COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on the European Union Drugs Agency
Date: 2022-01-12
Institutions: Directorate-General for Migration and Home Affairs, European Commission
Subjects: EU office or agency, drug addiction, drug traffic, fight against crime, operation of the Institutions, psychotropic substance

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 12.1.2022  SWD(2022) 8 final  COMMISSION STAFF WORKING DOCUMENT  IMPACT ASSESSMENT  Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on the European Union Drugs Agency {COM(2022) 18 final} - {SWD(2022) 9 final}  
 
 
TABLE OF CONTENTS 

LIST OF ABBREVIATIONS ............................................................................................. 3 

1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT ..................................... 4 

1.1.  Political context ................................................................................................. 4 
1.2.  Legal context ..................................................................................................... 5 

2.  PROBLEM DEFINITION .......................................................................................... 6 

2.1.  Overview of the findings of the evaluation of the EMCDDA ........................... 6 
2.2.  What are the problems for action? ..................................................................... 7 
2.3.  What are the problem drivers? ........................................................................ 11 
2.4.  Who is affected and in what ways? ................................................................. 12 
2.5.  How will the problem evolve? ........................................................................ 14 

3.  WHY SHOULD THE EU ACT? .............................................................................. 15 

3.1.  Legal basis ....................................................................................................... 15 
3.2.  Subsidiarity: Necessity of EU action ............................................................... 15 
3.3.  Subsidiarity: Added value of EU action .......................................................... 16 

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? ..................................................... 16 

4.1.  General objectives ........................................................................................... 16 
4.2.  Specific objectives ........................................................................................... 16 

5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? .......................................... 17 

5.1.  What is the baseline from which options are assessed? .................................. 17 
5.2.  Description of the policy options .................................................................... 18 
5.3.  Options discarded at an early stage ................................................................. 29 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? ................................. 35 

Impacts on the European Union (EU bodies) and value-added ...................... 36 
6.1. 
Impacts on national authorities ........................................................................ 43 
6.2. 
6.3. 
Impacts on simplification and/or administrative burden ................................. 45 
6.1.  Economic impacts ........................................................................................... 46 

7.  HOW DO THE OPTIONS COMPARE? .................................................................. 48 

Specific objective 1: To increase the Agency’s capacity to react faster 
and  in  a  more  targeted  way  to  new  challenges  in  the  field  of  drugs, 
harms and addictions, and related threats ........................................................ 48 

7.1.  48 
gdgdgdgdgd ............................................................................................................... 48 
7.2.  Specific  objective  2:  To  deepen  the  monitoring  and  analysis  of  the 
drug phenomenon in Europe, both on the demand and supply side and 
their implications for health and security ........................................................ 50 

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7.3.  Specific objective 3: To clarify the mandate of the Agency as regards 

what substances, behaviours and responses should be covered ...................... 51 
7.4.  Specific objective 4: To make the Agency more operational .......................... 52 
7.5.  Specific objective 5: To provide support to Member States in shaping 

and evaluating their drugs policies .................................................................. 53 

8.  PREFERRED OPTION ............................................................................................. 54 

8.1.  Summary of the preferred option .................................................................... 54 
8.2.  Explanation of the preferred option ................................................................. 55 
8.3. 
Impacts of the preferred option on the EU budget .......................................... 56 
8.4.  Scope for simplification and burden reduction ............................................... 58 

9.  HOW  WILL  ACTUAL 

IMPACTS  BE  MONITORED  AND 

EVALUATED? ......................................................................................................... 59 

OVERVIEW OF ANNEXES ............................................................................................ 61 

ANNEX 1: PROCEDURAL INFORMATION ................................................................ 62 

1. 
2. 
3. 
4. 
5. 

Lead DG, Decide planning/CWP references ................................................... 62 
Organisation and timing .................................................................................. 62 
Consultation of the Regulatory Scrutiny Board .............................................. 63 
Evidence, sources and quality ......................................................................... 68 
Limitations ....................................................................................................... 69 

ANNEX 2: STAKEHOLDER CONSULTATION ........................................................... 70 

1.  Main stakeholder groups ................................................................................. 70 
Exception from the public consultation obligation ......................................... 70 
2. 
Inception Impact Assessment .......................................................................... 71 
3. 

ANNEX 3: WHO IS AFFECTED AND HOW? ............................................................... 74 

1. 
2. 

Summary of benefits ........................................................................................ 74 
Summary of costs ............................................................................................ 75 

ANNEX 4: INTERVENTION LOGIC OF REGULATION (EC) 1920/2006 ................. 79 

ANNEX  5:  PROBLEM,  DRIVERS,  OBJECTIVES  AND  OPTIONS 

(INTERVENTION LOGIC OF THE CURRENT INITIATIVE) ............................. 80 

ANNEX  6:  SCHEMATIC  OVERVIEW  OF  THE  CONTRIBUTION  OF  THE 

POLICY OPTIONS TO THE SPECIFIC OBJECTIVES ......................................... 81 

ANNEX 7: RELEVANT DRUG-RELATED FIGURES ................................................. 82 

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LIST OF ABBREVIATIONS 

Term or acronym 

Meaning or definition 

CEPOL  

DG GROW 

DG SANTE 

DG TAXUD 

ECDC 

EMA 

EMCDDA  

ENFSI 

EU 

Europol 

EWS 

Founding Regulation (of 
the Agency) 

HERA 

MAOC-N 

MDMA 

NPS 

Reitox 

SMEs 

TFEU 

THC 

UN 

European Union Agency for Law Enforcement Training 

Directorate-General for Internal Market, Industry, 
Entrepreneurship and SMEs  

Directorate‑General for Health and Food Safety  

Directorate-General for Taxation and Customs Union 

European Centre for Disease Prevention and Control 

European Medicines Agency 

European Monitoring Centre for Drugs and Drug Addiction 
(also referred to as ‘the Agency’) 

European Network of Forensic Science Institutes 

European Union 

European Union Agency for Law Enforcement Cooperation 

EU Early Warning System on new psychoactive substances 

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. 

European Health Emergency Preparedness and Response 
Authority 

Maritime Analysis and Operations Centre – Narcotics  

Methylenedioxy-methylamphetamine; commonly known as 
“ecstasy” 

New Psychoactive Substances 

European Information Network on Drugs and Drug Addiction 
(Réseau Européen d’Information sur les Drogues et les 
Toxicomanies) 

Small and medium sized enterprises 

Treaty on the Functioning of the European Union 

Tetrahydrocannabinol 

United Nations 

UNODC 

United Nations Office on Drugs and Crime 

3 

 
 
 
 
1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT 

1.1. 

Political context 

Illicit drugs are a complex security and health problem  that affects millions of people in the 
EU and globally. The European Drug Report 20211 points out that 83 million adults in the EU 
are  estimated  to  have  tried  illicit  drugs  during  their  lives.  In  2019,  at  least  5,150  overdose 
deaths  occurred  in  the  EU.  The  report  shows  a  deteriorating  situation  with  the  volumes  of 
cocaine and heroin introduced in the EU at an all-time high. Production of drugs in particular 
synthetic  drugs  (amphetamines  and  MDMA)  takes  place  within  the  EU  for  domestic 
consumption and for export.2 The illicit drug market is estimated at a minimum retail value of 
EUR 30 billion per  year3, and it  remains  the largest  criminal  market  in  the EU and a major 
source of income for organised crime groups4.  

Among people who use drugs, poly-drug use5 is widespread. Cannabis is the most commonly 
used drug. The use of heroin and other opioids continue to be most commonly associated with 
the more harmful forms of drug use.6 The European Drug Report 2021 observed a rise in use 
of  benzodiazepines  among  high-risk  drug  users,  prisoners  and  some  groups  of  recreational 
drug  users,  potentially  reflecting  the  high  availability  and  low  cost  of  these  substances  and 
pandemic-related mental health issues. This is having a detrimental impact on public health. 
Increased  availability  of  other  drugs,  particularly  cocaine  and  some  synthetic  substances,  is 
associated with increased levels of drug related violence and other crimes.7  

The European Monitoring Centre for Drugs and Drug Addiction (‘EMCDDA’; ‘the Agency’) 
was  founded  in  19938  to  address  the  escalating  drugs  problem  in  Europe  at  the  time.  The 
recast of the founding Regulation in 20069 kept the mandate of the Agency largely as it was, 
mainly  making  relevant  institutional  changes.  The  main  substantive  changes  were  the 
mandate  for  sharing  and  promoting  evidence-based  interventions  (‘best  practices’),  the 
inclusion  of  new  psychoactive  substances10,  and  the  transformation  of  the  European 
Information  Network  on  Drugs  and  Drug  Addiction  (‘Reitox’)  network  from  a  computer 
network  to  a  network  of  national  focal  points.  The  revision  of  the  legislation  on  new 
psychoactive substances  in 2017 was the only other occasion when the founding Regulation 

1   EMCDDA, European Drug Report 2021, https://www.emcdda.europa.eu/edr2021.   
2  

In  2019,  more  than  370  illegal  drug  production  laboratories  were  dismantled  in  Europe;  European  Drug 
Report (footnote 1). 
3   See Annex 7, Figure 3. 
4   The proceeds of organised crime  within the EU are estimated at about €110 billion/year. 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; 
and 
Organised Crime Threat Assessment (SOCTA), 2021. 

Europol, 

Serious 

5   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.  The 
concept carries the connotation of illicit use, though alcohol, nicotine, and caffeine are the substances most 
frequently 
Source: 
https://www.who.int/substance_abuse/terminology/who_lexicon/en/.    

combination  with 

industrialized 

societies. 

others 

used 

in 

in 

6   See Annex 7, Figure 1. 
7   EMCDDA/Europol, EU Drug Markets Report 2019, https://www.emcdda.europa.eu/2019/drug-markets.  
8   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. 

9   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. 

10   Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control 

of new psychoactive substances, OJ L 127, 20.5.2005, p. 32.   

4 

 
                                                           
was  adapted.  This  revision  integrated  the  main  provisions  of  the  three-step-approach  of 
controlling new psychoactive substances into the founding Regulation.11  

In 2018/19, the Commission carried out the fourth evaluation of the Agency in line with the 
requirements of the founding Regulation.12 It concluded that the Agency works overall well, 
but  further  improvements  are  possible  in  several  areas,  in  particular  in  view  of  the 
developments of the drug phenomenon. 

As  was  shown  by  the  evaluation  and  by  the  regular  contacts  with  the  Agency  and  its 
stakeholders,  there  is  an  increasing  disconnect  between  the  complexity  of  the  drug 
phenomenon and what the Agency mandate provides for. The founding Regulation does not 
reflect the current reality of the drug phenomenon and is out of step with the tasks the Agency 
needs  to  perform  to  address  the  challenges  of  the  drug  phenomenon  and  the  requests  by  its 
main stakeholders.  

The  drug  phenomenon  represents  an  integral  element  of  the  health  and  security  challenges 
that Europe  faces. With the drugs  landscape developing  constantly  and new drugs  regularly 
coming on the market, the drug phenomenon is becoming more complex and pervasive. This 
situation calls for an enhancement of the efforts at EU level.  

In response, the Commission adopted the EU Agenda and Action Plan on Drugs 2021-2025 in 
July 2020.13 On that basis, the Council adopted in December 2020 the new EU Drugs Strategy 
2021-202514,  which  provides  the  overarching  political  approach  and  priorities  for  EU  drugs 
policy  for  the  next  five  years.  It  advocates  a  balanced,  integrated,  multidisciplinary  and 
evidence-based  approach  to  the  drugs  phenomenon.  The  Strategy  inter  alia  invites  the 
Commission to present a proposal to revise the mandate of the EMCDDA as soon as possible, 
to ensure that the agency plays a stronger part in addressing the current and future challenges 
of the drug phenomenon.15  

This impact assessment report prepares the ground for a targeted revision of the mandate of 
the Agency to address current and future challenges.   

1.2.  Legal context 

The objective of the founding Regulation was to establish a European agency to provide the 
EU  and  its  Member  States  with  factual,  objective,  reliable  and  comparable  information  at 
European level on drugs and drug addiction and their consequences.16  

In order to meet this objective, the key areas of activity of the Agency are defined in Article 2 
of the founding Regulation as follows: collection and analysis of existing data; improvement 
of  data  comparison  methods;  dissemination  of  data;  cooperation  with  European  and 
international bodies and organisations as well as with third countries; information obligations; 
and  exchange  of  information  on,  early  warning  system  for,  and  risk  assessment  of  new 
psychoactive substances. 

11   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, OJ L 305, 21.11.2017, p. 1.  

12   COM(2019) 228.  
13   COM(2020) 606. 
14   OJ C 102I , 24.3.2021, p. 1; see for the related EU Drugs Action Plan 2021-2025, OJ C 272, 8.7.2021, p. 2.   
15   Strategic Priority 11, point 5.  
16   See the intervention logic of the current Regulation in Annex 4 of this report. 

5 

 
 
                                                           
The Regulation sets out the priority areas of the activities of the Agency as follows: 

1)  monitoring the state of the drugs problem, in particular using epidemiological or other 
indicators,  and  monitoring  emerging  trends,  in  particular  those  involving  poly-drug 
use; 

2)  monitoring  the  solutions  applied  to  drug-related  problems;  providing  information  on 
best  practices  in  the  Member  States  and  facilitating  the  exchange  of  such  practices 
among them; 

3)  assessing  the  risks  of  new  psychoactive  substances  and  maintaining  a  rapid 
information system with regard to their use and also regarding new methods of using 
existing psychoactive substances; 

4)  developing tools and instruments to help Member States to monitor and evaluate their 
national  policies  and  the  Commission  to  monitor  and  evaluate  European  Union 
policies. 

The  core  data  is  collected  through  the  Reitox  network.  The  remainder  of  the  founding 
Regulation deals with the organisational set-up of the Agency and horizontal rules about its 
functioning. 

2.  PROBLEM DEFINITION 

The  problem  definition  set  out  in  this  section  is  the  basis  for  the  development  of  the 
intervention logic, which is shown in Annex 5.  

2.1.  Overview of the findings of the evaluation of the EMCDDA 

The  evaluation,  supported  by  a  study  of  a  contractor17,  is  positive  as  regards  the  five 
evaluation criteria, but notes that improvements are possible in several areas. These are set out 
in  the  Commission  report  on  the  evaluation18  and  in  more  detail  in  the  accompanying  Staff 
Working Document19. The main findings can be summarised as follows: 

Relevance:  The  Agency’s  outputs  correspond  well  to  the  needs  expressed  by  stakeholders, 
including  covering  new  topics.  The  relevance  on  national  level  is  more  limited  than  on 
European level as several Member States have wider addiction policies in place. The question 
on whether to broaden the mandate of the Agency to other addictions was assessed in detail, 
but  the  outcome  was  inconclusive.  The  evaluation  concluded  that  there  is  scope  for  more 
engagement with the scientific community, practitioners and the public. It showed a need for 
more  forward-looking  products,  identifying  future  trends  and  risks,  to  better  support  EU 
preparedness and response. 

Effectiveness: The Agency is  recognised as a centre of excellence in providing information 
on  the  drugs  phenomenon  not  only  in  Europe  but  also  internationally.  The  information 
produced  by  the  Agency  is  considered  factual,  objective,  reliable  and  robust,  although 
comparability could be enhanced. The evaluation recognised the positive work of the Agency 
in  monitoring the European drug situation, including through the  EU  early  warning  system. 
The Reitox network has a central role in the collection of information, even if quality varies 

17   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.  

18   COM(2019) 228.  
19   SWD(2019) 174.  

6 

 
 
                                                           
from country to country. The evaluation further assessed that poly-drug use is not sufficiently 
addressed.  The  activities  undertaken  at  international  level  are  compatible  with  the  EU 
priorities  as  the  Agency  brings  the  EU’s  evidence-based  policy-making  about  drugs 
monitoring to third countries, and thus helps improving the global understanding of the drugs 
phenomenon. 

Efficiency: The evaluation concluded that the Agency uses the available human and financial 
resources efficiently. The budget  of the Agency  remained  relatively  flat  over the  evaluation 
period, at approximately EUR 16 million per year, although the Agency’s output has grown 
considerably  over  the  same  period.  The  Agency  is  delivering  the  benefits  envisioned  in  its 
mission  at  a  reasonable  cost.  The  evaluation  identified  scope  for  simplification  and 
improvements, including on the use of information and communications technology and more 
targeted outreach to its main audiences, including online.  

Coherence:  The  multiannual  work  programmes  of  the  Agency  were  well  aligned  with  the 
Agency’s founding Regulation, the EU Drugs Strategy 2013-202020 and the European Agenda 
on Security21. The objectives and activities set out in the Agency’s programming documents 
were  coherent  with  the regulatory framework. The Agency’s work was complimentary with 
the work of the EU institutions and agencies across the relevant strategic objectives. Although 
the Agency increased its focus on security issues, the evaluation concluded that more should 
be done on supply-side issues.  A  common theme across the interviewed  stakeholder  groups 
was the potential for the Agency to take an even more active role on the international stage.  

EU  added  value:  The  EU-level  overview  of  the  drug  situation  provided  by  the  Agency 
helped  the  Member  States  to  improve  their  capacity  to  monitor  and  respond  to  the  drug 
problems.  A  common  methodology  for  data  collection  was  considered  as  not  achievable 
without  the  Agency.  The  Agency’s  engagement  with  national  policy-makers  and  with 
practitioners  could  be  improved.  The  Agency  was  considered  the  most  effective  option  to 
carry  out  the  tasks  allocated  to  it.  As  regards  the  question  of  merging  the  EMCDDA  with 
another  EU  agency  or  its  termination,  the  answers  during  the  consultation  process  were  all 
negative. 

2.2.  What are the problems for action? 

The drug phenomenon has changed considerably since the adoption of the Agency’s current 
mandate through the recast of the founding Regulation in 2006. Whereas the worsening drug 
situation  is  a  much  wider  problem,  this  impact  assessment  report  only  considers  the 
limitations on the Agency due to the current mandate.  

The main supporting evidence for the new challenges of the drug phenomenon, are the annual 
European Drug Reports22 by the EMCDDA and the annual World Drug Report23 by the UN 
Office  on  Drugs  and  Crime  (UNODC).  They  show  the  developments  from  one  year  to  the 
next  and  longer  term  trends.  Another  important  source  are  the  EU  Drug  Markets  Reports24, 
the  third  edition  of  which  was  published  in  autumn  2019  by  the  EMCDDA  and  Europol. 
Many  other  topical  reports  by  the  EMCDDA25,  partly  together  with  other  agencies,  in 
particular  Europol,  and  by  international  organisations,  such  as  the  UNODC  and  the 

20   OJ C 402, 29.12.2012, p. 1.  
21   COM(2015) 185.  
22   https://www.emcdda.europa.eu/publications-database_en?f%5B0%5D=field_series_type%3A404.  
23   https://www.unodc.org/unodc/en/data-and-analysis/wdr2021.html.   
24   https://www.emcdda.europa.eu/publications/joint-publications/eu-drug-markets-report-2019_en.  
25   References are included throughout this report to such topical reports of the Agency. 

7 

 
                                                           
International  Narcotic  Control  Board  (INCB),26  can  provide  further  evidence  on  the 
development of the drug phenomenon.  

Complexity of new drug phenomena lead to a disconnect with the existing Agency mandate 

The Agency’s monitoring – based on the current founding Regulation – is largely backward 
looking. The core data, related to the five currently defined key epidemiological indicators27, 
is  collected  by  the  national  focal  points  and  provided  by  them  to  the  Agency.  This  data  is 
insufficient to cover new trends and developments as it covers only core data and comes with 
a time lag.28 Additional data may be provided by ad hoc projects.29 The analysis is published 
in  the  reports  of  the  Agency,  which  are  focussed  on  statistics  and  trends  based  on  past 
developments. However, the modern drug phenomenon would necessitate more real-time and 
forward-looking  analysis  about  emerging  threats  in  order  to  anticipate  developments,  as 
identified by the evaluation, and to provide information on the best ways to address these new 
phenomena.   

The current founding Regulation of the Agency is addressing illicit drugs, i.e. those controlled 
by  the  UN  Drug  Conventions30  and  those  defined  by  Council  Framework  Decision 
2004/757/JHA31,  and  does  not  go  beyond  that  to  include  other  (substance-based  or 
behavioural)  addictions  in  its  mandate.  Several  Member  States  have  developed  wider 
addiction  strategies,  often  covering  other  (legal)  substances,  such  as  alcohol  or  tobacco,  or 
even non-substance based addictions, such as gambling or compulsive gaming  based on the 
logic that they are all addictions and share biological and behavioural characteristics.  

26   For 

see 

the  UNODC, 

in 
https://www.unodc.org/unodc/en/drug-prevention-and-
https://www.unodc.org/unodc/en/data-and-analysis/drug-production-and-
treatment/index.html; 
trafficking.html and https://www.unodc.org/unodc/en/data-and-analysis/drug-use.html. For the INCB, see in 
particular  http://www.incb.org/incb/en/publications/incb-publications.html,  including  their  annual  report 
(www.incb.org/incb/en/publications/annual-reports/annual-report.html).  

particular 

27   The  five  key  epidemiological  indicators  are:  prevalence  and  patterns  of  drug  use;  problem  drug  use; 

treatment demand indicator; drug-related deaths and mortality; and drug-related infectious diseases. 

28   Annually reported statistical data typically has a delay. Data collected in a given year (N) requires time for 
collating  and  checking  at  national  level.  The  EMCDDA  allows  6  months  for  this  process  (N+6  months). 
National  focal  points  submit  their  data  in  September/October  of  year  (N+1).  Once  the  data  has  been 
provided, the EMCDDA carries out a verification of the data and conducts an analysis, which is checked by 
the national focal points. This data and analysis is the basis for the drafting of the European Drug Report of 
year (N+2). For example, the European Drug Report of 2021 is largely based on data from 2019. 

29   See  e.g.  the  wastewater  analysis,  https://www.emcdda.europa.eu/topics/wastewater,  or  hospital  emergency 
data through the Euro-DEN network, https://www.emcdda.europa.eu/topics/hospital-emergencies_en.   
30   The UN Drug Conventions refer to the UN Single Convention on Narcotic Drugs of 1961, as amended by 
the 1972 Protocol, United Nations Treaty Series, vol. 978, No. 14152, the UN Convention on Psychotropic 
Substances of 1971, United Nations Treaty Series, vol. 1019, No. 14956; and the UN Convention against the 
Illicit  Traffic  in  Narcotic  Drugs  and  Psychotropic  Substances  of  1988,  United  Nations  Treaty  Series,  vol. 
1582, No. 27627. 

31   See the Annex of 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. 

8 

 
                                                           
Source: EMCDDA Papers: New developments in national drug strategies in Europe32 (extract). 

Furthermore,  the  current  founding  Regulation  does  not  include  drug  precursors33  in  the 
Agency’s scope of action. Drug precursors are relevant as their diversion is closely linked to 
the increasing production of synthetic drugs on the territory of the EU.34   

The  concept  of  poly-drug  use  was  introduced  with  the  recast  of  the  founding  Regulation. 
However, it has  not  been  exploited sufficiently  by the Agency, as shown by the evaluation. 
This  is  mainly  due  to  the  concept  not  being  sufficiently  clear  and  insufficient  information 
being  available  as  the  national  focal  points  do  not  have  a  mandate  to  collect  data  going 
beyond drugs. However, this would be needed to fill the concept with content.  

Inadequate responses to new drug market challenges 

Drug  selling  on  online  marketplaces,  including  on  the  darknet,  social  media  platforms  and 
mobile  applications,  is  increasing,  including  during  the  height  of  the  COVID-19  pandemic. 
These emerging marketplaces present new challenges. New technologies have facilitated the 
appearance  of  an  online  drug  market  as  part  of  the  darknet  and  on  the  “normal”  internet. 
Equally,  changing  trafficking  routes  have  caused  a  spill  over  effect  into  new  areas.  Drug 
selling  is  moving  to  closed  groups  or  private  chats,  such  as  messaging  applications,  and  is 
using other routes of getting drugs to the customer, for example through alleged food delivery 
couriers.35 The Agency increased its collaboration with in particular Europol to better monitor 
these  new  marketplaces  and  to  increase  its  understanding  of  the  related  challenges.  In 
addition, drug production based in the EU is growing, in particular of MDMA (ecstasy) and 
increasingly  for  other  amphetamine-type  drugs.  In  recent  years,  laboratories  for  the 
production of other drugs have occasionally been detected in the Member States.36  

Based on these new challenges, it can be concluded that a major shortcoming of the founding 
Regulation is that it does not include any references to the monitoring of drug markets or of 
drug  supply.  However,  a  thorough  understanding  of  drug  market  and  security  issues  is 
necessary  for  the  Agency  to  provide  a  holistic  picture  to  policy-makers.  This  was  raised 
during  the  consultation  for  the  2018/19  evaluation,  when  several  stakeholders  mentioned 
supply-side  issues  as  one  element  where  further  information  from  the  Agency  would  be 

32   http://www.emcdda.europa.eu/system/files/publications/6402/20175662_TDAU17002ENN_PDF.pdf.  
33   Drug precursors  are  substances that are controlled and  monitored in accordance  with Regulation (EC) No 
273/2004 of the European Parliament and of the Council  and with Council Regulation (EC) No 111/2005; 
these  substances  are  chemicals  that  are  primarily  used  for  the  legitimate  production  of  a  wide  range  of 
products,  like  medicine,  perfumes,  plastics,  cosmetics  etc.  However,  they  can  be  misused  for  the  illicit 
production of drugs.  

34   Report  from  the  Commission  to  the  European  Parliament  and  the  Council,  Evaluation  of  the  EU  drug 

precursors regulations, COM(2020) 768. 

35   EMCDDA/Europol, EU Drug Markets – Impact of COVID-19, 2020. EMCDDA special report: COVID-19 
and  drugs  –  Drug  supply  via  darknet  markets,  2020;  https://www.emcdda.europa.eu/publications/ad-
hoc/covid-19-and-drugs-drug-supply-via-darknet-markets_en.  

36   EU Drug Markets Report (footnote 7). 

9 

 
 
                                                           
welcome.37  Although  Europol  and  the  EMCDDA  have  started  monitoring  online  drug 
markets,  they  do  not  have  adequate  tools  and  sufficient  resources  to  develop  appropriate 
responses.  

Finally,  the  Agency  has  –  based  on  the  founding  Regulation  –  a  key  responsibility  in  the 
monitoring of new psychoactive substances. However, it cannot do any of the analysis itself 
and  has  to  rely  completely  on  third  parties,  including  on  third-country  agencies,  for  the 
forensic and toxicological examination, as it does not have laboratory capacities.  

The Reitox network is not used to its full potential 

The Reitox network has a very limited role based on Article 5 of the founding Regulation. It 
is  the  interface  between  the  Agency  and  the  participating  countries38.  The  Reitox  national 
focal  points  provide  the  core  data  on  drugs  and  drug  addiction,  as  well  as  on  policies  and 
solutions applied, to the Agency on an annual basis.  

The evaluation  concluded that the Reitox network is  the main source of information  for the 
Agency.  Depending  on  the  national  context  and  situation,  the  position  and  outputs  of  the 
national focal points vary strongly, as the Regulation does not provide any details about their 
set-up  and  is  not  sufficiently  clear  on  their  rights  and  obligations  on  national  and  European 
level. The national focal points do not have access to all data required by the Agency for the 
key indicators as some other national authorities are reluctant to share relevant information.39 
Comparability of data could be further improved, as concluded in the evaluation.  

Insufficient support to Member States 

Several  Member  States  have  in  the  past  asked  for  support,  both  for  the  evaluation  and 
development of their national drug policies40, as well as for their international activities, such 
as  for the Agency to  provide data to  the UN41  or to  provide background  information  on the 
drug situation in the EU’s neighbourhood42. The founding Regulation does not address these 
issues beyond requesting the Agency to develop relevant tools.  

The evaluation concluded that Member States would be interested in more structural support 
in relation to evaluating and subsequently shaping national drug policies. Member States are 
not only interested in receiving data or comparing the national situation with the situation in 
other  Member  States,  which  is  in  the  current  mandate  of  the  Agency,  but  to  get  concrete 
advice  and  support  from  the  Agency,  as  they  do  not  necessarily  have  all  the  relevant 
knowledge or capacity on their own.  

