HOUSE YF REPRESENTATIVES

RECEIVED
Republic of the Philippines
HOUSE OF REPRESENTATIVES pave_07 UL 2016
me

Quezon City, Metro Manila

BY:
SEVENTEETH CONGRESS
First Regular Session

House Bill No.1300

RESISTR ATION UNIT
BALLS AND INDEX SERVICE

Introduced by Honorable Florida P. Robes

AN ACT REGULATING THE MANUFACTURE, DISTRIBUTION AND SALE OF
SUPPLEMENTARY COMPLEMENTARY ALTERNATIVE MEDICINES AND FOR
OTHER PURPOSES

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

SECTION 1. Short Title. This Act shall be known as the “Supplementary
Complementary and Alternative Medicine Regulation Act (SCAMRA)”.

SEC. 2. Declaration of Policy. It is hereby declared the policy of the State to enhance
and safeguard the health of the Filipino people by ensuring that medicines work, are acceptably
safe, properly prescribed by licensed health and medical professionals, and efficiently
administered.

SEC. 3. Objective, ‘The main objective of this Act is to safeguard public health and
safety by establishing and maintaining a scheme consistent with best practice for the regulation
of the quality, safety, and efficacy of complementary medicine and supplements, and of their
manufacture, sale and promotion,

SEC. 4, Definition of Terms. — As used in this Act, the following terms shall mean:

a, “Supplementary Medicine” ~ refers to biologically-based therapies which includes
herbs, minerals, teas, vitamins, amino acids, animal tissue extracts and essential oils.

b. “Complementary Medicine” — refers to medical products that are not part of standard
medical care which includes herbal remedies and medicines and dietary supplements,

c, “Alternative Medicine” — is any medical treatment that is not part of conventional
evidence-based medicine

d. “Fraudulent” ~ refers to a failure to disclose all information that the person knows or
ought reasonably to know, which is materially relevant.

e. “Regulation” — relates to the circumstances and manner in which, and the conditions
‘on which, a member of a prescribed class of health professional may administer,
possess, prescribe, supply or use a medicine.

f. “Herbal Medicines” — finished, labeled medicinal products that contain as active
ingredient/s aerial or underground part/s of plant or other materials or combination


thereof, whether in the crude state or as plant preparations. Plant material includes
juices, gums, fatty oils, essential oils, and other substances of this nature. They.
however, may contain plant material(s) combined with chemically-defined active
substances, including chemically-define, isolated constituents of plants, are not
considered to be herbal medicines.

g. “Manufacture” ~ refers to any and all operations involved in the production, including
preparation, propagation, processing, formulating, filling, packing, repacking,
altering, ormenting, finishing, or otherwise changing the container, wrapper, or
labeling of a consumer product in the furtherance of the distribution of the same from
the original place of manufacture to the person who makes the final delivery or sale to
the ultimate consumer.

h. “Advertising” - means the business of conceptualizing, presenting or making
available to the public, through any form of mass media, fact, data or information
about the attributes, features, quality or availability of consumer products, services or
credit,

i, “Consumer” — means a natural person who is a purchaser, lessee, recipient or
prospective purchaser, lessor or recipient of consumer products, services or credit.

SEC. 4, Prohibited Acts - The following fraudulent and deceptive marketing practices
shall be deemed prohibited under this Act:

a. Marketing Fraud ~ This refers to any illegal practice/s employed in the promotion of a
product or services which centers on making false claims and exaggerating the
qualities of a product or service, selling imitations, or hiding negative aspects or side
effects.

b. Misleading Advertising ~ This refers to any deceptive representations for the purpose
of promoting a product or a business interest and encouraging the provision of
sufficient information to allow consumers to make informed choices.

c. Deceptive Packaging and Labelling — This refers to the making of false or misleading
representations as products are required to bear accurate and meaningful labelling
information to help consumers make informed purchasing decisions, clearly
indicating that the product has “No Approved ‘Therapeutic Claims” written in English,
Filipino and Visayan languages or other languages used by target consumers.

d. Pyramid’ or Ponzi Scheme ~ Otherwise known as chain referral schemes, this
involves a marketing strategy in which an individual is offered a distributorship or
franchise to market a particular product and that real profit is earned. not by the sale
of the product, but by the sale of new distributorships.

e. Bait and Switch Tactic — This refers to an illegal business tactic in which the seller
advertises a product with the intention of persuading customers to purchase a more
expensive product.


f, Other offences punishable under this Act are:

a. Manufacture of complementary medicines not in accordance with an appropriate
license or professional authority or violated provisions of Republic Act No.8423;

b. Prescriptions of complementary medicines by a person without a license or
professional authority;

¢. Supply and referral of complementary medicines to patients believing that such
would be appropriate for therapeutic purposes, in spite of the label indicate
therein; and

d. Sale of complementary medicines without the seal of approval of the Food and
Drug Administration and certification by the Philippine Institute of Traditional
and Alternative Health Care.

¢. Medical Practice, punishable under the Revised Penal Code and other special
laws.

