1
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> **REGULATORY INSTITUTE**
>
> Copyright and editor: Regulatory Institute ASBL,
> [www.howtoregulate.org](http://www.howtoregulate.org/)
>
> RPM: Banque-carrefour des entreprises BCE-718994880,
>
> Rue du Cornet 107, BE-1040 Brussels, Belgium.
>
> Responsible person in terms of press / publications law:
>
> Ms Valerie Thomas
>
> Rua Principal 118, Jardia 2870-615, Portugal
>
> The following persons have contributed to this Handbook:
>
> Valerie Thomas and Ajda Mihelčič.
>
> Author of the first edition, Manfred Kohler.
>
> This Handbook has been developed as a pro bono sharing initiative and
> is available free of charge. Therefore, users cannot claim liability
> rights.
>
> **[Foreword to the second
> edition](#foreword-to-the-second-edition-of-the-handbook-2021)**
> [12](#foreword-to-the-second-edition-of-the-handbook-2021)
>
> [**of the Handbook
> 2021**](#foreword-to-the-second-edition-of-the-handbook-2021)
1. **[Introduction](#_bookmark9)** [13](#_bookmark9)
1. [Terminology](#_bookmark9) [13](#_bookmark9)
2. [Development of a practical method of regulating](#_bookmark11)
[14](#_bookmark11)
3. [Jurisdictions and sectors](#_bookmark12) [16](#_bookmark12)
4. [Correlation table: first and second edition](#_bookmark14)
[17](#_bookmark14)
2. **[The architecture of regulation](#_bookmark15)**
[20](#_bookmark15)
1. [Introduction to the topic of regulatory
architecture](#_bookmark15) [20](#_bookmark15)
2. [Four basic models of architecture](#_bookmark17)
[21](#_bookmark17)
3. [Advantages and disadvantages of the different
models](#_bookmark19) [24](#_bookmark19)
4. [Combining different model architectures](#_bookmark20)
[25](#_bookmark20)
5. [Application of the different models to a single
act](#_bookmark21) [26](#_bookmark21)
> [(intra-regulation architecture)](#_bookmark21)
6. [Technical annexes](#_bookmark23) [27](#_bookmark23)
7. [Subordinate acts versus annexes](#_bookmark23) [27](#_bookmark23)
8. [Referring to or integrating other regulation](#_bookmark24)
[28](#_bookmark24)
9. [Reference and architecture diagrams](#_bookmark26)
[29](#_bookmark26)
3. **[The small scale building blocks of regulation:](#_bookmark27)**
[31](#_bookmark27)
> [**the requirements and other provisions**](#_bookmark27)
1. [Conditions and characteristics used for establishing](#_bookmark28)
[32](#_bookmark28)
> [requirements or other provisions](#_bookmark28)
1. [- Organisational conditions and characteristics](#_bookmark28)
[32](#_bookmark28)
2. [- Personal conditions and characteristics](#_bookmark31)
[33](#_bookmark31)
3. [- Geographic conditions and characteristics](#_bookmark33)
[34](#_bookmark33)
4. [- Physical conditions and characteristics](#_bookmark33)
[34](#_bookmark33)
5. [- Legal conditions and characteristics](#_bookmark33)
[34](#_bookmark33)
6. [- Process conditions and characteristics](#_bookmark35)
[35](#_bookmark35)
7. [- Time-related conditions and characteristics](#_bookmark35)
[35](#_bookmark35)
8. [- Behavioural conditions and characteristics](#_bookmark35)
[35](#_bookmark35)
> [based on circumstances](#_bookmark35)
9. [- Logical links between conditions and
characteristics](#_bookmark36) [36](#_bookmark36)
2. [The distinction between conditions and consequences](#_bookmark36)
[36](#_bookmark36)
3. [Typology of consequences I: the descriptors](#_bookmark38)
[37](#_bookmark38)
1. [– Parallels between
conditions and characteristics on one](#_bookmark38)
[37](#_bookmark38)
> [side and consequences on the other](#_bookmark38)
2. [– Particular aspects of this typology](#_bookmark39)
[38](#_bookmark39)
4. [Typology of consequences II: aspects of](#_bookmark40)
[40](#_bookmark40)
> [procedure / process and aspects of substance](#_bookmark40)
1. [– Procedural consequences](#_bookmark40) [40](#_bookmark40)
2. [– Consequences of substance](#_bookmark41) [43](#_bookmark41)
3. [– Logical links between various consequences](#_bookmark42)
[45](#_bookmark42)
4. **[A typology of incentives and regulatory measures](#_bookmark43)**
[46](#_bookmark43)
1. [Types of incentives](#_bookmark43) [46](#_bookmark43)
1. [– Reputational advantages or risk of
disadvantages](#_bookmark45) [47](#_bookmark45)
2. [– Positive feelings or risk of negative
feelings](#_bookmark45) [47](#_bookmark45)
3. [– Status advantages or disadvantages](#_bookmark45)
[47](#_bookmark45)
4. [– Indirect financial advantages](#_bookmark46)
[48](#_bookmark46)
5. [– Indirect non-financial advantages](#_bookmark46)
[48](#_bookmark46)
6. [– Combination of incentives](#_bookmark46)
[48](#_bookmark46)
2. [Types of regulatory measures](#_bookmark47) [49](#_bookmark47)
1. [– Regulation](#_bookmark47) [49](#_bookmark47)
2. [– Regulatory measures other than regulation](#_bookmark48)
[50](#_bookmark48)
3. [Comparison of regulatory measures and](#_bookmark49)
[56](#_bookmark49)
> [selection of the right regulatory measures in individual
> cases](#_bookmark49)
5. **[The method of regulating](#_bookmark50)** [59](#_bookmark50)
1. [Analysing the issues of the sector](#_bookmark50)
[59](#_bookmark50)
1. [– The questions helping to analyse the
sector](#_bookmark53) [60](#_bookmark53)
2. [– Follow-up to the analysis: first steps towards a
response](#_bookmark56) [65](#_bookmark58)
3. [– Examples](#_bookmark59) [66](#_bookmark59)
2. [Identifying the policy goals](#_bookmark60) [69](#_bookmark60)
1. [– Analysing predetermined policy goals](#_bookmark60)
[69](#_bookmark60)
2. [– Determining further policy goals](#_bookmark62)
[74](#_bookmark62)
3. [Determining objectives, measures, requirements and
incentives](#_bookmark63) [75](#_bookmark63)
4. [Keeping the oversight on goals, objectives,
measures,](#_bookmark65) [77](#_bookmark65)
> [requirements and incentives](#_bookmark65)
5. [Finding the right regulatory process](#_bookmark66)
[79](#_bookmark66)
1. [– Description of regulatory processes](#_bookmark66)
[79](#_bookmark66)
2. [– Developing a tailor-made regulatory process](#_bookmark69)
[81](#_bookmark69)
> [6.](#_bookmark70)
>
> [6.1](#_bookmark70)
>
> [6.2](#_bookmark71)
>
> [6.3](#_bookmark72)
>
> [6.4](#_bookmark72)
>
> [6.5](#_bookmark73)
>
> [6.6](#_bookmark74)
>
> [6.7](#_bookmark74)
>
> [7.](#_bookmark76)
>
> [7.1](#_bookmark76)
>
> [7.2](#_bookmark76)
>
> [7.3](#_bookmark79)
>
> [8.](#_bookmark84)
[8.1](#_bookmark87)
[8.2](#_bookmark87)
[8.3](#_bookmark88)
[8.4](#_bookmark89)
[8.5](#_bookmark90)
[8.6](#_bookmark91)
[8.7](#_bookmark92)
> [8.8](#_bookmark93)
>
> [8.9](#_bookmark94)
>
> [8.10](#_bookmark97)
>
> [8.11](#_bookmark97)
>
> [**The scope**](#_bookmark70)
>
> [Distinction by complexity](#_bookmark70) [Distinction by
> elements](#_bookmark71)
>
> [Distinction by preciseness and flexibility](#_bookmark72)
>
> [Scopes with or without exemptions or clarifications](#_bookmark72)
> [Scopes followed by subject matter and purpose](#_bookmark73)
>
> [Scopes with or without references to other regulations](#_bookmark74)
> [Relationships between scopes of other regulation](#_bookmark74)
>
> **[Other basic questions of regulation](#_bookmark76)** [Selection of
> and reference to the legal basis](#_bookmark76) [Density of
> regulation](#_bookmark76)
>
> [Harmonisation approaches](#_bookmark79)
1. [– Notification procedures](#_bookmark79)
2. [– Mutual recognition of decisions](#_bookmark80)
3. [– Optional harmonisation](#_bookmark81)
4. [– Minimum harmonisation](#_bookmark83)
5. [– Total harmonisation](#_bookmark83)
> **[Understanding risks, quantified requirements](#_bookmark84) [and
> multi-dimensional impacts](#_bookmark84)**
>
> [Responding to various types of risks](#_bookmark87)
>
> [Full safety principle or other fixed risk limits](#_bookmark87)
> [Risk-benefit analysis](#_bookmark88)
>
> [Basic risk management obligations of operators](#_bookmark89) [Risk
> uncertainty and the precautionary principle](#_bookmark90) [Choosing
> amongst measures that deal with](#_bookmark91)
>
> [or cause one single risk](#_bookmark91)
>
> [Choosing between measures that deal with](#_bookmark92) [or cause
> different risks](#_bookmark92)
>
> [Multi-dimensional impacts](#_bookmark93)
>
> [Trade-off decisions between different quantifiable
> requirements](#_bookmark94)
1. [– Trade-off between two goals](#_bookmark94)
2. [– Trade-offs between three or more goals](#_bookmark96)
[Translating risk assessment reports](#_bookmark97)
> [into measures (risk management)](#_bookmark97)
>
> [Safety margins in risk assessment and risk management](#_bookmark97)
>
> [84](#_bookmark70)
>
> [84](#_bookmark70)
>
> [87](#_bookmark71)
>
> [89](#_bookmark72)
>
> [89](#_bookmark72)
>
> [90](#_bookmark73)
>
> [92](#_bookmark74)
>
> [92](#_bookmark74)
>
> [94](#_bookmark76)
>
> [94](#_bookmark76)
>
> [94](#_bookmark76)
>
> [95](#_bookmark79)
>
> [95](#_bookmark79)
>
> [96](#_bookmark80)
>
> [97](#_bookmark81)
>
> [98](#_bookmark83)
>
> [98](#_bookmark83)
>
> [99](#_bookmark84)
>
> [100](#_bookmark87)
>
> [100](#_bookmark87)
>
> [101](#_bookmark88)
>
> [102](#_bookmark88)
>
> [103](#_bookmark90)
>
> [104](#_bookmark91)
>
> [105](#_bookmark92)
>
> [106](#_bookmark93)
>
> [108](#_bookmark94)
>
> [108](#_bookmark94)
>
> [113](#_bookmark96)
>
> [114](#_bookmark97)
>
> [114](#_bookmark97)
>
> [8.12](#_bookmark98)
>
> [8.13](#_bookmark99)
[8.14](#_bookmark99)
[8.15](#_bookmark101)
[8.16](#_bookmark102)
[8.17](#_bookmark102)
[8.18](#_bookmark104)
> [9.](#_bookmark106)
>
> [9.1](#_bookmark106)
[9.2](#_bookmark112)
[9.3](#_bookmark114)
[9.4](#_bookmark116)
> [10.](#_bookmark118)
>
> [10.1](#_bookmark118)
>
> [10.2](#_bookmark120)
>
> [10.3](#_bookmark121)
>
> [10.4](#_bookmark121)
[10.5](#_bookmark126)
> [The proportionality principle](#_bookmark98)
>
> [Overview: the adaptation of risk and performance](#_bookmark99)
> [requirements to technical progress](#_bookmark99)
>
> [Quantitative and qualitative risk and performance
> requirements](#_bookmark99) [Establishing risk classes with different
> procedures](#_bookmark101)
>
> [High risk products and processes](#_bookmark102) [Bearing and causing
> risks](#_bookmark102)
>
> [Typology of risks related to devices, objects,
> substances](#_bookmark104)
>
> [**References**](#_bookmark106)
>
> [Typology of references](#_bookmark106)
1. [– Targets of references](#_bookmark106)
2. [– Static and dynamic references](#_bookmark108)
3. [– Starting points for using references](#_bookmark110)
4. [– End points for using references](#_bookmark111)
5. [– Full or partial applicability of the](#_bookmark112) [provision
or text referred to](#_bookmark112)
> [Reference time / reference stages](#_bookmark112) [References to
> standards](#_bookmark114)
>
> [References to non-legal documents other than
> standards](#_bookmark116)
>
> **[Verifying conformity in advance (ex ante)](#_bookmark118)**
> [Distinction between ex ante and ex post verification](#_bookmark118)
> [Basic decisions to be taken with regard](#_bookmark120)
>
> [to the conformity verification](#_bookmark120) [What needs to be
> verified?](#_bookmark121)
>
> [When shall this verification happen?](#_bookmark121)
1. [– Better ex ante or better ex post?](#_bookmark121)
2. [– When best to use ex ante?](#_bookmark124) [Who shall
verify?](#_bookmark126)
1. [– A choice frequently to be made: conformity](#_bookmark126)
[assessment bodies or state authority?](#_bookmark126)
2. [– Mixed regimes combining conformity assessment](#_bookmark128)
[bodies and state authority](#_bookmark128)
3. [– Other third party ex ante verification](#_bookmark129)
4. [– Special focus : involvement of insurers as](#_bookmark130) [ex
ante verifiers and rule-setters](#_bookmark130)
> [115](#_bookmark98)
>
> [117](#_bookmark99)
>
> [117](#_bookmark99)
>
> [120](#_bookmark101)
>
> [121](#_bookmark102)
>
> [121](#_bookmark102)
>
> [122](#_bookmark104)
>
> [124](#_bookmark106)
>
> [124](#_bookmark106)
>
> [124](#_bookmark106)
>
> [126](#_bookmark108)
>
> [127](#_bookmark110)
>
> [128](#_bookmark111)
>
> [129](#_bookmark112)
>
> 129
>
> [130](#_bookmark114)
>
> [133](#_bookmark116)
>
> [138](#_bookmark118)
>
> 138
>
> [139](#_bookmark120)
>
> [140](#_bookmark121)
>
> [140](#_bookmark121)
>
> [140](#_bookmark121)
>
> [142](#_bookmark124)
>
> [143](#_bookmark126)
>
> [143](#_bookmark126)
>
> [144](#_bookmark128)
>
> [147](#_bookmark129)
>
> [148](#_bookmark130)
>
> [10.6](#_bookmark132)
>
> [11.](#_bookmark140)
>
> [11.1](#_bookmark140)
>
> [11.2](#_bookmark142)
>
> [11.3](#_bookmark143)
>
> [11.4](#_bookmark145)
>
> [11.5](#_bookmark151)
>
> [11.6](#_bookmark162)
>
> [11.7](#_bookmark164)
>
> [11.8](#_bookmark166)
>
> [11.9](#_bookmark167)
>
> [11.10](#_bookmark168)
>
> [11.11](#_bookmark171)
5. [– Self-certification as an alternative or](#_bookmark131)
[complementing element](#_bookmark131)
> [The procedure of in-advance verification](#_bookmark132)
1. [– A basic typology of procedures](#_bookmark132)
2. [– Parameters applicable to procedures](#_bookmark135)
3. [– Special procedural techniques](#_bookmark137)
4. [– The results of procedures](#_bookmark138)
> [**Ex post verification / enforcement**](#_bookmark140)
>
> [Information and enforcement](#_bookmark140)
>
> [Content and density of state ex post verification](#_bookmark142)
> [When best to use ex post verification?](#_bookmark143)
>
> [Policing other than by authorities or conformity](#_bookmark145)
> [assessment bodies](#_bookmark145)
1. [– Mandatory surveillance by third parties](#_bookmark145)
2. [– Voluntary surveillance by third parties](#_bookmark147)
3. [– Special focus: whistleblowers and witnesses](#_bookmark149)
4. [– On the way to complete outsourcing](#_bookmark151)
> [of enforcement: mutual control systems](#_bookmark151) [Enforcement
> powers](#_bookmark151)
1. – General or explicit/detailed enforcement powers
2. [– Which enforcement powers to think of: a catalogue](#_bookmark153)
3. [– Some particular enforcement powers](#_bookmark157)
> [A standard programme for enhanced enforcement](#_bookmark162)
> [Registration systems embedding artificial
> intelligence](#_bookmark164) [to enhance enforcement](#_bookmark164)
>
> [Enforcement towards rogue operators](#_bookmark166)
>
> [Limiting own-brand-labelling to facilitate
> enforcement](#_bookmark167) [Enforcement challenges in the internet
> age: e-commerce](#_bookmark168) [and private imports](#_bookmark168)
1. [– Learning from extreme cases](#_bookmark168)
2. [– Clarifying applicability](#_bookmark170)
3. [– Approaching trading platforms](#_bookmark171)
4. [– International cooperation](#_bookmark171)
> [Assistance by other administrations, public](#_bookmark171) [and
> private entities](#_bookmark171)
>
> [149](#_bookmark131)
>
> [151](#_bookmark132)
>
> [151](#_bookmark132)
>
> [152](#_bookmark135)
>
> [153](#_bookmark137)
>
> [158](#_bookmark138)
>
> [166](#_bookmark140)
>
> [166](#_bookmark140)
>
> [169](#_bookmark142)
>
> [174](#_bookmark143)
>
> [175](#_bookmark145)
>
> [175](#_bookmark145)
>
> [176](#_bookmark147)
>
> [180](#_bookmark149)
>
> [184](#_bookmark151)
>
> 184
>
> 184
>
> [185](#_bookmark153)
>
> [192](#_bookmark157)
>
> [205](#_bookmark162)
>
> [207](#_bookmark164)
>
> [210](#_bookmark166)
>
> [212](#_bookmark167)
>
> [214](#_bookmark168)
>
> [214](#_bookmark168)
>
> [216](#_bookmark170)
>
> [218](#_bookmark171)
>
> [218](#_bookmark171)
>
> [218](#_bookmark171)
[11.12](#_bookmark173)
[11.13](#_bookmark174)
[11.14](#_bookmark175)
[11.15](#_bookmark176)
[11.16](#_bookmark179)
> [12.](#_bookmark180)
>
> [12.1](#_bookmark180)
>
> [12.2](#_bookmark181)
>
> [12.3](#_bookmark182)
>
> [12.4](#_bookmark183)
>
> [12.5](#_bookmark185)
>
> [12.6](#_bookmark186)
>
> [12.7](#_bookmark187)
>
> [12.8](#_bookmark187)
>
> [12.9](#_bookmark189)
>
> [12.10](#_bookmark190)
>
> [12.11](#_bookmark191)
>
> [12.12](#_bookmark192)
>
> [12.13](#_bookmark196)
>
> [Attributing enforcement responsibility to courts](#_bookmark173) [or
> to administrations](#_bookmark173)
>
> [Assigning or requiring persons responsible for
> compliance](#_bookmark174) [Enforcement in case of de-constructed
> products and services](#_bookmark175) [The particular case of
> 3D-printing](#_bookmark176)
1. [– Description of the regulatory challenge](#_bookmark176)
2. [– How to address the regulatory challenge?](#_bookmark177)
3. [– Special cases](#_bookmark178)
4. [– Applicability of the same principles to product
kits](#_bookmark179) [and pure manufacturing
instructions](#_bookmark179)
> [Services and products provided from zones](#_bookmark179) [without
> state control](#_bookmark179)
>
> [**Other implementation questions**](#_bookmark180)
>
> [Clear, authority friendly rules on burden, means](#_bookmark180) [and
> degree of proof](#_bookmark180)
>
> [Clear consequences of non-conformities or negative test
> results](#_bookmark181) [Discretionary powers and vague
> legal](#_bookmark182)
>
> [expressions / margins of appreciation](#_bookmark182) [Ensuring
> harmonised interpretation in general](#_bookmark183)
>
> [Ensuring the harmonised and stringent work of](#_bookmark185)
> [conformity assessment bodies](#_bookmark185)
>
> [Ensuring a harmonised and stringent implementation](#_bookmark186)
> [by authorities](#_bookmark186)
>
> [Strengthening authorities through](#_bookmark187)
> [intra-organisational measures](#_bookmark187)
>
> [Implementation tasks: Centre, agency or geographic
> entities?](#_bookmark187) [Ensuring that authorities decide in
> time](#_bookmark189)
>
> [Preventing corruption and other unlawful](#_bookmark190) [operations
> of authorities](#_bookmark190)
>
> [Co-operation amongst authorities](#_bookmark191) [International
> cooperation](#_bookmark192)
1. [– Two paths of international cooperation](#_bookmark194)
2. [– Empowering cooperation with other jurisdictions](#_bookmark195)
3. [– Empowering cooperation with](#_bookmark196) [international
organisations](#_bookmark196)
> [Decision making by committees](#_bookmark196)
>
> [219](#_bookmark173)
>
> [221](#_bookmark174)
>
> [222](#_bookmark175)
>
> [224](#_bookmark176)
>
> [224](#_bookmark176)
>
> [226](#_bookmark177)
>
> [228](#_bookmark178)
>
> [229](#_bookmark179)
>
> [229](#_bookmark179)
>
> [231](#_bookmark180)
>
> [231](#_bookmark180)
>
> [236](#_bookmark181)
>
> [237](#_bookmark182)
>
> [238](#_bookmark183)
>
> [240](#_bookmark185)
>
> [241](#_bookmark186)
>
> [242](#_bookmark187)
>
> [242](#_bookmark187)
>
> [245](#_bookmark189)
>
> [246](#_bookmark190)
>
> [249](#_bookmark191)
>
> [252](#_bookmark192)
>
> [253](#_bookmark194)
>
> [254](#_bookmark195)
>
> [257](#_bookmark196)
>
> [257](#_bookmark196)
[12.14](#_bookmark197)
[12.15](#_bookmark198)
[12.16](#_bookmark199)
[12.17](#_bookmark199)
[12.18](#_bookmark200)
> [12.19](#_bookmark201)
>
> [12.20](#_bookmark203)
>
> [13.](#_bookmark204)
>
> [13.1](#_bookmark204)
>
> [13.2](#_bookmark206)
[13.3](#_bookmark206)
[13.4](#_bookmark208)
[13.5](#_bookmark210)
[13.6](#_bookmark211)
[13.7](#_bookmark211)
[13.8](#_bookmark212)
> [14.](#_bookmark213)
>
> [14.1](#_bookmark213)
[14.2](#_bookmark216)
[14.3](#_bookmark217)
[14.4](#_bookmark218)
[14.5](#_bookmark219)
[14.6](#_bookmark219)
[14.7](#_bookmark220)
[14.8](#_bookmark221)
[14.9](#_bookmark223)
> [15.](#_bookmark224)
>
> [15.1](#_bookmark224)
>
> [15.2](#_bookmark225)
>
> [Means for dispute resolution](#_bookmark197) [De minimis
> clause](#_bookmark198) [Regularisation](#_bookmark199)
>
> [Rules on confidentiality](#_bookmark199)
>
> [Algorithms and other data processing tools, usage,](#_bookmark200)
> [storage or destruction of data](#_bookmark200)
>
> [Further collateral obligations](#_bookmark201) [Regulatory
> sandboxes](#_bookmark203)
>
> [**Miscellaneous**](#_bookmark204)
>
> [Transitional provisions and phasing in](#_bookmark204)
>
