Health - 19-02-06 MEDICAL CANNABIS PDF

Republic of the Philippines
CONGRESS OF THE PHILIPPINES

SENATE
Pasay City
COMMITTEE ON HEALTH AND DEMOGRAPHY

JOINT WITH THE
COMMITTEE ON FINANCE
DATE : Wednesday, February 6, 2019
TIME : 1:00 p.m.
VENUE : Sen. Geronima T. Pecson Room

2nd Floor, Senate of the Philippines
Financial Center, Roxas Boulevard
Pasay City
AGENDA : PHILIPPINE COMPASSIONATE MEDICAL

CANNABIS ACT:
HOUSE BILL NO. 6517 - AN ACT PROVIDING

COMPASSIONATE AND RIGHT OF ACCESS TO
MEDICAL CANNABIS, EXPANDING RESEARCH
INTO ITS MEDICINAL PROPERTIES AND FOR
OTHER PURPOSES [by Representatives Albano,
Manalo, Panganiban, Rodriguez (M.), Pimentel,
Silverio, Lopez (B.), Erice, Violago, Billones,
Belmonte (J.C.), Sacdalan, Palma, Belmonte
(R.), Nieto, Cojuangco, Lazatin, Bautista-
Bandigan, Estrella, Tolentino, Zamora (R.), Yap
(A.), Martinez, Del Rosario, Rocamora, Acop,
Unabia, Dimaporo (M.K.), Ocampo, Gonzalez,
Bag-Ao, Espina, Cagas, Singson, Mercado, Siao,
Panotes, Tejada, Eriguel, Cuaresma, Barbers,
Veloso, Arcillas, Jalosjos, Catamco, Marino,
Garcia (G.), Amante, Macapagal-Arroyo, Roque,
Celeste, Abaya, Ty, Marcoleta, Nolasco, Bulut-
Begtang, Roa-Puno, Salceda, Pineda, Sambar,
Lanete, Limkaichong, Ferrer (L.), Villanueva,
1
Committee on Health and Demography
Joint with the Committee on Finance
Wednesday, February 6, 2019
Page 2
Alonte, Labadlabad, Velasco-Catera, Villarin,

Robes, Fariñas, Boncod, Defensor, Hofer,
Crisologo, Gonzales (A.D.), Noel, Gonzales
(A.P.), Matugas, Savellano, Garin (R.), Nograles
(J.J.), Salo, Herrera-Dy, Primicias-Agabas, De
Vera, Bravo (A.), Campos, Abayon, Garcia-
Albano, Sarmiento (C.), Sarmiento (E.M.),
Mangaoang, Zarate, Fortun, Aggabao, Aragones,
Marcos, Castro (F.L.), Garbin, Arenas, , Mellana,
Dy, Suarez, Belaro, Teves, Calixto-Rubiano,
Ortega (V.N.), Salon, Ting, Tupas, Tinio,
Mendoza, Calderon, Angara-Castillo, Andaya,
Ramos, Malapitan, Lobregat, Lopez (M.L.),
Batocabe, Yap (M.), Ortega (P.), Gorriceta,
Alvarez (F.), Banal, Vergara, Roman, Kho,
Papandayan, Sangcopan, Mending, Revilla, Tan
(A.), Escudero, Paduano, Elago, Lagman, Yap
(V.), Cueva, Brosas, Casilao, De Jesus And Sy-
Alvarado]
___________________________________________
ATTENDANCE
SENATORS:
HON. JOSEPH VICTOR G. EJERCITO - Chairman, Committee on

Health and Demography
HON. MARIA LOURDES NANCY S. BINAY - Member
HON. AQUILINO “KOKO” PIMENTEL III - Member
RESOURCE PERSONS:
Hon. Rolando Domingo - Undersecretary, Department of Health

(DOH)
Mr. Catalino S. Cuy - Chairperson, Dangerous Drugs Board
(DDB)
Atty. Katherine Austria-Lock - Officer-in-Charge, Center for Drug
Regulation and Research, Food and
Drug Administration (FDA)
2
Page 3
Dr. Rhea Salonga-Quimpo - Pediatric Neurologist, University of the

Philippines-Philippine General Hospital
Dr. Leonor I. Cabral-Lim - Chair, Department of Neurosciences
Philippine General Hospital, Philippine
Neurological Association
Ms. Agnes Mandap - Acting Director of Compliance Service,
Philippine Drug Enforcement Agency
(PDEA)
Dr. Jose P. Santiago Jr. - President, Philippine Medical
Association (PMA)
Ms. Riciel Ballesteros - Executive Committee Member,
Philippine Cannabis Compassionate
Society (PCCS)
Dr. Donnabel T. Cunanan - Spokesperson, PCCS
Mr. Chuck Manansala - President, Medical Cannabis Research
Center
Dr. Gem Mutia - PCCS
Dr. Angel Joaquin Gomez - President, Philippine Society of
Anesthesiologists (PSA)
Dr. Socorro Reyes - Chief Policy Adviser, Office of Rep.
Rodolfo Albano III
Dr. Romy Quijano - Expert in Clinical Pharmacology,
General Practice and Toxicology,
Medical Cannabis Research Center
Dr. Manuel C. Panopio - President, Philippine College of
Addiction Medicine and Chief Health
Program Officer, DOH Drug Treatment
and Rehabilitation Center-Bicutan
Dr. Ma. Encarnita B. Limpin - Head of Advocacy Committee,
Philippine College of Physicians
SENATE SECRETARIAT:
Ms. Beatriz Tiongco-Cruda - Committee Secretary, Committee on

Health and Demography
Ms. Jo B. Cadaing - Committee Stenographer
Ms. Ma. Rosalinda J. Catadman - Committee Stenographer
Ms. Araceli D. Masicap - Committee Stenographer
Ms. Norma G. Dizon - Committee Stenographer
Ms. Nida A. Mancol - Committee Stenographer
Ms. Cindell B. Gealan - Committee Stenographer
Mr. Rommel P. Alger - Committee Stenographer
3
Page 4
Ms. Sherill M. Villadiego - Committee Stenographer

Ms. Rea P. Corpuz - Committee Stenographer
Ms. Mildred C. Fisico - Committee Support Staff
(For complete list, please see attached Attendance Sheet.)
/cbg/peg
4
COMMITTEE ON HEALTH AND DEMOGRAPHY JOINT WITH THE
JTBCadaing I-1 February 6, 2019 1:10 p.m. 1

AT 1:10 P.M., HON. JOSEPH VICTOR
“JV" G. EJERCITO, CHAIRMAN OF THE
COMMITTEE ON HEALTH AND DEMOGRAPHY,
CALLED THE HEARING TO ORDER.
THE CHAIRMAN (SEN. EJERCITO). Good afternoon. The
Committee on Health and Demography joint with the Committee on
Finance is hereby called to order.
Before we start, we will just wait for the other senators to come
because there’s an ongoing Commission on Appointments plenary. So
right after, some of them will be joining us.
So before that, I’d like to ask our Committee Secretary to first
acknowledge our resource persons present for today’s hearing.
THE COMMITTEE SECRETARY (MS. CRUDA). Good afternoon.
We would like to acknowledge the resource persons for this afternoon’s
public hearing.
From the Department of Health, Usec Rolando Domingo; Atty.
Katherine M. Austria-Lock from the FDA; Secretary Catalino S. Cuy,
Chairperson, Dangerous Drugs Board; Usec Benjamin Reyes, also from
the Dangerous Drugs Board; Dr. Rhea Salonga-Quimpo, Pediatric
Neurologist of UP-PGH; Dr. Leonor Cabral-Lim, Chair of the Department
of Neurosciences of PGH and also of Philippine Neurological Association;
5

Agnes Mandap, Acting Director of Compliance Service of Philippine Drug
Enforcement Agency.
From the NGOs and private organizations, we have Dr. Jose P.
Santiago, President of Philippine Medical Association; Riciel Ballesteros
of the Philippine Cannabis Compassionate Society; Dr. Donnabel
Cunanan, spokesperson of the Philippine Cannabis Compassionate
Society; Chuck Manansala, President, Medical Cannabis Research
Center; Dr. Romy Quijano also of Medical Cannabis Research Center;
Dr. Gem Mutia and Dr. Angel Joaquin Magalona Gomez of the Philippine
Doctors for Medical Cannabis; Dr. Manuel Panopio, President of the
Philippine College of Addiction; and Dr. Socorro Reyes, Chief Policy
Adviser, Office of Representative Rodolfo Albano III.
Thank you.
THE CHAIRMAN (SEN. EJERCITO). Thank you, Committee
Secretary.
Before we continue, the Chair would like to give his opening
statement. And probably for an orderly conduct of this hearing, we will
just go with the government representatives and then, probably, experts
in the medical, and then the individuals. Okay. Likewise, hopefully, our
Senate President will also be joining us after the plenary session of the
6

Commission on Appointments because as we know that he is very much
against this bill. But we have to hear all sides. Okay.
Thank you.
“Magandang hapon po sa inyong lahat. Narito po tayo ngayon
para maliwanagan ang isang issue na alam nating hanggang sa
kasalukuyan ay nananatiling kontrobersiyal. Gusto nating mapakinggan
ang bawat panig, pabor at hindi, at siyempre ang mga eksperto sa
larangan ng kalusugan upang mahingan sila ng kanilang mga
ekspertong opinyon upang kung magkakataon na kailanganin man
nating magpanukala ng batas ay nakatundog ito sa mga konkretong
pagsusuri. Kung tunay itong nakagagaling at kung ito na lamang ang
natitirang lunas o nakapagdurugtong ng buhay, marahil ay maaari na
natin itong bigyan ng pagkakataon. Siyempre, nakapaloob pa rin sa
regulasyon ng ating pamahalaan.
“Ang mga batas natin ay nariyan, hindi lamang upang magbawal
o magdisiplina, kung hindi nililikha rin upang magmalasakit. Gusto
nating matukoy kung kinakailangan pa bang magpanukala ng bagong
batas o sapat na ang pag-amyenda na lang sa kasalukuyang Dangerous
Drugs Act. Kailangan din nating matiyak na hindi maabuso ang
paggamit ng medical marijuana at manatili ito na para lamang sa
medical purposes.”
7

Again, for an orderly conduct of today’s hearing, we will proceed
first with our government representatives, the medical experts, and then
the individuals. Before we continue, the Chair would like to acknowledge
the presence of our colleagues: Senator Nancy Binay; of course, our
former Senate President and a very good lawyer is here, his insights will
help a lot, Senator Koko Pimentel is also here.
Thank you, sir, for being with us.
SEN. PIMENTEL. [Off-mike/Inaudible]
THE CHAIRMAN (SEN. EJERCITO). But your expertise will still
be helpful. Okay so—
SEN. PIMENTEL. On the law, not on the use. [Laughter]
THE CHAIRMAN (SEN. EJERCITO). Thank you.
So first, probably, the Chair would like to acknowledge, give the
floor to our Department of Health, Undersecretary Rolando Domingo.
Not so long, he was also here.
Usec Domingo, our suki. You have now the floor.
MR. DOMINGO. Thank you, Mr. Chair. Thank you, Madam
Senator and Senator Pimentel.
I would just like to give you the position of the Department of
Health. The Department of Health acknowledges the intent of House Bill
No. 6517, entitled “An Act Providing Compassionate and Right of Access
8

to Medical Cannabis and Expanding Research into Its Medicinal
Properties.” The proposed measure aims to enable access to medical
cannabis and research into its medicinal properties. It provides for
exemptions from civil and criminal liabilities for qualified dispensers and
patients and authorizes public and private research entities to undertake
research on the medical use of the drug and delineates regulatory roles
among identified government agencies.
Cannabis, right now, is classified as a “Schedule 1” drug, and as
such, it is deemed to have no accepted medical use and has high
addictive potential. However, in recent years, there has been emerging
evidence on its efficacy for chronic pain, neuropathic pain, spasticity
symptoms in multiple sclerosis and for improving nausea and vomiting
for cancer patients undergoing chemotherapy. Clinical studies to
support claims for its efficacy for a wide range of conditions, however,
are still insufficient. The evidence is still mixed whether the harmful
health effects of medical cannabis may outweigh its potential benefits is
still not sure.
The DOH maintains its position that making use of cannabis as a
means to alleviate chronic and debilitating medical conditions is not
necessary since some of the conditions that are claimed to be treated
by medical cannabis can be addressed by existing Food and Drug
9

Administration or FDA approved and regulated medications. And we will
give you a list of those drugs, sir.
On the use of medical cannabis for research and compassionate
use, the DOH recognizes alternative treatment options for unmet
medical disorders and acknowledges significant interest among various
stakeholders on the potential use of cannabis for a variety of medical
conditions which includes those that already have FDA-approved drug
products indicated for such. To address this concern, the DOH supports
the conduct of further medical research into this evolving field.
The DOH manifests its objection to the legalization of the use of
medical cannabis in its raw, herbal, or plant form because such forms
are not acceptable as medicine by FDA standards. For purposes of
research and compassionate use, however, the DOH does not oppose
the legalization and testing of finished or processed drug products that
contain only the active ingredients derived from cannabis. Compared to
raw, herbal, or plant forms, finished or processed drug products contain
very specific amounts of the active ingredients which would make it
easier to predict intended effects of the products. These products,
however, should follow international standards for quality, safety, and
efficacy as well as comply with other existing FDA rules and regulations.
10

