MEDICINAL PLANTS – THE JAMAICAN/CARIBBEAN EXPERIENCE
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Transcript of MEDICINAL PLANTS – THE JAMAICAN/CARIBBEAN EXPERIENCE
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MEDICINAL PLANTS – THE JAMAICAN/CARIBBEAN EXPERIENCE
MINISTRY OF HEALTH JAMAICA PRINCESS THOMAS OSBOURNE
2006 March 24
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OBJECTIVES
Provide a Caribbean/Jamaican Perspective on herbal medicinals
Update WG participants regarding status of Regional regulatory framework governing herbal medicines
Briefly outline challenges faced in developing the framework.
Recommend a way forward for harmonisation on herbal medicines
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INTRODUCTION
PUBLIC HEALTH : STATE RESPONSIBILITY
SCOPE OF PUBLIC ROLE/ RESPONSIBILITY INTEGRITY OF INDIVIDUAL
CHOICE Access to safe goods & services
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Situation Analysis - English Speaking Countries of CARICOM
Increasing use of, and demand for products of “natural origin”
Rapid introduction to markets of new, unfamiliar medicinal plants, from local and international sources, in dosage forms not necessarily regulated.
False notion that “natural” is synonymous with safe i.e. free of adverse effects. Supported by many alternate medicinal practitioners.
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Situation Analysis contd.
Truth regarding beneficial medicinal effects often blurred
Territories without regulatory mechanisms more at risk or vulnerable
Other Challenges e.g. the right to trade.
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Regulatory Intervention Regulatory mechanism supported by legislation
absent in all but three English speaking Caribbean territories
Strong Supporting evidence exists for: benefits potentially harmful effects In the absence of therapeutic claims every
product is a “Dietary Supplement” but no significant value over carefully “planned and balanced diet’.
Basis for harmonised regulatory approach therefore long established.
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Why Regulate- Shared Caribbean Position
Protect consumer interests– unsubstantiated product claims
Protect product integrity- evaluation parameters Maintain requisite standards – batch to batch
consistency Ensure public safety not compromised – toxicities
Are safe, effective, beneficial Products, practices lead to positive clinical
outcomes.
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HISTORICAL OVERVIEW- Jamaica
INTRODUCTION OF NEW CATEGORY CALLED “HERBAL PRODUCTS”-1993
ESTABLISHMENT OF WHOLISTIC HERBAL ASSOCIATION- 1995
LONG CONSULTATIVE PROCESS WITH STAKEHOLDERS - > 6 years
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Contd.
WHA recommendations reviewed by MOH
Further discussions Consensus
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WHO Regional Workshop on Regulation of Herbal Products - Nov. 2000
Representatives from drug regulatory bodies from 11 Caribbean countries participated on :-
Issues relating to safety, efficacy, quality control of herbal products
Requirements for registration
Proposal on harmonized standards & regulations to ensure safety and quality
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Workshop Outcome- Jamaica
WHO General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine introduced
WHO Guidelines for Assessment and Safety of Herbal Medicines used as guide for categorization and definition of categories for purpose of amendment to Food & Drugs Act
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MOH Prepared Proposal for Cabinet based on:
consultative process: MOH, Wholistic Herbal Assoc., Open fora with Select Committee on
Human Resources & Social Development Reference to legal approach taken by
Competent Authorities in Australia, Canada, Germany, England, United States, others.
Reference to WHO Guidelines on the Assessment of Herbal Products. Definitions adapted, in use.
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OVERVIEW contd.
First Special Stakeholder Meeting of Cabinet Select Committee on Human and Social Development - January 2001- examined MOH proposal, accomodated hearing from WHA, other stakeholders.
Total of three meetings- to consider MOH proposal to Cabinet.
Proposal approved .
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Scope of Amendment to F&D Act:
Five new categories of substances included in Draft Amendment: Herbs Herbal Materials Herbal Remedies Finished Herbal Products Health Foods
Drugs, Foods remain in Act as previous Herbal remedies only registered.
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Over-the-Counter category introduced Draft Regulations to Act to reflect new requirements including standards for sale of herbal products completed.
Awaiting gazetting by CPC
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Definitions:
Herbs:Include crude plant material e.g. leaves, flowers, seeds, fruit, stems, wood, bark, roots, rhizomes or other plant parts ,which may be entire, fragmented or powdered.
Herbal Material: Include in addition to herbs, fresh juices,
gums, fixed oils, essential oils, resins, dry powders of herbs.
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Herbal Remedy:
Any botanical product consisting of a substance produced by subjecting a plant /plants to drying, crushing or any other process or mixture whose sole ingredients are two or more substances so produced. May have potential to be used for risk reduction, therapeutic or treatment purposes. Include traditionally used and new ones.
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Finished Herbal Product
“herbal preparation made from one or more herbs. If more than one herb is present the term mixture may be used. These may contain excipients in addition to the active ingredients. Where chemically defined active substances are added they are not considered to be
herbal.”
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Health food:
“Any product other than tobacco taken by mouth that is intended to supplement the diet, such as, vitamin, mineral, amino acid, enzyme, neutraceutical, dietary substance or concentrate, metabolite, constituent, extract or combination of these ingredients”
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Definitions in existing Legislation - Food & Drugs Act
Food – “ any article used for food or drink by man, including chewing gum and any ingredient that may be mixed with food or drink for any purpose”
Drug – “any substance or mixture of substance manufactured, sold or represented for use in -
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contd.
