European Parliament: Plenary Sitting

European Parliament
2019-2024
Plenary sitting
A9-0289/2022
7.12.2022
***I
REPORT
on the proposal for a regulation of the European Parliament and of the Council
on the European Union Drugs Agency
(COM(2022)0018 – C9-0010/2022 – 2022/0009(COD))
Committee on Civil Liberties, Justice and Home Affairs
Rapporteur: Isabel Santos
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EN United in diversity EN
PR_COD_1amCom
Symbols for procedures

* Consultation procedure
*** Consent procedure
***I Ordinary legislative procedure (first reading)
***II Ordinary legislative procedure (second reading)
***III Ordinary legislative procedure (third reading)
(The type of procedure depends on the legal basis proposed by the draft act.)
Amendments to a draft act

Amendments by Parliament set out in two columns
Deletions are indicated in bold italics in the left-hand column. Replacements

are indicated in bold italics in both columns. New text is indicated in bold
italics in the right-hand column.
The first and second lines of the header of each amendment identify the
relevant part of the draft act under consideration. If an amendment pertains to
an existing act that the draft act is seeking to amend, the amendment heading
includes a third line identifying the existing act and a fourth line identifying
the provision in that act that Parliament wishes to amend.
Amendments by Parliament in the form of a consolidated text
New text is highlighted in bold italics. Deletions are indicated using either
the ▌symbol or strikeout. Replacements are indicated by highlighting the
new text in bold italics and by deleting or striking out the text that has been
replaced.
By way of exception, purely technical changes made by the drafting
departments in preparing the final text are not highlighted.
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CONTENTS
Page
DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION .................................5
EXPLANATORY STATEMENT ............................................................................................66
OPINION OF THE COMMITTEE ON BUDGETS ................................................................68
PROCEDURE – COMMITTEE RESPONSIBLE ...................................................................89
FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE ....................................90
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DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
on the proposal for a regulation of the European Parliament and of the Council on the
European Union Drugs Agency
(COM(2022)0018 – C9-0010/2022 – 2022/0009(COD))
(Ordinary legislative procedure: first reading)
The European Parliament,
– having regard to the Commission proposal to Parliament and the Council

(COM(2022)0018),
– having regard to Article 294(2) and Article 168(5) of the Treaty on the Functioning of
the European Union, pursuant to which the Commission submitted the proposal to
Parliament (C9-0010/2022),
– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,
– having regard to Rule 59 of its Rules of Procedure,
– having regard to the opinion on the Committee on Budgets,
– having regard to the report of the Committee on Civil Liberties, Justice and Home
Affairs (A9-0289/2022),
1. Adopts its position at first reading hereinafter set out;
2. Calls on the Commission to refer the matter to Parliament again if it replaces,

substantially amends or intends to substantially amend its proposal;
3. Instructs its President to forward its position to the Council, the Commission and the
national parliaments.
Amendment 1
Proposal for a regulation

Recital 2
Text proposed by the Commission Amendment
(2) The European Monitoring Centre (2) The European Monitoring Centre
for Drugs and Drug Addiction was set up for Drugs and Drug Addiction was set up
to provide factual, objective, reliable and to provide factual, objective, reliable and
comparable information concerning drugs, comparable information concerning drugs,
drug addiction and their consequences at drug addiction and their consequences in
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Union level to provide the Union and the the Union and to provide the countries
Member States with evidence to inform participating in the work of the Centre
policymaking and guide initiatives to with an overall view of that information
tackle drugs and thus give them added and evidence to inform policymaking and
value when, in their respective areas of guide initiatives to tackle drugs and thus
competence, they take measures or decide give them added value when, in their
on action to address the drugs respective areas of competence, they take
phenomenon. The creation of the measures or decide on action to address the
European Monitoring Centre for Drugs and drugs phenomenon. The work of the
Drug Addiction has manifestly improved European Monitoring Centre for Drugs and
the availability of information on drugs and Drug Addiction has manifestly improved
drug addiction across Europe. the availability of information on drugs and
drug addiction, and their consequences,
across Europe and internationally.
Amendment 2

Recital 3
(3) Whereas its general objective is still (3) Whereas its general objective is still
valid and should be retained, Regulation valid and should be retained, Regulation
(EC) No 1920/2006 as such no longer fits (EC) No 1920/2006 as such no longer fits
for addressing the current and future drug for addressing the current and future drug
challenges. Therefore, the mandate of the challenges. Therefore, the mandate of the
European Monitoring Centre for Drugs and European Monitoring Centre for Drugs and
Drug Addiction should be revised, Drug Addiction should be revised,
including its replacement and renaming including its replacement, strengthening
into “European Union Drugs Agency” (‘the and renaming into “European Union Drugs
Agency’). Since substantial amendments to Agency” (‘the Agency’). Since substantial
Regulation (EC) No 1920/2006 are needed amendments to Regulation (EC) No
to accommodate the common approach for 1920/2006 are needed to accommodate the
Union decentralised agencies48 and to take common approach for Union decentralised
account of the developments of the drug agencies48, to reflect the balanced,
phenomenon, in the interest of clarity that evidence-based, integrated and
Regulation should be replaced by a new multidisciplinary approach enshrined in
Regulation. the Union strategies on drugs while
incorporating a gender equality, age and
health equity perspective, and to take
account of the developments of the drug
phenomenon, in the interest of clarity and
efficiency, that Regulation should be
replaced by a new Regulation.
__________________ __________________
48 Joint Statement of the European 48 Joint Statement of the European
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Parliament, the Council of the EU and the Parliament, the Council of the EU and the
European Commission on decentralised European Commission on decentralised
agencies of 19 July 2012, https://european- agencies of 19 July 2012, https://european-
union.europa.eu/sites/default/files/docs/bod union.europa.eu/sites/default/files/docs/bod
y/joint_statement_and_common_approach y/joint_statement_and_common_approach
_2012_en.pdf. _2012_en.pdf.
Amendment 3

Recital 4
(4) The main focus of Regulation (EC) (4) The main focus of Regulation (EC)
No 1920/2006 was on health-related issues. No 1920/2006 was on health-related issues,
However, addressing also drug markets which should continue to be the main
and drug supply issues, is necessary to focus and a priority for the Agency.
understand the impacts of the drug However, addressing also drug markets
phenomenon on public health, reduce the and drug supply issues, is also necessary to
availability of drugs in the Union and curb understand the impacts of the drug
drug demand. Health- and supply-related phenomenon on public health, reduce the
issues are intrinsically linked. The Agency availability of drugs in the Union and curb
should therefore address the drug drug demand. Health- and supply-related
phenomenon more holistically. issues are intrinsically linked. The Agency
should therefore address the drug
phenomenon more holistically in its
approach in order to provide factual,
objective, reliable, comparable and
Union-wide data and analysis. The
approach of the Agency to addressing the
drug phenomenon should incorporate a
human rights, gender equality, age, public
health, health equity and social
perspective in relation to drugs, drug use,
drug use disorders and addictions,
prevention, treatment, care, risk and harm
reduction, rehabilitation, social
reintegration, recovery, drug supply,
including illicit production and
trafficking, and other relevant drug-
related issues and their consequences.
Amendment 4
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Recital 5
(5) The work of the Agency should be (5) The work of the Agency should be
carried out with due regard to the carried out with due regard to the
respective powers of the Union and its respective powers of the Union and its
Member States in the area of drugs. It Member States in the areas of drugs and
should cover the various facets of the drugs the protection and improvement of public
phenomenon and the solutions applied. In health. It should cover the various facets of
doing so, the Agency should be guided by the drugs phenomenon and the solutions
relevant strategies and action plans adopted applied. In doing so, the Agency should be
by the Union, in particular the applicable guided by and reflect the balanced,
EU Drugs Strategy and Action Plan. evidence-based, integrated and
multidisciplinary approach enshrined in
the relevant strategies and action plans
adopted by the Union, in particular the
applicable EU Drugs Strategy and Action
Plan.
Amendment 5

Recital 6
(6) In pursuing its activities, the (6) In pursuing its activities, the
Agency should cooperate with other Union Agency should cooperate with other
agencies and bodies, in particular the relevant Union bodies, offices and
European Union Agency for Law agencies within their respective mandates,
Enforcement Cooperation (Europol), the and should take account of their activities
European Union Agency for Law in order to avoid duplication. Cooperation
Enforcement Training (CEPOL), the should also take place on an international
European Union Agency for Criminal level with relevant authorities and bodies
Justice Cooperation (Eurojust), the in third countries, in particular candidate
European Medicines Agency (EMA), the countries, potential candidate countries
European Centre for Disease Prevention and countries covered by the European
and Control (ECDC), and the European Neighbourhood Policy, and on the United
Education and Culture Executive Agency Nations level. It is necessary that such
(EACEA), and should take account of their cooperation comply with international
activities in order to avoid duplication. human rights norms.
Cooperation should also take place on an
international level with relevant authorities
and bodies in third countries and on the
United Nations level.
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Amendment 6

Recital 6 a (new)
(6a) In order to attain maximum

efficiency in addressing the drugs
phenomenon, the Agency should actively
cooperate with the scientific community,
organisations of healthcare professionals,
academia, the affected communities, civil
society organisations, including
organisations of people who use drugs,
and other relevant stakeholders.
Amendment 7

Recital 7
(7) Poly-substance use, that is the (7) The Agency’s work should pay due
concomitant use of one or more regard to poly-substance use because it is
psychoactive substance or type of becoming increasingly common.
substance, whether licit or illicit, when
those substances are taken together with
drugs, is becoming increasingly common.
Therefore, the Agency should address
other substance-based addictions when
those substances are taken together with
drugs by developing monitoring systems
that would consider, instead of focusing
only on one substance, heroin for
example, the important role played by
concurrent or sequential use of other
substances as well, such as non-controlled
opioids or misused medications.
Amendment 8
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Recital 9
(9) The collection, analysis and (9) The collection, analysis and
dissemination of data should continue to be dissemination of data should continue to be
the main task of the Agency. The standard the main task of the Agency. When
data is collected through the national focal collecting, analysing and disseminating
points, which should remain one of the data, the Agency should comply with the
main data providers for the Agency. legal framework on the processing of
Additional, closer to real-time data sources personal data and should not disseminate
are increasingly available through any data which would make it possible to
innovative data collection methods. identify individuals or small groups of
Therefore, the Agency should have access individuals. The standard data is collected
to all data available to get a holistic picture through the national focal points, which
of the drug phenomenon in the Union and should remain one of the main data
the external factors influencing it. providers for the Agency. Additional,
closer to real-time data sources are
increasingly available through innovative
data collection methods. Therefore, the
Agency should have access to all data
available to get a holistic picture of the
drug phenomenon in the Union and the
external factors influencing it.
Amendment 9

Recital 9 a (new)
(9a) The national focal points are

important players with respect to
improving data collection methodologies
and tools and developing relevant
guidelines for their implementation.
Amendment 10

Recital 10
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(10) The data requirements of the (10) The data requirements of the
Agency should be mirrored in the national Agency should be mirrored in the national
focal points. They should be empowered focal points. They should be empowered
within the Member States to receive all within the Member States to receive all
relevant data from the different national relevant data from the different national
authorities. Data collection in the Member authorities. Data collection in the Member
States should be streamlined as far as States should be streamlined as far as
possible to avoid double reporting and possible to avoid double reporting and
duplication of efforts. duplication of efforts and should comply
with fundamental rights and data
protection law.
Amendment 11

Recital 11
(11) In order to facilitate and structure (11) In order to facilitate and structure
data collection, information exchange, both data collection, information exchange, both
qualitative and quantitative, and to support qualitative and quantitative, and to support
the establishment of an integrated and the establishment of an integrated and
interoperable monitoring system enabling interoperable monitoring system enabling
real-time monitoring, the Agency should real-time monitoring, the Agency should
have an appropriate digital solution. This develop and apply the appropriate digital
should allow for the automation of data solutions necessary for the performance of
and information management and its tasks.
exchange. Such solution should also
facilitate the real-time monitoring of
technology-enabled drug markets,
including the darknet.
Amendment 12

Recital 14
(14) The drug phenomenon is becoming (14) The drug phenomenon is becoming
more and more technology-enabled, as was more and more technology-enabled, as was
shown again during the COVID-19 shown again during the COVID-19
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pandemic where a greater adoption of new pandemic where a greater adoption of new
technologies to facilitate drug distribution technologies to facilitate drug distribution
has been observed. It is estimated that has been observed. It is estimated that
about two-thirds of the offers on darknet about two-thirds of the offers on darknet
markets are drug-related. Drug trading is markets are drug-related. Drug trading is
using different platforms, including social using different platforms, including social
media networks and mobile applications. media networks and mobile applications.
This development is mirrored in responses This development is mirrored in responses
to the drug phenomenon, with an increased to the drug phenomenon, with an increased
use of mobile applications and e-health use of internet communications, mobile
interventions. The Agency, together with applications and e-health interventions.
other relevant Union agencies and avoiding The Agency, together with other relevant
duplication of efforts, should monitor such Union agencies and avoiding duplication of
developments as part of its holistic efforts, should monitor such developments
approach to the drug phenomenon. as part of its holistic approach to the drug
phenomenon. Taking into account
technological advancements and more
sophisticated encryption methods, the
Agency should be able to recommend
appropriate digital solutions to Member
States in order to tackle the drug
phenomenon in a coordinated and
coherent manner.
Amendment 13

