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Parallel Trade of Pharmaceuticals - Competition Law Developments
Assimakis Komninos
The Reform of EC and Greek Competition Law, 1-2 June 2007
Page 2
New Era? Safe Harbour for Pharmaceutical Companies? – Art. 81(1) EC
Art. 81(1) EC - No agreement - Unilateral quota schemes
Bayer (Adalat) BUT devil lies in the detail (facts)
Art. 81(1) EC - Not an object infringement of Art. 81(1) EC
GSK Spain BUT (a) special legal & economic context
(b) no naked restriction of exports – freedom to export at the normal price
(c) Spanish legislation → no intention to be exported
Art. 81(1) EC - Effect?
GSK Spain: Minimal benefits
The Reform of EC and Greek Competition Law, 1-2 June 2007
Page 3
New Era? Safe Harbour for Pharmaceutical Companies? – Art. 81(3) EC
Pharmaceutical companies bear burden of proof
BUT
Commission must take their arguments seriously
Undertaking must employ “convincing arguments and evidence” → Commission must “adequately examine those arguments and that evidence”, conduct a “proper examination”, “validly take into account all the factual arguments and the evidence pertinently submitted by an undertaking, and refute certain of those arguments, especially if they are “sufficiently relevant and substantiated to require a response” or if they are “relevant, reliable and credible, having regard to their content”.
Glaxo Spain, ¶¶ 235, 236, 263, 303
CFI gives some comfort to pharmaceutical companies
The Reform of EC and Greek Competition Law, 1-2 June 2007
Page 4
New Era? Safe Harbour for Pharmaceutical Companies? – Art. 82 EC
Dominance – Market definition?
GSK Spain: interesting dicta
BUT see
(a) HCC Decisions of 2002/2006
(b) Commission Astra Zeneca Decision 2005
No per se or otherwise abuse
BUT Syfait and Lelos are about refusals to supply (exceptional circumstances); contrast Astra Zeneca (positive conduct)
The Reform of EC and Greek Competition Law, 1-2 June 2007
Page 5
What to keep from the GSK cases
New generation of case law: consumer welfare → ultimate aim of competition law
In line with the new Article 81(3) Notice-Guidelines
Viewing the older case law through this angle (Consten & Grundig)
Market integration → not an aim in itself but usually an irrebuttable proxy of consumer welfare
That presumption may be disproved in cases of very particular legal and economic context (pharma)
Object – Effect (Article 81 EC) Even object infringements can be saved through Article 81(3) EC
Object should not be seen as set in stone → in reality, an empirical presumption that certain conduct usually produces anti-competitive harm
The Reform of EC and Greek Competition Law, 1-2 June 2007
Page 6
What to keep from the GSK cases
Burden and standard of proof clarifications
Article 81(3) EC Undertaking must employ “convincing arguments and evidence” →
Commission must “adequately examine those arguments and that evidence”, conduct a “proper examination”, “validly take into account all the factual arguments and the evidence pertinently submitted by an undertaking, and refute certain of those arguments, especially if they are “sufficiently relevant and substantiated to require a response” or if they are “relevant, reliable and credible, having regard to their content”.
Glaxo Spain, ¶¶ 235, 236, 263, 303
Procedural curiosity Must the Commission take an “exemption decision” in this case (transitional
problem)