People
Glenn Cohen
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Labor Department Officials Frustrated With White House Over COVID-19 Vaccine and Testing Mandate
September 27, 2021
When President Joe Biden directed the Occupational Safety and Health Administration (OSHA) on Sept. 9 to impose strict COVID-19 vaccination and testing protocols on large businesses, the OSHA employees were ready. ... Public opinion may not have been behind the original ETS, either. Support for a widespread federal response is higher now than it was at the start of Biden’s term, says N’dea Moore-Petinak, a doctoral candidate at the University of Michigan and coauthor of the book Coronavirus Politics. And businesses may be more open to a vaccine and testing mandate than they would be to a masking mandate like the one included in the original ETS, says Glenn Cohen, an expert on health law and bioethics at Harvard Law School. “While I think masking is terrific, politically it’s a harder sell and the compliance rates may be lower,” he says. “With vaccination, it’s easier to ensure compliance.”
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FDA deploying ‘fast-track’ arsenal against COVID-19
September 23, 2021
Food and Drug Administration officials said in July that Pfizer’s application for full approval of its COVID-19 vaccine would enjoy “priority review,” and set a target deadline for finishing by January 2022. They beat the deadline easily, licensing the shots in late August. That’s faster than other vaccines and drugs that have been marked as priorities for the agency. ... “EUAs were used pretty sparingly till recently. There was some use in 2009 related to H1N1, but other than that you don’t see many notable uses,” said I. Glenn Cohen, a health expert at Harvard Law School. “In terms of its pre-history, you might trace it to some of the pressure FDA faced during the AIDS crisis at being too slow to meet the needs of the infected, which among other things prompted it to introduce a priority review designation and accelerated-approval program in 1992.”
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Biden careful not to play favorites, but Pfizer enjoys some ‘comparative advantage’ in mandate era
September 17, 2021
The COVID-19 vaccine from Pfizer and BioNTech was the first to reach American arms, and it accounts for more than half of the 380 million doses administered in the U.S. so far. ... Still, analysts don’t expect Mr. Biden to speak on behalf of Pfizer. His team spent months saying a similar vaccine from Moderna and a one-shot option from Johnson & Johnson were highly effective against COVID-19. “Why the ecumenical attitude? First off, they don’t want to tell Americans who received one up until now they have to be revaccinated. Second, J&J, with its one-dose regimen, for example, has been preferred by some communities. And when people are hard to reach or mildly vaccine skeptical, the ability to provide only one, not two, doses may be a big plus,” said I. Glenn Cohen, a health care expert at Harvard Law School. He said emerging data suggests the vaccines perform differently for fighting the delta variant or maintaining immune responses. “So we may reach a point where the administration will more strongly endorse one over the other. But at the moment, I don’t see them going there, and I think it would take a lot for them to get to that point,” he said.
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Biden Orders Shots for Millions, Calling Unvaccinated a Threat
September 10, 2021
President Joe Biden said he’d order all executive branch employees, federal contractors and millions of health-care workers to be vaccinated against the coronavirus, and that his administration would issue rules requiring large private employers to mandate shots or testing. ... The executive branch is on strong footing to require staff vaccinations, particularly since the Pfizer Inc.-BioNTech vaccine received full approval, rather than just emergency authorization, according to Glenn Cohen, a law professor at Harvard Law School. The OSHA rule is likely to face the most legal challenges, with likely litigation over whether the agency is exceeding its authority.
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VACCINE Fact-checking 3 claims about proof of vaccination requirements
September 8, 2021
As the highly contagious delta variant continues to spread across the United States, many businesses and cities have been rethinking their COVID-19 vaccination requirements. In August, New York City became the first major U.S. city to announce that people who are fully vaccinated against COVID-19 need to show proof of vaccination in order to dine indoors, work out at the gym or go see a movie. Can private businesses ask customers for proof of COVID-19 vaccination? ... Glenn Cohen, a professor at Harvard Law School, told VERIFY that private businesses asking for proof of vaccination is not a violation of the Health Insurance Portability and Accountability Act, or HIPAA. According to the U.S. Department of Health and Human Services, HIPAA only applies to covered entities, such as health care providers and health insurers, and their business associates. “Because the average business is not a covered entity or a business associate of a covered entity within the meaning of HIPAA, the statute does not prohibit them from asking them about vaccination status,” said Cohen.
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A community of belonging
September 2, 2021
At this year's First Class dinner, Harvard Law School Dean John F. Manning, faculty, and students offer support and advice to first-generation students.
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An op-ed by I. Glenn Cohen: The COVID-19 pandemic not over for the U.S., but the Delta variant means the “war has changed,” as leaked CDC slides made clear. The development and production of COVID-19 vaccines are an achievement on the scale of the Manhattan Project, but unless and until more of the U.S. public is vaccinated infections, hospitalizations, and deaths are likely to increase in scale across much of the country. After an impressive roll out, our vaccination rates have stalled. Canada, which faced challenges early on getting enough doses and thus started later than the U.S., by mid-July had surpassed the U.S. both in first-dose and full vaccinated and enters August much better poised to confront Delta.
