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目录
Contents
前言
Preface
一、科学准确界定芬太尼类物质
I. Defining Fentanyl-Related Substances Based on Science
二、保障合理用药与严格管制双管齐下
II. Ensuring Both Rational Use and Rigorous Control
三、依法严厉打击芬太尼类物质犯罪
III. Striking Hard Against Fentanyl-Related Crimes in Accordance with the Law
四、严格芬太尼类物质前体管控
IV. Enforcing Strict Control over Precursors of Fentanyl-Related Substances
五、加快推进科技手段研发应用
V. Accelerating Technology Research, Development, and Application
六、多措并举提升整体管控效能
VI. Adopting Comprehensive Measures for More Efficient Drug Control
七、推进芬太尼类物质全球共治
VII. Promoting Global Governance of Fentanyl-Related Substances
结束语
Conclusion
前言
Preface
毒品是人类社会的公害，治理毒品问题事关人类前途命运。当前，国际毒潮持续泛滥，全球毒品种类、产量、滥用人员不断增多，对人类生存发展构成严重威胁。近年来，以芬太尼类物质为代表的合成毒品问题来势凶猛，给国际社会带来的危害日趋严重，给全球毒品治理带来新挑战。特别是一些国家因芬太尼失控引发严重社会问题深刻警示，如果对芬太尼类物质防范不严、管控不力，导致其泛滥蔓延，将严重危害公众健康，影响经济发展和社会稳定。
Drug abuse is a hazard to human society, and control of drugs is essential to the future of humanity. As international drug abuse and crime continue to expand, the numbers of drug types, output, and abusers are increasing, posing a grave threat to human life. In recent years, synthetic drugs such as fentanyl-related substances have spread menacingly, doing increasing harm to the international community and presenting new challenges to global drug control. In particular, the serious social issues in some countries caused by the loss of control over the availability of fentanyl sound a dire warning – unless fentanyl-related substances are effectively monitored and controlled, they will spread and spiral, causing severe damage to public health, hindering economic development, and threatening social stability.
中华民族曾经饱受毒祸之害，中国人民对毒品有切肤之痛。新中国成立后，坚持不懈开展禁毒斗争，锲而不舍解决毒品问题。近年来，中国高度重视芬太尼类物质管控，未雨绸缪、统筹谋划，综合施策、系统治理，严格监管芬太尼类药品，严密防范芬太尼类物质滥用，严厉打击走私、制贩芬太尼类物质及其前体化学品违法犯罪，取得明显成效。中国加强国际禁毒合作，务实开展对话交流、联合侦查和经验分享，推动建立平等互信、合作共赢的合作关系，与包括美国在内的有关国家在应对芬太尼类物质及其前体问题方面深入开展合作并取得明显成效。
Narcotics once inflicted appalling suffering on the Chinese nation, causing wounds that are still keenly felt by the people. Since the founding of the People’s Republic of China in 1949, the government has relentlessly fought the illegal drug trade and worked tirelessly to solve the problem. In recent years, China has attached great importance to maintaining control over fentanyl-related substances, and has taken advance precautions, improved overall planning, and adopted comprehensive measures and systematic control. It has exercised strict supervision over fentanyl-related medications, rigorously prevented the abuse of fentanyl-related substances, and stricken hard against the smuggling, manufacturing, and trafficking of fentanyl-related substances and related precursor chemicals. These have delivered notable results.
China has strengthened cooperation on international drug control through down-to-earth dialogues and exchanges, joint investigations, and experience sharing, and promoted mutually beneficial cooperation based on equality and mutual trust. China has achieved notable successes in in-depth cooperation with countries concerned, including the United States, in addressing problems with fentanyl-related substances and their precursors.
中国加强芬太尼类物质管控，是防范新型毒品潜在危害的有效措施，彰显了以人民为中心、保障人民群众健康福祉的禁毒理念，彰显了积极参与全球毒品治理，推动毒品问题全球共治，维护全人类健康、安全和福祉的责任与担当。
Strengthening control of fentanyl-related substances is an effective measure by which China can prevent the potential hazards brought about by these new drugs. It reflects China’s people-centered anti-drug philosophy to ensure the health and wellbeing of the people. China also demonstrates its sense of responsibility by participating in global drug control, promoting global governance of drug-related issues, and safeguarding the health, safety, and wellbeing of all of humanity.
