Infopack on the manifesto on secondary legislation

INFOPACK

September 2012

Professionals and civil society propose 10 measures to streamline delegated and implementing acts

CONTENT

-‐ Why you should support the Manifesto on secondary

legislation

-‐ Final version of Manifesto

-‐ Concerns over the EU legal order (Europolitics article)

-‐ Concerns over the EU legal order (long version)

Why you should support the Manifesto on secondary legislation

Good reasons for stakeholders to support the Manifesto

By introducing delegated and implementing acts, the Lisbon Treaty changes the implementation of EU legislation radically, as well as the balance of power between the EU Institutions.

• Delegated acts: ad hoc, non-‐transparent yet fundamental -‐ For delegated acts, the familiar “comitology” committees disappear, leaving the Commission autonomous in its adoption of substantial and general measures that can modify legislative dispositions. The way delegated acts are adopted can vary from one legal text to another and often occurs in a non-‐transparent way. Stakeholders could well discover important delegated acts already adopted, without having had any prior notice or opportunity to contribute.

• • Implementing acts: on the surface, nothing changes

but subtle details create a more complex and less balanced system – Whilst the comitology committees continue to function and the European Parliament is left on the sidelines, the examination procedure and the appeal committee create more complexity (with many exceptions and derogations) for stakeholders.

How did the text come about?

Based on these developments, various interest groups (representing industry as well as civil society) have expressed concerns in terms of predictability in EU rule-‐making, democratic legitimacy and transparency.

Accepting that delegated & implementing acts are legally embedded in the EU treaties, the initiators of the Manifesto are not pushing for a change in the basic rules. We do however propose 10 operational measures that should generate a more streamlined, fluid and transparent way of adopting delegated and implementing acts, taking into account the precious role stakeholders can play in shaping EU legislation.

In close cooperation with Thierry Reveau de Cyrières, EU representative of TOTAL in Brussels, Daniel Guéguen, in his capacity as Professor on comitology at the College of Europe and Chairman of PACT European Affairs, has drafted the Manifesto. It was validated on 5 September

2012 by a Steering Committee composed of a variety of stakeholders including EUROPIA, CEFIC, Orgalime and ELO.

Next steps for the Manifesto

This committee will meet on a regular basis to discuss and pilot further actions in the context of the Manifesto. These include the distribution of the Manifesto, the recruiting of supporters, the organisation of a workshop, the publication of the Manifesto in Europolitics and ultimately, contacts with the European Commission, (the Secretariat General in particular).

What type of support are we looking for?

The first action on the Manifesto is to seek out organisations and individuals willing to support the measures listed in the Manifesto and in turn to circulate it among other contacts and organisations. This multiplication effect aims to generate as wide a support as possible from all sectors and different interest groups.

Benefits of signing up to the Manifesto

• Contributing to and striving constructively for more fluidity, transparency and predictability in the adoption of delegated and implementing acts, for the benefit of all EU public affairs practitioners;

• • Exchanging views with other industry sectors / civil

society groups and even decision-‐makers on the challenges all parties are facing with the new system of delegated and implementing acts;

• Obtaining first-‐hand information on key developments with regard to delegated and implementing acts.

Further information and the opportunity to sign up can be found on www.comitology.eu

Contact: [email protected]

PROFESSIONALS AND CIVIL SOCIETY PROPOSE 10 MEASURES TO STREAMLINE DELEGATED AND IMPLEMENTING ACTS

EU secondary legislation must be brought out of the back rooms

to guarantee the continuity and stability of the European legal order

Reminder: The new provisions on secondary legislation (delegated acts and implementing acts) introduced by the Lisbon Treaty can be dated back to the work of the Convention on the Future of

Europe, prelude to the Constitutional Treaty rejected by the French and Dutch referenda in 2005.

The European Convention delegated secondary legislation reform to the “simplification” working group. In December 2001, the Laeken European Council had initiated this approach, underlining the necessity to start simplifying procedures and increasing transparency within comitology committees.

