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An opinion on pharmaceutical patents

The recent global COVID-19 pandemic has prompted us to look inward to reflect. One aspect subject to this reflection is none other than our healthcare system. More specifically, Covid has presented an opportunity to investigate the shortcomings and advantages of our current healthcare system, especially as it operates within the market/mixed economy ecosystem in modern American life. In this examination, a key ethical issue emerges: pharmaceutical abuse of patents. 

The practice of medical research in pharmaceuticals is all but new. Yet, due to the very nature of research and innovation, research practices give rise to many smaller infant industries. Each discovery for a new drug or treatment creates a micro industry for itself, carving out its own section of the greater pharmaceutical industry for the taking. Each new drug then captures the demand of patients in that section, hopeful that the drug will be the cure for what ails them.  

Pharmaceutical companies that have developed a new drug can apply for a patent for it, which gives them exclusive access to the licensure, manufacturing, and distribution of their drug for 12 years. (12 years itself, I may add, is a nontrivial amount of time, especially for those suffering with a degenerative disease, but patents may be stacked on top of each other, leading to exclusive ownership for far upwards of the initial 12 year mark.) Patents effectively create a monopoly for the micro infant industry. Patents allow pharmaceutical companies to set their own prices. For life-saving medication though, this price-setting can seem to hold patients hostage, and the hefty ransom price tag can loom over them.

Some examples of this monopolistic and often exploitative behavior are the following, from the Association for Accessible Medicines:

  1. “The world’s top-selling brand drug, Humira, treats arthritis and other chronic conditions. On the market since 2002, 132 patents block competition for up to 39 years.”
  2. “One of the most prescribed cancer treatments, Revlimid, was approved by the FDA in 2005. The patent thicket consists of 96 patents providing potentially 40 years without competition.”
  3. “Diabetes patients who rely on the insulin treatment, Lantus, may not see a generic alternative for 37 years due to the 49 patents issued.”

The issue of access to affordable medicine has incredibly high stakes when we consider the desperation of the ill, especially those with terminal illness. It reaches far beyond the issue of paying more for brand name drugs as opposed to generics. But why are these mini monopolies allowed to exist? Why are there patents to begin with?

Patents incentivise innovation and research because they provide a “light at the end of the tunnel” for what is a long, arduous research process. Research requires a lot of upfront investment. Suppose Company A researches and tests a drug. Company A invests years of work and millions of dollars. Without rights to their intellectual property, Company B can swoop in after the research and testing is finished and sell the drug on the market. So why did Company A invest all of that just to be undercut? Patents disallow this story to take place. 

A further advantage of patents is that in creating the public and formal tie of ownership, they create a relationship of accountability between the company and the product. If and when things go wrong, consumers know who to turn to (or who to sue, as the case may be). Intellectual property relationships allow for consumers to air their grievances, as demonstrated by many personal injury lawyers, class-action lawsuits and even individual cases like that of the biomedical startup Theranos or that against the oral contraceptive brand Yaz. Theranos failed to deliver on its promise to accurately test low volume blood samples. Yaz was proven an ineffectual contraceptive. We are capable of knowing this now in part because of the relationships that patents formalize and reinforce. 

Patents have clear benefits. But, just as clearly, there is a trade-off between their benefits and disadvantages. We must negotiate this trade-off.

It would be quite easy for an ethicist with no more than a cursory understanding of this issue of patent abuse to draw overly simplistic conclusions. “Free healthcare for all” and “Healthcare is a human right” are slogans thrown about in modern political discourse that only begin to touch on the issues at hand. The simple and “equitable” solution that those uneducated on the topic come to is that patents should be waived completely. But if healthcare is paid for by the government, then why does the price of drugs matter? Who’s to say the government will pay for name brand drugs rather than waiting for patents to expire to qualify them for coverage? 

Another possible solution a non-expert ethicist may propose is for the government to seize control of the pharmaceutical industry, subsidizing their research and therefore owning their intellectual property. But doesn’t that just shift the monopoly from one entity (the companies) to another (the government)? And how much of our tax dollar will we allot for medical research? 

These are just a few of the important questions we need to consider for possible solutions to the patent problem. If there were a simple and effective solution available, we’d have solved the problem already. It is not enough to simply wish for free healthcare or for all the power to be seized from “Big Pharma.” There are many considerations to take into account. 

Alexa Schlaerth is a junior at the University of Notre Dame studying anthropology and linguistics. When she’s not slamming hot takes into her laptop keyboard, she can be found schooling her peers in the daily Wordle and NYT mini crossword, rewatching South Park or planning her next backpacking trip. As an Angeleno, Alexa enjoys drinking overpriced non dairy iced lattes and complaining about traffic because it’s “like, totally lame.” Alexa can be reached on Twitter at @alexa_schlaerth or via email at aschlaer@nd.edu.

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