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.

(China Daily 05/31/2004 page5)