EUROPEAN COMMISSION Brussels, 12.1.2022 COM(2022) 18 final 2022/0009(COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency {SWD(2022) 8 final} - {SWD(2022) 9 final}



EXPLANATORY MEMORANDUM 1.CONTEXT OF THE PROPOSAL •Reasons for and objectives of the proposal 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, with a steady increase every year since 2012, including among teenagers aged 15-19. The report also shows a deteriorating situation concerning the volumes of cocaine and heroin introduced in the EU, which is at an all-time high. Production of drugs, in particular synthetic drugs (amphetamines and ecstasy), takes place within the EU both for domestic consumption and for export. The 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. Cannabis is the most commonly used drug. The use of heroin and other opioids continues to be most commonly associated with the more harmful forms of drug use. Crack cocaine is increasingly available; different illicit drugs are also becoming available in smaller doses or cheaper packages, considered more suited for home use. A rise in use of benzodiazepines is also observed among high-risk drug users, prisoners and some groups of recreational drug users, potentially reflecting the high availability and low cost of these substances as well as pandemic-related mental health issues. Among people who use drugs, poly-substance use is widespread having a detrimental impact on public health. Furthermore, increased availability of other drugs, particularly cocaine and some synthetic substances, is associated with increased levels of drug related violence and other crimes. According to the latest studies, drug markets have been remarkably resilient to disruption caused by the pandemic. Not only were drugs production and trafficking largely unaffected but the pandemic also brought increased risks for marginalised populations. During the initial lockdowns related to the COVID-19 pandemic, some changes in routes and methods at wholesale level, as well as disruptions and some local shortages have been observed. Nevertheless, drug sellers and buyers have adapted to the new situation quickly, notably by increasing the use of encrypted messaging services, social media applications, online sources as well as mail and home delivery services. The reduction in drug consumption seen during the initial lockdowns disappeared with the easing of restrictions on movement. As a result, by mid-2021, the levels of use of most drugs bounced back to pre-COVID levels or possibly even higher. Moreover, no decline in supply was noted. On the contrary, multi-tonne seizures of cocaine were reported in European ports in 2020 and early 2021, while cannabis cultivation and synthetic drug production within the European Union continued at pre-pandemic levels during 2020, with increasing numbers of cases involving cannabis adulterated with synthetic cannabinoids. While drugs services across Europe, including low-threshold services, drug consumption rooms, and residential and outpatient treatment services, returned to operation, they continue to be limited by strict COVID-19 measures in place and operate at reduced capacity. These developments call for effective action at Union level. The EU Drugs Strategy 2021-2025 and the EU Drugs Action Plan 2021-2025 provide the strategic framework for this. The Strategy inter alia invites the Commission “to present a proposal to revise the mandate of the EMCDDA [European Monitoring Centre for Drugs and Drug Addiction] as soon as possible, to ensure that the agency plays a stronger part in addressing the current and future challenges of the drug phenomenon”. The current proposal delivers on this commitment. In 2018/19, the Commission carried out the fourth evaluation of the Centre in line with the requirements of Regulation (EC) No 1920/2006. It concluded that the Centre works overall well, but further improvements are possible in several areas, in particular in view of the developments of the drug phenomenon. This finding has been further substantiated during regular contacts with the Centre and its stakeholders, which underlined an increasing disconnect between the complexity and rapid developments of the drug phenomenon and what the Centre’s mandate provides for. Regulation (EC) No 1920/2006 does not reflect the current reality of the drug phenomenon and is out of step with the tasks the Centre needs to perform to address the current and future challenges of the drug phenomenon. Therefore, this proposal provides for a targeted revision of the mandate of the European Monitoring Centre for Drugs and Drug Addiction, and seeks to strengthen its mandate in order to ensure that the future Agency can react effectively to new challenges, provide better support to Member States, and contribute to developments at the international level. Notably, the proposal aims to expressly cover poly-substance, i.e. other substance-based addictions when these substances are taken together with illicit drugs; to strengthen monitoring and threat assessment capabilities; to establish a laboratory to ensure that all forensic and toxicological information is available to the Agency; to reinforce the position of national focal points to ensure that they are able to provide relevant data; to establish the competence of the Agency to develop EU-level prevention and awareness raising campaigns as well as issue alerts in case particularly dangerous substances are available on the market. Finally, the proposal clarifies the role of the Agency in the international arena. At the same time, the proposal will also adapt the institutional framework of the Agency to the common approach of the European Parliament, the Council of the EU and the European Commission on decentralised EU agencies. •Consistency with existing policy provisions in the policy area This legislative proposal takes account of a wide range of EU policies in the area of internal security and public health. When it comes to drugs policies, this legislative proposal takes account of the EU Drugs Strategy 2021-2025 and the related Action Plan. It also takes account of the amendment of Regulation (EC) No 1920/2006 as well as several acts to add substances to the definition of drugs under Council Framework Decision 2004/757/JHA. This legislative proposal also takes account of cooperation of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) with other Union bodies, in particular the European Union Agency for Law Enforcement Cooperation (Europol), the European Union Agency for Criminal Justice Cooperation (Eurojust), the European Union Agency for Law Enforcement Training (CEPOL), the European Medicines Agency (EMA), and the European Centre for Disease Prevention and Control (ECDC), but also other EU decentralised agencies and bodies. •Consistency with other Union policies This legislative proposal takes account of other relevant Union policies that have been adopted or launched since the entry into force of Regulation (EC) No 1920/2006 on the European Monitoring Centre for Drugs and Drug Addiction (recast). As regards innovation, this legislative proposal takes account of EU funding for drugs policy under Horizon 2020, the Internal Security Fund, the Drugs Policy Initiatives under the Justice Programme, the EU4Health Programme, and Horizon Europe. As regards public health, this legislative proposal takes account of the establishment of an early warning and response system in relation to serious cross-border threats to health and the proposals for the changes in the mandates of some of the above-mentioned agencies. When considering cooperation with Union agencies and bodies, the proposal also considered the establishment of the European Health Emergency Preparedness and Response Authority (HERA). As regards the Agency’s cooperation with third countries, this legislative proposal takes account of the Union’s external policies.

2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY •Legal basis Regulation (EC) No 1920/2006 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), third subparagraph, TFUE reads: “The Union shall complement the Member States' action in reducing drugs-related health damage, including information and prevention”. Article 168(5) TFUE 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, the content of this legislative proposal is covered by the public health legal basis and does not go beyond what is possible under that legal basis. •Subsidiarity (for non-exclusive competence) EU action to revise the mandate of the Agency is necessary. The drug phenomenon affects 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 drug trafficking is a transnational crime. Organised crime groups involved in drug trafficking exploit differences in regulatory and legal approaches across Member States. A problematic health or security pattern detected in a Member State very often appears in other Member States as well. 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 thus a need for EU-level action. This legislative proposal will lead to considerable EU added value. 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 characterised by the widespread availability of a diverse range of drugs of increasingly high purity or potency, supported by the misuse of innovation and technological developments, and leading to more complex patterns of use and an increasing impact on public health and security. The revision of the mandate of the Agency is part of the reaction of the EU to these developments. As the evaluation showed, 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. However, the current mandate of the Agency is limiting its action, the support it can give to Member States, and the role it can play internationally. The fact that, for example, the Agency’s current mandate covers poly-substance use only to a limited extent, leads to a loss of the EU-level overview of the drug phenomenon, with data collected being fragmented or possibly non-existent. 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. The targeted revision proposed in this legislative proposal strengthens the Agency in crucial areas to enable it to address these common issues better. The revision of current mandate would also contribute to a reduction of the administrative burden for and a simplification of administrative procedures in the Member States. Among the contributing factors to this are the proposed streamlining and centralisation of reporting obligations in the Member States through the national focal points, monitoring drug markets and maintaining an early warning system and drug alert system, organisation of training, development of best practices, etc. This would lead to a reduction of administrative costs in the Member States. Another example is that better information would be available from the Agency for the benefit not only of the EU but also of the Member States. Member States on their own would not be able to collect and analyse data to the same extent as they lack either the knowledge or the resources, or the problem is a cross-border one. The latter element is also an argument for administrative simplification as no Member State could address those issues on their own and cooperating with numerous countries would lead to a high administrative burden. •Proportionality The proposal is proportionate as it is the only way for the necessary changes in the Agency’s mandate to come about. EU-level action does not intend to replace national actions or authorities nor to 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. •Choice of the instrument Given that Agency’s mandate is set out in Regulation (EC) No 1920/2006, the revision of its mandate has to take the form of a Regulation as well. 3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS •Stakeholder consultations The main stakeholder consultation for this proposal was undertaken as part of the evaluation of the Agency carried out in 2018/19. This process included an extensive stakeholder consultation, including a 12-weeks public consultation. The details of this stakeholder consultation are available in Annex III of the related Staff Working Document. The Annex also includes a short summary of the outcomes of the public consultation. The synopsis report of the public consultation has been published as Annex 5 of the evaluation report.

