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Table of Contents
Title: Implementing Rules and Regulations of R.A. No.
8423
Rule 1 “Policies and Objectives”
Section 1 Title
Section 2 Declaration of Policy
Section 3 Objectives
Rule 2 “Definition of Terms”
Rule 3 “The Philippine Institute of Traditional and
Alternative Health Care”
Section 1 Creation of PITAHC
Section 2 Powers and Functions
Rule 4 “Board of Trustees”
Section 1 Composition of the Board of Trustees
Section 2 Powers and Functions
Section 3 Appointment and Tenure
Section 4 Meetings and Quorum
Section 5 Creation of Working Committees
Section 6 Conduct of Business of Working
Committees
Section 7 Allowances and Per Diems
Rule 5 “Research and Development”
Section 1 Approach
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Section 2 Principles
Section 3 Partnership with Public / Private Sector
and Academe
Section 4 Strategy and Process
Section 5 Research Fund Allocation
Rule 6 “Promotion, Advocacy and Training”
Section 1 Promotion and Advocacy
Section 2 Partnership with TESDA, DECS, CHED
and PCHRD
Section 3 Training Center for Trainers
Section 4 Collaboration with WHO and WHO
Collaborating Centers
Section 5 Traditional Medicine Coordinating Unit
Section 6 Accreditation of Traditional Medicine
Institution/Programs
Section 7 Misleading or Unlawful Information
Rule 7 “Rules and Guidelines for the Manufacture,
Distribution and Sales of Natural Products”
Section 1 Herbal Medicine / Phyto-Medicine
Rule 8 “Codes of Practice”
Section 1 Phyto-therapy
Section 2 Acupuncture
Section 3 Massage Therapy
Section 4 Other Modalities
Section 5 Accreditation
Section 6 Continuing Education
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Rule 9 “Protection of Biological and Genetic Resources
Including Indigenous Knowledge Systems”
Section 1 Free and Prior Informed Consent
Section 2 Access to Biological & Genetic
Resources Including Indigenous Knowledge
Systems
Section 3 Documentation of Indigenous
Knowledge Systems on Traditional and
Alternative Health Care
Section 4 Intellectual Property Rights
Rule 10 “Conservation and Protection”
Rule 11 “Holistic Health Care Delivery System”
Section 1 Approach
Section 2 Traditional and Alternative Medicine
Treatment Centers
Section 3 Accreditation of Traditional Medicine
Centers
Section 4 Hospital-based Services
Section 5 Community-based Services
Section 6 Livelihood Programs and Training
Section 7 Insurance
Rule 12 “Monitoring and Reporting”
Section 1 Monitoring Program
Section 2 Reporting Procedures
Rule 13 “Organization”
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Section 1 Structure
Section 2 Human Resource Development
Rule 14 “Executive Officers of the Institute”
Section 1 Director General
Section 2 Powers, Functions and Duties of the
Director General
Section 3 Deputy Director General
Section 4 Other Officers
Rule 15 “Funds”
Section 1 Traditional and Alternative Health
Care Development Fund
Section 2 Trust Fund
Section 3 Income from Operations and other
Activities
Rule 16 “Business Plan”
Rule 17 “Amendments and Revisions of the
Implementing Rules and Regulations”
Section 1 Succeeding Amendments of the
Implementing Rules and Regulations
Rule 18 “Transitory and Final Provisions”
Section 1 Transfer of Functions, Personnel and
Assets of the Traditional Medicine Unit and
other related units
Section 2 Interim Staff
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Section 3 Initial Funding
Section 4 Hiring of Institute Personnel
Section 5 Separation or Retirement Benefit
Section 6 Existing Policies and Programs
Section 7 Separability Clause
Section 8 Effectivity
RULES AND REGULATIONS TO IMPLEMENT
REPUBLIC ACT No. 8423
CREATING THE PHILIPPINE INSTITUTE OF
TRADITIONAL AND ALTERNATIVE HEALTH
CARE (PITAHC)
TO ACCELERATE THE DEVELOPMENT OF
TRADITIONAL AND ALTERNATIVE HEALTH
CARE
IN THE PHILIPPINES
PROVIDING FOR A TRADITIONAL AND
ALTERNATIVE HEALTH CARE DEVELOPMENT
FUND
AND FOR OTHER PURPOSES,
OTHERWISE KNOWN AS THE TRADITIONAL
AND
ALTERNATIVE MEDICINE ACT (TAMA) OF 1997
PURSUANT TO SECTION 19 of Republic Act No. 8423, otherwise known as
the “Traditional and Alternative Medicine Act (TAMA) of 1997”, the following rules and
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regulations are hereby promulgated FOR THE GUIDANCE AND COMPLIANCE OF
ALL CONCERNED.
RULE I
POLICIES AND OBJECTIVES
Section 1. TITLE. These Rules shall be known and cited as the “Rules and
Regulations Implementing the Traditional and Alternative Medicine Act of 1997.
Section 2. DECLARATION OF POLICY. It is hereby declared the policy of the
State to improve the quality and delivery of health care services to the Filipino people
through the development of traditional and alternative health care and its integration into
the national health care delivery system.
It shall also be the policy of the State to seek a legally workable basis by which
indigenous societies would own their knowledge of traditional medicine. When such
knowledge is used by outsiders, the indigenous societies can require the permitted users
to acknowledge its source and can demand a share of any financial return that may come
from its authorized commercial use.
Section 3. OBJECTIVES. The objectives of Republic Act No. 8423 are as follows:
(a) To encourage scientific research on and develop traditional and alternative
health care systems that has a direct impact on public health care.
(b) To promote and advocate the use of traditional, alternative health care
modalities that have been proven safe, effective, cost-effective and consistent
with government standards on health care practice.
(c) To develop and coordinate skills training courses for various forms of
traditional and alternative health care modalities.
(d) To formulate standards, guidelines and codes of ethical practice appropriate
for the practice of traditional and alternative health care as well as in the
manufacture, quality control and marketing of different traditional and
alternative health care materials, natural and organic products, for approval
and adoption by the appropriate government agencies.
(e) To formulate policies for the protection of indigenous and natural health
resources and technology, natural products, by-products and derivatives from
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unwarranted exploitation, for approval and adoption by the appropriate
government agencies.
