Health

The Policy Future for Telehealth After the Pandemic

April 14, 2023
COVID-19, Cyber Security, Data Privacy, Health, Healthcare, Healthcare Reform, Public Health

Jack Atterberry, MJLST Staffer

The Pandemic Accelerated Telehealth Utilization

Before the Covid-19 pandemic began, telehealth usage in the United States healthcare system was insignificant (rounding to 0%) as a percentage of total outpatient care visits.[1] In the two years after the beginning of the pandemic, telehealth usage soared to over 10% of outpatient visits and has been widely used across all payer categories including Medicare and Medicaid.[2] The social distancing realities during the pandemic years coupled with federal policy measures allowed for this radical transition toward telehealth care visits.

In response to the onset of Covid-19, the US federal government relaxed and modified many telehealth regulations which have expanded the permissible access of telehealth care services. After a public health emergency was declared in early 2020, the Center for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) modified preexisting telehealth-related regulations to expand the permissible use of those services.  Specifically, CMS temporarily expanded Medicare coverage to include telehealth services without the need for in-person visits, removed telehealth practice restrictions such as expanding the type of providers that could provide telehealth, and increased the reimbursement rates for telehealth services to bring them closer to in-person visit rates.[3] In addition, HHS implemented modifications such as greater HIPAA flexibility by easing requirements around using popular communication platforms such as Zoom, Skype, and FaceTime provided that they are used in good faith.[4]  Collectively, these changes helped lead to a significant rise in telehealth services and expanded access to care for many people that otherwise would not receive healthcare.  Unfortunately, many of these telehealth policy provisions are set to expire in 2024, leaving open the question of whether the benefits of telehealth care expansion will be here to stay after the public emergency measures end.[5]

Issues with Telehealth Care Delivery Between States

A big legal impediment to telehealth expansion in the US is the complex interplay of state and federal laws and regulations impacting telehealth care delivery. At the state level, key state differences in the following areas have historically held back the expansion of telehealth.  First, licensing and credentialing requirements for healthcare providers are most often licensed at the state level – this has created a barrier for providers who want to offer telehealth services across state lines. While many states have implemented temporary waivers or joined interstate medical licensure compacts to address this issue during the pandemic, many states have not done so and huge inconsistencies exist. Besides these issues, states also differ with regard to reimbursement policy as states differ significantly in how different payer types insure differently in different regions—this has led to confusion for providers about whether to deliver care in certain states for fear of not getting reimbursed adequately. Although the federal health emergency helped ease interstate telehealth restrictions since the pandemic started, these challenges will likely persist after the temporary telehealth measures are lifted at the end of 2024.

What the pandemic-era temporary easing of telehealth restrictions taught us is that interstate telehealth improves health outcomes, increases patient satisfaction, and decreases gaps in care delivery.  In particular, rural communities and other underserved areas with relatively fewer healthcare providers benefited greatly from the ability to receive care from an out of state provider.  For example, patients in states like Montana, North Dakota, and South Dakota benefit immensely from being able to talk with an out of state mental health provider because of the severe shortages of psychiatrists, psychologists, and other mental health practitioners in those states.[6]  In addition, a 2021 study by the Bipartisan Policy Center highlighted that patients in states which joined interstate licensure compacts experienced a noticeable improvement in care experience and healthcare workforces experienced a decreased burden on their chronically stressed providers.[7]  These positive outcomes resulting from eased interstate healthcare regulations should inform telehealth policy moving forward.

