“1. To facilitate efficient official monitoring of dietary foods for special medical purposes, when a product is placed on the market, the manufacturer, or where a product is manufactured in a third country, the importer, shall notify the competent authority of the Member States where the product is being marketed by forwarding to it a model of the label used for the product. Member States may, if they can demonstrate that notification is not necessary in order to monitor those products efficiently in their territory, not impose that obligation. 2. The competent authorities within the meaning of this Article are those referred to in Article 9(4) of Directive 89/398/EC”
“(1) The Drug Tariff referred to in section 127(4) of the 2006 Act (arrangements for additional pharmaceutical services) is the aggregate of— (a) the determinations of remuneration made by the Secretary of State, acting as a determining authority, under section 164 of the 2006 Act (remuneration for persons providing pharmaceutical services), but not of the remuneration of dispensing doctors; (b) the determinations of remuneration made by the NHSCB, acting as a determining authority, pursuant to regulation 91(1); and (c) any other instruments that the Secretary of State is required by virtue of these Regulations or the 2006 Act to publish, or does publish, together with those determinations, in the publication known as the Drug Tariff, which the Secretary of State shall publish in such format as the Secretary of State thinks fit.”
“Souvenaid is being marketed as a Food for Special Medical Purposes with the claim “for the dietary management of early Alzheimer’s Disease”
“A.04 Request from the United Kingdom for a discussion on Article 1.2(b) of Commission Directive 1999/21/EC on dietary foods for special medical purposes On the request of the UK the Committee discussed whether a product containing a combination of nutrients such as vitamins, minerals and omega-3 fatty acids and marketed “For the dietary management of early Alzheimer’s disease” would fall within the scope of the definition of Food for Special Medical Purposes (FSMP), according to Article 1(2)(b) of Commission Directive 1999/21/EC on dietary foods for special medical purposes. The UK delegation explained that their authorities are currently in talks with an operator who manufactures a product with this composition. After having informed the operator of their initial doubts that the product would comply with the definition of FSMP, the UK authorities were asked by the operator to reconsider their decision since the product is also marketed as an FSMP in other Member States. The UK delegation therefore asked for the views of other Member States and in particular whether the principle of mutual recognition applies in this situation. Discussions within the Committee confirmed that the product is on the market of different Member States as an FSMP. Of the delegations that intervened, one explained that the product was accepted because of the principle of mutual recognition. Another one explained that the product was accepted following an assessment of the data submitted by the operator. The operator was however asked to market the product “for the dietary management of cognitive loss among the elderly population” rather than “for the dietary management of early Alzheimer's disease”
“The first part of the definition of a FSMP indicates that a product should be intended for feeding patients with specific nutrient requirement as a consequence of a limited, impaired or disturbed capacity to take, digest, absorb metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites or with other medically-determined nutrient requirements The Department of Health has carefully considered all the evidence submitted by Nutricia Limited and has concluded that the evidence does not demonstrate that people with early Alzheimer’s Disease have special nutritional requirements. This results in the Department maintaining the view that the product Souvenaid does not fall within the definition of an FSMP and the Directive 1999/21/EC and should not therefore be presented as a Food for Special Medical Purposes with the indication “for the dietary management of early Alzheimer’s Disease”
“56. The Commission points out that, according to Article 8 of the Directive, the information referred to in Articles 5, 6 and 7 is also to 'mention the authorities responsible for implementing the measures referred to in those articles'. The practice of the French authorities, whereby details of the responsible authorities are given through the media used for informing the general public, cannot in that respect be regarded as sufficient to ensure the correct and complete implementation of Article 8 of the Directive. It does not meet the requirements of legal certainty. 57. It must be borne in mind that, according to the very terms of the third paragraph of Article 161 EA, the Member States are entitled to choose the form and methods for implementing directives which best ensure the result to be achieved by the directives. It is clear from that provision that the transposition of a directive into national law does not necessarily require legislative action in each Member State. Thus, the Court has repeatedly held that it is not always necessary formally to enact the requirements of a directive in a specific express legal provision (see, to that effect,Case C-233/00 Commission v France[2003] ECR I-6625 , paragraph 76, andCase C-296/01 Commission v France[2003] ECR I-0000 , paragraph 55). 58. It is in the light of that case law that the Commission's sixth complaint must be considered. 59. In this case, the Commission has not in any way demonstrated that compliance with the obligation laid down in Article 8 of the Directive requires specific implementing measures to be incorporated into national law. 60. Moreover, the Commission acknowledges the existence of a practice on the part of the French authorities, whereby details of the responsible authorities are given through the media used for informing the general public, but has not shown how that practice is contrary to the obligation laid down in Article 8 of the Directive. 61. Accordingly, the sixth complaint must be rejected as unfounded.”
