MEDICINAL PLANTS THE JAMAICANCARIBBEAN 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 medicines
  
• Update WG participants regarding status of
  Regional regulatory framework governing herbal
  products
  
• 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 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 -
  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 FD 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 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 TT, 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, Jamaicas
  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

• 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!