Article 1 Objective
1. This Regulation provides for the European Monitoring Centre for Drugs and Drug Addiction (‘the Centre’). 2. The Centre's objective is to provide, in the areas referred to in Article 3, the Community and its Member States with factual, objective, reliable and comparable information at European level concerning drugs and drug addiction and their consequences. 3. The statistical, documentary and technical information processed or produced is intended to help provide the Community and the Member States with an overall view of the drug and drug addiction situation when, in their respective areas of competence, they take measures or decide on action. The statistical element of this information shall be developed, in collaboration with the relevant statistical authorities, using as necessary the Community Statistical Programme to promote synergy and avoid duplication. Account shall be taken of further data from the World Health Organisation and the United Nations Organisation (the ‘UN’) available worldwide. 4. Without prejudice to Article 2(d)(v), the Centre may not take any measure which goes beyond the sphere of information and the processing thereof. 5. The Centre shall not collect any data making it possible to identify individuals or small groups of individuals. It shall refrain from any transmission of information relating to specific named cases.
Article 2 Tasks
In order to achieve the objective set out in Article 1, the Centre shall perform the following tasks within its areas of activity: (a) Collection and analysis of existing data (i) collecting, registering and analysing information, including data resulting from research, communicated by Member States and data emanating from Community, non-governmental national sources and competent international organisations, including the European Police Office (Europol); providing information on best practices in the Member States and facilitating the exchange of such practices among them; this collection, registration, analysis and information work shall also cover data on emerging trends in poly-drug use, including the combined use of licit and illicit psychoactive substances; (ii) carrying out surveys, preparatory studies and feasibility studies, together with any pilot projects necessary to accomplish its tasks; organising meetings of experts and, whenever necessary, setting up ad hoc working parties for the purpose; setting up and making available open scientific documentation resources and assisting in the promotion of information activities; (iii) providing an organisational and technical system capable of supplying information on similar or complementary programmes or action pursued by the Member States; (iv) establishing and coordinating, in consultation and in cooperation with the competent authorities and organisations in the Member States, the network referred to in Article 5; (v) facilitating exchanges of information between decision-makers, researchers, specialists and those involved in drugs-related issues in governmental and non-governmental organisations; (b) Improvement of data-comparison methods (i) ensuring improved comparability, objectivity and reliability of data at European level by establishing indicators and common criteria of a non-binding nature, compliance with which may be recommended by the Centre, with a view to ensuring greater uniformity of the measurement methods used by the Member States and the Community; in particular, the Centre 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; (ii) facilitating and structuring information exchange in terms of both quality and quantity (databases); (c) Dissemination of data (i) making the information produced by it available to the Community, the Member States and competent organisations; (ii) ensuring wide dissemination of work done in each Member State and by the Community itself, and, where appropriate, by third countries or international organisations; (iii) ensuring wide dissemination of reliable non-confidential data, publishing on the basis of data which it gathers, a yearly report on the state of the drugs problem, including data on emerging trends; (d) Cooperation with European and international bodies and organisations and with third countries (i) contributing to improving coordination between national and Community action in its areas of activity; (ii) without prejudice to Member States' obligations with regard to transmission of information under the provisions of the United Nations Conventions on drugs, promoting the incorporation of data on drugs and drug addiction gathered in the Member States or emanating from the Community into international monitoring and drug-control programmes, particularly those established by the UN and its specialised agencies; (iii) cooperating actively with Europol to attain maximum efficiency in monitoring the drugs problem; (iv) cooperating actively with the organisations and bodies referred to in Article 20; (v) transferring, at the request of the Commission and with the approval of the Management Board referred to in Article 9, its know-how to certain third countries such as candidate countries or the countries of the western Balkans and assist in the creation and strengthening of structural links with the network referred to in Article 5 and the setting-up and consolidation of the national focal points referred to in that Article; (e) Information obligations In principle, the Centre shall, if it identifies new developments and changing trends, inform the competent authorities of the Member States thereof.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal O ver the past decade there has been a massive growth in new psychoactive substances (NPS), at global level and in Europe as well, and there are no signs of a slowdown. In 2015, 100 new substances were reported for the first time to the EU Early Warning System (EWS), bringing the total number of new substances monitored to more than 560 – with more than 380 (70%) of these detected in the last five years alone. 