Policy Bottlenecks to Telehealth Care Access Expansion

The presence of telehealth in American healthcare is surprisingly uncertain as the US emerges from the pandemic years.  As the public health emergency measures which removed various legal and regulatory barriers to accessing telehealth expire next year, many Americans could be left without access to healthcare via telehealth services. To ensure that telehealth remains a part of American healthcare moving forward, federal and state policy makers will need to act to bring about long term certainty in the telehealth regulatory framework.  In particular, advocacy groups such as the American Telehealth Association recommend that policy makers focus on key policy changes such as removing licensing barriers to interstate telehealth care, modernizing reimbursement payment structures to align with value-based payment principles, and permanently adopting pandemic-era telehealth access for Medicare, Federally Qualified Health Centers, and Rural Health Clinics.[8]  In addition, another valuable federal regulatory policy change would be to continue allowing the prescription of controlled substances without an in-person visit.  This would entail modifying the Ryan Haight Act, which requires an in-person medical exam before prescribing controlled substances.[9]  Like any healthcare reform in the US, cementing these lasting telehealth policy changes as law will be a major uphill battle.  Nonetheless, expanding access to telehealth could be a bipartisan policy opportunity for lawmakers as it would bring about expanded access to care and help drive the transition toward value-based care leading to better health outcomes for patients.

Notes

[1] https://www.healthsystemtracker.org/brief/outpatient-telehealth-use-soared-early-in-the-covid-19-pandemic-but-has-since-receded/

[2] https://www.cms.gov/newsroom/press-releases/new-hhs-study-shows-63-fold-increase-medicare-telehealth-utilization-during-pandemic#:~:text=Taken%20as%20a%20whole%2C%20the,Island%2C%20New%20Hampshire%20and%20Connecticut.

[3] https://telehealth.hhs.gov/providers/policy-changes-during-the-covid-19-public-health-emergency

[4] Id.

[5] https://hbr.org/2023/01/its-time-to-cement-telehealths-place-in-u-s-health-care

[6] https://thinkbiggerdogood.org/enhancing-the-capacity-of-the-mental-health-and-addiction-workforce-a-framework/?_cldee=anVsaWFkaGFycmlzQGdtYWlsLmNvbQ%3d%3d&recipientid=contact-ddf72678e25aeb11988700155d3b3c69-e949ac3beff94a799393fb4e9bbe3757&utm_source=ClickDimensions&utm_medium=email&utm_campaign=Health%20%7C%20Mental%20Health%20Access%20%7C%2010.19.21&esid=e4588cef-7520-ec11-b6e6-002248246368

[7] https://bipartisanpolicy.org/download/?file=/wp-content/uploads/2021/11/BPC-Health-Licensure-Brief_WEB.pdf

[8] https://hbr.org/2023/01/its-time-to-cement-telehealths-place-in-u-s-health-care

[9] https://www.aafp.org/pubs/fpm/issues/2021/0500/p9.html

Mental Health Telehealth Services May Not Be Protecting Your Data

March 5, 2023
Administrative Law, COVID-19, Data Privacy, Health, Healthcare, Internet, New Technology, Privacy

Tessa Wright, MJLST Staffer

The COVID-19 pandemic changed much about our daily lives, and nowhere have those changes been more visible than in the healthcare industry. During the pandemic, there were overflowing emergency rooms coupled with doctor shortages.[1] In-person medical appointments were canceled, and non-emergency patients had to wait months for appointments.[2] In response, the use of telehealth services began to increase rapidly.[3] In fact, one 2020 study found that telehealth visits accounted for less than 1% of health visits prior to the pandemic and increased to as much as 80% of visits when the pandemic was at its peak.[4] And, while the use of telehealth services has decreased slightly in recent years, it seems as though it is likely here to stay. Nowhere has the use of telehealth services been more prevalent than in mental health services.[5] Indeed, as of 2022, telehealth still represented over 36% of outpatient mental health visits.[6] Moreover, a recent study found that since 2020, over one in three mental health outpatient visits have been delivered by telehealth.[7] And while this increased use in telehealth services has helped make mental health services more affordable and accessible to many Americans, this shift in the way healthcare is provided also comes with new legal concerns that have yet to be fully addressed.

