Drug Policy on New Psychotropic Substances (NPS) in the United States of America and the European Union
by Mallory Plunkett
The use of New Psychotropic Substances (NPS), a range of drugs designed to mimic illicit drugs, is increasing across the globe. The proliferation of NPS poses law enforcement challenges because the chemical composition of these drugs is constantly evolving to avoid legal enforcement. Drug laws are not effective to regulate NPS because they are not updated rapidly enough to control the sale and use of NPS. This is leading to an imminent threat to public safety as the use of NPS is growing in popularity with significant health consequences. Part I describes the extent of problems associated with the use of NPS. There have been a variety of different approaches by governments to combat this issue, so several jurisdictions are then studied. Part II reviews how the European Union has evolved its drug law processes to accommodate NPS, as well as how countries such as Germany, Sweden, and the Netherlands have taken their own unique approaches to policy change. Part III reviews how the United States has changed its drug policies in response to NPS. Part IV analyzes the similarities and differences between the approaches taken in the European Union and the United States and recommends future legislation based on the analysis.
New Psychotropic Substances (NPS), legislation, health, drug, policy
The increasing use of New Psychotropic Substances (NPS) has become a worldwide legal crisis with serious public health and safety ramifications. NPS, which are also known by a variety of different names such as “legal highs,” “synthetic drugs,” or “designer drugs,” are classified as any drugs whose chemical composition is not addressed by the UN conventions of 1961 or 1971. Due to unregulated drug composition, unknown health consequences, and unclear legal action for usage, NPS pose an extreme threat to both healthcare and legal systems. They have become popular due to deceptive marketing by dealers as a legal and cheap alternative to traditional street drugs such as cannabis, methamphetamine, and cocaine. Since consumers are unaware of the composition or dosage amount of the drugs, overdose of NPS is extremely common and hospitalizations for NPS-related reasons have greatly risen in both the United States and the European Union in recent years. Legally, drug traffickers beat law systems around the world by creating new NPS before legislation can be created against them. Consequently, over 800 unique NPS are on the market right now, with new derivatives emerging frequently. This ability to manipulate chemical compositions so quickly is largely due to the widespread information that is readily available on the internet. This large-scale drug modification would not have been possible in the past due to a lack of readily available information on drug composition and creation. There have many different attempts by governments around the world to create an efficient system that regulates NPS. However, the speed at which NPS can be created and distributed is the largest challenge to lawmakers. A new NPS is often created to replace the ones that have been legislated against. Most countries do not have a flexible enough legislative process to adequately combat the pace of NPS creation. This is also caused by a lack of knowledge on the composition of NPS, which is often required to draft and pass new legislation.
The purpose of this review is to highlight the global issues caused by NPS, show how different legislative bodies in the EU and the USA have decided to approach NPS law and analyze how the similarities and differences have resulted in various successes or failures. To compare the EU, which is made up of many member countries, and the USA, three EU nations have been chosen for this paper. These nations were chosen to showcase the range of legal attitudes towards NPS in the EU. Germany will be discussed as a nation that generally has a median approach to drug laws. A median approach refers to a legislative attitude that is neither lenient nor strict on drug policy. In contrast, the opposite ends of the range will be reviewed with the Netherlands, which is known for its less strict drug laws, and Sweden, which has a relatively rigorous drug policy. After this, NPS policy in the USA will be analyzed in comparison to the previous analysis of EU policy. Succeeding these individual analyses, NPS legislation in the discussed nations will be compared to see similarities and differences in policies and outcomes. Ultimately, suggestions will be made for future NPS policy based on the content explored in this study. These suggestions include policy changes, implementation of harm reduction programs, and increased international cooperation. An effective approach to NPS will need to be multi-faceted and collaborative.
