The U.S. system is distinctive not only for its capacity to generate medical breakthroughs, but also for how quickly it makes these innovations accessible. This is the result of policies that recognize the value of scientific discovery and create the conditions for new therapies to reach the people who need them.
The U.S. ecosystem behind this is highly connected. From basic research and academic science to venture-backed startups and early-stage biotech, to established pharmaceutical companies that design, deliver and fund discovery and clinical development, each partner plays a distinct, complementary role in advancing new medicines from bench to bedside.
Innovation thrives where incentives support research
The U.S. leads the world in medical innovation because its policies encourage investment in research and development. Developing a new medicine requires years of research, extensive clinical trials and billions of dollars in funding. Global private-sector R&D investment was $276B in 2021, with U.S. headquartered companies accounting for 55% of overall R&D and 65% of all development-stage funding. Policies that recognize the immense value of successful innovations help sustain this high-risk, high-reward process.
In contrast, other countries have adopted policy approaches—such as centralized price controls and certain health technology assessment frameworks—that dampen incentives for R&D and fail to fully value innovation. In some European countries, government price setting weakened innovation incentives and led to fewer new drugs available to patients, delayed drug launches, reduced R&D investment and large losses in high-value life sciences jobs. Research indicated that if the U.S. had adopted such policies, Americans would have lost 117 medicines that would have never come to market. Other estimates suggested that adopting such policies may impose economic costs of up to $8 trillion in the United States over a 50-year period, with an additional $5 trillion in Europe. The magnitude of these figures underscores how important innovation-friendly policies are for U.S. biopharmaceutical leadership and millions of Americans who count on them.
U.S. patients gain faster market access to life-saving treatments
America has the fastest availability to the broadest set of novel medicines. An IQVIA study found that among 329 drugs approved by both the U.S. Food and Drug Administration (FDA) and the European Union’s (EU) European Medicines Agency (EMA) between 2014 and 2022, 79% (260) were approved in the United States first, with U.S. approval occurring an average of 0.4 years earlier than in the EU.
The time from approval to actual patient availability – when a drug is covered and accessible – was longer in 25 of the 27 EU countries than in the U.S., with 22 of those countries experiencing median delays of one year or more. These delays are not abstract statistics, especially in cases of serious or life-threatening illness.
Delays can mean prolonged reliance on older, less effective treatments, fewer clinical options when disease progresses and, in some cases, the loss of a meaningful chance for survival or improved quality of life.
What policies should be adopted to promote innovative medicines in the U.S.?
Making novel innovative medicines available in the U.S. reflects long-standing support for a uniquely American ecosystem that turns scientific discoveries into a broad set of novel medicines available to patients.
To guarantee that Americans continue to benefit from these therapeutic advances, policymakers must prioritize patient-centered policies, such as enabling access through insurance and protecting intellectual property (IP) policies. While comprehensive systemic changes will take sustained effort, the following tangible objectives can be advanced now:
- Ensuring insurer cost sharing reflects the net price of medicines, so patients are not overcharged at the pharmacy counter.
- Reforming pharmacy benefit manager (PBM) practices that create administrative barriers and distort patient access.
- Strengthening the balanced IP framework that supports the development of innovative medicines and generic entry.
By preserving policies that reward innovation while improving patient access, the United States can continue to deliver the medical breakthroughs that improve and save lives.
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