Regulatory Affairs: What You Should Know About Implementing and Delegated Acts

Regulatory Affairs: What you should know about implementing and delegated acts
Free Webinar - 22 May 2013 -1-2pm Please turn up your computer speakers or put on your headset You can ask questions in writing in the chat panel
WELCOME to the 3rd FREE webinar
Free Webinar - 22 May 2013 -1-2pm Please turn up your computer speakers or put on your headset You can ask questions in writing in the chat panel
1
ABOUT THE WEBINAR SERIES
EU Lobbying, Ethics & Transparency: "Do"-s and "Don't"-s
Risk Regulation in the EU: Sectors, Advocacy and the Precautionary Principle
Regulatory Affairs Explained: What you must know about implementing & delegated acts
How to Master EU Interest Representation: The BM guide to EU lobbying best practices
7 Tips for Effective EU Public Affairs: Practical ideas to reach the highest impact for your issue
Digital Communication in EU Affairs: How to master Twitter, Linkedin & social media in public affairs
EU Public Affairs Forecast until June 2014: What to expect until the end of Barroso II and beyond?
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3
SPEAKER & ORGANISER
SPEAKER David OLeary:

Director at Burson-Marsteller Brussels. He specialises in the workings of the EU institutions and in policy areas such as food, consumer goods and ICT.
SPEAKER David OLeary

Director at Burson-Marsteller Brussels. He specialises in the workings of the EU institutions and in policy areas such as food, consumer goods and ICT.
MODERATOR Andrs BANETH

Director European Training Academy
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THE PRESENTATION
THE NEW COMITOLOGY: WHAT YOU SHOULD KNOW ABOUT IMPLEMENTING AND DELEGATED ACTS
David OLeary // Burson-Marsteller Brussels
Evidence-based communications. Inform. Measure. Monitor. Succeed.
TODAYS PRESENTATION
Part 1 Comitology basics: what, who, why, when? Part 2 New comitology a) Delegated acts b) Implementing acts Part 3 Conflicts and controversies Part 4 Tips for working with the new comitology
PART 1 COMITOLOGY BASICS: WHAT, WHO, WHY, WHEN?
WHAT IS COMITOLOGY?
Filling in the gaps or dealing with details An obscure system for taking important decisions
WHAT IS COMITOLOGY?
A way of filling in the gaps or dealing with details An obscure system for taking big decisions
WHAT IS COMITOLOGY?
Affects a wide range of sectors:
WHAT IS COMITOLOGY?
12 to 48 months Commission
PROPOSES LEGISLATION
EP
Council
CO-DECISION
WHAT IS COMITOLOGY?
12 to 48 months Commission
PROPOSES LEGISLATION
EP
Counil
2 days to several months
CO-DECISION
EP
Commission (+ experts)
Council
NON-LEGISLATIVE ACTS (VIA COMITOLOGY)
WHOS INVOLVED?
BASIC ACT
Commission proposes Consults expert committees

COMMISSION ADOPTS NON-LEGISLATIVE ACT
Legislator (EP & Council) controls (scrutiny or veto)
WHOS INVOLVED
Around 250 committees of national experts, chaired by the Commission
WHY COMITOLOGY?
Speed: faster than co-decision Efficient: does not block EP/Council Reactive: no need to convene ministers, MEPs Expertise: technical details need specialist knowledge
But: Democracy? Accountability? Transparency?
A BRIEF HISTORY OF COMITOLOGY

CAP needs rules Ad hoc procedures 60s

Rapid development 70s

First horizontal rules 1987

1999
New horizontal decision + EP involved


2006
1999
Amended rules: RPS + EP veto

2009
2006
1999
Lisbon: Delegated & Implementing Acts (plus RPS hangover)
Amended rules: RPS + EP veto
PART 2 NEW COMITOLOGY : CHANGES AFTER LISBON
THE PRE-LISBON REGIME

One legal basis: Article 202 EC One legal framework / set of rules: Comitology Decision (Council Decision 1999/468)
THE POST-LISBON REGIME

Two legal bases: Delegated acts (DAs): Articles 290 TFEU Implementing acts (IAs): Article 291 TFEU Two legal frameworks / sets of rules: DAs: Article 290 IAs: Article 291 + Comitology Regulation (Council and EP Regulation 182/2011)
CHOOSING THE RIGHT PROCEDURE

Delegated acts Non-legislative act Amend/supplement legislation Non-essential
CHOOSING THE RIGHT PROCEDURE

