The government will more closely supervise the process for
setting drug prices in an effort to bring more transparency to the
drug industry.
A regulation published by the National Development and Reform
Commission (NDRC) lays out a five-step procedure for drug pricing
that includes an investigation of production costs, expert
evaluations and public hearings.
The regulation is to take effect on Thursday.
Under the new regulation, at least two drug price regulators are
to be dispatched directly to drug companies to review production
costs. The goal is to further standardize and regulate drug
pricing.
Designated drug price regulators will be strictly prohibited
from cashing in on their investigations or taking gifts of any
sort, such as accepting invitations to banquets or trips abroad,
from drug manufacturers.
The regulation also establishes a five-year work rotation system
to keep drug regulators from becoming too entrenched or familiar
with the people they are supposed to be monitoring.
The regulation also calls for the creation of a pool of experts
to help establish a more scientific review and verification system
for drug pricing. The experts would be selected randomly to ensure
transparency and impartiality.
Drug industry insiders said the move would help restore public
confidence in the country's drug industry, which has been
criticized for its opaque pricing system and the high costs
consumers must bear.
The NDRC has capped the prices of hundreds of drugs to control
the soaring costs and regularly orders price reductions.
Meanwhile, the State Food and Drug Administration (SFDA) has
also waded into the fray, announcing that it had set up a high-risk
drug production supervisory system on Sunday on its website.
By the end of next month, supervisors will be dispatched to
companies that make blood products and vaccines to oversee the
implementation of the Good Manufacturing Practice (GMP)
certification system, which was initiated and pushed forward by the
disgraced former SFDA chief Zheng Xiaoyu, who allegedly abused his
power by taking bribes.
The drug supervisors are to be selected from among local drug
watchdog administrations or their subsidiaries and trained by the
SFDA.
"They have to behave morally and be honest and quite experienced
in drug supervision," the SFDA posting said.
However, the credibility of GMP certification has been called
into question in the wake of repeated health crises caused by
low-quality pharmaceuticals.
The SFDA announced a campaign in January to re-examine drug
companies who had acquired a GMP certificate for registering new
medicines in 2004 and 2005.
(China Daily February 27, 2007)