Current Trends and Hot Topics from a MHRA Borderline Perspective - - PowerPoint PPT Presentation

Current Trends and Hot Topics from a MHRA Borderline Perspective

2

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

3

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.

4

Medicines Food Devices Biocides General Products Cosmetics PSA MDA

5

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

Safeguarding public health

6

The Medicines Borderline Section

• Review thousands of products each year.

1 April – 31 March 2017

• Majority food (‘botanical/herbal’) supplements
• Work with trade bodies

6

Safeguarding public health

Closed Cases # Products Urgent Notices FDN 913 3528 174 4

7

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

8

Question Can / how should similar products co-exist and be regulated differently? There may be scenarios where this should be the case

8

9

Borderline Classification Consider chlorhexidine an antiseptic / antibacterial agent Is it a medicine? It depends on the product

9

10

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

11

11

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.

12

12

Safeguarding public health

But what is meant by evidence?

Labels? Claims on Websites? Personal testimonies? History?

Purpose / Manner of use

13

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

14

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

15

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

16

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

17

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

18

The Glucosamine Case

18

19

The current situation

• Longstanding use of glucosamine in food

supplements

• POM for OA of knee
• Glucosamine medicines and food supplements

coexist

• Not unique

19

20

Legal Question

• Should all glucosamine products be

medicines?

• Should all glucosamine products at 1500mg be

medicines?

• Case by case assessment?

20

21

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

22

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

23

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

24

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

• n how product is to be marketed

24

25

The Glucosamine Case

How relevant is it in the context of borderline herbal products?

25

26

• Significant differences
• History of use
• Evidence
• Presentation / Perception
• Manner of use criterion requires evidence

pharmacological effect

26

The Glucosamine Case

27

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

28

Herbals & Borderline

• Some notable wins in 2016
• Exploring alternative approaches

28

29

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

30

Herbals & Borderline

Echinacea IRP case late 2016 Strong challenge FDN issued Significant because under both limbs Reflecting on its potential impact

30

31

Herbals & Borderline

2016/17 - Diuretics Current area of significant action Looking to gain voluntary compliance

31

32

Herbals & Borderline

2016/17 - Cannibidiol MHRA opinion is published Currently working with industry to achieve compliance Plethora of clinical trials Not straightforward

32

33

Herbals & Borderline

On-line marketplaces We are very grateful for BHMA assistance in this area Can get products off market quickly

33

Herbals & Borderline

34

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

35

Herbals & Borderline

• Does the public understand the issues?
• Is there a need for communication in respect of

quality [and dosage]

• Role of Agency ?

35

36

Thank you for listening Any questions?