Transforming How America Manufactures Medicine & Vaccines

This report examines The Next System Project’s approach to creating a public option in medicine & vaccine production. This is part of Retake’s on how to transform how the US & NM address a range of social, economic, racial, health & environmental challenges.

Transforming How We Research, Develop & Manufacture Medicine & Vaccines

Retake has begun a series on strategies that can transform how the US and NM address a wide range of social, economic, racial, health and environmental challenges. On Monday, we published “Bailing Out Workers & Building Community NOT Corporate Wealth, A Five Part Plan“. The post focused on how we could take a different path to regenerating our economy post COVID, creating a reparative economy that revitalizes small businesses across the country and includes NM-specific strategies that could be introduced in the 2021 Legislative Session. I strongly recommend you take a look at this important post.

Today, we feature the second transformational initiative in the series. It is based upon a report from Common Dreams reprinted from a piece written by Dana Brown and published by The Next System Project of which she is the Director.

In September 2019, Brown published Medicine For All: The Case for a Public Option in the Pharmaceutical Industry. Six months before COVID, this prescient piece illustrated with surgical precision exactly why such a transformational concept is timely and necessary.

Brown opens her report by observing that far too many Americans die prematurely or suffer from debilitating conditions because big pharma controls the research, development and manufacturing of medicines and vaccines. Brown notes that big pharma is driven by seeking the greatest possible profit, not necessarily to the benefit of public health. What’s more, because of big pharma’s inordinate political leverage and lobbying efforts, effective regulation is nearly impossible. Brown proposes that rather than trying to regulate the industry we should nationalize it and in the process achieve more effective medicines, more quickly, more efficiently and at far less cost to consumers.

Democratic, public ownership of pharmaceutical development, production, and distribution in the U.S. is necessary to combat the increasingly harmful impacts of Big Pharma which decades of regulation have failed to counteract.”

From Next System Project: “Medicine For All: The Case for a Public Option in the Pharmaceutical Industry

That is precisely the kind of transformational idea that the Democratic Party of the future must endorse and in Brown’s full report, she outlines how the pharmaceutical industry fails to serve the needs of the American people while ensuring obscene profits for shareholders and exorbitant salaries for executives. I highly recommend your reviewing Brown’s report.

In the midst of Covid, Brown built upon Medicine for All, collaborating with three other co-authors to prepare “Reclaim Public Medicine for Public Health.” Published by Common Dreams, this new article responds to the urgent need for a more sensible, thoughtful, science-based and human-focused approach to the development of medicines and vaccines in a world where COVID is unlikely to be the last pandemic we face. Too much is at stake and Brown et al have done an excellent job of laying out exactly how a truly public health and “public” medical system could be achieved and how it could more effectively respond to future pandemics.

Brown et al propose a four step process for essentially nationalizing our development of medicines and vaccines.

Step One. Codify open science practices that accelerate innovation, reduce costs, and strengthen the evidence base on which our medicines system rests.

Step One would unfold in two phases. The first phase can be done almost immediately and without legislation. The National Institutes of Health (NIH), the Food and Drug Administration (FDA), and other public agencies would open up their research institutions to facilitate an open exchange of knowledge and put that knowledge in service of science and public health instead of its being in service of private profit. Congress could codify this by making such practice mandatory but the agencies could do this on their own without legislative authorization.

Phase two will be trickier and would face immense political opposition from the pharmaceutical industry, hence the need for visionary strong political leadership. In phase two, Brown et al propose opening the entire medicine manufacturing process. To achieve this,

“Congress should amend federal statute (such as the Food, Drug, and Cosmetic Act or the Biologics Price Competition and Innovation Act) to require manufacturers and the FDA to share information that is currently protected as trade secrets once the appropriate exclusivity period has passed.” Congress could also include in the legislation the capacity for the FDA to share results of clinical trials and manufacturing processes before the “exclusivity period” ends, if it is in the public health interest. The first step of this four-step process would accelerate the speed with which medical innovation is available to consumers while significantly reducing the cost of pharmaceuticals.

From Common Dreams: “Reclaim Public Medicine for Public Health.”

This will obviously require a groundswell of advocacy to press Representatives and Senators to do the people’s work. That is not likely to become the charge of the GOP, so it is all the more important that the “We the People” Democratic Party purge itself of influence from big pharma lobbyists and campaign contributions. These kinds of initiatives make perfect sense and in such essential ways would benefit all of us, all of us, that is except a small number of CEO’s and wealthy share holders.

Second. Create public sector capacity for full-cycle pharmaceutical innovation and production of essential medicines.

