# C_2015354EN.01002501.xml

| 26.10.2015 | EN | Official Journal of the European Union | C 354/25 |
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Reference for a preliminary ruling from High Court of Justice, Queen's Bench Division (Administrative Court) (United Kingdom) made on 17 August 2015 — The Queen on the application of Nutricia Limited v Secretary of State for Health

(Case C-445/15)

(2015/C 354/27)

Language of the case: English

Referring court

High Court of Justice, Queen's Bench Division (Administrative Court)

Parties to the main proceedings

Applicant: Nutricia Limited

Defendant: Secretary of State for Health

Questions referred

| 1. | In order for a product to be a dietary food for special medical purposes (‘FSMP’) within the definition set out in Article 1(2)(b) of Commission Directive 1999/21/EC on dietary foods for special medical purposes( 1 ):
a.
Must it be the case, objectively, that:
(i)
all patients suffering from the particular disease, disorder or other medical condition for the dietary management of which the product is marketed (‘the Indicated Condition’) or (ii)
a subgroup of such patients
have a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or other medically-determined nutrient requirements that arise as a result of the Indicated Condition? Or b.
Alternatively, is it also sufficient if the manufacturer intends that the product’s use should be ‘medically determined’ for the purpose of Article 1(2)(b) in the sense that: (i) the manufacturer intends the product to be used only under medical supervision by clinicians treating patients with the Indicated Condition, and (ii) a responsible supervising clinician could properly form a clinical judgment, on a patient-by-patient basis, that the use of such product would be an appropriate form of dietary management for some patients suffering from the Indicated Condition because the clinician reasonably considers such a patient to have particular nutritional requirements related to the Indicated Condition? c.
If the answer to question 1(a)(ii) is ‘yes’, then (i) what proportion of patients with the Indicated Condition must have the relevant limited, impaired or disturbed capacity or other medically-determined nutrient requirements, or is there no minimum proportion, and (ii) is it necessary for that subgroup of patients to be identifiable in advance at the time when the product is marketed? d.
If the answer to question 1(b) is ‘yes’, then what are the ‘particular nutritional requirements’ which the use of the product must be safe, beneficial and effective in meeting for the purposes of Article 3? | a. | Must it be the case, objectively, that:
(i)
all patients suffering from the particular disease, disorder or other medical condition for the dietary management of which the product is marketed (‘the Indicated Condition’) or (ii)
a subgroup of such patients
have a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or other medically-determined nutrient requirements that arise as a result of the Indicated Condition? Or | (i) | all patients suffering from the particular disease, disorder or other medical condition for the dietary management of which the product is marketed (‘the Indicated Condition’) or | (ii) | a subgroup of such patients
have a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or other medically-determined nutrient requirements that arise as a result of the Indicated Condition? Or | b. | Alternatively, is it also sufficient if the manufacturer intends that the product’s use should be ‘medically determined’ for the purpose of Article 1(2)(b) in the sense that: (i) the manufacturer intends the product to be used only under medical supervision by clinicians treating patients with the Indicated Condition, and (ii) a responsible supervising clinician could properly form a clinical judgment, on a patient-by-patient basis, that the use of such product would be an appropriate form of dietary management for some patients suffering from the Indicated Condition because the clinician reasonably considers such a patient to have particular nutritional requirements related to the Indicated Condition? | c. | If the answer to question 1(a)(ii) is ‘yes’, then (i) what proportion of patients with the Indicated Condition must have the relevant limited, impaired or disturbed capacity or other medically-determined nutrient requirements, or is there no minimum proportion, and (ii) is it necessary for that subgroup of patients to be identifiable in advance at the time when the product is marketed? | d. | If the answer to question 1(b) is ‘yes’, then what are the ‘particular nutritional requirements’ which the use of the product must be safe, beneficial and effective in meeting for the purposes of Article 3? |
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| a. | Must it be the case, objectively, that:
(i)
all patients suffering from the particular disease, disorder or other medical condition for the dietary management of which the product is marketed (‘the Indicated Condition’) or (ii)
a subgroup of such patients
have a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or other medically-determined nutrient requirements that arise as a result of the Indicated Condition? Or | (i) | all patients suffering from the particular disease, disorder or other medical condition for the dietary management of which the product is marketed (‘the Indicated Condition’) or | (ii) | a subgroup of such patients
have a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or other medically-determined nutrient requirements that arise as a result of the Indicated Condition? Or | | | | | | | | |
| (i) | all patients suffering from the particular disease, disorder or other medical condition for the dietary management of which the product is marketed (‘the Indicated Condition’) or | | | | | | | | | | | | |
| (ii) | a subgroup of such patients
have a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or other medically-determined nutrient requirements that arise as a result of the Indicated Condition? Or | | | | | | | | | | | | |
| b. | Alternatively, is it also sufficient if the manufacturer intends that the product’s use should be ‘medically determined’ for the purpose of Article 1(2)(b) in the sense that: (i) the manufacturer intends the product to be used only under medical supervision by clinicians treating patients with the Indicated Condition, and (ii) a responsible supervising clinician could properly form a clinical judgment, on a patient-by-patient basis, that the use of such product would be an appropriate form of dietary management for some patients suffering from the Indicated Condition because the clinician reasonably considers such a patient to have particular nutritional requirements related to the Indicated Condition? | | | | | | | | | | | | |
| c. | If the answer to question 1(a)(ii) is ‘yes’, then (i) what proportion of patients with the Indicated Condition must have the relevant limited, impaired or disturbed capacity or other medically-determined nutrient requirements, or is there no minimum proportion, and (ii) is it necessary for that subgroup of patients to be identifiable in advance at the time when the product is marketed? | | | | | | | | | | | | |
| d. | If the answer to question 1(b) is ‘yes’, then what are the ‘particular nutritional requirements’ which the use of the product must be safe, beneficial and effective in meeting for the purposes of Article 3? | | | | | | | | | | | | |

