Pharmaceutical patents and the right to life

Almost 85 years back, in a serendipitous event, Alexander Fleming discovered Penicillin and started the medical stream of antibiotics. His discovery changed the direction of medicine and he won numerous accolades for his path-breaking work. This includes, a Nobel Prize in 1945 in his lifetime, and afterwards, a place in TIME magazine's list of 100 most influential people of 20th century. It is said that he financially supported his research work by side practice of treating rich patients afflicted with Syphilis.

Fleming's career partly coincided with that of a scientist of Indian origin, Yellapragada Subbarao, who moved to United States for research. Subbarao's list of achievements includes discovering the role of ATP (Adenosine Triphosphate), a building block of energy in human body, developing a method to synthesize Folic acid and creation of one of the first anti-cancer drugs, Methotrexate.

He also directed work that resulted in the discovery of Tetracyline, the first broad-spectrum antibiotic. This is just a representative list of his achievements. During those days of racial exclusion and tight immigration laws, Subbarao failed to get tenure as a Professor in Harvard University and died an unsung genius. Experts say that similar achievements by a white person, at that time, would have earned him at least one Nobel Prize for medicine.

Both Fleming and Subbarao worked selflessly towards improving the lives of diseased people. Had there been a clamour for patents and intellectual property rights during those days, medical research would have been a generation behind now.

On the other side of the research spectrum are large pharmaceutical companies whose perennial goal is to find the next "blockbusterdrug".

Novartis, a Swiss MNC is one of the global pharmaceutical giants. A couple of months back, its Chairman and CEO, Daniel Vasella, retired. In a parting sweetener, the company allowed a non-compete agreement, committing Vasella US Dollars 78 million over a 6 year period. With deep economic problems in Europe, public and shareholder response was scathing and, the company had to rescind the offer and Vasella made a public acceptance of his mistake.

During his time in Novartis, Vasella, co-authored a book titled "Magic cancer bullet". It traces the journey of drug discoverytocure a form of cancer named chronic myeloid leukemia (CML). The name of this drug is � Gleevec/Glivec.

This is the drug at the very heart of a recent Supreme Court of India judgement. The court ruling allows Indian generic drug manufacturers to make low-cost versions of the drug for Indian market. Reports suggest that Gleevec could cost US Dollars 75,000 (INR 40 Lacs) per year whereas the generic version would bring it down to US Dollars 2,500 (INR 1.5 Lacs), expensive but much more affordable for patients in developing and poor countries.

A supportive regulatory environment in United States allows pharmaceutical companies to extend their hold on a drug, beyond its original patent life, by minor modifications like changes in formula or dosage and prices are kept high. The unsustainability of this environment is being felt in US, where the healthcare spending is 18% of the GDP. One of the prime reasons of this high cost is the skewed cost structure of drug discovery. With the new healthcare regime under President Obama, the focus has shifted to primary care and prevention. Recent fallout has been a dip in sale of prescription drugs in 2012.

Pharmaceutical MNCs have shifted their attention to emerging economies like China, India and Brazil, which are expected to constitute 30% of global pharmaceutical spending in 2016 compared to 20% in 2011. This is the reason why pharmaceutical companies want to secure their turf in these markets and hence a number of patents related cases, in recent times.

After the Supreme Court judgement, pharmaceutical MNCs maintain that innovation will suffer and drug discovery process will be unviable, resulting in fewer new drugs and delayed cure for some of the widespread and deadly diseases. But this argument sounds specious. Drug research targets the most profitable segments of disease afflicted. In 2011, 3 of the 5,largest selling drugs in the world wereheart-related.

Two of these were statins (cholesterol reducing drugs), which one normally associates with affluent societies. As Bill Gates pointed out recently, it is a travesty of research priorities that more money is spent on finding a cure for baldness than to develop a vaccine for malaria. The former may not save lives but latter would save over 500,000 lives annually, most of them children in Africa.