EUROPEAN COMMISSION Brussels, 12.1.2022 SWD(2022) 8 final COMMISSION STAFF WORKING DOCUMENT



IMPACT ASSESSMENT

Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on the European Union Drugs Agency {COM(2022) 18 final} - {SWD(2022) 9 final}



Table of contents List of abbreviations 1.Introduction: Political and legal context 1.1.Political context 1.2.Legal context 2.Problem definition 2.1.Overview of the findings of the evaluation of the EMCDDA 2.2.What are the problems for action? 2.3.What are the problem drivers? 2.4.Who is affected and in what ways? 2.5.How will the problem evolve? 3.Why should the EU act? 3.1.Legal basis 3.2.Subsidiarity: Necessity of EU action 3.3.Subsidiarity: Added value of EU action 4.Objectives: What is to be achieved? 4.1.General objectives 4.2.Specific objectives

5.What are the available policy options? 5.1.What is the baseline from which options are assessed? 5.2.Description of the policy options 5.3.Options discarded at an early stage 6.What are the impacts of the policy options? 6.1.Impacts on the European Union (EU bodies) and value-added 6.2.Impacts on national authorities 6.3.Impacts on simplification and/or administrative burden 6.1.Economic impacts 7.How do the options compare? Specific objective 1: To increase the Agency’s capacity to react faster and in a more targeted way to new challenges in the field of drugs, harms and addictions, and related threats 7.1. gdgdgdgdgd 7.2.Specific objective 2: To deepen the monitoring and analysis of the drug phenomenon in Europe, both on the demand and supply side and their implications for health and security 7.3.Specific objective 3: To clarify the mandate of the Agency as regards what substances, behaviours and responses should be covered 7.4.Specific objective 4: To make the Agency more operational 7.5.Specific objective 5: To provide support to Member States in shaping and evaluating their drugs policies 8.Preferred option 8.1.Summary of the preferred option 8.2.Explanation of the preferred option

8.3.Impacts of the preferred option on the EU budget 8.4.Scope for simplification and burden reduction 9.How will actual impacts be monitored and evaluated? Overview of Annexes Annex 1: Procedural information 1.Lead DG, Decide planning/CWP references 2.Organisation and timing 3.Consultation of the Regulatory Scrutiny Board 4.Evidence, sources and quality 5.Limitations Annex 2: Stakeholder consultation 1.Main stakeholder groups 2.Exception from the public consultation obligation 3.Inception Impact Assessment Annex 3: Who is affected and how? 1.Summary of benefits 2.Summary of costs Annex 4: Intervention logic of Regulation (EC) 1920/2006 Annex 5: Problem, drivers, objectives and options (intervention logic of the current initiative) Annex 6: Schematic overview of the contribution of the policy options to the specific objectives

Annex 7: Relevant drug-related Figures List of abbreviations Term or acronym Meaning or definition CEPOL European Union Agency for Law Enforcement Training DG GROW Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs DG SANTE Directorate‑General for Health and Food Safety DG TAXUD Directorate-General for Taxation and Customs Union ECDC European Centre for Disease Prevention and Control EMA European Medicines Agency EMCDDA European Monitoring Centre for Drugs and Drug Addiction (also referred to as ‘the Agency’) ENFSI European Network of Forensic Science Institutes EU European Union Europol European Union Agency for Law Enforcement Cooperation EWS EU Early Warning System on new psychoactive substances Founding Regulation (of the Agency) Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (recast), OJ L 376, 27.12.2006, p. 1. HERA European Health Emergency Preparedness and Response Authority MAOC-N Maritime Analysis and Operations Centre – Narcotics MDMA Methylenedioxy-methylamphetamine; commonly known as “ecstasy” NPS New Psychoactive Substances Reitox European Information Network on Drugs and Drug Addiction (Réseau Européen d’Information sur les Drogues et les Toxicomanies) SMEs Small and medium sized enterprises TFEU Treaty on the Functioning of the European Union THC Tetrahydrocannabinol UN United Nations UNODC United Nations Office on Drugs and Crime



1.Introduction: Political and legal context 1.1.Political context Illicit drugs are a complex security and health problem that affects millions of people in the EU and globally. The European Drug Report 2021 points out that 83 million adults in the EU are estimated to have tried illicit drugs during their lives. In 2019, at least 5,150 overdose deaths occurred in the EU. The report shows a deteriorating situation with the volumes of cocaine and heroin introduced in the EU at an all-time high. Production of drugs in particular synthetic drugs (amphetamines and MDMA) takes place within the EU for domestic consumption and for export. The illicit drug market is estimated at a minimum retail value of EUR 30 billion per year, and it remains the largest criminal market in the EU and a major source of income for organised crime groups. Among people who use drugs, poly-drug use is widespread. Cannabis is the most commonly used drug. The use of heroin and other opioids continue to be most commonly associated with the more harmful forms of drug use. The European Drug Report 2021 observed a rise in use of benzodiazepines among high-risk drug users, prisoners and some groups of recreational drug users, potentially reflecting the high availability and low cost of these substances and pandemic-related mental health issues. This is having a detrimental impact on public health. Increased availability of other drugs, particularly cocaine and some synthetic substances, is associated with increased levels of drug related violence and other crimes. The European Monitoring Centre for Drugs and Drug Addiction (‘EMCDDA’; ‘the Agency’) was founded in 1993 to address the escalating drugs problem in Europe at the time. The recast of the founding Regulation in 2006 kept the mandate of the Agency largely as it was, mainly making relevant institutional changes. The main substantive changes were the mandate for sharing and promoting evidence-based interventions (‘best practices’), the inclusion of new psychoactive substances, and the transformation of the European Information Network on Drugs and Drug Addiction (‘Reitox’) network from a computer network to a network of national focal points. The revision of the legislation on new psychoactive substances in 2017 was the only other occasion when the founding Regulation was adapted. This revision integrated the main provisions of the three-step-approach of controlling new psychoactive substances into the founding Regulation. In 2018/19, the Commission carried out the fourth evaluation of the Agency in line with the requirements of the founding Regulation. It concluded that the Agency works overall well, but further improvements are possible in several areas, in particular in view of the developments of the drug phenomenon. As was shown by the evaluation and by the regular contacts with the Agency and its stakeholders, there is an increasing disconnect between the complexity of the drug phenomenon and what the Agency mandate provides for. The founding Regulation does not reflect the current reality of the drug phenomenon and is out of step with the tasks the Agency needs to perform to address the challenges of the drug phenomenon and the requests by its main stakeholders. The drug phenomenon represents an integral element of the health and security challenges that Europe faces. With the drugs landscape developing constantly and new drugs regularly coming on the market, the drug phenomenon is becoming more complex and pervasive. This situation calls for an enhancement of the efforts at EU level. In response, the Commission adopted the EU Agenda and Action Plan on Drugs 2021-2025 in July 2020. On that basis, the Council adopted in December 2020 the new EU Drugs Strategy 2021-2025, which provides the overarching political approach and priorities for EU drugs policy for the next five years. It advocates a balanced, integrated, multidisciplinary and evidence-based approach to the drugs phenomenon. The Strategy inter alia invites the Commission to present a proposal to revise the mandate of the EMCDDA as soon as possible, to ensure that the agency plays a stronger part in addressing the current and future challenges of the drug phenomenon. This impact assessment report prepares the ground for a targeted revision of the mandate of the Agency to address current and future challenges. 1.2.Legal context The objective of the founding Regulation was to establish a European agency to provide the EU and its Member States with factual, objective, reliable and comparable information at European level on drugs and drug addiction and their consequences. In order to meet this objective, the key areas of activity of the Agency are defined in Article 2 of the founding Regulation as follows: collection and analysis of existing data; improvement of data comparison methods; dissemination of data; cooperation with European and international bodies and organisations as well as with third countries; information obligations; and exchange of information on, early warning system for, and risk assessment of new psychoactive substances. The Regulation sets out the priority areas of the activities of the Agency as follows:

1)monitoring the state of the drugs problem, in particular using epidemiological or other indicators, and monitoring emerging trends, in particular those involving poly-drug use; 2)monitoring the solutions applied to drug-related problems; providing information on best practices in the Member States and facilitating the exchange of such practices among them; 3)assessing the risks of new psychoactive substances and maintaining a rapid information system with regard to their use and also regarding new methods of using existing psychoactive substances; 4)developing tools and instruments to help Member States to monitor and evaluate their national policies and the Commission to monitor and evaluate European Union policies. The core data is collected through the Reitox network. The remainder of the founding Regulation deals with the organisational set-up of the Agency and horizontal rules about its functioning. 2.Problem definition The problem definition set out in this section is the basis for the development of the intervention logic, which is shown in Annex 5. 2.1.Overview of the findings of the evaluation of the EMCDDA The evaluation, supported by a study of a contractor, is positive as regards the five evaluation criteria, but notes that improvements are possible in several areas. These are set out in the Commission report on the evaluation and in more detail in the accompanying Staff Working Document. The main findings can be summarised as follows: Relevance: The Agency’s outputs correspond well to the needs expressed by stakeholders, including covering new topics. The relevance on national level is more limited than on European level as several Member States have wider addiction policies in place. The question on whether to broaden the mandate of the Agency to other addictions was assessed in detail, but the outcome was inconclusive. The evaluation concluded that there is scope for more engagement with the scientific community, practitioners and the public. It showed a need for more forward-looking products, identifying future trends and risks, to better support EU preparedness and response. Effectiveness: The Agency is recognised as a centre of excellence in providing information on the drugs phenomenon not only in Europe but also internationally. The information produced by the Agency is considered factual, objective, reliable and robust, although comparability could be enhanced. The evaluation recognised the positive work of the Agency in monitoring the European drug situation, including through the EU early warning system. The Reitox network has a central role in the collection of information, even if quality varies from country to country. The evaluation further assessed that poly-drug use is not sufficiently addressed. The activities undertaken at international level are compatible with the EU priorities as the Agency brings the EU’s evidence-based policy-making about drugs monitoring to third countries, and thus helps improving the global understanding of the drugs phenomenon. Efficiency: The evaluation concluded that the Agency uses the available human and financial resources efficiently. The budget of the Agency remained relatively flat over the evaluation period, at approximately EUR 16 million per year, although the Agency’s output has grown considerably over the same period. The Agency is delivering the benefits envisioned in its mission at a reasonable cost. The evaluation identified scope for simplification and improvements, including on the use of information and communications technology and more targeted outreach to its main audiences, including online. Coherence: The multiannual work programmes of the Agency were well aligned with the Agency’s founding Regulation, the EU Drugs Strategy 2013-2020 and the European Agenda on Security. The objectives and activities set out in the Agency’s programming documents were coherent with the regulatory framework. The Agency’s work was complimentary with the work of the EU institutions and agencies across the relevant strategic objectives. Although the Agency increased its focus on security issues, the evaluation concluded that more should be done on supply-side issues. A common theme across the interviewed stakeholder groups was the potential for the Agency to take an even more active role on the international stage. EU added value: The EU-level overview of the drug situation provided by the Agency helped the Member States to improve their capacity to monitor and respond to the drug problems. A common methodology for data collection was considered as not achievable without the Agency. The Agency’s engagement with national policy-makers and with practitioners could be improved. The Agency was considered the most effective option to carry out the tasks allocated to it. As regards the question of merging the EMCDDA with another EU agency or its termination, the answers during the consultation process were all negative. 2.2.What are the problems for action? The drug phenomenon has changed considerably since the adoption of the Agency’s current mandate through the recast of the founding Regulation in 2006. Whereas the worsening drug situation is a much wider problem, this impact assessment report only considers the limitations on the Agency due to the current mandate. The main supporting evidence for the new challenges of the drug phenomenon, are the annual European Drug Reports by the EMCDDA and the annual World Drug Report by the UN Office on Drugs and Crime (UNODC). They show the developments from one year to the next and longer term trends. Another important source are the EU Drug Markets Reports, the third edition of which was published in autumn 2019 by the EMCDDA and Europol. Many other topical reports by the EMCDDA, partly together with other agencies, in particular Europol, and by international organisations, such as the UNODC and the International Narcotic Control Board (INCB), can provide further evidence on the development of the drug phenomenon. Complexity of new drug phenomena lead to a disconnect with the existing Agency mandate The Agency’s monitoring – based on the current founding Regulation – is largely backward looking. The core data, related to the five currently defined key epidemiological indicators, is collected by the national focal points and provided by them to the Agency. This data is insufficient to cover new trends and developments as it covers only core data and comes with a time lag. Additional data may be provided by ad hoc projects. The analysis is published in the reports of the Agency, which are focussed on statistics and trends based on past developments. However, the modern drug phenomenon would necessitate more real-time and forward-looking analysis about emerging threats in order to anticipate developments, as identified by the evaluation, and to provide information on the best ways to address these new phenomena.

The current founding Regulation of the Agency is addressing illicit drugs, i.e. those controlled by the UN Drug Conventions and those defined by Council Framework Decision 2004/757/JHA, and does not go beyond that to include other (substance-based or behavioural) addictions in its mandate. Several Member States have developed wider addiction strategies, often covering other (legal) substances, such as alcohol or tobacco, or even non-substance based addictions, such as gambling or compulsive gaming based on the logic that they are all addictions and share biological and behavioural characteristics.

Source: EMCDDA Papers: New developments in national drug strategies in Europe (extract). Furthermore, the current founding Regulation does not include drug precursors in the Agency’s scope of action. Drug precursors are relevant as their diversion is closely linked to the increasing production of synthetic drugs on the territory of the EU. The concept of poly-drug use was introduced with the recast of the founding Regulation. However, it has not been exploited sufficiently by the Agency, as shown by the evaluation. This is mainly due to the concept not being sufficiently clear and insufficient information being available as the national focal points do not have a mandate to collect data going beyond drugs. However, this would be needed to fill the concept with content. Inadequate responses to new drug market challenges Drug selling on online marketplaces, including on the darknet, social media platforms and mobile applications, is increasing, including during the height of the COVID-19 pandemic. These emerging marketplaces present new challenges. New technologies have facilitated the appearance of an online drug market as part of the darknet and on the “normal” internet. Equally, changing trafficking routes have caused a spill over effect into new areas. Drug selling is moving to closed groups or private chats, such as messaging applications, and is using other routes of getting drugs to the customer, for example through alleged food delivery couriers. The Agency increased its collaboration with in particular Europol to better monitor these new marketplaces and to increase its understanding of the related challenges. In addition, drug production based in the EU is growing, in particular of MDMA (ecstasy) and increasingly for other amphetamine-type drugs. In recent years, laboratories for the production of other drugs have occasionally been detected in the Member States. Based on these new challenges, it can be concluded that a major shortcoming of the founding Regulation is that it does not include any references to the monitoring of drug markets or of drug supply. However, a thorough understanding of drug market and security issues is necessary for the Agency to provide a holistic picture to policy-makers. This was raised during the consultation for the 2018/19 evaluation, when several stakeholders mentioned supply-side issues as one element where further information from the Agency would be welcome. Although Europol and the EMCDDA have started monitoring online drug markets, they do not have adequate tools and sufficient resources to develop appropriate responses. Finally, the Agency has – based on the founding Regulation – a key responsibility in the monitoring of new psychoactive substances. However, it cannot do any of the analysis itself and has to rely completely on third parties, including on third-country agencies, for the forensic and toxicological examination, as it does not have laboratory capacities. The Reitox network is not used to its full potential The Reitox network has a very limited role based on Article 5 of the founding Regulation. It is the interface between the Agency and the participating countries. The Reitox national focal points provide the core data on drugs and drug addiction, as well as on policies and solutions applied, to the Agency on an annual basis. The evaluation concluded that the Reitox network is the main source of information for the Agency. Depending on the national context and situation, the position and outputs of the national focal points vary strongly, as the Regulation does not provide any details about their set-up and is not sufficiently clear on their rights and obligations on national and European level. The national focal points do not have access to all data required by the Agency for the key indicators as some other national authorities are reluctant to share relevant information. Comparability of data could be further improved, as concluded in the evaluation. Insufficient support to Member States Several Member States have in the past asked for support, both for the evaluation and development of their national drug policies, as well as for their international activities, such as for the Agency to provide data to the UN or to provide background information on the drug situation in the EU’s neighbourhood. The founding Regulation does not address these issues beyond requesting the Agency to develop relevant tools. The evaluation concluded that Member States would be interested in more structural support in relation to evaluating and subsequently shaping national drug policies. Member States are not only interested in receiving data or comparing the national situation with the situation in other Member States, which is in the current mandate of the Agency, but to get concrete advice and support from the Agency, as they do not necessarily have all the relevant knowledge or capacity on their own. The exchange of best practices on health and other demand side issues is too limited to be of real assistance for the Member States. National stakeholders expressed in the evaluation a need to move beyond the simple identification of best practices to supporting the implementation of evidence-based practices and the delivery of effective interventions, for example through training or accreditation schemes for such interventions. The international dimension of the Agency is insufficiently defined Analysing how international developments impact on the EU is becoming increasingly important due to the globalisation of the drug phenomenon. The tasks in the founding Regulation as regards international issues are mainly focussed on cooperation on a bilateral and multilateral level and are carried out on a case-by-case basis upon the request of the Commission. The same is true for the input the Agency is providing to the EU and to the Member States on the impact of drug policies in third countries on the EU markets. UN bodies currently receive information directly from Member States, but also rely extensively on the Agency. Conversely, Member States provide information both to UN bodies and to the Agency. This creates risks of duplication of efforts and calls for better coordination, which was one of the conclusions of the evaluation. 2.3.What are the problem drivers? The analysis of the evidence supporting the impact assessment, in particular the evaluation of the Agency, identified the following problem drivers:

