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Journal of Food and Drug Analysis, Vol. 20, No. 4, 2012, Pages 778-785 doi:10.6227/jfda.2012200306

Evolution of the Legislative and Administrative System of Controlled Drugs in

JIH-HENG LI*

School of Pharmacy and Ph.D. Program in Toxicology, College of Pharmacy, Medical University, Kaohsiung, Taiwan, R.O.C.

(Received: July 17, 2012; Accepted: November 19, 2012)

ABSTRACT

Controlled drugs are psychoactive drugs with dependence (addiction) and abuse potentials. They evolved from free-trade goods to scheduled substances that are strictly regulated in the United Nations drug-related Conventions. This paper began with a brief review on the history of addictive substance abuse in Taiwan. Then the progress of controlled-drug-related law enactment and the functions of National Narcotics Bureau and its successor, National Bureau of Controlled Drugs, were succinctly depicted. The experiences of substance abuse prevention and control, which have been accumulated in the past two decades since the methamphetamine deluge, have evolved into a controlled-drug regulatory system that now conforms to the spirit of the three UN anti-drug Conventions in general and a comprehensive system for the surveillance and prevention of substance abuse. However, according to the present substance-abuse problems and future developing trend, it is advised that (1) the operation of scheduling system should be more expertized and the inspection should be further strengthened; (2) whether the narcotic manufacturing maintains the status quo as a monopoly or seeks privatization should be based on the benefit of the general public; (3) in addition to the law enforcement from the supply side, a thorough anti-drug strategy should be equipped with a monitoring and reporting system for early substance-abuse detection and surveillance, a proactive education program that touches the need of the risk groups and a cost-effective and humanistic treatment program.

Key words: controlled drugs, substance abuse, legislation, drug policy, UN conventions, harm reduction

INTRODUCTION occur until the Shanghai Opium Commission was held in 1909. China, the first and main country plagued by the opium Controlled drugs refer to a variety of psychoactive drugs epidemic, maneuvered to call for such international coop- or substances that possess dependence (addiction) and abuse eration(2). The declaration of the Shanghai Opium Commis- potentials. Individuals who abuse or misuse such drugs often sion gradually evolved into the 1961 Single Convention on enter a miserable relapse cycle(1). Drug (substance) abuse or Narcotic Drugs(3). Subsequently, the United Nations (UN) misuse not only undermines an individual’s health, but also expanded the control of narcotics to psychotropic substances results in substantial medical and social problems. As a result, and precursors by enacting two additional Conventions, i.e., both national and international authorities impose strict regu- the 1971 UN Convention on Psychotropic Substances(4) and lations on the flow and use of these drugs. the 1988 UN Convention against Illicit Traffic in Narcotic Current international drug control system originates Drugs and Psychotropic Substances(5). However, the latter from endeavors made a century ago to address the Chinese two UN Conventions did not take effect timely in Taiwan opium epidemic, which was regarded as the largest substance because Taiwan has been deprived of the UN membership abuse problem the world has ever had(2). This epidemic, as since 1971. As a result, the methamphetamine epidemic it is now known to all Chinese, occurring in the nineteenth occurred in the 1990s. century during the reign of Qing Dynasty of China, has The author, as the last-term director-general of National begotten aftermath and legacies, especially in the aspects of Narcotics Bureau and the first-term director-general of international treaties, conventions and regulations. Although National Bureau of Controlled Drugs under the Department many countries have exerted efforts in implementing anti- of Health, Taiwan, R.O.C. from 1994 till 2005, witnessed the drug policy and measures since the epidemic, a truly inter- drastic changes in drug abuse situation and was involved in national cooperation to tackle this global problem did not the law enactment and policy-making of addictive substance control. Therefore, the author briefly reviews the progress * Author for correspondence. Tel: +886-7-3121101 ext. 2651; Fax: +886-7-3210683; E-mail: [email protected] of legislative and administrative system for the control of 779