| 2. | As regards the phrase ‘whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two’ in Article 1(2)(b), how should the potential for modification of the diet be assessed? In particular:
a.
Are considerations of safety and practicability of diet modification relevant in this assessment? If so, how are they to be taken into account? b.
Is such potential for modification of the normal diet (and, if relevant, are considerations of safety and practicability) to be assessed:
(i)
Generically, and in advance, by reference to: (i) a typical person with a typical diet with the typical abilities of such a person to modify their diet; or (ii) a typical sufferer of the Indicated Condition, with the diet typical of such a sufferer, and the ability to modify diet typical of such a sufferer; or (iii) some other assumed set of patient characteristics? (ii)
Individually and in the course of patient treatment, using the clinical judgment of the supervising clinician, such that it is enough if a manufacturer reasonably intends the product to be clinically useful because a supervising clinician may come to decide on reasonable patient-specific grounds (for instance, on patient-specific safety or practicability grounds) that the use of a FSMP may be clinically preferable to other forms of diet modification for some patients with the Indicated Condition? Or (iii)
Otherwise, and if so how? c.
Does ‘modification of the normal diet’ include the use of ‘food supplements’ within the meaning of Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements, or of ‘fortified foods’ falling within Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods? d.
Where a patient group suffering from a particular disease, disorder or other medical condition has difficulty remembering to eat a normal diet unless prompted, is a product designed to facilitate the consumption by such patients of nutrients which would form part of the normal diet capable of being a dietary food for medical purposes within Commission Directive 1999/21/EC on dietary foods for special medical purposes? | a. | Are considerations of safety and practicability of diet modification relevant in this assessment? If so, how are they to be taken into account? | b. | Is such potential for modification of the normal diet (and, if relevant, are considerations of safety and practicability) to be assessed:
(i)
Generically, and in advance, by reference to: (i) a typical person with a typical diet with the typical abilities of such a person to modify their diet; or (ii) a typical sufferer of the Indicated Condition, with the diet typical of such a sufferer, and the ability to modify diet typical of such a sufferer; or (iii) some other assumed set of patient characteristics? (ii)
Individually and in the course of patient treatment, using the clinical judgment of the supervising clinician, such that it is enough if a manufacturer reasonably intends the product to be clinically useful because a supervising clinician may come to decide on reasonable patient-specific grounds (for instance, on patient-specific safety or practicability grounds) that the use of a FSMP may be clinically preferable to other forms of diet modification for some patients with the Indicated Condition? Or (iii)
Otherwise, and if so how? | (i) | Generically, and in advance, by reference to: (i) a typical person with a typical diet with the typical abilities of such a person to modify their diet; or (ii) a typical sufferer of the Indicated Condition, with the diet typical of such a sufferer, and the ability to modify diet typical of such a sufferer; or (iii) some other assumed set of patient characteristics? | (ii) | Individually and in the course of patient treatment, using the clinical judgment of the supervising clinician, such that it is enough if a manufacturer reasonably intends the product to be clinically useful because a supervising clinician may come to decide on reasonable patient-specific grounds (for instance, on patient-specific safety or practicability grounds) that the use of a FSMP may be clinically preferable to other forms of diet modification for some patients with the Indicated Condition? Or | (iii) | Otherwise, and if so how? | c. | Does ‘modification of the normal diet’ include the use of ‘food supplements’ within the meaning of Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements, or of ‘fortified foods’ falling within Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods? | d. | Where a patient group suffering from a particular disease, disorder or other medical condition has difficulty remembering to eat a normal diet unless prompted, is a product designed to facilitate the consumption by such patients of nutrients which would form part of the normal diet capable of being a dietary food for medical purposes within Commission Directive 1999/21/EC on dietary foods for special medical purposes? |
