CHINA LEX PHARMA LAW NEWSLETTER
Vol. 2 , No.16- June 29, 2001
TOPICS THIS ISSUE:
- Rare Animals, Plants Banned for Medicinal Use
- China Pharmaceutical Market Update
- 600,000 Chinese Suffer from AIDS
- New Regulations on Genetically Modified Organisms Enacted
- New Regulations on Sino-foreign JV Hospitals Promulgated
Rare Animals, Plants Banned for Medicinal Use
The Chinese government has initiated steps to protect the countries ever depleting supply of rare plant and animal life. Long thought to be the magical cure to just about any ailment, rare species of plants and animals are a valuable commodity on the Chinese market.
In order to avoid their extinction, China's Ministry oif Health issued a notice on June 22 banning the use of animals and plants on the State Council's endangered list as ingredients for health-related products. The list was jointly established by the State Council's administrative departments in charge of agriculture, fishery and forestry, and in accordance with the Law of the People's Republic of China on the Protection of Wildlife, Regulations for the Protection of Wild Plants and other relevant Chinese laws and regulations.
The Ministry also confirmed that such plant and wildlife that has been cultivated or domesticated should also not be used.
(Source: ChinaOnline/Xinhua)
China Pharmaceutical Market Update
China's pharmaceutical industry developed rapidly in the first quarter of this year, with an increase in production, steady recovery of sales and improvement of economic efficiency, according to the State Economic and Trade Commission (SETC).
The national pharmaceutical industrial output value amounted to RMB 61.7 billion in the first quarter of this year, an increase of 16 percent over the same period last year. The industrial added value came to RMB 15.3 billion, also up 16 percent from last year and five percentage points higher than the national average level.
The industrial added value of the 12 coastal provinces and municipalities including Shanghai, Jiangsu, Zhejiang, Shandong, Guangdong, Beijing and Liaoning made up 60 percent of the country's total.
China purchased seven major categories of drugs totaling RMB 29.13 billion during the period, an increase of 10.83 percent over the same period last year; sales came to RMB 34.36 billion, up 9.75 percent.
The sales of medicine increased 11.34 percent year on year to RMB 23.87 billion; the sales of medical instruments and meters were down 1.75 percent; the sales of chemical reagents were the same as last year; sales of glassware went up 11.02 percent; the sales of traditional Chinese medicine registered decreases; and the sales of Chinese preparations increased 8.89 percent.
According to customs statistics, the foreign trade volume of medicine in the first quarter of this year came to 1.59 billion US dollars, an increase of 13.6 percent over last year, with exports increasing 12 percent, and imports 14 percent.
Statistics show that pharmaceutical enterprises posted a profit of RMB 2.4 billion in the first quarter, an increase of 20 percent over the same period last year; commercial enterprises also registered an increase in profits.
(Source: Xinhua)
600,000 Chinese Suffer from AIDS
China's Minister of Health, attending the first ever United Nations Conference on AIDS, announced that roughly 600,000 of China's 1.3 billion people are currently infected with the AIDS virus - approximately 0.5% of the population. More significant, however, is the current growth rate of 30% per year.
It is believed that 70% of all HIV infections are the result of intravenous drug use, 10% from sexual transmission, and 6% from the illegal blood market (down from 40% 5 years ago).
U.N. figures on AIDS in China indicate some 500,000 adults were living with HIV or AIDS in 1999 and that 17,000 died from AIDS during that year.
The Health Minister announced that China would combat the problem with a five-year plan aimed at cutting the growth rate down to 10%. The plan will call for more education and AIDS awareness. Such initiatives will include public service announcements from famous film stars as well as increasing the availability of condoms by having condom vending machines. China is also among countries that are petitioning US drug companies to sell them drugs contained in the AIDS "cocktail" at a reduced rate.
These plans come after similar efforts from Chinese doctors and scientists in the past have met resistance from the government, mainly out of fear of attracting attention to the problem. The most highly publicized case involves the Chinese authorities determination to block the efforts of a mainland scientist, Dr. Gao Yaojie, who recently won the prestigious Jonathan Mann Award from the Global Health Council.
Officials refused to issue Dr. Gao a passport to go to Washington, D.C. to accept the award from U.N. Secretary General Kofi Annan. The government's behavior is tied into the fact that while uncovering the problem of AIDS in China, Gao also revealed government negligence in regard to the disease. People who have visited her at home have been detained and officials have blocked her from distributing donated medicine and cash to AIDS victims.
(Source: AP)
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New Regulations on Genetically Modified Organisms Enacted
The Regulations on the Administration of Agricultural Genetically Modified Organism Safety were adopted by the State Council on May 9, 2001 and promulgated on May 23, 2001. The new regulations govern the research, trial testing, production, processing, business dealings and import/export of genetically modified organisms ("GMO").
Agricultural GMOs are divided into four grades-Grades I, II, III and IV-according to the degree of danger that they present to humans, animals, plants, microorganisms and the ecological environment. The new regulations require various reporting and approval requirements for various stages of testing.
After initial trial tests, parties may apply for an agricultural GMO safety certificate from the State Department of Agriculture. An agricultural GMO safety certificate must be obtained before carrying out "examination, approval and registration" or "assessment, examination and approval" for (i) genetically modified seed, breeding stock, breeding fowl or aquatic seedlings or (ii) breeding stock, breeding fowl, aquatic seedlings, pesticides, veterinary medicine, fertilizers or additives produced using agricultural GMOs or containing agricultural GMO ingredients.
Sino-foreign joint ventures and wholly foreign-owned entities (WFOEs) that engage in agricultural GMO research and trial tests in China must obtain approval from the State Council department in charge of agriculture.
The new regulations also address required production licenses, approvals for production and processing, licenses for dealing in genetically modified agricultural products, required packaging marks for GMOs sold in China, import/export requirements, civil liability for accidents occurring when handling GMOs and penalties.
(Source: Chinalegalchange.com)
New Regulations on Sino-foreign JV Hospitals Promulgated
New regulations governing the affairs of Sino-Foreign Joint Venture Hospitals will go into effect starting July 1, 2001. The laws will be enforced by the Ministry of Foreign Trade and Economic Cooperation as well as the Ministry of Health. These two organizations shall be in charge of all procedures regarding the setting up and establishing of all JV hospitals in China.
Major provisions call for a minimum of RMB 20 million (US $2.4 million) to be invested by the Chinese partner. Moreover, the equity or rights and interest of the Chinese Party in the Chinese-foreign joint or cooperative institution shall be no less than 30 percent; and the term of joint or cooperative medical institutions shall not exceed 20 years.
The regulations allow for certain requirements to be relaxed if the Sino-foreign medical institution is located in China's central and western areas, the old revolutionary base areas, areas inhabited by minority nationalities, frontier areas or poverty-stricken areas. Moreover, provincial Health and FTEC departments of all provinces, autonomous regions and municipalities directly under the central government may make specific regulations according to local conditions.
It is also mentioned in the regulations that applications for the establishment of solely foreign-funded medical institutions within the territory of China shall not be approved.
(Source: ChinaOnline)
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