Journal of Food and Drug Analysis, Vol. 20, No. 4, 2012 THE 20TH ANNIVERSARY ISSUE controlled drugs in Taiwan in the hope of providing refer- inspect medical narcotics in Taiwan(8). ences for the future direction. III. National Narcotics Bureau as a State-run Enterprise from 1959 through 1999 in Taiwan BRIEF HISTORY OF ADDICTIVE SUBSTANCE CONTROL IN TAIWAN After World War II, Japan was defeated and the Republic of China resumed jurisdiction on Taiwan. There were only I. Japanese Colonial Government and Opium Licensing some two thousand opium addicts left and Taiwan was essen- Policy (1895-1945) tially drug free in the subsequent two decades (1940s and 1950s)(6). However, sporadic cases of substance abuse were In the early seventeenth century, opium was a common still observed from time to time. These included glue sniffing commercial product during the Dutch occupation period. As (inhalation of toluene) in the 1960s, pentazocine in the one of the free-trade goods, opium was readily available. 1970s, and sedatives-hypnotics (secobarbital, amobarbital After the Qing dynasty of China took over Taiwan in the late and methaqualone) in the early 1980s. It was estimated that seventeenth century, opium smoking has already become a the substance-abuse population would be several thousand popular social hobby even though it was officially banned. at most(6). As a result, there was no legislation for compre- In 1895, the Qing dynasty ceded Taiwan to Japan after losing hensive management and control of psychotropic substances, the Sino-Japan War(6). Opium smoking, with a prevalence such as sedatives-hypnotics that were scheduled in the 1971 of 6.3% (some 169,000 opium addicts of the total 2,500,000 Convention on Psychotropic Substances(4) at the time. inhabitants in 1900), was one of the most serious social prob- In 1959, the NNB was categorized as one of the state- lems in Taiwan at that time. Then, the colonial government run enterprises by the Executive Yuan(8). Therefore, the high adopted the “opium licensing” policy by selling opium to priority of the NNB was to pursue excess surplus in every licensed opium addicts with the government monopoly(6). fiscal year rather than to prevent medical narcotics from Such a policy was similar to today’s methadone maintenance diversion, resulting in a policy that erroneously deviated from program and alleviated the abuse situation eventually(6). its original mission. In 1982, the World Health Organization expressed II. Promulgation of Narcotics Control Act and Establishment concerns over the management of cancer pain and subse- of National Narcotics Bureau on the Mainland quently enacted a guideline for cancer pain relief in 1986(9). In Taiwan, however, probably due to the profound influ- Although the 1909 Shanghai Opium Commission was ence of the Opium War, both physicians and patients were the first international cooperation to encounter the global very conservative towards the narcotic use for cancer pain drug problem, its declaration was non-binding. Therefore, treatment. In order to manage the pain problem of cancer a genuine binding convention, the International Opium patients, the NNB promulgated the guideline for clinical use Convention of The Hague, which was designed to curb ship- of medical narcotics and the guideline for homecare use of ments of narcotic drugs from non-medical purposes, was held medical narcotics in terminal cancer patients in 1993, and in 1912 and took effect in 1915(2). Subsequently, under the collaborated with the Taiwan Pain Society to develop an mandates of the League of Nations, three main conventions educational program that trained the medical professionals on were further developed in 1925, 1931 and 1936, respectively. proper prescription of opioids (mainly morphine) for patients Accordingly, the Republic of China (ROC) on the mainland with cancer pain or in hospice care in 1995(10,11). Meanwhile, enacted and promulgated in 1929 the first law for medical the NNB-affiliated pharmaceutical plant developed the first narcotics control, the Narcotics Control Act(7). The National new medicine of morphine sulfate controlled-release tablet Narcotics Bureau (NNB) was thereby established in Nanjing (30 mg) in 1996(12) and marketed the product in 1999(10). As in 1935 under the Hygiene Research Institute of the Ministry a result, in Taiwan from 1987 to 2010, while the consump- of Interior to supply narcotics for medical and scientific tions of codeine and pethidine remained stable, a 33.9-fold purposes(8). However, the breakout of the Second World War increase in oral morphine consumption was observed(13), and the invasion of the Japanese military forced the newly implying the education program did have a beneficial effect established NNB to meander westward with the Central for the cancer patients (Figure 1). Government of ROC to Chongqing, Sichuan(8). The Second World War ended in 1945 and the NNB resumed its full func- tions in Nanjing. In 1946, the Shanghai and Beijing sales RECENT SITUATION OF SUBSTANCE ABUSE branches, as well as the Tianjin and Changsha sales repre- AND ANTI-DRUG MEASURES sentative offices were established. In 1947, the Taiwan sales representative office was established. In 1949, all the sales I. Deluge of Methamphetamine Abuse and Revision of the offices and sales representative offices on the mainland were Obsolete Laws in the 1990s seized by the communists due to the civil war. The NNB, along with a shipment of 26 tons of opium reserve, resumed Along with the lift of martial law and flourishing its official functions to manufacture, supply, distribute and economy in Taiwan in the early1990s, methamphetamine 780