Delegated acts Non-legislative act Amend/supplement legislation Non-essential Implementing acts Non-legislative act Implement legislation Often essential
In detail: Delegated acts
DELEGATED ACTS: KEY FEATURES

No formal committees of national experts: Commission formally acts alone (but informal consultation with national experts)

No formal committees of national experts: Commission formally acts alone (but informal consultation with national experts) No horizontal procedure, only treaty rules: Legislator decides case-by-case on how to delegate (but common understanding to avoid confusion)

No formal committees of national experts: Commission formally acts alone (but informal consultation with national experts) No horizontal procedure, only treaty rules: Legislator decides case-by-case on how to delegate (but common understanding to avoid confusion) Strong powers for legislator Either EP or Council can veto measure or revoke power

No formal committees of national experts: Commission formally acts alone (but informal consultation with national experts) No horizontal procedure, only treaty rules: Legislator decides case-by-case on how to delegate (but common understanding to avoid confusion) Strong powers for legislator Either EP or Council can veto measure or revoke power Inter-institutional parity EP and Council have equal powers, right to information (but informal consultation with national experts)

No formal committees of national experts: Commission formally acts alone (but informal consultation with national experts) No horizontal procedure, only treaty rules: Legislator decides case-by-case on how to delegate (but common understanding to avoid confusion) Strong powers for legislator: Either EP or Council can veto measure or revoke power Inter-institutional parity: EP and Council have equal powers, right to information (but informal consultation with national experts)
COMMON UNDERSTANDING
No horizontal procedure, only treaty rules: Legislator decides case-by-case on how to delegate in terms of objectives, content, duration and scope Common understanding gives basic models:

No formal committees of national experts: Commission formally acts alone (but informal consultation with national experts) No horizontal procedure, only treaty rules: Legislator decides case-by-case on how to delegate (but common understanding to avoid confusion) Strong powers for legislator: Either EP or Council can veto measure or revoke power Inter-institutional parity: EP and Council have equal powers, right to information (but informal consultation with national experts)
VETOING OR REVOKING POWERS

EP and Council cannot amend draft measures Nuclear options: veto or revoke power Big majorities needed to veto or revoke: EP: absolute majority of all MEPs Council: qualified majority
VETOING OR REVOKING POWERS

EP and Council cannot amend draft measures Nuclear options: veto or revoke power Big majorities needed to veto or revoke: EP: absolute majority of all MEPs Council: qualified majority EP/Council have 2+2 months to object to an act Any reason allowed for veto or revocation Under common understanding, EP and Council must give each other one months notice of intention to revoke
Delegated acts: An example
AN EXAMPLE: ENERGY LABELLING

New labels from 1 July 2013:
A +++ A ++ A+
A++
A
B C
D
In detail: Implementing acts
IMPLEMENTING ACTS: KEY FEATURES

Formal committees of national experts: Commission cannot act as it wishes

Formal committees of national experts: Commission cannot act as it wishes Horizontal procedures set by EP and Council: Advisory and examination procedures

Formal committees of national experts: Commission cannot act as it wishes Horizontal procedures set by EP and Council: Advisory and examination procedures Weaker powers for legislator: Only right of scrutiny oblige Commission to review act

Formal committees of national experts: Commission cannot act as it wishes Horizontal procedures laid down by EP and Council: Advisory and examination procedures Weaker powers for legislator: Only right of scrutiny oblige Commission to review act Inter-institutional disparity Member states in control in committees

Formal committees of national experts: Commission cannot act as it wishes Horizontal procedures set by EP and Council: Advisory and examination procedures Weaker powers for legislator: Only right of scrutiny oblige Commission to review act Inter-institutional disparity Member states in control in committees
IMPLEMENTING ACTS: TWO PROCEDURES

Advisory procedure: Default procedure Used for funding decisions; less controversial measures Commission takes utmost account of committees views

Advisory procedure: Default procedure Used for funding decisions; less controversial measures Commission takes utmost account of committees views Examination procedure: Applies to issues of general scope or sensitive topics e.g. trade, taxation, human health, animal health, plant health, the environment, agriculture, fisheries Committee votes on measures Appeal committee (deputy perm reps) may intervene Member states keep significant control

