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Protecting drug developers
By Xiao Xin (China Daily)
Updated: 2004-05-31 09:07
China is strengthening co-operation with foreign drug manufacturers to
promote intellectual property rights protection for medicines.
A recent move is the co-operation between Shanghai Municipal Food and Drug
Administration and US-based Pfizer Inc, one of the world's largest
pharmaceutical companies.
According to sources with the municipal administration, Pfizer will
co-operate with government officials to detect and shut down bogus drug
manufacturers.
In April and May, Chinese authorities co-operated with several transnational
drug makers, including US-based Eli Lilly and Pfizer, UK-based GlaxoSmithKline
and Germany-based Bayer in conducting seven operations and seizing drugs worth
an estimated US$8 million.
"China has paid great attention to the war on counterfeit drugs," said Zheng
Xiaoyu, head of the State Food and Drug Administration, at a recent news
conference in Beijing.
Statistics indicate 994 fake drug manufacturers and distributors were ordered
to cease operations last year, with counterfeit drugs and facilities worth 496
million yuan (US$60 million) seized.
A total of 276 cases were transferred to the judicial system and 48 people
received criminal penalties. In addition, 217 registration certificates for
medical devices and 134 manufacturing licences for medical devices were revoked.
The World Health Organization carried out an assessment on drug regulatory
capacities in China last September and concluded the country has an independent
regulatory system and relatively comprehensive legal system.
Patent drug protection
Besides all the actions fighting fake drugs, the country has been building a
drug Intellectual Property Rights (IPR) protection system.
"Promoting drug IPR protection can encourage innovation and research on new
drugs, strengthen supervision over medicines, regulate the market and ensure
people's safety," said Zhang Qingkui, director general of the Pharmaceutical and
Biological Invention Examination Department at the State Intellectual Property
Office.
The Patent Law, first enacted in 1985 and revised in 1992, plays an important
role in the system.
"The revised law, which came into force in 1993, signalled a huge step
forward," said Zhang.
According to the Patent Law, all pharmaceutical inventions can apply for
patent protection since 1993 and drugs can enjoy 20 years' patent protection.
Previously only inventions during the medicine's preparation process and
medical apparatus and instruments were eligible to apply for patent rights.
The change came in 1992 when China held IPR talks with the United States.
To provide a fair trade environment, China agreed to revise the Patent Law
and grant protection to pharmaceutical inventions.
The revised law deleted the provision that no patent right shall be granted
for pharmaceutical products and substances obtained by means of a chemical
process.
The revision on the Patent Law led to a rush of patent applications in the
pharmaceutical manufacturing industry.
Incomplete statistics show the Patent Office under the State Intellectual
Property Office received 2,415 applications for drug patent protection in 1993,
an increase of 91 per cent over the previous year.
Before 1993, the average year-on-year increase in drug patent applications
was only 15 per cent.
The number of applications for drug patent protection kept growing in the
following years, reaching a peak of 8,564 in 2000, according to official
statistics.
In addition to the Patent Law, the laws and regulations related to drug IPR
protection also include the Trademark Law, the Law on Pharmaceutical
Administration and several administrative protection regulations.
"The administrative protection has been adopted as a way to protect foreign
pharmaceuticals invented before 1993 which were not granted patent protection
because of the old law," Zhang said.
The administrative protection length is set at seven and a half years, but
gradually, along with the expiration of the administrative protection length,
this way of pharmaceutical invention protection will finally disappear, he said.
Challenges
Strengthened IPR protection on pharmaceutical inventions has placed China's
pharmaceutical industry in an inferior position in the fierce global
competition.
"Many domestic pharmaceutical enterprises have got used to relying on copying
others' inventions to survive, so now they have been confronted with huge
pressure and challenges," said Zhang Qingkui.
Statistics show at least 90 per cent of western medicine produced by domestic
pharmaceutical manufacturers is the result of replication of others' inventions.
Between 1992 and 1997, only 21 per cent of all the applications for patent
protection on western medicine inventions were sent by domestic pharmaceutical
enterprises.
Even in the field of traditional Chinese medicine, domestic pharmaceutical
manufacturers have been confronted with threats about forfeiting their
advantages to foreign counterparts.
Zhang said the number of overseas pharmaceutical manufacturers applying for
patent protection on inventions about traditional Chinese medicine has been
increasing since 1994.
From two in 1985, the number reached 12 by 1997 and is still increasing.
Japan, South Korea and the United States are the top three competitors.
Conversely, the number of domestic research institutions and enterprises
applying for patent protection in the field of traditional Chinese medicine is
decreasing.
He Xingdong, an official with the State Administration of Traditional Chinese
Medicine, said foreign drug makers and institutions have accelerated their
pursuit of IPR on traditional Chinese medicine in the past few years.
After distilling effective components from some unique traditional Chinese
medicine with advanced facilities and abundant funding, these foreign
enterprises and institutions apply for patent protection even in China, He told
Xinhua News Agency at a recent international meeting.
As many domestic enterprises have not realized the importance of IPR, He said
the country will draft a strategy to strengthen protection on IPR of traditional
Chinese medicine in the future.
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