The latest battle over access to medicines is taking place in Ukraine, where Doctors Without Borders is urging Gilead Sciences to drop a court action that, if successful, would prevent a generic version of the Sovaldi hepatitis C treatment from remaining available.
In a Sept. 5 letter released publicly Tuesday (click here), Gilead was asked to “reconsider its business strategy in high-burden, middle-income countries, especially Ukraine,” since its strategies “threaten sustainable access to hepatitis C treatment in a number of countries” where the advocacy group treats patients.
The issue arose last June, when Gilead filed a claim against a Ukranian drug wholesaler, the Ukrainian Drug Regulation Authority, and the Ministry of Health, alleging several of its patents prevent generic drug makers from marketing a version of Sovaldi for the next few years. A hearing is scheduled for Sept. 12.
In doing so, the company is challenging the right of Pharco Pharmaceuticals, a generic drug maker based in Egypt, to sell a copycat version of Sovaldi in the Ukraine, where more than 1.3 million people are believed to be infected with hepatitis C, according to the World Health Organization.
“Competition is crucially important for affordable prices for medicines while [the] creation of [a] monopoly regarding sofosbuvir may lead to [an] increase or [freezing of] its price for many years.”said Sergiy Kondratyuk, of the All-Ukrainian Network of People Living with HIV/AIDS in a statement on the group’s web site.
The dispute has its roots in a far-reaching attempt Gilead undertook to blunt criticism over the cost of Sovaldi. The company caused a ruckus when it priced its first hepatitis C treatment at $84,000 for a 12-week regimen. With a 90 percent cure rate, the product was quickly in high demand.
So two years ago, Gilead reached licensing deals with seven generic drug makers based in India to sell lower-cost versions in 101 low-income and middle-income countries. The goal was to provide greater access and avoid reputational damage as many countries began complaining about the price.
However, the licensing deals excluded such countries as Brazil, China, Turkey, Thailand, and Ukraine — where patient groups have worried that governments and individuals may not be able to afford the drug, potentially excluding millions of people infected with the virus from gaining access to treatment.
As a result, Gilead and patient groups have skirmished over Sovaldi patents. The All-Ukrainian Network of People Living with HIV/AIDS and the Initiative for Medicines, Access, and Knowledge, or IMAK, have challenged the patents that the drug maker has filed in Ukraine, and Gilead lost the first two rounds. Last May, however, the drug maker submitted yet another patent application.
IMAK, by the way, is working with various advocacy groups in different middle-income countries to challenge Gilead patents. Last May, the drug maker won an unexpected victory when Indian officials reversed a decision by the government patent office, which had rejected a Gilead patent.
A Gilead spokesman wrote us that the company does “recognize that the country faces a significant and challenging hepatitis C burden. The company is currently engaged in constructive discussions with Ukraine’s Ministry of Health on the establishment of a comprehensive national treatment and prevention program, which includes access to Gilead’s lowest available pricing for its chronic hepatitis C medicines ($250 per bottle of Sovaldi), far below the unlicensed generic pricing ($800 per bottle) currently being offered in the country.”
By Ed Silverman