Cannabis Medicalization Act of the Philippines

TWENTIETH CONGRESS OF THE REPUBLIC OF THE PHILIPPINES First Regular Session 25 JUL -2 P4:27 SENATE S. No. _ Introduced by Senator Robinhood Padilla AN ACT PROVIDING FOR THE MEDICALIZATION OF CANNABIS, EXPANDING ACCESS TO MEDICAL CANNABIS AS A MEANS OF MEDICAL TREATMENT, EXPANDING RESEARCH INTO ITS MEDICINAL PROPERTIES, ENUMERATING PROHIBITED ACTS AND PRESCRIBING PENALTIES THERETO EXPLANATORY NOTE The 1987 Constitution guarantees every Filipino's rights to life, liberty, and the pursuit of well-being. These include the right to health and the right to make informed decisions about one's own medical treatment - a cornerstone of patient autonomy. This proposed measure seeks to uphold that right through the medicalization of cannabis in the country. In 2020, the United Nations Commission on Narcotic Drugs, based on the recommendation of the World Health Organization, reclassified cannabis from Schedule IV to Schedule I on the ground of its medical use and potential abuse. Scientific evidence that medical cannabis possesses therapeutic benefits, particularly for individuals suffering from debilitating medical conditions such as epilepsy, chronic pain, multiple sclerosis, cancer, and other terminal or life-altering illnesses is continuously growing in many countries across the globe. This bill is anchored on science and evidence contained in many researches and medical journals that states that medical cannabis can serve as a complementary or

alternative treatment to alleviate the suffering of patients who continue to endure pain, seizures, or loss of function, despite undergoing conventional treatments. The bill also proposes the creation of the Philippine Medical Cannabis Authority (PMCA) under the Department of Health, which shall serve as the key agency that will regulate every aspect of the medical cannabis ecosystem-from cultivation, manufacturing, labelling to prescription, dispensation, and monitoring. Safeguards through regulatory measures are likewise embedded throughout the bill to ensure that misuse and diversion are prevented. These safety nets include the following: a) Issuance of prescriptions only by trained, licensed physicians with an S2 license; b) Establishment of a Prescription Monitoring System and a Cannabis Plant Monitoring System; c) Limitation of use only to specific, serious and debilitating medical conditions; d) QR-coded patient registry cards and electronic verification protocols; and e) Strict licensing, location zoning, and security requirements for industry players. The bill also penalizes any individual, whether a patient, doctor or industry player that commits any of the prohibited acts and violates any provision of the measure. During the 19th Congress, a version of this bill was approved on third and final reading at the House of Representatives while this Senate version had already reached the Plenary until the period of interpellations. This feat, which was the farthest that a medical cannabis had reached in Congress demonstrates the strong and growing consensus among legislators for compassionate and science-based healthcare reform. Contrary to the fears of many, this legislation is not, in any way, paving the road toward the recreational use of cannabis. It is a clearing the way to a responsible, health-centered response to human suffering, guided by science, ethical principles, and stringent safeguards. Through this measure, we are not only expanding treatment options for our countrymen - we are reaffirming the dignity of every Filipino patient and their right to choose a better quality of life.

In view of the foregoing, the immediate passage of this bill is earnestly sought. ROBINHOOD PADILLA Senator

TWENTIETH CONGRESS OF THE REPUBLIC OF THE PHILIPPINES ) First Regular Session JUL -2 P4:21 SENATE S. No. Introduced by Senator Robinhood Padilla AN ACT PROVIDING FOR THE MEDICALIZATION OF CANNABIS, EXPANDING ACCESS TO MEDICAL CANNABIS AS A MEANS OF MEDICAL TREATMENT, EXPANDING RESEARCH INTO ITS MEDICINAL PROPERTIES, ENUMERATING PROHIBITED ACTS AND PRESCRIBING PENALTIES THERETO Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:

Section 1. Short Title. - This Act shall be known as the "Cannabis Medicalization

Act of the Philippines."