Today, we are a long way from achieving this goal!

What do we propose?

Procedures applying to delegated acts and implementing acts are what they are. But we must make

them viable by limiting room for the interpretation of procedures, reducing the opacity and facilitating access for stakeholders to all necessary information on comitology. To put it short, we must get rid of current lax and unclear practices to guarantee stakeholders legal certainty.

A Treaty change is not an option. Limit oneself to a simple Code of best practices would be

insufficient. Hence, revising the Inter-‐Institutional Agreement on delegated acts of 16 December 2010 and Regulation 182/2011 on implementing acts is clearly the best solution.

10 measures for clarification and guidance

1. Comply in a coherent manner with the legal definition of:

• Delegated acts: they are of general scope and amend or complement certain non-‐essential

elements of basic legal acts. They are quasi-‐legislative and not individual or purely technical measures. They should not deplete the basic legal act of its substance;

• Implementing acts: they implement the legal basic act and correspond to former comitology stricto-‐sensu. The implementing power belongs to Member States and the Commission cannot object to their will when they adopt a negative opinion in the examination committee

and/or appeal committee. 2. Register for implementing and delegated acts:

• Ensure that the Comitology Register is genuinely mandatory and make sure draft implementing measures, agendas, minutes of meetings, are uploaded on a regular basis. Acquire necessary information at least 15 days before the first committee meeting in

question or 15 days before the proposition is officially sent to Member States in case of a written procedure.

• Extend the register (possibly by renaming it) to delegated acts and make the publication of all draft delegated acts and accompanying documents compulsory (e.g. impact assessments) at least 15 days before the adoption of the legislative act in question.

3. Make public the names of examination committee, advisory committee and appeal

committee members; there is no justification for the standard argument for non-‐

communication that committee members rotate from one meeting to another.

4. Delegated acts:

• Try to work towards a harmonisation of consultation procedures and systematically include

professionals and representatives of civil society in these consultations. Make public a list of

organisations and/ or consulted experts;

• Extend impact assessments to delegated acts of major impact.

5. Strictly adhere to all deadlines concerning delegated and implementing acts. Make non-‐

compliance with legal deadlines a reason for annulment of the procedure.

6. Establish a one-‐stop information desk on secondary legislation, allowing all stakeholders to

be informed on a given dossier by officials specialised in the procedure in question.

7. Develop a uniform planning format on delegated acts and implementing acts to be used

across different Directorates General and updated every month.

8. Prepare and make public a plan of action for aligning the Community acquis to the system

of delegated acts and implementing acts introduced by the Treaty of Lisbon, as well as its

state of progress by trimester.

9. Delimit the scope of authority by specifying in Regulation 182/2011 that the Commission

must modify its draft implementing regulation according to the Member States’ will when the appeal committee adopts a negative vote and by establishing that the Commission

cannot re-‐table its initial proposal to the examination committee.

10. Organise a dialogue between professionals in European public affairs, Commissioner

Šefčovič and Commission Secretary-‐General Catherine Day to concretize the above-‐mentioned recommendations.

20 Wednesday 16 May 2012 N° 4375 EUROPOLITIcs

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The Lisbon Treaty is not the best of trea-ties. In appearance, the treaty simplifies the legal framework and decision making pro-cesses. In practice, however, post-Lisbon procedures have become more complex, opaque and increasingly ad hoc. To put it bluntly, one gets the impression that Euro-pean decision makers are easing/simplifying procedures and bending them as it suits.

Since the beginning of 2010, when my book ‘Comitology: Hijacking European power?’ was published, a number of cases showing procedural flaws have been brought to my attention. This made me question the Community method, the balance of power and in general the EU legal order.

Based on these cases and reflections, I have written a ten-page dissertation, which is available at www.pacteurope.eu. A summary is provided here.

First of all, what is a legal order?A good definition for this - in appearance

- very clear concept is hard to find. After searching, the most compelling reflection comes... from Canada. Guy Rocher, full professor at Harvard and Laval University defines it as “a set of binding rules whose adoption is based on legitimacy. The rules and agents or bodies must demonstrate stability over time, relative permanence”.