(f) To formulate policies to strengthen the role of traditional and alternative
health care delivery system; and
(g) To promote traditional and alternative health care in international and national
conventions, seminars and meetings in coordination with the Department of
Tourism, Duty Free Philippines Incorporated, Philippine Convention and
Visitors Corporation and other tourism-related agencies as well as non-
government organizations and local government units.
RULE II
DEFINITION OF TERMS
Section 1. DEFINITION OF TERMS. As used in this Implementing Rules and
Regulations (IRR), the
following terms shall mean:
1. “Acupressure”
A method of healing and health promotion that uses the application of pressure on
acupuncture points without puncturing the skin.
2. “Acupuncture”
A method of healing using special needles to puncture and stimulate specific
anatomical points on the body.
3. “Albularyo”
A general practitioner of all indigenous modalities of healing (e.g. hilot, herbalist,
people who drive/cast away spirit possession)
4. “Alternative Health Care Modalities”
Other forms of non-allopathic, occasionally non-indigenous or imported healing
methods though not necessarily practiced for centuries nor handed down from one
generation to another. Some alternative health care modalities include reflexology,
acupuncture, massage, acupressure, chiropractic, nutritional therapy and other similar
methods.
5. “Alternative/Complementary/Integrative Medicine”
The field of health care outside the scope and coverage of biomedicine.
6. “Aromatherapy”
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The art and science of the sense of smell whereby essential aromatic oils are
combined and then applied to the body in some form of therapeutic treatment.
7. “Biological Medicine”
Involves methods of healing for which, in all procedures and therapy, the highest
guiding principle maybe formulated as follows: maintenance and furtherance of the
human biosystem. It employs substances, which are produced in vital processes, as
much as therapeutic technique, which are closely oriented to the functions of life. The
goal of which is the support or the restoration of development and self-healing.
Biological Medicine employs, as required, the possibilities of natural substances,
physical forces and psychological methods, in effectively coordinated manner.
8. “Biomedicine”
That discipline of medical care advocating therapy with remedies that produce effects
differing from those of the diseases treated. It is also called “allopathic medicine ”,
“western medicine”, “regular or mainstream medicine”, “orthodox medicine” or
“cosmopolitan medicine”.
9. “Chiropractic”
A discipline of the healing arts concerned with the pathogenesis, diagnosis, therapy
and prophylaxis of functional disturbances, pathomechanical states, pain syndromes
and neurophysiological effects related to the static and dynamics of the locomotor
system, especially of the spine and pelvis.
10. “Community Intellectual Rights”
A sui generis or unique set of rights which provides the legal basis for the indigenous
and local communities to control, protect, and regulate access to their knowledge
systems concerning plants and biological resources used in traditional and alternative
health care practices and includes the right to receive benefits from its sustainable
utilization as well as the commercialization of products that may be derived from it.
11. “Functional Foods”
Foods derived from naturally recurring substances containing significant levels of
biologically active compounds that impart health benefits or desirable physiological
effects beyond basic nutrition. It can and should be part of the daily diet. Functional
foods have a particular function when ingested, serving to regulate a particular body
process such as enhancing the body’s immune system, or help prevent or control
disease in cancer and diabetes or aid recovery from, such as cholesterol lowering
foods or regulate body metabolic rhythms for digestion or suppress aging.
12. “Herbal Medicine / Phyto medicine”
Finished, labeled, medicinal products that contain as active ingredients aerial or
underground part/s of plant or other materials or combination thereof, whether in the
crude state or as plant preparations. Plant materials include juices, gums, fatty oils,
essential oils and other substances of this nature. Herbal medicines, however, may
contain excipients in addition to the active ingredient(s). Medicines containing plant
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material(s) combined with chemically defined active substances, including chemically
defined isolated constituents of plants, is not considered to be herbal medicines.
13. “Hilot”
A traditional healer that practices bone-setting and massage similar to acupressure
and reflexology. These healers are also capable of redirecting body temperature
through the use of massage.
14. “Homeopathic Medicine”
The practice of treating the syndromes and conditions which constitute diseases with
remedies that have produced similar syndromes and conditions in healthy subjects.
Homeopathy is a natural pharmaceutical science that uses various plants, minerals or
animals in very small doses to stimulate the sick person’s natural defenses. The
medicines are individually chosen for their ability to cause in overdose the similar
symptoms the person is experiencing. “Homoios” in Greek means similar and
“pathos” means disease or suffering.
15. “Indigenous Healer”
A person who practices healing based on the modalities handed down by tradition
from our ancestors.
16. “Indigenous Cultural Communities/Indigenous Peoples”
Refers to a group of people or homogenous societies identified by self-ascription and
ascription by others, who have continuously lived as an organized community on
communally bounded and defined territory, and who have, under claims of ownership
since time immemorial, occupied, possessed and utilized such territories, sharing
common bonds of language, customs, traditions and other distinctive cultural traits, or
who have, through resistance to political, social and cultural inroads of colonization,
non-indigenous religions and cultures, became historically differentiated from the
majority of Filipinos. Indigenous Cultural Communities/Indigenous Peoples shall
likewise include people who are regarded as indigenous on account of their descent
from the populations which inhabited the country, at the time of conquest or
colonization, or at the time of inroads of non-indigenous religions and cultures, or the
establishment of present state boundaries, who retain some or all of their own, social,
economic, cultural and political institutions, but who may have been displaced from
their traditional domains or who may have resettled outside their ancestral domains.
17. “Intellectual Property Rights”
Those property rights which result from the physical manifestation of the original
thought.
18. “Iridology”
A method of examining the iris of the human eye used as a means of diagnosing
diseases and other pathologic changes.
19. “Manufacture”
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Any and all operations involved in the production, including preparation, propagation,
processing, formulating, filling, packing, repacking, altering, ornamenting, finishing
or otherwise changing the container, wrapper, or labeling of a consumer product in
the furtherance of the distribution of the same from the original place of manufacture
to the person who makes the final delivery or sale to the ultimate consumer.
20. “Massage”
A method wherein the superficial soft parts of the body are rubbed or stroked or
kneaded or tapped for remedial or aesthetic or hygienic or even limited therapeutic
purposes. It also includes the practice of reflexology, synchrotherapy, myotherapy,
physical therapy and other similar techniques that use instruments and/or other parts
of the body.
