KYIV. Feb 23 (Interfax-Ukraine) – Ukraine has signed an amicable agreement with U.S. Gilead Sciences, Inc. biopharmaceutical company on the Sovaldi medicine used to treat chronic hepatitis C infection in adults, acting Ukrainian Health Minister Ulana Suprun said at a press conference on Wednesday.
“The amicable agreement signed on Wednesday morning with our colleagues from Gilead will give Ukrainians more access to medicines treating hepatitis C at affordable prices, including at drugstores,” she said.
The Sovaldi medicine procured through international organizations will be priced at $250, or UAH 6,750 at the current forex rate, per pack.
Head of the Patients of Ukraine charity foundation Dmytro Sherembei said in turn that the price of this medicine at drugstores is UAH 10,000 per pack, whereas the price of its generic, Grateziano, whose registration in Ukraine was cancelled under a Health Ministry resolution on February 22, 2017, is UAH 15,000.
In general, the whole course of hepatitis C treatment with the use of Sovaldi in Ukraine will cost about $750, while it is about $60,000 in Europe and $70,000 in the United States, he said.
Gilead Senior Vice President for Access Operations & Emerging Markets Clifford Samuel said that Ukraine had been included in Gilead’s program for affordable access to chronic hepatitis C treatments because the economic situation in the country is difficult, its GDP level is low, but the pace of the spread of hepatitis C is fast. Thus, the price of Sovaldi and Harvoni is significantly lower for Ukraine.
He also disclosed the company’s plans to register another medicine for the treatment of adult patients with chronic hepatitis C virus, Epclusa.
“Now we’re working to make Epclusa available in Ukraine in the near future,” he said.
Gilead and the Health Ministry plan to jointly work to create programs for preventive medicine to raise public awareness of hepatitis C and boost the number of hepatitis C diagnostic procedures for Ukrainians.
Justice Minister Pavlo Petrenko, who was present at the press conference, in turn, commented on the legal side of the amicable agreement, saying that it helped Ukraine avoid a claim from Gilead worth $800 million.
“The Ukrainian government together with civil society, perhaps for the first time in 15 years have found a civilized way for reaching understanding with the largest foreign investor involved in innovative developments of drugs for the treatment of hepatitis C,” he said.
As reported, the Ukrainian Health Ministry in November 2015 registered the Grateziano generic drug with the active substance Sofosbuvirum after Gilead in October 2015 registered the Sovaldi original innovative drug in Ukraine. Therefore the registration of the generic medicine violated the producer’s five-year exclusivity rights.
Kyiv’s district administrative court late in October 2016 refused to cancel the registration of the generic product.
At the end of January 2017, Ukraine’s government decided to sign a settlement agreement with the pharmaceutical producer, under which Ukraine undertook to take measures to eliminate the violations of the legitimate exclusive marketing rights. Gilead, in turn, stated that it would give up the compensation claims against Ukraine and will give a discount on its drug.
Ukraine’s Health Ministry on February 22, 2017 issued an order to cancel the registration of Grateziano and exclude it from the State Register of Medicinal Products of Ukraine.
