REPUBLIC OF THE PHILIPPINES
HOUSE OF REPRESENTATIVES
QUEZON CITY

EIGHTEENTH CONGRESS
First Regular Session

2486
HOUSE BILL NO.

Introduced by REPRESENTATIVES ENRICO A. PINEDA and
MICHAEL ODYLON L. ROMERO, PhD.

EXPLANATORY NOTE

Section 2, Paragraph 2 of Republic Act No. 9165, otherwise known as the
Dangerous Drugs Act of 2002, provided that “the government shall however aim to achieve a
balance in the national drug control program so that people with legitimate medical needs are not
prevented from being treated with adequate amounts of appropriate medications, which include
the use of dangerous drugs.”

This bill seeks for the use of cannabis for medicinal Purposes. For more than 5,000
years, people have been using cannabis as a substance for relieving various ailments. It
was used extensively as a cure for severe pain, as an anti-pyretic to reduce high fever, a
sleeping aid to people with insomnia, administered as a relaxant to those with
involuntary muscle spasms or seizures and as a salve to treat gastro-intestinal disorders,
among other things.

Recently, cannabis, popularly known as marijuana, is being prescribed for the
treatment of people with epilepsy where it is proven to be effective in quelling severe
seizures, especially in children. It has also been given to patients afflicted with cancer
because of its ability to reduce the painful symptoms of the disease, while providing relief
from the nausea and vomiting associated with chemotherapy. It remains an effective
analgesic, able to relieve severe neurological and muscular pain. Likewise, itis prescribed
for the relief of rheumatoid-arthritis,

The use of medicinal marijuana has, as of 2017, been made legal in more than half
of the territory of the United States of America. Worldwide, there are now more than 30
countries that have legalized the use of medicinal marijuana. While other countries
legalized cannabis even for recreational uses, this measure only seeks to provide our
countrymen an additional treatment option where conventional methods are found
ineffective, while providing for control measures and strict regulation of its use. The
intention of this bill is in consonance with Section 11 of the Constitution which provides
that “it is the policy of the State to adopt an integrated and comprehensive approach to health


development which shall endeavor to make essential goods health and other social services available
to all the people at affordable cost.”

This bill was filed in the 17 Congress, underwent thorough deliberations and was
subsequently passed on the Third Reading. Hence, immediate passage of this measure
is earnestly prayed for.

Wee

in INEDA MICHAEL ODYLON L. ROMERO, PhD

1PACMAN 4 1PACMAN


REPUBLIC OF THE PHILIPPINES
HOUSE OF REPRESENTATIVES
QUEZON CITY

EIGHTEENTH CONGRESS
First Regular Session

House BILL No._2485 _

Introduced by REPRESENTATIVES ENRICO A. PINEDA and
MICHAEL ODYLON L. ROMERO, PhD.

AN ACT PROVIDING COMPASSIONATE AND RIGHT OF ACCESS TO
MEDICAL CANNABIS AND EXPANDING RESEARCH INTO ITS MEDICINAL
PROPERTIES

Be it enacted by the Senate and the House of representatives of the Philippines in Congress
assembled:

SECTION 1. Short Title. - This Act shall be known as the “Philippine Compassionate
Medical Cannabis Act”.

SECTION 2. Declaration of Policy. - Pursuant to Section 11, Article XIII of the 1987
Constitution, it shall be the policy of the State to adopt an integrated and comprehensive
approach to health development which shall endeavour to make 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.

Furthermore, in accordance with Section 2 of Republic Act No. 9165 or the
Comprehensive Dangerous Drugs Act, as amended, the State shall provide measures to
achieve balance in the national drug control Program so that patients with debilitating
medical condition may receive adequate amount of treatment and appropriate
medications from the regulated use of dangerous drugs.