The mandate of the Agency has not been adapted to the changes of the drugs phenomenon The drugs phenomenon has changed considerably since the founding of the Agency in the early 1990s. It has become more complex and it now encompasses a broader range of illicit substances and drug-related behaviours. The drug market has become much more innovative, digitally enabled and globally connected. This means that new developments in both drug trafficking and drug use spread more rapidly than was previously the case. The Agency’s EU Early Warning System is monitoring currently more than 830 new psychoactive substances, of which 46 were identified for the first time in 2020. The vast majority of these substances have appeared on the European market over the last 10 years. Whenever a new psychoactive substance is included in the list of drugs, the drug criminals develop a new substance by slightly altering the chemical composition. Therefore, the demands on the Agency by its main stakeholders, in particular by the European and national policy-makers, have grown over time. In the 1990s, no EU-level information to describe the drug situation and its consequences in an objective way was available and a related data collection system was missing. Nowadays, this is in place, but more sophisticated information, including real-time analysis about emerging threats and advice on the best possible ways to address those, is required. As the Agency mandate has not been revised since 2006 – and at the time only to a limited extent – the Agency is working based on an outdated mandate that is almost 30 years old. As explained above, there is an increasing disconnect between what Europe needs to address the drug phenomenon and what the Agency mandate provides for in legal terms. The founding Regulation does not reflect the current reality of the drug phenomenon and is out of step with the tasks the Agency needs to perform to address the related modern day challenges. Multi-jurisdictional challenges due to new threats Drug markets are cross-border by nature and many of the most commonly used drugs and precursors used in the EU are imported from third countries. New security challenges stem from the growing involvement of organised crime groups in several criminal activities, such as drug trafficking, human trafficking, migrant smuggling, or financing of terrorist activities. Organised crime groups often use drug trafficking to obtain the cash needed for their other activities. These links have considerable impacts on the development of the drug phenomenon. Drug production based in the EU is growing and is driving greater levels of intimidation, corruption and violence within the EU and will lead to further challenges in the future. In addition, online trafficking of drugs is increasing. Monitoring these developments is crucial for a better understanding of the drug phenomenon. However, the challenges related to these new threats cannot be addressed by any Member State on its own. Evolving national policies lead to changing priorities The importance given to the topic of drugs policy in the Member States changes over time. Member States shift their policies, whether in terms of health-orientation or security perspectives. Several Member States broadened their drugs strategies to a wider addiction approach over the last years. Such developments have significant impacts on the Agency as they lead to new needs and requests from its stakeholders, and ultimately to the need to refocus the priorities. Recent developments in international drug policy The drugs phenomenon is increasingly global and decisions taken in third countries can have considerable impact on the drug situation in the EU. This is rendering the EU’s drug situation more and more intertwined with that of other countries and regions. Work of the UN bodies in the drugs field increased over the last years, which lead to important recent developments in international drugs policy. An important impetus was the 2016 Special Session of the United Nations General Assembly on the World Drug Problem. 2.4.Who is affected and in what ways? The drug phenomenon is a far-reaching problem, which can affect everyone’s life. The revision of the founding Regulation itself only has limited direct impact on some stakeholders, whereas other potential stakeholders, in particular citizens, would only indirectly be affected. This section sets out the most affected stakeholders and explains in what ways they would be affected. In addition to its main stakeholders, the Agency itself would be affected by a proposal for the revision of its mandate. Policy-makers on European and national level The main stakeholders of the Agency are policy-makers on European and national level. Their primary need is information and evidence on which to base policy decisions and related actions. As concluded by the evaluation, the Agency is more relevant to the needs of European than national policy-makers. On the national level, the relevance depends on the scope of national policies. The Agency is less relevant for those Member States that have a wider addiction policy, as the Agency would not be able to provide all necessary data. The availability of objective data is key for EU level policy-makers as it forms the basis of the EU’s evidence-based policy-making in drugs policy. Moreover, the relevance depends on the stage of development of national drug information systems. Member States with better-developed national drug information systems may rely less on the information available from the Agency. Nevertheless, national policy-makers rely on the Agency for cross-EU comparative analysis as this element cannot be covered by national systems. If the Agency would not be able to address properly and in a timely manner the current and future challenges of the drugs phenomenon, the Agency would lose its relevance for policy-makers. Not collecting relevant data would have a negative impact as comparable data would not be available, would have to be gathered on an ad hoc basis or would not lend itself to identifying important new threats in a timely manner.

Scientific community As regards the scientific community, the evaluation concluded that there is scope for greater engagement, although overall the needs of the scientific community were well addressed. Nonetheless, the Scientific Committee of the Agency has pointed out in its contribution that the Agency could provide added value by being more active and establishing greater synergies within the context of the EU research knowledge cycle. This would include in particular helping to identify research gaps, helping or facilitating engagement with national scientific networks and experts, and ensuring the dissemination of research findings after a project finished and maintaining a registry of what has been funded, and more. Practitioners Practitioners rely on the Agency for information and for the exchange of best practices. The evaluation concluded that practitioners from the public health area appreciated the increased work on that pillar, in particular the focus on harm reduction and prevention. Several non-governmental (civil society) organisations underlined in their feedback to the inception impact assessment their appreciation for the work of the Agency and the need for a neutral scientific agency, and stressed that any change in the mandate of the Agency should not be to the detriment of its public health focus. In addition, the Agency is increasing its engagement with law enforcement practitioners, in particular through input into trainings of the European Union Agency for Law Enforcement Training (CEPOL) and closer cooperation with Europol, although there is scope to do more in this area, as concluded by the evaluation. The Agency itself The Agency itself might suffer most if the mandate remains as it is. In practice, the Agency is interpreting its mandate already quite widely and is undertaking work, which is not explicitly covered by the current mandate. This is due to requests from its main stakeholders and necessitated by the developing drug landscape. However, such an approach has limits, in particular in view of the available human and financial resources, and the need to keep within the legal mandate. 2.5.How will the problem evolve? Without any intervention, the problems identified in this impact assessment will persist or get worse over time. The drug phenomenon is constantly changing and will become even more complex. Unless sufficient and timely information on the real situation of the drug phenomenon is available, as regards public health, safety and security, there will be severe negative implications on EU and national level policy-making and ultimately on the responses afforded by public authorities. This would be exacerbated by the need for Member States to act unilaterally in the absence of an adequate EU-level solution, which would be particularly damaging as the drug phenomenon becomes more and more global. The COVID-19 pandemic showed that drug criminals are able to adapt their illicit activities relatively easily and quickly to new circumstances, for example through virtual means (online markets, messaging applications, etc.) and reduced face-to-face interactions. It is expected that these recent developments will have long-term impacts on drug markets. By maintaining the status quo of the mandate, the Agency’s capacity to address emerging and future challenges would continue to diminish. The tension between the reality of the drug phenomenon and the founding Regulation would increase further. Although the Agency adapted well to changes in the past, there are limits – set by the mandate, but in particular by financial and human resources – how far these adaptations can go. Adaptations are not only needed in relation to drug markets, which are not explicitly mentioned in the mandate of the Agency, but also in relation to health-related issues. The COVID-19 pandemic demonstrated that it is important to have the capacity to exchange information and experiences rapidly and to share best practices between Member States to learn from each other. Without a revised mandate, the Agency runs the risk of losing its added value, its relevance for stakeholders, and ultimately its status as a centre of excellence and as a model for other regions in the world. 3.Why should the EU act? 3.1.Legal basis The founding Regulation of the Agency was based on Article 152 of the Treaty establishing the European Community, i.e. on the public health legal basis. This provision corresponds to Article 168 of the Treaty on the Functioning of the European Union (TFEU). Article 168(1) 3rd subparagraph reads: “The Union shall complement the Member States' action in reducing drugs-related health damage, including information and prevention”. Article 168(5) provides that the European Parliament and the Council may adopt “measures concerning monitoring, early warning of and combating serious cross-border threats to health”. Addressing supply and drug market related issues supports reducing the availability of drugs in the EU and curbing drug demand and ultimately public health. The health and security dimensions of the drug phenomenon are intrinsically linked and cannot be addressed separately. Therefore, addressing supply-side issues is covered by the public health legal basis and does not go beyond what is possible under that legal basis. Drugs are also referred to in Article 83 TFEU. Article 83(1) states that the European Parliament and the Council can adopt rules to “establish minimum rules concerning the definition of criminal offences and sanctions in the areas of particularly serious crime with a cross-border dimension resulting from the nature or impact of such offences or from a special need to combat them on a common basis”. Illicit drug trafficking is one of the relevant areas of crime. However, Article 83 TFEU is not relevant for the current initiative as it does not intend to set such minimum rules. 3.2.Subsidiarity: Necessity of EU action EU action to revise the mandate of the Agency is necessary.

