“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

Plant23%Fungus

11%Marine

1%Bacteria

4%

Animal18%Synthetic

43%

Global Herbal Market

Rest of Europe12%

Japan17%

Asia19%

North America11%

Other 2%

Germany26%

France13%

North America

121

Central America

50

South America

64

Europe

336

Africa

83

Southern Africa

14

Asia

337

97

Eastern Asia

Australia

11

Map: www.brponline.co.uk

CONTINENTAL DIVERSITY OF COMMERCIALISED MEDICINAL PLANTSCourtesy Ben Erik Van Wyk WOCMAP 2009

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 southernAfrican flora

Arnold et al. (2002):2942 species

12.9% of the southernAfrican flora

Top 12 import and export countries 1991-2000

893,400,000344,400Total978,150,000326,300Total4,950,0007,800Pakistan50,600,0006,300Singapore

13,300,0008,000Morocco27,000,0007,650UK56,600,0009,600Singapore27,650,0009,100Spain14,500,00010,050Bulgaria11,150,00011,050Pakistan28,200,00011,600Chile42,850,00011,700Italy13,850,00011,750Egypt41,600,00013,650China11,250,00013,000Mexiko52,000,00021,350France

115,500,00013,500USA52,300,00032,250Rep. Korea70,050,00015,100Germany110,200,00045,300Germany56,650,00033,900India135,500,00049,600USA

226,800,00063,150Hong Kong 136,000,00051,350Japan281,800,000147,000China291,200,00067,000Hong Kong

Value[USD]

Quantity[t]

Country of export

Value[USD]

Quantity [t]

Country of import

ORIGINS OF PLANTS CONSUMED IN EUROPESource: Lange 2002

605

454

343 318

207

5513

849

0

100

200

300

400

500

600

700

800

900

Asia te

mperate

EuropeNorth

America

Africa

Asia tro

pical

South America

Australa

sia

Pacific

Num

ber o

f spe

cies

Europe 605 speciesGermany 441 speciesItaly 511 speciesSpain 482 speciesRomania 451 speciesBulgaria 421 species Albania 391 speciesPoland 386 speciesYugoslavia 489 species

1. Round leaf buchu - Agathosma betulina2. 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`

TEN KEY SADEC MEDICINALS

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 FoodsFood SupplementsFunctional Foods

Health Claims/LabellingMedicines

Overlapping Codes of PractiseDenzil Phillips International 2005

`

HACCP

Good AgriculturalPractise(GAP)

FAO/WHOCodexAlimentarius

Good Trade & DistributionPractise(GTDP)

Good LaboratoryPractise(GLP)Good

Manufacturing Practise (GMP)

Good Collection Practise(GWP)

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 agro-forestry 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 GAP• Good Farming Practice GFP• Good Agriculture & Hygiene Practice GAHP• Good Agricultural & Collection Practice GACP• Good Agriculture & Sourcing Practice GASP• Good Wild Crafting Practice GWP• Good Sourcing Practice GSP• Good Field Collection Practice GFCP

Medicinal plants under CITES Appendix 2• Adonis Vernalis Adonis• Aloe Ferox Cape Aloes• Aquilera spp Agarwood• Bletilla Striata Bletilla Hyacinth• Cibotium Barometz Vegetable Lamb• Dendrobium Nolibe Dendrobium• Discorea Deltoidea Wild Yam• Gastrodia Elata Gastrodia• Guaiacum Officinale Pockwood Tree• Hydrastis Canadensis Goldenseal• Hoodia gordinii Hoodia• Nardostachys Grandifolia Spikenard• Picrorhiza Kurrooa Kutki• Panax Quinquefolius Ginseng• Podophyllum Hexandrum Himalayan May Apple• Prunus Africana Pygeum• Pterocarpus Santalinus Santal• Rauwolfia Serpentina Rauwolfia• Taxus Wallichiana 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

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

Understanding the value added chain

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

Botany

Foundation

Farming& Harvesting

Licence and alliance

Manufacturing Marketing & Commercialization

Licence and alliance

Foundation

REG

ULA

TOR

Y A

PPR

OVA

L

Research & Development

PharmAfri-Can

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

(Courtesy Sue Wehrner, BDA Foundation 2009)

1. GACP  Cultivation 2. Clinical Data 3. GMP production

Product development CycleCourtesy CSIR WOCMAP 2008

WHY PROJECTS FAIL?

