“updates on the new legislation pertaining to tcm”

Traditional and Complementary Medicine DivisionMinistry of Health Malaysia

Datin Napsah Mahmud

DirectorTraditional & Complementary Medicine Division

“Updates on the new legislation pertaining to

TCM”.


Flow of the presentation

• Government Policy on T/CM • Current Regulatory Situation• T/CM Practices• T/CM Division• Integrative medicine


Government Policy on T/CM


• Malay – Indigenous; from Indonesia

• Chinese – 18th Century : Brought in from China / Korea

• Indian– 18th Century : (Ayuverda, Siddha and Unani) brought in

from India / Pakistan /Bangladesh/Sri Lanka

• Complementary Medicine– 19th Century from India & Sri Lanka (homeopathy) and

the West

• Homeopathy

T/CM in Malaysia


WHO Traditional Medicine

Strategy 2002-2005

1. Develop National Policy- integrate TM/CAM with national health care systems

2. Encourage evidence based practice - safety, efficacy and quality: - evaluation, guidance and support for

effective regulation3. Enhancing Access:

- public awareness, availability and affordability of TM/CAM, including essential herbal medicines

4 Rational use: - therapeutically sound use of TM/CAM by

providers and consumers



• The growing interest in T/CM that has prompted the Malaysian government to establish a special committee to look into all aspects of T/CM in the country .

• Vision to integrate T/CM optimally into the National Health system has been set.This is supported with a mission to ensure quality and safe use of traditional /complementary medicine practices and product.


Government Policy on T/CM:

• Formation of Standing Committee for T/CM (1996)

• chaired by Deputy Director General of Health (Research and Technical Support)

• The function is to advise and assist the Ministry of Health in formulating policies as well as strategies for monitoring T/CM activities in the countries.

• Members comprise professionals from research institutions, government agencies, universities, T/CM organizations (5 practitioner bodies), Malaysian Medical Association (MMA) and World Health Organization (WHO)


Phases of development

• 1987– Position paper for Research Agenda in Alternative Medicine

• 1996 – Post-Cabinet decision to set-up organizational structure for

Traditional & Complementary Medicine in Malaysia– Unit of T/CM was formed

• 1998 – Formation of the Standing Committee on T/CM

• 1999 – Formation of the 5 T/CM Umbrella Bodies

• 2000– Formation of The Herbal Medicine Research Centre in IMR

• 2001 – Launching of the National Policy in Traditional and

Complementary Medicine


Phases of development-II

• 2002– Cabinet approval for the development of Global

Information Hub for Integrated Medicine

– Cabinet approval for the setting up of the National Committee for R & D in Herbal Medicine

• 2003• National Institute for Natural Products, Vaccines and Biologicals

• December 2004• Division of T/CM in the Ministry of Health



• Launching of National T/CM Policy in 2001

The ground for implementation was reinforced with the launching of the National Traditional and Complementary Policy in year 2001. Five strategic areas has been identified namely practice, products, education/training, research and international collaboration.


National T/CM Policy


The Policy statements for T/CM

Promotion of proper practice of T/CM in accordance to standard ethics particularly in the Primary Health Care delivery system

Appropriate education and training of T/CM practitioners

Adherence to acceptable standards of safety and quality for products and practice

Facilitate the development of responsible advertisement with relevant agencies

Establishment of strong research and development activities in T/CM.


The Policy statements for T/CM (cont..)

Promotion and advocacy of T/CMFacilitate the development and protection of

intellectual property rights related to T/CM knowledge, culture and biological resources.

