Explanatory Memorandum to 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. |
---|---|
source | COM(2022)18 |
date | 12-01-2022 |
1. CONTEXT OF THE PROPOSAL
• Reasons for and objectives of the proposal
Illicit drugs are a complex security and health problem that affects millions of people in the EU and globally. The European Drug Report 2021 1 points out that 83 million adults in the EU are estimated to have tried illicit drugs during their lives. In 2019, at least 5,150 overdose deaths occurred in the EU, with a steady increase every year since 2012, including among teenagers aged 15-19. The report also shows a deteriorating situation concerning the volumes of cocaine and heroin introduced in the EU, which is at an all-time high. Production of drugs, in particular synthetic drugs (amphetamines and ecstasy), takes place within the EU both for domestic consumption and for export 2 . The drug market is estimated at a minimum retail value of EUR 30 billion per year 3 , and it remains the largest criminal market in the EU and a major source of income for organised crime groups 4 .
Cannabis is the most commonly used drug. The use of heroin and other opioids continues to be most commonly associated with the more harmful forms of drug use. Crack cocaine is increasingly available; different illicit drugs are also becoming available in smaller doses or cheaper packages, considered more suited for home use. A rise in use of benzodiazepines 5 is also observed among high-risk drug users, prisoners and some groups of recreational drug users, potentially reflecting the high availability and low cost of these substances as well as pandemic-related mental health issues. Among people who use drugs, poly-substance use 6 is widespread having a detrimental impact on public health. Furthermore, increased availability of other drugs, particularly cocaine and some synthetic substances, is associated with increased levels of drug related violence and other crimes 7 .
According to the latest studies 8 , drug markets have been remarkably resilient to disruption caused by the pandemic. Not only were drugs production and trafficking largely unaffected but the pandemic also brought increased risks for marginalised populations. During the initial lockdowns related to the COVID-19 pandemic, some changes in routes and methods at wholesale level, as well as disruptions and some local shortages have been observed. Nevertheless, drug sellers and buyers have adapted to the new situation quickly, notably by increasing the use of encrypted messaging services, social media applications, online sources as well as mail and home delivery services. The reduction in drug consumption seen during the initial lockdowns disappeared with the easing of restrictions on movement. As a result, by mid-2021, the levels of use of most drugs bounced back to pre-COVID levels or possibly even higher. Moreover, no decline in supply was noted. On the contrary, multi-tonne seizures of cocaine were reported in European ports in 2020 and early 2021, while cannabis cultivation and synthetic drug production within the European Union continued at pre-pandemic levels during 2020, with increasing numbers of cases involving cannabis adulterated with synthetic cannabinoids. While drugs services across Europe, including low-threshold services, drug consumption rooms, and residential and outpatient treatment services, returned to operation, they continue to be limited by strict COVID-19 measures in place and operate at reduced capacity.
These developments call for effective action at Union level. The EU Drugs Strategy 2021-2025 9 and the EU Drugs Action Plan 2021-2025 10 provide the strategic framework for this. The Strategy inter alia invites the Commission “to present a proposal to revise the mandate of the EMCDDA [European Monitoring Centre for Drugs and Drug Addiction 11 ] as soon as possible, to ensure that the agency plays a stronger part in addressing the current and future challenges of the drug phenomenon” 12 . The current proposal delivers on this commitment.
In 2018/19, the Commission carried out the fourth evaluation of the Centre in line with the requirements of Regulation (EC) No 1920/2006 13 . It concluded that the Centre works overall well, but further improvements are possible in several areas, in particular in view of the developments of the drug phenomenon.
This finding has been further substantiated during regular contacts with the Centre and its stakeholders, which underlined an increasing disconnect between the complexity and rapid developments of the drug phenomenon and what the Centre’s mandate provides for. Regulation (EC) No 1920/2006 does not reflect the current reality of the drug phenomenon and is out of step with the tasks the Centre needs to perform to address the current and future challenges of the drug phenomenon.
