The EU Early Warning System on new psychoactive substances (NPS)
Introduction
The EU Early Warning System, operated by the EUDA in close cooperation with Europol, plays a central role in supporting national- and EU-level preparedness and responses to new psychoactive substances (NPS). In operation since 1997, it comprises those two agencies, 29 national early warning systems across Europe, the European Medicines Agency and the European Commission.
About the EU Early Warning System
Operated by the EUDA, in close cooperation with Europol, the European Union Early Warning System on New Psychoactive Substances (EWS) is the first step in a three-step legal framework designed to allow the European Union (EU) to rapidly detect, assess, and respond to health and social threats caused by new psychoactive substances (NPS)(1). The work of the EWS aims to build, maintain, and strengthen situational awareness, preparedness, and response activities at national- and EU-level to NPS.
The European Union Early Warning System on new psychoactive substances (EWS) has evolved and been strengthened through several legal frameworks since its inception. Here is an overview of its development:
- The EWS was initially established in 1997 under Joint Action 97/396/JHA.
- In 2005, the system was strengthened by Council Decision 2005/387/JHA.
- Further enhancements were made in 2017 through Regulation (EC) 1920/2006, as amended by Regulation (EU) 2017/2101.
- The most recent update came with the EUDA's Regulation (EU) 2023/1322) which maintained the existing structure of the EWS, as well as the Initial Reports and Risk Assessment processes.
It operates as the first step in this process, followed by risk assessment and control measures.
The EWS is composed of a multiagency and multidisciplinary network, which includes the EUDA, 29 national early warning systems (27 EU Member States, Turkey, and Norway), Europol and its law enforcement networks, the European Medicines Agency (EMA), the European Commission, and other partners. The EUDA, in cooperation with Europol, is responsible for collecting, collating, analysing, assessing, and communicating the information reported by the network in order to provide them with any information required for the purposes of early warning and to allow the EUDA to draw up an initial report on an NPS that may pose health or social risks at EU level or a combined initial reports on several similar NPS.
Underpinning each of the national early warning systems (NEWS), and, in turn, the EWS, is the exchange of information on the chemical identification of new psychoactive substances from forensic and toxicology laboratories. Principally, these laboratories handle casework related to seizures of NPS by law enforcement agencies (such as police, customs, and border forces) from poisonings (such as those from hospital emergency departments and medico-legal death investigations), and from samples collected from people who use NPS and from test-purchases, e.g. from online market places. This approach allows the collection and rapid reporting of event-based information on the appearance of, and, harms caused by, NPS at national level to the EUDA. These data are complemented by annual reports, which include aggregated data on seizures by law enforcement and from poisonings. The organisation and functioning of the national early warning systems is a national responsibility. While these systems have developed to meet national needs, they draw on a common format, guidelines and tools to report information to the EUDA.
Detailed information on the rationale, steps, procedures, roles, and responsibilities for the operation of the early warning system is provided in the EUDA operating guidelines for the European Union Early Warning System.
(1) Other names commonly used to refer to new psychoactive substances include 'novel psychoactive substances', 'new drugs', 'designer drugs', and 'legal highs'.
Formal notification
Most new substances are identified for the first time following the chemical analysis of a seizure made by law enforcement. When a substance is suspected of being an NPS, the national early warning system reports this to the EUDA. This includes chemical and analytical information, as well as the circumstances of the event. The submission of analytical data is also required; to a certain extent, such data are substitutes for analytical reference standards, which are often not available when an NPS is first detected.
Following a review of the reported information, the EUDA identifies other relevant information that may be available in the literature. If confirmed as a new substance, then a formal notification is issued on behalf of the reporting Member State. The notification includes the names and identifiers of the substance, chemical and physical properties, analytical methodologies used for its identification, pharmacology, toxicology, circumstances of the detection, and any other relevant information. At this stage, the EUDA begins to formally monitor the substance. The formal notification process is one of the foundations of a successful early warning system as it ensures that members of the network are alerted as soon as possible to the detection of a new substance in Europe. This allows the network to identify and analyse any potential threats as well as to identify and implement any response measures that might be needed. This process also allows forensic and toxicology laboratories to include the substance in their analytical screening allowing it to be detected and therefore monitored.
As of December 2021, the EUDA is monitoring more than 860 NPS that have been formally notified since 1997.
Monitoring and responses
Once an NPS has been formally notified it is monitored through the EWS for signals of harm. In doing so the EUDA uses a range of interconnected systems that make up the EWS, including event-based data, toxicovigilance, signal management, and open source information. Depending on the signal, responses include placing the NPS under intensive monitoring, issuing risk communications including public health-related alerts, and the production of an initial report which may lead to a risk assessment.
Initial report
Based on the information reported to the EWS, if the EUDA considers that an NPS may pose health or social risks at EU level, it produces an initial report on the substance. This report includes information on:
- the nature, number and scale of incidents showing health and social problems in which the new psychoactive substance may potentially be involved, and the patterns of use of the new psychoactive substance;
- the chemical and physical description of the new psychoactive substance and the methods and precursors used for its manufacture or extraction;
- the pharmacological and toxicological description of the new psychoactive substance;
- the involvement of criminal groups in the manufacture or distribution of the new psychoactive substance.
- information on the human and veterinary medical use of the new psychoactive substance, including as an active substance in a medicinal product for human use or in a veterinary medicinal product;
- information on the commercial and industrial use of the new psychoactive substance, the extent of such use, as well as its use for scientific research and development purposes;
- information on whether the new psychoactive substance is subject to any restrictive measures in the Member States;
- information on whether the new psychoactive substance is currently or has been under assessment within the system established by the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, and the 1971 Convention on Psychotropic Substances (‘United Nations system’);
- other relevant information, where available.
For the initial report, the European Medicines Agency provides information on whether the NPS is used as an active substance in a medicinal product for human or veterinary use. Europol provides information on the involvement of criminal groups in the manufacture, distribution and distribution methods, and trafficking of the new psychoactive substance, and in any use of the new psychoactive substance. The European Chemicals Agency (ECHA), the European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA) also provide the information and data at their disposal on the NPS.
Based on the initial report, the Commission may request the EUDA to formally assess the potential risks posed by the new psychoactive substance and to draw up a risk assessment report, where there are indications in the initial report to believe that the substance may pose severe public health risks and, where applicable, severe social risks.
Joint Report
Under the previous legal framework setup by Council Decision 2005/387/JHA, the initial report was known as a Joint Report that was prepared in conjunction with Europol. The EUDA and Europol prepared 25 Joint Reports on new psychoactive substances between 2005 and 2018.
Related resources
Operating guidelines
New psychoactive substances (NPS) topic hub
A new psychoactive substance (NPS) is defined as 'a new narcotic or psychotropic drug, in pure form or in preparation, that is not controlled by the United Nations drug conventions, but which may pose a public health threat comparable to that posed by substances listed in these conventions'.
New psychoactive substances topic hub
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