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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
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
25 Stanmore Gardens, Kew, Surrey, TW9 2HNTel 44 8940 4100 Fax 44 20 8948 2673
www.denzil.com