Recital 16
(16) Based on the strengthened (16) Based on the strengthened

monitoring by the Agency and the monitoring by the Agency and the
experience gained in the risk assessment of experience gained in the risk assessment of
new psychoactive substances, the Agency new psychoactive substances, the Agency
should develop general threat assessment should develop general health and security
capabilities. A more proactive capacity to threat assessment capabilities. A more
rapidly identify new threats and inform the proactive capacity to rapidly identify new
development of counter-measures is threats and inform the development of
urgently needed as the dynamic nature of counter-measures is urgently needed as the
the modern drug phenomenon means that dynamic nature of the modern drug
related challenges can rapidly spread phenomenon means that related challenges
across borders. can rapidly spread across borders.
Amendment 14
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Recital 17
(17) As dangerous substances might (17) As dangerous substances might

lead to harm for public health, the Agency lead to harm for public health, the Agency
should be able to issue alerts. To support should be able to issue alerts. To support
such a function, the Agency should such a function, the Agency should
develop a European drug alert system, develop a European drug alert system,
accessible by national authorities. Such a accessible by national authorities. Such a
system should facilitate the rapid exchange system should facilitate the rapid exchange
of information that may require rapid of information that may require rapid
actions to safeguard public health, safety, actions to safeguard public health, social
and security. The Agency should be able to and human rights, safety, and security.
inform not only national authorities, but The Agency should be able to inform not
also potential users of these substances. only national authorities, but also potential
users of these substances.
Amendment 15

Recital 21
(21) To further the knowledge in this (21) To further the knowledge in this
area and support Member States, the area and support Member States, the
Agency should define and finance relevant Agency should define and finance relevant
projects, such as the development of projects, such as the development of
reference standards on new drugs, the reference standards on new drugs, the
elaboration of toxicological or elaboration of toxicological or
pharmacological studies, and drug pharmacological studies, the
profiling. Such an approach would support implementation of innovative approaches
the sharing of information between to research, and drug profiling. Such an
relevant laboratories and would decrease approach would support the sharing of
the costs for individual laboratories. information between relevant laboratories
and would decrease the costs for individual
laboratories. The projects that the Agency
finances and the amounts invested in
each project should be included in the
Agency’s annual work programme and be
made public.
Amendment 16
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Recital 22
(22) Since the Agency has access to data (22) Since the Agency has access to data
and the necessary scientific experience to and the necessary scientific experience to
develop and promote evidence-based develop and promote evidence-based,
prevention strategies, it should be involved gender-sensitive and age-appropriate
in prevention work, in particular interventions and best practices on harm
exchange of best practices and reduction, treatment, recovery, care and
implementable research results in drug rehabilitation, and policies and awareness
prevention, drug-related crime prevention raising, it should be involved in drug
and the prevention of drug-related harms, prevention and the prevention of drug-
including the elaboration of quality related harms, including the elaboration of
standards for drug prevention (European quality standards for drug prevention
Drug Prevention Quality Standards) or of a (European Drug Prevention Quality
curriculum providing decision- and policy- Standards) or of a curriculum providing
makers with the knowledge about the most decision- and policy-makers with the
effective evidence-based prevention knowledge about the most effective
interventions and approaches (European evidence-based prevention interventions
Union Prevention Curriculum) and approaches (European Union
Prevention Curriculum), especially how to
reach high-risk populations.
Amendment 17

Recital 23
(23) Given its Union perspective, the (23) Given its Union perspective, the
Agency should be able to evaluate national Agency should be able to evaluate national
measures and training, for example on measures and training, for example on
prevention, treatment, harm reduction and prevention, including gender-sensitive and
other related measures, in view of their age-appropriate prevention, treatment,
compliance with the latest scientific state harm reduction, recovery and other related
of play and of their proven usefulness. measures, in view of their compliance with
Member States or relevant professional the latest scientific state of play and of
bodies should be given the possibility to their proven effectiveness. Member States
use the accreditation or certification as a or relevant professional bodies should be
quality label for their work. given the possibility to use the
accreditation or certification as a quality
label for their work.
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Amendment 18

Recital 25
(25) The responsibilities of the Agency (25) International cooperation should be

in the area of international cooperation a core task of the Agency with
should be defined in more clear terms in responsibilities defined in clear terms in
order to allow it to fully engage in such order to allow it to fully engage in such
activities and respond to requests from activities and respond to requests from
third countries and bodies. The Agency third countries and bodies. The Agency
should be able to contribute to the should be able to offer adequate scientific
development and implementation of the and evidence-based tools for the
external dimension of the Union’s drugs development and implementation of the
policy and the leadership role of the Union external dimension of the Union’s drugs
at multilateral level as a means to ensure policy and the leadership role of the Union
the efficient and coherent implementation at multilateral level as a means to ensure
of the Union drug policies internally and at the efficient and coherent implementation
international level. In order that the of the Union drug policies internally and at
Agency can allocate adequate levels of international level. Work in that area
resources to this task, the work on should be based on an international
international cooperation should be part cooperation framework of the Agency,
of the core tasks of the Agency. It should which should be in line with the Union
be based on an international cooperation priorities on international cooperation and
framework of the Agency, which should be guided by the United Nations Sustainable
in line with the Union priorities on Development Goals. The Agency should
international cooperation and should be revise the international cooperation
revised on a regular basis to ensure that it framework on a regular basis in order to
adequately reflects international ensure that it adequately reflects
developments. international developments.
Amendment 19

Recital 26
(26) In order to help Union funding for (26) In order to help Union funding for
security research to develop its full security and health research to develop its
potential and address the needs of drugs full potential and address the needs of
policy, the Agency should assist the drugs policy, the Agency should assist the
Commission in identifying key research Commission in identifying key research
themes, drawing up and implementing the themes and in drawing up and
Union framework programmes for research implementing the Union framework
and innovation that are relevant to the programmes for research and innovation
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Agency’s objectives. Where the Agency that are relevant to the Agency’s
assists the Commission in identifying key objectives. Where the Agency assists the
research themes, drawing up and Commission in identifying key research
implementing a Union framework themes and in drawing up and
programme, it should not receive funding implementing a Union framework
from that programme in order to avoid a programme, it should not receive funding
potential conflict of interest. Finally, the from that programme and should take all
Agency should participate in Union-wide necessary measures in order to avoid
initiatives addressing research and conflicts of interest. Finally, the Agency
innovation to ensure that technologies should participate in Union-wide initiatives
necessary for its activities are developed addressing research and innovation to
and available for use. ensure that technologies necessary for its
activities are developed and available for
use. Planned research and innovation
activities should be set out in the single
programming document containing the
Agency’s multiannual and annual work
programme.
Amendment 20

Recital 27
(27) The Management Board should be (27) The Management Board should be
assisted by an Executive Board to prepare assisted by an Executive Board to prepare
its decisions. The Agency should be its decisions. The Agency should be
headed by an Executive Director. A headed by an Executive Director. A
Scientific Committee should continue Scientific Committee should continue
assisting the Management Board and the assisting the Management Board and the
Executive Director with regard to relevant Executive Director with regard to relevant
scientific matters. scientific matters. When appointing people
to positions within the administrative and
management structure of the Agency,
including the Management Board, due
consideration should be paid to their
professional backgrounds and to the
gender balance of the structure in
question.
Amendment 21

Recital 27 a (new)
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(27a) In order to ensure the independent

functioning and integrity of the Agency,
the Management Board should adopt
practical arrangements for the prevention
and management of conflicts of interest,
giving due consideration to the
recommendations of the European
Ombudsman. Those arrangements should
ensure, in particular, that senior
representatives of the Agency do not
undermine its integrity during or after
their term of office.
Amendment 22

Recital 28
(28) The national focal points should be (28) The national focal points should be
one of the main data providers to the one of the main data providers to the
Agency. It is necessary to set minimum Agency. It is necessary to set minimum
requirements for their creation by Member requirements for their creation by Member
States and their certification by the States and their certification by the
Agency. In order to guarantee the adequate Agency. In order to guarantee the adequate
functioning of the national focal points, functioning of the national focal points,
they should be set up on a permanent basis, they should be set up on a permanent basis,
with a dedicated budget and a certain with a dedicated budget, appropriate
degree of independence in carrying out human resources and a certain degree of
their function. independence in carrying out their
function.
Amendment 23

Recital 29
(29) The Agency should be properly (29) The Agency should be adequately
resourced to carry out its tasks and granted resourced to carry out the tasks, objectives
an autonomous budget. It should be and responsibilities assigned to it under
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mainly financed by a contribution from the this Regulation. That should be properly
general budget of the Union. The Union reflected in the multiannual financial
budgetary procedure should be applicable framework by means of a dedicated and
as far as the Union contribution and any ambitious budget. The Agency should be
other subsidies chargeable to the general mainly financed by a contribution from the
budget of the Union are concerned. The general budget of the Union with the
auditing of accounts should be undertaken necessary appropriations drawn
by the Court of Auditors of the European exclusively from unallocated margins
Union. under the relevant heading of the
multiannual financial framework or
through the mobilisation of the relevant
special instruments. The Union budgetary
procedure should be applicable as far as the
Union contribution and any other subsidies
chargeable to the general budget of the
Union are concerned. The auditing of
accounts should be undertaken by the
Court of Auditors of the European Union.
Amendment 24

Recital 30
(30) Fees improve the funding of an (30) Fees could improve the funding of
agency and may be considered for specific the Agency and may, to the extent that
issues that can be clearly separated from such fees are duly justified and necessary,
the core tasks of the agency. Any fees be considered for specific activities that
levied by the Agency should cover its costs can be clearly separated from the core tasks
for providing the respective services. of the agency. The method by which fees
levied by the Agency are calculated
should be transparent, and such fees
should cover only the Agency’s human
and financial costs for providing those
non-core services. An annual independent
external audit, separate from the annual
audit undertaken by the Court of
Auditors, which specifically focuses on
such fees should be undertaken and
transmitted to the European Parliament.
Amendment 25
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Recital 35
(35) The Agency should cooperate (35) The Agency should cooperate
closely with relevant international closely, in full compliance with
organisations, other governmental and non- fundamental rights and data protection
governmental bodies and relevant technical rules, with relevant international
bodies from inside and outside the Union organisations, other governmental and non-
in the implementation of its work governmental bodies and relevant technical
programme, notably to avoid duplication of bodies from inside and outside the Union
work and to ensure access to all data and in the implementation of its work
tools needed for carrying out its mandate. programme, notably to avoid duplication of
work and to ensure access to all data and
tools needed for carrying out its mandate.
Amendment 26

Recital 35 a (new)
(35a) In order to raise awareness at

Union level, the Agency should establish a
structured cooperation with relevant civil
society organisations for the purposes of
regular and extensive consultation and
regular and extensive exchange of
information, without transferring any
decision-making power to such civil
society organisation.
Amendment 27

Article 3 – paragraph 1 – point 3
(3) ‘poly-substance use’ means the (3) ‘poly-substance use’ means the
concomitant use of one or more consumption of one or more psychoactive
psychoactive substance or type of substance or type of substance, whether
substance, whether licit or illicit, when illicit or licit, in particular medicinal
those substances are taken together with products, alcohol or tobacco, at the same
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drugs; time as the consumption of drugs, or the
sequential consumption of one or more
such substance or type of substance,
within a short period of time, together
with drugs;
Amendment 28

Article 4 – paragraph 1
The Agency shall provide the Union and The Agency shall:
its Member States with factual, objective,
reliable and comparable information,
early warning and risk assessment at
Union level concerning drugs, drug
addiction, drug markets and their
consequences, and to recommend
appropriate and concrete, evidence-based
actions on how to address the related
challenges in a timely manner.
Amendment 29

Article 4 – paragraph 1 – point a (new)
(a) provide the Union and its Member

States with factual, objective, reliable and
comparable information, early warning
and risk assessment at Union level
concerning drugs, drug markets, drug
use, drug use disorders, drug addictions,
prevention, treatment, care, risk and harm
reduction, rehabilitation, social
reintegration, recovery, drug supply and
other relevant drug related issues and
their consequences; and
Amendment 30
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Article 4 – paragraph 1 – point b (new)
(b) recommend appropriate and

concrete evidence-based actions on how to
address the challenges set out in point (a)
in an efficient and timely manner.
Amendment 31

Article 4 – paragraph 1 a (new)
In carrying out its tasks, the Agency shall

ensure full compliance with fundamental
rights and data protection rules, act in a
transparent, objective, impartial and
scientifically rigorous manner, and take
an evidence-based, integrated, balanced
and multidisciplinary approach to the
drugs phenomenon. That approach shall
incorporate human rights, gender, age,
public health, health equity and social
perspectives.
Amendment 32

Article 5 – paragraph 1 – point a – point 1
(1) the collection of information and (1) the collection and analysis of
data pursuant to Article 6(1); information and data pursuant to Article
6(1);
Amendment 33

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(2) the dissemination of information (2) the dissemination of information,

and data pursuant to Article 6(5); and data and results of analyses pursuant to
Article 6(5) and
Amendment 34

(3) the monitoring of the drug (3) the monitoring of the drug
phenomenon, encompassing the public phenomenon, encompassing the public
health, safety and security dimension, health, social and human rights, safety
pursuant to Article 7. and security dimension, pursuant to Article
7.
Amendment 35

Article 5 – paragraph 1 – point b – point 2
(2) threat assessment and preparedness (2) health and security threat
pursuant to Article 12; assessment and preparedness pursuant to
Article 12;
Amendment 36

Article 5 – paragraph 1 – point c – point 1
(1) the development, expansion and (1) the development and promotion of
promotion of Union-wide prevention evidence-based interventions, best
programmes and campaigns pursuant to practices and awareness raising pursuant
Article 16; to Article 16;
Amendment 37
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3. The Agency shall act in an deleted

objective, impartial and scientifically
rigorous manner when carrying out and
implementing the tasks referred to in
paragraph 1.
Amendment 38

4. The Agency shall improve 4. The Agency shall support and

coordination between national and Union improve coordination between national and
action in its areas of activity and facilitate Union action in its areas of activity and
exchanges of information between facilitate exchanges of information
decision-makers, researchers, specialists between decision-makers, researchers,
and those involved in drug-related issues in specialists and those involved in drug-
governmental and non-governmental related issues in governmental and non-
organisations. governmental organisations.
Amendment 39

