United Laboratories (Unilab), a Filipino-owned pharmaceutical firm, came up with Vidastat, its own version of the anti-cholesterol drug simvastatin, after its patent expired in 2002. Simvastatin was first produced by a drug company in the United States.
Philippine laws allow pharmaceutical firms to produce their own copies of off-patent drugs.
"After we launched our product at a lower price, the prices of other drugs went down by over 50 percent," said James Dio, vice president and general manager of Unilab’s Therapharma.
Dr. Mariano Lopez, Therapharma medical director, told The STAR that while anti-cholesterol drugs do not cure patients with cardiovascular disease (CVD), they prevent the illness from getting worse.
"When you have CVD, you may have to take medication for life. It’s not reversible. Many Filipinos could not afford the drugs — they’ll have to sacrifice a meal for the family — so they prefer to stop taking their medication," he said.
High cholesterol leads to CVD, currently the leading killer disease and the seventh leading cause of morbidity in the Philippines.
Department of Health statistics show that CVD accounts for 74 deaths per 100,000 population.
Dio said there was nothing anomalous about producing their own version of simvastatin because the patent of the original brand has ended.
"We secured a certificate of product registration from the Bureau of Food and Drugs (BFAD)," he said. "It’s done by other companies when the patent of a brand expires. It’s regular practice."
Health Undersecretary for Public Health Enrique Domingo said when a drug goes off-patent, it becomes a "free-for-all formula."
"Actually, 85 to 95 percent of the drugs in the market now are copied from an original patented brand. After a patent has expired, there is no restriction on copying off-patent drugs. It becomes a common thing to do," he said.
Domingo explained that it is a "general phenomenon" that when a formerly patented drug is copied, the prices of similar medications go down.
Domingo said copycat drugs are naturally cheaper because the manufacturer did not spend on researches and clinical trials.
In the Philippines, a patent lasts for 17 years — covering research, development and clinical trials — to allow companies to recover their investment.
Domingo said that while a patent is still in effect, the company that owns the patent can dictate drug prices. He said that manufacturers of patented drugs cannot be blamed for charging high prices because they invested a lot of time and money into their products.
"It is very costly to produce a drug. For one, you’ll spend for research, clinical trials and marketing. You’ll also spend for patenting. The only way for manufacturers to recoup their investment is through their prices," he said.
Many companies in India, on the other hand, make their own versions even while these drugs are still under patent. Cheaper Indian-manufactured versions have been flooding international markets, to the indignation — and financial loss — of the companies that put money into researching and developing these patented drugs.
This has prompted the World Trade Organization to require Indian drug firms to apply international patent standards on their local products by 2005. These standards prohibit Indian manufacturers from copying drugs still under patent.
According to Manolo Escueta, Unilab’s vice president for cooperate affairs, raw materials and technology needed for drug production are not available in the Philippines, making it difficult for local drug companies to come up with their own products.
He said that coming up with new drugs can run into millions of dollars because of the research and trials a company needs to do to determine the efficacy and safety of a drug.
Escueta said Unilab plans to come up with more "off-patent medicines for serious and chronic illnesses from reputable and reliable companies to ensure the efficacy of the medication."