Here, the plan calls for the US to create its own pharmaceutic research and development institute and then an array of public pharmaceutical manufacturers. Brown notes that the US funds the majority of the advances in medicines in the US and while this step would not fully nationalizing the pharmaceutical industry, it would create a “public option” if you will, for researching and manufacturing the development of medicines. In this way, public resources could be focused upon the most critical medical needs leaving private pharmaceutical companies responsibility for developing drugs to remove wrinkles or whiten teeth. Such a system would be far more nimble than for-profit operations with the additional benefit of recycling profit to fund further research, development and manufacturing while also reducing pharmaceutical costs.

“The U.S. should establish a public full-cycle pharmaceutical research and development institute and one or more public sector pharmaceutical manufacturers. These institutions would work together based on a new bottom line: the public good. The American public already funds many breakthroughs in the discovery and development of new drugs—far more than even the largest drug companies. But we currently depend on those companies, and the profit motive, to get those breakthroughs to patients.”

From Common Dreams: “Reclaim Public Medicine for Public Health”

Third. Use the full power of compulsory licensing to ensure access to essential medicines.

Right now, the licensing and patenting of medicine allows pharmaceutical companies to use their patents to monopolize the production and sale of critically needed medicines. This is NOT in the interest of public health, but trying to regulate reasonable rates with CEOs whose bonuses depend upon exorbitant profits is a fruitless endeavor. But Brown et al report that there are many examples of government using compulsory licensing to break Big Pharma’s grip on medicines.

“Compulsory licenses call for a reasonable royalty to be paid to the holder of the patent instead of the typical massive monopoly mark-up. Therefore, prescription drugs manufactured through compulsory licensing can be much cheaper, while innovators are nonetheless compensated for their work.”

From Common Dreams: “”Reclaim Public Medicine for Public Health”

Fourth. Take the vaccine industry into public ownership to assure its products are available to all.

Brown et al clearly lay out the fundamental problem with a private sector vaccine research and development system.

“In a profit-driven pharmaceutical industry, vaccines for infectious diseases simply do not offer the kind of return on investment that owners believe they deserve.

This has led most major pharmaceutical companies to pull out of vaccine development altogether, leaving us with a highly consolidated and non-competitive oligopoly of producers–none with the capacity to alone produce a coronavirus vaccine at scale.”

From Common Dreams: “”Reclaim Public Medicine for Public Health”

Currently, the US and the world rely upon a small number of, as Brown et al put it, “non-competitive oligopoly of producers.” We are reading of sole-source contracts with private Big Pharma firms to produce COVID tests, COVID PPE and COVID vaccines, all certain to generate obscene profits for those corporations and none capable of addressing the public need with efficiency or at a reasonable cost. Instead by de-privatizing the industry, we achieve this scenario:

“By taking the vaccine industry into full public ownership, we can provide an internationalized response to this and future pandemics that properly recognizes vaccines as a global public good. Vaccines developed in the public sector could be licensed through a global pool—or developed and marketed without patents altogether—so that they are available to all, ensuring the prompt and equitable access necessary for coherent public health interventions.”

“From Common Dreams: “”Reclaim Public Medicine for Public Health”

For example, imagine how differently tests and equipment would be developed and distributed in the US during the current COVID crisis. States would have a single point of contact for securing needed tests, treatments, equipment and ultimately vaccines. Instead of competing with each other, and in doing so, driving up the prices for all states, there would be national established pricing and a rational distribution system, one driven by need, not profit.

In closing, the common thread to all of the transformative strategies Retake has described and will continue to publish is that the public benefit is placed above private profit. The needs of the planet are prioritized above the greed of extractive industries and the needs, safety and priorities of workers is prioritized above shareholder profit.

All of this is legally achievable, but politically challenging to a Herculean degree, unless and until we elect political leadership truly committed to “we the people” as a reality, not just a slogan to get your vote.

Click here to read the full Common Dreams report..

In solidarity,

Paul & Roxanne, co-founders of Retake Our Democracy

Categories: Healthcare

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2 replies

  1. Public ownership of pharmaceutical production would pay off exponentially. Currently we are seeing the politicization of our FDA, and other agencies. The FDA used to be the global gold standard, but no longer. Over they years we saw the corporate infiltration, as the FDA made decisions based on corporate profits, not our health. The Corona virus pandemic is exposing all of the flaws, including the inability to scale up on testing, vaccines and pharmaceuticals. This led to unnecessary deaths, long expensive hospitalizations, and an explosion in lies and misinformation.

  2. Having public ownership of the vaccine industry seems like an excellent and doable idea. Big Pharma won’t fight tooth and nail to keep making vaccines since there’s not that much $$ in it. Vaccines would be cheaper, reliably produced, and all made inside the US.
    Now the CDC provides private sector manufacturers with vaccine viruses. Instead of those private sector manufacturers, the CDC would provide the candidate viruses to a part of the US government. The CDC works with WHO Global Influenza Surveillance and Response System, one of myriad reasons to be a member of the WHO and why we need allies in this complex world. And of course why it’s incredibly important to kick out the Moron in Charge.

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