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

In Orphan Drug Congress, Whitepapers by Freya Smale

Corporate Social Responsibility

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Pharmaceutical companies are becoming aware that intentional initiatives to support CSR can improve their competitive advantage. CSR affects many stakeholders across sociocultural, political, economic, and regulatory environments. In the past, a medium to large pharmaceutical company could donate to various charities and claim to be a good corporate citizen. Companies are now expected to engage in programs that affect the health and well-being of patients as well as influence sustainable positive change in local and global communities.

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Ethical Access to Needed Medicines

Defining ethical EAP and trying to apply the definition uniformly across continents can be complicated. It is occasionally unclear on one continent across multiple industry participants. In the US the term EAP and CU programs can be used interchangeably, while in Europe the terms do not have the same meaning  CU typically refers to a process where a  pharmaceutical manufacturer temporarily allows access to treatment for a patient who has run out of alternative treatments. A product can receive regulatory approval in one country and be available for CU or PLS prior to market authorization in other countries. Some companies offer the drug at no charge while others seek out payment programs .

We are thrilled to announce that One-World inc. are joining us as a sponsor at this year’s World Orphan Drug Congress USA 2016. Register today to meet them in D.C. on April 20-22.

World Orphan Drug Congress USA 2016