Sec. 2. Declaration of Policy. - It is the policy of the State to adopt an integrated

4 and comprehensive approach to health development which shall endeavor to make 5 essential goods, health, and other social services available to all the people at affordable cost. The State shall protect and promote the right to health of the people and instill health consciousness among them. Pursuant thereto, the State shall legalize and regulate the medical use of cannabis which has been confirmed to have beneficial and therapeutic uses for known debilitating medical conditions.

Sec. 3. Definition of Terms. - As used in this Act:

a. Cannabis includes every species and variety of the genus cannabis, whether dried or fresh and flowering or fruiting tops, or any part or portion of the plant and seeds thereof, and all its geographic varieties, whether as a reefer, resin, extract, tincture or in any form whatsoever;

b. Closed Locked and Controlled Facility refers to a closet, room or other comparable, stationary, and fully enclosed area equipped with secured locks, or other functioning security devices that permit access only to authorized personnel of the medical cannabis industry players' cultivation, extraction, processing, manufacturing and production sites and dispensary; C. Debilitating Medical Condition refers to a condition that is severe, persistent, and seriously affecting the patient's strength and ability to function and carry on most of daily living activities, as identified and included in the Good Clinical Practice to be formulated and developed by the Philippine Medical Cannabis Authority (PMCA) established under this Act; d. Medical Cannabis refers to cannabis based medicinal products (CBMP) in their pharmaceutical formulation which shall contain cannabidiol (CBD) with no more than 0.3 percent (0.3%) tetrahydrocannabinol (THC). THC shall only be allowed as a component of CBD. e. Medical use refers to the use of medical cannabis as a complementary treatment to alleviate a qualified patient's debilitating medical condition or symptoms, and shall include its acquisition, possession, transportation, delivery, dispensation, administration, cultivation, or manufacturing, research and development for medical purposes; f. 52 License refers to a license issued by the PDEA to a Professional Regulatory Commission (PRC)-registered physician; and g. Written Prescription refers to a document dated and signed by a PRC- registered physician possessing an S2 License, containing the debilitating medical condition of the qualified patient under Section 8 of this Act, the recommended dosage of medical cannabis, and treatment plan for palliative care.

Sec. 4. Medicalization of Cannabis. - The use of cannabis for medical purposes,

as herein provided under this Act, is hereby permitted, in the formulation provided

under Sec. 3(d) hereof, to treat or alleviate a qualified patient's debilitating medical condition or symptoms. The medicalization of cannabis includes its acquisition, possession, transportation, delivery, dispensing, administration, cultivation, or manufacturing by private individuals or entities only for medical and research 5 purposes.

Sec. 5. Philippine Medical Cannabis Authority. - There shall be created a

7 Philippine Medical Cannabis Authority, herein referred to as "PMCA" under the 8 Department of Health (DOH), which shall be the principal regulatory agency in the 9 access and use of medical cannabis and in the implementation of this Act. It shall be 10 headed by a Director to be designated by the President of the Republic of the Philippines upon recommendation of the Secretary of Health. The DOH shall organize the Authority, including its staffing pattern, and shall ensure its knowledge, competence, and experience with the use of cannabis and regulation of dangerous drugs for medical purposes. Necessary staffing requirements may be requested from the Department of Budget and Management. The PMCA shall be assisted by an inter-agency Medical Cannabis Advisory 17 Committee.

