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I&EHL: EU Competition law in Health Care

I&EHL: EU Competition law in Health Care. André den Exter Andre.denExter@ua.ac.be. Outline. EU competition law Health care sectors Recent developments Discussion. E U Competition law: Scope and Application. Scope: - Cartels (Art. 101 FTEU) - Abuse dominant position (Art. 102 FTEU)

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I&EHL: EU Competition law in Health Care

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  1. I&EHL: EU Competition law in Health Care André den Exter Andre.denExter@ua.ac.be

  2. Outline • EU competition law • Health care sectors • Recent developments • Discussion

  3. EU Competition law: Scope and Application Scope: - Cartels (Art. 101 FTEU) - Abuse dominant position (Art. 102 FTEU) - Merger control (Merger Control Regulation No. 139/2004) - State aid (Art. 107 FTEU) Application: - Concept of undertaking (art. 101) - Border crossing element

  4. EU Competition law: Cartels • Forbidden agreements, decisions, concerted practices • Object or Effect: prevention, restriction or distortion competition • Exceptions (art 101 (3))

  5. EU Competition law • Abuse dominant position (Art. 102 EC) - What is dominant position? - Abuse • Types: • Remedies:

  6. EU Competition law • Article 106 – Exclusive rights and other anti-competitive state measures • Concept of ‘Services of General Economic Interest’ (SGEI), art.106(2)

  7. EU Competition law & Health Care: Providers • Hospitals • FENIN (T-319/99): • Ambulance services • AmbulanzGlöckner (C-475/99), abuse and “SGEI” (Art. 106(2) TFEU)

  8. EU Competition law & Health Care: Buyers (Health Insurers) • Poucet and Pistre(C-160/91): • FFSAandBrentjes Drijvende bokken (C-244/94; C-115/97): • Complementary, voluntary pension insurance: social activity? • AOK Bundesverband (C-264/01):

  9. EU Competition law & Health Care: Big Pharma

  10. Big Pharma and EU competition law: Parallel trade • Dual pricing system (101(1)): GSK Spain C-501/06 • Object or effect of harming consumers • 101(3) exception? • Supply quota system (Art 102) GSK Greece (Syfait) case, C-468/06: - Does refusal to supply per se an abuse of dominant position? - Arguments GSK: “specific factors” pharma market should be taken into account

  11. IPR: The cutting-edge of competition law • Protecting patent rights • Patents and abuse dominant position: AstraZeneca (Case T‑321/05) • Eur.Comm: € 60 m. fine misusing national patent systems (supplementary patent certificates, the SPC abuse), and national MA under 102 FTEU (deregistration abuse) • General Court: • upheld misleading representation patent offices • Anulled delisting abuse • Reduction fine • Appeal: fine for 'bullying' (C-457/10

  12. Recent developments: Pharmaceutical sector inquiry • Reasons: “There’s something rotten in the pharmaceutical world” (Shakespeare, Hamlet Act I, scene IV) • Scope • Outcomes: - Industry trends - “tool-box” delay/blockinggenerics or enforcing patent rights?: Payfor delay tactic • Patent settlementagreements • Vexatious patent litigationagainstgenericMA’s • Patent linkage • Interventions pricing/reimbursementbodies • Safety or effectivenessrelated claims generics • Life cyclestrategy (AstraZeneca v Commission) • Innovator launchesowngeneric - Regulatorydeficiencies

  13. Source: final report PhSI 2009

  14. Discussion: What’s next? Solutions • Actions by European Commission • Antitrust: Commission confirms unannounced inspections in pharmaceutical sector (Brussels, 3 December 2010) • Commission launches 3rd monitoring exercise of patent settlements in pharma sector (2012) • Commission sends statement of objections to J&J and Novartis on delaying entry of generic painkiller (31 Jan 2013) • Suggestions • Harmonizing patenting: unitary patent protection/ EU Patent Court • Incorporating business’ HR responsibilities • Strengthening corporate accountability

  15. EC fines Drug Companies for Delaying Generics (June 19, 2013)Europe’s top antitrust enforcer on Wednesday continued a campaign on both sides of the Atlantic to crack down on drug company efforts to keep low-cost generic versions of their medicines off the market, fining a Danish pharmaceutical and a number of generic producers a total of €146 million, or $195 million. The European Commission said that Lundbeck of Denmark colluded with companies including Ranbaxy of India and Merck of Germany in 2002 and 2003 to delay market entry of a less-expensive generic version of Lundbeck’s blockbuster antidepressant called citalopram. Lundbeck, fined €93.8 million, the highest amount, went as far as destroying significant quantities of the less expensive version of the drug, according to Joaquín Almunia, the competition commissioner, whose office enforces antitrust law on behalf of the 27-nation European Union.The commission can fine companies up to 10 percent of their most recent annual worldwide sales. The fine against Lundbeck amounts to about 4.6 percent of its 2012 sales of €2 billion.

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