Commercialisation and Export of Herbal Plants and Extracts from Africa

“Commercialisation and Export of Herbal Plants and Extracts from Africa” June 24th 2010 Laikipia, Kenya L. Denzil Phillips www.denzil.com Origins ...
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“Commercialisation and Export of Herbal Plants and Extracts from Africa”

June 24th 2010 Laikipia, Kenya

L. Denzil Phillips www.denzil.com

Origins of the top 150 prescription drugs Animal 18%

Synthetic 43%

Marine Bacteria 1% 4%

Fungus 11%

Plant 23%

Global Herbal Market North America 11%

Other 2%

Germany 26%

Asia 19%

Japan 17%

France 13% Rest of Europe 12%

CONTINENTAL DIVERSITY OF COMMERCIALISED MEDICINAL PLANTS Courtesy Ben Erik Van Wyk WOCMAP 2009

North America

Europe

121

336

Asia 337 97

Central America 50

Eastern Asia Africa 83

South America

Australia

64

11 Southern Africa 14 Map: www.brponline.co.uk

DIVERSITY OF MEDICINAL PLANTS IN AFRICA AFRICA: Neuwinger (2000): 5400 species 10.8% of the African flora

SOUTHERN AFRICA: Van Wyk & Gericke (2000): 3000 species 13.8% of the southern African flora

Arnold et al. (2002): 2942 species 12.9% of the southern African flora

Top 12 import and export countries 1991-2000 Country of import Hong Kong Japan

Quantity [t] 67,000 51,350

Value [USD] 291,200,000 136,000,000

Country of export China Hong Kong

135,500,000 India 110,200,000 Germany

Quantity [t] 147,000 63,150

Value [USD] 281,800,000 226,800,000

33,900 15,100

56,650,000 70,050,000

USA Germany

49,600 45,300

Rep. Korea

32,250

52,300,000 USA

13,500

115,500,000

France China Italy

21,350 13,650 11,700

52,000,000 Mexiko 41,600,000 Egypt 42,850,000 Chile

13,000 11,750 11,600

11,250,000 13,850,000 28,200,000

Pakistan Spain

11,050 9,100

11,150,000 Bulgaria 27,650,000 Singapore

10,050 9,600

14,500,000 56,600,000

UK Singapore Total

7,650

27,000,000 Morocco

8,000

13,300,000

6,300 326,300

50,600,000 Pakistan 978,150,000 Total

7,800 344,400

4,950,000 893,400,000

ORIGINS OF PLANTS CONSUMED IN EUROPE Source: Lange 2002

900

Europe 605 species Germany 441 species Italy 511 species Spain 482 species Romania 451 species Bulgaria 421 species Albania 391 species Poland 386 species Yugoslavia 489 species

849

800 700 605 600 500

454 343

318

300 207 200 100

55 13

Pa ci fic

Au st ra la si a

Am er ic a

So ut h

tro pi ca l As ia

Af ric a

Am er ic a

No rth

As ia

Eu ro pe

0 te m pe ra te

Number of species

400

TEN KEY SADEC MEDICINALS

1. Round leaf buchu - Agathosma betulina 2. Bitter aloe - Aloe ferox 3. Rooibos tea - Aspalathus linearis 5. Devil’s claw - Harpagophytum procumbens 6. Ghaap - Hoodia gordonii 7 “Umckaloabo” - Pelargonium sidoides 8. Cancer bush - Sutherlandia frutescens 9. Pepperbark tree - Warburgia salutaris 10. Cancer bush - Sutherlandia frutescens`

EU Market Sizes

• • • •

Functional Foods US $3.5 billion Food Supplements US $ 2.5 billion Herbal Medicines US $4 billion Essential Oils US $ 250 million

= Opportunity

EU Key Regulations

Novel Foods Food Supplements Functional Foods Health Claims/Labelling Medicines

Overlapping Codes of Practise Denzil Phillips International 2005

HACCP

Good Agricultural Practise (GAP)

Good Collection Practise (GWP)

Good Manufacturing Practise (GMP)

FAO/WHO Codex Alimentarius

Good Laboratory Practise (GLP) Good Trade & Distribution ` Practise (GTDP)

Certification options  Ecologically responsible forest management standards (e.g. FSC) that assess water and soil conservation, preservation of wildlife and habitat, and maintenance of forest structure, function and processes;  Fair trade certification programs that assure equitable sharing of profits with producers, worker’s rights and decent working conditions;  Organic certification standards that assure pesticide-free agricultural production (and are occasionally applied to agroforestry and forestry production systems);  Good agricultural practice (GAP) criteria that seek to reduce the incidence of contamination in starting materials for the botanicals industry;  Good manufacturing practice (GMP) criteria that assess facilities and processing procedures;

Terminology - Just to confuse you?

