European Court of Justice backs UK in pay-for-delay fine against GSK

Home/Policies & Legislation | Posted 14/02/2020 post-comment0 Post your comment

The European Court of Justice has backed an earlier decision by the UK financial regulator, the Competition and Markets Authority (CMA), to fine pharma giant GlaxoSmithKline (GSK) in connection with ‘pay for delay’ deals for one of its off-patent medications.

Pay for Delay V13C29

Advocate General Kokott found on 30 January 2020 that a deal between GSK and generics makers involving its now off-patent antidepressant Seroxat/Paxil (paroxetine) ‘may be contrary to European Union (EU) competition law’.

The CMA fined GSK in February 2016 for anti-competitive conduct and agreements in relation to the supply of paroxetine [1]. GSK then took this decision to the Competition Appeal Tribunal (CAT), but the tribunal agreed with the ruling made by the CMA in 2016 and upheld the decision that GSK’s conduct and agreements made in relation to the supply of paroxetine were anti-competitive. However, it also said that it had referred ‘all substantive points’ to the European Court of Justice [2].

To clarify its decision, the European Court of Justice stated:
1. that such agreements are only unlawful if they have ‘a negative and appreciable effect on competition within the internal market’
2. that generics companies must have a ‘real and concrete possibility’ of launching a generic drug in order for a deal to be deemed anti-competitive
3. patents do not constitute, in themselves, a barrier to market entry, since their validity can be contested

The European Court of Justice ruling concluded that such deals were not necessarily barriers to competition and that each individual case had to be considered on its own. The court therefore referred the final decision back to the UK’s CAT for a final judgment.

The UK’s CMA said that it welcomed the ruling. It added that the ruling had ‘clarified a number of important questions and will help competition authorities, including the CMA, in their work to tackle this type of harmful behaviour by pharmaceutical companies’.

Related article
Generics companies defend against illegal ‘pay-for-delay’ charges

References
1. GaBI Online - Generics and Biosimilars Initiative. UK’s competition authority fines GSK for pay-for-delay [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 14]. Available from: www.gabionline.net/Policies-Legislation/UK-s-competition-authority-fines-GSK-for-pay-for-delay
2. GaBI Online - Generics and Biosimilars Initiative. GSK fined GBP 37.6 million in pay-for-delay appeal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 14]. Available from: www.gabionline.net/Generics/News/GSK-fined-GBP-37.6-million-in-pay-for-delay-appeal

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.

Source: CMA

comment icon Comments (0)
Post your comment
Related content
A new dawn for China’s patent law
China-flag
Home/Policies & Legislation Posted 16/07/2021
Affordable Care Act to stand in USA
151 MD002298
Home/Policies & Legislation Posted 09/07/2021
Proposals for the commercialisation of generics move forward in Chile
51 MD002353
Home/Policies & Legislation Posted 02/07/2021
President Biden signs ‘Advancing Education on Biosimilars Act’
Law V13C29
Home/Policies & Legislation Posted 04/06/2021
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010