Therefore, this proposal provides for a targeted revision of the mandate of the European Monitoring Centre for Drugs and Drug Addiction, and seeks to strengthen its mandate in order to ensure that the future Agency can react effectively to new challenges, provide better support to Member States, and contribute to developments at the international level. Notably, the proposal aims to expressly cover poly-substance, i.e. other substance-based addictions when these substances are taken together with illicit drugs; to strengthen monitoring and threat assessment capabilities; to establish a laboratory to ensure that all forensic and toxicological information is available to the Agency; to reinforce the position of national focal points to ensure that they are able to provide relevant data; to establish the competence of the Agency to develop EU-level prevention and awareness raising campaigns as well as issue alerts in case particularly dangerous substances are available on the market. Finally, the proposal clarifies the role of the Agency in the international arena 14 . At the same time, the proposal will also adapt the institutional framework of the Agency to the common approach of the European Parliament, the Council of the EU and the European Commission on decentralised EU agencies 15 .
• Consistency with existing policy provisions in the policy area
This legislative proposal takes account of a wide range of EU policies in the area of internal security and public health.
When it comes to drugs policies, this legislative proposal takes account of the EU Drugs Strategy 2021-2025 and the related Action Plan. It also takes account of the amendment of Regulation (EC) No 1920/2006 16 as well as several acts to add substances to the definition of drugs under Council Framework Decision 2004/757/JHA 17 .
This legislative proposal also takes account of cooperation of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) with other Union bodies, in particular the European Union Agency for Law Enforcement Cooperation (Europol) 18 , the European Union Agency for Criminal Justice Cooperation (Eurojust) 19 , the European Union Agency for Law Enforcement Training (CEPOL), the European Medicines Agency (EMA) 20 , and the European Centre for Disease Prevention and Control (ECDC) 21 , but also other EU decentralised agencies and bodies.
• Consistency with other Union policies
This legislative proposal takes account of other relevant Union policies that have been adopted or launched since the entry into force of Regulation (EC) No 1920/2006 on the European Monitoring Centre for Drugs and Drug Addiction (recast).
As regards innovation, this legislative proposal takes account of EU funding for drugs policy under Horizon 2020 22 , the Internal Security Fund 23 , the Drugs Policy Initiatives under the Justice Programme 24 , the EU4Health Programme 25 , and Horizon Europe 26 .
As regards public health, this legislative proposal takes account of the establishment of an early warning and response system in relation to serious cross-border threats to health 27 28 and the proposals for the changes in the mandates of some of the above-mentioned agencies 29 . When considering cooperation with Union agencies and bodies, the proposal also considered the establishment of the European Health Emergency Preparedness and Response Authority (HERA) 30 .
As regards the Agency’s cooperation with third countries, this legislative proposal takes account of the Union’s external policies.
2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
• Legal basis
Regulation (EC) No 1920/2006 of the Agency was based on Article 152 of the Treaty establishing the European Community, i.e. on the public health legal basis. This provision corresponds to Article 168 of the Treaty on the Functioning of the European Union (TFEU).
Article 168(1), third subparagraph, TFUE reads: “The Union shall complement the Member States' action in reducing drugs-related health damage, including information and prevention”. Article 168(5) TFUE provides that the European Parliament and the Council may adopt “measures concerning monitoring, early warning of and combating serious cross-border threats to health”.
Addressing supply and drug market related issues supports reducing the availability of drugs in the EU and curbing drug demand and ultimately public health. The health and security dimensions of the drug phenomenon are intrinsically linked and cannot be addressed separately. Therefore, the content of this legislative proposal is covered by the public health legal basis and does not go beyond what is possible under that legal basis.
• Subsidiarity (for non-exclusive competence)
EU action to revise the mandate of the Agency is necessary.
