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  • Sep 19, 2014
  • Updated: 6:58am
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REGULATION

Long path in bid for safer food and drugs

A new super-agency to clean up the scandal-hit sectors is seen as encouraging, but experts say the mainland has a lot of catching up to do

PUBLISHED : Monday, 18 November, 2013, 5:25am
UPDATED : Monday, 18 November, 2013, 5:25am

The mainland has a new super-agency to clean up the food and drug sectors, which have been plagued by corruption and safety scandals. But it has a long way to go before it catches up with advanced economies like the United States in food and drug regulations, speakers at a recent conference in Beijing on food and drug laws said.

Timothy Stratford, a partner at US law firm Covington & Burling, cited the case of one of his clients that was building an instant noodle plant on the mainland. It was prevented from opening for six months because tainted raw materials were discovered.

"This is a very serious challenge in China," Stratford said. Shen Weixing, vice-dean of the Tsinghua University law school, said Beijing was strengthening its supervision of food and drugs.

"The Chinese government is putting strong efforts into food safety at a remarkably fast pace. Food packaging regulations in China have strengthened in the past three to four years," said David Ettinger, a lawyer at US law firm Keller and Heckman.

David Acheson, chief executive of the Acheson Group, a US food and drug consultancy, said the government realised following the melamine scandal in 2008 that it had to straighten out food safety.

In 2007, the US Food and Drug Administration (FDA) discovered some food products contaminated with melamine were exported from China. In 2008, the discovery of melamine in baby formula led to a massive recall of product recall on the mainland, with the deaths of at least six children blamed on melamine-tainted milk powder.

"There is no doubt the melamine scandal was a factor in China implementing a food safety law in 2009," said John Chapple, a general manager of Sino Analytica, a mainland-based food testing company.

In August, Beijing halted all milk powder imports from New Zealand after several major drinks and baby formula companies were found to have used products contaminated with bacteria that could cause botulism. In recent months, the Chinese government has launched investigations of foreign drug firms including GlaxoSmithKline and Sanofi for allegedly bribing mainland doctors and hospitals.

With the recent restructuring of government agencies, Beijing is actively revising laws and regulations on food, drugs, medical devices and health supplements, said Yang Chen, a partner at Sidley Austin, an international law firm. "The top priority is safety."

On March 22, the China Food and Drug Administration (CFDA) was established as part of the government's plan to raise food and drug safety standards, said Zhang Qi, head of laws and regulations at CFDA. The new agency replaces the State Food and Drug Administration (SFDA).

CFDA will incorporate the functions of not only SFDA, but also the food production safety functions of the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), and the food distribution safety functions of the State Administration of Industry and Commerce, said Helen Zhang Haixiao, a partner at Zhong Lun, a Chinese law firm. The food import safety functions of AQSIQ will remain in AQSIQ. "There will be more concentrated administrative powers in CFDA," Helen Zhang said.

Yang said the mainland was consolidating into CFDA regulations that used to be scattered over multiple authorities.

"What we are seeing in China is akin to what was happening in the US in the early 20th century, when food safety crises led to the establishment of the FDA," said Laurel West, Asia director of industry and management research at the Economist Intelligence Unit.

Previously, SFDA had 10 departments, but now CFDA has 17 departments, Zhang Qi said. With an increased number of departments, CFDA has a wider range of functions that are more specialised, Zhang Qi said. Other changes include putting the supervision of cosmetics under CFDA, she said. The central government was expected to approve soon a new set of rules that would regulate CFDA's drafting of food and drug regulations in future, Zhang Qi said.

"The main motivation of creating these rules is to raise the standards of our ability to create regulations. The demands of the Chinese government on food and drugs have changed," she added.

Annie Yin, regulatory affairs director of Medtronic, a US medical technology firm, said CFDA had the power to approve some regulations, but more important regulations required approval by higher central government authorities. The agency has the responsibility to draft food and drug laws, but these laws require the central government to pass them, Yin clarified.

"At the moment, CFDA procedures for products are getting more standardised and specific. The situation in China is improving a lot," Yin said.

Since the mainland implemented its food safety law in 2009, it had proved difficult to implement, Chapple said. "There are 240 million farmers and one million food production establishments in China. How do you control them?" he said.

"It is wrong to say China's food safety law is a failure, but it has not gotten where it wanted. What is implemented in Beijing may not be implemented similarly elsewhere. That is why the Chinese government set up CFDA this year, to strengthen food safety," Chapple added.

Yang said the central government had made it a priority to revise the Food Safety Law, which was in the process of being amended. In addition, CFDA is revising regulations on labelling, manufacturing and other aspects of the mainland's food and drug industries, Yang added. There would be increased pricing control through regulations, Yang predicted. However, she was unable to forecast what the new laws would be in future.

"Institutions like CFDA cannot be expected to move up overnight. CFDA is going to take time to build institutional experience and expertise," said Alex Fowkes, vice-president of WuXi AppTec, a pharmaceutical, biopharmaceutical and medical device outsourcing company based in the US and China.

Chen Shaoyu, a partner at Covington & Burling, said the CFDA has 15 lawyers, while the US FDA has more than 100. In overall numbers, the Chinese agency has 375 people, while its US counterpart has more than 10,000 staff.

While the mainland's drug laws were introduced in 1984, US food and drug laws were more than 100 years old and were highly comprehensive, Chen said.

Jonathan Kahan, a partner at international law firm Hogan Lovells, said: "My client companies try hard to prevent corruption and bribery in China, have corruption training sessions, but it is hard to wipe out bribery entirely in China."

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