Regulation (EU) 2023/1322 of the European Parliament and of the Council of 27 June 2023 on the European Union Drugs Agency (EUDA) and repealing Regulation (EC) No 1920/2006

REGULATION (EU) 2023/1322 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 June 2023 on the European Union Drugs Agency (EUDA) and repealing Regulation (EC) No 1920/2006

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,

Having regard to the opinion of the European Economic and Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1) The European Monitoring Centre for Drugs and Drug Addiction (the ‘EMCDDA’) was established by Council Regulation (EEC) No 302/93 (3). That Regulation was recast in 2006 by Regulation (EC) No 1920/2006 of the European Parliament and of the Council (4).

(2) The EMCDDA was established to provide the Union, Member States and participating third countries with factual, objective, reliable and comparable information concerning drugs, drug addiction and their consequences at European level in order to help provide them with an overall view of that information for the purpose of informing policymaking and guiding initiatives to tackle drugs and, thus, giving such initiatives added value when, in their respective areas of competence, they take measures or decide on action to address the drugs phenomenon. The establishment and functioning of the EMCDDA has manifestly improved the availability of information on drugs and drug addiction, and their consequences, across the Union and internationally.

(3) While its general objective is still valid and should be retained, Regulation (EC) No 1920/2006 no longer provides an adequate framework for addressing current and future drug challenges. Therefore, the mandate of the EMCDDA should be revised in order, amongst other things, to replace and strengthen it. The EMCDDA should be renamed the European Union Drugs Agency (EUDA) (the ‘Agency’). Since substantial amendments to Regulation (EC) No 1920/2006 are needed to accommodate the common approach on Union decentralised agencies adopted on 19 July 2012 by the European Parliament, the Council and the Commission and to take account of the developments of the drugs phenomenon, in the interest of clarity and efficiency, that Regulation should be repealed and replaced by this Regulation.

(4) The main focus of Regulation (EC) No 1920/2006 was on health-related issues. While it is essential to maintain that focus, as health- and supply-related issues regarding the drugs phenomenon are intrinsically linked, it is also necessary to address drug supply in order to reduce the availability of drugs in the Union and curb drug demand and, thus, to contribute to addressing related safety and security concerns. In order to provide factual, objective, reliable, comparable and Union-wide significant data and analysis, the Agency should address the drugs phenomenon, taking an evidence-based, integrated, balanced and multidisciplinary approach to drugs, drug use, drug use disorders and addictions, prevention, treatment, care, risk and harm reduction, rehabilitation, social reintegration and recovery, drug markets and supply, including illicit production and trafficking, and other relevant drug-related issues and their consequences. The Agency’s approach should incorporate human rights, gender and gender equality, age, health, health equity and social perspectives.

(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 particular, the Agency should consider all aspects related to the protection and improvement of health, including physical and mental aspects, and the potential impact on public health. The Agency should also look into social aspects, including considerations linked to stigmatisation, marginalisation and the reintegration of people who use drugs. In doing so, the Agency should be guided by Union drug-related strategic documents.

(6) In pursuing its activities, the Agency should cooperate with other relevant Union bodies, offices and agencies within their respective mandates and should take account of their activities in order to avoid duplication. In particular, with due regard for their respective mandates, the Agency should cooperate with the European Union Agency for Law Enforcement Cooperation (Europol), established by Regulation (EU) 2016/794 of the European Parliament and of the Council (5), in order to ensure the collection of data, and the monitoring of trends, on drug supply, including illicit production and trafficking and other related crimes, on the use of new technologies and on new psychoactive substances. The Agency should also cooperate at international level with relevant authorities and bodies in third countries, in particular in candidate countries, and in support of Union and Member State action at the level of the United Nations. It is necessary that such cooperation comply with human rights norms.

