Considerations on COM(2022)18 - EU Drugs Agency - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2022)18 - EU Drugs Agency. |
|---|---|
| document | COM(2022)18  |
| date | June 27, 2023 |
(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 48 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 49 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 50 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) 51 , 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.