Nutricia Ltd, R (on the application of) v The Secretary of State for Health

A competent authority may form a non-binding view on whether a product falls within the regulatory definition of a food for special medical purposes where the domestic scheme, read purposively with the relevant EU directive, requires effective monitoring. The authority’s view is not a prior authorisation or enforcement decision.

Judicial review may examine the competence of experts, the legality of the legal test applied, and whether the decision-maker considered relevant evidence. It should not substitute the court’s assessment for a specialist evaluation of technical scientific material absent manifest error. The court referred unresolved questions concerning the meaning of the FSMP definition to the Court of Justice.

Nutricia sought judicial review of the Secretary of State’s view that Souvenaid, a nutritional product intended for people with early Alzheimer’s disease, was not a food for special medical purposes under the FSMP Directive.

The challenge concerned the Secretary of State’s power to classify the product for monitoring purposes, the competence of the experts consulted, the rationality of the assessment of the evidence, and alleged restrictions on trade under Article 34 TFEU. The central unresolved issues concerned the meaning of special nutritional requirements, the relevance of a normal diet and the effect of possible diet modification.

1. Power to decide classification. The Secretary of State acted intra vires. The Medical Food (England) Regulations 2000 had to be read together with the FSMP Directive and the Food Safety Act 1990. The notification and monitoring regime necessarily permitted the competent authority to form a view on classification. The view was limited and non-binding. It did not authorise or prohibit marketing, create a prior approval regime, or determine criminal liability.
2. Purposive interpretation. The Marleasing principle required national law within the directive’s field to be interpreted, so far as possible, to achieve the directive’s result. That principle did not permit domestic wording to be distorted or new criminal sanctions or civil consequences to be created. Any necessary gap in the monitoring scheme could also be filled by necessary implication and supplementary administrative practice.
3. Experts. The choice of Public Health England and Dr Dangour fell within the Secretary of State’s margin of appreciation. Their nutritional and clinical research expertise was relevant to the intake and modification issues. The court could review competence, but the evidence did not show that the decision-maker had relied uncritically on incompetent advice.
4. Rationality. Assuming the Secretary of State’s legal test was correct, the evidence did not establish that the study participants had a normal or par diet, nor that the product was necessary because ordinary diet modification could not meet the relevant needs. The conclusions were therefore rational on the assumed legal basis. The legal questions were sufficiently uncertain and important to require a reference.
5. Article 34 TFEU. The claim failed. Nutricia did not establish that the non-binding view was capable of materially hindering imports. The new challenge concerning delay in Drug Tariff consideration was inadequately formulated, unsupported by sufficient evidence and materially different from the pleaded claim.
6. The questions concerning the interpretation of the FSMP definition were referred to the Court of Justice. The proceedings were stayed and costs were reserved.

First-instance judicial review proceedings. The court referred questions concerning the interpretation of Commission Directive 1999/21/EC to the Court of Justice under Article 267 TFEU and stayed the proceedings.