It is clear that the institutional instabil-ity that the EU has known over the last ten years is in itself a source of legal instability. Just as a reminder of the long list of reforms the EU has undergone: the draft Consti-tutional Treaty, the comitology reform of 2006, the Treaty of Lisbon end-2009, a new comitology reform in 2011.

The top EU institutions set the bad example

“Free interpretations” of the European legal order are probably linked to some extent to the institutional, economic and monetary upheavals affecting the European Union since 2008, as if the urgency or gravity of the situation constitutes sufficient ground to adapt the law to the circumstances.

Three examples are particularly illumi-nating: the adoption of the energy and cli-mate change package in December 2008, de facto sidelining the European Parlia-ment and the Council of Ministers to the benefit of the European Council of heads of state or government, at the time not even an EU institution.

The dismantling of the Community method by Merkel-Sarkozy to the ben-efit of the intergovernmental approach is a second striking example. The third example is linked to the struggle for power between the Commission-Council-Parliament when dividing implementing measures in delegated acts and implementing acts.

This bad example contaminates the overall EU decision making process

Three cases in particular show the trend towards bad procedural practices: legal window-dressing, shortcut procedures, approximations, interpretations of the rules… and overall a lack of respect for the spirit of the treaties.

The first case: the Fuel Quality Direc-tive. In this file, the letter of the rules is respected but in spirit they are violated. Whether it concerns the impact assess-ment, the consultation process, the publi-cation in the comitology register, alternate compromise proposals by member states, inter-service consultation, it all amounts to a stop-and-go process, U-turns and opacity.

The second case: the revision of the pharmacovigilance legislation in which we find delegated acts co-existing with the regulatory procedure with scrutiny. These two procedures can in principle not fea-ture together in one and the same piece of legislation, as one applies to legal acts pre-

Lisbon and the other to acts post-Lisbon. Legal experts at the Commission justify this anomaly by indicating that the rules can be adapted if they facilitate a political compromise.

The third case: Orphacol, disavowing implementing measures. Orphacol is a medicine used for the treatment of two extremely rare and serious child liver dis-eases, and is an alternative to liver trans-plantation. The medicine was approved twice unanimously by the European Medicines Agency. Nevertheless the Commission opposes it and drafts a pro-posed regulation refusing market authori-sation. In the Examination and Appeal Committee, member states oppose the Commission’s refusal with qualified majority. The Commission, however, persists in its refusal. The file is taken to the Court of Justice, which accepts an accelerated procedure and schedules a hearing on 24 April 2012. Barely one week after this hearing, the Commission re-introduces its proposal for refusal of market authorisation to the Examination Committee, on 8 May (a public holiday in a number of EU member states). The same proposal the Examination Commit-tee voted on and rejected at QMV, on 13 October 2011! Member states come short of a few votes to reject the Commission’s proposal at qualified majority. The Com-mission now has the free hand to adopt its proposal. The court’s ruling is expected with impatience.

Urgent action is needed. The ‘Commu-nity procedures’ are dispersed among vari-ous texts that are sometimes referred to as “rules of procedure,” then as mere “guide-lines” or “guidances”. It seems indispens-able to consolidate all these texts – and to clarify their content – creating one single clear, coherent, uniform and mandatory Community code, with national codes of procedure serving as models. n

(*) Daniel Guéguen is professor at the College of Europe on comitology

By Daniel guéguen (*)

oPEn FoRuM

Concerns over the Eu legal order

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How far can the European Commission go in interpreting procedural rules? Several recent cases

fuel this discomfort

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CONCERNS OVER THE EU LEGAL ORDER How far can the European Commission go in interpreting procedural rules?

Several recent cases fuel this discomfort

by Daniel Guéguen1

Both in civil and criminal cases, procedure is the cornerstone of life in society. The law defines the rules and how the rules should be applied. When the police officer, the examining magistrate or

the prosecutor omit an element of the procedure or disrespect an element of the procedure, consequently, the measures become void.