The drug phenomenon is affecting all Europeans and is cross-border and multi-jurisdictional in nature, in particular when it comes to drug markets and organised crime. There are many common challenges across Member States, both on the health and security side, which need to be tackled. It is not possible to address the drug phenomenon only on a national or regional/sub-national level as drugs move around Europe. A problematic health or security pattern detected in a Member State very often appears in other Member States. National legislation or even the best national practice would not be able to address the cross-border aspects of the drug phenomenon. Due to this transnational character, there is a need for EU-level action. The action is proportionate as it is the only way that the necessary changes in the Agency’s mandate can come about. EU-level action does not intend to replace national actions or authorities or question their relevance. The drug phenomenon can only be addressed if all levels – EU, national and local – work together. The current proposal will not go beyond what is proportionate to tackle an EU-wide phenomenon. When it comes to the possible new rules and responsibilities of the national focal points, it will remain for the Member States to decide exactly how they want to set up a national focal point. However, in order to ensure that the national focal points are in a position to provide to the EU-level what is necessary and to access the funding available at EU level, they should comply with a set of minimum requirements. Moreover, as the provision of the core data from the Member States to the Agency through the national focal points is the basis for the overall drug monitoring system, it is proportionate to set such minimum requirements. 3.3.Subsidiarity: Added value of EU action The EU added value of a revision of the Agency mandate will be considerable. Adopting a targeted revision of the Agency’s mandate, thereby enabling it to address current and future challenges, is in the interest of the EU, in particular in view of the recent deterioration of the drug situation in the EU. The revision of the mandate of the Agency is part of the reaction of the EU to these developments. As the evaluation showed, and this is relevant also for the revision of the mandate, the existence of the Agency has an important added value compared to addressing the drug phenomenon solely at national level. Many of the phenomena are by nature cross-border, and increasingly global, and therefore cannot be addressed by a Member State alone. The absence of the Agency would imply the loss of the EU-level overview of the drug phenomenon, as the data collected by Member States would be fragmented or possibly non-existent, with important consequences at national, EU and international level. This would run contrary to the requirements of the EU’s evidence-based policy-making in drugs policy, which relies on a neutral body to provide factual and objective data. A targeted revision would strengthen the Agency in crucial areas to enable it to address these common issues better. 4.Objectives: What is to be achieved? 4.1.General objectives The general objective of the proposal, i.e. the aim of a targeted revision of the founding Regulation, is: ·To have an Agency, which is appropriately equipped to deal with the current and future challenges posed by drugs in the EU, leading to efficient action and support for Member States. 4.2.Specific objectives The specific objectives of the proposal are: 1)To increase the Agency’s capacity to react faster and in a more targeted way to new challenges in the field of drugs, harms and addictions, and related threats; 2)To deepen the monitoring and analysis of the drug phenomenon in Europe, both on the demand and supply side and their implications for health and security; 3)To clarify the mandate of the Agency as regards what substances, behaviours and responses should be covered; 4)To make the Agency more operational; and 5)To provide support to Member States in shaping and evaluating their drugs policies.

5.What are the available policy options? 5.1.What is the baseline from which options are assessed? The baseline scenario is established by the founding Regulation of the Agency, i.e. Regulation (EC) No 1920/2006, and the current functioning of the Agency. The Agency’s mandate is focussed on data collection, monitoring, harmonisation of data, analysis and publication of the outcomes of these exercises as regards (illicit) drugs, drug addiction and their consequences. Areas of activity The key areas of activity of the Agency are set out above. The “EMCDDA Strategy 2025” attributed the activities and the tasks of the Agency to two main pillars, health and security. In addition, it defined four business drivers. The strategic objectives of the two main pillars reflect the priority areas set out by the founding Regulation. While the Agency’s focus is primarily on Europe, it works with partners in other world regions, exchanging information and expertise. The Agency cooperates with candidate and potential candidate countries as part of their accession process to the EU. Cooperation takes place based on bilateral agreements or in the context of EU-funded projects. Cooperation ranges from implementation of technical assistance projects to ad-hoc training or consultative support. Collaboration with European and international organisations in the drugs field is central to the Agency’s work. Reitox network The Reitox network is the European information network on drugs and drug addiction. Members of the Reitox network are designated national institutions or agencies responsible for data collection and reporting on drugs and drug addiction (‘national focal points’ or ‘national drug observatories’). The Reitox network links national drug information systems and is the main way in which the Agency exchanges data and methodological information on drugs and drug addiction in Europe. The financing of the national focal points is provided by the Member States, but is supported by a grant from the Agency. Current monitoring system The current monitoring system is based on the provision of data by the national focal points. It implies the collection of both quantitative data and qualitative information using different types of standardised data collection and reporting tools. The Agency collects data also from the projects it participates and through contracts with third parties. Different innovative data collection methods provide data on specific phenomena and closer to real time. Examples include wastewater analysis, hospital emergency data, analysis of data from drug checking facilities, and recent work to measure drug related violence. In addition, the EU Early Warning System collects data on the detection of new psychoactive substances. The information is available in the European Database on New Drugs (EDND). The Agency itself does not conduct the forensic or toxicological analysis as it does not have a laboratory. The Agency is the only body, which collects drug-related data on a European level. Contrary to other policy areas, Eurostat is not involved in the collection of data related to drug policy. Europol does not collect any data, but only has information from its operations. Such data would not be sufficient to provide an overview on European level on the developments of the drug phenomenon as it is focussed on specific issues. Finally, the EU health agencies only collect health-related data and not drug data. Implementation of the founding Regulation The main achievement of the establishment of the Agency is the availability of factual, objective, reliable and comparable information at European level concerning drugs and drug addiction. This information is the basis for the development of an integrated, balanced and evidence-based approach to EU drugs policy. When it comes to the monitoring of the state of the drugs problem, the solutions applied to drug-related problems as well as to European and national policies, the Agency has published almost 400 scientific and institutional reports from 2013 to 2017. Among its flagship publications are the annual European Drug Report, including the country reports, the EU Drug Markets Report, published most recently in 2019, and the “Health and social responses to drug problems – A European Guide”. The Agency has facilitated the exchange of best practices and of drug-related information through the participation of its staff in more than 1 500 events (contributions to conferences, policy fora, etc.). It has established an online best practice portal. In addition, the Agency organises regular and frequent meetings with its stakeholders for the sharing of best practices. In order to address, at least partially, new developments, the Agency is interpreting its mandate as widely as possible within the legal framework. As regards health-related issues and the best practice portal, it is regularly updated with new ways of providing support to people who use drugs and will develop further in this sense, also taking into account the experience gained during the COVID-19 pandemic. The Agency is monitoring the developments on the drug markets to a certain extent and in close cooperation with Europol. This wide interpretation is reaching its limits, including in relation to the available resources. The Agency cannot go beyond the legal framework as set out in the founding Regulation. 5.2.Description of the policy options Non-legislative options Policy option 0: Baseline scenario - Maintaining the current approach without changes

This option preserves the status quo and is described in Section 5.1. In this scenario, the current mandate, objectives, tasks, governance and organisation of the Agency would remain unchanged. Policy option 1: Minimal revision - Stronger cooperation Taking into account current cooperation between the Agency and various EU and UN bodies on various aspects of drug phenomena, cooperation on European level could be enhanced with, among others, Europol, the Maritime Analysis and Operations Centre – Narcotics (MAOC-N), the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC), and on an international level with the United Nations Office on Drugs and Crime (UNODC). The envisaged reinforcement of the mandates of the relevant agencies would need to be taken into account. Furthermore, the creation of the European Health Emergency Preparedness and Response Authority (HERA) could also provide an opportunity for fruitful cooperation with the Agency. Stronger cooperation among the Member States themselves or between the Agency and the Member States, should also be pursued. However, this needs to remain within the competencies of the Member States and the Agency, or respective EU bodies. This option would not lead to any legislative changes to the founding Regulation. The current mandate, objectives, tasks, governance and organisation of the Agency would remain unchanged. Legislative options Policy option 2: Dismantling of the Agency - Repeal of the founding Regulation In line with the common approach on decentralised agencies, common and objective criteria should be used to assess the opportunity to dismantle agencies, when the mandate of an agency is thoroughly reviewed. This option would effectively result in the repeal of the founding Regulation and ultimately the termination of the Agency. Policy option 3: Merging of the Agency with another EU body Further in line with the common approach on decentralised agencies, the possibility to merge the agency with another EU body should be considered. This option entails an assessment on whether merging the Agency with another EU body, such as Europol, the Maritime Analysis and Operations Centre – Narcotics (MAOC-N), the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC) or the European Health Emergency Preparedness and Response Authority (HERA) would be feasible. This would lead to the creation of a new body, absorbing the merging entities. The analysis takes into account the planned reinforcement of the mandates of the relevant agencies and the creation of HERA. Policy option 4: Targeted revision – Delivering more value in drugs policy The targeted revision option is a legislative option to amend/revise the founding Regulation and hence the Agency’s mandate, by responding to the different issues outlined in the problem definition through a targeted degree of intervention in terms of: thematic scope of action for the Agency, the monitoring system, the Reitox network of national focal points, support to Member States, and international cooperation. The targeted revision option would be fully aligned with the strategic priorities covered by the EU Drugs Strategy 2021-2025. Thematic scope of action As the Agency was founded in early 1990s and the mandate has not been revised since 2006 – and at the time only to a limited extent – the Agency is working based on an outdated mandate that is almost 30 years old. This makes the thematic scope of action of the Agency a key intervention area. There is an increasing disconnect between the current reality of the drug phenomenon and what the Agency’s mandate provides for in legal terms. The targeted revision option would deepen the efforts of the Agency in the drug area to address the key elements of the new drug phenomena – (i) other substance-based addictions when these substances are taken together with illicit drugs, i.e. poly-substance use; (ii) drug supply and drug market issues. Firstly, the drug phenomena have become complex, now encompassing a broader range of substances, while the drug market has become much more innovative, digitally enabled and globally connected. Many problems related to illicit drug use are augmented with the simultaneous or sequential use of other psychoactive substances. For example, the combined use of heroin and alcohol increases the risk of overdoses. This is further exacerbated if different (illicit) drugs are used together. A better understanding of poly-substance use would help to better address the drug phenomena. Secondly, the work of the Agency is – as previously explained – based on the two pillars, health and security. The recent evaluation concluded that the Agency could and should do more on supply-side issues. However, supply-side issues are not explicitly covered in the current mandate of the Agency. On the other hand, a drugs agency, which is not able to monitor supply-side issues, would ignore an important dimension of the drug phenomenon and would not be able to provide a holistic picture. Drug supply issues are intrinsically linked with the public health dimension of the Agency and, therefore, the Agency already managed to address some supply issues in its work. Furthermore, the diversion and trafficking of drug precursors is a major input for drug production. The Agency is addressing drug precursors as a side issue in the context of drug market monitoring. The Commission collects data on diverted and trafficked drug precursors through a database hosted by the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) in line with the applicable precursor legislation. The competent authorities nominated for this task by the Member States feed this database. The reporting is mandatory for a number of basic data elements, but Member States are invited to provide as much circumstantial information as possible. The information is then used by the Directorate-General for Taxation and Customs Union (DG TAXUD) for coordinating and sending the annual FORM D-reporting to the International Narcotics Control Board on behalf of the EU. The data is also provided to the Agency, which summarises the data and includes it in its regular reports. In order to get a better understanding of the situation of diversion and trafficking of precursors in the EU, the Agency should be in charge not only of analysing the data provided through the Commission’s database, but collecting the relevant data should also be considered. Monitoring system