4a. In cooperation with civil society

organisations, the Agency shall develop a
communication strategy in order to raise
public awareness and actively disseminate
information about its work.
Amendment 40

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7. In carrying out and implementing 7. In order to attain maximum

the tasks referred to in paragraph 1, the efficiency in monitoring, assessing and
Agency shall cooperate actively with other responding to the drugs phenomenon, the
Union decentralised agencies and bodies, Agency shall, in carrying out and
in particular Europol, Eurojust, the implementing its tasks, cooperate actively
European Medicines Agency, the with all of the following:
European Centre for Disease Prevention
and Control, civil society organisations
and other relevant stakeholders, to attain
maximum efficiency in monitoring,
assessing and responding to the drugs
phenomenon.
Amendment 41

Article 5 – paragraph 7 – point a (new)
(a) other relevant Union bodies,

offices and agencies, within the limits of
their mandates, in particular Europol,
Eurojust, the European Union Agency for
Fundamental Rights, the European
Union Agency for Law Enforcement
Training (CEPOL), the European
Medicines Agency, the European Centre
for Disease Prevention and Control and
the European Foundation for the
Improvement in Living and Working
Conditions (Eurofound);
Amendment 42

Article 5 – paragraph 7 – point b (new)
(b) other international bodies, offices

and agencies, in particular the UN
Economic and Social Council and the UN
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Narcotics Board; and
Amendment 43

Article 5 – paragraph 7 – point c (new)
(c) the scientific community,

academia, civil society organisations, in
particular the Civil Society Forum on
Drugs, and affected communities,
including people who use drugs;
Amendment 44

Article 6 – paragraph 1 – point a
(a) collect all relevant information and (a) collect relevant information and
data, including information and data data, including information and data
communicated by the national focal points, communicated by the national focal points,
resulting from research, available from resulting from research, available from
open sources, and data emanating from open sources, and data emanating from
Union, non-governmental sources and Union, non-governmental sources and
competent international organisations; competent international organisations and
bodies;
Amendment 45

Article 6 – paragraph 1 – point b
(b) collect information and data needed (b) collect information and data needed
for the monitoring of poly-substance use as for the monitoring of poly-substance use
referred to in Article 7(1), point (c); and its consequences as referred to in
Article 7(1), point (ac);
Amendment 46
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2. The Agency shall collect relevant 2. The Agency shall collect relevant
national data through the national focal national data through the national focal
points. It shall also cooperate closely with points. It shall also cooperate closely with
other national, European and international other national, European and international
organisations and bodies that already have organisations and bodies that already have
information of this kind. information of this kind. The Agency may
use additional national sources of
information.
Amendment 47

Article 6 – paragraph 4 – subparagraph 1
The Agency may develop the necessary The Agency shall develop the necessary
digital solutions through which information digital solutions through which information
and data are managed and automatically and data are collected, validated, analysed,
exchanged. reported, managed and exchanged,
including in an automated manner.
Amendment 48

If such digital solutions are developed, deleted

they shall:
(a) enable the automated collection of
data, including open source information,
while keeping the possibility of manual
data provision available;
(b) apply artificial intelligence for
data validation, analysis and automated
reporting;
(c) allow for the computerised
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handling and exchange of information,
data and documents.
Amendment 49

(b) ensuring wide dissemination of its (b) ensuring wide dissemination of its
analysis, conclusions and reports; analysis, conclusions and reports,
including to the scientific community,
civil society organisations and affected
communities, including people who use
drugs, with the exception of classified and
sensitive non-classified data;
Amendment 50

Article 6 – paragraph 5 – point e
(e) providing information on quality (e) providing information on quality

standards, innovative best practices and standards, innovative best practices,
implementable research results in the innovative and implementable research
Member States and facilitating the results in the Member States and
exchange and implementation of such facilitating the exchange and
standard and practices. implementation of such standard and
practices.
Amendment 51

Article 6 – paragraph 5 – subparagraph 1 a (new)
Where relevant, the Agency may

disseminate information and data
disaggregated by Member State, gender,
age, disability and socio-economic status,
in accordance with the relevant national
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legal framework and Union data
protection law.
Amendment 52

6. The Agency shall not collect any 6. The Agency shall not disseminate
data making it possible to identify or transmit any data making it possible to
individuals or small groups of individuals. identify individuals or small groups of
It shall refrain from any transmission of individuals.
information relating to specific
individuals.
Amendment 53

Article 7 – title
Monitoring of the drug phenomenon Monitoring of the drug phenomenon and

sharing of best practices
Amendment 54

(a) the drugs phenomenon in the Union (a) the drugs phenomenon in the Union
holistically, through epidemiological and holistically, through epidemiological and
other indicators, covering the health, safety other indicators, covering the public health,
and security aspects, including the social and human rights, social
implementation of the applicable Union reintegration, safety and security aspects
strategies on drugs; thereof, including the implementation of
the applicable Union strategies on drugs;
Amendment 55
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Article 7 – paragraph 1 – point a a (new)
(aa) evidence-based best practices and

innovative approaches to respond to the
public health, social and human rights,
safety and security aspects of the drugs
phenomenon in the participating
countries;
Amendment 56

Article 7 – paragraph 1 – point a b (new)
(ab) emerging trends in the Union and

internationally with respect to drug use,
drug use disorders, drug addictions and
related health risks and harm in so far as
they impact the participating countries;
Amendment 57

Article 7 – paragraph 1 – point a c (new)
(ac) poly-substance use and its

consequences, in particular the increased
risks of health and social problems, the
social determinants of drug use, drug use
disorders and drug addictions, and the
implications for policies and responses;
Amendment 58

Article 7 – paragraph 1 – point a d (new)
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(ad) drug and poly-substance use and

its consequences from an age and gender
perspective, in particular its impact on
gender-based violence;
Amendment 59

Article 7 – paragraph 1 – point c
(c) poly-substance use and its deleted

consequences, in particular the
implications for policies and responses
arising from the interaction between the
use of drugs with one or more
psychoactive substance or type of
substance, whether licit or illicit;
including the increased risks of health
and social problems, which may occur
when drugs and other psychoactive
substances are consumed at the same time
or sequentially within a short period of
time or when different substances are
produced or sold together; the need to
consider the common causes of drug use
and addictions; and the implications for
monitoring and exchange of best
practices, which arise when policies and
responses target multiple substances
holistically;
Amendment 60

Article 7 – paragraph 1 – point d
(d) drug-related problems and the deleted

solutions applied, in particular the
implementation of innovative best
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practices and research results;
Amendment 61

Article 7 – paragraph 1 – point h
(h) Technology-enabled drug markets, deleted

in cooperation with Europol within their
respective mandates.
Amendment 62

2. Based on its monitoring activities, 2. Based on its monitoring activities,

the Agency shall identify innovative best the Agency shall develop and identify
practices and develop them further. The innovative and evidence-based best
Agency shall provide and share practices, share them with the Member
information on innovative best practices States and facilitate the exchange of such
in the Member States and facilitate the practices among them.
exchange of such practices among the
Member States.
Amendment 63

3. The Agency shall undertake 3. The Agency shall provide data,

regular foresight exercises, taking into analysis and best practices to, and share
account the information available. It shall the latest evidence-based policy
develop, on that basis, relevant predictions recommendations with, the Commission
for the development of future drugs policy. and the Member States, provided that
such data, analysis, best practices and
policy recommendations concern Union
and national policies which address the
phenomenon of drug addictions. The
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Agency shall develop, on that basis,
relevant scenarios for the development of
future drugs policy. The Agency shall
undertake regular foresight exercises,
taking into account the information
available.
Amendment 64

Article 9 – paragraph 2 – point f a (new)
(fa) information on the health-related

risks associated with new psychoactive
substances;
Amendment 65

3. For the purpose of the initial report, 3. For the purpose of the initial report,
the Agency shall use information, which is the Agency shall use information, which is
at its disposal. at its disposal, including information
obtained pursuant to Article 8.
Amendment 66

4. Where the Agency considers it 4. Where the Agency considers it

necessary, it shall request the national focal necessary, it shall request the national focal
points to provide additional information on points and the relevant stakeholders,
the new psychoactive substance. The including the scientific community,
national focal points shall provide that healthcare professionals, civil society
information within two weeks of receipt of organisations and affected communities,
the request. to provide additional information on the
new psychoactive substance. The national
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focal points and the relevant stakeholders,
as applicable, shall provide that
information within two weeks of receipt of
the request.
Amendment 67

10a. Where appropriate, the Agency

shall disseminate the initial report to the
relevant stakeholders, including the
scientific community, civil society
organisations and affected communities,
for the purpose of raising awareness.
Amendment 68

(c) an analysis of the health risks (c) an analysis of the health risks
associated with the new psychoactive associated with the new psychoactive
substance, in particular with respect to its substance, in particular with respect to its
acute and chronic toxicity, abuse liability, acute and chronic toxicity, abuse liability,
dependence-producing potential, and dependence-producing potential, and
physical, mental and behavioural effects; physical, mental and behavioural effects
and in relation to drug-related deaths,
including where they are a result of
overdoses;
Amendment 69

(d) an analysis of the social risks (d) an analysis of the social risks
associated with the new psychoactive associated with the new psychoactive
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substance – in particular its impact on substance – in particular its impact on
social functioning, public order and social functioning and social
criminal activities, and the involvement of marginalisation, public order and criminal
criminal groups in the manufacture, activities, and the involvement of criminal
distribution and distribution methods, and groups in the manufacture, distribution and
trafficking of the new psychoactive distribution methods, and trafficking of the
substance; new psychoactive substance;
Amendment 70

(fa) available information on

recommended evidence-based demand
reduction, harm reduction and recovery
responses to minimise the risks and harms
associated with the new psychoactive
substance;
Amendment 71

6a. Where appropriate, the Agency

shall disseminate the risk assessment
report or the combined risk assessment
report to the relevant stakeholders,
including the scientific community, civil
society organisations and affected
communities, for awareness-raising
purposes.
Amendment 72

Article 12 – title
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Threat assessment and preparedness Health and security threat assessment and
preparedness
Amendment 73

1. The Agency shall develop a 1. The Agency shall develop a

strategic general threat assessment strategic evidence-based health and
capability to identify at an early stage new security threat assessment capability to
developments of the drugs phenomenon identify at an early stage new
that have a potential to impact negatively developments of the drugs phenomenon
on public health, safety and security and, that have a potential to impact negatively
through doing so, to help increase the on public health, social matters, safety and
preparedness of the relevant stakeholders security in the Union and, through doing
to respond to new threats in a timely and so, to help increase the preparedness of the
effective manner. relevant stakeholders to respond to new
threats in a timely and effective manner.
Amendment 74

The Agency shall set out a set of criteria to The Agency shall set out a set of objective
evaluate when to trigger a threat criteria to evaluate when to trigger a health
assessment. and security threat assessment.
Amendment 75

A threat assessment may be launched by A health and security threat assessment

the Agency on its own initiative based on may be launched by the Agency on its own
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an internal appraisal of signals arising from initiative based on an internal appraisal of
routine monitoring, research or other signals arising from routine monitoring,
appropriate information sources. A threat research or other appropriate information
assessment may also be launched at the sources. A health and security threat
request of the Commission or of a Member assessment may also be launched at the
State, if the defined criteria are met. request of the Commission or of a Member
State, if the defined criteria are met.
Amendment 76

3. A threat assessment shall consist of 3. A health and security threat

a rapid evaluation of existing information assessment shall consist of a rapid
and, where necessary, the collection of new evaluation of existing information and,
information through the Agency’s where necessary, the collection of new
information networks. The Agency shall information through the Agency’s
develop appropriate scientific rapid information networks. The Agency shall
assessment methods. develop appropriate scientific rapid
assessment methods.
Amendment 77

4. The threat assessment report shall 4. The health and security threat
describe the identified threat, the current assessment report shall describe the
situation based on available evidence, the identified threat, the current situation based
potential outcomes in the event of no on available evidence, the potential
action, and set out options for preparedness outcomes in the event of no action, and set
and response that may be adopted to out options for preparedness and response
mitigate the threat identified. It may also that may be adopted to mitigate and to
contain potential follow-up measures to be respond to the threat identified, including
adopted. The threat assessment report shall evidence-based interventions on demand
be sent to the Commission and the Member reduction, risk and harm reduction and
States, as appropriate. recovery. It may also contain potential
follow-up measures to be adopted. The
health and security threat assessment
report shall be sent to the Commission and
to the Member States. Where appropriate,
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the Agency shall disseminate health and
security threat assessment reports to
scientific community, healthcare
professionals, civil society organisations
and affected communities. The Agency
shall make summaries of those reports
publicly available on its website.
Amendment 78

5. The Agency shall cooperate closely 5. The Agency shall cooperate closely
with other Union decentralised agencies with Member States, other Union bodies,
and bodies, Union and international offices and agencies and international
organisations in carrying out a threat organisations in carrying out a health and
assessment by involving them in the security threat assessment by involving
assessment as appropriate. Where the them in the assessment as appropriate.
potential threat is already subject to an Where the potential threat is already
analysis under another Union mechanism, subject to an analysis under another Union
the Agency shall not carry out a threat mechanism, the Agency shall not carry out
assessment. a health and security threat assessment.
Amendment 79

6. With the agreement of the 6. With the agreement of the

Commission, the Agency shall conduct Commission, the Agency shall conduct
threat assessments on drug related threats health and security threat assessments on
emerging from outside the Union, which drug related threats emerging from outside
have the potential to impact public health, the Union, which have the potential to
safety and security within the Union. impact public health, social matters, safety
and security within the Union.
Amendment 80
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6a. The Agency shall monitor the

evolution of new developments of the
drugs phenomenon as referred to in
paragraph 1 and update the threat
assessments accordingly.
Amendment 81