In addition, the views of specific stakeholders, such as the Member States, the national focal points or other agencies, were adequately addressed through meetings and/or particular information requests. Several discussions in view of the revision of the mandate of the Agency have taken place since the study of the consultant has been done, including discussions in the Management Board of the EMCDDA in December 2018 and June 2019, presentation of the evaluation results to the Horizontal Drugs Group in July 2019, presentation to the heads of national focal points in their meeting in May 2019. In 2019 and 2020, several formal and informal meetings took place. This included informal meetings with different staff members of the Agency, the head of the national focal points, the Civil Society Forum on Drugs, and representatives of Member States. More formal meetings were also organised by the Commission services. A virtual meeting with the core group of the Civil Society Forum on Drugs took place on 1 July 2020. The proposed revision of the EMCDDA mandate was also discussed at the Plenary meeting of the Civil Society Forum on Drugs on 8 October 2020. A discussion on the aspects related to the national focal points took place at the technical meeting of the Reitox network on 7 October 2020 and at the Head of National Focal Points meeting on 26 November 2020. A virtual informal workshop was organised for the members of the EMCDDA Management Board on 26 October 2020, which discussed the policy option and the main ideas for the preferred option. During these exchanges, the need to adapt the EMCDDA regulation to the current challenges relevant to drugs, such as poly-substance use, and to ensure appropriate funding to the Agency were underlined. Participants called for further development of the monitoring, data collection and the assessment capacities of the Agency, as well as of its competence to initiate information campaigns and risk communication, strengthening its relationship with Member States’ authorities, and in particular National Focal Points. The role of EMCDDA in relation with the international drug policy was also underlined and the need for proper forensic and toxicological laboratory capacity stressed as well. •Collection of data and use of expertise The Commission carried out an evaluation of the Agency with the support of a consultant in line with the requirements of Article 23 of Regulation (EC) No 1920/2006. The main outcomes of the evaluation were summarised in a Report from the Commission to the European Parliament and the Council and an accompanying Staff Working Document. The evaluation overall was positive as regards the five evaluation criteria (relevance, effectiveness, efficiency, coherence, EU added value), but also noted that improvements are possible in several areas. For example, the availability of more forward-looking products, the relationship with the scientific community and general practitioners, and general public awareness measures could be improved. The evaluation underlined as well the need to improve the provision of data, to address poly-substance use and to support to Member States in evaluating their national drug policies. The cooperation with third countries and international organisations could be further strengthened. The evaluation was inconclusive on the potential future broadening of the scope of the Agency to other licit and illicit substance and addictive behaviours. The Agency provided expert input to the impact assessment and the legislative proposal in the course of its drafting, including estimates of the cost impacts of the different policy options. •Impact assessment In line with its “Better Regulation” policy, the Commission conducted an impact assessment. A number of legislative and non-legislative policy options have been considered. Some policy options were discarded at an early stage and were not subject to deeper analysis and assessment. Two policy options have been assessed in detail: they both have similar objectives but lead to a different level of impact in terms of costs, benefits and administrative burden. –Policy option 4: Targeted revision - Delivering more value in drugs policy This option provides a thematic scope of action focussed on illicit drugs and 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 inputs from the Agency at the national level. Under this policy option, the Agency would also gain agility in terms of responding to the needs arising in the drugs policy field through various tailored services for Member States. This option would bring an important reduction of administrative burden as well as simplification of procedures for Member States. It would also be more suitable as regards the necessary financial and human resource reinforcement. –Policy option 5: Expansive revision - Focusing on diverse addictions This option provides a thematic scope of action expanded to cover addiction broadly, beyond drugs, and revamping the Agency’s monitoring system based on applicable methodologies and indicators covering diverse addictions. The extended thematic scope on addictions would affect the body of data that would need to be provided by national focal points to the Agency, as well as the Agency’s role as a hub for knowledge sharing. Finally, the involvement of the Agency in international cooperation would mainly be limited to the current drugs-related activities as other addictions do not have the same level of international and cross-border exposure. This option could result in possible overlaps with existing policies. It also raises questions over possible interference with national competencies and might be difficult from a subsidiarity perspective. It would also imply a serious increase of the financial and human resources necessary to the Agency to carry out its tasks. Following a detailed assessment of the impact of the above mentioned policy options, the preferred option is policy option 4 leading to a targeted revision of the mandate. The main elements of this targeted revision are the following: –The Agency’s scope of action would be expanded to address poly-substance use, i.e. other substance-based addictions when these substances are taken together with illicit drugs. The revision should thus clarify what poly-substance use includes and in which conditions the concept can be applied. This limited widening of the mandate would necessitate the reporting of relevant data by the national focal points. –The Agency’s mandate would be expanded to explicitly address drug supply and drug market issues as this is an increasingly important dimension of the drug phenomenon and an EU Drugs Agency (EUDA) has to be able to fully address that dimension. –The Agency’s monitoring and threat assessment capabilities would be strengthened and the Agency would provide further support to the Member States to increase the impact of the Agency on the drug phenomenon and its ability to react to new challenges. –A virtual laboratory, i.e. a network of laboratories combined with a competence centre in the Agency, would be established to ensure that more forensic and toxicological information is available to the Agency.

