Activities of Romeo FRANZ related to 2022/0009(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on the European Union Drugs Agency
Amendments (124)
Amendment 95 #
Proposal for a regulation
Recital 2
Recital 2
(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 an overall view and 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 creationwork of the European Monitoring Centre for Drugs and Drug Addiction has manifestly improved the availability of information on drugs and drug addiction, and their consequences, across Europe.
Amendment 97 #
Proposal for a regulation
Recital 3
Recital 3
(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 agencies48, to protect and promote public health, including health literacy, to implement the evidence- based, integrated, balanced and multidisciplinary approach to the drugs phenomenon, incorporating a gender equality and health equity perspective, enshrined in the EU Drugs Strategy 2021-2025, and to take account of the developments of the drug phenomenon, in the interest of clarity and efficiency that Regulation should be replaced by a new Regulation. _________________ 48 Joint Statement of the European Parliament, the Council of the EU and the European Commission on decentralised agencies of 19 July 2012, https://european- union.europa.eu/sites/default/files/docs/bod y/joint_statement_and_common_approach _2012_en.pdf.
Amendment 100 #
Proposal for a regulation
Recital 4
Recital 4
(4) The main focus of Regulation (EC) No 1920/2006 was on health-related issues, which should continue to be the main focus and a priority for the Agency. However, addressing also drug markets and drug supply, issues, is also 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 regarding the drug phenomenon are intrinsically linked. The Agency should therefore address the drug phenomenon more holistically, by applying a multidisciplinary approach incorporating a human rights, gender equality, public and human health, health equity, sustainable development and social perspective in relation to drugs, drug use, drug use disorders and addictions, prevention, treatment, care, risk and harm reduction, rehabilitation, social reintegration and recovery, drug supply, including illicit production and trafficking, and other relevant drug- related issues and their consequences, including the potential unintended negative consequences associated with the implementation of policies and actions.
Amendment 104 #
Proposal for a regulation
Recital 5
Recital 5
(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 areas of drugs and the protection and improvement of public and human health. It should cover the various facets of the drugs phenomenon and the solutions applied. In doing so, the Agency should be guided by the evidence- based, integrated, balanced and multidisciplinary approach to the drugs phenomenon, which should include a gender equality and health equity perspective, as enshrined in relevant strategies and action plans adopted by the Union, in particular the applicable EU Drugs Strategy and Action Plan.
Amendment 106 #
Proposal for a regulation
Recital 6
Recital 6
(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)relevant Union bodies, offices and agencies, within their mandates and in full compliance with fundamental rights and data protection rules, 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. Cooperation should comply with the international human rights obligations of the Union.
Amendment 109 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6 a) In order to attain maximum efficiency in addressing the drugs phenomenon, the Agency should maintain a close and structured dialogue with the scientific community, healthcare professionals’ organisations, academia, civil society organisations, including organisations of people who use drugs and the affected communities.
Amendment 111 #
Proposal for a regulation
Recital 7
Recital 7
(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 addresspay due regard to 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 medication, whether licit or illicit, are consumed at the same time or sequentially within a short period of time together with drugs.
Amendment 114 #
Proposal for a regulation
Recital 9
Recital 9
(9) The collection, analysis and dissemination of data should continue to be the main task of the Agency. TWhe 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, tn collecting, analysing and disseminating data, the Agency should pay particular attention to respecting the legal framework on processing of personal data and should not collect any personal data, nor any data which would make it possible to identify individuals or groups of individuals. The standard data is collected through the national focal points, which should remain one of the main data providers for the Agency. 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.
Amendment 118 #
Proposal for a regulation
Recital 10
Recital 10
(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 and should comply with fundamental rights and data protection law.
Amendment 119 #
Proposal for a regulation
Recital 11
Recital 11
(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 necessary for the performance of its tasks which should be in full compliance with fundamental rights and data protection rules.
Amendment 121 #
Proposal for a regulation
Recital 12
Recital 12
(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 repor on the drug phenomenon, which encompasses the public health, social and human rights, and alertsafety dimensions, and to enhance the Union’s preparedness for future developments, the monitoring and analytical capacity of the Agency should be strengthened.
Amendment 124 #
Proposal for a regulation
Recital 17
Recital 17
(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, social and human rights, safety, and security. The Agency should be able to inform not only national authorities, but also potential users of these substances.
Amendment 125 #
Proposal for a regulation
Recital 19
Recital 19
(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” laboratorynetwork 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.
Amendment 126 #
Proposal for a regulation
Recital 21
Recital 21
(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. The projects that the Agency finances and the amounts invested in each project should be included in the Agency's annual working programme and be made public.
Amendment 128 #
Proposal for a regulation
Recital 22
Recital 22
(22) Since the Agencywide implementation of evidence-based interventions for demand as well as risk and harm reduction is essential to the objective of promoting public health and improving the well- being of communities and individuals, the Agency should hasve access to data and obtain the necessary scientific experience to develop and promote evidence-based prevention strategies, it should be involand gender-sensitived in pretervention 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 elabors, best practices and awareness raising in drug prevention, risk and harm reduction, treatment, care, rehabilitation and recovery, including the promotion of the implementation and updationg of existing 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), as well as the research on and promotion of other demand reduction interventions such as psychosocial behavioural and medication- assisted treatment, rehabilitation and recovery services, and risk and harm reduction interventions, including innovative harm reduction interventions to reach high-risk populations.