37   The need to do more work on supply-side issues was already raised by the previous evaluation in 2011/12; 
see Centre for Strategy and Evaluation Services (CSES), External Evaluation of the European Monitoring 
https://publications.europa.eu/en/publication-detail/-
Centre 
/publication/7d189e3b-f767-460b-b748-acf44d2daf9a/language-en/format-PDF/source-74343049.  

and  Drugs  Addiction, 

for  Drugs 

38   In  addition  to  the  EU  Member  States,  Norway  and  Turkey  are  members  of  the  EMCDDA  without  voting 

rights. 

39   Information provided by several focal points.  
40   This was the case in 2015 for Germany, Ireland and Luxembourg, who asked for support in the evaluation of 
their drugs policies. Other Member States followed suit, e.g. most recently Portugal, where the evaluation of 
the national drugs strategy is on-going. 

41   All  Member  States  need  to  explicitly  agree  every  year  that  the  EMCDDA  reports  on  their  behalf  the 
numbers  and  information  related  to  the  detection  of  new  psychoactive  substances,  which  are  collected 
through the EU Early Warning System. 

42   The rotating EU Presidencies regularly ask the Agency for updated information ahead of the formal EU drug 

dialogues. 

10 

 
                                                           
The exchange of best practices on health and other demand side issues is too limited to be of 
real  assistance  for  the  Member  States.  National  stakeholders  expressed  in  the  evaluation  a 
need  to  move  beyond  the  simple  identification  of  best  practices  to  supporting  the 
implementation  of  evidence-based  practices  and  the  delivery  of  effective  interventions,  for 
example through training or accreditation schemes for such interventions. 

The international dimension of the Agency is insufficiently defined 

Analysing  how  international  developments  impact  on  the  EU  is  becoming  increasingly 
important  due  to  the  globalisation  of  the  drug  phenomenon.  The  tasks  in  the  founding 
Regulation  as  regards international  issues  are mainly focussed on cooperation on a bilateral 
and  multilateral  level  and  are  carried  out  on  a  case-by-case  basis  upon  the  request  of  the 
Commission.  The  same  is  true  for  the  input  the  Agency  is  providing  to  the  EU  and  to  the 
Member States on the impact of drug policies in third countries on the EU markets.  

UN  bodies  currently  receive  information  directly  from  Member  States,  but  also  rely 
extensively  on  the  Agency.  Conversely,  Member  States  provide  information  both  to  UN 
bodies  and  to  the  Agency.  This  creates  risks  of  duplication  of  efforts  and  calls  for  better 
coordination, which was one of the conclusions of the evaluation.  

2.3.  What are the problem drivers? 

The analysis of the evidence supporting the impact assessment, in particular the evaluation of 
the Agency, identified the following problem drivers: 

The mandate of the Agency has not been adapted to the changes of the drugs phenomenon  

The  drugs  phenomenon  has  changed  considerably  since  the  founding  of  the  Agency  in  the 
early 1990s. It has become more complex and it now encompasses a broader range of  illicit 
substances and drug-related behaviours. The drug market has become much more innovative, 
digitally  enabled  and  globally  connected.  This  means  that  new  developments  in  both  drug 
trafficking and drug use spread more rapidly than was previously the case.43  

The  Agency’s  EU  Early  Warning  System44  is  monitoring  currently  more  than  830  new 
psychoactive substances45, of which 46 were identified for the first time in 2020.46 The vast 
majority  of  these  substances  have  appeared  on  the  European  market  over  the  last  10  years. 
Whenever  a  new  psychoactive  substance  is  included  in  the  list  of  drugs,  the  drug  criminals 
develop a new substance by slightly altering the chemical composition.  

Therefore, the demands on the Agency by its main stakeholders, in particular by the European 
and national policy-makers, have grown over time.47 In the 1990s, no EU-level information to 
describe  the  drug  situation  and  its  consequences  in  an  objective  way  was  available  and  a 
related data collection system was missing. Nowadays, this is in place, but more sophisticated 
information,  including  real-time  analysis  about  emerging  threats  and  advice  on  the  best 
possible ways to address those, is required. 

43   European Drug Report 2021 (footnote 1).  
44   https://www.emcdda.europa.eu/publications/topic-overviews/eu-early-warning-system.  
45   A new psychoactive substance (NPS) is defined as a new narcotic or psychotropic drug, in pure form or in 
preparation, that is not controlled by the UN Drug Conventions, but which may pose a public health threat 
comparable to that posed by substances listed in these conventions.  

46   European Drug Report 2021 (footnote 1).  
47   See  EMCDDA,  Looking  back  on  25  years  of  annual  reporting  on  the  drugs  problem  in  Europe  (2020), 

https://www.emcdda.europa.eu/publications/brochures/25-years-annual-reporting_en.  

11 

 
                                                           
As the Agency mandate has not been revised since 2006  – and at the time only to a limited 
extent – the Agency is working based on an outdated mandate that is almost 30 years old. 
As explained above, there is an increasing disconnect between what Europe needs to address 
the drug phenomenon and what the Agency mandate provides for in legal terms. The founding 
Regulation does not reflect the current reality of the drug phenomenon and is out of step with 
the tasks the Agency needs to perform to address the related modern day challenges.  

Multi-jurisdictional challenges due to new threats 

Drug  markets  are  cross-border  by  nature  and  many  of  the  most  commonly  used  drugs  and 
precursors used in the EU are imported from third countries.  

New  security  challenges  stem  from  the  growing  involvement  of  organised  crime  groups  in 
several criminal activities, such as drug trafficking, human trafficking, migrant smuggling, or 
financing  of  terrorist  activities.  Organised  crime  groups  often  use  drug  trafficking  to  obtain 
the  cash  needed  for  their  other  activities.  These  links  have  considerable  impacts  on  the 
development  of  the  drug  phenomenon.  Drug  production  based  in  the  EU  is  growing  and  is 
driving greater levels of intimidation, corruption and violence within the EU and will lead to 
further challenges in the future. In addition, online trafficking of drugs is increasing.  

Monitoring these developments is crucial for a better understanding of the drug phenomenon. 
However,  the  challenges  related  to  these  new  threats  cannot  be  addressed  by  any  Member 
State on its own.  

Evolving national policies lead to changing priorities 

The importance given to the topic of drugs policy in the Member States changes over time. 
Member  States  shift  their  policies,  whether  in  terms  of  health-orientation  or  security 
perspectives.  Several  Member  States  broadened  their  drugs  strategies  to  a  wider  addiction 
approach over the last  years. Such developments have significant impacts on the Agency as 
they  lead  to  new  needs  and  requests  from  its  stakeholders,  and  ultimately  to  the  need  to 
refocus the priorities. 

Recent developments in international drug policy 

The drugs phenomenon is increasingly global and decisions taken in third countries can have 
considerable impact on the drug situation in the EU. This is rendering the EU’s drug situation 
more and more intertwined with that of other countries and regions.48 Work of the UN bodies 
in the drugs field increased over the last years, which lead to important recent developments 
in  international  drugs  policy.  An  important  impetus  was  the  2016  Special  Session  of  the 
United Nations General Assembly on the World Drug Problem.49  

2.4.  Who is affected and in what ways? 

The  drug  phenomenon  is  a  far-reaching  problem,  which  can  affect  everyone’s  life.  The 
revision  of  the  founding  Regulation  itself  only  has  limited  direct  impact  on  some 
stakeholders,  whereas  other  potential  stakeholders,  in  particular  citizens,  would  only 
indirectly  be  affected.  This  section  sets  out  the  most  affected  stakeholders  and  explains  in 

48   For  example,  the  decision  by  China  to  put  a  long  list  of  fentanyl  derivatives  under  control  lead  to  less  of 

these substances reaching the EU market. 

49   https://www.unodc.org/ungass2016/;  for  the  Outcome  Document  of  UNGASS  2016,  entitled  “Our  joint 
see 

the  world 

addressing 

countering 

problem”, 

drug 

and 

commitment 
to 
https://undocs.org/A/RES/S-30/1.  

effectively 

12 

 
                                                           
what  ways  they  would  be  affected.  In  addition  to  its  main  stakeholders,  the  Agency  itself 
would be affected by a proposal for the revision of its mandate.  

Policy-makers on European and national level 

The main stakeholders of the Agency are policy-makers on European and national level. Their 
primary  need  is  information  and  evidence  on  which  to  base  policy  decisions  and  related 
actions.  

As concluded by the evaluation, the Agency is more relevant to the needs of European than 
national policy-makers. On the national level, the relevance depends on the scope of national 
policies.  The  Agency  is  less  relevant  for  those  Member  States  that  have  a  wider  addiction 
policy,  as  the  Agency  would  not  be  able  to  provide  all  necessary  data.  The  availability  of 
objective data is key for EU level policy-makers as it forms the basis of the EU’s evidence-
based policy-making in drugs policy.   

Moreover,  the  relevance  depends  on  the  stage  of  development  of  national  drug  information 
systems.  Member  States  with  better-developed  national  drug  information  systems  may  rely 
less on the information available from the Agency. Nevertheless, national policy-makers rely 
on  the  Agency  for  cross-EU  comparative  analysis  as  this  element  cannot  be  covered  by 
national systems. 

If the Agency would not be able to address properly and in a timely manner the current and 
future challenges of the drugs phenomenon, the Agency would lose its relevance for policy-
makers. Not collecting relevant data would have a negative impact as comparable data would 
not  be  available,  would  have  to  be  gathered  on  an  ad  hoc  basis  or  would  not  lend  itself  to 
identifying important new threats in a timely manner.  

Scientific community 

As regards the scientific community, the evaluation concluded that there is scope for greater 
engagement,  although  overall  the  needs  of  the  scientific  community  were  well  addressed. 
Nonetheless, the Scientific Committee of the Agency has pointed out  in its contribution that 
the  Agency  could  provide  added  value  by  being  more  active  and  establishing  greater 
synergies  within  the  context  of  the  EU  research  knowledge  cycle.50  This  would  include  in 
particular helping to identify research gaps, helping or facilitating engagement with national 
scientific  networks  and  experts,  and  ensuring  the  dissemination  of  research  findings  after  a 
project finished and maintaining a registry of what has been funded, and more.  

Practitioners 

Practitioners rely on the Agency for information and for the exchange of best practices. The 
evaluation concluded that practitioners from the public health area appreciated the increased 
work  on  that  pillar,  in  particular  the  focus  on  harm  reduction  and  prevention.  Several  non-
governmental (civil society) organisations underlined in their feedback to the inception impact 
assessment their appreciation for the work of the Agency and the need for a neutral scientific 
agency,  and  stressed  that  any  change  in  the  mandate  of  the  Agency  should  not  be  to  the 
detriment of its public health focus. In addition, the Agency is increasing its engagement with 
law  enforcement  practitioners,  in  particular  through  input  into  trainings  of  the  European 

50   EU-ANSA  agencies’  engagement 

in 

the  EU 

research  knowledge  cycle  –  An  overview, 

https://op.europa.eu/en/publication-detail/-/publication/46ff56e9-12cb-11e8-9253-01aa75ed71a1/language-
en/format-PDF/source-search.  

13 

 
                                                           
Union Agency for Law Enforcement Training (CEPOL) and closer cooperation with Europol, 
although there is scope to do more in this area, as concluded by the evaluation.  

The Agency itself 

The Agency itself might suffer most if the mandate remains as it is. In practice, the Agency is 
interpreting its mandate already quite widely and is undertaking work, which is not explicitly 
covered  by  the  current  mandate.  This  is  due  to  requests  from  its  main  stakeholders  and 
necessitated  by  the  developing  drug  landscape.  However,  such  an  approach  has  limits,  in 
particular in view of the available human and financial resources, and the need to keep within 
the legal mandate.  

2.5.  How will the problem evolve? 

Without any intervention, the problems identified in this impact assessment will persist or get 
worse over time. The drug phenomenon  is  constantly changing and  will  become even more 
complex.  Unless  sufficient  and  timely  information  on  the  real  situation  of  the  drug 
phenomenon  is  available,  as  regards  public  health,  safety  and  security,  there  will  be  severe 
negative implications on EU and national level policy-making and ultimately on the responses 
afforded by public authorities. This would be exacerbated by the need for Member States to 
act unilaterally in the absence of an adequate EU-level solution, which would be particularly 
damaging as the drug phenomenon becomes more and more global.  

The COVID-19 pandemic showed that drug criminals are able to adapt their illicit activities 
relatively easily and quickly to new circumstances, for example through virtual means (online 
markets,  messaging  applications, etc.) and  reduced face-to-face interactions.51  It is  expected 
that these recent developments will have long-term impacts on drug markets. 

By maintaining the status quo of the mandate, the Agency’s capacity to address emerging and 
future  challenges  would  continue  to  diminish.  The  tension  between  the  reality  of  the  drug 
phenomenon  and  the  founding  Regulation  would  increase  further.  Although  the  Agency 
adapted well to changes in the past, there are limits – set by the mandate, but in particular by 
financial and human resources – how far these adaptations can go. Adaptations are not only 
needed in relation to drug markets, which are not explicitly mentioned in the mandate of the 
Agency, but also in relation to health-related issues. The COVID-19 pandemic demonstrated 
that it is important to have the capacity to exchange information and experiences rapidly and 
to share best practices between Member States to learn from each other.52 

Without a revised mandate, the Agency runs the risk of losing its added value, its relevance 
for stakeholders, and ultimately its status as a centre of excellence and  as a model for other 
regions in the world.  

51   EMCDDA/Europol, EU Drug Markets – Impact of COVID-19, 2020. EMCDDA special report: COVID-19 
and  drugs  –  Drug  supply  via  darknet  markets,  2020;  https://www.emcdda.europa.eu/publications/ad-
hoc/covid-19-and-drugs-drug-supply-via-darknet-markets_en;. 

52   EMCDDA trendspotter briefing – Impact of COVID-19 on drug services and help-seeking in Europe, 2020; 
https://www.emcdda.europa.eu/publications/ad-hoc/impact-of-covid-19-on-drug-services-and-help-seeking-
in-europe_en. 

14 

 
 
                                                           
3.  WHY SHOULD THE EU ACT? 

3.1.  Legal basis 

The founding Regulation of the Agency was based on Article 152 of the Treaty establishing 
the European Community, i.e. on the public health legal basis. This provision corresponds to 
Article 168 of the Treaty on the Functioning of the European Union (TFEU).  

Article 168(1)  3rd  subparagraph  reads:  “The  Union  shall  complement  the  Member  States' 
action  in  reducing  drugs-related  health  damage,  including  information  and  prevention”. 
Article 168(5) provides that the European Parliament and the Council may adopt  “measures 
concerning  monitoring,  early  warning  of  and  combating  serious  cross-border  threats  to 
health”.   

Addressing supply and drug market related issues supports reducing the availability of drugs 
in  the  EU  and  curbing  drug  demand  and  ultimately  public  health.  The  health  and  security 
dimensions  of  the  drug  phenomenon  are  intrinsically  linked  and  cannot  be  addressed 
separately. Therefore, addressing supply-side issues is covered by the public health legal basis 
and does not go beyond what is possible under that legal basis. 

Drugs  are  also  referred  to  in  Article  83  TFEU.  Article  83(1)  states  that  the  European 
Parliament  and  the  Council  can  adopt  rules  to  “establish  minimum  rules  concerning  the 
definition of criminal offences and sanctions in the areas of particularly serious crime with a 
cross-border dimension resulting from the nature or impact of such offences or from a special 
need to combat them on a common basis”. Illicit drug trafficking is one of the relevant areas 
of  crime.  However,  Article  83  TFEU  is  not  relevant  for  the  current  initiative  as  it  does  not 
intend to set such minimum rules. 

3.2. 

Subsidiarity: Necessity of EU action 

EU action to revise the mandate of the Agency is necessary.  

The drug phenomenon is affecting all Europeans and is cross-border and multi-jurisdictional 
in nature, in particular when it comes to drug markets and organised crime.  There are many 
common challenges across Member States, both on the health and security side, which need to 
be  tackled.  It  is  not  possible  to  address  the  drug  phenomenon  only  on  a  national  or 
regional/sub-national  level  as  drugs  move  around  Europe.  A  problematic  health  or  security 
pattern  detected  in  a  Member  State  very  often  appears  in  other  Member  States.  National 
legislation  or  even  the  best  national  practice  would  not  be  able  to  address  the  cross-border 
aspects of the drug phenomenon. Due to this transnational character, there is a need for EU-
level action.  

The action is proportionate as it is the only way that the necessary changes in the Agency’s 
mandate can come about.  

EU-level  action  does  not  intend  to  replace  national  actions  or  authorities  or  question  their 
relevance. The drug phenomenon can only be addressed if all levels – EU, national and local 
– work together. The current proposal will not go beyond what is proportionate to tackle an 
EU-wide phenomenon.  

When  it  comes  to  the  possible  new  rules  and  responsibilities  of  the  national  focal  points,  it 
will remain for the Member States to decide exactly how they want to set up a national focal 
point. However, in order to ensure that the national focal points are in a position to provide to 

15 

 
the EU-level  what is necessary and to  access the funding  available  at EU level, they should 
comply with a set of minimum requirements. Moreover, as the provision of the core data from 
the Member States to the Agency through the national focal points is the basis for the overall 
drug monitoring system, it is proportionate to set such minimum requirements. 

3.3. 

Subsidiarity: Added value of EU action 

The EU  added value of  a revision of the Agency  mandate will be considerable.  Adopting  a 
targeted revision of the Agency’s mandate, thereby enabling it to address current and future 
challenges, is in the interest of the EU, in particular in view of the recent deterioration of the 
drug situation in the EU. The revision of the mandate of the Agency is part of the reaction of 
the EU to these developments.  

As  the  evaluation  showed,  and  this  is  relevant  also  for  the  revision  of  the  mandate,  the 
existence  of  the  Agency  has  an  important  added  value  compared  to  addressing  the  drug 
phenomenon solely at national level. Many of the phenomena are by nature cross-border, and 
increasingly global, and therefore cannot be addressed by a Member State alone. The absence 
of the Agency would imply the loss of the EU-level overview of the drug phenomenon, as the 
data  collected  by  Member  States  would  be  fragmented  or  possibly  non-existent,  with 
important consequences at national, EU and international level. This would run contrary to the 
requirements  of  the  EU’s  evidence-based  policy-making  in  drugs  policy,  which  relies  on  a 
neutral body to provide factual and objective data. A targeted revision would strengthen the 
Agency in crucial areas to enable it to address these common issues better.  

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? 

4.1.  General objectives 

The  general  objective  of  the  proposal,  i.e.  the  aim  of  a  targeted  revision  of  the  founding 
Regulation, is: 

  To  have  an  Agency,  which  is  appropriately  equipped  to  deal  with  the  current  and 
future challenges posed  by drugs in  the EU, leading to  efficient  action and support 
for Member States. 

4.2. 

Specific objectives 

The specific objectives of the proposal are: 

1)  To increase the Agency’s capacity to react faster and in a more targeted way to new 

challenges in the field of drugs, harms and addictions, and related threats;  

2)  To deepen the monitoring and analysis of the drug phenomenon in Europe, both on 

the demand and supply side and their implications for health and security;  

3)  To  clarify  the  mandate  of  the  Agency  as  regards  what  substances,  behaviours  and 

responses should be covered;  

4)  To make the Agency more operational; and 

5)  To provide support to Member States in shaping and evaluating their drugs policies. 

16 

 
 
5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? 

5.1.  What is the baseline from which options are assessed? 

The baseline scenario is established by the founding Regulation of the Agency, i.e. Regulation 
(EC)  No  1920/2006,  and  the  current  functioning  of  the  Agency.  The  Agency’s  mandate  is 
focussed on data collection, monitoring, harmonisation of data, analysis and publication of the 
outcomes of these exercises as regards (illicit) drugs, drug addiction and their consequences.  

Areas of activity 

The key areas of activity of the Agency are set out above. The “EMCDDA Strategy 2025”53 
attributed the activities and the tasks of the Agency to two main pillars, health and security. In 
addition,  it  defined  four  business  drivers.  The  strategic  objectives  of  the  two  main  pillars 
reflect the priority areas set out by the founding Regulation. 

While  the  Agency’s  focus  is  primarily  on  Europe,  it  works  with  partners  in  other  world 
regions,  exchanging  information  and  expertise.  The  Agency  cooperates  with  candidate  and 
potential candidate countries as part of their accession process to the EU.  Cooperation takes 
place based on bilateral agreements54 or in the context of EU-funded projects55. Cooperation 
ranges from implementation of technical assistance projects to ad-hoc training or consultative 
support.  Collaboration  with  European  and  international  organisations  in  the  drugs  field  is 
central to the Agency’s work. 

Reitox network 

The  Reitox  network  is  the  European  information  network  on  drugs  and  drug  addiction. 
Members  of  the  Reitox  network  are  designated  national  institutions  or  agencies  responsible 
for  data  collection  and  reporting  on  drugs  and  drug  addiction  (‘national  focal  points’  or 
‘national  drug  observatories’).  The  Reitox  network  links  national  drug  information  systems 
and is the main way in which the Agency exchanges data and methodological information on 
drugs and drug addiction in Europe. The financing of the national focal points is provided by 
the Member States, but is supported by a grant from the Agency.  

Current monitoring system 

The current monitoring system is based on the provision of data by the national focal points. It 
implies  the  collection  of  both  quantitative  data  and  qualitative  information  using  different 
types of standardised data collection and reporting tools. The Agency collects data also from 
the projects it participates and through contracts with third parties. Different innovative data 
collection  methods  provide  data  on  specific  phenomena  and  closer  to  real  time.  Examples 

53 https://www.emcdda.europa.eu/system/files/publications/4273/2017.1998_EMCDDA_STRATEGY_2025_we

b-1.pdf.  

54   Working  arrangements  are  in  place  with  the  Russian  Federation,  Ukraine,  Moldova,  Israel,  Armenia, 

Georgia, Switzerland, Albania, Kosovo* and Serbia.  
* This designation is without prejudice to positions on status, and is in line with UNSCR 1244/1999 and the 
ICJ Opinion on the Kosovo declaration of independence. 

55   See for the Western Balkan countries the projects financed by the Instrument for Pre-accession Assistance 
(IPA)  (https://www.emcdda.europa.eu/about/partners/cc/ipa7_en)  and  for  the  European  Neighbourhood 
Policy (ENP) area the EU4 Monitoring Drugs project (https://www.emcdda.europa.eu/topics/eu4md_en).  

17 

 
 
                                                           
 
include wastewater analysis56, hospital emergency data57, analysis of data from drug checking 
facilities58, and recent work to measure drug related violence59.  

In addition, the EU Early Warning System collects data on the detection of new psychoactive 
substances.  The information  is  available in  the European Database on New Drugs (EDND). 
The Agency itself does not conduct the forensic or toxicological analysis as it does not have a 
laboratory.  

The Agency is the only body, which collects drug-related data on a European level. Contrary 
to other policy areas, Eurostat is not involved in the collection of data related to drug policy. 
Europol  does  not  collect  any  data,  but  only  has  information  from  its  operations.  Such  data 
would not be sufficient to provide an overview on European level on the developments of the 
drug  phenomenon  as  it  is  focussed  on  specific  issues.  Finally,  the  EU  health  agencies  only 
collect health-related data and not drug data.  

Implementation of the founding Regulation 

The  main  achievement  of  the  establishment  of  the  Agency  is  the  availability  of  factual, 
objective, reliable and comparable information at European level concerning drugs and drug 
addiction.  This  information  is  the  basis  for  the  development  of  an  integrated,  balanced  and 
evidence-based approach to EU drugs policy.  

When it comes to the monitoring of the state of the drugs problem,  the solutions  applied to 
drug-related problems as well as to European and national policies, the Agency has published 
almost  400  scientific  and  institutional  reports  from  2013  to  2017.  Among  its  flagship 
publications are the annual European Drug Report, including the country reports, the EU Drug 
Markets  Report,  published  most  recently  in  2019,  and  the  “Health  and  social  responses  to 
drug problems – A European Guide”60.  

The  Agency  has  facilitated  the  exchange  of  best  practices  and  of  drug-related  information 
through the participation of its staff in more than 1 500 events (contributions to conferences, 
policy fora, etc.).  It  has  established  an online  best  practice portal61.  In addition,  the Agency 
organises regular and frequent meetings with its stakeholders for the sharing of best practices.  

In  order  to  address,  at  least  partially,  new  developments,  the  Agency  is  interpreting  its 
mandate  as  widely  as  possible  within  the  legal  framework.  As  regards  health-related  issues 
and  the  best  practice  portal,  it  is  regularly  updated  with  new  ways  of  providing  support  to 
people  who  use  drugs  and  will  develop  further  in  this  sense,  also  taking  into  account  the 
experience  gained  during  the  COVID-19  pandemic.  The  Agency  is  monitoring  the 
developments on the drug markets to a certain extent and in close cooperation with Europol. 
This wide interpretation is reaching its limits, including in relation to the available resources. 
The Agency cannot go beyond the legal framework as set out in the founding Regulation.  

5.2.  Description of the policy options 

Non-legislative options 

56   https://www.emcdda.europa.eu/topics/wastewater.  
57   https://www.emcdda.europa.eu/topics/hospital-emergencies_en.  
58   https://www.emcdda.europa.eu/topics/drug-checking.  
59   https://www.emcdda.europa.eu/topics/drug-related-homicide_en.  
60 https://www.emcdda.europa.eu/system/files/publications/6343/TI_PUBPDF_TD0117699ENN_PDFWEB_201

71009153649.pdf.  

61   https://www.emcdda.europa.eu/best-practice_en.  

18 

 
                                                           
Policy option 0: Baseline scenario - Maintaining the current approach without changes 

This  option  preserves  the  status  quo  and  is  described  in  Section  5.1.  In  this  scenario,  the 
current mandate, objectives, tasks, governance and organisation of the Agency would remain 
unchanged.  

Policy option 1: Minimal revision - Stronger cooperation 

Taking into account current cooperation between the Agency and various EU and UN bodies 
on  various  aspects  of  drug  phenomena,  cooperation  on  European  level  could  be  enhanced 
with,  among  others,  Europol,  the  Maritime  Analysis  and  Operations  Centre  –  Narcotics 
(MAOC-N)62, the European Medicines Agency (EMA) and the European Centre for Disease 
Prevention and Control (ECDC), and on an international level with the United Nations Office 
on Drugs and Crime (UNODC). The envisaged reinforcement of the mandates of the relevant 
agencies  would  need  to  be  taken  into  account.  Furthermore,  the  creation  of  the  European 
Health  Emergency  Preparedness  and  Response  Authority  (HERA)63  could  also  provide  an 
opportunity for fruitful cooperation with the Agency.  

Stronger  cooperation  among  the  Member  States  themselves  or  between  the  Agency  and  the 
Member  States,  should  also  be  pursued.  However,  this  needs  to  remain  within  the 
competencies of the Member States and the Agency, or respective EU bodies. 

This option would not lead to any legislative changes to the founding Regulation. The current 
mandate,  objectives,  tasks,  governance  and  organisation  of  the  Agency  would  remain 
unchanged.  

Legislative options 

Policy option 2: Dismantling of the Agency - Repeal of the founding Regulation  

In line with the common approach on decentralised agencies64, common and objective criteria 
should  be  used  to  assess  the  opportunity  to  dismantle  agencies,  when  the  mandate  of  an 
agency is thoroughly reviewed.  

This option would effectively result in  the repeal of the founding Regulation and ultimately 
the termination of the Agency. 

Policy option 3: Merging of the Agency with another EU body  

Further  in  line  with  the  common  approach  on  decentralised  agencies65,  the  possibility  to 
merge the agency with another EU body should be considered.  

62   www.maoc.eu.  
63   For Europol, see COM(2020) 796 final; for EMA, ECDC and HERA, see in general COM(2020) 724, and 
in more detail for EMA COM(2020) 725; for ECDC COM(2020) 726; and for HERA the inception impact 
assessment: 
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12870-European-
Health-Emergency-Preparedness-and-Response-Authority-HERA-.  

64   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. 

