Author: Chandan Seth Nanda Edited by: Emil Fristed
With the advent of new breakthroughs in science and technology, not only does our lifestyle change, but so does out life values. It’s a two edged sword; on one side, these novel avenues bring us the promise and potential of great power; but on the other side, they leave us with an equally great responsibility. This might be especially true for developments in medical science. Big Pharma, as the global pharmaceutical industry is known, has enabled great advances in medical treatments by generating drugs and small molecule entities to treat various medical conditions. And it has in this process been associated with unbelievably ‘big money’, ‘big impact’ and ‘big conspiracies’.
As we all can appreciate, the pharma business is incredibly complex; it dwells in the grey zone of not just one, but multiple realms of ethics and human welfare, and must balance core business activities with investments in innovation and knowledge generation. This is to sustain industrial growth and return to investors. It is noteworthy that being in this intersection involves a multitude of ruling laws or principles, but also a vast array of people like patients, clinicians, research scientists, managers, economists, advertisers, industrialists and legal advisors. With the incredible amount of money, principles and people involved in this business, it certainly isn’t easy! Hence, while big pharma displays appreciable values and core strategies on stage, behind the scenes moral conflicts are almost inevitable.
In the last few decades the pharmaceutical industry has seen a surge in patents of drugs; this has led to increased drug prices, which is especially problematic in the developing world. For years now, while the World Intellectual Property Organisation (WIPO) headquarters made and implemented patent policies, countries like India vetoed WIPO rulings in their own country. India has been a hub of generic drug production, which not only brought down the prices of drugs locally, but also impacted the global drug market. An exceptional case of Novartis versus Union of India at the Indian Supreme Court (ISC) in 2013 has been seen as an exemplification of the ‘patients before money’ perspective. ISC opposed Novartis's proprietary rights to produce and sell the so-called ‘newer, better and hence more expensive’ version of Gleevec (a blood cancer drug) over the older version, keeping in line with the WIPO TRIPS agreement. The older version of Gleevec was off the patent regime and local generic drug mass production was ready to enter the supply chain, with the formulation cost being as little as 3.5% of the original price (i.e. about $2500 round of clinical treatment per patient as opposed to about $70,000)[See BBC and Indiatimes]). Such a defeat of big pharma by generic manufacturers was quite unprecedented and shook the global setting. While big pharma calls this a chaos in the global patent setting, millions of patients using the drugs call it no less than a life-saving blessing.
The stir that India caused in the global intellectual property rights (IPR) regime had its repercussions. Not very long after the Novartis vs Union of India 2013 ruling, the US Chamber of Commerce and European trade channels expressed their extreme disappointment and warned that such a decision could take a toll on international relations with a developing country like India. Such global dynamics not only threaten to perturb the trade and investments in India, which affect economic growth, but also create a bottleneck in the supply of new drugs, affecting the health of a billion people. This led to several diplomatic meetings and collaborations between different countries, including the US and India.
These collateral meetings revealed two different views on the case. On one side, it was too late for India to undo a decision that could lead to a big economic and diplomatic loss, which ultimately affects patients’ health. On the other side, it was considered a feat for India in terms of human welfare and local economic growth.
Seldom are the outcomes of months of such international talks and diplomatic meetings directly publicised. Instead, India’s take on this has come to light with a new patent case against Pfizer. The end of last year saw Pfizer fighting to get authorisation for a pneumococcal vaccine, Prevenar 13. The company was granted sole rights to distribute this vaccine in India for the next decade as opposed to a locally-produced generic version. The victory of Pfizer might have come as a disappointment to patients, but these landmark cases do highlight how the status of life evolves in the patent world of big pharma: Even though the industry is in the ‘saving lives business’, it is a business after-all, and thus creating monopoly in the game directs a big pharma's mission & vision.
But how much thought is given to the status of human life in this modern gold-fever rush?