Case C-445/15, Nutricia – is an Alzheimer dairy product, a food for a special medical purpose?

A company has made a dairy product for patients with early onset Alzheimer’s Disease. The company believes that this makes it a ‘food for a special medical purpose’ within the EU Commission’s Directive 1999/21/EC. However, in the United Kingdom, the Secretary of State for Health believes that that the company has failed to demonstrate that the product satisfies the Directive’s definition of ‘a food for a special medical purpose’. The issue in this case is how should that be test be understood?

Background
According to Nutricia, people diagnosed with early Alzheimer’s Disease need special nutrients. To that end, they sell a dairy product called ‘Souvenaid’, and the company recommends that patients drink 125ml of their product every single day.

The Dutch French-owned company, Nutricia, makes its product in Holland and already sells it in 11 other EU Member States. The company has notified the relevant authorities in those Member States that it is a food for a special medical purpose, in accordance with the EU Commission’s ‘foods for special medical purposes’ Directive 1999/21/EC (the FSMP Directive).

However, the situation in the UK is a little peculiar in two respects. First, the commercial reality is that despite the fact that people can buy the product via Nutricia’s own website; the product is marketed directly at healthcare practitioners. The product is not available in supermarkets or over the counter in UK pharmacies.

Second, the legal reality is that in 2014 the UK took the view that Nutricia’s product was not a ‘food for special medical purposes’. The Secretary of State for Health provided two reasons to justify why the product was not a food for special medical purposes. First, Nutricia’s evidence had not proved that its product satisfied a ‘special nutritional’ requirement. Second, even if the Secretary of State for Health was wrong on that point, then Nutricia had still failed to show that a patient’s needs could not be met by them altering their diet, for example, in the form taking food supplements.

Nutricia challenged the legality of the decision of the Secretary of State for Health.

At the Queen’s Bench Division
The dispute between Nutricia and the Secretary of State for Health was heard in the Administrative Court of the High Court of England and Wales (the Queen’s Bench Division), before Judge Green who is a specialist in EU law.

He noted that determining whether a product was deemed to be a FSMP depended on the definition in Article 1(2)(b) of the Directive, a definition that comprised of several elements:

“… a category of foods [1] for particular nutritional uses [2] specially processed or formulated and [3] intended for the dietary management of patients and to be used [4] under medical supervision. They are [5] intended for the exclusive or partial feeding of patients [5a] with a limited or disturbed capacity to take, digest, absorb metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites or [5b] with other medically-determined nutrient requirements, [6] whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional purposes, or by a combination of the two”.

The definition might be complicated but it was important. If companies in the UK misclassified their product, then they could fall foul of English criminal law. Furthermore, a clear understanding of the definition was also important to the functioning of the internal market because authorities in the various Member States were currently applying the definition in divergent ways.

So how should the definition be interpreted? The judge summarised the positions of the parties. In essence, Nutria claims that it is up to a company to decide subjectively whether its product complies with the FSMP rules – if it gets it wrong, then it can be punished under national law. This might sound subjective on the part of the company but Nutricia was at pains to point out that there was still an element of objectivity housed in the company’s decision. That is to say, a company would still need to base its decision on whether a product qualified as an FSMP on the basis of generally accepted scientific data. Consequently, it was not appropriate for a national authority to second-guess the manufacturer’s assessments of that data.

The force of Nutricia’s legal argument was denied by the Secretary of State for Health. It interpreted the EU Directive to mean that there was an objective test as to whether a product could be deemed to be a FSMP. There were also several disadvantages to a subjective test. First, if the test were subjective, then public authorities would have no chance to exercise objective control over a product. Equally, if the test was subjective then authorities would have no opportunity to disagree with a manufacturer’s classification – in effect, they would be deprived of being able to form a definitive assessment as to a particular product. If a company disagreed with that decision, then it was still capable of being reviewed by the courts.

