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

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

Free Webinar - 22 May 2013 -1-2pm

Please turn up your computer speakers or put on your headsetYou can ask questions in writing in the chat panel

Free Webinar - 22 May 2013 -1-2pm

Please turn up your computer speakers or put on your headsetYou can ask questions in writing in the chat panel

WELCOME to the 3rd FREE webinar

ABOUT THE WEBINAR SERIES

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"Don't"-s

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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?

GOOD TO KNOW

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SPEAKER & ORGANISER

SPEAKERDavid O’Leary:

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 MODERATORDavid O’Leary András BANETH

Director at Burson-Marsteller Brussels. He specialises Director – European Training Academyin the workings of the EU institutions and in policy areassuch as food, consumer goods and ICT.

THE PRESENTATION

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

THE NEW COMITOLOGY: WHAT YOU SHOULD

KNOW ABOUT IMPLEMENTING AND DELEGATED ACTS

David O’Leary // Burson-Marsteller Brussels

TODAY’S PRESENTATION

Part 1Comitology basics: what, who, why, when?

Part 2New comitologya) Delegated actsb) Implementing acts

Part 3Conflicts and controversies

Part 4Tips for working with the new comitology

PART 1COMITOLOGY 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:

Commission

EP Council

CO-DECISION

PROPOSES LEGISLATION

WHAT IS COMITOLOGY?12

Commission

EP Counil

CO-DECISION

PROPOSES LEGISLATION

WHAT IS COMITOLOGY?

NON-LEGISLATIVE ACTS(VIA COMITOLOGY)

EP CouncilCommission(+ experts)

BASIC ACT

WHO’S INVOLVED?

COMMISSION ADOPTS NON-LEGISLATIVE ACT

Consults expert committees

Commissionproposes

Legislator (EP & Council)

controls(scrutiny or

WHO’S 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 rulesAd hoc procedures

Rapid development

First horizontal rules

Rapid development

New horizontal decision + EP involved

Rapid development

20061999

Amended rules: RPS + EP veto

Rapid development

2009 20061999

Lisbon: Delegated & Implementing Acts

(plus RPS ‘hangover’)

Amended rules: RPS + EP veto

PART 2NEW 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 TFEUImplementing acts (IAs): Article 291 TFEU

• Two legal frameworks / sets of rules:DAs: Article 290IAs: 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 horizontal procedure, only treaty rules:Legislator decides case-by-case on how to delegate(but… ‘common understanding’ to avoid confusion)

• Strong powers for legislatorEither EP or Council can veto measure or revoke power

• Inter-institutional parityEP and Council have equal powers, right to information(but… informal consultation with national experts)

• 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:

• 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 month’s notice of intention to revoke

Delegated acts:An example

AN EXAMPLE: ENERGY LABELLING

New labels from 1 July 2013:

In detail:Implementing acts

IMPLEMENTING ACTS: KEY FEATURES

• 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

• Horizontal procedures laid down by EP and Council:‘Advisory’ and ‘examination’ procedures

• Inter-institutional disparityMember 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 committee’s 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

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

COM may adopt unless:Simple majority against

Basic act forbids‘Sensitive topic’

EXAMINATION COMMITTEE

No QMQM - ACT ADOPTED

COM acts:(Within two months) Submits new draft act(Within one month) Send to appeal cttee

EXAMINATION PROCEDURE

COM may adopt unless:Multilateral trade safeguard

On sensitive issues, decision must reflect predominant view

APPEAL COMMITTEE

No QMQM - ACT ADOPTEDACT NOT ADOPTED

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 Implementing actsSupplement and amend ‘non essential elements’

Role Provide uniform conditions for implementing EU acts

General application Scope General or individual application

No (not formally) Expert committees Yes

In individual legislation + ‘common

understanding’

Legal basis Horizontal EP/Council Regulation

EP/Council can veto or revoke delegation

Scrutiny Member states can block; EP/Council scrutiny

Ongoing replacement of ‘RPS’ until 2014 – and

some disputes…

Alignment Automatically replaced old comitology on 1 March 2011

PART 3CONFLICTS AND

CONTROVERSIES

ISSUE 1: POST-LISBON ALIGNMENT

OLD PROCEDURES NEW PROCEDURES

IMPLEMENTING ACTS (AUTOMATIC ALIGNMENT)

ADVISORY ADVISORY

MANAGEMENTEXAMINATION

REGULATORY

ADVISORY ADVISORY

REGULATORY

DELEGATED ACTS (ONGOING ALIGNMENT OF EACH LAW)

REGULATORY PROCEDURE WITH SCRUTINY

DELEGATED ACTS

ADVISORY ADVISORY

REGULATORY

DELEGATED ACTS (ONGOING ALIGNMENT OF EACH LAW)

REGULATORY PROCEDURE WITH SCRUTINY

DELEGATED ACTS

COUNCIL PRESSURE

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”

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

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 4TIPS FOR WORKING WITH THE NEW COMITOLOGY

‘NEW COMITOLOGY’ TIPS

Impact:• Don’t 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)

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)

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

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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