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Setting the Scene: The Role of Ethics and Compliance in the Biopharmaceutical Market

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: I ndustry’s Most S ignificant I nterface.

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Setting the Scene: The Role of Ethics and Compliance in the Biopharmaceutical Market

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  1. Setting the Scene: The Role of Ethics and Compliance in the Biopharmaceutical Market

  2. 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

  3. 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

  4. 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

  5. Media Community Coverage Legitimacy Government NGOs Access Advocacy Investors Customer Employees Money Loyalty Commitment Industry Stakeholders World of Opportunity

  6. HCPs Represent Most Significant Interface Grants Promotion Promotional Aids / IMUs CME Research Congresses Samples Consulting Advisory Boards Speaker / KOL

  7. Ethics versus Compliance

  8. Key Responsibilities of ‘Corporate Compliance’ • Strengthen ethical decision-making and behaviourwithin the organization • Identify and oversee the management of compliance risks • Enable business partners to developpolicy • Communicate and train on policy • Guide, conduct or support investigations and enforce policy compliance

  9. Use the Ethical Compassin 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?

  10. Key Components of a Compliance Programme • Written Policies & Procedures • Designated Compliance Officer and Committee • Effective Training and Education • Clear lines of Communication • Auditing and Monitoring • Enforcement and Disciplinary Actions • Response to Detected Problems & Corrective Actions

  11. 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

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