The Chinese government has never approved Korean “Botulinum toxin” products to sell in China. That means no Korean drugmakers are officially exporting their botulimum toxins to China. Yet Korean-made Botulinum toxins are being smuggled into China – in tens of millions of dollars.
According to customs statistics released by Korea Customs Service(KSC), even though China has approved no Korean Botulinum toxin products, the quantity of the products’ export to China (HS code 3002093090) has sharply increased. The export of the corresponding HS code drastically rose from $226,000 in 2014 to $4.07million in 2015, $15.8 million in 2016, and $18.2 million in the first five months of this year.
The code is the other customs number which includes toxins other than saxitoxin and ricin, such as toxoid, crypto-toxin, anti-toxin, and Botulinum toxin belongs to this code.
Export to China
However, pharmaceutical industry watchers think Botulinum toxin would account for the most of the shipments made under this other customs code. It means the related products have frequently been smuggled to China.
“Some industry executives know a Korean maker has set one of its –sub-brand Botulinum toxin products as an export brand exclusively for China. Chinese export account for a considerable share of this product’s sales,” an industry insider said.
An official at another botulinum toxin maker agreed, saying, “I can hardly say none of our products are entering into China.”
An official at yet another maker acknowledged part of their products are being sold to Chin but emphasized his company is not directly handing over the volume.
“Our company doesn’t know how sales agents market our products,” the official said. “As botulinum toxin is used for the cosmetic purpose and can’t get medical insurance, we don’t have accurate data. We can only estimate even the domestic market size, and nobody knows it exactly.”
“Because we don’t have data about who sells how much of it to which regions, the industry has doubts about customs data to countries which don’t approve the import of Korean-made products,” he went on to say. “We just presume the amount the volume handed over by our foreign partners.”
These industry officials acknowledge much of their Botulinum toxin products have flown into China but say in unison they do not know how.
The customs data is based on export, and import declarations and customs officials are highly likely to detect unapproved medical products in import clearance processes. And this explains why some think the smuggling of Botulinum toxin to China is being made by wholesalers and peddlers without formal declaration procedures.
"China has tightened regulations, but it is still possible for the peddlers to bring Botulinum toxin into China,” an official at a trading company said. “But they might not declare the import because they don’t go through the official distribution process.”
"Smuggling may be possible through bonded areas or special trading zones,” the official said. “In this case, they may need to use irregular means of bringing them in the form of intermediate goods or bulk to make finished botulinum toxin in China."
He said they often passed the China’s customs service in the form of medical materials.
"Not just botulinum toxin but many other medicines enter the Chinese market in this way,” he said. “As Botulinum toxin is used by dilution, many people can use it with only 1 milliliter or 1 liter of undiluted product. It is possible to bring them into China in bulk and distribute them illegally in individual packages.”
He added there are high demands in China for Korean fillers or Botulinum toxin products, but approval procedures are complicated, so some Chinese companies ask for consulting services to import the products legally.
‘It’s up to the Chinese government to control it’
Korean government officials said they don’t have the legal basis to crack down on unauthorized medicine exports to China.
Botulinum toxin is a biological product designated as “a drug subject to government approval for outbound shipments.” Even if the product had won the U.S. approval, it has to win the approval of the Korean Ministry of Food and Drug Safety (MFDS)식품의약품안전처 through verification to be used in Korea. However, the ministry controls only products for domestic use whether they were made here or imported from abroad.
"Biological drugs should receive governmental approval. But the medical law stipulates the government can approve only products displayed and sold in Korea,” said an official at the Vaccine Examination Division at the ministry. “If a drug isn’t approved by the exporting country, we can’t import it from the country."
The Pharmaceutical Affairs Act stipulates the ministry has to check safety and effectiveness of products used by Koreans, but the outflow of approved drugs is beyond the ministry’s administrative jurisdiction.
Another ministry official agreed. “According to the act, the ministry has no reason for showing interests in the outflows of unapproved medicine and medical supplies,” he said. “The Chinese government has to deal with products used by its people, so we don’t control it or has any basis to manage it.”
KCS said chiefs of customs houses check only items set by each related law and decree. They don’t have to confirm in the process whether a medical product has won the other country’s approval or not.
"China has to manage whether a product can or cannot clear its customs houses, according to its laws and regulations,” said an official at the Clearance and Planning Division of KCS. “A product can be shipped abroad if it is legal under the Korean procedure. It is common sense that if a product was not approved by the exporting country, it would not clear the customs of an importing country. Why send products that will be destroyed?”
Customs clearance of biological drugs, including toxins, is subject to not only governmental approvals but is applied by laws on banning chemical and biological weapons and manufacturing and trading specific chemical materials and biotic agents. Even this law, however, excludes products used for “prevention and treatment of diseases and other peaceful purposes” from biological weapons.
This notwithstanding, the distribution of Botulinum toxin, which can prove lethal for human lives when they don’t undergo refinement process, through these loopholes of national controls, needs to be rectified, government and business officials say.
The long-term smuggling of unapproved Korean medical products to China can have adverse effects on the trustworthiness of Korean products in China, which has emerged as one of fastest growing markets in the world, they say.