Transcript The Role of Compliance

Setting the Scene:
The Role of Ethics and Compliance
in the Biopharmaceutical Market
Overview
Perception of the Biopharmaceutical Industry
What is Changing & Why Change?
Industry Stakeholders – Why they matter?
HCPs: Industry’s Most Significant Interface
Ethics vs. Compliance
Perception of the Biopharmaceutical Industry
 Negative perceptions of the biopharmaceutical industry
 Media publicises negative stories; rarely positive stories
 Recent stories in the United States, China and elsewhere
 Increasing demands for openness and transparency not
experienced by other industry sectors
 Disclosure of clinical trial data
 US Sunshine Act; EFPIA transparency model; JPMA
transparency Code; Australian transparency model
What is Changing & Why Change?
 Public and Government expectations
 Demand for healthcare is increasing
 Affordability & accessibility challenged
 Transparency demanded (payments / relationships / data)
 New and reinforced laws
 US Foreign Corrupt Practices Act & UK Bribery Act
 Local Laws Updated / OECD Anti-Bribery Convention
 Competition driving change
 Local vs. international companies
 Generics vs. branded / patented
Industry Stakeholders
World of Opportunity
Media
Community
Coverage
Legitimacy
NGOs
Government
Advocacy
Access
Investors
Money
Employees
Customer
Commitment
Loyalty
HCPs Represent Most Significant Interface
Grants
Promotion
Promotional
Aids / IMUs
CME
Research
Congresses
Consulting
Samples
Advisory
Boards
Speaker / KOL
Ethics versus Compliance
COMPLIANCE
• Conduct in accordance with the
agreed rules and standards
ETHICS
• Moral principles that govern a
person’s or group’s behaviour and
judgement of what is ‘right’
Key Responsibilities of ‘Corporate Compliance’
 Strengthen ethical decision-making and behaviour within the
organization
 Identify and oversee the management of compliance risks
 Enable business partners to develop policy
 Communicate and train on policy
 Guide, conduct or support investigations and enforce
policy compliance
Use the Ethical Compass
in Decision Making
 Is it consistent with our mission, values and spirit?
 Is it legal and ethical?
 Is it consistent with policy and Code of Conduct, both in word
and spirit?
 Can I justify it to my family and friends?
 What perception does it create in the external environment?
 Would I be comfortable if it appeared in the newspaper?
Key Components of a
Compliance Programme
1.
Written Policies & Procedures
2.
Designated Compliance Officer and Committee
3.
Effective Training and Education
4.
Clear lines of Communication
5.
Auditing and Monitoring
6.
Enforcement and Disciplinary Actions
7.
Response to Detected Problems & Corrective Actions
Who Owns Compliance?
 Risk of ‘Compliance’ usually thought to be the
responsibility of ‘the Compliance Department / Officer’
 Transition from a ‘culture of compliance’ to ‘values-based
decision making’
 From making ‘rules-based’ decisions to ‘ethical’ decisions
 Every employee is ultimately responsible for ethical
business practices