RA 7719

MEDICAL TECHNOLOGY LAWS & ETHICS

I. TOPIC OVERVIEW

  • REPUBLIC ACT NO. 7719
    • Also known as the "National Blood Services Act of 1994"
      • Promotes voluntary blood donation.
      • Provides an adequate supply of safe blood.

II. PURPOSES OF RA 7719

  • Rising Problems in Blood-Transmissible Diseases
    • Diseases linked to blood commercialization prompted health advocates to promote voluntary blood donation.
  • Main Objectives
    • To promote voluntary blood donation.
    • To declare that blood provision is a service, not a sale of a commodity.
    • To provide an adequate supply of safe blood.
    • To inform the public of the hazards of commercial blood.
    • To require blood banks to operate on a non-profit basis.
    • To phase out commercial blood banks.

III. WHY IS IT NEEDED

  • Philippine Constitution (Section 15, Article II)
    • The State shall protect and promote the right to health of the people and instill health consciousness among them.
  • Government Regulations
    • Ensures:
      • Safe blood collection.
      • Proper screening of blood.
      • Proper storage and distribution.
      • Prevention of blood-borne diseases.

IV. TITLE & DECLARATION OF POLICY

  • SECTION 1
    • This act may be cited as the National Blood Services Act of 1994.
  • SECTION 2
    • Declared policies to promote public health, including:
      • Promote voluntary blood donation by encouraging citizens.
      • Establish blood as a service, not a commodity.
      • Ensure a safe, adequate, affordable, and equitably distributed blood supply.
      • Raise public awareness of voluntary blood donation's need to prevent hazards from commercial blood sale.
      • Integrate education on the benefits of voluntary blood donation into curricula and community programs.
      • Mobilize community participation for support of voluntary blood collection.
      • Mandate the establishment of a National Blood Transfusion Service Network by the Department of Health (DOH).
      • Support institutions that promote voluntary blood donation through reimbursements and donations.
      • Require non-profit operations for all blood collection units and blood banks.
      • Establish scientific and professional standards for blood service operations.
      • Ensure regulatory safety for blood-related activities.
      • Upgrade blood banks to include preventive services and education to control blood-transfusion transmissible diseases.

V. DEFINITION OF TERMS

  • SECTION 3
    • Commercial Blood Bank: A blood bank that operates for profit.
    • Hospital-Based Blood Bank: Located within a hospital, it can perform blood compatibility testing.
    • Blood Collection Unit: An institution authorized by the DOH to recruit and screen donors and collect blood.
    • Voluntary Blood Donor: Donates blood freely, without monetary compensation.
    • Department: Refers to the Department of Health (DOH).
    • Blood/Blood Product: Human blood, processed or unprocessed, including components, products, and derivatives.
    • Blood Transfusion Transmissible Diseases (BTTDs): Diseases transmitted via blood transfusion, including AIDS (HIV), Hepatitis B, Malaria, Syphilis.
    • Blood Bank/Center: A laboratory or institution that can recruit and screen donors, collect, process, store, transport, and issue blood.
    • Secretary of Health: The delegated official responsible for implementing the act.
    • Walking Blood Donor: A qualified voluntary donor ready to donate blood when needed in the community.

VI. PROMOTION OF VOLUNTARY BLOOD DONATION

  • SECTION 4
    • To ensure an adequate supply of human blood, measures for promoting voluntary blood donation include:
      • Public Education:
        • National campaigns led by DOH, PNRC, PBCC, involving various community sectors.
        • Funding from patient reimbursements and other donations with non-monetary incentives for donors.
      • Promotion in Schools:
        • Incorporate voluntary blood donation benefits into health subjects across educational levels.
      • Professional Education:
        • Train health professionals on the rational use of blood and blood products, including voluntary donations.
      • Establishment of a Blood Services Network:
        • Strategic establishment of blood centers across provinces and cities, led by DOH and coordinated with community organizations.
      • Walking Blood Donors:
        • Maintain a list of qualified voluntary donors in health centers for areas with limited blood banks.

VII. NATIONAL VOLUNTARY BLOOD SERVICES PROGRAM (NVBSP)

  • Government Budget Allocation
    • Managed through the Department of Health.
    • Allocation contributions:
      • Philippine Charity Sweepstakes Office (PCSO): P25,000,000
      • Philippine Amusement and Gaming Corporation (PAGCOR): P25,000,000
      • Duty Free Philippines: P20,000,000
      • Other contributions from civic organizations.

VIII. UPGRADING OF SERVICES AND FACILITIES

  • SECTION 5
    • DOH, in cooperation with PNRC, PBCC, and other NGOs, will develop the NVBSP to meet transfusion needs equitably across the Philippines.
    • Preventive Health Services at blood banks include:
      • Education on BTTDs.
      • Donor and patient counseling.
    • Encourage public and private hospitals to establish voluntary blood donation programs.

IX. PHASE-OUT OF COMMERCIAL BLOOD BANKS

  • SECTION 7
    • All commercial blood banks must be phased out within two years of the law's enactment, with a potential two-year extension by the Secretary of Health.

X. NON-PROFIT OPERATION

  • SECTION 8
    • Blood banks/centers must operate on a non-profit basis, collecting service fees limited to necessary operational costs.
    • Blood must only be collected from healthy voluntary donors.

XI. REGULATION OF BLOOD SERVICES

  • SECTION 9
    • Establishment or operation of blood banks/centers requires registration and a license from the DOH.
    • Emergency exemptions allow blood collection without a license under specific conditions set by DOH.
    • Licensing details include:
      • LTO (License to Operate) for blood banks/centers, valid for three years.
      • ATO (Authority to Operate) for blood collection units.
      • Required compliance with DOH standards - managed by qualified physicians integrated with adequate medical technologist support.

XII. IMPORTATION OF BLOOD BANK EQUIPMENT, BLOOD BAGS, AND REAGENTS

  • SECTION 10
    • Tax and duty-free importation of necessary equipment is allowed for certain entities involved in NVBSP.
  • Violations of Fee Limits
    • Suspensions or revocation of licenses may occur for non-compliance with the fee structure, with penalties including imprisonment and fines.

XIII. RULES AND REGULATIONS

  • SECTION 11
    • DOH Secretary to establish rules within 60 days of the law's approval, including maximum fees for services and allowable spoilage costs.

XIV. PENALTIES

  • SECTION 12
    • Violations can lead to fines, suspension or revocation of licenses, and criminal charges for dispensing contaminated blood or operating without a license.
    • Penalties include imprisonment and significant fines.