A Rule of Law which questions, depletes, applies approximately or interprets civil or criminal

procedures would simply not be a Rule of Law.

In Brussels however -‐ seat of the main European Institutions -‐ alarming signals have been appearing for the past two or three years. A number of legislative and regulatory files have been

characterized by "legal window-‐dressing" or by "short-‐cut procedures". In consequence, they do not comply with the legal exactitude required when adopting these regulations or directives.

The EU legal order cannot suffer approximation, subjectivity or opportunism. Not respecting each step of the procedure or applying the procedures “a la carte” leads to unclear, not to say opaque,

procedures, giving rise to a triple risk:

• Loss of trust between the public authority and its citizens (businesses, citizens, interest groups,...), or even between the European public authorities and their Member States;

• An increased number of actions for annulment before the European Court of Justice for breach of the rules of procedure;

• A decline of the necessary counter-‐balance of EU trade associations, consumer organisations, NGOs and trade unions, whose role has always been appreciated in the development of European policies (in particular the Single Market).

1 Visiting professor at the College of Europe (Bruges) and at the Institute of European Studies (ULB) – Chairman and founder of PACT European Affairs – Author of reference books on the EU Institutions and the decision-‐making process, in particular: “Comitology: Hijacking European Power?”.

Full Version

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First of all, what is a legal order?

A good definition for this -‐ in appearance -‐ very clear concept is hard to find. After searching, the

most compelling reflection comes ... from Canada. Guy Rocher, full Professor at Harvard, Laval University and the University of Montreal estimates that a legal order is built on the following

four criteria:

• A set of rules, standards accepted -‐ at least theoretically – as binding by members of a particular social unit (nation, society, organization, group, ...);

• Specialized agents or bodies to develop new rules or modify existing ones; interpret the existing rules; apply and enforce them;

• The intervention of agents or bodies is based on legitimacy (the social unit recognizes the authority required to make, interpret or enforce the rules);

• The rules and agents or bodies must demonstrate stability over time, relative permanence. These rules should not vary continuously nor should agents constantly be shifted.

The European legal order challenged at the top of EU Institutions

"Free interpretations" of the European legal order are probably linked to some extent to the

institutional, economic and monetary upheavals affecting the European Union since 2008, as if the urgency or gravity of a situation constitutes sufficient ground to adapt the law to the circumstances.

Three examples of recent distortions of the European legal order are particularly illuminating:

• First example: the adoption of the energy and climate change package in December

2008. The European Council – not having the institutional status later conferred by the Lisbon Treaty – led a very accelerated procedure. The European Parliament was de facto side-‐lined and “summoned” to approve the intergovernmental agreement reached at the

level of Heads of State or Government. What was the result? A “victory” for the French Presidency, but a package adopted too fast to be anything more than simple guidelines, transferring most of the outstanding key issues to comitology implementing measures.

• Second example: a weakened Community method that favours an intergovernmental

approach and finds its essence in the initiatives taken by Merkel-‐Sarkozy regarding the

financial stability pact. Remember the comments made by President Nicolas Sarkozy in a joint TV interview with Chancellor Angela Markel broadcast at the Elysée on 6 February 2012: “Europe does not consist of handing over part of French sovereignty to a

technocratic body [the Commission!]”. This says it all.

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• Third example: the Commission-‐Council-‐Parliament struggle for power when dividing implementing measures in delegated acts and implementing acts. Although the definition of these two categories is not 100% precise, which is regrettable, it is

nevertheless clear that:

o delegated acts correspond to "general, but non-‐essential" measures

complementing or amending legislation, and

o implementing acts to "individual, administrative and technical" measures that implement legislation.

Therefore, the Commission (generally supported by the Parliament) strongly tends to mainstream delegated acts, whereas Member States push for implementing acts (because the committees of national experts are maintained). This gives rise to great concern, as

the nature of the legal act is no longer solely determined by law, but is based on a political struggle for power.

