R Nutricia Ltd v The Secretary of State for Health
| Jurisdiction | England & Wales |
| Judge | Mr Justice Green |
| Judgment Date | 31 July 2015 |
| Neutral Citation | [2015] EWHC 2285 (Admin) |
| Date | 31 July 2015 |
| Court | Queen's Bench Division (Administrative Court) |
| Docket Number | Case No: CO/5151/2014 |
[2015] EWHC 2285 (Admin)
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
Mr Justice Green
Case No: CO/5151/2014
Thomas de la Mare QC and Simon Antrobus (instructed by DWF LLP) for the Claimant
Andrew Henshaw QC (instructed by Treasury Solicitor) for the Defendant
Hearing dates: 3 rd— 4 th June and 7 th July 2015
| A. | Introduction, issues and conclusion | 1–21 |
| (i) Introduction | 1–12 | |
| (ii) Issues | 13–18 | |
| (iii) Conclusions | 19–21 | |
| B. | Legislative Framework | 22–21 |
| (i) The four categories of product | 22 | |
| (ii) Fortified foods | 23–24 | |
| (iii) Food supplements | 25–27 | |
| (iv) PARNUTS | 28–38 | |
| (v) Foods for Special Medical Purposes | 39–69 | |
| (a) The FSMP Directive | 39–47 | |
| (b) Guidance provided by the Defendant on FSMPs | 48–52 | |
| (c) The Medical Food (England) Regulations 2000 – "MFER" | 53–64 | |
| (d) The new regime – Regulation (EU) 609/2013: 12 th June 2013 | 65–69 | |
| C. | Relevant facts | 70–21 |
| (i) Souvenaid | 71–72 | |
| (ii) The notification of Souvenaid to the Defendant | 73 | |
| (iii) The Defendant's concerns as to whether Souvenaid was an FSMP | 74–76 | |
| (iv) The Advisory Committee on Borderline Substances ("ACBS") | 77–86 | |
| (v) The discussions at EU level | 87 | |
| (vi) The First Decision: 23 rd September 2013 | 88–92 | |
| (vii) The EU Standing Committee meeting: 10 th February 2014 | 93–96 | |
| (viii) The instruction of Dr Dangour | 97–99 | |
| (ix) The Final Decision | 100–101 | |
| D. | Issue I: Did the Department of Health have the power to take the Final Decision? | 102–21 |
| (i) The issue | 102-105 | |
| (ii) Analysis of Final Decision | 106–111 | |
| (iii) Conclusions | 112- | |
| (a) The Final Decision was intra vires | 112–113 | |
| (b) The Marleasing approach to interpretation | 114–119 | |
| (c) The limits of the Marleasing approach | 120 | |
| (d) The mechanics of implementation: The choice of "form and method" | 121–125 | |
| (e) The application of the Marleasing principle to the MFER | 126–138 | |
| E. | Issue II: Did the experts relied upon by the Department of Health have the relevant competence and expertise? | 139–21 |
| (i) The issue as articulated by the Claimant | 139–140 | |
| (ii) The facts relevant to the issue | 141–145 | |
| (iii) The extent to which the issue is properly justiciable/conclusions | 146–154 | |
| F. | Issue III: Did the Department of Health act perversely or irrationally in rejecting the evidence of the Claimant? | 155–21 |
| (i) The provisional nature of the issue | 155 | |
| (ii) The scope and nature of the review process | 156–164 | |
| (iii) The intake point | 165–175 | |
|
| (iv) The modification point | 176–179 |
| G. | Issue IV: Does the Final Decision amount to a breach of Article 34 TFEU? | 180–21 |
| (i) Articles 34 and 36 TFEU | 180–185 | |
| (ii) Claimant's submissions | 186–193 | |
| (iii) Analysis: Nutricia's formal case | 194–197 | |
| (iv) The new case: Alleged delay in processing Drug Tariff decisions | 198–208 | |
| H. | Questions for reference to the Court of Justice | 209–21 |
| (i) Questions to be referred | 209 | |
| (ii) The reasons for reference | 210–214 | |
| (iii) The difference in overall approach: objective or subjective? | 215–217 | |
| (iv) Questions relating to the size of the relevant patient group | 218 | |
| (v) The intake point | 219 | |
| (vi) The modification point | 220–223 | |
| I. | Conclusion | 224–21 |
A. Introduction, issues and conclusion
(i) Introduction
There is before the Court an application for permission to apply for judicial review and, if granted, the substantive judicial review in a complex case concerning a decision adopted by the Defendant which expressed the "view" that a yoghurt style food product called "Souvenaid" produced by Nutricia Limited ("Nutricia" or the "Claimant") could not be classified as a food for special medical purposes or "FSMP". I indicated during the hearing that this was a case in which it was appropriate to grant permission and the case thus proceeds as the substantive application for judicial review.