65   Ibid. 65.   

19 

 
                                                           
This  option  entails  an  assessment  on  whether  merging  the  Agency  with  another  EU  body, 
such as Europol,  the Maritime Analysis and Operations Centre  – Narcotics (MAOC-N), the 
European  Medicines  Agency  (EMA),  the  European  Centre  for  Disease  Prevention  and 
Control  (ECDC)  or  the  European  Health  Emergency  Preparedness  and  Response  Authority 
(HERA)  would  be  feasible.  This  would  lead  to  the  creation  of  a  new  body,  absorbing  the 
merging entities. The analysis takes into account the planned reinforcement of the mandates 
of the relevant agencies and the creation of HERA.66 

Policy option 4: Targeted revision – Delivering more value in drugs policy   

The targeted revision option is a legislative option to  amend/revise the founding Regulation 
and  hence  the  Agency’s  mandate,  by  responding  to  the  different  issues  outlined  in  the 
problem  definition  through  a  targeted  degree  of  intervention  in  terms  of:  thematic  scope  of 
action  for  the  Agency,  the  monitoring  system,  the  Reitox  network  of  national  focal  points, 
support to Member States, and international cooperation. The targeted revision option would 
be fully aligned with the strategic priorities covered by the EU Drugs Strategy 2021-2025.   

Thematic scope of action 

As the Agency was founded in early 1990s and the mandate has not been revised since 2006 – 
and  at  the  time  only  to  a  limited  extent  –  the  Agency  is  working  based  on  an  outdated 
mandate that is almost 30 years old. This makes the thematic scope of action of the Agency a 
key  intervention  area.  There  is  an  increasing  disconnect  between  the  current  reality  of  the 
drug phenomenon and what the Agency’s mandate provides for in legal terms.  The targeted 
revision  option  would  deepen  the  efforts  of  the  Agency  in  the  drug  area  to  address  the  key 
elements  of  the  new  drug  phenomena  –  (i)  other  substance-based  addictions  when  these 
substances  are taken together with  illicit drugs, i.e. poly-substance use;  (ii) drug supply and 
drug market issues.  

Firstly,  the  drug  phenomena  have  become  complex,  now  encompassing  a  broader  range  of 
substances,  while the drug market  has become much more innovative, digitally enabled and 
globally  connected.  Many  problems  related  to  illicit  drug  use  are  augmented  with  the 
simultaneous or sequential use of other psychoactive substances. For example, the combined 
use  of  heroin  and  alcohol  increases  the  risk  of  overdoses.  This  is  further  exacerbated  if 
different (illicit) drugs are used together. A better understanding of poly-substance use would 
help to better address the drug phenomena.  

Secondly,  the  work  of  the  Agency  is  –  as  previously  explained  –  based  on  the  two  pillars, 
health  and  security.  The  recent  evaluation  concluded  that  the  Agency  could  and  should  do 
more  on  supply-side  issues.  However,  supply-side  issues  are  not  explicitly  covered  in  the 
current  mandate  of  the  Agency.  On  the  other  hand,  a  drugs  agency,  which  is  not  able  to 
monitor  supply-side  issues,  would  ignore  an  important  dimension  of  the  drug  phenomenon 
and would not be able to provide a holistic picture. Drug supply issues are intrinsically linked 
with the public health dimension of the Agency and, therefore, the Agency already managed 
to address some supply issues in its work.  

Furthermore,  the  diversion  and  trafficking  of  drug  precursors  is  a  major  input  for  drug 
production. The Agency is addressing drug precursors as a side issue in  the context of drug 
market monitoring. The Commission collects data on diverted and trafficked drug precursors 
through  a  database  hosted  by  the  Directorate-General  for  Internal  Market,  Industry, 

66   See footnote 63.  

20 

 
                                                           
Entrepreneurship and SMEs (DG GROW)67 in line with the applicable precursor legislation68. 
The competent  authorities nominated for this task by the Member States feed this  database. 
The  reporting  is  mandatory  for  a  number  of  basic  data  elements,  but  Member  States  are 
invited  to  provide  as  much  circumstantial  information  as  possible.  The  information  is  then 
used  by  the  Directorate-General  for  Taxation  and  Customs  Union  (DG  TAXUD)  for 
coordinating and sending the annual FORM D-reporting to the International Narcotics Control 
Board on behalf of the EU. The data is also provided to the Agency, which summarises the 
data and includes it in its regular reports. In order to get a better understanding of the situation 
of diversion and trafficking of precursors in the EU, the Agency should be in charge not only 
of analysing the data provided through the Commission’s database, but collecting the relevant 
data should also be considered. 

Monitoring system 

The  current  monitoring  system  of  the  Agency  is  largely  retrospective,  dependent  on 
established approaches and often comes with a considerable reporting time lag due to the data 
collection  method.  The  targeted  revision  option  would  strengthen  the  Agency’s  monitoring 
and threat assessment capabilities to increase its ability to react to new challenges and have an 
increased impact on the drug phenomena. Therefore, the monitoring system under the targeted 
revision  would  no  longer  act  as  a  passive  observatory  tool,  but  in  addition  to  information 
gathering and analysis, the Agency would be able to act and react on its analysis.    

Deepening the focus of the monitoring system on the drugs phenomena would entail the need 
to  enhance  it  with  capabilities  for  real-time  and  forward-looking  analysis  about  emerging 
threats,  in  order  to  anticipate  developments,  as  identified  by  the  evaluation,  and  to  provide 
information  on  the  best  ways  to  address  these  new  phenomena.  Both  the  health  and  the 
security angles would be addressed.  

A crucial  aspect of this enhanced monitoring system would be to  ensure  that the Agency is 
less reliant on third parties, including on third-country agencies, for forensic and toxicological 
examination. In this context, the Agency should develop targeted laboratory capacities. As 
the  Agency  does  not  have  any  laboratory  capacities,  it  has  to  rely  for  the  analysis  of 
substances  on  the  laboratories  in  the  Member  States  and  in  third  countries.  Mechanisms  to 
exchange forensic and toxicological data, knowledge and standards exist, but their operation 
is sporadic, on a bilateral basis or based on small EU funded projects.  The laboratory of the 
Joint Research Centre (JRC) is supporting national laboratories in the analysis only on a case-
by-case  basis.  This  is  financed  and  organised  in  the  framework  of  the  Customs  Laboratory 
European  Network.  The  2018/19  evaluation  identified  a  need  to  support  the  EU  and  its 
Member States’ forensic and toxicological capacity.69 

67   Database 

further 

to 

Article 

13a 

of 

Regulation 

(EU) 

No 

273/2004: 

https://webgate.ec.europa.eu/drugprecursors/index.cfm?fuseaction=dp.homepage.  

68   Regulation  (EC)  No  111/2005  on  trade  in  drug  precursors  between  EU  and  third  countries,  OJ  L  22, 
26.2.2005,  p.  1;  Regulation  (EC)  No  273/2004  on  trade  in  drug  precursors  within  the  EU,  OJ  L  47, 
18.2.2004, p. 1. 

69   The determination of the origin of drugs on the European market is becoming increasingly important when 
confronted  with  multiple  cross-border  drug-related  threats.  The  EU  relies  on  the  Cocaine  Signature 
Programme  of  the  US  Drug  Enforcement  Administration  when  it  comes  to  cocaine  profiling.  Information 
gained from such analysis is highly useful for policy and decision-making at EU-level and for operational 
purposes. Significant EU funding was provided in the past to develop profiling methods for synthetic drugs, 
but the methods were later abandoned. A potential reason was that the success of the projects was framed in 
terms of their utility to help with the prosecution of cases rather than as a tool used to improve the strategic 
understanding of drug markets.  

21 

 
                                                           
 
There  are  two  variations  of  targeted  laboratory  capacities  that  were  identified  as  possible 
solutions: 

-  First laboratory solution is a reference laboratory that would provide key services and 
support for EU-level priorities and specific projects. In this case, a choice would have 
to  be  made  what  scientific  areas  a  reference  laboratory  could  cover.  The  main 
elements  of  the  laboratory  capacities,  such  as  information  exchange,  provision  of 
reference material and access to specialised equipment, should be covered in any case. 

-  Second  laboratory  solution  is  a  virtual  laboratory  that  would  act  as  a  highly 
operational  competence  centre.  In  that  case,  the  Agency  would  continue  relying  on 
existing laboratories in the Member States and the JRC70. These would work closely 
together in a virtual laboratory, i.e. a specialist network of scientists and laboratories 
engaged in forensic and toxicological analysis. The set-up of such a virtual laboratory 
could be inspired by the Reitox network or the European Network of Forensic Science 
Institutes71. Sufficient laboratory and scientific competence and experience would still 
be needed in the Agency to steer the work of the virtual laboratory. 

In addition, to deepen the focus of the monitoring system on the drug phenomena in order to 
provide  information  on  the  best  ways  to  address  trends  and  threats  relevant  to  the  targeted 
thematic scope of action, the Agency should also gain the ability to react to new challenges 
and to act on its analysis. The existing cooperation between the Agency and EU bodies would 
need  to  be  enhanced  and  reinforced,  especially  with  Europol,  Frontex  and  the  Maritime 
Analysis  and  Operations  Centre  –  Narcotics  (MAOC-N)  due  to  the  new  thematic  scope  of 
action, especially on drug supply and drug market issues. This will also support with the new 
monitoring  capacities  needed  for  the  implementation  of  the  EU  Drugs  Strategy.  In  this 
context, the Agency could develop the following types of products:  

-  Alert system:  The Agency  hardly has any  tasks  with  an operational  dimension as it 
currently  is  a  mere  monitoring  centre  with  a  strong  scientific  focus,  in  line  with  the 
founding  Regulation.  The  only  task  of  the  Agency,  which  can  be  considered 
operational,  is  the  EU  early  warning  system.  The  Agency  decides,  based  on  certain 
criteria, to put a substance under intensive monitoring and to prepare an initial report. 
This  is  the  basis  for  potential  future  control  measures  on  European  level.  Under  the 
EU  early  warning  system,  the  Agency  can  issue  alerts  or  advisories  to  the  EU  early 
warning network, informing its members about specific events or situations related to 
new psychoactive substances. Therefore, the existing system does not include an alert 
system, which could quickly inform people who use drugs about dangerous substances 
being on the market.  

The  developments  over  the  last  years  show  that  dangerous  substances  appear 
regularly. These can be new substances, of which the impacts are not known yet and, 
therefore,  the  danger  of  fatal  or  non-fatal  overdoses  are  higher.  These  can  be  drugs, 
which are cut with dangerous substances, e.g. carcinogenic or toxic substances used as 
cutting  agent.  If  the  Agency  gets  information  of  such  dangers,  it  passes  it  on  to  its 
networks, in particular the EU Early Warning System network. It then depends on the 
Member States’ authorities on how they use the information received and if and how 
they inform the potentially affected users.  

70   https://ec.europa.eu/jrc/en/research-facility/open-access.  
71   www.enfsi.eu. ENFSI, partly funded by the EU, works to improve the expertise, performance and quality of 
forensic  science  provision  in  Europe,  in  order  to  improve  the  administration  of  justice,  however,  it  relies 
heavily on certain Member States with advanced capabilities. 

22 

 
 
 
 
                                                           
Therefore, the Agency could be enabled to issue EU-level alerts or targeted warnings 
in case of such dangers. Such alerts could  go to  organisations, which support people 
who  use  drugs,  be  passed  on  to  the  media  for  further  dissemination,  be  posted  on 
relevant  drug-related  websites  or  fora,  or  be  published  in  other  ways,  which  would 
reach  people  who  use  drugs  quickly.  The  exact  way  in  which  such  an  alert  system 
could be set up would have to be defined by the Agency itself, in cooperation with the 
Member States and relevant civil society organisations. 

-  Prevention  and  awareness  campaigns:  The  Agency  supports  the  development  of 
prevention  programmes  and  shares  experiences  through  its  best  practice  portal.  The 
Agency could get involved in developing cross-EU campaigns targeted e.g. at parents, 
teachers and local decision-makers, raising awareness of their prevention potential. 

-  Risk  analysis  and  intelligence  reports:  The  Agency  could  develop  responses  to 
supply-side  topics  and  better  address  drug  market  issues  by  supporting  national  law 
enforcement authorities with risk analysis and intelligence reports to law enforcement 
authorities,  in  close  collaboration  with  relevant  EU  bodies  or  agencies,  especially 
Europol. 

The Reitox network of national focal points 

As  the  national  focal  points  are  the  main  data  providers  to  the  Agency,  any  changes  in  the 
Agency’s monitoring system or the extent of its mandate have to be mirrored in their mandate 
as well. The scope of the national data collection needs to be clearly defined in the founding 
Regulation. While it is for the Member States to decide how a national focal point is set up, 
organised and with  what means it is equipped, the mandate of the national focal points will 
have to reflect the revision of the Agency’s mandate. The targeted revision would imply that 
data collection of national focal points on drug phenomena, particularly on poly-substance use 
would  need  to  be  improved  to  respond  to  the  new  thematic  scope  of  action  of  the  Agency. 
Furthermore,  the  targeted  revision  would  empower  national  focal  points  to  provide  the 
relevant  data  to  the  Agency,  and  enable  them  to  act  as  more  effective  intermediaries 
translating and implementing key messages from the Agency, nationally.  

The  targeted  revision  would  focus  on  improving  the  data  collection  of  the  national  focal 
points  on the drug phenomena and enhancing their effectiveness  and  efficiency  within their 
current  set-up.  The  national  focal  points  should  assist  the  Agency  in  analysing  and 
interpreting the national drug situation, and report and disseminate the Agency’s products. In 
addition, being positioned as a central data hub, the national focal points could have a stronger 
(coordinating)  role  on  national  level  as  a  service  provider  to  national  stakeholders  and  get 
additional specific assignments relevant in the national context.  

Minimum  requirements  would  be  important  to  ensure  the  provision  of  high  quality  data 
from every Member State and to  give some continuity and consistency to the national  focal 
points.  A  certification  procedure  could  verify  the  compliance  with  the  minimum 
requirements.  A  certification  solution  could  be  implemented  through  a  peer-to-peer  review 
process.  The  peer  pressure  would  result  in  a  quasi-binding  nature  of  the  minimum 
requirements.  As  this  would  not  be  laid  down  in  a  binding  decision  of  the  Agency,  there 
would not be any subsidiarity concerns with such an option. Another certification solution is 
to  continue  with  the  status  quo  of  a  voluntary  certification  procedure  carried  out  by  the 
Agency. The main downside of a voluntary certification system is that the minimum criteria 
would remain as recommendations without any binding nature.  

Support to Member States 

23 

 
 
 
Currently,  the  Agency  provides  support  to  Member  States  on  a  demand  basis.  This  mainly 
refers to  the evaluation  and shaping of national  drug policy  as well as the exchange of best 
practices or their implementation. However, the Agency could build on its core activities and 
strengths,  and  provide  more  support  to  Member  States.  The  targeted  revision  option  would 
position the Agency as a service provider to Member States offering tailored services based 
on  the  needs  arising  in  the  drugs  policy  field.  New  services  would  be  introduced  based  on 
core 
data 
collection/monitoring/harmonization/analysis  capabilities.  Services such  as accreditation and 
certification  of  (national)  key  intervention  schemes,  reporting  of  data  on  behalf  of  the 
Member States to the UN agencies, or training would be considered. 

the  Agency 

and  where 

strengths 

leverage 

can 

its 

of 

it 

International dimension  

The  evaluation  was  clear  on  the  potential  for  the  Agency  to  increase  its  involvement  on 
international issues. The recast of the founding Regulation in 2006 gave the Agency a more 
explicit role as regards cooperation with international organisations and third countries.72 The 
Agency is quite active in the international arena, supporting the EU and its Member States in 
multilateral fora and in the cooperation with third countries. The Agency already carries out 
EU-financed projects in third countries, which contribute to improving national and regional 
responses  to  security  and  health  threats  in  these  countries/regions.  The  targeted  revision 
option would clarify the role of the Agency in this area in order to improve the evidence base 
for EU drug policy-making, improve the outreach of the EU to third countries and contribute 
to the development and implementation of the external dimension of EU drugs policy.  

The targeted revision would align the issues where the Agency has competences on an EU-
level,  with  where  it  would  be  able  to  contribute  on  an  international  level.  As  the  Agency’s 
work  would  better  reflect  the  EU’s  balanced,  evidence-based,  integrated  and  multi-
disciplinary approach to drugs policy, it would be able to further act to promote this approach 
in  third  countries.  The  Agency  would  be  given  a  clear  mandate  to  participate  in  EU 
cooperation  programes  and  to  analyse  global  developments  and  developments  in  third 
countries, which have the potential to  affect  the EU. The expert input of the Agency would 
not only benefit the EU’s international partners, but the EU itself. It would contribute to the 
development  and  implementation  of  the  external  dimension  of  EU  drugs  policy  and  the 
leadership role of the EU at multilateral level.  

Policy option 5: Expansive revision – Focusing on diverse addictions   

The expansive revision option is a legislative option to amend/revise the founding Regulation 
and  hence  the  Agency’s  mandate,  by  responding  to  the  different  issues  outlined  in  the 
problem  definition  by  using  the  thematic  scope  of  action  as  a  starting  point.  The  expansive 
revision option would broaden the efforts of the Agency away from the drug area and open up 
the  scope  of  action  to  address  a  full  thematic  scope  related  to  wide  range  of  substance  and 
behavioural addictions.  

Thematic scope of action 

The current thematic scope of action of the Agency refers to “drugs and drug addiction and 
their  consequences”73.  The  founding  Regulation  itself  does  not  define  the  terms  further. 
Therefore,  recourse  has  to  be  made  to  the  definition  of  drugs  in  EU  law.  At  the  time  of 
adoption of Regulation (EC) 1920/2006, Council Framework Decision 2004/757/JHA defined 
drugs with  reference to  the UN Drug Conventions and Joint Action 97/396/JHA of 16 June 

72   Article 2(d) of the founding Regulation.  
73   Article 1(2) of the founding Regulation. 

24 

 
                                                           
1997 concerning the information exchange, risk assessment and the control of new synthetic 
drugs.74 The definition was slightly adapted through Regulation (EU) 2017/2101.  

Based  on  this  definition,  the  thematic  scope  of  action  of  the  Agency  covers  (illicit)  drugs. 
When  revising  the  mandate,  the  question  is  whether  it  should  be  broadened  to  other 
(problematic)  forms  of  substance  use,  including  alcohol,  tobacco,  prescription  medicines, 
and/or  addictions  not  directly  linked  to  substance  use,  such  as  gambling  and  compulsive 
gaming.  

Alcohol  and  tobacco  addictions  are  a  serious  health  issue  and  lead  to  significant  social  and 
economic consequences. Addiction to prescription medicines is an increasing problem in the 
EU, and the possible magnitude of the problem can be seen in the opioid crisis in the US75. 
Behavioural addictions do not involve the use of substances, but can cover a wide variety of 
problematic  behaviours,  such  as  gambling,  compulsive  gaming,  internet  addiction,  sex 
addiction,  shopping  addiction,  and  binge  eating.  Addictions  are  to  some  extent  similar 
biologically and behaviourally, result in a similar compulsivity, and sometimes are addressed 
through similar policy approaches.  

Licit and illicit markets involve different types of actors and have different types of problems. 
However,  some  consider  the  distinction  arbitrary  from  a  scientific  point  of  view  and  the 
distinction can change over time.76 Possible changes in the classification of a substance as licit 
or illicit have to be taken into account in any consideration on the future mandate. This is also 
relevant  as  regards  low-THC77  products  and  products  containing  cannabinoids,  which  are 
already on the market, or prescription drugs, which are misused widely in some areas of the 
world (e.g. opioid-based painkillers). 

The stakeholder consultation during the 2018/19 evaluation revealed that while a majority of 
national  stakeholders  and  Agency  were  largely  in  favour  of  broadening  the  scope  to  other 
addictions,  other  stakeholder  groups  (including  EU-level  stakeholders)  were  critical.  The 
expansive revision option would have to address possible overlaps with  existing policies on 
these  addictions  while  building  on  areas  that  fit  closely  with  the  current  activities  of  the 
Agency.  It  would  also  imply  a  serious  increase  of  the  financial  and  human  resources 
necessary to the Agency to carry out its tasks. 

Monitoring system 

The  current  monitoring  system  of  the  Agency  is  largely  built  to  monitor  drug  phenomena, 
mainly focused around drug use and related trends. Not only is the monitoring system largely 
retrospective, but it is dependent on established approaches. Therefore, the monitoring system 
of  the  Agency  would  have  to  be  revised  under  the  expansive  revision  based  on  the  broad 
thematic  scope  of  action,  in  order  to  provide  analysis  and  information  on  the  best  ways  to 
address applicable threats and trends covering not only the drug phenomena but also diverse 
addictions.  While  it  would  be  relatively  easy  to  extend  some  aspects  of  the  current  data 
collection  system  of  the  Agency  to  other  substance-based  addictions,  in  particular  alcohol, 
tobacco and prescription medicines, collecting data regarding addictive behaviours would be 
more difficult as it requires different methodologies and studies. 

74   OJ L 167, 25.6.1997, p. 1. 
75   https://www.whitehouse.gov/opioids/.  
76   See e.g. related to cannabis, which has been liberalised in some areas of the world, such as Canada, Uruguay 

and some States in the US. 

77   THC stands for tetrahydrocannabinol, which is the main psychoactive substance found in cannabis. 

25 

 
                                                           
The  existing  cooperation  between  the  Agency  and  other  EU  agencies  would  need  to  be 
enhanced  and  reinforced,  especially  with  the  European  Medicines  Agency  (EMA)  and  the 
European Centre for Disease Prevention and Control (ECDC) who do not specifically collect 
addiction-related  data,  but  some  of  their  data  might  be  useful  for  a  better  understanding  of 
addictions.   

In  addition,  it  has  to  be  determined  what  tasks  should  be  included  to  serve  the  monitoring 
system  within  this  expansive  scope  of  action,  i.e.  whether  the  Agency  should  integrate 
existing  data  into  routine  reporting;  develop  further  the  existing  data  collection  regarding 
other  addictions;  monitor  the  health  impacts  of  these  addictions;  and/or  monitor  all  the 
consequences  of  these  addictions.  The  assessment  would  have  to  address  possible  overlaps 
with existing policies on these addictions and should identify areas, which fit closely with the 
current activities of the Agency.    

Since  the  monitoring  system  of  the  Agency  requires  updates  in  order  to  anticipate 
developments  in  the  drug  phenomena,  as  identified  by  the  evaluation,  for  the  Agency  to  be 
less  reliant  on  third  parties  for  forensic  and  toxicological  examination,  an  expanded 
laboratory solution was identified. As previously mentioned, the Agency does not have any 
laboratory  capacities,  it  has  to  rely  for  the  analysis  of  substances  on  the  laboratories  in  the 
Member  States  and  in  third  countries.  If  the  Agency  would  have  its  own  centralized 
laboratory  housed  within  the  Agency  itself,  it  would  be  able  to  work  on  and  answer  key 
strategic questions about the composition of drugs and drug markets. These questions often go 
unanswered  due  to  lack  of  capacities  on  national  and  European  level,  especially  as  the 
laboratory of the JRC supports national laboratories only  on a case-by-case basis within the 
Customs Laboratory European Network.     

In addition to providing the Agency with an updated monitoring system that has the support 
of  a  developed  laboratory,  the  expanded  revision  should  include  the  different  elements  that 
would allow the Agency to react to new challenges and to act on its analysis. As outlined and 
described in the targeted revision option above, these are the  alert system, prevention and 
awareness  campaigns,  and risk analysis and intelligence reports, and they  would enable 
an  operational  response  from  the  Agency  on  drug  issues,  in  conjunction  with  the  topics  of 
diverse addictions.  

The Reitox network of national focal points 

As previously mentioned, the national focal points are the main data providers to the Agency. 
Therefore,  any  changes  in  the  Agency’s  monitoring  system  have  to  be  mirrored  in  their 
mandate, which is for the Member States to decide as well as how a national focal point is set 
up, organised and with what means it is equipped. Nevertheless, the expansive revision affects 
the mandate of the national focal points even more than the targeted revision, which will have 
to be taken into consideration.  

Minimum  requirements  regarding  the  provision  of  high  quality  data  from  every  Member 
State and to give continuity and consistency to the national focal points can be foreseen in the 
expansive revision option through a stronger certification option than the targeted revision or 
the  current  practice.  Instead  of  continuing  with  the  status  quo  of  verifying  the  minimum 
requirements  with  the  voluntary  certification  procedure  carried  out  by  the  Agency,  the 
expansive revision lays out a mandatory certification by the Agency. This would lead to a 
decision of the Agency as regards to compliance with the minimum requirements. In the case 
the  Agency  could  make 
of  non-compliance  with 
recommendations  on  how  these  should  be  achieved,  accompanied  by  a  timetable.  This 
solution could be considered as interfering with national competencies and might be difficult 

the  minimum 

requirements, 

26 

 
from  a  subsidiarity  perspective  as  not  only  the  minimum  requirements,  but  also  the 
recommendations on how to implement them would be binding. However, this solution would 
respond to main weakness of the voluntary certification, which is that the recommendations 
cannot be enforced.  

In  addition,  the  expansive  revision  will  increase  the  body  of  data  to  be  provided  by  the 
national focal points to the Agency based on the expansive thematic scope of action covering 
diverse  addictions.  Therefore,  the  expansive  revision  would  have  to  broaden  efforts  for 
collection  of  data  across  addictions.  The  majority  of  this  data  is  already  collected  by  the 
Member  States  based  on  EU  legislation  and/or  because  national  strategies  apply  a  wider 
addiction approach. However, clear rules on what data and information has to be provided by 
Member  States  through  the  national  focal  points  to  the  Agency  under  this  broader  thematic 
approach, would need to be developed and established.  

Support to Member States 

In  addition  to  the  support  the  Agency  currently  provides  to  Member  States  such  as  support 
with  evaluations  and  shaping  of  national  drug  policies  or  exchange  of  best  practices,  the 
expansive revision presents an opportunity to enhance and further expand the added-value to 
Member States. In addition to the services outlined in the targeted revision (i.e. accreditation, 
training), the expansive revision option would  also build on the Agency’s current role as an 
important  hub  for  knowledge  sharing,  but  with  an  increased  thematic  scope  on  diverse 
addictions. The best practice portal78 is the best example of this. Key challenges for the EU, 
particularly on prevention and treatment, need the implementation of best practice standards 
and the transfer and adoption of best practice methods, which are laid out and discussed in the 
best  practice  portal.  In  the  expansive  revision,  this  role  could  be  increased  to  include 
prevention and treatment of diverse addictions.  

International dimension  

The  expansive  revision  would  work  towards  clarifying  the  role  of  the  Agency  in  this  area 
mainly in  terms  of drug  policy, as the drug phenomena topic is  the most international  topic 
within  general  addictions.  The  Agency  already  carries  out  EU-financed  projects  in  third 
countries,  which  contribute  to  improving  national  and  regional  responses  to  security  and 
health threats in these countries/regions. However, the Agency’s envolvement is not garanteed 
to be consistent due to the setup of funding. Building on the solutions laid out in the targeted 
revision, the expansive revision should lead to providing the Agency with a sustanable budget 
for  international  activities,  thus  reconsidering  the  current  “ad  hoc”  and  “project  funding” 
approach  when  participating  in  EU-financed  projects  in  third  countries,  which  impedes  the 
Agency’s performance and consistent involvement. 

5.3.  Options discarded at an early stage 

In the course of the impact assessment exercise the following policy options were discarded at 
an early stage and thus were not subject to deeper analysis and assessment: 

Policy option 0: Baseline scenario - Maintaining the current approach without changes 

Keeping the baseline scenario in place would not address any of the problems and would not 
achieve the general objective of the proposed initiative. Section 2.5 sets out how the problem 
would evolve if no policy change would be implemented. 

78   See footnote 61. 

27 

 
 
                                                           
Policy option 1: Minimal revision option - Stronger cooperation 

This  option  would  not  achieve  the  general  objective  of  the  proposed  initiative,  although 
improving  the  cooperation  between  the  Agency  and  the  Member  States  and  with  other  EU 
agencies is important.  

Member  States  are  interested  in  getting  European-wide  analyses  of  the  drug  phenomenon 
from the Agency and its support in the evaluation and shaping of their national drug policies. 
More cooperation among Member States themselves would not be able to address this, as they 
do  not  have  the  resources,  capabilities  or  the  competence  to  analyse  the  cross-border 
dimension of the drugs phenomenon. 

