[REPUBLIC ACT NO. 11525]

Republic of the Philippines Congress of the Philippines Metro Manila Eighteenth Congress Second Regular Session Begun and held in Metro Manila, on Monday, the twenty-seventh day of July, two thousand twenty.

AN ACT ESTABLISHING THE CORONAVIRUS DISEASE 2019 (COVID-19) VACCINATION PROGRAM EXPEDITING THE VACCINE PROCUREMENT AND ADMINISTRATION PROCESS, PROVIDING 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 and cited as “COVID-19 Vaccination Program Act of 2021”.

SEC. 2. Declaration of Policy. – It is hereby declared the policy of the State to adopt an integrated approach to health development which shall endeavor to make essential social services available to all people at an affordable cost. For this reason, the State shall undertake a COVID-19 Vaccination Program with the following objectives:

(a)

Address the adverse impact of COVID-19 through the procurement and administration of safe and effective COVID-19 vaccines by the National Government through the Department of Health (DOH) and the National Task Force Against COVID-19 (NTF), and other duly constituted authorities and instrumentalities;

(b)

Source and procure through the DOH and the NTF, either through themselves jointly or in cooperation with any national government agency or instrumentality or local government unit (LGU), safe and effective COVID-19 vaccines;

(c)

Recognize the experimental nature of COVID-19 vaccines available in the market and compensate any serious adverse effects (SAEs) arising from the use of COVID-19 vaccine, experienced by people inoculated through the COVID-19 Vaccination Program; and

(d)

Creation of a COVID-19 National Vaccine Indemnity Fund to be administered by the Philippine Health Insurance Corporation (PhilHealth) to compensate persons encountering SAE pursuant to the preceding paragraph.

SEC. 3. Procurement of COVID-19 Vaccines and Ancillary Supplies and Services. - Notwithstanding any law to the contrary, the DOH and the NTF, either through themselves jointly or in cooperation with any national government agency or instrumentality or LGU, are authorized to procure COVID-19 vaccines, including ancillary supplies and services necessary for their storage, transport, deployment, and administration through Negotiated Procurement under Emergency Cases pursuant to Section 53(b) of Republic Act No. 9184 and Section 53.2 of the 2016 Revised Implementing Rules and Regulations of Republic Act No. 9184: Provided, That in the procurement of COVID-19 vaccines, the DOH and the NTF shall be authorized to negotiate and approve the terms and conditions thereof in behalf of LGUs and other Procuring Entities including, but not limited to, the price and payment terms, making sure that there is price uniformity and to prevent price competition: Provided, further, That after the negotiations by the DOH and the NTF, the LGUs and other Procuring Entities are authorized to enter into supply agreement, advance market commitment, advance payment, research investment, purchase order or any similar

arrangements or other requirements as may be identified by the DOH and the NTF. Provided, finally, That an LGU is authorized to directly procure ancillary supplies and services necessary for the storage, transport, deployment, and administration of COVID-19 vaccines through negotiated procurement under emergency cases prescribed under this section.

Section 338 of Republic Act No. 7160, as amended, otherwise known as the "Local Government Code of 1991", Section 88 of Presidential Decree No. 1445, as amended, otherwise known as the "Government Auditing Code of the Philippines", and any law to the contrary notwithstanding, provinces, cities and municipalities may advance payment if required by the supplier, manufacturer, or distributor: Provided, That the authority to make advance payment shall be for the procurement of COVID-19 vaccines and to secure other goods and services necessary for their storage, transport, deployment, and administration: Provided, further, That the deployment of vaccines in every province, city and municipality must be in accordance with the criteria set by the Interim National Immunization Technical Advisory Group (NITAG): Provided, finally, That this section shall have retroactive application from January 1, 2021.