> [Validity of decisions, legal acts and certificates
> based](#_bookmark206) [on the previous law](#_bookmark206)
>
> [Applicability of other regulation](#_bookmark206) [Authenticity of
> acts](#_bookmark208)
>
> [Applicability of general administrative or civil law](#_bookmark210)
> [Separability clause](#_bookmark211)
>
> [Sunset clause](#_bookmark211) [Review clause](#_bookmark212)
>
> [**Working methods and ethics**](#_bookmark213)
>
> [Elaboration methods](#_bookmark213)
1. [– Advanced electronic tools for the elaboration
process](#_bookmark215) [Negotiating](#_bookmark216) regulation
> [The ethical values as a means to find consensus](#_bookmark217)
> [Creative solution finding](#_bookmark218)
>
> [Finding the optimal path](#_bookmark219) [Managing regulatory
> work](#_bookmark219) [Attitudes towards regulatory
> work](#_bookmark220)
>
> [Ethical considerations in regulatory work](#_bookmark221)
> [Temporality of regulatory measures](#_bookmark223)
>
> [**Integral quality verification**](#_bookmark224)
>
> [The need for integral quality verification](#_bookmark224)
>
> [Suggested elements for an integral quality
> verification](#_bookmark225)
1. [– Questions regarding all regulatory measures](#_bookmark226)
2. [– Questions regarding regulation only](#_bookmark227)
[259](#_bookmark197)
[262](#_bookmark198)
[263](#_bookmark199)
[263](#_bookmark199)
[264](#_bookmark200)
[268](#_bookmark201)
[269](#_bookmark203)
[271](#_bookmark204)
[271](#_bookmark204)
[274](#_bookmark206)
[274](#_bookmark206)
[276](#_bookmark208)
[277](#_bookmark210)
[278](#_bookmark211)
[278](#_bookmark211)
[279](#_bookmark212)
[280](#_bookmark213)
[280](#_bookmark213)
[281](#_bookmark215)
[282](#_bookmark216)
[283](#_bookmark217)
[284](#_bookmark218)
[286](#_bookmark219)
[286](#_bookmark219)
[288](#_bookmark220)
[289](#_bookmark221)
[290](#_bookmark223)
[292](#_bookmark224)
[292](#_bookmark224)
[294](#_bookmark225)
[295](#_bookmark226)
[298](#_bookmark227)
[15.3](#_bookmark233)
[15.4](#_bookmark233)
3. [– Questions regarding regulatory acts only](#_bookmark228)
4. [– Particular checklist for regulation on products](#_bookmark228)
[(also partly applicable to materials)](#_bookmark228)
5. [– Particular checklist for regulation on services](#_bookmark231)
[(also partly applicable to materials)](#_bookmark231)
> [A further possible element of quality verification:](#_bookmark233)
> [the analysis of affected interests](#_bookmark233)
>
> [A final quality check perspective: completeness](#_bookmark233) [of
> empowerments](#_bookmark233)
1. [– Determining non-financial rights](#_bookmark235)
2. [– Determining non-financial obligations of natural
and](#_bookmark235) [legal persons](#_bookmark235)
3. [– Determining financial rights and obligations of
natural](#_bookmark236) [and legal persons](#_bookmark236)
4. [– Imposing costs on natural or legal persons](#_bookmark236)
5. [– Sanctions and penalties](#_bookmark237)
6. [– Additional empowerments for all financial
obligations](#_bookmark238) [and financial sanctions or
penalties](#_bookmark238)
7. [– Enforcement with the help of non-designated](#_bookmark238)
[third parties](#_bookmark238)
8. [– Enforcement via regional authorities, geographic](#_bookmark238)
[entities or designated third parties](#_bookmark238)
9. [– Designation and supervision of public](#_bookmark239)
> [or private organisations entrusted to play a special](#_bookmark239)
> [role in the application of regulation](#_bookmark239)
10. [– Investigations and data](#_bookmark239)
11. [– Enforcement in general](#_bookmark240)
12. [– Information](#_bookmark241)
13. [– Cooperation, including exchange of data with](#_bookmark242)
[other jurisdictions](#_bookmark242)
14. [– Cooperation, including exchange of data with](#_bookmark243)
[international organisations](#_bookmark243)
15. [– Intra-organisational measures](#_bookmark243)
> [**Annex I: Literature and tools**](#annex-i-literature-and-tools)
>
> [306](#_bookmark228)
>
> [306](#_bookmark228)
>
> [309](#_bookmark231)
>
> [310](#_bookmark233)
>
> [310](#_bookmark233)
>
> [311](#_bookmark235)
>
> [311](#_bookmark235)
>
> [312](#_bookmark236)
>
> [312](#_bookmark236)
>
> [313](#_bookmark237)
>
> [314](#_bookmark238)
>
> [314](#_bookmark238)
>
> [314](#_bookmark238)
>
> [316](#_bookmark239)
>
> [316](#_bookmark239)
>
> [318](#_bookmark240)
>
> [319](#_bookmark241)
>
> [320](#_bookmark242)
>
> [321](#_bookmark243)
>
> [321](#_bookmark245)
>
> [322](#annex-i-literature-and-tools)
# FOREWORD TO THE SECOND EDITION OF THE HANDBOOK 2021
> Officials in possession of an inventory of regulatory techniques have
> more choic-es and can conceive of better regulation. The same goes for
> officials disposing of methodological knowledge. This Handbook strives
> to provide both an inventory of regulatory techniques and a basic
> method of law-making.
>
> The second edition goes beyond the first edition of 2014 by presenting
> two addi-tional perspectives on regulation:
- a macro-view: an introduction into the topic of regulatory
architecture (Chapter 2) that can help in the harmonious configuration
of different pieces of regulation,
- a micro-view: a typology of requirements and other provisions
(Chapter 3) that helps to complement or otherwise improve individual
provisions.
- These two new1 chapters and about 70 new sections or sub-sections
com-plement the inventory of regulatory techniques and methodology of
the first edition.
> The second edition is edited by the Regulatory Institute. It builds on
> the first edi-tion written by Manfred Kohler, an official of the
> European Union with more than 20 years of experience in law-making in
> various national and international con-texts. The second edition
> integrates knowledge and in particular good examples of regulation
> identified by the Regulatory Institute. The number of jurisdictions
> referred to has thereby increased from nine to 42. Likewise, the
> number of sec-tors2 covered by the referenced regulations has
> increased to 82. For details about the jurisdictions and sectors, see
> [Subsection 1.3](#_bookmark13).
>
> The identification of generally interesting and useful regulatory
> techniques in so many different and diverse jurisdictions and sectors
> confirmed a basic assump-tion of this Handbook: the topic “regulatory
> techniques” is universal, not limited to specific sectors. Regulators
> can all learn from each other, across jurisdictions and sectors, by
> profiting from the remarkable intelligence laid down in existing
> legislation.
>
> 1 Chapter 2 also contains, at the end, some Sections which were
> already present in the first edition.
>
> 2 For the definition of “sector”, see the following [Section
> 1.1](#_bookmark10).
1\. TÍTULO 13
> 1
1. Terminology
> In this Handbook, we use the following expressions:
>
> “Jurisdiction” means a nation state or a conglomerate of nation states
> that has its own regulatory empowerments. A part of a nation state
> that has autonomy to regulate is also referred to as a:
- “jurisdiction”.
- “Geographic entities” refers to parts of a jurisdiction.
- Geographic entities are, for example, the various states in a federal
state like the U.S, Brazil, Canada or Argentina or the member states
of the Mercosur, the ECOWAS, the EU, ASEAN or of another conglomerate
of nation states with its own regulatory empowerments. Geographic
entities necessarily have au-tonomy in the execution of law, but not
necessarily the autonomy to regu-late. Thus some geographic entities
are also jurisdictions whereas most are not. Geographic entities can
be part of other geographic entities.
- We borrow the expression “centre” from the Indian and Canadian
political and administrative practice to refer to the central
government in the case of a nation state or to the central organs in
the case of a conglomerate of nation states with its own regulatory
empowerments.
- We call a “sector” a certain rather limited regulatory subject matter,
which however encompasses a variety of issues. For example, the
“safety of cars”, covering issues like braking, steering, and
crash-test-behaviour, can be distinguished from the sector “emissions
of cars”. Similarly, the sector “telephone services” is separate from
the sector “internet services”. The is-sues of a certain sector are
usually the same across various jurisdictions.
> The expression “sector”
> is thus not related to one single jurisdiction.
- The expression “field” refers to several parallel sectors which fall
under the same more generic topic, e.g. environmental protection,
product safety, or telecommunication services. For example, the sector
“safety of cars” per-tains to the field of product safety. The
expression “field” is also not related to one single jurisdiction.
> We strive for a consistent use of the following terms which fit for
> various jurisdic-tions:
- Regulation: Legal acts of general applicability (thus not only for
individual cases). Regulation consists either of legislation (=
legislative acts) or of regu-latory acts. We use “act” or “a
regulation” for an individual piece of regula-tion and “regulation”
for the abstract category of text.
- Legislation (legislative acts): regulation adopted by the respective
legislative power(s).
- Regulatory acts: regulation adopted by the administration (ministry,
depart-ment, agency etc.).
- Regulatory measures: regulation or other measures that influence
behaviour in more than just individual cases. We sometimes also use
the expression “regulatory measures other than regulation” whose
meaning can be deduced from the previous definitions.
> Decisions on individual cases are mostly not dealt with in this
> Handbook, though they might, in exceptional cases, also have a
> regulatory effect, e.g. if they are published and thereby influence
> the behaviour of operators other than those formally addressed. We
> sometimes refer to them as “administrative acts”.
>
> In some chapters, finally, we refer to legislative and regulatory acts
> jointly as “acts” (although the term “acts” normally includes
> administrative acts, we never mean to include administrative acts
> unless we explicitly say so).
2. Development of a practical method of regulating
> There are millions of lawyers in the world. However, only a very small
> fraction of them are involved in law-making or regulating in general.
> Law-making or regulating
>
> in general is mostly not part of university law studies. Law studies
> focus on the ap-plication of law, not on regulating. Studies of
> political science also do not prepare for the activity of regulating
> at an operational level. Only some administrative schools do so.
> Unfortunately, most of them only offer training for specific aspects.
> A few schools deal with the general method and with the tools
> (regulatory tech-niques). There seems to be a vacuum at the level of
> professional training, maybe with the exception of a few jurisdictions
> such as Australia, the U.S. and Switzer-land. To respond to that need,
> the Handbook includes methodological recom-mendations. The Handbook
> presents a basic universal method encompassing the following branches:
- analysis of the sector ([Section 5.1](#_bookmark51)),
- identification of possible goals, objectives, measures, requirements,
incen-tives, and information or enforcement tools ([Section
5.2](#_bookmark61) and [5.3](#_bookmark64) and
[Chapter](#_bookmark118) [10](#_bookmark118) to [12](#_bookmark180)),
- conception of regulatory measures with a focus on regulation (from
[Section](#_bookmark64) [5.3](#_bookmark64) to [Chapter
14](#_bookmark213)),
- basic quality verification ([Chapter 15](#_bookmark224)),
- basic analytical and planning elements regarding the topic of
regulatory ar-chitecture ([Chapter 2](#_bookmark15)), helping to
better embed a new regulation,
- an analytical grid for individual provisions and in particular
conditions and requirements ([Chapter 3](#_bookmark27)), presenting
possibilities for fine-tuning of individu-al provisions, and
- an overview on regulatory measures and incentives.
> The method presented here is admittedly basic. The seven branches
> could be extended by ever more details and alternatives. We refrained
> from presenting more details for a specific reason: some jurisdictions
> have developed regulatory policies. If we had presented more details,
> the presented method would come into conflict with the regulatory
> policies of the various jurisdictions. By tackling only the top level
> of the methodology pyramid and the detailed regulatory tech-niques
> which are below the radar of regulatory policies, this conflict is
> hopeful-ly avoided. Readers are of course invited to complement or
> even to correct the method in view of the practice and the regulatory
> policies of their jurisdiction.
3. Jurisdictions and sectors
> The second edition of this Handbook has come very diverse in terms of
> jurisdic-tions and regulatory sectores referred to.
>
> It refers to examples from the following 47 jurisdictions:
>
> Alberta (Canada), Argentina, Armenia, Australia, Belgium, Bermudas,
> Bhutan, Bosnia and Herzegovina, Brazil, Canada, China, Costa Rica,
> ECOWAS, Euro-pean Union (EU), France, Gambia, Georgia, Germany, India,
> Indonesia, Israel, Japan, Kerala (India), Malaysia, Maldives, Mexico,
> New Zealand, Pakistan, Pan-ama, Philippines, Senegal, Serbia,
> Singapore, South Korea, St. Kitts, Taiwan (China), Tanzania, Thailand,
> Tunisia, South Africa, Uganda, UNECE, United King-dom, United States
> of America, Uruguay, Victoria (Australia), and WTO/TBT3.
>
> Overall, our selection of references is geographically balanced. The
> most fre-quently quoted or referred to jurisdictions are the EU (37x),
> Canada (27x), Brazil (16x), Philippines (14x), Singapore (14x), India
> (12x) and Uganda (10x). Regula-tion of the European Union,
> recognisable by the letters “EU” or “EC” before or after the number of
> the act, is technically interesting and merits this lead-role in so
> far as it combines best practices of its Member States. However, the
> second edition of this Handbook is not dominated anymore by its EU
> roots, as was the first edition. In terms of continents, the Americas
> lead with 61 quotes or refer-rals4, followed by Asia with 55, Europe
> with 535, Africa with 23 and Australia/Pa-cific with five. Three
> additional references to UN provisions bring us up to a total of 200
> quotes or referrals6.
>
> The regulatory examples stem from the following 82 sectors or
> sub-sectors:
>
> Access to information, accounting, agriculture in remote regions, air
> naviga-tion security, air navigation services, aircraft –
> airworthiness and environment,
>
> 3 World Trade Organisation / Technical Barriers to Trade.
>
> 4 31 quotes or referrals relate to Canada (27) and the US (4) and thus
> from the North, 25 from the South and 4 from Middle America.
>
> 5 If UNECE was to be counted as regional UN organisation though
> developing cross-continental regulation in the examples quoted in this
> Handbook, Europe would also come up with 53 quotes or referrals.
>
> 6 In order to facilitate the retrieving of original examples, the same
> examples have in many instances been referred to several times.
> Therefore, the overall number of texts referred to should be just
> above 100.
>
> alcoholic drinks –
> labelling and marking, anti-bullying, anti-trust law, (dormant) bank
> accounts, baby bottles and their nipples, blood, border control,
> (anti) child abuse, status of children and assisted reproduction,
> classification, labelling and packaging of substances and mixtures,
> corporations’ law, compensation for land acquisition and resettlement,
> consumer protection, contractual law, cosmetics, credit institutions,
> credit rating agencies, customs (including rules of origin), data
> protection, disaster alert via mobiles, doping control in sports,
> eco-design of televisions, eggs (marketing), electricity and gas
> inspection, electricity mar-keting, electro-magnetic compatibility,
> electronic documents and signatures, emissions caused by the
> production of cement, lime and magnesium oxide ex-plosives, emissions
> of road vehicles, endangered species protection, energy ef-ficiency,
> energy savings in buildings, fire arms and ammunition, fire safety (of
> petroleium and materials), food contact materials, food - residues of
> veterinary drugs, food security, graphic health warnings, invasive
> alien species, investment funds / firms, investment transparency,
> labour law (making conventions gener-ally applicable), liability of
> legal persons (for acts against the national or inter-national
> authorities), medical devices, mineral water, (anti-) money
> laundering, nuclear materials, organ donation, organic products,
> pensions, pharmaceuti-cals, pipelines, product conformity declaration,
> professional law, public tenders or services for authorities – model
> contracts, right to public consultation, rec-ognition of foreign
> documents and marks on conformity, refugee law, research risks,
> revenue taxation, road traffic, road vehicles safety, road vehicles
> minimum noise / sound, securities trade, seeds, sodium consumption,
> technology risks, (anti-) terrorism, tobacco products labelling,
> traceability and verification (of used medical devices), transparency
> in public life, tire retreading, victim and witness protection,
> whistle-blower and informant protection, and wine (marketing).
4. Correlation table: first and second edition
> Quite some articles on the Regulatory Institute’s website
> [howtoregulate.org](http://howtoregulate.org/) refer to
> specific sections or sub-sections of the first edition of the
> Handbook. In order to permit readers of these articles to retrieve the
> corresponding sections or sub-sections of the second edition can be
> retrieved with the help of the fol-lowing chart:
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style="width:2.35672in;height:0.11885in" />[CONTENTS
> 
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style="width:0.32678in;height:0.12357in" /> MAX VALUE
> 
MEDIUM VALUE
>
> 
style="width:2.35672in;height:0.11885in" />[CONTENTS
> ](#_bookmark1)
>
> In order to see whether the deficiencies are
> specific to a certain target audience, also insert your estimations
> into the following graph – the better the performance, the further to
> the outside:
>
> Geographic entities’ knowledge
>
> Citizens’ responsiveness
>
> Geographic entities’ com-pliance
>
> Citizens’ compliance
>
> Geographic entities’ responsiveness
>
> Citizens’ knowledge
>
> Operators’ knowledge
>
> Operators’ responsiveness Operators’ compliance
>
> MAX VALUE MEDIUM VALUE
4. – *Verification*
> Is the verification of compliance of operators and of citizens:
1. intense enough?
2. targeting the right aspects?
3. executed by the right authorities or entrusted to the right private
bodies?
4. executed at the right time and the right step of the processes
regulated?
5. executed in the right procedure?
6. provided by the right means?
7. optimised in terms of synergy with other sectors’ verification and
supervi-sion?
- Do the authorities or entrusted private bodies have enough staff,
equip-ment and money at their disposal to efficiently execute
their verification and supervision function?
- Is the verification of compliance of
geographic entities intense enough? Insert your estimations into
the following graph – the better the performance, the
1. – *Top problems and potentials*
> Looking back at the answers to questions listed in
> [5.1.1.1](#_bookmark54) to [5.1.1.5](#_bookmark55) or other weak
> points identified:
>
> What are the top five problems of the sector?