(7) In order to attain maximum efficiency in addressing the drugs phenomenon, the Agency should have exchanges with relevant stakeholders and, in particular, with the scientific community, including academia, and civil society organisations, including organisations of people who use drugs and of communities affected by the consumption and sale of drugs or drug-related crime. Given the particular relevance of the experience of civil society organisations in the Agency’s area of competence, the Agency should maintain cooperation on its activities with civil society organisations, such as those active in the relevant Commission expert groups on drugs composed of civil society organisations. The Agency should dedicate the necessary means to consult, exchange information and pool knowledge with those organisations, including in the area of new psychoactive substances. Where appropriate, the Agency should organise dedicated consultations on the topics within its mandate.

(8) With a view to disseminating reliable information on drugs and the drug situation, the Agency should engage in communication activities on topics within its mandate. However, communication to the wider public in the area of drugs can sometimes have unintended negative consequences. As part of its communication activities and where appropriate, the Agency should, therefore, consider disseminating its reports, including initial reports and risk assessment reports on new psychoactive substances, to the scientific community and civil society organisations with a view to minimising possible drug-related harm. Where the Agency is prevented from disseminating its reports, in particular due to the presence of classified or sensitive non-classified information, it could consider publishing summaries of those reports with a view to minimising possible drug-related harm.

(9) In its work, the Agency should pay due regard to poly-substance use because such use is becoming increasingly common.

(10) The Agency should develop its activities around three main areas of competence, namely monitoring, leading to better informed policies; preparedness, leading to better informed actions; and competence development, leading to stronger Union and Member State responses to the drugs phenomenon.

(11) The collection, analysis and dissemination of data should continue to be the main task of the Agency. When collecting, analysing or disseminating data, the Agency should comply with the legal framework on the processing of personal data and should not disseminate or transmit any data which would make it possible to identify individuals or small groups of individuals. Standard data are collected through national focal points, which should remain the primary data providers for the Agency. The Agency could also use additional sources and organise meetings of experts, including virtual meetings. In addition, closer to real-time data sources are increasingly available through innovative data collection methods. Therefore, the Agency should have access to relevant available data to obtain a holistic picture of the drugs phenomenon in the Union and the external factors influencing it. With a view to ensuring that each national focal point remain informed of the situation in its Member State, it should be informed on a regular basis of data concerning its Member State that are collected from additional sources of information and of the activities of the network of forensic and toxicological laboratories set up by this Regulation.

(12) The national focal points are key players in the Union’s drug monitoring and reporting system. They collect information and produce comparable and scientifically sound data on the national drug situation, which feed into monitoring the situation across the Union. The national focal points are also key in the process of improving data collection methodologies and tools and of developing relevant guidelines for their implementation. In addition, the national focal points participate in an early warning system and report on new trends in the use of existing psychoactive substances. It is therefore essential that the Agency and the national focal points have a mutually reinforcing relationship. The data requirements of the Agency should be mirrored in the national focal points. The national focal points should be empowered within the Member States to receive all relevant data from the different national authorities. While avoiding any harmonisation measures and leaving the decisions as to the governance, structure or basic tasks of the national focal points in respect of other national competent authorities to the Member States, in line with the Treaties, the mandate of the Agency should enable a streamlining of data collection in the Member States as far as possible so as to avoid double reporting and duplication of efforts.

(13) It is necessary to establish the foundations of a relationship of mutual trust and continuous dialogue between the Agency and the national focal points, based on a clear and effective functioning mechanism and a set of rules. The Agency should therefore be empowered to financially support the national focal points and contribute to their effective functioning, including by providing an assessment of each national focal point relating directly to its contribution to coordinated Union action in the field of drugs.

(14) With the aim of supporting effective Union action in the field of drugs and contributing to the work of the Agency, the national focal points should, inter alia, assume a coordinating role in activities related to ensuring coherent drug-related data collection and monitoring, communication with the Agency and promotion of evidence-based decision making, ensuring a cross-sectoral and comprehensive national view of the drug situation, including any relevant information on new trends and challenges, and contributing to the establishment of relevant indicators. In addition, and in line with national competence, the national focal points have a key role in promoting and supporting evidence-based decision-making, supporting systems of collaboration, assessing the information needs of relevant stakeholders and compiling an up-to-date inventory of national drug information sources.

(15) In order to facilitate and structure data collection and 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 develop and apply the appropriate digital solutions necessary for the performance of its tasks.

