New Psychoactive Substances: Where Lies the Regulatory Problem?

Author: Lin Wei-Ting^[1]　Legal Policy Researcher, Judicial Reform Foundation

The Regulatory Net for New Substances in Taiwan

Taiwan's regulatory net for new substances is roughly intertwined by the Controlled Drugs Hazard Prevention Act, the Pharmaceutical Affairs Act, and the Controlled Drugs Act^[2]. These laws have a division of labor among them while also having overlapping regulatory scopes. There are regulatory gray areas and areas that genuinely fall outside regulatory reach, which will be explained respectively below.

(1) Controlled Drugs Hazard Prevention Act

When the government deems a new substance harmful and finds it necessary to adopt regulatory measures such as prohibition and criminal sanctions, the substance is scheduled as a "drug" under the Controlled Drugs Hazard Prevention Act. "Drugs" are divided into four schedules based on their addictiveness, abuse liability, and social harmfulness (hereinafter referred to as the "three traits of drugs"), which determine the varying severity of penalties. Schedule 1 carries the heaviest penalties and Schedule 4 the lightest, with Schedule 4 also including drug precursor materials. According to current drug scheduling practices, only substances with established domestic abuse trends are scheduled. This also forms the backdrop for the Ministry of Justice's proposed amendments: when new substances first enter Taiwan, they cannot be penalized as drugs upon initial seizures. It requires waiting until domestic abuse trends are confirmed before a new substance is scheduled as a drug.

This does not mean that once a substance is scheduled as a drug, it is entirely barred from circulation or use in Taiwan; rather, its circulation or use must be opened up through other laws that establish justified reasons and scopes for circulation and use. This is an important function of the Controlled Drugs Act.

Not all abused substances can be scheduled as "drugs." The two major categories of abused substances that cannot be scheduled are as follows:

1. Doubtful Psychoactivity

   According to Article 2 of our country's Controlled Drugs Hazard Prevention Act, to be scheduled as a drug, a substance must first constitute "narcotic drugs and their preparations, and psychoactive substances and their preparations." Conversely, substances whose psychoactivity is in question cannot be scheduled as controlled drugs. For instance, nitrites commonly found in recreational drugs are colloquially known as Rush Poppers. In July 2018, the Liberty Times published a report entitled "Judicial Topics: New Drugs Emerging Constantly, Many Cases Beyond Legal Reach":

   When cracking down on drugs in the past, police often encountered new substances that had not yet been scheduled, such as… Rush, a restricted drug frequently used to "enhance sexual pleasure." Even when knowing full well that its effects resemble those of drugs, authorities were helpless and could only passively submit reports to central authorities to study and plan its scheduling, becoming a major loophole.

   Rush is not scheduled as a drug because psychoactive substances must, in principle, be able to cross the blood-brain barrier, directly affect the central nervous system, and produce stimulant, depressant, or hallucinogenic effects. However, Rush does not directly affect the central nervous system; it is a smooth muscle relaxant commonly used among gay men to enhance sexual pleasure, at most affecting blood vessels via smooth muscle relaxation. Since the brain also contains blood vessels, it has an indirect effect.

   Rush indeed presents situations of abuse, and how it should be regulated has become a problem. When the UK enacted the Psychoactive Substances Act, this was debated, and it was eventually decided to exclude it from the scope of the act for the reasons mentioned above. Japan regulates Rush as a designated substance under the Pharmaceutical Affairs Act (currently renamed the "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices," but referred to as the Pharmaceutical Affairs Act here for simplicity). However, this is somewhat problematic because, by definition, designated substances are substances that "are highly likely to produce stimulation, depression, or hallucinations on the central nervous system, and when used on humans, may pose hazards to public health and hygiene" (see Apple Daily, Sun Ping: How Japan Regulates New Psychoactive Substances). As noted earlier, Rush does not directly affect the central nervous system, making its classification as a designated substance already quite strained. Listing it under Japan's narcotics-related laws—equivalent to our Controlled Drugs Hazard Prevention Act—is even more impossible. Even if the Ministry of Justice's proposed amendments to the Controlled Drugs Hazard Prevention Act to bulk-schedule new drugs pass, they would not be suitable for scheduling Rush.

   Does inability to schedule it as a drug mean it cannot be penalized? The answer is: recreational use of Rush is penalized through the Pharmaceutical Affairs Act as unapproved unauthorized import or manufacture, because its import, sale, or supply is currently penalized under unapproved pharmaceuticals/fake or prohibited drugs (see Taiwan High Court 100-Su-3680 Judgment, Kaohsiung District Court 94-Su-4282 Judgment). This part will be explained in the subsequent discussion on the Pharmaceutical Affairs Act.

2. Widespread Social Use

   Some substances could arguably be considered "narcotic drugs and their preparations, and psychoactive substances and their preparations," with high addictiveness, abuse liability, and social harmfulness, yet they are not scheduled as drugs because of widespread social use—such as alcohol.

   Alcohol is frequently used in domestic and foreign studies to compare with substances scheduled as "drugs." Regular alcoholic beverages contain ethanol, whose molecules are quite small, enabling rapid absorption by the human body and the ability to cross the blood-brain barrier to directly affect the central nervous system. Ethanol exerts a depressant effect on the central nervous system and promotes the brain's reward center to release more dopamine, triggering the activation of the brain's pleasure circuit. Chronic heavy drinking severely damages bodily systems such as the brain, liver, and digestive system, and excessive drinking can even be fatal. The physiological withdrawal symptoms of alcohol are also very dangerous and carry the possibility of death.

   Why is alcohol not scheduled as a drug? That is because the basic operational mechanism of the Controlled Drugs Hazard Prevention Act is criminal punishment. If a criminal penalty were established and a considerable number of people in society violated it, the criminal justice system would overload and fail to function altogether. Unless criminal penalties can be paired with the severance of substance sources and strict social monitoring, criminalization would merely lead to the collapse of the criminal justice system or even worsen social order. Refraining from regulating alcohol through criminal penalties does not mean it is unregulated; rather, it is governed through various administrative methods, including taxation, age restrictions on acquisition, state manufacturing or authorized manufacturing to ensure quality (poor brewing processes can produce methanol, which is far more harmful than ethanol), and public education and advocacy.

(2) Controlled Drugs Act

In our country, new substances may be scheduled not only as "drugs" under the Controlled Drugs Hazard Prevention Act, but also as "controlled drugs" under the Controlled Drugs Act, similarly categorized into four schedules. Why must a substance be scheduled as a "controlled drug" in addition to being scheduled as a "drug"? What is the difference between the two? To explain this, we must first introduce Taiwan's rather unique legislative model of the "separation of narcotics and drugs/medicines."

United Nations conventions (the Single Convention on Narcotic Drugs of 1961 and the Convention on Psychotropic Substances of 1971) and most countries worldwide adopt a legislative model that combines narcotics and medicines, meaning that once a substance is scheduled, the law defines the permitted scope of manufacture, circulation, or use, alongside penalties for exceeding that scope. However, Taiwan's "separation of narcotics and medicines" legislative model operates as follows: the Controlled Drugs Act governs the legal scope and administrative regulatory measures for manufacture, circulation, or use based on medical and scientific needs, along with administrative penalties for non-compliance with administrative regulations; whereas the Controlled Drugs Hazard Prevention Act governs criminal and administrative penalties for manufacture, circulation, or use without justifiable reason outside medical and scientific needs. For example, morphine is a common painkiller, and how it circulates according to medical needs is handled under the Controlled Drugs Act. But if an individual privately purchases morphine from a dealer for personal use, they fall under the scope of the Controlled Drugs Hazard Prevention Act. If morphine were not scheduled as a controlled drug, hospitals would not even be able to prescribe morphine to patients for pain relief.