Part I: Extent of problems associated with the use of NPS
While the different types of NPS all have different specific medical repercussions, the widespread use of NPS has proven to cause overwhelmingly negative results. Among the common side of effects reported by NPS users are hallucination, psychosis, violence, coma, and death. These side effects can be extremely severe, and this is a major reason why NPS are such a great issue. The volume and severity of these effects can largely be attributed to the lack of regulation on NPS. Most commonly, NPS are rapidly created, lacking testing processes or safety standards. This results in NPS users being unaware of the correct dosage or potential side effects of the drug. Moreover, many NPS are impure and are contaminated with other substances, many of which can be extremely harmful. For example, in the 1980s, a popular synthetic opiate was contaminated with a substance that caused many users to develop Parkinson’s disease. The most common and one of the most lethal synthetic drugs today is known as fentanyl. Fentanyl is a synthetic opioid that is one hundred times stronger than morphine, and new analogs of fentanyl have been found to be even more potent, namely carfentanyl and acetyl fentanyl. Prescription fentanyl is available as a pain medication and its highly addictive nature leads to high rates of opioid dependence and abuse.  Fentanyl and its derivatives have been increasingly found in traditional street drugs, causing the rates of drug overdose to spike in recent years. The long-term health effects of many NPS are currently unknown and are extremely difficult to determine due to the variety of NPS, the novelty of the issue, and the co-usage of NPS with other drugs.
The emergence of NPS has become a larger problem in recent years largely due to the rise of the Internet. The Internet has caused people to be able to more easily access information that allows them to synthetically mimic drugs. This freedom of information offered by the Internet also gives NPS dealers a platform to advertise and distribute drugs to consumers across the world. As of today, the majority of NPS production can be traced to manufacturing warehouses in India and China, but they are being produced worldwide. Since NPS require the alteration of the chemical structure of known drugs, they tend to be extremely difficult to drug test for. This is where the name “legal highs” is derived from, as NPS users can sometimes pass a drug test. Producers of NPS are actively trying to circumvent drug laws and put new products on the market as fast as possible without testing them for side effects or long-term health consequences. Moreover, NPS producers use Internet marketplaces to market and sell their products worldwide.
Part II: Review of the evolution of drug laws in the European Union to accommodate NPS
EU in whole
Europe has the highest usage rate of NPS among young adults. According to the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), there were around 790 new psychoactive substances being monitored in 2019. In Europe, an early warning system has been implemented to help detect NPS with severe public health implications. There have been several agencies formed in Europe that work together to support the EU such as the EMCDDA, the European Union Agency for Law Enforcement Cooperation (Europol), and the European Medicines Agency (EMA). In 1997, the EU passed a bill to facilitate the passage of information on NPS between member countries. This allowed member countries to compare risk assessments and implement legislation preemptively before the drugs could become an issue in their respective country. The exchange of information between countries was delegated as the responsibility of a subset of Europol known as the Europol Drugs Unit (EDU). While this legislation allowed for the rapid spread of knowledge on NPS, it did not necessarily aid in the regulation of NPS. So, in 2005, the EU passed an updated version of the bill that was designed to help control NPS. Even with the new version of the bill, countries of the EU have all adopted different legislative approaches.
Germany schedules substances based on the body of legislation is known as the Narcotics Law or Betäubungsmittelgesetz (BtMG). The BtMG has been in effect since 1930 and has been used for scheduling narcotic substances including NPS. However, the process to schedule new substances into the BtMG is lengthy and resulted in the immediate replacement of NPS once legislated against. To resolve this issue, in 2016 the German law on NPS, the Neue-psychoaktive-Stoffe-Gesetz (NpSG) ,was passed. The NpSG schedules groups of substances by their structures based on research conducted on how NPS modifications are created. This type of NPS legislation is referred to as the “group definition” approach. By banning entire groups of substances, legislators hope that this will stop or slow the modifications of NPS that beat the law. Germany went from struggling to regulate NPS with the BtMG to legally covering the vast majority of relevant NPS with the NpSG. Both the BtMG and the NpSG are revised twice a year. This process begins with a committee that submits revision recommendations to the German Federal Government, which sends them to the Federal Council where they are implemented by being published in the Federal Law Gazette. In cases of extreme risk, the emergency procedure can be employed to schedule a substance in as little as one week. After a substance is scheduled through the emergency procedure, it has one year to be scheduled through the standard procedure before the regulation expires. However, after a few years of monitoring NPS use after the implementation of NpSG, it was found that the legislation had a minimal effect on the type or extent of NPS usage. These findings suggest neither the slow legislation under BtMG nor the group legislation under NpSG are effective in curbing NPS usage.