The drug phenomenon affects all Europeans and is cross-border and multi-jurisdictional in nature, in particular when it comes to drug markets and organised crime. There are many common challenges across Member States, both on the health and security side, which need to be tackled. It is not possible to address the drug phenomenon only on a national or regional/sub-national level as drug trafficking is a transnational crime. Organised crime groups involved in drug trafficking exploit differences in regulatory and legal approaches across Member States. A problematic health or security pattern detected in a Member State very often appears in other Member States as well. National legislation or even the best national practice would not be able to address the cross-border aspects of the drug phenomenon. Due to this transnational character, there is thus a need for EU-level action.
This legislative proposal will lead to considerable EU added value. Adopting a targeted revision of the Agency’s mandate, thereby enabling it to address current and future challenges, is in the interest of the EU, in particular in view of the recent deterioration of the drug situation in the EU characterised by the widespread availability of a diverse range of drugs of increasingly high purity or potency, supported by the misuse of innovation and technological developments, and leading to more complex patterns of use and an increasing impact on public health and security. The revision of the mandate of the Agency is part of the reaction of the EU to these developments.
As the evaluation showed, the Agency has an important added value compared to addressing the drug phenomenon solely at national level. Many of the phenomena are by nature cross-border, and increasingly global, and therefore cannot be addressed by a Member State alone. However, the current mandate of the Agency is limiting its action, the support it can give to Member States, and the role it can play internationally. The fact that, for example, the Agency’s current mandate covers poly-substance use only to a limited extent, leads to a loss of the EU-level overview of the drug phenomenon, with data collected being fragmented or possibly non-existent. This would run contrary to the requirements of the EU’s evidence-based policy-making in drugs policy, which relies on a neutral body to provide factual and objective data. The targeted revision proposed in this legislative proposal strengthens the Agency in crucial areas to enable it to address these common issues better.
The revision of current mandate would also contribute to a reduction of the administrative burden for and a simplification of administrative procedures in the Member States. Among the contributing factors to this are the proposed streamlining and centralisation of reporting obligations in the Member States through the national focal points, monitoring drug markets and maintaining an early warning system and drug alert system, organisation of training, development of best practices, etc. This would lead to a reduction of administrative costs in the Member States. Another example is that better information would be available from the Agency for the benefit not only of the EU but also of the Member States. Member States on their own would not be able to collect and analyse data to the same extent as they lack either the knowledge or the resources, or the problem is a cross-border one. The latter element is also an argument for administrative simplification as no Member State could address those issues on their own and cooperating with numerous countries would lead to a high administrative burden.
• Proportionality
The proposal is proportionate as it is the only way for the necessary changes in the Agency’s mandate to come about.
EU-level action does not intend to replace national actions or authorities nor to question their relevance. The drug phenomenon can only be addressed if all levels – EU, national and local – work together. The current proposal will not go beyond what is proportionate to tackle an EU-wide phenomenon.
When it comes to the possible new rules and responsibilities of the national focal points, it will remain for the Member States to decide exactly how they want to set up a national focal point. However, in order to ensure that the national focal points are in a position to provide to the EU-level what is necessary and to access the funding available at EU level, they should comply with a set of minimum requirements. Moreover, as the provision of the core data from the Member States to the Agency through the national focal points is the basis for the overall drug monitoring system, it is proportionate to set such minimum requirements.
• Choice of the instrument
Given that Agency’s mandate is set out in Regulation (EC) No 1920/2006, the revision of its mandate has to take the form of a Regulation as well.
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
• Stakeholder consultations
The main stakeholder consultation for this proposal was undertaken as part of the evaluation of the Agency carried out in 2018/19. This process included an extensive stakeholder consultation, including a 12-weeks public consultation. The details of this stakeholder consultation are available in Annex III of the related Staff Working Document 31 . The Annex also includes a short summary of the outcomes of the public consultation. The synopsis report of the public consultation has been published as Annex 5 of the evaluation report 32 .
In addition, the views of specific stakeholders, such as the Member States, the national focal points or other agencies, were adequately addressed through meetings and/or particular information requests.