The foregoing mainly concerns scheduling aspects. Next, the Controlled Drugs Act also contains provisions regarding the monitoring and early warning mechanism for controlled drug abuse. This mechanism now extends not only to already scheduled controlled drugs but also to unscheduled emerging abused drugs; this constitutes the legal basis for our country's new substance monitoring and early warning mechanism. Article 34-1 of the Controlled Drugs Act stipulates: "To detect controlled drug abuse and conduct early warning advocacy, the central health competent authority shall establish a monitoring and early warning reporting system, and may reward medical (institutional) and other relevant institutions, organizations, and personnel who report abuse cases; the reporting targets, contents, procedures, and relevant reward measures shall be prescribed by the central health competent authority." Furthermore, Article 5 of the Regulations Governing the Reporting and Rewarding of Controlled Drug Abuse, promulgated pursuant to the authorization of this article, stipulates: "Emerging abused drugs that have not yet been reported to the Executive Yuan for approval, announcement, and categorized management pursuant to Article 3 of this Act may, upon review and determination by the central health competent authority, be governed mutatis mutandis by the reporting provisions of these Regulations."

Some readers may wonder why monitoring and early warning are prescribed in the Controlled Drugs Act rather than the Controlled Drugs Hazard Prevention Act, given that the focus of monitoring clearly lies on abuse rather than purposive use. The legislative reasoning behind the addition of Article 34-1 to the Controlled Drugs Act in 2004 sheds light on this:

Controlled drugs are restricted to medical and scientific uses; if allowed to fall into abuse, they will endanger personal health and public safety.
Using controlled drugs without justifiable medical reasons constitutes drug abuse. Our country's prevention strategy is divided into the supply side and the demand side. Cutting off drug supply is primarily the responsibility of judicial investigative and police authorities, while the Bureau of Controlled Drugs of the Department of Health under the Executive Yuan primarily focuses on reducing demand through early warning advocacy. To grasp abuse trends, it is necessary to establish an early warning system.

Simply put, it is a matter of division of labor. The competent authority for the Controlled Drugs Hazard Prevention Act is the Ministry of Justice, while the competent authority for the Controlled Drugs Act is the Ministry of Health and Welfare (formerly the Department of Health). Placing the monitoring and early warning mechanism within the Controlled Drugs Act from the perspective of the competent authority has an important significance: monitoring and early warning of controlled drug abuse are crucially important in their own right at the public health level and are not subordinate to drug enforcement. This is even more apparent when the scope of the monitoring and early warning mechanism is explicitly extended to unscheduled emerging abused drugs. In an era where new substances constantly emerge, the monitoring and early warning mechanism becomes all the more critical, because we need to understand what kind of effects new substances have on the human body, whether they will spread on a large scale in society or remain confined to specific groups, whether they will persist or disappear after a short time, and whether they are accompanied by particularly harmful behavioral patterns. The information gathered can serve as a reference basis for new substance prevention strategies as well as the scheduling and grading of drugs and controlled drugs.

Scheduling and monitoring/early warning mechanisms are two different matters. Even if a new substance has not yet been scheduled as a drug or controlled drug, it should still have a monitoring and early warning mechanism, because it is inherently important at the public health level. In fact, one could say that monitoring and early warning should precede scheduling procedurally, because information gathered by the monitoring and early warning mechanism provides the basis for judging whether a substance needs to be scheduled and into which schedule it should be placed.

Although this is how it works conceptually, experts and scholars interviewed point out that the main reason why domestic scheduling has lagged behind the continuous emergence of new substances, as mentioned at the beginning of this article, is that scheduling requires proof of the three traits of drugs. However, two of those traits—abuse liability and social harmfulness—suffer from a bit of a "chicken-and-egg" problem: a substance must have actual abuse facts to be regulated, but if it is not yet regulated, it is difficult to report and record, making it naturally unclear whether abuse and social harm exist. Without proof of abuse liability and social harmfulness, it is difficult to schedule a substance as a drug.

Even though our legal system treats scheduling and monitoring/early warning mechanisms as two separate things, experts and scholars still believe that in Taiwan, a substance must be scheduled before it is easily reported and recorded. This implies that our monitoring and early warning mechanism relies too heavily on law enforcement agencies gathering information driven by arrests and securing convictions, while the importance of monitoring and early warning at the public health level is undervalued. The mechanisms for gathering and utilizing information on new substances from a public health perspective are likely imperfect. Such a monitoring and early warning mechanism can be said to be a severe loophole in the prevention and control of new substances.

Undervaluing the public health dimension of the new substance monitoring and early warning mechanism not only results in insufficient data for discussing drug scheduling and grading, but also reduces the prevention of new substances to issues of "catching suspects to secure convictions" and "detecting substances in forensic tests." For example, when scholars "suggest emulating advanced nations in conducting drug surveillance research to grasp and prevent the influx of new types of drugs at an early stage," the entity that steps forward to issue a press release in response is the Ministry of Justice, not the Ministry of Health and Welfare. The content of the press release emphasizes that the Ministry of Justice is already promoting legislation to bulk-schedule new substances en masse, strengthen testing mechanisms, and enhance advocacy and enforcement.

(3) Pharmaceutical Affairs Act

A substance may be scheduled as a drug while simultaneously constituting a fake or prohibited drug under the Pharmaceutical Affairs Act. A substance constitutes a fake or prohibited drug under the Pharmaceutical Affairs Act when it meets the conditions of Articles 20 and 22 of the Act.

Article 20 of the Pharmaceutical Affairs Act:
Fake drugs referred to in this Act mean pharmaceuticals that, upon inspection or testing, fall under any of the following circumstances:
1. Manufactured without approval.
2. The names of active ingredients contained therein do not match those approved.
3. Products of another person have been substituted or adulterated.
4. The labeling of the expiration date has been altered or replaced.

Article 22 of the Pharmaceutical Affairs Act:
Prohibited drugs referred to in this Act mean pharmaceuticals that fall under any of the following circumstances:
1. Poisonous drugs explicitly ordered and announced by the central health competent authority to be prohibited from manufacture, compounding, import, export, sale, or display.
2. Pharmaceuticals imported without approval. However, this shall not apply to travelers or transport service personnel carrying self-use pharmaceuticals into the country.
The quantity limits for self-use pharmaceuticals referred to in subparagraph 2 of the preceding paragraph shall be announced by the central health competent authority in conjunction with the Ministry of Finance.

The manufacture or import of fake or prohibited drugs shall be penalized pursuant to Article 82 of the Pharmaceutical Affairs Act:
(Paragraph 1) Anyone who manufactures or imports fake or prohibited drugs shall be sentenced to imprisonment for not more than 10 years and may be concurrently fined not more than NT$100 million.
(Paragraph 2) Anyone who commits the crime of the preceding paragraph and thereby causes death shall be sentenced to life imprisonment or imprisonment for not less than 10 years, and may be concurrently fined not more than NT$200 million; anyone who causes grievous bodily injury shall be sentenced to imprisonment for not less than 7 years, and may be concurrently fined not more than NT$150 million.

The sale or supply of fake or prohibited drugs shall be penalized pursuant to Article 83 of the Pharmaceutical Affairs Act:
(Paragraph 1) Anyone who knowingly sells, supplies, compounds, transports, stores, brokers, transfers fake or prohibited drugs, or displays them with intent to sell, shall be sentenced to imprisonment for not more than 7 years and may be concurrently fined not more than NT$50 million.
(Paragraph 2) Anyone who commits the crime of the preceding paragraph and thereby causes death shall be sentenced to imprisonment for not less than 7 years, and may be concurrently fined not more than NT$100 million; anyone who causes grievous bodily injury shall be sentenced to imprisonment for not less than 3 years and up to 12 years, and may be concurrently fined not more than NT$75 million.

There are no penalty provisions for personal possession or use of fake or prohibited drugs. This is because the primary requirement under the Pharmaceutical Affairs Act is for drug providers to supply consumers with lawfully approved pharmaceuticals. Consumers who acquire or use unapproved pharmaceuticals are viewed more as victims rather than criminals.

