The new HCV Treatment: Negotiations that Lack Transparency and a Medicine Egyptians Can't Afford
Last month, the government announced a new strategic plan to address hepatitis C virus (HCV) in Egypt, which claims the lives of thousands of Egyptians every year. The announcement was accompanied with a celebration of a deal with the pharmaceutical giant, Gilead, which would provide the Egyptian government with a new revolutionary treatment for HCV costing $300 per box. The treatment course requires at least six boxes which means the government pays $1800 (about EGP12,800) per patient.
However, the deal also puts the price of the medication outside of the government program at $2130 or over 15 thousand pound for only one box. So, a patient who is not registered in the government’s program should pay over 91 thousand pounds for a six-month treatment course making it far beyond the purchasing ability of the majority of Egyptians. Also, the government has failed to disclose the details of the contract signed with Gilead which makes it impossible to determine the number of patients who would actually benefit from the reduced price.
“This new medicine, which happens to be the first among a new family of oral HCVcure, will remain unaffordable outsidethe government program. Only the very rich will be able to pay for it”, said Heba Wanis, a researcher at the Egyptian Initiative for Personal Rights (EIPR) and the author of a research paper EIPR has launched Tuesday under the title of “Hepatitis C Treatment in Egypt: Why Cost Remains a Challenge.”
Egypt has the highest prevalence of HCV in the world, making it one of the major public health challenges facing the country. In the absence of effective early detection mechanisms for HCV, the exact number of patients affected by the virus is impossible to determine. But research has found that an estimated 8-15 million Egyptians are affected by HCV.
The year 2008 marked the beginning of a state plan to address viral hepatitis “National Control Strategy for Viral Hepatitis”. From 2008 to 2012, only 2.8 percent of Hepatitis C patients received treatment and only 1.67 percent of these were cured. The prevention element of the strategy proved to be inadequate, and HCV continues to infect at least 150,000 new patients every year.
Currently a new action plan for 2014-2018 with a bigger budget than its predecessor is under development. The new plan has received the support of several global partners including the World Health Organization, the French Pasteur Institute, and the US Center for Disease Control.
On October, 16, 2014, the Ministry of Health released the executive summary of the new plan, titled “Action Plan for the Prevention, Care, and Treatment of Hepatitis C 2014-2018.” The same day, the new treatment program using sofosbuvir (brand name Sovaldi) was launched.
Negotiations between the Egyptian government, represented by the National Committee for the Control Viral Hepatitis, and Gilead Sciences, the US manufacturer of Sovaldi, have led to a deal which allows the government to provide the new medication for a limited number of patients for the reduced price of $300 for one box of 28 pills, with patients requiring one box a month for six months. (The treatment regimen may also require pegylated interferon and ribavirin, depending on the protocol).
According to the National Committee for the Control of Viral Hepatitis, the agreement with Gilead does not preclude the Health Ministry and other official bodies from freely contracting with other companies to manufacture the drug locally. EIPR’s paper shows how, in 2004, the local production of interferon, the former standard treatment for HCV which has a much lower efficacy than the new medication, led to a sharp reduction in the price of the imported drug in the local market. This sort of competition is necessary to prevent monopolies by foreign drug companies in the Egyptian market, since the primary victims of these monopolies are Egyptian patients.
In the early stages of negotiations between Gilead and the Egyptian government, Egyptian pharmaceutical companies showed an interest and readiness to produce sofosbuvir locally at a discounted rate. However, their attempts did not receive adequate support from the Health Ministry, which feared possible violations of Gilead’s intellectual property rights—rights which the company has not yet claimed. Since Gilead has not yet received patent protection for its product in Egypt, and it is unlikely to happen, local manufacture of the drug remains an effective option for providing a low-cost product to deal with the epidemic.
The paper identifies another problem in that sofosbuvir,which will be produced locally by national pharmaceutical companies, will nevertheless be affected by the high price negotiated by the Egyptian government In keeping with current drug pricing policy, the price of the domestically produced drug will be 65% of Sovaldi’s price outside the treatment program. This will put the retail price of the domestic generic alternative at about EGP10,000 per box meaning that a six-month treatment course would cost around EGP 60,000, which is still far beyond the reach of most Egyptians, especially that HCV prevalence is higher among the poorer in the country. About 26.3% of Egyptians live in poverty with an average monthly income of around 327 EGP.
Generic drugs should be within the reach of ordinary patients, but the high price of generic sofosbuvir—which several companies have indeed registered to manufacture for sale in the Egyptian market—demonstrates the importance of reconsidering the drug-pricing regime in Egypt. Drug pricing has been the subject of lengthy debates over the past few years, since 2009 when Egypt stopped pricing drugs based on actual cost plus a small margin of profit and moved to using foreign prices as a benchmark.
EIPR demands that the government makes the details of the contract with Gilead public and to uphold transparency as a policy in similar, future negotiations. EIPR also stresses the importance of supporting the local pharmaceutical manufacturing industry in order to bring the price down for Egyptians to be able to afford. The government must also adopt a drug-pricing policy that makes it a priority to put drugs within the reach of all patients, rich and poor alike, as a fundamental requirement to achieve social justice in regards to Egyptians’ basic right to health.