Moreover, AO No. 172 of 2004 which provides for the guidelines
of the registration of herbal medicines defined herbal medicine as
“finished, labeled medicinal product that contains an active ingredient,
aerial or underground parts of the plant or any other plant material or a
combination of such whether in the crude state or as plant preparation
which may contain other excipients.”
The fresh plant material for which has not undergone any process
or treatment, such as proper drying, packaging and storage, is not
included in the said guidelines to which the marijuana plant must
undergo in order to extract its active ingredient that has the medicinal
property. Likewise, the fresh plant material does not fall under the
definition of traditionally-used herbal products which consists of
preparation from plant material whose claimed application is based only
on traditional experience of long usage of at least five or more decades.
The said product still requires documentation in medical, historical, and
ethnological literature.
Given the absence of both local scientific data and sparse rigorous
clinical evidence in the literature regarding medical cannabis, the DOH
recommends to focus on the conduct of scientific and rigorous…/jtbc/trs
11
MRCatadman II-1 February 6, 2019 1:20 p.m. 1
MR. DOMINGO. … conduct of scientific and rigorous assessment
of cannabis from drug product development to regulation of marketing.
The results of the studies will provide for recommendations as to
whether cannabis in its product formulation can be clinically effective
and safe.
The Philippine Institute of Traditional and Alternative Health Care,
or PITAHC, a DOH attached research institution mandated by law to
carry out herbal research, is willing to partner with academic institutions
to manage and implement research for the herbal drug development for
medical cannabis provided that funding and regulatory mechanisms are
in place.
Nonetheless, the conduct of herbal drug development which
necessarily includes processing of raw, herbal or plant forms of cannabis
for research would entail collaboration among concerned DOH units such
as FDA and PITAHC, also DOST, the Dangerous Drugs Board, and the
Philippine Drug Enforcement Agency or PDEA.
On the existing laws, regulations on medical cannabis for research
and compassionate use, Section 16 of the Dangerous Drugs Act and its
implementing rules and regulations already contains provisions for
cultivation or culture of plants classified as dangerous drugs. Section
15, let me quote, says, “Cultivation or culture of plants classified as
12
dangerous drugs or sources thereof, provided that in the case of medical
laboratories and medical research centers, which cultivate or culture
marijuana, opium poppy and other plants, or materials of such
dangerous drugs for medical experiments and research purposes, or for
the creation of new types of medicine, the Board shall prescribe the
necessary implementing guidelines for the proper cultivation, culture,
handling, experimentation and disposal of such plants and materials.”
Such provision of law contemplates already research of cannabis for
medical use as well as its use in accordance with regulations already set
forth by the DDB.
Section 14 of DDB Resolution No. 1 of 2014, on the other hand, also
provides for the issuance of permits in relation to laboratory use and/or
programs for medical, and/or scientific research for dangerous drugs
including cannabis: “Permits in Relation to Laboratory Use and
Programs for Medical and Scientific Research or Instructional and
Training Purposes: The PDEA may, on written application made in the
prescribed form, grant a permit to conduct medical and scientific
research, laboratory analysis or instructional/training or other programs
and purposes that would require the import, possession, cultivation or
use of a dangerous drug; a controlled chemical; a plant source of
13
controlled substance; a drug preparation containing a controlled
chemical.”
The FDA already also gives out Compassionate Special Permits
under its Administrative Order No. 4 of 1992, which grant specialized
institutions and specialty societies the privilege to avail of an
unregistered drug, medical device, or food product through a licensed
importer, for a specific kind/type of patients, specific volume and
period.” Mayroon na rin pong paraan para maka-access sa mga
pasyente and the doctor can ask this on behalf of a patient.
For specific regulation that would apply to cannabis, the DOH
respectfully submits that the existing RA 9165, with some administrative
fine-tuning, would suffice. Such fine-tuning can be implemented
through a revision of the implementing rules and regulations, or
issuance of board resolutions by the DDB, and administrative orders by
the FDA. Perhaps such revisions could specify regulations for
compassionate use of medical cannabis and for the research thereon.
Effective control measures must be in place to prevent diversion of
cannabis to illicit and recreational use. This may be a public health
concern, as studies show substantial evidence for the serious adverse
health effects of both acute and chronic use of cannabis use, such as
increased risk of motor vehicular accidents, impaired cognition and
14
neurodevelopment; increased risk of schizophrenia and other
psychoses; dependence, addiction and substance abuse. This also
poses a public health risk for vulnerable populations such as adolescents,
pregnant and breastfeeding women.
And, lastly po, on the establishment of facilities for medical
cannabis purposes, the DOH opines that the proposed designation of
Medical Cannabis Compassionate Centers within hospitals, and Medical
Cannabis Research and Safety Compliance Facilities is not necessary and
will compromise the limited resources that the Department of Health
already has which we use to treat life-threatening illnesses. Moreover,
AO No. 4 of 1992 of the FDA allows specialized institutions to apply for
compassionate medical use of a particular drug. The regulation of such
facilities for dispensing medical cannabis for compassionate use, which
the bill proposes to be lodged to the Health Facilities and Services
Regulations Bureau or HFSRB of DOH, should be rightfully assigned to
DDB. Maintaining such facilities along with their requisite procedures
require a high level of security that is within the expertise of the DDB,
and not the DOH. Prescription and dispensation of medical cannabis for
compassionate use should only be through guidelines stipulated by the
FDA and the DDB, and only through a special S-license issued by PDEA.
15
And, finally, sir, our recommendations: Legalization of the use of
medical cannabis should take into consideration its health benefits and
risks based on available evidence, its cost-effectiveness, the regulatory
capacity of the concerned agencies, and its impact on personal care of
affected individuals. Public health monitoring systems for tracking
prevalence and patterns of cannabis use should also be in place, to guide
future policymakers in making decisions on how to regulate the use of
medical cannabis.
The DOH supports research and compassionate use of medical
cannabis for specific indications. Based on the foregoing, the current
law is already in place, as well as resolutions of concerned government
agencies that are already adequate to implement the intent of the
proposed bill.
We will be submitting the official position to the Committee.
Thank you, Your Honor.
THE CHAIRMAN (SEN. EJERCITO). Okay. Thank you, Usec
Rolando Domigo.
So, in summary, the DOH is against? Or not yet supportive, but
you are in favor of the research, continuous studies and research. And
still, for compassionate use.
16
MR. DOMINGO. Yes, Mr. Chair, we believe that there are already
existing regulations that address the regulatory needs. And if it’s for
research, definitely not in the raw or platform, but only the extracted
medicinal substance.
THE CHAIRMAN (SEN. EJERCITO). Well, actually, we have to
make it clear also that this hearing would also be strictly for medicinal,
not really recreational. So, hindi po talaga natin papayagan. We are
just hearing for medicinal.
As Chair of the Committee, of course, we have to open. We have
to hear if it will prolong the life, if it will relieve the pain, why not? But,
of course, we have to hear our panel of experts today.
Okay. So next, I would like to ask FDA, Atty. Katherine Austria-
Lock, probably your agency’s position regarding this measure from the
House.
MS. LOCK. Your Honor, we already submitted the FDA’s position
to the DOH, and it’s already consolidated in the position paper read by
Usec Eric Domingo.
THE CHAIRMAN (SEN. EJERCITO). Okay.
MS. LOCK. Thank you, Your Honor.
THE CHAIRMAN (SEN. EJERCITO). So that was consolidated
already?
17
MS. LOCK. Yes, Your Honor.
Thank you.
THE CHAIRMAN (SEN. EJERCITO). Thank you.
SEN. BINAY. Mr. Chair.
THE CHAIRMAN (SEN. EJERCITO). Yes, Senator Binay.
SEN. BINAY. Kasi nabanggit ho ni Usec Domingo na based doon
sa AO No. 4S 1992 of the FDA, it allows specialized institutions to apply
for compassionate medical use of a particular drug.
May existing na ho ba tayo that you allowed? And can you please
siguro cite the example?
MR. DOMINGO. We’ve only so far had four applications. Iyong
iba po parang kulang, mayroon pa pong deficiency sa submissions. But
recently one was approved for the use of Epidiolex or cannabidiol, and
the doctor is here, Dr. Rhea Salonga-Quimpo is the doctor of the patient.
SEN. BINAY. Since only apat lang naman, can you cite—
MR. DOMINGO. Apat pa lang po iyong nag-apply. Iyong tatlo,
ma’am, may kulang pa na documentation. Isa pa lang ang na-approve.
SEN. BINAY. Isa pa lang ang na-approve. Iyong tatlo, pending
pa?
MR. DOMINGO. Ma’am, may pending pa pong deficiencies lang
ng requirements for use.
18
SEN. BINAY. So itong na-approve, puwede nang—papayagan niyo
nang makuha nila?
MR. DOMINGO. Yes, ma’am. For that particular patient,
magagamit na po niya iyong gamot.
SEN. BINAY. And I think Dr. Quimpo will explain it further.
Okay. Siguro mamaya na lang, Mr. Chair.
THE CHAIRMAN (SEN. EJERCITO). Yes, we will just finish all the
resource persons.
Please make it very brief as we only have a few hours. Until 3
o’clock, we have to finish all of the resource persons. As much as
possible, we want to hear all of the experts and all the other agencies.
So, we will move on.
Next is probably we would like to hear from Dr. Maria Teresa
Mendoza. Is she here? No, she is not here. So, probably—Yes, ma’am.
VOICE. [Off-mike] Sir, it’s already consolidated.
THE CHAIRMAN (SEN. EJERCITO). Also consolidated. Okay,
that’s good. At least we save time. Kaya pala ang haba nang binasa
ninyo, Usec.
Thank you.
At least we have three agencies that were consolidated under that
position.
19
Probably, we can hear from…/mrjc/imjv
20
ADMasicap III-1 February 6, 2019 1:30 p.m. 1
THE CHAIRMAN (SEN. EJERCITO). …Probably, we can hear from
Secretary Catalino Cuy, Chairperson of Dangerous Drugs Board for your
position.
MR. CUY. Yes, sir. Your Honor, ladies and gentlemen, good
afternoon.
The Dangerous Drugs Board would like to thank the Committee on
Health and Demography for inviting us to discuss the issues on the
compassionate use of medical marijuana.
At the outset, please be informed that Section 16, as mentioned by
Usec Domingo of Republic Act 9165 already provides among others, that
medical laboratories and medical research centers are allowed to cultivate
or culture cannabis, opium poppy and other plants or materials of such
dangerous drugs for medical experiments and research purposes or for the
creation of new types of medicine with the statutory mandate for the DDB
to promulgate the necessary implementing guidelines for the proper
cultivation, culture, handling, experimentation and disposal of such plants
and materials.
In relation therewith, the Board previously issued Board Regulation
No. 3, Series of 2003, regarding comprehensive guidelines on importation,
distribution, manufacture, prescription, dispensing and sale of, and other
21
lawful acts in connection with any dangerous drugs, controlled precursors
and essential chemicals and other similar or analogous substances
wherein the Philippine Drug Enforcement Agency or PDEA was given the
authority to grant permit to conduct laboratory analysis or a program for
scientific or instructional or strictly limited medical purposes that would
require the import, possession or use of dangerous drugs or controlled
chemical.
It was subsequently repealed by DDB Board Regulation No. 1, Series
of 2014, which expanded the authority granted to PDEA to include, but
not limited to the grant of permit to conduct medical and scientific
research, laboratory analysis or instructional training or other programs
and purposes that would require the cultivation of a dangerous drug,
controlled chemical, a plant source of a controlled substance or a drug
preparation containing a controlled substance with the corresponding
security arrangement that would be undertaken while a controlled
substance is being cultivated or is in possession, used or disposed of by
the requested party.
It further provides that PDEA may authorize the use of controlled
substances in the conduct of such medical or scientific research or
laboratory analysis or instructional/training or any program if satisfied
22
that: (a) the conduct of a laboratory analysis or a program cannot be
carried out satisfactorily without the use of the specified dangerous drugs
or controlled chemicals; (b) the applicant is a fit and proper person to
conduct the laboratory analysis or program; (c) the program will be
adequately supervised; and (d) the program is to be conducted at or under
the auspices of a recognized institution or government institution or
acknowledged scientist or researcher or inventor.
Based on the foregoing, it is clear that the use of cannabis for
medical or scientific research and laboratory use is allowed under the law
which was enacted in 2002 and relevant rules or regulations issued by the
Board as early as 2003.
Nevertheless, as early as 2013, the International Narcotics Control
Board, the primary monitoring body for the implementation of the United
Nations Drug Convention has cautioned countries to fully consider the
negative impact of medical cannabis schemes or the establishment of such
programs which may indirectly lead to increase in the abuse of cannabis
which leads to increase in public health costs.
We have also taken note of and considered the position statements
issued by the coalition of sixteen medical organizations led by the
Philippine Medical Association and the technical working group of Medical
23
Cannabis of the University of the Philippines-Manila which both manifest
the insufficiency of evidence on the efficacy of medical cannabis in the
treatment of any disease and that the use thereof may cause more harm
to patients. Simply put, there is still no definitive or conclusive findings as
to the advantages vis-à-vis the risk involved in using cannabis for medical
purposes. On this aspect, the Board will rely on the recommendation of
the Department of Health which is one of the member agency of the Board
that has the technical knowledge and expertise on the matter.
Finally, in the event that the Department of Health will issue a
favorable recommendation on the proposal, the DDB shall complement the
same as it is currently conducting research on policy formulation that
would prevent abuse and illegal use of medical cannabis, as what
transpired in other countries which allowed sale, use, possession,
cultivation and distribution thereof.
Thank you, sir.
THE CHAIRMAN (SEN. EJERCITO). Thank you, Secretary Cuy.
So, anyway, that will be also one of the things that we have to
stress. Just in case it will be allowed that measures and safeguards will
be in place to prevent abuse. Kaya lang ang problema sa atin maraming
madaling magpalusot so we really have to be--maraming nag-aabuso.
24
Maraming lumulusot. So, we really have to make sure that we have
stricter safeguards to make sure that it will be really for medical use, just
in case.
So, now we go to the medical experts. The Chair would like to
recognize Dr. Rhea Salonga-Quimpo, pediatric neurologist of UP-Manila,
UP-PGH.
And then after her Dr. Leonor Cabral-Lim, also of PGH; then Agnes
Mandap of PDEA; and then Dr. Jose Santiago of the Philippine Medical
Association. In that order so that you will be ready. Okay.
Thank you.
Dr. Quimpo, please. You have the floor.
MS. SALONGA-QUIMPO. Good afternoon, Your Honor.
In the interest of time, I will first present briefly the medical evidence
that we have available. So, when we talk about medical evidence, it’s
not merely the presence of evidence because we know that there are
thousands of studies on the use of medical marijuana. But we have to
look at the quality of evidence. And when drugs are approved it is because
there is good quality clinical evidence because, of course, we want to
safeguard the safety of our patients.
25
So, just in the definition of terms, medical marijuana is actually a
legal definition. It just refers to the use of cannabis on the
recommendation of the healthcare provider. So, it’s a very general term
that could include any form of the plant. So, what is important to note is
that we should recognize that marijuana or cannabis has several varieties.
And just this, I am just presenting the two major varieties. And depending
on the variety, it is important to know that the proportion of the various
chemicals in it may be different and various chemicals are important