An  obvious  candidate  for  further  cooperation  is  Europol79.  The  two  agencies  are  already 
cooperating on a number of issues, in particular when it comes to the early warning system 
and  the  development  of  reports  on  drug  market  issues.  Potential  overlaps  in  their  tasks,  in 
particular on drug markets, are addressed by a close cooperation of the two agencies, where 
each  focusses  on  its  strengths  in  the  area.  A  further  extension  of  the  cooperation  would  be 
difficult as the EMCDDA’s mandate does not refer to drug supply or drug market issues.  

Another option would be the Maritime Analysis and Operations Centre – Narcotics (MAOC-
N).80 Enhancing and reinforcing the existing cooperation between MAOC-N and the Agency 
could involve sharing of data, intelligence analysis, and information on the substances seized. 
Further  improving  the  cooperation  between  the  two  entities  would  be  of benefit  for  both  as 
MAOC-N would get additional strategic information, whereas the Agency could benefit from 
the operational knowledge of MAOC-N. However, there would be limits to what information 
MAOC-N  would  be  able  to  share  with  the  Agency  due  to  the  confidential  nature  of  the 
information they hold. 

As  regards  the  European  Medicines  Agency  (EMA)81,  the  European  Centre  for  Disease 
Prevention  and  Control  (ECDC)82  and  the  European  Health  Emergency  Preparedness  and 
Response Authority (HERA), the focus of cooperation would be on health issues. Looking at 
the mandates and the focus of these bodies, including of HERA83, cooperation on drug-related 
issues  would only be an ancillary task  for them. Although ECDC and EMA look  at  serious 
cross-border  health  threats,  their  focus  is  on  ensuring  the  functioning  of  the  internal  market 
and the general health security framework. Therefore, strengthened cooperation with these EU 
bodies would only address the objective of the proposed initiative to a limited extent. 

Enhanced  cooperation  could  be  considered  with  the  UN  Office  on  Drugs  and  Crime 
(UNODC).  The  evaluation  concluded  that  there  are  some  overlaps  between  the  work  of  the 

79   Existing 

arrangements: 
https://www.emcdda.europa.eu/system/files/attachments/10200/Draft_Working_Arrangement_EMCDDA_E
uropol%20for%20MB_290618.pdf.  

working 

80   MAOC-N  is  an  operational  platform  with  the  co-location  of  experienced  law  enforcement  liaison  officers 
and military attachés from six Member States (Spain, France, Ireland, Italy, Netherlands and Portugal) and 
the UK. Its main objective is to improve the cooperation in the  fight against illicit drug trafficking by sea 
across the Atlantic Ocean and the Mediterranean Sea towards Europe and the West African Seaboard. The 
budget of MAOC-N is provided mainly by project grants from the Internal Security Fund – Police.  

81   Existing 

arrangements: 
https://www.emcdda.europa.eu/system/files/attachments/10204/Draft_Working_Arrangement_EMCDDA_E
MA%20for%20MB_290618-1.pdf.  

working 

82   Existing 

working 

arrangements: 

https://www.emcdda.europa.eu/system/files/attachments/10396/Working_Agreement_EMCDDA_ECDC_4
December.pdf.  
83   See footnote 63. 

28 

 
 
 
 
 
                                                           
Agency  and  UNODC,  in  particular  in  relation  to  the  collection  of  drug-related  data.  It  was 
suggested by consulted stakeholders that the Agency could support the Member States in their 
reporting  to  UNODC.  The  Agency’s  stakeholders  identified  further  scope  for  increased 
cooperation on issues such as sharing best  practices and adoption of common  guidelines on 
data  collection.84  The  remit  of  UNODC  is  global  and,  therefore,  the  emphasis  of  the  two 
bodies is very different. Therefore, further strengthening the cooperation with UNODC would 
achieve the objectives of this initiative only to a limited extent. 

The assessment of this non-legislative policy option leads to the conclusion that it would – on 
its  own  –  not  be  able  to  achieve  the  general  objective  of  the  proposed  initiative  and  would 
only  to  a  very  limited  extent  be  able  to  address  the  problem  drivers.  However,  cooperation 
with  other  agencies  should  be  strengthened  in  any  case  in  order  to  make  full  use  of  the 
complementarities outlined above. Addressing existing or potential future overlaps would be 
difficult  in  a  non-legislative  option  and  would  have  to  be  addressed  from  the  outset  in  any 
(revised or new) working arrangements.  

As policy option 1 is not able to address the problems set out in the problem definition nor to 
achieve the general and specific objectives of the proposed initiative,  it will not be assessed 
further.  

Policy option 2: Dismantling of the Agency - Repeal of the founding Regulation  

According to the common approach, “closing down an agency could be a solution for dealing 
with underperforming agencies unless  the agency is  still the most relevant  policy option, in 
which case the Agency should be reformed”.85 

The recent  evaluation showed that the EMCDDA is considered not only on European level, 
but  also  internationally,  as  a  centre  of  excellence.  All  stakeholders  agreed  during  the 
evaluation  that  the  termination  of  the  Agency  would  have  negative  impacts  and  should  be 
avoided.  In  the  context  of  the  recent  discussions  of  the  new  EU  Drugs  Strategy  in  the 
Council’s Horizontal Working Party on Drugs, all Member States were fully supportive of the 
work of the agencies involved and in particular stressed how much the Agency is needed to 
further EU drugs policy.  

While  at  the  first  instance  it  would  be  policy-makers  who  would  be  affected  by  the 
termination of the Agency as they would not have access to EU-level information, ultimately, 
the  general  public  would  feel  the  impacts,  albeit  more  indirectly.  As  there  would  be  no 
obligation to collect the relevant data and no more centralised support, some countries would 
cease to collect the data. This would result in incomplete and fragmented data and imply the 
loss of the EU-level overview of the drug phenomenon.86  

The exchange of best practice would be more difficult without a central organisation bringing 
the  information  and  people  together.  The  cessation  of  the  Agency  would  undermine  the 
possibility  to  design  and  implement  drug  policies  and  strategies  based  on  objective  and 
scientific evidence, both at EU and at national level. Closing down the Agency would have a 
negative impact on evidence-based policy-making. 

84   See footnote 19, p. 34. 
85   Point 5 of the Common Approach (see footnote Error! Bookmark not defined.).  
86   See footnote 19, p. 37/38; see the counterfactual case study in Annex 4 of the final report of the evaluation. 

29 

 
                                                           
Based on the conclusions of the evaluation and the very good performance87 of the Agency, it 
cannot  be  concluded  that  the  Agency  is  underperforming.  Such  a  conclusion  would  be 
contrary  to  the  perception  of  stakeholders  that  the  Agency  in  an  important  neutral  voice 
providing factual, objective, reliable and high-quality data on drugs and dismantling it would 
cause serious issues for drug monitoring in Europe.88  

The termination of the  Agency  would have negative consequences on the role of the EU  at 
international and multilateral level, as it would diminish EU leadership in drugs policy, would 
likely  negatively  impact  its  ability  to  speak  with  one  voice  in  international  fora,  and  would 
lead to an incomplete picture of the situation of drugs in the EU, which would be contrary to 
the EU’s interests.  

The  assessment  considered  alternatives  to  the  Agency  based  on  the  analysis  during  the 
evaluation in view of their effectiveness in implementing EU drugs policy.  

Allocating some of the tasks to the Commission services in cooperation with EU bodies (such 
as Europol, EMA, ECDC or HERA) or directly to these bodies would still ensure regular EU-
level  data  collection  and  analysis.  Attributing  the  tasks  to  the  Commission  would  have  two 
main disadvantages: a) the Commission might have to outsource some of the activities, which 
would lead to a loss of capacity and expertise in the mid- and longer term; and b) this loss of 
expertise  might  compromise  the  quality  of  the  data  analysis.  Attributing  the  tasks  to  the 
mentioned EU  bodies  might  limit  the loss of expertise, but  would create a fragmentation of 
the work and increase the coordination role to be played by the central services  – which, at 
time of scarce human resources, would not be effective.  

Another  alternative  would  see  the  responsibility  for  monitoring  the  drug  phenomenon 
reverting  back  to  the  Member  States.  The  Member  States  would  need  to  ensure  that  the 
collection  of  data  continues  among  themselves  with  limited  or  no  coordination at  EU level. 
An  agreement  on  common  standards  would  be  more  difficult  to  reach,  compromising  the 
comparability  of  data.  In  addition,  the  reliability  and  impartiality  of  the  information  might 
suffer. Some Member States may decide not to take part in European data collection anymore.   

The  third  alternative  option  would  be  to  rely  exclusively  on  the  activities  of  international 
organisations,  such  as  the  UN  Office  on  Drugs  and  Crime  (UNODC),  the  World  Health 
Organisation  (WHO),  the  Council  of  Europe  (in  particular  the  Pompidou  Group)  or  others. 
Although the collection of data would be coordinated by a central body (external to the EU), it 
would mean that the picture of the drugs phenomenon in the EU could be incomplete based 
on available world data as opposed to European data. In addition, the collection would be less 
relevant  as  it would not  be targeted to  the interests of the EU. This  would  lead to  a loss of 
expertise and understanding of the influencing factors on the drug phenomenon in the EU. It 
would imply a loss of EU visibility on the global stage, given that the EU is seen as a model 
in terms of data collection and evidence-based drugs policy.  

The  dismantling  of  the  Agency  would  imply  the  disinvestment  of  the  EMCDDA  budget  of 
about EUR 16-17 million per year (if dismantled without replacement). If the tasks would be 
reallocated  to  another  EU  body,  all  or  a  large  share  of  this  budget  would  be  needed  in  the 
receiving body and, therefore, the dismantling would lead to only limited budget savings for 
the EU. In case of a dismantling of the Agency without replacement on EU level, additional 

87   See  the  general  reports  of  activities  and  the  annual  accounts;  https://www.emcdda.europa.eu/publications-

database?f[0]=field_series_type:472.  

88   The  feedback  received on  the  inception  impact  assessment  confirmed  this  view.  Six  (out  of  a  total  of  24) 
respondents stated that the dismantling of the Agency would lead to a serious threat for and weakening of 
the European drug monitoring system. 

30 

 
                                                           
efforts and investments by national public authorities would be needed. This would likely lead 
to a higher total cost than the current solution. Unfortunately, very limited data is available as 
regards investments by Member States on drug policy.89 Therefore, the real “costs of non-EU” 
cannot be estimated in a reliable way.  

In conclusion, the assessment shows that the Agency is the most effective solution compared 
to  the  alternatives  in  achieving  the  objectives  of  EU  drugs  policy.  The  dismantling  of  the 
Agency would furthermore be in contradiction with the EU Drugs Strategy 2021-2025.   

Policy option 3: Merging of the Agency with another EU body  

According to the common approach, “merging agencies should be considered in cases where 
their  respective  tasks  are  overlapping,  where  synergies  can  be  contemplated  or  when 
agencies would be more efficient if inserted in a bigger structure”.90  

The  evaluation  looked  into  possible  overlaps  and  synergies  with  other  organisations  and 
concluded that there are hardly any overlaps. Stakeholders highlighted that the reason for the 
few  overlaps  is  that  the  Agency  is  unique  as  a  provider  of  an  overview  of  the  EU  drug 
situation. The main overlap identified is with the UN Office on Drugs and Crime (UNODC) 
as regards data collection as both collect standard drug data, but at different times of the year, 
based on different definitions and in different formats.  

As regards possible synergies between the  Agency  and other  bodies, the  evaluation showed 
that  good  cooperation  is  in  place,  many  synergies  are  already  exploited  and  that  there  is 
minimal duplication of work. Beyond the UNODC, stakeholders identified some unexploited 
synergies with the Commission, in particular with DG SANTE on health-related issues.  

The  potential  to  merge  the  EMCDDA  with  another  EU  body  was  not  deemed  desirable  by 
stakeholders.  There  were  no  positive  interview  responses  during  the  evaluation  to  the 
prospects  of  merging  the  EMCDDA  with  another  EU  agency.  The  primary  reason  was  the 
very  specific  activities  of  the  Agency.91  For  the  same  reason  interviewees  considered  that 
such a merger would have a detrimental effect on the quality of the scientific outputs.  

The  potential  candidates  with  whom  the  EMCDDA  could  be  merged  are,  based  on  current 
cooperation  levels,  synergies  and  potential  complementarities  of  work,  Europol,  MAOC-N, 
ECDC, EMA and HERA.  

The Agency and Europol are cooperating closely on drug markets issues and on the EU early 
warning  system  for  new  psychoactive  substances.  Whereas  Europol  has  operational 
information from law enforcement (in particular police) authorities, the EMCDDA has access 
to  strategic  information.  The  outcome  of  this  work  are  several  joint  reports92  and  the 
involvement  of  the  two  agencies  in  each  other’s  working  groups.  A  merger  of  these  two 
agencies  might  lead  to  a  better  understanding  of  drug  market  issues  and  the  availability  of 
additional information for law enforcement authorities on the functioning of drug markets. On 
the  other  hand,  drug  trafficking  is  for  Europol  one  of  many  crime  areas.  Europol  is  large 
compared  to  the  EMCDDA  and  the  danger  is  that  the  drug-related  issues  would  get  lost 

89   Evaluation of the EU Drugs Strategy 2013-2020 and EU Action Plan on Drugs 2017-2020, SWD(2020) 150 

final.  

90   Point 5 of the Common Approach (see footnote Error! Bookmark not defined.). 
91   54%  of  all  interviewed  stakeholders  expressed  this  view.  In  addition,  almost  all  participants  in  the  public 
consultation provided a clear negative answer to the potential closing or merging of the Agency with another 
body. 

92   The joint flagship report is the EU Drug Markets Report (footnote 7).  

31 

 
                                                           
among the many priorities of a merged agency. Furthermore, Europol reshuffles its priorities 
based  on  regular  assessments.  Only  recently,  due  to  the  escalation  of  activities  in  the  drug 
markets,  Europol  started  to  re-engage  stronger  on  issues  related  to  drug  trafficking.  The 
conclusion that a merger with Europol would not be beneficial for EU drugs policy does not 
change  with  the  proposed  revision  of  the  Europol  Regulation  as  it  is  focused  on  issues  not 
addressing the problems identified in this impact assessment.93 In addition, it is likely that a 
merged entity would focus mainly on drug market and crime issues and reduce the focus on 
health  issues.  This  would  not  be  in  line  with  requests  from  stakeholders,  in  particular  civil 
society and Member States, to continue the Agency’s important work on public health issues.  

The  integration  of  MAOC-N  with  the  Agency  was  considered  because  both  organisations 
work  on  drug  issues,  have  clearly  complementary  activities,  are  both  located  in  Lisbon  and 
because  this  could  give  the  Agency  an  operational  dimension.  If  MAOC-N  would  be 
integrated  while  keeping  its  specificities,  it  would  allow  for  the  continuation  of  the  current 
working  model  of  MAOC-N,  which  would  ensure  that  the  confidentiality  and  protection  of 
the  information  exchanged,  distribution  of  intelligence,  and  de-confliction  would  be  kept 
separate. This could get the buy-in of the partner countries. Keeping a separate structure for 
MAOC-N within the Agency would lead however to considerable legal challenges as a hybrid 
governance model would be needed. Although a full inclusion of MAOC-N into the Agency 
would give the Agency a real operational dimension without raising the legal challenges of a 
hybrid  governance  model,  it  would  most  probably  not  be  feasible  as  it  would  raise  serious 
opposition  from  MAOC-N  partners  as  the  current  functioning  would  not  be  feasible  in  a 
bigger  structure.  The  integration  of  MAOC-N  with  the  Agency  could  address  the  issue  of 
financial  sustainability  of  MAOC-N94,  but  not  the  problems  addressed  in  this  impact 
assessment. Due to the specificities of the information held by MAOC-N, which can only be 
shared with the partner countries, the expected impact of giving the Agency a real operational 
dimension would not materialise.  

The  links  between  the  Agency  and  EMA  or  ECDC  are  in  relation  to  a  limited  number  of 
health issues. The main common work strands with EMA are in relation to medicinal products 
and  their  potential  misuse.  The  ECDC  and  the  EMCDDA  have  a  common  interest  in 
monitoring, communicating on, and preventing the spread of drug-related infectious diseases 
in  Europe.95  While  ECDC  analyses  trends  in  these  diseases  across  the  whole  population, 
EMCDDA focuses on specific drug-related risk groups such as injecting drug users. However, 
drug use as such is not a disease. 

Merging with EMA or ECDC would have considerable downsides. It would lead to a loss of 
focus  on  drug-related  issues  due  to  the  dilution  in  wider  health  aspects.  This  is  particularly 
problematic in the aftermath of the COVID-19 pandemic, where the focus of these agencies 
will be on addressing the effects of the pandemic and bolstering the response to potential new 
pandemics in the future. As shown in practice during the pandemic, drug issues do not have 
the  status  of  essential  services  and  therefore  are  not  in  the  core  of  general  health 
considerations.96 The current cooperation between EMCDDA, on the one hand, and EMA or 

93   COM(2020) 796 final. The three core issues addressed by the revision are the lack of effective cooperation 
between  private  parties  and  law  enforcement  authorities  to  counter  the  abuse  of  cross-border  services  by 
criminals;  the  big  data  challenge  for  law  enforcement  authorities;  and  gaps  in  innovation  and  research 
relevant for law enforcement.  

94   This  is  however  addressed  to  some  extent  with  the  renewed  and  increased  support  of  the  EU  to  the 

functioning of MAOC-N for the period 2022-2026. 

95   See Proposal for a Regulation on serious cross-border threats to health, COM(2020) 727 final. 
96   Closing  remarks  on  the  impact  of  the  COVID-19  pandemic  on  the  world  drug  situation  –  the  European 
perspective,  at  the  occasion  of  the  United  Nations  Commission  on  Narcotic  Drugs  special  event  on  the 
June,  Vienna), 
and 
International 

trafficking 

against 

abuse 

illicit 

drug 

day 

(26 

32 

 
                                                           
ECDC,  on  the  other  hand,  extends  to  the  EU  early  warning  system.  For  both  agencies, 
Article 5b  of  the  founding  Regulation  defines  what  information  they  should  provide  to  the 
EMCDDA in case of the development of an initial report on a new psychoactive substance.97 
This kind of information is not available to EMCDDA and there is no intention to extend the 
Agency’s  mandate  in  these  directions.  Taking  into  account  the  proposed  extensions  of  the 
mandates  of  EMA  and  ECDC  as  well  as  the  intentions  for  the  revision  of  the  EMCDDA 
mandate  as  set out  in  the preferred option, there are no  risks of overlaps regarding the data 
collection and/or analysis. In addition, the drug market related issues would likely not get the 
attention  they  deserve  in  a  merged  entity.  Moreover,  EMA  is  based  on  a  regulatory  logic, 
which does not fit with drug-related issues.  

The  mission  for  HERA  is  to  strengthen  the  EU’s  preparedness  and  response  in  terms  of 
medical  countermeasures  for  serious  cross-border  threats  to  health.  Based  on  the  inception 
impact  assessment98,  the  main  objective  of  the  new  EU  body  is  to  enable  adequate  EU 
preparedness via an EU level countermeasure management system that would allow rapid and 
equal  access,  availability,  development  and  deployment  of  the  most  advanced  medical 
countermeasures in the event of a health emergency. HERA should contribute to the Security 
Union, through improving the  availability of countermeasures for preparedness  and respond 
to intentional release scenarios and Chemical, Biological, Radiological and Nuclear (CBRN) 
threats. The specific focus of this new agency does not seem to lead to any complementaries 
or overlaps with the work of the EMCDDA. 

No  evidence  is  available  that  would  indicate  that  addressing  drug-related  issues  would  be 
more efficient if the Agency would be merged with any of the aforementioned bodies. To the 
contrary, addressing these issues in a bigger structure of a merged entity includes the danger 
of dilution, i.e. that the  drug topic would be marginalised and not  addressed sufficiently.  In 
addition, a merger with any of the aforementioned EU bodies would lead to a loss of balance 
between the health and security dimension in the new entity. Not having the balance between 
the two main pillars would be detrimental to EU drugs policy.  

In case of a merger with another EU body or the shifting of the competences to one of them, 
human  and  financial  resources  would  have  to  be  transferred.  Moreover,  the  transfer  of 
undertaking would have to be carefully assessed as such a transfer of obligations can be quite 
expensive  and  time  consuming.  In  addition,  the  simplification  potential  is  quite  small,  as  it 
would  be  mainly  limited  to  the  administration  of  the  new  entity  vis-à-vis  having  these 
administrative functions in two agencies. Therefore, such a merger would not lead to relevant 
efficiency gains on the European level.  

In  conclusion,  merging  of  the  Agency  with  another  EU  body  would  be  incoherent  with  the 
drug phenomenon in the EU, which necessitates stronger  – not weaker – intervention at EU 
level.  This  option  would  fail  to  address  the  problems  set  out  in  the  problem  definition  and 
would  not  help  in  achieving  any  of  the  general  or  specific  objectives  of  the  proposed 
initiative.  Moreover,  merging  the  Agency  would  be  against  the  approach  of  the  new  EU 
Drugs Strategy 2021-2025, which explicitly asks for the Commission to present a proposal for 
a revision of the EMCDDA mandate. Therefore, this policy option will not be further assessed 
in the impact assessment.  

https://www.emcdda.europa.eu/system/files/attachments/13134/Speech-
EMCDDA_Europol_Goosdeel_FINAL.pdf.  

97   The working arrangements of the EMCDDA with the two agencies (see footnotes 81 and 82) were adapted 
to the update of this provision in 2018; see the related Commission opinions in C(2018)6815 (ECDC) and 
C(2018)6779 (EMA). 

98   https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12870-European-Health-

Emergency-Preparedness-and-Response-Authority-HERA-.  

33 

 
                                                                                                                                                                                     
6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? 

This section analyses the impacts of the policy options 4: targeted revision and policy option 
5:  expansive  revision.  The  main  impacts  are  on  the  European  Union  (EU  bodies)  and  on 
national  authorities.  Linked 
impacts  on  simplification  and/or 
this  are  possible 
administrative burden and economic impacts. The following sections of the report, assess the 
impact of the two package policy options defined in chapter 5.2. 

to 

When it comes to other impacts, those on other stakeholders, in particular citizens/individuals 
and businesses, are limited and largely indirect through the better ability to tackle the drugs 
phenomenon  in  the  EU.  In  terms  of  impacts  on  the  economy  and  competitiveness,  social 
impacts,  environmental  impacts,  and  impacts  on  fundamental  rights,  the  revision  of  the 
mandate  of  the  Agency  only  has  very  limited  and  indirect  impact.  Therefore,  these  impacts 
will only be addressed below as far as relevant.  

As  regards  impact  on  the  economy  and  competitiveness,  a  revised  mandate  of  the  Agency 
would  contribute  positively  through  limiting  the  loss  of  manpower  in  the  economy  due  to 
people  who  use  drugs  not  being  able  to  work  or  provide  work  to  their  full  abilities,  and 
through disrupting the income of organised crime groups. These are indirect impacts, which 
would be due to a better understanding of the drug situation. The only direct economic impact 
is on the EU and, depending on the option, national budgets.  

An  Agency,  which  would  be  better  equipped  based  on  a  revised  mandate,  would  help  – 
together with Europol – to tackle drug supply in the EU based on better available information 
on  drug  trafficking  and  production,  and  thereby  tackling  crime  and  supporting  the  internal 
security of the EU. Another social impact of the revision would be improved access to best 
practices in the area of drug demand and other public health responses. In addition, based on 
the  experience  with  drugs,  the  Agency  could  have  an  important  contribution  to  actions  in 
support of the mental health of users.  

the 

territory  of 

The  revision  of  the  mandate  would  have  a  certain  indirect  environmental  impact.  Drug 
in  particular  of  MDMA  (ecstasy)  and 
production  on 
(meth-)amphetamines,  has  considerable  impacts  on  the  environment,  in  particular  when  it 
comes  to  the  dumping  of  the  waste  of  drug  production.  Better  knowledge  regarding  the 
production  methods  and  precursor  diversion  would  support  the  work  of  law  enforcement  in 
discovering illicit drug labs and subsequently in reducing the illicit dumping of drug waste.  

the  EU, 

The  revision  as  such  does  not  have  any  direct  impacts  on  fundamental  rights.  The  data 
provided  to  the  Agency  are  statistical  data,  but  do  not  include  personal  data;  therefore, 
Article 8 of the Charter of Fundamental Rights (“protection of personal data”) is not affected. 
Other fundamental rights are even less impacted. It should be added, however, that the work 
of  the  Agency  tackles  important  issues  related  to  fundamental  rights,  e.g.  the  work  on 
alternatives  to  coercive  sanctions,  the  work  on  minimum  quality  standards  in  drug  demand 
reduction,  best  practices  on  treatment  and  harm  reduction.  In  that  sense,  improving  the 
functioning of the Agency could have positive indirect impacts on fundamental rights. 

None of the options proposed has impacts on small and medium sized enterprises (SMEs).  

6.1. 

Impacts on the European Union (EU bodies) and value-added  

Policy option 4: Targeted revision – Delivering more value in drugs policy   

34 

 
This option provides a thematic scope of action targeted on deepening the evidence base on 
drug  phenomena,  while  strengthening  the  Agency’s  monitoring  and  threat  assessment 
capabilities to increase its ability to act and react to new challenges, including internationally. 
National  focal  points  would  need  to  be  empowered  to  act  as  more  effective  intermediaries 
translating  and  implementing  key  messages  from  the  Agency,  nationally.  Under  this  policy 
option, the Agency would also gain in agility in  terms of responding to the needs  arising in 
the drugs policy field through various tailored services for Member States.  

Thematic scope of action 

Such a targeted revision of the scope of action of the Agency would overall be coherent with 
EU policies. It would also allow a more holistic view on drugs issues by addressing both drug 
demand  and  drug  supply  in-depth,  as  well  as  the  poly-substances  angle  of  the  drug 
phenomenon, without interfering with Member States’ competencies, and therefore might be 
the most effective option of expanding the Agency mandate. 

While targeting the thematic scope of action of the Agency more holistically on drug demand 
and  supply,  including  poly-substance  is  relatively  straight-forward,  the  issue  of  the  Agency 
monitoring  the  diversion  and  trafficking  of  drug  precursors  requires  further  consideration. 
While it would strengthen the EU’s response to drug precursors, as the Agency would be able 
to carry out a more thorough and complete analysis through triangulating drug precursor data 
with  other  drug  supply  indicators,  in  order  to  get  a  better  understanding  of  the  situation  of 
diversion and trafficking of precursors in the EU, the Agency should be in charge not only of 
analysing  the  data  provided  through  the  Commission’s  database,  but  also  to  collect  the 
relevant  data.  Probably  the  quickest  way  would  be  to  transfer  those  parts  of  the  current 
precursor  database,  which  relate  to  the  FORM  D-reporting,  from  the  Commission  to  the 
Agency, despite its limited scope. However, this could raise criticism from Member States as 
it would lead to a split of the database and potentially to the national authorities having to use 
different databases to report on international obligations. Another, possibly more sustainable 
option would be that the Agency uses its own tools to collect the relevant data. However, this 
would currently not be in line with the EU drug precursor legislation.  

Monitoring system and support to Member States  

The targeted revision would have the added value of closing the gap regarding the monitoring 
system for drugs, including for technology-enabled drug markets and responses. This would 
be beneficial for the EU, including its Member States, as it would allow for a full picture of 
the drug phenomenon in the EU. EU drug policy – and based on that, national drug policies – 
take an evidence-based approach. Therefore, a neutral body is needed to address drug-related 
issues and ensure a holistic monitoring system.99 Without modern tools and methodologies for 
the  detection  and  analysis  of  new  phenomena,  any  drug  information  system  would  become 
increasingly  blind  to  emerging  threats  and  signals.  This  would  affect  the  overall 
understanding  of  the  drug  phenomenon  and  might  lead  to  the  EU  losing  its  leadership  in 
international  drug  policy.  The  question  is  therefore  not  whether  to  have  a  more  modern 
monitoring system in place or not, but who should implement it. 

A  modern  monitoring  system  would  form  the  basis  for  general  threat  assessments,  which 
should  identify  at  an  early  stage  new  developments  of  the  drugs  phenomenon.  Such  a 
capability  is  crucial  in  a  fast-changing  drug  environment.  Threats  in  one  Member  State  or 
even in a third country can have major impacts on the drug market and services to be provided 
in  another  Member  State  –  or  the  whole  EU.  Establishing  an  appropriate  threat  assessment 

99   See footnote 88. 

35 

 
                                                           
capacity  in  the  EU  is  therefore  important  for  better  understanding  not  only  the  threats 
themselves, but also the links between different phenomena and different markets. This would 
contribute  further  to  an  evidence-based  EU  drug  policy  and  have  considerable  EU  added 
value.   

