MEDICINAL PLANTS – THE JAMAICAN/CARIBBEAN EXPERIENCE

MINISTRY OF HEALTH JAMAICA PRINCESS 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

THANK YOU!