Republic of the Philippines a ,

HOUSE OF REPRESENTATIVES ee
Quezon City “CEIVED @
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EIGHTEENTH CONGRESS Ue a
First Regular Session \ Ry
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LNDEX

House Bill No. 6211

Introduced by CIBAC Party-List Representatives
Eduardo “Bro. Eddie” C. Villanueva and Domingo C. Rivera

AN ACT PROVIDING A STANDARD OF CARE FOR THE
TREATMENT OF PERSONS WITH BLEEDING DISORDERS,
ESTABLISHING TREATMENT CENTERS AND
APPROPRIATING FUNDS THEREFOR

EXPLANATORY NOTE

In the Philippines, about one million Filipinos are affected by Hemophilia, von
Willebrand Disease and other bleeding disorders. However, only around 1,500 have
been registered with the Philippine Hemophilia Foundation. This is partly due to the
lack of awareness and understanding on this group of medical conditions.

Bleeding disorder is a genetic condition where the blood does not clot properly.
It is caused by deficiency of proteins in the blood called clotting factors. There are 13
factors in the blood, and when one of it is missing or is deficient, it results in a bleeding
disorder.

People with bleeding disorders can bleed for longer than normal, and some
may experience spontaneous bleeding into joints, muscles, or other parts of their
bodies. Women with bleeding disorders may experience menorrhagia (excessive
menstruation) and post-partum hemorrhage, on top of other bleeding problems.

The most known of this group of medical conditions is Hemophilia, classified as
Hemophilia A (Factor VIII deficiency) and Hemophilia B (Factor IX deficiency), which
occurs mostly in males. But the most prevalent is von Willebrand Disease (deficiency
in von Willebrand factor), which affects around 1 percent of the population — both



males and females. Other factor deficiency disorders are: |, Il, V, VII, X, Xl, XIII.
(Source: World Federation of Hemophilia)

Bleeding disorders like Hemophilia, von Willebrand Disease and other factor
deficiencies are usually inherited and genetic. Thus, there may be multiple members
in a family affected by the condition and they will have it for life. There is no known
cure yet for bleeding disorders.

The World Health Organization and the Department of Health cited post-partum
hemorrhage as one of the top causes of maternal deaths. Incidentally, the Philippines
did not meet the Millennium Development Goal on maternal health. It is very possible
that a big percentage of those mothers who died of post-partum hemorrhage had
undiagnosed bleeding disorders.

Bleeding disorders are treated by replacing the missing or deficient factors
either through blood products such as cryo-precipitate, cryo-supernate, fresh frozen
plasma, packed red blood cells (RBC) and whole blood or by manufactured plasma-

derived factor concentrates and recombinant (genetically engineered) factor
concentrates.

The cost of treatment is very high, and therefore, inaccessible to majority of
Filipino patients. Many of them suffer with chronic pain and deformities in the joints
because of lack of access to proper treatment. Availability of factor concentrates in
the country is also inconsistent.

Other countries like India and Malaysia give free treatment to their citizens who
have bleeding disorders. This bill seeks to provide medical and financial support to
patients affected with this condition.

The immediate passage of this bill is earnestly sought.

=e. Wile

HON. EDUARDO “BRO. EDDIE” C. VILLANUEVA

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Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

EIGHTEENTH CONGRESS
First Regular Session

House Bill No. £011

Introduced by CIBAC Party-List Representatives
Eduardo “Bro. Eddie” C. Villanueva and Domingo C. Rivera

AN ACT PROVIDING A STANDARD OF CARE FOR THE
TREATMENT OF PERSONS WITH BLEEDING DISORDERS,
ESTABLISHING TREATMENT CENTERS AND APPROPRIATING
FUNDS THEREFOR

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 “Bleeding Disorder
Standards of Care Act.”