21. “Mind Therapy”
An alternative form of medicine that explores the principles, methods, means and
interventions related to the mind-body spiritual aspects of wellness and the healing
process. This includes studies with emphasis on exploring spiritual perspectives and
practices that will put the body in a state of homeostasis which will induce healing.
Some of these approaches include Light and Sound (Cymantics) therapy, Color
therapy, Medical Astrology, Aromatherapy, Bach therapy, Shape and Design
Structures, Meditation, Imagery Healing, Hypnotherapy etc.
22. “Natural Product”
Natural products include those foods that grow spontaneously in nature whether or
not they are tended by man. It also refers to organic foods that have been derived
from grains, vegetables, fruits, nuts, meats, fish, eggs, honey, raw milk and the like,
without the use or addition of additives, preservatives, artificial colors and flavors, or
manufactured chemicals of any sort after harvest or slaughter. Other natural products
include food supplements, drugs and personal care products using plant and animal
parts or extracts.
23. “Naturopathic Medicine”
An inclusive term for all forms of health care that support the body’s ability to defend
and heal itself through the use of natural therapies such as acupuncture, clinical
nutrition, herbal medicine and hydrotherapy.
24. “Nutra/Nutriceuticals”
Any natural substance, usually of plant origin, that is packaged as a dietary
supplement for therapeutic use.
25. “Nutritional Therapy”
It is the use of food as medicine and to improve health by enhancing the nutritional
value of food components that reduces the risk of disease. Nutritional therapy is
synonymous with Nutritional healing.
26. “Oracion”
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Modalities of traditional healing used by our ancestors to induce changes in the body
through prayers, chanting, mantras and breathing.
27. “Phyto-therapy”
The use of plant-based drugs to prevent or cure diseases or alleviate symptoms of said
diseases.
28. “Pranic Healing”
A holistic approach of healing which follows the principle of balancing energy.
29. “Reflexology”
The application of therapeutic pressure on the body’s reflex points to enhance the
body’s natural healing mechanisms and balance body functions. It is based on the
principle that internal glands and organs can be influenced by properly applying
pressure to the corresponding reflex area on the body.
30. “Spiritista”
A healer who claims to be a medium to other spirit entities.
31. “ Traditional and Alternative Health Care”
The sum total of knowledge, skills and practices on health care, other than those
embodied in biomedicine, used in the prevention, diagnosis and elimination of
physical or mental disorder.
32. “Traditional Healers”
Highly respected community members with a profound knowledge of indigenous
healing remedies.
33. “Traditional Medicine”
The sum total of knowledge, skills and practice on health care, not necessarily
explicable in the context of modern, scientific, philosophical framework, but
recognized by the people to help maintain and improve their health towards the
wholeness of their being, the community and society, and their interrelations based on
culture, history, heritage and consciousness. Philippine traditional medicine does not
include Chinese or Indian traditional medicine practiced by said groups in the
country.
RULE III
THE PHILIPPINE INSTITUTE OF
TRADITIONAL AND ALTERNATIVE HEALTH CARE
(PITAHC)
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Section 1. CREATION OF PITAHC. To implement Republic Act 8423, otherwise
known as the Traditional and Alternative Medicine Act (TAMA) of 1997, a Philippine
Institute of Traditional and Alternative Health Care is established as a corporate entity
hereinafter referred to as the Institute. It shall be attached to the Department of Health.
Section 2. POWERS AND FUNCTIONS. The Institute shall have the following
powers and functions:
(a) To plan and carry out research and development activities in the areas of
traditional and alternative health care and its ultimate integration into the
National Health Care Delivery System;
(b) To verify, package and transfer economically viable technologies in the field
of traditional and alternative health care, giving emphasis on the social
engineering aspects necessary for group endeavor;
(c) To provide the data base or policy formulation that will stimulate and sustain
production, marketing and consumption of traditional and alternative health
care products;
(d) To organize and develop continuing training programs for physicians, nurses,
pharmacists, physical therapists, and other professional health workers and
students, as well as scientists, research managers and extension workers in the
field of traditional and alternative health care;
(e) To formulate policies that would create public awareness through educational
activities, conventions, seminars, conferences, and the like by focusing on the
promotion of healthy living for preventing diseases, thereby uplifting the
health care industry;
(f) To acquire or obtain from any governmental authority whether national or
local, foreign or domestic, or from any person, corporation, partnership,
association or other entity, such charters, franchises, licenses, rights,
privileges, assistance, financial or otherwise, and concessions as are
conducive to and necessary or proper for the attainment of its purposes and
objectives;
(g) To receive and acquire from any person and/or government and private
entities, whether foreign or domestic, grants, donations and contributions
consisting of such properties, real or personal, including funds and valuable
effects or things, as may be useful, necessary or proper to carry out its
purposes and objectives and administer the same in accordance with the terms
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of such grants, donations and contributions, consistent with its purposes and
objectives;
(h) To serve as the coordinating center of a national network of traditional and
alternative health care stations located in the different regions of the country;
(i) To formulate a code of ethics and standards for the practice of traditional and
alternative health care modalities for approval and adoption by the appropriate
professional and government agencies;
(j) To formulate standards and guidelines for the manufacture, quality control and
marketing of different traditional and alternative health care materials and
products for approval and adoption by the Bureau of Food and Drugs;
(k) To coordinate with other institutions and agencies involved in the research of
herbal medicines;
(l) To adopt and use a corporate seal;
(m) To sue and be sued in its corporate name;
(n) To succeed by its corporate name;
(o) To adopt its by-laws and promulgate such rules and regulations as may be
necessary or proper to implement this Act, and to amend or repeal the same
from time to time;
(p) To enter into, make and execute contracts and agreements of any kind of
nature;
(q) To borrow, raise or obtain funds, or to enter into any financial or credit
arrangement in order to support or carry out its research programs, finance its
capital and operating expenses, subject to pertinent laws governing public
debts and expenditures;
(r) To invest, purchase or otherwise acquire, own, hold, use, mortgage, pledge,
encumber, sell assign, convey, exchange, or otherwise deal in real and/or
personal properties of whatever kind and nature, or any interest therein,
including shares of stock, bonds, notes, securities and other evidences of
indebtedness of natural or juridical persons, whether domestic or foreign and
whether government or private;
(s) To exercise all the powers of a corporation under the General Corporation
Law, insofar as such powers are not in violation of the provisions of this Act;
and,
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(t) To exercise such other powers and functions, and perform such other acts as
may be necessary, proper or incidental to the attainment of its purposes and
objectives.
