Key definitions established by law
- Section 2 defines “Blood” as human blood, processed or unprocessed, including its products and derivatives.
- Section 2 defines “Person” to include corporations, partnerships, associations, and organizations.
- Section 2 defines “Cost” as the actual purchase price of unprocessed blood and its handling charges, including collection, processing, storage, transportation, and sale, plus a reasonable allowance for spoilage.
Coverage: who may act, and what is regulated
- Section 3 regulates the establishment or operation of blood banks and blood processing laboratories, and the collection or processing of blood.
- Section 3 prohibits unlicensed activity by any person (including entities under Section 2) involving blood bank/laboratory operations, or blood collection/processing.
- Section 3 requires a license from the Department of Health for the sale of blood collected from another person, even if the transferor authorized the sale.
- Section 3 requires licensing compliance for both blood bank/laboratory operations and blood collection/processing activities.
Licensing requirements and controls
- Section 3 makes it unlawful for any person to establish or operate a blood bank or blood processing laboratory, or to collect or process blood if the operator is not a licensed physician, unless a Department of Health license is first secured.
- Section 3 also makes it unlawful for any person to sell blood collected from another person, even if authorized by the latter, without first securing a Department of Health license.
- Section 3 allows emergency blood transfusion under the responsibility of the attending physician without such license.
- Section 3 requires that no license shall be granted or renewed unless the blood bank or laboratory:
- is established or operated in accordance with accepted scientific standards;
- is under the administration, direction, and supervision of a licensed and qualified physician; and
- has blood collected and/or processed by licensed physicians or under their direct supervision and responsibility.
- Section 3 requires that no license shall be granted or renewed for blood collection and/or processing unless the licensee complies with the requirements imposed for blood banks and blood processing laboratories.
Non-profit operation and cost-based sale
- Section 4 requires blood banks and processing laboratories to be operated on a non-profit basis.
- Section 4 requires blood collecting or processing by other blood collectors or processors or by individual physicians to also be on a non-profit basis.
- Section 4 mandates that blood shall be sold by such banks and laboratories, other blood collectors or processors, and individual physicians at cost.
- Section 2 fixes the meaning of cost for the purpose of Section 4 as purchase price of unprocessed blood plus handling charges and a reasonable allowance for spoilage.
Department of Health enforcement and rate ceilings
- Section 5 charges the Secretary of Health with strictly enforcing the Act.
- Section 5 directs the Secretary to issue rules and regulations necessary to carry out the Act’s provisions.
- Section 5 requires rules and regulations prescribing, from time to time, the maximum ceilings for handling charges of blood, including charges for collection, processing, storage, transportation, and sale.
- Section 5 provides that the reasonable allowance for spoilage shall be considered as part of the cost of blood for purposes of charge ceilings.
Penalties for violations
- Section 6 punishes any person who violates any provision of the Act or its rules and regulations with imprisonment for not less than one month and not more than one year.
- Section 6 imposes a fine of not less than PHP 100 and not more than PHP 1,000, and allows punishment by both fine and imprisonment at the court’s discretion.
- Section 6 makes compliance with both the Act and the Department of Health’s implementing rules mandatory for avoiding criminal liability.
Transitional authority for existing operators
- Section 3 allows persons operating blood banks and blood processing laboratories on the date of approval of the Act to continue operating.
- Section 3 requires those existing operators to secure the required license within sixty days from the date of the issuance of the rules and regulations under Section 5.
Effectivity
- Section 7 provides that the Act takes effect upon its approval.
- The Act was approved on June 16, 1956.