This constitutes a clear threat to the European legal order as well as the risk of multiple actions

before the Court of Justice via Article 263 §4 TFEU, which expands the criteria for annulment. This results in increased confusion as the stable legal order is completely circumvented.

The case of the Fuel Quality Directive (FQD)

Although not part of the energy and climate change package, this directive was debated within

the same timeframe. The FQD contains a significant number of implementing measures to be adopted via comitology.

One of the implementing measures provided for by the directive concerns the calculation

methods and reporting requirements (implementation of article 7a). The procedure for the adoption of this implementing measure is the Regulatory Procedure with Scrutiny (RPS).

According to the RPS (applicable for basic legal acts adopted before the entry into force of the Lisbon Treaty), the Commission initiates a proposal. It is reviewed by a Regulatory Committee

(composed of national experts and chaired by the Commission) before it is submitted to the Parliament and the Council for a possible veto.

In this complex procedure all three Institutions are involved at different stages, with the Commission having a predominant role. At each stage we observe a series of inaccuracies,

interpretations, breaches, and a veil of opacity and opportunism which individually are not likely to convince the Court of Justice to annul, but -‐ taken together -‐ cast a cloud over the compliance with the EU legal order.

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The lengthy process leading up to the Commission’s proposal is characterized by a number of flaws

The Commission issued a consultation paper in July 2009, inviting stakeholders to comment. Many comments were received, and a considerable amount of concerns were expressed from

various perspectives.

The Commission’s thinking appears to have gone back and forth in response to the various reactions it received. For instance, a GHG emissions default value associated with tar sands was first included in the consultation paper, then dropped and finally reinserted again due to pressure

from various sides.

Although no flagrant legal errors were made in the process leading up to the proposal, a number of procedural points can be criticised and questioned.

1. Impact Assessment: a stop and go process

Although an Impact Assessment (IA) was carried out in 2006-‐2007 before the publication of the proposal for the Directive on Fuel Quality (the basic legal act), the Commission did not perform an

Impact Assessment for the implementing measure based on article 7a. Even though the latter is not a legislative proposal, but a proposal for an implementing measure, this is astonishing for two reasons.

• First of all, the Commission itself has developed Impact Assessment Guidelines in the

context of its “better regulation” and “transparency” initiatives. Furthermore, in 2009, the Commission explicitly stated that the scope of its IA system was extended to implementing rules (“comitology” decisions). This commitment, although not binding as

law, was not respected in the context of the Fuel Quality Directive’s measure on calculation methods.

• Secondly, the measure has all the features for performing an Impact Assessment:

• The proposed measure has “significant impact”. The choice of FQD methodology is not “routine implementing legislation”. It goes to the very heart of the EU’s Fuel Quality Directive as it amounts to its practical accomplishment.

• The “significant impact” is also illustrated by the legislative history of the Fuel Quality

Directive. During the legislative discussions, the European Parliament questioned whether the Commission should make the important choice on methodology through comitology, indicating that it would perhaps be more appropriate to legislate on this

matter via co-‐decision (now ordinary legislative procedure).

The purpose of an IA is to evaluate alternatives, in order to ensure that the EU takes appropriate steps and decisions. The involvement of the Impact Assessment Board, composed of high-‐level Commission civil servants, whose mission it is to ensure objectivity and respect of procedures,

further indicates the need for an objective analysis and scrutiny. Skipping this essential step renders the Commission’s action legally vulnerable.

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Finally, after months of intense lobbying by the stakeholders, Climate Action Commissioner Connie Hedegaard announced on 20th April that the Commission would carry out an Impact Assessment and submit the proposal to the Council in early 2013. Even if we may praise this U-‐

turn, the loss of time and the uncertainty created in the procedures is strongly regrettable.

2. Concerns expressed during the consultation are ignored in the Commission proposal

The concerns expressed during the consultation process where not integrated in the Explanatory Memorandum of the proposed measure. The lack of an impact assessment should be reason

enough for the Commission to report on various reactions expressed by stakeholders in the consultation process. Thus, omitting to report such concerns or any opposition to the proposed measure basically means ignoring their existence.

