Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

EIGHTEENTH CONGRESS
First Regular Session
6560

HOUSE BILL No.

Introduced by
BAYAN MUNA Representatives FERDINAND R. GAITE,
CARLOS ISAGANI T. ZARATE and EUFEMIA C. CULLAMAT

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

EXPLANATORY NOTE,

Article 25 of the Universal Declaration of Human Rights provides: “Everyone has the right to a
standard of living adequate for the health and well-being of himself and of his family, including
food, clothing, housing and medical care and necessary social services, and the right to security in
the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood
in circumstances beyond his control.”

In the Philippines, about one million Filipinos are affected by Hemophilia, von Willebrand
Disease and other bleeding disorders. Data from the World Federation of Hemophilia (WFH)
suggests that more than 90% of the cases remain undiagnosed as only around 1,500 have been
registered with the Philippine Hemophilia Foundation. There is also an obvious 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 itis 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 hemorthage,
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: 1, Il, V, VI, X, XI, 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. Many
patients with hemophilia probably died without ever being diagnosed or treated.

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.

In developed countries, the life expectancy of persons with hemophilia is close to that of healthy
persons. Other countries like India and Malaysia give free treatment to their citizens who have
bleeding disorders. Many Filipinos with hemophilia on the other hand grow up with disabilities
mostly due to prolonged bleeding into joints as a result of lack of access to treatment.

According to Hemophilia Advocates - Philippines, hemophilia care in our country is sub-optimal
and inadequate. Filipinos with hemophilia and bleeding disorders rely heavily on humanitarian
aid for treatments. 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.

‘The government has no program for hemophilia. Hemophilia is not included among rare
disesases covered by Republic Act 10747 or the Rare Diseases Act. Likewise, it is not covered by
the Z. benefit package of Philhealth for health conditions with very expensive treatments and
prolonged hospitalization.

The cost of treatment is very high, and therefore, inaccessible to majority of Filipino patients yet
the government provides very minimal support. A mild bleed in the joints can cost P30,000 to
50,000 per treatment. Yet, Philhealth coverage only provides P2,000 per incident, not even
enough for a bag of blood for transfusion which costs P5,700 per bag.

‘The challenge is to find ways to develop and implement a viable, practical and sustainable
hemophilia care programs in the country. If hemophilia is to be diagnosed and treated adequately
in our country, available treatment options must be backed by support and commitment from
our government and must be performed within the context of the national healthcare system.

‘This bill seeks to provide medical and financial support to patients affected with this condition
by providing treatment facilities, increasing Philhealth coverage, inclusion of Hemophilia in
assessment and screening tools and to increase public awareness to help in early diagnosis and
timely intervention.

‘Thus, the immediate passage of this bill is earnestly sought.
Approved,

“FERDINAND R. GAITE
Bayan Muna Partylist

\
REP. REDcarPRRre REP. EUFEMIA C. CULLAMAT

Bayan Murid Partylist Bayan Muna Partylst



Republic of the Philippines
HOUSE OF REPRESENTATIVES

Quezon City

EIGHTEENTH CONGRESS
First Regular Session
6560

HOUSE BILL No. __

Introduced by
BAYAN MUNA Representatives FERDINAND R. GAITE
CARLOS ISAGANI T. ZARATE and EUFEMIA C. CULLAMAT

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 ofthe Philippines in Congress assembled:

Section 1. Short Title. — This Act shall be known as the “Bleeding Disorder Standards of Care Act of
2020.”

Section 2. Declaration of Policy. — Itis hereby declared the policy of the State:

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

2) Toensure the establishment of treatment centers in public hospitals; and

@) — Tocstablish 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:

(1) "Bleeding Disorder"- \ 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.

(2) "Blood clotting product" - An intravenously administered medicine manufactured
from human plasma, recombinant biotechnology techniques and other processes,
approved for distribution by the BFAD and which is used for the treatment and
prevention of symptoms associated with bleeding disorders. The term includes, but is

not limited to:
(A) Factor Vila, Factor VIII and Factor IX products;
8) ‘Von Willebrand Factor products;
© Prothrombin complex concentrates;
©) Activated prothrombin complex concentrates;

® Other products approved by the BFAD for the treatment of bleeding,


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disorders and associated inhibitors.
(3) “Indigent Patient”— 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.
(4) "DOH - refers to the Department of Health.
(5) "BFAD"~ refers to the Bureau of Food and Drugs.
(6) "Hemophilia" — A human bleeding disorder caused by a hereditary deficiency of the
Factor VIII, Factor IX or Factor XI blood clotting protein in human blood.
(2) "von Willebrand disease" \ human bleeding disorder caused by a hereditary
deficiency or abnormality of the von Willebrand Factor in human blood.
Section 4. Hemophilia 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 Facilities shall provide to all hemophilia patients:
(1) 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;

(2) A room exclusively for hemophilia patients; and

(3) A clinical coagulation laboratory for the screening, diagnosis, provisional
diagnosis and treatment of bleeding disorders ot suspected bleeding disorders
and such services shall be provided free of charge to all indigent patients.

Section 5. Inclusion of Hemophilia in Patients Assessment Tools. Hemophilia and other
bleeding disorders shall be included in patients’ history and assessment tools including familial
history and history or presence of bleeding episodes.

Section 6. Inclusion of Hemophilia Screening in Newborn Screening. Screening tests for
hemophilia shall be included in the comprehensive newborn screening tests.

Section 7. Increase in Philhealth Benefits. — Philhealth shall review and increase as
appropriate based on the recommendations of the Department of Health and Hemophilia
patients group the benefit for bleeding disorders. The benefit package shall include, among
others, blood transfusion and/or injection of blood coagulating products, and laboratory and
diagnostic procedures.

Section 8. Health Education and Public Awareness. — The Department of Health shall
provide educational materials to increase public awareness on hemophilia and other bleeding
disorders.

Section 9. Funding. — The amount necessary for the initial implementation of this Act shall be
sourced from the current budget of the Department of Health. Thereafter, the funds necessary
for the continuous implementation of this Act in the ensuing years shall be included in the
General Appropriations Act.

‘The treatment facilities are allowed to use five percent (5%) of the amount given to it for the
maintenance of the rooms that will be used exclusively for hemophilia patients. However, ninety
percent (90%) of the amount 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. ‘The remaining five percent (5%) shall be used for blood screening of
hemophilia patients.


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Each treatment facility shall submit an annual report to the DOH on how the amount given to it
is used.

Section 10. Regulations. - Within sixty (60) days from the approval of this Act, the
Department of Health (DOH) shall, in consultation with hemophilia groups, promulgate the
Implementing Rules and Regulations (IRR) to carry out the provisions of this Act.

Section 11. Separability Clause. — If for any reason, any provision of this Act is declared
unconstitutional ot invalid, the other parts or provisions hereof which are not affected thereby
shall continue to be in full force and effect.

Section 12. Effectivity Clause. — This Act shall take effect on the fifteenth day following its
publication in the Official Gazette or any newspaper of national circulation.

Approved,