–The national focal points would be empowered to provide the relevant data to the Agency. The new Regulation would set minimum requirements for their set-up, which are then certified by the Agency. The mandate of the national focal points has to reflect the revision of the Agency mandate. –The Agency would get the competence to act on its analysis and develop EU-level prevention and awareness raising campaigns as well as issue alerts in case particularly dangerous substances are available on the market. –These elements would be complemented by strengthened cooperation with Member States, Union decentralised agencies and bodies, which is crucial, although would not deliver on its own on the objectives of this initiative. –As regards the international dimension, the tasks of the Agency would be clarified to include in the mandate itself the relevant competencies. This policy option is fully reflected in this legislative proposal. It would give the Agency the tools and capabilities to address all dimensions of the modern day drugs phenomenon. In addition to revising the mandate of the Agency in substance, the legislative proposal will also adapt it to the common approach on decentralised EU agencies. This has not been done yet as no substantive revision of Regulation (EC) No 1920/2006 has been undertaken since the agreement on the common approach in 2012. The adaptation to the common approach necessitates that many provisions regarding the institutional and governance rules of the Agency are expanded, even if the main content of these provisions remains the same. Adopting these new rules will bring the Agency’s governance in line with the latest set of legislation on issues related to financial rules, data protection, combatting fraud and similar. It will also align the governance rules of the Agency to the ones of other EU decentralised agencies. The main impacts of the current proposal are on the Commission and the Agency itself, and on national authorities. Linked to this, there would be possible impacts on simplification and/or administrative burden as demonstrated above. The main economic impacts are on the EU budget, as regards the necessary increase of the EU contribution to the budget of the Agency, and to a much more limited extent on national budgets. Impacts 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. •Fundamental rights The revision as such does not have any direct impacts on fundamental rights. The data collected by and for the Agency are statistical data, but do not include any personal data; therefore, Article 8 of the Charter of Fundamental Rights (“protection of personal data”) is not affected. Other fundamental rights are not impacted either by the proposal. It should be added, however, that the analysis of the Agency addresses important issues with possible implications for fundamental rights, even if the Agency does not decide on or manage itself such measures. In that sense, improving the functioning of the Agency could have positive indirect impacts on fundamental rights. 4.BUDGETARY IMPLICATIONS This legislative proposal would have an impact on the budget and staff needs of the Agency as currently provided for in the Multiannual Financial Framework (MFF) and which are insufficient for the tasks the Agency should carry out to better address the drug phenomenon, including as regards drug markets and drug supply. It is estimated that an additional budget of around EUR 63 million and around 40 additional posts would be needed for the remainder of the period of the Multiannual Financial Framework (MFF) to ensure that the Agency has the necessary resources to enforce its revised mandate. The new tasks for the Agency proposed in this legislative proposal therefore require additional financial and human reinforcements compared to the resources earmarked in the adopted Multiannual Financial Framework 2021-2027, which provides for a 2% yearly increase of the EU contribution to the Agency. The budgetary impact of the additional financial resources for the EU Drugs Agency will be offset through a compensatory reduction from programmed spending under Heading 4 and should also stabilise the resource needs of the Agency over the period 2021-2027. 5.OTHER ELEMENTS •Implementation plans and monitoring, evaluation and reporting arrangements The monitoring and evaluation of the Agency’s mandate would largely be performed by the applicable mechanisms under this Regulation. Article 52 provides for an evaluation which assesses, in particular, the impact, effectiveness and efficiency of the Agency and of its working practices and may address the possible need to modify the structure, operation, field of action and tasks of the Agency, and the financial implications of any such modification. Further to this evaluation, the Commission will draw data through its representation in the Agency’s Management Board meetings and its supervision, along with the Member States, of the Agency’s work. •Detailed explanation of the specific provisions of the proposal Chapter I (Articles 1 to 5) includes the objectives and general tasks of the Agency. After setting out that the European Union Drugs Agency (EUDA) replaces the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) (Article 1) and defining the legal status and seat of the Agency (Article 2) as well as providing some definitions (Article 3), Article 4 defines the objective of the Agency, which remains the same as in Regulation (EC) No 1920/2006. Article 5 provides the overall tasks of the Agency around three main competence areas, which are detailed further in Chapters II to IV. Chapter II (Articles 6 and 7) clarifies the monitoring tasks of the Agency. Article 6 defines what data the Agency has to collect and what actions they should undertake to have the most up-to-date information available for their analysis. It also defines the dissemination tasks of the Agency. Article 7 sets out the main monitoring tasks of the Agency. Chapter III (Articles 8 to 15) defines the early warning and risk assessment tasks of the Agency. Articles 8 to 11 set out the rules on the information exchange on, the early warning system and the risk assessment procedure for new psychoactive substances. These provisions have not been changed compared to Articles 5a to 5d of Regulation (EC) No 1920/2006 (introduced through Regulation (EU) 2017/2101). The work undertaken by the Agency in this regard is the basis for the possible inclusion of a new psychoactive substance in the definition of ‘drug’ through a delegated directive under Council Framework Decision 2004/757/JHA. Article 12 sets out the possibility for the Agency to develop threat assessments on new developments of the drug phenomenon that have a potential to impact negatively public health, safety and security. These threat assessments will help increase the preparedness of the EU to react to new threats and support other tasks of the Agency. Article 13 builds on the information available from the EU Early Warning System, the threat assessments and other information from the Member States about the appearance of a serious direct or indirect drug-related risk. It provides for a European drug alert system, which facilitates the rapid exchange of information that may require rapid actions to be taken to safeguard public health, safety, or security. Article 14 establishes competencies of the Agency in the area of drug precursors. Finally, Article 15 sets up a network of forensic and toxicological laboratories (a “virtual laboratory”). Chapter IV (Articles 16 to 21) defines the tasks to be addressed as part of competence development. Article 16 sets out the competencies of the Agency in relation to prevention. The Agency is already working in this area, e.g. through the development of a European Prevention Curriculum or through the Exchange prevention registry. This should be taken forward by enabling the Agency to develop cross-EU prevention programmes and campaigns, but also supporting Member States in preparing national campaigns. Article 17 provides for an accreditation and certification procedure for national programmes, in particular national prevention, treatment, harm reduction and other related programmes. Such an accreditation or certification would give the national authorities or professional bodies the certainty that their programmes are in line with the latest scientific state of play and have been proven useful. Article 18 empowers the Agency to provide support to the Member States, e.g. in the evaluation and development of their national strategies, but also in sharing innovative best practices or other relevant information. Article 19 enables the Agency to provide training within the scope of its mandate, being it as a core or a supporting task, the latter of which could be provided subject to separate fees, if so decided. Article 20 sets out the international cooperation and technical assistance activities of the Agency, which it should develop further. The provision also clarifies that international cooperation is part of the Agency’s core tasks. Article 21 provides a mandate to the Agency to be more active in the context of the EU research knowledge cycle. This should also include the Agency’s involvement in the EU Innovation Hub for Internal Security.

Chapter V (Articles 22 to 34) sets out the rules on the organisation of the Agency. The rules are based on Regulation (EC) No 1920/2006. The changes introduced to the rules in this Chapter are due to the implementation of the common approach. The specificities of the Agency, such as the existence of a Scientific Committee or a network of national focal points, were kept, but have been adapted as appropriate. Article 22 defines the structure of the Agency. Articles 23 to 27 set out the composition, functions and the working methods of the Management Board. They are developed based on Article 9 of Regulation (EC) No 1920/2006, the rules of procedure of the Management Board of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and the common approach. Article 28 sets out the rules for the Executive Board, which supports the Management Board and prepares its meetings. The basis for his provision is Article 10 of Regulation (EC) No 1920/2006, the rules of procedure of the EMCDDA Management Board and the common approach. Article 29 sets out the responsibilities of the Executive Director and is based on Article 11 of Regulation (EC) No 1920/2006 and the common approach. Article 30 sets out the rules for the Scientific Committee and is in line with Article 13 of Regulation (EC) No 1920/2006. Finally, Articles 31 to 34 set out the rules for the Reitox network of national focal points and the national focal points themselves. The national focal points need to be strengthened in line with the revision of the Agency mandate and therefore the rules on the national focal points were expanded to set out their roles and responsibilities in more detail. The national focal points need to be empowered to act as a central body in the Member States for all drug-related data and should also get an appropriate role on national level. In order to be able to fulfil their role appropriately, their set-up should comply with certain minimum requirements, the compliance with which should be certified by the Agency. Beyond those minimum requirements, it is for the Member States to decide how to set up the national focal points within their national legal system. Chapter VI (Articles 35 to 41) includes the financial provisions. Article 35 sets out the rules on the Single Programming Document of the Agency, which includes the three-year planning as well as the work programme of the next year. This provision has been adapted to the latest financial regulations. Changes in the financial provisions compared to Regulation (EC) No 1920/2006 are due to the implementation of the common approach and the currently applicable financial rules for EU decentralised agencies. The changes introduced as regards the budget procedures and the presentation of accounts and discharge are minor. The only new provision in this Chapter is Article 37, which would allow the Agency to charge fees for certain tasks, which are not part of the core tasks of the Agency. It will be up to the Agency to decide at a later stage, once this Regulation is applicable, whether it will use this option or not. Chapter VII (Articles 42 to 44) includes the staff rules. Changes compared to Regulation (EC) No 1920/2006 are due to the implementation of the common approach and changes to the Staff Regulations and the Conditions of Employment of Other Servants (Articles 42 and 44). Article 43 includes the staff rules applicable to the Executive Director. Chapter VIII (Articles 45 to 63) includes general and final provisions. Changes compared to Regulation (EC) No 1920/2006 are due to the implementation of the common approach and adaptations to more recent legislation. The majority of these provisions was already included in Regulation (EC) No 1920/2006. This Chapter also includes transitional provisions (Articles 58 to 61) to enable a proper transition from the European Monitoring Centre for Drugs and Drug Addiction to the European Union Drugs Agency.



2022/0009 (COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(5) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, After consulting the European Economic and Social Committee, After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure, Whereas: (1)The European Monitoring Centre for Drugs and Drug Addiction was set up by Council Regulation (EEC) No 302/93. This founding act was recast in 2006 through Regulation (EC) No 1920/2006 of the European Parliament and of the Council. (2)The European Monitoring Centre for Drugs and Drug Addiction was set up to provide factual, objective, reliable and comparable information concerning drugs, drug addiction and their consequences at Union level to provide the Union and the Member States with evidence to inform policymaking and guide initiatives to tackle drugs and thus give them added value when, in their respective areas of competence, they take measures or decide on action to address the drugs phenomenon. The creation of the European Monitoring Centre for Drugs and Drug Addiction has manifestly improved the availability of information on drugs and drug addiction across Europe.