1 The United Nations General Assembly at the Special Session on the world drug problem (UNGASS, 19-21 April 2016 ) adopted the outcome document "Our joint commitment to effectively addressing and countering the world drug problem" 2 . A specific section deals with addressing emerging and persistent challenges and threats including NPS. The joint commitment calls for strengthening action to address the challenge of NPS as well as for enhancing information-sharing and early warning networks. On 17 September 2013, the Commission put forward a package of two legislative proposals on new psychoactive substances: a proposal for a Regulation on new psychoactive substances 3 and a Directive amending Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking, as regards the definition of drug 4 . The objective was to reduce the availability of new psychoactive substances that pose risk through swifter, more effective action on Union level compared to the currently applicable system based on Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk assessment and control of new psychoactive substances 5 . Inter-institutional negotiations of this legislative package have been ongoing for more than two years. The European Parliament adopted its legislative resolutions on 17 April 2014 6 . The Council did not adopt a general approach on the proposals; during the examination of the proposals Member States expressed doubts concerning the choice of Article 114 of the Treaty on the Functioning of the European Union (TFEU) as the legal basis for the proposed Regulation. To achieve the same objective of a swifter, more effective EU action on NPS, the Permanent Representatives Committee (COREPER) on 6 April 2016 7 agreed to the approach proposed by the Netherlands Presidency in its discussion paper, including amendments of the draft Directive based on Article 83 TFEU that will in particular contain a definition of new psychoactive substances and provisions on swift Union level decision making in order to criminalise harmful new psychoactive substances in all Member States. COREPER also invited the Commission to present a proposal on amending the founding Regulation of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), Regulation 1920/2006 . According to the Summary Record of the 2580th meeting of COREPER this decision triggers the start of the 3 months' opt-in deadline for the Member States concerned by Protocol 21 and has consequences under Protocol 22 annexed to the TEU. The European Parliament is informed about this change by a letter from the Council. Given that the decision of COREPER aims to achieve the same objectives as proposed by the package of 2013, the Commission proposes targeted amendments of Regulation 1920/2006 integrating the draft provisions on early warning system and risk assessment procedure that were part of the 2013 Commission proposal for a Regulation on new psychoactive substances into the founding Regulation of the EMCDDA. The Commission will consider the withdrawal of the proposal on a Regulation on new psychoactive substances in preparing Commission's Work Programme for 2017. The new proposal as the previous one aims at strengthening the EU early warning system and the risk assessment and at streamlining procedures to ensure more effective and fast action. Therefore, in order to speed up the process, deadlines are substantially shortened compared to the current system based on Council Decision 2005/387/JHA. For the purpose of swift and effective collection of information on NPS, the EMCDDA should conclude working arrangements with Europol, the European Medicines Agency, the European Chemicals Agency and the European Food Safety Authority without undue delay following the publication of the Regulation in the Official Journal. This proposal also ensures a participation of EUROPOL in the early warning system and risk assessment procedure, in particular as input on the involvement of criminal groups in the manufacture and distribution of new psychoactive substances is concerned. According to Article 23 of Regulation 1920/2006 the Commission may propose, if appropriate, and in the light of developments in respect of regulatory agencies on the basis of the next evaluation of the Centre further amendments to the EMCDDA founding Regulation. Consistency with existing policy provisions in the policy area The proposal reflects the priorities set out by the European Agenda on Security 8 adopted on 28 April 2015. The European Agenda of Security stresses that the market for illicit drugs remains the most dynamic of criminal markets, with a recent trend being the proliferation of new psychoactive substances. It also states that the production of these substances is increasingly taking place in the Union thus pointing to the urgency of adopting a new legislative framework . This proposal has to be read in conjunction with Directive (EU) …/ … [amending Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking 9 ]. Both instruments are designed to replace the mechanism established by Council Decision 2005/387/JHA.
Revised version (Article 2 Tasks):
In order to achieve the objective set out in Article 1, the Centre shall perform the following tasks within its areas of activity: (e) Information obligations In principle, the Centre shall, if it identifies new developments and changing trends, inform the competent authorities of the Member States thereof;
Article 3 Priority areas of activity
The objective and tasks of the Centre, as set out in Articles 1 and 2, shall be implemented following the order of priorities indicated in Annex I.
Article 4 Working method
1. The Centre shall progressively carry out its tasks in the light of the objectives adopted in the three-year and annual work programmes referred to in Article 9(4) and (5) and with due regard to the available resources. 2. In pursuing its activities, the Centre shall, in order to avoid duplication, take account of activities already carried out by other existing or future institutions and agencies, notably Europol, and shall ensure that it adds to their value.