SECTION 2. Declaration of Policy. — It is hereby declared the policy of the State:

a) To ensure the adequate treatment of hemophilia at the lowest possible cost and
endeavor to make them available for free to indigent patients;

b) To ensure the establishment of treatment centers in public hospitals; and

c) To establish a standard of care so that patients with severe bleeding disorders
can receive necessary and appropriate medical care.

SECTION 3. Definitions. — The following words and phrases when used in this Act

shall have the meanings given to them in this Section unless the context clearly
indicates otherwise:


b)

c)

qd)

e)

Bleeding Disorder refers to a medical condition characterized by a severe
deficiency or absence of one or more essential blood clotting proteins in the
human blood, often called factors, including all forms of hemophilia, von
Willebrand disease and other bleeding disorders which result in uncontrollable
bleeding or abnormal blood clotting.

Blood clotting product refers to an intravenously administered medicine
manufactured from human plasma, recombinant biotechnology techniques and
other processes, approved for distribution by the Food and Drugs Administration
(FDA) and which is used for the treatment and prevention of symptoms
associated with bleeding disorders. The term includes, but is not limited to:

1) Factor Vila, Factor Vill and Factor IX products;

2) Von Willebrand Factor products;

3) Prothrombin complex concentrates;

4) Activated prothrombin complex concentrates;

5) Other products approved by the BFAD for the treatment of bleeding
disorders and associated inhibitors.

Indigent Patient refers to any patient deemed unable to pay for services and or
medical treatment, laboratory testing of blood and/or coagulation studies, or
blood coagulating products and/or ancillary infusion equipment.

DOH refers to the Department of Health.

Hemophilia refers to a human bleeding disorder caused by a hereditary
deficiency of the Factor VIII, Factor IX or Factor XI blood clotting protein in human
blood.

Von Willebrand disease refers to a human bleeding disorder caused by a
hereditary deficiency or abnormality of the von Willebrand Factor in human blood.

SECTION 4. State Treatment Facilities. - The State shall establish hemophilia
treatment facilities in key cities and regions nationwide in designated hospitals with
Cancer and Hematology Departments.

Each Hemophilia Treatment Facility shall provide to all hemophilia patients:

a)

b)

c)

Care by qualified hematologists and medical doctors and shall also provide free
of charge the necessary blood clotting products and ancillary infusion equipment
necessary for the infusion of such blood clotting products;

A room exclusively for hemophilia patients; and
A clinical coagulation laboratory for the screening, diagnosis, provisional

diagnosis and treatment of bleeding disorders or suspected bleeding disorders
and such services shall be provided free of charge to all indigent patients.

SECTION 5. Funding. - The amount necessary for the initial implementation of this
Act shall be sourced from the current budget of the DOH. Thereafter, the funds


necessary for the continuous implementation of this Act in the ensuing years shall be
included in the General Appropriations Act.

The funds given to the treatment facilities shall be used as follows:

a) five percent (5%) shall be used for the maintenance of the rooms that will be
used exclusively for hemophilia patients;

b) ninety percent (90%) shall be used exclusively for necessary blood clotting
products and ancillary infusion equipment necessary for the infusion of such
blood clotting products to hemophilia patients; and

¢) _ five percent (5%) shall be used for blood screening of hemophilia patients.

Each treatment facility established under this Act shall submit an annual report to the
DOH on the utilization of the amount given to it.

SECTION 6. Implementing Rules and Regulations. - Within sixty (60) days from
the approval of this Act, the Department of Health (DOH), in consultation with
hemophilia groups and other relevant stakeholders, shall promulgate the
Implementing Rules and Regulations (IRR) to carry out the provisions of this Act.

SECTION 7. Separability Clause. — If for any reason, any provision of this Act is
declared unconstitutional or invalid, the other parts or provisions hereof which are not
affected thereby shall continue to be in full force and effect.

SECTION 8. Effectivity Clause. - This Act shall take effect fifteen (15) days after its
publication in the Official Gazette or in at least two (2) newspapers of general
circulation.

Approved,