CHINA LEX PHARMA LAW NEWSLETTER
Vol. 2 , No.32 - December 4, 2001
TOPICS THIS ISSUE:
- Foreign Companies to Enter China's Retail Pharmacy Market in 2003
- China's First Methadone Project Launched in Response to Growing AIDS Concerns
- Two Chinese Pharmaceutical Companies Hope to Produce Cheap Anti-HIV Drugs
- China Prohibits Mass Advertising Of Prescription Products
- List of China GMP Facilities (Continued)
Foreign Companies to Enter China's Retail Pharmacy Market in 2003
In 2003, foreign companies will be granted the right to operate retail and wholesale pharmaceutical businesses with no geographical or capital restrictions. This comes as part of China's commitment to broaden market access after it joins the World Trade Organization, claims the State Economic and Trade Commission.
The China Daily reported, citing Yu Mingde, the deputy director of the State Economic and Trade Commission's Economic Operation Department, that prior to 2003, Sino-foreign joint venture trials will be held in key cities such as Beijing, Shanghai and Guangzhou.
Under the joint venture regulations, it is required that foreign partners must have annual sales exceeding US $2 billion for three consecutive years before applying to set up the venture and they should also have total assets exceeding US $200 million.
China Daily also cited SETC sources as saying that negotiations to permit foreign pharmaceutical retailers to set up joint ventures in Beijing and Shanghai has been occurring for many years.
(Source: AFX, China Daily)
China's First Methadone Project Launched in Response to Growing AIDS Concerns
China is planning to launch its first project using methadone in an attempt to help drug users fight their addictions. This comes as a further sign that China is finally beginning to take its AIDS crisis more seriously.
The experiment will be expected to begin next year, Li Jianhua, deputy director of southwest China's Yunnan Institute for Drug Abuse, told reporters on the last day of a conference on HIV/AIDS in Beijing.
Held behind closed doors, this four-day national conference was the first event dealing with HIV/AIDS that China has ever staged. Li said that methadone is a synthetic opiate-type drug that is widely used in other countries to wean addicts off heroin. The drug can be ingested orally as well as injected. However, taking the drug orally could prevent HIV from being transmitted through needle sharing.
The conference also debated on possibility of distributing clean syringes to addicts in efforts to prevent infection. Such discussions illustrate how China's official attitude towards AIDS looks to be changing slowly but surely.
In previous years, Chinese authorities have openly shown their disdain for anti-AIDS measures, which was stemmed largely from their impression that the disease was associated with "social evils," such as drug users and homosexuals.
At the opening of the AIDS conference, the head of the United Nations AIDS organization (UNAIDS), Peter Poit, praised China for its increased efforts to stem the epidemic. However, he also warned that "if there is no change to the intensity of the response to AIDS, then the epidemic will inevitably grow." It is believed that the epidemic will spread to 10 million over the next decade.
Experts have said that although intravenous drug usage is a significant factor in the widespread transmission of the epidemic, official efforts to counter this have fallen behind efforts to counter other areas such as contaminated blood supplies.
Earlier this week, Charles Rycroft, the spokesman for the United Nations children's fund UNICEF in Beijing, singled out China's refusal to use methadone therapy as a mistake, saying, "They don't want to work with people who use drugs because they don't want to give the impression that they are too permissive."
According to the official assessment, there are more than 600,000 people with HIV in China. However many experts outside of China regard this figure as a great understatement, especially given the number of people who may have become infected through selling their blood to mercenary collectors using unsanitary practices.
(Source: Agence France Presse)
Two Chinese Pharmaceutical Companies Hope to Produce Cheap Anti-HIV Drugs
Two Chinese drug companies have recently applied to the State Drug Administration in hopes of producing two generic anti-HIV drugs. They are hoping that these applications will take advantage of domestic patent laws which allow generic drug makers to copy and sell medicines alongside patented versions. Shanghai Desano Biopharmaceutical Co, a privately-owned company, claimed that it has applied to the State Drug Administration to produce two generic anti-HIV drugs, to which Bristol-Myers Squibb holds patents, and it also plans to apply to make AZT, the first drug recognized to treat HIV, to which GlaxoSmithKline holds the patent.
