Umbilical Cord Blood Donation Act

Senate Office of the Secretary TWENTIETH CONGRESS OF THE ) REPUBLIC OF THE PHILIPPINES 26 FEB -5 P1:06 First Regular Session SENATE 1751 RECEIVED BY: S.B. No. _ Introduced by SENATOR IMEE R. MARCOS AN ACT PROMOTING AND REGULATING THE DONATION OF UMBILICAL CORD BLOOD, APPROPRIATING FUNDS THEREFOR, AND FOR OTHER PURPOSES EXPLANATORY NOTE

Section 15, Article II of the 1987 Philippine Constitution provides that "the State

shall protect and promote the right to health of the people and instill health consciousness among them." Umbilical cord blood refers to the blood that remains in the umbilical cord and placenta after childbirth. Medical studies have shown that umbilical cord blood is rich in hematopoietic stem cells-immature cells capable of developing into various types of blood cells, such as red blood cells, white blood cells, and platelets. These stem cells are the same type of blood-forming cells used in bone marrow transplants and have been utilized in the treatment of more than seventy (70) diseases, including certain cancers, blood disorders, and immune system deficiencies. In many countries, the collection and banking of umbilical cord blood have been institutionalized as part of their public health systems. Umbilical Cord blood banking enables the preservation of potentially life-saving stem cells that may be used in future medical treatments. The collection of umbilical cord blood is safe, painless, and poses no risk to both mother and child. Once collected, cord blood units are processed, cryogenically preserved, and stored in accredited cord blood banks for future therapeutic use. Cord blood banking offers several advantages over other sources of stem cells. Cord blood contains a higher concentration of stem cells than those typically obtained from adult bone marrow, is easier to collect, carries a lower risk of transmitting

infectious diseases, and has a lower likelihood of immune rejection when used for transplantation. These attributes underscore the importance of promoting cord blood banking as a viable and accessible option for patients in need of stem cell therapy. Thus, this measure seeks to promote and regulate the system of umbilical cord blood banking in the country, establish appropriate standards for its collection, processing, storage, and use, and ensure the protection of donors and the safety of recipients. It likewise aims to integrate public information and education on umbilical cord blood banking into existing prenatal and maternal healthcare programs. Expectant families should be provided with standardized, accurate, and objective information on the benefits, limitations, and options available under both public and private cord blood banking systems, enabling them to make informed decisions. In light of the increasing incidence of infectious diseases, genetic disorders, and terminal illnesses, there is a compelling need for the State to adopt proactive and preventive healthcare strategies. The institutionalization and regulation of umbilical cord blood banking will strengthen the country's healthcare system, expand treatment options for patients, and promote a culture of health consciousness among Filipino families. For the foregoing reasons, the immediate passage of this bill is earnestly sought. Free h. marca AMEE R. MARCOS

Senate Office of the Saccretarp TWENTIETH CONGRESS OF THE ) REPUBLIC OF THE PHILIPPINES ) ) 26 FEB -5 P1:06 First Regular Session SENATE S.B. No. 1751 RECEIVED BY: Introduced by SENATOR IMEE R. MARCOS AN ACT PROMOTING AND REGULATING THE DONATION OF UMBILICAL CORD BLOOD, APPROPRIATING FUNDS THEREFOR, 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 "Umbilical Cord Blood

Donation Act."

SEC. 2. Declaration of Policy. - It is hereby declared the policy of the State to

protect and promote the right to health of the people and instill health consciousness among them. For this reason, the State aims to educate pregnant women regarding the potential benefits of umbilical cord blood banking and to provide opportunities for the donation and storage of umbilical cord blood when desired by a pregnant woman thereby adopting proactive methods in treating diseases such as cancer, anemia, and blood diseases, among others.