‘The diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state or the symptoms thereof in man or animal;
Restoring, correcting or modifying organic functions in man or animal;
Disinfection in premises in which food is manufactured, prepared, preserved, packaged ….for sale or sold for the control of vermin or insects in such premises..”
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Implemented so far -Jamaica:-
Official list of requirements for registration of herbal drugs developed- in use
Vitamins/minerals included in health food category however registered as prescription drug if in injectable
form, mega doses for specific therapeutic indications, or make therapeutic claims substantiated or otherwise
registered as Over-the Counter drugs at concentrations deemed to exceed levels specified for “free sale”
Permit required
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Other Health Foods:-- Not registered as drugs but Permit required
- Special requirements for labels to include warnings and any particular conditions for use
- Finished herbal products singly or in combination may also be registered as drugs.
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Advisory Panel Mechanism established –
Panel on Complementary Medicines functional.
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Consultation with English speaking sister territories in Caribbean:
Meeting of the RABDAT, TAC, St. Vincent 2002- need for harmonization on regulation of herbal products unanimously accepted;
Jamaica, Trinidad et al to prepare position paper for submission to CARICOM Health Desk;
CRDTL provides critical linkage among English speaking territories.
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Jamaica willing to provide support for countries without Regulatory systems.
Numerous attempts made to harmonize on requirements for product regulation since 2000
Principle of registration requirements similar for T&T, Jamaica, Guyana.
Now working towards mechanism for harmonisation
involving territories without existing regulatory framework
Discussed at length at recent TAC meeting (Feb. 2006) in Guyana. Draft proposal in preparation
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Regulatory Intervention
Regulation of “Herbalists”: Ensures purchase of medicines and
ingredients from reputable suppliers Ensures practitioners take
responsible, informed approach regarding safety issues
Appropriate training and skills necessary
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Products -Integrity
QUALITY: “Certificate of Analysis” Conformity assessment for proper
identity Content verification Impurities/contaminants
Heavy metals, aflatoxins, moisture. Synthetic material added?
Raw materials - source etc. GMP, GAP Product stability
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Integrity contd. EFFICACY
Ability to effect label claim - indication/action
Pharmacological activity Potency -justification for effective
dose. Rationale for combination
therapy – multi-herb combination a matter of concern
Nature of claims - justification
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Integrity contd. SAFETY
Toxicity Acute Long-term Mild, severe
Reporting responsibility Interactions, contraindications Use in children
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Requirements for Health Foods:
Review of : Active ingredients. Concentration a
consideration Validification of Label claims Verification of purity - Certificate of Analysis Samples Proof of approval in country of origin Scientific support claims may be requested.
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Documentation Requirements for Registration- Herbal Remedies
Statement of content Posology Rationale for combinations Toxic/side effects Tests to confirm quality, potency Approval in country of origin Samples Fees Other pertinent information
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Regional Challenges: Availability of resources to
effectively address issues. Geographical barriers- distance,
absence of physical borders Commitment to follow-up Matter of Whose priority
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Regulatory Challenges
Attempts to circumvent existing legislation
Need for constant market vigilance - Cosmetics with herbs?
Teas & other beverages Persistence of local Alt Med.
Practitioners in use of prohibited herbs eg. Chaparral, Comfrey, Ma Huang
Customs. Trinidad has dedicated inspectorate
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Regulatory Challenges Public suspicion-inadequate public
education. Insufficient scientific information
on many herbs presents barrier to proper scientific review
Inability of many applicants to provide requisite documentation
Lack of resources to develop adequate laboratory support.
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Local publications help build consumer awareness eg. “Poisonous Plants of Jamaica, Jamaica’s Ethnomedicine- Its Potential in the Healthcare System”
published by local authors. Work by local scientists on
medicinal plants – UWI & others
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Present Regulatory Framework
Encompasses recommendations based on collaborative work.
Similar product classification scheme presently used.
Legislation amended to reflect position. Advisory Panel Mechanism for
Complimentary Medicines established (Jamaica).
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Note: Jamaica
All products regulated except Homeopathic preparations more dilute
than a one thousand fold dilution of a mother tincture.
Herbal teas except where there are claims.
Products which exist and function principally as food if they make no therapeutic claims e.g. garlic
Fees required for passive assessment All injectible presentations registered as
prescription drugs
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New Drug Applications
More stringent requirements: Clinical pharmacology: pharmacokinetics,
pharmacodynamics, bioavailability, bioequivalence
Chemistry: chemical composition, morphology- structure activity relationship
Proof of efficacy: controlled, un0controlled studies
Safety: scientifically established Toxicology
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Some Herbs Restricted in Jamaica- Info. Shared with other territories
Chaparral Comfrey- external use only Germander Lobelia Magnolia Jin Bu Huan Ma Huang Stephania Willow Bark Yohimbe Kava Kava?
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THE WAY FORARD
Territories to agree on mechanism for harmonisation
Seek representation on political agenda
Develop Regional legislation to address key issues on timely basis
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THANK YOU!