Northeast General Pharmaceutical Factory, a State-owned company, said it too has applied to the government to make and domestically sell HIV drugs.
These two companies already manufacture and export raw materials to markets such as Brazil and India. There, these raw materials are used to make AIDS drugs. The two companies could benefit from the loopholes in Chinese law, which allow for generic drug makers to copy and sell medicines alongside the patented versions.
They see a market opportunity in China due to the rising number of HIV infected, which is estimated at 600,000 nationwide and growing at a rate of 30% per year. Most of the infected cannot afford patented versions of the medicines, which could cost them US $10,000 a year.
Li Jinliang, deputy general manager of Shanghai Desano, was quoted saying, "We can produce everything an HIV person needs for US $400 a year". He is expecting a decision on this matter sometime around June of next year.
Foreign drug makers maintain that the law contains loopholes which allow domestic pharmaceutical companies to reproduce medicines through paltry changes in Formulation. It also allows domestic companies to register to sell a drug in China while its foreign developer is still in the process of applying for administrative protection for it.
Dr. Shen Jie, the director of the National center for AIDS Prevention and Control told reporters the government has been in negotiations with both GlaxoSmithKline and Bristol-Myers Squibb to try to reduce the price of their HIV drugs in China.
(Source: AFX)
China Prohibits Mass Advertising Of Prescription Products
Advertisements for prescription medicines which can be seen virtually anywhere in China due largely to the media, will cease to exist starting from December 1. This announcement comes after the issuance of a new set of regulations by the State Drug Administration (SDA).
According to this new regulation, the manufacturers of prescription medicines for cardiac disease, angina, hypertension, hepatitis and diabetes, as well as those for non-antibiotics and hormonal medicines, will be required to limit their advertisements to professional medical media only starting from February 1, 2002. Commercials or advertisements of any sort for medicines that do not meet national standards can not be promoted in any type of media.
Sources say that medicines which have been available to the public for a duration of five years can be advertised on public media, subject to approval by relevant departments.
(Source: Asia Pulse)
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List of China GMP Facilities (Continued)
Name of Enterprise | Certified Scope |
451. Xiangbei Willman Pharmaceutical Co., Ltd. | Powder-injection (Cephalosporin) |
452. Zhunzhou Qianjin Pharma Co., Ltd. by Shares | Tablet |
453. Tianjin Huajin Pharmaceutical Factory | Powder-injection (Penicillin), High dose injection |
454. Tianjin Nanhua Pharma Co., Ltd. | Powder-injection (Penicillin) |
455. Tianjin Hualida Bio-engineering Co., Ltd. | Recombinant human interferon-a2b |
456. Shanghai Wanxing Bio-pharma Co., Ltd. | Recombinant human interferon-a2a, a2b |
457. Chongqing Yaoyou Pharma Co., Ltd. | Bulk drug (Penicillin), Powder-injection (Penicillin, Cephalosporin) |
458. Shanghai Livzon Pharmaceutical Co., Ltd. | Bulk drug (Bio-products and polypeptide), Tablet, Capsule |
459. Shanghai Changzheng Pharma Co., Ltd. | High dose injection |
