Policy, purpose, and governing principles
- Section 2 states the IRR is adopted to disseminate the principles of Republic Act No. 8504, and to prescribe guidelines, procedures and standards for implementation.
- Section 3 declares AIDS as a disease without territorial, social, political, and economic boundaries, and recognizes that even if a cure is discovered, the Act continues to guide prevention, control, and care.
- Section 3 requires strong State action for prevention, control, and caring for people of all ages already infected.
- Section 3 commands:
- A comprehensive nationwide education and information campaign to promote value formation, use scientifically proven approaches, focus on family, and cover schools, training centers, workplaces, and communities.
- Full protection of human rights and civil liberties for persons suspected or known to have HIV/AIDS.
- That compulsory HIV testing is unlawful unless otherwise provided in Republic Act No. 8504.
- Guarantee of privacy of individuals with HIV/AIDS.
- That discrimination against individuals with HIV/AIDS or persons perceived or suspected to have HIV/AIDS is inimical to individual and national interest.
- Assurance of basic health and social services for individuals with HIV/AIDS.
- Section 3 requires promotion of utmost safety and universal precautions in practices and procedures that carry risk of HIV transmission.
Core definitions used in the IRR
- Section 4 defines Acquired Immune Deficiency Syndrome (AIDS) as a condition caused by HIV that attacks and weakens the body’s immune system, making the afflicted person susceptible to other life-threatening infections.
- Section 4 defines AIDS Registry as the official record of reported HIV-positive and AIDS cases and deaths confirmed by BRL or RITM, and reported to the National HIV Sentinel Surveillance System (NHSSS).
- Section 4 defines Anonymous Testing as HIV testing where identity is protected or not known, including:
- Unlinked anonymous testing where blood is tested without subjects’ knowledge and identifying data is removed; and
- Voluntary anonymous testing where volunteers have identifying information removed except a code number matched to the test result code.
- Section 4 defines Compulsory HIV Testing as HIV testing without consent, including lack of consent of a parent for a minor or legal guardian for an insane person, or testing by physical force, intimidation, or any form of compulsion.
- Section 4 defines Medical Confidentiality as protection of privacy of a person tested or diagnosed with HIV, including any information that may directly or indirectly disclose the person’s identity and HIV status.
- Section 4 defines Informed Consent as voluntary verbal or written agreement to undergo or be subjected to a procedure based on full information.
- Section 4 defines Window Period as usually two (2) weeks to six (6) months when an infected person may test negative for HIV antibodies while still capable of transmitting HIV.
Education, information, and training duties
- Section 5 requires HIV/AIDS education and information to be accessible to all Filipinos and targeted to:
- Students and teachers in primary, secondary, tertiary and vocational schools;
- Health workers and clients in government and private sectors;
- Employers and employees in government and private offices;
- Filipinos going abroad;
- Tourists and transients;
- Communities; and
- Population groups with relatively higher risk of acquiring or transmitting HIV/AIDS.
- Section 6 provides the purpose: timely, accurate, adequate, appropriate, and relevant HIV education and information to empower persons and communities to protect themselves, minimize transmission risk, and decrease socio-economic impact.
- Section 7 requires standardized basic information on HIV/AIDS as the minimum content, guided by criteria of being accurate, clear, concise, appropriate, gender-sensitive, culture-sensitive, affirmative, non-moralistic and non-condemnatory, and non-pornographic, while avoiding alarmist, fear-arousing, and coercive messages.
- Section 8 requires development of a prototype module/instructional design on standardized basic information, including instructional objectives, content/topics and time allocation, teaching methods, evaluation methods/tools, and recommended qualifications of resource persons.
- Section 8 mandates the prototype be developed by DOH through SHAPCS within six (6) months from the effectivity date of the IRR, in partnership and consultation with named government agencies and private/NGO representatives.
- Section 12 mandates DOH through SHAPCS to conduct a national and regional training of trainers at least once a year, requiring participants to include qualified health workers/educators and committed trainers/offerors.
