Administrative Court refers medical food issues to Court of Justice

05/08/15

Nutricia v Secretary of State for Health 

The Administrative Court (Green J) has given judgment on Nutricia Limited’s judicial review challenge to the conclusions of the Department of Health about the status of the product Souvenaid, marketed by Nutricia as a medical food for the dietary management of early Alzheimer’s disease (“AD”).  Green J dismissed three of Nutricia’s four grounds of challenge, and has referred to the Court of Justice of the EU certain questions of interpretation relevant to the remaining ground.

The Department determined that Souvenaid was not a medical food, within the definition given in Commission Directive 1999/21/EC on foods for special medical purposes, because (a) the evidence did not demonstrate that people with early AD have particular nutritional requirements so as to fall within the definition, and (b) even if people with early AD did have such requirements, they could be met by a modification of the normal diet, by other foods for particular nutritional uses, or by combination of the two.

Nutricia challenged the Department’s conclusion on four grounds, namely that:

(1) it was outside the Department’s powers, because the UK regulations implementing the Directive gave the Department no power to classify products, that being a matter solely for local food authorities and the criminal courts;

(2) the Department acted perversely and irrationally in accepting advice from expert nutritionists who lacked clinical competence to assess Souvenaid against the test laid down in the Directive;

(3) the Department misdirected itself on the law, because its interpretation of the definition of medical food was too narrow, and/or was wrong in not accepting and/or giving adequate weight to pre-clinical and clinical evidence submitted by Nutricia relating to the medical benefits and efficacy of Souvenaid; and

(4) it effectively prevented Souvenaid from being sold as an medical food in the UK, and amounted to a measure having equivalent effect to a quantitative restriction contrary to Article 34 TFEU.

Green J concluded that the Department acted within its powers in adopting the challenged decision (Issue 1).  He also accepted that the Department acted lawfully in relying upon the experts instructed to provide advice (Issue 2). Further, he rejected the submission that the Department acted unlawfully under Article 34 TFEU (Issue 4).

With regard to the issues of construction and interpretation arising out of Issue 3, Green J decided that they should be referred to the Court of Justice (a course which neither party opposed) because there was real doubt as to the meaning of a medical food, and there was also evidence that differing views were held by different Competent Authorities across the EU.

A link to the judgment is here