COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT 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

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   EUROPEAN COMMISSION  Brussels, 12.1.2022  SWD(2022) 9 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT  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) 8 final}  
 
 
Executive Summary Sheet 

Impact assessment on a proposal for a Regulation on the European Union Drugs Agency (revision 
of the mandate of the European Monitoring Centre for Drugs and Drug Addiction, i.e. of Regulation 
(EC) 1920/2006) 

A. Need for action 

Why? What is the problem being addressed?  
The  European  Monitoring  Centre  for  Drugs  and  Drug  Addiction  (‘the  Agency’)  was  founded  in 
1993,  with  its  founding  Regulation  recast  in  2006  (Regulation  (EC)  1920/2006).  In  2018/19,  the 
Commission carried out the latest evaluation (COM(2020) 228). The problem definition builds on 
the  outcomes  of  the  evaluation  and  addresses  shortcomings  raised  by  the  Agency’s  main 
stakeholders. Whereas 25 years ago it was necessary to collect and analyse data to describe the drugs 
situation in Europe and its consequences, nowadays stakeholders need also real-time analysis about 
emerging challenges and advice on the best ways to address the fast evolving threats, such as new 
psychoactive substances entering the EU, which are more dangerous to (public) health and create 
also  new  security  concerns.  Policy-makers  need  more  support  and  information  to  take  informed 
choices and provide adequate responses. The Agency cannot provide sufficient support to Member 
States and the network of national focal points of the Agency (Reitox) is not used to its full potential. 
Finally,  the  international  dimension  of  the  Agency’s  work  is  insufficiently  defined.  For  the 
implementation of the new EU Drugs Strategy 2021-2025, which takes an evidence-based approach 
to drugs policy, the information provided by the Agency is crucial. 
What is this initiative expected to achieve?  
The  general  objective  of  the  initiative  is  to  make  sure  that  the  Agency  is  fit  for  purpose  and  is 
appropriately equipped to deal with the challenges posed by drugs in the EU, leading to appropriate 
action and support by the EU and the Member States. The proposed revision of the mandate would 
be a targeted one. It should clarify the Agency’s mandate as regards its scope of action (in particular 
the  substances  to  address);  increase  its  capacity  to  react  faster  and  in  a  more  targeted  way  to 
challenges  and  emerging  threats;  deepen  the  monitoring  and  analysis  of  the  drug  phenomenon; 
provide support to Member States; and clarify the international dimension of the work of the Agency. 
What is the value added of action at the EU level?  

The drug phenomenon is affecting all Europeans and is cross-border, and global, in nature. There 
are many common challenges, which apply across Member States, both  on the drug demand and 
supply side. It is not possible to address the drug phenomenon only on a national level, as such an 
approach  would  lead  to  a  fragmentation  and  Member  States  learn  from  each  other  by  sharing 
experiences and best practices. EU action provides for an effective and efficient way to address these 
issues. 

B. Solutions 

What legislative and non-legislative policy options have been considered? Is there a preferred 
choice or not? Why?  
The  non-legislative  policy  option  (further  co-operation)  and  the  dismantling  or  merging  of  the 
Agency were discarded from further analysis, as they would not address the problems identified. 

The  preferred  option  is  a  targeted  revision  of  the  mandate.  To  address  the  request  of  some 
stakeholders to widen the scope of the Agency to other addictions, the question was analysed, but 
the  impact  assessment  concluded  that  the  Agency’s  main  focus  should  remain  on  illicit  drugs. 
However, poly-substance use should be better addressed. Drug supply and the drug markets should 
also be in the thematic scope of action of the Agency. In order to provide a more agile and forward-
looking analysis, the monitoring and threat assessment capabilities of the Agency should be further 

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developed. To inform the public quickly and alert about threats present in several Member States, 
the Agency should support the development or develop itself information campaigns and EU-level 
alerts. In order to increase the Agency’s information base, a specialist network of laboratories should 
be  set  up.  The  mandate  of  the  national  focal  points  should  be  strengthened  to  better  use  their 
capacities in support of the Agency and to mirror the changes to be introduced to the mandate of the 
Agency. Finally, the international dimension of the work of the Agency should be better clarified. 
Who supports which option?  
Main  stakeholders,  i.e. national  and European policy-makers on drugs  policy support  – and even 
request  –  a  strengthening  of  the  Agency  mandate.  The  new  EU  Drugs  Strategy,  adopted  by  the 
Council in  December 2020, explicitly invites the Commission to  present  a proposal  to  revise the 
mandate as soon as possible. Some Member States having wider addiction strategies would like a 
broader mandate for the Agency. Other Member States have a drugs-only framework and would be 
happy with the current mandate accompanied by a clarification on poly-drug use. Setting minimum 
criteria for the national  focal  points  might  also  be contentious  with  some Member States as they 
might  consider  it  interfering  with  their  prerogatives.  However,  these  criteria  would  be  needed  to 
ensure a level playing field across Europe and ensure data provision to the Agency. 

C. Impacts of the preferred option 

What are the benefits of the preferred options (if any, otherwise main ones)?                                       
The preferred option would contribute to better informed policies and actions; this would lead to 
more effective European (and national) responses to the drug phenomenon in the EU. This would be 
a major contribution for an effective and evidence-based response to the drugs phenomenon, both 
from a health and a security perspective. The mandate of the Agency would remain focussed mainly 
on monitoring, supporting the EU and its Member States, in line with the subsidiarity principle. Such 
a  targeted  revision  of  the  Agency  mandate  would  lead  to  better  preparedness  on  European  and 
national level as regards the growing new threats in the drugs area. 
What are the costs of the preferred options (if any, otherwise main ones)?                                       
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.  It  is 
estimated  that  an  additional  budget  of  around  EUR  51  to  63  million  and  around  40  additional 
establishment posts would be needed for the new MFF period. 
How will businesses, SMEs and micro-enterprises be affected?  
There will be no direct impacts on businesses, SMEs and micro-enterprises. The revision might have 
positive indirect impacts through limiting the loss of manpower in the economy due to drug users 
not being able to work or provide work to their full abilities and through disrupting the income of 
the organised crime groups. 
Will there be significant impacts on national budgets and administrations?  
Although the preferred option would lead to an increase in tasks and responsibilities of the Agency, 
overall, the initiative would contribute to a reduction of administrative burden and a simplification 
of administrative procedures, in particular in the Member States. The main contributing factor is the 
proposed  streamlining  and  centralisation  of  reporting  obligations.  Due  to  a  lack  of  data  on  the 
available funds for drugs policy, it is not possible to quantify the impacts of simplification and burden 
reduction. 
Will there be other significant impacts?  
No. 

D. Follow up 

When will the policy be reviewed?  
In line with the common approach, the Agency Regulation will include an external evaluation of the 
Agency every 5 years.  

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