27 SEPTEMBER 2006

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IT'S EASY enough to see, though, what Filipinos are buying at pharmacies: branded medicines, not generics, despite the wide gap in cost. In large part, this is because they are simply following their doctor's orders — as much as their wallets would allow, that is. Comments Ramos: "We place a lot of trust on our doctors. When they write down a brand name, we no longer consider another option."

Many doctors do list down generic names in the prescriptions, but most of them do not encourage patients to consider the generic equivalent of the branded medicine they recommend. According to a 2002 World Bank report, this is true especially among private doctors.

It's Not Easy Being Generic

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." — Alecks P. Pabico

"Generic prescribing in the public sector appears to be the rule rather than the exception," said the report, which looked at the government's generic-drugs promotion. "It is in the private sector where prescribing habits of doctors have hardly changed: only about a third say they would advise generics to their patients."

Blame a particular marketing practice by big drug companies, say some medical personnel. They say that the endorsement of branded medicines in exchange for a whole gamut of favors — dinners, spa treatments, appliances, plane tickets, foreign trips, etc. — from pharmaceuticals remains prevalent especially among the likes of internists and pediatricians who get to see patients fairly regularly and prescribe medication.

"What these doctors are promoting is for people to become more stylish," says an upset Romualdez. "It's like branding in clothes. That's the whole issue of branding in health. In medicine, hindi dapat may branding as it should not be as important as the actual cure."

Yet most of the doctors interviewed for this article say it is really a matter of quality, which they say generics simply lack. One doctor who used to work in public health, for example, says that while he prescribes generics to lower-income families to help them afford the medication, it's a different case when he treats patients with severe illnesses. "It has to be branded, otherwise the patient might die," he says.

A young doctor who trained at the Philippine General Hospital before pursuing private practice also admits to a certain "double standard" in his prescriptions — he does not prescribe generics to his own family. Yet another clinician says that she relies more on the more popular brand since they are already "tried and tested."

But BFAD's Ramos says that going by his agency's laboratory analyses of branded and generics medicines, there is actually not much difference. "The percentage conformity of generic drugs is even higher than that of branded medicines," he says, referring to results of BFAD's tests conducted on drugs submitted to it from January to August this year.

BFAD is the government regulatory agency that ensures the safety, efficacy, and quality of pharmaceutical products, as well as food, cosmetics, and other invasive devices (such as condoms, IUDs, pacemakers, implants, etc.) sold in the country.

Of the 1,235 generic drugs submitted to BFAD between January and August 2006, 1,138 (92 percent) conformed to the agency's standards while 11 (0.89 percent) failed; 81 (seven percent) are still being processed. Among the branded medicines, 3,000 (91 percent) met BFAD standards while eight (0.24 percent) did not; 275 (8 percent) are still being analyzed.

Ramos says any perceived difference in quality between branded and generic drugs is "really more of a marketing strategy to condition the public's mind that generic drugs, because they are cheaper, are inferior in quality."

Last year, a multinational drug company even came out with an ad that had the line "kaduda-duda ang presyo (dubiously priced)." The ad was actually part of an official campaign against fake drugs, but Ramos says it was misleading at the very least since it seemed to imply that a low price tag makes a drug's quality suspect.

Philhealth's Banzon, however, says the credibility problem of generics also stems from government drug procurement fiascos. He says many reports that reach him often involve substandard generics bought by public hospitals, as well as by national and local government units. "The problem might be in the procurement process because government has to buy the cheapest price," he says, hinting at the possibility that the quality of medicines could be sacrificed because of cost considerations.

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