Rule to exempt unapproved drugs that are imported in tiny amounts

Drugs legally available overseas but unapproved by Chinese drug authorities will no longer be deemed fake drugs, according to a revised law passed by China's top legislature on Monday.

Importing "a little amount" of such drugs for use that does not cause health damage or interfere with treatment for patients can be exempt from legal consequences, according to the revised Drug Administration Law, approved by the National People's Congress Standing Committee.

However, in general, companies importing drugs without approval still face serious legal consequences, including revocation of business permits and fines of up to 30 times the value of the imported drugs, according to the law, which will take effect on Dec 1.

According to the existing law, unapproved drugs, whether they are effective or not, are classified as fake medicine. Selling such drugs may result in a prison sentence of up to three years, even if there are no serious consequences, with harsher penalties possible in cases of serious consequences, such as death.

Yuan Jie, director for the administrative law department of the Legislative Affairs Commission under the NPC Standing Committee, said the revision is "a response to public concern".

"However, approval is still needed first before importing medicine," she said. "Importing or selling fake or substandard drugs will still lead to severe punishment."

Many effective drugs used for serious diseases that are already available overseas have not gained domestic approval and are not available on the domestic market, resulting in many patients buying such drugs from overseas or through dealers engaged in legal risks.

A popular movie screened last year, Dying to Survive, based on a real event, stirred heated public debate through its story of a group of leukemia patients whose survival depended on a drug from India that was not approved in China.

Lu Yong, a businessman and leukemia patient from Wuxi, Jiangsu province, was detained for selling fake drugs after buying a generic version of a leukemia drug from India and selling it to patients for less than one-10th the patented original. He was later released after prosecutors withdrew the charges following the petition of more than 300 patients who purchased the copycat drug from Lu because they could not afford the patent drug.

Zhao Peng, associate professor and vice-president of the School of Law-based Government, under the China University of Political Science and Law, in Beijing, said the revision shows progress.

"It's too strict to consider all overseas drugs that are not domestically approved as fake drugs, which entail criminal punishment for selling them even if they have caused no health damage," he said, adding it is necessary for drug authorities in any country to approve drugs before they can be available in the domestic market.

"Businesses are not allowed to import drugs without approval, according to the law," he said. "But for individuals, especially for patients whose lives are at stake, legal regulation should not be too tough, and they should have the right to try unapproved drugs to save lives. The revision can ensure that right."

Further details are needed to define the amount of such drugs allowed to be imported by individuals to help law enforcement, Zhao said.