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35 and 1988) UN drug-related Conventions and followed the UN drug scheduling system to classify addictive substances 30 Morphine Codeine Pethidime into four schedules. Furthermore, in the new Acts, an addict’s status was switched from a criminal to a “diseased criminal,” 25 a term coined to describe the status of an addict who would obtain full medical and psychosocial treatments in a correc- 20 tion center. The Controlled Drugs Act also authorized the National Bureau of Controlled Drugs (NBCD), which was 15 reorganized from the NNB on July 1, 1999, to be responsible for the control of licit use and flow of controlled drugs(24). 10 Fold change in consumption in change Fold (with amount in 1987 as 1 unit) 5 II. Establishment of National Bureau of Controlled Drugs and Construction of Anti-drug Infrastructures 0 87' 88' 89' 90' 91' 92' 93' 94' 95' 96' 97' 98'99 ' 00' 01' 02' 03' 04' 05' 06' 07' 08' 09' 10' From its establishment in 1999, the NBCD, in collabora- Year tion with the Ministry of Justice and the Ministry of Educa- Figure 1. Consumption of oral narcotic analgesics from 1987 to 2010 tion, endeavored to construct the comprehensive anti-drug in Taiwan. infrastructures that included: (I) Implementation of drug-flow and use control system to ensure controlled drugs for medical and scientific purposes: abuse surged with a prevalence of ca. 1% in the total popula- In accordance with the Controlled Drugs Act(23), addictive tion(14). In addition to the methamphetamine deluge, cases of drugs were classified into 4 schedules and a licensing system heroin abuse also began to increase. To cope with the esca- was established to mandate all handlers to register when lating situation of drug abuse, the Executive Yuan (Cabinet) possessing or using controlled drugs. To prevent diversion or organized the Central Anti-Drug Committee (CADC) in misuse of controlled drugs, periodical submission of records February 1994 to tackle the problem from both supply and of drug flow and use to the NBCD was required by law and demand sides(15). Under the CADC, three task forces, namely these records were subjected to inspection by the NBCD and seizure enforcement, anti-drug education, and addiction treat- local health bureaus. By the end of 2001, two years after the ment, were structured and led by the Ministry of Justice, the establishment of NBCD, 11,531 certificates of controlled Ministry of Education, and the Department of Health, respec- drugs for legal possession (41.53% or 11,531/27,764 of all tively. However, methamphetamine and its precursors such professional institutions) and 29,743 licenses for prescrip- as ephedrine and pseudoephedrine, which are not narcotics, tion of controlled drugs (70.96% or 29,743/41,915 of all belong to the domains of the 1971 Convention on Psychotropic medicine-related professionals) were issued. As of December Substances and the 1988 United Nations Convention against 2011, the issued certificates and licenses have steadily Illicit Traffic in Narcotic Drugs and Psychotropic Substances. increased to13,760 (41.30% or 13,760/33,317) and 44505 Taiwan’s two obsolete anti-drug related laws, i.e., the Act for (85.67% or 44,505/51,952), respectively. The functions of the Eradication of Narcotics (for illicit narcotics control) and the controlled-drug management system complied with the three Narcotics Control Act (for licit narcotics control), conformed UN anti-drug Conventions. Therefore, when the NBCD was only to the UN 1961 Single Convention on Narcotic Drugs. mandated to merge into the Taiwan Food and Drug Adminis- Furthermore, the policy and effectiveness of addiction treat- tration (TFDA) in 2010, the scheduling and licensing systems ment was hard pressed to be evaluated because incarceration remained unchanged except that the incumbent agency now was the only solution for narcotic addicts as stated in these two became TFDA. Acts(16). To acquire the experiences of anti-drug programs and (II) Implementation of a comprehensive substance related legislation from other countries, the NNB elaborated abuse detection and reporting system to monitor the trend a plan to visit drug control-related institutions and organiza- of substance abuse and identify the high-risk groups for tions in many countries including the Netherlands, Belgium, preventive of substance abuse(25). Because misuse or abuse Sweden(17), U.S.A.(18), Malaysia, Singapore(19), Korea(20), of schedule I and II drugs are punishable by law, as a result, the United Kingdom, France and Germany(21). One of the the illicit drug use is often underestimated with only a single main conclusions of the reports from these official visits surveillance system. Therefore, with the anti-drug measures pointed to the necessity of immediate law reform to fully implemented in the U.S. and some European countries as abide by the UN Conventions. Thus, the “Act for Prevention reference(17,18), a comprehensive detection and reporting and Control of Illicit Drug Hazard(22)” was enacted in May system was established. This system was composed of: 1998 to replace the old “Act for Eradication of Narcotics”. 1. Data collection subsystem on arrests, seizures and For licit drug control, the Narcotics Control Act was also laboratory testing for urine samples. The data were collected revised and promulgated as the Controlled Drugs Act in June monthly from the Investigation Bureau, Ministry of Justice; 1999(23). the National Police Administration, Ministry of Interior; These two new Acts incorporated all three (1961, 1971 the Headquarters of Military Police, Ministry of Defense; 781