(3)Whereas its general objective is still valid and should be retained, Regulation (EC) No 1920/2006 as such no longer fits for addressing the current and future drug challenges. Therefore, the mandate of the European Monitoring Centre for Drugs and Drug Addiction should be revised, including its replacement and renaming into “European Union Drugs Agency” (‘the Agency’). Since substantial amendments to Regulation (EC) No 1920/2006 are needed to accommodate the common approach for Union decentralised agencies and to take account of the developments of the drug phenomenon, in the interest of clarity that Regulation should be replaced by a new Regulation. (4)The main focus of Regulation (EC) No 1920/2006 was on health-related issues. However, addressing also drug markets and drug supply issues, is necessary to understand the impacts of the drug phenomenon on public health, reduce the availability of drugs in the Union and curb drug demand. Health- and supply-related issues are intrinsically linked. The Agency should therefore address the drug phenomenon more holistically. (5)The work of the Agency should be carried out with due regard to the respective powers of the Union and its Member States in the area of drugs. It should cover the various facets of the drugs phenomenon and the solutions applied. In doing so, the Agency should be guided by relevant strategies and action plans adopted by the Union, in particular the applicable EU Drugs Strategy and Action Plan. (6)In pursuing its activities, the Agency should cooperate with other Union agencies and bodies, in particular the European Union Agency for Law Enforcement Cooperation (Europol), the European Union Agency for Law Enforcement Training (CEPOL), the European Union Agency for Criminal Justice Cooperation (Eurojust), the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC), and the European Education and Culture Executive Agency (EACEA), and should take account of their activities in order to avoid duplication. Cooperation should also take place on an international level with relevant authorities and bodies in third countries and on the United Nations level. (7)Poly-substance use, that is the concomitant use of one or more psychoactive substance or type of substance, whether licit or illicit, when those substances are taken together with drugs, is becoming increasingly common. Therefore, the Agency should address other substance-based addictions when those substances are taken together with drugs by developing monitoring systems that would consider, instead of focusing only on one substance, heroin for example, the important role played by concurrent or sequential use of other substances as well, such as non-controlled opioids or misused medications. (8)The Agency should develop its activities around three main competence areas, i.e. monitoring, leading to better informed policies; early warning and risk assessment, leading to better informed actions; and competence development, leading to stronger Union responses to the drug phenomenon. (9)The collection, analysis and dissemination of data should continue to be the main task of the Agency. The standard data is collected through the national focal points, which should remain one of the main data providers for the Agency. Additional, closer to real-time data sources are increasingly available through innovative data collection methods. Therefore, the Agency should have access to all data available to get a holistic picture of the drug phenomenon in the Union and the external factors influencing it. (10)The data requirements of the Agency should be mirrored in the national focal points. They should be empowered within the Member States to receive all relevant data from the different national authorities. Data collection in the Member States should be streamlined as far as possible to avoid double reporting and duplication of efforts. (11)In order to facilitate and structure data collection, information exchange, both qualitative and quantitative, and to support the establishment of an integrated and interoperable monitoring system enabling real-time monitoring, the Agency should have an appropriate digital solution. This should allow for the automation of data and information management and exchange. Such solution should also facilitate the real-time monitoring of technology-enabled drug markets, including the darknet. (12)In order to enable the Agency to make better use of the information it has available, for example to issue more proactive measures such as threat assessments, strategic intelligence reports and alerts, and to enhance the Union’s preparedness for future developments, the monitoring and analytical capacity of the Agency should be strengthened. (13)In order to improve the Union’s preparedness, it is also necessary to have a holistic picture of the potential future developments of the drug phenomenon. To prepare itself and policymakers for such future developments, the Agency should conduct regular foresight exercises taking into account megatrends, that is long-term driving forces that are observable now and will most likely have significant influence on the future, aiming at identifying new challenges and opportunities for responding to drug problems. (14)The drug phenomenon is becoming more and more technology-enabled, as was shown again during the COVID-19 pandemic where a greater adoption of new technologies to facilitate drug distribution has been observed. It is estimated that about two-thirds of the offers on darknet markets are drug-related. Drug trading is using different platforms, including social media networks and mobile applications. This development is mirrored in responses to the drug phenomenon, with an increased use of mobile applications and e-health interventions. The Agency, together with other relevant Union agencies and avoiding duplication of efforts, should monitor such developments as part of its holistic approach to the drug phenomenon. (15)New psychoactive substances which pose public health and social risks across the Union, should be addressed at Union level. It is therefore necessary to monitor them and, to enable a quick response, to maintain the EU Early Warning System. The information exchange on and early warning system for new psychoactive substances, including the initial report and the risk assessment of new psychoactive substances has been amended recently and should remain unchanged. (16)Based on the strengthened monitoring by the Agency and the experience gained in the risk assessment of new psychoactive substances, the Agency should develop general threat assessment capabilities. A more proactive capacity to rapidly identify new threats and inform the development of counter-measures is urgently needed as the dynamic nature of the modern drug phenomenon means that related challenges can rapidly spread across borders. (17)As dangerous substances might lead to harm for public health, the Agency should be able to issue alerts. To support such a function, the Agency should develop a European drug alert system, accessible by national authorities. Such a system should facilitate the rapid exchange of information that may require rapid actions to safeguard public health, safety, and security. The Agency should be able to inform not only national authorities, but also potential users of these substances. (18)Drug precursors are substances necessary for the production of drugs such as amphetamines, cocaine and heroin. As illegal drug production in the Union is increasing, the prevention of trafficking and diversion of drug precursors from legal channels to illegal drug production should be strengthened. To support those efforts, the Agency should have a role in monitoring the diversion and trafficking of drug precursors and assisting the Commission in the implementation of the Union drug precursors legislation. (19)As there is a growing need for forensic and toxicological data and specialist expertise, and a lack of coordination between laboratories in the Member States, it is necessary to set up a “virtual” laboratory, i.e. a network of forensic and toxicological laboratories knowledgeable in the area of drugs and drug-related harms. This “virtual” laboratory should enable the Agency access to relevant information, increase its capacities in the area and support knowledge exchange between the relevant laboratories in the Member States, without incurring the high costs of creating and running its own laboratory. (20)The network of forensic and toxicological laboratories should be representative of the Member States by allowing them to appoint two laboratories to the network, covering toxicological and forensic expertise. In order to ensure the broadest coverage possible, experts from other laboratories relevant for the work of the Agency, including from the Customs Laboratories European Network, should also be given the possibility to participate in the network. Such cooperation would enable all laboratories involved to learn from each other across different domains. (21)To further the knowledge in this area and support Member States, the Agency should define and finance relevant projects, such as the development of reference standards on new drugs, the elaboration of toxicological or pharmacological studies, and drug profiling. Such an approach would support the sharing of information between relevant laboratories and would decrease the costs for individual laboratories. (22)Since the Agency has access to data and the necessary scientific experience to develop and promote evidence-based prevention strategies, it should be involved in prevention work, in particular exchange of best practices and implementable research results in drug prevention, drug-related crime prevention and the prevention of drug-related harms, including the elaboration of quality standards for drug prevention (European Drug Prevention Quality Standards) or of a curriculum providing decision- and policy-makers with the knowledge about the most effective evidence-based prevention interventions and approaches (European Union Prevention Curriculum)

(23)Given its Union perspective, the Agency should be able to evaluate national measures and training, for example on prevention, treatment, harm reduction and other related measures, in view of their compliance with the latest scientific state of play and of their proven usefulness. Member States or relevant professional bodies should be given the possibility to use the accreditation or certification as a quality label for their work. (24)Considering that the Agency has a unique position at Union level allowing it to compare data and best practices, the Agency should support evaluation and drafting of national drug strategies in a more structured way across Member States, in particular as regards policy development. In addition, the Agency’s role in providing training and support to Member States in the implementation of quality standards and good practices should be strengthened in light of the expertise it developed in these areas. (25)The responsibilities of the Agency in the area of international cooperation should be defined in more clear terms in order to allow it to fully engage in such activities and respond to requests from third countries and bodies. The Agency should be able to contribute to the development and implementation of the external dimension of the Union’s drugs policy and the leadership role of the Union at multilateral level as a means to ensure the efficient and coherent implementation of the Union drug policies internally and at international level. In order that the Agency can allocate adequate levels of resources to this task, the work on international cooperation should be part of the core tasks of the Agency. It should be based on an international cooperation framework of the Agency, which should be in line with the Union priorities on international cooperation and should be revised on a regular basis to ensure that it adequately reflects international developments. (26)In order to help Union funding for security research to develop its full potential and address the needs of drugs policy, the Agency should assist the Commission in identifying key research themes, drawing up and implementing the Union framework programmes for research and innovation that are relevant to the Agency’s objectives. Where the Agency assists the Commission in identifying key research themes, drawing up and implementing a Union framework programme, it should not receive funding from that programme in order to avoid a potential conflict of interest. Finally, the Agency should participate in Union-wide initiatives addressing research and innovation to ensure that technologies necessary for its activities are developed and available for use. (27)The Management Board should be assisted by an Executive Board to prepare its decisions. The Agency should be headed by an Executive Director. A Scientific Committee should continue assisting the Management Board and the Executive Director with regard to relevant scientific matters. (28)The national focal points should be one of the main data providers to the Agency. It is necessary to set minimum requirements for their creation by Member States and their certification by the Agency. In order to guarantee the adequate functioning of the national focal points, they should be set up on a permanent basis, with a dedicated budget and a certain degree of independence in carrying out their function. (29)The Agency should be properly resourced to carry out its tasks and granted an autonomous budget. It should be mainly financed by a contribution from the general budget of the Union. The Union budgetary procedure should be applicable as far as the Union contribution and any other subsidies chargeable to the general budget of the Union are concerned. The auditing of accounts should be undertaken by the Court of Auditors of the European Union. (30)Fees improve the funding of an agency and may be considered for specific issues that can be clearly separated from the core tasks of the agency. Any fees levied by the Agency should cover its costs for providing the respective services. (31)The Executive Director should present the annual report of the Agency to the European Parliament and to the Council. Furthermore, the European Parliament and the Council should be able to invite the Executive Director to report on the performance of her or his duties. (32)Regulation (EC) No 1049/2001 of the European Parliament and of the Council should apply to the Agency. The Agency should be as transparent as possible about its activities, without jeopardising the attainment of the objective of its operations. (33)Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council and the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-Fraud Office (OLAF), to which the European Monitoring Centre for Drugs and Drug Addiction already acceded, should apply to the Agency. (34)In order to control and ensure the performance of the Agency and that its mandate allows it to carry out the necessary activities required by drug market and policy developments, an external evaluation of the Agency’s work should be conducted on a regular basis and its mandate adapted accordingly, if needed. (35)The Agency should cooperate closely with relevant international organisations, other governmental and non-governmental bodies and relevant technical bodies from inside and outside the Union in the implementation of its work programme, notably to avoid duplication of work and to ensure access to all data and tools needed for carrying out its mandate. (36)The Agency replaces and succeeds the European Monitoring Centre for Drugs and Drug Addiction established by Regulation (EC) 1920/2016. It should therefore be the legal successor of all its contracts, including employment contracts, liabilities and properties acquired. International agreements concluded by the European Monitoring Centre for Drugs and Drug Addiction before the date of application of this Regulation should remain in force. (37)Since the objectives of this Regulation, namely the establishment of an agency to address the drugs phenomenon, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS REGULATION: CHAPTER I OBJECTIVES AND GENERAL TASKS OF THE AGENCY Article 1 Establishment of the Agency