Amendment 131 #
Proposal for a regulation
Recital 23
Recital 23
(23) Given its Union perspective, the Agency should be able to evaluate national measures and training, for example on good quality gender-sensitive prevention, treatment, harm reduction and other related measures, in view of their compliance with the latest scientific state of play and of their proven usefuleffectiveness. Member States or relevant professional bodies should be given the possibility to use the accreditation or certification as a quality label for their work.
Amendment 133 #
Proposal for a regulation
Recital 25
Recital 25
(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, taking into account that international cooperation in the field of drugs should address the whole range of policy aspects of the drugs phenomenon, be guided by the Sustainable Development Goals, be in full compliance with international human rights obligations and be committed to gender equality. 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 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. and fully complies with international human rights obligations, including gender equality and the Sustainable Development Goals.
Amendment 135 #
(26) In order to help Union funding for health and 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. The European Parliament should be informed regarding the support that the Agency provides to the Commission in the area of research and innovation.
Amendment 137 #
Proposal for a regulation
Recital 27
Recital 27
(27) The Management BoarAgency should have a Management Board, composed of two experts appointed by the European Parliament and representatives of the Commission and of the Member States. The Management Board should be responsible for overseeing the work of the Agency and should be assisted by an Executive Board to prepare its decisions. The Agency should be headed by an Executive Director who should be responsible for day-to-day management of the Agency. A Scientific Committee should continue assisting the Management Board and the Executive Director with regard to relevant scientific matters. When making their appointments, the Member States, the Commission and the European Parliament should ensure gender balance, in particular regarding the composition of the Management Board as a body. During a period of one year after ceasing to hold office, the former members of the Executive Board, including the its chairperson, should be prohibited from engaging in any gainful occupational activity with any entity where a conflict of interest exists or could be perceived to exist. The Executive Director should be appointed by the Management Board on the basis of a gender-balanced shortlist of candidates proposed by the Commission and after having obtained the consent of the European Parliament. The shortlisted candidates should be heard by the competent committee(s) prior to their approval by the Parliament. Full compliance with rules and principles on transparency and conflict of interests, particularly when engaging with stakeholders, should be ensured.
Amendment 143 #
Proposal for a regulation
Recital 30
Recital 30
(30) Fees improve the funding of an agency and may, to the extent such fees are duly justified and necessary, be considered for specific issues that can be clearly separated from the core tasks of the agency. AnyThe method by which fees levied by the Agency are calculated should be transparent. The fees should cover itsthe costs of the Agency for providing the respective services.
Amendment 146 #
Proposal for a regulation
Recital 32
Recital 32
(32) Regulation (EC) No 1049/2001 of the European Parliament and of the Council49 should apply to the Agency. The Agency should be asfully transparent as possible about its activities, without jeopardising the attainment of the objective of its operations. _________________ 49 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
Amendment 148 #
Proposal for a regulation
Recital 35
Recital 35
(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, which should be in full compliance with fundamental rights and data protection rules.
Amendment 150 #
Proposal for a regulation
Recital 36
Recital 36
(36) The Agency replaces and succeeds the European Monitoring Centre for Drugs and Drug Addiction established by Regulation (EC) No 1920/20106. 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.
Amendment 151 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
(3) ‘poly-substance use’ means the concomitant usesumption of one or more psychoactive substance or type of substance, whether illicit or illicit, when those substances are takenin particular medical products, alcohol or tobacco, at the same time or sequentially within a short period of time, together with drugs;
Amendment 153 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
The Agency shall provide the Union and its Member States with factual, objective, reliable and comparable information, early warning and risk assessment at Union level concerning drugs, drug use, drug use disorders and addictions, drug marketprevention, treatment, care, risk and harm reduction, rehabilitation, social reintegration and recovery, drug supply, including illicit production and trafficking, and other relevant drug related issues and their consequences, and to recommend appropriate and concrete, evidence-based actions on how to address the related challenges in an efficient and timely manner. In carrying out its tasks, the Agency shall take an evidence-based, integrated, balanced and multidisciplinary approach to the drugs phenomenon, incorporating a human rights, gender equality, public and individual health and health equality, and social perspective.
Amendment 158 #
Proposal for a regulation
Article 5 – paragraph 1 – point a – point 2
Article 5 – paragraph 1 – point a – point 2
(2) the dissemination of information and data pursuant to Article 6(5) and 6(5a); and
Amendment 160 #
Proposal for a regulation
Article 5 – paragraph 1 – point a – point 3
Article 5 – paragraph 1 – point a – point 3
(3) the monitoring of the drug phenomenon, encompassing the public health, social and human rights, safety and security dimension, pursuant to Article 7.