3. No timely publication in the Comitology register

When the draft measure first came out it was not published in the Comitology register. Publication in this register is not an obligation and thus failing to do so is not a violation of procedure. However, it is the Commission itself, via its transparency and better regulation

initiatives that has set up and developed this register.

The existence of such a register is useful for stakeholders when documents are uploaded and updated on a regular and consistent basis. Now, using this register selectively or using it when it appears more convenient is strongly misleading – as is the delayed publication of documents.

Hence, the registration of documents in the Comitology register should first, become mandatory and second, be regulated in detail.

4. Genuine evaluation and discussion of Member states’ compromise proposals?

Certain Member states such as Italy, the United Kingdom and the Netherlands, have come up with

“compromise proposals” in the Fuel Quality Committee. However, their compromise solutions were either not discussed at all or not sufficiently evaluated. Some of these proposals provided viable alternative solutions taking into account both concerns expressed by industry

representatives and environmentalist groups.

The role of the Member states in the committee – and thus in the Committee on Fuel Quality -‐ is not only to listen and agree. They are obliged to discuss and find a suitable and workable solution with the Commission. Neglecting Member States’ input too easily means disregarding their

important role in terms of implementing EU legislation.

5. Inter-‐service consultation comments too easily set aside?

Comments by certain DGs in the inter-‐service consultation were not really taken into account. However, echoes indicate that some profound divergent views between Commission services

existed on this measure and that they persisted until the summer of 2011.

Inter-‐service consultation is an essential part of the Commission’s internal decision-‐making process as it allows for a balanced proposal that takes into account various angles of the issue.

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The tendency of individual Directorates General to push forward their views, undermines, in essence, the collegial character of Commission decisions. This is highly regrettable and puts the Community method into question.

Another example of deviation from the normal legal path: the pharmacovigilance legislation

When the revised pharmacovigilance Directive was adopted on 15 December 2010, the Lisbon

Treaty was already in force. So in principle, the pharmacovigilance legislation should use for its completion and implementation the new system of delegated and implementing acts created by the Lisbon Treaty.

However, when looking into this legislation, one sees a mix of implementing and delegated acts,

and more troublesome acts adopted via the Regulatory Procedure with Scrutiny (RPS). It can be argued that delegated and RPS acts have the same nature and scope. However, they were not intended to co-‐exist in one single piece of legislation and their adoption process is very different,

notably with regard to Member states’ involvement.

When looking for answers at the Legal Service of the European Commission for this “un-‐usual” situation, it seems it was maintained to avoid re-‐opening discussions on an already, at the time, very advanced compromise. The Legal Service of the EU Commission seems to have accepted this

“deviation”, seemingly saying the rules can be bent, if they accommodate political negotiations. The question remains whether this does not jeopardises the EU legal order.

Orphacol: disavowing the implementing process !

Orphacol is a medicine developed by the academic research centre of “Assistance publique – Hôpitaux de Paris” (AP-‐HP). For years, the most prominent specialists have used this medicine for

the treatment of two extremely rare and serious child liver diseases, which can place the child in mortal danger if not medicated in the first few months of life. The alternative to Orphacol is a liver transplantation, a ponderous and expensive procedure which often results in failures and

consequently, the young patient’s death.

In 2007 the patent rights for the medicine were transferred to the French laboratory CTRS, which in agreement with the European Medicines Agency, filed an application for market authorization

according to the centralized registration procedure.

In 2010, the Committee for Medicinal Products for Human Use (expert committee of the European Medicines Agency) unanimously issued a positive opinion and – on the Commission’s

request – reconfirmed unanimously its position in April 2011.

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1. A double rejection by the Examination Committee and the Appeal Committee

In July 2011 the Commission nevertheless issued a proposal REFUSING the market authorization and submitted it to the Standing Committee on Medicinal Products for Human Use. This comitology committee -‐ composed a representative per Member State and chaired by a

Commission official -‐ voted against the Commission proposal by a qualified majority, which occurs very rarely.