Article 5 European Information Network on Drugs and Drug Addiction (Reitox)
1. The Centre shall have at its disposal the European Information Network on Drugs and Drug Addiction (Reitox). The network shall consist of one focal point for each Member State and each country which has concluded an agreement pursuant to Article 21 and a focal point for the Commission. The designation of the national focal points shall be the exclusive responsibility of the countries concerned. 2. The national focal points shall form an interface between the participating countries and the Centre. They shall contribute to the establishment of key indicators and data, including guidelines for their implementation with a view to obtaining reliable and comparable information at European Union level. They shall collect and analyse in an objective manner at national level, bringing together experience from different sectors – health, justice, law enforcement – in cooperation with experts and national organisations active in the field of drugs policy, all relevant information on drugs and drug addiction, as well as on policies and solutions applied. In particular, they shall provide data for the five epidemiological indicators specified by the Centre. Each Member State shall ensure that its representative in the Reitox Network provides the information set out in Article 4(1) of Decision 2005/387/JHA. The national focal points may also provide the Centre with information on new trends in the use of existing psychoactive substances and/or new combinations of psychoactive substances which pose a potential risk to public health as well as information on possible measures related to public health. 3. The national authorities shall ensure the operation of their focal point for the collection and analysis of data at national level on the basis of guidelines adopted with the Centre. 4. The specific tasks allocated to the national focal points shall appear in the Centre's three-year programme as referred to in Article 9(4). 5. While fully respecting the primacy of the national focal points, and in close cooperation with them, the Centre may have recourse to additional expertise and sources of information in the field of drugs and drug addiction.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal O ver the past decade there has been a massive growth in new psychoactive substances (NPS), at global level and in Europe as well, and there are no signs of a slowdown. In 2015, 100 new substances were reported for the first time to the EU Early Warning System (EWS), bringing the total number of new substances monitored to more than 560 – with more than 380 (70%) of these detected in the last five years alone. 1 The United Nations General Assembly at the Special Session on the world drug problem (UNGASS, 19-21 April 2016 ) adopted the outcome document "Our joint commitment to effectively addressing and countering the world drug problem" 2 . A specific section deals with addressing emerging and persistent challenges and threats including NPS. The joint commitment calls for strengthening action to address the challenge of NPS as well as for enhancing information-sharing and early warning networks. On 17 September 2013, the Commission put forward a package of two legislative proposals on new psychoactive substances: a proposal for a Regulation on new psychoactive substances 3 and a Directive amending Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking, as regards the definition of drug 4 . The objective was to reduce the availability of new psychoactive substances that pose risk through swifter, more effective action on Union level compared to the currently applicable system based on Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk assessment and control of new psychoactive substances 5 . Inter-institutional negotiations of this legislative package have been ongoing for more than two years. The European Parliament adopted its legislative resolutions on 17 April 2014 6 . The Council did not adopt a general approach on the proposals; during the examination of the proposals Member States expressed doubts concerning the choice of Article 114 of the Treaty on the Functioning of the European Union (TFEU) as the legal basis for the proposed Regulation. To achieve the same objective of a swifter, more effective EU action on NPS, the Permanent Representatives Committee (COREPER) on 6 April 2016 7 agreed to the approach proposed by the Netherlands Presidency in its discussion paper, including amendments of the draft Directive based on Article 83 TFEU that will in particular contain a definition of new psychoactive substances and provisions on swift Union level decision making in order to criminalise harmful new psychoactive substances in all Member States. COREPER also invited the Commission to present a proposal on amending the founding Regulation of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), Regulation 1920/2006 . According to the Summary Record of the 2580th meeting of COREPER this decision triggers the start of the 3 months' opt-in deadline for the Member States concerned by Protocol 21 and has consequences under Protocol 22 annexed to the TEU. The European Parliament is informed about this change by a letter from the Council. Given that the decision of COREPER aims to achieve the same objectives as proposed by the package of 2013, the Commission proposes targeted amendments of Regulation 1920/2006 integrating the draft provisions on early warning system and risk assessment procedure that were part of the 2013 Commission proposal for a Regulation on new psychoactive substances into the founding Regulation of the EMCDDA. The Commission will consider the withdrawal of the proposal on a Regulation on new psychoactive substances in preparing Commission's Work Programme for 2017. The new proposal as the previous one aims at strengthening the EU early warning system and the risk assessment and at streamlining procedures to ensure more effective and fast action. Therefore, in order to speed up the process, deadlines are substantially shortened compared to the current system based on Council Decision 2005/387/JHA. For the purpose of swift and effective collection of information on NPS, the EMCDDA should conclude working arrangements with Europol, the European Medicines Agency, the European Chemicals Agency and the European Food Safety Authority without undue delay following the publication of the Regulation in the Official Journal. This proposal also ensures a participation of EUROPOL in the early warning system and risk assessment procedure, in particular as input on the involvement of criminal groups in the manufacture and distribution of new psychoactive substances is concerned. According to Article 23 of Regulation 1920/2006 the Commission may propose, if appropriate, and in the light of developments in respect of regulatory agencies on the basis of the next evaluation of the Centre further amendments to the EMCDDA founding Regulation. Consistency with existing policy provisions in the policy area The proposal reflects the priorities set out by the European Agenda on Security 8 adopted on 28 April 2015. The European Agenda of Security stresses that the market for illicit drugs remains the most dynamic of criminal markets, with a recent trend being the proliferation of new psychoactive substances. It also states that the production of these substances is increasingly taking place in the Union thus pointing to the urgency of adopting a new legislative framework . This proposal has to be read in conjunction with Directive (EU) …/ … [amending Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking 9 ]. Both instruments are designed to replace the mechanism established by Council Decision 2005/387/JHA.