How can a substance scheduled as a drug simultaneously be deemed a fake or prohibited drug? This is because judicial practice in Taiwan tends to adopt a broad definition of "pharmaceuticals," whereby chemical synthetic substances that, upon ingestion, are sufficient to affect human bodily structures and physiological functions may be considered "pharmaceuticals" (refer to Article 6, Subparagraph 3 of the Pharmaceutical Affairs Act), regardless of whether they involve a medical use context. And any "pharmaceutical" manufactured without approval is a "fake drug." If imported without approval, it is, in principle, a "prohibited drug." Since substances scheduled as drugs must first be "narcotic drugs and their preparations, and psychoactive substances and their preparations," meaning substances scheduled as "drugs" are necessarily "sufficient to affect human bodily structures and physiological functions," it follows that substances scheduled as "drugs," when manufactured without approval, are "fake drugs"; and when imported without approval, they are, in principle, "prohibited drugs." Coupled with the fact that judicial practice also concurrently broadens the definition of subjective intent regarding "fake and prohibited drugs," convictions are easily secured. For instance, judicial practice (such as Supreme Court 104-Tai-Shang-147 Judgment) holds that ketamine is a Schedule 3 drug and a Schedule 3 controlled drug. Pursuant to Article 39 of the Pharmaceutical Affairs Act, Schedule 3 controlled drugs shall be registered with the central health competent authority (i.e., the Ministry of Health and Welfare), and drug licenses must be obtained before they can be manufactured, imported, and used for medical purposes. Anyone involved in unauthorized import is subject to Article 22, Paragraph 1, Subparagraph 2 of the Pharmaceutical Affairs Act and constitutes a prohibited drug; anyone involved in unauthorized manufacture is subject to Subparagraph 1 of the same article and constitutes a fake drug. This is not limited to circumstances where drugs are impersonated or adulterated within a medical use context to constitute fake and prohibited drugs.

In principle, fake and prohibited drugs do not require individual announcements; fulfillment of legal elements warrants punishment. However, under the Pharmaceutical Affairs Act, there are also cases of announced prohibited drugs, namely "poisonous drugs." Taiwan rarely issues announcements for poisonous drugs, and such announcements are difficult to search for, requiring individual inquiries to the Food and Drug Administration (FDA) for confirmation. Currently, the most frequently cited poisonous drug announcement in judicial practice is the poisonous drug announcement regarding amphetamines. Transferring the Schedule 2 drug amphetamine is also frequently deemed to constitute the crime of transferring prohibited drugs under the Pharmaceutical Affairs Act (e.g., Taipei District Court 107-Shen-Su-69 Judgment).

Although judicial practice tends to adopt a broad definition of "pharmaceuticals," it has not yet expanded it to psychoactive "plants"^[3]. In the case of plants rather than chemical synthetic substances, they must be announced as poisonous drugs to trigger the penalty provisions for prohibited drugs. Cannabis is a plant; on October 2, 1971, via Order Wei-Shu-Yao-Zi-04795, "Marihuana" was announced as a poisonous drug. Consequently, transferring the Schedule 2 drug cannabis is also deemed to constitute the crime of transferring prohibited drugs under the Pharmaceutical Affairs Act (e.g., Taichung District Court 104-Shen-Jian-1202 Judgment).

When a substance constitutes both a drug and a fake/prohibited drug, judicial practice currently applies the legal principle of "heavier laws override lighter laws," prioritizing the heavier law (refer to Supreme Court 97-Tai-Shang-3490 Judgment). Because the statutory penalty for transferring fake or prohibited drugs under the Pharmaceutical Affairs Act is heavier than that for transferring Schedule 2 to Schedule 4 drugs under the Controlled Drugs Hazard Prevention Act, when a substance simultaneously constitutes a drug (Schedules 2–4) and a fake/prohibited drug, the transfer act is typically penalized under the crime of transferring fake/prohibited drugs pursuant to the Pharmaceutical Affairs Act. Furthermore, in cases where transferring fake/prohibited drugs results in death (life imprisonment or imprisonment for not less than 10 years) or grievous bodily injury (imprisonment for not less than 7 years), since the minimum statutory penalty is higher than that for the crime of transferring drugs, the Pharmaceutical Affairs Act is also preferentially applied. What circumstances would constitute fake or prohibited drugs in the case of new substances not yet scheduled as drugs? The logic is the same as for those already scheduled as drugs:

• Plant-based new substances, such as kratom and khat. Plant-based new substances must be announced as poisonous drugs to fall within the scope of the Pharmaceutical Affairs Act. Otherwise, under current judicial practice, they do not fit the definition of "pharmaceuticals" and cannot be subjected to the penalty provisions for fake and prohibited drugs under the Pharmaceutical Affairs Act.
• Chemically synthesized new substances, in principle, constitute fake or prohibited drugs. Regulations concerning fake and prohibited drugs do not penalize personal use and possession. Judgments retrieved so far all concern import, manufacture, sale, or other supply acts. However, if a prosecutor indicts a case where the seized substances include both already-scheduled drugs and unscheduled new substances, and the seized quantity of new substances is small with limited impact on sentencing, courts tend to strictly interpret that the new substances do not constitute pharmaceuticals; the criminal offenses concerning fake/prohibited drugs in that respect will be acquitted, though the overall judgment will certainly contain guilty parts and not result in complete acquittal—for example, Taipei District Court 91-Jian-Shang-87 Judgment, Yilan District Court 104-Su-177 Judgment. Examples where defendants involved in import, manufacture, sale, or other supply acts of chemically synthesized new substances were convicted of crimes related to fake and prohibited drugs are summarized below:

It is noteworthy that in some cases sentenced under fake/prohibited drug crimes, the penalties are relatively low: for instance, attempted sale of prohibited drugs involving N-ethylpentylone resulted in 5 months' imprisonment with 2 years of probation. After N-ethylpentylone was scheduled as a Schedule 3 drug, it is hard to imagine similar behavioral patterns maintaining comparable sentencing. This does not mean that sentencing for a substance convicted under fake/prohibited drug crimes will necessarily be low; what is involved here is the court's degree of understanding of the substance and the consequences of the behavior. When the degree of understanding is low and behavioral consequences are unclear, sentencing tends to be conservative. In addition, there are certain behavioral patterns not regulated by the Controlled Drugs Hazard Prevention Act, such as "storing." Such behavior can only be deemed "possession" under the Controlled Drugs Hazard Prevention Act, and possession of Schedule 3 and Schedule 4 drugs is, in principle, subject to administrative penalties. In such cases, even after a substance is scheduled as a drug, the Pharmaceutical Affairs Act may still be applied to heavier penalize the act of storing. For example, Taiwan High Court Taichung Branch Court Criminal Judgment 105-Su-81.

However, there is one new substance that has not been scheduled as a drug because of its widespread industrial use domestically, and judicial practice currently clearly holds that in non-medical contexts, it is not a "pharmaceutical" under the Pharmaceutical Affairs Act and thus does not constitute a fake or prohibited drug: namely, "nitrous oxide N₂O," commonly known as "laughing gas." Supplying N₂O for inhalation purposes was deemed supplying a fake drug with knowledge, resulting in a conviction, in Taoyuan District Court 96-Li-Jian-316 Judgment. Apart from this, however, courts have universally held that outside of medical contexts, N₂O cannot be considered a "pharmaceutical" and thus cannot constitute a fake or prohibited drug. Therefore, even if a defendant knowingly supplies N₂O to unspecified persons for inhalation, it still does not constitute the crime of supplying fake drugs under the Pharmaceutical Affairs Act (e.g., Taoyuan District Court 95-Su-1882 Judgment, Taiwan High Court 104-Shang-Su-2172 Judgment; other acquittal judgments can be found using "laughing gas" as a keyword). Currently, knowingly supplying N₂O for inhalation by unspecified persons is beyond legal penalty.^[4]

During legislative interpellations when lawmakers inquired how to regulate new substances not scheduled as drugs, lawmakers asked the Ministry of Health and Welfare whether the provisions on fake and prohibited drugs in the Pharmaceutical Affairs Act could be used for regulation. The representative of the Ministry of Health and Welfare explicitly stated that the Pharmaceutical Affairs Act is not very suitable for regulating new substances because under the Pharmaceutical Affairs Act, only substances with therapeutic purposes are called pharmaceuticals, otherwise they are purely drugs (refer to Legislative Yuan Gazette, Vol. 107, Issue 44, page 219). Naturally, the Ministry of Health and Welfare may consider the provisions concerning fake and prohibited drugs in the Pharmaceutical Affairs Act "unsuitable" in legal theory for penalizing the import, manufacture, sale, or other supply of new substances. But undeniably, aside from N₂O, judicial practice does indeed use the Pharmaceutical Affairs Act to penalize the aforementioned acts.

Finally, the relationship between new substances (excluding N₂O) and fake or prohibited drugs under the Pharmaceutical Affairs Act is briefly tabulated below.