>
> class="anchor">What are the top three development
> potentials for the sector, taking upcoming developments into
> particular account (see [5.1.1.1](#_bookmark54))?
1. – Follow-up to the
analysis: first steps towards a response
> There are many ways to find responses to the outcome of the analysis.
> Basically, all management approaches can be applied. We present here
> an approach that is item-oriented and an integral approach. Both
> approaches can also be combined. One can also use one method to verify
> the result of the other.
1. – *The items-oriented approach*
- What are the necessary political, legal, managerial, and
informational steps and means to solve each of the top five
problems?
- Which of the steps and means identified for the previous question
are useful or even necessary to resolve more than one problem?
- What are the necessary political, legal, managerial, and
informational steps and means to realise each of the top three
potentials?
- Which of the steps and means identified for the previous question
are useful or even necessary to seize more than one potential?
- How can the relevant steps and means best be combined so as to
strengthen one another?
- Can some of the non-top-five-problems also be elegantly solved?
- Is it even necessary to integrate solutions to the
non-top-five-problems, e.g. to avoid negative repercussions on the
system?
- What resources do we have at our disposal, at the level of the
Centre and in the geographic entities?
- How can the available resources be used so as to optimise the
system?
> The items-oriented approach is the one that many of us instinctively
> apply. It provides a feeling of “being in control of things”. However,
> we tend to limit the number of problems that we are willing to analyse
> or process. Accordingly, there is a risk of overlooking “secondary”,
> non-top-five-problems, or to underestimate the systemic relevance of
> such problems. To illustrate this with an analogy: if you
>
> have to repair a pot with
> many holes, it might give you a good feeling to repair the five
> biggest holes, but the pot still cannot be used after your attempt to
> repair it.
2. – *The integral approach*
- What would be the best scenario that you can imagine for your
sector for the next five and for the next ten years?
- What would be the second best?
- What resources are needed to ensure that these two scenarios will
become a reality?
- Which elements of the scenarios are important, but can be realised
with few resources?
- Which elements of the scenarios are important, but need many
resources?
- Which elements of the scenarios are less important, but can be
realised with few additional resources?
- What resources do we have at our disposal, both at the level of
the Centre and in the geographic entities?
- How shall we use the available resources so as to optimise the
system?
> If readers find it difficult to answer the questions raised in
> [Subsection 5.1.2](#_bookmark57) with-out thinking of concrete
> measures, they are invited come back to these questions once they have
> read the other parts of this chapter in which the various types of
> measures are presented.
2. – Examples
> The training sessions on regulatory techniques that were based on the
> first edi-tion of this Handbook contained a practical part. In this
> practical part, one, two or three real cases were presented by the
> participants and analysed in group work. Though this type of
> mini-analysis is not as systematic and comprehensive as the previously
> outlined sector analysis, the experience gained in the group work
> illus-trates why a sector analysis is useful: it triggers a new
> perspective on the issues. During the group work, the primary topic
> was often shifted and always comple-
>
> mented by secondary topics. Mostly new candidate measures were
> identified. The following, partly fictional17, examples illustrate
> this.
1. – *Example 1: “The method gap”*
> When the training course participant presented her case to her peers,
> she feared that the parliament would accuse her department of being
> inactive with regard to risks linked to the size of particles used as
> coating for certain devices falling under the relevant sector
> regulation. The sector regulation indeed had no provisions on micro-
> and nanoparticles, but contained general clauses which could be
> under-stood as obliging one to reduce risks linked to particle size.
> Evidently, no specific risk evaluation methods were set out.
> Individual manufacturers have undertaken research both on risks and
> risk assessment, but were reluctant to share the re-sults. They feared
> that their products would be regarded as unsafe by authorities. To
> anticipate pressure from the parliament, the superior of the
> participant wanted to launch an amending regulatory act. The
> participant felt uncomfortable: what should the regulatory act be
> about given that risk assessment methods were not yet well
> established? And how could the method, once laid down in the future
> reg-ulatory act, be updated given that science was still evolving so
> fast? Despite these questions, she was constantly thinking in terms of
> an amending regulatory act.
>
> After the discussion with her peers, the participant came to the
> conclusion that, instead of adopting a new regulatory act, it would be
> more appropriate to draft a short guidance document explaining why and
> how risks linked to particle size were to be evaluated under the
> current regulation. In parallel thereto, she envis-aged developing,
> together with the industry and stakeholder associations, a web-site
> that would inform users of the methodological state of the art. Beyond
> sci-entific literature, industry methodological instructions, so far
> kept secret, would also be made available in an anonymised form by the
> respective industry associ-ation. The sector could thus defend itself
> against pressure from the parliament by demonstrating that law cannot
> contain more than the general safety requirement which already exists,
> that this general safety requirement is basically sufficient and that
> the crucial issue of methodology can best be dealt with by a dynamic
> internet based information platform.
>
> 17 The real cases were modified in such a way (e.g. by changing topics
> and merging similar cases) that the text presented here cannot be
> regarded as representing a real situation whilst still exemplifying
> the learning effects of analysing the system.
2. – *Example 2: “No empowerment for the real thing”*
> The participant presented a dilemma: she had to deal with a three-step
> decision making and information process. There was an empowerment to
> regulate by reg-ulatory acts the second and the third step which both
> dealt with pure information transmission. However, there was no
> empowerment to regulate on the first which was the crucial step in the
> process. The crucial first step fell under the compe-tence of
> geographic entities. Geographic entities were extremely vigilant as to
> their prerogatives in this respect. Unfortunately, the steps 2 and 3
> could not be correctly processed unless the communication regarding
> step 1 is standardised and channelled. Otherwise there would be a high
> risk of misunderstandings and mistakes.
>
> In the discussion with her peers, the view was broadened. Instead of
> simply re-flecting in terms of instruments (“Which tool to choose?”),
> the entire process was looked at. The question arose: How to convince
> geographic entities to manage all three steps in an integral way? A
> solution consisted in developing a form and making it mandatory for
> steps 2 and 3. But this form should also cover the com-munication
> needs of step 1! Geographic entities could of course decide not to use
> the form for step 1, but the form would allow them to economise in
> terms of time and human resources. Furthermore, it would be risky for
> them to use another form just for step 1: mistakes could occur when
> transferring data from this other form to the form to be mandatorily
> used for steps 2 and 3. Thus it would be sim-ply irrational for
> geographic entities not to also use the form for step 1. Finally, by
> presenting the criteria relevant for step 1 in a non-binding way in
> the form, it might even influence the substantive decision making for
> step 1. Although there is no formal empowerment to regulate for step 1
> and the criteria to be applied therein, the simple informal listing of
> all relevant criteria might have a harmonis-ing effect on the practice
> of the various geographic entities.
3. – *Example 3: “Not only clarification needed”*
> According to the initial view of the participant, there was a need for
> legal clarifi-cation with regard to certain rules. This was perceived
> as the major issue by the course participant when he presented his
> case. The clarification could be achieved by new legislation or by
> guidance. A deeper analysis showed that some operators, namely those
> based outside the jurisdiction, were not willing to comply with the
> existing rules or were not even aware of them. Nor would they respect
> new guid-
>
> ance. Clarification by
> new legislation would not be better unless the enforcement by certain
> geographic entities was strengthened. Thus the enforcement came into
> the focus of the course participant.
>
> At the end of the case study, the participant recognised that new
> legislation would further deepen the already uneven playing field,
> unless the new legislation were to set up minimum resource and
> activity requirements for authorities in charge of ensuring
> compliance. The participant seemed more inclined to investigate
> possi-bilities of exerting pressure on certain geographic entities
> with weak authorities so as to get them to increase their enforcement
> efforts. The question of wheth-er new legislation was needed for
> purposes of clarification or whether guidance would be sufficient
> remained open for the time being. But the participant could not
> exclude the fact that, with stronger enforcement, guidance might be
> suffi-cient. Thus he left the course with the intention (1) to firstly
> check possibilities of exerting pressure on geographic entities to
> address the enforcement issue. If this was successful, he would (2)
> need to assess whether guidance would be sufficient to reach the
> clarification goal. Only if (1) or (2) turned out not to work would he
> suggest to his superiors the proposal of new legislation (3). But this
> legislation would have a second chapter on the geographic entities’
> enforcement obligations to address the newly identified issue of
> enforcement.
1. Identifying the policy
goals
> Policy goals can either be predetermined, e.g. by politicians or
> superiors in the administration (5.2.1), or still to be determined
> (5.2.2).
1. – Analysing predetermined policy goals
> Officials working for administrations are often told to follow a
> certain policy goal. In this case it is useful for identifying the
> appropriate regulatory measures to an-alyse what is behind the set
> policy goal: the “goals behind the goals”, so to speak. Some of the
> “goals behind the goals” build chains. The goals which do not de-pend
> on other goals, at the end of the chains, shall be called primary
> goals in this text. The goals which are between the primary goals and
> the officially set goals shall be called intermediate goals.
>
> Let us take a simple example: politicians may
> declare the following goal to be pursued: “to reduce tobacco smoking
> as much as possible”. Behind the declared
>
> But these two goals might just be intermediate goals. They might have,
> subject to the views of the politicians, a common primary goal: to
> increase the number of healthy years in life. Behind the second
> intermediate goal is another interme-diate goal: to reduce public
> spending on health. Behind this goal, there is an-other goal: to
> achieve a healthy public budget. This goal can be regarded as a
> primary goal.
>
> GOALS BEHIND THE GOALS
More healthy years
> Healthy budget
>
> Reduce spending
>
> Reduce sickness
>
> Reduce casualties
> Reduce tobacco smoking
>
> [CONTENTS](#_bookmark1)
>
> To see how the analysis of primary and intermediate goals can widen
> the range of policy choices, let us examine an imagined case. Imagine
> that an official in an autonomous nation state’s ministry is in charge
> of proposing measures *“to reduce as much as possible the use of
> smoking tobacco”*. S/he has so far considered a panel of possible
> measures:
- Increase taxes18 on tobacco products, creating a financial incentive
to smoke less;
- Offer lower health insurance rates for non-smokers, creating another
finan-cial incentive to smoke less;
- Oblige manufacturers of tobacco products to place warnings and
deterring images on the packaging with a view to deterring smokers;
- Launch information campaigns managed by media, health insurances and
schools; and
- Offer anti-addiction courses (e.g. managed by health insurances).
> Let us look at the first of the possible measures. Increasing taxes on
> tobacco will increase the overall tax revenue, but it will only
> increase it up to a certain taxa-tion rate. From a certain taxation
> rate onwards, any further increase will decrease the overall revenue,
> as economists have found out and as the political reality in some high
> tax states has also proven. This is because the taxation rate becomes
> either too prohibitive or because it becomes too appealing to commit
> tax fraud when taxes are extremely high. Accordingly, from a certain
> level onwards there can be a conflict between “creating by higher
> taxes a financial incentive for not smoking” and “increasing the
> overall revenue”. As the official has detected this potential
> conflict, the official may quantify the two contrary financial
> effects. When doing so, the official can also analyse secondary
> financial effects of the measure, namely the effect of the costs of
> less smoking on the health insuranc-es. Different theories have been
> circulated in this respect: subject to the overall costs triggered by
> an increased longevity, health insurances might win or lose with the
> increased taxes.
>
> 18 We use here the commonly used expression “taxes” although “excises”
> would be the right expression in most states.
>
> Even when higher taxes have a negative
> financial effect overall, it might be good for the health of the
> population to increase the taxes beyond the critical level. Thus the
> official can offer the politicians a useful choice to make: optimise
> reve-nue or optimise positive health effects or choose a compromise in
> between.
>
> A similar analysis can be undertaken for the four other measures that
> our offi-cial is considering. All the other four measures will
> evidently cost money. Their respective benefit-cost-ratio merits can
> be examined individually and compara-tively (comparing the measures
> against each other) so that the politicians (or the administrative
> decision maker) can select the most cost-efficient ones.
>
> Thus we can deduce already from this relatively simple example that
> knowing the primary goals of the politicians can trigger second
> thoughts. The official can offer the decision maker(s) a wider range
> of measures and thus a wider choice. S/he can point out trade-offs
> that nobody would have detected without analysing the primary goals of
> the politicians.
>
> In a second example, we will go further and show that the analysis of
> the goals can even trigger collateral measures which are useful to
> optimise the pursuit of the goals. Let us imagine a fully autonomous
> nation state with some domestic oil production and the power to fix
> oil prices on the internal market. In this state, politicians are in
> favour of the goal: “reduce private transport in cars”.
>
> The politicians are in favour of this goal for a wide range of
> reasons:
- Some politicians wish to reduce congestion with a view to reducing the
loss of working-time of employees.
- Some wish to slow down climate change.
- Some wish to reduce toxic pollution and noise in cities to avoid
illness and casualties.
- Some wish to reduce the number of accidents in order to avoid injuries
and casualties.
- Some wish to keep the internal fuel prices low. In this group, the
politicians follow different primary goals: some wish to keep industry
production costs low, some have the same wish for agricultural
production costs, and other politicians aim at keeping food prices low
so that the poor can afford their food19.
> The immediate response to the request of the politicians could consist
> of suggest-ing the following measures:
- Increase the price of petrol and diesel on the internal market;
- Establish a vehicle taxation system which is based on fuel consumption
as primary or sole parameter;
- Limit the right to circulate in a certain car to every second working
day in order to promote commuter communities; and
- Tax or circulation right privileges for electric cars or for cars with
fuel con-sumption at least 50% below the average.
> But in view of the primary goals pursued by the politicians, more
> (groups of) measures could be offered:
- In view of local noise and toxicity reduction: Introduce limitations
for car circulation subject to noise and fuel consumption (no cars
with medium or high noise or toxic emissions in the inner city, no
cars with high noise or toxic emissions in cities at all);
> 19 There is a double correlation between food and oil prices: a high
> oil price makes food production more costly and agricultural surfaces
> can be used either for food or bio-fuel production, thus both markets
> are linked.
- In view of reduction of
cancer provoking fine particles mainly emitted by die-sel engines:
give an incentive to use petrol instead of diesel cars, either by tax
incentives or by extended circulation rights; and
- In view of industry and agricultural production costs: determine
different price levels for oil, subject to its use.
> In addition, the official can inform his superiors or the politicians
> of the subtle trade-off which has to be made in order to optimise the
> result in view of the dif-ferent, partly conflicting goals. Here are
> two of them:
- Weight is an important factor for fuel consumption of vehicles. But
safety features increase weight.
- NOx optimisation of engines is to a certain limited extent
counter-productive for fuel consumption reduction and vice-versa.
> We stop the analysis here as we do not aim at presenting all
> possibilities and side-effects. We simply aimed to show that the
> analysis of primary and interme-diate goals can lead to new measures
> and to the optimisation of measures.
1. – Determining further policy goals
> Even if some goals are pre-determined by politicians or the head of
> the admin-istration, officials should examine whether further goals
> need to be determined or spelled out (sometimes goals have not been
> consciously set, but are implicitly expected). It is very unlikely
> that the politicians or the head of the administration have undertaken
> a complete analysis of the sector, that they are aware of all the
> problems and that they see all the possible positive developments
> (potentials). By examining whether further goals should be set,
> officials can inform their supe-riors and/or the politicians of
> further possibilities to improve the sector.
>
> The best basis for setting goals is the analysis of the sector. Each
> of the problems identified in the sector analysis can be turned into a
> goal. But one should not limit oneself to the problems. As we have
> also seen in the sector analysis, there can be potentials for
> improvement which are not linked to a problem.
>
> If properly done, a sector analysis will detect so many problems and
> potentials for improvement that it is hardly possible to manage them
> all in the regulatory
>
> process. Therefore, it
> can be advisable to split problems and potentials into two groups:
> major and minor issues.
1. Determining objectives,
measures, requirements and incentives
> To illustrate what is meant by “objectives”, “measures”,
> “requirements” and “in-centives”, let us use an example. Imagine that
> local politicians have decided to pur-sue the political goal “to
> reduce the number of traffic accidents in town”. Together with the
> local administration, they have developed different objectives that
> are deemed to concretise the goal. One of the objectives is to ensure
> that vehicles do not drive too fast. One of the requirements
> concretising this objective could be: vehicles should not drive faster
> than 30 km/h in an area of 100 meters surround-ing schools. Respect of
> the requirement shall be ensured by three measures:
- Establishment of a zone with reduced maximum speed by speed limit
indi-cations;
- Enforcement of the speed limit by radar surveillance, vehicle
identification and financial sanctions; and
- Establishment of radars displaying: “Thank you for respecting the
speed limit”.
> The first two measures are based on the incentive “avoid sanctions”.
> The last measure uses the incentive “praise”.
>
> Once the goals have been determined, officials might think of
> determining the objectives. Objectives are, like goals, determining
> targets, but they are more con-crete and measurable than goals.
> Objectives are sometimes explicitly laid down in regulation20.
> Determining objectives can be mandatory according to the planning or
> impact assessment mechanism of the respective jurisdiction. However,
> objec-tives are not always necessary for the identification of
> measures, requirements and incentives. If the goals are already quite
> concrete, it might be easier to skip the level of objectives and think
> immediately in terms of measures, requirements and incentives.
> Furthermore, it is sometimes impossible to establish ambitious but
> realistic objectives without having examined requirements, their
> incentives and the measures which are to refer to them. If the
> enumeration of objectives is
>
> 20 See as example Article 2 of the [Uruguayan Law N° 19855 on
> alcohol consumption](https://perma.cc/9487-4B6N) (Creacion de
> marco regulatorio para el consumo problematico de bebidas alcoholicas)
> of 23/12/2019.
>
> mandatory according to applicable regulatory policies, but the
> official does not need them for his personal planning, the official
> might also proceed without enu-merating the objectives and might
> deduce the objectives later, thus filling in the gap for the official
> planning process or impact assessment.
>
> Is it best to start with the measures, requirements or the incentives?
> It is difficult to establish an order that is valid and best for all
> cases. Instinctively, one might think that measures come first. But
> starting with the measures might focus the view automatically on the
> requirements and incentives that fit with the meas-ures identified.
> Other requirements and incentives are lost to sight. Accordingly, it
> might be better to note the measures which have come to mind naturally
> when doing the system analysis or the analysis of the goals, but to
> put these measures “into the fridge” until the requirements and
> incentives have been analysed and cast into measures.
>
> As for the order in which requirements and incentives should come, it
> is advisable to undertake two exercises:
- Examining requirements and attributing to them the appropriate
incentives; and
- Identifying suitable incentives and inventing appropriate
requirements. These requirements invented on the basis of incentives
may differ from the requirements so far identified under the first
indent. They may differ in na-ture or in terms of stringency.
> Once the requirements and incentives have been identified, one can
> think anew on the measures. It is possible to deduce appropriate
> measures from the require-ments and incentives. During this exercise,
> one may also reflect on the measures that were put aside. If some of
> the latter do not match with the requirements and incentives whilst
> still felt to be worthwhile, there is a certain likelihood that some
> requirements and incentives have been missed in the previous step.
> Here again,double-checking and back-tracking may help to identify
> loopholes.
>
> Whatever order has been chosen, it is always advisable to try, in
> addition, a differ-ent starting point. Different starting points
> usually lead to the identification of ad-ditional requirements,
> incentives and even measures. By using different starting points,
> there is a wider choice and therefore more possibilities to get
> positive poli-cy results. The use of this method reduces the
> likelihood of missing opportunities.
1. Keeping the oversight
on goals, objectives, measures, requirements and incentives
> We have seen, by the sheer number of parameters presented so far, how
> complex decision-making can be. We will see throughout the Handbook
> how these and many more aspects can be taken into account content-wise
> and how they are interlinked. How can one maintain oversight and
> perspective?
>
> One way to maintain oversight and perspective is to write the
> different goals, ob-jectives, measures, requirements and incentives on
> cards and to pin the cards on a wall, board or big sheet of paper.
> Goals would be placed on the left, objectives on the medium left,
> measures in the middle, requirements on the medium right and
> incentives on the right21. All five should be linked by lines or
> arrows going from left to right or right to left to express
> relationships and impacts. Accordingly, the best vertical arrangement
> is the one with the least crossing of lines. The least crossing of
> lines can often best be achieved if similar goals are close to each
> other, if similar objectives are also close to each other etc. A
> similar picture can of course also be developed electronically. The
> downside of the method is: one needs a lot of space. The major
> advantage is the visual impression.
>
> OVERVIEW ON GOALS, MEASURES ETC.
