ERM and the Pharmaceutical Industry
Risk An innate part of every aspect of life, and the business environment is of no exception Severity, both in terms of impact and likelihood, of risks are increasing in general due to the influence of globalization Systematic risks › General economic conditions, competition, regulation Industry specific risks › Ex: Political tensions and their impact on the oil industry
Pharmaceutical Industry More than ever before, advances in healthcare are reaching new horizons never before believed to be possible Perhaps the riskiest industry due to its unique environment › Intense competition to create new drugs and from generic drug manufacturers › Government regulation -- FDA Drug Approval Process › Patent protection issues › Drug failure › Litigation exposure
FDA Approval Process Food and Drug Administration (FDA) regulates pharmaceuticals in the United States › Drug safety, quality standards, labeling and warnings, etc. The drug approval process is extremely complex › Preclinical laboratory testing (often involves experimentation with animals) › Three phases of human testing › Post market monitoring
FDA Approval Process › Graphical Depiction › Statistical Reality › For every 5,000 compounds that enter preclinical testing, only about 5 reach first phase of human testing › Of the 5 that make it to human testing, only roughly 1 will achieve approval
COSO’s ERM Framework Enterprise Risk Management (ERM) involves the procedures and methods used by an organization to assess, manage, and mitigate risk Committee of Sponsoring Organizations of the Treadway Commission (COSO) developed a widely used ERM framework during a period of widespread corporate scandals
COSO’s ERM Framework ERM Objectives (4) › strategic objectives › operations objectives › reporting objectives › compliance objectives ERM Components (8) › internal environment › objective setting › event identification › risk assessment › risk response › control activities › information and communication › monitoring
Application of ERM to Pharmaceutical Companies Internal environment is a vital component in terms of protecting an organization’s sensitive research and development information › Corporate culture built upon high ethical standards › Proactive measures to hire individuals with integrity › Adequate and effective internal controls
Conclusion Clearly, pharmaceutical companies face a myriad of risk factors › Intense competition and government regulation (FDA approval process) However, ERM is an effective way for pharmaceutical companies to manage their risks › Reduce exposure to losses due to competition, drug failure, litigation, etc.