Having introduced our country's regulatory net for new substances, we can roughly outline the shape of this regulatory net as follows:

Problems with the Ministry of Justice's Draft Bill

After explaining Taiwan's existing regulatory net for new substances, we return to examine the amendment bill proposed by the Ministry of Justice: what effects it can actually achieve, and what side effects it may bring.

The main differences between the revised provisions proposed by the Ministry of Justice and the current provisions are as follows:

Simply put, this adds "pose a risk of" to "addictiveness, abuse liability, and social harmfulness," and expands the scope to "substances having a chemical structure similar to" currently scheduled drugs.

The reasons put forward by the Ministry of Justice for this amendment are:

1. Adding "pose a risk of" is because the original wording easily led to the misconception that there must be actual circumstances of addiction, abuse, and social harm "within the country" before a new substance can be scheduled as a drug. Adding "pose a risk of" allows scheduling by referencing abuse reporting data from various countries in the United Nations' early warning reporting system for new psychoactive substances (NPS), or scheduling based on scheduling practices or data from countries worldwide, without waiting for actual domestic harm to materialize.

2. Adding "substances having a chemical structure similar to" is because the current Review Committee for Drug Review (RCDR) adopts a single-substance sequential review and scheduling model, which cannot cope with the rapid emergence of new substances. Therefore, referencing Japan's designated substance system, it adds the provision allowing substances with similar chemical structures to be scheduled in a single drug review procedure, drastically shortening the timeframe for scheduling new drugs. Taking Japan's approach as an example, between February and March 2013, the competent authority announced 772 new substances, such as "synthetic cannabinoid types," as designated substances in one go.

It is noteworthy that the Ministry of Justice's draft bill emphasizes that new substances must still be scheduled through the drug review procedure and that no substance will be deemed a drug without being scheduled merely because its chemical structure is similar to existing drugs. If this is the case, the statutory text should actually avoid terms like "substances having a chemical structure similar to." This is because such phrasing easily creates the misconception that a substance can be regarded as a drug without scheduling, and precisely how "similar" a chemical structure must be to qualify as "similar" is currently difficult to define legally.^[5]

Assuming for the moment that the phrase "substances having a chemical structure similar to" does not cause the problem of being regarded as a drug without scheduling, based on preceding discussions, the effects that the Ministry of Justice's amendment bill can achieve are:

• It will announce which substances are subject to penalties, and the scope of penalties will be clearer than that of fake and prohibited drugs, which in principle do not require announcement to be penalized.
• Pre-emptive scheduling allows new substances to be penalized under relevant provisions of the Controlled Drugs Hazard Prevention Act as soon as they enter the country. Compared to the fake and prohibited drug provisions of the Pharmaceutical Affairs Act, the primary difference lies in whether users are penalized.

Problems that cannot be solved:

• The inadequacy of monitoring and early warning capabilities at the public health level in Taiwan's new substance prevention.
• How to regulate psychoactive substances in widespread social use.

Potential side effects: confused grading and insufficient rationale.

The reason this article suggests the new law may produce the aforementioned side effects is predicted from problems appearing in current scheduling practices, which will be discussed below.

The scheduling and grading of drugs in our country are decided by the Review Committee for Drug Review (hereinafter referred to as the "RCDR") through voting resolutions, which are subsequently announced by the Executive Yuan. The reports underlying the RCDR's resolutions are not currently made public; however, there are general explanations of amendment drafts for the appendices of various paragraphs of Article 2 of the Controlled Drugs Hazard Prevention Act (i.e., items of Schedule 1 to Schedule 4 drugs not explicitly listed in the statutory text) issued by the Ministry of Justice.^[6] The contents of these general explanations of amendment drafts have become increasingly rich over time. From the latest general explanations of amendment drafts, one can roughly discern that the reports underlying current RCDR resolutions generally encompass the following categories of information:

• Pharmacology and toxicology, accompanied by comparisons with already scheduled drugs sharing similar chemical structures. Because sources are omitted, it is sometimes impossible to fully verify what evidence they are based upon—such as animal experiments, human experiments, molecular modeling, or merely educated guesses. Some entries state that no relevant research exists.
• Addictiveness: Some entries state there is no research related to physical and psychological dependence. Some state "addictiveness is anticipated," which presumably is an educated guess. Others directly state "addictiveness and dependence will occur," but the underlying evidence is not discernible.
Abuse liability and social harmfulness: What dimensions the concept of "social harmfulness" encompasses and what information must be gathered to prove it are not entirely clear. However, textually it appears to be proven through abuse trends and fatality cases. Generally speaking, evidence falls into the following categories:
• Statistics on drug abuser usage reports from medical institutions in the Taiwan region (usually zero).
• Statistics on non-urine specimen test results for suspected drug and controlled drug cases in the Taiwan region (i.e., test results obtained after sending seized suspected illicit drugs and pharmaceuticals to laboratories and testing institutions).
• Statistics on cases seized or accepted for appraisal by law enforcement agencies.
• Statistics on autopsy cases appraised by the Institute of Forensic Medicine, Ministry of Justice.
• International scheduling status: Sources are unclear, and countries mentioned vary each time.
• Industrial uses: The Industrial Development Bureau provides results of industrial survey inquiries.

From the contents of the general explanations of amendment drafts, one can understand why a specific substance should be scheduled as a drug, but the rationale for scheduling it into "which specific schedule" is difficult to discern:

• Drugs with similar chemical structures are scattered across different schedules; grading cannot be directly deduced from chemical structure. For instance, among tryptamine-class central nervous system hallucinogens, dimethyltryptamine and diethyltryptamine are in Schedule 2, 5-methoxy-N-methyl-N-isopropyltryptamine is in Schedule 3, and 5-methoxy-N,N-diisopropyltryptamine is in Schedule 4. Another example is methcathinone in Schedule 2, and 4-methylmethcathinone (mephedrone, 4-MMC) in Schedule 3. Even though chemical structures are "similar," different substances may still possess vastly different mechanisms of action and effects. Therefore, claiming that substances with similar chemical structures should all be graded into the same schedule is unreasonable; one must still look at whether the explanations manifest grading rationales, which are currently not very apparent.
• Addictiveness is stated to exist, but degrees are hard to distinguish.
• The reference value of international scheduling status is unclear. Regulatory frameworks vary across countries, and one can roughly only tell whether international scheduling is prevalent or rare.
• The only discernible pattern is that as abuse trends escalate, substances may be "upgraded." For example, methoxymethamphetamine was upgraded from Schedule 3 to Schedule 2. However, once substance abuse becomes prevalent to a certain degree, upgrading is not easy because heavier penalties bring excessive social side effects—such as the scheduling upgrade issue for ketamine.

Aside from the difficulty in discerning why a substance should be scheduled into "which schedule" from the explanations, existing explanations also show that the rationale for substance grading is flawed. For example, amphetamine-class substances are frequent subjects of discussion in scheduling and grading, yet amphetamine-class substances have different mechanisms of action and resulting effects depending on their chemical structures. These differences are rarely seen in the explanations, let alone how these differences influence decisions on scheduling and grading.

To illustrate this problem, we must first explain the mainstream neurobiological explanation of "addiction" to readers.^[7] The mainstream explanation posits that addiction occurs when the effects of a substance interact with the brain's reward pathway. Many activities in daily life—including specific types of food, sex, gaming, etc.—can stimulate the activity of the reward pathway, causing individuals to feel pleasure when engaging in these activities and to continuously pursue related behaviors. Specific substances or behaviors, such as video games and gambling, become addictive precisely because they "utilize" such reward pathways to satisfy individuals and "modify" these circuits, requiring individuals to seek higher objective levels of stimulation to achieve the same subjective level of satisfaction.

In this circuit, dopamine as a neurotransmitter and the activity of neurons capable of secreting dopamine occupy prominent positions. Of course, merely stimulating dopamine neuronal activity is insufficient to fully explain the physiological and psychological mechanisms of addiction (which include learning, conditioning, memory, withdrawal, and relapse); however, certain highly addictive substances, such as cocaine, amphetamine, and methamphetamine, derive their ability to induce intense euphoria and easily establish subsequent dependence from a strong correlation with their mechanisms of interfering with dopamine neurons. In the case of amphetamine and methamphetamine, their mechanisms of action include: causing dopamine neurons to massively release dopamine into the synaptic cleft, and releasing norepinephrine into the synaptic cleft, thereby comprehensively affecting activities related to the reward pathway, leading to euphoria and, at high doses, producing phenomena such as perseveration, stereotyped behavior, and amphetamine psychosis.

