As researchers around the world join forces to tackle the COVID-19 pandemic, there is growing interest in the process to develop new medicines and understanding what roles government, academia and the biopharmaceutical industry play in participating in the research and development (R&D) ecosystem to bring about new treatments and cures. America’s biopharmaceutical companies are at the heart of this robust R&D ecosystem, and the United States develops more innovative medicines than any other country in the world.
Some critics have claimed that this success is because the National Institutes of Health (NIH) use public funds to discover new therapies which are then just handed off to biopharmaceutical companies to be manufactured, packaged and monetized. This fundamental misunderstanding of the way drug development works has led to policy proposals that could seriously harm the U.S. research ecosystem and jeopardize its longstanding success.
Now more than ever, it is critical that both public and private assets can be brought to bear in addressing critical diseases such as COVID-19.
How do we develop the fundamental knowledge that fuels breakthroughs in medicine?
Every day, academic, government and private industry scientists contribute to the vast body of basic science discoveries. Often called “fundamental” or “bench” research, this pursuit seeks to understand the function of newly discovered molecules and cells, strange phenomena or little-understood processes. The goal is to further scientific knowledge without an obvious or immediate benefit. It takes time—often years, or even decades—to advance this science into a discovery that provides practical benefit to humans or animals.
In short, fundamental knowledge comes from everywhere, and it is shared and expanded upon by scientists through peer-reviewed publications, scientific meetings and licensing of intellectual property (IP).
Over the years, treatments for infectious diseases have grown steadily more complex, and today, our ability to respond to diseases like COVID-19 is radically different than it would have been even a few decades ago.READ MORE
Between the public and private sector, who is responsible for the vast development of new medicines?
Fundamental research is a necessary first step in the process to create new treatments and cures. But without the investment and risk-taking of the biopharmaceutical industry, the knowledge resulting from this research would generate many ideas for potential medicines and drug targets—but very few new medicines. As Dr. Anthony Fauci of National Institute of Allergy and Infectious Disease (NIAID) explains, “We always need a pharmaceutical partner…I can’t think of a vaccine, even one in which we’ve put substantial intellectual and resource input, that was brought to the goal line without a partnership with industry.”
NIH has a critical public health mission to uncover new knowledge that will lead to better health for everyone—and we should keep it that way.
Imagine the loss for the advancement of public health if the NIH was solely focused on developing new therapeutics. The NIH provides research grants to academic researchers who not only advance basic science research but also have a critical role to play in training future scientists. The NIH also has a critical role in developing and supporting medical libraries, training medical librarians and other health information specialists, and educating on the importance of prevention for maintaining good health.
NIH-funded studies are critical for understanding the natural history of diseases, identifying critical biomarkers, and establishing clinical guidelines for best standard of care. Private sector companies regularly collaborate with the NIH by providing funding and drug supplies, contracting with clinical trial networks to run industry-sponsored clinical trials, and providing scientific expertise to those networks through advisory committees. However, similar to the way NIH cannot fulfill all of the responsibilities of the industry, the industry cannot fulfill all of NIH’s responsibilities. Each member of the biopharmaceutical ecosystem plays a unique and vital role.
Over the course of decades, private industry has developed the significant scientific expertise and deeply integrated teams required for large-scale drug development, research, manufacturing, supply chain security and distribution. In combatting COVID-19, these capabilities have supported the following:
- Building on deep scientific knowledge gained from decades of experience with viruses such as MERS, SARS, influenza, HIV and Hepatitis C, the private sector has made unprecedented progress in advancing potential treatments and vaccines to help address COVID-19. It took 20 months to have a vaccine ready to test in SARS patients a decade ago, and it only took a couple of months to have the first candidates to test against coronavirus.
- Biopharmaceutical manufacturers are rapidly screening vast global libraries of medicines to identify potential treatments for COVID-19 and making those medicines available to patients—right now—through clinical trials and compassionate use.
- The private sector has invested billions in existing therapies that can potentially be used to treat infected patients. Already, there are more than 1,112 such trials underway that could lead to approved treatments and vaccines for COVID-19.
- Despite the substantial risks involved, biopharmaceutical innovators have begun expanding manufacturing capabilities and ramping up production capacity, so they are prepared to supply vaccines and treatments to the public when successful candidates are identified.
Should the government set the price of new medicines?
Congress passed the Bayh-Dole Act in 1980 with bipartisan support to incentivize the private sector to make the substantial and risky investments needed to translate discoveries from government-funded basic research into useful products. Bayh-Dole has helped lay the foundation for the robust and entrepreneurial U.S. R&D ecosystem. Prior to enactment of the Bayh-Dole Act, the government retained the patents on federally-sponsored inventions—and only 5% of those patents were ever used in the private sector.
The reason the U.S. is the global leader of biopharmaceutical innovation is that the IP system promotes competition by ensuring each player excels at their role and is incentivized to take risks and share information throughout the process. Strategic public-private partnerships help support collaboration among governments, scientific institutions and biopharmaceutical, medical device, diagnostics companies and many others to stimulate progress in research and science to develop effective vaccines as well as diagnostics and treatment options critical to address COVID-19. More than 200 new drugs and vaccines have been developed through public-private partnerships facilitated in part by the Act—a stark contrast to the period preceding its passage, during which no drugs had been created from federally funded inventions.
During public health emergencies such as pandemics, the biopharmaceutical industry has a track record of responsible pricing and actively partnering with the government to ensure availability and affordability. In fact, Dr. Fauci has said, “I have not seen in my experience situations in which we were involved in the development of a vaccine, particularly for low- and middle-income countries that really needed it, where the pharmaceutical companies priced it out of their reach.” Any new additional policies that would set prices in the commercial market or make it less attractive to collaborate with the federal government would not only fundamentally set back the industry’s ability to respond in a timely way to COVID-19 but would also deter companies from making long-standing investments needed to be able to respond quickly in times of future global health emergencies.
In these unprecedented times, America’s biopharmaceutical companies are coming together to achieve one shared goal: to end COVID-19. Learn about our latest efforts at PhRMA.org/Coronavirus.
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