RULE IV
BOARD OF TRUSTEES
Section 1.COMPOSITION OF THE BOARD OF TRUSTEES. The corporate powers
of the Institute shall be exercised, and all its business, activities and properties shall be
controlled by a Board of Trustee; hereinafter referred to as the Board. It is composed of
the following:
• Secretary of Health – Ex-officio Chairman
Permanent Representatives of the following government offices:
• Department of Science and Technology
• Department of Environment and Natural Resources
• Department of Agriculture
• Department of Education, Culture and Sports; and
• Commission on Higher Education
Representatives of the following industries/sectors:
A. One Physician who is engaged in the practice of traditional and
alternative health care.
B. One member from a duly recognized academe/research institution
engaged in traditional and alternative health care research.
C. One traditional and alternative health care practitioner who is not
a physician.
D. One biomedical/allopathic/western medical practitioner preferably
from the Philippine Medical Association.
E. One member from the natural food industry and/or organic food
industry, and
F. One member from the environmental sector organization.
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Section 2. POWERS AND FUNCTIONS. The Board of Trustees shall have the
following powers and functions:
(a) To define and approve the programs, plans, policies, procedures and
guidelines for the Institute in accordance with its purposes and objectives, and
to control the management, operation and administration of the Institute.
(b) To approve the Institute’s organizational structure, staffing pattern, operating
and capital expenditure, and financial budgets prepared in accordance with the
Corporate Plan of the Institute.
(c) To approve salary ranges, benefits, privileges, bonuses and other terms and
conditions of service for all officers and employees of the Institute, upon
recommendation of the Director General and consistent with the salary
standardization and other laws.
(d) To appoint, transfer, promote, suspend, remove or otherwise discipline any
subordinate officer or employees of the Institute, upon recommendation of the
Director General.
(e) To create such committee or committees and appoint the members thereof, as
may be necessary or proper for the management of the Institute or the
attainment of its purposes and objectives.
(f) To determine the research priorities of the Institute consistent with the
framework of its purposes and objectives and in coordination with other
government agencies; and
(g) To exercise such other powers and functions and perform such other acts as
may be necessary or proper for the attainment of the purposes and objectives
of the Institute, or may be delegated by the Secretary of Health.
Section 3. APPOINTMENT AND TENURE. The six members representing the
above-mentioned sector/industry shall be appointed by the President of the Philippines
upon recommendation of the Secretary of Health. Of the appointive members, the first
two shall have a term of three years, the second two shall have a term of two years, and
the third two shall have a term of one year. Public sector representatives shall seat as
member of the Board of Trustees upon the recommendation of their respective
Department Secretaries.
Any member appointed to a vacancy shall serve only for the unexpired term of the
member whom he/she shall succeed.
Any sectoral representative who may be reappointed to the Board shall serve the
same terms as provided by law for the sector he/she is representing. Whereas, permanent
representatives from government offices shall not hold a rank lower than that of a
Director.
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Section 4. MEETINGS AND QUORUM. The Board shall meet regularly at least
once a month or as often as the exigencies of the service demands. The presence of at
least six (6) members shall constitute a quorum, and the majority vote of the members
present, there being a quorum, shall be necessary for the adoption of any resolution,
decision or any act of the Board.
The Director-General shall inform the members of the Board of Trustees in
writing transmitted electronically, by courier or any other practicable means of any
regular or special meeting of the Board, at least one week before the date of the
scheduled meeting furnishing them with a copy of the Notice, Meeting Agenda and
Minutes of the Previous Meeting.
The Board shall hold its regular meeting every first Wednesday of the month in an
identified venue unless the exigencies of the service require that a special meeting be held
which may not require a quorum of at least six (6) members of the Board. Whenever the
circumstances require, the Board may avail of existing technologies to conduct its
meetings, which may be through teleconferencing or any other means that are practicable
and economical.
Section 5. CREATION OF WORKING COMMITTEES. The Board may create
such adhoc Working Committees, composed of at least three (3) of its members, one of
whom shall chair the said Committee created for that purpose. This adhoc Working
Committee shall study, receive and/or review expert advise from representatives of
concerned agencies and designated officers/managers of the Institute and others and
subsequently make the appropriate recommendations to the Board during its regular or
special meeting, provided there is a quorum on the following matters of concern:
a) The formulation of specific Code of Ethics and Standards for the practice of
identified traditional and alternative health care modalities;
b) The formulation of specific standards and guidelines for the manufacture,
quality control and marketing of different traditional and alternative health
care products and similar materials;
c) The development of the Institute’s organizational structure, staffing pattern,
operating and capital expenditure, budgets and related concerns;
d) To discipline and/or reprimand a particular member or members of the Board
including officers and staff of the Institute who may have been found, after
due process of law, to have violated pertinent laws, rules and regulations;
e) To formulate standards and guidelines for the accreditation of providers of mandatory continuing education for practitioners.
f) Other matters as may be deemed by the Board as necessary or proper for the
management of the Institute or for the attainment of its policies, purposes and
objectives.
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However for the following issues and concerns, the Board will decide en banc
a) The review and restructuring of existing investments, direct services as well as
incentive schemes for manufacturers of traditional and alternative health care
products;
b) The entry by the Institute into any financial arrangement or credit
arrangements that will raise funds for the programs, capital expenditures or
any activities requiring significant and/or substantial funding support; and,
c) The management of the Institute’s statutory and regular funds as well as
properties and assets to ensure the viability and self-reliance of the Institute as
a corporate entity.
Provided however, the following issues and concern shall be decided by the working
committee without need of any appropriate action from the Board:
a) To recommend with the proper government agency for appropriate
investigation persons/entities that do not comply with the standards and
guidelines formulated by the Institute;
b) To accept complaint regarding non-compliance with the standards and
guidelines formulated by the Institute and if necessary to conduct the
inspection to validate the complaint; and
c) To institute appropriate complaint with the proper government agency and/or
judicial court.
Section 6. CONDUCT OF BUSINESS OF WORKING COMMITTEES. The
Board shall leave to the respective Working Committees the manner by which they will
conduct the business of fulfilling their tasks which the Board has delegated upon them,
subject to guidelines and other conditions the Board may lay down in creating the said
Committees.