The current monitoring system of the Agency is largely retrospective, dependent on established approaches and often comes with a considerable reporting time lag due to the data collection method. The targeted revision option would strengthen the Agency’s monitoring and threat assessment capabilities to increase its ability to react to new challenges and have an increased impact on the drug phenomena. Therefore, the monitoring system under the targeted revision would no longer act as a passive observatory tool, but in addition to information gathering and analysis, the Agency would be able to act and react on its analysis. Deepening the focus of the monitoring system on the drugs phenomena would entail the need to enhance it with capabilities for real-time and forward-looking analysis about emerging threats, in order to anticipate developments, as identified by the evaluation, and to provide information on the best ways to address these new phenomena. Both the health and the security angles would be addressed. A crucial aspect of this enhanced monitoring system would be to ensure that the Agency is less reliant on third parties, including on third-country agencies, for forensic and toxicological examination. In this context, the Agency should develop targeted laboratory capacities. As the Agency does not have any laboratory capacities, it has to rely for the analysis of substances on the laboratories in the Member States and in third countries. Mechanisms to exchange forensic and toxicological data, knowledge and standards exist, but their operation is sporadic, on a bilateral basis or based on small EU funded projects. The laboratory of the Joint Research Centre (JRC) is supporting national laboratories in the analysis only on a case-by-case basis. This is financed and organised in the framework of the Customs Laboratory European Network. The 2018/19 evaluation identified a need to support the EU and its Member States’ forensic and toxicological capacity. There are two variations of targeted laboratory capacities that were identified as possible solutions: -First laboratory solution is a reference laboratory that would provide key services and support for EU-level priorities and specific projects. In this case, a choice would have to be made what scientific areas a reference laboratory could cover. The main elements of the laboratory capacities, such as information exchange, provision of reference material and access to specialised equipment, should be covered in any case. -Second laboratory solution is a virtual laboratory that would act as a highly operational competence centre. In that case, the Agency would continue relying on existing laboratories in the Member States and the JRC. These would work closely together in a virtual laboratory, i.e. a specialist network of scientists and laboratories engaged in forensic and toxicological analysis. The set-up of such a virtual laboratory could be inspired by the Reitox network or the European Network of Forensic Science Institutes. Sufficient laboratory and scientific competence and experience would still be needed in the Agency to steer the work of the virtual laboratory. In addition, to deepen the focus of the monitoring system on the drug phenomena in order to provide information on the best ways to address trends and threats relevant to the targeted thematic scope of action, the Agency should also gain the ability to react to new challenges and to act on its analysis. The existing cooperation between the Agency and EU bodies would need to be enhanced and reinforced, especially with Europol, Frontex and the Maritime Analysis and Operations Centre – Narcotics (MAOC-N) due to the new thematic scope of action, especially on drug supply and drug market issues. This will also support with the new monitoring capacities needed for the implementation of the EU Drugs Strategy. In this context, the Agency could develop the following types of products: -Alert system: The Agency hardly has any tasks with an operational dimension as it currently is a mere monitoring centre with a strong scientific focus, in line with the founding Regulation. The only task of the Agency, which can be considered operational, is the EU early warning system. The Agency decides, based on certain criteria, to put a substance under intensive monitoring and to prepare an initial report. This is the basis for potential future control measures on European level. Under the EU early warning system, the Agency can issue alerts or advisories to the EU early warning network, informing its members about specific events or situations related to new psychoactive substances. Therefore, the existing system does not include an alert system, which could quickly inform people who use drugs about dangerous substances being on the market. The developments over the last years show that dangerous substances appear regularly. These can be new substances, of which the impacts are not known yet and, therefore, the danger of fatal or non-fatal overdoses are higher. These can be drugs, which are cut with dangerous substances, e.g. carcinogenic or toxic substances used as cutting agent. If the Agency gets information of such dangers, it passes it on to its networks, in particular the EU Early Warning System network. It then depends on the Member States’ authorities on how they use the information received and if and how they inform the potentially affected users. Therefore, the Agency could be enabled to issue EU-level alerts or targeted warnings in case of such dangers. Such alerts could go to organisations, which support people who use drugs, be passed on to the media for further dissemination, be posted on relevant drug-related websites or fora, or be published in other ways, which would reach people who use drugs quickly. The exact way in which such an alert system could be set up would have to be defined by the Agency itself, in cooperation with the Member States and relevant civil society organisations. -Prevention and awareness campaigns: The Agency supports the development of prevention programmes and shares experiences through its best practice portal. The Agency could get involved in developing cross-EU campaigns targeted e.g. at parents, teachers and local decision-makers, raising awareness of their prevention potential. -Risk analysis and intelligence reports: The Agency could develop responses to supply-side topics and better address drug market issues by supporting national law enforcement authorities with risk analysis and intelligence reports to law enforcement authorities, in close collaboration with relevant EU bodies or agencies, especially Europol. The Reitox network of national focal points As the national focal points are the main data providers to the Agency, any changes in the Agency’s monitoring system or the extent of its mandate have to be mirrored in their mandate as well. The scope of the national data collection needs to be clearly defined in the founding Regulation. While it is for the Member States to decide how a national focal point is set up, organised and with what means it is equipped, the mandate of the national focal points will have to reflect the revision of the Agency’s mandate. The targeted revision would imply that data collection of national focal points on drug phenomena, particularly on poly-substance use would need to be improved to respond to the new thematic scope of action of the Agency. Furthermore, the targeted revision would empower national focal points to provide the relevant data to the Agency, and enable them to act as more effective intermediaries translating and implementing key messages from the Agency, nationally. The targeted revision would focus on improving the data collection of the national focal points on the drug phenomena and enhancing their effectiveness and efficiency within their current set-up. The national focal points should assist the Agency in analysing and interpreting the national drug situation, and report and disseminate the Agency’s products. In addition, being positioned as a central data hub, the national focal points could have a stronger (coordinating) role on national level as a service provider to national stakeholders and get additional specific assignments relevant in the national context.