MDMA, which is also classified as an amphetamine-class substance, has a rather different mechanism of action and resulting effects. Compared to amphetamine and methamphetamine, MDMA primarily (though not exclusively) stimulates the release of serotonin, ^[8] leading users to experience elevated mood and relaxation. Such mechanistic differences are also reflected in different use habits. According to reports from drug-using communities, among long-term heavy amphetamine users, the interval between one use and the next can be extremely short, or even continuous without interruption; however, the interval between MDMA uses must be maintained for at least several days, and using MDMA within a shorter interval fails to produce the "drug's kick." These explanations are not meant to deny MDMA's neurotoxicity and potential damage to the brain, but differences in post-use experiences and use patterns affect users' subsequent behaviors and the ways helping professionals might intervene.

MDMA and amphetamine/methamphetamine are both listed as Schedule 2 drugs. Because data on MDMA's scheduling and grading cannot be found, the rationale for its initial grading cannot be verified. However, in the "Part of Grading and Items of Grading and Items of Drugs" announced by the Executive Yuan via Yuan-Tai-Fa-Zi-1050188237, effective December 28, 2016, a series of amphetamine-class substances were added and upgraded. Similarly, from the general explanation of the amendment draft, there is no sufficient explanation regarding the differences among various amphetamine-class substances, nor is it discernible whether and how these differences influenced grading. In the general explanation of the amendment draft, the texts concerning methoxymethamphetamine (MMA), fluoroamphetamine (FA), methoxyethylamphetamine (MEA), and chloroamphetamine (CA) differ slightly, but their descriptions are very similar:

• It is known that OOO is an amphetamine-class chemical synthetic substance. Side effects of amphetamine-class substances include insomnia, nervousness, irritability, loss of appetite, weight loss, mood changes, elevated blood pressure, accelerated heart rate, elevated body temperature, paranoid schizophrenia, hallucinations, auditory hallucinations, compulsive repetitive behaviors, stroke, etc.
• It is known that amphetamine possesses high potential for addictiveness and may cause severe psychological or physical dependence; the addictiveness of OOO can be anticipated to be similar to that of amphetamine.

However, analogizing the effects produced by all these substances to amphetamine is unreasonable.

Taking MMA as an example, MMA's isomer 4-methoxymethamphetamine (also known as para-methoxymethamphetamine, abbreviated in English as PMMA; hereinafter referred to by its English abbreviation)^[9] is a substance commonly adulterated into ecstasy to simulate the effects of MDMA. The European Union in 2003 and the World Health Organization in 2015 both issued risk assessment reports on PMMA, both predating our country's discussion of MMA in 2016. The WHO risk assessment report explicitly stated that in animal experiments, low doses of PMMA produce effects characteristic of "entactogen" substances like MDMA. There are currently no systematic studies on PMMA's dependence potential. The absence of dopamine effects may imply low dependence potential, but there are no published human data to confirm this.

In fact, the truly serious danger of PMMA is not addiction, but the problem of adulteration. The dose of PMMA that allows users to feel effects is close to the lethal dose. Its action is slower than MDMA, yet it gets adulterated into ecstasy to simulate MDMA effects. Drug users may not necessarily know that the ecstasy contains PMMA; feeling no effect, they take additional doses within a short period, causing overdose fatalities.

Facing PMMA's low addictiveness but high use risk—where that use risk stems from users being unaware that their tablets are adulterated—how our country's Controlled Drugs Hazard Prevention Act should grade it is a headache-inducing issue. In Executive Yuan Announcement Yuan-Tai-Fa-Zi-1050188237, MMA was classified as a Schedule 2 drug, and PMMA, as an isomer of MMA, was likewise classified as a Schedule 2 drug. According to law, using Schedule 2 drugs is punishable by imprisonment for not more than three years. But for users, had they known or had a way to choose, they would not use PMMA; criminal penalties are hardly necessary to deter users. However, in terms of regulating sales, adulterating ecstasy with PMMA is unacceptable as it heightens the risk of death; considering its harmfulness, classifying it as a Schedule 2 drug is reasonable. Our country's Controlled Drugs Hazard Prevention Act treats addictiveness, abuse liability, and social harmfulness as mutually supportive and non-contradictory concepts: the higher the addictiveness, the easier it is to induce abuse, and the greater the social harm. With new substances, however, this is precisely not necessarily the case.

Setting aside the rationale for grading and looking simply at the statistical results of drug grading, one can see that in recent years, the grading of new substances has mostly fallen into Schedule 3, with a minority in Schedule 2. The statistical results are shown in the table below:

The statistics in this table begin following the announcement of Executive Yuan Announcement Yuan-Tai-Fa-Zi-0940080295-A on January 14, 2005, which established the inclusion of drug precursor materials into Schedule 4. Since then, the definitions and scopes of Schedules 1 through 4 have been fixed, becoming less prone to scope alterations driven by definitional changes. The year 2018 is excluded because the year has not yet concluded. Upgrades or downgrades are counted solely based on the schedule listed in the announcement; for instance, upgrading from Schedule 3 to Schedule 2 deletes the listed items in Schedule 3 and adds listed items in Schedule 2, which is counted as Schedule 2 listed item +1.

Looking at the table, 2011 saw a peak wave of adding new substances, with 7 new substances all classified as Schedule 3. Thereafter, apart from listing "Propofol" as a Schedule 4 drug in 2015, the rest were classified as Schedule 3 or Schedule 2 drugs. From 2011 onwards, a total of 33 Schedule 3 items and 18 Schedule 2 items were added, a ratio of roughly 2:1.

The purpose of pointing out the statistical items of scheduled grading is to indicate that under existing law, the grading of new substances mostly oscillates between Schedule 2 and Schedule 3 amid insufficient rationales. Personal use and possession of Schedule 3 drugs currently incur administrative penalties, whereas Schedule 2 incurs criminal penalties. Such choices affect whether users might be sent to prison and the burden placed on the domestic criminal justice system. When facing the constant emergence of new substances, our country is not all that capable of appropriately operating the drug grading system. Thus, one cannot help but worry: how will the Ministry of Justice's draft bill—which expands the definition of drugs to "pose a risk of" and bulk-schedules new substances—grade them, and how can it avoid arbitrary grading? Substances arbitrarily graded into higher schedules will likely remain difficult to downgrade later, even if evidence subsequently emerges showing that the severity of their three drug traits falls short of expectations.

Suggested Approaches

Reviewing all the conditions surrounding new substance regulation in Taiwan, this article's suggested approaches are divided into discussions on the new substance regulatory model itself and how monitoring and risk assessment should be conducted.

(1) Regarding the Regulation of New Substances

Regarding how new substances should be regulated, the amendment version of the Controlled Drugs Hazard Prevention Act proposed by the Ministry of Justice is indeed deficient and not recommended for adoption. As for what constitutes a proper regulatory approach, this article proposes two possible methods.

1. Flexibly Utilizing the Provisions on Fake and Prohibited Drugs in the Pharmaceutical Affairs Act

   Currently, when facing new substances not scheduled as drugs, our country's judicial practice penalizes them using provisions concerning fake and prohibited drugs under the Pharmaceutical Affairs Act. Regarding the current determination of fake and prohibited drugs, the only aspect that poses a problem is plant-based new substances, such as kratom and khat. If one wishes to use the Pharmaceutical Affairs Act to penalize the import, manufacture, sale, or other supply acts of plant-based new substances, they must be declared "poisonous drugs," just as cannabis was declared a poisonous drug.

   The Pharmaceutical Affairs Act does not penalize personal use or possession of new substances, which legally speaking cannot be considered a regulatory loophole. First, criminalizing personal use and possession from the perspective of criminal jurisprudence is already a controversial practice. Criminal law does not punish self-harming acts, which is why suicide or self-harm is not criminalized under criminal law. If an individual harms others due to the abuse of psychoactive substances, logically, criminal law should penalize the act of harming others. If people believe that personal use and possession should be penalized because substances scheduled as drugs carry a high potential risk of harming others upon use—the so-called "abstract danger offenses"—then one should actually examine the drug use of each individual item to see how much crime drug use actually triggers. Because the use contexts and bodily effects of different drug items vary, in Taiwan, even substances with sleeping pill ingredients are scheduled as drugs; surely crimes triggered by taking sleeping pills must be investigated?

