Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global...

21
Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement and Compliance Congress March 28, 2007

Transcript of Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global...

Page 1: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

Implementing International Codes of Conduct:

The Daunting Issues and Questions Surrounding Global

Compliance

The Medical Device Regulatory, Reimbursement and Compliance Congress

March 28, 2007

Page 2: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

2

Today’s AgendaToday’s Agenda

IntroductionsIntroductions

Challenges in today’s global compliance Challenges in today’s global compliance environmentenvironment

Panel discussion: Daunting questions regarding Panel discussion: Daunting questions regarding how to operationalize compliance in a global how to operationalize compliance in a global companycompany

Self-Regulated Guidance – Creating an Self-Regulated Guidance – Creating an international structure and foundation for global international structure and foundation for global compliancecompliance

Page 3: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

Challenges in Today’s Global Challenges in Today’s Global Operating EnvironmentOperating Environment

Page 4: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

4

Challenges in Today’s Global Operating EnvironmentChallenges in Today’s Global Operating Environment

Oversight and enforcement in EuropeOversight and enforcement in Europe Oversight and enforcement in developing regionsOversight and enforcement in developing regions The U.S. Foreign Corrupt Practices ActThe U.S. Foreign Corrupt Practices Act

Heightened risk for U.S.-based companiesHeightened risk for U.S.-based companies Recent settlementsRecent settlements Other investigationsOther investigations

Self-Regulatory Codes of ConductSelf-Regulatory Codes of Conduct

Page 5: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

Panel Discussion: Panel Discussion: Daunting Questions in Today’s Daunting Questions in Today’s Global Compliance EnvironmentGlobal Compliance Environment

Page 6: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

6

Panelist MembersPanelist Members

John Bentivoglio, Esq., Partner, King & Spalding LLPJohn Bentivoglio, Esq., Partner, King & Spalding LLP

William Fitzgerald, Esq., Vice President, Global Compliance, Alcon William Fitzgerald, Esq., Vice President, Global Compliance, Alcon LaboratoriesLaboratories

Daniel Garen, Esq., Senior Counsel, Seimens AGDaniel Garen, Esq., Senior Counsel, Seimens AG

Donna Hill, Esq., Assistant General Counsel, SCA AmericasDonna Hill, Esq., Assistant General Counsel, SCA Americas

William J. Hrubes, Corporate Compliance Officer, Gambro, Inc.William J. Hrubes, Corporate Compliance Officer, Gambro, Inc.

Laura O’Donnell, Chief Compliance Officer, Zimmer, Inc.Laura O’Donnell, Chief Compliance Officer, Zimmer, Inc.

Rosemary E. Weghorst, Manager, Huron Consulting GroupRosemary E. Weghorst, Manager, Huron Consulting Group

Christopher White, Esq., EVP, General Counsel and Secretary, Christopher White, Esq., EVP, General Counsel and Secretary, AdvaMedAdvaMed

Scott Willoughby, Managing Director, Huron Consulting GroupScott Willoughby, Managing Director, Huron Consulting Group

Page 7: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

7

Daunting Questions Today’s Global Daunting Questions Today’s Global Compliance EnvironmentCompliance Environment

Considering local laws and customsConsidering local laws and customs Applying local law on a global levelApplying local law on a global level What are the barriers to implementing a code of conduct What are the barriers to implementing a code of conduct

across different cultures and languages? across different cultures and languages? Does “one size fit all”?Does “one size fit all”? Applying code from a developed/developing country to an Applying code from a developed/developing country to an

underdeveloped country underdeveloped country What is the effect on competition?What is the effect on competition?

Applying Codes of Conduct

Page 8: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

8

Daunting Questions Today’s Global Daunting Questions Today’s Global Compliance EnvironmentCompliance Environment

What are the obligations of compliance delegates outside What are the obligations of compliance delegates outside the United States?the United States?

Who is responsible for compliance at a country or regional Who is responsible for compliance at a country or regional level?level?

How do we structure compliance (e.g., product line How do we structure compliance (e.g., product line discipline) in order to be most effective?discipline) in order to be most effective?

Does compliance have the authority and autonomy it Does compliance have the authority and autonomy it needs to drive compliance at the country level?needs to drive compliance at the country level?

Compliance Roles and Responsibilities

Page 9: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

9

Daunting Questions Today’s Global Daunting Questions Today’s Global Compliance EnvironmentCompliance Environment

How do we audit the effectiveness of compliance How do we audit the effectiveness of compliance delegates/officers outside the U.S.? delegates/officers outside the U.S.?

How can or should a medical device company handle How can or should a medical device company handle corporate level vs. country/divisional level SOPs to ensure corporate level vs. country/divisional level SOPs to ensure that appropriate controls are being adhered to, and that that appropriate controls are being adhered to, and that policies are not in conflict?policies are not in conflict?