Unrealistic market expectations JojobaArtificially created market CitronellaConsumers switched to alternatives ClovesReplaced by man made substitutes YohimbeBenefits concentrated in a few hands Ginko BilobaCheaper growing areas were found CardamonLarge scale production centres developed Aloe VeraRegulatory restrictions killed the market KavaPolitical interference Hoodia Environmental damage Taxus Brevifolia War or civil disturbances 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 CraftingWild 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)

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

Glc

Harpagoside

O

HO OH

HO

O CH3

O

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 inthe quality of life in HIV/AIDS patients.

CH2N H

COOH

CH2CH2ONCNH2

NH

OHOH

CH3

OH

OH

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) skin fungal infetion• Sodom apple ( Calotropis procera) Skin depilatory• Bitter leaf ( Acmella Caliriza) Emollient• Dragons Blood ( Harungana paniculata) Scabies• Lubino (Cassia didymobotrya) Fungal skin infections• Mignonette ( Reseda luteola) Dermatitis• Wild Olive (Olea africana) Moisturizer• Whistling thorn ( Acacia stenocarpa) Eruptive skin conditions• Grewia ( Corchurus trilocularis) Skin abscesses

• Source: Bethwell Owuor: Nairobi 2002

Profile Template

* 1 GENERAL DESCRIPTIONo 1.1 Scientific Name with Authoro 1.2 Synonymso 1.3 Familyo 1.4 Vernacular Nameso 1.5 Botanical Descriptiono 1.6 Origin and Distributiono 1.7 Plant Part Usedo 1.8 Imageso 1.9 Possible Alternative Source Species

* 2 ETHNOBOTANICAL INFORMATIONo 2.1 Major EthnopharmacologicalUseso 2.2 Other Relevant Uses

* 3 CHEMICAL CONSTITUENTSo 3.1 Compoundso 3.2 Images

* 4 QUALITY CONTROLo 4.1 Identificationo 4.2 Organoleptic Propertieso 4.3 Macroscopic Characteristicso 4.4 Imageso 4.5 Microscopic Characteristicso 4.6 Imageso 4.7 Solubilityo 4.8 Moisture Contento 4.9 TLC / HPLC / GC

o 4.10 Imageso 4.11 Markers and Quantitative Methodso 4.12 NIR Spectroscopyo 4.13 Imageso 4.14 DNA finger printingo 4.15 Imageso 4.16 Purity Tests / Requirementso 4.17 Adulterants and Adulterationso 4.18 Standard Preparationso 4.19 Standard specifications (WHO, 1998)

* 5 PHARMACOLOGICAL PROPERTIESo 5.1 In Vitro Experimentso 5.2 In Vivo Experimentso 5.3 Clinical Studieso 5.4 Pharmacokinetic Properties

* 6 SAFETY DATAo 6.1 Ethnic Use Safety Datao 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) USAGEo 7.1 Therapeutic Indicationso 7.2 Dosageo 7.3 Method and Duration ofAdministration

o 7.4 Contraindicationso 7.5 Special Warnings and Precautions for Useo 7.6 Effects on Ability to Drive and Use Machineso 7.7 Interactionso 7.8 Pregnancy and Lactationo 7.9 Adverse Effectso 7.10 Overdoseo 7.11 Evaluation of Efficacy

* 8 TRADE INFORMATIONo 8.1 Volume of production in thecountryo 8.2 Volume of domestic consumptiono 8.3 Volume of exporto 8.4 Average priceo 8.5 Nature of plant materialo 8.6 Nature of plant productso 8.7 Processing and storage

* 9 REGULATORY INFORMATIONo 9.1 Pharmacopoeias / Monographso 9.2 Regulatory / Registration Statuso 9.3 Patentso 9.4 Traditional Information

* 10 POSSIBLE DEVELOPMENTSo 10.1 Outlook on Further Uses and Research

* 11 REFERENCESo 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

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www.denzil.com