   Furthermore, the reason the Pharmaceutical Affairs Act does not penalize personal use and possession is that the Act requires those who supply pharmaceuticals to provide consumers with pharmaceuticals proven safe through rational use. Consumers who acquire or use unapproved pharmaceuticals are treated more like victims rather than criminals. This rationale holds true in the regulation of new substances as well. When new substances first enter the market, they are also unknown to users; suppliers claim they are safe, yet these substances may cause severe bodily harm. New substances may also be used as adulterants, causing users to consume them unknowingly.

   Historically speaking, our country has long had a practice of responding to psychoactive substance abuse by pairing the Pharmaceutical Affairs Act with the Controlled Drugs Hazard Prevention Act. Early definitions of fake and prohibited drugs by the Department of Health (predecessor of the Ministry of Health and Welfare) indeed included non-medical use contexts. As can be seen from Announcement Wei-Shu-Yao-Zi-904142 issued by the Department of Health of the Executive Yuan on October 9, 1990, the Pharmaceutical Affairs Law (predecessor to the current Pharmaceutical Affairs Act) and the Narcotic Drugs Control Ordinance (predecessor to the current Controlled Drugs Act and Controlled Drugs Hazard Prevention Act) were regarded as regulatory tools of differing severity. The Department of Health first announced amphetamine-class pharmaceuticals as poisonous prohibited drugs, imposing criminal penalties on manufacture, import, sale, or other supply acts, while exempting use from penalties. Later, considering that "amphetamine" was increasingly rampant, urgent, and possessed mild addictiveness, it announced that "amphetamine-class" pharmaceuticals be managed under Article 2, Subparagraph 4 of the Narcotic Drugs Control Ordinance and Schedule 4 of the Enforcement Rules of the Ordinance as "chemically synthesized narcotic drugs," thereby penalizing illicit possession or use. It was precisely within this context that judicial practice generated discussions on whether the Pharmaceutical Affairs Act or the Controlled Drugs Hazard Prevention Act should be "preferentially applied" to substances already scheduled as drugs. If the Pharmaceutical Affairs Act had nothing to do with abuse outside the medical use context from the very beginning, the question would not be which law to "preferentially apply," but rather that such acts never constituted fake and prohibited drug crimes under the Pharmaceutical Affairs Act in the first place.

   Perhaps the Ministry of Health and Welfare worries that if the provisions on fake and prohibited drugs are used to penalize the import, manufacture, sale, or other supply of new substances, and since the Ministry is the competent authority for the Pharmaceutical Affairs Act, the responsibility for enforcement would fall upon its shoulders. However, from a legal systems perspective, the fears of the Ministry of Health and Welfare will not materialize. Because the penalty for supplying fake and prohibited drugs is criminal punishment, enforcement is handled by prosecutors, police, and investigative authorities equipped with crime prosecution powers. Currently, if a citizen reports to the FDA of the Ministry of Health and Welfare that someone is supplying fake and prohibited drugs for others to use, the FDA also transfers the case to the Criminal Investigation Bureau. Unless emulating Japan's Ministry of Health, Labour and Welfare by establishing Narcotics Control Officers endowed with judicial police status, enforcement of supplying fake and prohibited drugs should not be the responsibility of the Ministry of Health and Welfare. At most, the FDA conducts administrative inspections of licensed drug wholesalers, pharmacies, and pharmaceutical factories; if suspected supply of fake and prohibited drugs is discovered, the case is subsequently handed over to personnel with crime prosecution powers for investigation.

2. Establishing a "Watch-List Substance" Regulatory Category to Schedule New Substances

   If there is a societal consensus that the Pharmaceutical Affairs Act should not be used to handle psychoactive substance abuse outside medical contexts, and that new substance abuse should be handled via the Controlled Drugs Hazard Prevention Act, that is also acceptable. A better approach then would be to establish a watch-list substance regulatory category within the Controlled Drugs Hazard Prevention Act to schedule new substances, rather than directly expanding the scope of the three traits of drugs to "pose a risk of," which risks arbitrarily grading new substances.

   This suggestion stems from analyzing existing drug scheduling and grading situations. Considering that drug scheduling under current law is rational but the rationales for specific schedules are often insufficient or flawed, and the Ministry of Justice's amendment bill provides no mechanism to improve this problem, it is recommended to establish a watch-list substance regulatory category within the Controlled Drugs Hazard Prevention Act. If the RCDR believes a specific substance exhibits the three traits of drugs based on foreign evidence and wishes to pre-emptively schedule it before it enters the country, it can first place the new substance into the watch-list category. Once the new substance enters the country and the degree of data gathering from domestic and foreign sources is deemed sufficient to judge how it should be graded, it can then be incorporated into the existing drug grading framework.

   The penalties for supplying substances in the newly established watch-list category should not exceed those of the lowest schedule of drugs in the existing framework (i.e., Schedule 4 drugs). The logic of existing drug scheduling and grading is based on a clear grasp of substances, requiring certainty regarding the severity of their three traits. However, the harm of new substances to the country remains unclear, and heavy penalties do not align with the underlying regulatory rationale of the Controlled Drugs Hazard Prevention Act. Furthermore, personal use and possession should not be penalized, for reasons identical to those outlined under "Flexibly Utilizing the Provisions on Fake and Prohibited Drugs in the Pharmaceutical Affairs Act." Such an approach is also similar to Europe's legal responses to new substances, where, regardless of whether new substances are regulated through standalone legislation or special regulatory categories, penalties are usually kept relatively low, and the regulatory focus is placed on the supply side rather than the demand side (i.e., penalizing personal use and possession).

   Aside from the Controlled Drugs Hazard Prevention Act, the Pharmaceutical Affairs Act also requires amendment. If the Pharmaceutical Affairs Act is not amended, one can foresee that due to historical factors, fake and prohibited drug provisions in the Pharmaceutical Affairs Act will continually be invoked to heavier penalize the transfer of drugs, even though drug transfers for abuse purposes are outside the medical use context from beginning to end. This article suggests amending Article 6 of the Pharmaceutical Affairs Act to: "Pharmaceuticals referred to in this Act mean active pharmaceutical ingredients and preparations based on medical needs listed in the following subparagraphs..." Adding the phrase "based on medical needs" explicitly limits pharmaceuticals strictly to the medical use context. However, if amended this way, acts of importing, manufacturing, selling, or otherwise supplying Rush for abuse purposes could no longer be penalized under fake/prohibited drug crimes. As noted earlier, Rush does not directly affect the psyche and cannot be regulated under the Controlled Drugs Hazard Prevention Act, so alternative regulatory methods must be devised.

   Regardless of whether the first or second regulatory model above is adopted, while both are superior to the Ministry of Justice's current amendment bill, neither solves: how to regulate substances in widespread social use, our country's undervalued public health-oriented monitoring and early warning mechanism, and the problem of insufficient rationales for drug grading.

   The problem of how to regulate substances in widespread social use requires replacing "regulation" with "management" in our thinking—meaning approaches may not only seek prohibition, but also limited allowance of circulation and use, mitigating abuse harms through various prevention strategies. A similar mindset can be adopted when tackling the problem of nitrous oxide; it does not necessarily need to be scheduled as a drug, but can be permitted for circulation and use under limited alternative management frameworks. Given Taiwan's circumstances, however, if nitrous oxide abuse continues to expand, this article predicts it is still more likely to be handled in a manner similar to Japan's model—namely, scheduled under the Controlled Drugs Hazard Prevention Act, affirmatively listing permitted uses while prohibiting the supply, possession, or use for other purposes.

   As for public health-level monitoring and early warning mechanisms and grading rationales, this article will elaborate further below.

(2) Regarding Monitoring, Early Warning, and Risk Assessment

Regarding the reinforcement of public health-level monitoring/early warning mechanisms and grading rationales, one can look to the European Union's approach. The EU faces the same problem of deciding whether to schedule new substances amidst their continuous emergence, but an important difference from Taiwan lies in its emphasis on early warning and surveillance systems and their regard for drug users' health.