Conservations of plants and animals for progress of T/CM development with participation of all relevant agencies

Enhancing international technical co-operation and exchanges relevant to T/CM


Current Regulatory Situation


The regulatory situation

(For traditional medicine products):

Control of Drug and Cosmetic Regulation, 1984

• Registration for Traditional Medicine Products – January 1992

• Ensure safe and quality product• More than 10000 products registered



(For traditional medicine products)Quality and Safety Criteria:

• Limits for heavy metals and microbial contamination

• Absence of steroids and other adulterants

• Prohibitions of herbs with adverse effect • Compliance to Good Manufacturing

Practice



(For traditional medicine products)Enforcement Activity:

• Control at entry points• Surveillance and Raids• Inspections – distributors and

retail outlet.• Prosecutions, confiscation and

penalties



(For traditional medicine products):Other laws that regulate the T/CM product industry:

• Poison Act 1952,• Sale of Drug Act 1952,• Advertisement and Sale Act 1956• Protection of Wild Life 1972 and


RESEARCH

• National Committee for Research and Development in Herbal Medicines (NRDHM)

• Ministry of Health as lead agency

- Set directions for research- Co-ordinate research, integrate clinical trials using

T/CM in Malaysia- Already produced guidelines for research to improve

standards of evidence


Guidelines

• Guidelines for levels and kinds of evidence to support claims for therapeutic products

• Guidelines for the clinical evaluation of T/CM interventions

• Guide to intellectual property management

• Guidelines for standardisation of herbal medicinal products


Published

Malaysian Herbal Monograph and Compendium of Medicinal Plants Used in Malaysia.

Established an Information Hub on Integrated Medicine for the World through Malaysia utilising strategic partnership with other agencies.


T/CM Practices


Definition

• Conventional /Allopathic/Modern Medicine is defined as

Practice by holders of MD/MBBS or equivalent and by their allied health professionals (Physiotherapists, registered nurses etc)

Form of medicine supported and used by most government


Definition

• Traditional Medicine The sum total of knowledge,

skill and practices on holistic health care,

Recognised and accepted by the community for its role in the maintenance of health and the treatment of diseases.


Definition

Traditional Medicine (cont…) based on theory, beliefs and

experiences, that are indigenous to the different cultures and developed and handed down from generation to generation

WHO 2000


Definition

Complementary Medicine

Refers to a wide range of health interventions which is recognised and accepted by the community for its role in preventing or treating illness or or promoting health and wellbeing.


Definition

Traditional and Complementary Medicine (T/CM)

Traditional and Complementary Medicine practice together , is other than practice of medicine or surgery, by registered medical practitioners as defined in Medical Act 1971.

Malaysian Medical Council,Ministry of Health, Malaysia, 2001


T/CM Practice

• The government recognizes the role played by T/CM, supports its proper use, particularly as a community and individual practice

• Initiates efforts to bring proven traditional and complementary medicine into mainstream health services

• Takes measures to control its safe practice although not part of mainstream medicine


T/CM Practice

• Formation of practitioner bodies in 1999• 5 bodies namely; Malay, Chinese, Indian ,

Complementary and Homeopathy• MOH set up term of reference for the

practitioner bodies• T/CM practitioner bodies self regulate and

have developed criteria and standard of practice endorsed by MOH.


T/CM Division


Director General Of Health

Deputy Director General[Research & Tech. Support]

DirectorT/CM Division

Practice TrainingPolicy & Development Administration & Finance

Organization Chart T/CM Division


Objectives of T/CM Division

• To coordinate and implement various activities on T/CM especially in areas related with the practitioners, training and policy

– Product: by the National Pharmaceutical Control

Bureau– Research: NRDHM (IMR/NIH for MOH)

• Integration of T/CM into the National Healthcare

Delivery


Current Initiatives of T/CM Division

• T/CM Bill – Currently Drafting• T/CM Division monitor entry of

foreign T/CM practitioners.• T/CM Division is in the process of

listing all the T/CM practitioners in the country

• Standardisation of training and practice


Foreign Practitioners

• Thai Traditional Massage

• Ayuverdic Therapist

• Chinese Physician

• Reflexologist

• Acupuncturist

• Chiropractor


Current initiatives of T/CM Division

– Establish standards of practice, procedure,

training etc for common modalities

– Technical Working Group (TWG) for each practice

– Start with acupuncture, reflexology, chinese physician, aromatherapy and massage (malay, thai, swedish, tuinalogy indian etc )