Revised version (Article 5 European Information Network on Drugs and Drug Addiction (Reitox)):
1. The Centre shall have at its disposal the European Information Network on Drugs and Drug Addiction (Reitox). The network shall consist of one focal point for each Member State and each country which has concluded an agreement pursuant to Article 21 and a focal point for the Commission. The designation of the national focal points shall be the exclusive responsibility of the countries concerned. 2. The national focal points shall form an interface between the participating countries and the Centre. They shall contribute to the establishment of key indicators and data, including guidelines for their implementation with a view to obtaining reliable and comparable information at European Union level. They shall collect and analyse in an objective manner at national level, bringing together experience from different sectors – health, justice, law enforcement – in cooperation with experts and national organisations active in the field of drugs policy, all relevant information on drugs and drug addiction, as well as on policies and solutions applied. In particular, they shall provide data for the five epidemiological indicators specified by the Centre. The national focal points may also provide the Centre with information on new trends in the use of existing psychoactive substances and/or new combinations of psychoactive substances which pose a potential risk to public health as well as information on possible measures related to public health. 3. The national authorities shall ensure the operation of their focal point for the collection and analysis of data at national level on the basis of guidelines adopted with the Centre. 4. The specific tasks allocated to the national focal points shall appear in the Centre's three-year programme as referred to in Article 9(4). 5. While fully respecting the primacy of the national focal points, and in close cooperation with them, the Centre may have recourse to additional expertise and sources of information in the field of drugs and drug addiction.
Article 6 Protection and confidentiality of data
1. Data on drugs and drug addiction provided to or by the Centre may be published subject to compliance with Community and national rules on the dissemination and confidentiality of information. Personal data may not be published or made accessible to the public. Member States and the national focal points shall be under no obligation to provide information classified as confidential under their national law. 2. Regulation (EC) No 45/2001 shall apply to the Centre.
Article 7 Access to documents
1. Regulation (EC) No 1049/2001 shall apply to documents held by the Centre. 2. The Management Board referred to in Article 9 shall adopt the arrangements for implementing Regulation (EC) No 1049/2001. 3. Decisions taken by the Centre pursuant to Article 8 of Regulation (EC) No 1049/2001 may give rise to the lodging of a complaint to the Ombudsman or form the subject of an action before the Court of Justice of the European Communities, under the conditions laid down in Articles 195 and 230 of the Treaty respectively.
Article 8 Legal capacity and location
1. The Centre shall have legal personality. In each of the Member States, it shall enjoy the most extensive legal capacity accorded to legal persons under their laws. It may, in particular, acquire or dispose of movable and immovable property and may be a party to legal proceedings. 2. The seat of the Centre shall be located in Lisbon.
Article 9 Management Board
1. The Centre shall have a Management Board consisting of one representative from each Member State, two representatives from the Commission, two independent experts particularly knowledgeable in the field of drugs designated by the European Parliament and one representative from each country which has concluded an agreement pursuant to Article 21. Each member of the Management Board shall have one vote, except for the representatives of the countries which have concluded agreements pursuant to Article 21, who shall not have the right to vote. The decisions of the Management Board shall be taken by a two-thirds majority of the members with a right to vote, except in the cases provided for in paragraph 6 of this Article and in Article 20. Each member of the Management Board may be assisted or represented by a substitute. Where a full member who has the right to vote is absent, his or her substitute may exercise that right. The Management Board may invite as non-voting observers representatives of international organisations with which the Centre cooperates in accordance with Article 20. 2. The Chairperson and Vice-Chairperson of the Management Board shall be elected from amongst and by its members for a three-year period. Their terms of office shall be renewable once. The Chairperson and Vice-Chairperson shall have the right to take part in the voting. The Management Board shall draw up its own rules of procedure. 3. The meetings of the Management Board shall be convened by its Chairperson. It shall hold an ordinary meeting at least once a year. The Centre's Director, as referred to in Article 11, shall take part in the meetings of the Management Board, without voting rights, and shall, under Article 11(3), provide for the Board's Secretariat. 4. The Management Board shall adopt a three-year work programme on the basis of a draft submitted by the Director, after consulting the Scientific Committee referred to in Article 13 and obtaining the opinion of the Commission, and shall forward it to the European Parliament, the Council and the Commission. 5. Under the three-year work programme, the Management Board shall adopt each year the Centre's annual work programme on the basis of a draft submitted by the Director, after consulting the Scientific Committee and obtaining the opinion of the Commission. The work programme shall be forwarded to the European Parliament, the Council and the Commission. It may be adjusted in the course of the year in accordance with the same procedure. 6. Where the Commission expresses its disagreement with the three-year or annual work programme, those programmes shall be adopted by the Management Board by a three-fourths majority of the members with a right to vote. 7. The Management Board shall adopt the annual report on the Centre's activities and forward it by 15 June to the European Parliament, the Council, the Commission, the Court of Auditors and the Member States. 8. The Centre shall forward annually to the budgetary authority any information relevant to the outcome of the evaluation procedures.