Faced with unscheduled new substances, the EU responds in three steps: early warning system, risk assessment, and decision on scheduling.

The emphasis of building an early warning system lies in gathering and exchanging information on new substances. At this stage, substances under continuous tracking and monitoring are not necessarily scheduled substances—this holds true for both the EU and UN early warning systems. The reason why substances are not scheduled immediately upon discovering abuse is that research on the hazards of new substances is lacking, their toxicology and pharmacology are often unclear, and they may appear for a while and then disappear (e.g., users simply cannot get used to them or dislike their effects), lacking practical utility for scheduling. Domestic media and lawmakers have constantly worried that domestic scheduling speeds cannot keep up with the list of new substances gathered in the UN early warning system; however, it must be pointed out that even the UN itself does not schedule all new substances on that list, for reasons identical to those mentioned above.

Data collection and exchange within the early warning system can be broadly divided into law enforcement and public health dimensions. The law enforcement dimension is handled by Europol, while the public health dimension is handled by the EMCDDA (though the EMCDDA also collects non-public health information, so this is a rough division). In both law enforcement and public health dimensions, one encounters the problem of whether testing methods can detect new substances—a topic already heavily discussed in Taiwan and requiring no further elaboration. Similarly, data collection on the law enforcement side is heavily emphasized in Taiwan and need not be elaborated. This article intends to spend more space explaining data collection and exchange on the public health side.

Regarding public health data collection and exchange, in addition to reporting unannounced substances that may harm public health, the scope of the EU's early warning system also includes:

• Changes in the purity of scheduled substances (e.g., in 2014, high-purity MDMA tablets suddenly appeared on the European black market, reaching purity levels risking severe side effects or even death)
• Adulteration of scheduled substances with abnormal or harmful substances (e.g., cocaine adulterated with levamisole, causing agranulocytosis)
• Sold substances differing from what was claimed (e.g., in 2014 in Amsterdam, street dealers sold white heroin to tourists claiming it was cocaine, causing three tourist deaths)
• Newly emerging use patterns (e.g., cathinones were traditionally nasal-inhaled or oral, but injection use newly emerged, increasing infection risks)
• Fatal or non-fatal drug poisonings

The points above clearly all involve data collection from the perspective of safeguarding drug users' health. Accompanying this data collection is the issuance of health alert messages. Such an early warning system is hard to imagine in Taiwan, where it would mean the government gathers information and issues warnings to remind domestic drug users of new changes appearing in the drug black market that could elevate poisoning or even death risks. In Taiwan, advocacy is more commonly indiscriminate warnings about how dangerous drugs are and that the government will eradicate drugs entirely, whereas advocacy grounded in drug users' health and safety to gather and release information is rare.

Sources of public health data collection may include healthcare systems, including treatment centers, emergency rooms, ^[10] poison centers, psychiatric departments, outreach services, drug prevention and harm reduction agencies, low-threshold services (focusing on contacting drug users to provide required services, including food), etc. Service delivery channels should include online formats in addition to physical ones. Online services are mentioned because the internet increasingly forms part of younger generations' daily lives, offering high anonymity and potentially reaching users physical services cannot.

Understandably, the more completely a locality builds a support network for drug users, the better it can gather data through these diverse information sources. The mindset behind public health data collection can also differ from that of law enforcement data collection, adopting a perspective focused on caring for drug users' health rather than surveillance and arrest. Taiwan currently operates the Controlled Drug Abuse Reporting Information System, requiring medical institutions and rehabilitation villages to fill out forms reporting received drug abuse cases. However, looking at our country's drug scheduling data, related statistics usually show as "zero" when discussing new substance scheduling. This is partly related to insufficient service reach to users; yet judging from EU data, the number of new substance users is relatively small to begin with. In gathering public health data on new substances, a more probable approach is targeted monitoring of particularly dangerous new substances, conducting in-depth qualitative analysis via case reports when cases arise to serve as references for scheduling.

From the perspective of caring for drug users' health, one can further develop practices of grasping new substance trends in cooperation with drug users—such as monitoring user discussion groups and forums (^[11]), and understanding conditions through key informants. But the most promising approach is "drug checking" initiated by users themselves (drug checking). In parts of Europe, drug checking services are provided where users wanting to know the actual composition of substances they acquired can submit them for testing. Drug checking typically not only informs users of the tested substance's composition, but also provides explanations of drug use risks, harm reduction information, or brief interventions. Drug checking can become an important source of gathering new substance information. A very famous example is the Netherlands' DIMS (Drugs Information and Monitoring System). DIMS is the national focal point for the EMCDDA in the Netherlands and supplies information to the EMCDDA. Utilizing substances submitted by users for testing, DIMS publishes annual reports. If high-risk substances are detected through drug checking, DIMS issues red alerts to warn users—for instance, the 2016 report mentioned that submitted ecstasy contained no MDMA but high doses of PMMA carrying high fatality risks, prompting an immediate red alert.

Of course, simply introducing a user drug-checking mechanism in Taiwan does not mean one can immediately expect to grasp domestic new substance trends. For this mechanism to operate well, it must be backed by the state genuinely adopting a perspective of caring for drug users' health to build a service network, prompting drug users to begin trusting these mechanisms.

In the EU, information gathered via early warning systems leads certain new substances to be prioritized for attention or even considered for scheduling—for instance, when evidence shows a substance has high toxicity or lethality, massive seizure volumes, rising abuse trends, or organized crime involvement. Such new substances may then enter the "risk assessment" stage.

The scope of risk assessment includes health and social risks related to the use, manufacture, and trafficking of new substances, the extent to which substances involve organized crime, and potential consequences of regulatory measures. Regarding how risk assessments are conducted, readers may refer to the Risk assessment of new psychoactive substances: Operating guidelines by the EU's EMCDDA. Interested readers can consult this guideline themselves; this article only highlights parts inspiring for how Taiwan might conduct drug scheduling and grading assessments.

1. Risk Assessment Reports Prepared by Independent Scientific Organizations

   In the EU, risk assessment reports for new substances are prepared by EMCDDA's Scientific Committee, composed of scientists with outstanding academic achievements and independence. Risk assessment reports are founded on two main foundational documents: first, a technical report, produced by an EMCDDA working group with invited external experts. EMCDDA's founding mandate is to provide the EU and its member states with a factual overview of European drug problems and provide a solid evidence base to support drug-related debates. EMCDDA's scientific research or reports influence policy, but it is not a decision-making body. The second foundational document of the risk assessment report is the EMCDDA–Europol Joint Report. Joint reports are necessary because risk assessments must be grounded in evidentiary data, and EMCDDA and Europol possess respective information gathering and exchange networks across Europe to provide data.

   The benefit of having risk assessment reports prepared by independent scientific organizations is that it is easier to prevent report authors from intentionally or unintentionally influencing the presentation of report contents due to desires for or against scheduling, fears of bearing responsibility or facing criticism, or public opinion pressure.

   Reports underlying Taiwan's drug scheduling and grading are currently still authored by relevant administrative departments. Whether the presentation of these reports is easily influenced by the pressures faced by administrative departments and their desired scheduling targets warrants attention. However, even if reports are authored by relevant administrative departments, achieving a relatively complete factual description remains possible by establishing report-writing methodologies and formats.

2. Evidence-Based Report Writing Methodologies and Formats

   EU risk assessment reports for new substances follow established writing methodologies and formats, ensuring through these writing requirements that assessments are evidence-based. Detailed report-writing methodologies and formats can be found in Risk assessment of new psychoactive substances: Operating guidelines and risk assessment reports. Below, this article highlights basic yet important principles.

   • Citations must meet basic academic requirements

     If report contents cite data and literature, citations must be provided, with reference sources listed at the end. While this sounds basic, it distinguishes which contents are substantiated and upon what basis, versus those that are not. If discussions are currently absent from data or literature, honesty regarding insufficient data is maintained.

     For example, our country's scheduling explanation for chloroethylcathinone states: "Currently, chloroethylcathinone has no pharmacological or toxicological research; side effects are presumed to resemble methcathinone and ethcathinone, potentially causing anxiety, confusion, visual distortion, and physiologically causing tachycardia and elevated blood pressure. Due to the inhibition of the monoamine oxidase (MAO) neurotransmitter pathway, co-use carries a high fatality risk." Stating clearly in the explanation that this substance lacks pharmacological and toxicological research is an honest writing approach. Since explanations are not risk assessment reports themselves, if it were a report meeting basic academic requirements, citations would clarify whether text following "presumed" reflects expert discussion or the report author's opinion.