Article 13 – paragraph 2 – introductory part
2. Member States shall immediately 2. Member States shall immediately

notify the Agency of any information notify the Agency of any information
relating to the appearance of a serious relating to the appearance of a serious
direct or indirect drug-related risk to direct or indirect drug-related risk to
human health, safety or security as well as human health, social aspects, safety or
any information that may be useful for security as well as any information that
coordinating a response whenever they may be useful for coordinating a response
become aware of such information, such whenever they become aware of such
as: information, such as:
Amendment 82

(fa) social and human rights risks;
Amendment 83

Article 13 – paragraph 2 – point f b (new)
(fb) safety and security risks;
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Amendment 84

3. The Agency shall analyse and 3. The Agency shall analyse and
assess the available information and data assess the available information and data
on potential serious risks to human health on potential serious risks to human health
and complement it with any scientific and and complement it with any scientific and
technical information it may have available technical information it may have available
from the early warning system referred to from the early warning system referred to
in Article 8 and other threat assessments in Article 8 and other threat assessments
undertaken in accordance with Article 12, undertaken in accordance with Article 12,
from other Union agencies and bodies and from other Union agencies and bodies and
from international organisations, in from international organisations, in
particular the World Health Organisation. particular the World Health Organisation.
The Agency shall take into account The Agency shall take into account
information obtained through its data information obtained through its data
collection tools and from open source collection tools and from open source
information. information and consultations with
scientific community, academia, civil
society organisations and affected
communities.
Amendment 85

8. The Agency may develop an alert 8. In close cooperation with the

system through which it can directly relevant national authorities, in particular
reach and address people who use or the national focal points, and with
potentially use drugs. relevant stakeholders, including the
scientific community, civil society
organisations and affected communities,
the Agency shall develop an alert system
to make information on identified risks
available, where appropriate, to people
who use or potentially use specific drugs.
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Amendment 86

2. The network shall act primarily as a 2. The network shall act primarily as a
forum for generating data and information forum for generating data and information
exchange on new developments and trends, exchange on new developments and trends,
organising training to enhance the organising training to enhance the
competence of forensic drug experts, competence of forensic drug and
supporting the implementation of quality toxicology experts, supporting the
assurance schemes and supporting the implementation of quality assurance
further harmonisation of data collection schemes and supporting the further
and analytical methods. harmonisation of data collection and
analytical methods.
Amendment 87

5. The network shall closely cooperate 5. The network shall closely cooperate
with existing networks and organisations with existing networks and organisations
active in this area. The network referred to active in this area and shall take into
in Article 31 shall be informed regularly account their work in order to avoid
about the work of the network of forensic overlaps. The network referred to in
and toxicological laboratories. Article 31 shall be informed regularly, and
at least twice a year, about the work of the
network of forensic and toxicological
laboratories.
Amendment 88

Prevention campaigns Evidence-based interventions, best

practices and awareness raising
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Amendment 89

1. The Agency shall design, develop 1. The Agency shall develop and
and promote Union-wide programmes and promote scientific, evidence-based and
campaigns for the prevention of drug- gender-sensitive interventions, which take
related problems and raising awareness of into account the age dimension, and best
the adverse effects of drugs. practices on prevention, risk and harm
reduction, treatment, recovery, care and
rehabilitation and awareness raising of the
adverse effects of drugs.
Amendment 90

2. The programmes and campaigns 2. The interventions, best practices

referred to in paragraph 1 shall be in line and awareness raising referred to in
with the political orientations set out in the paragraph 1 shall be in line with
applicable EU Drugs Strategy and Action international human rights norms and
Plan. They shall address important political orientations set out in the
dimensions of the drug phenomenon, applicable EU Drugs Strategy and Action
shall be targeted to specific groups and be Plan. They shall ensure a balanced
informed by the Agency’s collection of approach to demand reduction, harm
evidence and best practice. reduction and recovery interventions, be
adapted to the national context where
necessary and be implemented at the
national level. They may be targeted to
specific groups.
Amendment 91

3. The Agency shall develop and 3. The Agency shall develop and
promote the implementation of quality promote the implementation of quality
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standards for drug prevention and provide standards for drug prevention, risk and
or support training pursuant to Article 19. harm reduction, treatment, recovery, care
and rehabilitation, update them as
appropriate and provide or support training
pursuant to Article 19.
Amendment 92

4. The Agency shall assist Member 4. The Agency shall assist Member
States in developing national prevention States in developing national interventions
campaigns in the area of its mandate, in the area of its mandate, including in
including the development of prevention relation to the prevention of drug use and
programmes aimed at the reduction of the related impact on health.
drug-related criminality and prevention of
the exploitation of vulnerable individuals
within the drug market.
Amendment 93

2. The Agency shall support the 2. The Agency shall support the
Member States in implementing their Member States in implementing their
national drug strategies, quality standards national drug strategies, quality standards
and innovative best practices and it shall and innovative best practices and it shall
facilitate exchanges of information facilitate exchanges of information
between national decision-makers. between national authorities and experts.
Amendment 94

3. In supporting policy evaluation, the 3. In supporting policy evaluation, the

Agency shall act independently and shall Agency shall act independently and shall
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be guided by its scientific standards. be guided by its scientific standards and an
evidence-based approach.
Amendment 95

The Agency shall, within the scope of its The Agency shall, within the scope of its
mandate, in accordance with the staffing mandate and in coordination with other
and budgetary resources at its disposal Union bodies, offices and agencies:
and in coordination with other Union
decentralised agencies and bodies:
Amendment 96

Article 20 – paragraph 1 – point f
(f) promote the incorporation of data (f) promote the incorporation of all
on drugs and drug addiction gathered in relevant data on drugs covered by this
the Member States or emanating from the Regulation and gathered in the Member
Union into international monitoring and States or emanating from the Union into
drug-control programmes, particularly international monitoring and drug-control
those established by the UN and its programmes, particularly those established
specialised agencies, without prejudice to by the UN and its specialised agencies,
Member States' obligations with regard to without prejudice to Member States'
transmission of information under the obligations with regard to transmission of
provisions of the United Nations Drug information under the provisions of the
Conventions; United Nations Drug Conventions;
Amendment 97

(h) support third countries in (h) support third countries, in

developing their drug policies in particular candidate countries, in
accordance with the principles of the developing their drug policies in
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Union drug strategies, including through accordance with the principles of the
providing support to the independent Union drug strategies, including through
evaluation of their policies. providing support to the independent
evaluation of their policies and provide
support to, and establish dialogue with,
civil society organisations working in the
field of drugs in those countries.
Amendment 98

2. The international cooperation 2. The international cooperation

framework referred to in paragraph 1, point framework referred to in paragraph 1, point
(a), shall take into account the relevant (a), shall seek to further strengthen and
policy documents of the Union and support third countries' efforts to address
consider the developments of the drug drug issues in an evidence-based,
phenomenon, in particular trafficking integrated, balanced and multidisciplinary
routes and drug production areas. It shall manner and in full compliance with
set out the priority countries or regions for international human rights norms. That
cooperation and the key outcomes of the international cooperation framework shall
cooperation. The Agency shall evaluate take into account the relevant policy
and review the international cooperation documents of the Union and consider the
framework regularly. developments of the drug phenomenon. It
shall set out the priority countries or
regions for cooperation and the key
outcomes of the cooperation. It shall take
into account the activities undertaken by
the Member States. The Agency shall
evaluate and review accordingly the
international cooperation framework
regularly.
Amendment 99

The Agency shall transfer, at the request of The Agency shall transfer, at the request of
the Commission and with the approval of the Commission and with the approval of
the Management Board, its know-how and the Management Board, its know-how and
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provide technical assistance to third provide technical assistance to third
countries. countries, in particular candidate
countries, potential candidate countries
and countries covered by the European
Neighbourhood Policy.
Amendment 100

Technical assistance shall focus in Technical assistance shall focus in

particular on setting up or consolidating particular on setting up or consolidating
national focal points, national data national focal points, national data
collection systems and national early collection systems and national early
warning systems, and subsequently assist warning systems and on the promotion of
the creation and strengthening of structural best practices in the field of prevention,
links with the early warning system risk and harm reduction, recovery,
referred to in Article 8 and the network treatment, care and rehabilitation, and
referred to in Article 31. If the third subsequently assist the creation and
country so requests, the Agency may strengthening of structural links with the
provide a certification for these national early warning system referred to in Article
bodies. 8 and the network referred to in Article 31.
If the third country so requests, the Agency
may provide a certification for these
national bodies.
Amendment 101

1. The Agency shall assist the 1. The Agency shall assist the
Commission and the Member States in Commission and the Member States in
identifying key research themes, drawing identifying key research themes, drawing
up and implementing the Union framework up and implementing the Union framework
programmes for research and innovation programmes for research and innovation
activities that are relevant to achieve its activities that are relevant to achieve its
general task set out in Article 4. Where the general and specific tasks set out in
Agency assists the Commission in Articles 4 and 5. In doing so, the Agency
identifying key research themes, drawing shall pay due attention to the gender and
up and implementing a Union framework age dimensions and take into
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programme, the Agency shall not receive consideration intersectionality as a cross-
funding from that programme. cutting principle. Where the Agency
assists the Commission in identifying key
research themes, drawing up and
implementing a Union framework
programme, the Agency shall not receive
funding from that programme.
Amendment 102

2. The Agency shall proactively 2. The Agency shall proactively

monitor and contribute to research and monitor and contribute to research and
innovation activities to achieve its general innovation activities to achieve its general
task set out in Article 4, support related and specific tasks set out in Articles 4 and
activities of Member States, and implement 5, support related activities of Member
its research and innovation activities States, and implement its research and
regarding matters covered by this innovation activities regarding matters
Regulation, including the development, covered by this Regulation, including the
training, testing and validation of development, training, testing and
algorithms for the development of tools. validation of algorithms for the
The Agency shall disseminate the results of development of tools. The Agency shall
that research to the European Parliament, disseminate the results of that research to
to the Member States and to the the European Parliament, to the Member
Commission in accordance with Article 49. States and to the Commission in
accordance with Article 49.
Amendment 103

5. The Agency shall make public 5. The Agency shall ensure full
information on its research projects, compliance with transparency and
including demonstration projects, the conflict of interest rules and make public
cooperation partners involved and the information on its research projects,
project budget. including demonstration projects. Such
information shall include the cooperation
partners involved and the project budget.
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Amendment 104

The members of the Agency’s

administrative and management structure
shall not have any financial or other
interests that could affect their
impartiality. They shall act in the public
interest and carry out their activities in an
independent, impartial and transparent
manner, and shall make an annual
declaration of their financial interests. All
indirect interests which could affect their
impartiality, including in the
pharmaceutical industry, shall be entered
in a register that is held by the Agency
and is accessible to the public upon
request.
Amendment 105

(a) one independent expert particularly (a) two independent experts

knowledgeable in the field of drugs particularly knowledgeable in the field of
designated by the European Parliament, drugs designated by the European
with the right to vote; Parliament, with the right to vote;
Amendment 106

3. Each member of the Management 3. Each member of the Management

Board shall have an alternate. The alternate Board shall have an alternate. The alternate
shall represent the member in her/his shall represent the member in her/his
absence. absence and may attend the meetings of
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the Management Board.
Amendment 107

4. Members of the Management 4. Members of the Management

Board and their alternates shall be Board and their alternates shall be
appointed in light of their knowledge in the appointed in light of their knowledge in the
field of drugs and drug addiction, taking fields set out in Article 4(1), point (a),
into account relevant managerial, taking into account relevant managerial,
administrative and budgetary skills. All administrative and budgetary skills. All
parties represented in the Management parties represented in the Management
Board shall make efforts to limit turnover Board shall make efforts to limit turnover
of their representatives, in order to ensure of their representatives, in order to ensure
continuity of the Management Board's continuity of the Management Board's
work. All parties shall aim to achieve a work. All parties shall aim to achieve a
balanced representation between women gender balanced representation on the
and men on the Management Board. Management Board.
Amendment 108

5. The Management Board may invite, 5. The Management Board may invite,
as observers, representatives of as observers, representatives of
international organisations with which the international organisations with which the
Agency cooperates in accordance with Agency cooperates in accordance with
Article 53. Article 53 and representatives from
relevant civil society organisations.
Amendment 109

6. The term of office for members and 6. The term of office for members and
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their alternates shall be four years. That their alternates shall be four years. That
term may be renewable. term may be renewed once.
Amendment 110

Article 24 – paragraph 1 – point i
(i) adopt rules for the prevention and (i) adopt rules for the prevention and
management of conflicts of interest in management of conflicts of interest in
respect of its members, the members of the respect of its members, the members of the
Executive Board, Scientific Committee, Executive Board, Scientific Committee,
and the European Information Network on and the European Information Network on
Drugs and Drug Addiction (Reitox), as Drugs and Drug Addiction (Reitox), as
well as of seconded national experts and well as of seconded national experts and
other staff not employed by the Authority other staff not employed by the Agency as
as referred to in Article 44, and shall referred to in Article 44, and shall publish
publish annually on its website the annually on its website the declarations of
declarations of interests of the interests of the Management Board
Management Board members; members;
Amendment 111

Article 24 – paragraph 1 – point l
(l) approve the level of minimum co- (l) approve the level of minimum co-
financing referred to in Article 32(7); financing referred to in Article 32(6);
Amendment 112

Article 24 – paragraph 1 – point n
(n) adopt its rules of procedure; (n) adopt and make publicly available
its rules of procedure, including practical
arrangements for the prevention and
management of conflicts of interest,;
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Amendment 113

Article 24 – paragraph 1 – point t
(t) approve the list of experts to be (t) approve the list of experts to be
used to extend the Scientific Committee in used to extend the Scientific Committee in
accordance with Article 10(4); accordance with Article 30(6);
Amendment 114

