India’s rejection of Novartis’ claim on drug improvements highlights the flexibility of India’s patent laws. Such flexibility stands in sharp contrast to the World Trade Organization’s efforts to set standards for intellectual property regulation (via TRIPS agreement) and has enabled India to become a worldwide producer of cheap drugs. Various health agencies have proclaimed the Novartis judgment a triumph for global access to medicine, depicting the case as a battle between good (those who seek to make drugs affordable) and evil (pharmaceutical companies guided by commercial gain). This portrayal, however, oversimplifies a complex issue by failing to recognize the commercial reality and the dangers inherent in a relaxation of patent laws.
It is important to recognize that access to affordable medicine is a pressing global issue. This is clear from the millions of people who are dying annually from such diseases as AIDS, malaria, and typhoid fever (to name a few). Granting drug patents to pharmaceutical companies may seem incompatible with the notion of accessibility. Corporations are governed by the desire to profit, not rules of morality, therefore, what is to stop them from charging excessively for a drug that has the potential to save countless lives? If a generic version can be produced and distributed at a fraction of the cost (as is often done in India), should this not be permitted (if not promoted)? The obvious answer seems yes, but unfortunately, there are other factors that must be taken into consideration. Although patents have the potential to hinder access to drugs, without their enforcement, drug innovation may very well be precluded. That is, patents provide pharmaceutical companies with the incentive to invest time, money, and effort into research and development. If other countries decide to follow India’s lead, the result will likely be a standstill in drug development. The short-term benefits of relaxing patent law, namely increased production and access to drugs, are incompatible with long-term goals of expenditure in research and development.
Furthermore, attention must be drawn to the fact that Indian pharmaceutical companies are not producing the cheaper generic drugs for the altruistic purpose of increasing global access to drugs, rather, they are profiting from the production of such drugs. Does this seem fair? Should companies be allowed to reap the benefits of other’s labour if the end result is increased availability of life sustaining treatment? Does the end justify the means? In my opinion, the production of these generic drugs is tantamount to theft and cannot be justified by increased access to drugs. Why should these generic companies be able to profit without paying their dues? At the very least, is it not possible to implement a system that provides for some form of royalties to the company that originally developed the drug?
It should also be acknowledged that granting a pharmaceutical company an absolute monopoly over a drug puts a lot of power in a few hands and can lead to a situation that is contrary to the best interests of the human population. Therefore, it is necessary to re-assess our drug patent system to take into account moral considerations. We must implement safeguards that would enable patents to be invalided if necessary. It also seems necessary to implement an ethical code that pharmaceutical companies must abide by. Such a code may demand the provision of drugs at a reduced price to impoverished countries. Furthermore, we must question the role that the government plays in the situation. Should the government be required to provide funding for drug research and development? Clearly, these are all very basic suggestions that would involve much consideration before implementation. What is important to recognize, however, is that there are solutions other than a complete relaxation of patent laws. The interests of pharmaceutical companies in seeking patents are not incompatible with the interests of those who seek to increase access to drugs. Instead of viewing the situation in the two-dimensional light of good vs. evil, as the proponents of the Novartis judgment tend to do, we must acknowledge the complexity of the situation and strive to find a balance between commercial interests and the interests of those who are denied access to life saving treatment. To do otherwise is tantamount to ignorance.
One Response
Under TRIPS drugs are patentable, are protected for twenty years, and companies have no obligation to produce—or sell—the drug in the country where they hold the patent. While I agree with my colleague that TRIPS is overly protective of drug patents, I believe that we must look to the language of the Doha Agreement of 2001 for assistance.
Under Doha, developing countries are given some latitude regarding patents relating to exigent circumstances surrounding public health. Novartis attempted to renew for twenty years in India a patent it held on a cancer drug. The new patent disclosed little new material other than minor changes to the drug that barely affected its functionality. Such a patent should not have issued.
Unfortunately, I cannot agree with my colleague that a country should be given the power under TRIPS to invalidate a patent simply because of a public health concern. Invalidating a patent is a serious action and must be considered in the broader rubric of encouraging innovation. If a company’s patent could be invalidated in a developing country simply because of a public health issue (which is not clearly defined in Doha or TRIPS), then companies would never pursue a patent in the developing world. Regrettably, Doha did not go so far as to require compulsory licensing. In this instance, if compulsory licensing had been enacted, Novartis would have profited from generic drug production in India for a full twenty years and the developing world would have had cheaper drugs.
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