T/CM Training Centres

• Existence of Training Centres conducted by practitioner bodies– Federation of Chinese and

Acupuncturist Association of Malaysia– Federation of Chinese Physicians and

Medicine-Dealers Associations of Malaysia

– Chinese Physician’s Association of Malaysia

– Homeopathic


Common T/CM Practices and Facilities

• Acupuncture together with moxibustion• Outpatient treatment for minor ailments• In patient rehabilitation for stroke

patients• Chinese Physician prescribing herbs and

decoction

• Pharmacy dispensing raw herbs.


Common T/CM Practices and Facilities

• Reflexology • Massage

– Tuinalogy– Swedish massage– Thai Massage– Malay Massage (Post Natal Care)

• Homeopathy• Ayurvedic • Yoga, Reiki and others• Diet modification


INTEGRATIVE MEDICINE


T/CM in Primary Care

Widespread use of T/CM Continue to use T/CM as a result

of historical circumstances and cultural beliefs.

Availability of registered products – evaluated on safety and quality.

Use of Complementary therapies in wellness paradigm


Definition

Integrated Medicine

Medicine that combines mainstream medical therapies and T/CM therapies, for which some high-quality scientific evidence of safety and effectiveness.– Practising medicine that selectively incorporates

elements of TM into comprehensive treatment plans alongside solidly orthodox methods of diagnosis and treatment

Alternative Medicine

The practice of medicine that is other than modern medicine, which offers as an alternative approach for treatment or management of health conditions. Alternative medicine is used in place of conventional medicine.


Prerequisites before endorsing Integrated Medicine

– Adequate Information of T/CM• Potential clinical benefits, safety, risks

– Enough Scientific Evidence• Credible evidence-based information

– Appropriate Legislation & Enforcement• Law against illegal practices or misleading

labelling or claims

– Formalised training for T/CM practitioners

– Identify areas for integration: incremental

– Adherence to National T/CM Policy


Planning ….

• Type of service to be provided

• Raise awareness

• Identify client/patients needs

• Keep people informed

• Identify existing networks and integrated services


Planning ….Selecting practitioners:• Qualifications • Experience• Training history• Affiliations to professional

organisations• Code of conduct• Practice• Ethics


Training

• Qualifications from accredited centres

• In service training

• Talks and demonstrations

• Practitioner networks and forums


Allopathic Practitioners need to know T/CM

They may be asked on T/CM Patient wish to consult further on its

usage Possible interaction with modern

drug Contents of T/CM Clinical problems and

complaints resulting from usage.


RM-9


Goal 1- Prevent and Reduce Disease Burden

To promote public awareness and education on the availability of safe T/CM practice


Goal 2- Enhance Healthcare Delivery System

1. Regulation of T/CM practice and practitioners

2. Implementation and enforcement of T/CM Act

3. Accreditation of training centres4. Training (credentialing) of registered

practitioners5. Training of MOH personnel in selected

T/CM6. Pilot selected T/CM to be integrated into

existing healthcare facilities


Goal 3 – Optimise Resources

To harness interagency collaboration locally and globally with all relevent stakeholders to ensure the availability / access to safe, efficacious, affordable T/CM Services.


Conclusion

Global population ageing bring greater incidence of chronic disease and T/CM offer a potential means for managing such diseases.

In developed countries, more and more people are using T/CM in combination with allopathic medicine — to help relieve chronic pain and/or to improve quality of life.


Conclusion To ensure optimal use of T/CM. ➤ integrate T/CM with national health care

systems, and implement National T/CM Policies and Programmes

➤ promote the safety, efficacy and quality of T/CM by expanding the knowledgebaseon T/CM, and by providing guidance on regulatory and quality assurance standards

➤ promote therapeutically sound use of appropriate T/CM by providers and consumers.

“updates on the new legislation pertaining to tcm”

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