• • • • • • • •

Good Agricultural Practice Good Farming Practice Good Agriculture & Hygiene Practice Good Agricultural & Collection Practice Good Agriculture & Sourcing Practice Good Wild Crafting Practice Good Sourcing Practice Good Field Collection Practice

GAP GFP GAHP GACP GASP GWP GSP GFCP

Medicinal plants under CITES Appendix 2 • • • • • • • • • • • • • • • • • • •

Adonis Vernalis Aloe Ferox Aquilera spp Bletilla Striata Cibotium Barometz Dendrobium Nolibe Discorea Deltoidea Gastrodia Elata Guaiacum Officinale Hydrastis Canadensis Hoodia gordinii Nardostachys Grandifolia Picrorhiza Kurrooa Panax Quinquefolius Podophyllum Hexandrum Prunus Africana Pterocarpus Santalinus Rauwolfia Serpentina Taxus Wallichiana

Adonis Cape Aloes Agarwood Bletilla Hyacinth Vegetable Lamb Dendrobium Wild Yam Gastrodia Pockwood Tree Goldenseal Hoodia Spikenard Kutki Ginseng Himalayan May Apple Pygeum Santal Rauwolfia Yew

KEY FACTORS TO CONSIDER • • • • • • • • •

UNDERSTANDING THE MARKET MARKET SIZE AND STRUCTURE PRODUCT SELECTION TECHNOLOGY & MANAGEMENT QUALITY , SAFETY, EFFICACY REGULATORY CONTROLS SUSTAINABILITY AND CONSERVATION PATENTS, LICENSES AND IPR BIODIVERSITY, CONSERVATION ISSUES

Understanding the value added chain  Fresh materials  Fresh extracts& tinctures  Crude dried plants  Sorted, cleaned, graded dried plants  Bulk semi processed single ingredients  Bulk refined single ingredients  Bulk formulated multi-ingredients  Contract packaged formulations  Branded packaged formulations

VALUE ADDITION CHAIN FRESH HERBS

DRYING, CLEANING, PACKING CHOPPING, BALING, PRESSING EXTRACTION, DISTILLATION FORMULATION, BLENDING, COMPOUNDING

BOTTLING, PACKAGING, LABELLING DISTRIBUTION, MARKETING, PROMOTION

VALUE ADDITION IN THE US NUTRITION INDUSTRY

LAUNCHING NEW HERBAL PROJECTS        

Identify crops has greatest agronomic potential Identify the best location for each crop Identify the best plant materials & multiply this for farmers Identify whether to contract or plantation grow the crop Identify the most cost effective way to grow the crop Identify the best way to harvest, clean and pack the product Identify the best post harvest handling and shipping method Identify the best way to process & get value addition

Implement TOGETHER solutions based on QUALITY CONTROL and address 3 major obstacles for an African food solution: • Quality control cultivation (GACP, HACCP) • Quality control conditioning and processing (GMP) • Improved clinical data on safety and efficiency

Botany

Foundation

Farming& Harvesting

Foundation

1. GACP  Cultivation

Research &

Development

PharmAfri-Can

2. Clinical Data

REGULATORY APPROVAL

(Courtesy Sue Wehrner, BDA Foundation 2009)

Manufacturing

Licence and alliance

Marketing & Commercialization

Licence and alliance

3. GMP production

Product development Cycle Courtesy CSIR WOCMAP 2008

WHY PROJECTS FAIL?

Unrealistic market expectations Artificially created market Consumers switched to alternatives Replaced by man made substitutes Benefits concentrated in a few hands Cheaper growing areas were found Large scale production centres developed Regulatory restrictions killed the market Political interference Environmental damage War or civil disturbances

Jojoba Citronella Cloves Yohimbe Ginko Biloba Cardamon Aloe Vera Kava Hoodia Taxus Brevifolia Gum Arabic

7 KEY SUCCESS FACTORS         

Far sighted sponsors Well trained management Good /unique products Appropriate technology Long term demand Efficient market servicing Educated labour force Sensible government policies Knowledgeable donor agencies staff

The Problems of Wild Crafting Wild crafting of medicinal and aromatic plants very often negative situations, especially in developing countries. The present EUROPAM Good Wild crafting Practice Guidelines provide additional standards for the production and processing of raw materials Harvestors of wild plants must ensure that they avoid damage to existing wildlife habitat. In particular they must avoid: a) Extinction of particular species in certain zones or certain rare genetic populations due to over-exploitation. Where possible, the principle of "collection rotation" to facilitate biological propagation and resource renewal should be employed. b) Destruction of the entire plant, due to carelessness and inexperience on behalf of the harvester, when in most cases it would be sufficient to harvest only a part of it. c) Confusion (due to ignorance or bad faith) in the harvesting of different species that are at first sight similar. d) Collection of endangered species, without abiding to local regulation. For plant intended for export a Convention on International Trade in Endangered Species of wild Fauna and Flora (CITES) certificate must be obtained.

7. DEVIL'S CLAW Harpagophytum procumbens (Pedaliaceae)

HO

OH

O O

Bitter tonic (stimulate appetite). Mainly osteoarthritis, fibrositis, rheumatism and small joint disease.

