Phenytoin sodium capsules: suspected unfair pricing

The CMA is investigating alleged excessive and unfair prices for phenytoin sodium capsules under Chapter II of CA98.

Remittal case timetable (Case 50908)

First published: 8 June 2020

Date Milestone
21 February 2023 Publication of non-confidential version of Infringement Decision
12 October 2022 Pfizer Inc., Pfizer Limited, Flynn Pharma Limited and Flynn Pharma (Holdings) Limited filed appeals in the Competition Appeal Tribunal against the CMA’s findings in the Infringement Decision. The CMA will defend the appeals.
21 July 2022 Infringement Decision issued: unfair pricing abuses in relation to the supply of phenytoin sodium capsules in the UK
August 2021 Statement of objections issued
March 2021 to June 2021 Continued evaluation and assessment of the evidence
March 2021 Decision to continue with the investigation
November 2020 to February 2021 Continuing investigation, including information gathering and assessment of evidence
June to October 2020 Initial investigation: information gathering, including issuance of formal or informal information requests and responses
June 2020 Remittal investigation opened
10 March 2020 Court of Appeal judgment partially allowing the CMA’s appeal and dismissing Flynn’s appeal in its entirety
7 June 2018 Competition Appeal Tribunal judgment setting aside the CMA’s infringement decision and remitting the case back to the CMA

Case timetable (Case C3/9742-13)

First published: May 2013

Date Milestone
15 June 2017 Publication of non-confidential version of infringement decision
December 2016 Infringement decision issued
February 2016 to November 2016 Consideration of parties’ written and oral representations on the statement of objections; further evidence gathering and analysis; issue of letters of facts; receipt and consideration of parties’ representations on letters of facts; decision on case outcome; preparation of decision
January 2016 Oral hearings with parties on written representations on statement of objections
November/December 2015 Receipt of written representations on the statement of objections
August 2015 Statement of objections issued
August 2014 to April 2015 Further investigation including further information requests and stakeholder meetings
August 2014 Decision on next phase of the investigation in light of evidence received to date
August 2013 to March 2014 Internal governance processes to inform next phase of the investigation
August 2013 to March 2014 OFT analysis and review of responses to information requests
May to August 2013 State of play meetings with parties under investigation
May to August 2013 OFT analysis and review of parties’ responses to information requests
May to August 2013 Initial investigation: information gathering, including issuance of formal or informal information requests and parties’ responses
May 2013 Investigation opened

Change log

The following changes have been made to the case timetable since it was first published in May 2013:

Date of change Reason for change Change made to timetable
28 September 2016 Additional time to consider parties’ representations, decide case outcome and prepare decision Issue of decision extended from September 2016 to November 2016
8 July 2016 Additional time to consider parties’ representations and to decide case outcome Issue of decision extended from August 2016 to September 2016
14 December 2015 Additional time given to the parties to submit written representations Period for written representations extended from October to November/December 2015

Non-confidential infringement decision

21 February 2023: The CMA has published a non-confidential version of the decision in this case.

Infringement decision

21 July 2022: The CMA has found competition law breaches in relation to the supply of phenytoin sodium capsules in the UK.

Statement of Objections

5 August 2021: Following the Court of Appeal’s judgment, the CMA decided to re-investigate the matters remitted by the CAT, and opened its current investigation in June 2020. Having reconsidered these matters, on 5 August 2021 the CMA issued a statement of objections provisionally finding that the parties have infringed competition law by charging unfairly high prices for phenytoin sodium capsules.

Press release: CMA accuses pharma firms of illegal pricing (5.8.21)

Decisions on appeal

10 March 2020: The Court of Appeal has today handed down its judgment partially allowing the CMA’s appeal and dismissing Flynn’s appeal in its entirety.

20 December 2018: Today, we learnt that the Court of Appeal granted the CMA permission to appeal the Competition Appeal Tribunal’s judgment of 7 June 2018 which partially set aside the CMA’s decision that fined Pfizer and Flynn for charging excessive prices to the NHS for the sale of anti-epilepsy Phenytoin sodium capsules. See our original news story for more info:

28 June 2018: The CMA has sought permission to appeal against the Competition Appeal Tribunal’s judgment of 7 June in its excessive pricing case against Pfizer and Flynn Pharma. The application for permission to appeal was made to the Tribunal although, if granted, the appeal itself would be heard in the Court of Appeal.

7 June 2018: The Competition Appeal Tribunal announced its provisional judgment in an appeal against the CMA’s infringement decision in this case. The Tribunal decided to remit the case back to the CMA for further consideration, after ruling against its finding of abuse. The CMA is considering an appeal.

Non-confidential infringement decision

15 June 2017: The CMA has published a non-confidential version of the decision in this case.

Infringement decision

7 December 2016: The CMA issued an infringement decision to Pfizer Limited and Pfizer Inc (collectively, ‘Pfizer’) and Flynn Pharma Limited and Flynn Pharma (Holdings) Limited (collectively, ‘Flynn’).

The CMA found that Pfizer and Flynn each abused their respective dominant positions by imposing unfair prices for phenytoin sodium capsules in the UK thereby infringing the Chapter II prohibition of the Competition Act 1998 (CA98) and Article 102 of the Treaty on the Functioning of the European Union (TFEU).

The CMA imposed a financial penalty of £84.2 million on Pfizer and £5.2 million on Flynn and directed both companies to reduce their prices.

Procedural Officer decisions

7 December 2016: The CMA has published Procedural Officer decisions concerning the investigation.

Penalty notice

12 April 2016: The CMA has published a notice of a penalty imposed on Pfizer under section 40A of the CA98. The CMA imposed the penalty on 31 March 2016 for a failure to comply, without reasonable excuse, with a requirement imposed on Pfizer under section 26 of CA98.

Statement of objections

6 August 2015: In May 2013, the Office of Fair Trading (OFT) launched a formal investigation into a suspected breach of competition law in relation to the price of phenytoin (an anti-epileptic drug). On 6 August 2015, the CMA issued a statement of objections alleging that certain pharmaceutical companies have infringed competition law in relation to the supply of phenytoin.

Contacts

Published 18 December 2015
Last updated 1 August 2023 + show all updates
  1. Figures 6.11, 6.16 and 6.17, and their Notes, corrected.

  2. Non-confidential infringement decision published.

  3. Infringement decision published.

  4. Statement of objections published.

  5. Remittal case timetable published and contact details updated.

  6. Update to Competition Appeal Tribunal decision section; application for permission to appeal made.

  7. Non-confidential infringement decision published.

  8. Infringement decision issued and Procedural Officer decisions added.

  9. Timetable updated.

  10. Timetable updated.

  11. Penalty notice published and timetable updated.

  12. Timetable updated.