R (National Association of Health Stores and Another) v Secretary of State for Health

JurisdictionEngland & Wales
JudgeLord Justice Sedley,Lord Justice Keene,Mr. Justice Bennett
Judgment Date22 February 2005
Neutral Citation[2005] EWCA Civ 154
Docket NumberCase No: C1/2004/0975 & C1/2004/0976
CourtCourt of Appeal (Civil Division)
Date22 February 2005
Between
The Queen on the Application of National Association of Health Stores & Anr
Appellant
and
Department of Health
Respondent

[2005] EWCA Civ 154

[2003] EWCA 3133 (Admin)

Before

Lord Justice Sedley

Lord Justice Keene and

Mr. Justice Bennett

Case No: C1/2004/0975 & C1/2004/0976

IN THE SUPREME COURT OF JUDICATURE

COURT OF APPEAL (CIVIL DIVISION)

ON APPEAL FROM QUEEN'S BENCH DIVISION

THE ADMINISTRATIVE COURT

MR JUSTICE CRANE

Rhodri Thompson QC and Sam Grodzinski (instructed by Messrs Irwin Mitchell) for the Appellant

John Cavanagh QC and Jason Coppel (instructed by the Solicitor to the Department of Health) for the Respondent

Lord Justice Sedley
1

This appeal is brought, with permission granted by Pill LJ, against the dismissal by Crane J on 19 December 2003 of the claimants' application to strike down two measures adopted under statutory powers by the Secretary of State for Health. The principal measure was an Order 1 made under the Medicines Act 1968 prohibiting the sale for medicinal purposes of kava-kava, a widely used herbal anxiolytic (or tranquilliser) originating in the Pacific region. Under the Food Safety Act 1990 the Secretary of State at the same time made Regulations 2 banning its use in foodstuffs. In each case the measure was authorised by a minister in the name of the Secretary of State.

2

The principal ground of challenge is that in each instance the minister authorised the measure in ignorance of the relevant fact that prohibition was opposed by a leading psychopharmacological authority, Professor Ernst, on cogent grounds which he had spelt out in a published meta-analysis.

3

It is secondly asserted by the appellants that the prior consultation was unlawful because it omitted the possibility of compulsory warning labelling rather than an outright ban. Thirdly, it is said that the proper consequence of the admitted failure to exempt goods in transit from the food prohibition was the quashing of the Regulations.

4

Wider questions were initially raised—including whether there was on any view enough evidence to justify a ban—but the foregoing are the issues now addressed.

The judgment of the Administrative Court

5

On the first issue, Crane J held that in point of law the knowledge of responsible civil servants was the knowledge of ministers without any requirement that the knowledge be communicated. He found also that in point of fact what one minister, Lord Hunt, who signed the Order, knew about Professor Ernst's views was "adequate and appropriate"; but he was able to make no similar finding about the other minister, Ms Hazel Blears, who signed the Regulation.

6

On the second issue Crane J held that the consultation process under the Medicines Act, but not under the Food Safety Act, was flawed by the omission of the possibility of requiring warning labelling. But he refused to quash the resultant Order because the more drastic option of making kava-kava available on prescription only had been consulted on and rejected, making the rejection of the labelling option a foregone conclusion. By a respondent's notice the Department contests Crane J's initial conclusion that the consultation process was flawed.

7

On the third issue, Crane J accepted that a mandatory exemption in favour of goods in transit had been omitted from the Regulations, and that the error was not severable. But he refused to quash them because there was no suggestion that anyone had been adversely affected by the omission and because the Department had offered an

undertaking to reconsider the matter. This has now been done, and by virtue of an amending Regulation 3 the exemption is in place.

8

Crane J's full and careful judgment, including the text of the statutory provision, can be found at [2003] EWHC 3133 (Admin.).

The legal framework

9

It is sufficient for present purposes to record the following. kava-kava is a medicinal product within the meaning of the Medicines Act 1968. By virtue of s.62(1) ministers may by Order prohibit the sale, supply and importation of such products. Alternatively, s.82 allows them to require such products to be labelled in order, among other things, to convey appropriate warnings. The use of kava-kava in food may also be prohibited by Regulation under s.16 of the Food Standards Act 1990. Alternatively, by virtue of the same section, labelling requirements can be imposed.