Sec. 6. Powers and Functions of the Philippine Medical Cannabis Authority. -

The PMCA shall have the following powers and functions: a. To formulate and adopt a Comprehensive Cannabis Medicalization Plan; b. To formulate, adopt and implement rules, regulations, and guidelines related to medical cannabis plants, its products and by-products, including but not limited to, propagation, cultivation, planting, harvesting, processing, manufacturing, packaging, labeling, distribution, dispensing, and patient licenses or prescription; c. To establish and maintain an information system especially to track cannabis growth from seed to sale for monitoring and regulation purposes: Provided, That the PMCA shall monitor or regulate the cultivation,

manufacture, storage, distribution, prescription, dispensation and sale of medical cannabis by licensed dispensaries; d. To formulate, adopt, publish and implement Standard Operating Procedures for every stage of producing medical cannabis, such as, but not limited, to the following: i. Good Clinical Practice (GCP); ii. Good Agriculture Practice (GAP); iii. Good Manufacturing Practice (GMP); iV. Good Distribution Practice (GDP); V. Good Waste Disposal Practice (GWDP); and vi. Good Security Practice (GSP). e. To issue licenses to duly registered entities or persons, private or government, that shall engage as medical cannabis industry players through cultivation, manufacturing, production, dispensing, research and development, and importation and sale of medical cannabis; f. To regularly and continuously conduct research and development on the medical cannabis industry and apply the same to further develop the industry in the country; g. To conduct or sponsor or arrange or permit training and educational programs on specific aspects of the medical cannabis industry: Provided, That the said training and educational programs shall be a prerequisite to permitting licensed physicians to prescribe and other medical practitioners to dispense medical cannabis products or by-products; h. To establish a Prescription Monitoring System and maintain an electronic database of registered medical cannabis patients, their physicians, and other qualified entities for monitoring and regulation purposes;

i. To hold seminars, workshops, conferences and information dissemination campaigns on the medical cannabis industry, its products, and by-products, particularly on the therapeutic and medical effects of cannabis as authorized in this Act and the risk associated with the use of cannabis for recreational activities; j. To make recommendations to the Commission on Higher Education to include medical cannabis as a subject or course in the curriculum of universities and colleges for academic degrees in agriculture, medicine, and applied science and technology; k. To make recommendations to PRC to develop and implement a Continuing Professional Development Program on Medical Cannabis for physicians, pharmacists, and other allied medical and health care professionals; I. To hire or contract consultants, local or foreign, individuals or entities, for technical capacity building; m. To import for resale in the Philippines for authorized users medical cannabis products from foreign manufacturers or companies: Provided, That the said medical cannabis products comply with the safety and quality standards prescribed by PMCA, in consultation with the Advisory Committee as provided for in this Act: Provided further, That the testing of any medical cannabis product to determine its potency, consistency, safety and effectivity, as well as compliance with packaging and labeling safety requirements shall remain with the Food and Drug Administration (FDA); n. To regulate prices of medical cannabis products in the country; o. To accept grants and technical assistance in support of medical cannabis research and development; and p. To perform other functions as may be deemed necessary to aid the implementation of this Act.

Sec. 7. Advisory Committee on Medical Use of Cannabis. - There is hereby

2 constituted an advisory committee on the medical use of cannabis, hereinafter referred 3 to as the Medical Cannabis Advisory Committee (MCAC), which shall assist and provide 4 directions in the formulation, implementation and assessment of the policies, 5 guidelines, and regulations under this Act. The Secretary of Health shall serve as the ex-officio chairperson of the MCAC. 7 The Chairman of the Dangerous Drugs Board (DDB), the Directors-General of the FDA 8 and the PDEA, the Secretary of Science and Technology and the Secretary of 9 Agriculture or their respective representatives shall be permanent members of the 10 Medical Cannabis Advisory Committee. The Secretary shall appoint the seven regular members of the MCAC who shall 12 serve for a term of three (3) years. It shall be comprised of three (3) PRC-registered 13 physicians, two (2) experts in the regulation of controlled substances for medical use, and two (2) representatives from nationally recognized organizations of patients with debilitating medical conditions: Provided, That the seven regular members must be 16 citizens and residents of the Philippines, of good moral character, of recognized probity 17 and independence, and must distinguish themselves professionally in public, civic or academic service and must have been in the practice of their professions for at least ten (10) years: Provided, further, That the regular members shall nominate a Vice- 20 Chairperson from among themselves, and shall receive an honoraria in accordance 21 with existing laws, rules and regulations. The MCAC shall meet once a month or as often as necessary at the discretion of the Chairperson.