depending on the disease entity that we are trying to treat.
So, since I am a pediatric neurologist and epilepsy specialist, our
main area of concern really is drug resistant seizures or seizures that are
not responsive to medication. And actually, this is where we have good
clinical evidence. So, for Dravet Syndrome, which is genetic syndrome
seen in young children, it is caused by a sodium channel defect, these
patients would have hundreds of seizures per day. And in this clinical trial,
it was shown that cannabidiol, which is a specific extract of cannabis has
been proven to result in greater seizure reduction in patients using this.
And in another category of patients in a syndrome called Lennox-
Gastaut Syndrome, again, a difficult to treat epilepsy syndrome where only
30 percent would respond to medication, add-on cannabidiol was proven
26
to be effective. And because of this good quality clinical trials, in June of
last year, cannabidiol was actually approved via Fast Track by the USFDA.
So, this was the medication, Epidiolex that Usec Domingo said was
approved for a patient who applied for it.
Doc, who did the clinical trial?
MS. SALONGA-QUIMPO. This is an international multi-center
study done by world experts on pediatric epilepsy and adult epilepsy. So,
this is recognized…/admasicap/jmb
27
NGDIZON IV-1 February 6, 2019 1:40 p.m. 1
MS. SALONGA-QUIMPO. … So, this is recognized actually by the
International League Against Epilepsy.
THE CHAIRMAN (SEN. EJERCITO). So, Doc, before you
continue, again just to follow-up so that research showed that it did
relieve or was able to help treat epilepsy seizures.
MS. SALONGA-QUIMPO. Yes, sir.
THE CHAIRMAN (SEN. EJERCITO). The reason I asked, Doc,
because I used to have a family member who is epileptic. And she
swears that with the cannabis—I don’t know how she gets it—she
doesn’t experience anymore seizure—Hindi, pag nasa America siya. But
every time she is here—That’s why she is pushing me. Before kasi,
nagkaka-attacks siya every night. But now, every time she has that, na
kung nakakakuha siya noong medical cannabis, wala daw iyong seizure.
Anyway, please continue po.
MS. SALONGA-QUIMPO. Okay. So important to know—
SEN. BINAY. Siguro one last question lang, Doc.
MS. SALONGA-QUIMPO. Yes.
SEN. BINAY. But it’s not a treatment, right? It just lessens the
attacks.
MS. SALONGA-QUIMPO. Yes, because we don’t have purely
anti-epileptic medication talaga. All our medications for seizures are
28
really just anti-seizures. Because depending on the cause of the
epilepsy, the treatment would differ. And remember that Epidiolex or
the medication, the data said is a purified—like pharmaceutical grade
product. It’s not just an ordinary like extract of cannabis. It’s 98 percent
cannabidiol. Because cannabidiol is the component of cannabis that’s
proven to be effective in treating seizures.
SEN. BINAY. Ano ho ba ito? Is it an oil? Do they—
MS. SALONGA-QUIMPO. Yes, this is an oral solution. So it’s a
purified extract already in a solution form. So this we know are
standardized quantities of the medication every time. All right.
So if we look at cost effectivity—we always look at cost effectivity
and, unfortunately, we still don’t have local data. Our medical societies
are only beginning to start our databases in pediatric neurology. But if
we look at current Philippine population of 107 million, prevalence
estimates of epilepsy in the Philippines is about one million.
If we look at Dravet Syndrome, worldwide prevalence is less than
one per 40,000. And if we extrapolate that, it’s probably around 2,500
Filipinos will have that.
If you look at Lennox-Gastaut, worldwide estimates will be about
15 per 100,000, which is around 15,000. So if we combine that, around
17,500 Filipinos with these two syndromes. But I put here plus a total
29
of 20,000 because there maybe 30 percent of those who may not have
this particular syndromes but do not respond to conventional anti-
epileptic medication treatment. So those are what we call drug-resistant
epilepsies.
So if we look at 5 percent response, meaning, those who would be
seizure free, not just reduction, so the response rates here—I’m quoting
are seizure freedom rates because there’s a difference between
completely having zero seizures as opposed to those having just a
reduction. If we look at seizure freedom from CBD or cannabidiol
treatment at a 5 percent response, that would be 1,000. If we look at
15 percent response, that will be 3,000. So if we look at the numbers,
it’s quite a small population of patients that we’re looking at, at least,
in the epilepsy population.
So the other condition where there has been proven to be some
benefit is for multiple sclerosis. For multiple sclerosis, OCE or oral
cannabis extracts has been found to be effective for reducing patient-
reported scores in terms of spasticity or iyong paninigas po ng muscles
which is particularly the one that’s burdensome in MS. And the other
one is the THC component or Nabiximol which is actually a combined
THC and CBD preparation of cannabis.
30
So they also looked at smoked marijuana but it’s of uncertain
efficacy and this is quoting from the systematic review done by the
American Academy of Neurology.
So for patients with multiple sclerosis, so it’s probably effective in
reduction of central pain and painful spasms. But these are the extracts
but not the smoked marijuana which is of unclear efficacy.
How about for HIV-related symptoms? So what they looked at was
weight change, nausea and vomiting and performance in mood. And
what we found based from a systematic was just seven randomized
control trials. All studies were just of short duration. There was one study
which looked at Dronabinol which is a synthetic preparation of
marijuana. And a conclusion was, there is still no sufficient no good
clinical trial data because of the small populations and some result
subject to bias.
The other big research area is for cancer pain. Because as we
know, it’s being looked at for palliative care, and I won’t bother you with
this very long tables. But suffice it to say, that when they compared
oral tetrahydrocannabinol or the component of marijuana with opioids,
it was superior to placebo, meaning, to not giving medication, but almost
same efficacy as the available medications such as codeine or other
opiate medications.
31
There were limited studies done on cancer patients and some
studies showed mix result. The most recent one is a systematic review
and meta analysis, again in palliative medicine, where they found that
there was no significant differences between cannabinoids and placebo
for improving food intake, for increasing appetite, nausea or vomiting,
for decreasing pain and for sleep problems. So these are what we have
in terms of good quality clinical trial data.
So in summary, where we have good evidence is really just for
epilepsy and multiple sclerosis. For the others, there is some suggestion
that it might be effective but we don’t have the good clinical trial
evidences available.
So if we look at what we have out there, outside of the Philippines,
we must remember that cannabis-based medications come in various
forms. So the ones in blue here are already the medicinal products,
meaning, pharmaceutical grade, those which are synthetic. And,
actually, this have been approved in other countries such as the US for
many, many years. And these synthetic tetrahydrocannabinols have
been used for the treatment of chemotherapy-induced nausea and
vomiting and loss of appetite.
So recently, Sativex, which is a plant-based combination of
cannabidiol and THC, has been approved in some countries for the
32
treatment of spasticity in multiple sclerosis. And as I mentioned earlier,
the most recent was last year was Epidiolex which was approved by the
US FDA and currently undergoing review by the European Regulatory
Authorities. So we only have two cannabis-based medications that are
plant-based that have been approved.
If you look at the other preparations, it could be raw cannabis or
magistral or compounded preparations. These are—You would tell the
pharmacists how many percent of CBD, how many THC they will put in,
and then standardized cannabis which are artisanal oils. So that’s why
the studies are not that good because the preparations vary from study
to study. So until we have that good evidence, I think we still have a
while to wait.
In the US actually, in the University of Mississippi, they got special
permission from the federal government to do research on their own
plant-based extract for epilepsy. So maybe something that we should
consider.
So briefly, I would just like to state the highlights of the UP-Manila
Technical Working Group statement. This actually already echoes what
was previously mentioned by the Department of Health and the DDB.
And I think a lot of our statements really rely on what is available out
there. So we have submitted a hard copy to the secretariat also.
33
So from the UP-Manila Technical Working Group on Medical
Cannabis, we state that we recognize that there are some patients who
do not respond to standard treatment who may benefit from medical
cannabis. However, there is no need for any new legislation to allow
access to cannabis as there are already existing national policies with
mechanisms that will allow access to cannabis for medical use, for
compassionate use and in the research setting as exemplified by the
patient who applied and got approved for Epidiolex.
And mind you, it was quite a quick approval. It was only January
that the patient was referred to me because of increased seizures and
we already have the approval from FDA.
SEN. BINAY. Doc, kayo ho iyong nag-prescribe doon sa patient?
MS. SALONGA-QUIMPO. I wrote because that patient was a
patient of another neurologist, but being an epilepsy expert, it was
referred to me for possible evaluation …/ngdizon/alcc
34
Mancol V-1 February 6, 2019 1:50 p.m. 1
MS. SALONGA-QUIMPO. … for possible evaluation because they
tried a lot of medications already.
So after reviewing the patient’s case, the patient has Lennox-
Gastaut Syndrome and we know that US-FDA approved na iyong
Epidiolex so I made a recommendation through—I think they got the
requirements from FDA for application for medical compassionate use for
Epidiolex po.
SEN. BINAY. Nakakuha na ho sila?
MS. SALONGA-QUIMPO. Hindi pa po. In process na po iyong
papers so actually, they are contacting sources in the US because we
don’t have it locally available. So they have to contact where it is
available po.
SEN. BINAY. At the moment wala pa hong nakakagamit nito.
MS. SALONGA-QUIMPO. At least for my patients iyon pa lang po
iyong first po. And, of course, because it’s illegal here, ma’am, so we
don’t recommend using it but actually, our medical societies, because we
really have high interest in getting this into the country, we have
petitioned earlier this last month, January, to DDB to reclassify
cannabidiol to “Schedule 5” so that it could be imported into the country
so that our patients could have access to it.
35
SEN. BINAY. Siguro, Mr. Chair, since we’re pressed for time, can I
just request the FDA to submit to the Committee the process? Kunwari,
I’m an epileptic patient. Ano ho ba iyong proseso for me to avail of the
medicine?
Thank you, Mr. Chair.
THE CHAIRMAN (SEN. EJERCITO). Thank you, Senator Binay.
Please, FDA, please submit na lang the requirements as requested by
Senator Binay.
MS. AUSTRIA-LOCK. Okay po, Your Honor, yes. We will submit
po.
THE CHAIRMAN (SEN. EJERCITO). Doktora Rhea, are there any
ongoing studies or research from UP-PGH? Wala ano, kasi wala pa kayo
kasi bawal. So once allowed, we will be able to conduct the research
studies.
MS. SALONGA-QUIMPO. Yes, sir. Actually, we have been
proposing since last year to form a medical Cannabis study group at the
National Institute of Health so that we could look at it, opo.
THE CHAIRMAN (SEN. EJERCITO). I just like to have an idea.
How much po is a bottle of cannabidiol? Ang hirap ng mga scientific
terms.
36
MS. SALONGA-QUIMPO. Actually po, if we look at US dollars, it’s
expensive. They estimate the cost for a year to be around US$20,000 to
US$25,000.
THE CHAIRMAN (SEN. EJERCITO). US dollars?
MS. SALONGA-QUIMPO. In a year. Remember these are highly
specialized but we know for a fact that medications are usually more
costly really in the US and when they market it in developing countries,
it’s usually a lower cost. Actually, Dra. Cabral-Lim can probably tell you
later that she has been trying to contact the pharmaceutical that
produces Epidiolex if it could be brought in probably so we could have the
access to it.
THE CHAIRMAN (SEN. EJERCITO). But you’re already in the
process, para ho iyong inyong request so that they can already use it for
your study and treat some of the patients.
Dra. Cabral, ma’am, sige ho.
MS. CABRAL-LIM. Thank you for giving us the opportunity to
present here, Senator JV and Senator Binay.
Thank you, Rhea, for presenting the evidence.
In the interest of time, it is quite clear that the medical community
and the Department of Health are agreed that we do not need a new
37
legislation to allow access, compassionate use of Cannabis and access for
research purposes.
So after presenting the evidence, I would just like to reiterate that
any Cannabis legislation that will promote cultivation, dispensing of
Cannabis outside or research outside the regulation of the current RA
9165, I think, is potentially dangerous because of the experience of other
countries and globally who has actually legalized medical Cannabis. And
quite a number of this, they started from medical Cannabis legalization
and went on onwards towards recreational Cannabis use.
SEN. BINAY. Dr. Lim.
MS. CABRAL-LIM. Yes.
SEN. BINAY. Can you please cite specific countries?
MS. CABRAL-LIM. Yes. I will be presenting most of the data in the
United States because these are the first ones who legalized it and then
I have recent data from Canada. And then the other countries I don’t
have. I think they’re still in the process because what is ironic here is
that these countries have legalized Cannabis without any data as to the
efficacy and safety. And now they are looking into the efficacy and safety
while at the same time this is being given to the patients. That is
definitely contrary to the ethics of medical practice. So most of these
data are data from medical Cannabis legalization but there are just a few
38
that the studies cannot sort out medical versus recreational. But, of
course, predominantly the data is on medical because there are just a
few countries that legalize recreational use. And despite the global
bandwagon on the legalization of medical Cannabis, actually medical
Cannabis legalization all over the world is actually through the ballot and
a political move. I am not aware of any medical group that is in favor of
legalization of medical Cannabis.
So what is the data on medical Cannabis legalization. I have all the
references in this PowerPoint. In the interest of time, I will just read the
summary.
Medical Cannabis legalization has led to increased prevalence of use
in medical Cannabis states. There was an increased Cannabis use due to
the decreased perception of risk especially among the youth who are the
most vulnerable and who are the most frequent users, the youth and the
young adults.
MS. CABRAL-LIM. Yes, please.
SEN. BINAY. Ito ho ba medical Cannabis, both for recreation and
medical purposes or in general na po?
MS. CABRAL-LIM. This slide is for medical Cannabis. I will mention
later the ones where I cannot tell whether it’s pure, okay.
39
So this one is all for medical Cannabis.
There is increased density of Cannabis outlets that increases
Cannabis use and dependence, and there is also diversion to recreational
use. In fact, there are studies stating that substance abusers, actually a
certain percentage of them, have access to medical Cannabis. And, of
course, medical Cannabis advertisement is associated with higher youth
use.
What are the harmful effects? There is substantial evidence of a
statistical association between Cannabis use and increased risk of motor
vehicle crashes. There is increased poison center calls hospitalization and
emergency department visits. This is because people start extracting
Cannabis from butane on their own and they have fires and accidents.
Now, if you look at medical Cannabis legalization, there are studies
showing the relationship between the medical Cannabis market,
recreational use and health harms. So, for every 1 percent point increase
in the share of adults registered as medical Cannabis patients, the
prevalence of Cannabis use among the youth increased by 5 to 6 percent.
So, for example, if we give 100 patients at the Philippine General
Hospital, there will be 500 to 600 patients among the youths who will use
it, and this is under medical Cannabis legalization. There is increased
40
alcohol poisoning and deaths by 4 percent, increased traffic fatalities by
7 percent.
Now, this is a very recent study from Canada—
MS. CABRAL-LIM. Yes.
SEN. BINAY. Doon ho ba sa US, kailangan ho ba prescribed by a
doctor first to avail?
MS. CABRAL-LIM. No, it’s only recommended because it is illegal
in the federal government. So actually, most of the physicians are at a
dilemma because it is illegal in the federal government, they are
authorized to recommend in their respective states. I don’t know how
much informed consent is required but I saw a form wherein if you write
the informed consent, I don’t think the patient will take it because if you
present the evidence and the harms and explain it to the patient, which