The Netherlands is widely famous for its acceptance of the use of many common street drugs. However, their official policy under the Opium Act technically bans the use of any drugs for non-medicinal purposes. The Opium Act separates drugs into “hard” or schedule I and “soft” drugs or schedule II. Dutch authorities tolerate the use of soft drugs that have low health risks and continue to try and curb the use of hard drugs with a high risk of addiction and negative health impacts such as opiates and stimulants. The main logic behind this is that drug use cannot be avoided, so it is more beneficial to legalize the less harmful drugs and implement harm reduction programs. The most popular schedule II or soft drug in the Netherlands is cannabis, which is allowed to be sold and consumed in stores known as coffee shops. Conversely to the tolerance of soft drugs, the Netherlands employs a strict policy toward hard drugs. So, while this country has a more tolerant drug policy than most nations, NPS are still a way for hard drug users to skirt law enforcement. The most popular type of NPS used in the Netherlands are “branded stimulants” and other stimulants. Most commonly, NPS are used by three categories: marginalized people, nightlife users, and online users who take NPS while on internet forums. All three groups reported negative side effects from NPS use, but the marginalized group seemed to be the most affected as they had the highest rates of long-term side effects such as mental health detriments. It is found that the motivation to use NPS in the Netherlands is the same as the motivation to use conventional street drugs, but NPS have the bonus of being cheaper and less prone to legal repercussions. In a study done in the Netherlands between 2013 to 2017, it was found that Dutch NPS usage increased a significant amount during the study period. Moreover, 96% of users experienced negative symptoms from NPS use while 43% experienced poisoning. The Dutch use synthetic cannabinoids much less than the global market, which is likely due to the widespread availability and the open legality of cannabis in the Netherlands.
To schedule an NPS as a Schedule I drug, an amendment must be made to the Opium Act. This process can be sped up in the case of a high-risk assessment. This occurred when a specific NPS named 4-FA caused several cases of severe toxicity in the Netherlands which prompted it to be named a schedule 1 drug. Because of this, usage of 4-FA dropped. However, new NPS were quickly created and rose in popularity to replace it. One common legislative approach to avoiding the immediate replacement of NPS is the group approach. However, this group approach often illegalizes controlled NPS that are being tested for potential medical benefits. So, while other countries in the EU have adopted the “group definition” approach to avoid the phenomenon of replacement NPS, the Dutch have not.
Sweden is generally viewed as strict on drug policy. Swedish policymakers want a drug-free society, so they are stricter on drugs in general than many other EU countries. In Sweden, there is no distinction between hard and soft drugs like there is in the Netherlands. To achieve the goal of a narcotic-free society, Sweden enacted the Comprehensive Strategy for Alcohol, Narcotics, Doping, and Tobacco (ADNT) in 2016. This policy is enforced in different ways at different levels of government. Drug law enforcement of the ANDT is delegated to the local municipalities. All drug trafficking, possession, and usage in Sweden are policed with the same intensity. In 2011, Sweden started to allow police and customs the power to seize any substances deemed as dangerous. This policy does seem to have produced lower overall drug usage rates, but Sweden also has an above-average and increasing number of drug-related deaths when compared to the rest of Europe. In a study on NPS poisonings in drug addicts in 5 Nordic countries, it was found that fatal poisonings in Swedish drug addicts have been increasing over the years. Moreover, while drug addicts in all Nordic countries exhibited poly-drug use, Sweden was found to have the largest selection of NPS available.
Substances are scheduled to the Act on the Prohibition of Certain Goods Dangerous to Health if it is classified as a good that is “dangerous to health.” In 2011, the Law on Destruction of Certain Substances of Abuse was passed to allow for the confiscation and destruction of NPS before they are classified. However, this law does not allow for any legal penalty to the owner. Sweden requires a risk assessment to determine how to legislate a substance, and if the substance is deemed harmful enough, then it could be put through a shortened legislative process. The process to ban NPS in Sweden usually takes at least a year, but the NPS tends to disappear after the ban is put in place. However, many of the NPS that have been studied in Sweden are very harmful and even fatal. The strict drug policies that have been put in place in Sweden have resulted in overall lower rates of drug use, but also have resulted in higher prevalence of overdose in drug users.
