Public Health

Taiwan 2002

Public Health

Pharmaceutical Regulation
All medicines and medical devices, both imported and locally produced, must be registered and licensed by the DOH before they are marketed in the Taiwan area. Local health authorities conduct regular and unscheduled inspections, sampling medicines and cosmetics that are manufactured, imported, or sold in their areas. Manufacturers and purveyors of medicines and cosmetics that fail to pass inspections are punished according to the Pharmaceutical Affairs Law 藥事法 and the Cosmetics Sanitary Control Law 化妝品衛生管理條例.
By 2001, the DOH and the Ministry of Economic Affairs 經濟部 had jointly issued the GMP seal to 229 certified pharmaceutical factories. An ongoing GMP monitoring program helps to maintain the integrity of the ROC pharmaceutical industry, as well as the quality of drug products in the market. All GMP drug manufacturers are inspected at least once every two years. Those which fail to make improvements may also be shut down by health authorities, and their applications for registration and market permits suspended during the probation period.
The DOH also monitors the safety of new medicinal products. During the monitoring period, manufacturers submit records of safety monitoring in designated teaching hospitals for their newly licensed drugs and immediately report any side effects observed. Test results of domestic clinical trials are also required. In July 1998, the Center for Drug Evaluation 財團法人醫藥查驗中心 was established to conduct research and develop standards on the safety, effectiveness, and labeling of all drug products, as well as review and evaluate applications for new drugs and medical devices before they reach the market. As of December 2000, 686 new pharmaceutical formulas were being monitored. On April 12, 1996, in preparation for entry into the World Trade Organization (WTO), the DOH promulgated ten basic standards for the registration and examination of imported medicines. Side effects from medicines would be reported through a monitoring system to safeguard patients' drug safety. For patients suffering from rare diseases and to ensure the supply of orphan drugs, the DOH encouraged the production of such drugs in Taiwan under the Law of Rare Diseases Prevention and Orphan Drugs 罕見疾病防治及藥物法, which was promulgated on February 9, 2000.
The DOH is currently conducting a truth-in-advertising campaign. The central and municipal health authorities strictly review applications for advertisements. According to the Pharmaceutical Affairs Law, media that run advertisements exaggerating the efficacy of medical products are subject to heavy fines.
The separation of the medical and pharmaceutical professions is one of the most important tasks in restructuring health services in Taiwan. On March 1, 1997, Taipei and Kaohsiung Cities were designated areas to first implement this separation. Gradually, the plan encompassed the entire Taiwan area. Effective August 2001, the separation policy covered most of Taiwan area except for Penghu county. About 3,000 community pharmacies that adhere to the "Good Dispensing Practice" were under contract with the Bureau of National Health Insurance as part of the health care delivery system. The DOH is also helping to upgrade the quality of pharmaceutical personnel through on-the-job training and by helping to set up computerized patient profiles, in order to prepare for the separation of the medical and pharmaceutical practice policy at the second phase.

Drug Injury Relief
The Key Points for Drug Injury Relief 藥害救濟要點 effective January 12, 1999, have been formulated to safeguard the interests of patients and pharmaceutical manufacturers. The Law of Drug Injury Relief 藥害救濟法 promulgated on May 31, 2000, extends the relief to cases related to Chinese medicinal products and practices. A drug injury review committee composed of experts has been set up under the Department of Health to examine and investigate all drug injury cases petitioned.
According to the Law of Drug Injury Relief, drug injury relief is based on no-fault liability insurance and covers drug injuries ranging from medical expenses for cases of reversible injury to compensation for fatal drug injuries. As stated, a maximum of US$64,040 in compensation can be given in a fatality.
In addition, a relief fund has been established. In order to operate the Drug Injury Relief Fund, the Foundation of Drug Injury Relief was established by the government in August 2001. The objective of the foundation is to assist the government in performing drug injury relief related tasks, such as fund collecting, fund disbursing, and research of adverse drug reaction prevention. The interests of consumers, medical facilities, and pharmaceutical firms are thus protected. Approximately 500 pharmaceutical companies have joined and contributed to the fund. According to the Law of Drug Injury Relief, around one-thousandth of the value of the company's annual domestic pharmaceutical sales is contributed. Thus far, the drug injury relief fund has raised US$2,657,700 and has given compensation in 53 cases involving drug injuries.
A special logo is provided to participating pharmaceutical manufacturers and sellers to inform consumers that they are covered by the relief fund in case of accidental drug injuries.

