Gilead is Criticized for Restrictions on Generic Hepatitis C Drug Deal

Source: The Wall Street Journal

20 March 2015

 In yet another fracas over Gilead Sciences and its hepatitis C treatments, Doctors Without Borders is harshly criticizing the drug maker over an agreement in which several generic companies will sell lower-cost versions of Gilead’s Sovaldi and Harvoni medicines in 91 developing countries. At issue is the effort Gilead is making to ensure its medicines are not sold in still other countries not covered by the deal.

The agreement, which Gilead announced last fall, is designed to forestall criticism over the price of its medicines, which in the U.S. cost $63,000 to $94,500, depending upon the drug and regimen. The medicines cure more than 90% of those infected and Gilead argues the cost is less expensive than hospitalizations or liver transplants. But the cost is considered out of reach in many countries.

With its deal, Gilead sought to provide greater access to the estimated 185 million people who live in low and middle-income countries. At the same time, the drug maker hopes to avoid the reputational damage the pharmaceutical industry sustained more than a decade ago in South Africa over litigation surrounding access to costly AIDS medications.

But the move is showing signs of backfiring. Doctors Without Borders notes that Gilead is attempting to enforce conditions on the 11 generic drug makers that would prevent the copies from being diverted to countries not covered by the agreement. But the relief organization argues Gilead is doing so in a way that may compromise patients in order to protect its commercial interests.

Specifically, the relief group says Gilead requires patients to present national identification and residency papers, which it argues could disqualify migrants and refugees. And the relief group says the generic drug makers must track patients and ensure the copies are dispensed in limited quantities. One stipulation is that patients must return empty bottles to continue treatment (more here). The relief group worries these moves create an “ugly precedent.”

“We’ve never seen anything like Gilead’s anti-diversion program before, where a company can potentially violate patient confidentiality and treatment outcomes in order to protect its profits,” says Manica Balasegaram, who heads the organization’s access to medicines campaign, in a statement. “Gilead is forcing medical providers to introduce policing measures that could lead to dangerous treatment interruption.”

A Gilead spokesman writes us that In Egypt, the government uses “unique label codes to confirm that each bottle is received and returned by the patient to whom it is prescribed. To date, more than 40,000 hepatitis C patients in Egypt have initiated treatment with Gilead medicines.”

He adds that discussions are under way with the 11 generic drug makers that are part of the agreement. The drug makers, which include Mylan Laboratories and Ranbaxy Laboratories, agreed to pay royalties to Gilead for the right to make both drugs. We asked for comment and will update you accordingly.

Separately, the relief group analyzed the agreement with the generic drug makers, which does not include 50 middle-income countries, such as Brazil and China. Doctors Without Borders objects to restrictions on where the generic copies can be sold and also an “excessively broad definition” for patents, which it claims allows Gilead to deny patients access who live in excluded countries, even if a Gilead patent has been denied in one of those countries.

In an analysis, the relief group also argues that Gilead is using a tiered pricing strategy for middle-income countries excluded from the agreement, which could cause high prices for those countries ranging from $2,000 to $15,000 for a three-month regimen.

The Gilead spokesman writes that the drug maker enforces tiered pricing as well as voluntary generic licensing to enable access. “There is no one-size-fits-all solution to this challenge and any measures implemented will take into account the needs of the patient and all concerned in delivering care,” he writes.

This entry was posted in Hepatitis C, Regulation, Sofosbuvir. Bookmark the permalink.

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