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

Factual and Procedural Background

An appeal was brought against the dismissal of an application to strike down two statutory measures adopted by the Secretary of State for Health. The primary measure was an Order made under the Medicines Act 1968 prohibiting the sale for medicinal purposes of kava-kava, a herbal anxiolytic. Concurrently, Regulations under the Food Safety Act 1990 banned kava-kava's use in foodstuffs. Both measures were authorised by ministers acting in the name of the Secretary of State.

The claimants challenged the measures primarily on the ground that the ministers authorised them in ignorance of a relevant fact: that a leading psychopharmacological authority, Professor Ernst, opposed the prohibition on cogent grounds detailed in a published meta-analysis. Additional grounds included the alleged unlawfulness of the consultation process for omitting the possibility of compulsory warning labelling and the failure to exempt goods in transit from the food prohibition, which appellants asserted should have led to quashing the Regulations.

The Administrative Court had previously addressed these issues, holding that the knowledge of responsible civil servants was legally imputed to ministers without requiring communication, finding adequate briefing for the minister who signed the Order but not for the minister who signed the Regulation. The court found the consultation process was flawed under the Medicines Act but refused to quash the Order due to the rejection of a more drastic alternative. It accepted the omission of an exemption for goods in transit but refused to quash the Regulations on grounds of no adverse effect and a departmental undertaking to amend the Regulations, which was subsequently done.

Legal Issues Presented

1. Whether the ministers authorised the measures in ignorance of relevant facts, particularly the opposition from Professor Ernst based on his meta-analysis.
2. Whether the prior consultation was unlawful due to omission of the possibility of compulsory warning labelling instead of an outright ban.
3. Whether the omission of an exemption for goods in transit in the Regulations was fatal and required quashing.

Arguments of the Parties

Appellants' Arguments

• The ministers acted without knowledge of a crucial fact: that Professor Ernst, a leading expert, opposed the prohibition and had produced a detailed meta-analysis supporting this position.
• The consultation process was unlawful because it did not consider mandatory warning labelling as an alternative to an outright ban.
• The omission of an exemption for goods in transit in the food Regulations rendered them invalid and required quashing.

Respondent's Arguments

• The knowledge of civil servants advising ministers is legally imputed to the ministers, even if the ministers themselves were not directly aware of Professor Ernst's opposition or meta-analysis.
• The consultation process under the Medicines Act was flawed but did not justify quashing the Order, as more drastic options had been considered and rejected.
• The omission of the exemption was not severable but did not cause adverse effects, and the Department had remedied the omission by amending the Regulations.
• Challenged the appellants' claim of consultation failure and contended the ministers had adequate advice and information to make lawful decisions.
• Contested the necessity of disclosure of the full ministerial briefing, relying on summaries provided by officials.

Table of Precedents Cited

Court's Reasoning and Analysis

The court analysed the legal framework governing ministerial decision-making under the Medicines Act 1968 and Food Safety Act 1990, including consultation requirements and the role of independent expert bodies. It considered the extent to which knowledge held by civil servants can be imputed to ministers, rejecting the proposition that ministers may lawfully decide in ignorance of material facts known to officials without being briefed themselves.

The court distinguished the doctrine in Carltona, which permits delegation of decision-making authority to civil servants acting in the minister's name, from the issue of imputing knowledge. It held that ministers must know or be told enough to ensure that no legally relevant matter is left out of account, though they need not know every detail. The court found that the minister who signed the Order was adequately informed of the key facts, including the Commission's advice and the fact that Professor Ernst dissented, with a summary of his objections.

Regarding the consultation process, the court accepted that the omission of compulsory warning labelling was a flaw but concluded that it did not justify quashing the Order because a more drastic alternative had been considered and rejected. On the omission of the exemption for goods in transit, the court found the error curable and remedied by subsequent amendment, thus not justifying invalidation.

The court also addressed the procedural issue of disclosure, acknowledging the policy against voluntary disclosure of ministerial briefings but expressing concern about reliance on secondary evidence. However, the parties' agreement to rely on a summary obviated the need to order production.

Finally, the court considered the European legal context, acknowledging the requirement for scientific objectivity and procedural guarantees but recognizing that the precise content of ministerial knowledge is a matter of judgment and practice, provided the decision-maker makes the final decision based on sufficient information.

Holding and Implications

The court DISMISSED THE APPEAL.

The decision confirms that while ministers may delegate decision-making authority to civil servants, they must be adequately informed of material facts relevant to their decisions. Knowledge held by civil servants is not automatically imputed to ministers unless communicated. The court emphasized the importance of ministers knowing sufficient salient facts to make an informed judgment but recognized that not every detail must be known. The ruling clarifies the limits of imputing departmental knowledge to ministers and affirms the legal standards for consultation and procedural fairness in public health regulatory decisions.

The direct effect is that the contested prohibition of kava-kava remains valid, and the Regulations were properly amended to address the omission. No new precedent was established beyond clarification of existing principles concerning ministerial knowledge and procedural requirements.