Annexes to COM(2022)18 - EU Drugs Agency - Main contents

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dossier	COM(2022)18 - EU Drugs Agency.
document	COM(2022)18
date	June 27, 2023

agreements, reported separately under section 4.3 of the EU budget. Recruitement dates are planned at mid-year. The amounts have been adapted accordingly: the costs of newly recruited staff have been estimated at 50% of the average costs for their recruitment year. The proposed addition in staff is deemed to increase efficiency of operations, since the number of administrative staff remains unchanged.

3.2.3.2.Estimated requirements of human resources for the parent DG

–◻ The proposal/initiative does not require the use of human resources.

–⌧ The proposal/initiative requires the use of human resources, as explained below:

Estimate to be expressed in full amounts (or at most to one decimal place)

	Year 2024	Year 2025	Year 2026	Year 2027
·Establishment plan posts (officials and temporary staff)
20 01 02 01 and 20 01 02 02 (Headquarters and Commission’s Representation Offices)	1	1	1	1
20 01 02 03 (Delegations)
01 01 01 01 (Indirect research)
10 01 05 01 (Direct research)

• External staff (in Full Time Equivalent unit: FTE) ⁹¹
20 02 01 (AC, END, INT from the ‘global envelope’)
20 02 03 (AC, AL, END, INT and JPD in the Delegations)
Budget line(s) (specify) ⁹²	- at Headquarters ⁹³
	- in Delegations
01 01 01 02 (AC, END, INT – Indirect research)
10 01 05 02 (AC, END, INT – Direct research)
Other budget lines (specify)
TOTAL	1	1	1	1

The human resources required will be met by staff from the DG who are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.

Description of tasks to be carried out:

Officials and temporary staff	Represent the Commission in the Management Board of the Agency. Draw up Commission opinion on the annual work programme and monitor its implementation. Monitor implementation of the budget. Assist the Agency in developing its activities in line with EU policies, including by participating in experts meetings.
External staff	No external staff foreseen

Description of the calculation of cost for FTE units should be included in the Annex V, section 3.

3.2.4.Compatibility with the current multiannual financial framework

–◻    The proposal/initiative is compatible the current multiannual financial framework.

–⌧    The proposal/initiative will entail reprogramming of the relevant heading in the multiannual financial framework.

Explain what reprogramming is required, specifying the budget lines concerned and the corresponding amounts.

The proposal includes additional financial and human resources for EMCDDA compared to what is currently budgeted in the MFF proposal (Fiche N°68). The budgetary impact of the additional financial resources for EMCDDA will be offset through a compensatory reduction from programmed spending under Heading 4.

–◻    The proposal/initiative requires application of the flexibility instrument or revision of the multiannual financial framework ⁹⁴ .

Explain what is required, specifying the headings and budget lines concerned and the corresponding amounts.

3.2.5.Third-party contributions

–⌧    The proposal/initiative does not provide for co-financing by third parties.

–The proposal/initiative provides for the co-financing estimated below:

EUR million (to three decimal places)

	Year N	Year N+1	Year N+2	Year N+3	Enter as many years as necessary to show the duration of the impact (see point 1.6)	Total
Specify the co-financing body
TOTAL appropriations co-financed

3.3.Estimated impact on revenue

–⌧    The proposal/initiative has no financial impact on revenue.

–◻    The proposal/initiative has the following financial impact:

–◻    on own resources

–◻    on other revenue

– ◻ please indicate, if the revenue is assigned to expenditure lines

EUR million (to three decimal places)

Budget revenue line:	Appropriations available for the current financial year	Impact of the proposal/initiative ⁹⁵
		Year N	Year N+1	Year N+2	Year N+3	Enter as many years as necessary to show the duration of the impact (see point 1.6)
Article ………….

For miscellaneous ‘assigned’ revenue, specify the budget expenditure line(s) affected.

Specify the method for calculating the impact on revenue.

