Editor’s Note: Randall Rutta, former president and CEO of Easterseals, is board chairman of the Partnership to Fight Chronic Disease. The opinions expressed in this commentary are his own.
Chronic disease is the leading cause of disability and death in the United States. Six in 10 US adults live with at least one chronic condition. And 4 in 10 adults battle two or more. It’s also a major driver of health care spending, accounting for 90 cents of every dollar spent.
Unfortunately, new efforts on Capitol Hill could make matters worse. 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.
Proposals include allowing the government to undermine patent rights, opening the door for generic versions to be made. Others propose eliminating patents on medical improvements like new dosing methods – such as pills and injections – and extended release formulations, which enable a treatment to be released into the body steadily over time, thereby reducing the number of doses a patient must take.
Sponsors like US Representatives Lloyd Doggett of Texas and Ohio Senator Sherrod Brown believe these bills would ultimately lower drug costs by making generic versions readily available to patients. But such efforts worry patient advocates like me.
Right now, federal laws offer inventors 20 years of patent protection for novel and innovative new products, including medical breakthroughs. If a company designs a new microchip for cell phones or a new chemical compound to lower cholesterol, patents allow the innovators to market their products exclusively until the patent runs out.
Without these protections, innovative startups would struggle to attract the investment dollars needed to develop new projects. No one would make the sizable investment required to discover and develop a new product if anyone can steal their innovation and profit without putting in the labor or financial risk.
Consider the biopharmaceutical space. Nine in ten drugs fail during clinical trials. Creating one new medicine requires over a decade of research and costs an average of 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.
Patents expire typically 7 to 10 years after a new medicine hits the market. And when patents expire, rival drug firms are free to create generic versions of the original medicines. This competition often drives prices down by 80% or more.
The current patent system benefits patients. America invents half of the world’s new drugs. Patent protections last long enough to incentivize research and development investments. And when patents expire, patients can access cheaper generics. That’s a win-win.
In fact, Americans take generics at a higher rate than the citizens of virtually every other country. American pharmacists fill about 9 in 10 prescriptions with generic drugs. By contrast, generics account for only 70% of prescriptions in Canada and just 30% in France.
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The patent system also encourages pharmaceutical companies to continuously improve their products.
For example, manufacturers might reformulate a drug to administer it by patch rather than by pill to make taking it easier. 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 that they will get a sufficient financial return for backing for these important improvements for patients.
The proposed reforms by some lawmakers are dangerously misguided – and have major consequences for patients in need. Few investors would take a risk on a new line of research – and companies would be challenged to let their scientists work on improving 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 antidepressants or antipsychotics – even though innovations that extend the availability of a drug in the body for a longer period of time or reduce the number of pills people have to take can make a huge difference for the Americans who battle mental illness.
We need continued innovation, and patent protections play a critical role in this process. There are many ways to lower health care spending and reduce the burden of illness without undermining patents and disincentivizing medical research.
Correction: An earlier version of this article incorrectly identified one of the representatives supporting the patent legislation.