By Viet Tran
The hepatitis C virus (HCV) chronically affects approximately 185 million people worldwide, with 350,000 terminal cases reported per year. In December 2013, the United States Food and Drug Administration (FDA) approved Sovaldi™, a new pharmaceutical tablet produced by Gilead Sciences, Inc. for the treatment of chronic HCV infection. Scientifically known as sofosbuvir, the drug is a salient component of an antiviral treatment regimen that increases the chances of successful eradication in patients within 12 weeks. Further information on the drug can be found here.
Despite the introduction of this medical game-changer, the drug comes with a hefty price tag of $1,000 per pill and costs as much as $80,000 for a single course of treatment. A standard course of treatment spans 12 weeks but certain patients may need to undergo the regimen for twice as long. The outrageous price tag attached to the drug raises serious questions of accessibility for those unable to afford the medication.
According to the World Health Organization (WHO), the virus disproportionately burdens developing countries, with Egypt carrying the highest rate of infection. The prevalence of HCV in developing countries and the astronomical costs of the sofosbuvir treatment place hope of viral eradication out of reach for most victims of HCV. Meanwhile, pharmaceutical companies estimate upwards of $15 billion in sales of the treatment in affluent countries, where only a mere five percent of HCV patients reside. Instead of fixating upon the potential of high profits in affluent countries, pharmaceutical companies should focus on improving accessibility in low and middle-income countries, where more than three-quarters of chronic hepatitis C victims reside.
Else Torreele, director of Open Society Foundation’s Access to Essential Medicines Initiatives, recently commented on the barriers presented by pharmaceutical companies that hinder developing countries’ efforts in medicinal treatment and accessibility.
How have we got to a global system where new drugs being developed are out of reach of most of the population? It’s totally normal today to price drugs at $100,000. Something is wrong with a system where drugs that so many people need are costing so much. This is not sustainable for anyone.
Several proposals directed towards the Gilead biopharmaceutical company call for lowering the cost of the sofosbuvir drug. Doctors Without Borders proposes a target price of less than $500. However, based on similar experiences with HIV drugs in the past, Gilead will unlikely provide such a steep price reduction in the near future. In retrospect, HIV medicine was only made accessible when generic competitors entered the market and drove down prices. Over a decade ago, HIV/AIDS medicine cost $10,000 per person per year. Nowadays, the same treatment costs an affordable $100. But how much longer must hepatitis C patients in impoverished countries wait until the sofosbuvir drug becomes financially accessible to them? Unless there is a strong political commitment and activist mobilization, it may be some time before the sofosbuvir drug follows the path of its HIV predecessors.
Another option to ensure access is granting compulsory licenses to low cost generic drug manufacturers. Such an action would force Gilead to reduce the price of its $1,000 pill. However, this is easier said than done. The global system we live in appears to maintain a greater proclivity towards making profits than addressing issues of global health and poverty. The World Trade Organization’s 1995 Trade Related Aspects of Intellectual Property Rights (TRIPS) created strict regulations on the issuing of temporary licenses to drug manufacturers. These temporary licenses would permit production of low-cost drugs in countries such as India, home to one of the world’s leading pharmaceutical industries in engineering accessible generic drugs. However, this ‘pharmacy of the developing world‘ is now facing a patent imposition by Gilead that threatens to block production of low-cost versions of sofosbuvir.
However, an opposition has been filed by the Initiative for Medicines Access and Knowledge (I-MAK) to impede the legalization of Gilead’s drug patent. India’s Patent Law provides that drugs, medication and other forms of treatment that are not profoundly new cannot qualify for patent protections. Tahir Amin, a lawyer and director of I-MAK claims:
India’s patent law doesn’t give monopolies for old science or for compounds that are already in the public domain. We believe this patent on sofosbuvir does not deserve to be granted in India and have legal grounds to prove it.
I-MAK argues Gilead derived sofosbuvir from antiretroviral drugs. If the I-MAK’s patent opposition succeeds, affordable generic versions of the drug can be made accessible to the millions that are affected by chronic hepatitis C. Though the struggle to provide affordable medication in developing countries continues, the intellectual property disagreement provides some hope of resolution.
As individuals, we can stand in solidarity with developing countries and mobilize for accessibility of hepatitis C treatments. Meanwhile, pharmaceutical companies should set aside their capitalistic instincts and realize that patient treatment comes before profits, If not, hepatitis C will continue to ravage impoverished communities despite the availability of a cure.
Photo by cambodia4kidsorg