(16) In order to enable the Agency to make better use of the information available to it, for example to take 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 as compared to that of the EMCDDA.

(17) In order to improve the Union’s preparedness, it is necessary to have a holistic picture of potential future developments of the drugs phenomenon. To prepare itself and to better equip policymakers for such future developments, the Agency should conduct regular foresight exercises taking into account megatrends, that is to say long-term driving forces that are currently observable and will most likely have a significant influence on the future, with the aim of identifying new challenges and opportunities for responding to drug problems.

(18) The drugs phenomenon is becoming increasingly technology-enabled, as was shown during the COVID-19 pandemic where a greater adoption of new technologies to facilitate drug distribution was observed. It is estimated that about two-thirds of the offers on darknet markets are drug-related. Drug trading uses different platforms, including social media networks and mobile applications. That development is mirrored in responses to the drugs phenomenon, with an increased use of internet communications and online interventions, including mobile applications and e-health interventions. The Agency, together with other relevant Union bodies, offices and agencies and while avoiding duplication of efforts, should monitor such developments as part of its holistic approach to the drugs phenomenon.

(19) New psychoactive substances which pose public health and social risks across the Union should be adequately addressed. It is therefore necessary to monitor new psychoactive substances and, in order to enable a quick response, to maintain the early warning system set up under Regulation (EC) No 1920/2006. The provisions of that Regulation relating to the exchange of information on, and the early warning system for, new psychoactive substances, including initial reports and risk assessments on new psychoactive substances, were amended recently and should remain unchanged in this Regulation.

(20) Based on strengthened monitoring by the Agency and the experience gained in the risk assessment of new psychoactive substances, the Agency should develop general health and security threat assessment capabilities. Greater capacity to proactively and rapidly identify new threats and inform the development of counter-measures is urgently needed as the current dynamic nature of the drugs phenomenon means that related challenges can rapidly spread across borders.

(21) As dangerous substances and certain consumption patterns might lead to harm for health, the Agency should be able to issue alerts complementing and without prejudice to the relevant national alert systems. To support that function, the Agency should develop a European drug alert system which is accessible by national authorities. That system should facilitate the rapid exchange of information that might require rapid actions to safeguard health, social aspects, safety and security. The Agency should, under the conditions laid down in this Regulation, be able to develop an alert system to make information on identified risks available to people who use or potentially use specific drugs.

(22) 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 diversion and trafficking of drug precursors from legal channels to illegal drug production should be strengthened. To support that effort, the Agency should have a role in monitoring the diversion and trafficking of drug precursors and in assisting the Commission in the implementation of Union law on drug precursors.

(23) As there is a growing need for forensic and toxicological data and specialist expertise, matched by a need for better coordination between laboratories in the Member States, a network of forensic and toxicological laboratories knowledgeable in the area of drugs and drug-related harm should be set up. That network should enable the Agency to have access to relevant information, increase the Agency’s capacities in that area and support knowledge exchange between the relevant laboratories in the Member States, without the Agency incurring the high costs of creating and running its own laboratory.

(24) The network of forensic and toxicological laboratories should be representative of the Member States in that each of them should be allowed to appoint up to three 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, support the sharing of information between relevant laboratories and decrease the costs for individual laboratories.

(25) To further knowledge in the area covered by the mandate of the Agency and support Member States, the Agency should identify and finance relevant projects, such as the development of reference standards on new drugs, the elaboration of toxicological or pharmacological studies, the implementation of innovative approaches to research, and drug profiling. The projects that the Agency finances should be included in the Agency’s consolidated annual activity report and be made public.

(26) The Agency will be in a position to access data and gain necessary scientific experience to develop and promote evidence-based interventions and best practices, to raise awareness about the adverse effects of drugs, prevention, risk and harm reduction measures, treatment, care, rehabilitation and recovery, and, where relevant, to take a gender-sensitive approach and to take into account the age dimension. The Agency should promote the implementation and updating of existing quality standards for drug prevention (European Drug Prevention Quality Standards) and 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), including how to reach high-risk populations.

