BAKGRUNN (fra europaparlaments- og rådsforordningen)

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

(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of the developments of the drugs phenomenon, in the interest of clarity and efficiency, that Regulation should be repealed and replaced by this Regulation.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 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 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 and (EU, Euratom) 2015/444. 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,