Impotence or Importance? Judicial Review in an Era of Explicit NHS Rationing
| Date | 01 March 2004 |
| DOI | http://doi.org/10.1111/j.1468-2230.2004.00487.x |
| Published date | 01 March 2004 |
| Author | Keith Syrett |
CASES
Impotence or Importance? Judicial Review in an Era of
Explicit NHS Rationing
Keith Syrett
n
In R (on the application of P¢zer Limited) vSecretary of State for Health,
1
the Court of
Appeal was obliged to consider the legality of the Government’s continued
restriction on the availability of the impotence drug V|agra, arguably the most
high-pro¢le instance of rationing of a particular treatment ever witnessed in the
history of the National Health Service (NHS).The case therefore provides a con-
venient opportunity to reassess whether any useful contributioncan be made by
the courts in an area ofpublic policy which is of growing signi¢cance to govern-
ments in the UK and worldwide.
2
Although there is academic endorsement in
both the ¢elds of public law
3
and health policy
4
for the closer involvement of
courts in structuring the process of decision-making on the allocation of limited
health care resources, the judgment in P¢zer indicates that the judiciary remains
highly reluctant to undertake any such role. The purpose of this article is to ex-
plorethe implications of suchcontinued judicialabstention in the light of notable
recent changes in the manner in which allocative decisions are taken in the NHS.
THE VIAGRA LITIGATION
The challenge in P¢zer was the latest episode in the drug manufacturer’s campaign
of opposition to the Government’s refusal to approve sildena¢l (better known by
its brand name V|agra) for routine prescriptio n upon the NHS, in the light of con-
cerns as to the potential ¢nancial impact of the treatment. Initially, the Govern-
ment had purported to provide interim guidance in a circular that ‘doctors should
not prescribe sildena¢l [and that] health authorities are also advised not to support
the provision of sildena¢l at NHS expense to the patients requiring treatment for
erectile dysfunction, other than in exceptional circumstances which they should
requirebeclearedinadvancewiththem’.
5
This circular was held unlawful in the
earlier case of RvSecretary of Statefor Health, ex p P¢zer Ltd.
6
Collins J ruled that its
n
Universityof Bristol.
2 For an informative survey of developments in a variety of health systems, see A. Coulter and
C. Ham (eds),The Global Challengeof Health CareRationing (Buckingham: Open University Press,
2000).
3 Se e eg R. James and D. Longley, ‘Judicial Review and Tragic Choices: ex par te B ’[1995]PL367;
A. Parkin,‘Al locatingHealth Care Resources in an ImperfectWorld’(1985)58 MLR 867.
4 Se e C.Ham and S. McIver, Contested Decis ions (London: King’s Fund, 2000),especial lyat 77.
5 HSC 1998/158 (16September 1998).
6 [1999]Lloyd’sRep Med 289.
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(2004) 67(2)MLR 289^321
mandatory phraseology acted as an improper constraint upon the professional
judgment which GPswere expected to exercise in determining which treatments
were necessaryand appropriate under their statutoryTerms of Service.
7
Addition-
ally, si nce the circularconstituted a‘decisionto exclude’a medicinal product from
the coverage of a national health insurance system, it fell within the scope of Di-
rective 89/105/EEC (the‘Transparency Directive’)which requires that publicitybe
given to the criteria which inform such decisions. Consequently, the Govern-
ment’s failure to communicate such criteria to the Commission, to set them out
in an appropriate publicationand to providethe manufacturerwith ‘a statement of
reasons based on objective and veri¢able criteriayincluding, if appropriate, any
expert opinions or recommendations on which the decisions are based’,
8
amounted to a breach of the Directive.
Following the judgment, the Secretary of State utilised the powers vested in
him by the National Health Service Act 1977 to issue Regulations which added
V|agra to the Schedule of drugs whose NHS availability was limited to speci¢ed
medical conditions or classes of patient.
9
The practical e¡ect was to restrict the
prescription of V|agra onthe NHS to those who were alreadyreceiving treatment
for erectile dysfunction prior to the date of the circular, those with medical
conditions such as diabetes or prostate cancer and those undergoing specialist
treatment in hospital, for example in cases such as radical pelvic surgery. All other
British men su¡ering from the disorder ^ evidence submitted to Collins J esti-
mated that 1.8 million su¡ered complete and 8 million partial dysfunction
10
^
would therefore be forced to obtain the drug through private prescription.
The policy of restricted availability was reviewed and con¢rmed by the Gov-
ernment in October 2001. It was the decision to continue to operate this policy
which formed the subject-matter of the challenge in the second P¢zer case. The
lawfulness of partially ‘blacklisting’ V|agraby means of its inclusion on Schedule
11of the 1992 Regulations was not called into question. Instead, the drug manu-
facturer again sought to rely upon the Transparency Directive. The Government
had by now informed the Commission of the basis for thedecision to exclude. It
made a statement that‘amedici nalproductymaybesoexcludedwherethefore-
cast aggregatecost to the NHS of allowingthe productyto be supplied on N HS
prescription, or to be supplied more widely than the permitted exceptions, could
not be justi¢ed having regard to all the relevant circumstances including in parti-
cular the Secretary of State’s duties pursuant to the National Health Service Act
1977 and the priorities forexpenditure of NHS resources’. However, it wasargued
that this was insu⁄cient to comply withthe Directive, since neither the statement
nor letters from the Secretaryof State to the manufacturer (estimating the cost of
removing the restrictions at d100 mill iona year and emphasising that thecriterion
upon which the decisionwas based entailed‘the makingof an overall judgmentas
to what level of expenditure upon impotence can be justi¢edyhaving regard to
7 Para. 12 (1), National Health Service (General Medical Ser vices) Regulations 1992,SI 1992 No. 635.
8 Article 7(3).
9 Schedule 11, National Health Service (Ge neral Medical Services) Regulations 1992 as amended by
NationalHealth Service (Ge neralMedical Services) Amendment (No.2) Regulations1999,SI 1999
No. 1627.
10 n 6 a bov e, 29 0.
Judicial Reviewi n an Era of Explicit NHS Rationing
290 rThe Modern LawReview Limited 2004
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