Amendment 163 #
Proposal for a regulation
Article 5 – paragraph 1 – point b – point 2
Article 5 – paragraph 1 – point b – point 2
(2) health threat assessment and preparedness pursuant to Article 12;
Amendment 164 #
Proposal for a regulation
Article 5 – paragraph 1 – point c – point 1
Article 5 – paragraph 1 – point c – point 1
(1) the development, expansion and promotion of Union-wide prevention programmes and campaignsevidence-based interventions, best practices and awareness raising pursuant to Article 16;
Amendment 166 #
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
4. The Agency shall support and improve coordination between national and Union action in its areas of activity and facilitate exchanges of information between decision-makers, researchers, specialists and those involved in drug- related issues in governmental and non- governmental organisations.
Amendment 170 #
Proposal for a regulation
Article 5 – paragraph 7
Article 5 – paragraph 7
7. In carrying out and implementing the tasks referred to in paragraph 1, the Agency shall cooperate actively with other Union decentralised agencies and bodies, in particular Europol, Eurojust, the European Medicines Agency, the European Centre for Disease Prevention and Control, civil society organisationsbodies, offices and agencies, within their mandates, in particular the European Union Agency for Fundamental Rights, Europol, Eurojust, the European Union Agency for Law Enforcement Training (CEPOL), the European Medicines Agency, the European Centre for Disease Prevention and Control, and the European Foundation for the Improvement in Living and Working Conditions (Eurofound), and with the scientific community, academia, civil society organisations, in particular the Civil Society Forum on Drugs, representatives of affected communities, including people who use drugs, and other relevant stakeholders, to attain maximum efficiency in monitoring, assessing and responding to the drugs phenomenon.
Amendment 174 #
Proposal for a regulation
Article 6 – paragraph 1 – point b
Article 6 – paragraph 1 – point b
(b) collect information and data needed for the monitoring of poly-substance use and its consequences as referred to in Article 7(1), point (c);
Amendment 175 #
Proposal for a regulation
Article 6 – paragraph 1 – point f
Article 6 – paragraph 1 – point f
(f) ensure improved comparability, objectivity and reliability of information and data at Union level by establishing indicators and common standards of a non- binding nature, compliance with which may be recommended by the Agency, with a view to ensuring greater uniformity of the measurement methods used by the Member States and the Union; in particular, the Agency shall develop tools and instruments to help Member States to monitor and evaluate their national policies and the Commission to monitor and evaluate Union policies.
Amendment 176 #
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Agency shall develop, within its mandate, data collection methods and approaches, including through projects with external partners.
Amendment 178 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1
Article 6 – paragraph 4 – subparagraph 1
The Agency may develop the necessary digital solutions through which information and data are managed and automatically exchanged.
Amendment 180 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 2
Article 6 – paragraph 4 – subparagraph 2
Amendment 181 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 2 – point a
Article 6 – paragraph 4 – subparagraph 2 – point a
Amendment 182 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 2 – point b
Article 6 – paragraph 4 – subparagraph 2 – point b
Amendment 183 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 2 – point c
Article 6 – paragraph 4 – subparagraph 2 – point c
Amendment 185 #
Proposal for a regulation
Article 6 – paragraph 5 – point b
Article 6 – paragraph 5 – point b
(b) ensuring wide dissemination of its analysis, conclusions and reports, including to the scientific community, civil society and affected communities, including people who use drugs;
Amendment 187 #
Proposal for a regulation
Article 6 – paragraph 5 a (new)
Article 6 – paragraph 5 a (new)
5 a. Where relevant, the Agency may disseminate information and data disaggregated by Member State, gender, age, race, ethnicity, disability and socio- economic status, in accordance with the relevant national legal framework and Union data protection law. When disseminating such information and data, the Agency shall make reference to the sources thereof.
Amendment 190 #
Proposal for a regulation
Article 6 – paragraph 6 a (new)
Article 6 – paragraph 6 a (new)
6 a. The collection and dissemination of information and data pursuant to this Article shall be in full compliance with fundamental rights and data protection rules.
Amendment 191 #
Proposal for a regulation
Article 7 – title
Article 7 – title
Monitoring of the drug phenomenon and sharing of best practices
Amendment 194 #
Proposal for a regulation
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a) the drugs phenomenon in the Union holistically, through epidemiological and other indicators, covering the health, social and human rights safety and security aspects, including the implementation of the applicable Union strategies on drugs;
Amendment 195 #
Proposal for a regulation
Article 7 – paragraph 1 – point a a (new)
Article 7 – paragraph 1 – point a a (new)
Amendment 197 #
Proposal for a regulation
Article 7 – paragraph 1 – point a b (new)
Article 7 – paragraph 1 – point a b (new)
(a b) poly-substance use and its consequences, in particular the increased risks of health and social problems, as well as the social determinants of drug use, drug use disorders and addictions;
Amendment 198 #
Proposal for a regulation
Article 7 – paragraph 1 – point a c (new)
Article 7 – paragraph 1 – point a c (new)
(a c) drug and poly-substance use and their consequences from a gender perspective, in particular their impact on gender-based violence;
Amendment 200 #
Proposal for a regulation
Article 7 – paragraph 1 – point b
Article 7 – paragraph 1 – point b
(b) emerging trends in the drugs phenomenon in the Union and internationally as far as these impact on the Union; this shall include the monitoring of the use of new technologies for drug services or drug trafficking, and links to other crime areas, as relevant;
Amendment 203 #
Proposal for a regulation
Article 7 – paragraph 1 – point c
Article 7 – paragraph 1 – point c
Amendment 205 #
Proposal for a regulation
Article 7 – paragraph 1 – point d
Article 7 – paragraph 1 – point d
Amendment 207 #
Proposal for a regulation
Article 7 – paragraph 1 – point g
Article 7 – paragraph 1 – point g
(g) the implementation of Union and national drugs policies, including in view of supporting their development and independent evaluation;
Amendment 208 #
Proposal for a regulation
Article 7 – paragraph 1 – point h
Article 7 – paragraph 1 – point h
Amendment 210 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Based on its monitoring activities, the Agency shall identify innovative best practices and develop them further. The Agency shall provide and share information on innovative best practices inand support evidence-based best practices, share them with the Member States and facilitate the exchange of such practices among the Member States.