Article 10 Executive Committee
1. The Management Board shall be assisted by an Executive Committee. The Executive Committee shall be made up of the Chairperson and the Vice-Chairperson of the Management Board, two other members of the Management Board representing the Member States and appointed by the Management Board and two Commission representatives. The Director shall take part in meetings of the Executive Committee. 2. The Executive Committee shall meet at least twice a year and whenever necessary to prepare the decisions of the Management Board and to assist and advise the Director. It shall decide on behalf of the Management Board on those matters provided for in the financial rules adopted pursuant to Article 15(10) that are not reserved to the Management Board by this Regulation. Decisions shall be adopted by consensus.
Article 11 Director
1. The Centre shall be headed by a Director appointed by the Management Board on a proposal from the Commission for a five-year term, which shall be renewable. 2. Before appointment to a first term, out of a maximum of two terms, the candidate selected by the Management Board for the post of Director shall be invited without delay to make a statement before the European Parliament and answer questions put by members of that institution. 3. The Director shall be responsible for: (a) preparing and implementing the decisions and programmes adopted by the Management Board, (b) day-to-day administration, (c) preparing the Centre's work programmes, (d) the preparation of the draft estimate of the Centre's revenue and expenditure and the implementation of the budget, (e) the preparation and publication of the reports provided for in this Regulation, (f) managing all staff-related matters, and in particular exercising the powers which are devolved on the appointing authority, (g) defining the Centre's organisational structure and submitting it to the Management Board for approval, (h) the performance of the tasks referred to in Articles 1 and 2, (i) carrying out a regular assessment of the Centre's work. 4. The Director shall be accountable for his activities to the Management Board. 5. The Director shall be the Centre's legal representative.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal O ver the past decade there has been a massive growth in new psychoactive substances (NPS), at global level and in Europe as well, and there are no signs of a slowdown. In 2015, 100 new substances were reported for the first time to the EU Early Warning System (EWS), bringing the total number of new substances monitored to more than 560 – with more than 380 (70%) of these detected in the last five years alone. 1 The United Nations General Assembly at the Special Session on the world drug problem (UNGASS, 19-21 April 2016 ) adopted the outcome document "Our joint commitment to effectively addressing and countering the world drug problem" 2 . A specific section deals with addressing emerging and persistent challenges and threats including NPS. The joint commitment calls for strengthening action to address the challenge of NPS as well as for enhancing information-sharing and early warning networks. On 17 September 2013, the Commission put forward a package of two legislative proposals on new psychoactive substances: a proposal for a Regulation on new psychoactive substances 3 and a Directive amending Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking, as regards the definition of drug 4 . The objective was to reduce the availability of new psychoactive substances that pose risk through swifter, more effective action on Union level compared to the currently applicable system based on Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk assessment and control of new psychoactive substances 5 . Inter-institutional negotiations of this legislative package have been ongoing for more than two years. The European Parliament adopted its legislative resolutions on 17 April 2014 6 . The Council did not adopt a general approach on the proposals; during the examination of the proposals Member States expressed doubts concerning the choice of Article 114 of the Treaty on the Functioning of the European Union (TFEU) as the legal basis for the proposed Regulation. To achieve the same objective of a swifter, more effective EU action on NPS, the Permanent Representatives Committee (COREPER) on 6 April 2016 7 agreed to the approach proposed by the Netherlands Presidency in its discussion paper, including amendments of the draft Directive based on Article 83 TFEU that will in particular contain a definition of new psychoactive substances and provisions on swift Union level decision making in order to criminalise harmful new psychoactive substances in all Member States. COREPER also invited the Commission to present a proposal on amending the founding Regulation of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), Regulation 1920/2006 . According to the Summary Record of the 2580th meeting of COREPER this decision triggers the start of the 3 months' opt-in deadline for the Member States concerned by Protocol 21 and has consequences under Protocol 22 annexed to the TEU. The European Parliament is informed about this change by a letter from the Council. Given that the decision of COREPER aims to achieve the same objectives as proposed by the package of 2013, the Commission proposes targeted amendments of Regulation 1920/2006 integrating the draft provisions on early warning system and risk assessment procedure that were part of the 2013 Commission proposal for a Regulation on new psychoactive substances into the founding Regulation of the EMCDDA. The Commission will consider the withdrawal of the proposal on a Regulation on new psychoactive substances in preparing Commission's Work Programme for 2017. The new proposal as the previous one aims at strengthening the EU early warning system and the risk assessment and at streamlining procedures to ensure more effective and fast action. Therefore, in order to speed up the process, deadlines are substantially shortened compared to the current system based on Council Decision 2005/387/JHA. For the purpose of swift and effective collection of information on NPS, the EMCDDA should conclude working arrangements with Europol, the European Medicines Agency, the European Chemicals Agency and the European Food Safety Authority without undue delay following the publication of the Regulation in the Official Journal. This proposal also ensures a participation of EUROPOL in the early warning system and risk assessment procedure, in particular as input on the involvement of criminal groups in the manufacture and distribution of new psychoactive substances is concerned. According to Article 23 of Regulation 1920/2006 the Commission may propose, if appropriate, and in the light of developments in respect of regulatory agencies on the basis of the next evaluation of the Centre further amendments to the EMCDDA founding Regulation. Consistency with existing policy provisions in the policy area The proposal reflects the priorities set out by the European Agenda on Security 8 adopted on 28 April 2015. The European Agenda of Security stresses that the market for illicit drugs remains the most dynamic of criminal markets, with a recent trend being the proliferation of new psychoactive substances. It also states that the production of these substances is increasingly taking place in the Union thus pointing to the urgency of adopting a new legislative framework . This proposal has to be read in conjunction with Directive (EU) …/ … [amending Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking 9 ]. Both instruments are designed to replace the mechanism established by Council Decision 2005/387/JHA.
