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 China wants to crack down on substandard drugs and healthcare as it
seeks to produce more of the drugs consumed in the country and to
build up its pharmaceutical exports. It also has ambitions to
develop cutting-edge drugs to combat major diseases, from cancer to
Ebola.
But in the past two months alone, high-profile scandals concerning a
criminal vaccine ring and experimental cancer treatments have
exposed what Li Guoqing, head of the China Food and Drug
Administration’s (CFDA) drug supervision department, in March
publicly called "dead spaces and blind zones.”
Current and former officials at the CFDA told Reuters the staffing
issues are hampering its ability to police the world's
second-largest drugs market, including the monitoring and testing of
new medicines.
"The brain drain of skilful people definitely impacts the CFDA's
ability to operate, especially for example its ability to evaluate
new drugs," said Cheng Gang, 44, a former CFDA section chief who
left to set up his own drugs company at the end of 2014.
He said senior staff eventually moved on for bigger pay packages at
drug companies, where he said they could earn more than 600,000 yuan
($92,000) a year, versus around 120,000 yuan at the regulator.
One current senior official at the CFDA, who declined to be named
because he is not authorized to speak to the media, told Reuters
some areas like drug supervision and front line enforcers were
particularly hard hit. An analysis by Reuters of professional
websites such as LinkedIn China show that departures have included
section heads and senior enforcement officers.
At the heavily guarded Beijing office block that houses the CFDA's
headquarters, a tightly controlled work environment has done little
to stem the flow of departures. Cheng said staff were not allowed to
go online or even use messaging apps when he was there, though it
could not be ascertained whether that was still the case.
In some ways, the CFDA is a victim of its own progress - those with
regulatory experience are increasingly in high demand in China
partly because drug firms are facing an ever more complex regulatory
environment. They leave the CFDA for multinational companies, local
drugmakers, consultancies and investment firms.
Ge Li, CEO of Shanghai-based drug research firm WuXi AppTec, said
only around a third of drugs approved in the United States have made
it through the approval process in China.
"China wants to set a standard, but it also needs to have the
expertise and the talent," he said.
In a speech earlier this year, CFDA boss Bi Jingquan, put the size
of his drug evaluation center at 130 people, versus 5,000 at the FDA
in the United States.
A third of front line drug evaluation staff have left in the last
three years, he added, moving to a private sector where salaries
could be as much as ten times higher.
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"We have been drained of a lot of our core people," said Bi. The
CFDA is candid about the challenge - it said in a statement to
Reuters that it needs to offer higher salaries and improved status
to deal with the staff shortage.
"Being able to evaluate and approve drugs is what decides the
competitiveness of a country's pharmaceutical market," the watchdog
said.
In his comments in response to the illegal vaccines scandal in
March, the CFDA’s Li was stark in his assessment of the talent
problem. "There aren't even 500 people with the aptitude to inspect
drugs," he said. "Regulatory targets are many, but there are few
people on the ground."
The CFDA declined to provide Bi or Li for interview for this story.
CRACKING DOWN
Since his appointment last year, Bi has sought to shake up
regulation by introducing new policies for drug approvals, tougher
testing for generic drugs and a crackdown on dodgy drug trial data.
Among others, Li Chen, the chief executive of drug development firm
Hua Medicine, said that Bi takes a "no mercy" approach to
regulation.
China's drug exports are rising: they hit 25 billion yuan in 2015,
up almost tenfold from 2002, according to Fitch-owned BMI Research.
These exports are set to hit around 44 billion yuan by 2020, BMI
said.
The staffing crunch, however, raises doubts, over whether China
really can implement and enforce the new rules - raising the risk
that bad corporate behavior will continue, and new drug development
will be held back, even as China's drugs reach more people.
Slow approvals for new drugs are already a bugbear for multinational
firms - despite China's pledges to speed up proceedings. Drugs like
Merck & Co's vaccine for HPV and others to treat hepatitis and
cancer have been waiting for approval for lengthy periods, a number
of years in some cases.
"China's growth and appetite for medicines are growing faster than
its regulatory infrastructure can keep up," said Sophie Cairns,
senior analyst at consultancy IHS Life Sciences.
(Reporting by Adam Jourdan; Additional reporting by SHANGHAI
newsroom and Damir Sagolj in BEIJING; Editing by Clara
Ferreira-Marques and Martin Howell)
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