SEC. 3. Definition of Terms. - For purposes of this Act, the following shall be

defined as: a. "Department" shall mean the Department of Health (DOH); b. "Health Care Facility' shall mean as an institution providing health care services to a pregnant woman that are directly related to her pregnancy, including a hospital, clinic or other inpatient center, outpatient facility or diagnostic or treatment center that is licensed by the Department of Health; c. "Health Care Provider" shall mean as a person who is licensed, certified, or otherwise authorized by law to provide or render health care services to

pregnant women in the ordinary course of business or practice of a profession but is limited to a medical physician, osteopathic physician, certified nurse practitioner and certified nurse-midwife; and d. "Umbilical Cord Blood" shall mean as the blood that remains in the umbilical cord and placenta after the birth of a newborn child.

SEC. 4. Option to Donate Umbilical Cord Blood. - All health care providers

providing health care services to a pregnant woman by the end of the second trimester (28th week), which health care services are directly related to her pregnancy, shall advise her of options to donate umbilical cord blood following the delivery of a newborn child, by providing standardized objective information about cord blood banking that is sufficient to allow a pregnant woman to make an informed decision on whether to participate in a public or private umbilical cord blood banking program. This shall include information on the free family banking and sibling donor programs where there is an existing medical need by a family member, among others. Provision in a timely manner of publications prepared by the Department, as provided in Section 6 of this Act, shall constitute compliance with this Section.

SEC. 5. Exemption. - Nothing in this Section shall impose an obligation upon a

health care provider to inform a pregnant woman regarding her umbilical cord blood banking options if such information conflicts with bona fide religious beliefs of the health care provider or the pregnant woman.

SEC. 6. Information Dissemination. - The Department shall, on its official

website and other publications, make available to health care providers printable publications regarding umbilical cord blood banking which shall include the following information, among others: (1) An explanation of the differences between public and private umbilical cord blood banking; (2) The medical processes involved in the collection of umbilical cord blood; (3) The medical risks to a mother and her newborn child of umbilical cord blood collection; (4) The current and potential future medical uses and benefits of umbilical cord blood collection to a mother, her newborn child and her biological family;

(5) The current and potential future medical uses and benefits of umbilical cord blood collection to persons who are not biologically related to a mother or her newborn child; (6) Any costs that may be incurred by a pregnant woman who chooses to make an umbilical cord blood donation; (7) The average costs of public and private umbilical cord blood banking; (8) Options for ownership and future use of the donated material; and (9) The availability of umbilical cord blood donations in the country.

SEC. 7. Donation of umbilical cord blood. -

(a) Arrangements for donations - Unless it is medically inadvisable, all health care facilities and health care providers treating a pregnant woman during the delivery of a newborn child shall, if requested by that woman, permit and assist her to arrange for an umbilical cord blood donation. (b) Exceptions relating to health of mother- Nothing in this section imposes an obligation upon a health care facility or health care provider to permit an umbilical cord blood donation if, in the professional judgment of a health care provider, the donation of umbilical cord blood would threaten the health of the mother or the newborn child. (c) Exceptions relating to religion - Nothing in this section imposes an obligation upon a health care facility or health care provider to permit an umbilical cord blood donation if the donation conflicts with bona fide religious beliefs of the health care facility or health care provider. Provided that, if a health care facility or health care provider declines to engage in umbilical cord blood donation, under reasonable circumstances, such fact shall be made known to pregnant patients of that facility or provider, as soon as reasonably feasible.

SEC. 8. Creation of a Committee. - There shall be established, within the

Department, an implementing committee to provide guidance and policy suggestions to the Department on the implementation of the Umbilical Cord Blood Collection Program created pursuant to this Act. The implementing committee shall be chaired by the Secretary of Health or his duly authorized representative with six (6) members, as follows: one (1) representative from the Department, one (1) representative from the Department of Science and

1 Technology (DOST), two (2) representatives from the academe, two (2) representatives from the private sector, all of whom with at least ten (10) years practice in the medical field or medical sciences. The Department shall use its existing authority to promote and implement the collection, storage, retrieval, and distribution of the umbilical cord blood.

