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 IndustryNegative 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

Media

Coverage

Community

Legitimacy

NGOs

Advocacy

Government

Access

Investors

Money

Customer

Loyalty

Employees

Commitment

World of Opportunity

HCPs Represent Most Significant Interface

Grants

CME

Congresses

Consulting

Advisory Boards Speaker / KOL

Samples

Research

Promotional Aids / IMUs

Promotion

Ethics versus Compliance

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

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?

Use the Ethical Compassin Decision Making

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’ decisionsEvery employee is ultimately responsible for ethical

business practices