1 Implementing a Unified Compliance Program Covering Multiple Global and Local Requirements – The Local Distributor/Agent Perspective 1. VP Medical & Regulatory Affairs, Neopharm Ltd. 2. Health Systems Management Department, Health Sciences Faculty , Ben-Gurion University Segev Shani PhD, MHA, MBA, LLB Disclaimer • The opinions expressed in this presentation are the author’s personal views, and do not necessarily represent his workplace.
Transcript
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Implementing a UnifiedCompliance Program Covering Multiple
Global and Local Requirements –The Local Distributor/Agent Perspective
1. VP Medical & Regulatory Affairs, Neopharm Ltd.2. Health Systems Management Department,
Health Sciences Faculty, Ben-Gurion University
Segev ShaniPhD, MHA, MBA, LLB
Disclaimer
• The opinions expressed in this presentation are the author’s personal views, and do not necessarily represent his workplace.
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The Supplier Perspective
• One global compliance policy / program to be implemented AS IS by the local distributor / agent.
The Distributor Perspective
• Negotiation and agreement with global corporate compliance department on the local ethics and compliance program to be implemented locally while solving conflicts between global and local laws and regulations.
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The Distributor’s Dilemma
• How to agree and comply with numerous global corporate compliance departments on the local ethics and compliance program to be implemented locally while solving conflicts between the different global requirements and local laws and regulations.
Neopharm Group ‐ Key Facts
– A private company established 1941
– 2nd largest marketing group of health care products –Rx, OTC, Medical Devices, Cosmetics, Dietary Supplements, etc.
– 500+ employees and $350M annual revenues
– Ranked among Israel’s top‐60 largest trading companies by D&B 2014
– A member of the exclusive club of 42 companieswhich hold Platinum Ratings in MaalaCorporate Social Responsibility Index
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Commitment to High Ethical Standards
• The first local\Israeli pharma company which nominated a Compliance Officer to enforce ethical conduct and promotional compliance
• Commitment to the Israeli code of ethics for interaction with health care professionals, adopted by the Israeli Medical Association and based on the IFPMA code of ethics
• Implemented internal SOPs regarding promotional compliance and ethical relations with HCPs (Health Care Providers)
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Define the market / Territory
Distributor / Agent selection process
Identify potential candidates
Perform Due Diligence
Review & Decision
Formal engagement - Agreement
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Key Medical device /Rx Partnerships (Partial List)
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Medical DevicesPharmaceuticalsTerritory
ADVAMED / MDMA
PhRMAUSA
EUCOMEDEFPIAEU
IMEDAIFPMAInternational
_Israeli Pharmaceutical companies
Israel
Diversity - Code of Ethics / Conduct
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Diversity – US states / ROW
Pictures from ASCO 2010Accessed at: http://scienceblogs.com/insolence/2010/06/09/the‐asco‐meeting‐the‐swag‐2010‐edition/
The Distributor’s Dilemma
• How to agree and comply with numerous global corporate compliance departments on the local ethics and compliance program to be implemented locally while solving conflicts between the different global requirements and local laws and regulations.
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The Implementation Dilemma
• Implement different compliance policies per different teams / organizational units as per the different global suppliers’ compliance policy?– Managers attention time and control– Different standards towards the
customers– Distributor’s own compliance policy
The Solution – one Voice
• Structuring a unified local ethics and compliance program to ensure consistency with multiple global corporate values as well as local laws and culture, instead of implementing several different global programs.
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Diversity – Gifts to customers
• Are gifts to customers allowed in general?
• Are there any restrictions / limits on the cost of the gift?
• Are there any restriction / limits on the type of the gift or the purpose of use?
• Are culture / holiday gifts allowed?
Pharmaceutical Research and Manufacturers of America®
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International Federation of Pharmaceutical Manufacturers & Associations
Advanced Medical Technologies Association
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Medical Device Manufacturers Association
Eucomed – European organization advocating the medical device industry
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• Glocalization combines the idea of globalization with that of local considerations.
• Allow for differentapproaches in a specific domain
The Solution – Act Glocal
Company DCompany CCompany BCompany AGift
√√√‐Pens
√√‐‐Cups/Mugs
√‐‐‐Branded snack
√‐‐√Notepad
√√‐√HolidayGifts
Unified for allAllowed Value
Diversity – implementation for gifts
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• A distributor / agent representing several suppliers must have one unified compliance program to accommodate for all requirements.
• The common denominator is the strictest demand in each conduct domain
• However, the program should be flexible enough to enable implementation of different conduct approaches in parallel in the organization in very defined and limited domains.