Finally, Section 2 of Republic Act No. 8423 or the Traditional and Alternative
Medicine Act (TAMA) of 1997 provides that it shall be the policy of the State to improve
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 also provides that the State shall seek a legally workable
basis by which indigenous societies would own their knowledge of traditional medicine.

‘Towards this end, the State shall legalize and regulate the medical use of cannabis
which has been confirmed to have beneficial the therapeutic uses to treat a chronic or
debilitating disease or medical condition that produces one or more of the following:
cachexia or wasting syndrome; severe and chronic pain; severe nausea; seizures,

including those characteristic of epilepsy; or severe and persistent muscle spasms,
including those associated with multiple sclerosis.


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

a.) Cannabis refers to every kind, class, genus, specie of the plant Cannabis sativa L.,
Cannabis Americana, hashish, bhang, guaza, churrus, ganjab and embraces every
kind, class and character of marijuana, 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.) Compassionate refers to a virtue combining concepts such as sympathy, empathy,
fellow feeling, benevolence, care, love, and sometimes pity and mercy. A
profound awareness of another's suffering coupled with a desire to alleviate that
suffering.

©.) Debilitating medical condition refers to any disease that produces one or more of
the following: cachexia or wasting syndrome; severe and chronic pain; severe
nausea; seizures, including those associated with multiple sclerosis. Debilitating,
medical conditions include the following diseases: 1) cancer; 2) glaucoma; 3.)
multiple sclerosis; 4) damage to nervous system of the spinal cord, with object
neurological indication of intractable spasticity; 5) epilepsy; 6) positive status for
human immunodeficiency virus (HIV) or acquired immune deficiency syndrome
(AIDS); 7) post-traumatic stress disorder; 8) rheumatoid arthritis or similar
chronic autoimmune inflammatory disorders; 9) diseases requiring admission
into hospice care; and 10) any other debilitating medical condition or its treatment
that is subsequently identified by the Department of Health as recommended by
a panel of doctors constituted for this purpose.

4d.) Medical Cannabis Compassionate Center (MCCC) refers to any entity duly
registered and licensed by the Department of Health (DOH) to acquire, possess,
deliver, transfer, transport, sell, supply and dispense cannabis, devices or related
supplies and educational materials to duly registered qualified patients.

©.) Medical Cannabis Research and Safety Compliance Facility (MCRSCF) refers to
any entity registered with the DOH that conducts scientific and medical research
on medical use of cannabis and provides testing services for its potency and
contaminants relative to its safe and efficient use, cultivation, harvesting,
packaging, labelling, distribution and proper security.

f) Medical Cannabis refers to the use of cannabis including its constituents,
tetrahydrocannabinol (THC), and other cannabinoids, as a physician-
recommended form of medicine or herbal therapy. Medical cannabis shall not be
used in its raw form.

8) Medical use refers to delivery, possession, transfer, transportation, or use of
cannabis and its devices to treat or alleviate a registered qualified patient’s medical
condition or symptoms associated with the patient's debilitating disease or its
acquisition, administration, cultivation, or manufacturing for medical purposes.


SECTION 4. Regulatory Agencies. - The following shall be the regulatory agencies for
this Act:

a) Department of Health (DOH). - The DOH, in consultation with the Food and Drug
Administration (FDA), shall be the principal regulatory agency for the use of
medical cannabis. It shall register and issue licenses to qualified entities engaged
in activities related to the use of medical cannabis. The DOH shall maintain a
registry of cannabis patients and their caregivers.

b) Philippine Drug Enforcement Agency (PDEA). - The PDEA shalll have a key role
in monitoring and regulating the dispensation of medical cannabis in health
facilities. It shall maintain a registry of qualified medical cannabis physicians and
caregivers licensed to prescribe and administer medical cannabis to qualified
patients under this Act.

SECTION 5. Advisory Committee on Medical Use of Cannabis. - The is hereby
established in the DOH an Advisory Committee on the Medical Use of Cannabis,
hereinafter referred to as the Advisory Committee, which shall assist and provide
directions in the formulation and implementation of the policies and regulations covered
under this Act. The Directors-General of the FDA and the PDEA or their representatives
shall be permanent members of the Advisory Committee.

