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7/25/2019 Bioactives_EMPAS - Consulting Herbal Medicine Products
1/23
EMPAS Consulting
EMPAS Consulting
Endelave Medicin Produktion A/SAddress: Birkevej 87
DK-5672 Broby, Denmark
Phone: +45 6263 3650 Fax: +45 6263 3433
e-mail: [email protected]
Bjarne F. Knudsen
Core competencies:
Herbal Medical Product and drug registrations in EU (GMP,
GLP, GCP standard).
Documentation and advice on cultivation of medical plants
(GAP standard).
Conduct clinical trials (GCP standard).
Develop market evaluations and business plans.
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EMPAS Consulting
Complexed mixtures in a disharmonised market
Bioactivity measures of Herbal Medicinal
Products are incompatible with the chosen
EU regulatory requirements - and marketharmonisation is "a town in Russia".
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EMPAS Consulting
Herbal Medicinal Products in the EU
Requirements related to Safety and Efficacy
Three types of documentation1. Full documentation with new tests and trials
mandatory for:
any herbal medicinal product never marketed in the EUtherapeutic innovationsnew indication / therapeutic area for old products
2. Full bibliographic documentation
3. Traditional medicinal product - registration (draft)
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Herbal Medicinal Products (HMP)
Are Complexed mixtures.
Consist of active and non-active components.
Not easy to standardise.
No international references or standards available. No biological activity measures.
Same botanicals differ from one company to another.
Botanicals differ from one batch to another due tobiological variation.
Botanicals differ from one growerto the other.
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EMEA and National Agencies demands to HMP
Quality acceptance criteria for HMP same as for drugs.
Complexed mixture is not highlighted.
Criteria for active and non-active substances are diffuse
Marker substances are often not bioactivity indicators. Constituents with known therapeutic activitydoes not
truly excist.
Marker substance release limits of 90-110% are unrealistic Tight control of one or two markers say nothing about the
bioactivity.
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EMPAS Consulting
X
T
C
B
A
Herbal medicinal
product for... (treatment,prevention ...)
New productsserious diseases
major claims
minor claims
Traditional
medicinal product
Fraudulent or
misleading
claims
Traditionally usedwithout supportive
scientific evidence
Grading of Recommendations
well-e
stablished
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Traditional Herbal Medicinal
Products Directive
Commission amended proposal:
The definition of a herbal medicinal product willbe modified by the Commission amendment to
the general medicine definitionNon-herbal substances will be included in thescope
The proof for time of use will be slightlyreduced in some cases
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EMPAS Consulting
Medic inal Product or Food
Supplement?Problem not fully resolved by CD 2002/46/EC
CD 2002/46/EC
Art. 2
purpose to supplement
the normal diet
substances with a nutritional
or physiological effect
CD 2001/83/EC
Art. 1
.. presented for treating orpreventing disease ..
administered with a
view ... to restoring, correcting
or modifying physiological
functions ..
Physiolog
icaleffect/function
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Traditional Herbal Medicinal Products Directive
COMMISSION
ECOSOC
COUNCIL
PARLIAMENT
COUNCILPARLIAMENT
PARLIAMENTDRAFT
LEGISLATION PUBLICATION
COMMON POSITION
Report
Feb 2001
Report
November 2002
October 2003
Early 2004
Mid 2004. MS legislation in place mid 2005
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Examples of medicinal herbs used in different industry sub-sectors
INDUSTRY SUB-SECTOR MEDICINAL HERBS
Dietary Supplements Pine Bark, Grape Seed, Psyllium, Rosemary
Phytochemicals Belladonna, Rauwolfia, Periwinkle, Poppy
Herbal Remedies Evening Primrose, Dong Quai, Centella, Ginseng
Prescription Drugs Foxglove, Strychnos Nux Vomica, Yew, Gingko
Biloba
OTC Medicines Aloe Gum, Senna, Peppermint, Sasparilla
Functional Foods Green Tea, Ascerola, Cranberry, Stevia
Herbal Teas Melissa, Senna, Hibiscus, Chamomille
Aromatherapy Eucalyptus, Geranium, Rose, Tea Tree
Flavours Peppermint, Garlic, Capsicum, Turmeric
Source: Denzil Phillips International Ltd
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ORIGINS OF THE TOP 150 PRESCRIPTION DRUGS
NAME DRUGS %
Animal 27 23
Plant 34 18
Fungus 17 11
Bacteria 6 4
Marine 2 1
Synthetic 64 43
Total 150 100
Source: K. Ten Kate & S. Laid 1999
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EMPAS Consulting
TOP 20 HERBSThe most popular herbs as selected by phytotherapists
Vitex agnus-castus
Paeonia lactiflora
Echinacea spp.
