Saturday, August 24, 2019

Saturday, August 24, 2019

Drug-patent reform seeks accessibility, less data


As prescription drugs remain inaccessible to most, the notion of patent reform is seemingly settling into public discourse.

"It’s no secret that the cost of prescription drugs is too high for many Americans to afford,” wrote law professor Lyrissa Lidsky in a Stat opinion piece. "These high prices are due in no small part to the ability of pharmaceutical companies to protect sometimes decades-long monopolies on their products. It’s past time for patent reform."

Patent reform isn’t so straightforward said Erika Lietzan, associate professor of law at the University of Missouri Law School’s Center for Intellectual Property and Entrepreneurship. She said reform and the road to generic or copycat drugs come with trade-offs and compromises.

“We, in the United States, have a very strong patent system and we have also been leading the world in the development of new medicines,” Lietzan said. “And it is, for the most part, the patent system that is driving that innovation engine. So when you make changes you have to consider the trade-off, do we want to have less of an incentive so that the drugs … can go generic faster?”

A Food and Drug Administration report concluded that generic competition correlates with lower drug prices, in particular, second-generation competitors. 

Lietzan also said that part of the compromise could be requiring less data generation before products go to market, making them available sooner. The implication being at what cost to product efficacy.

“We can always talk about whether we’re asking for too much data with new drugs,” she said.

She noted that the high-price pharmaceuticals window averages 12 years and that technology/products ultimately become cheaper. But prior to that point drugs seem unfairly and profoundly expensive to many consumers. The problem is that drug research is very expensive. She said the FDA is working on making research more efficient and streamlined to help offset approval costs.

But consumers aren’t completely in limbo. Lietzan said large pharmaceutical and biotech companies have patient assistance programs but they’re not well-publicized. They can provide assistance — free or discounted medicine — to those who have insurance issues or trouble with high co-payments.

Additionally, she said people can get involved in the patent-reform discussion by educating themselves about the trade-offs.

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University of Missouri School of Law US Food & Drug Administration

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