CHINA LEX PHARMA LAW NEWSLETTER
Vol. 2 , No.10- March 26, 2001
TOPICS THIS ISSUE:
- Manufacturing Under New Pharma Law
- NPC Deputy Proposes Law on Genetically-Engineered Medicines
- Online Medical Service Available in Shanghai
- Beijing to Host International Symposium on Biomedical Development
- Imported Chinese Herbal Remedies Immune to U.S. Regulations
- Chinese Lawmakers call for faster medical reform
- India to Impose Possible Anti-dumping Duty Against Chinese Drug
Manufacturing Under New Pharma Law
Under the new Pharmaceutical Law, effective December 1, 2001, drug manufacturers should apply to the Administration for Industry and Commerce for their business licenses upon receipt of permission from the State Drug Administration. The previous statutory requirement was that permission had to be obtained from three government agencies (rather than two).
The new Pharmaceutical Law requires qualified pharmaceutical producers to get good manufacturing practice (GMP) certification. Current GMP rules date from 1999. They include standards for institutes and personnel, plants and installation, equipment, materials, hygiene, verification, documentation, production management, quality control, product sales and returns, complaint and adverse action reports, self-inspection, etc. A new enterprise has to get a GMP certificate before beginning production, while an existing enterprise is given some time to get the certificate.
The new Pharmaceutical Law stresses that the production of drugs, except Chinese traditional medicine, must follow only State pharmaceutical standards and approved production processes. There used to be different State and local standards. Compliance will be easier under the new law.
The new Pharmaceutical Law allows drug manufacturers to subcontract manufacturing upon the approval of the State Drug Administration. The old law did not mention subcontract (toll) manufacturing, which was banned by other drug regulations in China. Toll manufacturing means the pharmaceutical manufacturer that owns the drug registration number entrusts another manufacturer to produce the drug. Production standards for manufacturing must meet or exceed those of the original specification.
The owner of the drug registration number is liable for its own products and subcontracted products. A toll manufacturer must be an enterprise with legal person status that has all necessary licenses for drug production, along with a suitable production workshop and equipment which fall in the scope of its drug production licenses. The workshop should have a GMP certificate. The owner and toll manufacturer should sign and have notarized a toll manufacturing contract, defining the responsibilities of both parties and complying with the drug administration regulations.
NPC Deputy Proposes Law on Genetically-Engineered Medicines
According to a motion tabled at the annual session of the National People's Congress (NPC), a law on the management of genetically engineered medicines needs to be enacted to promote and systematically standardize the research, development, utilization and transfer of China's genetically engineered medicines as well as the management of production, sales and safety of such products.
The motion was tabled jointly by a group of NPC deputies headed by Professor Kong Fanchao, president of the mathematics and physics college of Anhui University.
Kong said genetic technologies are expected to provide an effective approach to diagnosing diseases, developing new medicines and exploring new cures for diseases.
He said that Chinese scientists have developed gene-transferred test-tube cows, which carry human serum protein genes and can produce milk containing human serum protein. At present, at least 15 varieties of genetically-engineered medicines are on sale in China.
He suggested that the state take an active attitude toward the R&D of genetically engineered medicines while being cautious about the commercialization of such production.
(Source: http://www.xinhuanet.com)
Online Medical Service Available in Shanghai
A medical website has opened in Shanghai that makes it possible for local citizens to connect with health care providers online as well as find medical information.
The website www.91985.com is sponsored by the Shanghai Health Bureau and provides medical resources from selected local hospitals.
Some 1,000 senior doctors from 33 local hospitals are available for online consultation on the website. Citizens can obtain detailed information from over 3,500 medical experts in the city.
The website contains expert columns to offer medical information, including interactive exchanges with patients via email.
The website also opened a medical assistant hotline. The hotline number is 16091985.
(Source: http://www.xinhuanet.com)
Beijing to Host International Symposium on Biomedical Development
The Fifth Beijing International Symposium on the biomedical industry will be held May 11-14, 2001, according to the organizer, the Beijing Municipal Commission of Science and Technology.
Nearly 100 authorities from seven countries and regions, including the United States, Japan and Europe, are expected to give lectures on the development of traditional Chinese medicine, natural medicine, and the functions of modern technologies in the 21st century.
Biomedical experts from organizations and institutions in the US, Japan, and the European Union will hold a round-table during the symposium to coordinate their regulations on plant medicine and forecast future development.