As no decision is reached in the committee, the proposal is forwarded to the Appeal Committee, in line with the new post-‐Lisbon comitology procedure. The Appeal Committee – again composed

of national officials (however, higher up the hierarchy) and chaired by the Commission– voted by a qualified majority as well against the Commission proposal. This is an unprecedented case!

2. The Commission tramples the decision of the member states

The Commission persists in its intention to refuse the placing on the market of Orphacol and in

December 2011 the Laboratoires CTRS institute proceedings before the Court of Justice for failure to act and annulment. CTRS asks and obtains from the Court an accelerated treatment of the case and a hearing is scheduled on 24th April 2012.

Barely one week after this hearing, the Commission pushes its intention to refuse to the extreme.

Even though a negative vote was expressed in the Appeal Committee, the Commission re-‐introduces its proposal for refusal of market authorisation to the Examination committee on the 8th May; the same proposal that was already rejected by the same Examination Committee on 13th

October 2011!

The Commission, presiding over this Examination committee, schedules the date for the new meeting for the 8th May, a public holiday in a number of EU member states,… For amongst others that reason, certain member states that voted against the Commission’s proposal in the

Examination committee in October 2011 and again in the Appeal Committee, do not attend the 8th May meeting. The result? The Examination Committee comes short of a few votes to reject the Commission’s proposal at qualified majority.

Based on the new procedures, the Commission now has the free hand to adopt its proposal as the

lack of a qualified majority against allows it to adopt the text and to refuse Orphacol’s market authorisation!

3. The Commission tramples the decision of the member states

Orphacol is an exemplary case. It demonstrates a breach of the inter-‐institutional balance. Before

the Lisbon Treaty, it was uncommon for a comitology committee to oppose a Commission proposal by a qualified majority. Only a dozen cases each year. This meant, at the time, that the Council of Ministers would take charge of the file via the so-‐called “call-‐back right”.

This is no longer the case today. Although the Commission has been disavowed twice – in first

instance and in appeal – by a qualified majority – it continues to turn a deaf ear. Is there any

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objective reason why the control by the Member States vis-‐à-‐vis the Commission is trampled in this way, knowing that the case has been taken to the Court of Justice ?

The Court of Justice will provide the answer. But whatever the answer will be, the Commission will keep its monopoly of initiative, including for implementing acts. This means quasi-‐total

freedom in terms of content and timetable. Here we are faced with an emerging legal loophole which, in my view, requires urgent attention from European judges.

A fourth example: the maze of procedures for the phyto-‐pharmaceutical sector

It is logical that active substances used in phyto-‐pharmaceutical products are submitted to

substantial evaluations on their safety in terms of environment and human health in particular. However, the EU framework and procedure for granting these authorisations is not only complex

but is also overly rigid.

When the EU introduced its authorisation system in the beginning of the 90s, it was foreseen to last for 10 years to give the EU sufficient time for the necessary evaluations. However, in 2000 the EU extended the final deadline for review to 2008.

When in 2007 the Commission realized that it would be impossible to meet this deadline, it

adopted a regulation restricting the introduction of new information for the peer review of active substances. Concretely speaking, this meant that companies having introduced files for authorisations, sometimes years before, were not allowed to introduce newly available scientific

information because of procedure and time constraints. This, in combination with the non-‐transparent functioning of the European Food Safety Authority, creates uncertainty and gives the impression of changing the rules during the game rather than before or after.

Returning to a uniform application of the European legal order

In its case law, the European Court of Justice considers that only irregularities whose severity is

obvious may lead to the annulment of a Community measure.

This restrictive interpretation of the Court of Justice needs, in my opinion, to be reconsidered in light of the multiplication of cases that deviate in more or less significant terms from the normal procedures and the community decision-‐making spirit, even if they generally respect the letter of

the treaties.

