Do Current Drug Patent Laws Meet the ‘Preference for the Poor’ Standard?

By: Ken Ochs

drugs

All of us have seen the colorful television commercials promoting a brand-name prescription medication. As a butterfly alleviating a woman’s insomnia flies into her bedroom window, or a grandfather suffering from COPD runs through a field with his dog, in symbolic, memorable, stylish ways, one is told to “talk to your doctor” about whether or not the medication is “right for you.” A sharp observer might recognize that the drugs in these commercials eventually—within a few years—leave the television marketing airways without a trace. Where have they gone? Why are they no longer being advertised? And what does this all have to do with Catholic social teaching?

Just last month, the drug patent for Eli Lilly & Co.’s Cymbalta—approved by the Food and Drug Administration (FDA) to treat depression, anxiety disorders, fibromyalgia, and chronic nerve pain officially expired, opening the door for the subsequent approval of generic versions of the medication. Chemically known as Duloxetine, Cymbalta was the fifth best-selling medication of this past year and will now be more affordable to the millions of people for whom it might be prescribed. This sequence of events—consisting of drug development, patenting, FDA trials and approval, marketing campaigns, patent expiration, and public accessibility to generic, low-cost versions of the same medication—is commonplace in the pharmaceutical industry.

Though certainly a simplification of a complex process, the healthcare industry as a whole is affected by such developments, and patent expiration dates have begun to dictate when a brand-name medicine will become more affordable for patients. As a result, when the FDA permitted generic forms of Duloxetine in December, there was no sense of surprise but rather a confirmation of the long anticipated end of one company’s Cymbalta profit margins. However, patent expiration does not always lead to affordable generics. A Newsweek article from just last week points out that, remarkably, “American law allows a drug company to pay would-be makers of generic drugs to not produce the drug. That keeps prices, and profits, high.”

This setup raises several serious ethical concerns, namely: What does one make of the millions of people to whom the drug would have been affordable if it had not been for its patent and—by extension—its high cost? Is it ethical for doctors to wait to prescribe medication for people until an affordable generic version is available, knowing that the patients could benefit from (although not afford) the name-brand drug?  If someone cannot afford the drug, what is the alternative?

Catholic social teaching—spanning from the 19th Century through the Second Vatican Council and certainly including the modern Pope Francis era—has continually emphasized a pressing concern for vulnerable populations.Indeed, applying the principle of “preferential option for the poor” to the issue of drug patents would not condone economic policies that deprive patients of a medication essential for their health simply because of its high cost, their health insurance situation, or a combination of both factors.

Depending on circumstances, drug patents generally last for over twenty years, though the FDA approval process is factored into the patent duration, which alone could take a decade or more. Ultimately, drug companies are profoundly aware that a patent is essentially an economic gold mine they must take advantage of during the limited window for enormous profit before generic versions are sanctioned. A company must certainly make back its research investments on the product, but it may profit a half-billion dollars in the time period following that return. In this ongoing scheme—viewed through a lens of Catholic social teaching—who loses? Who is oppressed? Is there an unacceptable lack of concern for the most vulnerable in society?

Catholic social teaching might look at this intricate arrangement as a system of structural sin, for the newest medication options are stealthily denied to those who cannot afford to pay their high prices. Those who are able to pay the high brand-name drug prices automatically have a wider range of treatment options for any given condition. This arrangement might seem invisible to most, but it is an unfortunate reality that all stakeholders in the healthcare industry must acknowledge. Real people see their health decline every day because their preferred treatment options are out of reach, and drug patents only seem to further compound this difficult experience.

The U.S. Conference of Catholic Bishops has repeatedly called for expanded access to healthcare for impoverished populations, but has focused many of its statements on purely advocating for changes in the health insurance system or scrutinizing abortion details in Congressional healthcare bills. Though quality health insurance would likely help cover the high cost of patients’ brand-name drugs, once any medication has generic options in most cases it becomes exponentially less expensive for both the insured and uninsured alike. At any time, one can go on the Internet and see the exact times when many brand-name prescriptions will expire. Those dates unnervingly correspond to the precise moments when a multitude of pharmacological treatment options will be opened to masses of people who cannot currently afford them.

What can be done to alleviate the plight of the underprivileged in accessing the newest medications in the face of the FDA’s drug patent procedure? In light of Catholic social teaching, should society collectively address—in the midst of an ongoing national healthcare debate—this legal arrangement that impacts the health and wellbeing of its most vulnerable members? Or is a drug patent’s short but significant lifespan a reasonable compromise between a longer one and none whatsoever? Does the new Affordable Care Act address this issue sufficiently, or will patented drugs still be out of reach for those who cannot afford them?

If one does indeed find the current model to be against their moral principles, how would they advocate for meaningful change in the industry? Mindful that similar patterns and their societal repercussions are mere routine, one must consider Catholic social teaching’s concern with social justice and ensure that vulnerable populations are provided with the opportunity for adequate health care, including access to prescription medication.

Ken Ochs, FCRH Class of 2015, is a neuroscience major (concentration in cell & molecular neuroscience), theology secondary major, bioethics minor, and Student Editor of Student Voices.

2 comments

  1. Very good arricle. I cant see why allowing drug companies to pay generic producers to not produce a drug is not an illegal restraint of trade!!!
    Bill OConnor FCRH 1951

  2. This is a thorny issue. There are some additional factors not mentioned.

    Pharmaceutical companies (that’s ‘ethical’ pharmaceuticals, by the way) can often extend patents by coming out with variants on the expiring medication, many times by marketing a new extended release version when the patent for an immediate release original is lapsing. These extended release varieties typically have fewer side effects and may be slightly more efficacious as well. Patients confined to generics of older drugs may be getting similar care, but not similar comfort.

    Companies do sometimes have patient assistance programs to subsidize those for whom the latest – most expensive – treatment seems warranted due to inefficacy or intolerable side effects of other medications for the same condition.

    There is enormous expense in developing new drugs and achieving FDA approval. Big Pharma’s argument about this is not entirely specious. The cost of successful drugs must also cover the cost of the many more that never make it to clinical trials. This is not a charitable business.

    In this country, the way health care in general is managed is full of perverse incentives. As long as health care coverage, many hospitals and pharmaceutical development are for-profit industries, costs will continue to rise, leaving more and more patients behind.

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