2 Eur. L. Rep. 1 (1998)

handle is hein.journals/eurlawreo2 and id is 1 raw text is: [1998] EuLR

R v SECRETARY OF STATE FOR HEALTH
EX P. RP SCHERER LTD
High Court of Justice, Queen's Bench Division (Crown Office List)
Judge J
8 March 1996
B    Proportionality - Medicines - Judicial review - Applicant manufacturing drug -
Secretary of State for Health adding applicant's product to list of drugs not to be used
for National Health Service patients - Whether prohibition to be based purely on
question of costs - Whether duty on authority to provide reasons under Community law
higher than duty under domestic law - Whether decision disproportionate to risk -
Whether process flawed by procedural unfairness - National Health Service Act 1977
and the General Medical Services Regulations 1992 - Council Directive 89/105/EEC
Facts
The applicant company was the only company in the United Kingdom which
manufactured capsules of temazapam, a drug used in the treatment of insomnia.
D  The drug was also made as an elixir or as tablets. The capsules were a soft gelatine
container filled with liquid form temazapam. In November 1989 the applicant
changed the liquid in the capsules to a gel mix, in order to prevent the capsules being
abused by addicts who withdrew the liquid by a needle and injected the drug. In July
1993 the Advisory Council on the Misuse of Drugs reported to the Home Secretary
that stricter controls needed to be applied since the gel mix could also be drawn into
syringes after heating, with the effect that addicts suffered serious health problems. A
E  consultation process was commenced on whether the prescription of gel-filled
capsules should be banned under the General Medical Services Regulations 1992. On
17 October 1995 the Secretary of State for Health decided that the gel-filled capsules
should be added to the list of drugs which could not be prescribed for National
Health Service patients. On the same day the European Commission was given notifi-
cation of the policy in accordance with Council Directive 89/105/EEC. The applicant
F  sought judicial review of the decision, contending that the purported exercise of the
powers to add the capsules to the list of drugs which could not be prescribed for
National Health Service patients was illegal and ultra vires both under the National
Health Service Act 1977 and the General Medical Regulations 1992.
Held, refusing the applications
1. There was nothing in the 1977 Act to suggest that regulations made under s. 29 of
the 1977 Act had to be limited to considerations of cost and expense and could
not include questions of public health. The language was plain and, subject to the
provision of adequate care, there was nothing to inhibit the use of regulations
made under s. 29 to exclude prescriptions of drugs for health service patients in
such a way as to reduce significantly or extinguish altogether their availability for
H      misuse. See post p. 12F-G.
2. Nothing in reg. 44 or Sched. 10 of the 1992 Regulations suggested that a pro-
hibition was to be limited to, or based exclusively on, questions of cost to the

C 1998 John Wiley & Sons, Ltd
CCC 1091-3297/98/010001-21

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