ETHICAL DECISION FLOW — GENZYME CASE

Central Ethical Problem:Delay in disclosing viral contamination to protect corporate reputation and stock value.

Internal Actors and Interests• QA / Process Engineers → duty to report contamination• Senior Management → duty to shareholders and profit• Public / Patients → right to timely, safe treatment

CONFLICT ZONEEthical Duty (Safety) Financial Pressure

Outcome:• Management prioritised revenue and optics over safety.• QA staff limited by internal hierarchy from disclosure.• Regulator informed only after significant delay.

Type of Conflict• Actual COI – corporate self-interest directly compromised duty to protect public welfare.• Perceived COI – public viewed concealment as profit-motivated, eroding trust permanently.

Resolution Measures (Ethical Corrective Actions)• Separate safety authority from financial oversight.• Mandate immediate disclosure policy to regulators.• Require engineers’ whistle-blowing protection.

Problem Detected: Viral contamination in biomanufacturing tanks producing life-saving drugs (Cerezyme, Fabrazyme).

Step 1: Identify and Verify the Risk• Contamination confirmed by QA testing.• Internal review finds viral presence across equipment.

Step 2: Does the issue threaten public safety or patient welfare?

Step 3a: Report immediately to FDA and halt output.

Step 3b: Continue internal review and production (minimal disruption).

Step 4a: Conduct transparent risk communication; implement cleanup.

Step 4b: Delay disclosure; manage optics; minimise financial damage.

Step 5: Did delay worsen public impact or regulatory trust?

Step 5a: Risk mitigated quickly; production resumes.

Step 5b: Outcome: Reactive ethics; harm amplified; fines, loss of trust.

EG2401