By John “CZ” Czwartacki, Founder & Chairman
I’ve lived with multiple sclerosis for more than 30 years. In that time, I’ve been lucky to have access to a series of breakthrough treatments that gave me my career, family, and life I have today.
Each treatment I’ve benefited from started as an idea that someone was willing to spend years of research and resources with no guarantee it would work. During National IP Month, I want to recognize the system that made those bets possible and warn about the policies that put it at risk.
As America celebrates its 250th anniversary, it’s worth remembering that intellectual property has been part of the country’s story from the start. The framers wrote it into the Constitution, giving Congress the power to “promote the progress of science and useful arts” by securing inventors’ rights to their discoveries. Congress passed the first Patent Act in 1790. The idea was simple then, and it still holds: if you protect what people create, more people will try to create.
That idea matters most in medicine. Developing a new treatment takes years of research, trials, and regulatory review, and most candidates fail along the way.
Investors and innovators can only take on that risk if success can generate a return on the time, money, and other resources invested in a single breakthrough. Strong IP protection is what makes that return possible.
Two key laws largely built the IP protections in our medical innovation system today:
The Bayh-Dole Act of 1980 let universities, small businesses, and nonprofits keep ownership of inventions they discovered, even if some of the basic research that was necessary was developed with federal funding. That gave them a reason to partner with private companies and turn lab discoveries into real products. Since then, more than 200 new drugs and vaccines have come out of those public-private partnerships.
The Hatch-Waxman Act of 1984 struck a balance between rewarding innovators and opening the door to generics, which are vital to broadening patient access. Today, 90 percent of U.S. prescriptions are filled with often cheaper, more available generic drugs.
Each of these laws has served patients well for decades, granting them access to the outputs of America’s innovation pipeline.
This foundation is under pressure as Washington’s policies undermine the incentives that drive innovation. Under the “Most Favored Nation” (MFN) pricing policy, American drug prices are tied to the lowest prices in other nations, where the government often controls the price. At the end of September, the Centers for Medicare and Medicaid Services (CMS) finalized the Global Benchmark for Efficient Drug Pricing (GLOBE) model, implementing MFN into Medicare Part B.
Foreign systems have worked in part because the American market rewards the risk of developing new treatments. If that reward goes away here, there’s no other market left to fund the next generation of research. At the same time, government price-setting under the Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program further disincentivizes new development. Every one of these policies sends the same signal to the people deciding whether to fund the next round of research: the reward may not be there.
This National IP Month, Survivors for Solutions is celebrating 250 years of American ingenuity and the lives that IP protection has helped save. We’re also asking policymakers to protect the system that made that progress possible. That means rejecting policies that import foreign price controls, resisting government price-setting that undercuts the incentive to innovate and remembering the patients still waiting for a breakthrough.