Several discussions in view of the revision of the mandate of the Agency have taken place since the study of the consultant has been done, including discussions in the Management Board of the EMCDDA in December 2018 and June 2019, presentation of the evaluation results to the Horizontal Drugs Group in July 2019, presentation to the heads of national focal points in their meeting in May 2019.
In 2019 and 2020, several formal and informal meetings took place. This included informal meetings with different staff members of the Agency, the head of the national focal points, the Civil Society Forum on Drugs, and representatives of Member States.
More formal meetings were also organised by the Commission services. A virtual meeting with the core group of the Civil Society Forum on Drugs took place on 1 July 2020. The proposed revision of the EMCDDA mandate was also discussed at the Plenary meeting of the Civil Society Forum on Drugs on 8 October 2020. A discussion on the aspects related to the national focal points took place at the technical meeting of the Reitox network on 7 October 2020 and at the Head of National Focal Points meeting on 26 November 2020. A virtual informal workshop was organised for the members of the EMCDDA Management Board on 26 October 2020, which discussed the policy option and the main ideas for the preferred option.
During these exchanges, the need to adapt the EMCDDA regulation to the current challenges relevant to drugs, such as poly-substance use, and to ensure appropriate funding to the Agency were underlined. Participants called for further development of the monitoring, data collection and the assessment capacities of the Agency, as well as of its competence to initiate information campaigns and risk communication, strengthening its relationship with Member States’ authorities, and in particular National Focal Points. The role of EMCDDA in relation with the international drug policy was also underlined and the need for proper forensic and toxicological laboratory capacity stressed as well.
• Collection of data and use of expertise
The Commission carried out an evaluation of the Agency with the support of a consultant in line with the requirements of Article 23 of Regulation (EC) No 1920/2006. The main outcomes of the evaluation were summarised in a Report from the Commission to the European Parliament and the Council 33 and an accompanying Staff Working Document 34 . The evaluation overall was positive as regards the five evaluation criteria (relevance, effectiveness, efficiency, coherence, EU added value), but also noted that improvements are possible in several areas. For example, the availability of more forward-looking products, the relationship with the scientific community and general practitioners, and general public awareness measures could be improved. The evaluation underlined as well the need to improve the provision of data, to address poly-substance use and to support to Member States in evaluating their national drug policies. The cooperation with third countries and international organisations could be further strengthened. The evaluation was inconclusive on the potential future broadening of the scope of the Agency to other licit and illicit substance and addictive behaviours 35 .
The Agency provided expert input to the impact assessment and the legislative proposal in the course of its drafting, including estimates of the cost impacts of the different policy options.
• Impact assessment
In line with its “Better Regulation” policy, the Commission conducted an impact assessment.
A number of legislative and non-legislative policy options have been considered. Some policy options 36 were discarded at an early stage and were not subject to deeper analysis and assessment. Two policy options have been assessed in detail: they both have similar objectives but lead to a different level of impact in terms of costs, benefits and administrative burden.
–Policy option 4: Targeted revision - Delivering more value in drugs policy
This option provides a thematic scope of action focussed on illicit drugs and targeted on deepening the evidence base on drug phenomena, while strengthening the Agency’s monitoring and threat assessment capabilities to increase its ability to act and react to new challenges, including internationally. National focal points would need to be empowered to act as more effective intermediaries translating and implementing key inputs from the Agency at the national level. Under this policy option, the Agency would also gain agility in terms of responding to the needs arising in the drugs policy field through various tailored services for Member States. This option would bring an important reduction of administrative burden as well as simplification of procedures for Member States. It would also be more suitable as regards the necessary financial and human resource reinforcement.