Privacy Concerns for Healthcare Providers

One of the largest concerns surrounding the increased use of telehealth in mental health services is privacy. There are several reasons for this. The primary concern has been due to the fact that telehealth takes place over the phone or via personal computers. When using personal devices, it is nearly impossible to ensure HIPAA compliance. However, the majority of healthcare providers now offer telehealth options that connect directly to their private healthcare systems, which allows for more secure data transmission.[8] While there are still concerns surrounding this issue, these secure servers have helped mitigate much of the concern.[9]

Privacy Concerns with Mental Health Apps

The other privacy concern surrounding the use of telehealth services for mental health is a little more difficult to address. This concern comes from the increased use of mental health apps. Mental health apps are mobile apps that allow users to access online talk therapy and psychiatric care.[10] With the increased use of telehealth for mental health services, there has also been an increase in the use of these mental health apps. Americans are used to their private medical information being protected by the Health Insurance Portability and Accountability Act (HIPAA).[11] HIPAA is a federal law that creates privacy rules for our medical records and other individually identifiable health information during the flow of certain health care transactions.[12] But HIPAA wasn’t designed to handle modern technology.[13] The majority of mental health apps are not covered by HIPAA rules, meaning that these tech companies can sell the private health data from their apps to third parties, with or without consent.[14] In fact, a recent study that analyzed 578 mental health-related apps found that nearly half (44%) of the apps shared users’ personal health information with third parties.[15] This personal health information can include psychiatric diagnoses and medication prescriptions, as well as other identifiers including age, gender, ethnicity, religion, credit score, etc.[16]

In fact, according to a 2022 study, a popular therapy app, BetterHelp, was among the worst offenders in terms of privacy.[17] “BetterHelp has been caught in various controversies, including a ‘bait and switch’ scam where it advertised therapists that weren’t actually on its service, poor quality of care (including trying to provide gay clients with conversion therapy), and paying YouTube influencers if their fans sign up for therapy through the app.”[18]

An example of information that does get shared is the intake questionnaire.[19] An intake questionnaire needs to be filled out on BetterHelp, or other therapy apps, in order for the customer to be matched with a provider.[20] The answers to these intake questionnaires were specifically found to have been shared by BetterHelp with an analytics company, along with the approximate location and device of the user.[21]

Another example of the type of data that is shared is metadata.[22] BetterHelp can share information about how long someone uses the app, how long the therapy sessions are, how long someone spends sending messages on the app, what times someone logs into the app, what times someone sends a message or speaks to their therapists, the approximate location of the user, how often someone opens the app, and so on.[23] According to the ACLU, data brokers, Facebook, and Google were found to be among the recipients of other information shared from BetterHelp.[24]

It is also important to note that deleting an account may not remove all of your personal information, and there is no way of knowing what data will remain.[25] It remains unclear how long sensitive information that has been collected and retained could be available for use by the app.

What Solutions Are There?

The U.S. Department of Health and Human Services recently released updated guidance on HIPAA, confirming that the HIPAA Privacy Rule does not apply to most health apps because they are not “covered entities” under the law.[26]  Additionally, the FDA put out guidance saying that it is going to use its enforcement discretion when dealing with mental health apps.[27] This means that if the privacy risk seems to be low, the FDA is not going to enforce or chase these companies.[28]

Ultimately, if mental telehealth services are here to stay, HIPAA will need to be expanded to cover the currently unregulated field of mental health apps. HIPAA and state laws would need to be specifically amended to include digital app-based platforms as covered entities.[29] These mental health apps are offering telehealth services, similar to any healthcare provider that is covered by HIPAA. Knowledge that personal data is being shared so freely by mental health apps often leads to distrust, and due to those privacy concerns, many users have lost confidence in them. In the long run, regulatory oversight would increase the pressure on these companies to show that their service can be trusted, potentially increasing their success by growing their trust with the public as well.

Notes

[1] Gary Drenik, The Future of Telehealth in a Post-Pandemic World, Forbes, (Jun. 2, 2022), https://www.forbes.com/sites/garydrenik/2022/06/02/the-future-of-telehealth-in-a-post-pandemic-world/?sh=2ce7200526e1.

[2] Id.

[3] Id.