(1) European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), European Drug Report 2021, European Drug Report 2021 | www.emcdda.europa.eu .
(2) In 2019, more than 370 illegal drug production laboratories were dismantled in Europe; European Drug Report 2021.
(3) EMCDDA/Europol, EU Drug Markets Report 2019, https://www.emcdda.europa.eu/2019/drug-markets .
(4) See Transcrime, From illegal markets to legitimate businesses: the portfolio of organised crime in Europe, 2015, http://www.transcrime.it/wp-content/uploads/2015/03/OCP-Full-Report.pdf ; Europol, Serious and Organised Crime Threat Assessment (SOCTA), 2021.
(5) This includes the misuse of benzodiazepines diverted from therapeutic use or appearing as new benzodiazepines. ‘New benzodiazepines’ are defined as new psychoactive substances that contain a benzodiazepine core, and that are not controlled under the international drug control system.
(6) The World Health Organisation defines poly-drug use as the use of more than one substance or type of substance by an individual consumed at the same time or sequentially within a short period of time. Source: https://www.who.int/substance_abuse/terminology/who_lexicon/en/ .
(7) EMCDDA/Europol, EU Drug Markets Report 2019, https://www.emcdda.europa.eu/2019/drug-markets.
(8) EMCDDA, European Drug Report 2021; EMCDDA, Impact of COVID-19 on drug markets, use, harms and drug services in the community and prisons, April 2021 | www.emcdda.europa.eu.
(9) OJ C 102I , 24.3.2021, p. 1.
(10) OJ C 272, 8.7.2021, p. 2.
(11) Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (recast), OJ L 376, 27.12.2006, p. 1–13
(12) EU Drugs Strategy 2021-2025, Strategic Priority 11, point 5.
(13) COM(2019) 228.
(14) For details, see the preferred option described below in Section 3.
(15) The common approach on EU decentralised agencies puts in place a comprehensive set of guiding principles to make the functioning of the EU’s decentralised agencies more coherent, effective and accountable; see Joint Statement of the European Parliament, the Council of the European Union and the European Commission on decentralised agencies – Common Approach, 2012; https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf .
(16) Regulation (EU) 2017/2101 of the European Parliament and of the Council of 15 November 2017 amending Regulation (EC) 1920/2006 as regards information exchange on, and an early warning system and risk assessment procedure for, new psychoactive substances (OJ L 305, 21.11.2017, p. 1).
(17) OJ L 335, 11.11.2004, p. 8. See also Directive (EU) 2017/2103 of the European Parliament and of the Council of 15 November 2017 amending Council Framework Decision 2004/757/JHA in order to include new psychoactive substances in the definition of ‘drug’ and repealing Council Decision 2005/387/JHA (OJ L 305, 21.11.2017, p. 12). Commission Delegated Directive (EU) 2019/369 of 13 December 2018 amending the Annex to Council Framework Decision 2004/757/JHA as regards the inclusion of new psychoactive substances in the definition of ‘drug’ (OJ L 66, 7.3.2019, p. 3); Commission Delegated Directive (EU) 2020/1687 of 2 September 2020 amending the Annex to Council Framework Decision 2004/757/JHA as regards the inclusion of the new psychoactive substance N,N-diethyl-2-[[4-(1-methylethoxy)phenyl]methyl]-5-nitro-1H-benzimidazole-1-ethanamine (isotonitazene) in the definition of ‘drug’ (OJ L 379, 13.11.2020, p. 55); Commission Delegated Directive (EU) 2021/802 of 12 March 2021 amending the Annex to Council Framework Decision 2004/757/JHA as regards the inclusion of the new psychoactive substances methyl 3,3-dimethyl-2-{[1-(pent-4-en-1-yl)-1H-indazole-3-carbonyl]amino}butanoate (MDMB-4en-PINACA) and methyl 2-{[1-(4-fluorobutyl)-1H-indole-3-carbonyl]amino}-3,3-dimethylbutanoate (4F-MDMB-BICA) in the definition of ‘drug’ (OJ L 178, 20.5.2021, p. 1).
(18) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, p. 53–114).
(19) Regulation (EU) 2018/1727 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA (OJ L 295, 21.11.2018, p. 138–183).
(20) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1–33).
(21) Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control (OJ L 142, 30.4.2004, p. 1–11).
(22) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1–68).
