The call comes years after a Metro Manila tertiary hospital unknowingly administered counterfeit anti-rabies vaccines sourced from an unauthorized distributor during a supply shortage.
More than 1,000 patients had to be traced, reassessed and revaccinated, exposing vulnerabilities in the medicine supply chain and underscoring the consequences of counterfeit and substandard products reaching patients.
Speakers at a recent health forum said the incident demonstrates that ensuring medicines are safe, effective, quality-assured and affordable cannot rest on a single institution but demands a whole-of-government and whole-of-society approach.
Regulatory role
Food and Drug Administration (FDA) director III for policy and planning Services Dr. Irene Florentino-Farinas said the agency's work extends far beyond approving products for sale.
"Every decision made by the FDA ultimately serves one purpose: to ensure that medicines and other health products are available to the Filipino people and that they are safe, effective, and of assured quality," she said in a statement.
Florentino-Farinas explained that the FDA oversees the entire regulatory process, from licensing manufacturers and evaluating product applications to conducting post-market surveillance and enforcing actions against counterfeit and substandard medicines.
"As regulators, our responsibility is to earn and sustain trust through sound science, integrity, and accountable regulatory leadership," she added.
Shared confidence
While regulatory approval is essential, experts said trust in medicines is built through consistent performance in actual clinical use.
"Trust itself cannot be regulated into existence," said Dr. Karl Henson, director of the National Center for Biosafety and Biosecurity at the University of the Philippines Manila National Institutes of Health.
"The government cannot simply instruct clinicians, hospitals, or patients to trust a medicine. Instead, trust is earned when medicines consistently perform as expected, and when systems can detect, investigate, and respond when quality issues arise."
Henson noted that hospitals and healthcare providers depend on the credibility of regulators because they cannot independently test every medicine they procure and administer.
He said protecting patients requires cooperation among regulators, hospitals, physicians, pharmacists, manufacturers, law enforcement agencies and academic institutions to ensure medicines reaching the public are legitimate and quality-assured.
Transparency matters
Ateneo School of Medicine and Public Health associate dean Dr. Roberto C. Tanchangco said physicians also rely on regulators to ensure medicines meet quality standards.
"I am an end-user. I rely on regulators," Tanchangco said, describing regulatory assurance as a relationship built on transparency and accountability.
He warned that without confidence in the system, patients may bypass healthcare professionals and instead purchase medicines online from unverified sources.
To strengthen trust, Tanchangco proposed several reforms, including public access to bioavailability and bioequivalence testing results by brand, manufacturer and batch; greater visibility on enforcement actions against companies that violate quality standards; point-of-sale verification tools for pharmacists and patients; and an annual FDA report written in plain language detailing products tested, quality failures and corresponding enforcement actions.
Quality culture
Representing the pharmaceutical industry, Unilab head of supplier quality management Kathleen Rose Reyes said medicine quality must be embedded throughout the entire production process rather than inspected only after products are manufactured.
"Quality is not a single check in the value chain. Quality starts at the source and goes across the entire value chain," Reyes said.
She explained that manufacturers maintain quality standards from supplier qualification and raw material testing through manufacturing, distribution and post-market monitoring.
"Quality is something we build, regulate, and sustain every single day because behind each product is a patient who trusts that the medicines they take are safe, effective, and reliable," she said.
Collective responsibility
Forum participants said achieving better health outcomes depends on every stakeholder fulfilling its role—from regulators and healthcare providers to pharmaceutical companies, policymakers and patients.
They emphasized that every medicine represents more than a treatment option. It also carries the trust of every Filipino who depends on its safety, quality and effectiveness. —Ed: Corrie S. Narisma
