Biotechnology leadership is too valuable to throw away
By Jeremy Levin
Dr. Jeremy Levin is the immediate past chairman of the Biotechnology Innovation Organization and Chairman & CEO of Ovid Therapeutics.
August 5, 2021
In medicine, it is axiomatic that patients don’t fully appreciate good health until suddenly threatened with its loss. Meteoric biomedical advances can postpone that reckoning with mortality. Ninety percent of Americans now live within five miles of access to the world’s most efficacious COVID vaccines, domestically produced.
Now, widen the aperture. What if what we’re taking for granted as a nation is even more profound: our ability to survive on this planet using the most sophisticated technology in human history? That most people could neither name nor define the sector that produces it begs the question: Will Americans know enough to miss our global leadership in biotechnology when it’s gone?
Biotechnology, at its core, is about the elegant repair of genetic malfunction and the careful enhancement of the genome to remedy an industrial society’s most desperate ills, from climate change to zoonotic disease threats. Biotechnology enables us to grow crops in the middle of a drought, synthetically produce gasoline with no carbon footprint, and make lifesaving mRNA vaccines in a matter of weeks without the need to put the offending virus under a microscope.
The U.S. biotechnology sector is an indispensable, strategic national asset. For the last two years, I’ve chaired the world’s largest biotechnology trade group as our member companies unlocked the mysteries of the genome to produce tools capable of bringing an expeditious end to a plague.
Our blossoming sector can also help us reach net zero emissions and conquer all manner of deadly afflictions impacting plants, animals, and human beings. No other industry offers comparable hope that modernity’s direst problems are solvable.
We fail to understand the origins of our current biotechnology strength, and how policy can build on that strength – or undermine it.
Yet, as a nation, we haven’t appreciated the importance or value of our biotechnology leadership position. American presidents rarely acknowledge the promise and the prominence of this global innovation engine. Only China’s 2012 elevation of biotechnology to a “strategic emerging industry,” leading to untold billions in government subsidies pouring into the sector, has, on occasion, coaxed them to acknowledge the possible fragility of U.S. biotechnology superiority.
President Biden warned in his April 2021 Joint Address to Congress that “China and other countries are closing in fast. We have to develop and dominate the products and technologies of the future: advanced batteries, biotechnology, computer chips, clean energy.”
So, we seem to realize that without our innovative technology sectors, biotechnology chief among them, the U.S. risks decline. Yet, we fail to understand the origins of our current biotechnology strength, and how policy can build on that strength – or undermine it. For example, House leaders are pushing forward with misguided plans to offset infrastructure spending with legislation that would control drug prices, ignoring that biotechnology itself is a crucial aspect of our 21st century medical, agricultural, and energy infrastructure.
That bill, HR3, is a blunt instrument written before the pandemic with almost no consideration of what its impact will be on the biotechnology innovation ecosystem – particularly the small companies that drive so much of the industry. If they succeed, our nation will pay for new roads and bridges by draining tens of billions in capital and tens of thousands of jobs from the sector that seeks to do to cancer what it just did to COVID. It will significantly reduce investment in the new technologies that we need to combat not just the next pandemic, but solutions to many other diseases. Meanwhile the savings will be fleeting, as society struggles under the weight of hospital and long-term care costs that can be avoided with new treatments.
Even more troubling, the United States is participating in the charge against itself at the World Trade Organization with an offer to waive sacrosanct intellectual property protections for American-made COVID vaccines that wouldn’t exist today without them. The waiver wouldn’t speed up global vaccination efforts but would hasten the reverse engineering of U.S. trade secrets.
Purchasing agreements are what drive companies to invest heavily in manufacturing plants. Waiving IP protections doesn’t change the fact that the world will need to pay someone to build more manufacturing plants, which takes not just money but knowhow. Contracting with companies that know how to make those doses because they invented them, or allowing the market to function through licensing deals, remain the smartest options.
Waiving IP protection undermines the private sector’s willingness to engage in biomedical innovation, and could in particular cool investment in the vaccines space, jeopardizing the robustness of our response to the next pandemic. The implications are real.
From seeds to vaccines
The past here is prologue. A decade ago, China’s industrial planners identified agricultural modernization as a key national goal. Eager to export GMO seeds that could withstand drought, pests and disease to China’s vast agrarian market, U.S. agritech producers sought regulatory approvals there in good faith.
However, mandatory environmental field trials required U.S. companies to provide viable seed and background studies to Chinese labs to run the tests on their soil. Many complied for the ephemeral promise of market access. This gave state-run research institutions opportunities to study and reverse-engineer Western technology. Talk of IP waivers gives the false impression that such theft is merely a head-start on a legitimate goal.
Meanwhile, China has approved few GMO food products to date, citing safety concerns. This has driven down U.S. demand for genetically modified crops, because it can be difficult to segregate GMO seeds at regional grain facilities. Many American farmers stopped adopting new technologies not yet approved by China for fear of exporting an intermingled batch that might jeopardize their access to a market with 1.4 billion mouths to feed.
President Xi Jinping is on the record saying, “[We] must boldly research and innovate, dominate the high points of GMO techniques, and cannot let foreign companies dominate the GMO market.” The Central Party’s most recent five-year plan calls for domestic investments in “genetic breeding, synthetic biology and biopharmaceuticals [and] creation of major new varieties of crops, livestock, aquatic animals, and agricultural microorganisms.”
Beijing is playing a cunning game of catch-up on biotech vaccines, too. China’s FDA is the world’s only major regulatory body to withhold authorization of Pfizer and BioNTech’s mRNA vaccine, which is 95 percent effective. Chinese heath authorities have been sitting on 100 million vials of it since December while promoting their own vaccine instead. Its efficacy, according to the head of China’s CDC, is “not high.” That hasn’t stopped China from sharing it with neighboring countries to curry favor and publicize the nation’s emerging biopharmaceutical enterprise.
We have a choice: continue to lead or be content to depend on others for the most important technological advances of the century.
If the WTO ratifies the IP waiver, China would have new leverage to expropriate American vaccine technology. It could, for example, insist on tech transfer from specific companies, or it could refuse to approve or sell the rest of that company’s product line. China is already building multiple mRNA plants in anticipation of acquiring the technical expertise. Meanwhile, imposing price controls on medicines that are primarily invented and developed in the U.S. would only tilt the scales in China’s favor, giving a determined nation more time to nurture its competing industry.
As China and others “move in fast,” as Biden put it, we have a choice: continue to lead or be content to depend on others for the most important technological advances of the century.
American leaders should embrace our home-grown medical and advanced technologies as much as they extoll the virtues of American-made trucks and power-tools and jeans. They should stand stronger to protect biotechnology funding and intellectual property rights. They should carefully examine the likely detrimental impact of current proposed drug pricing legislation on the biotechnology ecosystem. They should encourage American companies to compete to invent and make the world’s most valuable products, on a level playing field.
If they don’t, I fear they will learn a hard lesson of business: that failure to appreciate and protect a thing of great value often leads to its surrender. Our nation will suffer as a consequence.