As for any suggestion that capabilities in the area of threat assessments are not needed on a 
European level, the answer is that the main threats deriving from new technologies are of a 
cross-border nature. No Member State on its own can carry out the monitoring and assessment 
of the potential threats, and Member States are themselves requesting these capabilities at the 
EU level. 

When  it  comes  to  the  support  of  Member  States,  the  Agency  provides  such  support  upon 
request  as regards evaluating or designing national  drug policies. The Agency is  supporting 
training initiatives, including the European Prevention Curriculum (EUPC).100  

Although  the  Agency  currently  does  not  have  the  necessary  data  nor  the  resources  nor  the 
mandate to carry out this kind of monitoring and threat assessments or to expand its support to 
Member States, it would be well placed to develop such a capability. The Agency is already 
carrying  out  risk  assessments  for  new  psychoactive  substances.  It  has  done  work  on  the 
monitoring of online market places, together with Europol, and is now involved in the related 
preparatory action101.  

Based  on  these  experiences,  the  Agency  could  further  expand  its  activities  in  these  areas. 
Developing  these  capabilities  further  without  addressing  them  in  a  revised  mandate  will  be 
feasible only to a limited extent, as the Agency would need access to the relevant information, 
which is not covered by the data collection exercises based on the existing mandate.  

An alternative would be to attribute such work to other EU bodies or an international entity. 
As regards EU bodies, the most obvious candidate for threat assessments and the monitoring 
of  new  technological  developments  would  be  Europol.  The  EMCDDA  and  Europol  are 
cooperating  in  the  monitoring  of  the  darknet102  and  Europol  provides  input  to  the  EU  early 
warning  system.  However,  if  Europol  would  develop  this  capability,  it  would  not  cover  the 
health side of the drug phenomenon. On the other hand, attributing this capability to one of 
the EU bodies in the health area (the ECDC, EMA or HERA) would not be sufficient either as 
the  security  dimension  would  then  be  under-represented.103  As  regards  international 
organisations,  neither  the  UN  Office  on  Drugs  and  Crime  nor  the  International  Narcotic 
Control  Board  have  the  capacity  or  the  resources  to  carry  out  the  necessary  actions,  in 
particular if the main focus were to be on Europe. The practical experience of the past showed 
that these bodies are turning to the EU, including to the Agency, for such tasks. In addition, if 
they have to conduct new work, they would need financial support.  

As none of the aforementioned agencies or organisations are addressing or will in the future 
address  drug-related  monitoring  and  threat  analysis,  there  are  no  issues  related  to  the 
coherence with the work of other agencies (or the Commission). In addition, coherence will 

100   https://www.emcdda.europa.eu/best-practice/european-prevention-curriculum_en.  
101   The  involvement  of  the  EMCDDA  in  the  Steering  Committee  for  the  preparatory  action  on  darknet 
monitoring  (General  Budget  of  the  European  Union  for  the  Financial  Year  2020,  item  “18  02  77  04 
Preparatory action — EU-coordinated Darknet monitoring to counter criminal activities”, L 57, 27.2.2020, 
p. 1341) is important for identifying the appropriate tools to address such developments.  

102   EMCDDA/Europol,  Drugs  and  the  darknet:  perspectives  for  enforcement,  research  and  policy,  2017;  see 

also footnote 51.  

103   See further arguments in section 5.3., which are also applicable here. 

36 

 
                                                           
be ensured by a close cooperation of the Agency with these agencies and organisations, within 
their respective mandates.  

Laboratory capacities 

A  centralised  laboratory  could  produce  or  procure  reference  materials  and  then  distribute 
them  to  the  Member  States,  leading  to  significant  savings  and  improving  the  capacities  of 
Member  States.  Finally,  a  centralised  laboratory  could  support  laboratories  in  the  Member 
States in areas requiring specialised expertise.  

A  reference  laboratory  would  not  allow  for  all  the  aforementioned  benefits.  However,  it 
would give the Agency the possibility to provide key services to other laboratories and would 
alleviate  some  of  the  financial  burdens  from  other  (national)  laboratories.  This  would  be  in 
particular  true  if  the  Agency  could  still  provide  reference  materials  to  other  European 
laboratories. 

Lastly, a virtual laboratory would be the minimum option in this context. It would not allow 
for  a  centralisation  of  key  laboratory  functions  in  the  Agency.  The  main  impact  of  such  an 
option would be the sharing of information and experience among relevant laboratories across 
Europe.  The  EU  added  value  would  be  limited  compared  to  the  aforementioned  options  of 
having a “real” laboratory in the Agency, in whatever dimension. 

Early warning and alerts 

The Agency could be enabled to issue EU-level alerts or targeted warnings in case of various 
relevant dangers (e.g. quickly inform people who use drugs about dangerous substances being 
on the market). The main benefit of this being done directly by the Agency is the speed within 
which such information can be made available. In addition, Member States will usually not be 
aware of dangers, which originate in another Member State, but might spill over. As the EU 
early warning system could be an important basis of such alerts, the Agency seems to be well 
placed to prepare such alerts.  

Prevention programmes and experience sharing 

There  is  no  coordination  or  exchange  of  experiences  on  such  campaigns  happening  on  a 
European level so far. Although the development of campaigns cannot follow a “one-size-fits-
all-approach”, the Agency could have an important supporting role for developing EU-level 
campaigns. Member States, national focal points and relevant other EU bodies would have to 
be closely involved.  

The  EU  added  value  of  the  Agency  supporting  the  development  of  prevention  campaigns 
would be a common message across the EU on such issues. In addition, not all Member States 
have the capacity and/or knowledge to prepare such programmes or campaigns on their own 
and could benefit from the experience of the Agency. As the Agency would not develop such 
campaigns acting alone and would therefore not take this over from the Member States, there 
is no problem with the subsidiarity principle.  

Developing targeted prevention and  awareness campaigns as  well  as the  possibility to  issue 
alerts about dangerous substances would benefit the public health situation in the EU. People 
who use drugs and practitioners across the EU would benefit from more information.  

It  could  be  considered  that  Europol  or  the  relevant  EU  health  bodies  are  better  placed  to 
prepare such campaigns. However, no other EU agency has experience in addressing both the 
security and health dimensions of the drug phenomenon in their external communication. 

37 

 
Risk analysis and intelligence reports 

In order to expand further on drug supply and drug market issues, the Agency would need to 
obtain  the  relevant  data  from  the  Member  States.  Based  on  such  data  and  general  threat 
assessments,  the  Agency  could  provide  risk  analysis  and  intelligence  reports  to  law 
enforcement authorities. Close collaboration with Europol is essential.  

It could be questioned whether it could not be for Europol alone to take such measures. The 
best results would be achieved if the strengths and available information of the Agency and 
Europol are put together. There is no intention to give to the Agency powers, which would be 
equivalent  to  Europol’s,  as  Europol  is  operations-driven  and  the  Agency  focusses  on  data 
gathering and analysis.  

The Reitox network of national focal points  

The  impact  on  the  European  level  would  be  to  have  more  and  better  quality  information 
available. The availability of good data is key for the Agency to fulfil its mandate.  

Although the available data improved since the previous evaluation104, the 2018/19 evaluation 
concluded that further efforts are needed to ensure better comparability of data. If the national 
focal points would be further empowered by the revised mandate, it will be easier for them to 
get the necessary access to all relevant drug-related data and information. The national focal 
points would be in a position to ensure the implementation of the data quality standards.  

Defining minimum requirements – and making sure that these are complied with (through the 
certification procedure)  –  would give assurance to  the Agency and to  the EU-level  decision 
makers  that  the  national  focal  points  are  able  to  comply  with  their  tasks  and  obligations. 
Another impact on the European level would be the enhanced effectiveness and efficiency of 
translating and implementing key messages from the Agency, resulting in the national focal 
points  acting  as  true  intermediaries.  Therefore,  having  strong  national  focal  points  in  place 
adds value on EU-level. 

International dimension 

Further developing the role of the Agency in cooperation programmes, in particular as regards 
capacity  building,  would  improve  the  outreach  of  the  EU  to  third  countries.  One  of  the 
intentions  of  such  programmes  is  to  promote the  EU’s  balanced,  evidence-based,  integrated 
and multi-disciplinary drugs policy in third countries.  

The Agency does not have a clear mandate to analyse global developments and developments 
in  third  countries,  which  have  the  potential  to  affect  the  EU.  With  the  drug  phenomenon 
becoming increasingly  global, a good understanding of the impacts  of drug policies in  third 
countries onto the EU is important. This would again improve the evidence base for EU drug 
policy-making.  

The expert input of the Agency would not only benefit the EU’s international partners, but the 
EU  itself.  It  would  contribute  to  the  development  and  implementation  of  the  external 
dimension  of  EU  drugs  policy  and  the  leadership  role  of  the  EU  at  multilateral  level.  This 
should  lead  to  reconsidering  the  current  “ad  hoc”  and  “project  funding”  approach,  which 
impedes  the  Agency’s  performance  and  does  not  enable  the  EU  to  fully  live  up  to  the 
expectations  and  political  commitments  of  increased  cooperation  between  the  Justice  and 
Home Affairs agencies and priority third countries. 

104   See footnote 37. 

38 

 
                                                           
Policy option 5: Expansive revision – Focusing on diverse addictions   

This option provides a thematic scope of action expanded to cover addiction broadly, beyond 
drugs,  and  revamping  the  Agency’s  monitoring  system  based  on  applicable  methodologies 
and indicators covering diverse addictions. The extended thematic scope on addictions would 
affect the body of data that would need to be provided by national focal points to the Agency, 
as well as the Agency’s role as a hub for knowledge sharing. Finally, the involvement of the 
Agency  in  international  cooperation  would  mainly  be  limited  to  the  current  drugs-related 
activities  as  other  addictions  do  not  have  the  same  level  of  international  and  cross-border 
exposure.  

The  reasons  underpinning  broadening  the  scope  of  action  would  be  that  addiction  is  an 
overarching health problem that should be addressed holistically; that the distinction between 
licit and illicit substances may to a certain extent be arbitrary; and that some Member States 
moved to broader addiction strategies in the preceding years.  

The stakeholder consultation during the 2018/19 evaluation was inconclusive on the question 
whether the scope of action of the Agency should be broadened to other addictions. Whereas 
a majority of national stakeholders and Agency staff were largely in favour, other stakeholder 
groups (including EU-level stakeholders) were critical. Among those in favour of broadening 
the  scope,  alcohol  was  mentioned  most  frequently,  while  other  substance-related  addictions 
followed. There was less support to include behavioural addictions.105 

Those  Member  States  that  apply  at  national  level  a  broader  addiction  approach  have  an 
interest in the Agency broadening its scope to get access to the same quality data and analysis 
at  EU  level  as  they  are  accustomed  to  for  drugs.  They  argue  that  broadening  the  scope  of 
action would allow targeting risky behaviour instead of addiction to specific substances. Other 
Member States are more sceptical as they fear a weakening of the focus on drugs. They argue 
for a deepening of the efforts in the drug area, in view of the conclusions of recent reports that 
the drug phenomenon is worsening in the EU.106   

The Agency has a well-functioning data collection system in place to collect standard data on 
drugs. Many surveys and data collection tools used on a national level to gather drug-related 
data  already  collect  data  on  other  substance-based  addictions,  in  particular  on  alcohol  and 
tobacco, even in Member States that do not apply a wider addiction approach. In addition, the 
Agency collects some data on  other addictions through the European School Survey Project 
on Alcohol and Other Drugs (ESPAD).107  

Monitoring  the  use  of  illicit  substances  is  different  from  monitoring  licit  substances.  Licit 
substances are subject to internal market rules. The harm and health consequences of alcohol 
or  tobacco  are  well  known  and  documented,  whereas  this  is  not  always  the  case  for  drugs, 
especially  for  new  synthetic  drugs.  When  it  comes  to  behavioural  addictions,  it  could  be 
difficult to draw the line between what should still be considered as being part of the scope of 
action and what should not be covered.  

105   For details see Annex 3 and Annex 4 of the final report of the evaluation (footnote  18). See also paragraph 
25  of  the  European  Parliament  resolution  of  17  December  2020  on  the  EU  Security  Union  Strategy 
(2020/2791(RSP)), https://www.europarl.europa.eu/doceo/document/TA-9-2020-0378_EN.pdf.  

106   Positions taken by Member States representatives in an informal workshop on the revision of the EMCDDA 
mandate  on 26 October 2020 and previously during a discussion at the EMCDDA Management Board  on 
the outcomes of the evaluation. 

107   http://www.espad.org/.  

39 

 
                                                           
Collecting  certain  data  together  and  streamlining  data  collection  will  lead  to  economies  of 
scale  and  cost  efficiency.  It  would  be  relatively  easy  to  extend  some  aspects  of  the  current 
data  collection  system  of  the  Agency  to  other  substance-based  addictions,  in  particular 
alcohol,  tobacco  and  prescription  medicines.  There  will  be  efficiency  gains  long-term  from 
applying  or  adapting  methodologies  and  indicators  developed  for  drugs.  Collecting  data 
regarding addictive behaviours would be more difficult as it requires different methodologies 
and studies. In addition, behavioural addictions do not usually have a cross-border dimension 
and it could be questionable whether EU-level action would be appropriate.  

Another question to be analysed is who would be best placed to collect such information.  

On an international level, the UN Office on Drugs and Crime and the International Narcotic 
Control Board are already collecting some of the drug-related information, but their mandates 
do  not  go  beyond  illicit  substances.  Moreover,  assigning  the  data  collection  to  a  UN  body 
would reduce the focus on Europe, making available information less relevant for EU policy-
making.  

On a European level, both Eurostat and the Commission108 collect some of the health-related 
data  on  substance-based  addictions,  however  neither  of  them  collects  any  drug-related  data. 
The  European  Medicines  Agency  and  the  European  Centre  for  Disease  Prevention  and 
Control  do  not  specifically  collect  addiction-related  data,  but  some  of  their  data  might  be 
useful for a better understanding of addictions.  

Analysing information across different addictions would help in getting a better understanding 
of the underlying commonalities of addictions. Based on its experience on drugs, the Agency 
could  provide  such  services  for  other  addictions.  Comparability  of  data  and  sharing  of  best 
practices could be improved through the intervention of the Agency. This would help reaping 
synergies and help the EU and national policy-makers to have appropriate policy responses, 
applying a user-centric rather than a substance-centric perspective to addictions, and to better 
adapt  to  remaining  differences.  Therefore,  it  would  be  cost-efficient  to  increase  the 
responsibilities of the Agency in areas, which fit closely with its current activities on drugs. 
Even  going  for  the  expansive  option  of  broadening  the  mandate  of  the  Agency  to  the 
monitoring of all addictions would be coherent with current EU policies as no other agency or 
the Commission are monitoring this across the EU. Some of these monitoring activities would 
interfere  with  national  competencies  (e.g.  addictive  behaviours,  which  do  not  have  a  cross-
border dimension) and therefore could be problematic in terms of subsidiarity issues.  

6.2. 

Impacts on national authorities  

Policy option 4: Targeted revision – Delivering more value in drugs policy   

Targeting  the  thematic  scope  of  action  of  the  Agency  holistically  on  the  drug  phenomena, 
including  poly-substance  use,  and  increasing  the  monitoring  and  threat  assessment 
capabilities, would have similar impacts  on national authorities  as on the EU level. Missing 
information  on latest  developments  means that national  authorities are not  able to  react  fast 
enough  to  new  developments  and  threats.  This  reduces  their  preparedness.  By  looking  into 
innovative health approaches, the Agency could provide drug services in the Member States 
with the latest available knowledge, which would ultimately benefit the drug users. Carrying 
out  such  research  through  the  Agency  would  free  capacities  and  resources  in  the  Member 

108   For example the work of Directorate-General for Health and Food Safety on the facilitation of coordination 
and cooperation activities related to alcohol or the  work of the European Medicines Agency regarding the 
pharmacovigilance of medications in the EU. 

40 

 
                                                           
States.  In  addition,  some  developments,  such  as  selling  of  drugs  on  the  internet,  do  not  fall 
under  the  responsibility  of  a  single  Member  State  as  they  are  cross-border  phenomena  and 
therefore, by their nature, have to be addressed jointly.  

When  it  comes  to  support  of  the  Member  States,  national  authorities  can  already  use  the 
available  tools  for  the  evaluation  of  their  drugs  policies.109  However,  further  support  is 
requested  by  the  Member  States  for  improving  the  effectiveness  and  quality  of  their  drug 
policies and responses. When providing support, the Agency would have to take into account 
any national specificities.  

Developing a competence centre in the Agency for policy and programme development and 
evaluation  would  alleviate  a  considerable  burden  from  the  Member  States,  leading  to  less 
demands and efforts on Member States’ level. This is because it would allow them access to a 
major  source  of  information  and  an  independent  third  party’s  expert  view.  By  working  on 
national  strategies,  the  Agency  would  –  in  return  –  gain  additional  expertise,  which  would 
benefit other Member States. As this would be a supporting function, which Member States 
can use, but which is not taking away any competencies from the Member States, there are no 
subsidiarity concerns to be addressed.  

The  Agency  could  be  in  charge  of  accreditation  or  certification  of  national  prevention, 
treatment,  harm  reduction  and  other  related  interventions.  The  Agency  –  as  a  factual  and 
objective  expert  –  would  be  best  placed  to  evaluate  such  interventions  in  view  of  their 
compliance  with  the  latest  scientific  state  of  play  and  of  their  proven  usefulness.  Member 
States or relevant professional bodies could use the accreditation or certification as a quality 
label  for  their  work.  Alternatively,  such  accreditation  or  certification  could  remain  with  the 
Member States themselves, as far as such systems already exist. This option would necessitate 
more resources in the Member States as the centralisation effect would not apply and it would 
take away the neutral stance of the accreditation or certification. 

Finally,  the  Agency  could  support  Member  States  in  the  reporting  to  international 
organisations,  in  particular  to  the  UN  Office  on  Drugs  and  Crime  (UNODC).  This  could 
contribute to reducing overlapping reporting obligations of the Member States to the Agency 
and  UNODC.  Data  reporting  is  currently  done  for  some  data  by  different  data  providers 
and/or  with  different  formats  and/or  based  on  different  collection  methodologies.  Using  the 
Agency as a coordination point for such reporting obligations, in particular in relation to the 
data the Agency is already collecting, would reduce the reporting burden on Member States.  

A crucial element of the new monitoring system will be the laboratory capacities. An Agency-
run laboratory will provide a platform for Member States’ experts to exchange expertise and 
work on common projects. The main benefits for the Member States would be the availability 
of  more  information  on  drug  markets  and  the  reduction  of  costs.  Cost  reductions  for  the 
Member States would in particular derive from the fact that Member States would not need 
their  own  (full)  laboratory  capacities,  whereas  they  would  gain  access  to  shared  reference 
material  and specialised  equipment.  Some of the  analytical  equipment  needed is  not  readily 
available  to  authorities  in  the  Member  States  as  it  can  be  prohibitively  expensive.  In  other 
instances  it  may  be  available  in  certain  research  institutions,  but  with  limited  access  by 
authorities.  A  centralised  laboratory  would  free  up  capacities  in  existing  Member  State 
laboratories.  The financial  gains  for Member States cannot  be estimated,  as the availability, 
size and capacity of laboratories differ considerably across Member States.  

109   “Evaluating  drug  policy:  a  seven-step  guide  to  support  the  commissioning  and  managing  of  evaluations”, 
related  website 

www.emcdda.europa.eu/system/files/publications/4680/td0417390enn1.pdf, 
(www.emcdda.europa.eu/publications/topic-overviews/policy-evaluation). 

and 

the 

41 

 
                                                           
Regarding  the  national  focal  points,  in  most  Member  States,  they  are  hosted  by  a  public 
authority or are a body mandated by the Member State to carry out the tasks provided for by 
the founding Regulation. In some Member States, the national focal points are well integrated 
into  the  national  drug  coordination  system,  whereas  in  others  they  are  considered  as  mere 
European  level  data  providers  and  lack  visibility  at  national  level,  as  the  evaluation 
concluded.  During  the  COVID-19  pandemic,  some  governments  increased  their  recourse  to 
the work and information available from the national focal points.110  

A clearer definition of the tasks and responsibilities of the national focal point would benefit 
in  particular  the  institution  that  is  mandated  as  national  focal  point.  It  would  allow  the 
national focal point to become a central data hub and to access all the relevant data, so that it 
may provide a comprehensive overview on the national drug phenomenon to the Agency.  It 
would clarify the workflows for all drug-related data in the Member States and strengthen the 
position of the national focal points in the  national environment.  If the national focal points 
could  be  recognised  as  a  service  provider  not  just  for  the  Agency,  but  also  for  the  national 
authorities, it would be of benefit to all Member States.  

Establishing  well-functioning  and  empowered  national  focal  points  is  not  solely  about 
information. The innovative approaches, tools, trainings, etc. created by the collaboration with 
the Agency and within the Reitox network could be much better implemented on a national 
level,  including  with  respect  to  follow-up  and  evaluation.  Providing  services  creates  new 
opportunities for data and information collections and hence a circle in which data provision 
and  supporting  services  reinforce  themselves.  The  sharing  of  best  practices  and  the 
dissemination of information would be improved across Europe and as a consequence benefit 
the relevant authorities in the Member States.  

In  terms  of  impact  on  national  authorities  regarding  the  additional  new  tasks  (i.e.  early 
warning  and  alerts,  prevention  programmes  and  experience  sharing,  risk  analysis  and 
intelligence reports), the Agency’s support to Member States could be in developing targeted 
national actions as messaging might be easier. The involvement of the Agency would ensure 
receiving input from a neutral EU-level organisation. The evidence-based approach provided 
by the Agency would lead to a more objective basis for developing interventions. The Agency 
would not take over any competencies here, but only support Member States. 

When  it  comes  to  supply-side  actions,  the  national  authorities  would  be  concerned  as  they 
would  have  to  provide  the  relevant  information  to  the  Agency.  Most  of  this  information  is 
provided only to Europol as part of operations. However, it might not always be accessible to 
the national focal points as there are no obligations to provide this information to them. The 
easiest  way  forward  would  be  to  streamline  national  data  collection  and  clarify  the  data 
provision  on  the  European  level.  In  any  case,  it  has  to  be  ensured  that  these  new 
responsibilities do not lead to  a duplication of data provision  efforts by national  authorities. 
Finally,  national  law  enforcement  authorities  would  benefit  from  a  stronger  involvement  of 
the  Agency  in  drug-related  cases.  Having  available  well-informed  risk  analysis  and 
intelligence reports is important for addressing drug-related criminality.  

National authorities would not only benefit from streamlining of reporting obligations vis-à-
vis  UN  organisations,  but  also  from  a  better  knowledge  about  global  developments,  which 
would  have  positive  impacts  on  the  development  of  their  drug  policies  vis-à-vis  third 
countries. It  allows the national authorities to react quicker to potential threats coming from 

110   EMCDDA,  EMCDDA  national  focal  points’  activities  during  the  COVID-19  pandemic  (2020); 

https://www.emcdda.europa.eu/system/files/publications/13442/NFPs_activities%20during%20C19_final.p
df.  

42 

 
                                                           
outside the EU. An increased capacity of third countries to address their drug problems more 
effectively would benefit the Member States. 

Policy option 5: Expansive revision – Focusing on diverse addictions   

The main impact on national  authorities in addition to what was outlined under the targeted 
revision, would be the need to provide additional data to the Agency. The majority of this data 
is  already  collected  by  the  Member  States  based  on  EU  legislation  and/or  because  national 
strategies  apply  a  wider  addiction  approach.  If  the  scope  of  action  of  the  Agency  were 
extended to  other addictions, the addressee of the data provided would have to  change, e.g. 
from Eurostat or the Commission to the Agency.  

6.3. 

Impacts on simplification and/or administrative burden  

Policy option 4: Targeted revision – Delivering more value in drugs policy   

This option will have positive impacts on the administrative burden of national authorities as 
long as data provision regarding supply-side data is properly organised. Providing support to 
the Member States in addressing drug-related health and security threats would facilitate the 
work of the Member States as they would not have to do the analysis and development work.  

Under  this  option,  the  availability  of  an  improved  monitoring  system  and  better  developed 
threat  assessments  would  shift  some  of  the  analysis  to  the  European  level  and  therefore 
alleviate  Member  States’  administrative  burden.  Centralising  the  analysis  at  the  EU  level 
would avoid duplication and lead to an overall simplification of procedures.  

Strengthening the Agency’s capacity to support Member States in the evaluation and shaping 
of  national  drug  policies  would  add  new  tasks  to  the  Agency’s  mandate,  but  would  overall 
lead to a reduction of administrative burden in Member States. The same would be true if the 
Agency  sets  up  a  centralised  accreditation  or  certification  system  for  drug-related 
interventions. The centralisation of the reporting  obligations to  the UNODC, if this is made 
possible legally, would streamline reporting obligations and would reduce double reporting.  

As  regards  a  centralised  laboratory  on  European  level,  it  would  enable  streamlining  the 
forensic  and  toxicological  analysis  across  the  EU.  This  would  help  reducing  the  burden  on 
national  laboratories,  in  particular  as  substances  would  only  be  analysed  once  instead  of  by 
several national laboratories. In addition, it would help streamlining administrative procedures 
for  reporting  of  analytical  results.  However,  having  in  place  the  laboratory  of  the  Joint 
Research Centre (JRC), the potential for further simplification by establishing a laboratory in 
the Agency is limited. The high costs of a fully-fledged laboratory – and even of a reference 
laboratory  –  (see  below)  would  be  disproportionate  to  the  added  value  these  options  would 
have. 

The certification procedure for the compliance of the national focal points with the minimum 
requirements  would  be  a  new  administrative  task  for  the  Agency.  However,  the  additional 
burden would be limited as the Agency already has in place a voluntary process for national 
focal points to be certified. For the national focal points, it would require going through the 
certification procedure.  This  burden would be more relevant  for those, which did  so far not 
consider obtaining the voluntary certification. Adaptation to the new roles and responsibilities 
would represent an additional administrative burden during the implementation phase of the 
new  legislation.  However,  this  will  lead  to  more  streamlined  and  better  organised  data 
provision in the mid- and long-term and, therefore, the administrative burden would be overall 
reduced. 

43 

 
If the Agency would be able to support Member States in the reporting on international level, 
this  could  alleviate  a  separate  reporting  obligation  from  the  Member  States.  Therefore, 
reinforcing  the  international  dimension  of  the  Agency  would  have  a  positive  impact  on 
reducing the administrative burden of national authorities. 

Policy option 5: Expansive revision – Focusing on diverse addictions   

Member States already collect most data on diverse addictions, and although more data would 
have  to  be  provided  to  the  Agency,  the  additional  administrative  burden  for  the  Member 
States would be negligible. Centralising the data provision in one national entity and reporting 
to  only  one  EU-level  body  would  simplify  national  reporting  procedures.  However,  this 
would  only  be  feasible  if  clear  data  reporting  obligations  are  set  out  in  EU  legislation  and 
subsequently clear data flows are established in the Member States. As the Agency collects its 
data currently mainly through the Reitox network, the national focal points would have to be 
empowered  to  receive  the  relevant  data  from  other  competent  national  authorities.  This 
centralisation  would  not  only  help  the  European  data  collection,  it  would  also  enable  the 
Member States to get a better overview of the available information on addictions.  

It  has  to  be  acknowledged  that  the  benefits  from  streamlining  reporting  obligations  will 
depend on how reporting is organised in the Member States. In some countries, the national 
focal points are already the main body involved in the collection of addiction-related data due 
to their integration in the responsible entity (e.g. ministry). In other countries, such obligations 
would  lead  to  a  need  to  reorganise  data  collection.  Ultimately,  the  centralisation  of  data 
collection  on  addiction  information  would  lead  to  cost-efficiency  as  duplications  could  be 
eliminated.  

