It is difficult to understand how Sen. Pia Cayetano can declare an all-out war against counterfeit medicine, and at the same time brand the Bureau of Food and Drugs (BFAD) as ineffective in protecting the public against fake drugs, when in fact the Cheaper Medicines Law that she herself co-authored is also partly to blame for the present situation.

And while she is correct in pointing out that manufacturing, distributing, and selling counterfeit medicines are crimes punishable under Republic Act (RA) 8203, or the Special Law on Counterfeit Drugs, perhaps she fails to realize that her own RA 9502, or the Cheaper Medicines Act, creates a loophole relative to direct importation possibly of fake medicine.

In a recent decision involving RA 9502, the Supreme Court ruled that local drugstores could now bypass the local offices of international drug companies as they import medicine directly from abroad. Previously, drugstores could not do so without the prior approval of foreign drug manufacturers’ local offices.

The case stemmed from a complaint of a foreign drug maker against a drugstore owner in Pampanga for directly importing medicines, including a drug still to be registered with the local patent office. The drug maker claimed the drugstore owner violated RA 8203, which prohibited the sale of counterfeit drugs. In line with the complaint, the drugstore was raided by the National Bureau of Investigation and BFAD, and charges were filed against the importer.

Under RA 8203, imported medicine intended for local sale must first be registered by the manufacturer’s local representative with local authorities. In turn, any medicine imported by drugstores without the permission of the local representative, or was not registered with the local patent office, could be alleged as counterfeit.

This rule actually made sense, as it would have given the public greater protection against fake drugs. But in its recent decision, penned by Associate Justice Dante Tinga prior to his retirement, the Supreme Court upheld the direct importation of patented drugs by local drugstores since this was already allowed under RA 9502, notwithstanding penalties imposed for such under RA 8203.

Even the local sales of “unregistered imported drugs” are already tolerated because such are no longer classified as “counterfeit” under RA 9502, the court added. And all for the better, the court said, insisting that the state’s decision to practically liberalize the importation of cheaper medicines from abroad intends to serve public interest.

“The challenged provisions of [RA 8203] apparently proscribe a range of constitutionally permissible behavior. It is laudable that with the passage of RA 9502, the state has reversed course and allowed for a sensible and compassionate approach with respect to the importation of pharmaceutical drugs urgently necessary for the people’s constitutionally recognized right to health,” the court said.

The court said the importation of patented drugs was legally allowed under RA 9502, and that even RA 8203’s prohibition on the sale of “unregistered imported drugs” no longer applied for having been virtually set aside by the newer law. RA 9502 even amended the Intellectual Property Code by allowing third parties such as drugstores to import drugs or medicines whose patents were locally registered by the owner, the court said.

It noted that the implementing rules of RA 9502 actually allowed the importation of unregistered drugs even while there was no express provision under that law. The implied declassification of “unregistered imported drugs” as counterfeit under RA 9502, contrary to provisions of RA 8203, already indicated Congress’ intent to set aside the latter, the court added.

Incidentally, the court decision’s author, Justice Tinga, and RA 9502’s co-author, Senator Cayetano, both come from politically influential families in Taguig. And perhaps as a remedy to a situation that she herself created through her RA 9502, Senator Cayetano is now pushing a bill at the Senate that intends to strengthen the BFAD.

She is even helping raise public awareness on the proliferation and danger of counterfeit medicines, lobbying for the education of barangay health workers in terms of identifying and reporting the sale of fake drugs. But had the Senate been more industrious in crafting RA 9502, perhaps the situation against fake drugs would have been mitigated instead of aggravated.

RA 9502, as the court noted, invariably allowed the importation into the country of any “unregistered” drug or medicine, and this poses a public-health risk, more so if the same lacks not only a local patent but also regulatory approval from BFAD. Moreover, RA 9502 seemingly allows unscrupulous retailers to directly import near-expiry drugs or medicine, albeit cheaply, and pass these off to the public for a bigger profit.

And any ensuing liability or resulting damage from the sale of such near-expiry and possibly less effective if not harmful medicine, both on public health and the drug maker’s image, reputation and business, will all be borne by the drug maker’s local office, not by the unscrupulous importer. Unfortunately for drug makers, the court says RA 9502 allows the importer to do what he wants. That’s medicine import liberalization, thanks to Congress.

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