First International Medical Device Compliance Congress Industry Codes of Ethics: Analysis of Enforcement Mechanisms – taking Self Policing to a Whole New level First International Medical Device Compliance Congress Paris, May 27, 2008 Session 2.01 (12:45 – 13:45) Dirk Brinckman Senior Counsel Europe Johnson & Johnson

Complaint Handling Mechanism DISPUTE RESOLUTION Complaint Handling Mechanism Eucomed National Associations

EUCOMED – Dispute Resolution BASIC PRINCIPLES Complaints re Eucomed Code Realistic timelines Fair procedure / independence Cost-effective

EUCOMED – Dispute Resolution Decision tree Review by independent panel Predictable sanctions Publicity

National Dispute Resolution

Enforcement of the Code of Business Practice Country 1a) When? 1b) Pre-existing code? 1c) Changes to EU? 2) Legal hurdles? 3+4) Lobby? 5) Enforcement? 8) Experiences 9) New costs? Austria Planned introduction: Spring 2007 No Yes N/A Costs of arbitration are to be paid by defeated party; findings have decide about bearing costs. Appealing party has advance € 2.000 (á conto). Belgium Eucomed Code Law 2004 Czech Republic June 2005 The estimate enforcement costs would in range CZK 100,000,- (EURO 3,500,-) Denmark Turn the year 2003/2004 Finland 9/21/2005 but only professional societies France June 2003 Different from Eucomed code National and european laws trading practice French Public Health Code. Only industry Any legal expenses payable reprimanded. Germany 1996 Greece 6/15/2006 The code includes the main topics of Eucomed code, plus the national legal requirements Hungary Ireland Italy 2005 Yes, from 1993 Netherlands covered by guilty Norway 2001, updated in 2006 Mainly based on Yes, primarily hearing aids colostomy companies allocated general budget Poland Translation Limited Not yet Not decided yet Portugal Slovakia October 6, 2006. Few Still limited Compulsory bond deposit of SKK 10,000 (ten thousand Slovak Spain Jan.2005 Covered by fines Sweden July 2006 Yes (time) no fee Switzerland 2003 Covered by M-fee Romania Oct. 2004 Yes, complaints UK Some Estimation Enforcement of the Code of Business Practice

Questions on procedure rules Investigation body Composition of the body Findings Due timing Confidentiality Sanctions Q.10 Participation in your complaint process Austria Arbitration panel 3 arbitrators: 1 nomitated by AUSTROMED`s Board, General Assembly, chaired a lawyer (not member/ independant), nominated Board ( 3 years term). are delivered formally and reported to all ass. members. Arbitrators shall convene within 16 days after first complaint about alleged infringement. Yes Admonition, expulsion, publication findings AUTROMED´s media for members compulsory. Belgium No Unamec secretary in collaboration with company representatives not linked with the dossier. Reported only internally with the parties concerned N/A Code, art. 11 article. Czech Republic Ethical Committee CzechMed Association 6 members four weeks from delivery financial penalty exclusion Voluntary Denmark Not relevant Finland France Professional Code Ethics & Good Practices Commission 3 board members and a former board member or key figure who has had important functions within our Industry. Annual report A warning, Publication of information in SNITEM’s internal communication media, the content of which is decided on by the Ethics Commission or Expulsion from the Association. Germany Greece The Executive Committee of Hellasmes is responsible to investigate every complaint. Appeal: General Assembly of the Various ethical penalties, up exclude member Hungary Ireland Italy Comitato di Controllo + Giurì Member and lawyers Compulsory Netherlands Supervisory committee + monitoring group independent persons outside Nefemed. The chairman is lawyer. Complaints must be substantiated can dealt orally writing. In case oral procedure hearing public unless confidentiality is involved. Yes, articles 13-14 Yes, article 27 decision committee takes the form an advise Nefemed board. sanction varies reprimand membership. fee starting legal entities 1.000 euro’s individuals 50 euro’s. Questions on procedure rules