>
> Objective 1
>
> Goal 1 Measure 1
>
> Objective 2
Measure 2
> Objective 3
>
> Requirement 1
>
> Requirement 2
>
> Requirement 3
>
> Requirement 4
>
> Incentive 1
Goal 2
> Objective 4
>
> Measure 3
>
> Requirement 5
>
> Requirement 6
>
> Incentive 2
> 21 It is possible to extend the graph even further so as to include
> information and enforcement tools. These tools will be dealt with in
> [Section 11.1](#_bookmark141).
>
> [CONTENTS](#_bookmark1)
>
> Another, more classic way consists of numbering and listing the
> different goals, objectives, measures, requirements and incentives in
> separate charts and indicat-ing how they are linked:
>
> THE CHART OF GOALS\*
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style="width:3.10261in;height:2.8889in" /> class="anchor">*If you once forfeit the confidence of your
> fellow citizens, you can never regain their respect and es-teem. It is
> true that you may fool all of the people some of the time; you can
> even fool some of the peo-*
*ple all of the time; but you can’t fool all of the people all of the
time.*
***Abraham Lincoln***
> We start this chapter with a range of topics that are relevant both
> for ex ante and ex post verification. These are followed by the topic
> of harmonised interpretation in general and by other topics that
> influence the effectiveness of implementation.
1. Clear, authority friendly rules on burden, means and degree of proof
> Both ex ante and ex post verification can easily fail if the
> applicable rules on the burden of proof are difficult to fulfil on the
> part of the authorities. Furthermore, the interpretation of the rules
> on the burden of proof may deviate from one state, region or district
> to the next. To avoid this, regulators may think about establish-ing
> rules on the burden of proof and the degree of likelihood requested to
> state whether a certain condition is fulfilled.
>
> The [Argentinian Law 26.912 on the legal regime for the prevention
> and Control
> of](http://servicios.infoleg.gob.ar/infolegInternet/verNorma.do?id=224421)
> [Doping in Sport of 13 November
> 2013](http://servicios.infoleg.gob.ar/infolegInternet/verNorma.do?id=224421)
> contains, in its Article 16, rules on burden of proof and degree of
> likelihood requested for assuming doping. Article 17 of that act
> provides rules on means of proof, mixed with procedural elements.
> These two articles contain very sophisticated provisions on proof (in
> regulation outside criminal law):
>
> *“ARTICULO 16.- Carga y grado de la prueba del dopaje. Recae sobre la
> organ-ización antidopaje la carga de probar que se ha producido una
> infracción de la norma antidopaje. El grado de la prueba debe ser tal
> que la organización que haya establecido la infracción de las normas
> convenza al tribunal interv-iniente teniendo en cuenta la seriedad de
> la afirmación que hace. El grado de la prueba debe ser mayor al de un
> justo equilibrio de probabilidades pero in-ferior a la prueba más allá
> de cualquier duda razonable. Cuando el presente régimen haga recaer en
> un atleta o en cualquier otra persona que supuesta-mente hubiera
> cometido una infracción la carga de invertir tal presunción o de
> establecer la existencia de circunstancias o hechos específicos, el
> grado de la prueba debe ser el justo equilibrio de posibilidades,
> excepto en los casos contemplados en los artículos 26 y 32 del
> presente régimen, en los que recae sobre el atleta una mayor carga de
> la prueba.*
>
> *ARTICULO 17.- Medios de establecer hechos y presunciones. Los hechos
> rela-tivos a infracciones de la norma antidopaje pueden probarse por
> cualquier medio legítimamente obtenido, incluida la confesión. Las
> siguientes normas de prueba son de aplicación en los casos de dopaje:*
1) *Se presume que los laboratorios acreditados por la Agencia Mundi-al
Antidopaje realizan análisis de muestras y aplican procedimientos de
custodia de conformidad con la norma internacional para
labora-torios. El atleta u otra persona pueden desvirtuar esta
presunción de-mostrando que se ha producido una desviación, con
respecto a la norma internacional, que podría haber causado
razonablemente el resultado analítico adverso. En este caso, recae
sobre la organización antidopaje la carga de demostrar que esa
desviación no pudo haber sido el origen del resultado analítico
adverso;*
2) *Toda desviación con respecto a cualquier otra norma internacional u
otra norma o política antidopaje que no haya supuesto un resultado
analítico adverso u otras infracciones a las normas antidopaje, no
invalida tales resultados. Si el infractor demuestra que una
desviación con respecto a otra norma internacional u otra norma o
política de control del dopaje podría haber causado razonablemente
el resultado analítico adverso, recae sobre la organización
antidopaje la carga de establecer que esa desviación no ha originado
la infracción a la norma antidopaje;*
3) *Los hechos demostrados en una sentencia firme del Tribunal Nacional
Disciplinario Antidopaje constituyen una prueba irrefutable contra
el atleta o la otra persona a los que afecte la sentencia sobre
tales hechos, a menos que alguno de ellos demuestren que dicha
sentencia contraviene los principios generales del derecho; …”*
> Amended machine translation:
>
> *“ARTICLE 16 -. Burdens and standards of proof of doping. Anti-doping
> Organ-izations have the burden of proving that there has been a
> violation of an an-ti-doping rule. The standard of proof should be
> such that the organization which has established the infringement of
> the rules convinces the intervening court, considering the seriousness
> of the allegation. The degree of proof must be greater than a mere
> balance of probability but less than “proof beyond any reasonable
> doubt”. When this scheme places on an athlete or anyone else who has
> allegedly infringed the law the burden of inverting such a presumption
> or of establishing the existence of special facts or circumstances,
> the standard of proof should be the right balance of probabilities,
> except in the cases speci-fied in Articles 26 and 32 of this scheme,
> under which a greater burden of proof falls on the athlete.*
>
> *ARTICLE 17 -. Means of establishing facts and presumptions. The facts
> relating to anti-doping rule violations may be proved by any means
> lawfully obtained, including admissions. The following rules of
> evidence are applicable in doping cases:*
1) *It is assumed that the laboratories accredited by the World
Anti-Doping Agency conducted sample analysis and custodial
proce-dures in accordance with the International Standard for
Laboratories. The athlete or other person may rebut this presumption
by establish-ing a deviation from the international standard, which
could reason-ably have caused the adverse analytical finding. In
this case, the anti-doping organization has the burden of
establishing that such de-viation could not have been the origin of
the adverse analytical find-ing;*
2) *Any deviation from any other International Standard or other
anti-doping rule or policy which did not cause an adverse analytical
finding or any other anti-doping rule violation does not invalidate
such results. If the offender shows that a deviation from another
Inter*
> *national Standard or other standard or doping control policy could
> reasonably have caused the adverse analytical finding, the Anti-Doping
> Organization has the burden of establishing that such a deviation did
> not cause the violation of doping rule;*
3) *The facts established by a final determination of the National
Anti-Doping Disciplinary Tribunal constitute irrefutable evidence
against the athlete or the other person whom the judgment on those
facts affects, unless any of them show that the judgment is contrary
to the general principles of law; …”*
> Refugee law is a field where a presumption is widely used for quickly
> determining whether a person is a refugee or not. See for instance the
> Refugee Act of
> [Gambia](http://www.refworld.org/publisher%2CNATLEGBOD%2CLEGISLATION%2C%2C4a71a8202%2C0.html)
> which contains a clause on prima facie refugee recognition criteria:
>
> *“…the Secretary of State may, …, declare a person or persons
> belonging to a particular class or nationality, on the basis of
> objective, prevailing circum-stances in that person’s or those
> persons’ country of origin or nationality, to be a refugee or refugees
> recognised on a prima facie or group basis.”*
>
> Presumptions can be combined with the explicit possibility to counter
> them. A classic field where this technique is used is the consent to
> organ transplant after death. In the so-called “opt-out” systems it is
> stipulated that the consent is pre-sumed unless there is evidence for
> the contrary. Inter alia
> [France](https://solidarites-sante.gouv.fr/systeme-de-sante-et-medico-social/parcours-de-sante-vos-droits/respect-de-la-personne-et-vie-privee/article/les-modalites-du-don-d-organes-ou-de-tissus)
> and
> [Belgium](https://www.health.belgium.be/en/post-mortem-donation)
> have created “opt-out” systems.
>
> The Malaysian [Anti-Money Laundering, Anti-Terrorism Financing and
> Proceeds of](http://amlcft.bnm.gov.my/AMLCFT07.html) [Unlawful
> Activities Act 2001](http://amlcft.bnm.gov.my/AMLCFT07.html) has
> foreseen provisions on the standard of proof to be applied in the
> verification of conditions for state action. Similar to classic penal
> procedural law, it also indicates which documentary evidence and
> statements are acceptable:
>
> *“70.*
1) *Any question of fact to be decided by a court in proceedings under
this Act shall be decided on the balance of probabilities.*
2) *Subsection (1) shall not apply in relation to any question of fact
that is for the prosecution to prove in any proceedings for an
offence under this Act or any subsidiary legislation under it.*
71. *Where the Public Prosecutor or any enforcement agency has obtained
any document or other evidence in exercise of his powers under this
Act or by vir-tue of this Act, such document or copy of the document
or other evidence, as the case may be, shall be admissible in
evidence in any proceedings under this Act, notwithstanding anything
to the contrary in any written law.*
> *72.*
1) *In any trial or inquiry by a court into an offence under this Act,
any statement, whether the statement amounts to a confession or not
or is oral or in writing, made at any time, whether before or aker
the per-son is charged and whether in the course of an investigation
or not and whether or not wholly or partly in answer to questions,
by an ac-cused person to or in the hearing of an officer of any
enforcement agency, whether or not interpreted to him by any other
officer of such enforcement agency or any other person, whether
concerned or not in the arrest of that person, shall,
notwithstanding any law or rule of law to the contrary, be
admissible at his trial in evidence and, if that per-son tenders
himself as a witness, any such statement may be used in
cross–examination and for the purpose of impeaching his credit.*
2) *No statement made under subsection (1) shall be admissible or used
as provided for in that subsection if the making of the statement
appears to the court to have been caused by any inducement, threat
or promise having reference to the charge against the person,
pro-ceeding from a person in the enforcement agency and sufficient
in the opinion of the court to give that person grounds which would
appear to him reasonable for supposing that by making it he would
gain any advantage or avoid any evil of a temporal nature in
reference to the proceedings against him.”*
> As inspiration for further investigation of issues of proof that might
> be worthwhile being regulated, we recommend the part “Title IVB”
> (Articles 1353 onwards) of this translation of a part of the French
> Civil Code as recently amended: [The law
> of](https://perma.cc/ZM6L-655A) [contract, the general regime
> of obligations, and proof of obligations, the new pro-visions of the
> Civil Code created by Ordonnance n° 2016-131 of 10 February
> 2016](https://perma.cc/ZM6L-655A).
1. Clear consequences of
non-conformities or negative test results
> Enforcement authorities often struggle with cases in which there is no
> doubt about non-conformity, but for which no clear consequence of the
> non-conform-ity has been determined by regulation. In these cases, the
> question often arises: is the non-conformity important enough to ban
> the product, service or activi-ty in question? To avoid this
> uncertainty, it is useful to link in the regulation all different
> types of non-conformity with appropriately severe legal consequences.
> Legal consequences can e.g. be: rejection of the authorisation or
> certification, suspension of the authorisation or certification,
> prohibition to exert a certain ac-tivity, limitation of or conditions
> for exerting a certain activity, additional verifica-tion measures,
> additional procedural obligations (like partial re-authorisation or
> re-certification), or undergoing special training courses.
>
> A good example can be found in Section 6.1.1.3 of the [Brazilian
> Portaria n.º 35](https://perma.cc/VYX4-QKW2) of 3 February 2009
> “Requirements for conformity approvals for baby bottles and the teats
> for baby bottles”62. This regulatory act determines exactly the number
> of tests to be undertaken and how many of the tests must be negative
> to justify the rejection of a product.
>
> The [Brazilian Portaria INMETRO / MDIC Number
> 247](https://perma.cc/ZKL2-WJX4) of 26/05/2014 on the con-formity
> assessment for the retreading of tires also contains, for example, an
> in-struction on the number of tests to be conducted and what happens
> in case of negative test results. Furthermore, it highlights the
> relevance of doing the right sampling and determining the test
> setting:
>
> *“D.1.1 Definição dos ensaios a serem realizados*
1. *Os ensaios devem ser realizados em laboratório acreditado, de
acordo com os requisitos estabelecidos pelo RTQ para o Serviço de
Reforma de Pneus e de acordo com a respectiva família descrita no
subitem 4.5 deste RAC.*
2. *Os ensaios devem ser realizados em uma amostra de prova. No caso de
reprovação desta amostra, o ensaio deve ser repetido nas amostras de
contraprova e testemunha, devendo ambas serem aprovadas.*
> *D.1.2 Definição da amostragem*
>
> 62 “Requisitos de avaliacao da conformidade para mamadeiras e bicos de
> mamadeiras”.
>
> *A amostragem deve ser
> realizada por família de acordo com o subitem 4.5 deste RAC, composta
> por 01 (uma) unidade de prova, 01 (uma) unidade de contraprova e 01
> (uma) unidade de testemunha.”*
>
> Amended machine translation:
>
> *“D.1.1 Definition of tests to be performed*
1. *The tests shall be conducted in an accredited laboratory in
accordance with the requirements established by RTQ for Service Tyre
Retreading and ac-cording to their families described in subsection
4.5 of this RAC.*
2. *The tests must be conducted with a test sample. In case of failure
of this sample, the test must be repeated with a rebuttal and a
witness sample, and both should be approved.*
> *D.1.2 Definition of sampling*
>
> *Sampling must be performed by family in accordance with subsection
> 4.5 of this RAC, consisting of 01 (one) unit test, 01 (one) unit of
> rebuttal and 01 (one) unit of witness.”*
2. Discretionary powers and vague legal expressions / margins of
appreciation
> Discretionary powers and vague legal expressions are tools to allow
> for a fine-tuned implementation63.
>
> A discretionary power exists if an authority or another entity has the
> right to de-cide freely, provided that certain conditions are
> fulfilled. Discretionary powers are often expressed by the words “can”
> or “may” or by leaving a choice to the authority. Examples: “In case
> of infringement of the obligation to notify chang-es of the quality
> system, the authority may withdraw its authorisation ” and “In case of
> infringement of the obligation to notify changes of the quality
> system, the authority must withdraw its authorisation or impose
> additional conditions”. The empowerment of the authority is only given
> if certain conditions are fulfilled. These conditions can be precise
> or not.
>
> 63 We address them here under the perspective of implementation,
> though they are evidently also part of the requirements.
>
> Regulation often gives a
> certain discretionary power to authorities with a view to ensuring an
> implementation that is adapted to the local needs or the needs of a
> specific case. This can make sense if the regulator cannot precisely
> list all of the requirements for the authority or another entity to
> act or if the regulator considers that flexibility is needed to cover
> atypical cases. However, discretionary powers bring risks. The first
> is the risk of diverging administrative practice. The second is
> corruption which is linked to the third: limited judicial control. The
> risks can to a modest extent be reduced by indicating in the
> regulation to what purpose the discretionary power has been conveyed.
> The purpose can, subject to the jurisdic-tion, for instance be
> expressed in the recitals or in the rationale. In some jurisdic-tions,
> it is even possible to indicate the purpose of a discretionary power
> in the core text of the regulation.
>
> The disadvantages stated for discretionary powers are also to be noted
> for vague legal expressions. Vague legal expressions may be used as
> part of the conditions (“In case of infringement of the obligation to
> notify substantial changes of the quality system, ...”) or as part of
> the enacting part of a sentence (“... , the authority must take
> appropriate measures.”). Vague legal expressions open up a margin of
> appreciation that is, according to the rules of the respective
> jurisdiction, subject to full or limited judicial control. However,
> whilst opening up a margin of appreci-ation, they may be used to limit
> a discretionary power; see e.g. the fragment “... , the authority may
> take proportionate measures.”. Without the word “proportion-ate” the
> authority could take all measures, not just proportionate ones. The
> word “proportionate” thus has a limiting effect. Thus, there are many
> ways to combine the two instruments.
>
> Taking account the disadvantages of the two instruments, it is
> advisable to use them in a restricted way. To examine whether their
> use is really necessary, regu-lators might carefully check whether the
> cases intended to be covered cannot be better framed by more precise
> regulatory text.
3. Ensuring harmonised
interpretation in general
> Sometimes, questions of interpretation can even be clarified by simple
> defini-tions. To avoid diverging interpretations, regulation can also
> contain interpreta-tion guidelines or provide for an empowerment to
> adopt interpretation guide-lines later on.
>
> [Commission Delegated Regulation
> EU/231/2013](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32013R0231)
> of 19 December 2012 supple-menting Directive 2011/61/EU of the
> European Parliament and of the Council with regard to exemptions,
> general operating conditions, depositaries, leverage, trans-parency
> and supervision (of alternative investment funds) contains, in its
> Article 56, an interpretation guideline:
>
> *“In the absence of specific interpretation given by ESMA or by the
> Joint Com-mittee of the European Supervisory Authorities, the
> provisions of this Section shall be interpreted in a consistent manner
> with the corresponding provisions of Directive 2006/48/EC and with the
> Guidelines to Article 122a of the Capital Requirements Directive of 31
> December 2010 issued by the Committee of Euro-pean Banking Supervisors
> and their subsequent amendments.”*
>
> In some jurisdictions, it might be useful to establish as an
> “interpretative” or im-plementing rule that the law is to be applied
> in a strict way. See Section 18 of the [Graphic Health Warnings Law
> of the Philippines (Act
> 10643)](https://www.officialgazette.gov.ph/2014/07/15/republic-act-no-10643/):
>
> *“Section. 18. Strict Compliance and Inspections. – Absolutely no
> extensions of time to comply with the provisions of this Act shall be
> granted to tobacco man-ufacturers and importers or any other affected
> party.”*
>
> However, in some other jurisdictions, such a sentence could raise
> legal questions as to whether, in other cases, some leniency may be
> applied.
>
> Sometimes the interpretation guidelines cannot be established in
> advance be-cause it is, at the time of adoption of the regulation, not
> yet clear what questions will arise. In this case, it might be useful
> to provide for an empowerment to adopt interpretative measures. See as
> an example [Regulation (EU) No.
> 228/2013](https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32013R0228)
> of 13 March 2013 laying down specific measures for agriculture in the
> outermost re-gions of the Union and repealing Council Regulation (EC)
> No 247/2006. This Reg-ulation contains, in its Article 12, an
> empowerment for the Commission to adopt regulatory acts necessary to
> ensure the uniform application by the Member States of a certain
> article. It is noteworthy that it does not contain any specific
> condition except that the act must be necessary:
>
> *“3. The Commission shall adopt implementing acts regarding the
> measures necessary to ensure the uniform application by the Member
> States of this Ar-ticle, specifically relating to the introduction of
> the system of certificates and the commitment undertaken by operators
> at the time of registration. Those*
>
> *implementing acts shall
> be adopted in accordance with the examination pro-cedure referred to
> in Article 34(2).”*
4. Ensuring the harmonised and stringent work of conformity assessment
bodies
> The designation, supervision and removal processes form the central
> point of leverage for influencing the conformity assessment bodies’
> work. The design of these processes also determines to what extent
> conformity assessment bodies are compliant with legal requirements and
> with instructions given by the author-ities. There are many variables
> for the designation process:
- How many different authorities shall be involved? Subject to the
degree of impartiality and to the competence of the main authority, it
may make sense to involve more authorities.
- Shall there be a right to be designated once certain conditions are
met or is the designation based on a discretionary decision which is
not subject to full judicial control?
- Shall there be detailed documentation requirements for the
application, e.g. in relation to the fulfilment of designation
criteria?
- Shall there be an assessment in the premises of the conformity
assessment body or in the premises of an economic operator being
assessed by the con-formity assessment body (so-called “observed
audits”)?
- Shall the conformity assessment body be periodically assessed?
- Shall there be unannounced surveillance assessments?
- Shall the designation be based on accreditation or not? The weaker the
au-thorities and the stronger the respective accreditation bodies, the
more ac-creditation makes sense. However, accreditation is usually
judged against standards, not against requirements set up by
regulation. If there is a mis-match between the requirements in the
standards and the requirements in the regulation, accreditation is not
extremely useful.
> Besides the designation
> mechanism, there is a wide variety of other measures that can be used
> to strengthen and harmonise the work of conformity assessment bodies
> (legal or paralegal control mechanisms, peer review, codes of conduct,
> informal co-ordination of decision making, etc.). The best example so
> far found in regulation: [Commission Implementing Regulation (EU)
> No
> 392/2013](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32013R0392)
> of 29 April 2013 amending Regulation (EC) No 889/2008 as regards the
> control system for organic production. This Regulation contains a
> detailed programme for enforce-ment. The programme foresees assistance
> by entrusted private bodies, supervi-sion of entrusted private bodies,
> exchange of information between the entrusted bodies and authorities,
> and risk management. The programme determines a min-imum percentage of
> verifications and of unannounced verifications.