(27) Given its Union-wide perspective, the Agency should be able to assess national measures and training, for example on prevention, including gender-sensitive and age-appropriate prevention, treatment, harm reduction, recovery and other related measures, in order to determine whether they reflect the latest scientific state of play and whether they have proven effective. A positive assessment of national measures could serve as a quality label.

(28) Considering that the Agency will be in a unique position at Union level that allows it to compare data and best practices, the Agency should be able to offer support, including, where so required by Member States, assisting with the evaluation and drafting of national drug strategies in a more structured way across Member States. 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 will develop in those areas.

(29) International cooperation should be part of the core tasks of the Agency with responsibilities established in clear terms in order to allow it to fully engage in such activities and respond to requests from international organisations and other bodies and from third countries. The Agency should be able to offer adequate scientific and evidence-based tools for the development and implementation of the external dimension of the Union’s drugs policy and for the important role of the Union at multilateral level, in accordance with the Treaties, as a means to ensure the efficient and coherent implementation of the Union’s drugs policy internally and at international level. Work in that area should be based on an international cooperation framework developed by the Agency. The international cooperation framework should be in accordance with the Treaties and the Union priorities on international cooperation and guided by the relevant United Nations instruments. The Agency should revise the international cooperation framework on a regular basis in order to ensure that it adequately reflects international developments and priorities.

(30) In order to help Union funding for security and health research to develop its full potential and address what is required by a drugs policy, the Agency should assist the Commission in identifying key research themes and in 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 or in drawing up and implementing a Union framework programme, it should not receive funding from that programme and should take all necessary measures in order to avoid conflicts of interest. 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. Planned research and innovation activities should be set out in the single programming document containing the Agency’s multiannual and annual work programme.

(31) The Commission and the Member States should be represented on the Management Board of the Agency to effectively supervise its work. The members and the alternate members of the Management Board should be appointed taking into account their relevant managerial, administrative and budgetary skills. Alternate members should act as members in the absence of the relevant members. Alternate members may also attend meetings in the presence of the relevant members without their presence entailing additional costs for the Agency and without taking part in the votes.

(32) The Management Board should be given the necessary powers, in particular to adopt the budget, the appropriate financial rules and planning documents, and the consolidated annual activity report. In order to ensure the independent functioning and integrity of the Agency, the Management Board should also adopt rules for the prevention and management of conflicts of interest in respect of its members, the members of the Executive Board, the members of the Scientific Committee, the members of a European Information Network on Drugs and Drug Addiction (the ‘Reitox network’), seconded national experts and other staff not employed by the Agency. In so doing, it is important that the Agency give due consideration to the recommendations and guidelines on that matter, in particular those of the European Ombudsman and the Commission Guidelines on the prevention and management of conflicts of interest in EU decentralised agencies of 10 December 2013. The Management Board should exercise the appointing authority powers vis-à-vis the staff of the Agency, including the Executive Director.

(33) It is important that all parties represented on the Management Board endeavour to multiply perspectives and experiences represented in and contributing to its work, while ensuring the continuity of its work. All parties should aim to achieve gender-balanced representation on the Management Board.

(34) 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 assist the Management Board and the Executive Director with regard to relevant scientific matters.

(35) The Management Board should appoint the Executive Director following an open and transparent selection procedure organised and managed by the Commission. In line with the practice followed in the appointment of executive directors to the EMCDDA, the Commission should consider including a representative of the Management Board as an observer in the appointment procedure. The assessment by the Commission at the end of the initial five-year term of office of the Executive Director should include prior input from the Management Board on the performance of the Executive Director.

(36) It is important that the Agency be adequately resourced to carry out its tasks, objectives and responsibilities under this Regulation and be granted an autonomous budget reflecting its mission. 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 Court of Auditors should audit the Agency’s accounts.

(37) In order to further support Member States and other stakeholders in understanding and addressing the drugs phenomenon, the possibility for the Agency to deliver additional services, beyond its core tasks laid down in this Regulation, against the payment of fees should be introduced. The method by which fees levied by the Agency are calculated should be transparent. The fees levied by the Agency should cover the full cost of providing the activities related to the services delivered, including staff and operational costs. Where fees have been levied in a financial year, the Agency’s provisional accounts should be accompanied by a report on those fees. Such reports would also be subject to audit by the Court of Auditors. Fees should be set at a level that avoids a deficit or a significant accumulation of surplus and should be revised where that is not the case.