[4] Madjid Karimi, et. al., National Survey Trends in Telehealth Use in 2021: Disparities in Utilization and Audio vs. Video Services, Office of Health Policy (Feb. 1, 2022).

[5] Shreya Tewari, How to Navigate Mental Health Apps that May Share Your Data, ACLU (Sep. 28, 2022).

[6] Justin Lo, et. al., Telehealth has Played an Outsized Role Meeting Mental Health Needs During the Covid-19 Pandemic, Kaiser Family Foundation, (Mar. 15, 2022), https://www.kff.org/coronavirus-covid-19/issue-brief/telehealth-has-played-an-outsized-role-meeting-mental-health-needs-during-the-covid-19-pandemic/.

[7] Id.

[8] Supra note 1.

[9] Id.

[10] Heather Landi, With Consumers’ Health and Privacy on the Line, do Mental Wellness Apps Need More Oversight?, Fierce Healthcare, (Apr. 21, 2021), https://www.fiercehealthcare.com/tech/consumers-health-and-privacy-line-does-digital-mental-health-market-need-more-oversight.

[11] Peter Simons, Your Mental Health Information is for Sale, Mad in America, (Feb. 20, 2023), https://www.madinamerica.com/2023/02/mental-health-information-for-sale/.

[12] Supra note 5.

[13] Supra note 11.

[14] Id.

[15] Deb Gordon, Using a Mental Health App? New Study Says Your Data May Be Shared, Forbes, (Dec. 29, 2022), https://www.forbes.com/sites/debgordon/2022/12/29/using-a-mental-health-app-new-study-says-your-data-may-be-shared/?sh=fe47a5fcad2b.

[16] Id.

[17] Supra note 11.

[18] Id.

[19] Supra note 5.

[20] Id.

[21] Id.

[22] Id.

[23] Id.

[24] Id.

[25] Supra note 5.

[26] Id.

[27] Supra note 10.

[28] Id.

[29] Supra note 11.

The Apathetic Divide: Surrogacy and the Anglo-American Courtroom

February 20, 2023
Ethics, EU Law, Health, Healthcare, Reproductive Health

Kelso Horne, MJLST Staffer

The State of New York defines Gestational Surrogacy as “a process where one person, who did not provide the egg used in conception, carries a fetus through pregnancy and gives birth to a baby for another person or couple.” The process of surrogacy can be fraught with legal, technical, and moral issues, particularly when the surrogacy is paid for via contract with the surrogate, also called Compensated Gestational Surrogacy (CGS). Until 2020, this kind of contractual paid surrogacy was illegal in the state of New York. That year, it was legalized, and the regulatory regime normalized by the Child-Parent Security Act.  In contrast, the state of Louisiana has one of the harshest gestational surrogacy regimes in the world, outright banning CGS, and requiring both sets of gametes to come from a couple married residing in the state of Louisiana. But these competing regulatory regimes are not replicated across the nation. To the contrary, most states have not passed any laws legalizing or banning CGS or other fertility practices, like the sale of gametes. With sparse case law and frequent legal limbo, the question of “is CGS legal for me?” can be a difficult question for many Americans.

Across the Atlantic, the question used to be an easy one to answer. In 1985 the UK Parliament Enacted the Surrogacy Arrangements Act, which made it an offense to “initiate or take part in any negotiations with the view of making a surrogacy arrangement”, along with some related activities, like compiling information to assist in the creation of surrogacy arrangements. Critically, however, the Act did not criminalize the act of looking to hire a surrogate, or looking to become one, only being a middleman, or publishing advertisements on behalf of those looking to obtain the services of a surrogate. The Human Fertilisation and Embryology Act 1990 defined the mother of a child under UK law as “[t]he woman who is carrying or has carried a child… and no other woman”. In 2001, the Lords Appeal in Ordinary, which acted as the UK’s highest court until 2009, heard the appeal in Briody v. St Helens and Knowsley Area Health Authority. The question before the Lords was one of damages. A woman, rendered infertile as a result of medical negligence, sought £78,267 in order to obtain the services of a surrogate in California, which had legalized CGS in 1993 in the landmark case Johnson v. Calvert. The Lady Justice Hale, speaking for the court, foreclosed the use of CGS in California or elsewhere, as the proposal was “contrary to the public policy of the country”. While she did not entirely dismiss the idea of providing damages to pay for surrogacy procedures, she said it would be permitted only in the case of a voluntary, unpaid surrogate.

