General corruption risk approaches applicable to the health sector Overview of actors
2) Value Chain Analysis -VCA
Chart. Key Decision Points and Related Processes in the Drugs Sector that May Be Vulnerable to Corruption shows a more elaborate example of a VCA depicting corruption in pharmaceuticals.
| TABLE 1.1 | Key Decision Points and Related Processes in the Drug Sector that May Be Vulnerable to Corruption |
| Decision point | Processes |
| Manufacturing | Adherence to GMPs Quality management Packaging and labeling active pharmaceutical ingredients Master, batch, and laboratory control records Production and in-process controls Certificates of analysis Validation Tracking complaints and recalls |
| Registration | Full registration or abbreviated drug applications Safety and efficacy Labeling Marketing Indications Pharmacovigilence and warnings Batch testing Reevaluation of older drugs |
| Selection | Determine budget Assess morbidity profile Determine drug needs to fit morbidity profile Cost-benefit analysis of drugs Consistency with WHO (and other evidence-based) criteria Pricing and reimbursement decisions |
| Procurement | Determine model of supply/distribution Reconcile needs and resources Develop criteria for tender Issue tender Evaluate bids Award supplier Determine contract terms Monitor order Make payment Quality assurance |
| Distribution | Import approvals Receive and check drugs with order Ensure appropriate transportation and delivery to health facilities Appropriate storage Good distribution practices and inventory control of drugs Demand monitoring |
| Prescribing and Dispensing | Consulting with health professionals Inpatient and outpatient care Dispensing of pharmaceuticals Adverse drug reaction monitoring Patient compliance with prescription |
Source: Authors.a. Manufacturing processed section adapted from FDA (2000). Cohen et al. (2007): 35. For detailed information on this VCA, the decision points, etc. please refer to Cohen et al (2007).