Substance Abuse
Until the last decade, Taiwan's drug problem was considered minor in comparison with its neighbors, such as Japan and Hong Kong, but that began to change in the early 1990s, as evidenced by the increasing number of drug-related criminal arrests. Previously, such arrests accounted for 5 percent or less of the total number of arrests made per year; however, this rate increased to 13 percent in l991, climbed to 19 percent in 1992, and jumped to nearly 32 percent in 1993. By December 1994, drug offenders had replaced burglars as the largest group in Taiwan prisons, accounting for 63 percent of Taiwan's inmate population. The situation turned around in 1995, when there was a 7 percent decrease in drug-related criminal arrests, and this rate has continued to drop since then.
Substance and drug abuse in Taiwan appears to be heading toward harder drugs. In the 1970s, sporadic cases of glue sniffing were reported, and, in the 1980s, incidences of sedative abuse were occasionally uncovered. By the early 1990s, the drug of choice was amphetamines and heroin. Although there were fewer than 9,000 addicts in the Taiwan area in 2000, it is estimated that more than 200,000 people (or nearly 1 percent of the total population) are currently abusing at least one substance, primarily methamphetamine or heroin. In contrast to the 956 kilograms of amphetamines (including raw materials and semi-products) seized in 2000, 370 kilograms of other illegal drugs were confiscated. A total of 73.98 kilograms of marijuana were also seized in 2000, almost double the seizure of 47.92 kilograms in 1999. Thus, amphetamines have moved to the forefront of current drug abuse concerns in Taiwan. In addition, incidents of the abuse of new substitutes, such as FM2 and MDMA (a type of methamphetamine), have been discovered in the past years. The abuse of FM2, or the "ecstasy pill," has become a serious problem among youths and is becoming especially popular in dancing parlors and pubs.
Currently, there are 147 hospitals which treat drug addicts in the Taiwan area. Convicted drug abusers are sent for treatment before serving their sentences. There are also five special jails for inmates sentenced for drug-related offenses. Following the US DAWN model, a network for surveying the prevalence of drug abuse and case reporting for the Taiwan area has been set up. However, these detoxification, rehabilitation, and medical care facilities are insufficient for the estimated 200,000 drug addicts in Taiwan and need to be expanded.

Copyright (C) July 2002, Government Information Office. All rights reserved. Site design by L.F. Lee
Best viewed with Netscape 4.x or IE 5.x (medium font) at 800 x 600 True Color (32 bit) resolution

