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Unintended Consequences: The Risks of Vacating COVID-19 Vaccine Patents

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Unintended Consequences: The Risks of Vacating COVID-19 Vaccine Patents

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The following article is an opinion piece written by Michael S Kinch. The views and opinions expressed in this article are those of the author and do not necessarily reflect the official position of Technology Networks.

Last month, my co-author and I published a book on the history of drug pricing in recognition that an inability to pay for medicines is growing into a public health emergency, with the potential to be every bit as dangerous as the current pandemic. Nearly 40% of respondents claimed to have skipped medicines due to solely to cost. Public opinion in the US seems to be reaching a tipping point, where it seems likely that government intervention will be necessary to guarantee access to vital medicines.

Although the publisher elected to name the book, The Price of Health, we originally wrote a manuscript titled, Unintended Consequences. This concept captures the fact that runaway drug prices are largely a consequence of unforeseen problems arising from well-intended actions. This insight provides an important cautionary tale that is relevant to the news of today.

In researching this book, we learned that aggressive and sometimes abusive deployment of patents by the pharmaceutical industry contributes to high prices. We were hardly the first to state that the intellectual property system needs to be reviewed and likely reformed. As we do so, we must carefully consider the use of both incentives (carrots) and discouragements (sticks) in a manner that incentivizes the discovery of new medicines while assuring these will be widely available.

With this in mind, I was deeply troubled at the recent stance by the Biden administration that it would undermine or eliminate patent protection for COVID-19 vaccines.

This seeming inconsistency (given patents contribute to high prices) can be squared by referencing a 2018 book I composed about the history of vaccines. It is commonly stated that vaccines have saved more human lives than any other human invention, other than perhaps clean water. The title of this book, Between Hope and Fear, reflects two antithetical views of vaccines as perceived by the some in the public (e.g., anti-vaxxers) and views from the board rooms of many pharmaceutical companies.

Amidst relating the wonders of vaccines that eradicated scourges that had plagued our species from time immemorial, I pointed out a concerning trend revealed by scientific research published by the Center for Research Innovation in Biotechnology at Washington University in St Louis. In brief, the number of vaccine-preventable infectious agents has remained largely stagnant since the 1990s. Likewise, the number of companies performing research and development on novel vaccines has decreased, with comparatively few companies remaining actively engaged in the discovery of vaccines against pathogens.

These declines reflect neither a victory in our war against long-standing nemeses (e.g., pandemic forms of influenza, tuberculosis or malaria) nor a lack of newly-discovered microbes that can cause death and disease (e.g., Ebola, Zika and of course, coronaviruses such as SARS or MERS). Rather, the financial attraction (or lack thereof) of vaccines to the pharmaceutical industry pales in comparison with more lucrative markets, most notably cancer. Whereas insurance companies and consumers have become seemingly desensitized to six- or seven-digit price tags for new oncology drugs, a very different view prevails for vaccines. Yet a price tag of a few hundred dollars for Gardasil was sufficient to trigger considerable criticism. As a consequence of such experiences, many companies did the math and elected to decrease their exposure to, or walk away altogether from, vaccine research and development for infectious diseases. Much of the immunology expertise that had been devoted to infectious disease vaccines was instead redirected to the discovery of new cancer medicines, which could be offered at much higher prices.

It is no coincidence that most of the companies that have been rightfully praised for innovative mRNA vaccines (Moderna and BioNTech), were mostly focused upon oncology products prior to the pandemic. Cancer predominated despite the fact that mRNA technology held great potential to address both established and emerging infectious agents, from malaria to Dengue fever.

Most importantly, these technologies could offer a potential for a universal influenza vaccine to prevent periodic (and inevitable) recurrences of pandemic influenza viruses. For example, the H5N1 and H7N9 strains of influenza may have mortality rates in excess of 50%. Though controversies rage around this rate, even the low estimates eclipse even the worst imagined strains of SARS-CoV2. Such a calamity might still be averted were we to build upon the momentum and learnings of the COVID-19 vaccine development.

The announcement that the United States might waive intellectual property rights could stymie the discovery and deployment of new vaccines; returning us to the same vulnerable position we occupied in the closing days of 2019. All the wiser and yet, somehow, not. While I remain firmly in the camp that the patent system needs to be updated and reformed, we must appreciate that patents do indeed provide an incentive for innovation. The unintended consequences of a premature or arbitrary undermining this system could have lasting repercussions.

A dynamic and nimble patent system was described in Section 1, article 8 of the United States Constitution itself. This forward-looking approach allowed the United States to become and remain the world’s leading innovator since the foundation of the nation. Yet, this position looks increasingly fragile and relies upon public trust in intellectual property. The well-intended acts to waive patent rights for COVID-19 vaccines could have the unintentional consequence of squashing the development of future vaccines. There is no question that the patent system needs to be cleansed of abuse but we must do so in a manner that properly balances incentives and discouragement (carrots and sticks). Most importantly, we should take the time to consider the impact of unintended consequences.

About the author

Michael S. Kinch is associate vice chancellor, professor of biochemistry and molecular biophysics, and director of the Centers for Research Innovation in Biotechnology and Drug Discovery at Washington University in St. Louis. He is the author of Between Hope and Fear: A History of Vaccines and Human Immunity, The End of the Beginning: Cancer, Immunity and the Future of a Cure and A Prescription for Change: The Looming Crisis in Drug Development.

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