2. Where necessary, because of 2. Where necessary, because of

urgency, the Executive Board may take urgency, the Executive Board may take
certain provisional decisions instead of the certain provisional decisions instead of the
Management Board, in particular on Management Board, in particular on
administrative management matters, administrative management matters,
including the suspension of the delegation including the suspension of the delegation
of the appointing authority powers and of the appointing authority powers and
budgetary matters. budgetary matters. The conditions for
taking such provisional decisions shall be
set out in the rules of procedure of the
Management Board.
Amendment 115
The Executive Director shall take part in The Executive Director shall take part in
the meetings of the Executive Board, but the meetings of the Executive Board. The
shall not have the right to vote. The Executive Board may invite other
Executive Board may invite other observers to attend its meetings.
observers to attend its meetings.
Amendment 116
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4. The term of office of members of 4. The term of office of members of

the Executive Board shall be four years. the Executive Board shall be four years.
The term of office of members of the That term may be renewed once. The term
Executive Board shall end when their of office of members of the Executive
membership of the Management Board Board shall end when their membership of
ends. the Management Board ends.
Amendment 117

Article 29 – paragraph 5 – point g
(g) proposing to the Commission, after (g) proposing to the Management

consulting the Management Board, the Board, the amount of fees in accordance
amount of fees in accordance with Article with Article 37;
37;
Amendment 118

Article 29 – paragraph 5 – point i
(i) protecting the financial interests of (i) protecting the financial interests of
the Union by applying preventive measures the Union by applying preventive measures
against fraud, corruption and any other against fraud, corruption and any other
illegal activities, without prejudicing the illegal activities, without prejudicing the
investigative competence of OLAF and investigative competence of OLAF and
EPPO, by effective checks and, if EPPO, by effective checks and, if
irregularities are detected, by recovering irregularities are detected, by recovering
amounts wrongly paid and, where amounts wrongly paid and, where
appropriate, by imposing effective, appropriate, by imposing effective,
proportionate and dissuasive proportionate and dissuasive
administrative, including financial administrative, including financial
penalties; penalties and by reporting any criminal
conduct to the EPPO in respect of which
the EPPO could exercise its competence
in accordance with Article 24 of
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Regulation (EU) 2017/1939;
Amendment 119

6. The Executive Director shall 6. The Executive Director may decide

decide whether it is necessary to locate to post one or more liaison officers to the
one or more staff in one or more Member Union institutions and to relevant Union
States for the purpose of carrying out the bodies, offices and agencies for the
Agency's tasks in an efficient and effective purpose of carrying out the Agency's tasks
manner. Before deciding to establish a in an efficient and effective manner. The
local office, the Executive Director shall Executive Director shall obtain the prior
obtain the prior consent of the consent of the Commission and the
Commission, the Management Board and Management Board. The decision shall
the host Member State(s) concerned. The specify the scope of the activities to be
decision shall specify the scope of the carried out by the liaison officers in a
activities to be carried out at the local manner that avoids unnecessary costs and
office in a manner that avoids unnecessary duplication of administrative functions of
costs and duplication of administrative the Agency.
functions of the Agency. A headquarters
agreement with the host Member State(s)
concerned may be concluded.
Amendment 120

1. The Scientific Committee shall 1. The Scientific Committee shall be

consist of at most fifteen scientists composed of no less than ten and no more
appointed by the Management Board in than fifteen scientists appointed by the
view of their scientific excellence and their Management Board in view of their
independence, following the publication of scientific excellence and their
a call for expression of interest in the independence, following the publication of
Official Journal of the European Union. a call for expression of interest in the
The selection procedure shall ensure that Official Journal of the European Union.
the specialist fields of the members of the Before making appointments to the
Scientific Committee cover the most Scientific Committee, the Management
relevant fields linked to the objectives of Board shall consult the competent
the Agency. committee of the European Parliament.
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The selection procedure shall ensure that
the specialist fields of the members of the
Scientific Committee cover the most
relevant fields linked to the objectives of
the Agency. All parties involved in the
selection and appointment of scientists to
the Scientific Committee shall aim to
achieve gender balance in that committee.
Amendment 121

(a) coordinate at national level the (a) coordinate at national level the
activities related to drug-related data activities related to drug-related data
collection and monitoring; collection and monitoring, and discussions
on relevant indicators;
Amendment 122

(d) collect, analyse and interpret in an (d) collect, analyse and interpret in an
objective manner at national level all objective manner at national level all
relevant information on drugs, drug relevant information on drugs, drug
addiction, drug markets, drug supply and addiction, drug markets, drug supply and
crime-related issues as well as on policies crime-related issues as well as on policies
and solutions applied, needed for the and solutions applied, needed for the
Agency to comply with Article 6. In doing Agency to comply with Article 6. In doing
so, the national focal point shall bring so, the national focal point shall bring
together experience from different sectors together experience from different sectors
– in particular health, justice and law – in particular health, justice and law
enforcement – and cooperate with experts enforcement – and shall cooperate with
and national organisations active in the experts, national organisations, the
field of drugs policy; scientific community, civil society
organisations and other relevant
stakeholders active in the field of drugs
policy;
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Amendment 123

(h) provide the Agency with (h) provide the Agency with
information on new trends in the use of information on new trends and challenges
existing psychoactive substances or new in the use of existing psychoactive
combinations of psychoactive substances, substances or new combinations of
which pose a potential risk to public health psychoactive substances, which pose a
as well as information on possible potential risk to public health as well as
measures related to public health; information on possible measures related to
public health;
Amendment 124

2a. The national focal points shall

monitor, analyse and interpret relevant
information in the fields set out in Article
4(1), point (a), and shall provide
information on the policies and solutions
adopted.
Amendment 125

3. The national focal point shall have 3. The national focal point shall
the right to collect from other national cooperate, as necessary, with relevant
authorities, bodies, agencies and national and regional authorities, bodies,
organisations all the information it needs to agencies and organisations for the
carry out its tasks in accordance with collection of all the information it needs to
paragraph 2. The national focal point shall carry out its tasks in accordance with
maintain an extensive network of national paragraph 2. The national focal point shall
partners and data providers for the maintain an extensive network of national
collection of such information. partners and data providers for the
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collection of such information.
Amendment 126

3a. When collecting data pursuant to

this Article, the national focal points shall
ensure, where possible, that the data
collected are disaggregated by gender.
The national focal points shall consider
the gender-sensitive aspects of drugs
policy when collecting and presenting
data pursuant to this Article. The national
focal points shall not transmit any data
which would make it possible to identify
individuals or small groups of individuals.
The national focal points shall not
transmit information relating to specific
individuals.
Amendment 127

1. By 15 December of each year, the 1. By 15 December of each year, the

Management Board shall adopt a draft Management Board shall adopt a draft
single programming document containing single programming document containing
multi-annual and annual programming as multi-annual and annual programming as
well as all the documents listed in Article well as all the documents listed in Article
32 of Commission Delegated Regulation 32 of Commission Delegated Regulation
(EU) 2019/71522, based on a draft put (EU) 2019/71522, based on a draft put
forward by the Executive Director, after forward by the Executive Director, after
consulting the Scientific Committee, taking consulting the Scientific Committee, taking
into account the opinion of the into account the opinion of the
Commission, and in relation to multiannual Commission, and in relation to multiannual
programming after consulting the programming after consulting the
European Parliament. It shall forward it to European Parliament. Where the
the European Parliament, the Council and Management Board decides not to take
the Commission by 31 January of the into account elements of the opinion of
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following year. the Commission or of the Scientific
Committee, it shall provide a thorough
justification. The obligation to provide a
thorough justification shall also apply to
the elements raised by the European
Parliament when it is consulted. The
Management Board shall forward the
single programming document to the
European Parliament, the Council and the
Commission by 31 January of the
following year.
The Single Programming Document shall The Single Programming Document shall
become definitive after final adoption of become definitive after final adoption of
the general budget and if necessary shall be the general budget and if necessary shall be
adjusted accordingly. adjusted accordingly.
__________________ __________________
22 Commission Delegated Regulation (EU) 22 Commission Delegated Regulation (EU)
2019/715 of 18 December 2018 on the 2019/715 of 18 December 2018 on the
framework financial regulation for the framework financial regulation for the
bodies set up under the TFEU and Euratom bodies set up under the TFEU and Euratom
Treaty and referred to in Article 70 of Treaty and referred to in Article 70 of
Regulation (EU, Euratom) 2018/1046 of Regulation (EU, Euratom) 2018/1046 of
the European Parliament and of the the European Parliament and of the
Council, (OJ L 122, 10.5.2019, p. 1). Council, (OJ L 122, 10.5.2019, p. 1).
Amendment 128

Annual or multi-annual programming shall Annual or multi-annual programming shall

include the information about the include the information about the
implementation of the international implementation of the international
cooperation framework referred to in cooperation framework referred to in
Article 20 and the actions linked to this Article 20 and the actions linked to this
strategy. strategy. It shall also include the Agency’s
planned research and innovation
activities referred to in Article 21.
Amendment 129

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2. The Agency's budget shall be 2. The Agency's budget shall be

balanced in terms of revenue and of balanced in terms of revenue and of
expenditure. expenditure. The Agency shall be awarded
an adequate budget to ensure sufficient
staff and equipment in order to allow it to
achieve the objectives and tasks set out in
this Regulation.
Amendment 130

(c) the fees paid for services rendered (c) the fees paid for services rendered
in accordance with Article 37; and in accordance with Article 37;
Amendment 131

(d) any financial contributions from the (d) any financial contributions from the
organisations and bodies and third organisations and bodies and third
countries referred to in Articles 53 and 54, countries referred to in Articles 53 and 54,
respectively. respectively; and.
Amendment 132

Article 36 – paragraph 3 – point d a (new)
(da) Union funding under indirect

management or in the form of ad hoc
grants in accordance with the financial
rules applicable to the Agency and with
the provisions of the relevant instruments
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supporting the policies of the Union.
Amendment 133

The amount and origin of any revenue as

referred to in points (b), (c) (d) and (da) of
the first subparagraph of this paragraph
shall be included in the annual accounts
of the Agency and clearly detailed in the
annual report on the Agency's budgetary
and financial management referred to in
Article 40(2).
Amendment 134

1. The Agency may charge fees for 1. The Agency may charge fees for
the following: the following services where they are
clearly separated from the tasks of the
Agency laid down in this Regulation:
Amendment 135

(a) training programmes; (a) training programmes other than

those referred to in Article 19;
Amendment 136

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(b) certain support activities for (b) necessary and duly justified
Member States that have not been support activities for Member States other
identified as a priority but could be than those provided for in this Regulation
beneficially conducted if supported by that have not been identified as a priority
national resources; but could be beneficially conducted if
supported by national resources;
Amendment 137

(d) certification of national bodies set (d) certification of national bodies set
up in third countries pursuant to Article up in third countries, in particular
20(3); candidate countries, pursuant to Article
20(3);
Amendment 138

Article 37 – paragraph 1 – point e
(e) other services falling within its (e) other customised services falling
mandate and rendered at the request of a within its mandate and rendered at the
participating country which require the request of a participating country which
investment of resources in the support of require the investment of additional
national activities. resources in the support of national
activities.
Amendment 139

2. At the proposal of the Executive 2. At the proposal of the Executive

Director, the Management Board of the Director, the Management Board of the
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Agency shall set the amount of the fees and Agency shall set the amount of the fees and
the way in which they are paid. the way in which they are paid in a
transparent manner and after having
consulted the Commission. Those fees
shall cover only the human and financial
costs associated with the provision of the
services set out in paragraph 1.
Amendment 140

4. Fees should be set at a level such as 4. Fees should be set at a level such as
to avoid a deficit or a significant to avoid a deficit or a significant
accumulation of surplus in the budget. accumulation of surplus in the budget.
Should a significant positive balance in the Should a significant positive balance in the
budget, resulting from the provision of the budget, resulting from the provision of the
services covered by fees, become recurrent, services covered by fees, become recurrent,
a revision of the level of the fees, or of the a revision of the level of the fees, or of the
Union contribution, shall become Union contribution, shall become
mandatory. In case a significant negative mandatory. In case a significant negative
balance results from the provision of the balance results from the provision of the
services covered by fees, a revision of the services covered by fees, the level of the
level of the fees shall become mandatory. fees shall be revised.
Amendment 141

4a. An annual external audit shall be

undertaken with regard to the fees
collected by the Agency. The Agency shall
transmit the results of such audits to the
European Parliament without delay.
Amendment 142

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9. For any building project likely to 9. For any building project likely to
have significant implications for the budget have significant implications for the budget
of the Agency, the provisions of Delegated of the Agency, the provisions of
Regulation (EU) 2019/71566 apply. Commission Delegated Regulation (EU)
2019/71566 apply.
_________________ _________________
66 OJ L 122, 10.5.2019, p. 1. 66 OJ L 122, 10.5.2019, p. 1.
Amendment 143