		Public Health
		Pharmaceutical Regulation All medicines and medical devices, both imported and locally produced, must be registered and licensed by the DOH before they are marketed in the Taiwan area. Local health authorities conduct regular and unscheduled inspections, sampling medicines and cosmetics that are manufactured, imported, or sold in their areas. Manufacturers and purveyors of medicines and cosmetics that fail to pass inspections are punished according to the Pharmaceutical Affairs Law 藥事法 and the Cosmetics Sanitary Control Law 化妝品衛生管理條例. By 2001, the DOH and the Ministry of Economic Affairs 經濟部 had jointly issued the GMP seal to 229 certified pharmaceutical factories. An ongoing GMP monitoring program helps to maintain the integrity of the ROC pharmaceutical industry, as well as the quality of drug products in the market. All GMP drug manufacturers are inspected at least once every two years. Those which fail to make improvements may also be shut down by health authorities, and their applications for registration and market permits suspended during the probation period. The DOH also monitors the safety of new medicinal products. During the monitoring period, manufacturers submit records of safety monitoring in designated teaching hospitals for their newly licensed drugs and immediately report any side effects observed. Test results of domestic clinical trials are also required. In July 1998, the Center for Drug Evaluation 財團法人醫藥查驗中心 was established to conduct research and develop standards on the safety, effectiveness, and labeling of all drug products, as well as review and evaluate applications for new drugs and medical devices before they reach the market. As of December 2000, 686 new pharmaceutical formulas were being monitored. On April 12, 1996, in preparation for entry into the World Trade Organization (WTO), the DOH promulgated ten basic standards for the registration and examination of imported medicines. Side effects from medicines would be reported through a monitoring system to safeguard patients' drug safety. For patients suffering from rare diseases and to ensure the supply of orphan drugs, the DOH encouraged the production of such drugs in Taiwan under the Law of Rare Diseases Prevention and Orphan Drugs 罕見疾病防治及藥物法, which was promulgated on February 9, 2000. The DOH is currently conducting a truth-in-advertising campaign. The central and municipal health authorities strictly review applications for advertisements. According to the Pharmaceutical Affairs Law, media that run advertisements exaggerating the efficacy of medical products are subject to heavy fines. The separation of the medical and pharmaceutical professions is one of the most important tasks in restructuring health services in Taiwan. On March 1, 1997, Taipei and Kaohsiung Cities were designated areas to first implement this separation. Gradually, the plan encompassed the entire Taiwan area. Effective August 2001, the separation policy covered most of Taiwan area except for Penghu county. About 3,000 community pharmacies that adhere to the "Good Dispensing Practice" were under contract with the Bureau of National Health Insurance as part of the health care delivery system. The DOH is also helping to upgrade the quality of pharmaceutical personnel through on-the-job training and by helping to set up computerized patient profiles, in order to prepare for the separation of the medical and pharmaceutical practice policy at the second phase. Drug Injury Relief The Key Points for Drug Injury Relief 藥害救濟要點 effective January 12, 1999, have been formulated to safeguard the interests of patients and pharmaceutical manufacturers. The Law of Drug Injury Relief 藥害救濟法 promulgated on May 31, 2000, extends the relief to cases related to Chinese medicinal products and practices. A drug injury review committee composed of experts has been set up under the Department of Health to examine and investigate all drug injury cases petitioned. According to the Law of Drug Injury Relief, drug injury relief is based on no-fault liability insurance and covers drug injuries ranging from medical expenses for cases of reversible injury to compensation for fatal drug injuries. As stated, a maximum of US$64,040 in compensation can be given in a fatality. In addition, a relief fund has been established. In order to operate the Drug Injury Relief Fund, the Foundation of Drug Injury Relief was established by the government in August 2001. The objective of the foundation is to assist the government in performing drug injury relief related tasks, such as fund collecting, fund disbursing, and research of adverse drug reaction prevention. The interests of consumers, medical facilities, and pharmaceutical firms are thus protected. Approximately 500 pharmaceutical companies have joined and contributed to the fund. According to the Law of Drug Injury Relief, around one-thousandth of the value of the company's annual domestic pharmaceutical sales is contributed. Thus far, the drug injury relief fund has raised US$2,657,700 and has given compensation in 53 cases involving drug injuries. A special logo is provided to participating pharmaceutical manufacturers and sellers to inform consumers that they are covered by the relief fund in case of accidental drug injuries. Substance Abuse Until the last decade, Taiwan's drug problem was considered minor in comparison with its neighbors, such as Japan and Hong Kong, but that began to change in the early 1990s, as evidenced by the increasing number of drug-related criminal arrests. Previously, such arrests accounted for 5 percent or less of the total number of arrests made per year; however, this rate increased to 13 percent in l991, climbed to 19 percent in 1992, and jumped to nearly 32 percent in 1993. By December 1994, drug offenders had replaced burglars as the largest group in Taiwan prisons, accounting for 63 percent of Taiwan's inmate population. The situation turned around in 1995, when there was a 7 percent decrease in drug-related criminal arrests, and this rate has continued to drop since then. Substance and drug abuse in Taiwan appears to be heading toward harder drugs. In the 1970s, sporadic cases of glue sniffing were reported, and, in the 1980s, incidences of sedative abuse were occasionally uncovered. By the early 1990s, the drug of choice was amphetamines and heroin. Although there were fewer than 9,000 addicts in the Taiwan area in 2000, it is estimated that more than 200,000 people (or nearly 1 percent of the total population) are currently abusing at least one substance, primarily methamphetamine or heroin. In contrast to the 956 kilograms of amphetamines (including raw materials and semi-products) seized in 2000, 370 kilograms of other illegal drugs were confiscated. A total of 73.98 kilograms of marijuana were also seized in 2000, almost double the seizure of 47.92 kilograms in 1999. Thus, amphetamines have moved to the forefront of current drug abuse concerns in Taiwan. In addition, incidents of the abuse of new substitutes, such as FM2 and MDMA (a type of methamphetamine), have been discovered in the past years. The abuse of FM2, or the "ecstasy pill," has become a serious problem among youths and is becoming especially popular in dancing parlors and pubs. Currently, there are 147 hospitals which treat drug addicts in the Taiwan area. Convicted drug abusers are sent for treatment before serving their sentences. There are also five special jails for inmates sentenced for drug-related offenses. Following the US DAWN model, a network for surveying the prevalence of drug abuse and case reporting for the Taiwan area has been set up. However, these detoxification, rehabilitation, and medical care facilities are insufficient for the estimated 200,000 drug addicts in Taiwan and need to be expanded. Copyright (C) July 2002, Government Information Office. All rights reserved. Site design by L.F. Lee Best viewed with Netscape 4.x or IE 5.x (medium font) at 800 x 600 True Color (32 bit) resolution