- Section 13 requires DECS, CHED, and TESDA to develop school-based HIV/AIDS education programs using the prototype, add-on content, and multimedia instructional materials; it requires integration into specific subject areas at elementary, secondary, and tertiary levels, and integration into non-formal and indigenous learning systems.
- Sections 14 to 18 require HIV/AIDS education and information services for:
- Inpatients and outpatients in hospitals/clinics (with prototype-based materials and accessible self-instructional materials),
- Workplaces through employer-funded programs that include prototype-based materials, trainer lists, schedules, self-learning materials, distribution schedules, and monitoring/reporting,
- Filipinos going abroad via a pre-departure seminar (OFWs through DOLE pre-employment/pre-departure orientation; other officials via their agencies’ training),
- Tourists and transients through prominent displays and multimedia materials produced and disseminated by DOT and DOTC, with monitoring and coordination involving DOT, DFA, DOJ through BI, and collaboration with DOH, and
- Communities through LGU-led programs that coordinate with government agencies, NGOs, PLWHAs, and community organizations, cover provincial/city/municipal/barangay/household levels, use prototype-based modified materials, and integrate into existing LGU programs.
- Section 19 requires labeling materials attached to or provided with every prophylactic offered for sale or donation, meeting requirements on:
- Language (English and any locally used Filipino dialect),
- Size (at least 60 square cms),
- Font size (six (6) or bigger),
- One labeling material per pack.
- Section 19 requires each labeling material to include specific statements and instructions, including:
- Expiry and manufacture dates,
- “sexual abstinence and mutual fidelity are effective strategies for the prevention of HIV/AIDS and STDs,”
- “When used properly, the use of a condom is a highly effective method of preventing most sexually transmitted diseases,”
- Proper condom use instructions with an illustration,
- Advice against non-water-based lubricants like baby oil or petrolatum jelly,
- Advice that “each condom is used only once.”
- Section 19 delays compliance of labeling requirements until one year after the effectivity date of this IRR, and makes receiving agencies responsible for donor-supplied condoms meeting the requirements.
- Section 20 prohibits misleading information in false or deceptive advertisements by deeming information misleading where material facts or possible outcomes are not revealed and where specific prohibited advertisement patterns occur.
Prohibitions and penalties for misleading info
- Section 20 deems advertisements misleading when:
- Benefits/use of non-prescription drugs, devices, and treatments are advertised without complying with BFAD-approved indications and labeling specifications;
- Advertisements offer false hopes of temporary or permanent cure or relief; or
- References to laboratory data/statistics/scientific terms come from doubtful sources or are quoted inaccurately.
- Section 20 imposes criminal penalties for violations: imprisonment for two (2) months to two (2) years.
- Section 20 states penalties under this section do not prevent imposition of administrative sanctions or suspension/revocation of professional or business licenses.
Safe practices, blood/transplant rules, and sanctions
- Section 21 establishes Universal Precautions as the basic standard of infection control, requiring assumption that all patients and staff may be infected with blood-borne pathogens such as HIV and hepatitis B virus.
- Section 21 requires universal precautions procedures, including:
- Handwashing and standard hygienic procedures at all times,
- Faithful consultation and observance of hospital guidelines for disinfection and sterilization,
- Protective gloves or impermeable dressing for skin diseases or injuries,
- Covering blood spills liberally with household bleach (dilution of 1 to 10), leaving for 30 minutes, then wiping by gloved personnel,
- Use of gown, gloves, mask, and protective eyewear during surgery/childbirth/other procedures where contact with blood/body fluids is likely,
- Immediate disposal of needles/sharps after use in puncture-proof containers marked BIOHAZARD, without bending/breaking by hand, and without recapping used disposable needles,
- Safe handling and storage of reusable needles/syringes prior to cleaning and sterilization/disinfection,
- Minimizing handling of linen soiled with blood/body fluids while wearing gloves and protective apron,
- Handling of blood/specimens as potentially infectious.