Article 43
Article 43 Article 28a

Executive Director Executive Director
1. The Executive Director shall be 1. The Executive Director shall be
engaged as a temporary agent of the engaged as a temporary agent of the
Agency under Article 2, point (a), of the Agency under Article 2, point (a), of the
Conditions of Employment of Other Conditions of Employment of Other
Servants. Servants. The Executive Director shall be
responsible for the day-to-day
management of the Agency.
2. The Executive Director shall be 2. The Executive Director shall be
appointed by the Management Board, from appointed by the Management Board, from
a list of candidates proposed by the a list of candidates proposed by the
Commission, following an open and Commission, following an open and
transparent selection procedure. transparent selection procedure. Before
appointment to a first term, the candidate
selected by the Management Board for the
post of Executive Director shall be invited,
without delay, to make a statement before
the competent committee of the European
Parliament and answer questions put by
Members of that committee. After hearing
the statement and the responses, the
European Parliament may adopt an
opinion on the matter. The Management
Board shall take due account of that
opinion when appointing the Executive
Director. Where the European Parliament
is of the opinion that no candidate
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sufficiently fulfils the requirements for
the post, the open selection procedure
shall recommence.
3. For the purpose of concluding the 3. For the purpose of concluding the
contract with the Executive Director, the contract with the Executive Director, the
Agency shall be represented by the Agency shall be represented by the
Chairperson of the Management Board. Chairperson of the Management Board.
4. The term of office of the Executive 4. The term of office of the Executive
Director shall be five years. By the end of Director shall be five years. By the end of
that period, the Commission shall that period, the Commission shall
undertake an assessment that takes into undertake an assessment that takes into
account an evaluation of the Executive account an evaluation of the Executive
Director's performance and the Agency's Director's performance and the Agency's
future tasks and challenges. future tasks and challenges.
5. The Management Board, acting on 5. The Management Board, acting on
a proposal from the Commission that takes a proposal from the Commission that takes
into account the assessment referred to in into account the assessment referred to in
paragraph 4, may extend the term of office paragraph 4, may extend the term of office
of the Executive Director once, for no of the Executive Director once, for no
more than five years. more than five years. Before the
Management Board takes its decision to
extend the term of office, the Executive
Director may be invited to appear before
the competent committee of the European
Parliament and answer questions put by
members of that committee.
6. An Executive Director whose term 6. An Executive Director whose term
of office has been extended may not of office has been extended may not
participate in another selection procedure participate in another selection procedure
for the same post at the end of the overall for the same post at the end of the overall
period. period.
7. The Executive Director may be 7. The Executive Director may be
removed from office only upon a decision removed from office only upon a decision
of the Management Board acting on a of the Management Board acting on a
proposal from the Commission. proposal from the Commission. The
European Parliament and the Council
shall be informed of the reasons for such
removal.
8. The Management Board shall 8. The Management Board shall reach
reach decisions on appointment, extension decisions on appointment, extension of the
of the term of office or removal from office term of office or removal from office of the
of the Executive Director on the basis of a Executive Director on the basis of a two-
two-thirds majority of its members with thirds majority of its members with voting
voting rights. rights.
8a. Where called upon by the
European Parliament or by the Council to
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attend a hearing on any matter linked to
the Agency's activities, the Executive
Director shall attend.
(Article 43 in its entirety is placed after Article 28.)
Amendment 144

1. No later than [OP please insert the 1. No later than [OP please insert the
date = five years after the date referred to date = five years after the date referred to
in Article 63], and every 5 years thereafter, in Article 63], and every 5 years thereafter,
the Commission shall assess the Agency’s the Commission shall assess the Agency’s
performance in relation to its objectives, performance in relation to its objectives,
mandate, tasks and location in accordance mandate, tasks and location in accordance
with Commission guidelines. The with Commission guidelines. The
evaluation shall, in particular, address the evaluation shall, in particular, address the
possible need to modify the mandate of the possible need to modify the mandate of the
Agency, and the financial implications of Agency, and the financial implications of
any such modification. any such modification. It shall pay
particular attention to the changes to the
Agency's mandate and tasks introduced
by this Regulation.
Amendment 145

3a. The Agency shall publish working

arrangements entered into pursuant to
this Article on its website.
Amendment 146

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Consultation of civil society organisations Cooperation with civil society

organisations
Amendment 147

The Agency shall maintain a close The Agency shall maintain structured
dialogue with relevant civil society cooperation with relevant non-
organisations active in the fields covered governmental and civil society
by this Regulation at national, Union or organisations, and affected communities
international level. within Europe and active in the fields
covered by this Regulation, to ensure the
regular and extensive consultation and
exchange of information with civil
society. To that end, the Agency shall
appoint a person within the Agency
responsible for managing that
cooperation, under the authority of the
Executive Director.
Amendment 148

The cooperation referred to in the first

paragraph shall be open to all interested
and qualified stakeholders based in
participating countries and shall include
the Civil Society Forum on Drugs. To that
end, the Commission and the Member
States shall make available to the Civil
Society Forum on Drugs appropriate and
sustainable financial means and
reinforced administrative support.
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Amendment 149

Article 55 – paragraph 1 b (new)
The Agency shall publish the names and

the declared conflict of interests of
stakeholders involved in its work on its
website.
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EXPLANATORY STATEMENT
The Rapporteur hereby presents the underlying reasons to the amendments introduced in the
current draft report on the proposal for a Regulation of the European Parliament and of the
Council on the European Union Drugs Agency 2022/0009(COD), proposed by the European
Commission on 12 January 2022, and aimed at succeeding to Regulation (EC) No 1920/2006.
The European Commission’s proposal aims at strengthening the mandate of the European
Monitoring Centre for Drugs and Drug Addiction, transforming it into the European Union
Drugs Agency. This contemplates a revision of its organization and capabilities to properly
equip the soon-to-be agency with the right tools to be able to, more efficiently and more timely,
identify and address current and future challenges related to drugs in the EU.
The Rapporteur welcomes the overall objective of the expansion, considering that increased
resources and enhanced powers are essential to allow the agency to continue providing the
European Union and its member states with factual, objective, reliable and comparable
information at European level on drugs and drug addiction and their consequences.
In particular, the Rapporteur highlights the importance of the agency being provided with a
strengthened monitoring and analysis capacity system, but also with a faster and efficient early
warning system aimed at reacting to emerging threats and trends. Coupled with this stronger
capacity of response, the Rapporteur welcomes the additional budget allocation of EUR 63
Million and 40 additional posts that will make the revised mandate a reality. Of equal
importance to the Rapporteur is the possibility for the agency to engage more actively in
international cooperation role, while affirming the external dimension of the Union’s drugs
policy and the leadership role of the Union in this field at multilateral level.
However, the Rapporteur regrets the excessive focus that the proposal places on law
enforcement, supply, security and control-related issues in detriment of harm reduction and
health-related issues giving, therefore, raise to a certain imbalance throughout the text. For this
reason, a number of amendments proposed by the Rapporteur aim at making sure that the health,
social and human rights dimension continues to be given adequate emphasis in the Agency’s
mandate.
Moreover, the Rapporteur sees with concern that the budgetary impact of the additional
financial resources for the agency will be offset during the current Multiannual Financial
Framework through a compensatory reduction from programmed spending under Heading 4:
Migration and Border Management.
The Rapporteur also looks with apprehension to the proposed reduction of the presence of
European Parliament representatives on the EMCDDA Management Board and takes the view
that the experts designated by the EP should continue to be two as it is the case today
Last but not least, the Rapporteur strongly disapproves the lack of a comprehensive civil society
involvement, able to meaningfully take part in the work developed by the Agency, and insists
that relevant provisions should be included in the regulation for this purpose.
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The Rapporteur takes good note of the general approach adopted by the French Presidency of
the Council, considering it, in many aspects, a significant improvement to the European
Commission’s proposal. Therefore, the Rapporteur gets inspiration and adopts some of the
solutions that the text provides. Furthermore, the Rapporteur has proposed a large number of
amendments as a result of all the meetings and consultations held with the shadows of all
political groups involved, as well as following exchanges with the BUDG Rapporteur,
responsible for the respective opinion, the European Commission, the French Presidency of the
Council, the EMCDDA Director, the two European Parliament representatives on the
EMCDDA Management Board, and the representatives from civil society organizations. After
such extensive and encompassing work, the rapporteur expects that these proposals can form a
good and solid basis for swift agreement, first in the European Parliament, and later on in the
interinstitutional negotiations.
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30.8.2022
OPINION OF THE COMMITTEE ON BUDGETS
for the Committee on Civil Liberties, Justice and Home Affairs
on the proposal for a regulation of the European Parliament and of the Council on the
European Union Drugs Agency
(COM(2022)0018 – C9-0010/2022 – 2022/0009(COD))
Rapporteur for opinion: Niclas Herbst
SHORT JUSTIFICATION
While the COVID-19 pandemic devastated businesses and workers across the European Union,
drug markets showed remarkable resilience. Those producing and trafficking illegal drugs
continued to profit from the damage they do to people’s lives, particularly those in marginalised
groups. Drugs sellers have embraced new technologies, with use of encrypted messaging
services, social media and e-commerce, very often on the darknet. At the same time, people
using drugs are increasingly experimenting with poly-substance use, consuming more than one
drug or substance at the same time. The drugs phenomenon is therefore exhibiting increasing
complexity and moving with increasing speed.
The 2021-2025 EU Drugs Strategy1 and the 2021-2025 EU Drugs Action Plan2 demand greater
action at EU level to tackle the evolving drugs challenges and call on the Commission to
propose an expanded mandate for the European Monitoring Centre for Drugs and Drug
Addiction (EMCDDA) to take into account the evolving situation. The evaluation conducted
by the Commission of the EMCDDA’s work3 underlines the valuable work done by the agency,
but also highlights gaps in its mandate. This proposal seeks to fill these gaps and ensure that
the revamped agency’s mandate is fit for purpose by extending it to cover poly-substance use
and better monitoring and threat assessment capabilities. The proposal also beefs up data and
information gathering, enables the agency to develop EU-wide prevention and awareness-
raising campaigns and provides that it can issue alerts when a new dangerous substance appears
on the market. Finally, since the existing EMCDDA regulation dates from 2006, the proposal
brings the provisions into line with the Joint Statement of the European Parliament, the Council
and the Commission on decentralised agencies of 19 July 2012 and the Common Approach4.
Your Rapporteur welcomes the central aims of the proposal and is convinced that an expanded
mandate for the drugs agency will enable more effective action both to disrupt the illicit drugs
market and to protect European citizens from the dangers of drugs.
1 OJ C 1021, 24.3.2021, p.1

2 OJ C 272, 8.7.2021, p.2
3 COM(2019) 228
4 https://data.consilium.europa.eu/doc/document/ST-11450-2012-INIT/en/pdf
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Nevertheless, in line with his approach to decentralised agency files, he considers that the policy
substance of the proposal should be dealt with by the lead committee. As such, the draft opinion
focuses on those areas where the Committee on Budgets can add value, therefore in particular
on the financial provisions and governance rules.
Budgetary impact and financial provisions
According to the Commission proposal, the EU Drugs Agency will need an additional
EUR 63 million between 2024 and 2027 compared to the MFF programming and its total staff
will increase from 111 in the 2022 budget to 145 by 2027. It is of course imperative that the
agency has sufficient financial and human resources to execute its reinforced mandate and it
will be important to ensure that any further tasks and responsibilities that may be agreed in the
final legislation are properly funded.
Your Rapporteur strongly opposes the Commission’s intention of financing the additional
resources for the agency in heading 5 through a compensatory reduction of the Border
Management and Visa Instrument (BMVI) programme in heading 4. The BMVI benefits from
a EUR 1 billion top-up through a programme-specific adjustment agreed during the MFF
negotiations, meaning there was a clear political will to reinforce the instrument precisely to
deal with border management and not to provide a pot of money to reinforce agencies. The
importance of this top-up has been borne out by the Ukraine crisis and the proposed increase
for the BMVI in Drafting Amending Budget 3/2022. Moreover, the additional tasks assigned
to the Drugs Agency under the proposal are not tasks that would otherwise be carried out under
the BMVI.
Fees
The proposal introduces the possibility for the agency to charge fees for ‘non-core services’ as
a means of bringing in additional revenue. Your Rapporteur’s starting point is that agencies
should have the budget required to perform the tasks assigned to them by the legislator. While
fee-based financing models are entirely legitimate where fees are levied for core services (e.g.
the fees-based model employed by the European Medicines Agency or the European Banking
Authority), it is not clear why the Drugs Agency should charge fees for services that the
legislator has not considered it necessary to provide in the first place.
Moreover, the provisions governing fees lack clarity, with the nature of the services nebulously
defined and the Management Board enjoying considerable leeway to determine the nature and
level of fees, with no parliamentary control. As such, your Rapporteur introduces amendments
to delete the provisions enabling the agency to levy fees. Greater clarity in terms of the purpose
and nature of the fees and clear provisions on parliamentary scrutiny would be required to
consider the introduction of such fees.
Governance, parliamentary scrutiny and transparency
Your Rapporteur introduces a number of more technical amendments to ensure that provisions
in the regulation comply fully with the principles in the Common Approach. The majority of
these amendments seek to enhance parliamentary scrutiny and accountability, for example with
respect to the appointment of the Executive Director, and to ensure transparency in budgetary
reporting.
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AMENDMENTS
The Committee on Budgets calls on the Committee on Civil Liberties, Justice and Home
Affairs, as the committee responsible, to take into account the following amendments:
Amendment 1

Recital 14
(14) The drug phenomenon is becoming (14) The drug phenomenon is becoming
more and more technology-enabled, as was more and more technology-enabled, as was
shown again during the COVID-19 shown again during the COVID-19
pandemic where a greater adoption of new pandemic where a greater adoption of new
technologies to facilitate drug distribution technologies to facilitate drug distribution
has been observed. It is estimated that has been observed. It is estimated that
about two-thirds of the offers on darknet about two-thirds of the offers on darknet
markets are drug-related. Drug trading is markets are drug-related. Drug trading is
using different platforms, including social using different platforms, including social
media networks and mobile applications. media networks and mobile applications.
This development is mirrored in responses This development is mirrored in responses
to the drug phenomenon, with an increased to the drug phenomenon, with an increased
use of mobile applications and e-health use of mobile applications and e-health
interventions. The Agency, together with interventions. The Agency, together with
other relevant Union agencies and avoiding other relevant Union agencies and avoiding
duplication of efforts, should monitor such duplication of efforts, should monitor such
developments as part of its holistic developments as part of its holistic
approach to the drug phenomenon. approach to the drug phenomenon. Taking
into account technological advancements
and more sophisticated encryption
methods, the Agency should stress the
importance of adopting adequate digital
solutions by Member States, in order to
tackle the drug phenomenon in a
coordinated, coherent and interoperable
manner.
Amendment 2