(23) Regulation (EU) No 513/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for police cooperation, preventing and combating crime, and crisis management and repealing Council Decision 2007/125/JHA (OJ L 150, 20.5.2014, p. 93–111). See also the Commission proposal for the Internal Security Fund for the next multiannual financial framework (COM(2018) 472 final).
(24) Regulation (EU) No 1382/2013 of the European Parliament and of the Council of 17 December 2013 establishing a Justice Programme for the period 2014 to 2020 (OJ L 354, 28.12.2013, p. 73–83).
(25) Regulation (EU) 2021/522 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, p. 1–29).
(26) COM(2018) 435 final.
(27) Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1–15); see also the Commission proposal for a Regulation of the European Parliament and the Council on serious cross-border threats to health and repealing Decision No 1082/2013/EU, COM(2020) 727 final.
(28) Commission Implementing Decision (EU) 2017/253 of 13 February 2017 laying down procedures for the notification of alerts as part of the early warning and response system established in relation to serious cross-border threats to health and for the information exchange, consultation and coordination of responses to such threats pursuant to Decision No 1082/2013/EU of the European Parliament and of the Council (OJ L 37, 14.2.2017, p. 23–27), which includes illicit drugs related threats.
(29) For Europol, see COM(2020) 796 final; for the health agencies, see in general COM(2020) 724, and in more detail for EMA COM(2020) 725 and for ECDC COM(2020) 726.
(30) The related inception impact assessment can be found under the following link: European Health Emergency Preparedness and Response Authority (HERA) (europa.eu) .
(31) SWD(2019) 174.
(32) ICF, Final report – External evaluation of the EMCDDA, November 2018; link: https://op.europa.eu/en/publication-detail/-/publication/4eaca79c-72f6-11e9-9f05-01aa75ed71a1/language-en/format-PDF/source-search .
(33) COM(2019) 228.
(34) SWD(2019) 174.
(35) A summary of the main outcomes can also be found in Section 2.1 of the Impact Assessment.
(36) Policy option 0: Baseline scenario – Maintaining the current approach without changes; Policy option 1: Minimal revision - Stronger cooperation; Policy option 2: Dismantling of the Agency – Repeal of the founding Regulation; Policy option 3: Merging of the Agency with another EU body.
(37) See footnote 15.
(38) See section on “Subsidiarity”, page 5. No quantitative data is available regarding the simplification and burden reduction potential. The recent evaluation of the EU Drugs Strategy 2013-2020 concluded that there is no information available on the resources dedicated by Member States to drug-related issues. See Evaluation of the EU Drugs Strategy 2013-2020 and EU Action Plan on Drugs 2017-2020, SWD(2020) 150 final.
(39) For example, the work on alternatives to coercive sanctions, the work on minimum quality standards in drug demand reduction, best practices on treatment and harm reduction.
(40) For details, see the Financial Legislative Statement in Annex I.
(41) Council documents 12837/19, 12496/19, 7829/20.
(42) Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (OJ L 122, 10.5.2019, p. 1–38).
(43) OJ L 56, 4.3.1968, p. 1.
(44) OJ C , , p. .
(45) OJ C , , p. .
(46) Council Regulation (EEC) No 302/93 of 8 February 1993 on the establishment of a European Monitoring Centre for Drugs and Drug Addiction (OJ L 36, 12.2.1993, L. 1).
(47) Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (recast) (OJ L 376, 27.12.2006, p. 1).
(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/body/joint_statement_and_common_approach_2012_en.pdf.
(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).
(50) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1).
(51) OJ L 136, 31.5.1999, p. 15.
(52) 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 (OJ L 335 11.11.2004, p. 8).
(53) Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (OJ L 47, 18.2.2004, p. 1).
(54) Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors (OJ L 22, 26.1.2005, p. 1).
(55) United Nations Treaty Series, vol. 976, No. 14152.
(56) United Nations Treaty Series, vol. 1019, No. 14956.
(57) United Nations, Treaty Series, vol. 1582, No. 27627.
(58) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(59) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).
(60) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
(61) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