- Section 22 requires all hospitals and appropriate health care facilities to establish an HIV/AIDS Core Team (HACT) as a multi-disciplinary group with policy-making, implementing, coordinating, assessing, training, research, and project development functions.
- Section 22 requires HACT objectives to include facilitating safe, comprehensive, compassionate care; mobilizing hospital/community resources; and coordinating efforts to prevent/control transmission.
- Section 22 provides HACT functions, including implementation of guidelines, patient care and counseling, prevention/control promotion, coordination and referral networking, training and research, hospital planning recommendations, compliance monitoring of ethico-moral guidelines including confidentiality, record updating and reporting, and monitoring and evaluation.
- Section 22 requires HACT membership of five (5) to seven (7) members, and provides selection criteria for members and additional criteria for selecting the HACT leader.
- Section 23 prohibits acceptance for transfusion or transplantation of any blood, tissue, or organ testing positive for HIV; only those testing negative (-) for HIV may be accepted.
- Section 23 grants the recipient or immediate relative a right to demand a second HIV test before transfusion/transplantation, with an exception for emergency cases where testing is not practical/feasible/available, conditioned on written consent to the HIV test waiver.
- Section 23 requires proper and immediate disposition of donations testing positive (+), or acceptance only for research purposes by qualified medical research organizations subject to strict sanitary disposal requirements under the DOH Manual of Nosocomial Infections and Hospital Waste Management.
- Section 24 requires universal-precautions standards be observed during surgical, dental, embalming, cadaver/blood/organs/waste handling for HIV (+) persons, tattooing, and other similar procedures.
- Section 24 mandates DOH to develop and print separate manuals for each covered procedure within one (1) year from the effectivity date of the IRR, with formal signing and dating by the Secretary of Health and incorporation as integral part of the IRR.
- Section 24 requires manuals to be distributed to agencies regulating establishments for sanitary permits issuance, accreditation, or permit renewal, and makes regulatory agencies responsible for monitoring compliance.
- Section 24 preserves pre-existing issuances pending official DOH manual issuance, provided they do not conflict with the IRR, including:
- Administrative Order No. 18, s. 1995 (Guidelines for Management of HIV/AIDS in Hospitals),
- IRR of Chapter XXI of the Code of Sanitation of the Philippines (1997),
- Guidelines for Infectious Disease Control in Hospitals (DOH, July 1997),
- Chapter 8, pages 39 to 44 of the Manual on Nosocomial Infections (DOH, December 1993).
- Section 25 imposes imprisonment for individuals committing unsafe practices/procedures defined as non-compliance with universal precautions: six (6) to twelve (12) years, without prejudice to administrative sanctions such as fines and/or suspension or revocation of license to practice the profession.
- Section 25 imposes institutional consequences for failure to maintain safe practices/procedures as required: cancellation of the permit/license of the institution or agency, or withdrawal of accreditation of the hospital/laboratory/clinic.
Consent, testing rules, and counseling requirements
- Section 26 requires written informed consent before HIV testing, to be made by the individual tested, the parent of a minor, or the legal guardian of a mentally incapacitated person, with an exception for unlinked and voluntary anonymous testing.
- Section 26 allows use of an assumed name or code name by a person being tested, and provides that written informed consent using such assumed/code name constitutes lawful consent.
- Section 26 allows a thumbprint to substitute for a signature where the person is unable to write.
- Section 26 treats written consent to volunteer/donate blood, organ, or tissue for transfusion/transplantation/research as consent for HIV testing under the blood/organ/tissue rules.
- Section 26 mandates DOH through SHAPCS to develop a prototype informed consent form in English and locally used Filipino dialects, including the RA 8504 excerpt that prohibits HIV testing as a precondition for employment, admission to educational institutions, freedom of abode, entry/continued stay in the Philippines, right to travel, provision of medical service, or any other service.
- Section 26 requires the duly accomplished informed consent record to be kept confidential under the IRR’s confidentiality rules, and limits access except for a valid medical or legal need.
