Corporate Citizenship, Expanded Access, and Ethical Pre-License Drug Sales

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Corporate Citizenship, Expanded Access, and Ethical Pre-License Drug Sales

 

Keith Watts

Abstract

Global medicineHigh public expectations for corporate social responsibility (CSR) and accountability have directed pharmaceutical industry practices to influence positive change locally and globally. Drug companies often respond to issues affecting patient well-being following commercialization of new products. Today, pharmaceutical companies are held to higher standards as corporate citizens and must now consider how to implement this role throughout a product’s life-cycle. Channels that allow access to medicines to treat serious, life-threatening and debilitating disorders must be balanced with the interest of all stakeholders.

Today, this balancing act takes place earlier in the product life-cycle, often before commercialization, at the end, and even in those instances where market authorization is not sought. There are various ethical channels available to provide needed medications to patients with no alternatives. Some of these channels include Early and Expanded Access Programs (EAP), Named Patient Programs (NPP), Compassionate Use (CU), and Pre-License Sales (PLS). Confusion exists because these terms can have varying meanings throughout the globe. It is important that these channels are fully understood by pharmaceutical companies to uphold CSR, lessen risks, and preserve patient safety. Clearer definitions of these different channels are needed, as is understanding and expertise to ethically and compliantly leverage these pathways to benefit those around the world with rare, serious, and often life-threatening disorders. While this will surely be a difficult task, clarifying understanding of these pathways will eventually harmonize manufacturers, distributors, and patients.

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By | 2017-05-08T18:12:55+00:00 December 20th, 2016|White Papers|0 Comments