为全面介绍中国管控芬太尼类物质工作及取得的成效，分享中国创新管控经验，特发布此白皮书。
The Chinese government is publishing this white paper to introduce its work and progress on the control of fentanyl-related substances, and to share its innovative experiences in this regard.
一、科学准确界定芬太尼类物质
I. Defining Fentanyl-Related Substances Based on Science
芬太尼是可作用于生物体内的阿片受体、从而产生麻醉和镇痛作用的物质，属新型强效麻醉性镇痛剂，效果可达吗啡的100倍，常用于中到重度疼痛治疗，是联合国管制的麻醉药品。芬太尼最早由比利时的药理学家保罗·杨森于1960年合成，随后在比利时杨森制药公司生产，20世纪60年代中期开始在欧洲被广泛使用，美国于1968年批准芬太尼用于医疗用途。此后，舒芬太尼、瑞芬太尼和阿芬太尼先后研发上市，与芬太尼一起成为目前国际社会用于医疗用途的4种芬太尼类药品，常用剂型有注射剂、透皮贴剂、舌下片剂、鼻腔喷剂等。
Fentanyl is a substance that acts on opioid receptors in organisms and thus has narcotic and analgesic effects. As a potent new narcotic analgesic with 100 times the potency of morphine, it is often used for the treatment of moderate to severe pain and is a narcotic on the United Nations control list.
Fentanyl was first synthesized in 1960 by Belgian pharmacologist Paul Janssen. It was then produced by Janssen Pharmaceutica, Belgium, and has been widely used in Europe since the mid-1960s. It was approved for medical use in the United States in 1968. Later, sufentanil, remifentanil, and alfentanil were developed and came onto the market. These four fentanyl-related medications are now used globally for medical purposes. Their usual dosage form includes injection, transdermal patch, sublingual tablet, and nasal spray.
通过简单修饰芬太尼化学结构上的某个原子或基团，即可得到与芬太尼结构类似、作用相近甚至更强的芬太尼衍生物。这些物质绝大多数系不法分子从制药公司发表的学术文章中检索出来，或者为规避法律管制而设计出来，目前全球已发现滥用的芬太尼类物质有近百种，其潜在数量可能高达成千上万种。除4种芬太尼类药品外，其余的芬太尼类物质均未发现具有医疗价值，多与海洛因、可卡因等毒品混合滥用，使人产生阿片类毒品的欣快感，同时其麻醉镇静作用会影响滥用人员的中枢神经系统，超剂量使用可导致昏迷、呼吸抑制甚至死亡。
By slightly modifying the chemical structure of fentanyl, fentanyl-related derivatives with similar structures and effects – and even stronger effects – can be obtained. Most of them have either been illegally produced based on formulae retrieved from academic articles published by pharmaceutical companies, or designed to circumvent legal controls. At present, nearly 100 fentanyl-related substances are being abused around the world, and potentially they may number in the tens of thousands. Unlike the four fentanyl-related medications, the remaining fentanyl-related substances have not been found to have any medical value, and are often abused together with heroin, cocaine, or other controlled drugs to cause euphoria, an effect of taking opioids. In addition, their anesthetic and sedative effects affect the central nervous system of abusers, and an overdose can lead to coma, respiratory depression, or even death.