Section 7. ALLOWANCES AND PER DIEMS. The members of the Board shall
receive a per diem for every meeting actually attended subject to the pertinent budgetary
laws, rules and regulations on compensation, honoraria and allowances. The rates of
which shall be determined through appropriate Board
Resolutions.
RULE V
RESEARCH AND DEVELOPMENT
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Section 1. APPROACH. Pursuant to R.A. 8423, the Institute shall promote, initiate,
train and/or undertake research and development or provide venue/facilities;
projects/activities in the field of traditional and alternative medicine/health care
systems/modalities. The scope and coverage of the Research and Development Program
of the Institute shall include, but will not be limited to, the following:
a. Products – phytomedicines (herbal medicines) in its purified form or
natural state, neutraceuticals derived from medicinal plants, and food
supplements based on medicinal plants;
b. Modalities – Philippine indigenous healing, acupuncture, acupressure,
aromatherapy, therapeutic massage, reflexology, chiropractic,
naturopathy, homeopathy; and,
c. Social-Political-Economic and Market Research, and others.
Section 2. PRINCIPLES. The conduct of such researches and scientific validations
of all alternative health products and modalities shall, as deemed appropriate and
practicable, use accepted principles and techniques that are in compliance with the
agreements reached in the “Declaration of Helsinki” to ensure safety, efficacy and proper
administration.
Section 3. PARTNERSHIP WITH PUBLIC / PRIVATE SECTOR AND THE
ACADEME. The Institute shall network, collaborate and/or establish partnership with
public and private agencies/entities and academic institutions and individuals in the
conduct of its research and development activities and the formulation of strategies for
the development of a traditional and alternative medicine industry sector and complex.
Section 4. STRATEGY AND PROCESS. The Institute shall adopt a multi-pronged
strategy in the development and classification of natural products, by-products and
derivatives as well as in the validation of the safety and efficacy of such products and
derivatives and alternative modalities. In view of the rigorous process involved in
scientific validation, the “Principle of Precautionary Approach” shall be adopted in
products and modalities that have proven traditionally their safety and efficacies for
generations unless proven otherwise by scientific research.
Section 5. RESEARCH FUND ALLOCATION. The Institute shall allocate at a
minimum of 2% of its annual budget for Research and Development and related
activities.
RULE VI
PROMOTION, ADVOCACY AND TRAINING
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Section 1. PROMOTION AND ADVOCACY. The Institute shall promote and
advocate the use of appropriately-validated herbal medicines and alternative health
modalities in coordination with concerned government and private agencies such as the
Department of Health, Center for International Trade, Expositions and Missions of the
Department of Trade and Industry, Philippine Visitors and Convention Corporation of the
Department of Tourism, Philippine Information Agency and other similar agencies.
Section 2. PARTNERSHIPS WITH TESDA, DECS, CHED AND THE PCHRD.
The Institute in close coordination with Technical Education and Skills Development
Authority (TESDA), Department of Education, Culture and Sports (DECS), Commission
on Higher Education (CHED), Philippine Council for Health Research and Development
(PCHRD) and others shall formulate guidelines, rules and regulations for the
development of learning/training materials for short courses as well as for graduate and
post-graduate courses. It shall develop Human Resource Development (HRD) Programs
for medical and non-medical professionals with appropriate public and private
institutions particularly, Academic Centers of Excellence.
Section 3. TRAINING CENTER FOR TRAINERS. The Institute shall establish a
“Training Center for Trainers” using its existing resources and facilities. It shall serve as
a demonstration area and venue for the conduct of continuing health care education
courses for professors, consultants and trainers involved in the art and science of
alternative/complementary/integrative health care in schools throughout the country.
Section 4. COLLABORATION WITH WHO AND WHO COLLABORATING
CENTERS. The Institute shall exert efforts to evolve as a World Health Organization
(WHO)-recognized Training Center in Traditional Medicine. The Institute shall
undertake twinning programs with these other WHO collaborating centers as well as non-
WHO entities such as foreign universities and colleges and other similar institutions
where extensive research and education programs in the field of
traditional/alternative/complementary medicine exists.
Section 5. TRADITIONAL MEDICINE COORDINATING UNIT. The Institute
shall establish a unit in its Metro Manila Office for the development and implementation
of its computerized (tri-media) information system on traditional and alternative
medicine.
This unit shall establish, in collaboration with various Councils of the Department
of Science and Technology (DOST), other universities in the Philippines, and other
institutions around the world, databases for herbal medicine and alternative medicine.
Section 6. ACCREDITATION OF TRADITIONAL MEDICINE
INSTITUTION/ PROGRAMS. The Institute shall develop a system of accreditation
that will ensure quality training, services and programs in the field of Traditional and
Alternative Health Care.
20
Section 7. MISLEADING OR UNLAWFUL INFORMATION. The responsibility
to inform the public of misleading or unlawful information on traditional and alternative
medicine shall rest with both the Institute and the Bureau of Food and Drugs (BFAD) of
the Department of Health, in accordance with existing laws and regulations.
The Institute together with the BFAD shall regularly issue and publish guidelines
through tri-media facilities. The Institute, in collaboration with BFAD shall regularly
provide the consuming public with a list of natural products certified safe and efficacious,
with labels and other information materials free from misleading or unlawful or
irresponsible information.
RULE VII
RULES AND GUIDELINES FOR THE MANUFACTURE,
DISTRIBUTION AND SALES OF NATURAL PRODUCTS
Section 1. HERBAL MEDICINE / PHYTO MEDICINE. The Institute shall
formulate, in collaboration with the BFAD, the standards and guidelines for the
manufacture, quality control and marketing of natural products. This document shall
outline the requirements for a standardized procedure to be used by all local
manufacturers of alternative health products. This process to be called the Philippine
Current Good Manufacturing Practices for Natural Products (PCGMP-NP) will be a
consolidation of standards with the World Health Organization standard serving as a
benchmark. It shall also contain, the requirements and rules by which Philippine
distributors, traders, wholesalers and retailers of natural products are required to follow to
ensure the integrity of these products.
RULE VIII
CODES OF PRACTICE
Section 1. PHYTO-THERAPY. The Institute shall develop a Code of Practice for
practitioners of appropriately validated herbal medicines. This Code of Practice will
guide Institute-recognized medical and non-medical practitioners on the benefits,
indications, contraindications, limitations, rational use and prescription of alternative
21
health products from food to drug classifications. This Code will also include a referral
system between licensed medical and non-medical practitioners, their scope of
responsibilities, liabilities and accountabilities in accordance with relevant laws and
appropriate government regulations.
