Geneva, Switzerland, May 22, 2014 —Today, four years after introducing its first viral hepatitis resolution, the World Health Assembly (WHA)—the decision-making body of the World Health Organization (WHO)—passed the Hepatitis Resolution, which commits the WHO and United Nations (UN) member states to urgent action to address the global hepatitis pandemic, including that of hepatitis C virus (HCV).
Globally, an estimated 185 million people have been infected with HCV. Since 2010, more than a million of them have died from HCV-related liver disease, although hepatitis C is treatable and curable. Since 2010, 9–12 million people have become infected with hepatitis C, although it is preventable. In addition, in an increasing number of countries, liver disease caused by HCV has become the leading cause of non-AIDS-related death in people coinfected with HIV/HCV.
The resolution comes at a critical moment, as new drugs to treat HCV are hepatitis C virus (HCV) entering the market. These new drugs, called direct-acting antivirals (DAAs), demonstrate cure rates of more than 90 percent in clinical trials and provide radically simpler treatment. DAAs offer the unprecedented promise of global HCV eradication, especially in low- and middle-income countries (LMICs), where 85 percent of people with HCV live.
Yet, in high-income countries, a 12-week combination regimen of DAA treatment can cost US$140,000, although it costs less than US$250 to produce. During the resolution proceedings, dozens of countries, including Malaysia, Ukraine, South Africa, Venezuela, and France remarked on the prohibitive cost of new HCV treatments.
The World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides LMICs with certain legal flexibilities. The Hepatitis Resolution supports LMICs’ use of these flexibilities to produce or import generic versions of DAAs and other medications if companies refuse to offer them at affordable prices. Brazil, the sponsor of the resolution, which was unanimously voted in, stated during the vote that governments, “should use TRIPs flexibilities whenever needed” in order to gain access to safe, effective, quality generics.
The WHO must vocally and unequivocally support countries’ use of compulsory licenses, parallel importation, and other TRIPs flexibilities to facilitate universal access to lifesaving treatment and to stop the 500,000 annual deaths related to HCV.
The inclusion of harm reduction—an evidence-based approach to reducing transmission of bloodborne viruses and mortality among people who inject drugs (PWID)— is retained in this resolution as a key recommendation, despite early opposition by some countries. During the vote, a number of governments, including Indonesia, Iran, Russia, and Canada spoke out on the need to address PWID as a key population. Now the WHO must prioritize providing technical assistance to UN member states to dramatically scale up needle and syringe programs, opioid substitution therapy, access to HCV treatment, and decriminalization of PWID and harm reduction for this critically important population, 67 percent of whom are HCV-infected. Most new infections occur among PWID, yet access to sterile injection equipment and other HCV prevention tools is staggeringly inadequate, reaching only a tiny percentage of those who need it. This egregious public health failure allows the epidemic to continue spreading.
The Hepatitis Resolution challenges WHO Director–General Margaret Chan and her agency to mobilize global political will and resources to effectively address viral hepatitis, and to help UN member states develop the technical capacity to implement prevention, treatment, and care plans. Without a massive resource investment from donors and UN member states to support a global plan, millions will continue to become infected and die.
Ms. Chloé Forette, Médecins du Monde, +33-609-537-369 (France)
Ms. Karyn Kaplan, Treatment Action Group, +1-646-316-8979 (United States)
For further information on key issues concerning the Hepatitis Resolution at the World Health Assembly, please see: Defuse hepatitis C, the viral time bomb: Test and Treat Hepatitis C: Position Paper for the 67th World Health Assembly, May 19–24, 2014. Available at: http://www.hepcoalition.org/advocate/advocacy-tools/article/defuse-hepatitis-c-the-viral-time.
 Hill A, Khoo S, Fortunak J, Simmons B, Ford N. Minimum costs for producing hepatitis C direct-acting antivirals for use in large-scale treatment access programs in developing countries. Clin Infect Dis. 2014 Feb 13. 2014 Apr; 58(7):928–36. doi: 10.1093/cid/ciu012.