COVID-19 Vaccination Program Act of 2021

Case Overview and Summary

Summary of Republic Act No. 11525 (COVID-19 Vaccination Program Act of 2021)

Declaration of Policy (Section 2)
- Adopt an integrated approach to health development and make essential social services available at affordable cost.
- Undertake a COVID-19 Vaccination Program with the following objectives:
    a. Procure and administer safe and effective COVID-19 vaccines through the DOH and NTF. (Section 2a)
    b. Source and procure safe and effective COVID-19 vaccines through the DOH and NTF, jointly or with other agencies/LGUs. (Section 2b)
    c. Recognize the experimental nature of COVID-19 vaccines and compensate for serious adverse effects (SAEs). (Section 2c)
    d. Create a COVID-19 National Vaccine Indemnity Fund administered by PhilHealth to compensate for SAEs. (Section 2d)

Procurement of COVID-19 Vaccines and Ancillary Supplies and Services (Section 3)
- The DOH and NTF are authorized to procure COVID-19 vaccines, supplies, and services through negotiated procurement under emergency cases.
- The DOH and NTF shall negotiate and approve terms and conditions, including price and payment terms, to ensure price uniformity.
- LGUs and other procuring entities are authorized to enter into supply agreements, advance payments, or other arrangements as identified by the DOH and NTF.
- LGUs are authorized to directly procure ancillary supplies and services through negotiated procurement under emergency cases.
- Provinces, cities, and municipalities may advance payment if required by the supplier, manufacturer, or distributor.
- The deployment of vaccines must be in accordance with the criteria set by the Interim National Immunization Technical Advisory Group (NITAG).
- This section shall have retroactive application from January 1, 2021.

Procurement and Administration of COVID-19 Vaccines by LGUs (Section 4)
- LGUs may procure only in cooperation with the DOH and NTF through a multiparty agreement, including the relevant suppliers.
- LGUs shall procure no more than 75% of their target population for vaccination, subject to adjustment by the IATF-MEID.
- LGUs may directly accept donations of FDA-authorized and cleared COVID-19 vaccines, subject to DOH and NTF guidelines.
- For National Government-funded vaccines, LGUs shall prioritize healthcare workers, senior citizens, persons with comorbidities, frontline personnel, and indigent population.
- For LGU-funded vaccines, LGUs shall prioritize frontline workers in health facilities, senior citizens, and indigent persons.
- LGUs shall submit a masterlist of vaccinated residents to the DOH, subject to the Data Privacy Act.
- This section shall have retroactive application from January 1, 2021.

Procurement and Administration of COVID-19 Vaccines by Private Entities (Section 5)
- Private entities may procure COVID-19 vaccines only in cooperation with the DOH and NTF through a multiparty agreement, including the relevant supplier.
- Vaccines procured by private entities shall be for their sole and exclusive use.
- Priority shall be given to healthcare workers, senior citizens, economic frontliners, and essential workers.
- Chief medical officers of private entities may formulate their own vaccine recipient list and operational procedures in accordance with DOH policies.
- International humanitarian organizations, such as the Philippine Red Cross, may procure COVID-19 vaccines, with one vaccine donated for every one vaccine bought for the vulnerable and indigent.
- The DOH, NTF, LGUs, and private entities may partner with the Philippine Red Cross in vaccine administration or distribution.
- This section shall have retroactive application from November 1, 2020.

Transparency and Accountability in COVID-19 Vaccine Procurement (Section 6)
- Procuring entities may only procure COVID-19 vaccines registered with the FDA or with an Emergency Use Authorization (EUA).
- Within 30 days after award or execution of agreement, the following information shall be posted:
    a. Approved budget for the contract
    b. Name and details of the COVID-19 vaccine or ancillary service or supplies
    c. Name of the supplier, manufacturer, or distributor
    d. Amount of contract as awarded

Authority to Make Recommendations Based on Preliminary Data (Section 7)
- The Health Technology Assessment Council (HTAC) shall have the authority to make recommendations to the DOH on COVID-19 vaccines based on preliminary data from Phase III clinical trials and WHO recommendations, in the absence of completed Phase III and Phase IV clinical trials.
- This authority is valid only for as long as the EUA issued by the FDA is in effect.