Overall, the three European Union countries of interest have implemented different approaches to drug legislation that corresponds to their respective cultures around drug use and regulation. Sweden has the strictest approach, which consists of extremely strict policing of drug use and trafficking coupled with drug legislation at every level of the government. Germany’s drug legislation approach is relatively moderate and relies on quick emergency scheduling to curb the advance of NPS. In terms of drug legislation, the Netherlands is broadly considered one of the most lenient governments. The Dutch government does not enforce laws against “soft” drugs and instead focuses its resources to curtail “hard” drugs that are likely to be more detrimental to its citizens. To accompany this approach, they have implemented comprehensive harm reduction and drug education programs. As far as the effectiveness of each approach, the Netherlands reports the best outcomes on drug abuse and overdose and Sweden reports the worst levels of drug overdose.
Part III: Review of how the United States has altered drug policies in response to NPS
After a huge spike in the popularity of street drugs and NPS in the 1960s, the United States decided to form the Drug Enforcement Agency (DEA). The DEA began to regulate high-risk drugs by placing them into five different categories, or “schedules.” The DEA can quickly regulate NPS by using emergency authority to classify a drug. This emergency regulation lasts up to 36 months and occurs when an NPS causes an onslaught of poisonings, hospitalizations, or deaths. In the USA, drug policy is mostly dictated by the Controlled Substances Act (CSA). To schedule a drug to the CSA, there must be “potential for abuse.” Some indicators of this are if users of the drug pose a threat to themselves or others if users take the drug without advice from a doctor, and if the drug is chemically like a previously scheduled drug. If the drug is determined to have the potential for abuse, then it will be categorized into one of five categories. NPS are usually scheduled as Schedule I drugs, which means they have no legal medical use in the US, there is not a known safe way to use the drug, and there is a high risk for abuse. However, since the scheduling process often takes too long for NPS legislation, the Federal Analogue Act was created in 1986 to regulate substances not listed by the CSA. This Federal Analogue Act defines NPS as any substance that is not scheduled by the CSA but is illegally trafficked and has similar chemical structure and effects as a scheduled drug. If a substance is found to fit this definition, then it can be treated as a Schedule I drug under the CSA. However, this legislation has not halted NPS usage, as in 2021 NPS were listed as one of the most serious drug threats in the country. Like in the European Union, the majority of NPS on the market in the US can be traced through online marketplaces back to production in Asia, namely China.
Part IV: Analysis of approaches to NPS and suggestions for future legislation
The overall approach by the EU is generally to facilitate the freedom of information between member countries so that each can make individual legislation on NPS. The United States differs in that it generally legislated NPS federally without allowing large amounts of legislation by the states. However, these countries have many similarities in how they approach NPS legislation. The discussed EU countries and the USA both require a risk assessment of an NPS to schedule it. However, these countries employ different specific strategies for NPS legislation. In Germany, what is known as a blanket or group approach is enacted that bans entire groups of similar NPS. The Netherlands uses an individual scheduling system by adding amendments to the Opium Act to schedule new psychotropic substances. Sweden also employs an individual scheduling approach but supplements this with quick legislation and strict enforcement once an NPS is scheduled. Conversely, The USA operates on an analog system that allows for the easy scheduling of similar NPS without fully employing a group scheduling strategy. These nations also all have different ways of enforcing their scheduled drugs and handling NPS users. Most notably, the Netherlands emphasizes harm reduction programs while Sweden strictly enforces against drug users.
Each approach to NPS legislation has its own benefits and repercussions. Group bans of NPS lead to unintended consequences such as the emergence of new compounds, NPS being shifted onto the black market, people reverting to known drugs, and loss of potentially useful medical NPS. Individual scheduling of NPS is a lengthy process and often is not fast enough to outpace the drug markets. Even analog legislation cannot account for all substance modifications and may be outsmarted by NPS creators. An individual country’s NPS legislation can only be so effective when the drug market is globally operating against it. So, to effectively legislate against NPS, international cooperation must be sought. If law enforcement agencies fought against NPS manufacturing in countries like China and India where large supplies are created, then there would be fewer synthetic drugs on the market and slower creation of analogs. Moreover, since not all countries have the same rules on NPS, these drugs are easily trafficked across borders with less opportunity to be halted.
