2014
ADMINISTRATIVE COURT
UK
CORAM
AI Generated Summary
The case involves Claimants producing Dolenio, a glucosamine product for osteoarthritis treatment, challenging MHRA's refusal to classify all similar products as medicinal. The court focused on whether these products should be considered medicinal based on presentation and function, affirming MHRA's need for individual assessments of each product. The judgment stressed the criteria for medicinal product classification under EU law, emphasizing the need for case-by-case analysis.
Judgment
Mr Justice Supperstone :
Introduction
The Claimants produce and supply Dolenio , a glucosamine-containing product (“GCP”) used in the treatment of osteoarthritis (“OA”).
The Medicines and Healthcare Products Regulatory Agency (“MHRA”) is an agency of the Department of Health. It is responsible for classifying products as medicines, authorising medicines for lawful supply and enforcing compliance with the regulatory requirements that apply to such products.
Dolenio is correctly categorised as a “medicinal product” within the meaning of Directive 2001/83/EC (“the Medicines Directive”). The consequence is that the production and sale of Dolenio is heavily regulated. Indeed it is a prescription only medicine which cannot lawfully be purchased over the counter.
The Claimants complain that the Defendant wrongly refuses to treat as medicinal products the large number of GCPs described as “food supplements”.
The Claimants challenge the Defendant’s refusal to treat all GCPs consistently as medicinal products; alternatively the Claimants contend that all GCPs marketed with a daily recommended dose of 1500mg (the Dolenio dose) and/or in quantities which are plainly intended to make it easy for consumers to take that daily dose are medicinal products. It is the Claimants’ case that “there is no material difference for these purposes between the authorised and unauthorised GCPs” (Detailed Statements of Facts and Grounds for seeking judicial review, para 6).
The Claimants seek a declaration that all GCPs are medicinal; or a declaration that all GCPs with a daily recommended dose of 1500mg are medicines; and an order quashing the MHRA decision not to take enforcement action against all such GCPs.
By a proposed amendment, the Claimants also seek a declaration that the MHRA’s policy, as disclosed by the Defendant’s letter of 19 March 2014, of failing to conduct any case by case analysis as to whether unauthorised GCPs fall within the functional limb of the definition of medicinal products (see para 17 below) is unlawful.
The Factual Background
On 9 June 2009 the Defendant, acting through the MHRA, granted the First Claimant a UK marketing authorisation (“MA”), following the Mutual Recognition Procedure with Denmark acting as the reference Member State. The product was described as: “ Dolenio 1500mg Film Coated Tablets ”.
Each Dolenio tablet contains 1884.60mg of glucosamine sulphate sodium chloride. 1500mg of the tablet is glucosamine sulphate, of whic