Guest Viewpoints

Weakening Patient Protections Would Jeopardize Americans’ Health

August 29, 2019
Randall Rutta

Chronic disease is the leading cause of disability and death in the United States. Six in 10 U.S. adults live with at least one chronic condition. It’s also a major driver of health spending, accounting for 90 cents of every dollar spent.

Unfortunately, some lawmakers are pushing to weaken vital intellectual property protections for new medicines that improve health, reduce side effects, and help patients take their medicines as prescribed. Sponsors believe these bills would lower drug cost, but such efforts worry patient advocates like me.

Right now, federal laws offer inventors 20 years of patent protection for innovative products, including medical breakthroughs. If a company designs a new microchip for cell phones, or a new chemical compound to lower cholesterol, patents allow innovators to market their products exclusively until the patent runs out.

Without these protections, startups would struggle to attract the investment needed to develop new projects.

Consider the biopharmaceutical space. Nine in 10 drugs fail during clinical trials. Creating one new medicine requires a decade of research and costs nearly $3 billion.

Patents on potential new medicines are filed once a potential new drug is discovered – and the clock is ticking during the years required to test the medicine and demonstrate safety and effectiveness, so patents eventually expire, typically seven to 10 years after a medicine hits the market.

When patents expire, rival drug firms are free to create generic versions of the original medicines. This competition often drives prices down by 80 percent or more.

The current patent system benefits patients. America invents half of the world’s new drugs. Protections last long enough to incentivize research and development. When patents expire, patients can access cheaper generics. American pharmacists fill about nine in 10 prescriptions with generics. By contrast, generics account for only 70 percent of prescriptions in Canada and 30 percent in France.

The patent system also encourages companies to improve their products. For example, manufacturers might reformulate a drug to administer it via a patch rather than a pill. Or they might create an extended release version that has fewer side effects by regulating the amount of drug available in the body over time. They might also adjust dosages that allow patients to take a treatment once a month rather than biweekly. These advances can significantly lower the number of pills patients take daily.

But without the patent protections, investors would be less confident about their prospects of sufficient financial return to justify these small, but important improvements for patients.

Half of people living with a chronic illness do not take their medicines as prescribed. Each year, medical complications that result from this adherence issue cause preventable health issues as well as emergency department visits. Estimated costs add up to $300 billion.

Put differently, even incremental changes to drug dosing or methods often make a big difference for patient health.

Few investors would risk new research – and companies would be challenged to improve existing medicines – if intellectual property laws are weakened.

Drug makers would lose the incentive to develop innovative medicine like the insulin pill – an invention that could spare up to 30 million American diabetes patients the daily pain of injecting insulin into their bodies. Likewise, companies would have no reason to create multiple iterations of anti-depressants – even though innovations make a huge difference for the 46 million Americans who battle mental illness.

We need continued innovation, and patent protections play a critical role in this process.

Randall Rutta, the former president and CEO of Easterseals, is board chairman of the Partnership to Fight Chronic Disease.


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