The Secretary shall appoint the other members of the Advisory Committee which
shall include health care practitioners, patients or representatives of patients with
debilitating conditions, experts in the regulation of controlled substances for medical use,
medical cannabis industry professionals and law enforcement agencies.

The Secretary shall form a Subcommittee of the Advisory Committee to advise the
Secretary on clinical matters relating to medical cannabis, the members of which shall
predominantly be clinical professionals in appropriate areas of expertise and shall also
include representatives of patients. Members of the Subcommittee need not be members
of the Advisory Committee. Both members of the Advisory Committee, and
Subcommittee shall serve at the pleasure of the Secretary and may receive honoraria in
accordance with existing government rules and regulations.

SECTION 6. Qualified Medical Cannabis Physician. - To be considered competent to
certify a patient's medical need to use cannabis for treatment and to Prescribe such
treatment, a physician shall possess the following qualifications:

a) has an established bona fide relationship with the patient:

) is licensed by the PDEA to prescribe medical cannabis to qualified medical
cannabis patients; and

©) professional knowledge of the use of medical cannabis

SECTION 7. Qualified Medical Cannabis Patient. - A qualified medical cannabis
patient means a person who has been diagnosed by a certifying physician with bona fide
relationship with the patient as having a debilitating medical condition as defined in
Section 3 (c) and who, in the physician's professional evaluation, should receive
therapeutic or palliative benefits from the medical use of cannabis,


The patient shall have the right to choose the type of medicine and health care
services needed to alleviate the medical condition.

SECTION 8. Identification Cards. - The Secretary shall issue identification (ID) cards
to the following:

a) A registered qualified patient who complies with the DOH documentary
requirements and the provisions of this Act; and

b) Qualified caregivers as identified in Section 9 of this Act.

If the qualified patient is younger than eighteen (18) years of age, the certifying
physician is mandated to explain to the patient as well as to the custodial parent or
legal guardian who has responsibility to make health care decisions on behalf of the
qualified patient the potential risks and benefits of the medical use of marijuana.

The custodial parent or legal guardian shall signify, in writing, their consent to
the following:

1. Allow the qualified patient's medical use of cannabis;

2. Serve as the qualified patient’s designated caregiver; and

3. Regulate the acquisition, dosage, and frequency of medical use of cannabis by
the patient.

SECTION 9. Medical Cannabis Patient Caregiver. - The qualified patient's designated
caregiver as identified in Section 8 of this Act shall be licensed by PDEA to administer
dangerous drugs. A cannabis patient caregiver not covered by Section 8 of this Act must
be at least twenty-one (21) years of age, and as far as practicable, a registered nurse duly
licensed by PDEA, and must not have been convicted of an offense for the use of
dangerous drugs under Republic Act No. 9165 or the Comprehensive Dangerous Drugs
Act as amended. The caregiver shall give consent in writing to perform the following:

a) Assist the qualified patient in the medical use of cannabis,

b) Not divert the medical cannabis in one’s possession to any person other than the
patient, and

©) Assist only one (1) cannabis patient at a time.

Convicted drug pushers, importers, illegal cultivators and manufacturers, and
processors shall be disqualified as caregivers.