Few appellate court judges get to issue an opinion on the same facts twice in their career. In 2020, in one of her final cases prior to retiring, the Lady Justice Hale, now sitting on the UK Supreme Court, which by then had replaced the Lords Appeal in Ordinary, did just that.  In Whittington Hospital NHS Trust (Appellant) v XX, the court determined that a woman who had been rendered infertile as a result of medical negligence could claim damages, including the costs to pay a United States based surrogate to carry her children. CGS, while still entirely illegal in the UK, could now nevertheless provide the basis for damages in a UK court. The Court did note some factual differences between Whittington Hospital and Briody, notably, that the likelihood that a surrogacy arrangement would result in a child was higher in the former. However, the court’s main argument for its opposite ruling was a change in cultural attitude to surrogacy and its role in society, stating “[t]he use of assisted reproduction techniques is now widespread and socially acceptable.”

While admitting that surrogacy was now widely accepted in UK society, the dissent, authored by The Lord Justice Carnwath, nevertheless disagreed with the Court. It argued that the criminal law of the UK remained clearly averse to commercial surrogacy, and that by awarding damages for CGS in California the court misaligned the UK’s civil and criminal law. Thus, the CGS regimes of the UK and the U.S. are now bound together. UK citizens may seek surrogacy arrangements and have them compensated by the UK government through the UK’s National Health Service, but they must use an American “womb”. A financial arrangement which the UK itself deems too unethical to allow inside its own borders is nevertheless legalized and compensated when occurring in other countries. The deeply strange situation is mirrored in the opaque CGS law in the United States itself.

A quick glance at any 50-state review of laws, compiled either by supporters or opponents to commercial surrogacy, paint a similar picture. They show strange ad hoc mixes of case law which often cover ancillary issues or are at least 30 years old. Some scholars have started to publicly discuss the possible ethical pitfalls of “procreative tourism”, but without clear legal rules governing what arrangements are and are not allowed, it becomes difficult to discuss possible solutions. The dangers of this shadow regime were thrown into stark relief by the war in Ukraine, which prior to the Russian invasion was a major source of surrogate mothers. Mothers were paid on average $15,000 per child, which is considerable in a country where, prior to the invasion, the GDP per capita was less than $5,000. The United States needs to determine if it wishes to become a “destination” country for procreative tourism, as the result in Whittington would seem to suggest it is, and whether it wishes to allow its own citizens the opportunity to travel abroad to engage in CGS.

This blog has touched on only a small fraction of the issues which are faced when determining the ideal regulatory regime for surrogacy. However, a lack of discussion, and a failure to acknowledge possible risks leaves us ignorant of what the problems may be, let alone the route to potential solutions. States have largely failed to address the issue since the first CGS baby was born in their borders, usually in the late 1980’s and early 1990’s. It’s time for a serious examination of CGS regulation as it exists, as well as a meaningful discussion about safeguarding the health and wellbeing of those involved in such a transaction. The UK has now done the same, passing the buck without a serious response to the issues surrounding CGS. Regardless of one’s opinion on the results of the Louisiana and New York regulations, potential participants in a surrogacy arraignment in those two states know the boundaries. That should be the case nationwide.

Beef (and Residual Hormones?). It’s What’s for Dinner.

