UCLA’s Patent War in India Prevents Access to Prostate Cancer Treatment Worldwide

Drug prices are too high: One in five Americans ration their medicine due to high prices, and 10 million people die every year due to lack of access to medicines. Because of patent exclusivity laws, pharmaceutical corporations are able to set the price tag of a novel drug as high as they want, which often keeps it out of the hands of low-income populations. Patent rights, along with their political and economic power, allow Big Pharma to prioritize profit-making over health interests and leads to even larger inequalities in global access to medicines.

University research often plays a big role in the discovery of lifesaving medicines before manufacturers’ move in to price-gouge the new drugs. Take enzalutamide, a treatment for late-stage prostate cancer, as an example. The underlying research that led to its discovery was done at the University of California and funded in part by the Department of Defense and a $2.3 million grant from the National Institutes of Health. Many of the people it is intended to help cannot access the lifesaving medicine due to the high price set by its manufacturer, Pfizer. Further, Pfizer’s price in lower- and middle-income countries highlights the far-reaching monopoly power that US drug corporations have in the international market.

Intended to treat late-stage prostate cancer that is unresponsive to chemotherapy and surgical methods, enzalutamide — or Xtandi — has the potential to improve and prolong the lives of many people around the world living with untreatable prostate cancer. But the sticker price limits its impact. The University of California Los Angeles (UCLA) has raked in more than half a billion in profit by licensing its novel drug to the biotech company Medivation, Inc., later acquired by Pfizer, which currently sells enzalutamide at $101.16 per pill in the United States.

UCLA went on to pursue a patent on Xtandi in India, which would block generic manufacturers from producing and marketing enzalutamide at a lower price. When the Indian government denied the patent, the university responded by filing an injunction, which freezes generic marketing. India’s generic manufacturers often develop medicines for other low- and middle-income countries. Thus, UCLA’s patent case prevents many nations from accessing a lower-priced generic enzalutamide. Without generic competitors, Xtandi is unaffordable in countries like Argentina, where it has already been introduced as a successful treatment through its clinical trials.

Argentina, a country newly classified as high-income by World Bank, was host to pivotal Xtandi drug trials. However, given the country’s extreme inequality between the wealthy and poor populations, the high price of a medicine like enzalutamide has a compounding effect. The richest 10 percent of people in Argentina control more wealth than the poorest 60, and 32.9 percent of Argentinians live in poverty. Prostate cancer accounts 13 percent of all cancer mortalities in the country.

Although the government provides universal health care to its citizens with provincial governments responsible for the delivery of services, there are significant regional disparities in health outcomes. Insurance coverage was estimated to reach 64 percent of the population by 2010. According to the World Health Organization, the majority of Argentinians pay 45 percent of medicine costs out of pocket, even with insurance. Thus, the price of enzalutamide far exceeds the threshold for a catastrophic health care expenditure when compared with Argentina’s Gross National Income per capita (average income of a citizen) of $13,040 per year.

According to an online drug-pricing database managed by Knowledge Ecology International, the current price of Xtandi in Argentina is listed as $58.06 per pill, putting the daily price of treatment (four pills a day) at $232.24, and the yearly price at $84,767. This means that Argentinians with no insurance would be forced to spend more than six times the country’s average income to purchase a year’s supply of enzalutamide out of pocket. Factoring in a 45 percent out-of-pocket cost that most Argentinians pay for prescriptions, patients with insurance can expect to be responsible for covering $38,145 of the price. Even though enzalutamide is available on the Argentine market and trials were conducted in the country, the price of the medicine is far out of reach for those who need it.

The Council for International Organizations of Medical Sciences, an international nonprofit established by UNESCO and the World Health Organization, declares it unethical to conduct clinical trials in low-resource settings without making proper arrangements to ensure that the drug is available to the populations once it is released to the market. In guaranteeing that a drug is available to a low-resource population, researchers and sponsors must also consider financial availability; just because a drug is available for purchase in an area does not mean that the people will be able to afford it. Setting a price tag of more than $84,000 per year, making the drug far from available to these communities, is unethical. Dropping the patent case in India and allowing generic manufacturers to produce the drug would open the door to affordable, accessible treatment in Argentina, where patients have already witnessed the power of Xtandi.

The average Argentinian worker with insurance would have to almost triple their income to afford a year’s supply if they were to spend their income on the drug alone. The drug’s price tag is even more outrageous in low-income countries, which experience disproportionately higher rates of prostate cancer mortality (even though 68 percent of cases occur in high-income countries). The University of California’s Board of Regents has an ethical responsibility to drop the appeal for a patent on enzalutamide in India in order to ensure affordable access, not only in Argentina but worldwide, so that people living with untreatable prostate cancer can have a second chance at life. The university should hold true to its pledge to improve access to research for the betterment of the global society and allow generic manufacturers to produce the drug at a lower price.