National Association of Health Stores & Anor v Secretary of State for Health & Anor

A decision-maker need not consult on every possible option, but consultees must not be misled about the legal options available. Presenting voluntary warnings as the only possible warnings, when compulsory warnings were legally arguable, made consultation on a medicinal-products prohibition procedurally flawed. No relief was granted because warnings would have been insufficient in any event. Departmental knowledge may be imputed to a minister where held by responsible officials involved in advising the minister. An unjustified omission from subordinate legislation could not be cured by severance.

The claimants challenged prohibitions on the sale, supply, importation or possession for sale of products containing Kava-Kava under the Medicines for Human Use (Kava-Kava) Prohibition Order 2002 and the Kava-Kava in Food (England) Regulations 2002. They alleged failures concerning ministerial information, consultation on compulsory warnings, adverse-reaction data and differing exemptions.

The court also considered an application for disclosure of ministerial decision-making material and whether any procedural defects justified relief.

1. The complaints concerning Professor Ernst’s review and the classification of adverse-reaction reports failed. Responsible officials had considered the relevant material, and adequate information had been supplied to the minister.

2. Under the Carltona principle, knowledge held by officials responsible for receiving, considering and advising on material may be imputed to the minister. Information known only to uninvolved officials, or merely buried in a file, is not automatically imputed.

3. A decision-maker need not consult on every possible option. However, the medicinal-products consultation was misleading because it presented voluntary warnings as the only available warnings, although compulsory labelling was legally arguable. The consultation was therefore procedurally flawed.

4. The food consultation was not similarly defective. Labelling had been rejected as unworkable, and no irrationality was established.

5. The food Regulations unlawfully omitted an exemption for goods in transit corresponding to an exemption in the medicinal-products Order. The omission could not be cured by severance because the court could not write words into the Regulations.

6. No relief was granted for the defective consultation concerning the Order. Since medical supervision would not have sufficiently protected the public, compulsory warnings would also have been insufficient. The Secretary of State’s undertaking to reconsider the food exemption was accepted.