Advisory procedure: Default procedure Used for funding decisions; less controversial measures Commission takes utmost account of committees views Examination procedure: Applies to issues of general scope or sensitive topics e.g. trade, taxation, human health, animal health, plant health, the environment, agriculture, fisheries Committee votes on measures Appeal committee (deputy perm reps) may intervene Member states retain significant control
EXAMINATION PROCEDURE
Commission proposes EXAMINATION COMMITTEE
QM -
No QM
QM +
ACT ADOPTED
COM may adopt unless: Simple majority against Basic act forbids Sensitive topic
COM acts: (Within two months) Submits new draft act (Within one month) Send to appeal cttee
EXAMINATION PROCEDURE
APPEAL COMMITTEE
ACT NOT ADOPTED
QM -
No QM
QM +
ACT ADOPTED
COM may adopt unless: Multilateral trade safeguard On sensitive issues, decision must reflect predominant view
ACTING URGENTLY
Commission can adopt urgent measures if needed
Committees have ex-post control a negative opinion means the act is repealed
Example: post-Fukushima measures
Implementing acts: An example
AN EXAMPLE: ORPHACOL
Positive EMA opinion on Orphacol - but Commission proposed not to give a market authorisation Examination committee: QMV opposed Commission Appeal committee: QMV opposed Commission New draft tabled: no QMV either way Commission had discretion and stuck by its original decision
Overview: Delegated acts vs implementing acts
OVERVIEW
Delegated acts
Supplement and amend non essential elements General application Role Scope
Implementing acts
Provide uniform conditions for implementing EU acts General or individual application Horizontal EP/Council Regulation Member states can block; EP/Council scrutiny Automatically replaced old comitology on 1 March 2011
No (not formally) Expert committees Yes In individual legislation + common understanding EP/Council can veto or revoke delegation Ongoing replacement of RPS until 2014 and some disputes Legal basis Scrutiny Alignment
PART 3 CONFLICTS AND CONTROVERSIES
ISSUE 1: POST-LISBON ALIGNMENT

OLD PROCEDURES NEW PROCEDURES
IMPLEMENTING ACTS (AUTOMATIC ALIGNMENT) ADVISORY MANAGEMENT EXAMINATION REGULATORY ADVISORY

DELEGATED ACTS (ONGOING ALIGNMENT OF EACH LAW)
REGULATORY PROCEDURE WITH SCRUTINY
DELEGATED ACTS

DELEGATED ACTS (ONGOING ALIGNMENT OF EACH LAW)
REGULATORY PROCEDURE WITH SCRUTINY
DELEGATED ACTS
ISSUE 2: CHOICE OF PROCEDURE

WEEE EP vs Council EP concedes to Council IAs chosen over DAs Notes than shall not be used as a precedent

WEEE EP vs Council EP concedes to Council IAs chosen over DAs Notes than shall not be used as a precedent Cross-border healthcare EP/Council vs Commission EP concedes to Council IAs chosen over DAs Commission notes that legality of IAs may be questioned says they should be DAs

WEEE EP vs Council EP concedes to Council IAs chosen over DAs Notes than shall not be used as a precedent Cross-border healthcare EP/Council vs Commission EP concedes to Council IAs chosen over DAs Commission notes that legality of IAs may be questioned says they should be DAs Biocides EP/Council vs Commission, the ECJ rules EP concedes to Council IAs chosen over DAs Commission takes EP/Council to Court to challenge use of IAs

Procedure becoming part of the negotiation between EP and Council EP seems willing to trade substance for procedure Biocides case should give clearer indication of line between DAs and IAs
ISSUE 3: THE NUCLEAR OPTION

Take it or leave it choice can be tricky
Food additives: Commission included a meat glue in a list of 20 food additives EP vetoed, blocking all 20 additives Did Commission think EP would not veto all additives because it disliked one additive?
ISSUE 4: PUTTING POLICY IN SILOS

Some issues encompass wider interests that can be missed in policy-specific comitology procedures Airport body scanners: Commission draft act adopted by transport experts EP Transport Committee signalled its approval MEPs on Civil Liberties Committee heard about plan and objected to lack of privacy safeguards EP President wrote to Commission, which withdrew measure NB: a formal veto is not the only way to block a proposal
PART 4 TIPS FOR WORKING WITH THE NEW COMITOLOGY
NEW COMITOLOGY TIPS

Impact: Dont forget the impact of comitology: 60-70 legislative acts per year > 2,000 delegated or implementing acts per year It can affect key business issues labelling, marketing, authorisations Procedure: Ensure you know which one applies to your issue In the legislative phase, think about whether you can affect the choice in your favour (including for texts that need to be aligned)
NEW COMITOLOGY TIPS