actually will be our responsibility now because of the Mental Health Law
that all of us are required to give informed consent to our patients before
we give any form of treatment, I don’t think any patient knowing the
uncertain benefit because HB 6157 passed on third reading actually
legalizes the opening of medical dispensaries and then the physicians will
write a written certification for a gamut of indications which was actually,
if you review the different bills globally, they are quite similar but you can
41
only pick out the ones with the evidence and what we have now. For
now, it’s Dravet Syndrome and Lennox-Gaustaut Syndrome and
spasticity and epilepsy and multiple sclerosis. And regarding pain, the
Pain Society of the Philippines has enough data saying there is really no
evidence for pain now. And pain is a very difficult symptom. . . (nam/trs)
42
CBGealan VI-1 February 6, 2019 2:00 p.m. 1
MS. CABRAL-LIM. …And pain is a very difficult symptom to sort
of confirm or—I can say I have back pain, then therefore, I am
intractable, then, therefore, I deserve Cannabis. But the problem is I
have relief now, then I feel better, then I keep on getting the pain relief
and, of course, because Cannabis affects the reward system, I will start
looking for it. So imagine using it in chronic diseases, in a person who
is chronically ill, you will just keep on looking for it. It is no problem if
it is proven effective, if it is safe. I think any doctor will not hesitate to
give a drug to a patient if it is proven effective and safe. But we all know
that even FDA-approved drug, there’s no such thing as a medicine that
has no side effect. In fact, if you look at our PIMS, when the patient
reached all the adverse effects, they tell us, “How can I take this, it’s all
side effects?” And we assure them that, “We know the side effects, but
the regulations require that we have to list everything. So don’t worry,
we will take care of you. We’ll follow you up.” But of course, with the
knowledge gap na, we cannot tell that for Cannabis. We cannot even
educate our students what is the knowledge that we’re going to teach
you.
So going back to the data on—there’s a recent data on Canadian
Tobacco, Alcohol and Drugs Survey. So there are about 9.5 percent
non-medical users in Canada—2.8 percent use for self-defined medical
43
purposes in addition to non-medical use. And Cannabis users of any
type, this is already the data where it is mixed but, of course, Cannabis
legalization in Canada started also as medical. So they are male, they
are young, they use other illicit drugs, and at least one of three classes
of psychoactive pharmaceutical drugs non-therapeutically. They are
daily cigarette smokers and heavy drinkers. And there’s also evidence
showing that Cannabis use increases the risk of substance use of any
form—alcohol, tobacco, illicit drugs or any substance use.
Daily and near daily Cannabis use is common among self-defined
medical and non-medical Cannabis users. Factors associated with self-
defined medical and non-medical use include: worst general and mental
health. We believe that this bill is contrary to the mental health bill. I
am a strong advocate of the mental health bill, so I cannot imagine that
we are passing a legislation that will aggravate mental health conditions;
lower income and use of other psychoactive drugs.
The majority of households spending on Cannabis is for non-
medical use. A recent international survey looking at 12,000 youth aged
16 to 19 showed that in the United States and Canada youth, there is a
higher prevalence of use, easier access, lower perceived harm and a
higher driving rates after Cannabis compared to England.
44
So the prevalence of use is—this goes from USA, Canada and
England—14 percent to at least as 10 percent in England. Easier
access—two-thirds of the youth in Canada and the US, less than 50
percent in England, and it is perceived harmless by two-thirds to 70
percent of the youth. Because once you legalize something, the youth
starts to perceive it as safe. For example, how can you prevent your
teenage children of taking Cannabis when they tell you that, “Well, the
Department of Health agrees with it. it is legal, so it must be safe.” And
then driving rates, 27 percent of those who use Cannabis in the United
States drive; 15 percent in Canada; and less than 10 percent in England.
So I—
THE CHAIRMAN (SEN. EJERCITO). Dra. Cabral, sorry to cut
you short, but we’re pressed for time. But probably if you may
summarize what are your recommendations for the Committee.
MS. CABRAL-LIM. Okay.
THE CHAIRMAN (SEN. EJERCITO). And probably, just submit
a position paper for our better appreciation.
MS. CABRAL-LIM. Yes. Okay.
So in summary, we agree with the medical community and UP -
Manila and the Department of Health and DDB that there is no need for
any new legislation. The evidence of the efficacy of Cannabis is only
45
limited to very specific conditions. Cannabis is a harmful substance.
The current limited evidence on efficacy of medical Cannabis will
endanger the health and safety of our citizens. And we stand by the
Philippine Food Drug Administration’s approval process as the most
effective way to ensure the safety, efficacy and purity of medications for
use by our patients.
Thank you very much. We submitted the position statement.
THE CHAIRMAN (SEN. EJERCITO). Thank you, Dr. Cabral.
So next is Ms. Agnes Mandap, acting director of Compliance
Service of PDEA. And last on the left side, so ito iyong mga against, Dr.
Jose Santiago, President of Philippine Medical Association—Nakita ko na
iyong hati based on the facial reactions.
SEN. BINAY. [Inaudible]
THE CHAIRMAN (SEN. EJERCITO). Oo nga.
So on the right side, ito po iyong pro.
Okay. Ms. Mandap, please.
MS. MANDAP. Thank you very much, sir.
Good afternoon, sirs and ma’ams.
The PDEA, through its Compliance Service, implements the
regulations issued by the Dangerous Drugs Board. As mentioned earlier,
the policies and regulations involving medical research and
46
compassionate use for medical Cannabis were given. And, as of date,
the PDEA Compliance Service has not received a single application for
the import of a Cannabis-based product for the past several years armed
with the compassionate permit issued by the FDA.
THE CHAIRMAN (SEN. EJERCITO). So nobody is applying sa
PDEA?
MS. MANDAP. Not yet, sir. Wala pa po.
SEN. BINAY. Mr. Chair, kasi baka nasa FDA pa. Nasa FDA pa
lang.
THE CHAIRMAN (SEN. EJERCITO). It’s still with the FDA.
So none sa inyo, ano? Wala pa.
Okay. Thank you.
Kay Dr. Jose Santiago, President of PMA.
MR. SANTIAGO. Yes.
Honorable Senator JV Ejercito, Honorable Senator Nancy Binay,
my dear colleagues in the medical profession, my friends and, of
course—isang maningning na hapon po sa inyong lahat.
Wala ho ditong pro and anti, so—Well, anyway, let me really
sustain the statements made by Usec Domingo, Dr. Quimpo and Dr.
Cabral-Lim regarding this Cannabis.
47
You know that Philippine Medical Association—so don’t be
misconstrued about the PMA, Philippine Military Academy. So that’s
what I want to stress—Philippine Medical Association.
So Philippine Medical Association is the oldest and probably the
largest medical association in the country. Under PMA is eight special
divisions, 54 specialty and sub-special societies and, of course, 57
affiliate societies.
So, Your Honor, I would like to read the unified position statement
of the medical community on HB 6517.
So for and in behalf of the 81 members, medical doctors in the
country, the medical community is steadfast in its stand to, “First, do no
harm.” It’s our ethical responsibility as physicians to prescribe drugs
based on the proven efficacy and safety in order to safeguard the best
interest of our patients.
HB 6517 will expose our citizens to a natural, uncontrolled human
experiment with Cannabis and its derivatives. This human experiment,
under the guise of the law, requires no informed consent, no approval
from the professional institutional review board, no protection from our
drug regulatory agency, and no accountability and no recourse for
unfavorable consequences for its use.
48
Cannabis is harmful and can cause potentially fatal adverse drug
reaction and drug interactions. It is dangerous to developing brain and
it can cause neurocognitive, psychiatric and behavioral problems. The
evidence for the efficacy of Cannabis is only limited to epilepsy in Dravet
Syndrome, Lennox-Gastaut Syndrome and spasticity in multiple
sclerosis.
Access to medical Cannabis for compassionate use and research
is already provided by law through R.A. 9165. Hence, there is no need
for a new legislation to this end. HB 6517 is unnecessary and redundant.
We have just recently passed the Mental Health Law, and I would like to
thank Honorable Senator JV Ejercito and, of course, Senator Nancy
Binay for their support on this Mental Health Law, which promotes the
well-being of the Filipino people. And HB 6517 that proposes to legalize
medical Cannabis undermines the integral…/cbg/jmb
49
RPALGER VII-1 February 6, 2019 2:10 p.m. 1
MR. SANTIAGO. …undermines the integral policy of this law.
The HB 6517 is contrary to the policy of the State to safeguard the well-
being of citizenry, particularly the youth who’s most vulnerable to
harmful effects of dangerous drugs.
Legalization of Cannabis is a public health issue. HB 6517 poses
harm to the healthy, with no guaranteed cure for the sick. Cannabis is
one of the most widely cultivated, trafficked and abused illicit drug and
serves as a gateway for the use of more potent substance of abuse.
Medical Cannabis legalization in other countries has led to
increased Cannabis use as really presented by Dra. Cabral-Lim in US
and Canada, diversion to recreational use, increased incidence of traffic
accidents, accidental poisoning and the development and aggravation of
mental disorders.
HB 6517 is contrary to the interest of public safety and the
common good.
This is just probably the statements made by our colleagues in the
medical profession and I hope we could send the message loud and clear
to Your Honor, Senator JV Ejercito and, of course, to Senator Nancy
Binay.
Thank you, sir.
50
THE CHAIRMAN (SEN EJERCITO). Okay. Thank you, Dr.
Santiago.
But do you agree that there are some—it relieves or prevents
seizures and probably can help in multiple sclerosis and epilepsy.
MR. SANTIAGO. That’s correct.
THE CHAIRMAN (SEN EJERCITO). But you are against the
House bill.
MR. SANTIAGO. That’s a limited use—very limited use.
THE CHAIRMAN (SEN EJERCITO). You are against the House
bill, you need to summarize…
MR. SANTIAGO. Yes.
THE CHAIRMAN (SEN EJERCITO). …because there are already
existing processes which you can obtain.
MR. SANTIAGO. It’s correct.
THE CHAIRMAN (SEN EJERCITO). Anyway, I am just clarifying.
And we will go into that later, how come it is so hard or too difficult to
obtain kaya parang kaunti ho ang nag-a-apply, baka naman ganoon.
Okay.
MR. SANTIAGO. Well, probably—it will just probably, you know,
lessen the process or expedite the process on how to obtain the drugs.
51
THE CHAIRMAN (SEN EJERCITO). Okay. Please submit your
position.
MR. SANTIAGO. Yes, Your Honor.
THE CHAIRMAN (SEN EJERCITO). So, thank you very much,
Dr. Santiago.
Now, we move on to the Philippine Cannabis Compassion Society,
Riciel Ballesteros, excom member or spokesperson. Sino ho sa inyo?
MS. BALLESTEROS. Good afternoon, Senator JV and Senator
Binay.
THE CHAIRMAN (SEN EJERCITO). Ms. Riciel Ballesteros, okay.
But before you continue, then next probably Chuck Manansala and
the others para lang you will be ready. And probably we’d like to hear
from Dr. Reyes before we go to the others after Mr. Manansala because
Dr. Reyes is the chief policy adviser of the main proponent,
Congressman Rodito Albano of this House bill. So, we’ll hear from her
then go back to the others. Okay.
Ma’am, sige, go ahead.
MS. BALLESTEROS. Good afternoon.
My name is Riciel Ballesteros. I am from Quezon City. I am a PCCS
member, a mother advocate and a supporter of House Bill 6517 or the
Philippine Compassionate Medical Cannabis Act.
52
I am a mother of a 12-year old boy. His name is Jacobo Joachim,
whom we fondly called “Sachi.” He was diagnosed with infantile
hemiplegia, cerebral palsy and epilepsy with intractable seizures.
His seizures started when he was eight months old up to the
present.
He has been with five anticonvulsant medications as maintenance
namely: Levetiracetam, Lamotrigine, Clonazepam, Oxcarbazepine,
Topiramate and Midazolam when his seizures becomes uncontrollable.
These anticonvulsant medications are both regular and with S2
prescriptions.
Despite the five maintenance drugs and benzodiazepine
medication, his seizures remain uncontrollable that ranges an average
of 5 to 10 times per day or 50 per week. Every time he will have his
seizures, we can only watch in grief, praying for his seizures to stop
while we helplessly wait for the medication to kick in.
I am sorry, I am becoming emotional.
While we have been in these numerous medications for 12 years,
we also experienced a lot of side effects, including severe skin rashes,
lethargy and mood swings but we keep him in those medications with
the hope of seizure control despite all those side effects.
53
Sachi was also in ICU due to status epilepticus with seizures that
lasted for 45 minutes. He was intubated and that was the time when we
thought he’s going and he’s gone. He recovered after five days and so
our turning point for seeking all other possible options.
We came across numerous articles about medical Cannabis
including a series of CNN episodes of Dr. Sanjay Gupta, a neuro surgeon,
entitled WEED. Dr. Gupta had also his reservations on the benefit of
medical Cannabis, however he later apologized for he said he did not dig
deeper. He mentioned that after five years of studying and following
different researches for medical Cannabis, it changed his position, that
Cannabis is beneficial for different medical conditions. With that, it gave
us information on the medical benefits of Cannabis for patients with
different conditions including epilepsy and intractable seizures.
As a parent, you will seek for all possible options that will improve
the condition of your child and ensure that we provide them an
opportunity to grow and enjoy what a kid his age should experience and
to live his life to the fullest.
I am just one of those mothers whom life was changed completely
by having a child or family member with this kind of debilitating
condition. Hospital has been our second home. We experienced getting
confinement for several days, was able to get a discharge order only to
54
be back at night on the same day for another confinement because of
seizures.
This has been our journey in the last 12 years. Other than the
insurmountable medical bills during his hospitalization, the cost of
maintenance medication and other interventions like OT, PT, speech
therapy which averages around P70,000 monthly, it is the emotional
burden that mostly becomes unbearable. The constant concern whether
Sachi will be there the next day is always our biggest fear. It also
changed the dynamics of our family as most of our days are evolving
around him. And there are times when I almost want to give up as a
mother. I am always reminded that when Sachi was hanging on for his
dear life when he had status epilepticus, like a fish out of a fish bowl, he
vividly uttered to me, “Hold on, nanay, hold on.”
In behalf of PCCS members, advocates and mothers who are
holding on and holding on tight for the opportunity to have additional
option in the management of different debilitating conditions that our
loved ones are experiencing, we are humbly appealing to the Honorable
Senators for the opportunity to be heard on the following: to be able to
have a regulated access for medical Cannabis as a finished dosage form
that is safe and affordable; and to kindly consider House Bill 6517
approved in the Lower House to be adopted by the Senate.
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We are hoping for your favorable accommodation on the passage
of Compassionate Medical Cannabis Act now for the benefits of patients
who are really in dire need and are racing against time.
Maraming, maraming salamat po.
THE CHAIRMAN (SEN EJERCITO). Thank you, Ms. Riciel
Ballesteros of the Philippine Cannabis Compassionate Society.
Of course, we sympathize with your predicament. And of course,
that’s why we are hearing this measure, we’re trying to find ways on
how we will be able to relieve and probably relieve conditions like this.
But why do you—anyway, we’ll ask questions later. We’ll just finish the
other resource persons.
Dr. Donnabel, mayroon na ho kayo? Just quickly so that we can
finish all the others, so that we can already profound questions.
MS. CUNANAN. Good afternoon.
My name is Dr. Donnabel Trias-Cunanan, spokesperson, Philippine
Cannabis Compassion Society, also a mother of an epileptic child with
an intractable seizure known as the brain syndrome. She has around
100 seizures daily in her worst, that’s why I am passionately advocating
for this.
THE CHAIRMAN (SEN EJERCITO). And Dr. Donnabel, you are
a doctor of medicine also?
56
MS. CUNANAN. I am a dentist…/rommel/mva
57
SMVilladiego VIII-1 February 6, 2019 2:20 p.m. 1
MS. CUNANAN. …I am a dentist by profession.
THE CHAIRMAN (SEN. EJERCITO). You are a dentist. Okay.
MS. CUNANAN. The Philippine Cannabis Compassion Society is
an organization composed of patients, parents, caregivers—some of our
patients are here--caregivers and advocates pushing for safe,