Special forums concerning oceanic medicines, the human genome plan and Chinese medicine are also scheduled.
(Source: Xinhua News Agency)
Imported Chinese Herbal Remedies Immune to U.S. Regulations
Herbal remedies made in China and exported to the U.S. are not subject to the legal standards of the U.S. Food & Drug Administration (FDA). Categorized as 'dietary supplements', products from China have been known to contain such banned substances as dioxin, steroids, and ephedra.
Imported supplements are not under the jurisdiction of State or federal authorities and thus are not required to list their ingredients nor abide by quality control.
There is some debate in the U.S. that has stemmed from supplement users experiencing seizures, blackouts, and other disorders. There have been calls to regulate such substances classified as dietary supplements, yet nothing has been proposed by Congress thus far. The same lenient standards are enjoyed by the U.S. domestic herbal industry, but to a lesser extent
The herbal industry is a multi-billion dollar industry worldwide.
(Source: Ottawa Sun)
Medical Reform Atop Chinese Lawmakers Agenda
Regional deputies debated numerous medical reforms at the annual National People's Congress. They have proposed new laws to regulate medical services and accidents and tackle disputes between patients and hospitals. The vice-minister of health outlined medical reforms in the 10th Five-Year Plan. The reforms include private hospitals, urban medical insurance schemes, a public bidding system for drug purchasing and patient choice of hospitals.
According to a recent survey by the National Bureau of Statistics, disputes between patients and hospitals have become a potential threat to social stability, and 80 per cent of those polled said that they are concerned with medical reform.
Another poll by the Office for Economic Restructuring under the State Council in late 1999 found that falling ill, for the first time, now ranks tops among major concerns for ordinary Chinese -- ahead of concerns about unemployment, housing reform and wages.
The topic drew heated debate at the annual session of the Ninth National People's Congress (NPC) and the recently concluded annual session of the Chinese People's Political Consultative Conference (CPPCC) National Committee.
NPC deputies from Zhejiang Province in east China tabled a motion for a law that would regulate medical services and tackle rising distrust between patients and hospitals.
NPC deputies from Jiangsu Province called for amending regulations governing the handling of medical accidents, a key being the establishment of an ad hoc committee devoted to independent accident assessment.
Strong criticism of the mismanagement of hospitals and incompetent doctors by some CPPCC National Committee members also struck a chord among lawmakers and advisers.
The discontent of the public also stems from costly medical bills. The cost of medical services has been increasing at 12 to 18 per cent a year since the mid-1990s, compared to an eight per cent growth rate for the national economy. In 1990, a hospitalized patient was charged an average of 400 RMB. By 1998, this figure had soared to 2,300 RMB, with the cost of drugs accounting for 60 to 70 percent.
It is not rare for low-income urban dwellers and farmers to complain that they cannot afford to seek medical treatment in time of need.
In his report to the NPC session on the 10th Five-Year Plan, Premier Zhu Rongji said the government will "actively pursue reform of the medical insurance system for urban workers, as well as reform of medical institutions and the drug marketing system".
A major goal is to establish an urban medical insurance system to protect more urban dwellers while curbing the waste of drugs and other medical resources under the old, free system.
The reform will allow patients to choose hospitals, which the policy makers hope will force hospitals to compete and improve services.
Under the reform, hospitals will fall into profit-making and non-profit-making hospitals. Non-profit-making hospitals will be run by the government and provide basic medication, disease prevention and other public health services. Profit-making hospitals will not receive subsidies from the government but will be allowed to set prices themselves.
The government has also begun to impose a public bidding system for drug purchases and apply unified government prices for certain drugs in a bid to inject transparency into the drug marketing system.
Given the economic gap between urban and rural China, authorities are drawing up a separate set of guidelines for rural medical reform.
(Source: Xinhua News Agency)
India to Impose Possible Anti-dumping Duty Against Chinese Drug
The Indian Directorate General of Anti-dumping and Allied duties (DGAD) has recommended an anti-dumping duty of US$9.778/kg on all imports of the anti-inflammatory drug Analgin from China. The investigation, spurred by accusations from local Indian pharmaceutical company Vani Chemicals, was conducted between April 1999 and September 2000. The dumping margin was assessed at 115 percent of the export price - exceeding prescribed limits.
Analgin is a white crystalline powder, with a slight yellow tinge that is used primarily as an anti-inflammatory and anti-pyretic.
(Source: ASIA PULSE)
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