforceable-and
because of questionable production and marketing policies in gen-
eraL4 Most recently, discussion has centred on the anti-arthritis drug
Opren and several other anti-inflammatory drugs, withdrawn from
the market last year following allegations of.death and serious injury
associated with their use.5 Grave doubts have been raised about the
propriety of intensive promotion6; the effectiveness of post-market-
ing techniques for identifying adverse reactions’; and the adequacy
of
existing legal procedures as a means
of
providing redress.*
It is proposed here to consider, with particular reference to the
development and marketing of new prescription drugs, whether the
criticisms of present statutory arrangements are justified. Our pri-
mary focus will be on safety and efficacy requirements in the
approval
of
new drugs under the licensing provisions of the
1968
Act. But these elements of the licensing process cannot be satisfac-
torily examined in isolation from certain other aspects of drug
regulation, such as price controls, the prescribing habits of doctors
and the compensation mechanism.
Thus to the extent that innovation is a function of profitability,
account must be taken of governmental policy on drug prices, and
this has recently been the subject of detailed scrutiny.’ There are
several sources
of
tension in regard to price regulation in the
pharmaceutical industry. The desire to keep prices down in a country
where the National Health Service is in effect a monopoly purchaser
of
prescribed drugs is tempered by the perceived need to accom-
modate the powerful multi-national companies who dominate the
market and help boost exports. These companies, in turn, are
continually seeking to protect their intellectual property interests in
the face of the European Economic Community’s commitment to
the free movement
of
goods and the threat which generic substitution
Doses to brand-name moducts.
~~~~ ~ ~
‘
See, e.g. M. Silverman, P. Lee and M. Lydecker, Prescriptions
for
Death (1982): M.
Muller, The Health
of
Nations (1982); The Haslemere Group, Who Needs
the
Drug
Companies? (1976).
’
Opren was suspended by the Licensing Authority on August 3, 1982, after more than
3,500 reports
of
adverse reactions, including
61
fatal cases, predominantly among elderly
users.
A number
of
negligence actions on behalf
of
English as well as American claimants
are pending in the U.S.A., where there has already been one
jury
award
of
some f41
million: Sunday Times, December
4,
1983. Three other anti-arthritis drugs were withdrawn
from the market in 1983: The Guardian, December 14,1983: Concern over Opren prompted
introduction
of
the Medical Drugs (Manufacturers’ Liability) Bill, a private member’s Bill
which sought to impose strict liability. It received its First Reading
op
December 14, 1982,
but was not enacted.
T.
Mangold, “Relationships between doctors and salesmen are lurching out
of
control,”
The Listener, January 20, 1983. See also Editorial, British Medical Journal, August 14,
1982.
F. Lesser, “Drugs monitor needs sharper teeth,” New Scientist, March 17, 1983. A
D.H.S.S. working party was set up in 1983 with
a
view to improving provisions for
monitoring approved drugs. See
p.315.
A.
L. Diamond and D.
R.
Laurence, “Practical steps to improve drug safety,”
Correspondence, The Times, August 17, 1982.
See pp.318-320 below.
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