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nder pressure to widen access to a pricey hepatitis C medicine, Gilead Sciences (GILD) has expanded a licensing deal that will allow generic companies to now sell lower-cost versions in four middle-income countries – Ukraine, Belarus, Thailand and Malaysia.

The move comes amid an ongoing and far-reaching battle over the cost of Sovaldi, which has threatened to strain government budgets around the world since becoming available nearly four years ago. The Gilead decision, in fact, comes after heated skirmishes in at least two of those countries.

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  • The Gilead case is a classic business case study that is unfortunately repeated time and again. When pharmaceutical companies charge prices that evokes the wrath of governments and patient advocates alike, and then remediate the issue by responding to public pressure, the long term ramifications are significant, but typically go unnoticed by company executives, especially on the commercial side of the business.

    But on the clinical side, patient advocates remember the past actions of a company. As a result, enrollment into the company’s next clinical trial may be negatively impacted. As a case in point, one need only look to Biomarin. When the company set a price in Europe for more its orphan drug amifampridine (Firdapse) for Lambert Eaton myasthenic syndrome (LEMS), patient advocates globally, and especially in the US reacted by boycotting its clinical trial. This resulted in higher development costs, loss of company credibility, loss of market share, and ultimately a price adjustment.
    All too often the decisions on the commercial side of the business can impact operations on the clinical side. Key business decisions that impact patients as customers must be examined in a more holistic way. But this can only happen when internal silos are removed, and dialogue and decision-making involves both sides of the business. Gilead must now mend fences with the patient community, and monitor the enrollment of its clinical trials among Hepatitis patients.

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