Recital 25
(25) The responsibilities of the Agency (25) International cooperation should be

in the area of international cooperation a core task of the Agency, with
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should be defined in more clear terms in responsibilities defined in clearer terms, in
order to allow it to fully engage in such order to allow it to fully engage in such
activities and respond to requests from activities and respond to requests from
third countries and bodies. The Agency third countries and bodies. The Agency
should be able to contribute to the should be able to contribute to the
development and implementation of the development and implementation of the
external dimension of the Union’s drugs external dimension of the Union’s drugs
policy and the leadership role of the Union policy and the leadership role of the Union
at multilateral level as a means to ensure at multilateral level as a means to ensure
the efficient and coherent implementation the efficient and coherent implementation
of the Union drug policies internally and at of the Union drug policies internally and at
international level. In order that the international level. Work in this area
Agency can allocate adequate levels of should be based on an international
resources to this task, the work on cooperation framework of the Agency,
international cooperation should be part which should be in line with the Union
of the core tasks of the Agency. It should priorities on international cooperation and
be based on an international cooperation should be revised on a regular basis to
framework of the Agency, which should be ensure that it adequately reflects
in line with the Union priorities on international developments.
international cooperation and should be
revised on a regular basis to ensure that it
adequately reflects international
developments.
Amendment 3

Recital 26
(26) In order to help Union funding for (26) In order to help Union funding for
security research to develop its full security research to develop its full
potential and address the needs of drugs potential and address the needs of drugs
policy, the Agency should assist the policy, the Agency should assist the
Commission in identifying key research Commission in identifying key research
themes, drawing up and implementing the themes and in drawing up and
Union framework programmes for research implementing the Union framework
and innovation that are relevant to the programmes for research and innovation
Agency’s objectives. Where the Agency that are relevant to the Agency’s
assists the Commission in identifying key objectives. Where the Agency assists the
research themes, drawing up and Commission in identifying key research
implementing a Union framework themes and in drawing up and
programme, it should not receive funding implementing a Union framework
from that programme in order to avoid a programme, it should not receive funding
potential conflict of interest. Finally, the from that programme and take all
Agency should participate in Union-wide necessary measures to avoid conflicts of
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initiatives addressing research and interest. Finally, the Agency should
innovation to ensure that technologies participate in Union-wide initiatives
necessary for its activities are developed addressing research and innovation to
and available for use. ensure that technologies necessary for its
activities are developed and available for
use. Planned research and innovation
activities should be set out in the single
programming document containing the
Agency’s multiannual and annual work
programme.
Amendment 4

Recital 27
(27) The Management Board should be (27) The Agency should be organised
assisted by an Executive Board to prepare as follows. A Management Board,
its decisions. The Agency should be composed of representatives from the
headed by an Executive Director. A Member States and the Commission and
Scientific Committee should continue an expert appointed by the European
assisting the Management Board and the Parliament, should be responsible for
Executive Director with regard to relevant overseeing the work of the Agency. The
scientific matters. Member States, the Commission and the
European Parliament should respect the
principle of gender balance in their
appointments and particularly regarding
the overall composition of the
Management Board. The Management
Board should be assisted by an Executive
Board, which should also be able to take
specific decisions in clearly defined cases.
The Agency should be headed by an
Executive Director, who should be
responsible for the day-to-day
management of the Agency. A Scientific
Committee should assist the Management
Board and the Executive Director with
regard to relevant scientific matters
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Amendment 5

Recital 27 a (new)
(27a) The Executive Director should be

appointed by the Management Board
based on a shortlist drawn up by the
Commission and having obtained the
consent of the European Parliament. The
Executive Director should present the
annual report of the Agency to the
European Parliament and to the Council.
Furthermore, the European Parliament
and the Council should be able to invite
the Executive Director to report on the
performance of his or her duties.
Amendment 6

Recital 27 b (new)
(27b) In order to ensure the independent

functioning and integrity of the Agency,
the Management Board should adopt
practical arrangements for the prevention
and management of conflicts of interest,
giving due consideration to the
recommendations of the European
Ombudsman. Those arrangements should
ensure in particular that senior
representatives of the Agency do not
undermine its integrity during or after
their term of office.
Amendment 7

Recital 29
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(29) The Agency should be properly (29) The Agency should be provided
resourced to carry out its tasks and granted with the necessary human and financial
an autonomous budget. It should be mainly resources to fulfil the objectives, tasks and
financed by a contribution from the general responsibilities assigned to it under this
budget of the Union. The Union budgetary regulation. It should be granted an
procedure should be applicable as far as the autonomous budget. It should be mainly
Union contribution and any other subsidies financed by a contribution from the general
chargeable to the general budget of the budget of the Union, with the necessary
Union are concerned. The auditing of appropriations drawn exclusively from
accounts should be undertaken by the unallocated margins under the relevant
Court of Auditors of the European Union. heading of the multiannual financial
framework and/or through the
mobilisation of the relevant special
instruments. The Union budgetary
procedure should be applicable as far as the
Union contribution and any other subsidies
chargeable to the general budget of the
Union are concerned. The auditing of
accounts should be undertaken by the
Court of Auditors of the European Union.
Amendment 8

Recital 30
(30) Fees improve the funding of an deleted

agency and may be considered for specific
issues that can be clearly separated from
the core tasks of the agency. Any fees
levied by the Agency should cover its costs
for providing the respective services.
Amendment 9

Recital 31
(31) The Executive Director should deleted

present the annual report of the Agency to
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the European Parliament and to the
Council. Furthermore, the European
Parliament and the Council should be
able to invite the Executive Director to
report on the performance of her or his
duties.
Amendment 10

Recital 35
(35) The Agency should cooperate (35) The Agency should cooperate
closely with relevant international closely with relevant international
organisations, other governmental and non- organisations, other governmental and non-
governmental bodies and relevant technical governmental bodies and relevant technical
bodies from inside and outside the Union bodies from inside and outside the Union
in the implementation of its work in the implementation of its work
programme, notably to avoid duplication of programme, notably to avoid duplication of
work and to ensure access to all data and work and to ensure access to all data and
tools needed for carrying out its mandate. tools needed for carrying out its mandate.
In that regard, it should be possible for
the Agency to engage with civil society
organisations and other relevant
stakeholders in order to raise awareness
at Union level.
Amendment 11

1. The Agency shall assist the 1. The Agency shall assist the
Commission and the Member States in Commission and the Member States in
identifying key research themes, drawing identifying key research themes and in
up and implementing the Union framework drawing up and implementing the Union
programmes for research and innovation framework programmes for research and
activities that are relevant to achieve its innovation activities that are relevant to
general task set out in Article 4. Where the achieve its general and specific tasks set
Agency assists the Commission in out in Articles 4 and 5. Where the Agency
identifying key research themes, drawing assists the Commission in identifying key
up and implementing a Union framework research themes, drawing up and
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programme, the Agency shall not receive implementing a Union framework
funding from that programme. programme, the Agency shall not receive
funding from that programme. The Agency
shall take all necessary measures to avoid
conflicts of interest.
Amendment 12

2. The Agency shall proactively 2. The Agency shall proactively

monitor and contribute to research and monitor and contribute to research and
innovation activities to achieve its general innovation activities to achieve its general
task set out in Article 4, support related and specific tasks set out in Articles 4 and
activities of Member States, and implement 5, support related activities of Member
its research and innovation activities States, and implement its research and
regarding matters covered by this innovation activities regarding matters
Regulation, including the development, covered by this Regulation, including the
training, testing and validation of development, training, testing and
algorithms for the development of tools. validation of algorithms for the
The Agency shall disseminate the results of development of tools. The Agency shall
that research to the European Parliament, disseminate the results of that research to
to the Member States and to the the European Parliament, to the Member
Commission in accordance with Article 49. States and to the Commission in
accordance with Article 49.
Amendment 13

6. The term of office for members and 6. The term of office for members and
their alternates shall be four years. That their alternates shall be four years. That
term may be renewable. term may be renewed once.
Amendment 14

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(b) adopt the draft single programming (b) adopt the draft single programming
document referred to in Article 35 before document referred to in Article 35 by a
its submission to the Commission for its majority of two-thirds of members entitled
opinion; to vote in accordance with Article 23;
Amendment 15

(c) adopt, having requested the deleted

opinion of the Commission, the Agency's
single programming document by a
majority of two-thirds of members entitled
to vote in accordance with Article 23;
Amendment 16

Article 24 – paragraph 1 – point n
(n) adopt its rules of procedure; (n) adopt its rules of procedure,
including practical arrangements for the
prevention and management of conflicts
of interest;
Amendment 17

Article 24 – paragraph 1 – point t
(t) approve the list of experts to be (t) approve the list of experts to be
used to extend the Scientific Committee in used to extend the Scientific Committee in
accordance with Article 10(4); accordance with Article 30(6);
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Amendment 18

The Executive Director shall take part in The Executive Director shall take part in
the meetings of the Executive Board, but the meetings of the Executive Board. The
shall not have the right to vote. The Executive Board may invite other
Executive Board may invite other observers to attend its meetings.
observers to attend its meetings.
Amendment 19

4. The term of office of members of 4. The term of office of members of

the Executive Board shall be four years. the Executive Board shall be four years
The term of office of members of the and may be renewed once. The term of
Executive Board shall end when their office of members of the Executive Board
membership of the Management Board shall end when their membership of the
ends. Management Board ends.
Amendment 20

Article 28 a (new)
Article 28a
Executive Director
1. The Executive Director shall be
engaged as a temporary agent of the
Agency under Article 2, point (a), of the
Conditions of Employment of Other
Servants. He/she shall be responsible for
the day-to-day management of the
Agency.
appointed by the Management Board in
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accordance with the following procedure:
(a) on the basis of a shortlist drawn up
by the Commission after a call for
candidates and a transparent selection
procedure, applicants will be asked to
address the competent committee of the
and to reply to questions;
(b) the European Parliament and the
Council will then give their opinions and
state their preferences;
(c) the Management Board will
appoint the Executive Director taking
those opinions into account.
3. For the purpose of the concluding
the contract with the Executive Director,
the Agency shall be represented by the
Chairperson of the Management Board.
4. The term of office of the Executive
Director shall be five years. By the end of
that period, the Commission shall
undertake an assessment that takes into
account an evaluation of the Executive
Director's performance and the Agency's
future tasks and challenges.
5. The Management Board, acting on
a proposal from the Commission that
takes into account the assessment referred
to in paragraph 4, may extend the term of
office of the Executive Director once, for
no more than five years. The
Management Board shall inform the
about its intention to extend the Executive
Director's mandate. Before the
Management Board takes its decision to
extend the mandate, the Executive
Director may be asked to make a
declaration before the competent
committee of the European Parliament
and answer questions.
6. An Executive Director whose term
of office has been extended may not
participate in another selection procedure
for the same post at the end of the overall
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period.
7. The Executive Director may be
removed from office only upon a decision
of the Management Board acting on a
proposal from the Commission. The
shall be informed of the reasons.
8. The Management Board shall
reach decisions on appointment,
extension of the term of office or removal
from office of the Executive Director on
the basis of a two-thirds majority of its
members with voting rights.
called upon at any time by the European
Parliament or by the Council to attend a
hearing on any matter linked to the
Agency's activities.
Amendment 21

Article 29 – paragraph 5 – point g
(g) proposing to the Commission, after deleted

consulting the Management Board, the
amount of fees in accordance with Article
37;
Amendment 22

6. The Executive Director shall decide 6. The Executive Director shall decide
whether it is necessary to locate one or whether it is necessary to locate one or
more staff in one or more Member States more staff in one or more Member States
for the purpose of carrying out the for the purpose of carrying out the
Agency's tasks in an efficient and effective Agency's tasks in an efficient and effective
manner. Before deciding to establish a manner. Before deciding to establish a
local office, the Executive Director shall local office, the Executive Director shall
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obtain the prior consent of the obtain the prior consent of the
Commission, the Management Board and Commission, the Management Board and
the host Member State(s) concerned. The the host Member State(s) concerned. The
decision shall specify the scope of the decision shall specify the scope of the
activities to be carried out at the local activities to be carried out at the local
office in a manner that avoids unnecessary office in a manner that avoids unnecessary
costs and duplication of administrative costs and duplication of administrative
functions of the Agency. A headquarters functions of the Agency. A headquarters
agreement with the host Member State(s) agreement with the host Member State(s)
concerned may be concluded. concerned shall be concluded.
Amendment 23

1. The Scientific Committee shall 1. The Scientific Committee shall

consist of at most fifteen scientists consist of at most fifteen scientists
appointed by the Management Board in appointed by the Management Board in
view of their scientific excellence and their view of their scientific excellence and their
independence, following the publication of independence and in full respect of the
a call for expression of interest in the principle of gender balance, following the
Official Journal of the European Union. publication of a call for expression of
The selection procedure shall ensure that interest in the Official Journal of the
the specialist fields of the members of the European Union. Before making
Scientific Committee cover the most appointments to the Scientific Committee,
relevant fields linked to the objectives of the Management Board shall first consult
the Agency. the competent committee of the European
Parliament. The selection procedure shall
ensure that the specialist fields of the
members of the Scientific Committee cover
the most relevant fields linked to the
objectives of the Agency.
Amendment 24