Section 2. ACUPUNCTURE. The Institute shall formulate the Philippine
Acupuncture Code of Ethics and Standards of Practice in accordance with existing laws.
Section 3. MASSAGE THERAPY. The Institute shall formulate the Codes of
Practice in Massage Therapy, using as guideline, the Occupational Skills Standard for
Massage Therapy (OSSMT).
Section 4. OTHER MODALITIES. It shall be the responsibility of the Institute to
develop other Codes of Practice and Standards to cover other
traditional/indigenous/alternative health practices that may, because of new scientific
evidences, be included as an acceptable modality in our National Health Care Delivery
System.
Section 5. ACCREDITATION. The Institute shall develop a system to accredit
practitioners of traditional and alternative medicine.
Section 6. CONTINUING EDUCATION. It shall be the responsibility of
practitioners of traditional and alternative medicine to continually improve oneself thus
ensuring public safety by undergoing Institute accredited seminars, conventions, lectures,
etc.
RULE IX
PROTECTION OF BIOLOGICAL AND GENETIC
RESOURCES INCLUDING INDIGENOUS KNOWLEDGE
SYSTEMS
Section 1. FREE AND PRIOR INFORMED CONSENT. The exploration as
well as utilization of biological and genetic resources, including the indigenous
knowledge systems associated therein, shall be done with the free and prior informed
consent of the communities possessing these knowledge systems and living where these
resources may be found.
Section 2. ACCESS TO BIOLOGICAL & GENETIC RESOURCES
INCLUDING INDIGENOUS KNOWLEDGE SYSTEMS. The Institute shall
endeavor to effectively implement laws, executive issuances and ordinances governing
access to the country’s biological and genetic resources. It shall assume the
responsibilities of the Traditional Medicine Unit as a member of the Inter-Agency
22
Committee on Biological and Genetic Resources under Executive Order No. 247, the
Sub-Committee on Biodiversity of the Philippine Council for Sustainable Development,
the National Committee on Biosafety of the Philippines and other developmental bodies
and councils provided by law and executive issuance’s. In order to carry out this transfer,
the Board shall make the appropriate representations to the Secretary of Health.
The provisions of existing laws and regulations, particularly Executive Order 247
and Republic Act 8371 or the Indigenous Peoples Rights Act must be complied with
before access to biological and genetic resources can be made. Biodiversity prospecting
activities that do not comply with existing laws and regulations on the subject as well as
these rules shall be deemed an act of biopiracy. The Board shall take the appropriate
steps, in collaboration with all branches of government, in order to penalize the
perpetrators of these acts as well as to minimize and/or stop these activities
Section 3. DOCUMENTATION OF INDIGENOUS KNOWLEDGE SYSTEMS
ON TRADITIONAL AND ALTERNATIVE HEALTH CARE. The Board shall
endeavor to develop workable mechanisms, in accordance with the customary practices
of the place, for the identification and documentation of indigenous knowledge systems
relevant to the utilization of biological and genetic resources that are applied in traditional
and alternative health care practices of the community.
Section 4. INTELLECTUAL PROPERTY RIGHTS. All products and by-
products derived from Philippine medicinal plants using the resources and facilities of the
Institute in their development shall be the property of the Institute and the Philippine
Republic.
The Institute shall likewise endeavor to develop its intellectual property rights
portfolio to maximize the benefits that can be derived from the various intellectual
properties that it may secure from its research and development activities.
Assistance to Filipino inventors, scientists and entrepreneurs in the form of efforts
in securing appropriate intellectual property rights and technology transfer agreements in
the Philippines and abroad shall be provided by the Institute. Whenever appropriate and
necessary, the Institute shall apply for intellectual property rights protection in
accordance with applicable treaties and laws for any material, products and by-products
derived from medicinal plants including patents for the processes utilized in the
manufacture of these natural products and by-products, in behalf of the Philippine
Government, Philippine Herbal Industry and other stakeholders.
The Institute shall endeavor to monitor and inventory Philippine natural health
products that have been inappropriately applied for intellectual property rights protection
in the Philippines and abroad without complying with applicable laws and regulations
and shall make representations with the appropriate international institutions and agencies
with the assistance of other institutions and agencies of the Government of the
23
Philippines, to cancel this rights or to renegotiate the terms and conditions thereof that are
favorable to Philippine interests.
The application of existing forms of intellectual property rights on biological and
genetic resources as well as indigenous knowledge systems shall be without prejudice to
the application of whatever sui generis rights that may be provided by law to the
appropriate local and indigenous communities. The Board or other appropriate
governmental bodies shall also intervene, whenever it becomes necessary for the
protection of the general welfare of the communities involved, to protect and ensure the
rights of the communities during the negotiations for benefit sharing.
RULE X
CONSERVATION AND PROTECTION
The Institute shall identify certain protected areas, particularly those that have
been established by law and currently managed by the Department of Environment and
Natural Resources (DENR) and to take steps to develop them as priority conservation and
protection areas as its contribution to the conservation and protection strategy of the
country’s natural resources, as well as, provide a steady supply of raw materials for the
Institute’s medicinal plant research and development agenda. The Institute shall, as part
of its conservation and protection strategy, ensure that its partner organizations and
individuals involved in medicinal plant cultivation include reforestation and other
sustainable forestry and agriculture activities as an integral part of its farming practices.
RULE XI
HOLISTIC HEALTH CARE DELIVERY SYSTEM
Section 1. APPROACH. An appropriate scientific approach that takes into
consideration the wide discrepancies between the principles of Eastern and Western
medical practices will be adopted by the Institute in validating traditional and alternative
health products and modalities prior to its introduction and integration in the Philippine
Health Care Delivery System.
Section 2. TRADITIONAL AND ALTERNATIVE MEDICINE TREATMENT
CENTERS. For the protection of the general public and for the benefit of practitioners of
traditional and alternative medicine, The Institute shall establish “Treatment Centers”
initially in select government hospitals and other institutions where alternative health
modalities may be widely practiced under close monitoring of the Institute. These
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“Treatment Centers” will be venues by which accredited alternative health practitioners
may treat patients.
Section 3. ACCREDITATION OF TRADITIONAL MEDICINE CENTERS.