–Policy option 5: Expansive revision - Focusing on diverse addictions
This option provides a thematic scope of action expanded to cover addiction broadly, beyond drugs, and revamping the Agency’s monitoring system based on applicable methodologies and indicators covering diverse addictions. The extended thematic scope on addictions would affect the body of data that would need to be provided by national focal points to the Agency, as well as the Agency’s role as a hub for knowledge sharing. Finally, the involvement of the Agency in international cooperation would mainly be limited to the current drugs-related activities as other addictions do not have the same level of international and cross-border exposure. This option could result in possible overlaps with existing policies. It also raises questions over possible interference with national competencies and might be difficult from a subsidiarity perspective. It would also imply a serious increase of the financial and human resources necessary to the Agency to carry out its tasks.
Following a detailed assessment of the impact of the above mentioned policy options, the preferred option is policy option 4 leading to a targeted revision of the mandate. The main elements of this targeted revision are the following:
–The Agency’s scope of action would be expanded to address poly-substance use, i.e. other substance-based addictions when these substances are taken together with illicit drugs. The revision should thus clarify what poly-substance use includes and in which conditions the concept can be applied. This limited widening of the mandate would necessitate the reporting of relevant data by the national focal points.
–The Agency’s mandate would be expanded to explicitly address drug supply and drug market issues as this is an increasingly important dimension of the drug phenomenon and an EU Drugs Agency (EUDA) has to be able to fully address that dimension.
–The Agency’s monitoring and threat assessment capabilities would be strengthened and the Agency would provide further support to the Member States to increase the impact of the Agency on the drug phenomenon and its ability to react to new challenges.
–A virtual laboratory, i.e. a network of laboratories combined with a competence centre in the Agency, would be established to ensure that more forensic and toxicological information is available to the Agency.
–The national focal points would be empowered to provide the relevant data to the Agency. The new Regulation would set minimum requirements for their set-up, which are then certified by the Agency. The mandate of the national focal points has to reflect the revision of the Agency mandate.
–The Agency would get the competence to act on its analysis and develop EU-level prevention and awareness raising campaigns as well as issue alerts in case particularly dangerous substances are available on the market.
–These elements would be complemented by strengthened cooperation with Member States, Union decentralised agencies and bodies, which is crucial, although would not deliver on its own on the objectives of this initiative.
–As regards the international dimension, the tasks of the Agency would be clarified to include in the mandate itself the relevant competencies.
This policy option is fully reflected in this legislative proposal. It would give the Agency the tools and capabilities to address all dimensions of the modern day drugs phenomenon.
In addition to revising the mandate of the Agency in substance, the legislative proposal will also adapt it to the common approach on decentralised EU agencies 37 . This has not been done yet as no substantive revision of Regulation (EC) No 1920/2006 has been undertaken since the agreement on the common approach in 2012. The adaptation to the common approach necessitates that many provisions regarding the institutional and governance rules of the Agency are expanded, even if the main content of these provisions remains the same. Adopting these new rules will bring the Agency’s governance in line with the latest set of legislation on issues related to financial rules, data protection, combatting fraud and similar. It will also align the governance rules of the Agency to the ones of other EU decentralised agencies.
The main impacts of the current proposal are on the Commission and the Agency itself, and on national authorities. Linked to this, there would be possible impacts on simplification and/or administrative burden as demonstrated above 38 . The main economic impacts are on the EU budget, as regards the necessary increase of the EU contribution to the budget of the Agency, and to a much more limited extent on national budgets. Impacts on other stakeholders, in particular citizens/individuals and businesses, are limited and largely indirect through the better ability to tackle the drugs phenomenon in the EU.
• Fundamental rights
The revision as such does not have any direct impacts on fundamental rights. The data collected by and for the Agency are statistical data, but do not include any personal data; therefore, Article 8 of the Charter of Fundamental Rights (“protection of personal data”) is not affected. Other fundamental rights are not impacted either by the proposal.
It should be added, however, that the analysis of the Agency addresses important issues with possible implications for fundamental rights 39 , even if the Agency does not decide on or manage itself such measures. In that sense, improving the functioning of the Agency could have positive indirect impacts on fundamental rights.