>
> A comprehensive strategy on how the decision-making of conformity
> assessment bodies and authorities can be harmonised has been developed
> in [this
> article](https://www.howtoregulate.org/harmonise/#more-589).
1. Ensuring a harmonised and stringent implementation by authorities
> The implementation of regulation is often hampered by weak
> authorities. In order to ensure a minimum level of strength,
> regulators can set up various types of re-quirements, for example:
- Requirements on independence;
- Management requirements;
- Requirements on minimum resources (ideally with clear indication of
mini-mum full-time equivalences, not just vague clauses like
“appropriate number of staff” as the latter is difficult to enforce);
- Obligation to apply a quality system. The [Argentinian Decreto
Nacional
38/13](http://servicios.infoleg.gob.ar/infolegInternet/verNorma.do?id=207794)
of 22 January 2013 obliges, in its Article 13, obliges the National
Genetic Data Bank to undergo an annual quality system ISO
certification.
> Authorities can furthermore be strengthened by clearly defining their
> tasks and by explicitly providing for necessary empowerments to act.
> Without explic-it empowerments, authorities risk being helpless before
> unlawful operators or citizens. Examples of such clear empowerments
> have been presented in [Section](#_bookmark78) [7.2](#_bookmark78).
>
> A comprehensive strategy
> on how the decision-making of authorities and con-formity assessment
> bodies can be harmonised has been developed in [this
> article](https://www.howtoregulate.org/whistleblower-regulations-update/#more-935).
1. Strengthening authorities through intra-organisational measures
> The vast majority of intra-organisational measures for authorities do
> not depend on regulation or, if any at all, “just” financial
> regulation. Hence, they should not be a subject of this Handbook,
> which deals exclusively with regulation. However, subject to the
> jurisdiction, specific empowerments might exceptionally be need-ed for
> the following intra-organisational measures:
- (Re-)Assigning of human resources (in case of changing situation);
- (Re-)Assigning of financial resources (in case of changing situation);
- Assigning of and cooperation with external experts as advisors;
- Creating scientific or advisory bodies;
- Establishing procedures regarding scientific or other advisory bodies;
- Creating intra-organisational independence (e.g. for scientific or
advisory bodies that must have independence to be credible);
- Establishing statutory intra-organisational reporting obligations;
- Establishing intra-organisational control mechanisms (e.g. mandatory
re-view by superior instance for difficult or important decisions,
periodic con-trol review, right to instruct);
- Establishing intra-organisational disciplinary procedures; and
- Establishing whistle-blower protection mechanisms (a universe of its
own, see [Subsection 11.4.3](#_bookmark150) and this
[article](http://www.howtoregulate.org/whistleblowers-protection-incentives/#more-234)).
1. Implementation
tasks: Centre, agency or geographic entities?
> Four task assignment schemes are most frequently recommended:
- To centralise tasks with the Centre,
- To centralise tasks with a specialised agency, operating under control
of the Centre but not necessarily located at the same place,
- To decentralise tasks to geographic entities, and
- To partly decentralise to geographic entities.
> The advantages and disadvantages of these four task assignments can,
> from the perspective of the Centre, be summarised as follows:
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style="width:4.13682in;height:2.8889in" /> class="anchor">*I have nothing but contempt for the kind of
> governor who is afraid, for whatever reason, to follow the course that
> he knows is best for the State.*
***Sophocles***
1. Transitional
provisions and phasing in
> Each jurisdiction uses one or more standard formulations for
> determining the entry into application of regulation. Sometimes, these
> standard formulations are sufficient. Frequently, however, more
> questions should be reflected on:
- Shall the new law be introduced step by step for different parts of
the scope or for all in one go? See e.g. the [Canadian Electricity
and Gas Inspection Act
-](https://laws-lois.justice.gc.ca/eng/regulations/SOR-86-131/index.html)
[Regulations Amending the Electricity and Gas Inspection
Regulations.](https://laws-lois.justice.gc.ca/eng/regulations/SOR-86-131/index.html)
- For which stage in a process shall the new regulation be applied as
from date X and for which other stage from date Y? \[For products, the
stages can be de-termined with the help of the following questions: Is
the relevant product al-ready approved / certified? Has the product
been created? Has it been sold to customers (placed on the market)?
Has the product been handed over to the customer? Is the product
already in use?\] \[For services, the stages can be determined with
the help of the following questions: Has the service been approved /
certified? Has the service been offered? Has the service been sub-ject
to a contract? Has the service been provided?\] Regulation may also
refer to different stages in one single provision. E.g., the
[Tunisian Decree of
the](http://www.legislation.tn/fr/detailtexte/Arrêté-num-2014-0839-du-20-05-2014-jort-2014-043__20140430X8394?shorten=ilWn)
[Minister of Health of 20 May
2014](http://www.legislation.tn/fr/detailtexte/Arrêté-num-2014-0839-du-20-05-2014-jort-2014-043__20140430X8394?shorten=ilWn)
amending the Decree of 24 February 1999 laying down the procedures for
listing particulars which must be displayed on the outer cover of
packets and packages containing tobacco products
> refers both to the time of manufacturing and to the time of order:
>
> *“Article 8 (nouveau) - Les paquets et les emballages destinés aux
> produits de tabac qui sont fabriqués ou commandés avant l’entrée en
> vigueur du présent arrêté, peuvent être utilisés jusqu’au 30 avril
> 2015.”*
>
> Amended machine translation:
>
> *“Article 8 (new) - Packages and packaging for tobacco products that
> are manufactured or ordered before the entry into force of this Order
> may be used until 30 April 2015.”*
- Shall there be a period in which citizens / operators can choose
between the old and the new law? The anticipation of new law is,
generally speaking, in the interest of the jurisdiction, as the new
law is usually more advanced. However, it can create difficulties for
the administration of enforcement. They have to distinguish between
the products or services that are already fulfilling the new
requirements and those that are not.
- Should geographic entities have the option of keeping the old law
applicable for a period of time? Normally, previously applied law
shall cease to apply by a certain date. However, there might be a need
to give geographic entities the possibility of maintaining the law,
for a certain time at least.
- Is there a need to redirect references? If a legal act is repealed,
there might be a need to ascertain whether references to the repealed
act are redirected
> / transferred to the new act.
- Is there a need to repeal (parts of) other legal acts that have become
obso-lete with the repeal of the major act?
- Is there a need to stipulate the provisional application of certain
parts of the measure?
> Regulation needs to determine the date of its application. However,
> there can be, in exceptional cases, a need to leave the date of
> application open for a certain time and to determine it later.
>
> At the time of adoption, it is not necessarily clear (a) when the act
> will be pub-lished and (b) when the administration will be ready to
> apply the act. Accordingly, it can be advisable to empower the
> administration to determine the entering into force of the regulation
> within a certain period of time.
>
> The [Indian right to fair compensation and transparency in land
> acquisition, re-settlement and rehabilitation act of
> 2013](https://www.indiacode.nic.in/handle/123456789/2121?locale=en),
> provides in its Chapter I, Article 1 Par-agraph 3 that the act shall
> enter into force once the Government has so decided, provided that the
> decision is taken within three months after the act being agreed to by
> the president. Canada too uses this technique, and does so even for
> specific sections of a regulation; see for example the [Order
> Fixing February 13, 2014 as
> the](http://www.gazette.gc.ca/rp-pr/p2/2014/2014-02-26/html/si-tr12-eng.html)
> [Day on which Sections 178 and 185 of the Act come into
> Force](http://www.gazette.gc.ca/rp-pr/p2/2014/2014-02-26/html/si-tr12-eng.html)
> (i.e. of the Canada Marine Act).
>
> The entry into force or application date of a regulatory act may be
> linked to the entry into force or application date of another
> regulatory act; see e.g. the [Cana-dian Electricity and Gas
> Inspection Act - Regulations Amending the Electricity
> and](https://laws-lois.justice.gc.ca/eng/regulations/SOR-86-131/index.html)
> [Gas Inspection
> Regulations](https://laws-lois.justice.gc.ca/eng/regulations/SOR-86-131/index.html):
>
> *“8. These Regulations come into force on the day on which section 6
> of the Fairness at the Pumps Act, chapter 3 of the Statutes of Canada,
> 2011, comes into force, but if they are registered aker that day, they
> come into force on the day on which they are registered.”*
>
> Normally, regulation should not come into force prior to its
> publication. Howev-er, there might be special reasons to foresee a
> limited retroactivity (e.g. to avoid manipulations in the transition
> phase). The [Indian National Food Security Act
> No.](https://perma.cc/LNV3-Q5DE) [20 of
> 2013](https://perma.cc/LNV3-Q5DE), published on 10 September 2013,
> stipulates in Chapter I Section 1.(3) that it shall be deemed to have
> come into force prior to its publication:
>
> *“(3) Save as otherwise provided, it shall be deemed to have come into
> force on the 5th day of July, 2013.”*
>
> The [Senegalese law No.
> 2014-01](http://www.jo.gouv.sn/spip.php?article9965) of January 6,
> 2014 relating to the treatment of dormant accounts in the books of
> financial institutions of the Member States of the West African
> Monetary Union (WAMU) also provides for an entry into force and
> supposedly of an application date earlier than the date of adoption:
>
> *“Art. 23. - La présente loi entre en vigueur le 1er janvier 2014.”
> \[...\]*
>
> *Fait à Dakar, le 6 janvier 2014”*
>
> *“Art. 23 -. This Act comes into force on 1 January 2014. \[...\]*
>
> *Made in Dakar, January 6, 2014”*
2. Validity of decisions, legal acts and
certificates based on the previous law
> Something that is sometimes forgotten when preparing new regulation is
> the question of whether decisions, legal acts and certificates taken
> or issued under the old law shall remain valid, and if so under which
> conditions and for how long. Forgetting this question causes a lot of
> legal uncertainty or difficulties, or both, in the transition.
>
> Evidently, there is a conflict between the economic operators’ wish to
> maintain their legal position for as long as possible and the
> regulator’s interest in introduc-ing the obligations of the new
> regulation as fast as possible.
3. Applicability of other regulation
> There is a wide variety of clauses dealing with the applicability of
> other regulation:
- Repeal provisions;
- Provisions stipulating that other regulations remain unaltered;
- Provisions stipulating that other regulations prevail;
- Provisions stipulating that the new regulation prevails over other
regulations;
- Provisions stipulating that no other regulations apply.
> Repeal provisions can be specific, targeting one or several regulatory
> acts, or gen-eral. Section 20 of the [Graphic Health Warnings Law
> of the Philippines (Act
> 10643](https://www.officialgazette.gov.ph/2014/07/15/republic-act-no-10643/))
> repeals not just a specific regulatory act or part thereof, but
> stipulates, in addi-tion, in general terms: *“all other laws, decrees,
> executive orders and other admin-istrative issuances and parts thereof
> which are inconsistent with the provisions of this Act are hereby
> modified, superseded or repealed accordingly.”*
>
> The [Senegalese Law No.
> 2014-01](http://www.jo.gouv.sn/spip.php?article9965) of January 6,
> 2014 relating to the treatment of dormant accounts in the books of
> financial institutions of the Member States of the West African
> Monetary Union (WAMU) also provides for repeal of “contrary previous
> provisions”, and this is even combined with an application date
> earlier than the adoption date:
>
> *“Art. 23. - La présente loi entre en vigueur le 1er janvier 2014.*
>
> *Sont abrogées, à compter de cette date, toutes dispositions
> antérieures con-traires.”*
>
> Amended machine translation:
>
> *“Art. 23 -. This Act comes into force on 1 January 2014.*
>
> *All previous contrary provisions are repealed with effect from that
> date.”*
>
> It is sometimes useful to clarify that other regulation should remain
> unaltered; see as an example [Council Regulation
> EC/428/2009](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32009R0428)
> setting up a Community re-gime for the control of exports, transfer,
> brokering and transit of dual-use items:
>
> “*Article 26 - This Regulation does not affect:*
- *the application of Article 296 of the Treaty establishing the
European Com-munity,*
- *the application of the Treaty establishing the European Atomic Energy
Com-munity.”*
> However, the most common place for such kind of clearance is rather at
> the be-ginning of the legislative measure. Section 21 of the same
> [Graphic Health Warn-ings Law of the Philippines (Act
> 16043)](https://www.officialgazette.gov.ph/2014/07/15/republic-act-no-10643/)
> clarifies that the international obligations prevail over the new
> legislation:
>
> *“Section. 21. Compliance with Existing International Conventions. –
> Nothing in this Act shall modify the measures adopted to give effect
> to the obligations of the Philippines under international conventions
> existing at the time of the enactment of this Act.”*
>
> Such a clarification is not necessary in jurisdictions where
> international law auto-matically prevails over domestic regulation.
>
> An explicit statement that no other legal acts apply is contained in
> Section 3.(2) of the [Canadian Food and Drugs Act, Blood
> Regulations, P.C. 2013-1065
> October](http://www.gazette.gc.ca/rp-pr/p2/2013/2013-10-23/html/sor-dors178-eng.php)
> [9,
> 2013](http://www.gazette.gc.ca/rp-pr/p2/2013/2013-10-23/html/sor-dors178-eng.php):
>
> *“(2) Except for section A.01.045 of the Food and Drug Regulations, no
> other regulation made under the Act applies to blood that is the
> subject of these Regulations.”*
>
> We deal in this Section
> with simple statements on the applicability or non-ap-plicability of
> other regulation. References to or integration of other regulation is
> dealt with in [Section 2.8](#_bookmark25). See also [Section
> 6.7](#_bookmark75) on issues relating to overlap in scope between
> different regulations.
1. Authenticity of acts
> Many regulations foresee declarations or other acts of authorities,
> operators or citizens that trigger legal effects. If they do, the
> question arises as to how and whether the authenticity of these acts
> is to be proven. The acts can consist of:
- oral statements, to be made in front of an empowered official in a
precise form and with appropriate minutes, and
- written statements.
> For written statements, the first question that arises is that of the
> signature: is it to be authenticated by an official?
>
> Can the signature be replaced by an electronic signature? If so, what
> are the re-quirements for authenticity? Regulation should establish
> these requirements. It should be noted thatelectronic signatures are
> under threat from hackers. There-fore, the range of valid signatures
> must be established in a dynamic way. Appar-ently, this issue is
> becoming a business of its own. Canada has even set up reg-ulation
> establishing criteria for the regulator when determining requirements
> for electronic signatures, thus setting up a kind of horizontal
> meta-requirements. The [Canadian Department of Employment and
> Social Development Act -
> Electronic](http://www.gazette.gc.ca/rp-pr/p2/2014/2014-06-04/html/sor-dors117-eng.php)
> [Documents and Electronic Information
> Regulations](http://www.gazette.gc.ca/rp-pr/p2/2014/2014-06-04/html/sor-dors117-eng.php)
> provides:
>
> *“8. The standard of reliability required with respect to any
> electronic signature must be established taking into account the
> following factors, including*
1) *the purpose for which the electronic signature is required;*
2) *a secure electronic signature, which has the same meaning as in
subsection 31(1) of the Personal Information Protection and
Electronic Documents Act; or*
3) *a signature that
results from the application of any technology or process that is
determined by the Minister or the Commission as able to provide the
same level of security as a secure electronic signature.”*
> For written statements, the second question that arises is that of
> transmission. Transmission by classic letter, sent through the mail,
> is certainly the standard. But may transmission be made by e-mail or
> by fax? Or is it, on the contrary, necessary to request the letter to
> be sent as a “registered letter” or by bailiff?
>
> All these questions can evidently arise both for acts of the authority
> and for acts of private persons.
1. Applicability of general administrative or civil law
> The topic of authenticity brings us to the more general topic of
> applicability of general administrative or civil law in the respective
> sector, as a kind of underlying layer. Sector specific acts can hardly
> regulate in detail all issues like:
- validity of a declaration in case of error,
- validity of a declaration of a person which is not necessarily knowing
what s/ he does,
- prescription of rights and obligations,
- the rights and duties of one side where these depend on the fulfilment
of an obligation of another entity (natural or legal person or
authority)68,
- impossibility to perform69,
- representation, or
- means of proof,
> to name but a few. Even where explicitly or implicitly generic
> provisions of the respective jurisdiction are applicable, it makes
> sense to check whether these
>
> 68 For example, an obligation of an economic operator to register
> electronically cannot be fulfilled where the authority has not
> established the means to register. Moreover, it is sometimes unfair to
> maintain an obligation where “the other side” has not fulfilled its
> own. These so-called synallagmatic relationships exist not only in
> civil law, but also in public law.
>
> 69 See the example of the previous footnote.
>
> generic provisions are
> also appropriate in the respective sector or whether there is a need
> for adaptation, e.g. with regard to the minimum age as a condition for
> valid consent. Furthermore, where law is created at a higher level
> than the law of the underlying administrative or civil law, it has to
> be assessed whether the un-derlying administrative or civil law needs
> to be harmonised in the same process, in order to avoid discrepancies.
>
> As inspiration for further investigation, we recommend this
> translation of a part of the good old French Civil Code: [The law
> of contract, the general regime of ob-ligations, and proof of
> obligations, the new provisions of the Code civil
> created](https://perma.cc/ZM6L-655A) [by Ordonnance n° 2016-131
> of 10 February 2016](https://perma.cc/ZM6L-655A). Whilst these
> provisions relate to the civil law, the issues are mostly transposable
> to administrative law as well.
2. Separability clause
> Contracts often contain a clause stating that, if parts of the
> contract are invalid, the rest is deemed to remain valid. We found a
> similar clause applied to regula-tion in the [Graphic Health
> Warnings Law of the Philippines (Act
> 16043)](https://www.officialgazette.gov.ph/2014/07/15/republic-act-no-10643/):
>
> *“Section. 19. Separability Clause. – If any clause, provision,
> paragraph or part thereof shall be declared unconstitutional or
> invalid, such judgment shall not affect, invalidate or impair any
> other part hereof but such judgment shall be merely confined to the
> clause, provision, paragraph or part directly involved in the
> controversy in which such judgment has been rendered.”*
3. Sunset clause
> The sunset clause consists of fixing a date of cessation of
> applicability for a certain regulation. The sunset clause came out of
> fashion in some jurisdictions when it was discovered that problems do
> not necessarily disappear when a regulation ceases to be applicable. A
> full new legislative procedure became necessary in some of the cases
> for which no renewal was foreseen. The sunset clause was a measure to
> minimise bureaucratisation, however it became the cause of addi-tional
> procedures. Nevertheless, the sunset clause still constitutes a good
> tool if there really is only a temporary measure to be taken.
>
> The sunset clause can
> also be used for parts of legal acts. E.g., the [Canadian
> Motor](http://www.gazette.gc.ca/rp-pr/p2/2014/2014-04-23/html/sor-dors82-eng.php)
> [Vehicle Safety Act - Regulations amending the Motor Vehicle Safety
> Regulations](http://www.gazette.gc.ca/rp-pr/p2/2014/2014-04-23/html/sor-dors82-eng.php)
> contains section specific sunset clauses.
4. Review clause
> Sometimes it is useful to foresee a review of the regulation at a
> certain point in time or even at regular intervals. An obligation to
> review a set up by the regula-tor can enter into conflict with the
> right of initiative of another institution, if, ac-cording to law of
> higher order, only the other institution is authorised to develop
> drafts. However, this is a rather exceptional situation.
>
> Practically speaking, a review clause can be both useful and
> detrimental. It is use-ful if a review is necessary and would not take
> place without the review clause. It is detrimental if the institution
> in charge of initiating the review would at any rate act within a
> reasonable space of time. In that case, a stiff time-setting for
> review can hinder the institution in initiating the review at the most
> appropriate point in time. The most appropriate point in time may be
> subject to the maturity of pre-paratory investigations, experiences
> made, and developments of the respective sector or of neighbouring
> sectors or of the law of higher order.
>
> The [Energy Efficiency Act of
> Canada](https://laws-lois.justice.gc.ca/eng/acts/e-6.4/) creates
> even a regulatory improvement au-tomatism. Every three years the
> Minister shall demonstrate the extent to which the energy efficiency
> standards prescribed under this law are as stringent as compa-rable
> standards established by any Canadian province, the United Mexican
> States, the United States of America (USA) or any state of the USA.
1\. TÍTULO 280
> 1
>
>  class="anchor">*Achieve results, Because this is the natural
> way.*
>
> *Achieve results, But not through violence.*
*Force is followed by loss of strength.*
***Lao Tse***
1. Elaboration methods
> The old-fashioned approach of elaborating regulation can be described
> as fol-lows: The ministry / administration works behind closed doors
> on a proposal or the draft measure and consults some stakeholders as
> much as this cannot be avoided.