6.4.  Economic impacts  

Policy option 4: Targeted revision – Delivering more value in drugs policy   

While targeting the thematic scope of action on drug phenomena would have a minor direct 
economic effect, the main effect would be an increase of the resource needs of the Agency. 
The reduction of double reporting for the Member States would have a positive impact on the 
budgets of the reporting authorities. 

The main direct economic impact would be on the EU budget as the Agency should receive a 
sufficient  operational  budget  to  develop  or  buy  innovative  monitoring  tools,  to  develop  the 
threat assessment capabilities and provide additional support to Member States. Sufficient IT 
resources  would  be  needed.  However,  attributing  these  tasks  to  the  Agency  would  lead  to 
savings  for  the  Member  States  as  they  could  rely  on  the  Agency  to  carry  out  the  relevant 
monitoring activities.  

Another  main  economic  impact  would  be  for  a  laboratory.  Based  on  cautious  estimations, 
establishing a fully-fledged laboratory would require approximately EUR 30 million. It would 
take between 5 and 7 years to reach its full capacity. Annual running costs would be around 
EUR  20  million.  The  setting  up  of  a  reference  laboratory  would  take  about  2-3  years  to  be 
fully operational, would cost approximately EUR 15-20 million to establish and have annual 
running  costs  of  EUR  10-12  million.  The  costs  for  a  “virtual  laboratory”  would  be  much 
lower  and  are  estimated  at  around  EUR  5-6  million  a  year,  which  would  be  needed  for 
experienced staff, training, access to other laboratories and outsourcing of some of the work. 
However,  to  counterweight  the  high  costs,  a  laboratory  in  the  Agency  would  lead  to  a 
reduction  of  costs  in  the  Member  States  as  the  relevant  analyses  would  be  done  by  the 
Agency.  

44 

 
The main economic impacts  for developing the  mandate of the national  focal  points further 
would  be  on  the  EU  and  national  budgets.  More  tasks  for  the  national  focal  points  would 
mean that they need adequate resources. The national  focal  points are currently  co-financed 
by the Agency with a fixed amount111. The Agency provides this amount to the national focal 
points  from  its  budget  as  long  as  the  respective  Member  State  provides  at  least  the  same 
amount for the financing of the national focal point. The necessary resource increases could 
either  come  from  the  Member  States  themselves  or  the  co-financing  would  have  to  be 
increased.  

Policy option 5: Expansive revision – Focusing on diverse addictions   

The main impact  of extending the data collection would be on the resources needed for the 
collection  of  data,  i.e.  extension  of  the  databases,  increase  of  available  staff  to  do  the  data 
processing and analysis, and an increased support to  the national  focal  points to  ensure that 
they have the capacity for providing this data. The move from one system to another might 
lead to an initial increase of administrative costs for some of the Member States. These should 
however  be  balanced  out  by  the  simplified  procedures  and  the  streamlined  data  collection 
system in the mid- to long-term.  

Going beyond mere data collection  and  analysis  to  include other tasks currently undertaken 
for  illicit  substances,  such  as  proposals  for  policy  responses,  development  of  specific 
intervention  programmes,  monitoring  of  treatment  programmes,  etc.,  would  increase  the 
resource needs. The resource needs will depend on what other addictions should be addressed 
by the Agency. Adding more than one substance to the scope of action would, however, not 
necessarily lead to a duplication or triplication of the costs. 

Extending the mandate to  comprehensive monitoring of other substance-based addictions or 
even  all  addictions  (the  maximum  option  for  expanding  the  mandate)  in  relation  to  their 
health  impacts  is  expected  to  come  at  a  cost  of  between  EUR  5  and  12  million  per  year 
depending  on  the  width  of  the  coverage.  This  is  therefore  excluded  as  an  option,  given  the 
size of the cost in comparison to the overall budget of the Agency. The high additional costs 
would be due to the fact that new methodologies and systems would have to be established, in 
particular related to behavioural addictions.  

Expanding the mandate to poly-substance use, and thereby addressing in a targeted way the 
main  elements  of  other  substance-based  addictions,  would  come  at  an  estimated  cost  of 
approximately EUR 1.5 million per year. If drug precursor monitoring would be fully covered 
by  the  Agency  as  well,  e.g.  following  a  revision  of  the  drug  precursor  legislation,  an 
additional  EUR 1  million  per  year  would  be  needed  in  the  Agency.  The  costs  for  this 
expansion are relatively low as economies of scale could be applied in the Agency as many of 
the  methodologies  and  responses  applied  to  drugs  are  similar  for  other  substance-based 
addictions  and  therefore  this  could  be  relatively  easily  integrated  into  the  current  routine 
reporting and monitoring.  

7.  HOW DO THE OPTIONS COMPARE? 

This section compares the policy options for which the impacts are assessed in Section 6. The 
overall  conclusion  is  that  the  policy  option  4:  targeted  revision  would  be  the  best  way 
forward  to  achieve  the  general  objective  of  having  in  place  an  Agency,  which  would  be 
appropriately  equipped to deal  with  the  current  and future  challenges posed by drugs in  the 
EU, leading to efficient action and support for Member States. Both options contribute to the 

111   In the 2021 EMCDDA budget, this is a maximum of EUR 79 590 per year and national focal point. 

45 

 
                                                           
achievement of more than one specific objective.112 The tables comparing the options along 
the  five  specific  objectives  indicate  the  contribution  to  the  achievement  of  these  objectives 
from very positive (+++) to very negative (  ).113  

Unfortunately,  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.114 Therefore, it is not possible to quantify the impact the evaluated options have on the 
Member States. These are therefore described only in qualitative terms. 

7.1. 

Specific objective 1: To increase the Agency’s capacity to react faster and in 
a  more  targeted  way  to  new  challenges  in  the  field  of  drugs,  harms  and 
addictions, and related threats 

The  policy  option,  which  would  contribute  to  achieving  this  specific  objective,  are  the 
following: 

-  Policy option 4: Targeted revision   

Comparative assessment for specific objective 1 

Policy option 4: Targeted 
revision  

Policy option 5: Expansive 
revision 

Impact on the EU 
(effectiveness) 

Impact on national 
authorities 
(effectiveness) 

Impact on 
simplification / 
administrative burden 

Economic impacts 
(efficiency) 

+++ 

+++ 

+ 

  

++ 

++ 

  

    

Further developing the current monitoring system and setting up appropriate threat assessment 
capabilities as well as improving the ability to react to the identified threats are key functions 
for increasing the EU’s capacity to react faster and in a more targeted way to the challenges 
posed by the drug phenomenon. This  would include the better  coverage  of the international 
issues. If these capabilities are given to the Agency, this would have to be accompanied by a 
strengthened  role  of  the  national  focal  points.  Making  available  centralised  European 
laboratory capacities would support the achievement of this specific objective.  

Both policy options are coherent with existing EU policies or known policy initiatives. There 
are  no  other  EU  bodies,  which  carry  out  related  actions.  The  assessment  considered 
alternatives to  the Agency, in  particular Europol or the EU health  bodies  (the ECDC, EMA 
and  HERA).  The  main  reason  why  these  are  not  better  placed  to  provide  the  necessary 

112   See Annex 6 for an overview table. 
113   For the comparative assessment, the three main elements of policy option 4 are assessed separately as they 
may  contribute  differently  to  the  specific  objectives,  in  particular  have  very  different  economic  impacts. 
This is not done for the other policy options as the impacts are not as diverging as for policy option 4. 

114   See footnote 89. 

46 

 
 
                                                           
capabilities is that they would not be able to address the drug phenomenon in a holistic way. 
The focus would be either on security or on (public) health issues. In addition, those  bodies 
have very particular and partly quite wide mandates, where the drug issue might be “lost” due 
to other priorities. Therefore, the Agency is best placed to develop the mentioned capabilities. 
Closer cooperation with these bodies would be beneficial as a complementary measure. 

As  regards  the  national  level,  the  increased  capacity  of  the  Agency  would  benefit  the 
preparedness  in  the  Member  States  and,  therefore,  support  their  reactions  to  the  developing 
drugs phenomenon. Due to the cross-border nature of the drug phenomenon, Member States 
need the support of an EU-level body, as they would not be able to do the necessary analysis 
in  the  same  way  due  to  missing  data  from  other  Member  States.  As  the  Agency  is  already 
working  closely  with  Member  States,  through  the  Reitox  network  and  through  several 
working groups, it would be the best placed from that perspective.  

The  impact  of  the  different  policy  options  on  the  simplification  and/or  the  administrative 
burden is overall positive. The main impact would come from the setting up of a laboratory in 
the Agency as this would help streamlining forensic and toxicological analysis across the EU 
and thereby reduce the related needs in the Member States. A similar impact could come from 
a  new  operational  model  for  the  national  focal  points  as  the  streamlining  of  reporting 
obligations in the Member States could have a considerable positive impact. Streamlining the 
reporting obligations of the Member States and centralising them through the Agency would 
alleviate an important administrative burden from the Member States as it would reduce the 
double reporting of data. Supporting the Member States as regards prevention and awareness 
raising would lower the needs of Member States to be active in this area.  

When it comes to  the economic impact,  the main impacts  will be on the EU budget.  As  all 
options would lead to an increase in the activities of the Agency, further human and financial 
resources  would  be  needed.  The  option,  which  would  have  the  biggest  impact  on  the  EU 
budget, is the laboratory (see further in Section 7.2).  

In  order  to  achieve  specific  objective  1,  EU-level  legislation  and  action  is  needed.  Member 
States might raise subsidiarity concerns when it comes to the role of the national focal points, 
and in particular to setting minimum requirements for their functioning, and as regards EU-
level  prevention  and  awareness  raising  campaigns  or  EU-level  alerts.  As  regards  the 
campaigns and alerts, these would be supporting actions for national level actions; however, if 
the relevant threat has a cross-border component, actions could be carried out on a European 
level. None of the options goes beyond what would be proportional for the achievement of the 
specific objective.  

Setting  out  minimum  requirements  for  the  national  focal  points  in  EU  legislation  would 
provide  them  with  more  stability,  making  them  less  susceptible  to  political  pressure  and 
regular reorganisation. It would ensure a certain continuity and consistency in the functioning 
of the national focal points. However, the proposal does not intend to take over any functions 
from  the  Member  States  in  this  regard.  Therefore,  the  measure  is  proportionate  for  the 
provision of high-quality data in the long-term. The certification of the compliance with the 
minimum  criteria  by  the  Agency  is  possible  under  the  subsidiarity  principle,  or  even 
necessary, to ensure a level-playing field across the EU 

47 

 
7.2. 

Specific  objective  2:  To  deepen  the  monitoring  and  analysis  of  the  drug 
phenomenon  in  Europe,  both  on  the  demand  and  supply  side  and  their 
implications for health and security  

The  policy  option,  which  would  contribute  to  achieving  this  specific  objective,  is  the 
following: 

  Packaged policy option 4: Targeted revision  

Comparative assessment for specific objective 2 

Packaged policy option 4: 
Targeted revision  

Packaged policy option 5: 
Expansive revision 

Impact on the EU 
(effectiveness) 

Impact on national 
authorities (effectiveness) 

Impact on simplification / 
administrative burden 

Economic impacts 
(efficiency) 

+++ 

+++ 

0 

+ to +++ 

+ 

+ 

0 

  

Developing  the  current  monitoring  system,  in  particular  in  areas,  which  are  new  and 
innovative,  is  key  if  the  EU  wants  to  deepen  the  monitoring  and  analysis  of  the  drug 
phenomenon.  Making  available  centralised  European  laboratory  capacities  would  strongly 
contribute to the development of a new and more modern monitoring system and would make 
the  EU  more  independent  in  its  forensic  and  toxicological  analysis.  However,  this  specific 
objective could not be achieved without a stronger position of and more data provided by the 
national  focal  points  if  the  capabilities  are  developed  in  the  Agency.  Therefore,  the  data 
provision obligations need to be clarified.  

Both policy options  are  coherent  with  existing EU policies or known policy initiatives.  The 
Joint Research Centre (JRC) has laboratories, to which the Member States have access to and 
which  are  able  to  provide  toxicological  and  forensic  analysis  of  drugs,  in  particular  new 
psychoactive  substances.  The  Commission  supports  this.  However,  the  JRC  is  not  in  a 
position  to  provide  the  necessary  full  laboratory  services  as  detailed  and  resource-intensive 
investigations  are  needed  for  this  work.  Therefore,  close  cooperation  with  existing 
laboratories, in particular with the laboratory of the JRC, and existing networks, such as the 
European Network of Forensic Science Institutes, would have to be ensured. 

Establishing laboratory capacities in the Agency would free up capacities on the national level 
and  could  support  the  national  laboratories  with  reference  material  and  provide  access  for 
them to specialised equipment, which are either expensive or not accessible easily. It would 
make the analysis data available to the Member States.  

The  impact  of  the  different  policy  options  on  the  simplification  and/or  the  administrative 
burden is overall positive. The reasoning is the same as for specific objective 1 above.  

When it comes to  the economic impact,  the main impacts  will be on the EU budget.  As  all 
options  lead  to  an  increase  in  the  activities  of  the  Agency,  further  human  and  financial 
resources would be needed. The option, which has the biggest impact on the EU budget, is the 

48 

 
 
laboratory.115 In order to have all relevant data available and become independent from third-
country  laboratories,  a  fully-fledged  laboratory  would  be  needed.  A  reference  laboratory 
could  be  a  good  alternative  option,  but  still  comes  with  a  high  financial  impact.  The  least 
expensive option is a virtual laboratory, as it does not necessitate the setting up of a physical 
laboratory in the Agency, but only staff with sufficient competence and experience. Although 
this  would  not  achieve  the  independence  of  analysis  within  the  EU,  it  provides  for  a  good 
low-cost alternative to a “real” laboratory. Going for the maximum solution, a fully-fledged 
laboratory, would not be opportune in the current budgetary situation, even if it would have 
numerous benefits on a European level.  

7.3. 

Specific  objective 3: To clarify the mandate of the Agency as regards what 
substances, behaviours and responses should be covered  

The  policy  options,  which  would  contribute  to  achieving  this  specific  objective,  is  the 
following: 

  Packaged policy option 4: Targeted revision  
  Packaged policy option 5: Expansive revision  

Comparative assessment for specific objective 3 

Packaged policy option 4: 
Targeted revision 

Packaged policy option 5: 
Expansive revision 

Impact on the EU 
(effectiveness) 

Impact on national authorities 
(effectiveness) 

Impact on simplification / 
administrative burden 

Economic impacts (efficiency) 

+++ 

+++ 

+ 

0 

+++ 

+++ 

+ 

0 

Clarifying the mandate of the Agency as regards the substances, behaviours and responses to 
be covered is necessary due to recent developments in several Member States, which moved 
to a wider addiction approach, and requests from stakeholders. Any changes in the mandate 
have to be mirrored in the mandate of the national focal points and appropriate data provision 
obligations.  

Both policy options are coherent with existing EU policies or known policy initiatives.  

Addressing  substance-based  addictions,  i.e.  alcohol,  tobacco  and  prescription  medicines,  in 
their entirety might lead to overlaps with health-related legislation. Such data is collected and 
provided  to  Eurostat  and/or  the  Commission,  contrary  to  drug-policy  data,  which  is  solely 
provided to the Agency. On the other hand, the use of illicit and licit substances overlaps in 
three areas, where action might be useful in the context of poly-substance use. Firstly, poly-
substance use leads to increased risks and public health impacts. Secondly, good practices and 
possible  reactions  to  different  addictions  are  similar  and  could  be  considered  together. 
Thirdly, information and monitoring systems often tackle these addictions together as part of 
a holistic addiction approach.  

115   For the cost figures, see the economic impact section of policy option 4 (Section 6.2). 

49 

 
 
 
                                                           
The  main  concern  as  regards  behavioural  addictions  is  on  where  to  draw  the  line  of  what 
would  be  covered  in  a  future-proof  way  (not  too  wide  and  not  too  restrictive).  A  wide 
coverage  could  lead  to  the  scope  of  action  becoming  unmanageable  for  the  Agency.  In 
addition,  as  behavioural  addictions  only  have  limited  cross-border  risks,  it  might  not  be 
proportionate and in line with the subsidiarity principle to include behavioural addictions in a 
revised mandate.  

In conclusion, addressing substance-based addictions as part of a more modern definition of 
poly-substance  use  appears  to  be  the  most  appropriate  option  in  view  of  coherence  and 
proportionality considerations. Only those substances should be addressed in a new mandate 
for which the EU has competences. Data provision has to be addressed as the Agency would 
need additional data. In addition, it has to be ensured that this does not lead to duplication of 
data provision in the Member States. Some initial streamlining of data reporting flows might 
be needed in the Member States.  

As  several  Member  States  already  apply  a  broader  addiction  approach,  they  would  benefit 
strongly from an increased involvement of the Agency in these areas. Other Member States, 
who still have a drugs-only  policy, would  also  benefit from information  regarding the links 
between  different  addictions.  Therefore,  clarifying  the  mandate  as  regards  the  substances  to 
be covered would be beneficial on the national level.  

The  streamlining  of  reporting  obligations  across  different  addictions  would  have  a  positive 
impact  in  the  mid-  to  long-term.  Providing  data  to  one  entity  only,  which  carries  out  the 
analysis in an integrated way, would lead to an overall reduction of administrative burden.   

When it comes to the economic impact, the impact of packaged policy option 5 is expected to 
be  neutral.  On  the  one  hand,  adding  the  information  collection  and  analysis  regarding 
additional substances would lead to additional resources needs for the Agency. On the other 
hand, the streamlining of reporting obligations should lead to sufficient benefits to outweigh 
the  additional  costs,  at  least  in  the  mid-  to  long-term.  Moreover,  the  need  for  considerable 
additional resources in the Agency is a reason for not extending the mandate to all addictions. 

7.4. 

Specific objective 4: To make the Agency more operational 

The main policy options, which would contribute to achieving this specific objective, are the 
following: 

  Packaged policy option 4: Targeted revision  

Comparative assessment for specific objective 4 

Packaged  policy  option  4: 
Targeted revision  

Packaged  policy  option  5: 
Expansive revision  

Impact on the EU 
(effectiveness) 

Impact on national authorities 
(effectiveness) 

Impact on simplification / 
administrative burden 

Economic impacts (efficiency) 

+++ 

+++ 

0 

 

50 

+ 

+ 

0 

0 

 
 
 
 
The Agency currently does not have any operational tasks.  Empowering the Agency to take 
the  necessary  actions  based  on  its  monitoring  and  threat  assessment  would  be  a  significant 
and important step for the Agency to respond in a more effective manner to the deteriorating 
drug  situation  in  the  EU.  The  basis  for  such  work  would  be  availability  of  all  relevant 
information, which is why the mandate of the national focal points would have to mirror the 
decision taken at the EU level. 

The  new  EU  Drugs  Strategy  puts  a  stronger  emphasis  on  prevention  and  security  issues. 
Strengthening the Agency’s capabilities as regards prevention campaigns, EU-level alerts and 
the  provision  of  risk  analysis  and  intelligence  reports,  and  further  develop  its  international 
work would be in line with the new Strategy. Both policy options are coherent with existing 
EU policies or known policy initiatives. 

The Member States would benefit from the increased responsibilities of the Agency when it 
comes to the appropriate operational reactions to its monitoring and threat assessment work. 
As  most  of  the  threats  regarding  the  supply  dimension  and  deriving  from  dangerous 
substances  are  of  cross-border  nature,  Member  States  are  not  able  to  address  this 
appropriately on their own.  As regards campaigns, Member States would be able to  use the 
experience of the Agency and to learn from other experiences through the interaction in the 
Agency. This would overall lead to better informed campaigns. The proposed actions would 
not replace Member States actions, but complement them. Therefore, no subsidiarity concerns 
should emerge.  

Neither  policy  options  will  have  a  major  impact  on  the  simplification  and/or  the 
administrative burden on European and national level. The new operational tasks would lead 
to a reduction of administrative burden in the Member States as they would have to  put less 
work and efforts in these areas. 

When  it  comes  to  the  economic  impact,  the  main  impact  will  be  on  the  EU  budget.  As  all 
options would lead to an increase in the activities of the Agency, further human and financial 
resources for the Agency would be needed.  

7.5. 

Specific  objective  5:  To  provide  support  to  Member  States  in  shaping  and 
evaluating their drugs policies 

The main policy options, which would contribute to achieving this specific objective, are the 
following: 

-  Packaged policy option 4: Targeted revision 

Comparative assessment for specific objective 5 

Packaged  policy  option  4: 
Targeted revision  

Packaged  policy  option  5: 
Expansive revision  

Impact on the EU 
(effectiveness) 

Impact on national 
authorities (effectiveness) 

Impact on simplification / 
administrative burden 

Economic impacts 

++ 

+++ 

0 

 

51 

+ 

++ 

0 

 

 
 
(efficiency) 

Providing  more  support  to  Member  States  on  evaluation  and  shaping  their  drugs  policies 
would be beneficial  not  only for the individual Member State but  for the EU as a  whole.  It 
would enable the Member States to more efficiently deal with the challenges of the national 
drug phenomenon. On the other hand, with the Agency providing support, it would learn more 
about the national policies and could provide the learning from one Member State to another. 
It  would  lead  to  more  information  on  national  drug  policies  becoming  available  on  a 
European level. The national focal points would need to be closely linked to this work as they 
would be one of the main sources for the Agency to understand the national context.  

Both policy options are coherent with existing EU policies or known policy initiatives. There 
are  no  other  EU  bodies,  which  carry  out  the  related  actions  or  for  which  an  extension  of 
mandate is foreseen in this direction. 

However, packaged policy option 4 has the biggest impact on the national level. If the Agency 
is  mandated to  provide support  to  Member States in  the evaluation  and the shaping of their 
national drug polices, it is evident that the national authorities will be the main beneficiaries 
of such a policy option.  

This would lead to simplification and a reduction of the administrative burden in particular on 
the national level. On the contrary, not attributing the tasks to the Agency or attributing them 
only marginally would have a negative impact on national authorities as they would have to 
make sure on their own that drug-related interventions are in line with the scientific state of 
play.   

When  it  comes  to  the  economic  impact,  the  main  impact  will  be  on  the  EU  budget,  due  to 
limited extra requirements in terms of human and financial resources, whereas it would lead 
to cost savings on the national level.   

Member States are evaluating and shaping their drug policies independently from each other. 
They might use the tools provided by the Agency, but no further development towards more 
support to the Member States would be possible without strengthening the Agency’s mandate. 
There  are  no  subsidiarity  concerns  as  this  policy  option  concerns  a  supporting  competence 
and does not move any national responsibilities or competences to the EU level.  

8.  PREFERRED OPTION 

8.1. 

Summary of the preferred option 

Based on the impact  assessment, the preferred option would be  policy option 4 leading to  a 
targeted  revision  of  the  mandate.  The  main  elements  of  this  targeted  revision  are  the 
following:  

  The  Agency’s  scope  of  action  would  be  expanded  to  address  other  substance-
based addictions when these substances are taken together with illicit drugs, i.e. 
the  revision  is  to  provide  a  better  definition  of  poly-substance  use.  This  would 
necessitate the reporting of relevant data by the national focal points.  

52 

 
 
  The  Agency’s  mandate  would  be  expanded  to  explicitly  address  drug  supply  and 
drug  market  issues  as  this  is  an  increasingly  important  dimension  of  the  drug 
phenomenon and an EU Drugs Agency has to be able to fully monitor that dimension.  

  The  Agency’s  monitoring  and  threat  assessment  capabilities  would  be 
strengthened and the Agency would provide further support to the Member States to 
increase the impact of the Agency on the drug phenomenon and its ability to react to 
new challenges.  

  A  virtual  laboratory,  i.e.  a  network  of  laboratories  combined  with  a  competence 
centre  in  the  Agency,  would  be  established  to  ensure  that  more  forensic  and 
toxicological information is available to the Agency.  

  The Agency would get the competence to act on its analysis and develop EU-level 
prevention  and  awareness  raising  campaigns  as  well  as  issue  alerts  in  case 
particularly dangerous substances are available on the market.  

  These elements would be complemented by stronger cooperation with Member States 
and  EU  bodies,  which  is  crucial,  although  would  not  deliver  on  its  own  on  the 
objectives of this initiative.  

  The national focal points would be empowered to provide the relevant data to the 
Agency. The revised founding Regulation would set minimum requirements for their 
set-up,  which  are  then  certified  by  the  Agency.  The  mandate  of  the  national  focal 
points has to reflect the revision of the Agency mandate. 

  As regards the international dimension, the tasks of the Agency would be clarified to 

include in the mandate itself the necessary competencies.  

8.2.  Explanation of the preferred option 

The  future  scope  of  action  of  the  Agency  would  remain  limited  mainly  to  illicit  drugs,  but 
would  address  other  substance-based  addictions  when  these  substances  are  taken  together 
with  illicit  drugs.  To  that  end,  the  new  mandate  should  include  a  clearer  and  more  modern 
definition of poly-substance use. The main factors for not fully including other substances or 
addictions  in  the  mandate  of  the  Agency  are  related  to  the  need  to  have  a  clearly  defined 
mandate,  proportionality  and  cost  considerations.  The  concept  of  poly-substance  use  should 
be integrated both in the data gathering on consumption of other addictive substances and in 
terms  of  policy  responses  into  the  reporting.  A  revised  mandate  should  consider  drug 
precursors in view of their impacts on drug markets and the potential efficiency gains if the 
analysis is done by the Agency.  

The monitoring and threat assessment capabilities and the support functions for the Member 
States  would  be  strengthened.  The  Agency  is  best  placed  to  carry  out  these  functions,  as  it 
would be an extension of current responsibilities. In addition, the Agency covers both pillars 
of  the  drug  phenomenon  already  for  many  years,  whereas  the  other  options  of  EU  bodies 
would  lean  either  to  the  security  or  the  health  side.  These  capabilities  would  increase  the 
impact  of  the  Agency  on  the  drug  phenomenon  and  its  ability  to  react  to  new  challenges. 
Improving  the  monitoring  capabilities  would  be  the  basis  for  any  further  work  on  threat 
assessment and providing support to the Member States.  

53 

 
The Agency would get the competence to act on its analysis and support the development of 
EU-level campaigns as well as provide alerts in case of specific threats being identified by the 
Agency.  

As regards the laboratory capacities, the best option would be to set up a laboratory inside the 
Agency as it would allow for an independent EU-level analysis of illicit drugs. However, as 
the  costs  linked  to  the  setting  up  and  running  of  a  laboratory  are  very  high,  the  impact 
assessment opts for a more modest solution in the form of a virtual laboratory.  

When it comes to the national focal points, the necessary adaptations to the new mandate of 
the  Agency  have  to  be  implemented  to  mirror  the  changes  in  the  Agency  mandate.  At  the 
same  time,  minimum  requirements  for  their  set-up  would  be  established  to  strengthen  their 
position at national and European level. These minimum requirements would be certified by 
the Agency for each national focal point to ensure a level-playing field across Europe.  

Finally,  the  international  role  of  the  Agency  would  be  clarified  in  a  revised  mandate  of  the 
Agency.  The  Agency  should  not  be  restricted  to  EU-funded  projects  in  third  countries,  but 
overall  should  develop  the  international  dimension  as  part  of  its  tasks,  including  through 
capacity-building projects.  

Any  of  the  policy  options  would  not  be  able  to  address  –  on  its  own  –  the  problems  or 
problem  drivers  identified  in  this  report.  This  combination  of  policy  options  contributes  to 
better-informed  policies,  which  in  turn  lead  to  better-informed  actions  and  ultimately  to 
stronger  European  (and  national)  responses  to  the  developments  of  the  drug  phenomenon. 
This would be an important element on how to address the problems on the EU drug markets, 
both from a health as well as a security perspective. Stronger action and stronger cooperation 
is needed by all actors and a revised Agency would be central in these endeavours.  

The  preferred  option  adds  considerable  value  at  EU  level,  as  it  would  allow  for  pooling 
resources  in  an  EU-level  agency  instead  of  work  being  done  in  each  Member  State 
independently.  Implementing  the  preferred  option  would  avoid  duplication  of  work  in  the 
Member  States.  In  addition,  several  phenomena  are  cross-border  and  therefore  no  Member 
State could address them properly on its own.  