A stable legal order -‐ as defined by Professor Rocher – needs, amongst others, a permanent nature implying at least stable rules and agents. However, the EU legal order seems to be moving in an opposite direction going against the need for stability and uniformity:

• Increased “legal window –dressing”, the “politicised” split of execution measures

between delegated acts and implementing acts, the non-‐uniformity of procedures: all of this leads to a growing unease with stakeholders. They feel lost in the decision-‐making

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procedure and can no longer anticipate the next logical step. Consequently, they are paralysed in their lobbying actions.

• The retro-‐grading of the Community method to the benefit of an intergovernmental approach puts into question the collegial nature of the Commission. This decline in collegiality has detrimental effects, as it weakens the Commission’s internal culture of

work, and creates a "working culture per Directorate General", if not "per unit".

• The stakeholders’ concerns are reinforced by the current legal imbroglio. The ink of the 2006 comitology reform was barely dry, when a new comitology reform became fully operational. The two reforms currently co-‐exist: at present, some comitology measures

for a single file can refer either to the 2006 or to the 2011 reform. This makes it all the more complicated to understand (the pharmacovigilance case is a very good example in this context).

• The interpretations, approximations, inaccuracies, deficiencies, veil of opportunism and

opacity are disincentives for the cooperation between public authorities and interest

groups at large. This leads to uncertainties, doubts, and an inability to be heard, the dialogue with civil society gets lost. And democracy does not come off as a winner.

• Consultations, impact assessments, inter-‐service procedures, compromise proposals,… all these tools are supposed to be at the service of good governance. But one cannot both promote a project entitled "better regulation" and at the same time accept a kind of

“legal laisser-‐faire”, making way for arbitrary decision-‐making. And in law, there is nothing worse.

Urgent action is needed: five recommendations

1. The “Community procedures” are dispersed among various texts that are sometimes referred to as « rules of procedure », then as mere « guidelines » or « guidances ». It seems

indispensable to consolidate all these texts – and to clarify their content – creating one single clear, coherent, uniform and mandatory Community Code, with national codes of procedure serving as models.

2. The objective distribution of implementing measures between delegated and implementing

acts is a major problem to be solved either by a self-‐discipline of the legislators or via jurisprudence of the Court of Justice.

3. The political filter of the Member States vis-‐à-‐vis the Commission in the adoption of

implementing acts should be better defined, in order to avoid useless proceedings before the Court of Justice and the creation of legal loopholes whenever the Commission refuses to

accept a negative vote of the examination and appeal committees.

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4. Between 2012 and 2014 the old comitology system (RPS) must be aligned with the post-‐

Lisbon system (delegated/ implementing acts). This particularly opaque alignment procedure should be accelerated and become more transparent. It is important for the stakeholders to

be 100% informed about the alignment agenda and the modalities applied. Otherwise a multitude of files will go before the Court of Justice and create inextricable situations.

5. To put it more general, it is important to make all information on the activities of

committees accessible to the public (agendas, minutes of meetings, composition of the committees,…). This should apply to advisory committees and expert groups in the drafting

phase, Council working parties, and comitology committees in the implementing phase.

In the troublesome economic, monetary and institutional period which we are confronted to today and will be confronted to tomorrow, we need more European Union and certainly not

less. But this aspiration can only be accomplished with an equal dose of boldness, rigor and transparency; the confidence civil society and citizens put in the EU and its Institutions comes at this price.

After reading this article your contributions are welcome

• Do you agree or disagree with this analysis?

• Do you know of other cases strengthening this article?

• What are your proposals for improving procedural clarity?

• Would you like to participate in a discussion group on this issue?

To answer, please contact the author:

Daniel Guéguen

[email protected]

Tel : +32 (0)2 230 38 68

GSM : +32 (0)474 37 74 42

Web : http://www.pacteurope.eu

PACT European Affairs – 21 Square de Meeûs – 1050 Brussels Belgium – +32 (0)2 230 38 68 – www.pacteurope.eu – [email protected]

Infopack on the manifesto on secondary legislation

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