O Harpagosi de

H CH 3 O

Glc

13. SUTHERLANDIA, CANCER BUSH Sutherlandia frutescens (Fabaceae) Tonic “almost any disease”. It is widely used by many cultural groups for fever, poor appetite, unspecified wasting diseases, indigestion, gastritis, etc. Evidence of dramatic improvements in the quality of life in HIV/AIDS patients.

OH

OH

COOH H2N

CH3

C

H

CH2CH2ONCNH2 OH

OH NH

OH

Pinitol

Canavanine

WILD HARVESTING

Endangered East African Medicinal Trees • • • • • • • •

Pygeum ( Prunus Africana) Warburghia (Warburghia Salutaris ) African Olive (Olea Europaea) Chincona ( African Sandalwood ( Rauwolfia ( Rauwolfia Vomitoria) Frankincense ( Boswelia serrata) Myrrh ( Commiphora Myrha)

Some unusual African therapeutic cosmetics • • • • • • • • •

African aloe (Aloe lateritia) Sodom apple ( Calotropis procera) Bitter leaf ( Acmella Caliriza) Dragons Blood ( Harungana paniculata) Lubino (Cassia didymobotrya) Mignonette ( Reseda luteola) Wild Olive (Olea africana) Whistling thorn ( Acacia stenocarpa) Grewia ( Corchurus trilocularis)



Source: Bethwell Owuor: Nairobi 2002

        

skin fungal infetion Skin depilatory Emollient Scabies Fungal skin infections Dermatitis Moisturizer Eruptive skin conditions Skin abscesses

Profile Template

* 1 GENERAL DESCRIPTION o 1.1 Scientific Name with Author o 1.2 Synonyms o 1.3 Family o 1.4 Vernacular Names o 1.5 Botanical Description o 1.6 Origin and Distribution o 1.7 Plant Part Used o 1.8 Images o 1.9 Possible Alternative Source Species * 2 ETHNOBOTANICAL INFORMATION o 2.1 Major Ethnopharmacological Uses o 2.2 Other Relevant Uses * 3 CHEMICAL CONSTITUENTS o 3.1 Compounds o 3.2 Images * 4 QUALITY CONTROL o 4.1 Identification o 4.2 Organoleptic Properties o 4.3 Macroscopic Characteristics o 4.4 Images o 4.5 Microscopic Characteristics o 4.6 Images o 4.7 Solubility o 4.8 Moisture Content o 4.9 TLC / HPLC / GC

o 4.10 Images o 4.11 Markers and Quantitative Methods o 4.12 NIR Spectroscopy o 4.13 Images o 4.14 DNA finger printing o 4.15 Images o 4.16 Purity Tests / Requirements o 4.17 Adulterants and Adulterations o 4.18 Standard Preparations o 4.19 Standard specifications (WHO, 1998) * 5 PHARMACOLOGICAL PROPERTIES o 5.1 In Vitro Experiments o 5.2 In Vivo Experiments o 5.3 Clinical Studies o 5.4 Pharmacokinetic Properties * 6 SAFETY DATA o 6.1 Ethnic Use Safety Data o 6.2 Preclinical Safety Data + 6.2.1 Single Dose Toxicity + 6.2.2 Repeated Dose Toxicity + 6.2.3 Mutagenic Potential + 6.2.4 Carcinogenicity + 6.2.5 Sensitizing Potential + 6.2.6 Clinical Safety Data * 7 KEY (PROPOSED) USAGE o 7.1 Therapeutic Indications o 7.2 Dosage o 7.3 Method and Duration of Administration

o 7.4 Contraindications o 7.5 Special Warnings and Precautions for Use o 7.6 Effects on Ability to Drive and Use Machines o 7.7 Interactions o 7.8 Pregnancy and Lactation o 7.9 Adverse Effects o 7.10 Overdose o 7.11 Evaluation of Efficacy * 8 TRADE INFORMATION o 8.1 Volume of production in the country o 8.2 Volume of domestic consumption o 8.3 Volume of export o 8.4 Average price o 8.5 Nature of plant material o 8.6 Nature of plant products o 8.7 Processing and storage * 9 REGULATORY INFORMATION o 9.1 Pharmacopoeias / Monographs o 9.2 Regulatory / Registration Status o 9.3 Patents o 9.4 Traditional Information * 10 POSSIBLE DEVELOPMENTS o 10.1 Outlook on Further Uses and Research * 11 REFERENCES o 11.1 References * 12 AUTHOR OF THIS RECORD

The launch of the print publication was initially scheduled for the WOCMAP conference in Cape Town, South Africa in November 2008, however, due to uncompleted review and lab work the publication was delayed and is now scheduled for the 4th quarter of 2009.

Dedicated to the Development of Natural Products Worldwide •Source novel botanicals •Identify new supply centres for existing materials •Supply suitable process and extraction technology •Develop sustainable production protocols •Design and supervise crop and process trials •Recruit and train suitable staff and contract growers •Market test new products with global clients •Find appropriate financial and marketing partners •Organise world-wide sales and product promotion 25 Stanmore Gardens, Kew, Surrey, TW9 2HN Tel 44 8940 4100 Fax 44 20 8948 2673 www.denzil.com

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