(38) The Executive Director should present the annual report of the Agency to the European Parliament and 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.

(39) Regulation (EC) No 1049/2001 of the European Parliament and of the Council (6) 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.

(40) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (7) 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) (8), to which the EMCDDA acceded, should apply to the Agency.

(41) The Agency processes data that require particular protection, in particular European Union Classified Information (EUCI) and sensitive non-classified information. The Agency should draw up rules on the confidentiality and processing of such information. The rules on the protection of EUCI should be consistent with Commission Decisions (EU, Euratom) 2015/443 (9) and (EU, Euratom) 2015/444 (10). In accordance with those legal acts, the Agency should refrain from publishing sensitive data. It should also refrain from disclosing the confidential business information of third parties.

(42) In order to control and ensure the performance of the Agency and to ensure that its mandate allows it to carry out the necessary activities required by developments in drug markets and policy, an external evaluation of the Agency’s work should be conducted on a regular basis and its mandate adapted accordingly, if needed.

(43) The Agency should cooperate closely, in full compliance with fundamental rights, with relevant international organisations and other governmental and non-governmental bodies, including relevant technical bodies, from inside and outside the Union in the implementation of its work programme, in accordance with the relevant Treaty provisions and Member State competences, in particular to avoid duplication of work and to ensure access to all data and tools needed for carrying out its mandate.

(44) The Agency should replace and succeed the EMCDDA. It should therefore be the legal successor of all EMCDDA’s contracts, including employment contracts, liabilities and properties. International agreements concluded by the EMCDDA before 2 July 2024 should remain in force.

(45) Since the objective 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 (TEU). 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 that objective,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

Objectives and tasks of the Agency

Article 1

Establishment of the Agency

Article 2

Legal status and seat

Article 3

Definitions

For the purposes of this Regulation, the following definitions apply:

(2) ‘new psychoactive substance’ means new psychoactive substance as defined in Article 1, point 4, of Framework Decision 2004/757/JHA;

(3) ‘poly-substance use’ means the use of one or more psychoactive substances or types of psychoactive substance, whether illicit or licit, in particular medicinal products, alcohol and tobacco, at the same time as the use of drugs or sequentially within a short period of time of the use of drugs;

(4) ‘drug precursor’ means a substance that is controlled and monitored in accordance with Regulation (EC) No 273/2004 of the European Parliament and of the Council (12) and with Council Regulation (EC) No 111/2005 (13);

(5) ‘participating country’ means a Member State or a third country which has concluded an agreement with the Union in accordance with Article 54 of this Regulation;

(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 1971 United Nations Convention on Psychotropic Substances and the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances

(8) ‘United Nations system’ means the control mechanism system established by the United Nations Drug Conventions.

Article 4

General task of the Agency

(a) provide the Union and the Member States with factual, objective, reliable and comparable information, early warning and risk assessment at Union level concerning drugs, drug use, drug use disorders and addictions, prevention, treatment, care, risk and harm reduction, rehabilitation, social reintegration, recovery, drug markets and supply, including illicit production and trafficking, and other relevant drug-related issues and their consequences; and

(b) recommend appropriate and concrete evidence-based actions on how to address, in an efficient and timely manner, the challenges relating to drugs, drug use, drug use disorders and addictions, prevention, treatment, care, risk and harm reduction, rehabilitation, social reintegration, recovery, drug markets and supply, including illicit production and trafficking, and other relevant drug-related issues and their consequences.

Article 5

Specific tasks

(a) organise meetings of experts;

(b) set up ad hoc working groups; and

(c) finance projects, as necessary.

Where the Agency organises meetings, sets up working groups or finances projects under the first subparagraph, it shall keep the Reitox network informed.