4. BUDGETARY IMPLICATIONS
This legislative proposal would have an impact on the budget and staff needs of the Agency as currently provided for in the Multiannual Financial Framework (MFF) and which are insufficient for the tasks the Agency should carry out to better address the drug phenomenon, including as regards drug markets and drug supply. It is estimated that an additional budget of around EUR 63 million and around 40 additional posts would be needed for the remainder of the period of the Multiannual Financial Framework (MFF) to ensure that the Agency has the necessary resources to enforce its revised mandate. The new tasks for the Agency proposed in this legislative proposal therefore require additional financial and human reinforcements compared to the resources earmarked in the adopted Multiannual Financial Framework 2021-2027, which provides for a 2% yearly increase of the EU contribution to the Agency. The budgetary impact of the additional financial resources for the EU Drugs Agency will be offset through a compensatory reduction from programmed spending under Heading 4 40 and should also stabilise the resource needs of the Agency over the period 2021-2027.
5. OTHER ELEMENTS
• Implementation plans and monitoring, evaluation and reporting arrangements
The monitoring and evaluation of the Agency’s mandate would largely be performed by the applicable mechanisms under this Regulation. Article 52 provides for an evaluation which assesses, in particular, the impact, effectiveness and efficiency of the Agency and of its working practices and may address the possible need to modify the structure, operation, field of action and tasks of the Agency, and the financial implications of any such modification. Further to this evaluation, the Commission will draw data through its representation in the Agency’s Management Board meetings and its supervision, along with the Member States, of the Agency’s work.
• Detailed explanation of the specific provisions of the proposal
Chapter I (Articles 1 to 5) includes the objectives and general tasks of the Agency. After setting out that the European Union Drugs Agency (EUDA) replaces the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) (Article 1) and defining the legal status and seat of the Agency (Article 2) as well as providing some definitions (Article 3), Article 4 defines the objective of the Agency, which remains the same as in Regulation (EC) No 1920/2006. Article 5 provides the overall tasks of the Agency around three main competence areas, which are detailed further in Chapters II to IV.
Chapter II (Articles 6 and 7) clarifies the monitoring tasks of the Agency. Article 6 defines what data the Agency has to collect and what actions they should undertake to have the most up-to-date information available for their analysis. It also defines the dissemination tasks of the Agency. Article 7 sets out the main monitoring tasks of the Agency.
Chapter III (Articles 8 to 15) defines the early warning and risk assessment tasks of the Agency. Articles 8 to 11 set out the rules on the information exchange on, the early warning system and the risk assessment procedure for new psychoactive substances. These provisions have not been changed compared to Articles 5a to 5d of Regulation (EC) No 1920/2006 (introduced through Regulation (EU) 2017/2101). The work undertaken by the Agency in this regard is the basis for the possible inclusion of a new psychoactive substance in the definition of ‘drug’ through a delegated directive under Council Framework Decision 2004/757/JHA. Article 12 sets out the possibility for the Agency to develop threat assessments on new developments of the drug phenomenon that have a potential to impact negatively public health, safety and security. These threat assessments will help increase the preparedness of the EU to react to new threats and support other tasks of the Agency. Article 13 builds on the information available from the EU Early Warning System, the threat assessments and other information from the Member States about the appearance of a serious direct or indirect drug-related risk. It provides for a European drug alert system, which facilitates the rapid exchange of information that may require rapid actions to be taken to safeguard public health, safety, or security. Article 14 establishes competencies of the Agency in the area of drug precursors. Finally, Article 15 sets up a network of forensic and toxicological laboratories (a “virtual laboratory”).