“Nutrition scientists at Public Health England (PHE) have been asked by the Department of Health to review scientific evidence submitted by Nutricia Limited in support of Souvenaid as a Food for Special Medical Purposes (FSMP)”
“In my opinion the literature reviewed in these publications provides a strong basis for testing a nutritional approach to early AD”; (ii) Moreover, there is evidence of a meeting between PHE and Nutricia in which Dr Tedstone of PHE (who led the PHE review) indicated that she accepted that Nutricia had made out a plausible hypothesis. The Note of the meeting records: “You have a plausible hypothesis. I’m not being dismissive. Animal data makes it plausible. Be careful about leaping on to cause and effect.”
“…increased nutrient needs in order to support the metabolic Kennedy pathway for phospholipids formation, leading to the formation of neuronal membranes and synapses”
“The lack of any information regarding the dietary intake of the population group in studies was particularly problematic, as it made it impossible to conclude whether people in the study had reduced nutrient levels because they were not eating a healthy balanced diet or because of a disease mechanism. One of the risk factors for Alzheimer’s Disease is not eating a healthy balanced diet. I am aware that Nutricia have now suggested that the difference in nutrient levels may be caused because people with early AD would forget to eat a healthy balanced diet unless prompted to do so. Even if that were the case, it would not make their product an FSMP. Individuals who need prompting to eat could be supported in a number of ways to improve nutrient intake, but such interventions would not be FSMPs. If a product is an FSMP it can be marketed with the phrase “for the dietary management of [the particular medical condition]”
“…to answer such questions axiomatically and by reference to the treatable cohort as a whole…e.g. to ask the question for all sufferers of all forms of malnutrition…”
“Article 36 The provisions of Articles 34 and 35 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the protection of industrial and commercial property. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States.”
“… the DoH have adopted a procedure which goes far beyond that provided in the FSMP Directive, as applied by seven other Member States where Souvenaid is lawfully marketed. The consequence is the Decision the effect of which is to seek to restrict trade in Souvenaid in the UK.”
“Whilst we acknowledge that there could potentially be alternative presentations of Souvenaid as a food supplement (or fortified food), the information you have provided demonstrates that you are seeking to market Souvenaid as “for early Alzheimer’s disease”
“The [Defendant] contended that the “modification of the normal diet” limb requires a focus on the general or abstract use of foods, food supplements and fortified foods as a potential replacement for an FSMP. If such theoretical potential replacement is possible on the abstract level (even if not feasible for certain patients or in certain circumstances) then according to the [Defendant] the product cannot be an FSMP. This is fundamentally to misread the last limb of the definition, which is necessarily focused upon the particular patient with particular needs under medical supervision. It ignores the fact that the choice of an FSMP is a medically led/supervised step and in many cases will involve a choice of a FSMP over an alternative approach to diet on a patient specific basis. As [the Claimant’s evidence] demonstrates it will be very rare that a FSMP is the only way to provide certain nutritional requirements to patients (the point being most obvious with tube and sip feeds which can easily be replicated from ordinary foodstuffs or food supplements). From a clinical perspective, for some patients suffering, say, from disease related malnutrition it may be appropriate to prescribe a FSMP; for others it may be appropriate instead simply to give them a diet plan or diet advice. It is the role of the “medical supervision”, which limb 3 requires, to decide upon the appropriate dietary management for any particular patient. It is only such medical supervision that can decide whether a particular form of dietary modification not using FSMPs is realistic for that patient, or whether in fact the required “dietary modification” is one that “cannot be achieved”
“patients…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”
“The Commission recalled the definition of FSMPs given in Article 1(2)(b) of Directive 1999/21/EC and drew the attention of Member States on the consequences that a broad interpretation of this definition could entail. In this context, it called on Member States to take into account all the elements of the definition, including the one whereby FSMPs are intended for “(…) medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet (…)”
“The [Defendant] contended that the “modification of the normal diet” limb requires a focus on the general or abstract use of foods, food supplements and fortified foods as a potential replacement for an FSMP. If such theoretical potential replacement is possible on the abstract level (even if not feasible for certain patients or in certain circumstances) then according to the [Defendant] the product cannot be an FSMP. This is fundamentally to misread the last limb of the definition, which is necessarily focused upon the particular patient with particular needs under medical supervision. It ignores the fact that the choice of an FSMP is a medically led/supervised step and in many cases will involve a choice of a FSMP over an alternative approach to diet on a patient specific basis. As [the Claimant’s evidence] demonstrates it will be very rare that a FSMP is the only way to provide certain nutritional requirements to patients (the point being most obvious with tube and sip feeds which can easily be replicated from ordinary foodstuffs or food supplements). From a clinical perspective, for some patients suffering, say, from disease related malnutrition it may be appropriate to prescribe a FSMP; for others it may be appropriate instead simply to give them a diet plan or diet advice. It is the role of the “medical supervision”, which limb 3 requires, to decide upon the appropriate dietary management for any particular patient. It is only such medical supervision that can decide whether a particular form of dietary modification not using FSMPs is realistic for that patient, or whether in fact the required “dietary modification” is one that “cannot be achieved”
“patients…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”