Database

• The pact is a legacy of the 2015 migration crisis when EU countries saw more than 1 million people claim asylum after arriving, mainly by boat, to European countries.
• Front-line European countries, including Greece and Italy, were overwhelmed by the sheer numbers, prompting anti-migrant violence and a backlash from far-right political parties.
• Authorities there were struggling to provide the bare minimum of aid and failing to provide legal protection or process asylum claims.
• But to critics of the pact, the reforms will institutionalize inequality, instrumentalize migration crises and ignore the actual holes in migration governance.

Stalling reform

• Hungary, the Czech Republic and Poland refused to participate, and in 2020 the EU Court of Justice found they had broken EU law.
• Nevertheless, the quota system was never scaled up, leaving front-line states to continue to process much of Europe’s refugee population.
• Since 2016, the European Commission has proposed multiple reforms, but negotiations stalled because of opposition from far-right governments in Eastern Europe.

• Previously, the database included only fingerprints – not images or biographic details – of people above the age of 14.
• The pact also makes it easier for police to access the database.
• Together, these other four directives work to make it harder for people to make asylum claims in the EU.
• They claim that the reforms also undermine the right of appeal – sometimes deporting people before an appeals decision is finalized – and expand detention.

Leveraging migration flows

• Biden’s executive order paralleled President Donald Trump’s earlier transit and entry bans, arguing that asylum seekers must apply in the first safe country they transit.
• The EU reforms also parallel recent proposals from Biden to shut down the border during migration surges.
• There is growing academic literature on “migration diplomacy” and “refugee blackmail” that documents how states leverage migration flows as a tool in their foreign policy.
• Critics argue that this commodifies refugees – literally putting a price tag on individual lives – while undermining solidarity.

‘Fortress Europe’

The need for EU migration reform was made clear by the 2015 crisis faced by front-line European countries. But rather than address the real problems of low state capacity, processing times, human rights protections, or conditions in detention centers, I believe the pact will reinforce the concept of “Fortress Europe” by investing in deterrence and deportation, not human rights.
Nicholas R. Micinski does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

• The completed comments form should be sent to
  [email protected]
  10
  11
  Keywords

  Committee on Herbal Medicinal Products; HMPC; European Union herbal
  monographs; European Union list of herbal substances, preparations and
  combinations thereof for use in traditional herbal medicinal products; herbal
  medicinal products; traditional herbal medicinal products; traditional use;
  well-established medicinal use; benefit-risk assessment; assessment report

  12

  1
  2

  Changes introduced in section 6 Overall conclusions.

• Peer-reviewer

  If not the same peer-reviewer
  since last version, all peerreviewers should be listed, and
  the version specified in
  brackets.

• 22

  23

  
  on
  .

• It is a working

  24

  document, not yet edited, and shall be further developed after the release for consultation of the

  25

  
  .

• The principle of the template is to make clear
  distinctions between presentation of data (methodology and results)
  and the assessment of the data (?assessor?s comment?).
• likely from an article but it seems it is concluded by
  the rapporteur; ?According to the author? to be added.
• Chapters with
  a heading including the word ?conclusion? should include a summary
  of all critical assessment of the assessor for that particular
  chapter.
• If an assessor?s comment is not needed, the Rapporteur
  should delete the box inserted in the template.
• ?
  The report should be sufficiently detailed to allow for secondary
  assessment of the available data by other HMPC experts.
• Overview of available pharmacokinetic data regarding the herbal substance(s), herbal
  preparation(s) and relevant constituents thereof ........................................................... 16

  97
  98

  3.3.

• Overall conclusions on clinical pharmacology and efficacy ........................................ 27

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  Page 4/41

  119

  5.

• This sections is related to
  available quality standards and there is no need to repeat information
  on all preparations included in the monograph.
• Search and assessment methodology

  161

  The Rapporteur shall undertake a comprehensive search of relevant
  scientific literature and articles, Acts of law and regulations and
  other relevant sources.

• Cross-reference to the list of
  references in Annex, which should list separately the references
  supporting the assessment report.
• 143
  144
  145

  150
  151
  152
  153
  154

  162
  163
  164
  165
  166
  167
  168
  169
  170
  171
  172
  173
  174
  175

  Herbal substance(s)

  Herbal preparation(s)

  Relevant constituents for this assessment report

  Examples of scientific databases to be searched are Medline, PubMed,
  Cochrane Database of Systematic Reviews, EMBASE etc.

• Assessment report on
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  177
  178
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  184
  185
  186
  187
  188
  189
  190
  191
  192

  Additional relevant references could also be retrieved from the checked
  references.

• Examples of books are Hagers Handbuch, The Complete German
  Commission E Monographs, PDR for herbal medicines etc.
• In addition, information from non-EU regulatory
  authorities for examples Health Canada monographs or WHO monographs
  could be searched, if relevant to herbal substances and preparations in
  EU.
• 221

  225
  226
  227

  232

  When the assessment report is revised, the rapporteur should briefly
  summarise the main changes under this section.

• Data are collected using the template entitled ?Document
  for information exchange for the preparation of the assessment report
  for the development of European Union monographs and for inclusion of
  herbal substance(s), preparation(s) or combinations thereof in the
  list? (EMEA/HMPC/137093/2006).
• Assessment report on
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  Herbal substance/

  Indication

  Posology and
  method of

  preparation

  administration

  Posology, age
  groups,
  pharmaceutical
  form, method of
  administration,
  duration of use
  As reported in
  the market
  overview

  As reported in
  the market
  overview

  As reported in
  the market
  overview.

• Assessment report on
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  Herbal substance/

  Indication/Medicinal

  Posology and

  preparation

  use

  method of
  administration

  Posology, age
  groups,
  pharmaceutical
  form, method of
  administration,
  duration of use

  Regulatory Status

  Type of
  regulatory
  status where
  possible, date,
  Country

  287

  This overview is not exhaustive.

• Clinical Safety/Pharmacovigilance

  836
  837
  838
  839
  840
  841

  See ?Assessment of clinical safety and efficacy in the preparation of
  EU herbal monographs for well-established and traditional herbal
  medicinal products?(EMA/HMPC/104613/2005) for further details.

• Overall conclusions on clinical safety

  1067

  1068

  In terms of structure, the conclusion should follow the presentation of
  the results above.

• Overall conclusions

  1092

  1093

  1101

  Describe key aspects only briefly, these will already have been
  described in detail in the respective sections.

• This section should
  cover all recommended ?well-established use? and ?traditional use?
  indications and conclusions shall be provided for each therapeutic
  indication and each herbal preparation.
• 1102

  Well established use monograph

  1103
  1104

  The clinical studies supporting well-established use should be
  specified for each therapeutic indication and each herbal preparation.

• The choice for the wording of traditional use indications vis-?vis existing wordings in monographs in the same therapeutic area should
  be briefly discussed/justified.
• 1153

  List entry

  1154

  The conclusions should include a statement pointing to the
  possibility/non-possibility to support a European Union list entry.

• Abstract
  This paper extends Boone (2008) by introducing a competition measure at the individual
  firm level rather than for an entire market segment.
• We apply this extended Boone indicator to individual bank-level competition
  in the loan market in the four largest euro area countries and Austria.
• Our new measure of firm-level competition enriches and complements
  other competition measures and provides a promising starting point for future market
  power analyses.
• The only measure among non-structural measures that is based on the
  concept of competition as a process of rivalry is the Boone (2008) indicator.
• We introduce
  a new performance measure of competition by extending the Boone indicator to the
  individual firm level.
• Introduction
  The ability to reliably measure competition is valuable to researchers, analysts, and
  policymakers, especially antitrust authorities, financial supervisors, and central banks.
• One broad
  category of indicators often used to measure competition are structural competition
  measures, such as static concentration measures, and dynamic measures, e.g., entry and
  exit rates.
• Out of these measures, the only measure based on the
  concept of competition as a process of rivalry is the Boone indicator.
• This study introduces a new performance measure of competition by extending the
  Boone indicator to the individual firm level.
• It thus measures the
  increase in profits in percent of one percentage point increase in efficiency, with marginal
  costs as measure of efficiency.
• We extend the theoretical
  underpinning of the measurement of competition for the entire market of Boone (2008) by
  a new measure of individual firm-level competition.
• A concern of the literature is the gap
  between the practical application and the theoretical framework of Boone (2008).
• We introduce within the same theoretical
  framework a new measure of competition on firm level, the MRP.
• Our new
  measure significantly augments the antitrust evaluative framework by shedding light on
  whether a merger results in a less competitive market.
• Our novel indicator focuses on
  firms? incentives to enhance their relative efficiency, as manifested in the elasticity
  between relative profits and efficiency.
• However, an inefficient firm that is foreclosed could be more
  competitive than the larger efficient firm that relies on its scale economies.
• Our new metric of competition unveils
  banks? ability to influence their profitability in the short term by cutting costs relative to
  their peers.
• The new MRP indicator provides the ability to assess the impact
  of individual banks? competitiveness on their interest rate-setting behaviour in loan
  markets.
• Incorporating this information promises a more refined understanding of the impact and
  timing of monetary policy rates changes on the real economy.
• Section 3 introduces within the Boone
  (2008) theoretical framework our new measure of individual firm-level competition,
  including the interpretation of the MRP.
• Section 4 provides an application of our new
  ECB Working Paper Series No 2925

  6

  individual firm-level competition measure to the loan market.

• The StructureConduct-Performance paradigm (SCP) provides a traditional framework in the field of
  industrial organization for analysing competition behaviour in markets.
• Concentrated
  markets ease the possibilities to collude implicitly or explicitly and therefore concentrated
  markets result in higher prices and profits.
• For example, a tougher competition
  setup may lead to a reallocation of market shares, potentially forcing some firms to exit
  the market.
• This approach gives firms? strategic behaviour
  central stage and focuses on the strategic interaction on prices and quantities, known as
  conjectural variation.
• Another measure from
  this strand of literature is the H-statistic developed by Panzar and Rosse (1987).
• The only competition measure from this performance literature where competition is the
  outcome from a process of rivalry is the Boone indicator.
• A continuous and monotonically increasing relationship exists between
  RPD and the level of competition if firms are ranked by decreasing efficiency.
• (2013) compare the Boone indicator with the price-cost margin
  and conclude that the profit elasticity is a more reliable measure of competition.
• The high
  elasticity of profits to efficiency unequivocally indicates that the high market shares and
  therefore high profits are due to high efficiency.
• A firm that quickly passes changes to the input prices is seen as a price
  taker with little market power.
• Indicators of competition tend to measure different phenomenon and may provide
  conflicting messages, as reported for European banking by Carbo et al.
• Application 2: Test the ?quiet life? and related market structure hypotheses using the
  MRP as competition or market structure measure.
• Data
  Our application to individual bank-level competition in the euro area loan market uses
  balance sheet and income statement data from the Moody?s Analytics BankFocus for the
  calendar years 2013-2020.
• As such, most publications
  on competition in the euro area includes the largest four member states.
• Due to these restrictions the database was reduced to an unbalanced panel of up to 1862
  banks (depending on the year) from five euro area countries.
• Application 1: Measure bank competition using MRP
  Looking at the distribution of the MRP for individual banks (Fig.
• A similar finding for the four largest euro area countries as a group is
  reported in Carbo et al.
• Application 2: Test of market structure hypotheses using MRP
  Our new measure of individual-bank competition can be used to test market structure
  theories.
• Euro area banks? market power,
  lending channel and stability: the effects of negative policy rates, European Central Bank
  Working Paper, 2790 (February).
• A
  new approach to measuring competition in the loan markets of the euro area, Applied
  Economics, 43 (23), 3155?3167.
• Impact of bank competition on the interest rate pass-through in the euro area, Applied
  Economics, 45 (11), 1359?1380.