SEC. 4. Procurement and Administration of COVID-19 Vaccines and Ancillary Supplies and Services by Local Government Units. – Provinces, cities and municipalities may procure only in cooperation with the DOH and the NTF through a multiparty agreement, which shall include the DOH and the relevant suppliers of COVID-19 vaccines: Provided, That these LGUs shall procure no more than seventy-five percent (75%) of their target population for vaccination: Provided, further, That the seventy-five percent (75%) cap may be adjusted by the Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF-EID) when there is sufficient supply of vaccines as determined by DOH and the NTF: Provided, furthermore, That the provision on advance payment as provided in the preceding section shall also apply to procurement of COVID-19 vaccines and ancillary supplies and services: Provided, however, That LGUs may directly accept donations of FDA-authorized and cleared COVID-19 vaccines, subject to the guidelines and reportorial

requirements of the DOH and the NTF: Provided, finally, That this section shall have retroactive application from January 1, 2021. If the procurement of vaccine is funded by the National Government, the LGU shall comply with the science and evidence-based terms and conditions of deployment, prioritizing the needs of the following groups: healthcare workers; senior citizens; persons with comorbidities; frontline personnel in essential services, including uniformed personnel and teachers; and indigent population: Provided, That an LGU is authorized to directly procure ancillary supplies and services necessary for the storage, transport, deployment, and administration of COVID-19 vaccines through negotiated procurement under emergency cases prescribed under this section. For LGU-funded vaccines, the inoculation order must, at all times, be science and evidence-based, prioritizing the needs of the following special groups: frontline workers in health facilities, senior citizens, and indigent persons: Provided, That the local health officials shall be allowed to formulate their procedures in accordance with the national policies and procedures issued by the DOH if it will expedite and enhance the efficiency of the inoculation process and prevent the spoilage of vaccines. To ensure transparency, the LGUs shall also submit to the DOH a masterlist of the names and profiles of the residents who were vaccinated under the COVID-19 Vaccination Program, subject to the provisions of the Data Privacy Act.

SEC. 5. Procurement and Administration of COVID-19 Vaccines by Private Entities. – Private entities may procure COVID-19 vaccines only in cooperation with the DOH and the NTF through a multiparty agreement, which shall include the DOH and the relevant supplier of COVID-19 vaccine. Any such vaccines, supplies or services procured by private entities shall be for the sole and exclusive use of such companies, without prejudice to the multiparty agreement: Provided, That priority in the inoculation shall be given to its healthcare workers, senior citizens, economic frontliners, and essential workers: Provided, further, That the chief medical officers of private entities shall be allowed to formulate their own vaccine

recipient list and implement their own operational procedures in accordance with the national policies and procedures issued by the DOH if it will expedite and enhance the efficiency of the inoculation process and prevent the spoilage of vaccines: Provided, finally, That this section shall have retroactive application from November 1, 2020. With respect to international humanitarian organizations, such as the Red Cross movement, particularly the Philippine Red Cross, a voluntary, independent and autonomous nongovernmental society auxiliary to the authorities of the Republic of the Philippines in the humanitarian field, as set forth in Republic Act No. 10072, known as the "Philippine Red Cross Act of 2009", may procure COVID-19 vaccines: Provided, That the vaccines procured shall be for the use of individuals consistent with the priority list set, wherein for every one vaccine bought one vaccine shall be donated to the vulnerable and indigent. The DOH, NTF, LGUs and private entities procuring COVID-19 vaccines may partner with the Philippine Red Cross in the administration or distribution and inoculation of the vaccines.