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Department of Health, and all local Health Departments. can also be used to learn the pattern and trend analysis of drug These data have been useful in monitoring the trend of drug abuse. In a study conducted by the NBCD on 931 urine speci- abuse so that one can evaluate whether the anti-drug measures mens with a broad-spectrum drug-screening HPLC system as are effective in Taiwan. In addition, sharing of drug informa- the detection tool, the club drug use profile was successfully tion from the supply or demand sides is very important in the evaluated(32). international anti-drug efforts. The information sharing has (IV) Promotion of anti-drug education program in also played an important role in the collaborative relation- collaboration with the Ministry of Education. Substance ship with international anti-drug organizations such as Asian abuse results from many factors and can be discussed from Multicity Epidemiology Workgroup (AMCEWG) and United a variety of dimensions(33). Because the first-time abuse of Nations Office on Drugs and Crime (UNODC)(14,25,26). addictive substance occurred in the 12-17 years old, drug 2. Reporting subsystem for addiction treatment. In education focusing on the youth was deemed reasonable(33). collaboration with the designated medical care institutions According to the mandate from the Act for Prevention and and private institutions for addiction treatment, the toxi- Control of Illicit Drug Hazard and the assignment of the cology counseling laboratories of the Veterans General CADC, the incumbent agency for drug education program was Hospital and the Kaohsiung Medical University Hospital, the the Ministry of Education(15). The NBCD therefore worked NBCD set up an on-line reporting channels and a surveil- together with the Ministry of Education on drug education by lance and reporting system. The system first identified a surge helping training cadet teachers in the national normal univer- in the proportion of intravenous drug users (IDUs) among sities and providing professional expertise, skills and knowl- all addiction treatment admissions (from 34.7% in 2000 to edge on drug education. For example, a questionnaire survey 63.9% in 2004), as well as in the proportion of IDUs sharing was conducted by the NBCD on the high school students who needles (from 4.0% in 2000 to 15% in 2004)(6). The report of participated in the anti-drug ambassador campaign to learn this alarming trend facilitated the implementation of national their awareness on the danger of drugs(34). The results were harm reduction program by the Department of Health in discussed and incorporated in the drug education materials Taiwan(27). By the end of 2011, although the proportion for the high school students. of IDUs among addiction treatment admissions remained (V) Evaluation of effectiveness of an anti-drug program high (68.6%), the proportion of IDUs sharing needles has or policy from the aspect of total social costs. Although drug decreased to 3.4%. abuse is known to cause a lot of medical and social prob- 3. Reporting subsystem of HIV/AIDS from the Center lems that would eventually lead to tremendous social costs, for Diseases