SECTION 10. Medical Cannabis Compassionate Center (MCCC). - An entity shall
operate as a Medical Cannabis Compassionate Center after the approval of its application
and license to operate with the DOH - Health Facilities and Services Regulatory Bureau
(DOH-HFSRB). The Secretary shall establish a system for the evaluation of application


and licensing of a Medical Cannabis Compassionate Center based on the following
criteria:

a) The suitability of the applicant's proposed location including compliance with
any local zoning laws and the geographic convenience to patients;

b)

‘The qualification, character and relevant experience of principal officer and
board members, including any training or professional licensing related to
medicine, pharmaceuticals, natural treatments, botany, or cannabis cultivation
and preparation, and their experiences in running a health or medical center;

)

The applicant's effective and efficient system of operations and services,
including its staffing and training plans, the sufficiency of its capital to operate,
and its ability to provide an adequate and affordable supply of medical
cannabis to registered patients;

4) The sufficiency of the applicant's procedure for accurate record keeping;

©) The sufficiency of the applicant's measures for safety, security, and the
prevention of diversion, including proposed locations and security devices to
be employed;

£) The applicant's procedure for safe and accurate packaging and labelling of
medical cannabis, including the measures to ensure that all medical cannabis
shall be free from contaminants; and

8) The applicant's assurance that medical cannabis products being used are
organic, pesticide-free, and gluten-free, and that no chemicals have been used
in the extraction process as certified by the Food and Drug Administration.

SECTION 11. Access to Medical Cannabis. - Cannabis shall only be accessed through
the following health facilities:

a) DOH-retained hospitals,

b) Specialty hospitals, and

c) Private tertiary hospitals duly licensed and registered with the DOH for this
purpose.

An MCC shall be authorized by the abovementioned hospitals to dispense medical
cannabis within the hospital’s premises.

An MCC shall guarantee the appropriate dispensation of cannabis through a
pharmacist with an S3 license issued by the PDEA and shall not release more than the
prescribed dosage for more than one (1) month to a custodial parent, legal guardian or
designated caregiver who, as far as practicable, is a registered nurse licensed by the PDEA
to administer dangerous drugs.

An MCC shall comply with this limitation by maintaining internal confidential
record of each entry which include information on the date and time the cannabis was
dispensed, the amount of cannabis being dispensed and on whether it was dispensed


directly to the patient or to the designated caregiver. Such information shall be protected
under R.A. No. 10173, otherwise known as the “Data Privacy Act of 2012”.

The hospital’s management or its designated agents shall have access to an
MCCC'’'s records and premises at any time of the day or night whenever work is being
undertaken therein, and to question any employee and investigate any fact, condition or
matter which may be necessary to determine violations or which may aid in the
enforcement of this Act or its rules and regulations issued pursuant thereto. The PDEA
Compliance Service shall also have access to MCCC’s records and premises at any time.

SECTION 12. Medical Cannabis Research and Safety Compliance Facilities
(MCRSCF). - The Medical Cannabis Research and Safety Compliance Facilities
(MCRSCF) which include private research laboratories may conduct researches on
Medical Cannabis and operate only if they have been issued a valid registration certificate
by the DOH.

The DOH shall evaluate applications of Medical Cannabis Research and Safety
Compliance Facilities based on the following criteria:

a) The suitability of the applicant's proposed location including compliance with
any local zoning law, agricultural classification and the geographic
convenience to patients;

b) The proposed principal officers’ and board members’ relevant experiences,
including any training or professional licensing related to analytical testing,

medicine, pharmaceuticals, natural treatments, botany, or cannabis cultivation,

preparation, and testing and their experiences in running a drug testing facility
center;

The sufficiency of the applicant’s measures for safety, security, and prevention

of diversion, including proposed locations and security devices to be employed

and

) The proposed safety compliance facility's procedure for its operations and
services, including its staffing and training plans, and sufficiency of capital to
operate.

c

‘The MCRSCFs should also be compliant with the regulations and requirements of
the PDEA Compliance Center.

SECTION 13. Safety Requirements. - A registered MCRSCE shall:

a)

Implement appropriate security measures to deter and prevent the theft of

cannabis and unauthorized entrance into areas containing cannabis;

b) Cultivate or test cannabis in an enclosed, locked location at the physical
address or addresses provided during the registration process, which can only
be accessed by their employees or agents;

c) Display their registration certificates in their premises at all times; and

d) Allow PDEA to have continuous access to the facility.