Amendment 212 #
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. The Agency shall undertake regular foresight exercises, taking into account the information available. It shall develop, on that basis, relevant predictscenarions for the development of future drugs policy.
Amendment 214 #
Proposal for a regulation
Article 8 – paragraph 2 a (new)
Article 8 – paragraph 2 a (new)
2 a. The information collected pursuant to paragraph 2 shall not contain any personal data or information that makes it possible to identify individuals or groups of individuals.
Amendment 216 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. For the purpose of the initial report, the Agency shall use information, which is at its disposal pursuant to Article 8.
Amendment 217 #
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. Where the Agency considers it necessary, it shall request the national focal points and the relevant stakeholders, including the scientific community, healthcare professionals, civil society organisations and affected communities, to provide additional information on the new psychoactive substance. The national focal points and the relevant stakeholders, where applicable, shall provide that information within two weeks of receipt of the request.
Amendment 220 #
Proposal for a regulation
Article 10 – paragraph 3 – point c
Article 10 – paragraph 3 – point c
(c) an analysis of the health risks associated with the new psychoactive substance, in particular with respect to its acute and chronic toxicity and in relation to drug-related deaths including via overdose, abuse liability, dependence- producing potential, and physical, mental and behavioural effects;
Amendment 221 #
Proposal for a regulation
Article 10 – paragraph 3 – point d
Article 10 – paragraph 3 – point d
(d) an analysis of the social risks associated with the new psychoactive substance – in particular its impact on social functioning, social marginalisation, public order and criminal activities, and the involvement of criminal groups in the manufacture, distribution and distribution methods, and trafficking of the new psychoactive substance;
Amendment 222 #
Proposal for a regulation
Article 10 – paragraph 3 – point f a (new)
Article 10 – paragraph 3 – point f a (new)
(f a) available information on recommended evidence-based demand reduction and harm reduction responses to minimise the risks and harms associated with new psychoactive substances;
Amendment 224 #
Proposal for a regulation
Article 10 – paragraph 8 a (new)
Article 10 – paragraph 8 a (new)
8 a. Where appropriate or upon request, the Agency shall disseminate the risk assessment reports to the European Parliament and to the relevant stakeholders, including the scientific community, healthcare professionals, civil society organisations and affected communities, for awareness-raising of the risks of a new psychoactive substance and recommended responses. In addition, summaries of all reports shall be publicly available on the Agency’s web portal.
Amendment 227 #
Proposal for a regulation
Article 12 – title
Article 12 – title
Amendment 229 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The Agency shall develop a strategic generalevidence-based general health threat assessment capability to identify at an early stage new developments of the drugs phenomenon that have a potential to impact negatively on public health, social and human rights, safety and security and, through doing so, to help increase the preparedness of the relevant stakeholders to respond to new threats in a timely and effectiven efficient and timely manner.
Amendment 231 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1
Article 12 – paragraph 2 – subparagraph 1
The Agency shall set out a set of objective criteria to evaluate when to trigger a threat assessment.
Amendment 232 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 2
Article 12 – paragraph 2 – subparagraph 2
A threat assessment may be launched by the Agency on its own initiative based on an internal appraisal of signals arising from routine monitoring, research or other appropriate information sources. A threat assessment in accordance to paragraph 1 may also be launched at the request of the Commission or of a Member State, if the defined criteria are met.
Amendment 233 #
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. The threat assessment report shall describe the identified threat, the current situation based on available evidence, the potential outcomes in the event of no action, and set out options for preparedness and response that may be adopted to mitigate and respond to the threat identified, including evidence-based interventions on demand and risk and harm reduction. It may also contain potential follow-up measures to be adopted. The threat assessment report shall be sent to the Commission and the Member States, as appropriate. Where appropriate or on request, the threat assessment report shall also be sent to the European Parliament.
Amendment 236 #
Proposal for a regulation
Article 12 – paragraph 5
Article 12 – paragraph 5
5. The Agency shall cooperate closely with other Union decentralised agencies and bodies, Unionbodies, offices and agencies and international organisations, within their mandates, in carrying out a threat assessment by involving them in the assessment as appropriate. Where the potential threat is already subject to an analysis under another Union mechanism, the Agency shall not carry out a threat assessment.