(a) other relevant Union bodies, offices and agencies, within the limits of their mandates, in particular Europol, the European Union Agency for Criminal Justice Cooperation (Eurojust), established by Regulation (EU) 2018/1727 of the European Parliament and of the Council (14), the European Union Agency for Fundamental Rights, established by Council Regulation (EC) No 168/2007 (15), the European Union Agency for Law Enforcement Training (CEPOL), established by Regulation (EU) 2015/2219 of the European Parliament and of the Council (16), the European Medicines Agency, established by Regulation (EC) No 726/2004 of the European Parliament and of the Council (17), the European Centre for Disease Prevention and Control, established by Regulation (EC) No 851/2004 of the European Parliament and of the Council (18), and the European Foundation for the Improvement of Living and Working Conditions (Eurofound), established by Regulation (EU) 2019/127 of the European Parliament and of the Council (19);

(b) other international bodies, offices and agencies, in particular the United Nations Office on Drugs and Crime (UNODC), the United Nations Economic and Social Council and the International Narcotics Control Board (INCB); and

(c) the scientific community and civil society organisations.

CHAPTER II

Monitoring

Article 6

Collection and dissemination of information and data

(a) collect relevant information and data, including information and data which have been communicated by the national focal points, which result from research, which are available from open sources, and which emanate from Union sources, non-governmental sources and competent international organisations and bodies;

(b) collect information and data needed in order to monitor poly-substance use and its consequences pursuant to Article 7(1), point (d);

(c) collect the information and data available from national focal points, in cooperation with Europol, on new psychoactive substances and communicate that information without undue delay to the national focal points, the Europol national units and the Commission;

(d) collect and analyse information and data on drug precursors and on the diversion and trafficking of drug precursors;

(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, in cooperation with the national focal points, indicators and non-binding common standards with a view to ensuring greater uniformity of the measurement methods used by the Member States and the Union; the Agency may recommend compliance with such non-binding common standards;

(g) cooperate closely with relevant Union bodies, offices and agencies and international organisations and bodies, in particular the UNODC and the INCB, in order to facilitate notifications and avoid unnecessary burdens on Member States.

(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 analyses, conclusions and reports, including to the scientific community, civil society organisations and affected communities, including people who use drugs, with the exception of classified and sensitive non-classified information as referred to in Article 49;

(c) publishing, on the basis of data which it collects, a regular report on the state of the drugs phenomenon and emerging trends;

(d) setting up and making available open scientific documentation resources;

(e) providing information on quality standards, evidence-based best practices, innovative approaches and implementable research results in the Member States and facilitating the exchange of information on, and the implementation of, such standards and practices.

Article 7

Monitoring of the drugs phenomenon and sharing of best practices

(a) the drugs phenomenon in the Union in a holistic manner, using epidemiological and other indicators, covering the health, human rights, social, safety and security aspects thereof, including the implementation of the applicable Union drug-related strategic documents;

(b) evidence-based best practices and innovative approaches regarding health, human rights, social, safety or security responses;

(c) drug use, drug use disorders, drug addictions and related health risks, drug-related harm, risk behaviours associated with drug use and emerging trends in those fields;

(d) poly-substance use and its consequences, in particular the increased risks of health and social problems, the social determinants of drug use, drug use disorders and addictions, and the implications for policies and responses;

(e) drug and poly-substance use and its consequences from an age and gender perspective, in particular its impact on gender-based violence;

(f) emerging trends in the drugs phenomenon in the Union and internationally in so far as they impact the Union; monitoring under this point shall include the monitoring of drug supply, including illicit production, trafficking and other related crimes and the use of new technologies, without prejudice to the mandates of other Union bodies, offices and agencies;

(g) 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;

(h) drug precursors and the diversion and trafficking of drug precursors;

(i) the implementation of Union and national drugs policies, including with a view to supporting the development and independent evaluation of such policies.

CHAPTER III

Preparedness

Article 8

The exchange of information on, and the early warning system for, new psychoactive substances

The Agency shall draw up initial reports or combined initial reports pursuant to Article 9 based on the information collected pursuant to the first subparagraph.

