SO THINGS haven’t quite turned out as planned for Philippine generic-drug manufacturers and distributors. In fact, says Janet Estrañero, sales and marketing vice president of Pacific Pharmaceutical Generics that is the exclusive distributor of DLI Generics products, it’s all been a big disappointment.
“(The situation) is very, very far from what we expected it to be 18 years after the enactment of the generics law,” she says.
It’s bad enough that Filipinos — doctors included — continue to associate generic medicine with poor quality. Now some generic-drug manufacturers and distributors also say government agencies haven’t been very supportive of them, even if they are nothing less than willing participants in the government’s campaign to make basic medicines affordable.
These generics companies single out the Bureau of Food and Drugs, saying that what the agency calls guidelines to ensure the safety, efficacy, purity, and quality of pharmaceutical products are really “barriers” against local generic medicines.
One of their gripes against BFAD has to do with the agency’s slow pace. Generic-drug makers need to register their products with BFAD as alternatives to off-patent branded medicines. The registration normally takes a year but can extend up to two years.
A few generic-drug companies acknowledge that BFAD’s inadequate manpower may be a factor in the delay. But Estrañero echoes them in pointing out, “Because we’re not like multinational companies, we cannot afford delays in our product registration. A delay is business lost.”
While they wait for the certificate of product registration to be approved, generics manufacturers don’t earn. Yet they still have to sustain their plant, maintain equipment and a minimum skeletal force, and pay salaries. In the meantime, that delay is a plus for the big pharmaceutical firms because they continue to be free from competition.
Several generics companies likewise question the need for bioequivalence studies required of products for registration even when these have already been tried and proven after decades of being in the market.
Bioequivalence tests, conducted to determine the absence of any significant difference in the absorptive capacity of the active ingredient in both generic and brand-name drugs, are rather costly. They amount to hundreds of thousands of pesos — even millions, sometimes — that small players are barely able to afford.
But BFAD Deputy Director Joshua Ramos points out, “(The) quality of generics must be the same as the reference drug. We’re strict about that.”
He says that BFAD is pro-generics and pro-competition. He stresses, however, that certain drugs, particularly those listed under List B Prime of the Philippine National Drug Formulary, need to be tested because of their unstable bioequivalence.
Ramos, though, admits to the tests’ prohibitive costs. But that may cease to be an issue soon; the health department is thinking of creating a competitive market for the tests by institutionalizing the accreditation of laboratories, especially those in colleges and universities.
Recently, too, health secretary Francisco Duque III issued Administrative Order No. 2006-0021 that says drugs that have been registered in other countries no longer have to undergo clinical trials so long as these can be proven to be reputable and have no harmful effect on humans.
Estrañero, a pharmacist, herself says BFAD is duty-bound to uphold quality. Having good manufacturing practices is only wise, she says, especially for the pharmaceutical industry.
Sound marketing tactics also help, she says, and generic-drug makers can take a different path from the big players. Citing her company’s experience, she says a direct distribution approach works — a method that does away with the usual relationship between medical representatives and doctors. According to Estrañero, even other generics companies are saying this is the “right strategy…to maintain the low price of medicines.”