Amendment 238 #
Proposal for a regulation
Article 12 – paragraph 6
Article 12 – paragraph 6
6. With the agreement of the Commission, the Agency shall conduct threat assessments on drug related threats emerging from outside the Union, which have the potential to impact public health, social and human rights, safety and security within the Union.
Amendment 240 #
Proposal for a regulation
Article 12 – paragraph 6 a (new)
Article 12 – paragraph 6 a (new)
6 a. The Agency shall monitor new developments of the drugs phenomenon and, when needed, update threat assessments carried out in accordance with this Article.
Amendment 242 #
Proposal for a regulation
Article 12 – paragraph 6 b (new)
Article 12 – paragraph 6 b (new)
6 b. Where appropriate, the Agency shall disseminate threat assessment reports to the relevant stakeholders, including the scientific community, healthcare professionals, civil society organisations and affected communities. Summaries of those reports shall be publicly available on the Agency’s web portal.
Amendment 243 #
Proposal for a regulation
Article 13 – paragraph 2 – introductory part
Article 13 – paragraph 2 – introductory part
2. Member States shall immediately notify the Agency of any information relating to the appearance of a serious direct or indirect drug-related risk to human health, social and human rights, safety or security as well as any information that may be useful for coordinating a response whenever they become aware of such information, such as:
Amendment 245 #
Proposal for a regulation
Article 13 – paragraph 2 – point f a (new)
Article 13 – paragraph 2 – point f a (new)
(f a) social and human rights risks,
Amendment 250 #
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
3. The Agency shall analyse and assess the available information and data on potential serious risks to human health and complement it with any scientific and technical information it may have available from the early warning system referred to in Article 8 and other threat assessments undertaken in accordance with Article 12, from other Union agencies and bodies and from international organisations, in particular the World Health Organisation. The Agency shall take into account information obtained through its data collection tools and, from open source information, and via consultations with academia, civil society organisations and affected communities.
Amendment 251 #
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. Based on the information received pursuant to paragraph 3, the Agency shall provide targeted rapid alert risk communications or strategic intelligence notifications, or both, to the relevant national authorities, including the national focal points. Such risk communications or strategic intelligence notifications may propose response options, which Member States may consider as part of their preparedness planning and national response activities.
Amendment 252 #
Proposal for a regulation
Article 13 – paragraph 8
Article 13 – paragraph 8
8. The Agency may develop an alert system, in close cooperation with the relevant stakeholders, including the scientific community, civil society organisations and affected communities, and with the relevant national authorities, in particular the national focal points, may develop an alert system to make information on a identified risk available through which it can directly reach and address people who use or potentially use drugsparticular drugs and relevant civil society organisations, where appropriate.
Amendment 255 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The network shall act primarily as a forum for generating data and information exchange on new developments and trends, organising training to enhance the competence of forensic drug and toxicology experts, supporting the implementation of quality assurance schemes and supporting the further harmonisation of data collection and analytical methods.
Amendment 258 #
Proposal for a regulation
Article 15 – paragraph 5
Article 15 – paragraph 5
5. The network shall closely cooperate with existing networks and organisations active in this area and shall take into account their work in order to avoid overlaps. The network referred to in Article 31 shall be informed regularly, and at least once a year, about the work of the network of forensic and toxicological laboratories.
Amendment 259 #
Proposal for a regulation
Article 15 – paragraph 9
Article 15 – paragraph 9
9. The Agency shall create a database to store, analyse and make available the information and data collected or generated by the network. The database of the Agency shall not contain any personal data.
Amendment 260 #
Proposal for a regulation
Article 16 – title
Article 16 – title
Amendment 263 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The Agency shall design, develop and promote Union-wide programmes and campaigns for the prevention of drug- related problems and raising awareness ofscientific, evidence-based and gender-sensitive interventions and best practices and raise awareness about prevention, risk and harm reduction, treatment, care, rehabilitation and recovery and the adverse effects of drugs.
Amendment 264 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. The programmes and campaignsinterventions, best practices and awareness raising referred to in paragraph 1 shall be in line with the Union's international human rights obligations and the political orientations set out in the applicable EU Drugs Strategy and Action Plan. They shall address important dimensions of the drug phenomenensure a balanced approach to demand reduction and harm reduction interventions, shall be targeadapted to specific groups and be informthe national context where necessary, shall be implemented byat the Agency’s collection of evidence and best practicenational level, and may be targeted to specific groups.
Amendment 267 #
Proposal for a regulation
Article 16 – paragraph 3
Article 16 – paragraph 3
3. The Agency shall develop and promote the implementation of quality standards for drug prevention, risk and harm reduction, treatment, care, rehabilitation and recovery, update those standards as appropriate, and provide or support training pursuant to Article 19.
Amendment 268 #
Proposal for a regulation
Article 16 – paragraph 4
Article 16 – paragraph 4
4. The Agency shall assist Member States in developing national prevention campaiggender- sensitive interventions in the area of its mandate, including the development of prevention programmes aimed at the reduction of drug-related criminality andin relation to the prevention of drug use and the related impact on health as well as the prevention of the exploitation of vulnerable individuals within the drug market. Such interventions shall be tailored to the needs of individuals and affected communities.