Sec. 8. Qualified Patient. - The qualified patient is a person who has been

diagnosed by a certifying physician as having a debilitating medical condition as defined in Section 3 (c) and may receive therapeutic or palliative benefits from the use of medical cannabis. Qualified patients shall be registered with the PMCA and assigned a unique alphanumeric identification number and shall be issued a registry card with a quick response (QR) code for verification.

If the qualified patient is a minor or is incapable or incapacitated to fully give his consent, regardless of age, the certifying physician shall explain to the patient and to the custodial parent or legal guardian the potential risks and benefits of using medical cannabis. The custodial parent or legal guardian shall signify, in writing, their consent to allow the qualified patient's medical use of cannabis.

Sec. 9. Issuance of Written Prescription, Requisites. - A written prescription

allowing the use of medical cannabis shall be recognized and accepted if issued by a physician who: a. Is duly licensed by the PRC and in good standing; b. Has no previous or existing criminal or administrative case/s; and c. Is a holder of an S2 license issued by PDEA and has undergone appropriate medical cannabis training from PMCA. The certifying physician shall not issue a written prescription for his or her own use, or the use of his or her immediate family or relatives within the second civil degree of consanguinity or affinity. The certifying physician shall maintain a record of all his issued written prescriptions. He or she shall be responsible for maintaining a record of every qualified patient prescribed the use of medical cannabis, specifically describing the quantity administered/used, therapeutic/desired effect, and any adverse reaction, at the end of each year.

Sec. 10. Validity of Prescription. - The written prescription issued by all

certifying physicians shall include a validity period which shall in no case exceed one (1) year from the date of issuance.

Sec. 11. Grounds for Revocation of Prescription. - Any prescription issued by a

certifying physician may be revoked based on the following reasons: a. Misuse or diversion of the written prescription; b. Failure to abide by the prescribed dosage and form;

C. The patient no longer suffers from a debilitating medical condition; d. The patient has not received a therapeutic or palliative benefit from the use of medical cannabis; and e. When the qualified patient has died.

Sec. 12. Standardized Written Prescription. - The PMCA shall develop and

require the use of a standardized format for all written prescriptions and the same shall be made available to all certifying physicians. The standardized format shall include the following details: (a) name, date of 9 birth, and address of the qualified patient; (b) a statement that the qualified patient 10 has debilitating medical condition as provided in Section 3 (c) and that the qualified patient is under the certifying physician's care for the debilitating medical condition; 12 (c) recommended form and dosage of medical cannabis; (d) issue and expiry date of 13 the prescription; and (e) name, address, telephone number, handwritten signature.

Sec. 13. Administration of Medical Cannabis. - Medical cannabis may be

15 administered through the following: (a) oral; (b) sublingual; (c) inhalation inhalers; 16 (d) topical; and (e) suppositories.

Sec. 14. Medical Cannabis Industry Players. - Only duly registered entities or

18 persons shall be allowed to engage as medical cannabis industry players to conduct 19 any of the following acts in relation to medical cannabis: (a) cultivation; (b) 20 manufacturing; (c) production; (d) dispensing; (e) research and development; (f) importation; and (g) dispensing and sale: Provided, That all industry players shall 22 apply and be issued appropriate licenses by the PMCA and other national government agencies concerned prior to engagement in any business operations as regards medical cannabis: Provided further, That industry players shall be strictly regulated and shall, at all times, comply with the provisions of this Act and the rules, regulations, 26 guidelines and standard operating procedures to be formulated for its implementation.

