ACCESS TO MEDICINE: THE DEBATE CONTINUES WITH GILEAD’S SOVALDI

by Olumayowa O. Adesanya

Given the failed attempts at developing a vaccine for vaccine Hepatitis C, a disease with a higher mortality rate compared to HIV/AIDS, the announcement of a cure was greeted with much fervour. On December 6, 2013, the United States Food and Drug Administration (FDA) approved Gilead Sciences’ Sovaldi (sofosbuvir). This drug is expected to treat people with genotypes 1 through 4 of hepatitis C virus (HCV), including those co-infected with HIV and those who have liver cancer and are waiting for a transplant.

There is a catch.

Wait for it.

The drug is set to cost $1,000 per day and a cumulative of $84,000 for the given 24-week treatment regimen.

HCV is said to be most prevalent in Egypt and other middle-income countries like China, India, and Russia, a country that has been plagued with political crises in recent years. This sparks a debate similar to earlier disputes over access to generic HIV/AIDS drugs.

The World Health Organisation (WHO), civil society groups and patients have been at the forefront in the international Campaign for Access to Essential Medicines particularly in terms of availability and pricing. Access to medicine is a pivotal issue in Intellectual Property discuss particularly as it relates to Patents. The grant of a patent results in a monopoly where the sole player dictates the price of its product(s). As such, Gilead’s pricing is consistent with the norm. Their pricing, according to them, is justified by the benefits of the drugs and the friendly dosing schedule when compared to similar drugs in the market.

According to WHO’s Fact sheet on HCV N°164 updated July 2013, about 150 million people are chronically infected with hepatitis C virus, and more than 350 000 people die every year from hepatitis C-related liver diseases. With these statistics, comes the argument that sold at a price affordable to these millions and their health providers/insurers, Gilead is bound to recoup its investment in a matter of time. It would seem though that there is bound to be competition before the monopoly ends as other manufacturers are working towards perfecting their treatment for HCV.

Already, insurance companies, patient advocates and health organisations have begun to push against what they consider as unfair pricing.  However, with the alternatives to Sovaldi not as effective, patients and doctors are bound to embrace it regardless of the cost. Notwithstanding, the clamour for compulsory licensing in order to produce generics at a lower price remains.[1] As it stands, a New York-based legal group Initiative for Medicines, Access, and Knowledge (I-MAK) has filed suit to allow patenting of Sovaldi in India, so that a cheaper generic form could be available.

While one ponders the pricing rationale considering Gilead’s historical co-operation with the Medicines Patent Pool and other agencies dedicated to guaranteeing access of HIV medicines in developing countries, Gilead has announced its initiative known as Support Path. This is to assist eligible hepatitis C patients in the United States who do not have insurance, are underinsured or who otherwise need financial assistance to gain coverage for or access to Sovaldi. What about other sufferers across the globe?

It is interesting to read this article in Forbes and the comment of Bayer AG CEO, Marijn Dekkers, who is reported to have said that Bayer didn’t develop its cancer drug, Nexavar (sorafenib) for India but for Western patients that can afford it.

Olumayowa O. Adesanya is an LLM (IP) Candidate at Queen Mary, University of London and an Assistant Editor of the Queen Mary Journal of Intellectual Property Law.


[1] This formed the basis of the DOHA Declaration of 2001. Since the passage of Canada’s Access to Medicines Regime (CARM) in 2004, only two orders of Antiretroviral drugs for HIV/AIDS patients in Rwanda have been exported. Although India and the European Union have similar legislations, no generic drugs have been produced under compulsory licences solely for export to countries without manufacturing capability.