SEC. 5. Penalties.

a. Any person, natural or juridical, who shall violate any of the acts enumerated in
Section 4 of this Act shall upon conviction, be subject to a fine of five hundred
thousand pesos (PhPS00,000.00) but not more than one million pesos
(Php1,000,000.00) or imprisonment of not less than six months but not more than six
(6) years, or both upon the discretion of the court. If the offender is an alien, he shall
be deported after service of sentence and payment of fine without further deportation
procecdings.

b. In case the offender is a naturalized citizen, he shall, in addition to the penalty
prescribed herein, suffer the penalty of cancellation of his naturalization certificate
and its registration in the civil registrar and immediate deportation after service of
sentence and payment of fine.

©. Any director, officer or agent of a corporation who shall authorize, order or perform
any of the acts or practices constituting in whole or in part a violation of Section 6,
and who has knowledge or notice of noncompliance received by the corporation from
the concerned department, shall be subject to penalties to which that corporation may
be subject,

d. For medical malpractice, the punishments provided by the Revised Penal Code and
other special laws shall be prescribed.

In case the violation is committed by, or in the interest of a foreign juridical person duly licensed
to engage in business in the Philippines shall immediately be revoked, suspended or cancelled.

SEC, 7. Government Agency Support and Coordination. — The Department of
Health, Food and Drags Administration, the Nutrition Council of the Philippines, Department of
Trade and Industry, in coordination with the Philippine Institute of Traditional and Alternative
Health Care and Philippine Medical Association shall ensure the strict compliance of quality and
safety standards by manufacturers, distributors and sellers of complementary medicines. It shall
create a joint committee whose composition shall come from these agencies including affected
industries and shall implement the policies and guidelines for the compliance of this Act.



SEC. 8, Professionalization of Alternative Medical Practitioners,- The Department of
Health and the Professional Regulations Commission, in coordination with Philippine Medical
Association, are hereby mandated to formulate policies on the professionalization of alternative
medical practitioners,

SEC. 9, Appropriations. ~ The sum necessary for the effective implementation of this
‘Act shall be charged against the appropriations for the Department of health under the current
General Appropriations Act. Thereafter, such amount as may be necessary for the continued
operation of the Center shalll be included in the Annual General Appropriations Act.

SEC. 10. Implementing Rules and Regulations. - The DOH, FDA, NCP, DTI and
PITAHC and other concerned stakeholders shall promulgate within sixty (60) days the
Implementing Rules and Regulations necessary to implement the provisions of this Act.

SEC. 11. Repealing Clause. — All laws, ordinances, rules and regulations, and other

issuances or parts thereof which are inconsistent with this Act are hereby repealed or modified.
SEC. 12. Separability Clause, ~ If for any reason any section or provision of this Act is

declared unconstitutional or invalid, the other sections or provisions thereof, shall not be

repealed or modified.

SEC, 13, Effeetivity. — This Act shall take effect fifteen (15) days from its publication in
the Official Gazette or in any two newspapers of general circulation.

Approved,


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City, Metro Manila

SEVENTEETH CONGRESS
First Regular Session

House Bill No.1 300

Introduced by Honorable Florida P. Robes

EXPLANATORY NOTE

It is a declared mandate of the State to protect consumers against deceptive, unfair and
unconscionable sales acts and practices, especially if it pertains to medicines that affect their
health and total well-being.

Nowadays, nearly half of our population use some supplementary complementary
alternative medicine (SCAM), including dietary supplements. As such, their popularity has
surpassed conventional medicines. Mote so, there is an increase of their commercialization that
it seems anyone can produce and manufacture them and claim them to cure different illnesses
without sufficient evidenced-based information about their efficacy, safety, and drug interaction,

Inasmuch as the State recognizes the development and enhancement of traditional or
alternative medicine, as clearly enunciated in Republic Act. No. 8423 or otherwise known as the
“Traditional and Altemative Medicine Act of 1997", the State should be wary of incidents where
the patients, instead of getting treated of their illnesses, end up in a hospital, or worse, in a coma
because alternative medicines were taken instead of pharmaceutical products which take years
and thorough research to produce. The Author does not claim that herbal medicine such as that

extracted from malunggay, ginger, guyabano leaves, turmeric, ete. are inferior. There have been
studies on the effi

and medicinal value of these herbals. However, it seems that there is no
proper regulation to that effect. In fact, it is being prescribed by people, who sometimes are not
medical doctors, negligently. Many people are unaware of the potential health risks since most

products have not undergone quality control and without FDA Approval

Although they purport to be just supplementary as they do not have approved therapeutic
claims, complementary medicines are being sold in the market in such a manner that people are
convinced that they do have healing elements. Albeit the fact that they have not presented

persuasive evidence to support claims that they can treat, cure ot relieve specific conditions or

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symptoms, they are selling like pancakes. Advertisements of these products are misleading,
false, unfair or exaggerated. This is further aggravated by the marketing scheme employed by
manufacturers, which is known as pyramid as well as their prescriptions by non-medical doctors
or health professionals, With this in mind, the focus is on the marketing side and not on the
product itself.

For the interest and well-being of the citizens, the passage of this Bill is earnestly sought,

FLORJDA P. ROBES