MEDICINAL PLANTS – THE JAMAICAN/CARIBBEAN EXPERIENCE MINISTRY OF HEALTH JAMAICAPRINCESS THOMAS OSBOURNE 2006 March 24
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
INTRODUCTION • PUBLIC HEALTH : • STATE RESPONSIBILITY • SCOPE OF PUBLIC ROLE/ RESPONSIBILITY • INTEGRITY OF INDIVIDUAL CHOICE • Access to safe goods & services
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.
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.
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.
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.
HISTORICAL OVERVIEW- Jamaica • INTRODUCTION OF NEW CATEGORY CALLED “HERBAL PRODUCTS”-1993 • ESTABLISHMENT OF WHOLISTIC HERBAL ASSOCIATION- 1995 • LONG CONSULTATIVE PROCESS WITH STAKEHOLDERS - > 6 years
Contd. • WHA recommendations reviewed by MOH • Further discussions • Consensus
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
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
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.
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 .
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.
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
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.
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.
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.”
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”
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 -
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..”
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
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.
Advisory Panel Mechanism established – Panel on Complementary Medicines functional.
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.
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
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
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
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
Integrity contd. • SAFETY • Toxicity • Acute • Long-term • Mild, severe • Reporting responsibility • Interactions, contraindications • Use in children
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.
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
Regional Challenges: • Availability of resources to effectively address issues. • Geographical barriers- distance, absence of physical borders • Commitment to follow-up • Matter of Whose priority
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
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.
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
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).
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
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
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?
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