There are many suggestions for supplementary programs to legislation. Much can be learned from the different policies enacted around the world and the results they have produced. One of the most successful approaches to mitigating the effects of synthetic drug use has been the implementation of harm reduction programs. Harm reduction programs range from providing anti-overdose drugs to offering sterile needles to users. The Netherlands has enacted very successful harm reduction programs to reduce the health repercussions of NPS and other drugs. These programs have resulted in lower levels of drug-related deaths and drug-related illnesses such as hepatitis. On the contrary, Sweden’s strict no tolerance policy has led to a relatively low drug use rate, but higher rates of drug-related deaths and illnesses. In the United States, the legality of harm reduction strategies depend on region. One type of harm reduction strategy known as “drug checking” consists of providing test strips that check traditional drugs for the presence of impurities. A notable example of this is the illegal status of fentanyl testing strips in many areas across the United States. Fentanyl testing strips have been shown to save lives by preventing accidental overdose from fentanyl, a potent synthetic drug that is often found laced in traditional street drugs.  If harm reduction programs and strict enforcement were enacted together, this could potentially lower the negative effects of drug use and the total number of drug users.
Moreover, public health and informational programs could be implemented to spread awareness to the public about the dangers and prevalence of synthetic drugs. Many synthetic drugs, namely opioids, can be prescribed legally, making them especially susceptible to abuse. One reason behind the large amounts of synthetic drug addiction is that patients may be unaware of the addiction risk posed by their prescription drugs. A proposed solution to this issue is to start prescription drug monitoring programs to ensure the close patrol of synthetic prescriptions that are written and filled. These monitoring programs exist to make sure doctors are responsibly prescribing synthetic drugs and patients are correctly dosing them, thereby reducing the risk of addiction and abuse. To mitigate the abuse of prescription drugs, education programs for pharmacists on synthetic drug abuse could be implemented.
However, even with proper legislation and supplementary programs, trafficking remains an overarching issue. To effectively combat trafficking across borders, there needs to be an increase in international cooperation. In 2013, the DEA worked with drug enforcement agencies around the world to orchestrate Project Synergy, which became the largest bust of synthetic drugs to date. This project seized nearly 10,000 kilograms of NPS that were packaged for consumer use. Project Synergy showed that international cooperation makes the enforcement of NPS laws much more effective. However, international cooperation will be a lengthy process and likely take years to discuss and enforce. To combat online trafficking, internet patrols need to be increased to stop trafficking through online marketplaces. Internet marketplaces that sell synthetic drugs are extremely dangerous due to the ease of purchase they provide, and the false information spread through them.  By shutting down these channels, a large portion of the synthetic drug market could be controlled.
Synthetic drug use continues to be a legal issue and a threat to public health worldwide. While rates of synthetic drug usage and deaths continue to rise, the market for these substances continues to increase. Despite this, no legal approach in the EU or the USA to NPS legislation has proven to be fully effective. Each legislation approach such as analog, group, and individual, has its own drawbacks and legal issues. Additionally, the ever-changing nature of NPS and dubious online marketing strategies usually manage to skirt legislation even once it is enacted. Additionally, even effective legislation has shown to be ineffective due to the prevalence of trafficking. Some supportive policies such as harm reduction and educational programs have proven to be useful in mitigating the effects of NPS use. International legal cooperation and internet patrolling appear to be the current best strategy to effectively control NPS trafficking. These policies may reduce the negative impacts of synthetic drugs while the legal side of the issue is being resolved. Finally, while effective synthetic drug legislation is elusive, there are policies that can be implemented to reduce the negative impacts that accompany these substances.
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I would like to thank Dr. Marisa Pagnattaro, Vice President for Instruction & Senior Vice Provost for Academic Planning, for supporting me throughout the research process and providing invaluable expertise and guidance. This project would not have been possible without her support, and I am extremely grateful for her mentorship and help.
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