National Association of Health Stores & Anor, R (on the application of) v Department of Health

Where a Minister personally reserves an administrative decision, the Carltona principle does not impute to the Minister every fact known within the department. The Minister must, however, be given sufficient information to make a genuine and informed decision. This requires the salient facts that give shape and substance to matters which the Minister is legally bound to consider, not every relevant item of evidence.

A court may refuse relief for a consultation defect where a properly consulted and rejected more restrictive option establishes that the omitted lesser option could not rationally have altered the outcome. A curable omission from subordinate legislation which has caused no harm may properly be corrected by amendment rather than by quashing the whole instrument.

The claimants challenged a prohibition on the medicinal sale of kava-kava and associated food regulations. The measures had been made under the Medicines Act 1968 and food legislation following advice from expert bodies about possible hepatotoxicity.

Crane J dismissed the challenge, although he held that consultation on warning labelling had been defective and that the food regulations wrongly omitted an exemption for goods in transit. The claimants appealed from [2003] EWHC 3133 (Admin).

The central issue was whether the Minister who made the prohibition order had failed to take account of legally relevant information concerning Professor Ernst’s scientific review and opposition to a ban. The appeal also concerned the consultation defect and the remedy for the omitted transit exemption.

1. Appeal dismissed. Sedley LJ gave the principal judgment, with which Keene LJ and Bennett J agreed. The court upheld Crane J’s dismissal, although it rejected an important part of his reasoning about ministerial knowledge.

2. Carltona Ltd v Commissioners of Works [1943] 2 All ER 560 establishes that an authorised civil servant may act in the Minister’s name. It does not establish that all facts known to departmental officials are thereby known to a Minister who personally makes the decision. Nor did Bushell v Secretary of State for the Environment [1981] AC 75 support such an imputation. That case concerned fairness and departmental advice in the decision-making process.

3. A Minister who personally decides must take account of matters which the law requires to be considered. The content of that obligation depends on the statute’s subject matter, scope and purpose. The Minister need not read every document or know every relevant detail. Departmental officials may analyse, sift and summarise the material, but they must convey the salient facts necessary for an informed and genuine decision.

4. Lord Hunt had the advice of the Committee on Safety of Medicines and the Medicines Commission, the adverse-reaction data, and a summary of Professor Ernst’s opposition to prohibition. He was not told of Professor Ernst’s particular standing, the existence and character of his meta-analysis, or its precise conclusions. Those omitted matters would have strengthened the case against a ban, but were not so legally relevant that the Minister could not lawfully decide without them. The summary of the objections was sufficient.

5. The consultation on compulsory warning labels was defective. Relief was nevertheless properly refused. A more restrictive prescription-only option had been consulted upon and rejected. The decision-maker could not rationally have regarded warning labels as an adequate safeguard after reaching that conclusion.

6. The omitted exemption for goods in transit did not require the food regulations to be quashed. The omission was curable, had caused no identified harm, and could be made good by amendment without disrupting the lawful substance of the regulations.

7. The European authorities required a well-informed and scientifically objective process, especially where public-health restrictions are imposed. They did not prescribe that every underlying scientific datum be put before the final decision-maker. The legal requirement remained that the designated decision-maker make the final decision with sufficient knowledge to do so genuinely.

• Court of Appeal (Civil Division): Appeal dismissed: [2005] EWCA Civ 154.
• Administrative Court: Crane J dismissed the claim for judicial review, while finding defects in consultation and in the omission of a transit exemption: [2003] EWHC 3133 (Admin).