FOR nearly four decades since the passage of the Generics Law in 1988, the conversation on medicines has always revolved around affordability. Policymakers pushed for wider access, doctors sought cheaper treatment options, and pharmacies filled their shelves with lower-cost alternatives.
But as the pharmaceutical market grows more complex, a new conversation is emerging: price alone is not enough. What ultimately sustains public health is trust.
That theme surfaced sharply during a recent Senate Committee on Health and Demography hearing chaired by Senator Risa Hontiveros. Lawmakers confronted the growing risks posed by counterfeit and unregulated health products, particularly those proliferating through online platforms. The hearing exposed a sobering reality: the country’s regulatory manpower is dwarfed by the scale of the market.
According to data presented, the Food and Drug Administration (FDA) has only 250 evaluators to process some 254,000 pre-market applications annually. On the enforcement side, fewer than 300 field officers are tasked with monitoring tens of thousands of pharmacies, hospitals, diagnostic labs, and cosmetic outlets across the archipelago. The mismatch between regulatory capacity and market volume has become a critical fault line in public confidence.
Modernizing enforcement
Last year, Paolo S. Teston took over as Director General of the FDA with a mandate to restore public trust and modernize regulatory enforcement. He faced stern scrutiny at the Senate's budget hearing earlier this year from Senator Raffy Tulfo who challenged him to resign. He replied by saying he was assigned to solve the issues at hand.
To his credit, in his first year, Teston suspended new FDA fees to ease industry burdens, launched transparency tools such as the FDA Verification Portal and e-Sumbong platform, and initiated nationwide compliance checks to protect consumers from counterfeit products. He also forged international cooperation with Japan’s PMDA to strengthen science-based regulatory reliance, while pledging to cut approval timelines from 120 days to as little as 30–60 days.
For Teston, rebuilding confidence in the FDA means balancing speed with vigilance, ensuring that medicines reaching Filipino patients are not only affordable but consistently safe and effective.
Doctors’ warning
Doctors warn of the clinical consequences when counterfeit or unregistered medicines slip through the cracks. Maricar Limpin, former president of the Philippine College of Physicians, has cautioned against compounded versions of popular drugs sold online, citing risks of “incorrect dosing, inconsistent potency, and contamination.” Maria Minerva Calimag, past president of the Philippine Medical Association, has likewise emphasized that “substandard medicines prolong illness and erode patient trust in the health system,” underscoring the need for stronger pharmacovigilance.
Pharmacists, often the first point of contact for patients, echo these concerns. Yolanda Robles, former dean of the UP College of Pharmacy, explained that “patients may choose a medicine based on price, but they trust it based on the outcome.” She emphasized that pharmacists’ role has expanded beyond dispensing drugs to ensuring medication safety, educating patients, and spotting suspicious products. In her view, strict enforcement and public awareness are essential to preserving trust.
Industry insiders stress that quality is determined long before medicines reach pharmacy shelves. Manufacturing is not witnessed nor can it be monitored extensively by the FDA from medicines imported from abroad.
Local manufacturing advantageLocally manufactured pharmaceuticals can be inspected and monitored on ground level. On the manufacturing floor, raw materials undergo chemical verification, batch production is governed by software systems, and laboratories enforce strict quality assurance standards. Stabilization procedures ensure that products survive tropical transit without degradation.
However, patients cannot inspect these processes themselves. Their confidence rests entirely on the assumption that regulators are effectively policing the supply chain.
The stakes are rising as the Philippines accelerates its universal healthcare rollout. Access without quality guarantees, experts warn, is a hollow metric. A substandard medicine can prolong illness, drain household savings, and erode faith in the healthcare system. In a globalized supply chain where raw materials may originate in India, encapsulation in China, packaging in Europe, and distribution through regional hubs, local regulators must balance speed with vigilance.
Digital complexity
Digital commerce adds another layer of complexity. Online storefronts have opened efficient distribution channels for legitimate businesses, but they also provide entry points for counterfeit and unregistered products. Regulators now face the challenge of extending enforcement into cyberspace — a frontier where market integrity is increasingly tested.
For pharmaceutical companies, counterfeiting is not just a compliance issue; it is an existential threat. Markets function only when buyers trust the goods they purchase. Once that trust erodes, uncertainty spreads across the ecosystem — from manufacturers and distributors to doctors and patients.
Affordability remains vital in a country where out-of-pocket medical expenses strain household budgets. But the true value of a medicine lies in its clinical efficacy — its ability to reliably deliver the health outcome it promises. That outcome depends on unseen infrastructures: the discipline of laboratory technicians, the integrity of manufacturing plants, and the political will of institutions to enforce quality standards without compromise.