- A more modern approach consists of:
- sharing the basic analysis and ideas,
- describing a range of possible measures,
- consulting the stakeholders extensively by surveys and in open
debates,
- letting working groups draft various items, and
- coming up with a proposal or draft measure that does not catch anyone
by surprise.
> A third approach has not yet been practised yet, but is looming on the
> hori-zon: Letting administration staff and stakeholders work on the
> draft in an open
>
> peer-to-peer process70.
> Especially if the open issues to be regulated are extreme-ly numerous
> or complex, the peer-to-peer process might lead to better results
> (more aspects covered, a wider range of solutions etc.). This is no
> surprise as well arranged collective intelligence tends to be superior
> to the intelligence of a few individuals. On the other hand, the
> administration would have to make sure that lobbying in the
> peer-to-peer process does not block the development of good options.
>
> Contrary to what many think, the peer-to-peer method does not reduce
> the num-ber of options and the “influence” of those formally
> responsible, but increases them. More people tend to develop more
> thoughts and more options amongst which the formally responsible
> service can choose. Peer-to-peer work lessens not the right to decide,
> but the right to ignore (alternatives).
>
> Identifying the basic strengths of the more open working methods does
> not mean that the old-fashioned method cannot be the best in some
> cases. If the adminis-tration has good reason to take a certain
> political line opposing lobby interests, to work behind closed doors
> is sometimes the only way to defend the political line. Furthermore,
> it reduces the credibility of the administration’s participatory
> processes altogether to suggest that a certain question is debatable
> for the ad-ministration whereas, in reality, it is not. Therefore the
> open methods should only be used to the extent that the administration
> really is open and can afford to be.
>
> The more open the working method, the more the result will be
> influenced by the strongest lobbies. Naturally, those on whom legal
> measures impose a burden will try to avoid them. They will try to
> influence both the initial legislative process and any implementation
> afterwards. They often have more resources than the admin-istration
> and more stable personnel. Therefore it is important to introduce
> checks and balances, perhaps anticipating third-party review at
> regular intervals from the start or enforcing publication of results
> etc. in order to restore some balance.
1. \- Advanced electronic tools for the elaboration process
> Nowadays, everybody uses text editing software for the elaboration
> process. How-ever, there are also software systems which are made for
> the development and
>
> 70 More on the peer-to-peer processes to be found on
> [www.p2pfoundation.net](http://www.p2pfoundation.net/); see
> also the mostly American scientific debate on “E-Rulemaking”.
>
> the management of
> legislations. See as introduction into this topic this
> [article](https://ial-online.org/wp-content/uploads/2019/01/1.-Advanced-tools-for-legislationTimothy-Arnold-Moore.pdf).
1. Negotiating regulation
> We have observed a wide range of attitudes taken by officials when
> negotiating. The most frequent attitude is to take a position and to
> defend it, be it alone or be it in an alliance with others. This is
> the easy game which often leads to a power struggle, not necessarily
> to the benefit of the common cause. Other officials try to understand
> the reasons behind a certain view of their interlocutor. They think
> more in terms of interests. Thinking in terms of interests instead of
> positions is paramount for finding a consensus. Only on the basis of a
> good understanding of the interests of all sides can a good or at
> least acceptable solution be found. Some officials even feel
> responsible for the negotiation process without being the chair. These
> officials often have methodological knowledge on process steering and
> ne-gotiations. These officials are able to intervene when there is a
> deadlock in the elaboration or negotiation process. They can even
> prevent problematic situations upstream. They know when more
> collaborative work forms need to be applied, when a break-out session
> is necessary or when, on the contrary, more classic streamlining is
> required to get to a result. They are able to co-steer or even to
> steer the negotiation process, regardless of who is formally chairing
> the process.
>
> Sooner or later officials are confronted with difficult situations in
> which no pro-gress seems to be possible. In such situations, it is
> helpful to take a step back or to look at the situation from above.
> The following questions might help you to overcome the deadlock
> through new ideas. These questions might also be used to establish a
> controlling process during negotiations even when there is no
> dead-lock:
- What is the issue to be regulated?
- Why is this issue to be regulated?
- What are my major goals?
- How shall my major goals be weighed against one another?
- Who is best placed to regulate the issue? Who is second best placed?
- What major regulation parameters are there?
- Which are the most
appropriate incentives?
- What are the stakeholders’ preferences with regard to these
parameters?
- What are the stakeholders’ negotiation positions?
- What are their interests behind the positions?
- By which solutions can these interests (not positions) best be
accommodated?
- Which solutions have been found in parallel sectors of the same field
or even in other regulatory fields?
- Which solutions could be imported from completely different contexts,
e.g. from private business, engineering, or science?
> Often the devil is in the detail, for instance in the detailed
> requirements. If there is a dispute on detailed requirements, it is
> useful to be familiar with a basic typology of requirements as laid
> down above ([Section 5.3](#_bookmark64)). Knowledge of this typology
> per-mits the development of new options that might be accepted as a
> compromise.
>
> Sometimes negotiation deadlocks can be overcome by promising a review
> pro-cess after one to five years. However, such a review process binds
> important re-sources and creates uncertainty for stakeholders. In this
> respect, it is similar to dynamic conditions.
1. The ethical values as a means to find consensus
> In courses on negotiation techniques, one learns that talking about
> interests is more fruitful than talking about positions. In
> negotiations about regulation, this approach can be complemented by
> discussing ethical values, especially if the ne-gotiations are stuck.
> Explicitly expressed ethical values can help to understand the
> position of others. Ethical values can also become a basis for a good
> regula-tory solution based on mutual understanding and fairness. In
> the extreme case, discussing ethical values can trigger new solutions,
> new requirements, and even new measures.
>
> Ethical values can refer to the overall process of developing
> regulation or to the content of regulation. Ethical values may give
> new perspectives on the goals or objectives to be pursued, on the
> requirements to be set up, on the incentives
>
> to be used, or on the
> administrative principles to be applied, e.g. with regard to
> enforcement.
2. Creative solution finding
> We constantly miss occasions to find better solutions. We do so partly
> because we are not willing to invest in solution finding and partly
> because we think that things cannot become better anyway.
>
> The range of possible solutions we find to legislative problems is
> limited by basic assumptions, be they explicit or implicit. To put
> aside a basic assumption can help us to find new solutions.
>
> To identify and put aside basic assumptions is one way of finding
> creative solu-tions. There are many more ways to find creative
> solutions:
- Reflect on your issue while imagining that the opposite of a basic
assump-tion was true. If you find a solution with the opposite basic
assumption, think about how the opposite basic assumption could become
real by meas-ures that you can trigger.
- Put all the elements of your systems on cards and arrange them in a
way that best describes your system. Play around with the cards to
express a potential alternative system. You do not need to use all of
the cards.
- Check what element of your system is not really needed. Arrange the
cards without that element.
- Look at the ideal output of the system. Think backwards from the ideal
re-sult: what is really needed to get the ideal result? What is the
shortest way to this result?
- Look at how things are done in other fields. What could you copy or
adapt to your system?
- Look at processes in nature. What could you copy or adapt to your
system?
- Talk to managers, scientists or other people with a completely
different back-ground. Note their questions and hints, and do not
immediately judge them. Though they do not know your system, they
might indicate which assump-tion is questionable or where you could
learn from.
- Stretch: how is the issue to be defined on a larger scale and how
would it be approached at that scale?
- Squeeze: divide into sub-problems. How else can you approach them?
- List the components, functionalities, mechanisms etc.: Are they
needed? Can they be broken down further?
- How else could functionalities and mechanisms be ensured? What would
be the most natural, fluid way of ensuring these functionalities?
- Try to put the components, functionalities and mechanisms to other
use.
- Combine the components, functionalities and mechanisms.
- List attributes for components, functionalities and mechanisms: ask
how you could change or improve them. Could you cut them into
components and find solutions for the components?
- Whichever of the previously listed ways you use: separate the idea
finding phase from the idea evaluation. Reserve a second day for the
latter. On a dif-ferent day, you will have a clearer view.
> More hints and techniques are to be found in: Michael Michalko,
> [Thinkertoys](http://www.penguinrandomhouse.com/books/198264/thinkertoys-by-michael-michalko/),
> Ten Speed Press, Berkeley (California), 1st edition 1991.
>
> Another possibility for solution finding consists of involving the
> stakeholders in a special, creativity fostering setting. Frequently,
> the joint creative work not only increases acceptance, but also
> increases the number of options and insights.
>
> However, these methods are not a panacea. They do the job, but they
> are no guar-antee for the ideal solution. Why? Those who operate in a
> system (the “experts”) are not necessarily those who can best analyse
> and repair it. They also are not necessarily those who have the most
> creative potential. Furthermore, the experts need to forget their
> preconceptions and expertise for the purpose of the idea find-ing
> exercise. Not all experts are able or ready to do so. To involve
> outsiders with a particularly strong analytical capacity for systems
> and who have a high creative potential is therefore equally important.
> A combination of the two is ideal.
1. Finding the optimal
path
> Once the goal has been identified, some time and energy should be
> invested in identifying the optimal path towards achieving the goal.
> The following simple statements might help you to find the best path:
- The shortest path is not necessarily the fastest.
- The fastest path is not necessarily the path which brings about the
most sus-tainable result.
- Neither of these three is necessarily the safest.
- All four might require efforts that go beyond the available energy.
- The steering must be continuously adapted to follow the path chosen,
what-ever it may be.
> Change management knowledge or methodology can help to find a viable
> path and way of implementation. Change management is dealing with
> questions of transitions to a goal which is deemed worthy. Regulators
> are often unaware of the need for conscious change management.
> Accordingly, many initiatives unneces-sarily fail.
1. Managing regulatory work
> The answer to the following questions might influence not only the way
> of dealing with regulatory issues, but also the decision on what is to
> be dealt with by reg-ulations and by other means. Conscious reflection
> and a subsequent choice are especially needed if human resources are
> limited.
- For whom do we work? In whose interests do we work?
- For whom do we want to work? In whose interests do we want to work?
- How do we balance the different interests?
- What is really the core issue in the sector I have to deal with? How
can I best tackle it? What are the other issues? How do all these
issues interrelate?
- Do I know the ideal scenario to deal with these issues?
- If not, what is the best way to find out and trigger a process going
in the right
> direction? In which style do I want to steer the process, how narrowly
> shall it be steered? Do I have the necessary skills in-house? Who else
> could help me to steer the process?
- If yes, what would the ideal scenario be in five, ten or fifteen
years? Which is the time horizon I am mainly interested in?
- What is the easiest way to reach the ideal scenario?
- What is the fastest, what is the safest way?
- Who might oppose it? Why and how?
- How can opponents be convinced?
- What other uncertainties are there?
- What type of steering is needed to get to the ideal scenario? Linear,
cybernet-ic or multi-dimensional and complex steering? Do I have the
necessary skills for this type of steering?
- What time frame is needed as a minimum? Does a more generous time
frame lead to a better result? What are the consequences of a slower
preparation for the addressees of the measure and for the
jurisdiction? If more time leads to a better result, does the
additional win in quality outweigh the slower entry into application
of the measure?
- Where resources are limited: What can I achieve together with my
colleagues in one year if we work jointly on new regulation? What can
we achieve joint-ly if we work on regulatory measures other than
regulation? Where can we achieve most utility? For what kind of
measures will we receive how many staff? (System maintenance and
implementation might be less rewarded in terms of staffing than a
system renewal whilst not necessarily being less im-portant.)
> Sometimes, the answers to these questions depend on the time frame for
> which the answer is to be given. The answers may be different in a
> three-year perspec-tive when compared to a five-year perspective.
1. Attitudes towards
regulatory work
> There is a wide variety of attitudes towards regulatory work to be
> observed.
>
> Sometimes officials shift from one attitude to the other or combine
> two of them. Some examples:
- I develop regulatory measures only if it is advantageous for me or for
my unit in terms of visibility;
- I develop regulatory measures if I am asked by my line-managers or if
it is in the interest of my line-managers;
- I develop regulatory measures if powerful interest groups ask me to do
so;
- I develop regulatory measures if I am completely sure that it is the
right step or if it is less risky to take the measure than not to take
it;
- I develop regulatory measures if it is the best way to solve the
issues in the sector;
- I try to optimise the output I can reach with my staff in order to
develop the legal system as well as possible in the years to come;
- I try to optimise the output I can reach with my staff in order to
develop the legal system as well as possible in the years to come but
also in the longer term.
> In these attitudes, we can identify various goals:
- Improve reputation;
- Avoid nuisance from inside the institution - serving those who
legitimately represent the institution;
- Avoid nuisance from outside the institution - serving clients;
- Risk avoidance;
- Optimisation of the result for one specific issue;
- Optimisation of the short term overall result for the system;
- Optimisation of the long term overall result for the system.
1. Ethical considerations in regulatory
work
> When undertaking regulatory work, it is of the utmost importance to
> identify the constituency for which one is working. Is it a local
> constituency, a regional, a na-tion-state constituency or even a
> multi-national constituency? Is the constituency the entire population
> or only a certain part of it? Is the constituency more pre-cisely
> defined in terms of societal characteristics or economic functions?
> Once the constituency has been identified, one needs to further define
> to what extent the defence of the interests of the constituency should
> prevail over the interests of other people affected by the regulatory
> work. Defending the interests of citizens of a rich and powerful
> nation-state in terms of product safety will have effects on the
> economic chances of operators in poor parts of the world outside this
> nation-state and the people who depend on these operators for
> employment. International treaties may exceptionally contain limits to
> a strong unilateral imposition of rules on operators across the world,
> but mostly there are not such limits. At best some basic ethical
> principles in respect to this are contained in the national
> constitu-tion. But even in these cases there is room for ethical
> considerations which can help to fill any loopholes. Ethical
> considerations should of course be based on an analysis of the impacts
> of a considered regulatory measure.
>
> Another loophole contained in most legal systems relates to future
> generations, human beings not yet born. Research, economic and other
> activities today may have tremendous effects on future generations;
> see e.g. the multi-faceted issue of waste or today’s research on
> synthetic biology which can threaten, according to a symposium of the
> University of Oxford in 2014, the entirety of humankind (whilst there
> are also undoubtedly benefits thereof). See generally the work of the
> [2014](https://www.fhi.ox.ac.uk/about-fhi/) [oxford
> symposium](https://www.fhi.ox.ac.uk/about-fhi/) on the many
> threats to humanity’s future. Very few legal sys-tems provides for
> protection of future generations, although these human beings do not
> necessarily merit being protected less than those living today. Hence
> it is ethically worthwhile to think of the trans-generational effects
> of what takes place in society and the regulation thereof.
>
> A further topic for ethics is animals. Roughly every week there is new
> research published on the similarities of processes that take place in
> certain animals and in human beings, be they related to intelligence
> or to feelings. There are animals which can express joy after meeting
> a childhood friend after 30 years, as there are animals which mourn or
> even bury their mates. Even altruistic behaviour is not limited to
> humankind. Hence it might well be that, with further research
>
> completing the picture,
> future humankind will regard the lack of protection of the interests
> of animals as similar to the lack of protection of human beings held
> in slavery. We may remember that the shift of the majority view as to
> the ethical correctness of slavery took place only about a hundred
> years ago. As regulators, do we wish to be regarded, let us say in 50
> years, in a similar way as the defenders of slavery in 1900 are
> regarded by us today?
>
> We have added into the Chapter on Quality Verification ([Chapter
> 15](#_bookmark224)) a few ethical questions that can help to take
> account of these ethical aspects even if these eth-ical aspects are
> not (yet) laid down in the respective constitution.
2. Temporality of regulatory measures
> Some laws survive across thousands of years. The principle “eye for
> eye, tooth for tooth”, presumably first laid down in the penal code of
> the ancient empire of Babylon and aimed at limiting vengeance, has
> been transmitted via the Bible and the Quran to numerous legal
> systems. It is still a basis of penal law in some ju-risdictions
> today. However, this degree of endurance is rather an exception.
> Nor-mally, regulation is appropriate in a certain societal context
> only. The Babylonian principle, though progressive at times of
> adoption, is now regarded as outdated by most of the jurisdictions
> which can afford to run prisons. As societies change, it is a question
> of time as to when a certain piece of regulation becomes
> inappro-priate.
>
> There are two consequences to be drawn from this statement:
- Regulators should provide for updating mechanisms.
- Regulators should cast regulation in such a way that it can easily be
updat-ed – e.g. by a modular approach. Another technique for ensuring
endurance of regulation is to limit regulation to basic principles71.
Some of these basic principles, namely those of civil law, can be
traced back to Roman times.
> 71 The French Code Civil, initially also called Code Napoléon, could
> survive during two centuries in several European states because it is
> based on essential principles that are not very much subject to
> changing societal views.
>
> Thus there are ways to prepare regulation for the future. However,
> even if we were to respect this advice, we still need to bear in mind
> that everything that is built falls down sooner or later72, and so do
> regulatory systems. Again we might think of Babylon and its famous
> tower, today only visible by satellite as mere lines on the ground.
>
> 72 “Time crumbles things; everything grows old under the power of Time
> and is forgotten through the lapse of Time.” (Aristotle)
1\. TÍTULO 292
> 1
*Laws are like sausages.
It is better not to see them being made.*
***Unknown author, sometimes attributed to Otto von Bismarck***
*It is dangerous to be right in matters where established men are
wrong.*
***Voltaire***
1. The need for integral quality verification
> Is it already time to think in terms of integral quality verification
> for regulatory measures? The idea might be regarded as sacrilege or at
> least provoke substantial resistance. However, its time has come for
> different reasons:
- More and more regulation worldwide requires the application of a full
quali-ty system from economic operators, which is much more than
simple quality verification. It is a question of consistency and
credibility to apply the same principles, to whatever extent possible,
to one’s own activity as well.
- Quality verification as a first step towards quality systems is
nowadays used in most of the product- and service-providing industry
and also in more and more processes of public authorities. The reasons
for this trend are simple: quality verification leads to a better use
of resources, less liability risks, a bet-ter reputation, and less
risk of public criticism. Why should these reasons not also apply to
regulatory measures?
- Feasibility is no longer a hindrance. The classic negative reaction
“Quality verification is not possible for us!” has been observed in so
many other fields but has been overcome in most of them. With the
experience from other so-cietal activities, it is possible today to
describe the process of regulating, to
> name the points that are relevant for the elaboration of regulatory
> measures and to list the items to be verified at the end of the
> process.
- The complexity of societal processes continues to increase
tremendously. Regulatory measures, if well-conceived, respond to this
complexity – and thus become ever more complex themselves! Due to this
complexity, mis-takes and unconscious omissions become unavoidable.
Quality verification (and a systematic approach in the elaboration of
regulatory measures as suggested by this Handbook) could become a
means to reduce the likelihood of these mistakes and omissions.
> Are impact assessments not doing the job of integral quality
> verification? Impact assessments can only be regarded as a subset of
> what is called quality verification here. Subject to the design of the
> impact assessments in the respective jurisdic-tion, impact assessments
> go more or less into detail. However, impact assess-ments cover less
> than one fourth of the topics dealt with in the Handbook. Mostly,
> impact assessment methods limit themselves to much less. Furthermore,
> impact assessments do not / cannot go far enough into details. It is,
> for example, usually not the task of impact assessments to verify
> whether transitional provisions re-spond to the sector’s needs for a
> smooth transition from the old to the new legal regime or whether all
> necessary enforcement provisions have been integrated. Finally, impact
> assessments have to be limited to a few scenarios whilst devel-oping
> regulation consists of selecting one of several solutions for several
> dozen parameters and arranging them in a harmonious way. Even if there
> were only 10 parameters, we would end-up with one million possible
> combinations. Cal-culating impacts for one million possible
> combinations is not feasible. Inversely, analysing impacts for a
> handful scenarios falls short of capturing what is open to debate and
> legitimising the many choices already implicitly made when develop-ing
> the scenarios.
>
> All this does of course not mean that impact assessments have no
> merit. Impact assessments can prompt certain verification, and often
> they do so for the most important questions. Historically the concept
> of impact assessment has the merit of being a very first big step
> towards quality verification of regulatory measures. But this does not
> mean that jurisdictions should stay at that level for ever. Evo-lution
> is going on, and maybe our views on how regulatory measures should be
> conceived and controlled should evolve as well.
>
> In some jurisdictions,
> there are efforts to verify the quality of regulatory measures with
> regard to particular aspects, for example:
- administrative burden,
- citizen-friendliness,
- business-friendliness,
- rules of legal drafting, and
- leaving the utmost liberty to geographic entities / regulating only
what is strictly necessary at the level of the Centre.
> However, all these efforts do not cover more than a fringe of the
> aspects which need to be borne in mind by the officials selecting and
> preparing regulatory meas-ures. Accordingly, even all of these efforts
> together do not reach more than partial quality verification. Integral
> quality verification would go much further.
1. Suggested elements for an integral quality verification
> Quality verification needs to be adapted to the regulatory system
> under which it is applied. It is thus clear that the following list of
> questions is not an ideal fit for any jurisdiction because it is not
> adapted to it. However, readers might take it as a starting point for
> setting up their respective quality verification system or simply get
> inspired by the questions for the revision of the regulation they are
> re-sponsible for. Finally, officials who wish to improve their
> regulatory practice might also find the list to be helpful. To suit
> the latter, the questions are presented in an order that mirrors as
> much as possible the structure of the Handbook. It goes without saying
> that the questions could be regrouped in many other ways73.
>
> 73 E.g. thequestionscouldbeattributedtothefollowingcategories: 1.
> Impacts, efficacyand own policy; 2. Relationship with / consistency
> with other acts and policies; 3. Internal consistency; 4. Conformity
> control and enforcement; 5. Other implementation questions; 6.
> Regulatory policies and drafting rules; 7. Process
1. – Questions regarding
all regulatory measures
1. – *Process* (Sections [5.5](#_bookmark67) and
[14.1](#_bookmark214))
> *Has the regulatory measure been subject to a mandatory public
> consultation?*
>
> *Has the mandatory public consultation provided enough results to
> identify the needs and the characteristics of the sector?*
>
> *If not, have the necessary further consultations been initiated?*
>
> *Have all the mentioned consultations been appropriately considered?*
>
> *Did the stakeholders have enough opportunities to comment and to
> provide input, including input on the drak measure?*
>
> *Did the geographic entities have enough occasions to comment and to
> provide input, including input on the drak measure?*
>
> *Did the international partners (other jurisdictions and international
> organisations) have enough occasions to comment and to provide input,
> including input on the drak measure?*
>
> *Did other ministries / departments or advisory institutions (e.g.
> Court of Auditors, Ombudsmen) provide for sufficient input?*
>
> *Has the regulation of other sectors been studied for comparison and
> inspiration? Has experience from other sectors been appropriately
> used?*
>
> *Has regulation of other jurisdictions been studied for comparison and
> inspiration? Has experience from other jurisdictions been
> appropriately used?*
>
> *If there were different elaboration tracks: have all results of the
> different elabora-tion tracks been appropriately integrated? See
> (*[Subsection 5.5.1](#_bookmark68)*)*
2. – *Overall substance* ([Sections 5.1 to 5.4](#_bookmark51))
> *Have the real needs of the sector been identified?*
>
> *Do(es) the regulatory measure(s) selected fully respond to the
> identified sector needs?*
>
> *Should the selected measure(s) be complemented by other measures to
> cover the sector’s needs? Check against* [Section 5.3](#_bookmark64)*.
> Check also against information and en-forcement needs in Chapters*
> [10](#_bookmark118) *and* [11](#_bookmark140)*.*
>
> *Do(es) the selected measure(s) bring the sector closer and close
> enough to its ideal state?*
>
> *Do(es) the selected measure(s) tackle the issues which had been
> identified by the sector analysis?*
>
> *Do(es) the selected measure(s) fit with future developments? Check
> against* [5.1.1.1](#_bookmark54)*. Will the top five problems of the
> sector be solved by the measure(s)?*
>
> *Could some of the non-top-five-problems be elegantly solved in
> addition? Will the top three development potentials for the sector be
> used?*
>
> *Will the selected measure(s) ensure that the predetermined or set
> policy goals are reached?*
>
> *Will the measure(s) ensure that the set objectives are reached?*
>
> *Have all appropriate requirements been set? Check against the
> typology in* [Chap-ter 3](#_bookmark27) *and against the requirements
> of similar sectors and of other jurisdictions.*
>
> *Have all appropriate incentives been used? Check against the typology
> in* [Section](#_bookmark44) [4.1](#_bookmark44)*.*
>
> *Is it necessary to ensure that the regulatory measure(s) become(s)
> known? Have all appropriate information tools been used or foreseen?*
>
> *Given the state of the sector, is it realistic that the citizens,
> operators and geo-graphic entities can reasonably use or transpose the
> selected measure(s)?*
>
> *Do(es) the selected measure(s) lead to an optimised use of available
> resources at the level of the Centre and in geographic entities? Do we
> reach the best we can with the available resources?*
3. – *Ethics* (Sections [14.9](#_bookmark222) and
[8.17](#_bookmark103))
> *Are/is the measure(s) positive / optimised for the constituency?*
>
> *Do(es) the measures strike a fair balance between the interests of
> those persons (within the constituency) who take profit from it and
> the interests of those who bear the direct or indirect costs or
> negative effects?*
>
> *Are/is the measure(s) ethically acceptable with a view of persons not
> belonging to the constituency?*
>
> *Do(es) the measure(s) strike a fair balance between the positive
> effects for the con-stituency and the effects on persons not belonging
> to the constituency?*
>
> *Are/is the measure(s) ethically acceptable with a view to future
> generations? Are/is the measure(s) ethically acceptable with a view to
> animals?*
4. – Formal aspects and consistency (only some elements covered in
Chapters [2](#_bookmark15) and [9](#_bookmark106))
> *Does the regulatory measure follow the applicable editing policy? Is
> the regulatory measure correctly structured?*
>
> *Are the sections and subsections correctly numbered? Are the
> references correct?*
>
> *Is the terminology of the regulatory measure coherent with the
> terminology of other regulatory measures and above all with the
> terminology of the empowering regulation?*
>
> *Is the terminology consistently applied in the regulatory measure,
> including its an-nexes?*
>
> *Does the terminology correspond to the common language in the
> sector?*
>
> *Is the terminology and the syntax understandable for the targeted
> citizens or op-erators?*
>
> *Is the regulatory
> measure altogether understandable for the targeted citizens or
> operators?*
>
> *Do have citizens and operators a fair chance to fulfil the
> requirements set by the regulatory measure?*
>
> *Is the regulatory measure fair in terms of predictability (= not too
> surprising)? Is the regulatory measure fair in terms of equality?*
>
> *Is the average depth / the average level of detail appropriate?*
>
> *Are there important deviations from the average depth / the average
> level of de-tail? If so, are they justified?*
>
> *Are the Recitals / the rationale detailed enough?*
>
> *Are the Recitals / the rationale in line with the content?*
>
> *Does the regulatory measure follow the applicable regulatory policies
> (e.g. on “Bet-ter regulation”, “Smart regulation”, “Business
> friendliness”)?*
2. – Questions regarding regulation only
1. – *Basic legal choices for regulation*
> (Chapters [2](#_bookmark15), [6](#_bookmark70), [7](#_bookmark76) and
> 9)
>
> *Does the regulation cover all that it needs to cover? Check against
> regulation of other sectors, of other jurisdictions, against the
> typology of scopes presented in* [Chapter 6](#_bookmark70) *and the
> particular checklists for products and for services at the end of this
> Section (*[15.2.4](#_bookmark229) *and* [15.2.5](#_bookmark232)*).*
>
> *Are the subject matter or purpose and the scope of the future
> regulation rightly defined (i.e. pretending to cover something which
> is not covered in reality and vice versa)?*
>
> *Are the subject matter or purpose and the scope of the future
> regulation consistent with one another and with the content of the
> regulation?*
>
> *Has the right legal basis been chosen? Meaning: Does the legal basis
> cover the type of regulation to be adopted? Do the goals of the
> regulation fit with the legal basis? Does the content of the
> regulation fit with the legal basis?*
>
> *How does the future regulation fit into the overall regulatory
> architecture? See the basic models of architecture in* [Section
> 2.2](#_bookmark18)*.*
>
> Are overlaps with other regulation reasonably dealt with?
>
> *Is other regulation meaningfully referred to?*
>
> *Has the right legal instrument (amongst those authorised by the legal
> basis) been chosen?*
>
> *Mainly for international regulation: has the most appropriate
> harmonisation ap-proach been chosen?*
>
> *Does the regulation have the right degree of density?*
>
> *Is the regulatory measure consistent with other, similar measures of
> the same level? If not, are the deviations justified?*
>
> *Is the regulatory measure consistent with regulatory measures of a
> higher order (e.g. the Constitution)?*
>
> *Is the regulatory measure compatible with international law? Is the
> content of the articles rightly placed in the articles?*
>
> *Is the content of the annexes rightly placed in the annexes? See*
> [Sections 2.5 to 2.7](#_bookmark22)*.*
>
> *Has the right balance been struck between the various conflicting
> legislative and constitutional goals?*
>
> *Have the limits for the empowerment of agencies and subordinate
> bodies been respected?*
>
> *Does the regulatory measure include all necessary references? See the
> typology provided in* [Section 9.1](#_bookmark107)*.*
>
> *Was it right to refer / not refer to standards?*
>
> *Should certain standards be referred to in addition?*
>
> *Was it right to refer / not to refer to non-legal documents other
> than standards? Should certain other non-legal documents be referred
> to in addition?*
>
> *Has a conscious choice been made between the use of static or dynamic
> references and have the consequences of this choice been taken into
> account?* [See Subsection](#_bookmark109) [9.1.2](#_bookmark109)*.*
2. – Risks and performance in requirements and measures ([Chapter
8](#_bookmark84))
> *Have the different types of risks been identified and covered by the
> measure? Check against Sections* [8.1](#_bookmark85) *and*
> [8.18](#_bookmark105)*.*
>
> *Was it right to establish fixed, stable risk limits or would a
> risk-benefit analysis be more appropriate?*
>
> *Have basic risk management principles been imposed on operators?*
>
> *Have different types of risks been appropriately valued against one
> another?*
>
> *Have multi-dimensional impacts (including impacts going beyond the
> sector regu-lated) been appropriately evaluated?*
>
> *Have trade-offs between different quantifiable requirements been
> consciously and, to the extent possible, rationally weighed and
> addressed? See the example out-lined in* [Section
> 8.9](#_bookmark95)*.*
>
> *Was it right to apply / not to apply the precautionary principle? Was
> it right to apply / not to apply a safety margin?*
>
> *Has the proportionality principle (if applicable) been respected? Has
> adaptation to technical progress been ensured?*
>
> *Was it the right to establish static / dynamic risk and performance
> requirements?*
>
> *Was it right to establish quantitative / qualitative risk and
> performance require-ments?*
>
> *Have high risk products and processes been appropriately covered?*
>
> *Is a fair balance struck between the interests of those who bear the
> risks and the interests of those who cause them?*
>
> *Has the right reference time or stage been fixed for assessing
> whether the require-ments are fulfilled?*
3. – *Conformity verification and enforcement*
> (Chapters [10](#_bookmark118) and [11](#_bookmark140) and [Section
> 12.4 to 12.8](#_bookmark184))
>
> *Have operators and citizens been informed of their obligations? Is
> the regulation precise enough to be enforced?*
>
> *Is the regulation precise as to the verification and enforcement
> obligations con-tained therein?*
>
> *Is the regulation precise as to the what shall be the subject of
> verification (i.e. the end product or the production process)?*
>
> *Has the right balance between ex ante and ex post verification been
> found? Check against the considerations presented in* [Section
> 10.4](#_bookmark123).
>
> *Has the right balance between the involvement of state authorities
> and private conformity assessment bodies in ex ante verification been
> found?*
>
> *Should accredited reference laboratories be used?*
>
> *Have potential third parties to be involved in ex ante verifications
> been identified (e.g. insurers)?*
>
> *Does the relevant ex ante verification procedure (see typology in*
> [Subsection 10.6.1](#_bookmark134)*): take into account the parameters
> listed in* [10.6.2](#_bookmark136) *and* [10.6.4.2](#_bookmark139)*?*
>
> *include rules on renewal or transfer of authorisations /
> certificates?*
>
> *include rules on the recognition of foreign authorisations /
> certificates ? clearly specify the potential result of the procedure?*
>
> *specify the conditions that can be imposed on authorisations /
> certificates?*
>
> *take account of potential synergy with other sectors’ verification
> and supervision? Do the rules on ex post verification:*
>
> *specify the content and density of enforcement activities to an
> appropriate extent? take into account the parameters presented in*
> [Section 11.3](#_bookmark144)*?*
>
> *provide for the potential mandatory or voluntarily involvement of
> third parties? See option outlined in* [Section
> 11.4](#_bookmark146)*.*
>
> *Does the regulation provide the authorities or entrusted private
> bodies with the necessary enforcement powers? See more specifically
> the checklist provided in* [Section 15.4](#_bookmark234) *below.*
>
> *Have the necessary means been provided for to ensure the harmonised
> work of conformity assessment bodies?*
>
> *Does the regulation foresee minimum resource equipment for
> enforcement author-ities, be they at the Centre or in the geographic
> entities?*
>
> *Are the resources necessary for enforcement available in reality in
> the Centre and in the geographic entities?*
>
> *If not, can they be built up over time? Is there something that can
> be laid down in the regulation to build them up?*
>
> *Is there a need to build a new agency or shall an existing agency be
> entrusted with new tasks?*
>
> *If yes, is the necessary budget available?*
>
> *Do the entrusted private bodies possess enough staff, equipment and
> money to efficiently execute their verification and supervision
> function?*
>
> *If not, does the regulation foresee minimum resource equipment for
> such entrusted bodies?*
>
> *Does the regulation contain all the necessary provisions to ensure
> good cooper-tion between authorities and different levels of the
> relevant jurisdiction? See also* [15.4.15](#_bookmark244)*.*
>
> *Should the Centre take over the role of enforcement supervisor?*
>
> *Is the verification and supervision of compliance of geographic
> entities (with re-gard to verification and enforcement tasks) intense
> enough?*
>
> *Have possibilities for “enhanced enforcement” been used or, for good
> reason, dis-regarded? Check against the basic programme presented in*
> [Section 11.6](#_bookmark163) *(or the more detailed description of
> potential empowerments in* [Section 11.5](#_bookmark152)*) and more
> specifically the checklist provided in* [Section 15.4](#_bookmark234)
> *below.*
>
> *Should there be reimbursement of verification costs?*
>
> *Has own-brand-labelling been limited to acceptable practices? Have
> the possibilities of rogue operators been reduced?*
>
> *Have rights for indemnities, administrative sanctions (including
> confiscation) and penal provisions been introduced or, for good
> reason, disregarded?*
>
> *Are indemnities, administrative and penal sanctions high enough to
> deter? Has the responsibility of associated companies been dealt
> with?*
>
> *Have the special verification and enforcement needs of e-commerce and
> private imports been dealt with?*
>
> *Have the special verification and enforcement needs of deconstructed
> products been dealt with?*
>
> *Have the special verification and enforcement needs of services and
> products orig-inating from zones without state control been dealt
> with?*
>
> *Is there a need to attribute responsibilities to courts or
> administrations? Has this need been covered?*
4. – *Other implementation questions* ([Chapter 12](#_bookmark180))
> *Are the consequences of non-conformities or negative test results
> clearly spelled out?*
>
> *Is the regulation clear as to burden, means and degree of proof?*
>
> *Is there a need to provide authorities with the right to issue
> provisional orders to avoid imminent danger?*
>
> *Does the regulation provide enough, but not too much discretionary
> power? Is the use of vague legal expressions justified / not
> excessive?*
>
> *Are interpretation guidelines within the regulation or an empowerment
> for the adoption of interpretation guidelines needed?*
>
> *Are more definitions needed to avoid interpretative questions? Are
> the existing definitions precise?*
>
> *Are the requirements clear as to the legal persons to whom they
> apply? What about branches, subsidiaries (daughter companies), mother
> companies, joint-ventures?*
>
> *Are special rules needed for branches, subsidiaries (daughter
> companies), mother companies, joint-ventures?*
>
> *Have the necessary means been provided for to ensure that the
> authorities decide in time?*
>
> *Have the necessary means been provided for to ensure that the
> authorities are strengthened?*
>
> *Have the necessary means been provided for to prevent corruption or
> other unlaw-ful operations of authorities?*
>
> *Does the regulation contain the provisions necessary to allow for
> effective interna-tional cooperation?*
>
> *Have means for dispute resolution been provided for?*
>
> *Should certain decisions be taken by committees? If yes, have the
> necessary com-mittees been set up in the regulation or do they exist
> already? Do the committees have the appropriate means and internal
> rules?*
>
> *Should certain situations of minor importance be exempted from
> certain require-ments or even from the scope by a “de minimis
> clause”?*
>
> *Should the possibility of regularisation be offered?*
>
> *Should, for certain items, one authority of the geographic entities
> coordinate the work of their peers in other geographic entities?*
>
> *Does the regulation contain all the necessary provisions to empower
> international data-exchange and cooperation?*
>
> *Does the regulation contain all the necessary provisions to ensure
> confidentiality?*
>
> *Does the regulation contain all the necessary provisions to ensure
> that verification can take place on the territory of other
> jurisdictions?*
>
> *Is it clearly stipulated which regulatory measures geographic
> entities may take in the regulated sector, e.g. to further implement
> the regulation?*
>
> *Does the regulation contain the necessary provisions to set up the
> data processing tools needed for its implementation?*
>
> *Is the regulation easy to implement or at least implementable in
> terms of data processing?*
>
> *Does the regulation contain all necessary collateral obligations?
> Check against the list in [Section 12.19](#_bookmark202).*
5. – *Miscellaneous* ([Chapter 13](#_bookmark204))
> *Are the transitional provisions sufficient? Check against the
> questions in [Section](#_bookmark204) [13.1](#_bookmark204).*
>
> *Are the provisions on the validity of decisions, legal acts and
> certificates based on the so-far applicable law sufficient?*
>
> *Does the regulation contain the necessary provisions of the following
> types: Repeal provisions;*
>
> *Provisions stipulating that other regulations remain unaltered;
> Provisions stipulating that other regulations prevail;*
>
> *Provisions stipulating that the new regulation prevails over other
> regulations; and Provisions stipulating that no other regulations
> apply?*
>
> *Does the regulation
> contain what is necessary to determine which acts are authentic?*
>
> *Would it be useful to insert a “separability clause” in case of
> partial invalidity of the regulation?*
>
> *Would it be useful to insert a sunset clause (limiting the
> applicability of the regu-lation in time)?*
>
> *Has a review clause or another updating mechanism been foreseen or,
> for good reasons, disregarded?*
>
> *Is the regulation easy to update, e.g. by its modular construction?*
3. – Questions regarding regulatory acts only
> Can all the content be regulated by a regulatory act (regulation
> adopted by the administration) or does it fall under the prerogatives
> of the legislator?
>
> *Is the scope within the boundaries of the empowering legislation?*
>
> *Are the goals pursued covered by the empowerment contained in the
> legislation and/or by the legal basis of the first-level empowerment
> (e.g. in the Constitution)?*
>
> *Are the definitions in line with the definitions used in the
> empowering act?*
>
> *Are the obligations in line with the obligations contained in the
> empowering act? Are the obligations covered by the empowerment?*
4. – Particular checklist
for regulation on products (also partly applicable to materials)
> *Check whether you also need to regulate with regard to the following
> elements:*
- *Product components, replacement parts;*
- *Services used in the production process;*
- *Services with regard to products once they are placed on the
market74;*
- *Services with the products (offered to final users, consumers etc.);*
- *Long-distance sales (e.g. via Internet), with special focus on
salespersons out-side the jurisdiction;*
- *Advertisement;*
- *Distribution modalities;*
- *Parallel trade;*
- *Reprocessing;*
- *Manufacturing as an activity;*
- *Professional activities linked to the products and their
distribution;*
- *Fees for conformity assessment activities;*
- *Fees for enforcement / market surveillance activities;*
- *Fees for the application of conformity assessment bodies as
conformity as-sessment bodies.*
> *Check whether all of the following risks, if relevant, have been
> covered:*
- *Mechanical risks (e.g. failing of brakes, failing of steering,
squeezing mecha-nisms, cutting mechanisms),*
- *Sokware failure risks,*
- *Risks of sokware manipulation,*
- *Risks of electric failure,*
- *Risks linked to electricity,*
- *Risks of incompatibility of devices, connectors, chemical substances
etc.*
> 74 In some product legislation sectors, manufacturers try to make
> profit via expensive authorised repair services, blocking competition
> by cheaper “free” repair service providers. [Regulation
> 168/2013/EU](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32013R0168)
> of 15 January 2013 on the approval and market surveillance of two- or
> three-wheel vehicles and quadricycles counters this tendency by its
> Articles 55 to 60. These provisions guarantee access to information
> and technical documentation for all repair service providers.
- *Risks linked to electro-magnetic radiation (risk of interference with
devices, risks for ultra-sensitive persons),*
- *Risk of radioactivity,*
- *Risk of other tissue destructing radiation (e.g. by protons or other
parts of atoms),*
- *Risk of optical disturbance by beams and other light(s),*
- *Risk of too high or too low temperature,*
- *Risk of fire,*
- *Risk of spreading disease by use of human, animal or synthetic
tissues,*
- *Risk of uncontrolled proliferation of living tissues or beings,*
- *Risks of bio-compatibility of chemicals,*
- *Risk of too high pressure (e.g. in case of explosion),*
- *Risk of not performing sufficiently / as intended (e.g. medicine),*
- *Risk of misunderstanding instructions for use,*
- *Risk of unintended inappropriate use,*
- *Risk of intended inappropriate use (“off-label use”).*
> *Check whether the right risk management principles have been applied
> to each of these risks.*
>
> *Check whether you need specifically regulate on steps before the
> final product leaving the manufacturer, e.g. with regard to:*
- *Risks of research (e.g. the research on synthetic biology might
already consti-tute a risk),*
- *Development of intermediate products (like synthetic biology tissues
intended to be used for various types of final products falling under
different legisla-tion),*
- *Making available of intermediate products (like synthetic biology
tissues that could be used for various types of final products falling
under different legis-lation),*
- *Development of final
products (thus not the risk of the final product itself, but the risks
of developing final products).*
1. – Particular
checklist for regulation
> on services (also partly applicable to materials)
>
> *Check whether you also need to regulate with regard to the following
> elements:*
- *Intermediate services;*
- *Services used to provide the services;*
- *Products used to provide the services;*
- *Remedying deficient services;*
- *Long-distance services (e.g. via Internet), with special focus on
service provid-ers outside the jurisdiction;*
- *Advertisement;*
- *Distribution modalities;*
- *Professional activities linked to the services or linked to the
distribution;*
- *Service providing as a professional activity;*
- *Fees for conformity assessment activities;*
- *Fees for enforcement activities;*
- *Fees for the application of conformity assessment bodies as
conformity as-sessment bodies.*
> *Final note: If, during the revision process, substantial amendments
> have been in-troduced, it is recommended to apply the checklist a
> second time in view of these amendments. E.g. the amendments might go
> beyond the legal empowerment.*
1. A further possible
element of quality verification: the analysis of affected interests
> Once the regulatory measures have been developed, it might be suitable
> to an-alyse how the various elements or parts thereof or even
> particular requirements affect the interests of the targeted
> population. Such an analysis can be part of an official “impact
> assessment” or be undertaken separately. The analysis should
> establish, for each of the elements or parts:
- which interests are affected,
- to what extent the various interests are affected,
- to what extent the affected interests are legitimate and merit being
protected,
- whether the improvements reached by the measure(s) justify going
against the legitimate interests, and
- what can be done to accommodate legitimate interests without
dispropor-tionately endangering the improvements.
> The analysis might lead to the conclusion that some legitimate
> interests should be re-formulated as an additional regulatory goal or
> objective. Such conclusions might invite the officials to re-visit
> their measures, requirements and incentives in a sec-ond step. Once
> again, we see that a looping-back from quality verification to initial
> basic steps of planning can increase the overall quality of the
> regulatory measures.
1. A final quality check
perspective: completeness of empowerments
> Hardly anything is more annoying for the engaged official than being
> confronted with a situation where s/he should act but is not empowered
> to act, whilst the next revision of the regulation is too far away. At
> the same time, it is the empow-erments perspective that can easily
> detect many operational deficiencies of draft regulation in one
> strike. Thus we recommend an empowerments check-up in par-ticular to
> all those regulators who have no time to verify more.75 The following
> list
>
> 75 Therefore, we reprint here extracts of a dedicated article on
> empowerments: [”Empowerments (Part II):
> The](https://www.howtoregulate.org/empowerments-part-ii-the-empowerment-checklist/#more-441)
> [empowerment
> checklist”](https://www.howtoregulate.org/empowerments-part-ii-the-empowerment-checklist/#more-441)
> which was preceded by [“Empowerments (Part I):
> typology”](http://www.howtoregulate.org/empowerments-part-i-typology/#more-336).
> For a complete under-standing of the issue, we recommend reading the
> full two articles.
>
> of empowerments should
> be used to verify whether all necessary empowerments have been
> integrated into the draft regulation under development:
1. – Determining non-financial rights Empowerments might be needed for:
- Authorising undertakings/activities;
- Subjecting authorisations to conditions (from the beginning or even
later);
- Renewing an authorisation;
- Suspending authorisations;
- Withdrawing authorisations (with effect from the time when the
conditions were not met anymore);
- Repealing/revoking authorisations (in case conditions were not met
from the beginning and thus with effect from the beginning); and
- Stating that a certain right exists by virtue of the law.
1. – Determining non-financial obligations of natural and legal
persons
> This section can hardly be illustrated by concrete empowerments
> without taking the specific context of the respective sector into
> account. [Chapter 3](#_bookmark27) describes the building blocks of
> requirements as well as a range of different requirements and thus,
> indirectly, obligations and might serve as an illustration of what
> needs to be considered. However, two types of obligations and
> corresponding empower-ments are often forgotten and thus merit being
> mentioned explicitly from the beginning:
- Imposing injunctions, e.g. aiming at non-interference, toleration of
action of the state or third parties; and
- Imposing interim obligations (obligations pending a final decision).
1. – Determining
financial rights and obligations of natural and legal persons
> Empowerments might be needed for:
- Providing subsidies;
- Subjecting grants to conditions (from the beginning or at a later
point in time);
- Renewing grants;
- Withdrawing grants (with effect from the time when the conditions were
not met anymore);
- Repealing/revoking grants (in case conditions were not met from the
begin-ning and thus with effect from the beginning);
- Making financial contributions other than grants (e.g. joint
investment);
- Stating that a certain right exists by virtue of the law;
- Obliging to compensate damages;
- Compensating damages;
- Recovering compensation or other payments given to some persons from
others;
- Recovering payments (which were not due from the beginning or which
had to be returned for reasons arising later); and
- Recovering costs for state action, e.g. for investigations triggered
by infringe-ments.
1. – Imposing costs on natural or legal persons Empowerments might be
needed for:
- Imposing enforcement costs;
- Taking fees for state action (e.g. for authorisation procedures);
- Requesting securities (as guarantee for the fulfilment of financial
obliga-tions); and
- For all financial
obligations and financial sanctions or penalties: levying extra fees
and interests for delayed payment.
1. – Sanctions and penalties Empowerments might be needed for:
- Penalties for natural persons;
- Financial sanctions for legal persons: direct sanctions and indirect
sanctions like banning from receiving subsidies;
- Exclusions from public tenders;
- Imposing a ban from participating in certain activities other than
tenders;
- Imposing a ban from receiving grants;
- Public naming and shaming;
- Withdrawing titles and rewards;
- Withdrawing membership;
- Extending sanctions to mother or sister companies and their agents, at
least in cases where a company has been set-up as a shield for illegal
activities76;
- Extending sanctions to partner companies and their agents where they
con-tributed to illegal activities;
- Confiscating illegal objects or property used in or in connection with
the il-legal activity or obtained in return or in connection with the
illegal activity (“tainted property” according to the terminology used
in the [Ugandan
Anti](https://ulii.org/ug/legislation/act/2015/2013) [Money
Laundering Act
2013](https://ulii.org/ug/legislation/act/2015/2013), see for
details the Sections 61 onwards thereof);
- Restraining orders against objects (see Sections 71 onwards of the
[Ugandan](https://ulii.org/ug/legislation/act/2015/2013)
[Anti Money Laundering Act
2013](https://ulii.org/ug/legislation/act/2015/2013)); and
- Restraining orders against persons (obligation to stay in a certain
perimeter).
> 76 See [Subsection 11.5.3.10](#_bookmark161).
1. – Additional
empowerments for all financial obligations and financial sanctions
or penalties
> One might need an empowerment to enforce financial obligation or
> sanction through confiscation of objects, rights or money or via
> lawsuits or generic state enforcement procedures. This should in
> particular include “tainted property”, meaning property used in or in
> connection with the illegal activity or obtained in return or in
> connection with the illegal activity; see Sections 61 onwards of the
> [Ugandan Anti Money Laundering Act
> 2013](https://ulii.org/ug/legislation/act/2015/2013).
2. – Enforcement with the help of non-designated third parties
> Empowerments might be needed for:
- Establishing complaints, alert or whistle-blowing portals or specific
commu-nication channels;
- Communication campaigns aimed at introducing or giving information
about the whistle-blowing portals or communication channels; and
- Communicating with third parties to obtain further evidence and
details.
1. – Enforcement via regional authorities, geographic entities or
designated third parties
> We distinguish here between regional authorities and geographic
> entities, be-cause regional authorities can also be those that belong
> formally to the federal state though being just responsible for a
> region.
>
> Empowerments might be needed for:
- Establishing minimum resource requirements or a list of parameters for
de-termining how many full-time equivalents (FTE) are needed for
enforcement
at the level of geographic entities or designated third parties77.
- Benchmark designated third parties, regional authorities or geographic
enti-ties, applying the naming and shaming principle;
- Creating the legal possibility of steering grants away from
authorities not willing to enhance enforcement to those which are
strongly engaged;
- Creating incentives for highly performing third parties, regional
authorities or geographic entities78;
- Obliging to undertake certain enforcement activities (in some
jurisdictions: to be specified);
- Obliging to inform about enforcement activities;
- Obliging to inform about certain critical events, incidents, problems,
obsta-cles;
- Obliging to ensure qualification of staff by minimum recruitment
require-ments and training requirements;
- Obliging to participate in certain training or information or
coordination events;
- Obliging to undergo accreditation (by independent accreditation
bodies, see [IAF](https://www.iaf.nu/));
- Obliging to participate to peer-review;
- Delegating investigation tasks (by means of public or private law);
- Therein in particular: Delegating the collection and investigation of
com-plaints;
- Delegating enforcement tasks (by means of public or private law);
> 77 Parameters could include population, number of operators to be
> verified, or number of administrative districts. Quantified minimum
> resources could be, for example: 10 FTE per region and 1 FTE per
> million population at the central level for the overall management of
> enforcement (with no other tasks of course). 2 FTE per district and 1
> per 100,000 inhabitants in each district.
>
> 78 We heard that Bulgarian customs authorities obtain, when being
> particularly successful, financial rewards that they can use to
> improve their office facilities.
- Giving regional
authorities or geographic entities the right to delegate
inves-tigation or enforcement tasks; and
- Designating the lead regional authority, geographic entity or lead
third party in cases where different regional authorities, geographic
entities or third par-ties are involved and coordination is necessary.
1. – Designation and supervision of public or private organisations
entrusted to play a special role in the application of regulation
> Empowerments might be needed for:
- Preselecting potential cooperating organisations in cases of high
number of potential candidates;
- Establishing selection criteria;
- Selecting members of panels attributing subsidies, functions or other
advan-tages;
- Taking discretionary decisions regarding the attribution of subsidies,
func-tions or other advantages (which can exclude full legal control);
and
- Taking into account previous assessments of the candidate organisation
(by the same authority, by others, by foreign jurisdictions or by
third bodies like accreditation bodies).
1. – Investigations and data Empowerments might be needed for:
- Conducting, or cooperating with persons conducting research,
develop-ment, tests, demonstrations and studies and publishing this
research or test results;
- Imposing obligations to cooperate, without remuneration, with the
author-ity and in particular to permit samples to be taken or provide
samples on request, provide information, and to grant access to
documentation and premises;
- Arrest (and financial sanctions) in case these obligations are not
fulfilled;
- Visiting and inspecting offices, factories, warehouses, wholesaling
establish-ments, retailing establishments, laboratories, research
institutions and other premises in which products are produced or
kept, or where services provid-ed);
- Entering and inspecting any vehicle used to transport or hold products
or to provide services;
- Investigate alleged violations of laws and regulations
- Taking samples of the products covered by the regulation in question;
- Ordering anonymously or via proxy products or services in view of
assessing their conformity;
- Seizing and taking possession of all articles which are in
non-conformity, be they placed with the person responsible for the
infringement or other per-sons;
- Seizing and taking possession of all documents, data and objects which
might serve as means of proof for stating the non-conformity;
- Compelling the attendance of witnesses and the production by third
parties of evidence via a subpoena, when there are reasons to believe
or first evi-dence for assuming that any infringement there is;
- Compelling the production or delivery of data or documents of any
kind, in-cluding on property or other rights related to objects and
rights, issuing doc-ument search warrants and further empowerments
needed to search and confiscate documents (see the excellent Sections
44 and onwards of the [Ugandan Anti Money Laundering Act
2013](https://ulii.org/ug/legislation/act/2015/2013));
- An empowerment to request data from internet or telecommunication
ser-vice providers;
- Supervising the internet communication or telecommunication (meta-data
or even content) in a personalised or generic way;
- Acquiring data and documents from third parties, including against
payment or providing advantages;
- Processing data;
- Exchanging data with
other authorities, courts, natural or legal persons or other
jurisdictions and adopting agreements in this regard79; and
- Personal supervision of persons / monitoring orders (see as example
Sec-tions 56 onwards of the [Ugandan Anti Money Laundering Act
2013](https://ulii.org/ug/legislation/act/2015/2013)).
1. – Enforcement in general Empowerments might be needed for:
- Requesting from internet or telecommunication service provider
blocking of certain content;
- Blocking certain internet content by own means;
- Issuing notices of non-compliance and set an appropriate deadline for
recti-fication of the situation;
- Confiscating and destroying illegal products or means to produce them
or means to provide illegal services;
- Forbidding the use of premises or establishments;
- Closing plants and other premises;
- Retaining shipments (in particular for customs authorities);
- Requesting securities (as guarantee for the fulfilment of
non-financial obli-gations);
- Publishing evaluations on own compliance statistics, compliance
reporting by regional authorities and third parties (naming and
shaming);
- Publishing individual infringements;
- Obligating regional or local authorities to publish stated
infringements of op-erators (“naming and shaming”);
- Creating a label for those operators who, over a longer period, have
not been reported to infringe the law;
> 79 For these aspects, please have a look at Sections 37 and onwards
> and 46 and onwards of the [Ugandan Anti
> Money](https://ulii.org/ug/legislation/act/2015/2013)
> [Laundering Act
> 2013](https://ulii.org/ug/legislation/act/2015/2013).
- Creating a label for
those operators who undergo a voluntary compliance verification
program managed by the chambers of commerce or similar semi-public
organisations or by conformity assessment bodies engaged by them
(entrusted certification).
- Obliging economic operators to display information on the conformity
as-sessment of regulated products or services, e.g. by web link;
- Obliging operators to disclose (better online, but at least to the
authorities) the major components and substances/materials used;
- Obliging operators to disclose (better online, but at least to the
authorities) the supply chain for major components or service
providers and for sub-stances/materials used, ensuring traceability;
- Obliging operators to inform their clients of their rights in case of
illicit prac-tice; and
- Imposing immediate, temporary obligations by provisional order (e.g.
for reasons of imminent danger).
1. – Information Empowerments might be needed for:
- Information dissemination to media, with or without data concerning
natu-ral or legal persons;
- Information campaigns for the general public or specific target
groups;
- Blocking illegal information or information which endorses illegal
activities;
- Informing the clients of non-compliant operators of their rights; and
- Informing the clients of non-compliant operators of the legal
requirements applicable for the product in question, inviting them to
verify compliance and to report.
1. – Cooperation,
including exchange of data with other jurisdictions
> It is recommended to assess which of the national empowerments one can
> make available to other jurisdictions in return for assistance from
> these other jurisdic-tions. Furthermore, empowerments might be needed
> to make the other jurisdic-tion work on one’s own behalf or to operate
> on the ground of another jurisdiction with the agreement of the latter
> (e.g. common practice of food inspection author-ities with regard to
> foreign slaughter houses).
>
> Whilst the following list is not complete, we recommend verifying in
> particular the need for the following empowerments:
- Permitting foreign officers to take part in state operations;
- Disclosing confidential information to authorities of other
jurisdictions;
- Establishing joint expert committees and data exchange needed for that
pur-pose;
- Investigating or enforcing on the territory of the other jurisdiction;
- Empowering foreign authorities to investigate cases on one’s own
behalf on the territory of the other jurisdiction;
- Requesting foreign authorities to enforce on one’s own behalf on the
territo-ry of the other jurisdiction;
- Enforcing on request of the foreign authority;
- Empowering foreign authorities to investigate cases on their own
behalf on one’s own territory;
- Requesting foreign authorities to enforce on their own behalf on one’s
own territory;
- Recognising foreign certificates or approvals;
- Extension of domestic investigational empowerments to cases committed
outside the applicability of domestic law, but subject to the law of
another jurisdiction where there is mutual assistance between the two
jurisdictions (based on formal agreements or practical arrangements).
- Mutual legal assistance in general,
including for court procedures, see Sec-tions 106 and onwards of the
[Ugandan Anti Money Laundering Act
2013](https://ulii.org/ug/legislation/act/2015/2013);
- Extradition of offenders for offences committed in other
jurisdictions; and
- Transfer of witnesses in custody for court procedures in other
jurisdictions.
1. – Cooperation, including exchange of data with international
organisations
> Similar to the previous, except that some items might not be relevant.
2. – Intra-organisational
measures Empowerments might be needed for:
- (Re-)Assigning of human resources (in case of changing situation);
- (Re-)Assigning of financial resources (in case of changing situation);
- Assigning of and cooperation with external experts as advisors;
- Creating scientific or advisory bodies;
- Establishing procedures regarding scientific or other advisory bodies;
- Creating intra-organisational independence (e.g. for scientific or
advisory bodies that must have independence to be credible);
- Intra-organisational reporting obligations;
- Intra-organisational control mechanisms (e.g. mandatory review by
superior instance for difficult or important decisions, periodic
control review, right to instruct);
- Intra-organisational disciplinary procedures; and
- Whistle-blower protection mechanisms (a universe of its own, see this
[article](https://www.howtoregulate.org/whistleblower-regulations-update/#more-935 )).
# ANNEX I: LITERATURE AND TOOLS
> 322
> The Australian Government Guide to Regulation
>
> [https://www.cuttingredtape.gov.au/handbook/australian-government-guide-regulation](https://www.cuttingredtape.gov.au/handbook/australian-government-guide-regulation)
>
> “Victorian Guide to Regulation”
>
> (elaborated by the Australian province of Victoria):
>
> [http://www.dtf.vic.gov.au/Publications/Victoria-Economy-publications/Victorian-guide-to-regulation](http://www.dtf.vic.gov.au/Publications/Victoria-Economy-publications/Victorian-guide-to-regulation)
>
> OECD: Regulatory Policy and Behavioural Economics
> (DOI:10.1787/9789264207851-en):
>
> [http://www.oecd-ilibrary.org/governance/regulatory-policy-and-behavioural-economics_9789264207851-en](http://www.oecd-ilibrary.org/governance/regulatory-policy-and-behavioural-economics_9789264207851-en)
>
> OECD: International Regulatory Co-operation
>
> \- Addressing Global Challenges (DOI:10.1787/9789264200463-en):
>
> [http://www.oecd-ilibrary.org/governance/international-regulatory-co-operation_9789264200463-en](http://www.oecd-ilibrary.org/governance/international-regulatory-co-operation_9789264200463-en)
>
> Alan IRWIN et al,
>
> “[Regulatory Science – Towards a sociological
> Framework](http://www.kcl.ac.uk/sspp/departments/geography/people/academic/rothstein/RegulatorySciencetowardsaSociologicalFramework.pdf)”,
> in: Futures, Vol. 29 No. 1 pp 17-33, Elsevier Science Limited,
> Amsterdam 1997
>
> Fiona HAINES, [The Paradox of
> Regulation](https://www.e-elgar.com/shop/gbp/the-paradox-of-regulation-9780857932945.html),
> Edward Elgar Publishing, Cheltenham (UK) 2012
>
> Jacqueline PEEL, [Science and Risk Regulation in International
> Law](https://www.cambridge.org/core/books/science-and-risk-regulation-in-international-law/0BA10FB1BA28DC2E8AFF9500851F1D0D),
> Cambridge (UK) 2013
>
> Jaap SPIER, [Shaping the Law for Global
> Crises](https://www.bol.com/nl/f/shaping-the-law-for-global-crises/9200000002142311/),
>
> Eleven International Publishing, The Hague 2012
>
> More relevant books, including handbooks can be found at this site of
> the [International Association for
> Legislation](https://ial-online.org/publications/books/) and the
> website of the
> [Commonwealth](http://www.calc.ngo/drafting-manuals-and-other-resources)
> [Association of Legislative
> Counsels](http://www.calc.ngo/drafting-manuals-and-other-resources)
> that publishes also a periodic review with
>
> 
articles
> relevant for practitioners, named
> “[Loopholes](http://www.calc.ngo/publications/loopholes)”.
> Rather scientific articles on law-making can be found in the
> [review](https://www.tandfonline.com/toc/rtpl20/current) “The
> Theory and Practice of Legislation”.