Rules and Regulations Implementing the Traditional and Alternative Medicine Act of 1997

December 7, 1999

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 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 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" — 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 is the 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 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" — 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 of 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 of hygienic or even limited therapeutic purposes. It also includes the practices 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" — 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)

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 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,

(t) To exercise such other powers and functions, and perform such other act 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.

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 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.

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 ad hoc Working Committees, composed of at least three (3) of its members, one of whom shall chair the said Committee created for that purpose. This ad hoc 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; and,

e) 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.

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.

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

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

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. prcd

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.

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, contra-indications, limitations, rational use and prescription of alternative 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 and 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 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 issuances. 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 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. prcd

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 "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 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

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 and 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 Ad hoc 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

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 submit to the Board an annual report of the Institute;

(e) To submit to the Board an annual budget and such supplemental budget as may be necessary for its consideration and approval; and,

(f) 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 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 Appropriations 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

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 ad hoc 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 ad hoc Working Committee 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

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. — The 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.

Approved by the Board of Trustees of the Philippine Institute of Traditional and Alternative Health Care (PITAHC) on Nov. 24 under Board Resolution No. 7, series of 1999.

APPROVED in the City of Manila, Philippines, this 7th day of December, in the year of our Lord, Nineteen Hundred and Ninety-Nine.

BOARD OF TRUSTEES

Government Representatives

(SGD.) ALBERTO G. ROMUALDEZ, JR., MDChairman of the Board of Trustees

(SGD.) MR. DENNIS B. ARAULLOMember of the Board

ATTY. WILFRIDO S. POLLISCOMember of the Board

(SGD.) ADELFO A. TRINIDAD, MDMember of the Board

(SGD.) REMIGIA A. NATHANIELZ, Ph.D.Member of the Board

(SGD.) PACITA L. ZARA, MDMember of the Board

Sectoral Representatives

(SGD.) ARGENTE M. ALEJANDRO, MDMember of the Board

(SGD.) MS. GRACE B. ELEAZARMember of the Board

(SGD.) MR. BIBIANO S. FAJARDOMember of the Board

(SGD.) FRANCIS WADE Z. GOMEZ, MDMember of the Board

(SGD.) ATTY. ELPIDIO V. PERIAMember of the Board

(SGD.) ISIDRO C. SIA, MDMember of the Board

Published in the Manila Standard on December 17, 1999.