SECTION 14. Exemption from Ci

il and Criminal Liability. - The following shall be
exempt from civil and criminal liabil

ty:

a) The certifying physician for prescribing medical cannabis or providing written
certifications stating that in the physician's professional opinion, a patient is
likely to receive therapeutic or palliative benefit from the medical use of


cannabis to treat or alleviate the patient's serious or debilitating medical
condition or symptoms: Provided, That the physician has established a bona
fide relationship with the patient and conducted thorough clinical analysis of
the patient's medical conditions;

A qualified patient for using cannabis in the prescribed dosage for treatment
of debilitating medical condition as determined and certified by a bona fide
recommending physician;

A registered and designated cannabis caregiver for assisting a registered
qualified patient and for possessing not more than the exact prescribed dosage
of cannabis needed by the qualifying patient;

d) A registered Medical Cannabis Research and Safety Compliance Facility and
its agents for possessing and testing cannabis for medical research and
compliance purposes; and

A duly licensed Medical Cannabis Compassionate Centers and its agents
authorized to dispense medical cannabis within the hospital premises as
provided by Section 11 of this Act.

b)

°)

°)

SECTION 15. Prohibited Acts. - It shall be prohibited for:

a)

b)

°)

d)

A qualified patient to:

1. possess and smoke cannabis and engage in the medical use of cannabis in any
mode of public transportation or in any public place;

2. operate, navigate, or being in actual physical control of any motor vehicle,
aircraft, or motorboat while under the influence of cannabis: Provided, That a
registered qualified patient or visiting qualified patient shall not be considered
to be under the influence of cannabis that solely because of the presence of
metabolites or components of cannabis that appear in insufficient
concentration to cause impairment;

3. undertake, under the influence of cannabis, tasks that would require the use of
body or motor functions impaired by use of cannabis; and

4. use cannabis for purposes other than treatment of a debilitating medical
condition.

A qualified medical cannabis physician to:

1. prescribe medical cannabis to any person who is not a qualified patient under
this Act;

2. prescribe medical cannabis to any qualified patient without establishing a bona
fide relationship with said patient; and

3. refer patients or caregivers to a MCCC on which he or she holds any financial
interest.

A registered MCCC to:

1) acquire, possess, deliver, transfer, transport, supply, or dispense cannabis to
any person except to registered qualified patients or through their registered

caregivers;

acquire usable cannabis or mature cannabis plants from unregistered MCCC;

and

refer patients to an unauthorized physician.

2)

3)

Any physician who prescribes medical cannabis to any person or patient without
license required in Section 6 of this Act;


e) Any caregiver, not covered by Section 8 of this Act, who administers medical
cannabis to any qualified medical cannabis patient without the required license by
the PDEA for the purpose, or who, with license, but administers medical cannabis
to a person who is not a qualified medical cannabis patient;

f) Any person, to include foreigners, to:

1) advertise the sale of medical cannabis in printed materials, on radio or
television, social media, or by paid-in-person solicitation of customers. This
shall not prevent appropriate signs on the property of the registered MCCC,
listings in business directories including phone books, listings in cannabis-
related or medical publications, or the sponsorship of health o rcharity or
advocacy events;
violate the confidentiality of information under R.A. 10173, otherwise known
as the “Data Privacy Act of 2012”; and
purchase and access to medical cannabis in oil formulation or in any form not
prescribed by the DOH.