Another potential disadvantage to a subjective test was the spectre of a company wishing to peddle their product as a FSMP not solely for clinical reasons. That is to say, a company could be just as motivated by economic reasons for wanting their food to qualify as an FSMP. After all, once it was designated as an FSMP, it could then be sold to a specialised medical market and there also could be further benefits associated with drug tariffs and reimbursements. Yet, as the Secretary of State for Health was at pains to point out this area was an area of public health and consumer protection – and only an objective approach involving ‘effective monitoring’ would do.

The judge also noted that besides the disagreement surrounding whether the Directive’s test should be subjective or objective, there had also been discussion in the court as to the size or the scale of the studies that were required to show that a particular product qualified as an FSMP.

Again, there was no agreement between the parties. The Secretary of State for Health took the view that a qualifying-product had to be shown to be beneficial and efficacious for pretty much everyone in the medical cohort – in this case, patients with an early onset of Alzheimer’s Disease. That approach was denied by Nutricia.

Further discussion turned on the ‘normal diet’ proviso that was in Article 1(2)(b) of the Directive, which means that if the normal diet of a patient can be changed, then a product should not qualify as an FSMP.

That said, the correct interpretation of the definition might in turn depend on the purpose of the rule. One possibility was that the purpose was all about how an individual patient’s needs might be best served (for example by taking a handy product that a patient might be more likely to take).

Alternatively, if the purpose of the rule was really to restrict marketing claims being made about a product, then it would be possible to restrict the status of an FSMP only to those products that achieved an effect which could not be gained from a patient making changes to their diet, for example, by taking food supplements.

The latter interpretation seemed to be the view of the EU Commission, which had said that on the issue of changes to diet, the effect of taking food supplements should be taken into account. (In his referring order, Judge Green quoted the Summary Report of the Standing Committee on the Food Chain and Animal Health of the meeting of 10th February 2014.) If that interpretation prevailed, then it could prevent products from qualifying as an FSMP.

In fairness, the judge also recorded Nutricia’s criticism of the EU Commission’s view. The company had pointed out that it would be very rare for there not to be an alternative available, say from existing food supplements. The point could also be made in respect of tube feeds and sip feeds which equally replicate ordinary foods or food supplements. In the company’s view, the important thing to focus on was that FSMPs should meet medically identified nutritional needs for particular patients, in a situation where a clinician has decided that the FSMP is the required means to achieve the desired dietary management.

However, Nutricia’s criticism of the EU Commission was not shared by the UK’s Secretary of State for Health. Besides supporting the view expressed by the EU Commission, the Secretary of State for Health also added that the Directive had used the phrase “cannot be achieved”. Hence, the drafting implied a stricter test. Furthermore, if an FSMP designation were to be subject to the clinical judgment of an individual professional, then in the view of the Secretary of State for Health, that would make the scheme, as a whole, inconsistent and impossible to supervise.

Judge Green duly decided to make a preliminary reference to the CJEU.

Questions Referred
According to the Bailii website, the questions asked by the Administrative Court of the High Court of England and Wales (the Queen’s Bench Division) are:

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:
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 sub-group 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 sub-group 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 to 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 1925/2006/EC 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?

Comment
It is not altogether clear why the company suggests that ‘its’ data should not be second-guessed by an authority – all the more so since this private company has had the benefit of a study that was paid for by the Dutch tax-payer, and the EU tax-payer.

On the difficulties of accessing information from private companies about the effects of their products on the environment; see for example, Case C-442/14, Bayer CropScience – Bee deaths? Buzz Off! The data requested is confidential.

Update – 28 September 2015
On marketing that is directed solely at healthcare professionals and whether companies can then rely on this fact to escape the scope of the EU’s ‘nutrition and health claims made on foods’ Regulation 1924/2006; see further, Case C-19/15, Verband Sozialer Wettbewerb – stopping a company making health claims to doctors.

Update – 18 April 2016
In today’s Official Journal of the EU, it is apparent that the High Court (QBD) has withdrawn this ‘Nutricia’ reference to the CJEU and this has now been removed from the CJEU’s register.