November 6, 2022
Agencies, Agriculture, Animal Law, Environment, FDA, Food and Agriculture, Health, Industry, Public Safety

Kira Le, MJLST Staffer

The beef industry in the United States has been using hormones, both natural and synthetic, to increase the size of cattle prior to slaughter for more than a century.[1] Capsules are implanted under the skin behind a cow’s ear and release specific doses of hormones over a period of time with the goal of increasing the animal’s size more quickly. Because the use of these hormones in the beef industry involves both drug regulation and food safety regulations, both the U.S. Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) are responsible for ensuring the safety of the practice and regulating its use.[2] According to the FDA, “scientific data” is used to establish “acceptable” safe limits for hormones in meat by the time it is consumed.[3] Agricultural science experts support the fact that the naturally-occurring hormones used in beef production, such as estrogen, are used in amounts much smaller than those that can be found in other common foods, such as eggs and tofu.[4] However, the debate within the scientific community, and between jurisdictions that allow the sale of hormone-treated beef (such as the United States) and those that have banned its importation (such as the European Union), is still raging on in 2022 and has led to significant distrust in the beef industry by consumers.[5] With the release of research earlier this year presenting opposing conclusions regarding the safety of the use of synthetic hormones in the beef industry, the FDA has a responsibility to acknowledge evidence suggesting that such practices may be harmful to human health.

Some defend the use of hormones in the beef industry as perfectly safe and, at this point, necessary to sustainably feed a planet on which the demand for meat continues to increase with a growing population. Others, such as the European Union and China, both of which have restricted the importation of beef from cattle implanted with growth-promoting hormones, argue that the practice threatens human health.[6] For example, a report out of Food Research Collaboration found that a routinely-used hormone in United States beef production posed a significant risk of cancer.[7] Such a finding is reminiscent of when, in the not-too-distant past, known carcinogen diethylstilbestrol (DES) was used in U.S. cattle production and led to dangerous meat being stocked on grocery store shelves.[8]

This year, research published in the Journal of Applied Animal Research discussed the effects that residual hormones left in beef and the environment have on human health in the United States.[9] Approximately 63% of beef cattle in the United States are implanted with hormones, most of which are synthetic.[10] Despite organizations and agencies such as the FDA assuring consumers that the use of these synthetic hormones in cattle production is safe, the residues that can be left behind may be carcinogenic and/or lead to reproductive or developmental issues in humans.[11] Furthermore, the National Residue Program (NRP), housed in the USDA, is not only the “only federal effort that routinely examines food animal products for drug residues,” but also only examines tissues not commonly consumed, such as the liver and kidney.[12] Researchers Quaid and Abdoun offer the example of Zeranol, a genotoxic synthetic hormone used in beef production in the United States that activates estrogen receptors, causing dependent cell proliferation in the mammary glands that may result in breast cancer.[13] They also noted the problem of residual hormones found in the environment surrounding cattle production locations, which have been found to reduce human male reproductive health and increase the risk of some endocrine cancers.[14]

Also this year, researchers published an article in the Journal of Animal Science claiming that despite the “growing concern” of the effects of residual hormones on human health, including the earlier onset of puberty in girls and an increase in estrogen-related diseases attributed to the excessive consumption of beef, research shows that cattle treated with hormones, “when given at proper administration levels, do not lead to toxic or harmful levels of hormonal residues in their tissues.”[15] The researchers concluded that the hormones have no effect on human health and are not the cause of disease.[16]

Perhaps it is time for the FDA to acknowledge and address the scientific disagreements on the safety of the use of hormones – synthetic hormones, especially – in beef production, as well as reassure consumers that players in the agriculture industry are abiding by safety regulations. Better yet, considering the currentness of the research, the inconsistency of the conclusions, and the seriousness of the issue, formal hearings – held by either the FDA or Congress – may be necessary to rebuild the trust of consumers in the U.S. beef industry.

Notes

[1] Synthetic Hormone Use in Beef and the U.S. Regulatory Dilemma, DES Daughter (Nov. 20, 2016), https://diethylstilbestrol.co.uk/synthetic-hormone-use-in-beef-and-the-us-regulatory-dilemma/.

[2] Id.