affordable, available and regulated access to medical Cannabis. We are
in the forefront of the medical Cannabis movement in the Philippines.
We have been fighting and campaigning for the medical Cannabis
law since 2014. And sadly, many of our members have passed away
without seeing the advent of medicine that could have made their lives
more bearable and less suffering.
PCCS highly supports House Bill 6517 for the following reasons:
First, we believe that the access to Cannabis as medicine is a basic
human right. It is our right to health. And Filipinos have the right to
the highest attainable standard of physical and mental health which
includes the right to access medical services, sanitation, adequate food
and healthy environment.
House Bill 6517 will only allow qualified patients with debilitating
medical conditions to access medical Cannabis in a very strict
environment and very, very strict regulatory framework under the
Department of Health, FDA, DDB and PDEA.
58
The qualified patients must have a bona fide relationship with his
physician. Meaning that the patient and the physician have a continuing
relationship wherein a physician has made a complete assessment of the
patient’s medical history, including an appropriate diagnostic and
personal physical examination sufficient to determine that the patient is
suffering from a debilitating medical condition.
PCCS recognizes the use of medical Cannabis as a symptomatic
relief for patients suffering from chronic pain, cancer, seizure disorders,
and many diseases require admission to hospice care. It will only allow
legitimate patients that have medical conditions to have safe access.
I personally applied for the compassionate special permit, like
what Dr. Quimpo has been telling in the Committee. But, Your Honor, I
was declined. And also I am not as rich maybe of one of the patients of
Dr. Quimpo because the compassionate special permit is in FDA-finished
product form and it is around $32,000 per year.
Your Honorable Senators, I speak on behalf of all the patients from
the Philippine Cannabis Compassion Society na halos average or
mahihirap po ang aming mga pasyente. And we highly appeal to your
Honorable Senators, to please help us and be the champions of our
Filipino patients to access medical marijuana. We humbly ask our dear
Senators to please consider and pass House Bill 6517.
59
Maraming salamat po.
THE CHAIRMAN (SEN. EJERCITO). Thank you, Dr. Donnabel
Cunanan.
Anyway, I just like to ask, saan ho kayo nag-apply? Did you apply
already sa FDA?
MS. CUNANAN. Nag-apply po. Yes po.
THE CHAIRMAN (SEN. EJERCITO). When was this?
MS. CUNANAN. Two to three years ago po. Around two to three
years ago.
THE CHAIRMAN (SEN. EJERCITO). Two to three years ago.
SEN. BINAY. What was the reason?
THE CHAIRMAN (SEN. EJERCITO). It was declined?
Disapproved.
MS. CUNANAN. Yes. Because it has very, very hard
qualifications. First, I personally asked my neurologist to help me with
the application of the CSP. But unfortunately, I went to FDA around two
to three times. And then they don’t have a very, very specific IRR for
the application of the FDA compassionate special permit. And at that
time, I was informed, Your Honor, that it will be processed and it will
take around two to three months for the medicine to be—Yes.
60
THE CHAIRMAN (SEN. EJERCITO). Anyway, we will ask FDA
later on.
MS. CUNANAN. Yes.
THE CHAIRMAN (SEN. EJERCITO). We will just finish all the
other resource persons.
Likewise, the Chair would like to inform all of you that this will be
the last week of our session before we go on break for the campaign
break, we will still be back in May. So hindi pa po tapos ito. By May,
we can probably schedule committee hearings in between.
MS. CUNANAN. Thank you.
THE CHAIRMAN (SEN. EJERCITO). Okay. Yes, Senator Binay.
SEN. BINAY. Kasi parang kanina pa ho nababanggit iyong cost
of that drug.
THE CHAIRMAN (SEN. EJERCITO). Twenty-five thousand,
thirty. Very prohibitive.
SEN. BINAY. Nakikita ninyo ho ba iyong scenario na we will
locally manufacture that drug?
VOICES. Yes.
SEN. BINAY. And we can do that? I don’t know kung—
THE CHAIRMAN (SEN. EJERCITO). Dr. Domingo.
61
MR. DOMINGO. Iyon nga po kasi ang ano natin, wala pa po
kasing scientific evidence except for, of course--iyon nga po, katulad po
noong kay ma’am na iyong diagnosis ng kanyang seizure. These are
one of those that are actually known naman na may benefit.
THE CHAIRMAN (SEN. EJERCITO). Nare-relieve. Talagang it
relieves or prevents seizures.
MR. DOMINGO. Opo. Kaya lang until then—One of the
requirements for FDA for compassionate use, like any other drug,
halimbawa, cancer, any drug, kapag may compassionate use na gustong
ipasok sa Pilipinas, ang requirement po registered siya sa FDA ng
country of origin.
THE CHAIRMAN (SEN. EJERCITO). Iyong drug mismo?
MR. DOMINGO. Iyon pong drug mismo.
THE CHAIRMAN (SEN. EJERCITO). Of course.
SEN. BINAY. Pero kasi, Usec Domingo, ang nagiging problema
iyong cost.
MR. DOMINGO. Yes. Cost.
THE CHAIRMAN (SEN. EJERCITO). Very prohibitive.
SEN. BINAY. Mahal if we import the drug. So nakikita ninyo ho
ba iyong scenario that eventually we will produce that component?
62
THE CHAIRMAN (SEN. EJERCITO). Improvement.
Improvement that the efficacy, kung na-prove na natin lahat. Would you
recommend?
MR. DOMINGO. Opo.
SEN. BINAY. Hindi, USFDA approved na itong isang drug.
MR. DOMINGO. Opo.
SEN. BINAY. So kung tutuusin, baka pwedeng i-produce na siya
dito sa Philippines.
MR. DOMINGO. Yes. But if it is going to be a new product po
that is manufactured in the Philippines, it will have to go through the
regular development process. So marami rin pong research na
pagdadaanan iyon from phase 1 to phase 3 clinical research.
SEN. BINAY. But you are open to that idea?
MR. DOMINGO. Yes, ma’am. Iyong research naman po, as long
as it goes through the proper regulation which--hindi naman po kami
talaga against doon sa research at saka compassionate use. I think
what everybody here is saying we already have the mechanism that
allows it to be done. Papayagan naman po ng DDB--
THE CHAIRMAN (SEN. EJERCITO). So is there really existing
research already? Not yet? When do we start?
63
MR. DOMINGO. Ang mayroon po ngayon tayo sa PITAHC pero
pre-clinical pa po.
THE CHAIRMAN (SEN. EJERCITO). Pre-clinical.
MR. DOMINGO. So this is mga community studies.
SEN. BINAY. Iyon na nga. How do we start the process of—Kasi,
hindi ba, parang in the--
THE CHAIRMAN (SEN. EJERCITO). Yes, because siguro iyon
ang nag-aano—If I may? Dagdagan ko lang. Palagay ko iyong point ni
Senator Binay, like me, marami na ngayon kasing ganito ang situation
who are already helpless. Iba rin iyong pakiramdam na nakikita mong
inaatake. So I hope that we can already start the research at least,
Senator Binay. I think that is the ano na masimulan na natin.
SEN. BINAY. Oo. Kasi, I think in everything, ang pinakamahirap
iyong unang hakbang. So how do we start the process? Kasi nga, hindi
ba, kumbaga may buhay tayo na hinahabol. So I guess iyon din iyong
sigurong naririnig kong common complaint is parang it’s--you kept on
saying that there is already a process in place for them to avail. Kaso
lang parang ang perception is…
THE CHAIRMAN (SEN. EJERCITO). Parang medyo mahirap.
64
SEN. BINAY. …ang hirap ng proseso. So siguro while we are
discussing this bill, baka pwede na tayong magkaroon ng steps to make
the process easier.
MR. DOMINGO. Madam Chair, mag-a-apply lang naman po sa
DDB and then sa FDA. Wala pa po kasi, ma’am, nag-a-apply for
research.
THE CHAIRMAN (SEN. EJERCITO). Baka naman ang akala nila
na napakahirap, hindi na sila nagsusubok. So probably it came from our
agency heads already that basta lang ho may process that you will apply,
and then probably they will process as long as there is basis. Siguro if
the conditions are proven, probably it will be approved.
SEN. BINAY. Siguro, Mr. Chair, ang nagiging isang problema din
is funding. Kunwari ho, assuming na makakahanap tayo ng funding for
this study, will DOH be open to productive one?
MR. DOMINGO. Yes, Madam Chair. Even the UP—the National
Institute of Health would like to create a working study group for this.
So mayroon naman po. We have experts to do it. We have the facilities
to do it. And we have--what we say is we have the mechanism to do it.
Kailangan lang po talagang mag-apply.
THE CHAIRMAN (SEN. EJERCITO). At least the department is
ano--
65
SEN. BINAY. On your own, kahit walang applicant, hindi ba
pwedeng kayo na iyong magte-take ng lead doon sa pag-conduct ng
research?
MS. CABRAL-LIM. Can I speak po?
Hindi ho kasi ganoon kadaling mag-conduct ng research. Ang
National Institute of Drug Abuse sa America po mayroon na silang
plantation. They commissioned the University of Mississippi to conduct
research. Matagal na ho iyon. In 2017, they spent $140 million for the
research. Over the years, ang lumabas lang ho nilang data, there is a
certain variety that might be effective for pain. Hindi ho iyong Epidiolex
kasi plant iyong kanila. But ang sinasabi nila is this is not the variety
that is available in all the dispensaries in the United States. And then,
iyong pong sinasabing hindi in-approve ng FDA, in fairness to the FDA,
I think the one that is being applied was an extract with no evidence of
benefit. Naiintindihan po naman natin na mahal iyong gamot kasi ang
hirap po kasing i-extract ng cannabidiol…/smv/imjv
66
RPCorpuz IX-1 February 6, 2019 2:30 p.m. 1
MS. CABRAL-LIM. …i-extract ng cannabidiol. Iyon po kasing
marijuana kaya tinawag na pot, madali hong itanim iyan. Pero ang
tumutubo po diyan na madali, iyong nakaka-affect ng pag-iisip, iyong
may psychoactive. Sadly, iyong nakakagamot, kakaunti iyong
component, mahirap po siyang i-produce.
THE CHAIRMAN (SEN. EJERCITO). That’s why it’s very
expensive.
MS. CABRAL-LIM. Yes. So halimbawa po, magtanim tayo. Kung
magtatanim ka sa bakod mo, hindi ho pareho ng itatanim mo sa north
kung nakatira ka sa north, depende po sa soil, depende sa climate,
depende sa rainfall. So I would think iyong bago tayong umabot sa
stage na makapag-produce tayo ng variety that will be medicinal, I think
that’s good if we can do that right away. Pero halimbawa pong ma-
reschedule natin iyong certain forms, like with the very low cannabidiol
content that will be allowed by the international narcotics board, maaari
po iyon na pwedeng clinical trials na pwedeng i-apply sa DDB and then
you will look at the patients, kasi hindi naman natin pwedeng sabihin
unethical iyong isang grupo walang Cannabis, iyong isa mayroon, kasi
hindi naman po talagang proven benefit. Meaning, lahat po tayo kapag
uminom ng isang gamot, pwede mong sabihing, “Ako, maganda ang
pakiramdam ko, I feel good.” The other person is not necessarily—
67
THE CHAIRMAN (SEN. EJERCITO). Depende rin ano? Depende
sa reaction din, iba-iba.
MS. CABRAL-LIM. Oo. Pero ang science po ngayon, mayroon
tayong pharmacogenomic center, nandoon na nga tayo sa tinitingnan
iyong—kung ikaw ay ganitong sakit, kukunan ka ng DNA study, titingnan
pati iyong gamot na magkakaroon ng kaunting…
THE CHAIRMAN (SEN. EJERCITO). Effect.
MS. CABRAL-LIM. ...allergy sa iyo. Ganoon na po iyong
direction. And then we want to approve dispensing a plant na walang
ebidensiya na makakatulong siya, para po nating pinag-e-
eksperimentuhan ang pasyente.
THE CHAIRMAN (SEN. EJERCITO). Sige po.
MS. CABRAL-LIM. Naintindihan po natin iyong cause. Pero kung
ako po ang pasyente maski po ibigay mo sa akin ng libre, kung sasabihin
mo sa aking, “Hindi ako sure kung makakatulong sa iyo, depende sa
mga pagsusuri at hindi ko alam ang long-term effect sa iyo,” hindi ko po
iyon kukunin, hindi ko tatanggapin. Pero naintindihan ko po iyong
dilemma ng mga pasyenteng may drug resistance seizures. Ako po ay
epileptologist. All my life ang advocacy ko is promoting epilepsy care.
Tatlong dekada ko na pong pinaglalaban iyan sa Department of Health.
So finally ho, nagkaroon na kami—na included na kami sa Department
68
of Health program. At kami po ay committed to help the Department of
Health to promote epilepsy care. Iyon nga lang noong sa Philippine
General Hospital, iyon nga lang hong pambili ng conventional anti-
epileptic drugs, walang pambili. Kasi ang scenario po sa epilepsy, 70
percent ng pasyente kayang gamutin ng primary care, magre-respond.
We have a 20, 30 percent there who are difficult to treat. And globally
ho pinag-aaralan iyan, hindi lang ho tayo. Pero siyempre, parang sa
amin din ho, mahirap din hong tanggapin na being specialist, we still
have a gap out there. Pero at the same time, obligasyon naman ho
namin na huwag magbigay ng isang substance na possibility’ng
(possibility) magka-epekto sa bata. Lalo na ho sa kanila, pediatric
neurologist, these are children, it affects the developing brain. Epilepsy
is a chronic condition. Kagaya po nangyayari sa ibang herbal, iyong
ibang may diabetes, akala nila ampalaya, pwede na ang ampalaya so
they stop the medications then they take the ampalaya. So if you
legalize, these patients with epilepsy can even think na, “Oh, mas mura
iyan, bibili na lang ako ng capsule sa dispensary kasi mas mura and then
iinumin ko.” Wala hong data sa mga epilepsy na easy to treat. Kaya
nga ho pinag-aaralan iyan for difficult to treat. But I would think—
69
THE CHAIRMAN (SEN. EJERCITO). Thank you po, Doc. Sorry
to cut you but we only have less than 20 minutes and we still have four.
We’ll get back at you again later on.
Si Mr. Chuck Manansala, and probably those doctors that are on
the other side, siguro, please, quickly na lang ho so that we can all hear
your positions.
Mr. Chuck Manansala, and then Dr. Quijano, Dr. Reyes, doon po
sa position ng principal author which is Congressman Albano.
MR. MANANSALA. Thank you very much, Senator Ejercito, and
good afternoon, Senator Binay, and all the other stakeholders in this
legislative action on medical Cannabis.
Nag-a-apply na po kami sa inyo ngayon na maging research
center. Binago ko na ng kaunti ang aking statement.
Masikhay is a nonprofit research center focused on the scientific
study of Cannabis and its medicinal properties. Our objective is to help
develop Cannabis medicine in finished dosage form that will pass the
standards set by the Food and Drug Administration. We aim to help
create a medical Cannabis system that empowers doctors and patients.
We fully support all efforts to promote medical Cannabis and uphold the
people’s right to health.
70
We see HB 6517 or the Philippine Compassionate Medical Cannabis
Act as a step in the right direction. It creates a legal framework and the
regulatory environment that provides safe, available, and affordable
access to medical Cannabis. It complements RA 9165 and is congruent
with the regulations of the Dangerous Drugs Board.
Passing the medical Cannabis bill will surely be a cause for
celebration among the hopefuls. For instance—it is an old data but Dr.
Quimpo presented a newer one—in 2007, there were an estimated
750,000 Filipinos with epilepsy in the country but their estimate is about
25 percent would be intractable to current medical therapy. Cannabis
may help in reducing epileptic seizure.
According to the Philippine Cancer Society figures in 2015, at least
98,000 Filipinos are diagnosed with cancer each year, with 59,000 of
these dying. Seventy-five percent of them die with intense pain.
Cannabis may provide effective pain relief or serve as an adjuvant. But
we clarify that having a law is just the start of a long and arduous
process of seeking approval from the FDA before the medicine becomes
available whether the product is imported or locally manufactured.
There is great urgency in passing a medical Cannabis law.
We take particular notice that HB 6517 is explicit in providing for
expanding research into the medicinal properties of Cannabis. It is
71
auspicious that the Dangerous Drugs Board (DDB) has already issued
the guideline under which Masikhay and other research centers can
operate. We presently maintain a database of published research,
literature, and clinical studies from reputable medical and scientific
journals and institutions providing solid proof on the medical efficacy of
Cannabis for various ailments.
Our immediate goal is to collect, characterize, develop and
cultivate local Cannabis strains to lay the scientific basis and good
manufacturing process to create new and affordable Cannabis medicine
based on whole plant extracts here in the Philippines. We will adhere to
DDB’s Board Regulation No. 1, Series of 2014 which is about the
comprehensive guidelines on importation, distribution, manufacture,
prescription, dispensing and sale of, and other lawful acts in connection
with any dangerous drugs, controlled precursors and essential chemicals
and other similar or analogous substances and shall operate under the
prescribed rules in Section 14, titled, “Permits in Relation to Laboratory
Use and/or Programs for Medical and/or Scientific Research or
Instructional Training Programs.”
HB 6517 lays down the legal framework for providing access to
medical Cannabis. It prescribes very tight regulations and mechanism
to prevent illicit traffic and abuse. In fact, we do hope that the final
72
version of the bill does not become too restrictive and makes it very
difficult to access, bureaucratic, and too expensive. Let us all aim to
create affordable access to the medicine.
As a side note, GW Pharmaceutical, the manufacturer of Epidiolex
has announced that their estimated cost would be roughly $32,500 a
year or roughly $2,708 a month, $677 a week and $96 a day. The good
Doctor Cabral cited specific data coming from the US and Canada. I
submit that this is not…/rea/alcc
73