All  consulted  stakeholders,  in  particular  the  European  Parliament,  the  Member  States  and 
civil  society,  would  support  a  strengthening  of  the  Agency  and  the  overall  direction  as 
proposed  in  the  preferred  option.  The  only  element,  which  is  expected  to  be  subject  to 
diverging opinions, is the scope of action of the Agency. Some Member States will argue for 
widening  the  Agency’s  scope  of  action  further,  whereas  others  will  urge  for  caution  and 
would  prefer  the  Agency  to  remain  focussed  on  illicit  drugs  only.  The  preferred  option 
suggests a middle ground between these two positions. 

8.3. 

Impacts of the preferred option on the EU budget 

In 2014, the EU budget contribution and the number of staff in the authorised establishment 
plan116  was  reduced  by  approximately  5%  and  10%,  respectively,  compared  to  the  period 
before,  in  line  with  the  overall  request  by  the  budget  authorities  to  reduce  EU  staff.  Since 
then, the EU contribution to the Agency budget remained stable with an annual contribution 
of approximately EUR 16 million117, despite increased costs in line with the requirements of 

116   Information  provided  by  the  EMCDDA  in  January  2020  to  the  Commission  in  the  context  of  the  2021 

budgetary procedure. 

117   No changes in the authorised establishment plan, which provides for 76 authorised posts. 

54 

 
                                                           
the  EU  Staff  Regulation  and  a  strengthened  role  of  the  Agency  in  the  risk  assessment 
procedure for new psychoactive substances.  

The  preferred  option  would  require  the  reinforcement  of  the  financial  and  human  resources 
compared to the resources earmarked in the Multiannual Financial Framework (MFF) 2021-
2027.  The  MFF  2021-2027  includes  EUR 123.4  million  (current  prices)  for  the  EU 
contribution  to  the  EMCDDA  over  the  whole  MFF  period,  i.e.  a  2%  annual  increase 
compared to the 2021 budget, and a stable number of authorised posts. 

It  is  estimated  that  the  preferred  policy  option  would  require  an  increase  of  the  EU 
contribution to the Agency in the range of EUR 51 to 68 million over the period 2024-2027, 
with  the  coverage  of  poly-drug  use  issues  representing  approximatively  EUR  7  million, 
supply and security issues representing EUR 16 million, enhanced threat assessment capacity 
representing EUR 10 million, the set up and functioning of a virtual laboratory representing 
approximately EUR 18 million, information campaigns and risk communication representing 
EUR 3.5 million, and the international dimension requiring EUR 5 million. Such an increase 
of the EU contribution would include an overall increase of staff of approximately  40 FTEs 
(full-time equivalents). The final proposal will be in this range and would correspond to the 
most cost-effective option.  

Table 1: Additional appropriations needed for the revision of the Agency mandate based on 
the preferred option and attribution over the MFF period – EUR million 

2021 

2022 

2023 

2024 

2025 

2026 

2027 

2021-
2027 

16.6 

16.9 

17.3 

17.6 

18 

18.3 

18.7 

123.4 

0 

0 

0 

11-15 

14-21 

13-16 

13-16 

51-68 

EU contribution 
to EMCDDA  
MFF  
Additional 
appropriations 
needed  

Table 2: Estimated staff increase (projection) – Full-time equivalents 

2021 

2022 

2023 

2024 

2025 

2026 

2027 

Projected 
variation 
2021-2027 

111 

111 

111 

111 

111 

111 

111 

+0 

+14 

+18 

+5 

+3 

+ 40 

Total staff – Based on 
Draft Budget 2021118 

Additional 
staff 

Variation 

118   All  staff  categories  funded  by  EU  contribution:  temporary  agents,  contract  agents,  Seconded  National 

Experts. 

55 

 
 
 
 
 
 
 
                                                           
needed for 
revision119  Total staff 

125 

143 

148 

151 

The cost estimates presented in Annex 3 as well as the overall budget and number of posts are 
subject  to  budget  availability.  Any  increase  of  the  EU  contribution  to  the  Agency’s  budget 
resulting from a revision of the mandate would need to stay within the ceilings of Heading 5 
of  the  MFF  2021-2027  and  could  be  offset  through  a  compensatory  reduction  from 
programmed spending under other Headings of the Union Budget. 

By  reducing  the  ambitions  of  the  proposed  initiative,  the  budget  impacts  could  be  lowered. 
This could be achieved by either not attributing a specific task to the Agency or by reducing 
the human and financial resources available for carrying out a specific task. In any case, the 
final  proposal  will  not  opt  for  the  most  expensive  option,  but  will  take  into  account  the 
context  of  the  MFF  2021-2027.  Any  of  the  options  for  securing  the  additional  financial 
resources will remain within and compatible with the MFF 2021-2027. In addition, different 
possibilities  for  securing  the  necessary  budget  for  the  revision  of  the  mandate  are  being 
considered ahead of making the proposal.  

Depending on the outcome of the negotiations with DG Budget and the available resources, 
the  ambition  level  of  the  proposed  initiative  will  be  modulated.  This  is  why  this  impact 
assessment does not yet provide any concrete figures, but a range for the additionally needed 
appropriations. The estimated number for the staff increase is a minimum needed for the tasks 
considered  under  the  preferred  option.  The  new  budget  should  allow  for  a  re-balancing 
between  the  Agency’s  budget  lines  as  currently  the  main  weight  is  on  Title  1  (staff  costs), 
whereas only minor amounts are available for real operational tasks.120 

In  view  of  the  considerable  increase  of  the  budget  needs  for  the  implementation  of  the 
preferred  option,  the  revision  should  include  the  option  for  the  Agency  charging  fees  for 
certain services. Such services should be easily separable from the other services provided by 
the Agency. Examples could be the provision of targeted training and capacity building (on- 
and offline) or the accreditation and certification of certain interventions. Taking into account 
the limited resources dedicated to drugs policy in the Member States (as far as these figures 
are available), charging fees might have a prohibitive effect on using the services provided by 
the  Agency.  Therefore,  a  careful  case-by-case  assessment  of  the  possible  services,  which 
could be subject to the payment of fees, would have to be carried out by the Agency together 
with the Commission. However, it would be premature to carry out such an assessment at this 
stage, as it is not clear whether the Agency would use this option. The assessment has to be 
done if and when the Agency decides in favour of this options. Fees are set – in line with the 
common approach for decentralised agencies – by the Commission.   

8.4. 

Scope for simplification and burden reduction 

The  assessment  of  the  impacts  addressed  the  impacts  on  simplification  and/or  the 
administrative burden. Although the preferred option would lead to an increase in tasks and 
responsibilities  of  the  Agency,  overall,  the  revision  of  the  founding  Regulation  would 
contribute  to  a  reduction  of  administrative  burden  and  a  simplification  of  administrative 
procedures,  in  particular  in  the  Member  States.  The  main  contributing  factor  to  this  is  the 
proposed  streamlining  and  centralisation  of  reporting  obligations  in  the  Member  States 
through  the  national  focal  points.  This  would  lead,  at  least  in  the  mid-  to  long-term,  to  a 

119   Temporary agents and limited number of Seconded National Experts. 
120   Title 3 of the Agency budget includes the amounts needed for the Reitox co-financing.  

56 

 
 
 
 
                                                           
reduction  of  administrative  costs  in  the  Member  States.  Another  example  is  that  better 
information would be available from the Agency for the benefit not only of the EU, but also 
of the Member States. Member States on their own would not be able to collect and analyse 
data to the same extent as they lack either the knowledge or the resources, or the problem is a 
cross-border  one.  The  latter  element  is  an  argument  for  administrative  simplification  as  no 
Member  State  could  address  those  issues  on  their  own  and  cooperating  with  numerous 
(neighbouring) countries would lead to a high administrative burden.  

Unfortunately, it is not possible to quantify the burden reduction potential as concrete figures 
in  this  regard  do  not  exist.  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.121  This  is  an  area  where  further  research  should  be  done,  e.g.  by  the 
Agency. 

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? 

It  will  be  essential  that  the  implementation  of  the  revised  founding  Regulation  is  closely 
monitored.  New  tasks  will  be  added  to  the  mandate  of  the  Agency  by  the  revision,  while 
others will be clarified. The new functions will have to be closely assessed on a regular basis. 
Providing  for  a  robust  monitoring  and  evaluation  mechanism  is  crucial  to  ensure  that  the 
envisaged beneficial effects of the revised founding Regulation materialise in practice.  

The  monitoring  and  evaluation  of  the  revised  mandate  will  largely  be  performed  by  the 
applicable  mechanisms  provided  for  in  the  founding  Regulation.  The  founding  Regulation 
includes  the  requirement  on  the  Commission  to  initiate  an  evaluation  every  six  years.  A 
regular evaluation will be retained in the new regulation, but its periodicity will be adapted to 
the common approach for decentralised agencies. Therefore, an evaluation will take place in 
the future every five years. The next evaluation122 will be too early to conclude already on the 
effects of the revision along the five better regulation requirements. However, that evaluation 
will be an opportunity to develop a robust baseline for future evaluations.  

The Commission will monitor the performance of the Agency and the impacts introduced by 
the  revision  of  the  mandate  through  its  participation  in  the  Agency’s  bodies,  i.e.  in  the 
Management  Board,  the  Executive  and  Budget  Committees  and  the  Reitox  network.  The 
Agency is subject to the audit procedure of the annual accounts with the European Court of 
Auditors and the discharge procedure by the European Parliament. The Internal Audit Service 
is regularly undertaking audits of different aspects of the Agency’s work.  

In line with better regulation rules, the evaluation of the revised mandate will be based on a 
detailed programme for monitoring the outputs, results and impacts realised. The monitoring 
programme will set out the indicators and the intervals at which the necessary evidence will 
be collected. These indicators reflect and define the success of the policy options and will be 
measured  on  a  yearly  basis,  based  on  the  general  report  of  activity  of  the  Agency  and  the 
observations  gained  from  the  participation  in  the  Agency’s  bodies.  Overall  success  will  be 
assessed as part of the first regular evaluation after the entry into force of the new mandate.  

121   See footnote 89. 
122   Based on the current founding Regulation, the next evaluation would take place in 2024. 

57 

 
 
                                                           
The  table  below  summarises  tentative  indicators123  to  monitor  the  achievement  of  specific 
objectives linked to the building blocks of the preferred policy option. It should be noted that 
some indicators contribute to measuring the achievement of more than one specific objective, 
but are only mentioned once.  

Specific objective 

Indicator 

increase 

Specific  objective  1:  To 
the 
Agency’s  capacity  to  react  faster  and  in  a 
more  targeted  way  to  new  challenges  in  the 
field  of  drugs,  harms  and  addictions,  and 
related threats  

Number of general threat assessments carried 
out by the Agency 

Number  of  notifications  to  the  EU  early 
warning system  

the 
Specific  objective  2:  To  deepen 
monitoring  and  analysis  of 
the  drug 
phenomenon in Europe, both on the demand 
and  supply  side  and  their  implications  for 
health and security 

Specific  objective  3:  To  clarify  the  mandate 
of  the  Agency  as  regards  what  substances, 
behaviours  and responses should be covered  

New and innovative data collection methods 
developed and implemented 

Number  of  data  sets  collected  through  new 
and innovative data collection methods 

Virtual laboratory set up and involved in the 
regular work of the Agency 

Number  of  additional  standard  data  sets 
collected by the Agency on other addictions 

Number  of  publications  which  address 
addictions beyond illicit drugs in the context 
of poly-substance use 

Number  of  requests  refused  by  the  Agency 
going beyond its scope of action 

Specific  objective  4:  To  make  the  Agency 
more operational 

Number  of  campaigns  developed  or  their 
development supported 

Specific  objective  5:  To  provide  support  to 
Member  States  in  shaping  and  evaluating 
their drugs policies 

Number of EU-level alerts issued 

Number  of  intelligence  reports  on  supply-
side  issues  provided  to  law  enforcement 
authorities  

Number of requests made by Member States 

Number of requests accepted by the Agency 

Number  of  accreditations/certifications  of 
national intervention schemes 

123   It should be noted that these indicators do not include quantitative targets as they are dependent on external 
factors. In particular, they depend on the development of the overall drug phenomenon and future EU drug 
strategies. Success will have to be measures over time as for some indicators an upward trend and for others 
a  downward  trend  on  an  annual  basis  would  be  considered  successful.  In  some  cases,  zero  would  be  a 
successful outcome as it would mean that sufficient information is available and intervention by the Agency 
was not needed (e.g. EU-level alerts). 

58 

 
 
 
 
                                                           
OVERVIEW OF ANNEXES 

Annex 1: Procedural information 

Annex 2: Stakeholder consultation 

Annex 3: Who is affected and how 

Annex 4: Intervention logic of Regulation (EC) 1920/2006 

Annex 5: Problem, drivers, objectives and options (intervention logic of the current initiative) 

Annex  6:  Schematic  overview  of  the  contribution  of  the  policy  options  to  the  specific 
objectives 

Annex 7: Relevant drug-related figures 

59 

 
 
 
 
 
ANNEX 1: PROCEDURAL INFORMATION 

1. 

Lead DG, Decide planning/CWP references 

Decide Planning 

Short title 

Foreseen adoption  CWP Reference 

PLAN/2019/5417  Revision of the 
mandate of the 
European Monitoring 
Centre for Drugs and 
Drug Addiction 

Q4 2021 

--- 

2. 

Organisation and timing 

Evaluation of the Agency  

Article 23 of the founding Regulation provides for "an external evaluation of the Centre every 
six  years,  to  coincide  with  the  completion  of  two  of  the  Centre's  three-year  work 
programmes". The fourth evaluation of the European Monitoring Centre for Drugs and Drug 
Addiction (EMCDDA) was carried out in the period April to November 2018. The evaluation 
was conducted by a consortium lead by ICF Consulting Ltd., in collaboration with the Centre 
for the Study of Democracy (CSD) and Optimity Advisors. The final report on the evaluation 
was submitted to the Commission in the beginning of November 2018 and was published by 
the Commission.124  

The Commission adopted a report about the evaluation, which was accompanied by a detailed 
Staff  Working  Document,  in  May  2019.125  The  report  summarised  the  main  results  of  the 
evaluation. 

Inter-service Group (ISG) 

  A new ISG, chaired by DG HOME, was set up in January 2020. 

  The  following  Directorates-General  (DGs)  participated  in  the  ISG:  the  Secretariat-
General  (SG),  the  Legal  Service  (LS),  DG  Human  Resources  (HR),  DG  Budget 
(BUDG), European Anti-Fraud Office (OLAF), DG Mobility and Transport (MOVE), 
DG  Taxation  and  Customs  Union  (TAXUD),  DG  Internal  Market,  Entrepreneurship 
and  SMEs  (GROW),  DG  Research  and  Innovation  (RTD),  DG  Health  and  Food 
Safety  (SANTE),  European  Neighbourhood  and  Enlargement  Negotiations  (NEAR), 
International Partnerships (INTPA), Service for Foreign Policy Instruments (FPI), the 
Joint Research Centre (JRC); and the European External Action Service (EEAS). 

  The  ISG  met  for  its  first  meeting  on  12  February  2020.  As  a  follow-up  to  this  first 
meeting, the ISG had the opportunity to comment in writing on the inception impact 
assessment. 

124   See footnote 18.  
125   See footnote 19. 

60 

 
 
 
                                                           
  Due  to  the  restrictions  imposed  on  face-to-face  meetings  by  the  measures  taken  to 
tackle the COVID-19-pandemic, the ISG was consulted in writing on Sections 1 to 5 
of  the  draft  impact  assessment  report  between  15  and  24  June  2020.  The  comments 
received were taken into account and the structure of the report revised. 

  The  (virtual)  ISG  meeting  held  on  20  October  2020  discussed  the  complete  draft 
impact  assessment  report  (the  minutes  of  the  ISG  meeting  are  included  in  the  file 
submitted to the Regulatory Scrutiny Board). The comments received during the ISG 
meeting were taken into account in the final draft report. 

  The revised draft of the impact assessment was sent to the ISG for written comments. 
The  consultation  took  place  from  15  to  19  February  2021.  The  comments  received 
were taken into account. 

3. 

Consultation of the Regulatory Scrutiny Board 

The  Regulatory  Scrutiny  Board  received  the  draft  version  of  the  present  impact  assessment 
report  on  18  November  2020.  The  draft  impact  assessment  report  was  examined  by  the 
Regulatory Scrutiny Board on 16 December 2020.  

The overall opinion of the Regulatory Scrutiny Board was negative.  

In  response,  the  Directorate-General  for  Migration  and  Home  Affairs  submitted  a  revised 
version of the draft impact assessment to the Regulatory Scrutiny Board on 14 April 2021 that 
addressed the comments made by the Regulatory Scrutiny Board in the following way: 

Recommendations  of  the  Regulatory 
Scrutiny Board 

Implementation of the recommendations into the 
revised impact assessment report 

Summary of findings 

that 

differentiate 

the  problems 

report  does  not  clearly 
(1)  The 
this 
demonstrate 
initiative  aims  to  tackle.  It  does  not 
sufficiently 
between 
shortcomings  of  the  current  regulation 
and new drug challenges, for which the 
Agency  could  be  part  of  the  policy 
response. It does not provide an overall 
convincing  and  clear  narrative  that  is 
coherent  with 
the 
the 
preceding evaluation. 

results  of 

The  revised  impact  assessment  provides  more 
contextual  information  throughout  the  document. 
It  acknowledges 
founding 
Regulation  reached  its  overall  objective  and  that 
the revision is a targeted one.  

the  current 

that 

phenomenon,  which 

It  also  provides  the  context  within  which  the 
Agency works, i.e. the recent developments of the 
drug 
are  worrying. 
Strengthening  the  Agency  and  providing  it  with 
the necessary tools to help addressing the situation 
is one out of many measures to be taken to address 
the overall phenomenon.  

The explanations in the revised impact assessment 
have  been  streamlined  to  be  clearer  as  regards 
their narrative.  

(2) The presentation of policy options is 
overly  complex  and  not  sufficiently 
linked to the choices that policy makers 
should consider. 

The  revised  impact  assessment  streamlined  the 
policy options by combining several of the options 
and  included  options  for  the  policy-makers,  as 
regards other bodies to address the issues, clearer 
options  where  the  only  logical  option  is  the 

61 

 
(3)  The  report  insufficiently  assesses 
the  added  value  and  proportionality  of 
some  of  the  proposed  measures.  It  is 
not  specific  enough  about  the  options’ 
simplification 
reduction 
potential. 

cost 

and 

Agency, etc.  

The  revised  impact  assessment  made  an  effort  to 
provide more information on the added value and 
addressed proportionality issues further.  

However,  we  are  not  able  to  provide  quantified 
data  on  the  simplification  and  cost  reduction 
potential  of  the  different  options  as  such  data  is 
not  available  (see  the  main  body  of  the  impact 
assessment, in particular Section 8.4.). 

What to improve 

(1)  The  context  section  should  better 
present  the  current  mandate  of  the 
Agency.  It  should  briefly  explain  its 
monitoring  and  data  collection  tasks, 
and  their  intended  role  in  supporting 
EU and national anti-drugs policies. 

The context  section was updated to  refer more to 
the  issues  requested  by  the  Regulatory  Scrutiny 
Board and less to the development of the Agency 
over time.  

(2)  Given  the  largely  positive  findings 
of  the  preceding  evaluation,  the  report 
should  be  clearer  on  the  evidence-base 
of  the  problem  analysis.  It  should 
specify  which  problems  stem  from 
shortcomings  of  the  current  Regulation 
and which are the new issues that have 
emerged,  for  which  new  action  by  the 
Agency  could  be  an  element  of  the 
policy  response.  The  problem  analysis 
should  clearly  motivate  the  type  and 
scale of agency changes that the options 
suggest.  In  doing  so,  the  report  should 
differentiate  more  clearly  between  the 
drugs 
overall 
challenges  and  the  contribution  the 
Agency  could  realistically  make  in 
tackling those. 

development 

of 

DG HOME clarified already in the meeting of the 
Regulatory Scrutiny Board on 16 December 2020 
that the revision is a targeted one. This was stated 
more clearly in the revised draft.  

Further  information  as  regards  the  evidence-base 
for  the  evaluated  options  was  included  in  the 
revised 
further 
differentiation  between  the  shortcomings  of  the 
Regulation and the challenges stemming from the 
developments of the drug phenomenon.  

draft.  This 

included 

a 

It  was  further  clarified  that  the  revision  of  the 
mandate would support  addressing the  challenges 
of  the  modern-day  drug  markets,  without  being 
the only element to address the drug challenges.  

the  Agency’s 

(3) The report should better explain the 
added value of the Agency compared to 
instances  and 
other  data  collection 
bodies (national, EU and international). 
It  should  substantiate  the  need  for 
extending 
current 
mandate  to  develop  threat  assessment 
capacities,  indicating  the  operational 
testing  shortcomings  across  the  EU.  It 
should better argue the EU-added value 
of providing support to Member States. 
It  should  also  substantiate  the  benefits 
of  EU-level  drug  communication  as 

All  elements  addressed  in  this  comment  were 
further substantiated in the draft, by adding further 
explanations, despite the overall shortening of the 
text.  

When it comes to data collection, a comparison is 
not possible as the EMCDDA is the only body on 
EU-level  collecting  drug-related  data.  The  only 
other  bodies  collecting  similar  data  are  UN-level 
bodies,  such  as  the  United  Nationals  Office  for 
Drugs  and  Crime  and  the  International  Narcotic 
Control  Board.  However,  their  focus  is  much 
wider  than  Europe  and  specific  European  data 

62 

 
to 

compared 
communication 
regional or local level. 

more 

targeted 
at  Member  State, 

(4)  The  report  should  simplify  the 
presentation  of  options  and  better  link 
them  to  the  main  policy  choices  that 
policy  makers  should  consider. 
It 
should  present  genuine  alternatives  for 
each  of  the  key  issues  and  assess  and 
compare  them  more  systematically.  It 
should  consider  other  combinations  of 
the  preferred 
(sub-)  options  under 
policy  package,  possibly  differing  in 
terms of ambition level, scope of action 
or budgetary implications. 

(5)  The  report  should  further  develop 
the REFIT dimension and the scope for 
simplification  and  cost  reduction  under 
the  various  options.  As far  as  possible, 
it should provide quantitative estimates 
reductions 
of 
from 
(data  collection, 
centralising 
testing  capacity,  communication,  etc.). 
It should specify for each task why the 
Agency  would  be  more  efficient  in 
carrying it out than the Member States. 

foreseen  cost 
tasks 

(6)  The  report  should  present  a  clearer 
and  more  convincing  narrative. 
It 
should  be  shortened  by  avoiding 
repetitions  and  better  focusing  on  the 
relevant  information  in  the  problem 
definition, options and impact sections. 

would not be available anymore.  

The revised draft impact assessment packaged the 
different options into less, but clearer options. The 
main policy choices for policy-makers were better 
underlined and additional information included, as 
far as available. 

Further  qualitative  information  was  included  into 
the  revised 
the 
impact  assessment  regarding 
simplification potential of the various options.  

As explained in Section 8.4 of the revised draft, it 
is  not  possible  to  quantify  the  burden  reduction 
potential  as  concrete  figures in  this regard do not 
exist.  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. 

The  narrative  was  revised  by  shortening  the  text 
and  in  particular  by  taking  into  account  the 
technical  comments  provided  by  the  Regulatory 
Scrutiny Board ahead of the meeting. This lead to 
the  streamlining  of  the  text,  deleting  potential 
repetitions  and  focussing  the  text  on  the  main 
elements.  

Following  the  resubmission  of  the  draft  impact  assessment,  the  Regulatory  Scrutiny  Board 
gave  its  positive  opinion  with  reservations  on  12  May  2021.  The  comments  made  by  the 
Regulatory Scrutiny Board were addressed in the following way: 

Recommendations  of  the  Regulatory 
Scrutiny Board 

Implementation of the recommendations into the 
revised impact assessment report 

Summary of findings 

(1)  The  problem  analysis  does  not 
sufficiently  distinguish  between 
the 
shortcomings  of  the  Regulation  and 
new  challenges  that  may  require  a 
revision. 

Further  clarifications  have  been  included  in  the 
text,  in  particular  in  Section  2,  and  the  text  was 
shortened. 

63 

 
 
(2) The intervention logic is not clearly 
set out. 

(3) The presentation of policy options is 
confusing  and  does  not  bring  out 
clearly the available policy choices. 

(4)  The  report  does  not  show  the  costs 
and benefits  of individual  options.  It is 
unclear  on  how  the  preferred  option 
aligns  with  the  EU  budget  framework, 
and  what  the  corresponding  ambition 
level would be. 

The  intervention  logic  is  included  in  Annex  5, 
setting  out  the  problem,  the  problem  drivers,  the 
general and specific objectives of the proposal  as 
well as the policy options, which were analysed in 
the this impact assessment.  

The text was further clarified.  

the 

individual  options, 

The  benefits  of 
in 
particular as regards quantified benefits, cannot be 
is  not  available. 
provided  as 
in 
Therefore, 
qualitative terms.  

the  benefits  were  described 

related  data 

The  costs  of  the  individual  options  are  set  out  in 
Annex 3  and  will  be  further  detailed  in  the 
Legislative  Financial  Statement,  which  will 
accompany the proposal for a Regulation. 

What to improve 

the 

(e.g. 

through 

to  other 

shortcomings  of 

(1) The report should base the problem 
description  more  on  the  evaluation 
findings.  It  should  distinguish  between 
the 
current 
Regulation  and  new  challenges  that 
may  require  a  revision.  It  should  also 
better  differentiate  between  findings  of 
the  evaluation  and  other  evidence 
stakeholder 
gathered 
consultations)  that  might  change  the 
evaluation’s  conclusions.  The  problem 
analysis  should  explain  the  current 
restrictions  in  the  Agency’s  mandate 
relating 
substance-based 
addictions  and  polydrugs.  It  should 
resource 
discuss 
constraints  have  prevented  extending 
the  Agency’s  activities.  It  should  also 
clarify  the  relationship  and  interaction 
with other data collection instances and 
European  bodies  to  address  potential 
overlaps.  The  problems  ‘insufficient 
support  to  Member  States’  and  ‘the 
need  to  develop  EU-level  prevention 
and  awareness 
raising  campaigns’ 
should  be  substantiated  with  more 
robust  evidence  and  critically  assessed 
from a subsidiarity and EU added-value 
perspective. 

to  what 

extent 

further 

includes 

Further 
included 
clarifications  have  been 
throughout  the  text  to  address  the  issues  raised. 
This 
the 
shortcomings  of  the  current  Regulation  vis-à-vis 
the  modern-day  drug 
challenges  of 
the 
these  are  closely 
phenomenon.  However,  as 
interlinked, 
is  not  always 
possible.  

the  differentiation 

information  on 

As  regards  data  collection,  please  see  the  table 
above (first  opinion), point 3;  further information 
was included in the baseline (section 5.1).  

64 

 
It 

(2) Based on a more coherent narrative, 
the  report  should  present  a  clearer 
should 
intervention 
logic. 
convincingly  demonstrate  how 
the 
options  (and  the  measures  contained 
therein)  would  deliver  on  the  specific 
objectives  and  ultimately  tackle  the 
identified  problem  drivers.  A  clear 
visual  presentation  of  the  intervention 
logic  should  be  included  in  the  main 
text.  Specific  objectives  should  be 
expressed  in  more  SMART  terms,  so 
that progress can be measured. 

(e.g.  on 

(3)  The  presentation  of  the  policy 
options  remains  complex,  confusing 
and  geared 
the  preferred 
towards 
option.  On  the  one  hand,  some  of  the 
key  options  (e.g.  scope  of  action, 
priority activity  areas,  new tasks) seem 
artificial  and  not  really  presenting 
alternatives.  On  the  other  hand,  certain 
available  choices 
scope, 
laboratory  capacities,  national  focal 
points)  are  not  clearly  identified  or 
sufficiently  explained  upfront.  The 
report  should  therefore  be  revised  to 
present  genuine  alternative  options, 
possibly  with  different  ambition  levels 
(e.g.  minimum,  targeted  or  maximum 
tackle  either 
revision), 
identified 
simultaneously 
all 
inter 
problems  (in  case 
related) or by key problem area (in case 
these are independent).  Following such 
a  logic,  the  preferred  option  should  be 
one of the options. 

the 
these  are 

that  could 

in 

(4)  The  report  should  compare  all 
options 
terms  of  effectiveness, 
coherence  and  efficiency.  This  should 
allow  to  provide  greater  clarity  on  the 
(budgetary)  costs  and  benefits  of  the 
those 
alternative  options, 
resulting from different implementation 
choices (e.g. expanding  or merging the 
agency).  In 
it  seems 
premature  to  discard  a  merger  with 
another  agency  upfront,  given 
the 
potential  cost  savings  and  overall 

this  context, 

including 

Further  information  was  included  in  the  impact 
assessment  on  the  intervention  logic.  The  visual 
presentation itself was left in the annex (Annex 5) 
due to the format of the intervention logic.  

read 

should  be 

intervention 

logic  should  be 

in 
The 
conjunction  with  the  intervention  logic  of  the 
founding  Regulation. 
further 
It 
developed  by  the  first  evaluation  under  the  new 
Regulation,  in  particular  as  regards  the  SMART 
terms,  as the final  text  of the Regulation  depends 
on  outcome  of  the  legislative  process  (or  even 
already  by  the  last  evaluation  under  the  current 
founding  Regulation,  if  this  happens  towards  the 
end of the legislative process). 

