Generics medicine law enforcement dismal

SOME people addicted to conspiracy theories are beginning to ask: Did the pharmaceutical lobby insert the generics issue as an apple of discord in the House of Representatives’ Cheaper Medicines Bill?

The issue made the doctors and their Philippine Medical Association so mad that they threatened to go on strike—though they called it a “holiday.”

An amendment to the existing, two-decade old Generics Drug Act—the enforcement of which the Department of Health describes as “dismal”—is preventing the bicameral conference committee of the Philippine Congress from coming up with the unified version of the Cheaper Medicines Act (or if the Senate title is retained, the Quality, Affordable Medicines Act).

President Gloria Arroyo wants to sign it into law as soon as she gets it.

The generics provision is sponsored by Iloilo Congressman Dr. Ferjenel Biron. He is being accused by detractors supporting the pharmaceutical lobby of sponsoring the amendment because he was the top honcho of a leading generic medicine manufacturing company.

The Biron provision would amend the existing Generics Act of 1988 and the Pharmacy Law to require doctors to write only the generic names of drugs in the prescriptions they give their patients.

First in Asia

The Philippines is the first country in Asia to enact a Generics Drug Act. It was the government’s first legislative move to provide greater access to safe and affordable medicine. The Generic Drug Act of 1986 allows the production of unbranded drugs, using the same active ingredients and processes as the ones used in branded drugs, thus bypassing the patent system.

The law makes essential medicines, such as antibiotics, available at lower prices. A provision of the law requires pharmacies and physicians to support lower-priced, unbranded or generic drugs to solve the problem of millions of poor Filipinos unable to buy expensive branded medicines.

After two decades, the consensus among health sector people—and the public—is that the implementation of the landmark Generics Act has been a great disappointment.

Defective law

“Enforcement has not been all that good. In fact, it’s somewhat dismal,” says Health Undersecretary Alexa-nder Padilla. He also says the law itself is defective, because he sees it as bearing the mark of the strong pharmaceutical lobby that insists on the right of doctors to continue prescribing branded medicines.

“While the law compels doctors to issue generic prescriptions,” says Padilla, “it also allows them to continue prescribing the branded equivalent of their choice, the net effect of which has been to nullify generics altogether, “ Padilla explained.

Dr. Eduardo Banzon, a health economist, agrees with Padilla that the Generics Law has suffered from weak enforcement. While consumers are now familiar with the generic names of several popular over-the-counter branded medicine such as Tylenol (paracetamol) and Ponstan (mefenamic acid), he says that most people still do not ask for the generic equivalents. “How we’ve implemented the law hasn’t empowered consumers enough,” he says. “We need to push for it more.”

But can a new Cheaper Medicines Bill really lower the prices of medicine?

The Philippine Medical Association (PMA), the national organization of medical practitioners in all areas of specialization—is at the forefront of the menacing hospital strike threat to fight the Biron provision.

PMA president Dr. Jose Sabili said that the Cheaper Medicine Act is a positive development. But compelling doctors to write only the generic name of medicine they prescribe will put the health and safety of consumers at risk.

The doctors only want to remove Iloilo Congressman Biron’s provision. The passage of the Cheaper Medicines Law is okay by them.

Sabili explains, “The patient-doctor relationship is based on trust. The medicines that we prescribe to our patients are based on careful study of their illness and medical history. Our paramount concern is their safety and we cannot compromise this at all cost.”

In other words, even if a generic medicine is exactly the same as the branded one that comes from the foreign pharma company that they trust, the doctor must not be forced to prescribe the generic.

Sabili contended that this provision “violates the doctors’ rights to protect their patients” and take care of their health.

The Cheaper Medicines Bill has been lauded as a breakthrough that will lead to the lowering of the price of medicines and encourage local drug manufacturers and distributors to market quality and affordable drugs.

Most expensive medicines

The Philippines has the most expensive medicines in Asia, the prices here next only to those in Japan. According to the Philippine International Trading Corporation, the cost of medicine in the country is higher by 40 percent to 180 percent than other Asian countries.

As a result three out of five Filipinos get sick without being able to see a doctor at all. In 2005, Filipinos spending for medicines dropped by 2.2 percent while prices of medicines went up by 10 percent, according to the PITC.

For many Filipinos, buying drugs accounts for as much as 45 percent of the total health expenditures. Such a pattern is not seen in the US where drug expenditure accounts for a much lower 10 percent of health expenditures.

Citing an Asean survey, the PITC says the retail prices of medicine in Indonesia, Malaysia and Thailand are 40 percent to 70 percent lower than in the Philippines. Five out of every nine medicines in the Philippines cost more than in Malaysia or Indonesia. Some, like one brand of antibiotic, cost more in the Philippines than in the United Kingdom or Canada.

Former PITC President Roberto Pagdanganan says generics they are as efficacious and safe as branded medicines. A 2003 study showed that the utilization of generic medicine in Poland was 86 percent; United Kingdom, 60.06 percent; United States, 85.6 percent; Germany, 67.97 percent and Canada, 77.4.

In the Philippines today generics only account for 10 percent to 20 percent of medicine sales.

Under our Generics Law, doctors are required to write the generic name of a drug on the prescription. The branded medicine that they prefer must be written inside a parenthesis.

“People feel that ‘cheap’ generic medication is not going to do them any good so either they buy the expensive stuff or don’t bother to take medication at all,” Pagdanganan pointed out. Based on his experience with the PITC, he said it is not poor quality that makes generic medication cheap, but the add-on costs like marketing.

The PTIC, together with the Department of Health and the Bureau of Food and Drugs, are at the forefront of the government’s thrust to provide Filipinos with affordable medicine. “In order to do that we need to be able to provide them with more products and more venues or stores, as well as an educational campaign that corrects their wrong assumption about ‘cheap’ medication,” he said.

But the pharma companies keep publishing adds subtly suggesting that people must be careful with generic drugs because, who knows, these might be fake or in other ways unsafe?

Generik Botika Inc., a very young and versatile organization addressing the issue of the common people’s lack of access to good medicines, said in a statement: “There are only very few players from manufacturing to distribution in this 120 billion peso industry, where the multinational companies (MNC’s), corner as much as 70 percent of the total market.

The pharmaceutical business grows by no less than 10 percent every year either by price increase or volume. This very lucrative business has been out of sight from local entrepreneurs because of the many myths that haunts the mind of prospecting investors.”

The local price of the leading mefenamic acid product is P21.82 compared to P2.61 in India and P1.38 in Pakistan. (Mefenamic acid under the brand name Ponstan costs P20.98 here, but only P2.80 in India and P1.46 in Pakistan). A 5-mg anti-hypertensive pill costs P44.75 in the Philippines. In South Korea, the same brand costs only P22.25, while in India and Thailand, the pill costs only P5.15 and P29.85, respectively. (an anti-hypertensive pill under the brand name Norvasc costs P44.75 here, but only P6 in India). The top anti-asthma drug sells for P406.75 while India and Thailand sells it for only P83.88 and P230.54, respectively. While a drug against respiratory tract infection costs P17.75 while it only costs in P.51 in India and P4.63 in Thailand.

The Philippine College of Physicians (PCP) echoes the PMA’s concerns. In a statement, PCP said that disallowing doctors to write a brand name will not make medicines cheaper but will rather put their profession at risk because of unqualified and uncontrolled substitution at the pharmacy level. “We urge legislators to recognize that the therapeutic equivalence, palatability and safety differ among the various brands of prescribed drugs,” the statement said.

Source:www.manilatimes.net