SEC. 9. Functions. - The committee shall have the following functions:

(a) Define and identify qualified umbilical cord blood collection entities; (b) Design a competitive process to identify qualified participants licensed or accredited to harvest umbilical cord blood in a manner that complies with existing laws, rules and regulations; (c) Establish criteria for determining which units of umbilical cord blood may be used for research and/or transplant, and policy to address circumstances under which umbilical cord blood may be used for either purpose; (d) Create collection targets for ethnically diverse populations in accordance with identified deficiencies in inventories; (e) Consider a medical contingency response program to prepare for and respond effectively to biological, chemical, or radiological attacks, and other public health emergencies requiring treatment with umbilical cord blood; (f) Develop a public awareness campaign and increase hospital participation in the collection and storage efforts, and identify sources to offset the financial impact on hospitals; (g) Determine and conduct training programs for health care providers relative to the handling, labeling, transporting, and storing of the umbilical cord blood, among others; (h) Determine policy on obtaining patient consent and timing of consent in relation to existing laws and standards of care; (i) Ascertain whether current laws and guidelines applicable to donor confidentiality and security of donor information are sufficient and what other additional requirements or guidelines are necessary; i) Determine whether a sibling donor component would help achieve the overall inventory goals of the program; (k) Explore feasibility of operating the Umbilical Cord Blood Collection Program as a self-funding program;

(1) Ensure that the Umbilical Cord Blood Collection Program does not conflict with other national and international efforts to generate an adequate, high- quality inventory; and (m) Such other function/s that may be necessary for the implementation of this Act.

SEC. 10. Establishment of Umbilical Cord Blood Storage Facilities. - One (1)

year after the effectivity of this Act, all hospitals should have a facility where cord blood can be stored. Provided that, if existing hospital blood storage facilities are capable of storing cord blood, the hospital involved is deemed to have complied with the provisions of this Act.

SEC. 11. Umbilical Cord Blood Collection Program. - Within one year from the

effectivity of this Act, the DOH shall establish the Umbilical Cord Blood Collection Program for the purpose of collecting and storing umbilical cord blood for public use, human transplantation, and research.

SEC. 12. Confidentiality. - A health care provider or any employee of medical or

research facility shall comply with, and shall be subject to existing penalties for violations of all laws with respect to the confidentiality and protection of any information contained in the umbilical cord blood inventory and relative to the patients. All information collected pursuant to the Umbilical Cord Blood Collection Program shall be confidential, and shall be used solely for the purposes of this Act. Access to confidential information shall be limited to authorized persons who agree, in writing, to maintain the confidentiality of that information.

SEC. 13. Punishable Act. - Any person who, in violation Sec. 13 of this Act, uses

or discloses any information relevant to the Umbilical Cord Blood Collection Program and any patient thereof shall be subject to a civil liability of not exceeding one hundred thousand pesos (Php 100,000.00). Provided that, the penalty provided for in this provision shall not be construed as to limit or otherwise restrict any remedy, provisional or otherwise, provided by existing laws. Notwithstanding the restrictions of this Act, any individual to whom the confidential information pertains to shall have access to his or her own personal records.

SEC. 14. Implementing Rules and Regulations. - The Department shall

promulgate the necessary implementing rules and regulations within sixty (60) days following the effectivity of this Act.

SEC. 15. Appropriations. - The amount needed to initially implement the

provisions of this Act shall be charged against the appropriations of the current year of the Department. Thereafter, such sums, as may be necessary, for its continued implementation shall be included in the annual General Appropriations Act.

SEC. 16. Repealing Clause. - Any law, presidential decree or Issuance, executive

order, letter of instruction, administrative order, rule or regulation contrary to, or inconsistent with the provisions of this Act is hereby repealed, modified or amended accordingly.

SEC. 17. Separability Clause. - If any provision or part hereof is held invalid or

unconstitutional, the remainder of the law or the provision not otherwise affected shall remain valid and subsisting.

SEC. 18. Effectivity Clause. - This Act shall take effect fifteen (15) days after its

publication in at least two (2) newspapers of general circulation. Approved,