1. By 15 December of each year, the 1. By 15 December of each year, the

Management Board shall adopt a draft Management Board shall adopt a draft
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single programming document containing single programming document containing
multi-annual and annual programming as multi-annual and annual programming as
well as all the documents listed in Article well as all the documents listed in Article
32 of Commission Delegated Regulation 32 of Commission Delegated Regulation
(EU) 2019/71522, based on a draft put (EU) 2019/71522, based on a draft put
forward by the Executive Director, after forward by the Executive Director, after
consulting the Scientific Committee, taking consulting the Scientific Committee, taking
into account the opinion of the into account the opinion of the
Commission, and in relation to multiannual Commission, and in relation to multiannual
programming after consulting the programming after consulting the
European Parliament. It shall forward it to European Parliament. If the Management
the European Parliament, the Council and Board decides not to take into account
the Commission by 31 January of the elements of the opinion of the
following year. Commission or of the Scientific
Committee, it shall provide a thorough
justification. The obligation to provide a
thorough justification shall also apply to
the elements raised by the European
Parliament when it is consulted. The
Management Board shall forward the
single programming document to the
European Parliament, the Council and the
Commission by 31 January of the
following year.
The Single Programming Document shall The Single Programming Document shall
become definitive after final adoption of become definitive after final adoption of
the general budget and if necessary shall be the general budget and if necessary shall be
adjusted accordingly. adjusted accordingly.
__________________ __________________
22 Commission Delegated Regulation (EU) 22 Commission Delegated Regulation (EU)
2019/715 of 18 December 2018 on the 2019/715 of 18 December 2018 on the
framework financial regulation for the framework financial regulation for the
bodies set up under the TFEU and Euratom bodies set up under the TFEU and Euratom
Treaty and referred to in Article 70 of Treaty and referred to in Article 70 of
Regulation (EU, Euratom) 2018/1046 of Regulation (EU, Euratom) 2018/1046 of
the European Parliament and of the the European Parliament and of the
Council, (OJ L 122, 10.5.2019, p. 1). Council, (OJ L 122, 10.5.2019, p. 1).
Amendment 25

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Annual or multi-annual programming shall Annual or multi-annual programming shall

include the information about the include the information about the
implementation of the international implementation of the international
cooperation framework referred to in cooperation framework referred to in
Article 20 and the actions linked to this Article 20 and the actions linked to this
strategy. strategy. It shall also include the Agency’s
planned research and innovation
activities referred to in Article 21.
Amendment 26

(c) the fees paid for services rendered deleted

in accordance with Article 37; and
Amendment 27

The amount and origin of any revenue

referred to in points (b) and (d) of the first
sub-paragraph of this paragraph shall be
included in the annual accounts of the
Agency and clearly detailed in the annual
report on the Agency's budgetary and
financial management referred to in
Article 40(2).
Amendment 28

Article 37
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Article 37 deleted
Fees
1. The Agency may charge fees for
the following:
(a) training programmes;
(b) certain support activities for
Member States that have not been
identified as a priority but could be
beneficially conducted if supported by
national resources;
(c) capacity-building programmes for
third countries, which are not covered by
separate dedicated Union funding;
(d) certification of national bodies set
up in third countries pursuant to Article
20(3);
(e) other services falling within its
mandate and rendered at the request of a
participating country which require the
investment of resources in the support of
national activities.
2. At the proposal of the Executive
Director, the Management Board of the
Agency shall set the amount of the fees
and the way in which they are paid.
3. Fees shall be proportionate to the
costs of the relevant services as provided
in a cost-effective way and shall be
sufficient to cover those costs. Fees shall
be set at such a level as to ensure that they
are non-discriminatory and that they
avoid placing an undue financial or
administrative burden on stakeholders.
4. Fees should be set at a level such
as to avoid a deficit or a significant
accumulation of surplus in the budget.
Should a significant positive balance in
the budget, resulting from the provision of
the services covered by fees, become
recurrent, a revision of the level of the
fees, or of the Union contribution, shall
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become mandatory. In case a significant
negative balance results from the
provision of the services covered by fees, a
revision of the level of the fees shall
become mandatory.
Amendment 29

Article 43
Article 43 deleted
Executive Director
engaged as a temporary agent of the
Agency under Article 2, point (a), of the
Conditions of Employment of Other
Servants.
appointed by the Management Board,
from a list of candidates proposed by the
Commission, following an open and
transparent selection procedure.
3. For the purpose of concluding the
contract with the Executive Director, the
Agency shall be represented by the
Chairperson of the Management Board.
4. The term of office of the Executive
Director shall be five years. By the end of
that period, the Commission shall
undertake an assessment that takes into
account an evaluation of the Executive
Director's performance and the Agency's
future tasks and challenges.
5. The Management Board, acting on
a proposal from the Commission that
takes into account the assessment referred
to in paragraph 4, may extend the term of
office of the Executive Director once, for
no more than five years.
6. An Executive Director whose term
of office has been extended may not
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participate in another selection procedure
for the same post at the end of the overall
period.
removed from office only upon a decision
of the Management Board acting on a
proposal from the Commission.
8. The Management Board shall
reach decisions on appointment,
extension of the term of office or removal
from office of the Executive Director on
the basis of a two-thirds majority of its
members with voting rights.
Amendment 30

1. No later than [OP please insert the 1. No later than [OP please insert the
date = five years after the date referred to date = five years after the date referred to
in Article 63], and every 5 years thereafter, in Article 63], and every 5 years thereafter,
the Commission shall assess the Agency’s the Commission shall assess the Agency’s
performance in relation to its objectives, performance in relation to its objectives,
mandate, tasks and location in accordance mandate, tasks and location in accordance
with Commission guidelines. The with Commission guidelines. The
evaluation shall, in particular, address the evaluation shall, in particular, address the
possible need to modify the mandate of the possible need to modify the mandate of the
Agency, and the financial implications of Agency, and the financial implications of
any such modification. any such modification. It shall pay
particular attention to the changes to the
Agency's mandate and tasks introduced
by this Regulation.
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PROCEDURE – COMMITTEE ASKED FOR OPINION
Title European Union Drugs Agency

References COM(2022)0018 – C9-0010/2022 – 2022/0009(COD)
Committee responsible LIBE

Date announced in plenary 7.3.2022
Opinion by BUDG
Rapporteur for the opinion Niclas Herbst

Date appointed 1.2.2022
Discussed in committee 21.6.2022
Date adopted 31.8.2022
Result of final vote +: 32

–: 1
0: 4
Members present for the final vote Rasmus Andresen, Pietro Bartolo, Olivier Chastel, Lefteris
Christoforou, Andor Deli, José Manuel Fernandes, Eider Gardiazabal
Rubial, Alexandra Geese, Francisco Guerreiro, Valérie Hayer, Eero
Heinäluoma, Niclas Herbst, Monika Hohlmeier, Moritz Körner,
Joachim Kuhs, Zbigniew Kuźmiuk, Pierre Larrouturou, Camilla
Laureti, Janusz Lewandowski, Margarida Marques, Silvia Modig,
Siegfried Mureşan, Lefteris Nikolaou-Alavanos, Andrey Novakov,
Dimitrios Papadimoulis, Karlo Ressler, Bogdan Rzońca, Nicolae
Ştefănuță, Johan Van Overtveldt, Rainer Wieland, Angelika Winzig
Substitutes present for the final vote Rosa D’Amato, Fabienne Keller, Jan Olbrycht
Substitutes under Rule 209(7) present Clara Aguilera, Alessandra Basso, Vlad-Marius Botoş, Juozas Olekas
for the final vote
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EN
FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION
32 +
ECR Johan Van Overtveldt
NI Andor Deli
PPE Lefteris Christoforou, José Manuel Fernandes, Niclas Herbst, Monika Hohlmeier, Janusz Lewandowski,
Siegfried Mureşan, Andrey Novakov, Jan Olbrycht, Karlo Ressler, Rainer Wieland, Angelika Winzig
Renew Vlad-Marius Botoş, Olivier Chastel, Valérie Hayer, Fabienne Keller, Moritz Körner, Nicolae Ştefănuță
S&D Clara Aguilera, Pietro Bartolo, o, Eider Gardiazabal Rubial, Eero Heinäluoma, Pierre Larrouturou, Camilla
Laureti, Margarida Marques, Juozas Olekas
The Left Silvia Modig, Dimitrios Papadimoulis
Verts/ALE Rasmus Andresen, Rosa D'Amato, Alexandra Geese
1 -
ID Lefteris Nikolaou-Alavanos
4 0
ECR Zbigniew Kuźmiuk, Bogdan Rzońca
ID Alessandra Basso, Joachim Kuhs
Key to symbols:
+ : in favour
- : against
0 : abstention
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EN
PROCEDURE – COMMITTEE RESPONSIBLE
Title European Union Drugs Agency

References COM(2022)0018 – C9-0010/2022 – 2022/0009(COD)
Date submitted to Parliament 12.1.2022
Committee responsible LIBE

Committees asked for opinions BUDG ENVI

Date announced in plenary 7.3.2022 7.3.2022
Not delivering opinions ENVI
Date of decision 26.1.2022
Rapporteurs Isabel Santos

Date appointed 20.4.2022
Discussed in committee 5.9.2022
Date adopted 1.12.2022
Result of final vote +: 52

–: 1
0: 2
Members present for the final vote Abir Al-Sahlani, Konstantinos Arvanitis, Malik Azmani, Vladimír
Bilčík, Karolin Braunsberger-Reinhold, Patrick Breyer, Saskia
Bricmont, Joachim Stanisław Brudziński, Patricia Chagnon, Caterina
Chinnici, Clare Daly, Lucia Ďuriš Nicholsonová, Cornelia Ernst, Laura
Ferrara, Nicolaus Fest, Sylvie Guillaume, Andrzej Halicki, Evin Incir,
Sophia in ‘t Veld, Patryk Jaki, Marina Kaljurand, Alice Kuhnke, Jeroen
Lenaers, Juan Fernando López Aguilar, Erik Marquardt, Javier Moreno
Sánchez, Theresa Muigg, Paulo Rangel, Isabel Santos, Birgit Sippel,
Vincenzo Sofo, Ramona Strugariu, Yana Toom, Milan Uhrík, Tom
Vandendriessche, Jadwiga Wiśniewska, Javier Zarzalejos
Substitutes present for the final vote Daniel Freund, Alessandra Mussolini, Róża Thun und Hohenstein,
Romana Tomc, Dragoş Tudorache, Tom Vandenkendelaere, Loránt
Vincze
Substitutes under Rule 209(7) present Pablo Arias Echeverría, Jarosław Duda, Emmanouil Fragkos, Eva Kaili,
for the final vote Ska Keller, Alessandra Moretti, Ljudmila Novak, Andrey Novakov,
Christine Schneider, Annie Schreijer-Pierik, Marc Tarabella
Date tabled 7.12.2022
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EN
FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE
52 +
ECR Joachim Stanisław Brudziński, Emmanouil Fragkos, Patryk Jaki, Vincenzo Sofo, Jadwiga Wiśniewska
ID Patricia Chagnon
NI Laura Ferrara
PPE Pablo Arias Echeverría, Vladimír Bilčík, Karolin Braunsberger-Reinhold, Jarosław Duda, Andrzej Halicki,
Jeroen Lenaers, Alessandra Mussolini, Ljudmila Novak, Andrey Novakov, Paulo Rangel, Christine Schneider,
Annie Schreijer-Pierik, Romana Tomc, Tom Vandenkendelaere, Loránt Vincze, Javier Zarzalejos
RENEW Abir Al-Sahlani, Malik Azmani, Lucia Ďuriš Nicholsonová, Sophia in 't Veld, Ramona Strugariu, Róża Thun
und Hohenstein, Yana Toom, Dragoş Tudorache
S&D Caterina Chinnici, Sylvie Guillaume, Evin Incir, Eva Kaili, Marina Kaljurand, Juan Fernando López Aguilar,
Javier Moreno Sánchez, Alessandra Moretti, Theresa Muigg, Isabel Santos, Birgit Sippel, Marc Tarabella
THE LEFT Konstantinos Arvanitis, Clare Daly, Cornelia Ernst
VERTS/ALE Patrick Breyer, Saskia Bricmont, Daniel Freund, Ska Keller, Alice Kuhnke, Erik Marquardt
1 -
NI Milan Uhrík
2 0
ID Nicolaus Fest, Tom Vandendriessche
Key to symbols:
+ : in favour
- : against
0 : abstention
PE735.504v02-00 90/90 RR\1268675EN.docx
EN

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European Parliament

Committee on Civil Liberties, Justice and Home Affairs

Rapporteur: Isabel Santos

Symbols for procedures

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Deletions are indicated in bold italics in the left-hand column. Replacements

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PE735.504v02-00 2/90 RR\1268675EN.docx

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION .................................5

EXPLANATORY STATEMENT ............................................................................................66

OPINION OF THE COMMITTEE ON BUDGETS ................................................................68

PROCEDURE – COMMITTEE RESPONSIBLE ...................................................................89

FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE ....................................90

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(Ordinary legislative procedure: first reading)

The European Parliament,

– having regard to the Commission proposal to Parliament and the Council

– having regard to Rule 59 of its Rules of Procedure,

– having regard to the opinion on the Committee on Budgets,

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces,

Proposal for a regulation

Text proposed by the Commission Amendment

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Proposal for a regulation

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Proposal for a regulation

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Text proposed by the Commission Amendment

Proposal for a regulation

Text proposed by the Commission Amendment

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Proposal for a regulation

Text proposed by the Commission Amendment

(6a) In order to attain maximum

Proposal for a regulation

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Text proposed by the Commission Amendment

Proposal for a regulation

Text proposed by the Commission Amendment

(9a) The national focal points are

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Proposal for a regulation

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Proposal for a regulation

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Proposal for a regulation

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(16) Based on the strengthened (16) Based on the strengthened

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Text proposed by the Commission Amendment

(17) As dangerous substances might (17) As dangerous substances might

Proposal for a regulation

Text proposed by the Commission Amendment