(62) Regulation (EEC, Euratom, ECSC) No 259/68 of the Council of 29 February 1968 laying down the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Communities and instituting special measures temporarily applicable to officials of the Commission (OJ L 56, 4.3.1968, p. 1)
(63) Commission Decision 1999/352/EC, ECSC, Euratom of 28 April 1999 establishing the European Anti-fraud Office (OLAF) (OJ L 136, 31.5.1999, p. 20).
(64) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L 283 31.10.2017, p. 1).
(65) Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council, (OJ L 122, 10.5.2019, p. 1).
(66) OJ L 122, 10.5.2019, p. 1.
(67) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
(68) Council Regulation No 1 determining the languages to be used by the European Economic Community (OJ 17, 6.10.1958, p. 385).
(69) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
(70) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999, (OJ L 248, 18.9.2013, p. 1).
(71) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2).
(72) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41).
(73) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53).
(74) As referred to in Article 58(2)(a) or (b) of the Financial Regulation.
(75) The fourth evaluation of EMCDDA, ref. COM(2019) 228.
(76) Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006on the European Monitoring Centre for Drugs and Drug Addiction (recast)
(77) Reitox is an abbreviation used for the European Information Network on Drugs and Drug Addiction
(78) For instance, the key drugs report at EU level - EU Drug Markets Report – is issued jointly by EMCDDA and Europol. Another example includes cooperation with relevant Justice and Home Affairs Agencies on training for drug law enforcement and judicial decision-makers or in the context of the risk assessment procedure for new psychoactive substances.
(79) Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx .
(80) Working Document of the Commission Services on decentralised agencies and EPPO, 8 June 2020
(81) Regulation (EU) 2017/2101 of the European Parliament and of the Council of 15 November 2017 amending Regulation (EC) No 1920/2006 as regards information exchange on, and an early warning system and risk assessment procedure for, new psychoactive substances. The European Monitoring Centre for Drugs and Drug Addiction was set up by Council Regulation (EEC) No 302/93. This founding act was recast in 2006 through Regulation (EC) No 1920/2006, which was amended through Regulation (EU) No 2017/2101 by integrating the rules as regards information exchange on, and an early warning system and risk assessment procedure for new psychoactive substances.
(82) Financial Regulation of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) - https://www.emcdda.europa.eu/system/files/publications/1013/financial-regulation-emcdda-Jun2019.pdf
(83) https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf
(84) In line with the EMCDDA’s Financial Regulation, Article 30 “Internal control of budget implementation”
(85) Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.
(86) EFTA: European Free Trade Association.
(87) Candidate countries and, where applicable, potential candidates from the Western Balkans.
(88) Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).
(89) Staff levels indicated in Draft Budget 2022, with the assumption that staff will stay stable until 2024, calculated on the basis of the average staff unit costs to be used for LFS, indexed to the correction coefficient for Portugal (91,1%).
(90) It is not possible at this stage to provide the detailed allocation between temporary agent – AD and temporary agents – AST. The costs estimates for staff have been made on the basis of the average costs for temporary agent, indexed to the correction coefficient for Portugal (91,1%).
(91) AC = Contract Staff; AL = Local Staff; END = Seconded National Expert; INT = agency staff; JPD = Junior Professionals in Delegations.
(92) Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines).
(93) Mainly for the EU Cohesion Policy Funds, the European Agricultural Fund for Rural Development (EAFRD) and the European Maritime Fisheries and Aquaculture Fund (EMFAF).
(94) See Articles 12 and 13 of Council Regulation (EU, Euratom) No 2093/2020 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027.
(95) As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 20 % for collection costs.