CHINA LEX PHARMA LAW NEWSLETTER
Vol. 2 , No. 7- March 01, 2001
TOPICS THIS ISSUE:
- MSD Arthritis Medication Vioxx Launched in China
- Pharmaceutical Administration Law Under Review
- Biomedical Industry Set to Expand
- New TCM Regulations
- Chinese Scientists Awarded Over 100 Patents in Gene Research
MSD Arthritis Medication Vioxx Launched in China
Merck, Sharp & Dohme (MSD), a subsidiary of global pharmaceutical giant Merck, has been approved to produce and distribute its painkiller, Vioxx, in China.
Approved by the State Drug Administration, MSD's joint venture in Hangzhou will produce the prescription arthritis drug. MSD has called Vioxx "the first in a new class of drugs for symptomatic relief in the treatment of osteo-arthritis." The drug provides an alternative to traditional arthritis treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) and carries less risk of harmful side-effects such as gastrointestinal complications.
China is home to approximately 100 million arthritis-sufferers. An increase in the incidence of arthritis has been attributed by Chinese experts to overstrain, gluttony and endocrinal disorders.
(Sources: Xinhua, The Medicine Journal)
Pharmaceutical Administration Law Under Review
Chinese law is one step closer to ending the corruption rampant in its drug manufacturing and sales industries. Draft amendments to the Pharmaceutical Administration Law, presented this week to the National People's Congress, contain provisions restricting advertising for prescription medication, as well as prohibiting medical administrative departments from engaging in the sale or production of medicine.
As we have reported in this newsletter recently, the restrictions on advertising essentially ban the advertisement of prescription drugs in mass media. With the approval of the draft amendments, prescription medication will only be able to advertise in medical and pharmaceutical journals designated by national medicine administrative departments. According to media reports, local healthcare and drug companies were among the biggest advertising spenders in China last year.
Sales and production of medicine by China's hospitals, which are strapped for cash, have been found to be driven chiefly by financial pressures, which has resulted in rampant corruption.
Li Boyang, vice-chairman of the NPC Law Committee, noted also that medical administrative departments will be prohibited from recommending or supervising the manufacturing and marketing of any medicine. The draft amendments state that officials in medical administrative departments should be prosecuted should they be found responsible for any illegal actions regarding medicine-related enterprises whose authorization certificates are issued by the department.
This is the third presentation of the draft amendments to the NPC. The draft law is expected to be presented for a final approval vote by the end of the three-day legislative session.
(Source: BBC Worldwide Monitoring, Xinhua, SDA)
Biomedical Industry Set to Expand
China's biomedicine market is expected to show a dramatic increase in sales in coming years, according to national experts.
While only 48 of China's 200 biotechnological companies have been approved for the production and trial production of genetically-engineered drugs, it has been predicted that the market could expand by 20 per cent to 25 per cent annually.
Less than one hundred of China's biotech companies are currently involved with genetic engineering. Biomedical work netted US$ 145 million in profits in 1999.
(Source: AsiaPulse)
New TCM Regulations
The "Regulations on the Protection of Traditional Chinese Medicine Types" will be modified to further bolster the protection of China's burgeoning alternative medicine industry. The announcement, made at a recent national conference on the protection of Traditional Chinese Medicine (TCM), comes in the wake of a flurry of legislative revisions.
Originally issued by the State Council in 1992, the Regulations created 1582 types of TCM in 27 categories, while eliminating another 1458 types in 19 categories. To date, the Regulations have helped to increase the quality of TCM as well as promoting the pharmaceutical industry in China. The annual sales volume of 28 species has exceeded RMB 100 million (US $12 million) since the Regulations were issued, and the quality standards of over 700 species have been significantly improved.
The new Regulations will focus mainly on the extension of the protection term and the strength of enforcement of protection.
(Source: Health News)
Chinese Scientists Awarded Over 100 Patents in Gene Research
Chinese scientists have registered more than 110 patents for part of the genes they cloned from the human hypothalamus-pituitary-adrenal axis.
Chinese scientists have, for the first time in the world, obtained the gene expression profiling the human hypothalamus-pituitary-adrenal axis through large scale sequencing of express sequence tags (EST).
They have cloned more than 300 new genes they discovered through the sequencing.
Doctor Han Zeguang with the Nanfang Research Center of the State Human Genome Project said that the human hypothalamus-pituitary-adrenal axis bears great importance on the growth, reproduction and immunity of human bodies and plays a key role in stabilizing the interior environment of human bodies.
Han, who participated in the aforementioned sequencing of ESTs, said that the new genes they have discovered may have something to do with the key physiological functions of the human hypothalamus- pituitary-adrenal axis.
These ESTs play a key role in distinguishing human genes and in the research on the functions of genes, Han said in a telephone interview with Xinhua on Wednesday. He called it an important component part of the contributions that Chinese scientists have made to the Human Genome Project.
Han said that the fact that they applied for patents for some of the cloned genes is conducive to protecting China's independent intellectual rights in gene research achievements.
He disclosed that they have transferred part of the cloned genes to Guangzhou Funeng Co., in South China's Guangdong Province, for a fee of RMB 1.5 million (US $180,722). The deal also included more than RMB 2 million (US $240,963) as shares to join in the company.
(Source: Xinhua News Agency)
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