The Institute shall formulate guidelines on the accreditation of Traditional and
Alternative Medicine Centers. Such guidelines shall ensure the minimum requirements
required of a Traditional Medicine Center as well as the qualifications for personnel of
these Traditional Medicine Centers.
Section 4. HOSPITAL-BASED SERVICES. Aside from the “Treatment Centers”
located in state-run hospitals, sections for Traditional Medicine under the Department of
Family Medicine shall be established in partner private hospitals as part of a nationwide
hospital-base network coordinated and supported by the Institute. These sections shall
provide for structures, facilities and manpower that would facilitate the validation process
of thousands of medicinal plants and various alternative health care modalities currently
considered as pseudo-sciences.
Section 5. COMMUNITY-BASED SERVICES. The Institute in coordination with
the DOH and DILG will provide support to the local government units. This will come in
the form of technical assistance and skills transfer to be provided by the Institute and
Institute-accredited Academic Institutions and Non-Government Organizations involved
in promotion and advocacy of traditional medicine.
Section 6. LIVELIHOOD PROGRAMS AND TRAINING. In coordination with
Technology and Livelihood Resource Center (TLRC) and other organizations, the
Institute shall provide short-training courses in the propagation and small-scale
manufacture of natural health products will be provided to the general public.
Section 7. INSURANCE. The Institute shall also study ways and mechanisms
by which certified alternative health practitioners, products and accredited clinics,
hospitals and wellness centers may be included in the coverage of current health
insurance schemes and systems.
RULE XII
MONITORING AND REPORTING
25
Section 1. MONITORING PROGRAM. It shall be the responsibility of
selected personnel of the Institute along with agents of the DENR and BFAD to monitor
individuals, groups, schools and corporations engaged in the unauthorized export of
Philippine medicinal plant raw materials and importation or dumping of questionable
and/or banned foreign natural products and report such incident to the respective
government agency mandated by law to protect our natural resources and consuming
public. The Institute shall also endeavor to formulate the necessary regulations, in
collaboration with the DENR and BFAD, to penalize these acts.
Section 2. REPORTING PROCEDURES. The General Managers of the Herbal
Pharmaceutical & Processing Plants shall report to the Board of Trustees on a quarterly
basis the following reports:
1. Amount of herbal raw materials produced per quarter.
2. Amount of raw materials purchased from contract farmers.
3. Amount of semi-processed raw materials e.g. powders produced and sold.
4. Amount of finished products e.g. tablet, capsule, syrup produced and sold.
5. Miscellaneous services done for private contracting parties namely:
a) Bioassay procedures performed.
b) Microbiological quality tests and Chemical analysis performed.
c) Packaging services rendered, and
6. Financial Reports.
7. Others as determined by the Director General of the Institute.
RULE XIII
ORGANIZATION
Section 1. STRUCTURE. The Board shall develop an organizational structure that
shall be consistent with its Corporate Plan. An adhoc Working Committee shall be
organized to study/audit the existing organization, staffing pattern, and resources as well
as provide recommendations subject to the approval of the Board.
Section 2. HUMAN RESOURCE DEVELOPMENT. The Institute shall
develop a comprehensive Human Resource Development Plan for its personnel and
practitioners of traditional and alternative medicine.
RULE XIV
EXECUTIVE OFFICERS OF THE INSTITUTE
26
Section 1. DIRECTOR GENERAL. The Institute shall be headed by a Director
General who shall be appointed by the President of the Philippines upon the
recommendation of the Secretary of Health for a term of six (6) years. The Director
General shall enjoy the benefits, privileges and emoluments equivalent to the rank of
Undersecretary.
As Chief Executive Officer of the Institute, the Director General shall exercise
general supervision and control over operations and affairs of the Institute.
Section 2. POWERS, FUNCTIONS AND DUTIES OF THE DIRECTOR
GENERAL. The Director General shall have the following powers, functions and duties:
(a) To exercise overall supervision and direction over the implementation of all
research and development programs of the Institute, and to supervise and
direct the management, operation and administration of the Institute;
(b) To execute contracts, including deeds that may incur obligations, acquire and
dispose of assets and deliver documents on behalf of the Institute, within the
limits of authority delegated to him by the Board;
(c) To implement and enforce policies, decisions, order, rules and regulations
adopted by the Board;
(d) To act on the recommendation of the duly constituted Working Committee in
furtherance of the Institute’s authority to inspect and monitor compliance with
its standards and guidelines;
(e) To submit to the Board an annual report of the Institute;
(f) To submit to the Board an annual budget and such supplemental budget as
may be necessary for its consideration and approval; and,
(g) To exercise such other powers and functions and perform such other duties as
may be authorized or assigned by the Board.
Section 3. DEPUTY DIRECTOR(S) GENERAL. The Director General shall be
assisted by such Deputy Director(s) General (DDG), whose term of office shall be
determined by the Board. Designation of other DDG’s will be through the prerogative of
the Board. The Deputy Director (s) General shall be career official(s) and shall enjoy the
benefits, privileges and emoluments equivalent to the rank of an Assistant Secretary.
In instances when the office of the Director General becomes vacant, through
causes provided for by Civil Service Laws, Rules and Regulations, the Board may
designate such Deputy Director-General who shall serve the unexpired term of the
27
Director General, without prejudice to his reappointment to a new term, whenever the
Board finds it appropriate and necessary.
Section 4. OTHER OFFICERS. The Director General shall likewise be assisted by
department/ program manager/coordinator and such other officers as the Board may
authorize. The position titles, ranks and emoluments of such officers shall be determined
by the Board.
RULE XV
FUNDS
Section 1. TRADITIONAL AND ALTERNATIVE HEALTH CARE
DEVELOPMENT FUND. A Traditional and Alternative Health Care Fund is created
and to be managed/administered by the Institute. The Fund shall be used exclusively for
the programs and projects of the Institute. The Fund shall be initially sourced from
earnings of the Duty Free Philippines as follows:
(a) Fifty Million pesos (P50,000,000.00) for the first year
(b) Seventy Five Million pesos (P75,000,000.00) for the second year
(c) One Hundred Million pesos (P100,000,000.00) for the third year
Not more than fifteen percent (15%) of the Fund sourced from the Duty Free
Philippines shall be used for the administrative costs of the Institute.