中国于2019年4月1日发布的芬太尼类物质整类列管公告中明确，“芬太尼类物质”是指化学结构与芬太尼（N-[1-（2-苯乙基）-4-哌啶基]-N-苯基丙酰胺）相比，符合以下一个或多个条件的物质：使用其他酰基替代丙酰基；使用任何取代或未取代的单环芳香基团替代与氮原子直接相连的苯基；哌啶环上存在烷基、烯基、烷氧基、酯基、醚基、羟基、卤素、卤代烷基、氨基及硝基等取代基；使用其他任意基团（氢原子除外）替代苯乙基。中国创新引入“类物质”的概念，严谨、科学地明确了“芬太尼类物质”的法律定义，既保证该定义涵盖需要列管的所有品种，为打击和惩治芬太尼类物质毒品犯罪活动提供了有力的法律依据，又最大限度地减少对医药、工业、科研等领域合法需求的影响。
On April 1, 2019, China issued a statement to implement full control of fentanyl-related substances, in which these are clarified as substances with a chemical structure that meets one or more of the following conditions as compared to fentanyl (N-phenyl-N-[1-(2-phenylethyl) piperidin-4-yl] propanamide):
Replacement of the N-propionyl group by another acyl group;
Replacement of the N-phenyl group with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle;
Substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino, or nitro groups;
Replacement of the phenethyl group with another group, excluding hydrogen atom.
China introduced the concept of “related substances” and provided an accurate and scientific legal definition of fentanyl-related substances. This definition covers all types that require scheduling in the list of controlled substances, provides a strong legal basis for striking against drug crimes involving fentanyl-related substances, and minimizes the impact on legitimate needs in fields such as medicine, industry, and scientific research.
芬太尼类物质是通过化学合成得来的，用来制造芬太尼类物质的化学原料统称为芬太尼类物质的前体。化学物质的合成路线具有多样性，可选择性、替代性较强，近年来芬太尼类物质前体不断变化，品种持续增多。4-苯胺基-N-苯乙基哌啶（英文简称“4-ANPP”）和N-苯乙基-4-哌啶酮（英文简称“NPP”）是合成芬太尼类物质的两种最直接前体，2017年3月第60届联合国麻醉品委员会将其纳入1988年《联合国禁止非法贩运麻醉药品和精神药物公约》（以下简称《1988公约》）附表一予以管制，同年中国将其列入《易制毒化学品管理条例》附表《易制毒化学品的分类和品种目录》予以管制。随着4-ANPP和NPP两种芬太尼类物质前体被纳入管制，不法分子为逃避法律制裁，研究更新合成工艺，使用4-（N-苯基氨基）哌啶（英文简称“4-AP”）、1-叔丁氧羰基-4-（N-苯基氨基）哌啶（英文简称“1-boc-4-AP”）、N-苯基-N-（4-哌啶基）丙酰胺（英文名称“Norfentanyl”）和4-哌啶酮（英文名称“4-piperidone”）、1-叔丁氧羰基-4-哌啶酮（英文简称“1-boc-4-piperidone”）等多种前体合成芬太尼类物质，给打击走私和制贩芬太尼类物质前体犯罪带来挑战。
Fentanyl-related substances are obtained through chemosynthesis, and the chemical raw materials used to manufacture fentanyl-related substances are collectively known as their precursors. The synthetic routes to chemicals are diverse and the many alternatives make easy substitutions. In recent years, the precursors of fentanyl-related substances have constantly changed, and the number of variations soared. 4-anilino-N-phenethylpiperidine (4-ANPP) and N-phenethyl-4-piperidone (NPP) are two most immediate precursors of fentanyl-related substances. They were listed as controlled substances in Table I annexed to the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 (the “1988 Convention”) at the 60th session of the UN’s Commission on Narcotic Drugs in March 2017, and included in the Catalog of Classification and Types of Scheduled Precursor Chemicals annexed to the Regulations on the Administration of Scheduled Precursor Chemicals by China in the same year.
As the two precursors were brought under control, lawbreakers upgraded synthetic processes in order to evade legal sanctions by using multiple precursors to synthesize fentanyl-related substances. These include: N-phenyl-4-piperidinamine (4-AP), tert-butyl 4-(phenylamino) piperidine-1-carboxylate (1-boc-4-AP), N-phenyl-N-(piperidin-4-yl) propionamide (norfentanyl), 4-piperidone, and tert-butyl 4-oxopiperidine-1-carboxylate (1-boc-4-piperidone). This creates new challenges in the battle against the smuggling, manufacturing, and trafficking of precursors of fentanyl-related substances.
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