Timing: Think about comitology impact from legislative phase so that objective, scope, duration, content suit your needs Focus on comitology measures as soon as the law is passed the Commission will be thinking about them! Get in early influence the content while the Commission is drafting to avoid calling for a nuclear option Remember, the nuclear option is difficult to achieve:
Lack of expertise/understanding in EP/Council Too many measures Too little time (2+2 months) Thresholds are very high (absolute majority / QMV)
NEW COMITOLOGY TIPS

Network: For DAs and IAs, know the Commission desk officer responsible For IAs in particular, find out the committee involved and who sits on it often officials in national capitals For DAs in particular, consider which MEPs are interested and wish to be kept informed you may need them in the scrutiny phase (Baby milk health claim case) Consultations may include experts from Parliament or non-institutional actors - another chance to influence
NEW COMITOLOGY TIPS

Stay informed: Commission desk officer EP committee secretariats Perm Reps Comitology register
ANY QUESTIONS?
Thank you for your attention

and see you on 12 June!

Regulatory Affairs: What You Should Know About Implementing and Delegated Acts

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Regulatory Affairs: What You Should Know About Implementing and Delegated Acts

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Formats disponibles

Regulatory Affairs: What you should know about implementing and delegated acts

WELCOME to the 3rd FREE webinar

EU Lobbying, Ethics & Transparency: "Do"-s and "Don't"-s

How to Master EU Interest Representation: The BM guide to EU lobbying best practices

Turn off your Outlook, Skype and other programs

SPEAKER David OLeary:

SPEAKER David OLeary

MODERATOR Andrs BANETH

Evidence-based communications. Inform. Measure. Monitor. Succeed.

PART 1 COMITOLOGY BASICS: WHAT, WHO, WHY, WHEN?

Evidence-based communications. Inform. Measure. Monitor. Succeed.

Evidence-based communications. Inform. Measure. Monitor. Succeed.

Evidence-based communications. Inform. Measure. Monitor. Succeed.

Evidence-based communications. Inform. Measure. Monitor. Succeed.

Evidence-based communications. Inform. Measure. Monitor. Succeed.

2 days to several months

NON-LEGISLATIVE ACTS (VIA COMITOLOGY)

Evidence-based communications. Inform. Measure. Monitor. Succeed.

Commission proposes Consults expert committees

Legislator (EP & Council) controls (scrutiny or veto)

Evidence-based communications. Inform. Measure. Monitor. Succeed.

Evidence-based communications. Inform. Measure. Monitor. Succeed.

But: Democracy? Accountability? Transparency?

Evidence-based communications. Inform. Measure. Monitor. Succeed.

A BRIEF HISTORY OF COMITOLOGY

Evidence-based communications. Inform. Measure. Monitor. Succeed.

A BRIEF HISTORY OF COMITOLOGY

Rapid development 70s

Evidence-based communications. Inform. Measure. Monitor. Succeed.

A BRIEF HISTORY OF COMITOLOGY

Rapid development 70s

First horizontal rules 1987

Evidence-based communications. Inform. Measure. Monitor. Succeed.

A BRIEF HISTORY OF COMITOLOGY

Rapid development 70s

First horizontal rules 1987

New horizontal decision + EP involved

A BRIEF HISTORY OF COMITOLOGY

Rapid development 70s

First horizontal rules 1987

Amended rules: RPS + EP veto

New horizontal decision + EP involved

Evidence-based communications. Inform. Measure. Monitor. Succeed.

A BRIEF HISTORY OF COMITOLOGY

Rapid development 70s

First horizontal rules 1987

Lisbon: Delegated & Implementing Acts (plus RPS hangover)

Amended rules: RPS + EP veto

New horizontal decision + EP involved

Evidence-based communications. Inform. Measure. Monitor. Succeed.

PART 2 NEW COMITOLOGY : CHANGES AFTER LISBON

Evidence-based communications. Inform. Measure. Monitor. Succeed.

THE PRE-LISBON REGIME

Evidence-based communications. Inform. Measure. Monitor. Succeed.

THE POST-LISBON REGIME

Evidence-based communications. Inform. Measure. Monitor. Succeed.

CHOOSING THE RIGHT PROCEDURE

Evidence-based communications. Inform. Measure. Monitor. Succeed.

CHOOSING THE RIGHT PROCEDURE

Evidence-based communications. Inform. Measure. Monitor. Succeed.

In detail: Delegated acts

Evidence-based communications. Inform. Measure. Monitor. Succeed.

DELEGATED ACTS: KEY FEATURES