bioactives_empas - consulting herbal medicine products

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.


2/23

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)


4/23

EMPAS Consulting

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.


5/23

EMPAS Consulting

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.


6/23

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


7/23

EMPAS Consulting

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


8/23

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


9/23

EMPAS Consulting

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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EMPAS Consulting

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


11/23

EMPAS Consulting

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


12/23

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


13/23

EMPAS Consulting

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


14/23

EMPAS Consulting

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


15/23

EMPAS Consulting

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


16/23

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


17/23

EMPAS Consulting

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


18/23

EMPAS Consulting

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


19/23

EMPAS Consulting

Worldwide major herb sales 1999

Herbal Medicine Market $22 billion

Cosmetics $14.8 billion

Functional Foods $14 billion

Source:HerbWorx,2000


20/23

EMPAS Consulting

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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EMPAS Consulting

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


22/23

EMPAS Consulting

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


23/23

EMPAS Consulting

Selling medicinal herbs and extracts

is seldom as straightforward aslayman may imagine. There are

many issues that need to beconsidered.

bioactives_empas - consulting herbal medicine products

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