460. Longyan Tianquan Bio-chem Pharma Co., Ltd. | High dose injection |
461. Shandong Dayin Sea-biological Pharma Co., Ltd | Capsule |
462. Shanghai Medical University Hongqi Pharma Factory | Freeze-dried powder-injection |
463. Anhui Anke Bio-tech Co., Ltd. | Injected recombinant human somatotrophin |
464. Chongqing Yaoyou Pharma Co., Ltd. | Bulk drug (Penicillin), Powder-injection (Penicillin, Cephalosporin), High dose injection |
465. Zhangjiakou Pharmaceutical Factory | Powder-injection (Penicillin) |
466. Qingdao Guofeng Group Huayang Pharmaceutical Co., Ltd. | Powder-injection (Penicillin) |
467. Chongqing Daxin Pharma Co., Ltd by Shares | High dose injection |
468. Guangzhou Nanxin Pharma Co., Ltd. | Tablet, Capsule |
469. Southwest Synthetic Pharma Co., Ltd. by Shares | Powder-injection (Cephalosporin) |
470. Guangzhou Baiyunshan Pharma Factory | Powder-injection (Cephalosporin) |
471. Weilun Bio-product Company | Freeze-dried powder-injection |
472. Guangzhou Baiyunshan Chemical Pharma Factory | Bulk drug (Cephalosporin) |
473. Shenzhen Haibin Pharma Co., Ltd. | Powder-injection (Penicillin) |
474. . Guangdong Liguo Pharma Co., Ltd. | Bulk drug (Cefazolin Na) |
475. Livzon Synthetic Pharma Factory | Bulk drug (Cephalosporin) |
476. Shandong Zibo Xinda Pharma Co., Ltd. | Capsule, Granule (Cephalosporin) |
477. Sanyan Delin Pharma Co., Ltd. | Powder-injection, Capsule, Granule (Penicillin) |
478. Shantou Pinjiang Pharma Factory | Powder-injection (Cephalosporin) |
479. Shandong Huaifang Pharma Co., Ltd. | Powder-injection (Penicillin), bulk drug |
480. Sanyan Delin Pharma Co., Ltd. | Bulk drug (Tazobactam) |
481. Qilu Pharma Factory | Bulk drug (Penicillin), Powder-injection (Penicillin, Cephalosporin), Freeze-dried powder-injection |
482. Eisia (Suzhou) Pharma Co., Ltd. | Tablet |
483. Yongxin (Kunshan) Pharma Co., Ltd. | Tablet, Capsule |
484. Kunming Jida Pharma Co., Ltd. | Powder-injection (Cephalosporin) |
485. Ningxia Pharma Factory | Powder-injection (Penicillin) |
486. Yingxin Pharma (Kunshan) Co., Ltd. | Plaster |
487. Qilu Pharma Factory | Low dose injection, Tablet, Capsule |
488. Shenzhen Huashenyuan Gene-Engineering Co., Ltd. | Recombinant human growth factor liquid |
489. Kunmin Pharma Co., Ltd. by Shares | Powder-injection |
490. Anhu Longkema Bio-pharma Co., Ltd. | Freeze-dried cow mycobacterium |
491. Yongguang Pharma Co., Ltd. | Eye-drops, bulk drug |
492. Beijing Tiantan Bio-product Co., Ltd. | Recombinant hepatitis B Vaccine |
493. Chengdu Daxinan Pharma Co., Ltd. | Tablet, capsule, granule |
494. Chengdu TCM University Huashen Pharmaceutical Co., Ltd. | Tablet, capsule, granule, oral liquid |
495. Shanghai Roche Pharma Co., Ltd. | Recombinant human interferon a2a, low dose injection |
496. Yancheng Shengyuan Pharma Co., Ltd. | High dose injection |
497. Shenzhen Taitai Pharma Co., Ltd by Shares | Tablet, granule, oral liquid |
498. Jibiai Bio-tech (Beijing) Co., Ltd. | Diagnose agent |
499. Shanghai Taicifu Bio-engineering Co., Ltd. | Tablet |
500. Jiangsu Suzhong Pharma Factory | Tablet, capsule, granule |
Lehman Lee & Xu
China Lawyers, Notaries, Patent, Copyright and Trademark Agents
http://www.chinalaw.cc/
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The China Lex Pharma Law Newsletter is intended to be used for news purposes only. It should not be taken as comprehensive legal advice, and Lehman, Lee & Xu will not be held responsible for any such reliance on its contents.
