Question & AnswerQ&A (Republic Act No. 8203)
The official title of Republic Act No. 8203 is the "Special Law on Counterfeit Drugs."
The policy of the State is to protect and promote the right to health of the people, instill health consciousness among them, and provide protection against counterfeit drugs.
Drugs refer to any chemical compound or biological substance, other than food, intended for use in the treatment, prevention, or diagnosis of disease in humans or animals, including recognized articles in pharmacopeias and herbal or traditional drugs meeting specific criteria.
A counterfeit drug is a medicinal product with correct, wrong, insufficient, or no active ingredients leading to reduced safety, efficacy, or quality, deliberately mislabeled regarding identity or source, bearing fake packaging, unauthorized trademark use, unregistered importation (except for personal use), or less than 80% of supposed active ingredient.
Prohibited acts include manufacturing, selling, distributing, brokering, importing, or possessing counterfeit drugs; forging or using unauthorized marks or labels; photocopying or altering approved labels; and making or selling equipment to reproduce trademarks without authority.
Liable parties include manufacturers, exporters, importers and their agents (with knowledge), sellers, distributors, brokers, possessors of counterfeit drugs, managers and owners of establishments where counterfeit drugs are found, registered pharmacists who dispense such drugs with knowledge, and corporate officers inducing or allowing violations.
The Bureau can segregate, seal, and seize counterfeit drugs with a search warrant, order preventive closure of establishments for up to 30 days, initiate administrative proceedings, and enlist law enforcement assistance.
Sanctions include permanent closure and revocation of licenses, fines between 100,000 to 500,000 pesos, forfeiture and destruction of counterfeit products and related equipment, professional license cancellation for pharmacists, filing of criminal charges, and permanent disqualification from owning or operating supervised establishments.
Possession of counterfeit drugs as provided in Section 4(b) is punishable by imprisonment from six months and one day to six years. Other violations may lead to imprisonment from six years and one day to ten years, fines up to 500,000 pesos, or both.
Life imprisonment and a fine ranging from 500,000 pesos to 5 million pesos are imposed when a counterfeit drug is the proximate cause of death of an unsuspecting victim.
The Bureau of Food and Drugs (BFAD) of the Department of Health is authorized to administer and supervise the implementation of this Act.
They take effect thirty (30) days after publication in two national newspapers, following promulgation within ninety (90) days of the Act's approval.
The presence of counterfeit drugs within premises engaged in drug sale, manufacture, or distribution, or in unlicensed premises, vehicles, or private residences, constitutes prima facie evidence of a violation, except for legitimate trademark owners who comply with reporting and turnover requirements.
A possessor is excepted from liability if they can present sales invoices, receipts, or legally acceptable documents proving purchase from licensed sellers or show import/export certificates, and if the drugs do not bear markings to arouse suspicion and are in quantities consistent with personal use, supported by medical records.