Matricaria recutita
Hypericum perforatum
Coleus forskohlii
Achillea millefolium
Glycyrrhiza glabra
Calendula officinalis
Andrographis paniculata
Berberis aquifolium
Cimicifuga racemosa
Angelica archangelica
Dioscorea spp.
Stevia rebaudiana
Angelica sinensis
Trifolium pratense
Adhatoda vasica
Chamaelirium luteum
Rumex crispus
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Most Important Medicinal Plants Sold in Europe
PRODUCT $ MILLION PRODUCT $ MILLION
Gingko 600 Butcher Broom 120
Valerian 300 Evening Primrose 110
Horse Chestnut 250 Pygeum 105Saw Palmetto 230 Melilot 100
BitterOrange Extr 220 Grape Seed 90
Garlic 200 Milk Thistle 80
Hawthorn 140 Melissa 65
Gingseng 140 Nettle 60
Psyllium 125 Bilberry 60
Echinacea 120 Chamomille 45
Total 3,160Source: M. K. Eaves 2000
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Traditional Herbal Medicine are rapidly increasing in economic importance:
US $ 60 bilion world market sales of herbal medicinesSource: Secretariats of the Convention on Biological Diversity (CBD) 2000
West Eur
USA
Canada
Japan
China
Other countries
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Big Pharma versus Herbal Medicin(US $billion)World retail sales
0
50100
150
200
250300
350
400
450500
1997 2000 2003 2006
HMPTHM
Blockbust
all Ethical
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EMPAS Consulting
World Retail Sales of Herbal Medicines (US $Billion)
0
5
10
15
20
25
1994 1997 2000 2003
Europa
AsiaJapan
USA/Can
Others
TOTAL
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Global growth of HMP US $ billionconsumer prices
0
5
10
15
20
25
30
35
1994 1997 2000 2003 2006
Source: Grnwald, Phytopharm Berlin, 2003
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EU market of herb extracts for use in food in US$mioSource;Z.Arzn.Gew.Pfl 8, 2003
0
100
200
300
400
500
600
1999 2001 2003 2005 2007 2009
US$mio
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EMPAS Consulting
Worldwide major herb sales 1999
Herbal Medicine Market $22 billion
Cosmetics $14.8 billion
Functional Foods $14 billion
Source:HerbWorx,2000
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Herbal Medicinal Products in Europa 2002Total market (Price to consumer) US $ 7.0 Billion
Other
1,0%
Scandinavia
7,3%
CH/Austria
1,5%
Holl/Belgium
4,5%Spain
4,5%Poland
6,0%
France
21,0%
Germany
37,0%
Italy
10,0%
U.K.
7,2%
Source: Grnwald Pharma Consulting Berlin, 2003
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Total Herbal Supplement Market:
MarketRestraints Ranked in order of impact (US),2000-2006
1 Lack of knowledge
2 Questions of safety and
efficacy
3 Potentially unsafe herbs
4 Unproven health claims
5 Lack of patent protection
6 Lack of standardization
7 Claiming system
8 Shortage of shelf space in
mass markets
9 Mass market focus on
high-profile products
10 Limited supply of raw
materials
Source: frost & Sullivan
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Total Herbal Supplement Market:
MarketDrivers Ranked in Order of Impact (US)2000-2006
1 Deregulation
2 Dissatisfaction withmodern medicine
3 Aging population
(50 and up)4 Overall health trends
5 Shift towards natural
products6 Growing body of positive
scientific research
7 Greater awareness
8 Increased mass
distribution
9 Introduction of new
products
10 Acquisition possibilities
11 Long history of use
Source: Frost & Sullivan
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Selling medicinal herbs and extracts
is seldom as straightforward aslayman may imagine. There are
many issues that need to beconsidered.