Ravi Randhawa
Legal Director
Fellow of Cilex
Article
7
Nutricia Limited (part of the Danone group) sought a judicial review of the decision by the Department of Health (the Department) that the company's yoghurt style food product - Souvenaid - did not fall within the definition of "food for special medical purposes" (FSMP) as set out in the EU Directive 1999/21/EC (the FSMP Directive). The FSMP Directive is transposed into English law by the Medical Food (England) Regulations 2000 (the Implementing Regulations).
Souvenaid is formulated and marketed by Nutricia as a medical food that addresses the apparent special nutrient requirements for those diagnosed with early Alzheimer's disease - in other words as a FSMP. One of the reasons Nutricia considers it important for Souvenaid to be seen as a FSMP is for the purposes of enabling it to be being listed in the NHS "Drug Tariff" (which would mean that it would be approved for reimbursement at the public expense when prescribed by a NHS practitioner).
While there is no need to obtain prior authorisation to market a FSMP, there is a requirement to notify the Department (in its role as the competent authority under the FSMP Directive) when first marketing the product. Nutricia notified the Department of Souvenaid accordingly.
There is no specific statutory role conferred on the Department to review and determine whether or not any product notified to it falls within the classification of FSMP. However, the FSMP Directive includes a duty on Member States to enforce the rules, and the court confirmed that this duty includes a duty to ensure that food products are properly classified. It is in this context that the Department adopted its view that Souvenaid is not a FSMP (and noted that it may be either a food supplement and/or a fortified food and should therefore be marketed as such).
In considering the case, the judge (Green J) distilled Nutricia's arguments into four key grounds of challenge, namely that the Department -
In giving his judgment, Green J concluded that -
The reference to the Court of Justice was not opposed by either party and should be broadly welcomed by food businesses as it may provide some clarity in the interpretation of the test that needs to be satisfied in order for a food product to be a FSMP. It will be particularly helpful in this case given that some Member States have accepted Souvenaid as a FSMP but not necessarily for the same reasons and not necessarily with the same claim.
There is however a risk with regard to timings. The current EU framework for FSMP products is changing and is being replaced by a new EU Regulation (No. 609/2013), applicable from 20 July 2016.
Among other things, one of the changes is that the European Commission will have the power to decide whether a particular food product constitutes a FSMP. It is likely that the Court of Justice will not be in a position to give its preliminary ruling prior to the new provisions taking effect and the question could in the meantime be referred (by any Member State) to the European Commission for a substantive decision.
Finally, it is relevant to note that the Department does not have an enforcement role under the Implementing Regulations - that role is conferred on food authorities (namely most local authorities). The judgement notes (as acknowledged by the Department) that this means the decision has a limited effect and does not directly impact upon the legal rights and obligations of Nutricia.
The view of the Department (if indeed admissible as evidence) could be no more than a matter which an enforcement authority can take into account when deciding whether to bring enforcement proceedings. Therefore neither the Department's decision nor the High Court's ruling prevents Nutricia from continuing to market the product as a FSMP for the time being.
NOT LEGAL ADVICE. Information made available on this website in any form is for information purposes only. It is not, and should not be taken as, legal advice. You should not rely on, or take or fail to take any action based upon this information. Never disregard professional legal advice or delay in seeking legal advice because of something you have read on this website. Gowling WLG professionals will be pleased to discuss resolutions to specific legal concerns you may have.