The poor implementation of safety regulations as well as an apparently cozy relationship between pharmaceutical companies and the BFAD have resulted in the proliferation of substandard drugs in the Philippines, with erring pharmaceutical companies practically getting away with their crime.

(Conclusion)

By MIKE AC-AC and RACHEL ANNE CALABIA

In July 2000, Bureau of Food and Drug (BFAD) director William Torres sent an initial batch of six show-cause orders to different companies for violation of guidelines in the Food, Drugs, Devices, and Cosmetic Act (Republic Act 3720). The companies were directed to submit an explanation in 15 days. According to Torres, this list increased to 12.

But questions were raised that 15 days was too long, given that public safety was at stake. Torres, however, defended the need for due process as well as in allowing the companies to air their side. “The companies should be given a chance to explain. I want to help the local pharmaceutical industry,” he said.

Yet Torres also admitted that some companies use delaying tactics to avoid culpability. While some companies do abide by the BFAD guidelines regarding directives to show cause, recall and destroy “violative” products, not all local manufacturers and importers are willing to admit so without a legal battle. Litigation takes up to a year to settle and, in the past, fines as little as P1,000 would be levied at offenders.

Torres refrained from commenting on the current status of all the companies issued the show-cause orders. According to other sources, San Marino Laboratories and A.M. Europharma settled their cases with the BFAD. Both companies were fined only P21,000 for their violations and the certificate of product registration (CPR) for one San Marino drug was suspended voluntarily by the company.

Meanwhile, a civil case was filed last year by Phil Pharmawealth against officials of the Department of Health (DOH); the case ended in January with a compromise decision handed down by the Pasig Regional Trial Court.

The court ruled that Phil Pharmawealth “could import new batches of the same products included in the violative reports.” The ruling specified that only the defective batch can be removed. Unfortunately for the DOH, all of the defective drugs in question have been consumed or have expired by the time the ruling came out.

Furthermore, on February 7 this year, the suspension of the accreditation of five companies was lifted by Secretary Manuel Dayrit, enabling them to bid again for DOH contracts.

Just like the court ruling, the memorandum stated that the suspension did not extend to the accreditation of their known violative products. In effect, it still allowed companies to bid for a previously known product as long as they would offer a different batch or lot number.

This did not sit well with Dr. Romeo Quijano of the University of the Philippines. “The undue intervention of the court in the DOH decisions pertaining to substandard drug products is detrimental to public health. The judge has no competence to reasonably discern the nature and implications of such decisions. In this particular case cited, I think the ruling of the judge should be challenged at the higher courts. Measures to protect public health should not be undermined by legal technicalities,” he said.

Newly appointed DOH undersecretary for legal affairs Alex Padilla admitted to Ibon Features that there could have been “weaknesses” in the arguments of the BFAD legal office in the Phil Pharmawealth case. In his personal opinion, the BFAD has the authority to withdraw the batch in circulation if one sample is found to be substandard.

Losing Battle

Since the intensified study of violative drugs on the market last year, the BFAD has yet to fully prosecute and shut down any erring manufacturers and importers. The dismal record of the BFAD legal office extends to their inability to supply updates on which companies have been penalized. Further concrete data on violative drugs being recalled by the BFAD has yet to materialize.

To one of the sources who spoke to Ibon Features, these companies deserve nothing less than the death penalty. “It’s equivalent to murder. People should know the significance of substandard drugs, and pharmaceutical companies should be held accountable for their negligence.”

Fe Lanzaderas, one of the five Bohol mothers administered with suspected substandard methylergometrin maleate, said government officials and erring companies should be severely punished. Although she does not have any plans of bearing another child, having six already with husband Diego, the thought that she has lost her uterus — possibly due to a substandard drug — only makes her feel more incomplete.

She is seconded by Diego, who believes that certain people are benefiting by allowing substandard drugs in government hospitals at the expense of poor patients like them. “I’m a religious person who believes that humans can make mistakes. But this case is different. Those responsible for these transgressions deserve strict punishment,” he said.

Dr. Quijano believes both the pharmaceutical company and the government should be held accountable. “If a patient dies as a result of negligence or incompetence by the company or the government regulatory agency, this should be considered a criminal offense, something like homicide through reckless imprudence.”

“Conclusive Finding”

As if to deny allegations that the BFAD is not dealing with the problem, Torres issued Bureau Circular No. 3 dated April 5 regarding “the cancelation of the CPRs, seizure and confiscation of BFAD registered products which do not conform to their registered specifications.”

While the circular itself is a step in the right direction, Torres himself admitted that this served more as a warning to all food, drugs, and cosmetics manufacturers and distributors. Torres added that the circular was not retroactive, meaning that previous substandard drug lists will not be covered.

Part of the circular said: “Due to the seriousness of the violation and to provide immediate protection to the consumers against the hazards of non-registered and/or adulterated products, please take notice that the Certificates of Product Registration previously issued to these products shall be cancelled immediately upon a conclusive finding by this Office of the non-conformance and/or adulteration.” (Emphasis supplied.)

To which Dr. Quijano reacts: “A regulatory agency that is supposed to protect public health should not base its decisions on ‘conclusive finding.’ If it does, it would not be able to fulfill its mandate because ‘conclusive finding’ is rarely available. And if it is, it is usually at post-mortem or after people have already died or been injured.”

He added: “Rules and regulations that are intended to protect public health should be based on the precautionary principle -- that is, whenever there is threat of harm, preventive measures should be undertaken even if there is no ‘conclusive finding’ (scientific proof) that harm has actually occurred. It is sufficient that a reasonable cause for concern exist. This is what is commonly referred to as ‘being on the safe side’.”

While this attempt to prove that the BFAD is working toward the containment of substandard drugs comes at a questionable time, it does not fully address the current crisis of substandard drugs being sold on the market with impunity.

Moreover, it does nothing to educate unsuspecting consumers who are being kept ignorant of the current state of matters that primarily concerns them.

Part One: Substandard Drugs Are Killing Poor Filipinos

Part Two: Substandard Drugs Undermining Generics Law

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