The European Commission (EC) announced on 19 June 2013 that it had fined Danish pharmaceutical company Lundbeck and four generics makers for pay-for-delay deals in Europe.
Lundbeck and 4 generics makers fined for pay-for-delay deals
Home/Policies & Legislation
|
Posted 28/06/2013
0
Post your comment

The fines have been imposed on the companies due to what the EC terms ‘anticompetitive agreements’ which the companies entered into and which the EC finds delayed the entry of generics on to the market.
The case goes back to 2002 when Lundbeck paid eight other pharmaceutical companies (AL Industrier, Alpharma, Arrow, Generics UK, Merck KGaA, Ranbaxy, Resolution Chemicals and Xellia Pharmaceuticals) to stop sale of generic versions of its blockbuster antidepressant Celexa (citalopram) [1].
The fines imposed by the EC total Euros 145 million, with Euros 93 million to be paid by Lundbeck and the rest to be paid by generics makers Alpharma, Arrow, Merck KGaA and Ranbaxy.
The EC states in its decision that these practices are ‘simply unacceptable’ and that such pay-for-delay deals ‘constitute severe infringements of EU competition law’. It adds that these deals ‘occurred at the expense of patients who were deprived of access to cheaper medicines’, giving as an example that in the UK once generic versions of citalopram did enter the market, prices dropped by an average of 90%.
Industry body – European Federation of Pharmaceutical Industries and Associations (EFPIA) – reacted with concern over EC’s decision, stating that this ‘weakens the protection afforded by patents and will undermine confidence in the patent system itself to the detriment of innovation and growth in Europe’. They add that the patent system in Europe is fragmented and inefficient and call for a full policy debate at the level of the College of Commissioners.
Lundbeck in a statement said that it ‘strongly disagrees with the Commission’s decision’ and ‘intends to appeal’. The company insists that ‘the agreements did not restrict competition in the market beyond the protection already offered by society via the patent rights’ and that ‘the generic[s] companies acknowledged that their products violated Lundbeck’s patents’.
Related article
US Supreme Court backs FTC in pay-for-delay case
Reference
1. GaBI Online - Generics and Biosimilars Initiative. EU to fine 9 drugmakers over pay-for-delay deals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 28]. Available from: www.gabionline.net/Policies-Legislation/EU-to-fine-9-drugmakers-over-pay-for-delay-deals
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 © 2013 Pro Pharma Communications International. All Rights Reserved.
Source: EFPIA, Europa, Lundbeck
Guidelines
FDA issues guidance on AI use in drug and biologicals regulatory decision making
ICH adopts Good Clinical Practice Guideline for clinical trials
Reports
FTC reveals extent of PBM drug mark-ups and profits
Latin American patients face 4.7-year wait for innovative treatments
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
NPRA Malaysia trials new timelines for variation applications

Home/Policies & Legislation Posted 05/11/2024
Regulatory evolution and impact of simplified requirements for interchangeable biosimilars in the US

Home/Policies & Legislation Posted 18/09/2024
China’s NMPA expands global ties with the Netherlands and Indonesia

Home/Policies & Legislation Posted 04/09/2024
Japan's PMDA expands influence with new office in Thailand

Home/Policies & Legislation Posted 06/08/2024
The best selling biotechnology drugs of 2008: the next biosimilars targets

Post your comment