Minimum requirements would be important to ensure the provision of high quality data from every Member State and to give some continuity and consistency to the national focal points. A certification procedure could verify the compliance with the minimum requirements. A certification solution could be implemented through a peer-to-peer review process. The peer pressure would result in a quasi-binding nature of the minimum requirements. As this would not be laid down in a binding decision of the Agency, there would not be any subsidiarity concerns with such an option. Another certification solution is to continue with the status quo of a voluntary certification procedure carried out by the Agency. The main downside of a voluntary certification system is that the minimum criteria would remain as recommendations without any binding nature. Support to Member States Currently, the Agency provides support to Member States on a demand basis. This mainly refers to the evaluation and shaping of national drug policy as well as the exchange of best practices or their implementation. However, the Agency could build on its core activities and strengths, and provide more support to Member States. The targeted revision option would position the Agency as a service provider to Member States offering tailored services based on the needs arising in the drugs policy field. New services would be introduced based on core strengths of the Agency and where it can leverage its data collection/monitoring/harmonization/analysis capabilities. Services such as accreditation and certification of (national) key intervention schemes, reporting of data on behalf of the Member States to the UN agencies, or training would be considered. International dimension The evaluation was clear on the potential for the Agency to increase its involvement on international issues. The recast of the founding Regulation in 2006 gave the Agency a more explicit role as regards cooperation with international organisations and third countries. The Agency is quite active in the international arena, supporting the EU and its Member States in multilateral fora and in the cooperation with third countries. The Agency already carries out EU-financed projects in third countries, which contribute to improving national and regional responses to security and health threats in these countries/regions. The targeted revision option would clarify the role of the Agency in this area in order to improve the evidence base for EU drug policy-making, improve the outreach of the EU to third countries and contribute to the development and implementation of the external dimension of EU drugs policy. The targeted revision would align the issues where the Agency has competences on an EU-level, with where it would be able to contribute on an international level. As the Agency’s work would better reflect the EU’s balanced, evidence-based, integrated and multi-disciplinary approach to drugs policy, it would be able to further act to promote this approach in third countries. The Agency would be given a clear mandate to participate in EU cooperation programes and to analyse global developments and developments in third countries, which have the potential to affect the EU. The expert input of the Agency would not only benefit the EU’s international partners, but the EU itself. It would contribute to the development and implementation of the external dimension of EU drugs policy and the leadership role of the EU at multilateral level. Policy option 5: Expansive revision – Focusing on diverse addictions The expansive revision option is a legislative option to amend/revise the founding Regulation and hence the Agency’s mandate, by responding to the different issues outlined in the problem definition by using the thematic scope of action as a starting point. The expansive revision option would broaden the efforts of the Agency away from the drug area and open up the scope of action to address a full thematic scope related to wide range of substance and behavioural addictions. Thematic scope of action The current thematic scope of action of the Agency refers to “drugs and drug addiction and their consequences”. The founding Regulation itself does not define the terms further. Therefore, recourse has to be made to the definition of drugs in EU law. At the time of adoption of Regulation (EC) 1920/2006, Council Framework Decision 2004/757/JHA defined drugs with reference to the UN Drug Conventions and Joint Action 97/396/JHA of 16 June 1997 concerning the information exchange, risk assessment and the control of new synthetic drugs. The definition was slightly adapted through Regulation (EU) 2017/2101. Based on this definition, the thematic scope of action of the Agency covers (illicit) drugs. When revising the mandate, the question is whether it should be broadened to other (problematic) forms of substance use, including alcohol, tobacco, prescription medicines, and/or addictions not directly linked to substance use, such as gambling and compulsive gaming. Alcohol and tobacco addictions are a serious health issue and lead to significant social and economic consequences. Addiction to prescription medicines is an increasing problem in the EU, and the possible magnitude of the problem can be seen in the opioid crisis in the US. Behavioural addictions do not involve the use of substances, but can cover a wide variety of problematic behaviours, such as gambling, compulsive gaming, internet addiction, sex addiction, shopping addiction, and binge eating. Addictions are to some extent similar biologically and behaviourally, result in a similar compulsivity, and sometimes are addressed through similar policy approaches. Licit and illicit markets involve different types of actors and have different types of problems. However, some consider the distinction arbitrary from a scientific point of view and the distinction can change over time. Possible changes in the classification of a substance as licit or illicit have to be taken into account in any consideration on the future mandate. This is also relevant as regards low-THC products and products containing cannabinoids, which are already on the market, or prescription drugs, which are misused widely in some areas of the world (e.g. opioid-based painkillers). The stakeholder consultation during the 2018/19 evaluation revealed that while a majority of national stakeholders and Agency were largely in favour of broadening the scope to other addictions, other stakeholder groups (including EU-level stakeholders) were critical. The expansive revision option would have to address possible overlaps with existing policies on these addictions while building on areas that fit closely with the current activities of the Agency. It would also imply a serious increase of the financial and human resources necessary to the Agency to carry out its tasks. Monitoring system The current monitoring system of the Agency is largely built to monitor drug phenomena, mainly focused around drug use and related trends. Not only is the monitoring system largely retrospective, but it is dependent on established approaches. Therefore, the monitoring system of the Agency would have to be revised under the expansive revision based on the broad thematic scope of action, in order to provide analysis and information on the best ways to address applicable threats and trends covering not only the drug phenomena but also diverse addictions. While it would be relatively easy to extend some aspects of the current data collection system of the Agency to other substance-based addictions, in particular alcohol, tobacco and prescription medicines, collecting data regarding addictive behaviours would be more difficult as it requires different methodologies and studies. The existing cooperation between the Agency and other EU agencies would need to be enhanced and reinforced, especially with the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) who do not specifically collect addiction-related data, but some of their data might be useful for a better understanding of addictions. In addition, it has to be determined what tasks should be included to serve the monitoring system within this expansive scope of action, i.e. whether the Agency should integrate existing data into routine reporting; develop further the existing data collection regarding other addictions; monitor the health impacts of these addictions; and/or monitor all the consequences of these addictions. The assessment would have to address possible overlaps with existing policies on these addictions and should identify areas, which fit closely with the current activities of the Agency. Since the monitoring system of the Agency requires updates in order to anticipate developments in the drug phenomena, as identified by the evaluation, for the Agency to be less reliant on third parties for forensic and toxicological examination, an expanded laboratory solution was identified. As previously mentioned, the Agency does not have any laboratory capacities, it has to rely for the analysis of substances on the laboratories in the Member States and in third countries. If the Agency would have its own centralized laboratory housed within the Agency itself, it would be able to work on and answer key strategic questions about the composition of drugs and drug markets. These questions often go unanswered due to lack of capacities on national and European level, especially as the laboratory of the JRC supports national laboratories only on a case-by-case basis within the Customs Laboratory European Network. In addition to providing the Agency with an updated monitoring system that has the support of a developed laboratory, the expanded revision should include the different elements that would allow the Agency to react to new challenges and to act on its analysis. As outlined and described in the targeted revision option above, these are the alert system, prevention and awareness campaigns, and risk analysis and intelligence reports, and they would enable an operational response from the Agency on drug issues, in conjunction with the topics of diverse addictions.

The Reitox network of national focal points As previously mentioned, the national focal points are the main data providers to the Agency. Therefore, any changes in the Agency’s monitoring system have to be mirrored in their mandate, which is for the Member States to decide as well as how a national focal point is set up, organised and with what means it is equipped. Nevertheless, the expansive revision affects the mandate of the national focal points even more than the targeted revision, which will have to be taken into consideration. Minimum requirements regarding the provision of high quality data from every Member State and to give continuity and consistency to the national focal points can be foreseen in the expansive revision option through a stronger certification option than the targeted revision or the current practice. Instead of continuing with the status quo of verifying the minimum requirements with the voluntary certification procedure carried out by the Agency, the expansive revision lays out a mandatory certification by the Agency. This would lead to a decision of the Agency as regards to compliance with the minimum requirements. In the case of non-compliance with the minimum requirements, the Agency could make recommendations on how these should be achieved, accompanied by a timetable. This solution could be considered as interfering with national competencies and might be difficult from a subsidiarity perspective as not only the minimum requirements, but also the recommendations on how to implement them would be binding. However, this solution would respond to main weakness of the voluntary certification, which is that the recommendations cannot be enforced. In addition, the expansive revision will increase the body of data to be provided by the national focal points to the Agency based on the expansive thematic scope of action covering diverse addictions. Therefore, the expansive revision would have to broaden efforts for collection of data across addictions. The majority of this data is already collected by the Member States based on EU legislation and/or because national strategies apply a wider addiction approach. However, clear rules on what data and information has to be provided by Member States through the national focal points to the Agency under this broader thematic approach, would need to be developed and established. Support to Member States In addition to the support the Agency currently provides to Member States such as support with evaluations and shaping of national drug policies or exchange of best practices, the expansive revision presents an opportunity to enhance and further expand the added-value to Member States. In addition to the services outlined in the targeted revision (i.e. accreditation, training), the expansive revision option would also build on the Agency’s current role as an important hub for knowledge sharing, but with an increased thematic scope on diverse addictions. The best practice portal is the best example of this. Key challenges for the EU, particularly on prevention and treatment, need the implementation of best practice standards and the transfer and adoption of best practice methods, which are laid out and discussed in the best practice portal. In the expansive revision, this role could be increased to include prevention and treatment of diverse addictions. International dimension The expansive revision would work towards clarifying the role of the Agency in this area mainly in terms of drug policy, as the drug phenomena topic is the most international topic within general addictions. The Agency already carries out EU-financed projects in third countries, which contribute to improving national and regional responses to security and health threats in these countries/regions. However, the Agency’s envolvement is not garanteed to be consistent due to the setup of funding. Building on the solutions laid out in the targeted revision, the expansive revision should lead to providing the Agency with a sustanable budget for international activities, thus reconsidering the current “ad hoc” and “project funding” approach when participating in EU-financed projects in third countries, which impedes the Agency’s performance and consistent involvement. 5.3.Options discarded at an early stage In the course of the impact assessment exercise the following policy options were discarded at an early stage and thus were not subject to deeper analysis and assessment: Policy option 0: Baseline scenario - Maintaining the current approach without changes Keeping the baseline scenario in place would not address any of the problems and would not achieve the general objective of the proposed initiative. Section 2.5 sets out how the problem would evolve if no policy change would be implemented. Policy option 1: Minimal revision option - Stronger cooperation This option would not achieve the general objective of the proposed initiative, although improving the cooperation between the Agency and the Member States and with other EU agencies is important. Member States are interested in getting European-wide analyses of the drug phenomenon from the Agency and its support in the evaluation and shaping of their national drug policies. More cooperation among Member States themselves would not be able to address this, as they do not have the resources, capabilities or the competence to analyse the cross-border dimension of the drugs phenomenon. An obvious candidate for further cooperation is Europol. The two agencies are already cooperating on a number of issues, in particular when it comes to the early warning system and the development of reports on drug market issues. Potential overlaps in their tasks, in particular on drug markets, are addressed by a close cooperation of the two agencies, where each focusses on its strengths in the area. A further extension of the cooperation would be difficult as the EMCDDA’s mandate does not refer to drug supply or drug market issues.