1.This Regulation establishes the European Union Drugs Agency (‘the Agency’). 2.The Agency shall replace and succeed the European Monitoring Centre for Drugs and Drug Addiction established by Regulation (EC) No 1920/2006. Article 2 Legal status and seat 1.The Agency shall be a body of the Union with legal personality. 2.In each of the Member States, the Agency shall enjoy the most extensive legal capacity accorded to legal persons under national law. It shall, in particular, be able to acquire or dispose of movable and immovable property and be a party to legal proceedings. 3.The seat of the Agency shall be in Lisbon, Portugal. Article 3 Definitions For the purpose of this Regulation: (1)‘drugs’ means drugs as defined in Article 1, point 1, of Council Framework Decision 2004/757/JHA; (2)‘new psychoactive substances’ means substances as defined in Article 1, point 4, of Framework Decision 2004/757/JHA; (3)‘poly-substance use’ means the concomitant use of one or more psychoactive substance or type of substance, whether licit or illicit, when those substances are taken together with drugs; (4)‘drug precursors’ means substances that are controlled and monitored in accordance with Regulation (EC) No 273/2004 of the European Parliament and of the Council and with Council Regulation (EC) No 111/2005; (5) ‘participating countries’ means the Member States and third countries which have concluded an agreement with the Union in accordance with Article 54; (6)‘international organisation’ means an organisation and its subordinate bodies governed by public international law, or any other body which is set up by, or on the basis of, an agreement between two or more countries; (7)‘United Nations Drug Conventions’ means the United Nations Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol, the United Nations Convention on Psychotropic Substances of 1971 and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988; (8)‘United Nations system’ means the control mechanism system established by the United Nations Drug Conventions. Article 4 General task of the Agency

The Agency shall provide the Union and its Member States with factual, objective, reliable and comparable information, early warning and risk assessment at Union level concerning drugs, drug addiction, drug markets and their consequences, and to recommend appropriate and concrete, evidence-based actions on how to address the related challenges in a timely manner. Article 5 Specific tasks 1.In order to implement the general task set out in Article 4, the Agency shall perform the following tasks: (a)monitoring tasks that shall include: (1)the collection of information and data pursuant to Article 6(1); (2)the dissemination of information and data pursuant to Article 6(5); and (3)the monitoring of the drug phenomenon, encompassing the public health, safety and security dimension, pursuant to Article 7. (b)preparedness tasks that shall include: (1)the information exchange on and early warning system for new psychoactive substances, including the preparation of an initial report and risk assessment, pursuant to Articles 8 to 11; (2)threat assessment and preparedness pursuant to Article 12; (3)the establishment and operation of a European drug alert system pursuant to Article 13; (4)monitoring the developments related to trafficking and diversion of drug precursors and contributing to the implementation of drug precursors legislation pursuant to Article 14; (5) the establishment and operation of a network of forensic and toxicological laboratories pursuant to Article 15; (c)competence development tasks that shall include: (1)the development, expansion and promotion of Union-wide prevention programmes and campaigns pursuant to Article 16; (2)the accreditation and certification of national measures pursuant to Article 17; (3)support to Member States pursuant to Article 18; (4)training pursuant to Article 19; (5)international cooperation and technical assistance pursuant to Article 20;

(6)research and innovation activities pursuant to Article 21. 2.The Agency shall establish and coordinate, in consultation and in cooperation with the competent authorities and organisations in the participating countries, the network referred to in Article 31. 3.The Agency shall act in an objective, impartial and scientifically rigorous manner when carrying out and implementing the tasks referred to in paragraph 1. 4.The Agency shall improve coordination between national and Union action in its areas of activity and facilitate exchanges of information between decision-makers, researchers, specialists and those involved in drug-related issues in governmental and non-governmental organisations. 5.The Agency shall support the Commission, Member States and other relevant stakeholders, identified in the applicable Union strategies on drugs, in the implementation of those strategies, as appropriate. 6.In carrying out and implementing the tasks referred to in paragraph 1, the Agency may organise meetings of experts, set up ad hoc working groups and finance projects, as necessary. 7.In carrying out and implementing the tasks referred to in paragraph 1, the Agency shall cooperate actively with other Union decentralised agencies and bodies, in particular Europol, Eurojust, the European Medicines Agency, the European Centre for Disease Prevention and Control, civil society organisations and other relevant stakeholders, to attain maximum efficiency in monitoring, assessing and responding to the drugs phenomenon. 8.The Agency may engage in communication activities on its own initiative within its mandate. The allocation of resources to communication activities shall not be detrimental to the effective exercise of the tasks referred to in paragraph 1. Communication activities shall be carried out in accordance with relevant communication and dissemination plans adopted by the Management Board. CHAPTER II MONITORING Article 6 Collection and dissemination of information and data 1.The Agency shall: (a)collect all relevant information and data, including information and data communicated by the national focal points, resulting from research, available from open sources, and data emanating from Union, non-governmental sources and competent international organisations; (b)collect information and data needed for the monitoring of poly-substance use as referred to in Article 7(1), point (c); (c)collect the available information and data from the national focal points and the Europol national units on new psychoactive substances and communicate that information to the national focal points and the Europol national units as well as to the Commission without undue delay; (d)collect and analyse information and data on drug precursors, their diversion and trafficking; (e)conduct and commission research and monitoring studies, surveys, feasibility studies, and pilot projects necessary to accomplish its tasks; (f)ensure improved comparability, objectivity and reliability of information and data at Union level by establishing indicators and common standards of a non-binding nature, compliance with which may be recommended by the Agency, with a view to ensuring greater uniformity of the measurement methods used by the Member States and the Union; in particular, the Agency shall develop tools and instruments to help Member States to monitor and evaluate their national policies and the Commission to monitor and evaluate Union policies. 2.The Agency shall collect relevant national data through the national focal points. It shall also cooperate closely with other national, European and international organisations and bodies that already have information of this kind.