Article 9

Initial report

For the purposes of the first subparagraph, Member States shall inform the Commission and the other Member States of their wish that an initial report be drawn up. Where a majority of Member States has so informed the Commission, the Commission shall instruct the Agency accordingly and shall inform the Member States thereof.

(a) a preliminary indication of the nature, number and scale of incidents showing health and social problems in which the new psychoactive substance might 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 to manufacture or extract it;

(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, and its use for scientific research and development purposes;

(g) information on whether the new psychoactive substance is subject to any restrictive measures in any Member State;

(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.

(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 (20), Regulation (EC) No 726/2004 or Regulation (EU) 2019/6 of the European Parliament and of the Council (21);

(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 in accordance with Article 112(1), point (c), of Regulation (EU) 2019/6;

(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 (22).

Where information provided under the first subparagraph relates to marketing authorisations granted by Member States, the Member States concerned shall provide the European Medicines Agency with such information upon its request.

Article 10

Risk assessment procedure and report

(a) available information on the chemical and physical properties of the new psychoactive substance or substances and the methods and the precursors used to manufacture or extract it or them;

(b) available information on the pharmacological and toxicological properties of the new psychoactive substance or substances;

(c) an analysis of the health risks associated with the new psychoactive substance or substances, in particular with respect to its or their 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 or substances, in particular its or their impact on social functioning, public order and criminal activities, and of the involvement of criminal groups in the manufacture, distribution and distribution methods, and trafficking of the new psychoactive substance or substances;

(e) available information on the extent and patterns of use of the new psychoactive substance or substances and its or their availability and potential for diffusion within the Union;

(f) available information on the commercial and industrial use of the new psychoactive substance or substances, the extent of such use, as well as its or their use for scientific research and development purposes;

(g) other relevant information, where available.

Article 11

Exclusion from risk assessment

(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, Regulation (EC) No 726/2004 or Regulation (EU) 2019/6;

(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

Health and security threat assessment and preparedness

Article 13

European drug alert system

(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) health risks;

(g) social, safety and security risks;

(h) health measures implemented or intended to be taken at national level;

(i) measures other than health measures;

(j) any other information relevant to the serious risk to health in question.

Article 14

Drug precursors

Article 15

Network of forensic and toxicological laboratories

(a) generating data and exchanging information on new developments and trends;

(b) organising training to enhance the competence of forensic drug and toxicology experts;

(c) supporting the implementation of quality assurance schemes; and

(d) supporting the further harmonisation of data collection and analytical methods.

The national focal points shall be informed on a regular basis, at least once a year, about the activities of the network. The national focal points shall have access to the information and data generated by the network.

CHAPTER IV

Competence development

Article 16

Evidence-based interventions, best practices and awareness raising

Article 17

Assessment scheme for national measures

Article 18

Support to Member States

Article 19

Training

The Agency shall, within the scope of its mandate and in coordination with other Union bodies, offices and agencies:

(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

(a) develop an international cooperation framework, to be approved by the Management Board subject to the prior approval of 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(1);

(c) support the exchange and dissemination of Union best practices and implementable research results at international level;

(d) monitor developments of the international drugs phenomenon that might 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 all relevant data on drugs covered by this Regulation and collected in the Member States or emanating from the Union into international monitoring and drug-control programmes, particularly those established by the United Nations and its specialised agencies, without prejudice to Member States’ obligations with regard to the transmission of information under 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 substances to the UNODC and the World Health Organization;

(h) support third countries, in particular candidate countries, in developing their drug policies in accordance with the principles set out in the applicable Union drug-related strategic documents, including by providing support to the independent evaluation of their policies, and encourage those third countries to support the participation and involvement of civil society in the development, implementation and evaluation of drug policies.

Technical assistance shall focus, in particular, on setting up or consolidating national focal points, national data collection systems and national early warning systems and on the promotion of best practices in the fields of prevention, treatment, care, risk and harm reduction, rehabilitation, social reintegration and recovery, and subsequently assist in the creation and strengthening of structural links with the early warning system referred to in Article 8 and the Reitox network. The Agency may assess the national bodies of a third country where that third country so requests.

