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Drugs cut cost, but highten the risks

By Shan Juan and Wang Qingyun (China Daily)

Poor cancer patients turning to Indian copies from illegal traders

BEIJING – When Zong Jiujin was diagnosed with leukemia in his senior year at college, his doctor told him only two things could save his life: a bone marrow transplant or Gleevec, an approved cancer drug.
Both are expensive options in China, far too costly for the son of poor farmers from East China’s Jiangsu province.

Yet, as he got up to leave the examination room, the doctor suggested another alternative: unapproved, “generic” cancer medication imported from India. The costs are low but the risks are high.
“My parents could never have afforded the other remedies, so I began to take the Indian drugs,” said Zong, who has been successfully battling his condition since December 2010.

Instead of spending 24,000 yuan ($3,800) a month on Gleevec (or Glivec in some parts of the world), the 24-year-old said he pays a black-market trader just 1,600 yuan for generic copies.

“Another patient introduced me (to an agent),” he explained. “We’ve never met, we just communicate over the phone. The drugs are mailed to my home.”

Although illegal, health experts say there is a huge demand for such services in China, particularly among cancer patients, who are increasing in number at a rapid rate.

Ministry of Health data released ahead of World Cancer Day on Saturday show that there are 2.8 million new cases reported nationwide every year, with the disease killing an annual average of 1.8 million people. Over the past three decades, the mortality rate among cancer patients has soared by 80 percent on the mainland.
“I’ve been consulted about India-made drugs quite a lot by patients,” said Zhu Guangying, a lung specialist and head of radiotherapy at Peking University Cancer Hospital. “I always recommend my patients stay away from them, as without scientific evaluation it is difficult to determine the effect.”
Demand and supply

The wide availability of India’s generic drugs stems largely from patent laws it introduced in 2005, which state that only new compounds developed after 1995 can be protected. This means that many products are recognized as new versions of old treatments.

Jia Ping, a Beijing lawyer who specializes in public health cases, explained that, without intellectual property rights protection, manufacturers of generic drugs can freely copy these medicines and slash the price, sometimes by as much as 90 percent.

Analysis by Medicins sans Frontieres, an international health organization, suggests India now makes one-fifth of the world’s generic drugs, with about 50 percent shipped abroad and sold (often illegally) at a fraction of the cost.

An online sales agent for Bao An Tang, which supplies generic drugs, said the most popular product among Chinese customers were copies of Gleevec, Iressa, Tarceva and Nexavar, which are all used to treat cancer.
“We’ve been doing business for three years,” said Lu, the agent, over the QQ messaging service. “It’s kind of special business, so we only mail drugs and never meet clients in person.”
Lu added that the company sells hundreds of units every month.

The people who market generic drugs in China claim the medication can have the same effect as the expensive originals. However, manufacturers of the approved drugs warn otherwise.

“A number of noted authorities, including the World Health Organization, estimate that drugs purchased on the Internet are more likely to be substandard or counterfeit products,” said Novartis, the Switzerland-based pharmaceuticals company that makes Gleevec, in an e-mail statement. “Counterfeit and poor quality drugs may contain impurities and metabolic products exceeding international standards, which may pose health issues for patients using these medicines.”

In 2010, authorities in Jiangsu’s Huai’an reported that a man diagnosed with lung cancer had suffered adverse reactions after taking an India-made generic copy of Iressa purchased online.

An investigation by the State watchdog found that the drug was produced by a US-trained biochemist identified only as Zhang.

To tackle the problem of illegally imported drugs, the State Council last year launched a special health campaign.

“It mainly aimed at Internet scams in which profiteers promoted and sold fake drugs or those sourced through illegal channels,” said Bian Zhenjia, deputy director of the State Food and Drug Administration, who added that medication designed for long-term use, such as treatments for impotence, diabetes, hypertension and cancer, are major targets for criminals.

In November, public security officials in Guangdong province seized almost 40,000 illegally imported anti-cancer tablets and capsules during a raid on premises being used by an online-drugs seller.

“Drugs were special commodity and should be given special attention in terms of intellectual property rights protection,” Bian said, referring to India’s patent laws.

With research and development on new drugs sometimes taking more than 10 years, patents should be secured, “otherwise counterfeit and substandard drugs will enter the market, threatening public health and delaying treatment”, he added.

Crackdown on crime

Like many people in his position, Zong Jiujin knows the risks of buying generic drugs on the Internet. However, he argues that the more the government cracks down on black-market traders, the fewer options poor people have.

Treatments like Gleevec, which typically cost upwards of 10,000 yuan a month, are not covered by the government-run medical insurance system on the mainland. However, official data shows the average salary of Chinese urbanites in 2011 was about 24,000 yuan, and far less for rural residents.

“If I had the money, I’d definitely buy the legal drug, as it’s more secure,” Zong said. “But (with the crack down) it’s almost like we are being deprived by the government of the right to affordable treatment. Poor patients have no other choice but to buy cheap drugs. If the government wants to crack down, it should at least give us more subsidies.”

Lung specialist Zhu agreed, and added that more local governments should follow the example of Guangdong province, which has started to cover the cost of Iressa for cancer patients who respond well to the medicine.
International watchdogs such as Medicins sans Frontieres say generic competition has dramatically reduced drug costs in some countries. For pharmaceuticals that treat AIDS and tuberculosis, countries such as Brazil, South Africa, India, and Thailand have introduced compulsory licensing systems for domestic drug suppliers, allowing them to better guarantee safety.

However, lawyer Jia Ping said he fears that the drugs market is not currently a priority for authorities in China.
“The decision-makers have varied opinions,” he said. “Some say China has become rich and can afford patent drugs, others say the country should depend on innovation and develop its own drug research.”

Although there is no legal barrier to such a system in China, “no domestic pharmaceutical company has so far applied for compulsory licensing of a foreign patent drug”, he said, adding that Chinese manufacturers had a “relatively poor understanding about World Trade Organization treaties and public health”.

Li Jiancheng, an attorney based in Shandong province, said that, under current law, compulsory licensing of drugs can only be granted in the event of a major public health crisis.

“Conditions like cancer hardly fit that category,” he said.
China Daily



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