ETHICAL DECISION FLOW — GENZYME CASE

Problem Detected: Viral contamination in biomanufacturingtanks 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 threatenpublic 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?

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

Outcome: Preventive ethics satisfied; public welfare upheld.

Step 5a: Risk mitigated quickly; production resumes.

2nd diagram