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| a. | Are considerations of safety and practicability of diet modification relevant in this assessment? If so, how are they to be taken into account? | | | | | | | | | | | | | | |
| b. | Is such potential for modification of the normal diet (and, if relevant, are considerations of safety and practicability) to be assessed:
(i)
Generically, and in advance, by reference to: (i) a typical person with a typical diet with the typical abilities of such a person to modify their diet; or (ii) a typical sufferer of the Indicated Condition, with the diet typical of such a sufferer, and the ability to modify diet typical of such a sufferer; or (iii) some other assumed set of patient characteristics? (ii)
Individually and in the course of patient treatment, using the clinical judgment of the supervising clinician, such that it is enough if a manufacturer reasonably intends the product to be clinically useful because a supervising clinician may come to decide on reasonable patient-specific grounds (for instance, on patient-specific safety or practicability grounds) that the use of a FSMP may be clinically preferable to other forms of diet modification for some patients with the Indicated Condition? Or (iii)
Otherwise, and if so how? | (i) | Generically, and in advance, by reference to: (i) a typical person with a typical diet with the typical abilities of such a person to modify their diet; or (ii) a typical sufferer of the Indicated Condition, with the diet typical of such a sufferer, and the ability to modify diet typical of such a sufferer; or (iii) some other assumed set of patient characteristics? | (ii) | Individually and in the course of patient treatment, using the clinical judgment of the supervising clinician, such that it is enough if a manufacturer reasonably intends the product to be clinically useful because a supervising clinician may come to decide on reasonable patient-specific grounds (for instance, on patient-specific safety or practicability grounds) that the use of a FSMP may be clinically preferable to other forms of diet modification for some patients with the Indicated Condition? Or | (iii) | Otherwise, and if so how? | | | | | | | | |
| (i) | Generically, and in advance, by reference to: (i) a typical person with a typical diet with the typical abilities of such a person to modify their diet; or (ii) a typical sufferer of the Indicated Condition, with the diet typical of such a sufferer, and the ability to modify diet typical of such a sufferer; or (iii) some other assumed set of patient characteristics? | | | | | | | | | | | | | | |
| (ii) | Individually and in the course of patient treatment, using the clinical judgment of the supervising clinician, such that it is enough if a manufacturer reasonably intends the product to be clinically useful because a supervising clinician may come to decide on reasonable patient-specific grounds (for instance, on patient-specific safety or practicability grounds) that the use of a FSMP may be clinically preferable to other forms of diet modification for some patients with the Indicated Condition? Or | | | | | | | | | | | | | | |
| (iii) | Otherwise, and if so how? | | | | | | | | | | | | | | |
| c. | Does ‘modification of the normal diet’ include the use of ‘food supplements’ within the meaning of Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements, or of ‘fortified foods’ falling within Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods? | | | | | | | | | | | | | | |
| d. | Where a patient group suffering from a particular disease, disorder or other medical condition has difficulty remembering to eat a normal diet unless prompted, is a product designed to facilitate the consumption by such patients of nutrients which would form part of the normal diet capable of being a dietary food for medical purposes within Commission Directive 1999/21/EC on dietary foods for special medical purposes? | | | | | | | | | | | | | | |

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( 1 )  OJ L 91, p. 29.

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