Sec. 15. Cultivation, Production and Manufacturing of Cannabis. - The specific

areas allowable for the cultivation of cannabis shall be identified by the PMCA: 29 Provided, That cultivation shall only be permitted in a closed locked and controlled

facility and that cultivation shall not be located within one (1) kilometer of the property 2 line of a pre-existing public or private school, college or university, daycare center, child care facility or an area zoned for residential use: Provided, further, That colleges 4 or universities conducting research and development on medical cannabis are 5 exempted from the one (1) kilometer radius requirement. The PMCA shall issue appropriate licenses and permits for the cultivation, production, and distribution of medical cannabis subject to DDB guidelines. It shall also adopt measures that will ensure the prevention of misuse and illicit traffic of the 9 cannabis plant, such as the establishment of a cannabis plant monitoring system. The PMCA is hereby authorized to engage consultancy services of foreign 11 cannabis experts for the initial cultivation and production of medical cannabis. The PMCA shall facilitate the initial importation of seeds required for the 13 cultivation and production of medical cannabis: Provided, That the imported seeds are used solely for the initial cultivation of locally grown cannabis: Provided further, That importation of seeds shall be allowed only in the initial stage of the implementation of 16 this Act or a period of not more than five (5) years or until the industry players are 17 fully capacitated to independently cultivate locally-grown cannabis.

Sec. 16. Medical Cannabis Products. - Medical cannabis products shall be in the

19 form of edibles, pills, oil, tincture, flower, topicals, and inhalers. Importation of the same products from countries with stringent regulatory agencies or countries with established medical cannabis regimes or countries already using the same medical cannabis products in the last five years, shall be allowed under this Act. Importation 23 of medical cannabis products from countries not using their own products shall be prohibited.

Sec. 17. Medical Cannabis Product Label and Packaging. - All medical cannabis

products shall be properly and adequately labeled like that of any pharmaceutical products. The label shall contain the following information, among others: a. CBD and THC content and ratio; b. Batch and Series number;

C. Date of production and expiration; d. Clinical Indications and Contraindications; e. Dosage and Administration Instruction; f. Storage Instruction; and g. Other relevant information as may deemed necessary by the PMCA.

Sec. 18. Dispensing Medical Cannabis. - Prior to dispensing medical cannabis,

the authorized dispensaries must require the presentation of the registry ID card, scan 8 the QR code, examine the details, and update the data contained therein after the 9 sale. The QR code shall contain details such as the name of the certifying physician, the assigned unique alphanumeric identification number of the patient, the diagnosed medical condition of the qualified patient, the prescribed dosage, medical cannabis product and formulation, the duration of use, and the complete transaction history of 13 the qualified patient.

Sec. 19. Authorized Transport Vehicles. - Only authorized transport vehicles

shall be authorized to carry and transport medical cannabis plants and products.

Sec. 20. Electronic Verification. - The PMCA shall establish a Prescription

17 Monitoring System which shall be made accessible to the PDEA Compliance Service 18 and authorized dispensaries where they may electronically verify and determine the 19 validity of the registry ID card and information on whether the cardholder is a 20 registered qualified patient.

Sec. 21. Cannabis Plant Monitoring System. - The cultivation facilities shall

establish and maintain a Cannabis Plant Monitoring System for testing and data collection. It shall be available for inspection of regulatory agencies for purposes of documenting each cannabis plant and for monitoring plant development throughout the life cycle from seed planting to final packaging.

Sec. 22. Authority of the PMCA to Enter Premises. - To ensure compliance with

27 the provisions of this Act, the PMCA may, at all times, enter every building, room, enclosure, or premises occupied or used for the cultivation, production, preparation,

manufacture for sale, storage, and sale of medical cannabis, and to inspect the premises and all equipment, apparatuses, fixtures, furniture, and machinery used for the preparation thereof.

Sec. 23. Testing of Medical Cannabis. - The PMCA shall test all medical cannabis

5 products prior to their distribution, dispensation, and sale to determine their potency, consistency, safe and effective use. It shall ensure that all medical cannabis products are medical grade and safe for use. It shall ensure that all medical cannabis products are individually wrapped at the original point of preparation and conform to existing packaging and labeling requirements of the PMCA and FDA.