3.The Agency shall develop, within its mandate, data collection methods and approaches, including through projects with external partners. 4.The Agency may develop the necessary digital solutions through which information and data are managed and automatically exchanged. If such digital solutions are developed, they shall: (a)enable the automated collection of data, including open source information, while keeping the possibility of manual data provision available; (b)apply artificial intelligence for data validation, analysis and automated reporting; (c)allow for the computerised handling and exchange of information, data and documents. 5.The Agency shall disseminate information and data by: (a)making the information it produces available to the Union, the Member States and other interested parties, including as regards new developments and changing trends; (b)ensuring wide dissemination of its analysis, conclusions and reports; (c)ensuring wide dissemination of reliable data, excluding sensitive non-classified and classified data, through publishing, on the basis of data which it gathers, a regular report on the state of the drugs phenomenon, including data on emerging trends; (d)setting up and making available open scientific documentation resources and assisting in the promotion of information activities; (e)providing information on quality standards, innovative best practices and implementable research results in the Member States and facilitating the exchange and implementation of such standard and practices. 6.The Agency shall not collect any data making it possible to identify individuals or small groups of individuals. It shall refrain from any transmission of information relating to specific individuals. Article 7 Monitoring of the drug phenomenon 1.The Agency shall monitor: (a)the drugs phenomenon in the Union holistically, through epidemiological and other indicators, covering the health, safety and security aspects, including the implementation of the applicable Union strategies on drugs; (b)emerging trends in the drugs phenomenon in the Union and internationally as far as these impact on the Union; this shall include the monitoring of the use of new technologies for drug services or drug trafficking, and links to other crime areas, as relevant; (c)poly-substance use and its consequences, in particular the implications for policies and responses arising from the interaction between the use of drugs with one or more psychoactive substance or type of substance, whether licit or illicit; including the increased risks of health and social problems, which may occur when drugs and other psychoactive substances are consumed at the same time or sequentially within a short period of time or when different substances are produced or sold together; the need to consider the common causes of drug use and addictions; and the implications for monitoring and exchange of best practices, which arise when policies and responses target multiple substances holistically; (d)drug-related problems and the solutions applied, in particular the implementation of innovative best practices and research results;

(e)in cooperation with Europol and with the support of the national focal points and the Europol national units, all new psychoactive substances that have been reported by Member States; (f)drug precursors and their trafficking and diversion; (g)Union and national drugs policies, including in view of supporting their development and independent evaluation; (h)Technology-enabled drug markets, in cooperation with Europol within their respective mandates. 2.Based on its monitoring activities, the Agency shall identify innovative best practices and develop them further. The Agency shall provide and share information on innovative best practices in the Member States and facilitate the exchange of such practices among the Member States. 3.The Agency shall undertake regular foresight exercises, taking into account the information available. It shall develop, on that basis, relevant predictions for the development of future drugs policy. CHAPTER III PREPAREDNESS Article 8 Information exchange on, and early warning system for, new psychoactive substances 1.Each Member State shall ensure that its national focal point and its Europol national unit provide the Agency and Europol, taking into account their respective mandates, with the available information on new psychoactive substances in a timely manner and without undue delay. The information shall be related to the detection and identification, use and patterns of use, manufacture, extraction, distribution and distribution methods, trafficking, and commercial, medical and scientific use of, and potential and identified risks posed by, those substances. 2.The Agency, in cooperation with Europol, shall collect, collate, analyse and assess information on new psychoactive substances. It shall communicate this information in a timely manner to the national focal points, the Europol national units, and the Commission with a view to providing them with any information required for the purposes of early warning. The Agency shall draw up the initial report or the combined initial report pursuant to Article 9 based on the information collected pursuant to the first subparagraph. Article 9 Initial report 1.Where the Agency, the Commission or the majority of Member States considers that information shared on a new psychoactive substance collected in one or more Member States gives rise to concerns that the new psychoactive substance may pose health or social risks at Union level, the Agency shall draw up an initial report on the new psychoactive substance. For the purpose of the first subparagraph, Member States shall inform the Commission and other Member States of their wish that an initial report be drawn up. Where the majority of Member States is reached, the Commission shall instruct the Agency accordingly and shall inform the Member States thereof. 2.The initial report shall contain: (a)a preliminary indication of the nature, number and scale of incidents showing health and social problems in which the new psychoactive substance may potentially be involved, and the patterns of use of the new psychoactive substance;

(b)a preliminary indication of the chemical and physical description of the new psychoactive substance and the methods and precursors used for its manufacture or extraction; (c)a preliminary indication of the pharmacological and toxicological description of the new psychoactive substance; (d)a preliminary indication of the involvement of criminal groups in the manufacture or distribution of the new psychoactive substance; (e)information on the human and veterinary medical use of the new psychoactive substance, including as an active substance in a medicinal product for human use or in a veterinary medicinal product; (f)information on the commercial and industrial use of the new psychoactive substance, the extent of such use, as well as its use for scientific research and development purposes; (g)information on whether the new psychoactive substance is subject to any restrictive measures in the Member States; (h)information on whether the new psychoactive substance is currently or has been under assessment within the United Nations system; (i)other relevant information, where available. 3.For the purpose of the initial report, the Agency shall use information, which is at its disposal. 4.Where the Agency considers it necessary, it shall request the national focal points to provide additional information on the new psychoactive substance. The national focal points shall provide that information within two weeks of receipt of the request. 5.The Agency shall, without undue delay after the start of drawing up of the initial report pursuant to the first paragraph, request the European Medicines Agency to provide information on whether, at Union or national level, the new psychoactive substance is an active substance in: (a)a medicinal product for human use or in a veterinary medicinal product that has obtained a marketing authorisation in accordance with Directive 2001/83/EC of the European Parliament and of the Council, Directive 2001/82/EC of the European Parliament and of the Council or Regulation (EC) No 726/2004 of the European Parliament and of the Council; (b)a medicinal product for human use or in a veterinary medicinal product that is the subject of an application for a marketing authorisation; (c)a medicinal product for human use or in a veterinary medicinal product whose marketing authorisation has been suspended by the competent authority; (d)an unauthorised medicinal product for human use as referred to in Article 5(1) and (2) of Directive 2001/83/EC or in a veterinary medicinal product prepared extemporaneously by a person authorised to do so under national law in accordance with Article 10(1), point (c), of Directive 2001/82/EC; (e)an investigational medicinal product as defined in Article 2, point (d), of Directive 2001/20/EC of the European Parliament and of the Council. Where the information relates to marketing authorisations granted by Member States, the Member States concerned shall provide the European Medicines Agency with such information upon its request. 6.The Agency shall, without undue delay after the start of the drawing up of the initial report pursuant to the first paragraph, request Europol to provide information on the involvement of criminal groups in the manufacture, distribution and distribution methods, and trafficking of the new psychoactive substance, and in any use of the new psychoactive substance. 7.The Agency shall, without undue delay after the start of the drawing up of the initial report pursuant to the first paragraph, request the European Chemicals Agency, the European Centre for Disease Prevention and Control and the European Food Safety Authority to provide the information and data at their disposal on the new psychoactive substance. 8.The details of the cooperation between the Agency and the Union decentralised agencies referred to in paragraphs 5, 6 and 7 shall be governed by working arrangements. Such working arrangements shall be concluded in accordance with Article 53(2).

9.The Agency shall respect the conditions on use of the information, which are communicated to the Agency, including conditions on access to documents, information and data security and protection of confidential data, including sensitive data and confidential business information of third parties. 10.The Agency shall submit the initial report to the Commission and the Member States within five weeks of making the requests for information referred to in paragraphs 5, 6 and 7. 11.Where the Agency collects information on several new psychoactive substances that it considers to be of similar chemical structure, it shall submit to the Commission and to the Member States individual initial reports, or combined initial reports dealing with several new psychoactive substances, provided that the characteristics of each new psychoactive substance are clearly identified, within six weeks of making the requests for information referred to in paragraphs 5, 6 and 7. Article 10 Risk assessment procedure and report 1.Within two weeks of receipt of an initial report as referred to in Article 9(10), the Commission may request the Agency to assess the potential risks posed by the new psychoactive substance and to draw up a risk assessment report, where there are indications in the initial report to believe that the substance may pose severe public health risks and, where applicable, severe social risks. The risk assessment shall be carried out by the Scientific Committee. 2.Within two weeks of receipt of a combined initial report as referred to in Article 9(11), the Commission may request the Agency to assess the potential risks posed by several new psychoactive substances with a similar chemical structure and to draw up a combined risk assessment report, where there are indications in the combined initial report to believe that the substances may pose severe public health risks and, where applicable, severe social risks. The combined risk assessment shall be carried out by the Scientific Committee. 3.The risk assessment report or combined risk assessment report shall contain: (a)available information on the chemical and physical properties of the new psychoactive substance and the methods and the precursors used for its manufacture or extraction; (b)available information on the pharmacological and toxicological properties of the new psychoactive substance; (c)an analysis of the health risks associated with the new psychoactive substance, in particular with respect to its acute and chronic toxicity, abuse liability, dependence-producing potential, and physical, mental and behavioural effects; (d)an analysis of the social risks associated with the new psychoactive substance – in particular its impact on social functioning, public order and criminal activities, and the involvement of criminal groups in the manufacture, distribution and distribution methods, and trafficking of the new psychoactive substance; (e)available information on the extent and patterns of use of the new psychoactive substance, its availability and potential for diffusion within the Union; (f)available information on the commercial and industrial use of the new psychoactive substance, the extent of such use, as well as its use for scientific research and development purposes; (g)other relevant information, where available. 4.The Scientific Committee shall assess the risks posed by the new psychoactive substance or group of new psychoactive substances. The Commission, the Agency, Europol and the European Medicines Agency shall each have the right to appoint two observers. 5.The Scientific Committee shall carry out the risk assessment on the basis of the available information and of any other relevant scientific evidence. It shall take into account all opinions held by its members. The Agency shall organise the risk assessment procedure, including identifying future information needs and relevant studies. 6.The Agency shall submit the risk assessment report or the combined risk assessment report to the Commission and the Member States within six weeks of receipt of the request from the Commission to draw up a risk assessment report. 7.Upon receipt of a duly reasoned request of the Agency, the Commission may extend the period for completion of the risk assessment or combined risk assessment to allow for additional research and data collection to take place. That request shall contain information on the period of time needed to complete the risk assessment or combined risk assessment.

