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A handful of members of Congress recently sought to block any future coronavirus aid packages unless they include language stripping intellectual property protections and imposing price controls on any coronavirus vaccines and therapies.
Lawmakers and the public are understandably concerned about keeping life-saving treatments affordable. But this effort is unnecessary, unsuited to the emergency situation, and could have the unintended consequence of discouraging many efforts to innovate during a crisis.
Dozens of biotechnology and pharmaceutical companies are working overtime on the coronavirus. They embarked on this work before knowing whether or not the federal government, other agencies, or insurers would pay if they succeeded. Precedent and policy indicate that any resulting diagnostics, antivirals, and vaccines created by the biopharmaceutical industry for this pandemic will be made available at little to no cost to patients.
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And the pace of their progress is stunning. A vaccine candidate was created just 42 days after the sequences of coronavirus proteins were elucidated, and the vaccine candidate was dosed in the first patient in less than three months — record time by a wide margin. Now, the federal government has pledged to invest as much as $483 million in its potential success.
Thus, the lawmakers’ calculus on future emergency funding bills reveals a troublesome unfamiliarity with both the biopharmaceutical industry’s responses to public health emergencies and the nature of innovation itself. Consider the threat that AIDS posed to the world 30 years ago. Companies set aside their commercial interests and shared information with each other and academics. Together, they engineered breakthrough combination therapies that turned the once uniformly fatal disease into a manageable chronic condition. At the same time, it is worth noting that despite over three decades of effort and billions spent by industry, the vaccine effort remains unsuccessful.
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Following the 2002 outbreak of SARS — a virus similar to coronavirus — pharmaceutical researchers prepared a vaccine for clinical trials within 20 months. They dedicated comparable research and development efforts during both the 2014 Ebola and 2015 Zika outbreaks. Today, the industry is once again demonstrating its rapid response to a crisis. Companies are collectively redirecting substantial resources to create the vaccines, drugs, and diagnostics needed to overcome the COVID-19 pandemic.
Lawmakers’ failure to recognize the industry’s commitment to protecting the public is disappointing to those working so hard to meet the current challenge. The problem isn’t simply a lack of knowledge of prior industry responses. It’s also a profound misunderstanding about the process of invention, testing, and manufacturing, which are fundamental to inventing vaccines and drugs. The federal government — chiefly through the National Institutes of Health — drives early-stage research. It funds scientists at universities and nonprofits whose work investigates the basic building blocks of life — genes, cells, proteins, and so on. Occasionally, government-funded research generates eureka moments — some unique insight into the nature of a devastating disease. But rarely can these important advances result in vaccines and therapies without industry picking up the baton.
When biotechnology startups and pharmaceutical companies step in, they turn that early-stage research into products with clinical utility. This “translational” research is fueled by capital from venture firms, investors, and established research-driven companies.
Under normal circumstances, the entire development process takes more than a decade, as candidates advance from lab testing to animal trials and through to clinical trials in humans. For vaccines, clinical trials often involve tens of thousands of patients. Companies invest in manufacturing vaccines at this large scale, despite the lack of a “paying” market.
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For drugs, just 12 percent of compounds entering Phase I clinical trials earn regulatory approval. The capital needed to develop the average new medicine is roughly $2.6 billion. Thus, the few products that succeed must help recoup the billions spent on the whole collection, successful or not.
This intricate arrangement between the government, the biopharmaceutical industry, and investors has proved effective — it’s the “secret sauce” that makes America the innovation capital of the world, accounting for two-thirds of all new drugs. Last year alone, we produced 48 novel medicines, and another 6,700 medicines are currently in development.
At this moment, Moderna Therapeutics — a biotech originated by Flagship Pioneering, the life sciences venture firm where I work — is leading the race for a coronavirus vaccine. In collaboration with NIH, a clinical trial is underway, and investment in manufacturing capabilities and staff are being put in place even before the results are known, anticipating the demand.
Innovation depends on trust — and the drug pipeline is fragile. Government threats of price controls surely will not stimulate the invention of the vaccines and medicines that are needed to end this crisis. And a shift by the government to imperil intellectual property rights could easily shut down innovation. Without intellectual property protection, others who did not come up with the idea, and who did none of the research, are free to sell copies of the product without bearing the cost of the substantial and risky investment. During a global crisis, when rapid investment is needed most, lawmakers should reaffirm their support for research-based innovation.
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As long as our leaders don’t jeopardize the trust needed to innovate, a coronavirus vaccine — along with effective new therapies — should be near.
Dr. Michael Rosenblatt is chief medical officer of Flagship Pioneering. He previously served as chief medical officer of Merck and as dean of Tufts University School of Medicine.