Control, Department of Health. Because of the it also deserves our attention to see if an anti-drug program association between needle sharing among drug users and or policy is cost-effective. A study conducted on the social HIV infection, the system served as a real-time sentinel to costs of drug abuse in Taiwan in 1996 found that incarcera- monitor the situation of HIV spread due to drug use. tion and medical treatment cost 2.06 billion NTD and 2.38 4. National Household survey: In order to understand the billion NTD, respectively. If the costs of human capital of lifetime prevalence of substance abuse in the general popula- 6.05 billion NTD were added, the total social costs would tion, a cross-sectional study was conducted by the NBCD on sum up to 10.49 billion NTD in 1996(35). At a time when our the Greater Taipei area in 2004. The prevalence rate of illicit resources are limited yet our social problems seem unlimited, drug use was 1.6%. The major illicit drugs were amphetamine, the concept of cost-effectiveness will not only determine the marijuana, and glue(28). The experiences obtained from this priority of public issues, but also reasonableness of the costs. study were then extended to the lifetime prevalence survey of substance abuse of the general population in Taiwan by a joint task force of NBCD, National Health Research Institute and CONCLUSIONs AND FUTURE TREND National Bureau of Health Promotion in 2005(29). (III) Implementation of national certified laboratory As shown in Figure 2, the urine drug testing results indi- program for urine drug testing. In 1995, a laboratory certifi- cated that the abuse of methamphetamine, the predominant cation program, focusing on the detection of amphetamine(s) substance of abuse in the early 1990s, has been stabilized since and morphine in the urine in response to the heavy burden of the late 1990s. While the results may imply that the strategies drug testing endured by the local health bureaus, was initiated of supply reduction and demand reduction on methamphet- by the National Laboratories for Food and Drug Analysis(30). amine abuse have worked, it is also noteworthy that the trend After the NBCD was established, the program was expanded of heroin and ketamine abuse has been on the rise since early and re-implemented in the NBCD to cope with the escalating 2000s. In fact, a new trend of heroin use with needle-sharing drug abuse situation. Some new drugs of abuse, such as and club drug use with unprotected sex may have triggered 3,4-methylenedioxy-N-methylamphetamine (MDMA) and the spread of HIV(6). In 2005, harm reduction was adopted by ketamine, have been added in this new national certified labo- the Department of Health as a new strategy to curb the drug ratory program for urine drug testing(31). In 2001, the NBCD problems in addition to two other strategies of supply reduc- has certified 13 laboratories, which remained the same as of tion and demand reduction. Although Taiwan Centers for August 2012. In addition to serving as an objective tool to Disease Control proclaimed a dramatic 10% decrease in all detect recent drug use for court referral, urine drug testing new HIV seropositive after implementation of national pilot 782

