The Morning Call

To find tomorrow’s cures pass trade deal today

- Andrew Spiegel Andrew Spiegel is the executive director of the Global Colon Cancer Associatio­n.

Congress will soon consider the new North American trade deal, dubbed the United States-Mexico-Canada Agreement. When U.S. government officials negotiated the deal, they asked their Mexican and Canadian counterpar­ts to lift their nations’ intellectu­al property standards for certain advanced drugs.

But now, some U.S. lawmakers are taking issue with this provision, claiming it will adversely impact U.S. drug prices. They’re wrong. USMCA’s intellectu­al property rules will catalyze further investment in medi- cal research with- out affecting prices. If Congress wants to help patients here and abroad, they’ll pass the trade deal assigned by the three countries last fall.

The United States leads the world in medical innovation. American labs are responsibl­e for more than half of all drugs currently being developed worldwide. This includes more than 1,000 cancer treatments, 85 drugs to fight Alzheimer’s disease, and another 550 that combat rare diseases.

There’s a reason America leads in innovation. Our nation’s robust intellectu­al property protection­s encourage researcher­s to develop their products here. Thanks to our patent protection­s, firms pour billions of dollars into research and developmen­t projects in America each year — $90 billion in 2016 alone.

In particular, U.S. patent law has encouraged the developmen­t of biologics — complex drugs made using living organisms. Biologics have proven successful in treating a number of conditions, including multiple sclerosis and cancer. Since 2004, the FDA has approved five biologics to treat colon cancer. Treatment options are one key to advancing patient health. Good public

policies drives private industry investment and competitio­n.

The United States offers 12 years of “regulatory data protection” for biologics. For the duration of that window, rival companies can’t manufactur­er copycat versions of these drugs, called biosimilar­s. That gives innovators a chance to recoup their sky-high investment costs.

Many other countries recognize the value of strong intellectu­al property protection­s. The entire European Union, for example, provides 10 years of regulatory data protection for biologics. Existing Canadian law only provides eight years. Mexico doesn’t offer anything. USMCA would require both countries to offer at least 10 years of protection, bringing them closer to the U.S. standard.

That’s great news for patients. With scientific discoverie­s protected at home and abroad, more investors would be spurred to pour money into the next generation of biologics. Unfortunat­ely, a handful of lawmakers want to eliminate USMCA’s section on biologics. This doesn’t make sense. There’s no evidence to suggest that reducing intellectu­al property protection­s would cut costs. In fact, a report from the Geneva Network found that USMCA would have zero effect on drug prices and total drug spending within overall health care systems.

The Geneva Network report examined the effects of increasing regulatory data protection in Canada and Japan. More than a decade ago, both nations extended an eight-year window to all medicines, not just biologics. The report concludes that increasing the protection had no impact on drug spending in Japan or Canada. In fact, drug spending declined as a percentage of both countries’ health spending after they increased regulatory data protection.

Extending regulatory data protection­s wouldn’t hurt patients — but reducing them certainly would. After all, drug developmen­t is a risky business. It takes billions of dollars — and up to 15 years of dedicated research — to take a drug from the lab to patients. And most drug research fails long before they hit shelves. But researcher­s continue to pursue these projects in the hopes that a single successful drug will offset the cost of previous failures. Reducing these protection­s kills the incentive for innovation, and leaves patients worse off.

Cancer patients especially benefit from robust drug developmen­t. Since 1990, cancer death rates have plummeted by 26%, thanks in a large part to the availabili­ty of new drugs. But despite this progress, there’s still more work to be done.

Colorectal cancer effects around one in 23 people. More than 145,000 Americans are expected to be diagnosed with colorectal cancer in 2019 alone. And each year, colorectal cancer claims the lives of more than 51,000 patients in the United States. For these patients, drug developmen­t is a matter of life and death. By safeguardi­ng intellectu­al property, USMCA gives drug developmen­t a much-needed boost, and gives patients hope for the future. Hopefully U.S. lawmakers realize this before it’s too late.

 ?? MARTIN MEJIA/AP 2018 ?? President Donald Trump, center, Canada’s Prime Minister Justin Trudeau, right, and Mexico’s President Enrique Pena Nieto sign a new United States-Mexico-Canada Agreement that is replacing the NAFTA trade deal, during a ceremony at a hotel before the start of the G20 summit in Buenos Aires, Argentina.
MARTIN MEJIA/AP 2018 President Donald Trump, center, Canada’s Prime Minister Justin Trudeau, right, and Mexico’s President Enrique Pena Nieto sign a new United States-Mexico-Canada Agreement that is replacing the NAFTA trade deal, during a ceremony at a hotel before the start of the G20 summit in Buenos Aires, Argentina.
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