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 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 ComplianceCOMPLIANCE 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

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 Compass in 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’ decisions Every employee is ultimately responsible for ethical business practices