10

Both statutes make detailed provision for the obtaining of information and advice before ministers decide whether to introduce any of these restrictive measures.

Medicines

11

The Medicines Commission ("the Commission") is a body of experts established by s.2 of the 1968 Act. Among its functions, under s.3(1), is advising ministers on the exercise of any of their powers under the Act. Under s.4 ministers may set up specialist committees for any purpose within the Act. The committee involved in the present case is the Committee on the Safety of Medicines (CSM). The Commission and the CSM are bodies independent of the Department and of each other.

12

Ministers are required by s.62(3), subject to an exception for emergencies, to consult the appropriate committee, or if there is none the Commission, before making a prohibitory Order. They are also required by s.129(6) to consult "such organisations as appear to them to be representative of interests likely to be substantially affected" by the Order. There is no dispute that the first claimant is such an organisation. This being so, s.62(5) gave it the right, on giving notice, to appear before or to have its written representations referred to the Commission. In such cases, "the Commission shall report their findings and conclusions to the appropriate Ministers and those Ministers shall take that report into account in determining whether to make the order".

Food

13

The Food Standards Act 1999 created the Food Standards Agency (FSA) with the principal objective of protecting public health from risks carried by foodstuffs. The FSA, by choice rather than by law, takes advice from the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT), a body independent of the Department, with much the same role and status as the CSM.

14

The 1990 Act, as amended, by s.48(4A) requires the Secretary of State to have regard to any relevant advice given by the FSA. By s.48(4) it also requires the Secretary of State to consult organisations representative of potentially affected interests. But by s.48(4B) it allows the Secretary of State to treat consultation by the FSA with such organisations as consultation by himself or herself.

The issues

15

It is convenient to take the issues in reverse order.

Was the omission fatal to the Regulation?

16

It is as well to begin by recognising that to strike down an entire regulation because of a curable omission which appears to have affected nobody, however cogent the case in legal theory for doing so, would represent a triumph of logic over reason.

17

Rhodri Thompson QC, for the appellants, nevertheless contends that it is the correct course. He points out, first, that the Regulation has adversely affected the first claimant's members by damaging their business and the second claimant by restricting her freedom of choice. This misses the point. It is the Regulation, not the omission of the exemption, which has these effects.

18

Arguably more to the point, however, Crane J held that it was impossible, applying DPP v Hutchinson [1990] 2 AC 783, to correct the error by blue-pencilling: "The court cannot write in an exemption". But I do not accept that the corollary of this is to strike down the entire instrument. The appropriate corollary, by analogy with blue-pencilling, is to amend it.

19

There will of course be cases in which it is too late, or simply insufficient, to let the rule-maker take this course. Hutchinson furnishes a good example: because a lawful instrument would have been "totally different in character" from the impugned one, there was no option but to strike the latter down. But Lord Bridge went on to say that he had concluded, though not without hesitation, "that a rigid insistence that the test of textual severability must always be satisfied if a provision is to be upheld and enforced as partially valid will in some cases … have the unreasonable consequence of defeating subordinate legislation of which the substantial purpose and effect was clearly within the law-maker's powers …"

20

This reasoning, although directed in Hutchinson to improper inclusions rather than improper omissions, seems to me apposite to the latter as well. If an omission can be made good without disrupting the existing, presumptively lawful, text, and if so far the omission appears to have done no harm, I see no good reason why, instead of permitting the rule-maker to insert the missing brick, the entire structure should be pulled down.

Was the consultation legally deficient?

21

It is common ground that no consultation took place on the option of introducing compulsory warning labels, even though this was considered within the Department. John Cavanagh QC for the Respondent would if necessary have contested Crane J's holding that this was a justiciable failure of process. His skeleton argument sets out the case against the practicality of such a measure. But he has elected not to pursue it in the light of our indication that, having heard Mr Thompson, we were satisfied that Crane J's subtler answer was sufficient: that a more drastic expedient, making kava-kava a prescription-only drug, was rejected without any subsequent legal challenge. If after what was accepted as...

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