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State ‘Personhood’ Laws Threaten Embryonic Stem Cell Research

Aug. 4, 2022, 4:25 PM

Biomedical scientists using embryonic stem cells or fetal tissue could find their studies at risk in conservative states aiming to redefine personhood after the US Supreme Court’s rollback of abortion rights.

These states would give embryos and fetuses the same rights as people. A provision in Georgia’s new abortion law includes embryos, once there’s a detectable heartbeat, which is at about six weeks, and fetuses in population counts. The laws primarily are intended to focus on abortions, but they have downstream consequences on a range of issues, including biomedical research.

“They’re not thinking through the other possible consequences of declaring that an embryo is a person from the moment of fertilization,” Suzanna Sherry, a constitutional law scholar at Vanderbilt University, said. But it’s unclear how it’ll play out since these questions haven’t been tested in court, she said.

If states grant personhood to embryos without specific exceptions for derivation of stem cells from embryos, then there can be no stem cells on which to do research or develop therapeutic products, Mark Barnes, a research attorney with Ropes & Gray LLP, said.

Embryonic stem cells offer great promise in health and medicine because they can turn into any cell in the human body, offering the potential to repair and regenerate tissue damaged by a host of diseases. They also can be used to screen drug candidates for toxicity. But embryos must be destroyed in the process of generating stem cell lines for research. It’s illegal to create embryos specifically for research, but US researchers can use embryos from in vitro fertilization that would otherwise be discarded and have been donated for research.

Pipeline in Jeopardy

The National Institutes of Health funded more than $2 billion in stem cell research in fiscal 2021, including $309 million in embryonic stem cell research.

While there are just seven cell and gene therapies on the US market today, there are more than 1,000 cell and gene therapies are currently in the pipeline, according to Faster Cures, with 50 to 75 therapies expected to be approved in the US by 2030.

The global stem cell market is expected to grow to $27.7 billion by 2028 from nearly $12 billion in 2021, according to one market report.

“If you can’t do IVF at all, then you won’t have stem cells,” Sherry said. “There’s no answer to that. Nobody knows. It’ll have to be tested in court.”

The exact impact of personhood laws on biomedical research is unclear because it depends on the wording of each state statute, and whether it defines a person from conception or implantation or a heartbeat.

But if a state defines a person from the moment of conception, then it would effectively ban research using embryos, R. Alta Charo, who’s guided stem cell policies for the National Academies, President Barack Obama‘s transition team, as well as Wisconsin and California stem cell research institutes, said in an interview.

“If that applies to an embryo outside the body, effectively, it means that in vitro fertilization for fertility purposes itself is now in question,” Charo said.

IVF is a procedure with a high failure rate in which it’s common to implant embryos selectively based on whether an embryo appears to be healthy. But failure to use every embryo would presumably become illegal under the new laws, she said.

“All of these point inevitably to the conclusion that the deliberate use of an embryo in research or to derive embryonic stem cell lines—which we know will destroy the embryo—is almost certainly going to be illegal. The question is, is it illegal under what rubric? Is it homicide? Is it manslaughter?” Charo, a bioethicist and law professor at the University of Wisconsin-Madison, said.

States have “police power” to regulate directly all sorts of activities over which the federal government lacks direct jurisdiction, Barnes said.

“The problem here in the states that may move to adopt ‘embryonic personhood’ without specific exceptions for research and therapeutic use is that sophisticated research institutions will simply move their research to states without such laws, thus eroding the research and development resources of states that have adopted such restrictive measures,” Barnes said.

At least half a dozen states were considering proposals this year to ban abortion by establishing fetal personhood, according to the Guttmacher Institute, a research group that supports abortion rights.

Potential Brain Drain

Even the threat of a potential ban on research could create a brain drain in states with personhood laws, Michele Bratcher Goodwin, a law professor at the University of California, Irvine and director of the law school’s Center for Biotechnology and Global Health Policy, said.

“To the extent that there are laws that are being proposed and enacted” can have a chilling effect, Bratcher Goodwin said. “Someone who has invested more than 20 years of their life and education because they want to save lives now possibly might become the subject of a criminal investigation because they want to develop vaccines? Who would then want to teach in those states or teach at those universities?”

Researchers in a state with a personhood law are at risk, Sherry said. “If it’s worded to declare that it’s a person from the moment of conception, then a researcher could bring the lawsuit and could say my work is affected by this, I don’t know whether I can engage in this research or not, and could get an answer from the court.”

Politicization of Research

Bratcher Goodwin also said researchers in states with personhood laws are at risk of a ban on their research. Those threats are part of a greater movement of politicization of issues that have historically stayed out of the political arena.

Fetal tissue research, for example, has been around for decades but the Trump administration effectively stopped the work in 2019. The Biden administration undid those restrictions last April.

“Part of the challenge is that it’s happening so quickly,” she said. “In some ways, things that were seen as sacred before may no longer be. And even federal laws that would protect research or protect certain activities or certain procedures may fall vulnerable to the courts, where those kinds of procedures are being challenged.”

The 1993 NIH Revitalization Act permits donated fetal tissue to be used for research, which Bratcher Goodwin said raises the question of where to draw the line between fetal tissue and embryonic stem cell research.

“In the spaces where federal law has not spoken, then states are able to enact laws where the federal government has not spoken and where their laws do not contravene federal laws or Supreme Court decisions,” she said. “It would not be a surprise in this backdrop, that one would see lawmakers proposing laws that would ban research in these areas.”

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloombergindustry.com

To contact the editor responsible for this story: Karl Hardy at khardy@bloomberglaw.com