- Section 27 prohibits HIV testing as a precondition for employment, admission to educational institution, exercise of freedom of abode, entry or continued stay, right to travel, provision of medical service or any kind of service, and enjoyment of human rights and civil liberties including marriage and normal family life.
- Section 28 lifts the prohibition on compulsory HIV testing in these instances:
- Upon a court order when a person is charged with specified crimes under Act 3815 (Revised Penal Code), including Article 264, Article 335, Article 337, and Article 338, and when specific statutes apply for rape where the offender knows he is afflicted with AIDS under R.A. 7659 (Section 11, paragraph 5), and when rape under R.A. 8353 involves knowledge that the offender is afflicted with HIV/AIDS or another transmissible sexually transmitted disease;
- Upon court order when HIV status determination is necessary to resolve relevant issues under Executive Order No. 209 (Family Code), particularly Article 45 and Article 46, involving fraud tied to concealment of a serious incurable sexually transmissible disease or concealment of any sexually transmissible disease; and
- When complying with Republic Act No. 7170 (Organ Donation Act) and Republic Act No. 7719 (National Blood Service Act).
- Section 29 defines anonymous HIV testing and permits two methods: unlinked anonymous and voluntary anonymous.
- Section 29 provides that persons submitting to anonymous HIV testing are not required to provide name, age, address, or any identifying information; in voluntary anonymous testing, a symbol replaces identity and allows matching of test result to that symbol.
- Section 30 requires that no person, firm, corporation, center, hospital, clinic, blood bank, or laboratory performs HIV testing without DOH accreditation through BRL in the Office for Health Facilities, Standards and Regulation (OHFSR).
- Section 30 incorporates accreditation standards from Administrative Order No. 55-A, s. 1989 (Annex A) as part of the IRR, while amending Sections 7.1.6 and 9.3 to:
- Require reagents (HIV kits) registered with BFAD and evaluated/recommended by RITM; and
- Require reporting of confirmed seropositive individuals’ names, age, sex, and addresses to AIDSWATCH as provided in Section 38, using specified confirmatory testing standards.
- Section 30 requires SHAPCS and RITM to convene an annual or as-needed forum for technical review of HIV testing issues with listed stakeholders, and provides that RITM serves as the national reference center for HIV testing.
- Section 31 requires all individuals/centers/clinics/blood banks/laboratories offering HIV testing to provide, free of charge, pre-test and post-test counseling.
- Section 31 requires pre-test counseling to include: purpose of testing, applicable other diseases, window period, test procedure, meaning of negative/positive results, confidentiality and risk-free disclosure guarantees, result availability and who receives it, basic HIV/AIDS infection information (nature, transmission modes, risk behaviors, risk reduction), and informed consent plus prohibition of compulsory testing.
- Section 31 requires post-test counseling after negative results to include release of result to the test person or legal guardian of minor, review of meaning, immediate concerns discussion, HIV/AIDS basics review, and provision of literature plus community referral if necessary.
- Section 31 requires post-test counseling after positive results to include release of result, emotional support, immediate concerns discussion, meaning review, transmission/risk reduction review, importance of seeking health care explanation, referral arrangements to health care and community services and PLWHA organizations, and assistance with disclosure to spouse/sexual partner as soon as possible.
- Section 31 requires counseling in a private place away from interruptions; it may be at bedside, in a counseling room, or in a person’s home, preferably in a pleasant atmosphere.
- Section 31 permits group pre-test and post-test counseling for OFWs prior to overseas employment but requires individual counseling for OFWs with a positive (+) result.
- Section 31 requires only health workers trained in HIV/AIDS counseling to provide counseling.
- Section 31 requires SHAPCS to produce training kits for HIV/AIDS counseling and to conduct national and regional trainer training, with trainers conducting counseling training at provincial and institutional levels.
- Section 32 requires DOH through SHAPCS to coordinate training for testing center staff (medical technologists, pathologists, and other health workers), and mandates at least twice a year HIV testing training courses/workshops covering HIV biology, epidemiology, testing principles/methods, laboratory safety and precautions, counseling, and quality assurance.
