Medical innovation surrounds us, from fitness apps that track health goals to medicines that make life better. To maintain and even accelerate the pace of innovation, we need a policy framework that incentivizes competition and spurs progress by protecting intellectual property (IP) rights and ensuring patent security.
What’s one example of strong IP and patent protections creating real-life benefits? The field of pediatric medicine. While every treatment approved by the Food and Drug Administration (FDA) undergoes extensive research and testing, there isn’t always information in the product label about using the medicine in kids. Developing medicines for children comes with associated challenges and risks. As a result, many medicines are prescribed to kids based on adult data, but have not been proven to be safe and effective for people their age who have developing minds and bodies.
This is where legislation that includes IP safeguards, such as the Best Pharmaceuticals for Children Act (BPCA), come in to help bridge the gap in pediatric medicines. BPCA offers an additional six months of patent exclusivity to companies that voluntarily conduct pediatric research to fine-tune a treatment’s product label to address the specific needs of kids. The result of BPCA is more treatment options being used safely and effectively in children. Prior to the enactment of BPCA and its complementing legislation, the Pediatric Research Equity Act (PREA), more than 80 percent of medicines approved only for adult use were given to children despite not being evaluated for pediatric safety and efficacy. Today, this percentage has dropped to 50 percent.
IP protection as a driver of innovation isn’t a new concept. Even the U.S. Constitution contains protections laid out by our Founding Fathers that empower people to take risks and develop life-changing products. Without these protections, innovations that we often take for granted—like the transcontinental railroad—may have never come to fruition.
Discovering and developing new medicines isn’t easy, but the potential benefits to people are enormous. By protecting intellectual property and ensuring patent security, we can make sure the future of medical innovation looks bright.