MR. MANANSALA. ...I submit that this is not applicable in the
Philippines. Because in Canada and the US, patients are allowed to use
Cannabis on self-definition and they are also allowed to plant Cannabis
at home. It is impossible to do that in the Philippines under regulations,
9165, and especially under HB 6517 which personally to me is very, very
restrictive because it only allows cultivation by licensed growers to
create the medicine. Possession is still illegal.
So, the danger of abuse and dangers to mental health is
impossible because everything will be done under the supervision of a
qualified physician.
THE CHAIRMAN (SEN. EJERCITO). Okay. Mr. Manansala,
please wrap up because we have a session. We can’t have ano—
MR. MANANSALA. Sige, I will wrap up.
So, we were the first in Asia to initiate legislation for medical
Cannabis but we have been overtaken by two East Asian countries. Last
year, South Korea and Thailand amended their narcotic laws and
legalized medical Cannabis. They have become the first in Asia to
properly enter into the international Cannabis market which has been
estimated to reach $55.8 billion by 2025. Medical Cannabis may yet
prove to be a boon to our economy.
74

We have the opportunity for the Philippines to assert a leading role
in developing innovative medicine. We have made a great leap in having
herbal medicine as part of our arsenal to fight disease. The Philippines
is known as the home of world-class caregivers known for being kind,
cheerful, and compassionate. With the passage of HB 6517 and with
positive action from the Senate, we are simply being true to our nature.
Thank you very much.
THE CHAIRMAN (SEN. EJERCITO). Okay. Thank you, Mr.
Manansala.
Before we go back to Dr. Gem—si Dr. Quijano, same naman kayo,
ano? We’ll go back to you also, Dr. Gem. Probably, Dr. Reyes, after.
Siguro si Dr. Gem Mutia and then I’ll go to Dr. Reyes, then we’ll go back
to the others.
Would you like to say anything?
MR. MUTIA. Good afternoon, Honorable Senator JV and
Honorable Senator Nancy. Thank you for this opportunity.
May I just present very quickly my presentation?
Next slide, please. I’ll just wrap up very—
So, I’m just here to educate a little bit everyone that the reason
Cannabis—
75