Amendment 270 #
Proposal for a regulation
Article 17 – paragraph 3 – subparagraph 2 – point b
Article 17 – paragraph 3 – subparagraph 2 – point b
(b) the criteria according to which the national programme will be assessed in view of the accreditation or certification and which allow the verification of the conditions laid down in paragraph 2; programmes subject to an accreditation or certification shall include at least gender- sensitive prevention, treatment, harm reduction, and other related subjects;
Amendment 271 #
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. The Agency shall support the Member States in implementing their national drug strategies, quality standards and innovative best practices and it shall facilitate exchanges of information between national decision-makauthorities and experts.
Amendment 274 #
Proposal for a regulation
Article 18 – paragraph 3
Article 18 – paragraph 3
3. In supporting policy evaluation, the Agency shall act independently and shall be guided by its scientific standards and an evidence-based approach.
Amendment 275 #
Proposal for a regulation
Article 19 – paragraph 1 – introductory part
Article 19 – paragraph 1 – introductory part
The Agency shall, within the scope of its mandate, in accordance with the staffing and budgetary resources at its disposal and in coordination with other Union decentralised agencibodies, offices and bodagencies:
Amendment 279 #
Proposal for a regulation
Article 20 – paragraph 1 – point f
Article 20 – paragraph 1 – point f
(f) promote the incorporation of relevant data on drugs and drug addiction, gathered in the Member States or emanating from the Union into international monitoring and drug-control programmes, particularly those established by the UN and its specialised agencies, without prejudice to Member States' obligations with regard to transmission of information under the provisions of the United Nations Drug Conventions;
Amendment 283 #
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. The international cooperation framework referred to in paragraph 1, point (a), shall take into account the relevant policy documents of the Union and consider the developments of the drug phenomenon, in particular trafficking routes and drug production areas. It shall set out the priority countries or regions for cooperation and the key outcomes of the cooperation. The international cooperation framework shall also seek to support third countries’ efforts to address drug issues in an evidence-based, integrated, balanced and multidisciplinary manner that is in full compliance with the Sustainable Development Goals and international human rights obligations and committed to gender equality. The Agency shall evaluate and review the international cooperation framework regularly.
Amendment 287 #
Proposal for a regulation
Article 20 – paragraph 3 – subparagraph 2
Article 20 – paragraph 3 – subparagraph 2
Technical assistance shall focus in particular on setting up or consolidating national focal points, national data collection systems and national early warning systems, and the promotion of best practices in the fields of prevention, treatment, care, risk and harm reduction, rehabilitation and recovery, and subsequently assist the creation and strengthening of structural links with the early warning system referred to in Article 8 and the network referred to in Article 31. If the third country so requests, the Agency may provide a certification for these national bodies.
Amendment 290 #
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
2. The Agency shall proactively monitor and contribute to research and innovation activities to achieve its general task set out in Article 4, support related activities of Member States, and implement its research and innovation activities regarding matters covered by this Regulation, including the development, training, while ensuring full compliance with fundamental rights, data protescting and validation of algorithms for the development of toolon, transparency and conflict of interest rules. The Agency shall disseminate the results of that research to the European Parliament, to the Member States and to the Commission in accordance with Article 49.
Amendment 291 #
Proposal for a regulation
Article 21 – paragraph 5
Article 21 – paragraph 5
5. The Agency shall make public information on its research projects, including demonstration projects, which shall include the cooperation partners involved and the project budget.
Amendment 292 #
Proposal for a regulation
Article 21 – paragraph 6
Article 21 – paragraph 6
6. The Agency shall create a database to store, analyse and make available drug- related research programmes. The database shall not contain any personal data.
Amendment 293 #
Proposal for a regulation
Article 22 – paragraph 1 a (new)
Article 22 – paragraph 1 a (new)
The members of the Agency’s administrative and management structure shall not have any financial or other interests that could affect their impartiality. They shall act in the public interest and carry out their activities in an independent, impartial and transparent manner, and shall make an annual declaration of their financial interests. All indirect interests which could affect their impartiality, including in the pharmaceutical industry, shall be entered in a register that is held by the Agency and accessible to the public upon request.
Amendment 296 #
Proposal for a regulation
Article 23 – paragraph 2 – point a
Article 23 – paragraph 2 – point a
(a) onetwo independent experts particularly knowledgeable in the field of drugs designated by the European Parliament, with the right to vote;
Amendment 298 #
Proposal for a regulation
Article 23 – paragraph 3
Article 23 – paragraph 3
3. Each member of the Management Board shall have an alternate. The alternate shall represent the member in her/his absence and may attend the meeting of the Management Board.
Amendment 300 #
Proposal for a regulation
Article 23 – paragraph 4
Article 23 – paragraph 4
4. Members of the Management Board and their alternates shall be appointed in light of their knowledge in the field of drugs and drug addictions referred to in Article 4, taking into account relevant managerial, administrative and budgetary skills. All parties represented in the Management Board shall make efforts to limit turnover of their representatives, in order to ensure continuity of the Management Board's work. All parties shall aim to achieve a balanced representation between women and men on the Management Board.