8.The Agency shall also provide timely rapid risk assessments, in accordance with Article 20 of Regulation (EU) …/… on serious cross-border threats to health and repealing Decision No 1082/2013/EU, in the case of a threat referred to in points (b) of Article 2(1) of that Regulation, where the threat falls under the mandate of the Agency. Article 11 Exclusion from risk assessment 1.No risk assessment shall be carried out where the new psychoactive substance is at an advanced stage of assessment within the United Nations system, namely once the World Health Organisation Expert Committee on Drug Dependence has published its critical review together with a written recommendation, except where there are sufficient data and information available to suggest the need for a risk assessment report at Union level, the reasons for which shall be indicated in the initial report. 2.No risk assessment shall be carried out where, following an assessment within the United Nations system, it has been decided not to schedule the new psychoactive substance, except where there are sufficient data and information available to suggest the need for a risk assessment report at Union level, the reasons for which shall be indicated in the initial report. 3.No risk assessment shall be carried out where the new psychoactive substance is an active substance in: (a)a medicinal product for human use or in a veterinary medicinal product that has obtained a marketing authorisation in accordance with Directive 2001/83/EC, Directive 2001/82/EC or Regulation (EC) No 726/2004; (b)a medicinal product for human use or in a veterinary medicinal product that is the subject of an application for a marketing authorisation; (c)a medicinal product for human use or in a veterinary medicinal product whose marketing authorisation has been suspended by the competent authority; (d)an investigational medicinal product as defined in Article 2, point (d), of Directive 2001/20/EC. Article 12 Threat assessment and preparedness 1.The Agency shall develop a strategic general threat assessment capability to identify at an early stage new developments of the drugs phenomenon that have a potential to impact negatively on public health, safety and security and, through doing so, to help increase the preparedness of the relevant stakeholders to respond to new threats in a timely and effective manner. 2.The Agency shall set out a set of criteria to evaluate when to trigger a threat assessment. A threat assessment may be launched by the Agency on its own initiative based on an internal appraisal of signals arising from routine monitoring, research or other appropriate information sources. A threat assessment may also be launched at the request of the Commission or of a Member State, if the defined criteria are met. 3.A threat assessment shall consist of a rapid evaluation of existing information and, where necessary, the collection of new information through the Agency’s information networks. The Agency shall develop appropriate scientific rapid assessment methods. 4.The threat assessment report shall describe the identified threat, the current situation based on available evidence, the potential outcomes in the event of no action, and set out options for preparedness and response that may be adopted to mitigate the threat identified. It may also contain potential follow-up measures to be adopted. The threat assessment report shall be sent to the Commission and the Member States, as appropriate. 5.The Agency shall cooperate closely with other Union decentralised agencies and bodies, Union and international organisations in carrying out a threat assessment by involving them in the assessment as appropriate. Where the potential threat is already subject to an analysis under another Union mechanism, the Agency shall not carry out a threat assessment. 6.With the agreement of the Commission, the Agency shall conduct threat assessments on drug related threats emerging from outside the Union, which have the potential to impact public health, safety and security within the Union. Article 13

European drug alert system 1.The Agency shall set up and manage a rapid European drug alert system. 2.Member States shall immediately notify the Agency of any information relating to the appearance of a serious direct or indirect drug-related risk to human health, safety or security as well as any information that may be useful for coordinating a response whenever they become aware of such information, such as: (a)the type and origin of the risk; (b)the date and place of the event involving the risk; (c)the means of exposure, transmission or dissemination; (d)analytical and toxicological data; (e)identification methods; (f)public health risks; (g)public health measures implemented or intended to be taken at national level; (h)measures other than public health measures; (i)any other information relevant to the serious risk to health in question. 3.The Agency shall analyse and assess the available information and data on potential serious risks to human health and complement it with any scientific and technical information it may have available from the early warning system referred to in Article 8 and other threat assessments undertaken in accordance with Article 12, from other Union agencies and bodies and from international organisations, in particular the World Health Organisation. The Agency shall take into account information obtained through its data collection tools and from open source information. 4.Based on the information received pursuant to paragraph 3, the Agency shall provide targeted rapid alert risk communications or strategic intelligence notifications, or both, to the relevant national authorities, including the national focal points. Such risk communications or strategic intelligence notifications may propose response options, which Member States may consider as part of their preparedness planning and national response activities. 5.The Member States shall inform the Agency of any additional information at their disposal in order to further analyse and assess the risk as well as the actions implemented or measures taken following receipt of the notifications and information transmitted under the European drug alert system. 6.The Agency shall cooperate closely with the Commission and the Member States to promote the necessary coherence in the risk communication process. 7.The Agency may open up participation in the European drug alert system to third countries or international organisations. That participation shall be based on reciprocity and shall include confidentiality measures equivalent to those applicable in the Agency. 8.The Agency may develop an alert system through which it can directly reach and address people who use or potentially use drugs. Article 14 Drug precursors

1.The Agency shall assist the Commission in monitoring the developments related to the trafficking and diversion of drug precursors and in assessing the need to add to, remove from or change the category of listed scheduled and non-scheduled substances in relation to Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005, including in identifying and assessing their licit and illicit uses. 2.The Agency shall prepare on its own initiative or at the request of the Commission a threat assessment report on drug precursors. Article 15 Network of forensic and toxicological laboratories 1.The Agency shall set up a network of forensic and toxicological laboratories particularly active in the forensic and toxicological investigations of drugs and drug-related harms. 2.The network shall act primarily as a forum for generating data and information exchange on new developments and trends, organising training to enhance the competence of forensic drug experts, supporting the implementation of quality assurance schemes and supporting the further harmonisation of data collection and analytical methods. 3.Each Member State shall have the right to appoint, through its representative in the Management Board, two laboratories, one specialising in forensic analysis and one specialising in toxicology, as national representative laboratories to the network. The Agency may select additional laboratories or experts particularly active in the forensic and toxicological investigations of drugs and drug-related harms for specific projects. 4.The Joint Research Centre of the Commission shall be a member of the network and represent the Commission in the network. 5.The network shall closely cooperate with existing networks and organisations active in this area. The network referred to in Article 31 shall be informed regularly about the work of the network of forensic and toxicological laboratories. 6.The Agency shall chair the network and convene at least one meeting per year. The network may decide to create working groups, which may be chaired by members of the network. 7.The network shall enable the Agency to have access to forensic and toxicological laboratories, including for the analysis of new psychoactive substances where this is needed. 8.The Agency shall define and finance specific projects to further the network, as appropriate and based on clear and transparent rules and procedures, which are defined by the Agency beforehand. 9.The Agency shall create a database to store, analyse and make available the information and data collected or generated by the network. CHAPTER IV COMPETENCE DEVELOPMENT Article 16 Prevention campaigns 1.The Agency shall design, develop and promote Union-wide programmes and campaigns for the prevention of drug-related problems and raising awareness of the adverse effects of drugs. 2.The programmes and campaigns referred to in paragraph 1 shall be in line with the political orientations set out in the applicable EU Drugs Strategy and Action Plan. They shall address important dimensions of the drug phenomenon, shall be targeted to specific groups and be informed by the Agency’s collection of evidence and best practice. 3.The Agency shall develop and promote the implementation of quality standards for drug prevention and provide or support training pursuant to Article 19.