Revised version (Article 11 Director):
1. The Centre shall be headed by a Director appointed by the Management Board on a proposal from the Commission for a five-year term, which shall be renewable. 2. Before appointment to a first term, out of a maximum of two terms, the candidate selected by the Management Board for the post of Director shall be invited without delay to make a statement before the European Parliament and answer questions put by members of that institution. 4. The Director shall be accountable for his activities to the Management Board. 5. The Director shall be the Centre's legal representative.
Article 12 Hearing of the Director and of the Chairperson of the Management Board before the European Parliament
Each year the Director shall submit to the European Parliament the general report on the Centre's activities. The European Parliament may also ask for a hearing with the Director and the Chairperson of the Management Board on any subject related to the Centre's activities.
Article 13 Scientific Committee
1. The Management Board and the Director shall be assisted by a Scientific Committee which shall deliver an opinion where provided for in this Regulation on any scientific matter concerning the Centre's activities which the Management Board or the Director may submit to it. The opinions of the Scientific Committee shall be published. 2. The Scientific Committee shall consist of at most fifteen well-known scientists appointed in view of their scientific excellence and their independence by the Management Board, following the publication of a call for expressions of interest in the Official Journal of the European Union . The selection procedure shall ensure that the specialist fields of the members of the Scientific Committee cover the most relevant scientific fields linked to the problems of drugs and drug addiction. The members of the Scientific Committee shall be appointed in a personal capacity and shall give their opinions completely independently of the Member States and the Community Institutions. The Scientific Committee shall take into account the various positions expressed in national expert opinions, if available, before delivering any opinion. For the purpose of implementing Decision 2005/387/JHA, the Scientific Committee may be extended following the procedure laid down in Article 6(2) of that Decision. 3. Members shall serve on the Scientific Committee for a three-year period, which shall be renewable. 4. The Scientific Committee shall elect its chairperson for a three-year period. It shall be convened by its chairperson at least once a year.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal O ver the past decade there has been a massive growth in new psychoactive substances (NPS), at global level and in Europe as well, and there are no signs of a slowdown. In 2015, 100 new substances were reported for the first time to the EU Early Warning System (EWS), bringing the total number of new substances monitored to more than 560 – with more than 380 (70%) of these detected in the last five years alone. 1 The United Nations General Assembly at the Special Session on the world drug problem (UNGASS, 19-21 April 2016 ) adopted the outcome document "Our joint commitment to effectively addressing and countering the world drug problem" 2 . A specific section deals with addressing emerging and persistent challenges and threats including NPS. The joint commitment calls for strengthening action to address the challenge of NPS as well as for enhancing information-sharing and early warning networks. On 17 September 2013, the Commission put forward a package of two legislative proposals on new psychoactive substances: a proposal for a Regulation on new psychoactive substances 3 and a Directive amending Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking, as regards the definition of drug 4 . The objective was to reduce the availability of new psychoactive substances that pose risk through swifter, more effective action on Union level compared to the currently applicable system based on Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk assessment and control of new psychoactive substances 5 . Inter-institutional negotiations of this legislative package have been ongoing for more than two years. The European Parliament adopted its legislative resolutions on 17 April 2014 6 . The Council did not adopt a general approach on the proposals; during the examination of the proposals Member States expressed doubts concerning the choice of Article 114 of the Treaty on the Functioning of the European Union (TFEU) as the legal basis for the proposed Regulation. To achieve the same objective of a swifter, more effective EU action on NPS, the Permanent Representatives Committee (COREPER) on 6 April 2016 7 agreed to the approach proposed by the Netherlands Presidency in its discussion paper, including amendments of the draft Directive based on Article 83 TFEU that will in particular contain a definition of new psychoactive substances and provisions on swift Union level decision making in order to criminalise harmful new psychoactive substances in all Member States. COREPER also invited the Commission to present a proposal on amending the founding Regulation of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), Regulation 1920/2006 . According to the Summary Record of the 2580th meeting of COREPER this decision triggers the start of the 3 months' opt-in deadline for the Member States concerned by Protocol 21 and has consequences under Protocol 22 annexed to the TEU. The European Parliament is informed about this change by a letter from the Council. Given that the decision of COREPER aims to achieve the same objectives as proposed by the package of 2013, the Commission proposes targeted amendments of Regulation 1920/2006 integrating the draft provisions on early warning system and risk assessment procedure that were part of the 2013 Commission proposal for a Regulation on