Sec. 24. Exemption from Civil and Criminal Liability. - Subject to Section 25 of

this Act, the following shall be exempt from civil and criminal liability: a. The certifying physician, as defined in Section 9 of this Act, for issuing written prescriptions stating that in the physician's professional opinion, a patient is qualified to receive therapeutic or palliative benefit from the medical use of cannabis to treat or alleviate the patient's debilitating medical condition or symptoms; b. A qualified patient for using medical cannabis in the prescribed dosage and form for treatment of his debilitating medical condition as determined by a certifying physician; c. An authorized representative for assisting a registered qualified patient for possessing not more than the exact prescribed dosage of cannabis needed by the qualifying patient; d. The licensed medical cannabis industry players and their personnel authorized to dispense, cultivate, manufacture, or produce medical cannabis as provided under this Act; and e. Personnel of national government agencies tasked with testing medical cannabis and cannabis products, and other similar undertakings which

would require handling, transporting or otherwise possessing cannabis and cannabis products: Provided, That the said personnel of national government agencies are authorized by the PMCA to perform such undertakings: Provided further, That the said personnel are performing such undertakings while on duty inside an authorized or licensed cultivation, production, testing and dispensing facility.

Sec. 25. Prohibited Acts. - It shall be prohibited for:

a. A qualified patient to: i. Use cannabis for purposes other than for treatment of a debilitating medical condition and outside of the designated treatment facilities; ii. Use of cannabis with other illegal intoxicating or dangerous substances; and lil. Sell or give away medical cannabis. b. Any physician to: i. Prescribe medical cannabis without an S2 license; ii. Prescribe medical cannabis to any person who is not a qualified patient under this Act; ili. Prescribe the use of medical cannabis for purposes other than for treatment of a debilitating medical condition; iv. Prescribe medical cannabis in quantity more than the needed dosage; V. Fail or refuse to maintain the record of all his or her patients and prescriptions issued referred to in Section 9 of this Act; and

vi. Issue a written prescription for his or her own use, or the use of his or her immediate family or relatives within the second civil degree of consanguinity or affinity. c. A Medical Cannabis Industry Player to: i. Operate as a medical cannabis industry player without a license; ii. Acquire, possess, deliver, transfer, transport, supply, or dispense medical cannabis to any person except to registered qualified patients or through their authorized representatives; ili. Cultivate, manufacture, and store cannabis/medical cannabis in violation of any of the provisions of this Act; iv. Acquire usable cannabis or mature cannabis plants from illegal sources; V. Refer patients to an unqualified physician; vi. Dispense without presentation of the certifying physician's written prescription and valid registry ID card of the qualified patient or its authorized representative; vii. Dispense more than the required dosage for a patient; and viii. Fail to scan the QR Code of any qualified patient and update the Prescription Monitoring System prior to dispensing cannabis. d. Any person or entity to: i. Advertise the sale of medical cannabis in any manner, including printed materials, on radio or television, social media, internet or by paid-in-person solicitation of customers, and electronic games: Provided, That this shall not be construed to prohibit medical cannabis industry players from posting appropriate signages in their place of business or operation, and from being included in business directories, or sponsoring or organizing health, charity

or advocacy events, subject to the guidelines to be issued by the PMCA; ii. Violate the confidentiality of information under R.A. 10173, otherwise known as the "Data Privacy Act of 2012"; iii. Purchase of medical cannabis when not authorized to do so; iv. Falsifies an identification card issued by the DOH or an S2 license or possesses a falsified identification card and either attempts to use the card to obtain medical cannabis or obtains medical cannabis. Any person using or possessing a falsified identification card shall be presumed the author thereof; and Discriminates any qualified patient from any services in public or private establishment; employment in any public or private institution; or admission to any academic institution: Provided, That the qualified patient shall not partake in medical cannabis within the premises of the place of employment or the academic institution.