4.The Agency shall assist Member States in developing national prevention campaigns in the area of its mandate, including the development of prevention programmes aimed at the reduction of drug-related criminality and prevention of the exploitation of vulnerable individuals within the drug market. Article 17 Accreditation and certification of national programmes 1.At the request of a national authority of a participating country or a relevant professional body, in cases where the participating country does not have any similar accreditation or certification body, the Agency shall provide accreditation and certification for national programmes in accordance with the standard operating protocol provided for in paragraph 3. 2.Before granting an accreditation or certification to a national programme, the Agency shall evaluate the programme and assess whether it complies with the latest scientific state of play and whether it has been proven useful to address its declared objectives. 3.The Agency shall develop an accreditation and certification procedure, which shall be set out in a transparent way by the Agency in a standard operating protocol. The Management Board of the Agency shall approve the standard operating protocol and any changes to it before its application. The standard operating protocol referred to in subparagraph 1 should contain at least: (a)specific conditions relating to the capacity and resources of the Agency to carry out the accreditation or certification procedure; (b)the criteria according to which the national programme will be assessed in view of the accreditation or certification and which allow the verification of the conditions laid down in paragraph 2; programmes subject to an accreditation or certification shall include at least prevention, treatment, harm reduction, and other related subjects; (c)the details of the accreditation or certification process carried out by the Agency, including designation of the documentation to be provided and the timeframe for the procedure; (d)the conditions for restricting, suspending or withdrawing the accreditation or certification; (e)the procedures for the resolution of appeals, including, where appropriate, legal remedies against accreditation decisions or the absence thereof. Article 18 Support to Member States 1.At the request of a Member State, the Agency may support the independent evaluation of its drug policies and the development of evidence-based drug policies in line with the applicable Union strategies. 2.The Agency shall support the Member States in implementing their national drug strategies, quality standards and innovative best practices and it shall facilitate exchanges of information between national decision-makers. 3.In supporting policy evaluation, the Agency shall act independently and shall be guided by its scientific standards. Article 19 Training The Agency shall, within the scope of its mandate, in accordance with the staffing and budgetary resources at its disposal and in coordination with other Union decentralised agencies and bodies:

(a)provide specialised training and curricula in areas of Union interest and relevance; (b)provide training-related tools and support systems to facilitate Union-wide knowledge exchange; (c)assist Member States in organising training and capacity building initiatives. Article 20 International cooperation and technical assistance 1.The Agency shall: (a)develop an international cooperation framework, to be approved by the Management Board subject to a prior approval by the Commission, which shall guide the activities of the Agency in the area of international cooperation; (b)cooperate actively with the organisations and bodies referred to in Article 53; (c)support the exchange and dissemination of Union best practices and implementable research results at international level; (d)monitor developments of the international drug phenomenon that may pose a threat to or have implications for the Union through the monitoring and analysis of information available from international bodies, national authorities, research findings and other relevant information sources; (e)provide data and analysis on the European drug situation in appropriate international meetings and technical fora, in close coordination with the Commission, and support the Commission and the Member States in international drugs dialogues; (f)promote the incorporation of data on drugs and drug addiction gathered in the Member States or emanating from the Union into international monitoring and drug-control programmes, particularly those established by the UN and its specialised agencies, without prejudice to Member States' obligations with regard to transmission of information under the provisions of the United Nations Drug Conventions; (g)support the Member States in reporting the relevant information and providing the required analysis to the United Nations system, including the submission of all relevant data related to new psychoactive substance to the United Nations Office on Drugs and Crime and the World Health Organisation; (h)support third countries in developing their drug policies in accordance with the principles of the Union drug strategies, including through providing support to the independent evaluation of their policies. 2.The international cooperation framework referred to in paragraph 1, point (a), shall take into account the relevant policy documents of the Union and consider the developments of the drug phenomenon, in particular trafficking routes and drug production areas. It shall set out the priority countries or regions for cooperation and the key outcomes of the cooperation. The Agency shall evaluate and review the international cooperation framework regularly. 3.The Agency shall transfer, at the request of the Commission and with the approval of the Management Board, its know-how and provide technical assistance to third countries. Technical assistance shall focus in particular on setting up or consolidating national focal points, national data collection systems and national early warning systems, and subsequently assist the creation and strengthening of structural links with the early warning system referred to in Article 8 and the network referred to in Article 31. If the third country so requests, the Agency may provide a certification for these national bodies. 4.Cooperation with third countries and with international organisations shall be carried out in accordance with Articles 53 and 54. Article 21 Research and innovation

1.The Agency shall assist the Commission and the Member States in identifying key research themes, drawing up and implementing the Union framework programmes for research and innovation activities that are relevant to achieve its general task set out in Article 4. Where the Agency assists the Commission in identifying key research themes, drawing up and implementing a Union framework programme, the Agency shall not receive funding from that programme. 2.The Agency shall proactively monitor and contribute to research and innovation activities to achieve its general task set out in Article 4, support related activities of Member States, and implement its research and innovation activities regarding matters covered by this Regulation, including the development, training, testing and validation of algorithms for the development of tools. The Agency shall disseminate the results of that research to the European Parliament, to the Member States and to the Commission in accordance with Article 49. 3.The Agency shall contribute to and participate in the activities of the EU Innovation Hub for Internal Security, or any instrument that would replace it, in the framework of the research and innovation cycle. 4.The Agency may plan and implement pilot projects regarding matters covered by this Regulation. 5.The Agency shall make public information on its research projects, including demonstration projects, the cooperation partners involved and the project budget. 6.The Agency shall create a database to store, analyse and make available drug-related research programmes. CHAPTER V ORGANISATION OF THE AGENCY Article 22 Administrative and management structure The Agency's administrative and management structure shall comprise: (a)a Management Board, which shall exercise the functions set out in Article 24; (b)an Executive Board, which shall exercise the functions set out in Article 28; (c)an Executive Director, who shall exercise the responsibilities set out in Article 29; (d)a Scientific Committee, which shall exercise the functions set out in Article 30; (e)a European Information Network on Drugs and Drug Addiction (Reitox) in accordance with Article 31. Article 23 Composition of the Management Board 1.The Management Board shall be composed of one representative from each Member State and two representatives from the Commission, all with voting rights. 2.The Management Board shall also include:

(a)one independent expert particularly knowledgeable in the field of drugs designated by the European Parliament, with the right to vote; (b)one representative from each third country, which has concluded an agreement with the Union in accordance with Article 54, without the right to vote. 3.Each member of the Management Board shall have an alternate. The alternate shall represent the member in her/his absence. 4.Members of the Management Board and their alternates shall be appointed in light of their knowledge in the field of drugs and drug addiction, taking into account relevant managerial, administrative and budgetary skills. All parties represented in the Management Board shall make efforts to limit turnover of their representatives, in order to ensure continuity of the Management Board's work. All parties shall aim to achieve a balanced representation between women and men on the Management Board. 5.The Management Board may invite, as observers, representatives of international organisations with which the Agency cooperates in accordance with Article 53. 6.The term of office for members and their alternates shall be four years. That term may be renewable. Article 24 Functions of the Management Board 1.The Management Board shall: (a)give the general orientations for the Agency's activities; (b)adopt the draft single programming document referred to in Article 35 before its submission to the Commission for its opinion; (c)adopt, having requested the opinion of the Commission, the Agency's single programming document by a majority of two-thirds of members entitled to vote in accordance with Article 23; (d)adopt, by a majority of two-thirds of members entitled to vote, the annual budget of the Agency and exercise other functions in respect of the Agency's budget pursuant to Chapter VI; (e)assess and adopt, by a majority of two-thirds of members entitled to vote, the consolidated annual activity report on the Agency's activities and send both the report and its assessment by 1 July each year to the European Parliament, the Council, the Commission and the Court of Auditors. The consolidated annual activity report shall be made public; (f)adopt the financial rules applicable to the Agency in accordance with Article 41; (g)adopt an anti-fraud strategy, proportionate to fraud risks taking into account the costs and benefits of the measures to be implemented; (h)adopt a strategy for achieving efficiency gains and synergies with other Union decentralised agencies and bodies; (i)adopt rules for the prevention and management of conflicts of interest in respect of its members, the members of the Executive Board, Scientific Committee, and the European Information Network on Drugs and Drug Addiction (Reitox), as well as of seconded national experts and other staff not employed by the Authority as referred to in Article 44, and shall publish annually on its website the declarations of interests of the Management Board members; (j)adopt the standard operating protocol referred to in Article 17(3); (k)adopt the international cooperation framework of the Agency referred to in Article 20(1) and the technical assistance programmes referred to in Article 20(3);

(l)approve the level of minimum co-financing referred to in Article 32(7); (m)adopt and regularly update the communication and dissemination plans referred to in Article 5(8), based on an analysis of needs; (n)adopt its rules of procedure; (o)in accordance with paragraph 2, exercise, with respect to the staff of the Agency, the powers conferred by the Staff Regulatio