FDA lists 15 more drugs as VAT-free

The Food and Drug Administration (FDA) has added 15 more drugs to the list of essential medicines that are exempted from value-added tax (VAT), making these products more affordable.

Under FDA Advisory No. 2024-1063 signed by its director general Samuel Zacate, the regulatory body endorsed to the Bureau of Internal Revenue to make seven drugs for cancer, five drugs for hypertension, two drugs for mental illness and one drug for high cholesterol to be exempt from the 12-percent VAT.

 For cancer medicines, these are avelumab (200 mg/10 mL); acalabrutinib (100 mg); olaparib (100 mg and 150 mg); trastuzumab (150 mg and 440 mg); and trastuzumab deruxtecan (100 mg).

 Also made VAT-exempt were rosuvastatin (10 mg) used to treat high cholesterol; as well as hypertension medicines olmesartan medoxomil (10 mg); perindopril (5 mg and 10 mg); and indapamide + amlodipine (1.5 mg/10 mg and 1.5 mg/5 mg).

 Also made more affordable were sodium valproate (200 mg/5 mL) and valproic acid (250 mg/5 mL), which are used as treatment for epilepsy and bipolar disorder.

 The FDA, however, moved to remove nine medicines for hypertension, particularly trimetazidine (35 mg) and trimetazidine dihydrochloride (in various dosage strengths) from the VAT-exempt list.

 “The approved indication of the drug products for delisting is intended for symptomatic treatment of stable angina pectoris in patients inadequately controlled or intolerant to first line therapies,” the regulator noted in its justification.

The listed medicine were in addition to the more than 2,000 drugs indicated for the prevention and management of diabetes, hypertension, cancer, high cholesterol, mental illnesses, tuberculosis, and kidney diseases, which were exempted from VAT under Republic Act No. 10963, or the Tax Reform for Acceleration and Inclusion or Train Act, and RA 11534, or the Corporate Recovery and Tax Incentives for Enterprises (Create) Act.

Under BIR rules, the effectivity of the VAT exemption will start on July 18, when the FDA made public the updated list.

A searchable database of all the “VAT-Exempt Health Products” can be accessed at https://verification.fda.gov.ph.

 Currently there are a total of 2,167 VAT-exempt medicines: 660 for cancer; 534 for hypertension; 298 for diabetes; 290 for different mental illnesses; 160 for high cholesterol; 151 for kidney diseases; and 74 for tuberculosis.

 Of these, 58 medicines were endorsed by the FDA since the start of the year.

Under the law, the FDA must provide an updated list 30 days prior to the beginning of every quarter. As such, the FDA shall publish an updated list of VAT-exempt medicines within the months of February, May, August, and November of every year.