Senate President Vicente Sotto III is seeking to authorize the President of the Philippines to assume liabilities that may arise from the government's COVID-19 immunization program.
Sotto on Tuesday, February 16, filed his version of a vaccine indemnification bill that proposes the grant of an authority to the President to take responsibility for any and all liabilities to be incurred by vaccine manufacturers and their suppliers in relation to the administration of their products.
"This bill seeks to enact in one law the grant of authority to the President of the Philippines to assume, for and in behalf of the National Government, such liabilities which may arise from the administration of vaccine," the Senate leader said in the bill's explanatory note.
The Senate has started plenary debates on the Senate Bill No. 2057, or proposed "COVID-19 Vaccination Program Act", which includes a P500-million indemnity fund for those who will suffer adverse effects following their immunization.
Under Sotto's bill, the President would be authorized to assume liability for all liabilities arising from the vaccination, except if the damage or injury is due to:
a. Breach of Good Manufacturing (as applied as applied at the time of manufacture) before certification of batch-release of the vaccine for export, leading to a Quality Defect in the vaccine; or
b. Willful Misconduct of the manufacturer relating to the development, manufacture, use or administration of the Vaccine.
The bill defines "quality defect" as "a product quality defect resulting in an adverse impact on human health where the vaccine no longer possesses the quality attributes for it to be considered fit for its intended medical use, according to the product quality specifications and requirements of the marketing authorisation or the terms of the WHO pre-qualification procedure, having particular regard to the main principles described in the WHO guidelines on good manufacturing practices for pharmaceutical products."
The claim of the indemnification for serious adverse effect must be filed within one year from the day of the inoculation.
An adverse effect is considered "serious" if it results in death; or is life-threatening; requires hospitalization; results in disability or incapacity; or requires intervention to prevent permanent impairment or damage.
The indemnification covers the payment of medical expenses and lost wages, said the bill.
Unlike the SB 2057 that places the indemnity fund under the Philippine Health Insurance Corporation, Sotto's bill proposes to designate the Department of Finance, specifically its Secretary, as the fund manager in charge of all the disbursements.
In pushing for his proposal, Sotto noted of the "heightened fear" of the public on the possible adverse effects of the vaccines.
But he said this is "only half of the problem", saying that it is "equally important" to meet the requirements of vaccine makers not to hold them responsible for their products.