Key Findings and Conclusions

•   Public data on the magnitude of the problem of substandard and falsified medicines are limited.

•   The illegal trade and manufacture of medicines are a global problem, disproportionately affecting low- and middle-income countries.

•   Countries with weak regulatory oversight and law enforcement attract illegitimate manufacturers, while countries with strict law enforcement repel them.

•   Government and intergovernmental agencies, such as the U.S. Food and Drug Administration and Interpol, have taken action against substandard and falsified medicines.

There is a difference between secrecy and appropriate discretion with evidence for pending criminal prosecutions. The committee recognizes that undercover intelligence informs law enforcement agencies’ actions against criminals. Prematurely releasing confidential information about pharmaceutical crime can compromise an investigation. Too often, however, governments and industry withhold information years after incidents pass (Cockburn et al., 2005). Regulators should be able to access this data so that they can communicate it to the public as appropriate, as it informs consumer safety and can trigger epidemiological research on drug quality.

There is also value in sharing information on falsified and substandard medicines internationally. The modern pharmaceutical supply chain is complex. Drug manufacturers source chemicals from around the world, and different factories process ingredients into a final formulation that is packaged, repacked, and sold in many different countries. The chances that a drug quality problem in one country affects that country alone decrease when products travel along global supply chains. The interconnectedness of the drug supply chain makes it imperative that countries share information on falsified and substandard drugs.

The Pharmaceutical Security Institute Incident Reporting System

The Pharmaceutical Security Institute (PSI) is a nonprofit organization composed of the security departments of 25 major pharmaceutical companies

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