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Petrie-Flom Center announces new research initiative on psychedelics law and regulation
July 7, 2021
The Petrie-Flom Center at Harvard Law School has announced a new research initiative, the Project on Psychedelics Law and Regulation, to promote safety, innovation, and equity in psychedelics research, commerce, and therapeutics.
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Harvard Law faculty summer 2021 book recommendations
July 1, 2021
Looking for a new book to enjoy at the beach, park, or on your couch? Six HLS faculty members share what they’re reading this summer.
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For a second year, Harvard Law to offer pre-term ‘Zero-L’ course to other law schools for free
May 25, 2021
Harvard Law School today announced plans to make its online, pre-term course for incoming law students, Zero-L, available to other U.S. law schools for free again for a second year as law schools emerge from the pandemic. Beginning in the summer of 2022, HLS will return to its pre-pandemic plan to offer Zero-L as an educational tool that other law schools can purchase for a reasonable fee to share with their students... “We created Zero-L several years ago to help incoming Harvard Law students from all backgrounds gain a common baseline of knowledge as they begin their law school careers,” said Harvard Law School Dean John F. Manning ’85. “As the first in my family to graduate from college and the first to go to law school, I often had the feeling that everyone around me just got law school as soon as they walked through the door, and that I didn’t. Zero-L aims to help all new students feel prepared to succeed on day one.” Zero-L’s faculty director, Professor I. Glenn Cohen ’03, recalled his experience as a new law student similarly. “Like many law students, I found the first few months of law school daunting,” Cohen explained last May. “We built this program to substitute a ‘smooth on-ramp’ for the ‘steep climb’ I and many others encountered upon starting law school.”
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As the Centers for Disease Control and Prevention continues to relax safety measures for people who are fully vaccinated against the coronavirus and the country begins to reopen, many employers, businesses, families and friend groups are finding themselves in the at-times uncomfortable position of having to ask about others’ vaccination statuses. Some Americans, including Rep. Marjorie Taylor Greene (R-Ga.), are balking at such questions and are claiming that asking about or requiring proof of vaccination is a violation of the HIPAA federal privacy law...HIPAA has become one of the “most misunderstood statutes in existence,” said Glenn Cohen, a Harvard Law School professor who is an expert on health law and bioethics. “People think it does a lot more than it’s actually doing.” ... Employers are also legally allowed to ask about or require proof of vaccination from employees. In a December guidance, the Equal Employment Opportunity Commission, which enforces federal workplace anti-discrimination laws, essentially confirmed that “there’s no indication that there’s any federal law that would be violated by the employer asking this question,” Cohen said.
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Can your employer require a vaccine? The short answer is yes. As we continue to push toward a new normal, many employers are weighing whether or not to require employees to receive a COVID-19 vaccine in order to return to work. This week Delta Airlines became the largest U.S. company to announce all new employees must be vaccinated. Producers of the Broadway hit Hamilton have also mandated cast and crew be vaccinated. What rights or recourse do employees have? If your company requires it, there’s not much you can do about it—with a few exceptions. “Employers can demand proof of vaccination,” said Harvard Law Professor Glenn Cohen. “You, as an employer, can set conditions for work.” Cohen is an expert on health law and bioethics. He says that while many employees believe HIPAA laws may protect them from having to provide proof of vaccination, that’s just not the case. “HIPAA is largely irrelevant [in this case],” Cohen said. “Most of these employers are not going to be covered entities under the statutes, so they’re not even covered.” Cohen says HIPAA only applies in health care settings. “Health information generated in an encounter with a physician [would be covered by HIPAA],” he said. “That’s not what a vaccination card is.”
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For a second year, Harvard Law to offer pre-term ‘Zero-L’ course to other law schools for free
May 20, 2021
Harvard Law School today announced plans to make its online, pre-term course for incoming law students, Zero-L, available to other U.S. law schools for free again for a second year as law schools emerge from the pandemic.
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The Centers for Disease Control and Prevention (CDC) on May 13 updated its guidance regarding mask-wearing for people who are fully vaccinated against COVID-19...The question: Is a business asking a customer about their vaccination status a violation of HIPAA? No, most businesses would not violate HIPAA by asking about a customer’s vaccination status...HHS says protected health information under HIPAA includes information that relates to a person’s past, present or future physical or mental health or condition. HHS has a list of what information is protected on its website. While HIPAA rules apply to covered entities and specific business associates, the rules don’t extend to most businesses, according to Glenn Cohen, a professor at Harvard Law School. “Because the average business is not a covered entity or a business associate of a covered entity within the meaning of HIPAA, the statute does not prohibit them asking them about vaccination status,” Cohen said in an email to the VERIFY team.