[3] Steroid Hormone Implants Used for Growth in Food-Producing Animals, U.S. Food and Drug Admin (Apr. 13, 2022), https://www.fda.gov/animal-veterinary/product-safety-information/steroid-hormone-implants-used-growth-food-producing-animals.

[4] Amanda Blair, Hormones in Beef: Myths vs. Facts, S.D. State Univ. Extension (July 13, 2022), https://extension.sdstate.edu/hormones-beef-myths-vs-facts.

[5] See Julia Calderone, Here’s Why Farmers Inject Hormones Into Beef But Never Into Poultry, Insider (Mar. 31, 2016), https://www.businessinsider.com/no-hormones-chicken-poultry-usda-fda-2016-3 (discussing the debate within the scientific community over whether the use of hormones in animals raised for human consumption is a risk to human health).

[6] New Generation of Livestock Drugs Linked to Cancer, Rafter W. Ranch (June 8, 2022), https://rafterwranch.net/livestock-drugs-linked-to-cancer/.

[7] Id.

[8] Synthetic Hormone Use in Beef and the U.S. Regulatory Dilemma, DES Daughter (Nov. 20, 2016), https://diethylstilbestrol.co.uk/synthetic-hormone-use-in-beef-and-the-us-regulatory-dilemma/.

[9] Mohammed M. Quaid & Khalid A. Abdoun, Safety and Concerns of Hormonal Application in Farm Animal Production: A Review, 50 J. of Applied Animal Rsch. 426 (2022).

[10] Id. at 428.

[11] Id. at 429–30.

[12] Id. at 430.

[13] Id. at 432–33.

[14] Id. at 435.

[15] Holly C. Evans et al., Harnessing the Value of Reproductive Hormones in Cattle Production with Considerations to Animal Welfare and Human Health, 100 J. of Animal Sci. 1, 9 (2022).

[16] Id.

Making Moves on Marijuana: President Biden and Minnesota Update Marijuana Laws in 2022

October 23, 2022
Agencies, Drug Policy, Employment Law, FDA, Food and Drug Law, Health, Public Health, Regulatory

Emma Ehrlich, MJLST Staffer

Federal Pardoning 

Earlier this month, President Biden announced that he would be pardoning anyone with a federal conviction due to simple marijuana possession charges. This will affect approximately 6,500 people on the federal level, plus thousands of others who were convicted in the District of Columbia. However, this pardon does not cover anyone involved in the actual sale of marijuana or anyone convicted under state possession laws, meaning it affects only a subsection of those who have been convicted of marijuana related charges. The administration’s goal was to give a clean slate to those who were struggling to find housing or employment due to a possession charge, and to encourage state legislatures to do the same. 

The second half of President Biden’s announcement was to task the Attorney General with reviewing the federal government’s categorization of marijuana as a Schedule 1 drug, which President Biden pointed out is currently the same categorization as heroin. Drugs are supposed to be assigned to schedules based on their medical uses and addictive qualities. The Drug Enforcement Agency (“DEA”) currently categorizes marijuana as a “drug[] with no currently accepted medical use and a high potential for abuse.” The U. S. Food and Drug Administration (“FDA”) explains on their website, almost in a regretful tone, that only four cannabis drugs have been approved by the FDA, one containing CBD and the other three containing synthetically derived THC. This categorization issue is not new, but because legislation regarding marijuana is changing rapidly federal agencies have had to play catch up with the law.  

Minnesota and Beyond 

Meanwhile, the state of Minnesota is still chugging along in terms of marijuana legalization. In July of this year, the state of Minnesota legalized the production and sale of edibles containing 5-mg of THC, which can now be purchased by adults in bags containing no more than 50-mg of THC. This sounds like good news, but many state residents are baffled at the lack of a tax provision in the new state law. The University of Maryland actually did a study on Minnesota’s potential for taxing cannabis, and determined that if the newly legalized edibles were taxed at the same rate as Michigan taxes, the state could have collected over $40 million. Given this high estimate, it is not out of the question that a tax on marijuana will be implemented in the future. 