2)

3

SECTION 16. Penalty. - Any person who violates any provisions of Section 15 of this
Actor its Implementing Rules and Regulations shall, upon conviction and final judgment,
be punished with a fine of Fifty Thousand Pesos (P 50,000.00) to One Hundred Thousand
Pesos P (100,000.00) or higher at the discretion of the court. Likewise, the same penalty
shall be imposed on:

1. caregivers in violation of Section 9 of this Act;

2. MCCCs in violation of Section 10 and 11 of this Act; and
3. MCRSCFs in violation of Sections 12 and 13 of this Act.

In addition, the penalty of imprisonment of six (6) to twelve (12) years shall be
imposed on:

1. A qualified patient who commits any of the acts proscribed in paragraphs (a)
(1) and (a) (4) of Section 15 of this Act;

2. A qualified medical cannabis physician who commits any of the act proscribed
in paragraph (b) (1) and (a) (4) of Section 15 of this Act;

3. A caregiver who commits the proscribed acts in paragraph (e) of Section 15 of
this Act; and

4. A MCCC which commits the act proscribed in paragraph (c) (1) of Section 15
of this Act: Provided, that the persons liable shall be members of the Board of
Directors or Executive Officers of the MCCC, as the case may be.

Furthermore, the penalty shall include suspension or revocation of professional
license or registration of the persons or entities held as offenders hereof

The DOH shall impose administrative sanctions such as suspension or revocation

of the license to operate of any private entity found guilty of violating Section 15 of this
Act.


The Department shall constitute a Grievance Committee that will review
documents and evidence of cases brought to its attention for recommended resolutions
for final action of the Secretary.

SECTION 17. Research. - The DOH shall, within 120 days from the approval of
this Act, authorize the National Institutes of Health, the research arm of the University of
the Philippines, Manila; the Health Sciences Center of the UP System, the Philippine
Institute of Traditional and Alternative Healthcare (PITACH) and two (2) other
organizations it may deem qualified, to conduct research on the use of medical cannabis.
Participation to any research program on the part of practitioners, patients, and
designated care givers shall be highly encouraged.

Private research laboratories may conduct research studies only if their faci
are duly registered and licensed by the DOH as a MCRSCF.

For purposes of medical research and testing, the Dangerous Drugs Board (DDB)
shall formulate the regulations in naming the sources and specifying the methods in
accessing the sources of cannabis.

SECTION 18. Training of Medical Cannabis Physicians. - The DOH shall
provide training programs for medical cannabis physicians which shall include the
following topics: overdose prevention; drug. interactions; dosing; routes of
administration; risks and benefits; warnings and precautions; and abuse and dependence.
The DOH shall coordinate with the Commission on Higher Education to integrate the
aforementioned topics on medical cannabis in the medical curriculum of all medical
schools, colleges and universities.

SECTION 19. Reports. - The Department shall submit to the President of the
Philippines and Congress an annual report which shall include the following basic
information:
a) Number of applications and renewals filed for registry identification cards;
b) Number of registered qualified patients at the time of the report;
©) Number of registry identification cards that were issued to visiting qualified
patients at the time of the report;
d) Nature of the debilitating medical conditions of the patients;
e) Number of registry identification cards revoked for misconduct;
f) Number of authorized physicians who issued written certifications for
qualified patients; and
g) Number of registered MCCCs.

SECTION 20. 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 to be
appointed by the Senate President and the Speaker of the House of Representatives,
respectively. The Joint Congressional Oversight Committee shall be chaired by the
Chairpersons of the Senate Committee on Health and Demography and the House of
Representatives Committee on Health.

SECTION 21. Implementing Rules and Regulations. - Within ninety (90) days from the
effectivity of this Act, the Secretary of the DOH and the Director-General of PDEA, in


consultation with its Advisory Committee, shall promulgate rules and regulations
necessary for the effective implementation of this Act.

SECTION 22. Separability Clause. - If any provision or part of this Act is declared
invalid or unconstitutional, the remaining parts or provisions not affected shall remain
in full force and effect.

SECTION 23. Repealing Clause. - For purposes of this Act, pertinent provisions of
Republic Act No. 9165, otherwise known as the “Dangerous Drugs Act of 2002”, as
amended, 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.

SECTION 24. Effectivity. - This Act shall take effect fifteen (15) days after its publication
in the Official Gazette or in a newspaper of general circulation.

Approved,