THE CHAIRMAN (SEN. EJERCITO). Dr. Mutia, you are a doctor
of medicine?
MR. MUTIA. Yes, sir. I am a medical doctor.
THE CHAIRMAN (SEN. EJERCITO). Medical doctor.
MR. MUTIA. The reason Cannabis causes changes in the body is
because there are cannabinoids inside all mammals right now. They are
involved in physiological, ibig sabihin, normal processes. And there is
current hypothesis that the decreased amount of these circulating
cannabinoids actually cause diseases.
Next slide po. Next po.
So iyon pong sinasabi ko, iyon po iyong “endocannabinoid
system.” So, the endocannabinoid system, it’s not actually an organ
system because it’s actually a receptor system all over the body. I
mentioned this because I agree with Dr. Cabral-Lim that doctors do not
know how Cannabis works in the body. Because me personally, I got
licensed just six years ago and Cannabis is not studied as a medicine.
It is studied as a substance of abuse. But this study just shows us that
there is a gap in the knowledge because, actually, the endocannabinoid
system is very vital in health and in disease and we are not studying it
as of the moment.
Next slide po.
76

Just to summarize again the normal physiological functions of
these cannabinoids, hindi po marijuana, iyong natural cannabinoids
which are isomers or analogs, identical chemicals of the compounds
found in marijuana, their main function is to help us eat, relax, forget,
and protect normally.
Next slide, please. Next po.
Kaunting pharmacology na po ito. I-skip na po natin.
Next po.
So virtually, every organ system po, day-to-day activities of every
organ is under the influence of the natural cannabinoids in the body.
Ngayon po, this is very recent review, 2018, systematic review from the
European Journal of Internal Medicine, just to quote that they, the
researchers, found that there is conclusive evidence already, conclusive
evidence for pain, for muscles spasticity and multiple sclerosis, and
chemotherapy associated with nausea and vomiting. And there are
other diseases as well not that rich pa in evidence.
So it’s not that there is no evidence, it’s just that the research is
not that—Because again, just what Dr. Quimpo said, not all research is
the same. The weight of the evidence, it differs. But there are other
diseases pa currently studied abroad.
Next slide po.
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So, again, that’s for the therapeutic indications. Next, this is the
side effects. What harms does Cannabis cause? So, kanina ang usapan
natin was the endocannabinoids, natural cannabinoids in the body, then
we went to the therapeutic applications of supplementing the
cannabinoids in the body from cannabinoids from the plant.
Now, these are the side effects of exogenous cannabinoids when
taken. Just to mention that it doesn’t mention anywhere there mortality,
all-cause mortality or death. Cannabis does not cause death directly.
But we totally agree with the example cited kanina, it does cause lack
of motor coordination. So you are prone to vehicular accidents and not
contra-indicated for those who operate machineries. But then again, we
don’t expect cancer patients and epileptic children to drive vehicles and
operate heavy machinery.
And then it is also important there that Cannabis causes addiction.
Cannabis causes addiction, it is very important. But, if you can see
there—
THE CHAIRMAN (SEN. EJERCITO). …because as stated by the
two doctors earlier, iyong dependence, pag chronic especially magiging
dependent na talaga, magiging addict.
How do we treat that para hindi mag-ano iyong addiction? How
can we prevent?
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MR. MUTIA. Well, just to show you—next slide po. Ayan po,
iyan. Dependence po, this is for illicit substances.
And then, next slide.
Prescription drugs po also causes 14 percent dependence
compared to Cannabis which causes only 9 percent dependence. So,
tama po. Maski anong klaseng gamot, kung magko-cause ng
dependence, as much as possible—
THE CHAIRMAN (SEN. EJERCITO). Like pain relievers.
Sometimes, pain relievers.
MR. MUTIA. Yes po. But then again, kung titingnan ninyo po sa
side ng mga may high blood, diabetes, these are chronic conditions,
kung maintenance po iyon, I can’t call myself addicted or dependent if I
really need to take them. Lahat ba ng may high blood and diabetes—
And then last na lang po—next slide po—ito po. This is an
observational study in the US, in states where medical Cannabis is legal.
From 2010 to 2013, the patients—medical marijuana laws reduced
prescription medication use. So nabawasan po ang mga maintenance
medications ng mga pasyente sa mga lugar kung saan legal po ang
Cannabis and ang karamihan po sa mga gamot na pinalitan po, nandito
sa may left, iyong mga pain medications po. Iyong iba pang mga
indications po diyan sa ibang sakit. Iyan po iyong mga pinalitan ng
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Cannabis. And iyong nasa right po, iyong figures pong iyan, iyong
amount—Because it causes drop in prescription medication use, it also
lowers healthcare cost and that’s in hundreds of millions of dollars per
year saved because medical Cannabis was implemented.
So, next slide po.
Actually, last slide ko na po ito. Trivia lang po sa mga tao na,
actually, iyong pioneer ng Cannabis research sa Pinas, walang iba kung
hindi ang pinakatanyag na doctor sa Pinas, Dr. Jose Rizal. Siya po ang
pinaka-earliest—According sa kanyang diary, na “Even though no book,
no historian that I know of speaks of any plant similar to that in hashish,”
at that time, he opened his mind and actually kind of pioneered research.
Because laging sinasabing, “Walang research, walang research.” At this
time po, it already opened the mind of the most famous physician of the
country.
So, in summary po, gusto ko lang pong iparating na Cannabis po—
Agree po ako doon sa position kanina na “first do no harm.” And in that
line, I think we should prescribe the safer medications first before pa
iyong mga mas toxic po na maraming side effects, and safer…/jtbc/peg
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MR. MUTIA. …maraming side effects and safer medications first
before pa iyong mga mas toxic po na maraming side effects, and safer,
and it is effective and sometimes in some states it lowers health care
costs. Actually po hindi ko na po nasama that it is actually better. There
are few studies that when Cannabis was…
THE CHAIRMAN (SEN. EJERCITO). Sorry ha, but I have to cut
you because we have to go in plenary.
MR. MUTIA. Thank you so much, sir.
THE CHAIRMAN (SEN. EJERCITO). We cannot continue with the
plenary ongoing, we are prohibited.
Dr. Reyes, we would like to hear the position of the main author of
this measure, this controversial measure.
Ma’am.
MS. REYES. Thank you so much, Honorable JV Ejercito and
Senator Binay.
Finally, after four years of hard work and sustained advocacy, the
proposed Philippine Compassionate Medical Cannabis Act, authored by
Representative Rodolfo Albano III has reached the Senate. HB 6517 has
undergone various incarnations in its long journey: as HB 4477 in the
Fifteenth Congress and HB 180 in the Sixteenth Congress. Enormous
thanks to the 163 Members of the Seventeenth House of
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Representatives who believed in the medical use of marijuana. I am
terribly disappointed, actually, with the position now being taken by
DOH, by DDB, and by PDEA. They were consulted all throughout the
process of crafting this bill, and we thought they were already in our
pockets. In fact, we have talked about four—I mean, we already have
their support. That’s what I meant. And to be very honest, we have
talked to four DOH secretaries, and this is the fourth. And may I advise
the Department of Health to please look at the current version of the
bill because they are no longer hospital-based medical Cannabis
compassionate centers. We agree with you that these will strain and
drain the resources of hospitals, so they are no longer there. So can
you please look at the new bill?
HB 6517, Senator Ejercito, as early as 2014, we have conducted
consultations with doctors, with government agencies, with human
rights lawyers, with patients. So, it’s not like it’s only now that we are
hearing these arguments, and we have heard these.
Now, HB 6517, actually has one of the strictest regulatory
frameworks among countries that have legalized medical marijuana.
DOH, in consultation with FDA, is the principal regulatory agency,
while PDEA shall have a key role in monitoring and regulating the
dispensation of medical Cannabis. It shall maintain a registry of
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qualified medical physicians and caregivers. DDB, on the other hand,
shall identify specific areas for the cultivation of medical Cannabis and
formulate guidelines with respect to cultivation, importation, production,
and distribution of medical Cannabis. PDEA shall issue the appropriate
license and permits, and shall maintain a Cannabis Plant Monitoring
System.
HB 6517 values local research on marijuana thus mandates that
120 days from the approval of the Act, the DOH shall authorize the
National Institutes of Health of UP-Manila, the Health Sciences Centers
of the UP System, and the Philippine Institute of Traditional and
Alternative Health Care or PITAHC to conduct research in the medical
use of Cannabis. However, we also recognize and are guided by “gold
standard” research abroad that uses FDA clinical trial design such as
those conducted by the University of California Center for Medical
Cannabis Research published in 2012 at the Open Neurology Journal
which concluded that based on evidence currently available, marijuana
ought to be the “first line treatment” for patients with neuropathy and
other serious illnesses.
I also like to inform Dr. Cabral-Lim that there are actually 21
reputable medical organizations in the U.S. that support the legalization
of medical Cannabis, contrary to what you said that there is no medical
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association that endorses medical Cannabis. Also for the doctors—aside
from the doctors that you have here, we have also in the U.S. in 2014,
about 70 percent of the physicians in the U.S. believe that medical
marijuana should be legalized and that marijuana has therapeutic
qualities. This based on a survey of 1,544 doctors from 12 different
specialties living in 48 states. The majority who supported medical
Cannabis were oncologists and hematologists who believe that it can be
used to ease cancer pain and nausea related to chemotherapy and to
stimulate appetite.
I know that you are very, very much in a hurry, Senator Ejercito.
Now, HB 6517 has tried to cover all bases that are controversial to
some, but not too many. So I don’t understand this, you know, repeat,
repeat, repeat, repeat these arguments. I’ve heard this one thousand
and a million times. We hope that the Senate will find our bill acceptable
and adopt the House version.
We look forward to the enactment into law of the medical use of
marijuana in the country.
Abot-kamay na ang tagumpay, Senator Ejercito and all the
members of the Committee on Health. Sama-sama na tayo sa medical
marijuana.
Salamat po.
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THE CHAIRMAN (SEN. EJERCITO). Thank you, Dr. Reyes.
You haven’t changed, 30 years.
She was one of my very first teachers in the majors when she was
head of the Political Science Department a few years ago, about 1987,
to be exact—1988.
MS. REYES. Salamat po.
THE CHAIRMAN (SEN. EJERCITO). But you look younger na
because you had Ms. Tapia glasses back then.
MS. REYES. Yes.
THE CHAIRMAN (SEN. EJERCITO). I just like to ask a question
siguro before we wrap up. Ito iyong mga medyo importante, the
advocates and the …gaano ba kahirap ang mag-apply? Because
according to our doctors here, the other side, from PGH, PDEA, DDB,
and the Department of Health that there’s no need for legislation
because to the compassionate use—doon po sa provision ng DDB, and
it can be accessed. So gaano ba kahirap ang mag-apply? Anybody can
answer.
Sige, si Riciel.
MS. BALLESTEROS. I personally applied po.
THE CHAIRMAN (SEN. EJERCITO). Opo.
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MS. BALLESTEROS. I’m already on my second year. And just a
week ago I got an email coming from them na the one that I should
apply for should be the one that is approved from the source. In fact,
I’m trying to access a Haleigh’s Hope which is currently po USDA
organics ang classification, more on food, but up to this time hindi pa
rin po ako nakakakuha ng result. We are already on my second year
application.
And plus, if I may just say that one of the provisions po for the
compassionate permit is that you just need the dose that you are
needing. So it’s like you have it for two months, three months. So it
means that you are going to apply again for the next. So in terms of
the effort po of going to the FDA, and applying it like every two months
or three months. Kasi it’s explicit po that you need to put prescriptions
on the number of the items that you need.
So when you look at the patient, when you look at the profile, these
are parents mostly na hindi nga makaalis because of the condition of the
children. So, in terms po of accessibility and in terms of sustainability,
and mostly po in terms of the Epidiolex that is already approved, we
cannot afford it because its $30,000, it’s a 145,000 a month. Kasi before
po kami humarap sinource (source) ko na din po siya if I cannot afford
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it. And to be very honest, I can afford it maybe two times, but it will
never be sustainable.
Thank you.
THE CHAIRMAN (SEN. EJERCITO). FDA, can we hear from you?
Ano po iyong process? How come they are saying that it’s quite hard to
get the approval. Sige po, para lang magkaintindihan po tayo before we
go on because we can have another hearing after this.
MS. AUSTRIA-LOCK. Opo. Your Honor, doon sa unang concern
po na hindi napasok kasi hindi pa registered, one of the requirement po
is the drug that should be brought in, it has to be registered from the
country of origin.
Doon naman po sa quantity po na kailangan, kung ang kailangan
po ay supply for one year, ilalagay lang po sa prescription ng doktor na
ganoon po kadami ang kailangan. Kasi naka-specify po ang pangalan
ng pasyente, ang dosage form po, ang dosage strength, at iyong
quantity po eksakto. So, kung ang supply na kailangan ay for one year,
ang ilalagay lang po sa prescription ay for one year. So iyon po ang
aaprubahan namin.
THE CHAIRMAN (SEN. EJERCITO). Okay. Quickly lang,
tapusin—I will go to you also, quite quickly.
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Kay Dr. Reyes. Marami ho kayong binanggit kasi na mga
requirements: regulatory framework, DOH, DDB. Marami ho will be
involved. So, do you have any estimate how much will the government
need to establish this regulatory framework and the other things that
you spoke in the bill?
MS. REYES. Initially, we said, Senator Ejercito, that this will be
charged to the budget of the Department of Health. Now, to start with,
well, what about 250 million?…/mrjc/mva
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MS. REYES. …what about 250 million? After all, there is so
much money around in government. [Laughter]
THE CHAIRMAN (SEN. EJERCITO). Two hundred fifty million
for the research.
MS. REYES. That’s small, that is peanuts.
THE CHAIRMAN (SEN. EJERCITO). We will go back, ma’am,
for a while. Mayroon pa akong isa, last, Dr. Angel Magalona Gomez or
whoever. Silang dalawa. Quickly na lang po. Either, sino po? Seniority,
sir, Dr. Quijano.
MR. QUIJANO. May oras ba para ipakita iyong pitong slides sa
PowerPoint.
THE CHAIRMAN (SEN. EJERCITO). Sige po. Paki bilisan na lang
po.
MR. QUIJANO. Nandoon sa secretariat iyong PowerPoint.
THE CHAIRMAN (SEN. EJERCITO). Can you show the seven
slides? Can you do it in three minutes? Sorry, kasi we cannot have
simultaneous--bawal po kasi pag plenary.
MR. QUIJANO. Umpisahan ko na lang ho. Habang pinapakita
iyan puwedeng umpisahan ko na.
THE CHAIRMAN (SEN. EJERCITO). Sige po.
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MR. QUIJANO. Kung titingnan po natin iyong safety and efficacy,
huwag lang po nating gamitin iyong western parameters on science
which I--
THE CHAIRMAN (SEN. EJERCITO). Probably you can just
submit this presentation to me. Probably iyong brief ninyo na lang.
Sige po. Iyong pinaka-summary. Sige po.
MR. QUIJANO. Okay. Ang gusto ko lang pong sabihin ay dapat
gamitin din natin iyong historical evidence which we have a lot. In fact,
we recognize that. Even WHO--
THE CHAIRMAN (SEN. EJERCITO). Doc, you are a doctor of
medicine as well?
MR. QUIJANO. Yes.
THE CHAIRMAN (SEN. EJERCITO). Yes. Thank you.
MR. QUIJANO. As you can see I am a retired professor of
toxicology and pharmacology sa College of Medicine.
We recognize in fact the value of historical knowledge about
medicinal plants. So this is well-established so we should also consider
that. Even if we’d lack definitive scientific evidence, we should not be
restricted by the parameters of scientific evidence imposed by reduction
in science. There are things that we consider the mechanisms of
pharmacologic efficacy and this has been well-established as presented
90
by Dr. Angel Mutia. So, if we have a good explanation for the purported
therapeutic usefulness of certain herbal medicine, that is a very big
boost to the scientific evidence that it carries.
And third, we have sufficient scientific evidence to show the
significant therapeutic benefits from Cannabis. And this has been in
fact basically the conclusion of a recent WHO expert committee which
is shown there, WHO expert committee on drug dependence who met
June 4 to 7, 2018. And basically, the committee--I’ll just be citing some
significant excerpts from the conclusions of this committee.
` As far as toxicology is concerned, for example, cannabidiol, there
should be no controversy about this. The potential toxic effects of CBD
have been extensively reviewed contrary to the claims that there is a
lot of scientific evidence of toxicity. In fact, the contrary is true. And
with the recent update of the literature in general, CBD has been found
to have relatively low toxicity. Of course, not all potential toxic effects
can be covered.
Next slide, please. And across the number of controlled and open
label trials, cannabidiol of the potential therapeutic--CBD, it is generally
well. Meaning, the evidence for scientific efficacy is quite good. And
this is WHO expert committee conclusion.
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Next slide, please. In epilepsy it has been mentioned so I won’t
repeat that because even Doctor--the colleagues there admit the
efficacy on epilepsy but I just like to add that there are more studies
showing good therapeutic efficacy.
THE CHAIRMAN (SEN. EJERCITO). I think you agreed for
epilepsy. Kaya lang ang sa kanila kasi that there are--they can already
obtain through existing regulations sa kanila, iyon po ang sa kanilang
position, I think.
MR. QUIJANO. Well, sa kanyang sitwasyon, Senador,
nababahala lang ako baka hindi na naman maka-access iyong ating mga
kababayan na mahihirap.
THE CHAIRMAN (SEN. EJERCITO). We are trying to find ways
also.
MR. QUIJANO. Kaya dapat magkaroon din sana ng puwang para
ang mga mahihirap ay magkaroon din ng access at ang pinakamadaling
access--
THE CHAIRMAN (SEN. EJERCITO). Ang presyo masyadong
mataas.
MR. QUIJANO. At hindi lang iyong pure compounds dapat.
Dapat iyong locally produced na therapeutic standardized modalities
should be available na ginawa natin iyan sa sambong, lagundi at iba pa
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na nasa national formulary na. Kaya hindi tayo dapat palimita doon sa
pure compounds. At again, maski iyong mismong pinaka-ingredient na
masyadong vilified, iyong nakaka-high, iyong THC, ito ay who conclusion
sa toxicology. Lethal dose, the toxicity of tetrahydro-cannabinol is very
low compared to most other recreational and pharmaceutical drugs. In
fact, I would say that THC is safer than paracetamol compared to the
others. If you look at the number of mortality per year, scientific data
shows that there are more deaths in paracetamol compared to THC or
Cannabis.
Next please. Adverse reactions in humans. One of the studies
cited by the WHO expert committee which is one of the largest and
longest running trials which assessed the efficacy of daily oral 9 THC
administration for three years in multiple sclerosis patients, so it was
demonstrated. The efficacy was demonstrated but not only the efficacy
but also the safety.
Next please. So, as much as Cannabis safety profile is concerned,
Cannabis is much safer than methamphetamine and other dangerous
drugs. Cannabis is much safer than many prescription drugs that have
been approved by the FDA. Cannabis is in fact safer than many over-
the-counter medicines and many ordinary beverages. For example,
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iyong mga stimulants kagaya ng mga Cobra at kung anu-ano pa. Mas
delikado pa iyang mga over-the-counter drinks na iyan.
Sunod po. Ito iyong nagpapakita lang ng data sa LD 50 and if
you compare that makikita natin na THC is much safer than many other
prescription drugs here.
Sunod po. At iyong mortality per year, ito ay nabanggit ko
kanina, based on existing records, of course, it may not be complete.
You can see the comparative--you might say dangers from taking these
different substances and you compare that with Cannabis.
Next please. So, maybe as a conclusion, since we are pressed for
time, depriving access to medicinal Cannabis is a violation of the basic
human right to health. Every person has the right to the highest
sustainable standard of health. This basic human right includes the
right to access necessary medicines and if you make it too restrictive, I
think that is a violation of the basic right. Medicinal Cannabis is
undoubtedly a necessary medicine for many patients, I think that cannot
be denied. Preventing these patients from accessing medicinal Cannabis
is a violation of the fundamental human right to health.
Marami pong salamat.
THE CHAIRMAN (SEN. EJERCITO). Okay, Dr. Quijano,
maraming salamat po.
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Anyway, last siguro. We would like to hear from Dr. Manuel
Panopio, president of Philippine College of Addiction Medicine and chief,
health program officer of the DOH, Drug Treatment and Rehabilitation
Center, Bicutan.
MR. PANOPIO. Thank you, Senator JV. Tanggapin po ninyo ang
pasasalamat ko. Bagamat huli okay na rin.
But allow me to point out some salient features of the primer on
the House bill of what we are talking about, about the compassionate
use of Medical Cannabis Act. Remember, that it is intended out of
compassion to help qualified patients avail of medical Cannabis.
Number two, there is already scientific evidence to prove that
Cannabis has medical effects both palliative and therapeutic.
Number three, it does not legalize the general use of Cannabis or
marijuana because there is already an existing law with regard to the
prohibited drugs, the Comprehensive Dangerous Drugs Act of 2002.
With regard to the use and possession of the marijuana are left as is.
There have been scientific evidence and clinical trials showing the
efficacy of medical marijuana. Let us not close our doors, more so our
eyes with regard to such kind of literatures. Let us not be partial in
looking for research findings or clinical trials that will defend our vested
position regarding this House bill. But instead let us try to offer an
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alternative medicine or drug aside from the available armamentarium of
medicines that might and that will be beneficial for patients and
desperate parents or relatives in their quest to alleviate the suffering of
their loved ones.
True there is an Administrative Order No. 4 of Series of 1992. But
the process is quite too tedious. May I remind you, number one, you
have a written commitment on the part of all the authorized specialists
to submit a clinical case study report annually.
Number two, an estimate of the total product of one year.
Number three, a waiver of the BFAD responsibility from any
damage or injury arising from the use of the unregistered drug.
Number four, the society shall submit the clinical case study
report through the drug device establishment at the end of the year.
Failure to comply shall be grounds for denial of application of your
permit. The aforementioned procedure to avail of the medicine is
tedious on the part of the doctor and the specialized institution or
specialty division and probably costly on the part of the patients since it
will be imported…/admasicap/trs
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MR. PANOPIO. … since it will be imported.
As physicians, we have the professional obligations to our patients
and considering that our patients have to receive a high-quality of
medical care, it is of utmost importance that Cannabis-based medicines
meet the same standards we apply to other prescription medicines.
As in all medicines, priority will have to be the health of the public
especially in controlled substance—drugs that have abuse potential like
marijuana.
If marijuana is found to be effective and beneficial, in terms of
the chemicals found in the substance, then doctors should prescribe by
non-toxic routes of administration in controlled doses just like all other
medicines.
As literature says, the approval of the medical marijuana should
not be decided upon by the voting public or by the ballot but instead
should be decided upon by knowledgeable people like all of you in this
room and, of course, the Judiciary and the field of medicine.
As doctors in the field of addiction, any medicine is subject to
abuse or dependence. Morphine, which is derived from opium, is being
abused and is being used on terminally ill patients suffering from chronic
and severe pain. Medicines like phenobarbitals and benzodiazepines
like diazepam, Valium, Dormicums are prone to be abused.
97
All drugs of therapeutic uses has been approved after research
and evidence-based findings. However, the risk of dependence
sometimes outweighs the therapeutic benefits. So we clinicians, in
prescribing medications that are of abusive potential, should inform and
educate our patients for the development of dependence and addiction.
Physicians who will, in the future, engage in medical marijuana
prescription, for that matter must be adequately be informed regarding
the composition, the dose of the Cannabis medicine and must have an
adequate training in identifying substance dependence and addiction.
Having cited all these, I did not come here to the Senate to argue
with any of the distinguished guests that were invited by Senator JV
Ejercito. Instead, I come here humbly appearing and appealing to all of
you to kindly leave a part in your mind whether it’s cognitive or in your
heart to at least be compassionate with regard to the allowance of our
bill.
Having said all of these, I leave it to the distinguished senator to
decide the fate of this House Bill 6517, known as the Compassionate Use
of Medical Cannabis Act, and thank you, sir, for the privilege.
THE CHAIRMAN (SEN. EJERCITO). Thank you, Dr. Manuel
Panopio.
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Well, Dr. Limpin would like to say something. Dr. Gomez, would
you like to say something also later? Unahin ko na muna si Dr. Limpin
and I’ll go back to you.
Okay. Dr. Limpin.
MS. LIMPIN. Thank you, Your Honor, for allowing me to speak
up. I’m speaking in behalf of the Philippine College of Physicians, also a
member of the Philippine Medical Association.
Very clear ho sa medical community that for us, there is really no
need for any new legislation because there is already an existing
process, an existing law that will allow compassionate use of medical
Cannabis.
Kung ang pinag-uusapan lang po natin ay tungkol sa—Narinig na
ho natin ang sinasabing long and arduous process. That is the main
reason why they want to have legalization of Cannabis. When you refer
to a long and arduous process, I wonder kung ano ho ba talaga ang ibig
nilang sabihin doon sa long and arduous process? Kasi po ako I have
tried applying for compassionate use for other drugs. Katulad po noong
isang pasyente ko na who has primary pulmonary hypertension and so
far the only evidence as far as we are concerned the use of like
Sildenafil.
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In the US para maging mas specific iyong gamot, ang talagang
approved under the US FDA is iyong brand name na Revatio. Okay.
Iyong Revatio po is not available in the country. And since the patient
had the experience of being given Revatio for pulmonary hypertension
ay nakita kong maganda ang effect sa kanya because it was able to
reduce the pulmonary pressures in that patient. So I myself applied doon
sa ating FDA for the use of Revatio for this particular patient. Hindi
naman ho nagkaproblema. Kasi, una, approved siya sa source which is
in the US and then, secondly, ay nakita talaga na mayroong evidence
na it will lessen the pulmonary hypertension of the patient. So hindi ko
po masyadong maintindihan iyong sinasabing long and arduous process
because naging available iyon sa pasyente. And I was able to talk to the
pharma company and the patient was able to get it at a much lower
cost. So it’s just a matter of trying to talk also to pharma companies.
Pangalawa po, it has been said often that we are depriving
Filipinos, the patients from the attainment of the highest standard of
health. Ano ho ba ang highest standard of health? Is it a high standard
for us to just allow the Filipinos to get medicine without being assured
of the safety of that medicine? Hindi naman ho highest standard iyon
kung ganoon. Kasi kailangan ho nating siguraduhin hindi lang ho
effective iyong gamot but that drug should be safe as well. Kaya ho kami
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po talagang nagpupumilit kailangan masiguro ho natin na bago kinukuha
ng mga pasyente ang gamot, kailangan ay magiging safe siya in the
long run.
So I hope that Your Honor will actually consider the position of the
medical community. Sinasabi ho kanina ni Dra. Socorro Reyes na naiinis
siya kasi parang biglang nagbago ang ihip ng hangin. Pero for the
longest time din po, Dra. Reyes, we have been firm in our position but
the problem is our voices were not heard in the House of
Representatives.
Thank you.
THE CHAIRMAN (SEN. EJERCITO). Okay. Thank you.
Dr. Angel Gomez, would you like to ano your position?
MR. GOMEZ. Yes, Mr. Chairman. I know you’re raring to go. Good
afternoon. I’m an anesthesiologist by training and as such, I deal with
the management of pain and the alleviation of suffering.
I see patients, many of them elderly, who are in search of
alternatives to conventional FDA-approved pharmaceuticals which for
one reason or another have proven to be unsatisfactory. Like your own
family member experienced, there is a benefit to it and that’s the only
evidence I need to want to explore how these medicines can further
relieve pain and suffering. And they come to me with the product, like
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you say, you don’t know how they got it but it’s there and I try to guide
them in its use. And like any clinician, I go low and slow and I want them
to understand that this is part of a process that, you know, we can go
through together and explore what works and what doesn’t. And I
disagree that the only products of pharmaceutical companies should be
prescribed and I just want to be part of this discovery because I’m a
firm believer in its efficacy and its safety.
Thank you.
THE CHAIRMAN (SEN. EJERCITO). Okay. Thank you. Well,
probably this is not the last hearing. We still have to hear some positions
of our colleagues as well. I promised Senator Vicente Sotto that he’ll be
around. So probably, we’ll have another one.
I would like to thank all of you, all the resource persons for coming
this afternoon. It has been a very informative and productive hearing I
would say. Sorry for the time pressure for pressuring all of you, but we
only had two hours to hear all of you, your positions. But be rest assured
that probably to conclude—Of course, if it can alleviate the pain, the
suffering of those who have these conditions, why not? If it can prolong
the life, why not? But we have to make sure that the necessary
safeguards and measures are in place …/ngdizon/peg
102
THE CHAIRMAN (SEN. EJERCITO). … and measures are in place
so that we can prevent substance abuse and, likewise, to hear the other
side, the other medical practitioners that they want to make sure that
before we approve something, that all the research, iyong efficacy and
effectiveness has to be proven as well before they would support.
Probably, what we can do already is start the ball rolling by
continuing the research but DOH would already start the research. So
once and for all, we can already determine whether or not really medical
Cannabis would really be effective.
Anyway, I think may common ano naman positions that, indeed, it
relieves or prevents seizures. Iyon na iyong position kasi dito mayroon
nang—sa kanila, present laws are enough to obtain. But we will see. We
will have another one. At least we were able to say our positions of the
different organizations that are present.
Again, as chair of the Committee on Health, I would like to thank
everyone for coming: Secretary Cuy of DDB; Usec Benjamin Reyes; Usec
Domingo, our resident resource person of DOH; Atty. Katherine Austria-
Lock; and, of course, our expert panel of doctors. We have Dr. Rhea
Quimpo, Dr. Leonor Cabral-Lim, and Dr. Jose Santiago, and as well as
the other side, thank you very much for coming, Dr. Panopio, Dr. Mutia,
Dr. Gomez, Dr. Quijano, Dr. Manansala and, of course, the parents. Of
course, we feel for you. It’s very hard to see—I can just imagine how
103
helpless you feel every time your child is undergoing seizure. We feel for
you.
Dr. Cunanan, again, and to my professor in the majors−nice to see
after 30 years. Who would have thought that we will see each other in
this setting? Thank you very much for your passion as well.
Thank you very much, ladies and gentlemen.
[THE HEARING ENDED AT 3:22 P.M.] (nam/jmb)
104