   • Stating methodologies for data and literature collection

     Methodologies for data and literature collection within risk assessment reports—most notably in technical reports—hold significant reference value. For instance, literature collection methodologies clearly state keywords used, database search scopes, timeframes, query times, etc. When reports systematically collect sales data of new substances online, similar explanations are provided, such as the explanation on page 31 of the Acryloylfentanyl Risk Assessment Report.

     From public disclosures, reports underlying Taiwan's drug scheduling and grading do not appear to do this. If not, adopting such practices is recommended, as readers can then inspect whether data and literature collection methodologies are sound. Requiring stated data collection methodologies also reminds report authors, who know others may review their work, to present data comprehensively rather than intentionally or unintentionally omitting certain data to favor specific outcomes.

   • Gathering evidence as comprehensively as possible while distinguishing evidence quality

     Amid the continuous emergence of new substances, research on substances likely lags behind their emergence rate. When discussing scheduling under such conditions, one faces the dilemma of insufficient research to support discussions. To address this, the EU risk assessment broadens the scope of evidentiary data eligible for discussion while distinguishing the quality of different pieces of evidence.

     Risk assessment of new psychoactive substances: Operating guidelines lists the following categories as foundational for discussion: peer-reviewed scientific publications, formal reports from international organizations or government bodies, other reports or scientific publications, unpublished data from forensic and clinical laboratories, and other sources including EU databases, media, personal reports, informal publications, and the internet. The order above also distinguishes evidence quality, with items higher up indicating better quality. Additionally, assessing research methodologies employed across different pieces of evidence helps confirm their quality.

     In Taiwan, adopting such a perspective to write or view drug scheduling and grading assessments currently seems difficult to imagine. Existing public data conflates numerous elements, and the completeness of data collection remains unclear. Furthermore, common evidence is largely limited to: statistics on drug abuser usage reports from medical institutions in the Taiwan region, non-urine specimen test results from suspected drug and controlled drug cases, enforcement seizure and appraisal statistics, and forensic autopsy statistics—lacking diverse types of evidence. However, if one hopes to gradually reinforce public health data collection in the future, evaluating evidence quality will become increasingly important.

Conclusion: New Substance Regulation, from Fear to Understanding

The regulation of new substances is indeed an issue deserving careful reflection, but unfortunately, our country's long-standing practice is accustomed to discussing this issue based on fear rather than understanding. The reflexive action of fear is the pursuit of arrests and zero omissions, ensuring caught suspects face convictions—this is treated as a governmental achievement or highlight. The Ministry of Justice viewing its amendment bill to pre-emptively bulk-schedule new substances under the Controlled Drugs Hazard Prevention Act as a highlighted achievement exemplifies this.

This article hopes to discuss new substance regulation based on understanding. Starting from understanding, the first step should be monitoring and early warning, whereas securing convictions upon capture is secondary. Our country's provisions for monitoring and early warning mechanisms regarding new substances reside within the Controlled Drugs Act rather than the Controlled Drugs Hazard Prevention Act, making health competent authorities responsible by law. This manifests the vital importance of monitoring and early warning mechanisms at the public health level, which are not subordinate to drug enforcement. A sound monitoring and early warning mechanism allows us to understand new substances themselves, their circulation and usage patterns, and what harms they inflict on users, thereby enabling proper resource allocation to prioritize interventions against higher-harm substances. Information gathered therefrom can also serve as the basis for scheduling decisions. Regrettably, our country undervalues public health-level monitoring and early warning mechanisms.

As for the legal regulatory models relied upon for convictions upon seizing new substances, our country primarily relies on the Pharmaceutical Affairs Act rather than the Controlled Drugs Hazard Prevention Act. This is because fake and prohibited drugs under the Pharmaceutical Affairs Act do not, in principle, require individual scheduling; any unauthorized manufacture or import qualifies. Judicial practice applies penalties related to fake and prohibited drugs by characterizing new substances as such under the Pharmaceutical Affairs Act. However, for plant-based new substances, because judicial practice's definition of pharmaceuticals has not extended to plants, health competent authorities must still announce them as "poisonous drugs" before they can be penalized under prohibited drug provisions. Provisions on fake and prohibited drugs under the Pharmaceutical Affairs Act penalize import, manufacture, sale, or other supply acts, but do not penalize personal use and possession. As for the most commonly heard Controlled Drugs Hazard Prevention Act, current practice requires waiting until new substances enter the country and actual abuse trends manifest before scheduling them individually and imposing penalties. The major difference between this and Pharmaceutical Affairs Act regulations is that it penalizes personal use and possession—especially for Schedule 1 and Schedule 2 drugs, where personal use and possession incur criminal penalties, potentially sending offenders to prison.

The Ministry of Justice proposed amendments to the Controlled Drugs Hazard Prevention Act expanding the three traits of drugs to "pose a risk of" and adding the phrasing "substances having a chemical structure similar to" to the definition of drugs, driven primarily by the aforementioned circumstance: current determinations of the three traits of drugs require domestic abuse trends to be manifested before substances are deemed to possess abuse liability and social harmfulness, thus requiring all three traits to be fulfilled before scheduling as drugs, rendering authorities unable to penalize certain substances under the Controlled Drugs Hazard Prevention Act upon initial domestic appearance. The Ministry of Justice hopes to pre-emptively schedule new substances before domestic entry via these statutory amendments, enabling penalties upon seizure. However, as noted earlier, new substances entering the country can already be handled via fake and prohibited drug provisions under the Pharmaceutical Affairs Act; the primary difference between the Ministry of Justice's amendment bill and current practices is the penalization of personal use and possession—making the closed loopholes rather limited.

Apart from limited loophole-closing, the Ministry of Justice's amendment bill also risks increasing arbitrary grading without clear understanding of the three traits of drugs. Once classified into higher drug schedules, even if evidence subsequently emerges showing that the severity of the substance's three traits falls short of expectations, downgrading will likely remain difficult. This article's prediction that the Ministry of Justice's amendment bill will encounter such problems is anchored in an analysis of current drug scheduling and grading practices. Taiwan's current scheduling and grading of new substances mostly oscillates between Schedule 3 and Schedule 2; while justifications for scheduling are understandable, grading suffers from insufficient and flawed rationales. The Ministry of Justice's amendment bill proposes no mechanisms to improve this problem while mandating that the RCDR bulk-schedule large numbers of new substances (potentially hundreds at a time); how to avoid the risk of arbitrary grading is deeply worrisome.

Regarding legal regulatory models for convictions upon seizing new substances, this article proposes two possible models superior to the Ministry of Justice's amendment bill.

Whether adopting the Ministry of Justice's amendment bill, Suggested Model 1, or Model 2, all require reinforcing public health-level monitoring/early warning mechanisms and demanding that risk assessments underlying substance scheduling and grading be evidence-based. Reinforcing public health monitoring and early warning mechanisms requires complementing a perfected healthcare system, with the most promising approach being drug-checking services allowing users to voluntarily submit substances for testing. Where health-harming incidents arise and necessitate warning users, mechanisms to dispatch alerts to users should be established. Building these mechanisms and ensuring they exert monitoring and early warning utility cannot be achieved overnight; it requires building trust with users through repeated service provisions. While hard to showcase as a highlighted political achievement, this will steadily strengthen our country's capability to respond to health harms brought by new substances.

With sound monitoring and early warning mechanisms gathering information, risk assessments can be evidence-based. Good risk assessment reports must comply with basic academic citation requirements, state methodologies for data and literature collection, gather evidence as comprehensively as possible, and distinguish varying evidence qualities with appropriate appraisals. While having independent organizations produce risk assessment reports is ideal, following the aforementioned risk assessment writing practices is also acceptable. This will ameliorate our country's current problems of insufficient and flawed rationales in drug grading.

Through this, this article hopes our country can gradually establish a complete mechanism spanning monitoring and early warning, risk assessment, and scheduling—moving away from fear and truly grounding itself in understanding when confronting challenges brought by new substances.