Thereafter, such amount as may be necessary to fund the continued
implementation of this Act shall be included in the Annual General Appropriation Act.
Section 2. TRUST FUND. The Institute shall establish and generate a Traditional
and Alternative Medicine Trust Fund which may be sourced from donations, grants,
endorsements, legacies, devices and similar acquisitions which the Institute may generate
as provided for by law. The earnings/income from such fund shall be utilized exclusively
for institutional development and capability building as well as for the award of grants for
development activities in the area of traditional and alternative medicine.
Section 3. INCOME FROM OPERATIONS AND OTHER ACTIVITIES.
Income derived from the operations of the Herbal Pharmaceutical and Processing Plants
and other income generating services/activities of the Institute shall be utilized to
augment maintenance and operating expenses, capital outlays, upgrading and
modernization of the Institute.
RULE XVI
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BUSINESS PLAN
The Institute shall develop a business plan that will ensure its financial viability
and its sustainability as a corporation. Any amendments that will update and modify such
plans shall be undertaken by adhoc Working Committees.
RULE XVII
AMENDMENTS OR REVISIONS OF THE
IMPLEMENTING RULES AND REGULATIONS.
Section 1. SUCCEEDING AMENDMENTS OF THE IMPLEMENTING
RULES AND REGULATIONS. The Board may amend specific provisions of this
IRR or revise the entire contents thereof from time to time whenever in a regular meeting,
a member of the Board shall make a motion stating the necessity of an amendment or
revision.
The Board, by majority vote of all its members, shall adopt a resolution
concurring with such motion and making the corresponding preparations, to enable the
Board to undertake such amendment or revision. The Board may form an adhoc Working
Committee or hire technical consultants to formulate the provisions that may amend or
revise the existing Implementing Rules and Regulations.
The draft provisions amending or revising the IRR shall be subjected to public
consultations nationwide. The number of consultations shall be determined by the Board.
The final text of the amended or revised IRR shall be adopted by the Board in a regular
meeting by a majority vote of all its members.
RULE XVIII
TRANSITORY AND FINAL PROVISIONS
29
Section 1. TRANSFER OF FUNCTIONS, PERSONNEL AND ASSETS OF
THE TRADITIONAL MEDICINE UNIT AND OTHER RELATED UNITS. The
functions and schedule for the transfer of personnel and assets of the Traditional
Medicine Unit and all the Pharmaceutical and Herbal Processing Plants of the
Department of Health shall be drafted in coordination with the reorganization plans of the
Department of Health and in consultation with the Regional Offices involved.
Section 2. INTERIM STAFF. Pending the approval of and implementation of the
organizational structure, staffing pattern of the Institute, incumbent officials and
employees of the affected/merged offices/units including detailed personnel of the
Traditional Medicine Unit and Department of Health Central Office deployed personnel
shall constitute the interim workforce and shall continue to exercise their respective
functions, duties and responsibilities with corresponding benefits and privileges.
Section 3. INITIAL FUNDING. The budget of offices, agencies and units of the
Department of Health that have been merged shall be consolidated and utilized for the
operations of the Institute.
Section 4. HIRING OF INSTITUTE PERSONNEL. The hiring procedures shall
conform with existing civil service rules and regulations and/or those, which the Board
shall prescribe. To the greatest extent possible and in accordance with existing laws, all
employees of the affected offices, agencies and units shall be absorbed by the Institute.
Personnel to be absorbed shall express their willingness to be placed in any position
conferred to them that is appropriate to their qualification and without reduction in
remuneration.
Section 5. SEPARATION OR RETIREMENT BENEFITS. Those personnel who
are not hired by the Institute and/or separated from the service as a result of the
implementation of this Act shall be paid their separation or retirement under existing
laws.
Section 6. EXISTING POLICIES AND PROGRAMS. Existing policies and
programs/projects of offices, agencies and units merged and/integrated shall remain in
force unless or until awarded or revoked by these Rules or by the Institute.
Section 7. SEPARABILITY CLAUSE. If any provision of these Implementing
Rules and Regulations (IRR) is held invalid or unconstitutional, any other provision not
so affected shall continue to be in full force and effect.
Section 8. EFFECTIVITY. This Implementing Rules and Regulations and future
amended or revised versions shall take effect fifteen (15) days after its publication in the
Official Gazette or in at least two (2) newspapers of general circulation.
30
Approved by the Board of Trustees of the Philippine Institute of Traditional and
Alternative Health Care (PITAHC) on ____________________ under Board Resolution
No. _________, series of 1999.
Approved in the City of Manila, Philippines, this _________ of _________, in the
year of our Lord, Nineteen Hundred and ninety-nine.
BOARD OF TRUSTEES
______________________________________
(SGD) ALBERTO G. ROMUALDEZ JR., MD
Chairman of the Board of Trustees
Secretary, Department of Health
Government Representatives Sectoral
Representatives
_____________________________________
_____________________________________
(SGD) MR. DENNIS B. ARAULLO (SGD) ARGENTE M. ALEJANDRO,
MD
Member of the Board Member of the Board
Director, Department of Agriculture Representative, Philippine Medical
Association
31
_____________________________________
______________________________
_______
(SGD) ATTY. WILFRIDO S. POLLISCO (SGD) MS. GRACE B. ELEAZAR
Member of the Board Member of the Board
Director, Department of Environment and Representative, Natural/Organic Food
Natural Resources Industry Sector
_____________________________________
______________________________
_______
(SGD) ADELFO A. TRINIDAD, MD (SGD) MR. BIBIANO S. FAJARDO
Member of the Board Member of the Board
Director, Department of Education, Representative Non-physician from the
Culture and Sports Traditional and Alternative Health
Care Sector
______________________________________
______________________________
_______
(SGD) REMIGIA A. NATHANIELZ, Ph.D. (SGD) FRANCIS WADE Z. GOMEZ,
MD
Member of the Board Member of the Board
Director, Commission on Higher Education Representative Physician from the
Traditional
and Alternative Health Care Sector
______________________________________
______________________________
_______
(SGD) PACITA L. ZARA, MD (SGD) ATTY. ELPIDIO V. PERIA
32
Member of the Board Member of the Board
Executive Director, Department of Science Representative, Environmental Sector
and Technology
_________________________________
____
(SGD) ISIDRO C. SIA, MD
Member of the Board
Representative, Academe/Research
Institution Sector