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Total(+) cases Cases Morphine(+) cases 90,000 Methamphetamine(+) cases Morphine(+) cases & Methamphetamine(+) cases 80,000 MDMA (+) cases Ketamine (+) cases 70,000

60,000

50,000

40,000

30,000

20,000

10,000

– 93' 94' 95' 96' 97' 98' 99' 00' 01' 02' 03' 04' 05' 06' 07' 08' 09' 10' 11' Year Figure 2. Results of laboratory testing on the urines collected from drug offenders in Taiwan from 1993 through 2011. Methamphetamine and heroin were the two predominant drugs abused in the 1990s. Heroin is presented as its major metabolite, morphine, in the urine.

harm reduction program (PHRP) in 2005(36), our study(27), by in 2008(37). Control of drug precursors, such as ephedrine analyzing the risk and protection factors for HIV incidences and pseudoephedrine that are used for clandestine metham- among the regions with and without PHRP, showed that the phetamine manufacture, has been shown to work to reduce methadone maintenance treatment program was associated methamphetamine use(38-40).While it is important to prevent with higher HIV incidence, probably due to the concurrent overconsumption or misuse of licit controlled drugs, proper HIV testing upon admission. Further analysis indicated the health care to alleviate pain and suffering, especially cancer mandatory HIV testing executed in 2004 and the educational pain, is equally important(41). Therefore, the balance between program were essential for the effective HIV control upon law enforcement and pain control should be delicately justi- implementing the PHRP(27). Hence, the historical lesson is fied. In addition, to cope with challenges of globalization and that any anti-drug policy should be well planned before its new communication technologies, such as illicit drug shop- implementation for the sake of true cost-effectiveness. ping through internet, strategies and methods of law enforce- The experiences of substance abuse prevention and ment should be reshuffled(41). control have evolved into a controlled-drug regulatory With respect to the drug scheduling system, the crisis system that now conforms to the spirit of three UN anti-drug may come from new addictive substances that have not Conventions in principle. By the same token, a comprehen- been controlled by the UN scheduling system. Two well- sive system for monitoring and prevention of substance abuse known examples are ketamine and Salvia divinorum, which has also been established. Albeit we have learned a lesson have not yet been scheduled in the UN Conventions but from the methamphetamine epidemic, there are potential have been widely abused in the East Asia and in the United threats that await further endeavors: States, respectively(42,43). In Hong Kong, ketamine has even I. On balance between law enforcement and freedom replaced heroin as the drug of choice among the young drug from pain and suffering: the scheduling system for new abusers since 2000(42). Recently, based on a nine-category addictive substances and strength of inspection. matrix of harm, ketamine has been evaluated as a drug that After the Act for Prevention and Control of Illicit Drug is even more harmful than some scheduled drugs, including Hazard and the Controlled Drugs Act were enacted, the spirit cannabis, LSD and Ecstasy (MDMA)(44). For an addictive of three UN anti-drug Conventions is essentially observed. The substance that has not been listed in the UN Conventions but drug scheduling system that classifies addictive substances has caused serious abuse problems in a country or region, into suitable schedules and the licensing system that moni- scheduling of such a substance for control is imperative. In tors the drug flow and use are the two main pillars to main- Taiwan, although ketamine has been classified as a schedule tain the integrity of licit controlled-drug use. The licensing III drug, the ketamine seizures have been huge in recent system requires the reports/records submitted or kept by the years: from 598.7 kg in 2007, 799.5 kg in 2008, 1186.4 kg in licensees inspected from time to time. Without the strength 2009, 2594.3 kg in 2010, to 1371.9 kg in 2011(42).However, of inspection to monitor the drug flow and use, the licensing re-scheduling of ketamine has been stalled for years due to system alone would not work by itself. Prescription pain lack of consensus among the members of Committee for relievers and drug precursors are two important categories Drug Scheduling. Thus, development of a rational scale for for control. In the U.S., nonmedical use of prescription pain an objective decision-making of drug scheduling is in need. relievers such as hydrocodone, oxycodone, and morphine in II. On supply of medical narcotics and contingency the past years among the population have been the second inventory: privatization or state-run monopoly of narcotic highest in prevalence among illicit drugs, after marijuana manufacturing. 783

