Transcript PowerPoint-presentatie

I&EHL: EU Competition
law in Health Care
André den Exter
[email protected]
Outline
•
EU competition law
•
Health care sectors
•
Recent developments
•
Discussion
1
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
2
EU Competition law: Cartels
-
-
Forbidden agreements, decisions, concerted
practices
Object or Effect: prevention, restriction or
distortion competition
Exceptions (art 101 (3))
3
EU Competition law
•
Abuse dominant position (Art. 102 EC)
- What is dominant position?
- Abuse
- Types:
- Remedies:
4
EU Competition law
•
Article 106 – Exclusive rights and other anticompetitive state measures
• Concept of ‘Services of General Economic
Interest’ (SGEI), art.106(2)
5
EU Competition law & Health Care:
Providers
•
Hospitals
-
•
FENIN (T-319/99):
Ambulance services
-
Ambulanz Glöckner (C-475/99), abuse and
“SGEI” (Art. 106(2) TFEU)
6
EU Competition law & Health Care:
Buyers (Health Insurers)
• Poucet and Pistre (C-160/91):
• FFSA and Brentjes Drijvende bokken (C-244/94;
C-115/97):
- Complementary, voluntary pension insurance: social activity?
• AOK Bundesverband (C-264/01):
7
EU Competition law & Health Care:
Big Pharma
8
Big Pharma and EU
competition law: Parallel trade
-
Dual pricing system (101(1)): GSK Spain C501/06
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
9
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
10
•
•
•
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/blocking generics or enforcing patent
rights?: Pay for delay tactic
• Patent settlement agreements
• Vexatious patent litigation against generic MA’s
• Patent linkage
• Interventions pricing/reimbursement bodies
• Safety or effectiveness related claims generics
• Life cycle strategy (AstraZeneca v Commission)
• Innovator launches own generic
- Regulatory deficiencies
11
Source: final report PhSI 2009
12
13
•
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
14
• 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 27nation 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.
15