By Mike Leavitt & Gary Locke
August 10, 2016 at 5:00 am ET
New data shows that the number of patients with Hepatitis C will be in decline by 2017 and researchers today are projecting that with today’s effective cures, Hepatitis C could become a rare disease in the U.S. by 2036. This is a remarkable advance for a disease in which the only treatment option available five years ago cured just half of patients and caused debilitating side effects. This should also serve as a reminder that were it not for the continuing perseverance of our public and private sector researchers, cures would not be as readily available for patients today.
Our nation is constantly on the verge of new, life-changing innovations, but we also risk jeopardizing important research and development opportunities if policymakers react to using rules like the aptly named federal agency power “march-in” to disrupt the innovation process.
March-in power exists in a law called the Bayh-Dole Act, a bipartisan triumph that enables the development of new life-saving treatments. Enacted in 1980, the law allows universities and other research institutions to own and license innovations resulting from federally-funded R&D. It also gave the funding agencies (i.e. the National Institutes of Health) the power to “march-in” and require patent holders to issue additional licenses. This authority was included in case a licensee of a University or research institution such as a private sector company did not commercialize and produce the new, useful invention that was discovered. It is a safeguard that ensures promising inventions will reach consumers.
However, it is important to note that the NIH has repeatedly rejected using “march-in” rights as a way to micromanage the production and prices of products. We must be candid with policymakers – interfering with licenses and IP rights between researchers and developers will not only stall medical advancements, but it will also diminish job growth and hurt the economy. Evidence of this can be seen in Cooperative Research and Development Agreements between the NIH and the private sector stalling after the NIH introduced specific pricing regulations as a requirement for exclusive licenses in 1990-1994. After that requirement was removed, public-private collaborations increased again.
Medical discovery is the defining feature that separates the U.S. health care system from all others. Simply put, America is the epicenter of medical innovation; it improves the health of our patients and boosts our economy. Between 1996 and 2013, academia-industry patent licensing added an additional $518 billion to the U.S. GDP and supported more than 3.8 million jobs. Additionally, 909 start-ups were launched in 2014 alone as a result of technology transfer activities. Pro-innovation policies are critical to the drug development process, as it can take more than a decade to get a medicine approved by the Food and Drug Administration and ultimately to a patient, requiring perseverance that benefits patients everywhere.
Seeking solutions to the nation’s health care costs is a laudable pursuit. However, we should examine all health care cost-drivers and support bipartisan policies that advance innovative treatments and cures, rather than single out individual industries or companies — especially those that drive our economy so vigorously. Laws like the Bayh-Dole Act should be protected in the U.S. and modeled across the globe.
With the British voting to leave the European Union, life sciences R&D in Europe is in danger, and medical innovation needs U.S. leadership now more than ever. Regardless of how people are reacting in other countries, voters in America expect our health care policies to stay rooted in principles that support cures.
More recently, a poll commissioned by the Galen Institute and Center Forward shows that seventy-eight percent of voters in battleground states believe that policies that foster the development of new treatments and cures should be a top priority for Congress and candidates. With health care in focus this year, it is clear that voters can find a common ground with medical discovery and innovation.
Policymakers and businesses can find common ground, too. The Information Technology and Innovation Foundation’s (ITIF) recent report, “Why Life-Sciences Innovation Is Politically “Purple” – and How Partisans Get It Wrong,” emphasizes the important roles that both the private and public sectors play in developing new breakthroughs.
Speaking as former policymakers who come from different sides of the aisle, the need for consensus and practical policymaking has never been greater. When it comes to fighting disease, it’s important to remember that two central factors — perseverance and time — drive development.
If U.S. congressional leaders intervene in important pro-patient and pro-innovation policies, we risk undermining the future of medical discovery, the efforts of the scientific and medical community, success of the life sciences R&D ecosystem, and the health of patients everywhere. Any overreach is unwise and will negatively impact the state of medical discovery at a time when Americans are expecting Washington to create meaningful solutions.
Congress should by all means work to improve health care in America, but it should do so the right way and form bipartisan partnerships that foster innovation, preserve our country’s competitive edge in medical discovery and reflect one of our nation’s strongest assets: the ability to save lives.
Mike Leavitt was the governor of Utah from 1993 to 2003, the administrator of the Environmental Protection Agency from 2003 to 2005 and secretary of Health and Human Services from 2005 to 2009.
Former Washington Governor Gary Locke was the governor of Washington from 1997 to 2005, the U.S. Secretary of Commerce from 2009 to 2011 and U.S. Ambassador to China from 2011 to 2014.