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Gilead under fire for Sovaldi anti-diversion policy

Accused as generic versions of the drug start to reach the market


As generic versions of Gilead Sciences' hepatitis C virus (HCV) therapy Sovaldi start to reach the market, the company has been accused of impeding patient access.

Last year, Gilead reached a series of licensing deals with generic pharma companies to make low-cost versions of Sovaldi (sofosbuvir) available in more than 90 low-income countries around the world.

The agreement aimed to make the generics available for around $900 for a 12-week course of the drug - a fraction of its price in the developed world - although critics have suggested the price would have to fall to around $100 to be truly affordable.

Now, medical charity Médecins Sans Frontières (MSF) says Gilead's efforts to prevent bulk diversion or re-sale of from low- or middle-income countries to more affluent markets amount to "intrusive surveillance" of patients, according to a Financial Times report.

MSF first raised concerns about the anti-diversion programme last month, saying the drugmaker had introduced "a web of onerous and potentially harmful procedures that aim to preserve Gilead's ability to charge exorbitant prices in developed countries." 

The charity claims Gilead's programme violates patient privacy, undermines the confidentiality of patient data and "introduces coercion and policing upon medical providers [that] may result in treatment interruptions for patients, leading to treatment resistance and failure."

Sovaldi generics are now starting to reach the market in India as well as other countries such as Egypt. 

Gilead maintains that its efforts are simply aimed at preventing "broad, widescale diversion" and it denies requiring its Indian licensees to collect data on all patients receiving the therapy. MSF says the company is asking generic distributors to make the drug available on a named-patient basis, with proof of identity, citizenship and residence.

The charity is also concerned about the decision to mark each bottle of generic with a QR code, saying this will include a patient's name and address. 

India is in the process of introducing a 2D barcoding system on medicine packs to allow drug traceability and reduce the threat of counterfeiting, but the law requires this code only to include a unique serial number, global trade item number (GTIN), batch number and the expiry date. 

The FT cites the chief executive of one of the licensee companies in India as saying that - faced with the complexities of trying to keep tabs on patients across India's sprawling market - Gilead has already dialled down the programme. 

Article by
Phil Taylor

13th April 2015

From: Sales, Regulatory



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