Compliance Roles and Responsibilities (continued)

Page 10: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

10

Daunting Questions Today’s Global Daunting Questions Today’s Global Compliance EnvironmentCompliance Environment

What types of learning platforms should we be using?What types of learning platforms should we be using? How can you track global training and education How can you track global training and education

requirements required for compliance? requirements required for compliance? What types of systems or documentation methods can be What types of systems or documentation methods can be

used to ensure attendance and comprehension?used to ensure attendance and comprehension? How do we determine our end users of training (e.g., sales How do we determine our end users of training (e.g., sales

representatives, managers, line employees)?representatives, managers, line employees)? How much customization/tailoring do we allow at a local How much customization/tailoring do we allow at a local

level? How do we determine and monitor? level? How do we determine and monitor? What are the issues around translation of company policy What are the issues around translation of company policy

and training into other languages?and training into other languages?

Training and Education

Page 11: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

11

Daunting Questions Today’s Global Daunting Questions Today’s Global Compliance EnvironmentCompliance Environment

Varying standards of behaviorVarying standards of behavior Adapting to different cultures when “selling” the code of Adapting to different cultures when “selling” the code of

conduct abroadconduct abroad Potentially culturally offensive statementsPotentially culturally offensive statements Understanding religious customsUnderstanding religious customs Sensitivity to education and economic normsSensitivity to education and economic norms Special challenges in developing nationsSpecial challenges in developing nations

Practices necessary to do businessPractices necessary to do business Crime cartelsCrime cartels Kickbacks vs. cultural customs of gift givingKickbacks vs. cultural customs of gift giving

Cultural Differences

Page 12: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

12

Daunting Questions Today’s Global Daunting Questions Today’s Global Compliance EnvironmentCompliance Environment

Rights of work councilsRights of work councils Partnership with works councilsPartnership with works councils Translation of documentsTranslation of documents Recognition of human rightsRecognition of human rights

Interactions with Company Union Representatives

Page 13: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

13

Daunting Questions Today’s Global Daunting Questions Today’s Global Compliance EnvironmentCompliance Environment

Inconsistent definitions between countriesInconsistent definitions between countries Religious impact on definitionsReligious impact on definitions Impact on character of item as it changes between Impact on character of item as it changes between

countriescountries

Defining Medical Device

Page 14: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

14

Daunting Questions Today’s Global Daunting Questions Today’s Global Compliance EnvironmentCompliance Environment

How should issues such as 1-800 hotlines and other How should issues such as 1-800 hotlines and other anonymous means of communication be managed and anonymous means of communication be managed and tracked at a global level?tracked at a global level?

How do you ensure effective communication across How do you ensure effective communication across cultures and languages?cultures and languages?

Who is responsible for “delivering the compliance Who is responsible for “delivering the compliance message” in various countries and is it consistent with message” in various countries and is it consistent with corporate standards?corporate standards?

Use of confidential informationUse of confidential information Guidance from the CNIL (French Privacy Authorities)Guidance from the CNIL (French Privacy Authorities) Recent activity – McDonald’s caseRecent activity – McDonald’s case

Communication and Privacy Issues

Page 15: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

Self-Regulated Guidance: Self-Regulated Guidance: Providing a Foundational Providing a Foundational StructureStructure

Page 16: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

16

Self-Regulated Guidance: Self-Regulated Guidance: Providing a Foundational StructureProviding a Foundational Structure

In the absence of more definitive guidance In the absence of more definitive guidance from governmental authorities on the proper from governmental authorities on the proper guidelines for industry-physician relations, guidelines for industry-physician relations, manufacturer and provider self-regulatory manufacturer and provider self-regulatory codes offer the most definitive and generally codes offer the most definitive and generally well-accepted guidelines for such well-accepted guidelines for such relationships. relationships.

Page 17: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

17

Self-Regulated Guidance: Self-Regulated Guidance: Providing a Foundational StructureProviding a Foundational Structure

Eucomed: Austria, Belgium, Czech Republic, Denmark, Eucomed: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Norway, Poland, Portugal, Romania, Slovakia, Italy, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, Switzerland, and United Kingdom.Slovenia, Sweden, Switzerland, and United Kingdom.

EDMA: Austria, Belgium, Czech Republic, Denmark, EDMA: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Norway, Poland, Portugal, Romania, Slovakia, Italy, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, Switzerland, and United Kingdom.Slovenia, Sweden, Switzerland, and United Kingdom.

Regional Associations

Page 18: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

18

Self-Regulated Guidance: Self-Regulated Guidance: Providing a Foundational StructureProviding a Foundational Structure

MIAA - AustraliaMIAA - Australia

MEDEC - CanadaMEDEC - Canada

Medicoindustrien - DenmarkMedicoindustrien - Denmark

NEFEMED - NetherlandsNEFEMED - Netherlands

FENIN - SpainFENIN - Spain

AdvaMed – United StatesAdvaMed – United States

NEMA – United StatesNEMA – United States

Country Associations

Page 19: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

19

Self-Regulated Guidance: Self-Regulated Guidance: Providing a Foundational StructureProviding a Foundational Structure

AustriaAustria

France France

GermanyGermany

JapanJapan

SwedenSweden

Countries in which medical device companies follow pharmaceutical guidance

Page 20: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

20

Self-Regulated Guidance: Self-Regulated Guidance: Providing a Foundational StructureProviding a Foundational Structure

The International Medical Device

Compliance Code Compendium

Page 21: Implementing International Codes of Conduct: The Daunting Issues and Questions Surrounding Global Compliance The Medical Device Regulatory, Reimbursement.

QuestionsQuestions