Parallel Trade of Pharmaceuticals Competition Law Developments

1
Parallel Trade of Pharmaceuticals - Competition
Law Developments
Assimakis Komninos
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

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

4
New Era? Safe Harbour for Pharmaceutical
Companies? Art. 82 EC

• Dominance Market definition?
• GSK Spain interesting dicta
• BUT see
• HCC Decisions of 2002/2006
• 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)

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

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)