new psychoactive substances into the founding Regulation of the EMCDDA. The Commission will consider the withdrawal of the proposal on a Regulation on new psychoactive substances in preparing Commission's Work Programme for 2017. The new proposal as the previous one aims at strengthening the EU early warning system and the risk assessment and at streamlining procedures to ensure more effective and fast action. Therefore, in order to speed up the process, deadlines are substantially shortened compared to the current system based on Council Decision 2005/387/JHA. For the purpose of swift and effective collection of information on NPS, the EMCDDA should conclude working arrangements with Europol, the European Medicines Agency, the European Chemicals Agency and the European Food Safety Authority without undue delay following the publication of the Regulation in the Official Journal. This proposal also ensures a participation of EUROPOL in the early warning system and risk assessment procedure, in particular as input on the involvement of criminal groups in the manufacture and distribution of new psychoactive substances is concerned. According to Article 23 of Regulation 1920/2006 the Commission may propose, if appropriate, and in the light of developments in respect of regulatory agencies on the basis of the next evaluation of the Centre further amendments to the EMCDDA founding Regulation. Consistency with existing policy provisions in the policy area The proposal reflects the priorities set out by the European Agenda on Security 8 adopted on 28 April 2015. The European Agenda of Security stresses that the market for illicit drugs remains the most dynamic of criminal markets, with a recent trend being the proliferation of new psychoactive substances. It also states that the production of these substances is increasingly taking place in the Union thus pointing to the urgency of adopting a new legislative framework . This proposal has to be read in conjunction with Directive (EU) …/ … [amending Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking 9 ]. Both instruments are designed to replace the mechanism established by Council Decision 2005/387/JHA.
Revised version (Article 13 Scientific Committee):
1. The Management Board and the Director shall be assisted by a Scientific Committee which shall deliver an opinion where provided for in this Regulation on any scientific matter concerning the Centre's activities which the Management Board or the Director may submit to it. The opinions of the Scientific Committee shall be published. 2. The Scientific Committee shall consist of at most fifteen well-known scientists appointed in view of their scientific excellence and their independence by the Management Board, following the publication of a call for expressions of interest in the Official Journal of the European Union . The selection procedure shall ensure that the specialist fields of the members of the Scientific Committee cover the most relevant scientific fields linked to the problems of drugs and drug addiction. The members of the Scientific Committee shall be appointed in a personal capacity and shall give their opinions completely independently of the Member States and the Community Institutions. The Scientific Committee shall take into account the various positions expressed in national expert opinions, if available, before delivering any opinion. For the purpose of assessing the risks posed by the new psychoactive substance or group of new psychoactive substances, the Scientific Committee may be extended following the procedure laid down in Article 5c(4). 3. Members shall serve on the Scientific Committee for a three-year period, which shall be renewable. 4. The Scientific Committee shall elect its chairperson for a three-year period. It shall be convened by its chairperson at least once a year.
Article 14 Drawing up of the budget
1. Estimates of all the revenue and expenditure of the Centre shall be prepared for each financial year, corresponding to the calendar year, and shall be shown in the budget of the Centre. 2. The revenue and expenditure shown in the budget shall be in balance. 3. The Centre's revenue shall, without prejudice to other resources, consist of a subsidy from the Community entered in the general budget of the European Union (Commission Section), payments for services rendered and any financial contributions from the organisations and bodies and third countries referred to in Articles 20 and 21 respectively. 4. The Centre's expenditure shall include: (a) staff remuneration, administrative and infrastructure expenses, and operating costs; (b) expenditure in support of the Reitox focal points. 5. Each year the Management Board, on the basis of a draft drawn up by the Director, shall produce an estimate of revenue and expenditure for the Centre for the following financial year. This estimate, which shall include a draft establishment plan, shall be forwarded by the Management Board to the Commission by 31 March, together with the Centre's work programme. The estimate shall be forwarded by the Commission to the European Parliament and the Council (hereinafter referred to as the ‘budgetary authority’) together with the preliminary draft general budget of the European Union. 6. On the basis of the estimate, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty. 7. The budgetary authority shall authorise the appropriations for the subsidy to the Centre and shall adopt the establishment plan for the Centre. 8. The budget shall be adopted by the Management Board. It shall become final following final adoption of the general budget of the European Union. Where appropriate, it shall be adjusted accordingly. 9. The Management Board shall, as soon as possible, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of the budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof. Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks from the date of notification of the project.