Another option would be the Maritime Analysis and Operations Centre – Narcotics (MAOC-N). Enhancing and reinforcing the existing cooperation between MAOC-N and the Agency could involve sharing of data, intelligence analysis, and information on the substances seized. Further improving the cooperation between the two entities would be of benefit for both as MAOC-N would get additional strategic information, whereas the Agency could benefit from the operational knowledge of MAOC-N. However, there would be limits to what information MAOC-N would be able to share with the Agency due to the confidential nature of the information they hold. As regards the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC) and the European Health Emergency Preparedness and Response Authority (HERA), the focus of cooperation would be on health issues. Looking at the mandates and the focus of these bodies, including of HERA, cooperation on drug-related issues would only be an ancillary task for them. Although ECDC and EMA look at serious cross-border health threats, their focus is on ensuring the functioning of the internal market and the general health security framework. Therefore, strengthened cooperation with these EU bodies would only address the objective of the proposed initiative to a limited extent. Enhanced cooperation could be considered with the UN Office on Drugs and Crime (UNODC). The evaluation concluded that there are some overlaps between the work of the Agency and UNODC, in particular in relation to the collection of drug-related data. It was suggested by consulted stakeholders that the Agency could support the Member States in their reporting to UNODC. The Agency’s stakeholders identified further scope for increased cooperation on issues such as sharing best practices and adoption of common guidelines on data collection. The remit of UNODC is global and, therefore, the emphasis of the two bodies is very different. Therefore, further strengthening the cooperation with UNODC would achieve the objectives of this initiative only to a limited extent. The assessment of this non-legislative policy option leads to the conclusion that it would – on its own – not be able to achieve the general objective of the proposed initiative and would only to a very limited extent be able to address the problem drivers. However, cooperation with other agencies should be strengthened in any case in order to make full use of the complementarities outlined above. Addressing existing or potential future overlaps would be difficult in a non-legislative option and would have to be addressed from the outset in any (revised or new) working arrangements. As policy option 1 is not able to address the problems set out in the problem definition nor to achieve the general and specific objectives of the proposed initiative, it will not be assessed further. Policy option 2: Dismantling of the Agency - Repeal of the founding Regulation According to the common approach, “closing down an agency could be a solution for dealing with underperforming agencies unless the agency is still the most relevant policy option, in which case the Agency should be reformed”. The recent evaluation showed that the EMCDDA is considered not only on European level, but also internationally, as a centre of excellence. All stakeholders agreed during the evaluation that the termination of the Agency would have negative impacts and should be avoided. In the context of the recent discussions of the new EU Drugs Strategy in the Council’s Horizontal Working Party on Drugs, all Member States were fully supportive of the work of the agencies involved and in particular stressed how much the Agency is needed to further EU drugs policy. While at the first instance it would be policy-makers who would be affected by the termination of the Agency as they would not have access to EU-level information, ultimately, the general public would feel the impacts, albeit more indirectly. As there would be no obligation to collect the relevant data and no more centralised support, some countries would cease to collect the data. This would result in incomplete and fragmented data and imply the loss of the EU-level overview of the drug phenomenon. The exchange of best practice would be more difficult without a central organisation bringing the information and people together. The cessation of the Agency would undermine the possibility to design and implement drug policies and strategies based on objective and scientific evidence, both at EU and at national level. Closing down the Agency would have a negative impact on evidence-based policy-making. Based on the conclusions of the evaluation and the very good performance of the Agency, it cannot be concluded that the Agency is underperforming. Such a conclusion would be contrary to the perception of stakeholders that the Agency in an important neutral voice providing factual, objective, reliable and high-quality data on drugs and dismantling it would cause serious issues for drug monitoring in Europe. The termination of the Agency would have negative consequences on the role of the EU at international and multilateral level, as it would diminish EU leadership in drugs policy, would likely negatively impact its ability to speak with one voice in international fora, and would lead to an incomplete picture of the situation of drugs in the EU, which would be contrary to the EU’s interests. The assessment considered alternatives to the Agency based on the analysis during the evaluation in view of their effectiveness in implementing EU drugs policy. Allocating some of the tasks to the Commission services in cooperation with EU bodies (such as Europol, EMA, ECDC or HERA) or directly to these bodies would still ensure regular EU-level data collection and analysis. Attributing the tasks to the Commission would have two main disadvantages: a) the Commission might have to outsource some of the activities, which would lead to a loss of capacity and expertise in the mid- and longer term; and b) this loss of expertise might compromise the quality of the data analysis. Attributing the tasks to the mentioned EU bodies might limit the loss of expertise, but would create a fragmentation of the work and increase the coordination role to be played by the central services – which, at time of scarce human resources, would not be effective. Another alternative would see the responsibility for monitoring the drug phenomenon reverting back to the Member States. The Member States would need to ensure that the collection of data continues among themselves with limited or no coordination at EU level. An agreement on common standards would be more difficult to reach, compromising the comparability of data. In addition, the reliability and impartiality of the information might suffer. Some Member States may decide not to take part in European data collection anymore. The third alternative option would be to rely exclusively on the activities of international organisations, such as the UN Office on Drugs and Crime (UNODC), the World Health Organisation (WHO), the Council of Europe (in particular the Pompidou Group) or others. Although the collection of data would be coordinated by a central body (external to the EU), it would mean that the picture of the drugs phenomenon in the EU could be incomplete based on available world data as opposed to European data. In addition, the collection would be less relevant as it would not be targeted to the interests of the EU. This would lead to a loss of expertise and understanding of the influencing factors on the drug phenomenon in the EU. It would imply a loss of EU visibility on the global stage, given that the EU is seen as a model in terms of data collection and evidence-based drugs policy. The dismantling of the Agency would imply the disinvestment of the EMCDDA budget of about EUR 16-17 million per year (if dismantled without replacement). If the tasks would be reallocated to another EU body, all or a large share of this budget would be needed in the receiving body and, therefore, the dismantling would lead to only limited budget savings for the EU. In case of a dismantling of the Agency without replacement on EU level, additional efforts and investments by national public authorities would be needed. This would likely lead to a higher total cost than the current solution. Unfortunately, very limited data is available as regards investments by Member States on drug policy. Therefore, the real “costs of non-EU” cannot be estimated in a reliable way. In conclusion, the assessment shows that the Agency is the most effective solution compared to the alternatives in achieving the objectives of EU drugs policy. The dismantling of the Agency would furthermore be in contradiction with the EU Drugs Strategy 2021-2025. Policy option 3: Merging of the Agency with another EU body

According to the common approach, “merging agencies should be considered in cases where their respective tasks are overlapping, where synergies can be contemplated or when agencies would be more efficient if inserted in a bigger structure”. The evaluation looked into possible overlaps and synergies with other organisations and concluded that there are hardly any overlaps. Stakeholders highlighted that the reason for the few overlaps is that the Agency is unique as a provider of an overview of the EU drug situation. The main overlap identified is with the UN Office on Drugs and Crime (UNODC) as regards data collection as both collect standard drug data, but at different times of the year, based on different definitions and in different formats. As regards possible synergies between the Agency and other bodies, the evaluation showed that good cooperation is in place, many synergies are already exploited and that there is minimal duplication of work. Beyond the UNODC, stakeholders identified some unexploited synergies with the Commission, in particular with DG SANTE on health-related issues. The potential to merge the EMCDDA with another EU body was not deemed desirable by stakeholders. There were no positive interview responses during the evaluation to the prospects of merging the EMCDDA with another EU agency. The primary reason was the very specific activities of the Agency. For the same reason interviewees considered that such a merger would have a detrimental effect on the quality of the scientific outputs. The potential candidates with whom the EMCDDA could be merged are, based on current cooperation levels, synergies and potential complementarities of work, Europol, MAOC-N, ECDC, EMA and HERA. The Agency and Europol are cooperating closely on drug markets issues and on the EU early warning system for new psychoactive substances. Whereas Europol has operational information from law enforcement (in particular police) authorities, the EMCDDA has access to strategic information. The outcome of this work are several joint reports and the involvement of the two agencies in each other’s working groups. A merger of these two agencies might lead to a better understanding of drug market issues and the availability of additional information for law enforcement authorities on the functioning of drug markets. On the other hand, drug trafficking is for Europol one of many crime areas. Europol is large compared to the EMCDDA and the danger is that the drug-related issues would get lost among the many priorities of a merged agency. Furthermore, Europol reshuffles its priorities based on regular assessments. Only recently, due to the escalation of activities in the drug markets, Europol started to re-engage stronger on issues related to drug trafficking. The conclusion that a merger with Europol would not be beneficial for EU drugs policy does not change with the proposed revision of the Europol Regulation as it is focused on issues not addressing the problems identified in this impact assessment. In addition, it is likely that a merged entity would focus mainly on drug market and crime issues and reduce the focus on health issues. This would not be in line with requests from stakeholders, in particular civil society and Member States, to continue the Agency’s important work on public health issues. The integration of MAOC-N with the Agency was considered because both organisations work on drug issues, have clearly complementary activities, are both located in Lisbon and because this could give the Agency an operational dimension. If MAOC-N would be integrated while keeping its specificities, it would allow for the continuation of the current working model of MAOC-N, which would ensure that the confidentiality and protection of the information exchanged, distribution of intelligence, and de-confliction would be kept separate. This could get the buy-in of the partner countries. Keeping a separate structure for MAOC-N within the Agency would lead however to considerable legal challenges as a hybrid governance model would be needed. Although a full inclusion of MAOC-N into the Agency would give the Agency a real operational dimension without raising the legal challenges of a hybrid governance model, it would most probably not be feasible as it would raise serious opposition from MAOC-N partners as the current functioning would not be feasible in a bigger structure. The integration of MAOC-N with the Agency could address the issue of financial sustainability of MAOC-N, but not the problems addressed in this impact assessment. Due to the specificities of the information held by MAOC-N, which can only be shared with the partner countries, the expected impact of giving the Agency a real operational dimension would not materialise. The links between the Agency and EMA or ECDC are in relation to a limited number of health issues. The main common work strands with EMA are in relation to medicinal products and their potential misuse. The ECDC and the EMCDDA have a common interest in monitoring, communicating on, and preventing the spread of drug-related infectious diseases in Europe. While ECDC analyses trends in these diseases across the whole population, EMCDDA focuses on specific drug-related risk groups such as injecting drug users. However, drug use as such is not a disease. Merging with EMA or ECDC would have considerable downsides. It would lead to a loss of focus on drug-related issues due to the dilution in wider health aspects. This is particularly problematic in the aftermath of the COVID-19 pandemic, where the focus of these agencies will be on addressing the effects of the pandemic and bolstering the response to potential new pandemics in the future. As shown in practice during the pandemic, drug issues do not have the status of essential services and therefore are not in the core of general health considerations. The current cooperation between EMCDDA, on the one hand, and EMA or ECDC, on the other hand, extends to the EU early warning system. For both agencies, Article 5b of the founding Regulation defines what information they should provide to the EMCDDA in case of the development of an initial report on a new psychoactive substance. This kind of information is not available to EMCDDA and there is no intention to extend the Agency’s mandate in these directions. Taking into account the proposed extensions of the mandates of EMA and ECDC as well as the intentions for the revision of the EMCDDA mandate as set out in the preferred option, there are no risks of overlaps regarding the data collection and/or analysis. In addition, the drug market related issues would likely not get the attention they deserve in a merged entity. Moreover, EMA is based on a regulatory logic, which does not fit with drug-related issues. The mission for HERA is to strengthen the EU’s preparedness and response in terms of medical countermeasures for serious cross-border threats to health. Based on the inception impact assessment, the main objective of the new EU body is to enable adequate EU preparedness via an EU level countermeasure management system that would allow rapid and equal access, availability, development and deployment of the most advanced medical countermeasures in the event of a health emergency. HERA should contribute to the Security Union, through improving the availability of countermeasures for preparedness and respond to intentional release scenarios and Chemical, Biological, Radiological and Nuclear (CBRN) threats. The specific focus of this new agency does not seem to lead to any complementaries or overlaps with the work of the EMCDDA. No evidence is available that would indicate that addressing drug-related issues would be more efficient if the Agency would be merged with any of the aforementioned bodies. To the contrary, addressing these issues in a bigger structure of a merged entity includes the danger of dilution, i.e. that the drug topic would be marginalised and not addressed sufficiently. In addition, a merger with any of the aforementioned EU bodies would lead to a loss of balance between the health and security dimension in the new entity. Not having the balance between the two main pillars would be detrimental to EU drugs policy. In case of a merger with another EU body or the shifting of the competences to one of them, human and financial resources would have to be transferred. Moreover, the transfer of undertaking would have to be carefully assessed as such a transfer of obligations can be quite expensive and time consuming. In addition, the simplification potential is quite small, as it would be mainly limited to the administration of the new entity vis-à-vis having these administrative functions in two agencies. Therefore, such a merger would not lead to relevant efficiency gains on the European level. In conclusion, merging of the Agency with another EU body would be incoherent with the drug phenomenon in the EU, which necessitates stronger – not weaker – intervention at EU level. This option would fail to address the problems set out in the problem definition and would not help in achieving any of the general or specific objectives of the proposed initiative. Moreover, merging the Agency would be against the approach of the new EU Drugs Strategy 2021-2025, which explicitly asks for the Commission to present a proposal for a revision of the EMCDDA mandate. Therefore, this policy option will not be further assessed in the impact assessment. 6.What are the impacts of the policy options? This section analyses the impacts of the policy options 4: targeted revision and policy option 5: expansive revision. The main impacts are on the European Union (EU bodies) and on national authorities. Linked to this are possible impacts on simplification and/or administrative burden and economic impacts. The following sections of the report, assess the impact of the two package policy options defined in chapter 5.2. When it comes to other impacts, those on other stakeholders, in particular citizens/individuals and businesses, are limited and largely indirect through the better ability to tackle the drugs phenomenon in the EU. In terms of impacts on the economy and competitiveness, social impacts, environmental impacts, and impacts on fundamental rights, the revision of the mandate of the Agency only has very limited and indirect impact. Therefore, these impacts will only be addressed below as far as relevant. As regards impact on the economy and competitiveness, a revised mandate of the Agency would contribute positively through limiting the loss of manpower in the economy due to people who use drugs not being able to work or provide work to their full abilities, and through disrupting the income of organised crime groups. These are indirect impacts, which would be due to a better understanding of the drug situation. The only direct economic impact is on the EU and, depending on the option, national budgets. An Agency, which would be better equipped based on a revised mandate, would help – together with Europol – to tackle drug supply in the EU based on better available information on drug trafficking and production, and thereby tackling crime and supporting the internal security of the EU. Another social impact of the revision would be improved access to best practices in the area of drug demand and other public health responses. In addition, based on the experience with drugs, the Agency could have an important contribution to actions in support of the mental health of users. The revision of the mandate would have a certain indirect environmental impact. Drug production on the territory of the EU, in particular of MDMA (ecstasy) and (meth‑)amphetamines, has considerable impacts on the environment, in particular when it comes to the dumping of the waste of drug production. Better knowledge regarding the production methods and precursor diversion would support the work of law enforcement in discovering illicit drug labs and subsequently in reducing the illicit dumping of drug waste. The revision as such does not have any direct impacts on fundamental rights. The data provided to the Agency are statistical data, but do not include personal data; therefore, Article 8 of the Charter of Fundamental Rights (“protection of personal data”) is not affected. Other fundamental rights are even less impacted. It should be added, however, that the work of the Agency tackles important issues related to fundamental rights, e.g. the work on alternatives to coercive sanctions, the work on minimum quality standards in drug demand reduction, best practices on treatment and harm reduction. In that sense, improving the functioning of the Agency could have positive indirect impacts on fundamental rights.

None of the options proposed has impacts on small and medium sized enterprises (SMEs). 6.1.Impacts on the European Union (EU bodies) and value-added Policy option 4: Targeted revision – Delivering more value in drugs policy This option provides a thematic scope of action targeted on deepening the evidence base on drug phenomena, while strengthening the Agency’s monitoring and threat assessment capabilities to increase its ability to act and react to new challenges, including internationally. National focal points would need to be empowered to act as more effective intermediaries translating and implementing key messages from the Agency, nationally. Under this policy option, the Agency would also gain in agility in terms of responding to the needs arising in the drugs policy field through various tailored services for Member States. Thematic scope of action Such a targeted revision of the scope of action of the Agency would overall be coherent with EU policies. It would also allow a more holistic view on drugs issues by addressing both drug demand and drug supply in-depth, as well as the poly-substances angle of the drug phenomenon, without interfering with Member States’ competencies, and therefore might be the most effective option of expanding the Agency mandate. While targeting the thematic scope of action of the Agency more holistically on drug demand and supply, including poly-substance is relatively straight-forward, the issue of the Agency monitoring the diversion and trafficking of drug precursors requires further consideration. While it would strengthen