Article 21

Research and innovation

CHAPTER V

Organisation of the Agency

Article 22

Administrative and management structure

(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 30;

(d) a Scientific Committee, which shall exercise the functions set out in Article 31; and

(e) the Reitox network.

Article 23

Composition of the Management Board

(a) one representative from each Member State, with the right to vote;

(b) two representatives from the Commission, with the right to vote.

(a) two independent experts designated by the European Parliament, who are particularly knowledgeable in the field of drugs, 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.

Article 24

Functions of the Management Board

(a) provide the general orientation for the Agency’s activities;

(b) adopt the draft single programming document referred to in Article 36 before its submission to the Commission for its opinion;

(c) having obtained the opinion of the Commission, adopt the Agency’s single programming document by a majority of two-thirds of members with the right to vote;

(d) adopt, by a majority of two-thirds of members with the right to vote, the annual budget of the Agency and exercise other functions in respect of the Agency’s budget in accordance with Chapter VI;

(e) assess and adopt, by a majority of two-thirds of members with the right to vote, the consolidated annual activity report on the Agency’s activities, send both the report and its assessment thereof by 1 July each year to the European Parliament, the Council, the Commission and the Court of Auditors, and ensure that the consolidated annual activity is made public;

(f) adopt the financial rules applicable to the Agency in accordance with Article 42;

(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 bodies, offices and agencies;

(i) adopt rules for the prevention and management of conflicts of interest in respect of its members, the members of the Executive Board, the members of the Scientific Committee and the members of the Reitox network, and of seconded national experts and other staff not employed by the Agency as referred to in Article 44, and shall publish annually on the Agency’s website the declarations of interests of the Management Board members;

(j) approve the standard operating protocol referred to in Article 17(3);

(k) approve the international cooperation framework referred to in Article 20(1), point (a), and the technical assistance programmes referred to in Article 20(3);

(l) approve the level of co-financing referred to in Article 33(5);

(m) adopt and regularly update the communication strategies and dissemination plans referred to in Article 5(8), based on an analysis of needs;

(n) adopt and make publicly available its rules of procedure, including rules for the prevention and management of conflicts of interest;

(o) in accordance with paragraph 2 of this Article, exercise, with respect to the staff of the Agency, the powers conferred by the Staff Regulations of Officials of the European Union (the ‘Staff Regulations’) on the appointing authority and by the Conditions of Employment of Other Servants of the European Union (the ‘Conditions of Employment of Other Servants’) on the authority empowered to conclude a contract of employment, laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (27), (the ‘appointing authority powers’);

(p) in agreement with the Commission, adopt implementing rules for giving effect to the Staff Regulations and the Conditions of Employment of Other Servants in accordance with Article 110(2) of the Staff Regulations;

(q) appoint the Executive Director and, where relevant, decide on an extension of the term of office or on a removal from office in accordance with Article 29;

(r) appoint an accounting officer, subject to the Staff Regulations and the Conditions of Employment of Other Servants, who shall be independent in the performance of her or his duties;

(s) appoint the members of the Scientific Committee;

(t) approve the list of experts to be used to extend the Scientific Committee in accordance with Article 31(6);

(u) take decisions following the assessment of the national focal points in accordance with Article 35;

(v) set the method for calculating fees and the way fees are paid in accordance with Article 38;

(w) ensure adequate follow up to findings and recommendations stemming from internal or external audit reports and evaluations and from investigations of the European Anti-fraud Office (OLAF), established by Commission Decision 1999/352/EC, ECSC, Euratom (28), and of the European Public Prosecutor’s Office (EPPO), established by Council Regulation (EU) 2017/1939 (29), as referred to in Article 48 of this Regulation;

(x) take all decisions on the establishment and, where necessary, modification of the Agency’s internal structures, taking into consideration the Agency’s activity needs and having regard to sound budgetary management;

(y) adopt working arrangements in accordance with Article 53.

Where exceptional circumstances so require, the Management Board may, by way of a decision, temporarily suspend the delegation of the appointing authority powers to the Executive Director and those sub-delegated by the Executive Director and exercise them itself or delegate them to one of its members or to a staff member other than the Executive Director.

Article 25

Chairperson of the Management Board