Amendment 301 #
Proposal for a regulation
Article 23 – paragraph 5
Article 23 – paragraph 5
5. The Management Board may invite, as observers, representatives of international organisations with which the Agency cooperates in accordance with Article 53, as well as representatives from relevant civil society organisations.
Amendment 302 #
Proposal for a regulation
Article 23 – paragraph 6
Article 23 – paragraph 6
6. The term of office for members and their alternates shall be four years. That term may be renewabled once.
Amendment 303 #
Proposal for a regulation
Article 24 – paragraph 1 – point i
Article 24 – paragraph 1 – point i
(i) adopt rules for the prevention and management of conflicts of interest in respect of its members, the members of the Executive Board, Scientific Committee, and the European Information Network on Drugs and Drug Addiction (Reitox), as well as of seconded national experts and other staff not employed by the Authoritgency as referred to in Article 44, and shall publish annually on its website the declarations of interests of the Management Board members;
Amendment 304 #
Proposal for a regulation
Article 24 – paragraph 1 – point l
Article 24 – paragraph 1 – point l
(l) approve the level of minimum co- financing referred to in Article 32(76);
Amendment 305 #
Proposal for a regulation
Article 24 – paragraph 1 – point t
Article 24 – paragraph 1 – point t
(t) approve the list of experts to be used to extend the Scientific Committee in accordance with Article 130(46);
Amendment 307 #
Proposal for a regulation
Article 28 – paragraph 2
Article 28 – paragraph 2
2. Where necessary, because of urgency, the Executive Board may take certain provisional decisions instead of the Management Board, in particular on administrative management matters, including the suspension of the delegation of the appointing authority powers and budgetary matters. The conditions for doing so shall be set out in the rules of procedure of the Management Board. The rules of procedure of the Management Board shall be made public.
Amendment 308 #
Proposal for a regulation
Article 28 – paragraph 4
Article 28 – paragraph 4
4. The term of office of members of the Executive Board shall be four years with the possibility to be renewed once. The term of office of members of the Executive Board shall end when their membership of the Management Board ends.
Amendment 310 #
Proposal for a regulation
Article 29 – paragraph 5 – point i
Article 29 – paragraph 5 – point i
(i) protecting the financial interests of the Union by applying preventive measures against fraud, corruption and any other illegal activities, without prejudicing the investigative competence of OLAF and EPPO, by effective checks and, if irregularities are detected, by recovering amounts wrongly paid and, where appropriate, by imposing effective, proportionate and dissuasive administrative, including financial penalties, and by reporting to the EPPO any criminal conduct in respect of which the EPPO could exercise its competence in accordance with Article 24 of Regulation (EU)2017/1939;
Amendment 314 #
Proposal for a regulation
Article 29 – paragraph 6
Article 29 – paragraph 6
6. The Executive Director shall decide whether it is necessary to locate one or more staff in one or more Member States for the purpose of carrying out the Agency's tasks in an efficient and effective manner. Before deciding to establish a local office, the Executive Director shall obtain the prior consent of the Commission, the Management Board and the host Member State(s) concerned. The decision shall specify the scope of the activities to be carried out at the local office in a manner that avoids unnecessary costs and duplication of administrative functions of the Agency. A headquarters agreement with the host Member State(s) concerned mayshall be concluded.
Amendment 316 #
Proposal for a regulation
Article 30 – paragraph 1
Article 30 – paragraph 1
1. The Scientific Committee shall consist of at most fifteen scientists appointed by the Management Board in view of their scientific excellence and their independence, following the publication of a call for expression of interest in the Official Journal of the European Union and after the approval of the European Parliament. Gender-balance shall be ensured in that appointment. The selection procedure shall ensure that the specialist fields of the members of the Scientific Committee cover the most relevant fields linked to the objectives of the Agency.
Amendment 319 #
Proposal for a regulation
Article 33 – paragraph 2 – point d
Article 33 – paragraph 2 – point d
(d) collect, analyse and interpret in an objective manner at national level all relevant information on drugs, drug addiction, drug markets, drug supply and crime-related issues as well as on policies and solutions applied, needed for the Agency to comply with Article 6. In doing so, the national focal point shall bring together experience from different sectors – in particular health, justice and law enforcement – and cooperate with experts and national, national organisations, the scientific community and civil society organisations active in the field of drugs policy;
Amendment 322 #
Proposal for a regulation
Article 33 – paragraph 3
Article 33 – paragraph 3
3. The national focal point shall have the right to collect from other natestablish the necessary cooperation with relevant national and regional authorities, bodies, agencies and organisations allfor the collection of information it needs to carry out its tasks in accordance with paragraph 2. The national focal point shall maintain an extensive network of national partners and data providers for the collection of such information.
Amendment 325 #
Proposal for a regulation
Article 33 – paragraph 3 a (new)
Article 33 – paragraph 3 a (new)
3 a. When collecting data pursuant to this Article, the national focal points shall ensure, where possible, that the data collected is disaggregated by gender. The national focal points shall take into account gender-sensitive and intersectional aspects of drugs policy when collecting and presenting data pursuant to this Article. The national focal points shall not transmit any personal data or any data making it possible to identify individuals or groups of individuals.