Chapter IV (Articles 16 to 21) defines the tasks to be addressed as part of competence development. Article 16 sets out the competencies of the Agency in relation to prevention. The Agency is already working in this area, e.g. through the development of a European Prevention Curriculum or through the Exchange prevention registry. This should be taken forward by enabling the Agency to develop cross-EU prevention programmes and campaigns, but also supporting Member States in preparing national campaigns. Article 17 provides for an accreditation and certification procedure for national programmes, in particular national prevention, treatment, harm reduction and other related programmes. Such an accreditation or certification would give the national authorities or professional bodies the certainty that their programmes are in line with the latest scientific state of play and have been proven useful. Article 18 empowers the Agency to provide support to the Member States, e.g. in the evaluation and development of their national strategies, but also in sharing innovative best practices or other relevant information. Article 19 enables the Agency to provide training within the scope of its mandate, being it as a core or a supporting task, the latter of which could be provided subject to separate fees, if so decided. Article 20 sets out the international cooperation and technical assistance activities of the Agency, which it should develop further. The provision also clarifies that international cooperation is part of the Agency’s core tasks. Article 21 provides a mandate to the Agency to be more active in the context of the EU research knowledge cycle. This should also include the Agency’s involvement in the EU Innovation Hub for Internal Security 41 .
Chapter V (Articles 22 to 34) sets out the rules on the organisation of the Agency. The rules are based on Regulation (EC) No 1920/2006. The changes introduced to the rules in this Chapter are due to the implementation of the common approach. The specificities of the Agency, such as the existence of a Scientific Committee or a network of national focal points, were kept, but have been adapted as appropriate.
Article 22 defines the structure of the Agency. Articles 23 to 27 set out the composition, functions and the working methods of the Management Board. They are developed based on Article 9 of Regulation (EC) No 1920/2006, the rules of procedure of the Management Board of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and the common approach. Article 28 sets out the rules for the Executive Board, which supports the Management Board and prepares its meetings. The basis for his provision is Article 10 of Regulation (EC) No 1920/2006, the rules of procedure of the EMCDDA Management Board and the common approach. Article 29 sets out the responsibilities of the Executive Director and is based on Article 11 of Regulation (EC) No 1920/2006 and the common approach. Article 30 sets out the rules for the Scientific Committee and is in line with Article 13 of Regulation (EC) No 1920/2006. Finally, Articles 31 to 34 set out the rules for the Reitox network of national focal points and the national focal points themselves. The national focal points need to be strengthened in line with the revision of the Agency mandate and therefore the rules on the national focal points were expanded to set out their roles and responsibilities in more detail. The national focal points need to be empowered to act as a central body in the Member States for all drug-related data and should also get an appropriate role on national level. In order to be able to fulfil their role appropriately, their set-up should comply with certain minimum requirements, the compliance with which should be certified by the Agency. Beyond those minimum requirements, it is for the Member States to decide how to set up the national focal points within their national legal system.
Chapter VI (Articles 35 to 41) includes the financial provisions. Article 35 sets out the rules on the Single Programming Document of the Agency, which includes the three-year planning as well as the work programme of the next year. This provision has been adapted to the latest financial regulations 42 . Changes in the financial provisions compared to Regulation (EC) No 1920/2006 are due to the implementation of the common approach and the currently applicable financial rules for EU decentralised agencies. The changes introduced as regards the budget procedures and the presentation of accounts and discharge are minor. The only new provision in this Chapter is Article 37, which would allow the Agency to charge fees for certain tasks, which are not part of the core tasks of the Agency. It will be up to the Agency to decide at a later stage, once this Regulation is applicable, whether it will use this option or not.
Chapter VII (Articles 42 to 44) includes the staff rules. Changes compared to Regulation (EC) No 1920/2006 are due to the implementation of the common approach and changes to the Staff Regulations and the Conditions of Employment of Other Servants (Articles 42 and 44) 43 . Article 43 includes the staff rules applicable to the Executive Director.
Chapter VIII (Articles 45 to 63) includes general and final provisions. Changes compared to Regulation (EC) No 1920/2006 are due to the implementation of the common approach and adaptations to more recent legislation. The majority of these provisions was already included in Regulation (EC) No 1920/2006. This Chapter also includes transitional provisions (Articles 58 to 61) to enable a proper transition from the European Monitoring Centre for Drugs and Drug Addiction to the European Union Drugs Agency.