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A startup called Orchid is offering a spit test that tells a couple the odds that their children will grow up to have certain conditions...It’s sending the message that people affected by these diseases are not desired by society, says Glenn Cohen, a professor at Harvard Law School who specialises in bioethics. “What the company is really saying is, we're going to help determine if your child has schizophrenia, and then we’re going to affirm your view that having a child who has some risk of schizophrenia is not a child you want to have, and we're going to empower you to replace it with a child you prefer.” Cohen refers to this as “liberal eugenics” – the idea that individuals are empowered to voluntarily choose what kind of children they want to have. “If you're really concerned about what the life of a person with schizophrenia looks like in America or the UK, the solution is not to empower more parents to avoid children with schizophrenia – the solution ought to be to find ways to improve the lives of people with schizophrenia,” Cohen says. “I would love to hear what kind of work the company is doing to contextualise these polygenic risk scores in a way that actually helps people understand the disorders in question, rather than merely says, here's your number – good luck.” Siddiqui and Orchid failed to respond to multiple requests for an interview or comment. The company does have a number of blog posts on its website that feature the perspective of people whose loved ones suffered from some of these conditions.
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Pfizer and partner BioNTech have asked the Food and Drug Administration for full approval for their COVID-19 vaccine, a regulatory benchmark beyond the current emergency use authorization granted during the pandemic. Moderna and Johnson + Johnson are expected to submit similar requests before too long. Many are eager for COVID-19 vaccines to advance to full-approval status as they believe this will reassure those who are vaccine hesitant while also helping employers and universities to enforce vaccine mandates...Courts around the United States are reviewing challenges to these vaccine mandates on the grounds that they're authorized, not fully approved. A full approval, however, could effectively end those legal challenges, many of which, legal scholars have said, were dubious to begin with. "I don't think it makes a difference legally, as to mandates, whether the vaccine is EUA or BLA," I. Glenn Cohen, a professor and deputy dean at Harvard Law school, told ABC News, referring to a Biologics License Application. "I do think for many employers and universities it will make them much more comfortable with mandating vaccination, subject to disability and perhaps religious exemption."
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Members of the World Trade Organization are scheduled to meet Friday to discuss a proposal by India and South Africa to temporarily suspend patents on COVID-19 vaccines. Backers of the plan say it would increase the supply of vaccines around the world by allowing more countries to produce them. There’s now enough supply in the U.S that any adult who wants a shot should be able to get one soon...I. Glenn Cohen at Harvard Law School said the U.S. government had some leverage when it was making deals with drug companies as part of Operation Warp Speed. “One could have imagined a version of this where, as part of a condition of receiving the funding, there was more done to ensure access for less developed countries and sharing of technology and sharing of intellectual property,” Cohen said. More than 100 countries have backed the proposal to temporarily waive COVID-19 vaccine patents. The U.S isn’t one of them, but the White House has said it’s considering the idea.
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Florida colleges likely to face uphill battle with COVID-19 vaccine mandates, says legal expert
April 30, 2021
No vaccination, no class: That’s the message being sent to some Tampa Bay college students. A growing number of colleges and universities, more than 100 nationwide, say a COVID-19 vaccine will be mandatory this fall, according to a list maintained by The Chronicle for Higher Education...But is this legal? More than 115 years ago, the Supreme Court held that states can compel vaccinations. “The 1905 decision in Jacobson versus Massachusetts recognizes that states have significant powers under the Constitution,” said Professor I. Glenn Cohen, a Harvard Law professor and leading expert on medical ethics. “A state can definitely introduce a vaccination mandate should they so decide to do.” We know colleges require proof of vaccines for measles, mumps, and meningitis but the coronavirus is a bit different. The COVID-19 vaccines only have Emergency Use Authorization rather than the standard, full U.S. Food and Drug Administration approval. Some legal experts believe the shots, approved only for emergency use, can’t be mandated. Professor Cohen disagrees. “The statute is intended to tell people that they have a choice whether to get vaccinated or not but really has no meaning as to whether a private employer or a private university can require you to be vaccinated,” Cohen said. “It’s your choice, but if you choose not to be vaccinated, this is one of the consequences.”
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Evaluating President Biden’s first 100 days
April 28, 2021
As President Joe Biden approached his 100th day in office, Harvard Law Today asked faculty members and researchers from across Harvard Law School to weigh in on the new administration’s agenda, actions, accomplishments, and failures to date.
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I. Glenn Cohen ’03 and Carmel Shachar J.D./M.P.H. ’10 of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics discuss the Biden administration's healthcare agenda.
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Travelers are crossing borders for vaccines. Is that okay?
April 27, 2021
Enno Lenze, a German entrepreneur, journalist, and museum director, had what felt like another job looking for a vaccination, a hunt he had been on since December...Finally, an option came through. World Visitor, a Norwegian travel agency, offered a package that included flying to Moscow to get Sputnik V, the Russian vaccine. Lenze and 50 other Germans jumped at the chance and traveled there earlier this month for their first jabs...Traveling for treatments with either limited availability or cheaper options than ones’ home country is not new according to I. Glenn Cohen, a professor at Harvard Law School and director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. A thriving medical tourism market has existed for years. In the case of COVID-19 vaccines, as long as at-risk groups have first been protected, countries with surplus vaccines could use them to jumpstart travel, if it is done carefully. “What matters is where the net benefit goes,” he says. “It should benefit the poorest in the community and not just the rich.” While two-dose vaccinations might tempt countries to keep visitors for longer, since it takes time to build an immune response, most post-jab tourism activities should not be rushed. “I’d be a little concerned,” he says. “I hope these people aren’t going to markets and bazaars right away.”