Sec. 26. Penalties. - Violation of any provisions of this Act shall be subject to

the penalties provided for under Republic Act No. 9165, as amended, or the "Comprehensive Dangerous Drugs Act of 2002".

Sec. 27. Research and Development. - The PMCA shall, within one hundred

twenty (120) days from the approval of this Act, use existing research made by reputable international organizations, as well as research made or published by its counterpart in countries wherein medical cannabis is administered.

Sec. 28. Medical Cannabis Research and Development Fund. - A portion of the

25 proceeds from licensing and registration of medical cannabis industry players shall be earmarked for the medical cannabis industry research, protection and development.

Sec. 29. Training of Medical Cannabis Physicians, Pharmacists, and Other Allied

Medical and Health Care Professionals. - The PMCA shall develop an appropriate

1 training program for physicians, pharmacists, and other allied medical and health care professionals on the following topics: the pharmacology of cannabis; contraindications; side effects; adverse reactions; overdose prevention; drug interactions; dosing; routes of administration; risks and benefits; warnings and precautions; abuse and dependence, and other related topics. Completion of the program shall be a precondition for the physician, pharmacists, and other allied medical and health care professionals, as may be licensed, to prescribe, dispense and 8 administer medical cannabis to qualified patients. The PMCA shall coordinate with the Commission on Higher Education to integrate the aforementioned topics on medical cannabis into the medical curriculum of all medical schools, and academic curriculum for agriculture and applied science and technology in all colleges and universities. The PMCA shall likewise coordinate with the PRC for the development and implementation of a Continuing Professional Development program on medical cannabis for certified physicians.

Sec. 30. Annual Reports. - The PMCA shall submit an annual report to the DOH

and to both Houses of Congress, which shall include the following information: a. Number of applications and renewals filed for registry identification cards; b. Number of registered qualified patients at the time of report; C. Nature of debilitating medical conditions of the qualified patients; d. Number of physicians authorized to issue prescriptions; e. Number of registry identification cards revoked for misconduct; f. Number of medical cannabis industry players; g. Assessment of the use of medical cannabis, research, and treatment of patients with a debilitating medical condition; and h. Other pertinent information.

Sec. 31. Joint Congressional Oversight Committee. - There is hereby created a

Joint Congressional Oversight Committee to conduct a regular review of the implementation of this Act. The Joint Congressional Oversight Committee shall be composed of five (5) Members from the Senate and five (5) Members from the House of Representatives 6 to be appointed by the Senate President and the Speaker of the House of Representatives, respectively. The Joint Congressional Oversight Committee shall be 8 jointly chaired by the Chairpersons of the Senate Committee on Health and 9 Demography and the House of Representatives Committee on Health.

Sec. 32. Implementing Rules and Regulations. - Within ninety (90) days from

the effectivity of this Act, the PMCA, in consultation with the appropriate government agencies, shall promulgate rules and regulations necessary for the effective implementation of this Act.

Sec. 33. Appropriations. - The amount necessary to carry out the

implementation of this Act shall be charged against the current year's appropriations 16 of the DOH. Thereafter, such sums as may be necessary for the continued 17 implementation of this Act shall be included in the annual General Appropriations Act.

Sec. 34. Separability Clause. - If any provision or part of this Act is declared

19 invalid or unconstitutional, the remaining parts or provisions not affected shall remain in full force and effect.

Sec. 35. Repealing Clause. - For purposes of this Act, pertinent provisions of

22 Republic Act No. 9165, as amended, otherwise known as the "Comprehensive Dangerous Drugs Act of 2002," as amended, and Republic Act No. 9711 or the "Food 24 and Drug Administration Act of 2019", and all other laws, decrees, orders, rules and regulations, or parts thereof, inconsistent with any provision of this Act, are hereby repealed or modified accordingly.

Sec. 36. Effectivity. - This Act shall take effect after fifteen (15) days from its

28 publication in the Official Gazette or in a newspaper of general circulation. Approved,