- Section 32 requires formation of a network of HIV testing centers (with support services and quality assurance) with members meeting at least once a year.
Hospital and community care services
- Section 33 requires SHAPCS, through a Committee, to develop a Standard Operating Procedures (SOP) Manual for comprehensive and compassionate hospital-based care for PLWHAs within 90 days from the effectivity date of the IRR.
- Section 33 requires the SOP Manual to ensure accessibility of basic hospital services and include technical, managerial, quality, and procedural requirements for physical, physiologic, psychological, socio-economic, and spiritual care, including emergency treatment, laboratory services, and diagnosis/treatment of HIV/AIDS, STD, other infections, and complications.
- Section 33 requires the Committee to include representatives from OHFSR, HOMS, San Lazaro Hospital (SLH), RITM, accredited professional associations, NGOs, academe, and PLWHAs.
- Section 33 preserves interim hospital service guidelines in government hospitals pending SOP Manual effectivity, including Administrative Order No. 18, s. 1995 and Administrative Order No. 9, s. 1997.
- Section 33 requires continued effectiveness of specified IRR annex provisions until revision by SHAPCS.
- Section 34 requires LGUs, through health/social welfare/population officers and in collaboration with government agencies, NGOs, private sector organizations/establishments, PLWHAs, and other vulnerable groups, to develop and support community services for prevention and control and care of PLWHAs and families.
- Section 34 requires community services to include education/information campaigns, counseling, home-based care, organizing and networking community-based support groups, and a referral system, integrated into provincial/city/municipal/barangay development plans and existing programs.
Livelihood, STD control, and insurance feasibility
- Section 35 requires government agencies and private agencies to provide opportunities for PLWHAs to participate in skills training, skills enhancement, and livelihood programs, and prohibits deprivation of participation due to HIV/AIDS status alone.
- Section 35 requires livelihood support to include capital assistance, marketing assistance, and job placement, and requires DSWD with DOLE, DILG, and private agencies to jointly set up a referral system at regional and provincial levels for access to skills training and livelihood programs.
- Section 36 requires DOH, in coordination with other agencies, LGUs, and NGOs, to pursue prevention and control of STDs under the named STD administrative orders integrated in the IRR annexes until revised by SHAPCS.
- Section 36 requires DOH to conduct periodic studies on STD prevalence, antimicrobial drug resistance levels, and new STD treatment modalities, and to submit results to PNAC.
- Section 37 requires the creation within 60 days of IRR effectivity of a Task Force by the Secretary of Health and the Commissioner of the Insurance Commission to oversee feasibility studies on a package of insurance benefits for PLWHAs in accordance with guiding principles of Sections 26 and 39 of Republic Act No. 8504.
- Section 37 requires the Task Force to submit feasibility study results to PNAC within one year of creation.
- Section 37 requires PHIC to oversee implementation of an insurance program if feasibility finds coverage feasible.
Monitoring and national HIV surveillance
- Section 38 requires establishment of AIDSWATCH as the DOH comprehensive HIV/AIDS monitoring and review program.
- Section 38 mandates that upon IRR effectivity, AIDSWATCH integrates the NHSSS and the AIDS Registry.
- Section 38 requires AIDSWATCH to monitor magnitude, distribution, and progression of HIV infection in the country, including epidemics, and to evaluate adequacy and efficacy of HIV prevention and control measures.
- Section 38 requires AIDSWATCH monitoring through passive surveillance and active surveillance.
- Section 38 requires passive surveillance to report HIV/AIDS cases through identification of positive cases as a pre-screening procedure in blood banks/hospitals/clinics/accredited laboratories, confirmation by BRL for government sites and RITM for private sites, processing and analysis by AIDSWATCH, and public information dissemination on incidence of HIV/AIDS.
- Section 38 provides that passive surveillance reporting levels include primary health centers, LGUs, regional epidemiological surveillance units (RESUs), and the Field Health Surveillance and Intelligence Service.