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Republic of the Philippines

CONGRESS OF THE PHILIPPINES

COMMITTEE ON HEALTH AND DEMOGRAPHY

DATE : Wednesday, February 6, 2019

TIME : 1:00 p.m.

VENUE : Sen. Geronima T. Pecson Room

AGENDA : PHILIPPINE COMPASSIONATE MEDICAL

HOUSE BILL NO. 6517 - AN ACT PROVIDING

Alonte, Labadlabad, Velasco-Catera, Villarin,

HON. JOSEPH VICTOR G. EJERCITO - Chairman, Committee on

HON. MARIA LOURDES NANCY S. BINAY - Member

HON. AQUILINO “KOKO” PIMENTEL III - Member

Hon. Rolando Domingo - Undersecretary, Department of Health

Dr. Rhea Salonga-Quimpo - Pediatric Neurologist, University of the

Ms. Beatriz Tiongco-Cruda - Committee Secretary, Committee on

Ms. Sherill M. Villadiego - Committee Stenographer

(For complete list, please see attached Attendance Sheet.)

THE CHAIRMAN (SEN. EJERCITO). Good afternoon. The

Committee on Health and Demography joint with the Committee on

Finance is hereby called to order.

because there’s an ongoing Commission on Appointments plenary. So

right after, some of them will be joining us.

So before that, I’d like to ask our Committee Secretary to first

acknowledge our resource persons present for today’s hearing.

THE COMMITTEE SECRETARY (MS. CRUDA). Good afternoon.

We would like to acknowledge the resource persons for this afternoon’s

From the Department of Health, Usec Rolando Domingo; Atty.

Katherine M. Austria-Lock from the FDA; Secretary Catalino S. Cuy,

Chairperson, Dangerous Drugs Board; Usec Benjamin Reyes, also from

the Dangerous Drugs Board; Dr. Rhea Salonga-Quimpo, Pediatric

Neurologist of UP-PGH; Dr. Leonor Cabral-Lim, Chair of the Department

of Neurosciences of PGH and also of Philippine Neurological Association;

From the NGOs and private organizations, we have Dr. Jose P.

Santiago, President of Philippine Medical Association; Riciel Ballesteros

of the Philippine Cannabis Compassionate Society; Dr. Donnabel

Cunanan, spokesperson of the Philippine Cannabis Compassionate

Society; Chuck Manansala, President, Medical Cannabis Research

Center; Dr. Romy Quijano also of Medical Cannabis Research Center;

Doctors for Medical Cannabis; Dr. Manuel Panopio, President of the

Philippine College of Addiction; and Dr. Socorro Reyes, Chief Policy

Adviser, Office of Representative Rodolfo Albano III.

THE CHAIRMAN (SEN. EJERCITO). Thank you, Committee

Before we continue, the Chair would like to give his opening

statement. And probably for an orderly conduct of this hearing, we will

just go with the government representatives and then, probably, experts

against this bill. But we have to hear all sides. Okay.

“Magandang hapon po sa inyong lahat. Narito po tayo ngayon

para maliwanagan ang isang issue na alam nating hanggang sa

kasalukuyan ay nananatiling kontrobersiyal. Gusto nating mapakinggan

ang bawat panig, pabor at hindi, at siyempre ang mga eksperto sa

larangan ng kalusugan upang mahingan sila ng kanilang mga

ekspertong opinyon upang kung magkakataon na kailanganin man

nating magpanukala ng batas ay nakatundog ito sa mga konkretong

pagsusuri. Kung tunay itong nakagagaling at kung ito na lamang ang

natitirang lunas o nakapagdurugtong ng buhay, marahil ay maaari na

natin itong bigyan ng pagkakataon. Siyempre, nakapaloob pa rin sa

regulasyon ng ating pamahalaan.

“Ang mga batas natin ay nariyan, hindi lamang upang magbawal

o magdisiplina, kung hindi nililikha rin upang magmalasakit. Gusto

nating matukoy kung kinakailangan pa bang magpanukala ng bagong

batas o sapat na ang pag-amyenda na lang sa kasalukuyang Dangerous

Drugs Act. Kailangan din nating matiyak na hindi maabuso ang

paggamit ng medical marijuana at manatili ito na para lamang sa