Current Trends and Hot Topics from a MHRA Borderline Perspective
Trends and Hot topics • Products which are regulated under more than one legislative framework and how this relates to other areas of the borderline • Borderline herbal products – what the Section is doing 2 2
Q: What are borderline products ? • Only similarity is that the regulatory status of the product is unclear. • MHRA responsible for their classification .“This regulation applies if the licensing authority thinks that a product without a marketing authorisation, traditional herbal registration, certificate of registration or Article 126a authorisation is a medicinal product” • Can have situations where the status of products can be caught between more than one borderline. 3
Food General Devices Products Medicines PSA MDA Cosmetics Biocides 4
Safeguarding public health The Medicines Borderline Section • Manager, 4 Classifiers • Enforcement, Clinical Assessors, Licensing Division, Clinical Trials Unit, Devices • Work with industry stakeholders • Trade bodies provide valuable assistance 5 5
Safeguarding public health The Medicines Borderline Section • Review thousands of products each year. 1 April – 31 March 2017 Closed Cases # Products Urgent FDN Notices 913 3528 174 4 • Majority food (‘botanical/herbal’) supplements • Work with trade bodies 6 6
The Two Limbs of the Definition of a Medicinal Product. “ Any substance or combination of substances presented as having properties for treating or preventing disease in human beings ; Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis” Article 1.2 Council Directive 2001/83/EEC 7 7
Question Can / how should similar products co-exist and be regulated differently? There may be scenarios where this should be the case 8 8
Borderline Classification Consider chlorhexidine an antiseptic / antibacterial agent Is it a medicine? It depends on the product 9 9
Borderline Classification Topical disinfectant for clinical use. (e.g. pre-operative) and mouthwash to treat gum disease. Medicinal product General use as disinfectant (e.g. washing hands). Biocide Disinfectant for medical equipment. Medical Device Permitted use as a preservative e.g. in mouthwash Cosmetic 10 10
Safeguarding public health Classification The MHRA reaches a determination on whether a product is or is not a medicinal product on a case by case basis, in the light of: • the definition set out in the Directive; • relevant ECJ and domestic Court precedents and • following an assessment of all the available evidence . 11 11
Safeguarding public health But what is meant by evidence ? Labels? Claims on Websites? Personal testimonies? History? Purpose / Manner of use 12 12
First Limb “It is necessary to take the view that a product is presented for treating and preventing disease …. whenever any averagely well informed consumer gains the impression, which, provided it is definite, may even result from implication, that the product in question should, regard being had to its presentation, have an effect such as is described by the first part of the Community definition” ECJ C227/82 (Van Bennekom) 13 13
First Limb What is the product for? • Claims • The context of those claims, and the overall presentation • How a product appears to the public • The labelling, packaging and package inserts • Promotional literature • Advertisements • Product form • Target group 14 14
Second Limb Deciding the Status of a Product • Composition • Pharmacological, immunological and metabolic properties of the ingredients • Product form • How it is to be used • Target group • Similar licensed products 15
ECJ cases Case law is very important in borderline decisions C-319/05 Garlic Capsules C-147/07 HechtPharma C-211/03 Wareventriebs C-358/13& Markus D. and G C-181/14 16 16
Place greater emphasis on demonstrating pharmacological effect by the Regulator Loss of ‘with a view to’ While there may be evidence of a positive physiological effect, level of active present must be appreciably higher than in seen in food use (ie in daily diet). Requires a ‘beneficial’ effect in context of use – therapeutic? 17 17
The Glucosamine Case 18 18
The current situation • Longstanding use of glucosamine in food supplements • POM for OA of knee • Glucosamine medicines and food supplements coexist • Not unique 19 19
Legal Question • Should all glucosamine products be medicines? • Should all glucosamine products at 1500mg be medicines? • Case by case assessment? 20 20
The CA Judgment • An investigation into the manner of use of GCP whose active ingredient is glucosamine [sulphate] and which have a recommended daily dosage of 1500mg . 21 21
Where does this come from? Warenvertriebs and Orthica ..product should be assessed as medicinal by function, account should be taken of all the characteristics of the product. In particular, (i) its composition, (ii) its pharmacological properties – to the extent to which they can be established in the present state of scientific knowledge, (iii) the manner in which it is used (iv) the extent of its distribution, (v) its familiarity to consumers (vi) and the risks which its use may entail.” 22 22
The Judgment does not mean • MHRA was wrong in not classifying all GCP as medicines • MHRA was wrong in not classifying all GCP with an indicated 1500mg dosage as medicines 23 23
Review of Market • Product form – dosage & different salts • Assess manner of use – assistance of industry – MHRA • MHRA Procedures – GN8 - changes – Review of advice requests. More emphasis on how product is to be marketed 24 24
The Glucosamine Case How relevant is it in the context of borderline herbal products? 25 25
The Glucosamine Case • Significant differences • History of use • Evidence • Presentation / Perception • Manner of use criterion requires evidence pharmacological effect 26 26
Herbals & Borderline • Herbal products that are used to treat an underlying clinical condition are medicinal products. • Only authorised (Licensed or Registered) herbal medicinal products can be sold. • Significant resource committed to dealing with area 27 27
Herbals & Borderline • Some notable wins in 2016 • Exploring alternative approaches 28 28
Herbals & Borderline Senna, Hydroxyanthracene derivatives IRP case in early 2016 Challenge FDN issued Action taken against a significant number of ‘lifestyle products’, including teas. 29 29
Herbals & Borderline Echinacea IRP case late 2016 Strong challenge FDN issued Significant because under both limbs Reflecting on its potential impact 30 30
Herbals & Borderline 2016/17 - Diuretics Current area of significant action Looking to gain voluntary compliance 31 31
Herbals & Borderline 2016/17 - Cannibidiol MHRA opinion is published Currently working with industry to achieve compliance Plethora of clinical trials Not straightforward 32 32
Herbals & Borderline Herbals & Borderline On-line marketplaces We are very grateful for BHMA assistance in this area Can get products off market quickly 33 33
Herbals & Borderline Evidence Gathering Strong likelihood of challenge under limb 2 given the case law Can we be smarter? Can we employ alternative resources 34 34
Herbals & Borderline • Does the public understand the issues? • Is there a need for communication in respect of quality [and dosage] • Role of Agency ? 35 35
Thank you for listening Any questions? 36
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