Over recent years there have evolved a range of regulatory regimes which seek to govern how different foods are marketed and as to the nutritional and/or medical claims that may be made for them. Manufacturers increasingly produce foods which are formulated to act as dietary supplements or which are basic foods fortified with minerals or which are designed to address particular medical problems. A well known example is gluten free bread for those with some degree of gluten intolerance.
The product in issue in this case, Souvenaid, is a 1kcal/ml, vanilla or strawberry flavoured, milk-based drink containing Omega 3 fatty acids, Uridine, Choline and a range of vitamins and minerals. It is formulated to address the apparent special nutrient requirements for those diagnosed with early Alzheimer's disease ("AD").
The rules relating to the marketing (which include labelling) of foods for medical purposes are found in a specific EU directive on FSMP. This is Commission Directive 1991/21/EC upon dietary foods for special medical purposes (the "FSMP Directive").
This regime is unlike, say, the regime regulating the placing on the market or advertising of medicines, which requires prior authorisation. The FSMP Directive is more relaxed reflecting the fact that FSMP products are essentially safe and can be used as foods. Under the FSMP Directive the responsibility for determining whether a product complies with the rules resides in the first instance with the manufacturer or seller. The FSMP Directive prohibits the sale of non-compliant products; and in the UK the risk of non-compliance carries with it the risk of prosecution.
It is not necessary for the purposes of this judgment to set out in any detail the commercial considerations which underpin a producer's desire to market a product as an FSMP, as opposed to an ordinary food. Very broadly, if a food is an FSMP it entitles the producer to make certain claims about the food which may be valuable in enabling the product to reach a specialised medical market. There are also perceived to be advantages in relation to the rules relating to drug tariffs and reimbursement (the "Drug Tariff"). It follows that decisions made about the classification of a product as falling (or not) within the various regulatory regimes may have wide ranging commercial implications.
Under the FSMP Directive Competent Authorities in the Member States are required to conduct " efficient official monitoring" of the requirements in the directive. These requirements cover such matters as the name of the product, and the information that must be included on labels. It also imposes a duty on producers to notify the Competent Authorities of their plans to sell an FSMP upon first marketing and it requires Member States to prohibit marketing of products which have not been so notified.
In England the FSMP Directive has been implemented by regulations adopted under the Food Safety Act 1990 ("FSA 1990"). These can, without the risk of any party in this litigation disagreeing, be described as most unsatisfactory. The FSMP Directive is a "framework" measure i.e. one which describes a broad framework of rules that then needs to be filled in by the Member States when performing their duty to implement the measure into national law. However, in the present case rather than systematically draft out the scheme that needed to be put into place the legislature has adopted a variety of piecemeal devices. First, the regulations operate in large measure by cross reference to the Directive and assume necessarily that those provisions cross referred to are applicable without more; secondly, the regulations refer to a series of provisions in the FSA 1990 and then provide that they also apply by cross-reference, mutatis mutandis, to the implementing regulations. Thirdly, the regulations introduce a number of provisions which define a small number of key terms, introduce a restriction on sale for non-compliant products and introduce a criminal sanction for violation. The implementing regulations thus have to be read in the context of both the FSMP Directive and the FSA 1990. Additional guidance is provided by the promulgation by the Defendant of non-statutory Guidance Notes.
The net effect is that there is no single coherent source of rules and information for those subject to the regime.
In 2012 Nutricia notified the Defendant, who is the Competent Authority under the FSMP Directive, of the details of Souvenaid and it claimed that it was an FSMP. There followed a relatively lengthy process during which the Defendant assessed information provided to it by Nutricia and consulted with other Member States within the EU and with the Commission.
The Defendant also referred the issue to the Advisory Committee on Borderline Substances ("ACBS"). This committee is an ad hoc body and has no separate or statutory underpinning or authority. It exists to provide advice to the Defendant in particular in relation to how the Defendant should classify "borderline" products which fall under the Drug Tariff and for related reimbursement purposes. The ACBS however considered that to provide full advice it needed the Defendant to determine the proper classification of Souvenaid, including whether it was...
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Zaw Lin and Another v Commissioner of Police for the Metropolis
...detailed summary of the relevant principles of interpretation and its limits: R (Nutricia Ltd) v The Secretary of State for Health [2015] EWHC 2285 (Admin) at paragraphs [114] – [120]. In Campbell v. MGN [2002] EWCA Civ 1373; [2003] QB 633 (" Campbell"), Lord Phillips of Worth Matravers,......