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There have been debates on whether the pharmaceu- drug policy: In addition to law enforcement from the supply tical plant of controlled drugs (PPCD) that is now affiliated side, a thorough anti-drug strategy should be equipped with the TFDA should be privatized. For decades, medical with a monitoring and reporting system for early detection narcotics were supplied and distributed through a sole source and surveillance of substance abuse, a proactive education of government monopoly, the NNB or NBCD. While the program that touches the need of the risk groups and a cost- narcotics were conveniently controlled, medical needs were effective and humanistic treatment program for addicts. also successfully met. Since the NNB was re-organized as the To detect any new drug that can potentially undermine NBCD, the budgets for medical narcotic supply and produc- our health, a sentinel reporting system should be fully imple- tion had no longer been criticized for profit-making because mented. Such a system can be maneuvered through urine the PPCD was not a state-run enterprise. Instead, as an inte- drug testing or any epidemiological means. In the U.S., for grated part of the administrative system under the NBCD, it example, the report of Community Epidemiology Work Group was in fact easier for drug-flow control. However, the PPCD (CEWG) that integrates drug abuse information of metropo- is now under the jurisdiction of TFDA whose mission is to lises from both supply and demand sides is very useful in supervise all pharmaceutical products. On January 26, 2011, giving early warning of every emerging major drug trend in the Controlled Drugs Act was revised so that the PPCD is recent decades(47). An early detected drug of abuse can be permitted to operate as a state-run company(45). A draft statute very helpful for preventive purposes. An education program on the structure and function of the company have been can then be designed to prevent the potential abuse problem. discussed and passed by the Executive Yuan(46). However, As study on Drug Abuse Resistance Education (DARE), the before the draft is read into law by the , there most widely disseminated school-based prevention program are several factors that may be worthwhile to ponder: in the United States failed to indicate its effectiveness against (I) According to this newly revised Controlled Drugs drug use(48), such a result reveals the difficulty in evaluating Act (45), the status of the company in essence becomes a state- the effectiveness of drug education(49). run monopoly again. However, this company is still affiliated The effectiveness of drug abuse treatment is often ques- with the TFDA. Therefore, the issue of conflict-of-interest tioned because the relapse rate is relatively high(50). For best remains. cost-effective results, different treatment models are usually (II) During the days of NNB, the licensing system, with required for each drug with different pharmacological char- an aim to qualify the holders of controlled drugs and to monitor acteristics and dependent potentials(51,52). Nevertheless, with the drug flow and use, was not yet established. Therefore, the the cost of decreasing cocaine consumption by 1% as the indi- operation of a state-run monopoly was reasonable. However, cator of comparison, it was found that treatment programs are as such a licensing system has been established, maintenance more cost-effective than enforcement programs that included of a state-run enterprise may not be so critical. Manufacture, source-country control, interdiction and domestic enforce- distribution and sale of medical narcotics by private compa- ment(53). Furthermore, with evidence-based approaches, drug nies are common in most advanced countries. However, abuse treatments can significantly reduce drug use and crime, the current Controlled Drugs Act(45) states manufacture of thus improving health and social function for drug users(54). schedule I and II drugs is the responsibility of TFDA’s PPCD, Thus, it is highly recommended that our national drug and the reshuffle of PPCD as a state-run company or fran- policy should be elaborated with the concepts of total social chise/entrustment is pending at the Legislativer Yuan. Should costs and cost-effectiveness so that the budgets for various the manufacture of schedule I and II drugs be commissioned, anti-drug programs can be reasonably allocated. the function of a state-run company for easy monitoring of drug flow would no longer exist and thus be replaceable. (III) Would the reserve of opioids for contingency situ- ACKNOWLEDGMENTS ations, which has been a national policy for decades, be still kept by the government? For a company whose goal is profit- The author would like to thank Wen-Jing Yu for her making, it would be a capital loss if large quantity of opioid assistance in preparation of the figures. This work was reserve is stocked. supported in part by grants from Kaohsiung Medical Univer- (IV) In the long run, would a small company with a sity (KMUER013) and from Taiwan Food and Drug Admin- limited capacity for research and development operate cost- istration (DOH101-FDA-61401). effectively? Unless the business policy of the company is shifted to export products, the expansion of the company would be difficult. REFERENCES If the government monopoly is to sustain, the strength and weakness of keeping a state-run company should be eval- 1. Li, J. H. and Lin, L. F. 1998. Genetic toxicology of uated by justifying the total social costs. Whether the narcotic abused drugs: a brief review. Mutagenesis 13: 557-565. manufacturing maintains the status quo as a monopoly or 2. 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