Amendment 333 #
Proposal for a regulation
Article 37 – paragraph 1 – point a
Article 37 – paragraph 1 – point a
(a) training programmesursuant to Article 19;
Amendment 336 #
(b) certainnecessary and duly justified support activities for Member States that have not been identified as a priority but could be beneficially conducted if supported by national resources;
Amendment 341 #
Proposal for a regulation
Article 37 – paragraph 2
Article 37 – paragraph 2
2. At the proposal of the Executive Director, the Management Board of the Agency shall in a transparent manner set the amount of the fees and the way in which they are paid.
Amendment 344 #
Proposal for a regulation
Article 37 – paragraph 4
Article 37 – paragraph 4
4. Fees should be set at a level such as to avoid a deficit or a significant accumulation of surplus in the budget. Should a significant positive balance in the budget, resulting from the provision of the services covered by fees, become recurrent, a revision of the level of the fees, or of the Union contribution, shall become mandatory. In case a significant negative balance results from the provision of the services covered by fees, a revision of the level of the fees shall become mandatorymay be revised.
Amendment 347 #
Proposal for a regulation
Article 43 – paragraph 2
Article 43 – paragraph 2
2. The Executive Director shall be appointed by the Management Board, from a gender-balanced list of candidates proposed by the Commission, following an open and transparent selection procedure and with prior approval by the European Parliament. Before that approval, the candidate selected by the Management Board for the post of Executive Director shall be heard by the competent committee(s) of the European Parliament. Where the European Parliament is of the opinion that the selected candidate does not sufficiently fulfil the requirements for the post, the open selection procedure shall recommence.
Amendment 350 #
Proposal for a regulation
Article 43 – paragraph 5
Article 43 – paragraph 5
5. The Management Board, acting on a proposal from the Commission that takes into account the assessment referred to in paragraph 4 and after consulting the European Parliament, may extend the term of office of the Executive Director only once, for no more than five years.
Amendment 351 #
Proposal for a regulation
Article 43 – paragraph 7
Article 43 – paragraph 7
7. The Executive Director may be removed from office only upon a decision of the Management Board acting on a proposal from the European Parliament or the Commission.
Amendment 352 #
Proposal for a regulation
Article 47 – paragraph 3
Article 47 – paragraph 3
3. The Management Board shall, within six months of the date of its first meeting following the date of application of this Regulation, as referred to in Article 63, second subparagraph, establish measures for the application of Regulation (EU) 2018/1725 by the Agency, including those concerning the appointment of a Data Protection Officer of the Agency. Those measures shall be established after consultation of the European Data Protection Supervisor and shall be made public.
Amendment 353 #
Proposal for a regulation
Article 48 – paragraph 2
Article 48 – paragraph 2
2. The Agency shall accede to the Interinstitutional Agreement of 25 May 1999 concerning internal investigations by the OLAF by six months from the day this Regulation comes into force, and shall adopt appropriate provisions applicable to all employees of the Agency using the template set out in the Annex to that Agreement.
Amendment 354 #
Proposal for a regulation
Article 53 – paragraph 3 a (new)
Article 53 – paragraph 3 a (new)
3 a. Working arrangements entered into pursuant to this Article shall be made public on the Agency’s website.
Amendment 355 #
1. The Agency shall be open to the participation in its work of third countries that have entered intoconcluded agreements with the Union to this effect.
Amendment 356 #
Proposal for a regulation
Article 54 – paragraph 2 – subparagraph 1
Article 54 – paragraph 2 – subparagraph 1
Under the relevant provisions of the agreements referred to in paragraph 1, arrangements shall be developed specifying, in particular, the nature, extent and manner in which the third countries concerned are to participate in the work of the Agency, including provisions relating to participation in the initiatives undertaken by the Agency, financial contributions and stafftheir purposes, and staff. The arrangements shall ensure compliance with fundamental rights, data protection, transparency and conflict of interests rules.
Amendment 357 #
Proposal for a regulation
Article 54 – paragraph 2 – subparagraph 2
Article 54 – paragraph 2 – subparagraph 2
As regards staff matters, those working arrangements shall, in any event, comply with the Staff Regulations and shall be made public.
Amendment 358 #
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
1. The Agency shall maintain a structured and close dialogue with relevant civil society organisations active in the fields covered by this Regulation at national, Union or international level. To that end, the Agency shall create an adequately funded mechanism for the systematic., regular and extensive consultation and exchange of information with civil society and community organisations working within the scope of the Agency’s mandate. The mechanism shall be open to all interested and qualified stakeholders, including the EU Civil Society Forum on Drugs. 1a. The Agency shall appoint a focal point to manage the structured and close dialogue referred to in paragraph 1 under the authority of the Executive Director. A representative selected by the EU Civil Society Forum on Drugs shall attend the sessions of the Management Board as an observer. The names and the declared conflict of interests of stakeholders involved in the work of the Agency shall be made public on the website of the Agency.