A recent court case between the Indian Government and pharmaceutical company, Novartis, has caused a stir in the global community. Novartis is challenging Section 3(d) of India’s Patent Act, which requires companies to prove that their drug is more successful than alternative treatments for a disease to receive or extend a patent.
To get around this regulation, many companies begin “evergreening” – making minor changes to a drug that may not improve its efficacy but claim it does in order to extend its patent. If Novartis succeeds, this may open the door for other companies to follow suit, ultimately driving up prices for crucial medicines produced in India and needed around the world.
When I was a junior in college, I had to give a presentation for my honors Molecular Genetics class. The hot topics that year were avian influenza and HIV. I had just been accepted into the School of Rural Public Health’s MPH program, so I decided to get in the HIV-line, but with a twist: rather than present a paper on the mechanism of infection or a mutant viral protein, I would pull the lens back and look at the disease from a public health standpoint. It was an eye-opener for a lot of my classmates, most of whom were biochemistry majors whose only exposure to HIV had been through pictures of Western blots in peer-reviewed journal articles. Some of the strongest reactions were to cost of care, especially drug prices: when I cited several drugs that entered the market at $25 (darunavir), $29 (tipranavir), or even $61 (efuvirtide) for one day’s dose in the U.S., eyes widened and jaws dropped across the room.
The war on drug prices is a long-standing, bitter battle between the pharmaceutical industry and humanitarian groups and lobbyists, with governments and regulators perpetually caught in the middle. International health and humanitarian organizations argue that access to inexpensive medicines is vital to the survival of the poor who need them, and that Big Pharma is driven by greed and cares only for its profit margins. Pharmaceutical companies counter that intellectual property protection and patents encourage innovation and the development of newer and better drugs. The solution to this dilemma in developing countries, including India and many African nations, has been generics. India’s patent laws make it easy for regulators to deny drug patent applications, allowing Indian pharmaceutical companies to use the data from clinical trials already performed to get approval to produce cheap generic versions of patented medications. India is the world’s leading producer of inexpensive generic drugs – its pharmaceutical industry makes most of its money by producing generic versions of drugs patented by Western companies – which has earned its reputation as “the pharmacy of the developing world.” India supplies 80% of the medicines distributed by medical humanitarian organizations in poor countries; in particular, 93% of ARVs going to HIV patients in these countries are Indian-made.
The EU is currently negotiating a free-trade deal that may change all of this: in addition to agricultural tariffs and work visa agreements, Europe is trying to negotiate a period of exclusive access to pharmaceutical companies’ research and clinical trial data. No specific amount of time has been finalized, but without information from the clinical trials already conducted, generics manufacturers would have to conduct their own testing to register their products. Opponents of this provision fear that this will drive up the cost of generic medicines and make them unaffordable for the poor. Médicins sans Frontières (Doctors without Borders) has launched their “Europe! HANDS OFF our Medicine” campaign specifically against this component of the agreement. The WHO and the UN’s special rapporteur on the Right to Health Anand Grover are also concerned, and the Indian generic pharmaceutical industry is predicting a global health crisis if the trade agreements lead to production restrictions. The European Commission insists that the negotiations will not negatively impact India’s generics industry, but worries will persist until a draft of the agreement is released.
The ever-continuing debate underscores the need to find a balance between encouraging economic growth and innovation, and ensuring affordable access to medicines for those who need them. Though the start-to-finish cost of producing drugs can admittedly cost billions of dollars, the question of whether it justifies such high new value benchmarks has not yet been settled. The fact that so many millions wait in line for these drugs begs this ever-persistent question: what is the point of charging so much for drugs that so many need if so few can afford them?