Immunity from Liability (Section 8)
- Public officials, employees, contractors, manufacturers, volunteers, and representatives of authorized private entities carrying out the COVID-19 Vaccination Program shall be immune from suit and liability under Philippine laws, except for willful misconduct and gross negligence.

Pharmacists and Midwives as Vaccinators (Section 9)
- Licensed pharmacists and midwives who are duly trained by the DOH may administer COVID-19 vaccines registered with the FDA or with an EUA.

COVID-19 National Vaccine Indemnity Fund (Section 10)
- The COVID-19 National Vaccine Indemnity Fund, administered by PhilHealth, is established to compensate for death, permanent disability, or hospital confinement due to SAEs from the COVID-19 Vaccination Program.
- An amount of Five hundred million pesos (P500,000,000.00) is authorized to augment the funds of PhilHealth for this purpose.
- The fund shall be valid and available until terminated by the President, based on the recommendation of the Permanent Committee.
- PhilHealth, in consultation with other agencies, shall issue guidelines for the planning, administration, and monitoring of the fund.
- The IATF-EID shall establish a Special Task Group to monitor adverse effects and promulgate guidelines for monitoring, evaluation, investigation, and reporting.
- This section shall be valid for 5 years from the effectivity of this Act or until the completion of the COVID-19 Vaccination Program, whichever comes earlier.

Exemption from Import Duties, Taxes and Other Fees (Section 11)
- Beginning January 1, 2021, the procurement, importation, donation, storage, transport, deployment, and administration of COVID-19 vaccines through the COVID-19 Vaccination Program by the government, its subdivisions, and private entities shall be exempt from customs duties, value-added tax, excise tax, donor's tax, and other fees.
- The vaccines shall not be intended for resale or other commercial use and shall be distributed without consideration.

COVID-19 Vaccine Card (Section 12)
- The DOH shall issue a vaccine card to all persons vaccinated, subject to the Data Privacy Act.
- The DOH may delegate the processing and issuance of vaccine cards to LGUs and private entities.
- The vaccine card shall contain personal information, vaccine details, date of vaccination, vaccination site, and healthcare worker information.
- The vaccine card shall be digital, but accessible through other means such as printed cards.
- The DOH shall maintain a central database of vaccinations and mandate a uniform format for the vaccine card.
- Vaccine cards shall not be considered as an additional mandatory requirement for educational, employment, and other similar government transactions.
- Individuals vaccinated shall not be considered immune from COVID-19, unless declared by the DOH based on scientific evidence.
- No fees shall be collected for the issuance, amendment, or replacement of a vaccine card.
- The falsification of a vaccine card shall be punishable under the Revised Penal Code.

Reportorial Requirement and Creation of an Oversight Committee (Section 13)
- The Vaccine Czar, DOH, and IATF-EID shall submit a monthly report to Congress on the implementation of the COVID-19 Vaccination Program.
- Congress shall establish a Joint Congressional Oversight Committee to determine whether the implementation conforms with the provisions of this Act.

Implementing Rules and Regulations (Section 14)
- Within 5 days from the effectivity of this Act, the DOH, NTF, and GPPB shall issue guidelines and applicable procurement rules for the effective implementation of this Act.
- The non-promulgation of rules and regulations shall not prevent the immediate implementation of this Act.

Separability Clause (Section 15)
- If any provision of this Act is declared invalid or unconstitutional, the remaining parts or provisions not affected shall remain in full force and effect.

Repealing Clause (Section 16)
- All laws, presidential decrees, executive orders, rules and regulations, or parts thereof, which are contrary or inconsistent with this Act are hereby repealed, amended or modified accordingly.

Effectivity (Section 17)
- This Act shall take effect immediately upon its publication in a newspaper of general circulation or in the Official Gazette and shall remain in full force and effect during the period of the state of calamity as declared under Proclamation No. 1021 dated September 16, 2020 issued by the President of the Philippines.