Paper: Use patent law to curb unethical human-genome editing

Paper: Use patent law to curb unethical human-genome editing

A new paper co-written by a University of Illinois Urbana-Champaign scholar who studies the legal and ethical implications of advanced biotechnologies outlines an unexplored tool to regulate the medically and ethically dubious practice of heritable human-genome editing: patent law.

Applied judiciously, patent law could create an “ethical thicket” around human genome editing that ultimately discourages access to “germline editing” – that is, changing sperm and egg to create designer children – in more permissive countries such as China, Greece, Mexico, Spain, and Ukraine, said Jacob S. Sherkow, a professor of law and an affiliate of the Carl R. Woese Institute for Genomic Biology at Illinois.

The World Health Organization has explored international governance tools for human genome engineering, but as long as individual countries are allowed to set and enforce their own policies, the possibility of people engaging in medical tourism to other countries to circumvent domestic prohibitions remains a risk, the authors said in a paper published by the Journal of the American Medical Association.

“A lot of policymakers and medical practitioners are concerned with some of the genomic editing technologies out there, specifically with technologies that focus on allowing parents to pick and choose their children’s height, eye color, skin tone and the like,” Sherkow said. “Generally speaking, reproductive technologies are somewhat regulated, but U.S. rules are totally different from what they are in Canada, certain EU countries, the United Kingdom or China. And there is no international enforcement agency out there that’s going to stop people from engaging in genetic medical tourism.

“So there isn’t much international harmony on the issue, and it’s just inherently something that’s pretty inimical to an international governance framework. But the gene-editing technology itself is patentable – and that could potentially be an under-the-radar tool to thwart this undesirable behavior.”

There’s already a trend in the U.S. toward patenting human heritable germline-editing technology, Sherkow said.

“Patent protection affords researchers and their institutions significant power over the ethical limits of using such technologies,” he said. “For institutions that develop these technologies, it’s essential to build the ethical limits of their intellectual property into the patent licensing process.”

Even though patents are only enforceable in whatever country they’re granted, using patent law as an enforcement mechanism would potentially allow owners to go to court “to stop someone else from using a piece of technology in a way that they don’t like,” Sherkow said.

“The typical economic conceit behind patents is it allows an inventor who doesn’t like that they’re not getting paid for something they created to sue,” he said. “But that scope can also include the ways in which the technology is being used, like if it’s being used in an unethical manner by others.”

Sherkow and his co-authors said this could be especially important for countries where patent laws and regulatory systems surrounding gene-editing technologies diverge.

“Some countries have strong patent protections but weak regulatory protection, while other countries are the opposite,” Sherkow said. “Using patent protections that are granted in countries that otherwise have a weaker regulatory system – we think that’s an economically sensible and politically feasible path forward.”

As a strategy, it’s not a silver bullet but a hurdle to trip up bad actors, Sherkow said.

“It’s not a complete solution by any means, as it relies on private interests to police the social harms of a private activity,” he said. “But patents present an opportunity to combine the tools of commercialization and ethical behavior in a manner not readily available in other enforcement mechanisms, especially given the disparate international regulation. So this is a particularly important moment to consider ethical governance by patent, and we think it’s a pretty significant arrow in the regulatory quiver.”

Sherkow’s co-authors are Eli Y. Adashi, of Brown University, and I. Glenn Cohen, of Harvard Law School.

Editor’s notes: To contact Jacob S. Sherkow, call 217-300-3936; email jsherkow@illinois.edu.

The paper “Governing human germline editing through patent law” is available online.

DOI: 10.1001/jama.2021.13824



from ScienceBlog.com https://ift.tt/3gQhM75

Comments

Post a Comment

Popular posts from this blog

‘Massive-scale mobilization’ necessary for addressing climate change, scientists say

Image
A year after a global coalition of more than 11,000 scientists declared a climate emergency, Oregon State University researchers who initiated the declaration released an update today that points to a handful of hopeful signs, but shares continued alarm regarding an overall lack of progress in addressing climate risks. “Young people in more than 3,500 locations around the world have organized to push for urgent action,” said Oregon State University’s William Ripple, who co-authored “The Climate Emergency: 2020 in Review,” published today in Scientific American. “And the Black Lives Matter movement has elevated social injustice and equality to the top of our consciousness. “Rapid progress in each of the climate action steps we outline is possible if framed from the outset in the context of climate justice – climate change is a deeply moral issue. We desperately need those who face the most severe climate risks to help shape the response.” One year ago, Ripple, distinguished profess
Read more

Pandemic Underscores Value of Telehealth Options for AUD Treatment

Image
The need for physical distancing during the COVID-19 pandemic ushered in an expansion in the use of technologies to minimize person-to-person contact. The healthcare industry in particular saw a rapid growth of measures, collectively known as telehealth or telemedicine, to provide care and facilitate interactions between providers and patients. Telehealth encompasses a wide range of approaches. Its defining feature is that the visits are done remotely using technologies that may range from telephone and video calls to diverse internet-based platforms. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), telehealth has been used in clinical settings for more than 60 years. Between 2016 and 2019, the use of telehealth doubled from about 14 percent to about 28 percent. During the same period, the proportion of treatment facilities for alcohol and other substance use disorders that offered telehealth increased from about 14 percent to about 17 percent. T
Read more

Wiggling worms suggest link between vitamin B12 and Alzheimer’s

Image
Worms don’t wiggle when they have Alzheimer’s disease. Yet something helped worms with the disease hold onto their wiggle in Professor Jessica Tanis’s lab at the University of Delaware. In solving the mystery, Tanis and her team have yielded new clues into the potential impact of diet on Alzheimer’s, the dreaded degenerative brain disease afflicting more than 6 million Americans. A few years ago, Tanis and her team began investigating factors affecting the onset and progression of Alzheimer’s disease. They were doing genetic research with  C. elegans , a tiny soil-dwelling worm that is the subject of numerous studies. Expression of amyloid beta, a toxic protein implicated in Alzheimer’s disease, paralyzes worms within 36 hours after they reach adulthood. While the worms in one petri dish in Tanis’s lab were rendered completely immobile, the worms of the same age in the adjacent petri dish still had their wiggle, documented as “body bends,” by the scientists. “It was an observation
Read more