SEC. 6. Transparency and Accountability in COVID-19 Vaccine Procurement. — The National Government, as well as LGUs, private entities and the Philippine Red Cross, may only procure COVID-19 vaccines that are registered with the Philippine Food and Drug Administration (FDA) as evidenced by a valid Certificate of Product Registration or which possess an Emergency Use Authorization (EUA). For purposes of transparency, the following information shall be posted in a conspicuous place of the Procuring Entity and the Government Procurement Policy Board (GPPB) Online Portal within thirty (30) days after award or execution of definitive agreement or after the effectivity of this Act, whichever is applicable:

(a)

Approved budget for the contract;

(b)

Name and details of the COVID-19 vaccine or ancillary service or supplies;

SEC. 7. Authority to Make Recommendations Based on Preliminary Data from Phase III Clinical Trials. – Notwithstanding any law to the contrary, 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 World Health Organization recommendations, in the absence of completed Phase III and Phase IV clinical trials: Provided, That the COVID-19 vaccine manufacturer has been issued an EUA by the FDA: Provided, further, That the authority granted to the HTAC herein shall only be valid for as long as the EUA issued by the FDA is in effect, such that in the event of revocation or cancellation thereof by the FDA Director General, the HTA process shall be terminated regardless of stage, and if it has been completed, the results shall be set aside.

SEC. 8. Immunity from Liability. – Notwithstanding any law to the contrary, public officials and employees, contractors, manufacturers, volunteers, and representatives of duly authorized private entities who are duly authorized to carry out and are actually carrying out the COVID-19 Vaccination Program shall be immune from suit and liability under Philippine laws with respect to all claims arising out of, related to, or resulting from the administration or use of a COVID-19 vaccine under the COVID-19 Vaccination Program except arising from willful misconduct and gross negligence.

SEC. 9. Pharmacists and Midwives as Vaccinators. – Notwithstanding the provisions of Section 4(g) of Republic Act No. 10918, otherwise known as the “Philippine Pharmacy Act”, and Section 23 of Republic Act No. 7392, otherwise known as the “Philippine Midwifery Act of 1992”, and in furtherance of the COVID-19 Vaccination Program, licensed pharmacists and midwives who are duly trained by the DOH may administer COVID-19 vaccines that are registered with the FDA or which possess an EUA.

SEC. 10. COVID-19 National Vaccine Indemnity Fund. – The COVID-19 National Vaccine Indemnity Fund, which shall be administered by the PhilHealth, is hereby established.

as a trust fund to compensate any person inoculated through the COVID-19 Vaccination Program, in case of death, permanent disability or hospital confinement for any SAEs; Provided, That in case of death and permanent disability, PhilHealth is hereby authorized to pay compensation from the indemnity fund. The amount of Five hundred million pesos (P500,000,000.00) is hereby authorized to augment the funds of PhilHealth for this purpose which shall be sourced from the Contingent Fund, as provided under Republic Act No. 11518 or the General Appropriations Act of 2021. The indemnity fund shall be valid and available for release and disbursement until terminated by the President of the Philippines, based on the recommendation of the Permanent Committee, which was created under Executive Order No. 292, s. 1987, that the purpose for which it has been established has been fulfilled. The Permanent Committee shall also determine the amount that shall revert to the National Treasury upon its termination. The PhilHealth, in consultation with DOH, the Department of Finance, the Department of Budget and Management and the NTF, shall issue the necessary guidelines for the planning, administration, and monitoring of the utilization of the fund, including the determination of its sufficiency. For this purpose, the IATF-EID shall establish a Special Task Group composed of medical and vaccine experts with proven track record who will be in charge of monitoring the probable adverse effects following immunization from COVID-19. The Special Task Group shall promulgate the necessary guidelines on the monitoring, evaluation, investigation and reporting mechanism to be followed by all LGUs: Provided, That this section shall be valid and in effect for a period of five (5) years from the effectivity of this Act or until the government has declared the completion of the COVID-19 Vaccination Program, whichever comes earlier.

SEC. 11. Exemption from Import Duties, Taxes and Other Fees for the Procurement, Deployment and Administration of COVID-19 Vaccines. – 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 or any of its political subdivisions and by private entities shall be exempt from customs duties, value-added tax, excise tax, donor's tax, and other fees: Provided, That the vaccines shall not be intended for resale or other commercial use and shall be distributed without consideration from persons to be vaccinated.