The  text  was  further  clarified  to  address  the 
different  ambition  levels.  The  presentation  of  the 
policy  options  was  restructured  based  on  two 
ambition levels.  

information  was  added 

More 
to 
effectiveness, coherence and efficiency for all the 
policy options.  

in  relation 

in 

line  with 

A merger of the EMCDDA with another agency is 
impact 
the 
the  analysis 
– 
assessment  –  not  opportune.  The 
recent 
developments  of  the  drug  phenomenon  call  for  a 
stronger  agency,  not  for  a  weakening  of  the 
situation, which would however happen  in all the 
considered options for a merger.  

in 

The  potential  cost  savings  would  be  minor  as  a 

65 

 
merged  agency  would  have  to  continue  the 
majority of the tasks of the EMCDDA and would 
therefore need the related budget.  

This  information  will  be  presented  –  in  line  with 
the  available  templates  –  in  the  Legislative 
Financial  Statement  (LFS).  The  financial  (and 
related human) resources are being discussed with 
DG Budget.  

The option of the Agency to charge fees for some 
of its tasks is merely an option at this stage, which 
should be enabled by a revised Regulation. It will 
be  for  the  Agency  to  decide  whether  they  will 
make use of this option in the future. Therefore, it 
would be premature to analyse this option in more 
detail in this impact assessment.  

See the table above (first opinion), point 3.  

The comments were fully taken into account when 
revising  the  impact  assessment,  including  adding 
the  comments  from  Box  C  of  the  first  opinion  in 
Annex 1 of the impact assessment.  

budgetary constraints. 

(5)  The  report  should  clarify  how  the 
preferred option is aligned with the EU 
multiannual  financial  framework  2021-
2027  and  be  clear  on  what  ambition 
level will be possible within this frame. 
It  should further assess the potential of 
a  charging  fees  option,  by  at  least 
giving  broad  indications  on  potential 
costs  and  benefits  and  potential  impact 
on the overall budget for this initiative. 

(6)  The  report  should  further  develop 
the REFIT dimension by giving special 
to  simplification  and 
consideration 
burden  reduction  potential,  quantifying 
it as far as possible. 

further 
report  should  be 
(7)  The 
streamlined  in  order  to  have  a  more 
synthetic  and 
focused  presentation, 
bringing  out  a  more  convincing 
narrative.  Relevant  information  should 
be  presented  where  it  belongs  (e.g. 
description  of  options  in  the  option 
section and not in the impact analysis). 
Annex  1  should  provide  a  complete 
table indicating how all the suggestions 
of  the  Regulatory  Scrutiny  Board  have 
been taken into account, including ‘Box 
C – what to improve’. 

4. 

Evidence, sources and quality 

The main source of evidence was the outcome of the evaluation: 

o  Report from the Commission to the European Parliament and the Council, Evaluation 
of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) 2018, 
COM(2019)  228  final;  and  the  accompanying  Staff  Working  Document  SWD(2019) 
174 final. 

o  Evaluation  of  the  EMCDDA  –  Final  Report  (https://op.europa.eu/en/publication-
detail/-/publication/4eaca79c-72f6-11e9-9f05-01aa75ed71a1/language-en/format-
PDF/source-search); 
3 
/publication/598b184d-72f6-11e9-9f05-01aa75ed71a1/language-en/format-
PDF/source-search)  and  Annexes  4  to  6  (https://op.europa.eu/en/publication-detail/-

(https://op.europa.eu/en/publication-detail/-

Annex 

66 

 
 
/publication/604a15ae-72f6-11e9-9f05-01aa75ed71a1/language-en/format-
PDF/source-search) 

The  previous  evaluation  of 
the  EMCDDA 
https://op.europa.eu/en/publication-detail/-/publication/7d189e3b-f767-460b-b748-
acf44d2daf9a/language-en/format-PDF/source-74343049. 

in  2012  was  used  as  background: 

Drugs 

The outcome of the final evaluation of the EU Drugs Strategy 2013-2020 and EU Action Plan 
on 
https://ec.europa.eu/home-
affairs/sites/homeaffairs/files/what-we-do/policies/european-agenda-security/20200724_swd-
2020-150-commission-staff-working-document_en.pdf, has been taken into account. 

SWD(2020) 

2017-2020, 

final, 

150 

Formal and informal stakeholder consultations as well as the feedback to the inception impact 
assessment: see Annex 2. 

In addition, several publications of the Agency were used to provide information on the drug 
phenomenon, in particular 

o  The European Drug Report 2021; and 
o  The 3rd edition of the EU Drug Markets Report. 

Other publications are quoted in the report as appropriate. 

5. 

Limitations 

The following limitations to the robustness of the impact assessment could be identified: 

  Available  data  on  national  funding  for  drugs  policy:  as  concluded  in  the  final 
evaluation of the EU Drugs Strategy 2013-2020 and EU Action Plan on Drugs 2017-
2020,  very  limited  quantifiable  data  on  spending  on  drugs  policy  is  available  at 
Member States level. This prevented the evaluation from making a sound assessment 
of the implementation costs for Member States brought by the Strategy. Furthermore, 
national  financial  estimates  for  the  period  of  the  2017-2020  Action  Plan  are 
unavailable. Therefore, no quantifiable estimates on the benefits of the policy option 
on national level and the simplification and cost reduction potential could be made in 
this impact assessment. Recourse was made to a qualitative assessment.  

  Data  lag:  The  data  referred  to  in  the  impact  assessment  is  largely  referring  to  2018, 
only in limited cases to 2019, as there is a lag in the availability of data. This is linked 
to the way data is reported to and verified by the Agency.  

 

Intervention  logic  for  Regulation  (EC)  1920/2006:  At  the  time  of  adoption  of 
Regulation  (EC)  1920/2006,  no  intervention  logic  was  prepared.  Therefore,  the 
intervention  logic  used  in  this  impact  assessment  is  the  one  developed  by  the 
contractor for the 2018/19 evaluation of the Agency.  

  Reduced  possibility  for  informal  outreach  to  stakeholders:  Due  to  the  COVID-19 
pandemic,  it  was  not  possible  to  do  as  much  outreach  as  originally  planned.  The 
meetings  at  the  EMCDDA  were  cancelled  as  of  mid-March  2020  and  therefore  no 
informal meetings in the margins could take place. The same is true for the Council’s 
Horizontal  Working  Party  on  Drugs.  This  seriously  limited  additional  (informal) 
exchanges  for  the  preparation  of  the  proposal,  including  for  the  impact  assessment 
report. 

67 

 
 
ANNEX 2: STAKEHOLDER CONSULTATION  

1. 

Main stakeholder groups 

The main stakeholders of the Agency are: 

  European-level and national policy-makers; 
  Practitioners and professionals working in the drugs field; and 
  Scientists and researchers. 

2. 

Exception from the public consultation obligation 

The  main  stakeholder  consultation  for  this  proposal  was  undertaken  as  part  of  the  2018/19 
evaluation. This process included an extensive stakeholder consultation, including a 12-weeks 
public consultation. Details of this stakeholder consultation are available in Annex III of the 
Staff Working Document on the evaluation.126 This includes a short summary of the outcomes 
of the public consultation. The synopsis report of the public consultation has been published 
as Annex 5 of the evaluation report.127  

The  public  consultation  as  part  of  the  external  consultation  received  a  limited  number  of 
contributions  (147  in  total),  despite  the  considerable  efforts  by  the  Commission  and  even 
more  by  the  Agency  to  advertise  the  public  consultation.  The  low  response  rate  was  due 
probably to the rather technical nature of the issue, i.e. the evaluation of an agency with a very 
specific mandate. The technical nature of the evaluation was the reason why it was accepted 
that the public consultation questionnaire was translated from English only into five other EU 
languages  and  not  into  all  official  EU  languages.  It  should  be  noted  that  almost  half  of  the 
respondents were answering on behalf of organisations, the other half (55%) in their personal 
capacity. The latter group included inter alia members of the EMCDDA Scientific Committee 
and other people directly involved in the work of the Agency (despite answering on their own 
behalf, instead of on behalf of an organisation). 

The  public  consultation  for  the  evaluation  contained  some  forward  looking  questions,  in 
particular it asked questions about what other information would be usefully provided by the 
Agency,  what  other  research  domains  should  be  addressed  by  the  Agency  to  cover 
stakeholder  needs,  how  the  Agency  could  have  greater  impact,  about  future  synergies  with 
other  agencies,  and  finally  on  how  stakeholders  see  the  future  of  the  Agency  within  the 
evolving context of drugs policy. These questions were open-ended textual questions, which 
were  mandatory  to  be  completed.  Despite  the  mandatory  character  of  the  questions,  not  all 
stakeholders  had  an  opinion  on  these  issues.  Further  information  is  available  from  the 
synopsis  report,  which  was  provided  by  the  contractor  (see  Annex  5  of  the  final  evaluation 
report).   

The  revision  of  the  mandate  of  the  EMCDDA  was  considered  in  internal  discussions, 
including with  the Secretariat-General,  as  consisting of rather  “technical” changes128, which 

126   See footnote 19. 
127   See footnote 17.  
128   The evaluation included in its conclusion recommendations for several such changes. Some of the changes 
need  a  revised  legal  framework  to  be  implemented.  For  those  actions,  which  can  be  addressed  within  the 
current  mandate,  the  Agency  developed  an  action  plan  to  follow  up  on  those  recommendations  (Doc 
the  60th  Management  Board  meeting, 
EMCDDA/33/19;  see  point  5.3  of 

the  minutes  of 

68 

 
 
                                                           
are very specific and public knowledge about the Agency itself is lacking (as most answers to 
the public consultation during the evaluation came from experts). In addition, a second public 
consultation on the same issues would be seen by many as a duplication of the previous one 
and  therefore  they  would  likely  not  participate  again.  Therefore,  no  further  open  public 
consultation was launched.  

The  main  stakeholders,  which  will  be  directly  concerned  by  the  revision,  would  be  the 
Member States and their national focal points due to higher reporting obligations. The other 
direct  effects  will  be  on  the  Agency  itself.  Other  stakeholders  would  only  be  indirectly 
affected by having an Agency in place, which would be better equipped to deal with the future 
challenges posed by drugs in the EU.  

Several discussions on the potential revision have taken place since the evaluation report was 
made  available,  e.g.  discussion  in  the  Management  Board  of  the  EMCDDA  in  December 
2018 and June 2019, presentation to the Council’s Horizontal Working Party on Drugs in July 
2019, presentation to the heads of national focal points in their meeting in May 2019, etc. At 
all these occasions, the main conclusions of the evaluation were discussed.  

In 2019 and 2020, several formal and informal meetings took place. This included  informal 
meetings with several staff members of the Agency, the heads of the national focal points, the 
Civil Society Forum on Drugs, and representatives of Member States.  

More formal meetings were organised by DG HOME. A virtual meeting with the core group 
of the Civil Society Forum on Drugs took place on 1 July 2020. The proposed revision of the 
EMCDDA  mandate  was  discussed  at  the  plenary  meeting  of  the  Civil  Society  Forum  on 
Drugs  on  8  October  2020  (afternoon  session).  A  discussion  on  the  aspects  related  to  the 
national focal points took place at the technical meeting of the Reitox network on 7 October 
2020 and at the meeting of the Heads of National Focal Points in November 2020.129 A virtual 
informal workshop was organised for the members of the EMCDDA Management Board on 
26 October 2020, which discussed the policy option and the main  elements of the preferred 
option. 

The  Agency  provided  expert  input  to  the  impact  assessment  in  the  course  of  its  drafting, 
including estimates of the cost impacts of the different policy options.  

3. 

Inception Impact Assessment  

The inception impact assessment was published for feedback on the Commission website for 
8 weeks, i.e. from 4 June to 30 July 2020.130  

Statistical information about the feedback received  

The  publication  of  the  inception  impact  assessment  received  24  feedback  responses.  Non-
governmental  organisations  submitted  more  than  half  of  the  answers  (13  out  of  the  24 
responses),  with  the  other  answers  having  been  submitted  by  academic/research  institutions 
(3), public authority (3), other (3), and one each from a member of the European Parliament 
(marked as submitted from a citizen) and from a business association. Europol forwarded an 

https://www.emcdda.europa.eu/system/files/attachments/13078/EMCDDA_50_19_Final%20minutes%20M
B%20meeting%2012-13%20December%202019_060320_COM_PT_signed%20uploaded.pdf).   

129   As  a  follow-up  to  the  meeting  of  the  Heads  of  National  Focal  Points,  the  Reitox  network  submitted  a 

position paper to the Commission.  

130   https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12432-Revision-of-the-mandate-of-

the-European-Monitoring-Centre-for-Drugs-and-Drug-Addiction.  

69 

 
                                                                                                                                                                                     
additional  response,  not  recorded  on  the  Commission  website,  from  a  national  law 
enforcement agency.  

20  out  of  24  respondents  accepted  that  their  feedback  is  published  with  their  personal 
information.  

Eight out of 24 responses were submitted from Spain, four from Poland, three from Belgium, 
two  from  Romania,  one  each  from  France,  Germany,  Ireland,  Mexico  and  US.  In  addition, 
two responses were submitted by international bodies/organisations. 

Analysis of the feedback received 

All  respondents  expressed  general  support  to  the  work  of  the  Agency  and  stressed  the 
importance of the Agency  being a neutral  data provider. About half of the respondents  (11) 
did  not  provide  any  input  on  the  different  policy  options  proposed  in  the  inception  impact 
assessment, but only provided a general statement of support for the work of the Agency.  

The  general  comments  focussed mainly on the direction the  revision of the mandate should 
take.  There  was  a  strong  voice  for  focussing  the  work  of  the  Agency  also  in  the  future  on 
health-related  issues,  harm  reduction  and  related  topics.  Several  respondents  stressed  the 
importance of the Agency to continue its data collection and monitoring tasks, being it for the 
issues they are already in charge or for an expanded mandate. This was linked in several cases 
to  the  request  for  additional  resources  for  the  Agency  as  a  revision  should  not  be  to  the 
detriment  of  the  current  (excellent)  functioning  of  the  Agency.  Different  suggestions  were 
made as regards the issues to be addressed by the EMCDDA in the future. Drug supply issues 
were mentioned by several respondents as an area to work on, despite some mentioning that 
these are addressed  already by  other EU agencies (e.g. Europol). Overall, most respondents 
underlined the need for a balanced mandate. Several respondents suggested the widening of 
the  scope  of  action  to  other  (licit)  substances  and/or  addictive  behaviours.  One  respondent 
advocated the need to abandon the differentiation between illicit and licit substances.  

From those making statements on the different policy options, six respondents provided very 
clear negative statements as regards policy options 2 and 3 (dismantle the Agency or merge 
with another agency). The main gist of the statements in this regard was that the dismantling 

70 

 
 
of  the  Agency  would  lead  to  a  serious  threat  for  and  weakening  of  the  European  drug 
monitoring  system  as  stakeholders  heavily  rely  on  the  EMCDDA  for  data.  One  respondent 
stated that if a merger would be considered, it should be with the European Centre for Disease 
Prevention and Control as it has a health angle. 

Those  respondents  (9),  which  addressed  policy  options  3  and  4,  mentioned  issues  for  the 
Agency  to  address  in  the  future.  These  included  inter  alia  new  issues,  including  poly-
substance use, internet trade in  drugs, links to  drug supply,  research, precursors, role of the 
national  focal  points,  international  drug policy, and  shaping and  evaluation of national  drug 
strategies.  Respondents  underlined  the  need  to  avoid  overlaps  and  redundancies  in  case  the 
mandate of the EMCDDA is expanded.  

71 

 
 
 
 
 
 
ANNEX 3: WHO IS AFFECTED AND HOW?131 

1. 

Summary of benefits 

The tables below summarise the costs and benefits for the preferred option. Given the limitations created by the lack of available data, the tables 
have been filled to the extent possible. 

There  is  no  quantified  data  available  on  the  benefits  of  the  different  policy  options  (see  the  main  text  of  the  impact  assessment  report  for 
explanations). Different benefits are included and explained in a qualitative way. 

I. Overview of Benefits (total for all provisions) – Preferred Option 

Description 

Amount 

Comments 

Better understanding of the drugs 
phenomenon in the EU 

N/A 

Direct and indirect benefits 

Updating  the  Agency  mandate  to  equip  it  with  the  necessary  means  to  deal  with  the 
current  and  future  challenges  posed  by  drugs  in  the  EU  would  lead  to  a  better 
understanding of the drugs phenomenon. If better information were available, it would be 
easier for the European and national level to react to developments. It would be easier to 
do so in a coordinated manner across borders, which is crucial as the drugs phenomenon 
was  and  increasingly  is  of  cross-border  nature,  and  would  allow  addressing  new 
developments. Ultimately, the strengthened actions of the Agency would contribute to the 
health and security dimension of EU drugs policy. 

Savings in administrative costs in 
the Member States 

N/A 

The  streamlining  of  reporting  obligations  would  lead  to  a  reduction  of  administrative 
costs in the Member States, at least in the mid- to long-term. This has to be seen alongside 
the necessary increase of the EU contribution to the Agency. Unfortunately, due to a lack 

131   See Section 2.4., which describes who is affected and in what ways. 

72 

 
 
 
                                                           
Drug demand and supply 
reduction 

N/A 

of data, no quantified data is available on the possible savings in the Member States.  

The ultimate goal of any revision of the Agency would be the contribution of its work to 
drug  demand  and  supply  reduction.  The  Agency  cannot  do  this  on  its  own,  but  the 
information  it  makes  available  leads  to  a  better  understanding  of  the  drug  phenomenon 
and  availability  of  better  intelligence.  This  is  the  evidence-base  for  EU  drugs  policy, 
which  has  as  its  strategic  policy  areas:  drug  supply  reduction:  enhancing  security;  drug 
demand  reduction:  prevention,  treatment  and  care  services;  and  addressing  drug-related 
harms;  underpinned  by  three  cross-cutting  themes  in  support  of  the  policy  areas 
(international  cooperation;  research, 
innovation  and  foresight;  and  coordination, 
governance and implementation). 

2. 

Summary of costs 

As  regards  the  costs,  no  costs  occur  for  citizens/consumers  and  businesses  from  the  revision  of  the  current  initiative.  The  costs  are  on  the 
administrations only and there mainly on the EU budget. Some costs might occur on national level. Such potential costs will be indicated in the table, 
however, without quantified cost estimates, as these are not available.  

The cost estimates for the EU contribution to the Agency budget are based on the calculations provided by the EMCDDA, but have been verified by 
the Commission as regards them being in line with the actual operational needs of the preferred policy options. The estimates for staff costs have 
been calculated based on the current Commission average unit costs for human resources to which the correction coefficient for Portugal was applied. 

The  tables  provide  ranges  for  the  different  costs  as  the  final  costs  depend  on  the  choices  made  within  the  preferred  policy  option  for  the  final 
proposal.  The  amounts  are  the  additional  costs  needed  over  the  period  of  the  MFF  2021-2027.  The  cost  estimates  assume  that  the  European 
Parliament and the Council adopt the new Regulation at the earliest in 2023, with implementation starting in 2024. The hiring of the majority of the 
new  staff  is  spread  over  the  initial  two  years  in  order  to  allow  sufficient  time  for  absorption.  The  annual  amounts  of  recurrent  costs  refer  to  the 
financing needs once the Agency is fully up and running on the related tasks; therefore, the costs will be lower in the phase-in of the new mandate. 

It is estimated that the preferred policy options would require an increase of the EU contribution to the Agency in the range of EUR 51 to 68 million 
over the period 2024-2027, including an overall increase of staff of approximately 40 FTEs (full-time equivalents). These cost estimates are subject 
to budget availability. In any case, any increase of the EU contribution to Agency’s budget resulting from a strengthening of the mandate would need 
to stay within the ceilings of Heading 5 of the MFF 2021-2027. 

73 

 
II. Overview of costs – Preferred option 

Citizens/Consumers  

Businesses 

Administrations 

One-off  Recurrent  One-off  Recurrent 

One-off 

Recurrent132 

N/A 

N/A 

N/A 

N/A 

Direct costs 

Thematic 
scope of 
action   

Some IT-investments might 
be needed to extend the 
current data collection and 
monitoring system to other 
substances. However, these 
should not be major in view 
of the system already being 
in place and are integrated 
in the cost estimates of the 
recurrent costs.  

EU budget: 

Approx. EUR 1.5 million/year (without 
drug precursors); with drug precursor 
monitoring, this would increase to about 
EUR 2.5 million/year (only in the final 
years of the MFF)  
 Overall impact on MFF 2021-2027: 
EUR 6-11 million 

National budgets: 

There might be some minor cost 
increases for Member States in case data 
for the substance-based addictions is not 
yet collected in the way needed. 
However, in the mid- to long-term the 
streamlining of reporting obligations will 
reduce these costs. 

Indirect costs  N/A 

N/A 

N/A 

N/A 

   

   

Monitoring  Direct costs  N/A 

N/A 

N/A 

N/A 

See above. 

EU budget:  

132   The recurrent costs include staff costs. 

74 

 
 
 
                                                           
system 
(except 
virtual 
laboratory) 
and support 
to Member 
States; 
national 
focal points 

Approx. EUR 4.5-5.5 million/year  
 Overall impact on MFF 2021-2027: 
EUR 18-22 million 

If the co-financing of the national focal 
points would have to be increased, this 
would have an impact of up to EUR 2 
million/year  
 Overall impact on MFF 2021-2027: 
EUR 7-9 million 

National budgets: 

No costs to be expected for the 
monitoring, threat assessments and 
support to Member States. 

However, strengthening the role of the 
national focal points will lead to an 
increase in their resource needs. It is up 
to the Member States on how much 
(additional) funds they will make 
available for the national focal points; 
therefore, the overall impact on national 
budgets cannot be calculated. 

Indirect costs  N/A 

N/A 

N/A 

N/A 

   

   

Virtual 
laboratory 

Direct costs  N/A 

N/A 

N/A 

N/A 

As no physical laboratory 
is set up under the 
preferred option, no 
particular initial costs are 
needed, except for some 

EU budget:  

Approx. EUR 4-5 million/year annual 
running costs;  
the staff ramp up will be longer than for 
the other tasks to ensure smooth budget 

75 

 
possible IT investment. 

absorption. 
 Overall impact on MFF 2021-2027: 
EUR 16-20 million 

National budgets: 

No costs to be expected 

Indirect 
costs 

Internationa
l dimension 

Direct costs 

N/A 

N/A 

N/A 

N/A 

   

   

N/A 

N/A 

N/A 

N/A 

No set-up costs to be 
expected. 

EU budget: 

Approx. 1.5 million/year 
 Overall impact on MFF 2021-2027: 
EUR 4-6 million 

Indirect costs  N/A 

N/A 

N/A 

N/A 

   

   

76 

 
ANNEX 4: INTERVENTION LOGIC OF REGULATION (EC) 1920/2006 

Source: SWD(2019)174 final  

77 

 
 
 
 
 
ANNEX 5: PROBLEM, DRIVERS, OBJECTIVES AND OPTIONS (INTERVENTION LOGIC OF THE CURRENT INITIATIVE) 

Non-
legislative 

Option 0: 
Baseline 
scenario: 
Maintaining 
the current 
approach 
without 
changes 

Option 1: 
Non-
legislative & 
minimal 
revision 
option: 
Stronger 
cooperation 

Policy options 

Legislative 

Capacity to tackle the 
problem drivers 

Option 2: Dismantling of 
the Agency: Repeal of the 
founding Regulation 

Option 3: Merging of the 
Agency with another EU 
body 

Option 4: Targeted 
revision – Delivering more 
value in drugs policy   

Option 5: Expansive 
revision – Focusing on 
diverse addictions   

Option 0 would not achieve any of 
the specific objectives. 

Option 1 would achieve some of 
the specific objectives but would 
only to a very limited extent be 
able to address the problem 
drivers. 

Option 2 would not achieve any of 
the specific objectives and would 
seriously undermine EU drug 
policies. 

Option 3 would not achieve any of 
the specific objectives. 

Option 4 would achieve all 
specific objectives with a 
reasonable additional cost. 

Option 5 would achieve all 
specific objectives but at high 
additional costs. 

General 
objective 

To have an 
Agency, which is 
appropriately 
equipped to deal 
with the current 
and future 
challenges posed 
by drugs in the 
EU, leading to 
efficient action 
and support for 
Member States. 

Problem 

Problem drivers 

The mandate of the 
Agency has not 
been adapted to the 
changes of the 
drugs phenomenon  

Multi-
jurisdictional 
challenges due to 
new security 
threats 

Evolving national 
policies lead to 
changing priorities 

Recent 
developments in 
international drug 
policy 

Complexity of 
new drug 
phenomena 
lead to a 
disconnect with 
the existing 
Agency 
mandate 

Inadequate 
responses to 
new drug 
market 
challenges 

The Reitox 
network is not 
used to its full 
potential  

Insufficient 
support to 
Member States 

The 
international 
dimension of 
the Agency is 
insufficiently 
defined  

Specific objectives 

To increase the Agency’s 
capacity to react faster 
and in a more targeted 
way to new challenges in 
the field of drugs, harms 
and addictions, and 
related threats;  

To deepen the monitoring 
and analysis of the drug 
phenomenon in Europe, 
both on the demand and 
supply side and their 
implications for health 
and security;  

To clarify the mandate of 
the Agency as regards 
what substances, 
behaviours  and responses 
should be covered;  

To make the Agency more 
operational; and 

To provide support to 
Member States in shaping 
and evaluating their drugs 
policies. 

78 

 
ANNEX 6: SCHEMATIC OVERVIEW OF THE CONTRIBUTION OF THE POLICY OPTIONS TO THE SPECIFIC OBJECTIVES 

Specific objective 1: To 
increase the Agency’s 
capacity to react faster 
and in a more targeted 
way to new challenges in 
the field of drugs, harms 
and addictions, and 
related threats 

Specific objective 2: To 
deepen the monitoring 
and analysis of the drug 
phenomenon in Europe, 
both on the demand and 
supply side and their 
implications for health 
and security 

Specific objective 3: To 
clarify the mandate of the 
Agency as regards what 
substances, behaviours  
and responses should be 
covered 

Specific objective 4: To 
make the Agency more 
operational 

Specific objective 5: To 
provide support to 
Member States in 
shaping and evaluating 
their drugs policies 

Policy option 4: Targeted 
revision 
Policy option 5: 
Expansive revision 

X 

X 

X 

X 

X 

X 

X 

X  

79 

 
 
 
 
 
ANNEX 7: RELEVANT DRUG-RELATED FIGURES 

Figure 1: Estimates of drug use in Europe 

Source: European Drug Report 2021, p. 13. 

80 

 
 
 
 
 
 
 
Figure  2:  Number  of  substances  monitored  by  the  EU  Early  Warning  System  by 
category 

Source: European Drug Report 2021, p. 27. 

81 

 
 
  
 
 
 
Figure 3: Estimated retail value of the illicit market for the main drugs in the EU 

Source: EU Drug Markets Report 2019, Figure 1.1, p. 29. 

Figure 4: Trends in quantities of cannabis, cocaine and heroin in the European Union 

Source:  European  Drug  Report  2020  –  Key 
https://www.emcdda.europa.eu/edr2020.  

issues,  Figure  2,  p.  9, 

82 

 
 
 
 
 
Figure 5: Drug-induced deaths 

Source: European Drug Report 2021, p. 41. 

83