Fludrocortisone acetate tablets: anti-competitive agreement (50455)

Case OutcomeCA98 - infringement Chapter I
Decision Date13 October 2017
Date13 October 2017
Subject MatterCA98 and civil cartels
CourtCompetition and Markets Authority (EW)
Page 1 of 269
Decision of the Competition
and Markets Authority
Competition Act 1998
nti-competitive agreement with respect to
fludrocortisone acetate 0.1 mg tablets
Case 50455
A
9 July 2020
© Crown copyright 2020
You may reuse this information (not including logos) free of charge in any
format or medium, under the terms of the Open Government Licence.
To view this licence, visit www.nationalarchives.gov.uk/doc/open-
government-licence/ or write to the Information Policy Team, The National
Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Confidential information in the original version of this Decision has been
redacted from the published version on the public register. Redacted
confidential information in the text of the published version of the Decision
is denoted by [
].
The names of individuals mentioned in the description of the infringement
in the original version of this Decision have been removed from the
published version on the public register. Names have been replaced by a
general descriptor of the individual's role.
Page 2 of 269
Contents
1. INTRODUCTION AND EXECUTIVE SUMMARY .......................... 6
A. The purpose of this document ........................................................ 6
B. Summary of the infringement ......................................................... 6
C. Settlements and action being taken ............................................... 9
2. THE INVESTIGATION ................................................................. 10
A. Conduct of the Investigation up to the Statement of Objections ... 10
B. Conduct of the Investigation following the issuance of the Statement
of Objections ................................................................................ 12
C. Evidence gathering and engagement........................................... 14
3. FACTUAL AND REGULATORY BACKGROUND ...................... 18
A. Key companies and individuals .................................................... 18
B. Fludrocortisone Acetate ............................................................... 21
C. Framework for prescribing and dispensing Fludrocortisone Acetate
Tablets for human use.................................................................. 27
D. Regulatory framework for the supply of generic pharmaceuticals in
the UK such as Fludrocortisone Acetate Tablets.......................... 30
4. CONDUCT UNDER INVESTIGATION......................................... 39
A. Introduction................................................................................... 39
B. Parties’ positions and conduct in the Relevant Market prior to the
SDA.............................................................................................. 41
C. The Parties negotiate and agree the SDA .................................... 49
D. The SDA was terminated in October 2016 by the entry of Aspen and
Tiofarma into the SAA, pursuant to which Aspen purchased the MAs
for Ambient Storage Fludrocortisone............................................ 85
E. Third parties expressed an interest in MAs held by Tiofarma for
Ambient Storage Fludrocortisone ................................................. 89
F. Overview of the pricing, cost, volume and revenues related to the
supply of Fludrocortisone Acetate Tablets in the UK from 2014 to
2018 ............................................................................................. 91
G. Aspen’s actions with respect to parallel imports of Cold Storage
Fludrocortisone into the UK ........................................................ 101
5. THE PARTIES ARE UNDERTAKINGS FOR THE PURPOSE OF
COMPETITION LAW ................................................................. 103
A. Legal framework ......................................................................... 103
B. Assessment................................................................................ 103
6. THE RELEVANT MARKET AND ASPEN’S POSITION ON THE
MARKET .................................................................................... 104
A. Market definition ......................................................................... 104
Page 3 of 269

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