SEC. 12. COVID-19 Vaccine Card. — Subject to the provisions of Republic Act No. 10173 or the "Data Privacy Act of 2012", the DOH shall issue a vaccine card to all persons vaccinated. To fast track the process, the DOH may delegate the processing and issuance of vaccine cards to LGUs and private entities, subject to guidelines to be promulgated by the DOH. The vaccine card shall contain the following:

(a)

Basic personal information such as full name, present and/or permanent address, and birthdate;

(b)

Manufacturer, brand name, and batch number or other identifier of the COVID-19 vaccine;

(c)

Date of vaccination;

(d)

Name of the hospital, health center, or health facility where the vaccine was received;

(e)

Name, signature, and license number of the duly licensed physician, nurse or other health worker administering the vaccine;

(f)

Date of the last RT-PCR testing and the name of the laboratory that conducted the last RT-PCR testing, if applicable; and

(g)

Such other information which may be determined as necessary by the Secretary of Health or the IATF-EID in line with the declared policy of this Act. The issuance of a vaccine card is intended to be digital, but shall remain accessible through other means such as printed cards. The DOH, through the Department of Information and Communications Technology, shall develop the LGU-based digital systems and applications that will meet the objectives of the COVID-19 Vaccination Program while maintaining quality, safety, ease of use, and accessibility for all Filipinos: Provided, That the DOH shall maintain a central database of vaccinations, and mandate a uniform format for the vaccine card, the contents of which shall be updated accordingly to always conform with globally accepted standards: Provided, further, That the vaccine cards shall not be considered as an additional mandatory requirement for educational, employment and other similar government transaction purposes. Individuals vaccinated against COVID-19 as indicated in the vaccine card shall not be considered immune from COVID-19, unless otherwise declared by the DOH based on reliable scientific evidence and consensus. No fees shall be collected for the issuance, amendment, or replacement of a vaccine card. The amount needed for the initial implementation shall be charged against available funds for the purpose. Thereafter, such sums as may be necessary for its continued implementation shall be included in the annual General Appropriations Act. The falsification of a vaccine card shall be punishable under Act No. 3185, as amended, otherwise known as "The Revised Penal Code".

SEC. 13. Reportorial Requirement and Creation of an Oversight Committee. - Upon the effectivity of this Act, the Vaccine Czar, the DOH and the IATF-EID shall submit a monthly report to Congress on the implementation of the COVID-19 Vaccination Program which shall include agreements made by Procuring Entities pursuant to this Act, date of the delivery, storage and deployment of vaccines, the number of persons inoculated, and other relevant information as may be required by Congress.

For this purpose, Congress shall establish a Joint Congressional Oversight Committee composed of four (4) Members of each House to be appointed by the Senate President and the House Speaker, respectively. The Committee shall determine whether the implementation of the COVID-19 Vaccination Program conforms with the provisions of this Act.

SEC. 14. Implementing Rules and Regulations. – Within five (5) days from the effectivity of this Act, the DOH, the NTF and the GPPB shall, with prior consultation with the Department of the Interior and Local Government, the IATF-EID and other stakeholders, issue guidelines and applicable procurement rules, as may be necessary, for the effective implementation of this Act.

The non-promulgation of the rules and regulations provided under this section shall not prevent the immediate implementation of this Act upon its effectivity.

SEC. 15. Separability Clause. – If for any reason, any provision of this Act is declared invalid or unconstitutional, the remaining parts or provisions not affected shall remain in full force and effect.

SEC. 16. Repealing Clause. – 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.

SEC. 17. Effectivity. – 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.

Approved, LORD ALLAN JAY Q. VELASCO Speaker of the House of Representatives VICENTE C. SOTTO III President of the Senate This Act was passed by the Senate of the Philippines as Senate Bill No. 2057 on February 23, 2021 and adopted by the House of Representatives as an amendment to House Bill No. 8648 on February 23, 2021. Approved: FEB 26 2021 RODRIGO ROA DUTERTE President of the Philippines