Article 15 Implementation of the budget
1. The Director shall implement the Centre's budget. 2. By 1 March following each financial year, the Centre's accounting officer shall communicate the provisional accounts to the Commission's accounting officer together with a report on the budgetary and financial management for that financial year. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities ( 11 ) (hereinafter referred to as ‘the general Financial Regulation’). 3. By 31 March following each financial year, the Commission's accounting officer shall forward the Centre's provisional accounts to the Court of Auditors, together with a report on the budgetary and financial management for that financial year. The report on the budgetary and financial management for the financial year shall also be forwarded to the European Parliament and to the Council. 4. On receipt of the Court of Auditors' observations on the Centre's provisional accounts, pursuant to Article 129 of the general Financial Regulation, the Director shall draw up the Centre's final accounts under his own responsibility and submit them to the Management Board for an opinion. 5. The Management Board shall deliver an opinion on the Centre's final accounts. 6. The Director shall, by 1 July following each financial year, forward the final accounts to the European Parliament, the Council, the Commission and the Court of Auditors, together with the Management Board's opinion. The final accounts shall be published. 7. The Director shall send the Court of Auditors a reply to its observations by 30 September. He shall also send this reply to the Management Board. 8. The Director shall submit to the European Parliament, at the latter's request, any information required for the smooth application of the discharge procedure for the financial year in question, as laid down in Article 146(3) of the general Financial Regulation. 9. The European Parliament, on a recommendation from the Council acting by a qualified majority, shall, before 30 April of year N + 2, give a discharge to the Director in respect of the implementation of the budget for year N. 10. The financial rules applicable to the Centre shall be adopted by the Management Board after the Commission has been consulted. They may not depart from Commission Regulation (EC, Euratom) No 2343/2002 ( 12 ) on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 unless specifically required for the Centre's operation and with the Commission's prior consent.
Article 16 Combating fraud
1. In order to combat fraud, corruption and any other illegal activities affecting the Communities' financial interests, the provisions of Regulation (EC) No 1073/1999 shall apply without restriction to the Centre. 2. The decisions concerning funding and the implementing agreements and instruments resulting from them shall explicitly stipulate that the Court of Auditors and OLAF may carry out, if necessary, on-the-spot checks at the premises of the recipients of the Centre's funding.
Article 17 Privileges and immunities
The Protocol on the Privileges and Immunities of the European Communities shall apply to the Centre.
Article 18 Staff Regulations
The Staff Regulations of officials of the European Communities and the Conditions of Employment of other servants of the European Communities and the rules adopted jointly by the Community Institutions for the purpose of applying those Staff Regulations and Conditions of Employment shall apply to the staff of the Centre. Where it engages staff from third countries following the conclusion of the agreements referred to in Article 21, the Centre shall, in any event, comply with the Staff Regulations and Conditions of Employment referred to in paragraph 1 of this Article. The Centre shall exercise in respect of its staff the powers devolved to the appointing authority. The Management Board shall, in agreement with the Commission, adopt the appropriate implementing rules in accordance with the Staff Regulations, Article 110, and the Conditions of Employment referred to in paragraph 1. The Management Board may adopt provisions to allow national experts from other Member States to be employed on secondment at the Centre.
Article 19 Liability
1. The contractual liability of the Centre shall be governed by the law applicable to the contract in question. The Court of Justice shall have jurisdiction pursuant to an arbitration clause contained in a contract concluded by the Centre. 2. In the case of non-contractual liability, the Centre shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by the Centre or its staff in the performance of their duties. The Court of Justice shall have jurisdiction in disputes relating to the compensation of any such damage. 3. The personal liability of its staff towards the Centre shall be governed by the provisions applying to the staff of the Centre.
Article 20 Cooperation with other organisations and bodies
Without prejudice to relations which the Commission may maintain pursuant to Article 302 of the Treaty, the Centre shall actively seek to cooperate with international organisations and other, particularly European, governmental and non-governmental bodies competent in the sector of drugs. Such cooperation shall be based on working arrangements concluded with the organisations and bodies referred to in the first paragraph. Those arrangements shall be adopted by the Management Board on the basis of a draft submitted by the Director and after the Commission has delivered an opinion. Where the Commission expresses its disagreement with these arrangements, the Management Board shall adopt them by a three-fourths majority of the members with a right to vote.
Article 21 Participation of third countries
The Centre shall be open to the participation of any third country that shares the interest of the Community and of its Member States in the Centre's objectives and work, on the basis of agreements entered into between such third countries and the Community on the basis of Article 300 of the Treaty.
Article 22 Jurisdiction of the Court of Justice
The Court of Justice shall have jurisdiction in actions brought against the Centre under Article 230 of the Treaty.
Article 23 Evaluation report
The Commission shall initiate an external evaluation of the Centre every six years to coincide with the completion of two of the Centre's three-year work programmes. Such evaluations shall also include the Reitox system. The Commission shall forward the evaluation report to the European Parliament, the Council and the Management Board. In that context, the Commission shall, if appropriate, present a proposal for revision of the provisions of this Regulation in the light of developments in respect of regulatory agencies, in accordance with the procedure laid down in Article 251 of the Treaty.
Article 24 Repeal
Regulation (EEC) No 302/93 is hereby repealed. References made to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex III.
Article 25 Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .