Confidentiality

Central bank asset purchases and auction cycles revisited: new evidence from the euro area

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Friday, April 19, 2024

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Working Paper Series

Key Points:

Working Paper Series
Federico Maria Ferrara
Central bank asset purchases
and auction cycles revisited:
new evidence from the euro area

No 2927

Disclaimer: This paper should not be reported as representing the views of the European Central Bank
(ECB).
Abstract
This study provides new evidence on the relationship between unconventional monetary
policy and auction cycles in the euro area.
The findings indicate that Eurosystem?s asset purchase flows mitigate
yield cycles during auction periods and counteract the amplification impact of market volatility.
The dampening effect of central bank asset purchases on auction cycles is more sizeable and
precisely estimated for purchases of securities with medium-term maturities and in jurisdictions
with relatively lower credit ratings.
On the other hand, central banks may influence price dynamics in these markets, most notably
through their asset purchase programmes.
If so, do central bank asset purchases
affect bond yield movements around auction dates?
Auction cycles are present when secondary market yields rise in
anticipation of a debt auction and fall thereafter, generating an inverted V-shaped pattern around auction
dates.
ECB Working Paper Series No 2927
3

1

Introduction

The impact of central bank asset purchases on government bond markets is a focal point of economic and
financial research.
If so,
do central bank asset purchases shape yield sensitivity around auction dates?
The paper provides new evidence on the effects of Eurosystem?s asset purchases on secondary market
yields around public debt auction dates.
The analysis builds on previous research based on aggregate data
on central bank asset purchases and a shorter analysis period (van Spronsen and Beetsma 2022).
Using
granular data on Eurosystem?s asset purchases offers an opportunity to shed light on the mechanisms linking
unconventional monetary policy and auction cycles.
Given this legal constraint, the study
hypothesises that the effect of asset purchases on 10-year auction cycles is mostly indirect, and goes via price
spillovers generated by purchases of securities outside the 10-year maturity space.
Taken together, these results provide new evidence about auction cycles in Europe and contribute to a
larger literature on the flow effects of central bank asset purchases on bond markets.
Section 4 offers descriptive evidence about auction cycles in the euro area.
Auction cycles are defined by the presence of an inverted V-shaped pattern in secondary market yields
around primary auctions.
That is, government bond yields rise in the run-up to the date of the auction and
fall back to their original level after the auction.
Their limited risk-bearing capacities and inventory management operations are
seen as key mechanisms driving auction cycles (Beetsma et al.
ECB Working Paper Series No 2927
7

Second, central bank asset purchases can alleviate the cycle by (partly) absorbing the additional supply
of substitutable instruments in the secondary market (van Spronsen and Beetsma 2022).
This expectation is
supported by several analyses on the price effects of central bank bond purchases (D?Amico and King 2013;
Arrata and Nguyen 2017; De Santis and Holm-Hadulla 2020).
Empirically, previous research has provided evidence of auction cycles taking place across different jurisdictions.
(2016) detect auction cycles for government debt in Italy, but not in Germany, during the European
sovereign debt crisis.
Research on the impact of central bank asset purchases on yield cycles around auctions is still limited.
Their paper provides evidence
that Eurosystem?s asset purchases reduce the presence of auction cycles for euro area government debt.
Nonetheless, several questions remain open about auction cycles and unconventional monetary policy
in the euro area.
Therefore, they
provide only a partial picture of auction cycles and central bank asset purchases in Europe.
The use of granular data on central bank asset purchases is especially important in light of the modalities
of monetary policy implementation of the Eurosystem.
Altogether, these elements motivate further investigation of the relationship between central bank asset
purchases and auction cycles in the euro area.
Taken together, these results confirm that Eurosystem?s asset purchases mitigate yield cycles during auction periods and counteract the amplification impact of market volatility.
The findings confirm that the flow
effects of central bank purchases on yield movements around auction dates are driven by lower-rated countries.
Additional analyses provide evidence for an indirect effect of purchases on auction cycles and highlight
the presence of substantial heterogeneity across jurisdictions and purchase programmes.
Flow Effects of Central Bank Asset Purchases on Sovereign Bond
Prices: Evidence from a Natural Experiment.
Federico Maria Ferrara
European Central Bank, Frankfurt am Main, Germany; email: [email protected]
? European Central Bank, 2024
Postal address 60640 Frankfurt am Main, Germany
Telephone
+49 69 1344 0
Website
www.ecb.europa.eu
All rights reserved.

Draft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier

Retrieved on:

Thursday, April 18, 2024

Steps, Union, Patient, CTD, Syndrome, CCI, Local, Disclosure, Toxicity, Process validation, MAH, Clinical trial, IP, RMP, Pharmacovigilance, Cell, Legislation, Annex, Trial of the century, Escherichia coli, Safety, Pediatrics, INTRODUCTION, Documentation, Prevalence, Vital signs, Tablet, Design, Transparency, Conclusion, Pip, Analysis, European Parliament, INN, Record, Quality, Generic, Biology, CMO, Genotoxicity, Composition, CTIS, Uncontrolled, Health care, European Medicines Agency, Prejudice, Committee, Policy, HCP, Animal, Characterization, Cell bank, Fertility, IRB, CMOS, Risk management, Private law, European Pharmacopoeia, Telephone, Research, Good, Data Protection Directive, Ampere-hour, IEC, QP, Human, Personal data, Labelling, Bibliography, Figure, MAA, R4, Institutional review board, Elucidation, Marketing, M4, ChromeOS, Contract research organization, Mental, Impairment, Toxicokinetics, NCA, Independent, Metabolite, Drug, Risk, Metabolism, GMO, Organ, EMA, Common Technical Document, General Data Protection Regulation, Confidentiality, PPD, PI, Language, DRUG, Privacy, Result, Claimed, Medication, Comparison, Ethics, Drive, PD, Narrative, EEA, Developmental toxicity, Saccharomyces cerevisiae, Pharmacopoeia, PIP, MCB, HMA, Physical chemistry, Midol, Particle size, Council, GCP, European Economic Area, Draft, Fermentation, Overview, Justification, Control, Dicarboxylic acid, Pharmacology, WCB, Expert, Immunogenicity, Data, Study, Publication, European, ICH, Element, Analytical procedures (finance auditing), Name, Common, Guideline, Exceptional circumstances, ID, Liver, Chin Na, Toxicology, Protein primary structure, Immunosuppressive drug, Vaccine

See websites for contact details

Key Points:

See websites for contact details
Heads of Medicines Agencies www.hma.eu
European Medicines Agency www.ema.europa.eu
11

Table of contents

12

Abbreviations .............................................................................................. 3

13

Definitions ................................................................................................... 4

14

1.
redaction, masking,
68

hiding) in such a manner that the recipient can no longer attribute the resulting information to a data

69

subject and make it identifiable.
81
Contract Manufacturing Organisation (CMO): shall mean an arrangement under which a

82

manufacturer provides upstream manufacturing services under contract on behalf of third-party

83

pharmaceutical companies.
94
Protected Personal Data (PPD): shall mean any personal data which should be protected from

95

disclosure.
?Finalised? shall mean that the marketing
102

authorisation (MA) has been granted or refused or that the MAA has been withdrawn.
The application of the general principles laid down in this guidance is without prejudice to
106

national rules on transparency.
The guidance should be read in conjunction with the relevant applicable
107

legislation and case law on transparency and data protection.
117
This guidance document is intended to apply to information/documents on medicinal products for

118

human use, for which the procedure has been finalised under the national, mutual recognition,

119

decentralised and centralised procedures.
Third
124

parties shall be informed or consulted as needed depending on respective national and European legal

125

frameworks.
140
In the following sections, the agreed principles on PD and CCI are presented, including guidance on

141

whether such information can be disclosed.
EMA/131365/2024
Page 5/50

142

Any information identified as PD or CCI must be subject to a preliminary review by the EMA/NCA prior

143

to the possible disclosure of the information/documents.
Principles on the protection of personal data (PD)
145

The protection of PD is enshrined in EU legislation; it is a fundamental right of EU citizens.
In
146

compliance with the applicable European/national legislation, PD should be anonymised in order to

147

avoid the disclosure of the document undermining the privacy and integrity of any individual.
EMA/NCA applies a risk-based approach to assess which PD elements are to be
152

removed from the information/documents in order to limit the risk of re-identification.
are included in the MAA dossier because they have a legally
164

defined role or responsibility and it is in the public interest to disclose this data.
168
Applicants are advised that non-essential information (e.g., personal address, personal phone number)

169

should not be included in the MAA dossier.
The
183

confidentiality of records that could identify subjects should be protected, respecting the privacy and

184

confidentiality rules in accordance with the applicable regulatory requirement(s).
185
The applicant remains responsible for compliance with the relevant legislation in cases where such data

186

is inadvertently included in the MAA dossier.
188
EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

189

from the information/documents in order to limit the risk of re-identification.
194
EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

195

from the information/documents in order to limit the risk of re-identification.
205
Any proposal to consider information as commercially confidential should be properly justified by the

206

owner of the information.
In this respect, any reference(s) to the risk of that interest being
209

undermined should be foreseeable and not purely hypothetical.
210
Information that is already in the public domain is not considered to be commercially confidential.
Information on the Quality and Manufacturing of medicines
226

A general principle regarding quality and manufacturing information is that detailed information could

227

be considered commercially confidential but general information should be disclosed.
234
In general, and if not in the public domain, the names of manufacturers or suppliers of the active

235

substance or the excipients are considered commercially confidential.
248
A general description of the type of test methods used and the appropriateness of the specification is

249

not commercially confidential.
General information on the fermentation and purification process
259

is not commercially confidential, although details including operating parameters and specific material

260

requirements are commercially confidential.
273
A general description of the type of test methods used and the appropriateness of the specification is

274

not commercially confidential.
In general, the data included in clinical trial study reports is considered to be data that can be
283

disclosed once PD has been anonymised.
338
In each module, a non-exhaustive list of information that may be considered protected personal data (PPD) or commercially confidential information

332
333

339

(CCI) is included.
?
Direct contact details such as telephone

Therefore, please refer to the appropriate sub-

number, fax number, email, postal address,

modules hereafter for guidance.
?
Information that may reveal strategic
(contractual) agreements

?

Any quality information on the clinical batches

principal investigator

that might be included here (such as e.g.
?
Information that may reveal strategic
(contractual) agreements

principal investigator

Study Reports
5.3.3.3

as the evaluation of new formulation, innovative

number, fax number, email, postal

Paediatric Development Plan (PIP), etc.
This may include taking into
More Than One Study
5.3.5.4

Other Clinical Study Reports

5.3.6

Reports of Post-Marketing
Experience

5.3.7

Direct identifiers such as name,
signature, contact details, etc.

Federal Agencies Launch Portal for Public Reporting of Anticompetitive Practices in the Health Care Sector

Retrieved on:

Thursday, April 18, 2024

Patient, Social media, HHS, Policy, Blog, News, Privacy, DOJ, Complaint, Justice, Confidentiality, Justice minister, Administration, Federal Trade Commission, FTC

The online portal, HealthyCompetition.gov, allows the public to report potentially unfair and anticompetitive health care practices to the FTC and the Justice Department’s Antitrust Division.

Key Points:

The online portal, HealthyCompetition.gov, allows the public to report potentially unfair and anticompetitive health care practices to the FTC and the Justice Department’s Antitrust Division.
The launch of the new portal advances the Biden-Harris Administration’s efforts to lower health care and prescription drug costs and help create more competitive health care markets that are fairer to patients, providers, payers, and workers.
That’s why we are working to tackle anticompetitive practices in the health care markets,” said HHS Secretary Xavier Becerra.
“The Biden-Harris Administration and HHS know it is our responsibility to stop monopolistic, anti-competitive practices that undermine the delivery of health care to Americans.

Federal Agencies Launch Portal for Public Reporting of Anticompetitive Practices in the Health Care Sector

Retrieved on:

Thursday, April 18, 2024

Patient, Social media, HHS, Policy, Blog, News, Privacy, DOJ, Complaint, Justice, Confidentiality, Justice minister, Administration, Federal Trade Commission, FTC

The online portal, HealthyCompetition.gov, allows the public to report potentially unfair and anticompetitive health care practices to the FTC and the Justice Department’s Antitrust Division.

Key Points:

The online portal, HealthyCompetition.gov, allows the public to report potentially unfair and anticompetitive health care practices to the FTC and the Justice Department’s Antitrust Division.
The launch of the new portal advances the Biden-Harris Administration’s efforts to lower health care and prescription drug costs and help create more competitive health care markets that are fairer to patients, providers, payers, and workers.
That’s why we are working to tackle anticompetitive practices in the health care markets,” said HHS Secretary Xavier Becerra.
“The Biden-Harris Administration and HHS know it is our responsibility to stop monopolistic, anti-competitive practices that undermine the delivery of health care to Americans.

Certiverse Attains SOC 2 Compliance, Elevating Standards in Certification and Licensure Industry

Retrieved on:

Tuesday, April 9, 2024

Workforce, SOC, Education, AICPA, Certification, SOC 2, Privacy, American Institute, Certified Public Accountant, Confidentiality, Licensure

In collaboration with Johanson Group LLP, a distinguished entity specializing in certification and compliance services, Certiverse underwent a meticulous audit process to demonstrate adherence to the stringent standards outlined by the American Institute of Certified Public Accountants (AICPA).

Key Points:

In collaboration with Johanson Group LLP, a distinguished entity specializing in certification and compliance services, Certiverse underwent a meticulous audit process to demonstrate adherence to the stringent standards outlined by the American Institute of Certified Public Accountants (AICPA).
This achievement underscores Certiverse's commitment to upholding the highest levels of security, availability, integrity, confidentiality, and privacy in handling customer data.
The SOC 2 compliance certification signifies Certiverse's capability to deliver secure, reliable, and trustworthy exam development and delivery services.
With a focus on industries reliant on certification and licensure, including but not limited to healthcare, financial services, and education, Certiverse ensures the integrity and confidentiality of critical data, essential for high-stakes testing environments.

SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action Against InMode Ltd. - INMD

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Monday, April 8, 2024

Prior, News, Ext, LLP, Complaint, Confidentiality, Pomerantz, Action Replay, Court, Cryptocurrency

NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against InMode Ltd. (“InMode” or the “Company”) (NASDAQ: INMD).

Key Points:

NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against InMode Ltd. (“InMode” or the “Company”) (NASDAQ: INMD).
Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
The class action concerns whether InMode and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against InMode, Innodata, Fox Factory, and X and Encourages Investors to Contact the Firm

Retrieved on:

Monday, April 8, 2024

InMode is a global provider of aesthetic medical devices and technology, including devices purporting to offer body sculpting and other rejuvenation technologies.

Key Points:

InMode is a global provider of aesthetic medical devices and technology, including devices purporting to offer body sculpting and other rejuvenation technologies.
Specifically, Defendants repeatedly touted the demand for InMode’s devices and told investors that those devices were never sold at a discount.
The complaint further alleges that when these misleading statements and omissions about Fox Factory’s business reached the market, investors were harmed significantly.
For more information on the Palo Alto Networks class action go to: https://bespc.com/cases/PANW

InMode Ltd. investors: Please contact the Portnoy Law Firm to recover your losses; April 15, 2024 deadline

Retrieved on:

Saturday, April 6, 2024

Defendant, FDA, Confidentiality, Pharmaceutical industry

LOS ANGELES, April 05, 2024 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises InMode Ltd. (“InMode” or the “Company”) (NASDAQ: INMD) investors that a lawsuit was filed on behalf of investors that purchased InMode securities between June 4, 2021 and October 12, 2023, inclusive (the “Class Period”).

Key Points:

Investors are encouraged to contact attorney Lesley F. Portnoy , by phone 310-692-8883 or email : [email protected], to discuss their legal rights, or click here to join the case via www.portnoylaw.com .
The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors’ options for pursuing claims to recover their losses.
On February 17, 2023, an investigative report disclosed that InMode had issued legal threats against certain customers who had voiced complaints about the Company's devices and sales practices.
The Portnoy Law Firm represents investors in pursuing claims caused by corporate wrongdoing.

KopenTech Achieves Milestone with Successful SOC 2 Type II Audit Certification

Retrieved on:

Friday, April 5, 2024

System and Organization Controls, SOC, AICPA, Certification, Privacy, American Institute, Certified Public Accountant, Confidentiality, Audit

LOS ANGELES, April 05, 2024 (GLOBE NEWSWIRE) -- KopenTech LLC (“KopenTech”), a leading electronic trading and analytics platform for structured products, has successfully completed the rigorous System and Organization Controls (SOC) 2 Type II audit.

Key Points:

LOS ANGELES, April 05, 2024 (GLOBE NEWSWIRE) -- KopenTech LLC (“KopenTech”), a leading electronic trading and analytics platform for structured products, has successfully completed the rigorous System and Organization Controls (SOC) 2 Type II audit.
The SOC 2 Type II audit, developed by the American Institute of Certified Public Accountants (AICPA), is a comprehensive evaluation that assesses an organization's information security practices against stringent criteria.
Achieving a SOC 2 Type II certification signals to clients and partners alike that KopenTech is dedicated to safeguarding data with robust, reliable controls that meet the complexities of the digital age.
Notably, KopenTech’s SOC 2 Type II report concluded without any exceptions, earning a “clean” audit opinion from Sensiba.

Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against InMode Ltd. (INMD)

Retrieved on:

Thursday, April 4, 2024

GPM, Defendant, News, Suite, Confidentiality, FDA, Court

On this news, InMode’s stock price fell $1.21, or 3.3%, to close at $35.81 per share on February 21, 2023, thereby injuring investors.

Key Points:

On this news, InMode’s stock price fell $1.21, or 3.3%, to close at $35.81 per share on February 21, 2023, thereby injuring investors.
Additionally, that same day, another investigative publication revealed that InMode had routinely and significantly discounted the prices of its devices.
To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.
Glancy Prongay & Murray LLP, Los Angeles