Minnesotan employers were similarly not thrilled when the law passed as they felt ill equipped to update their drug policies. Employers “can bar workers from using, possessing, and being under the influence of THC during work hours or in the workplace,” as well as conduct “random drug testing for safety-sensitive positions” and “employees suspected of being intoxicated.” The gray area exists in the employer’s ability to hire and fire based on an applicant or employee’s use of marijuana outside of work. It is currently illegal to make hiring and firing decisions based on tobacco usage or alcohol consumption, and it is unclear if marijuana will be treated in the same manner. The added layer to marijuana testing is that a positive drug test for marijuana does not mean an employee consumed THC right before work since THC lingers in the body for so long. Thus, an employee could test positive for mairjuana at work even if they had used the drugs days ago and were no longer feeling its effects. Though the employee would have ingested the drug legally, they may not be considered for a job position or could be fired from a job they already hold. This is the type of issue that has led a number of municipalities in Minnesota to put a pause on the sale of the state legalized edibles. In contrast, California passed a law just last month protecting employees, apart from some exceptions, from being discriminated against based on their marijuana usage when not at work. What might be a little concerning is that California made recreational marijuana legal in 2016, and this law won’t go into effect until 2024, meaning there was an eight year gap in the legislation. Regardless, this may serve as the beginning of a pattern, pointing to what Minnesota may do down the line. 

In 2020 New Jersey passed a law legalizing recreational marijuana use which went into effect in April of this year. Similarly to California, part of the law protects workers from being discriminated against because of their marijuana use outside of work. However, Walmart and Sam’s Club have continued to administer drug tests to job applicants to search for traces of marijuana, a practice that has gotten them into legal trouble in New Jersey. Walmart is arguing that only the state Cannabis Regulatory Commission can enforce the new employment law, and that this case should be dismissed because it was brought by individuals. Courts in other states in which similar laws have been passed have issued decisions that oppose Walmart’s position, ruling that individual workers can sue under the law. It seems that Minnesota is not the only state that has enacted fuzzy recreational drug use laws that directly affect employers and employees. 

On the bright side of this employment confusion, many appreciate the baby step the Minnesota legislature has taken to legalize marijuana use. The state has been in dire need of updated marijuana legislation, and the hope is that continuing this legalization process will lessen the disparities between black and white arrests for marijuana possession. This change is necessary, because as of 2020 Minnesota was found to rank 8th in the United States for largest racial disparities in marijuana possession arrests. In 2021, the Minnesota Bureau of Criminal Apprehension released data showing that out of the over 6,000 marijuana related arrests made in the state, 90% were for simple possession charges, and a black person was almost five times more likely to be arrested for these types of charges than a white person. This statistic is down from almost eight times more likely back in 2010, but is still extremely present. 

In Conclusion

President Biden’s pardon is just a beginning step towards moving the US forward on marijuana legislation. Though states such as Minnesota are moving in the right direction by gradually legalizing recreational marijuana use, the laws are often unclear and lead to a multitude of logistical issues like those seen in the employment sector. Regardless, making continued progress is important to the U.S. for many reasons and is crucial for helping to lessen racial arrest disparities. Hopefully this pardon will have the effect the administration aimed for and will encourage more state legislatures to update their policies on marijuana usage.

 

 

Predicted Effects of Price Transparency on Healthcare Economics

March 29, 2022
Administrative Law, Health, Healthcare

David Edholm, MJLST Staffer

In 2019, the Centers for Medicare and Medicaid Services (CMS) promulgated the Price Transparency Rule in order to allow patients to access healthcare pricing information. The stated purpose of the Price Transparency Rule is as follows:

By disclosing hospital standard charges [including payer-specific negotiated charges and discounted-cash prices], we believe the public (including patients, employers, clinicians, and other third parties) will have the information necessary to make more informed decisions about their care. We believe the impact of these final policies will help to increase market competition, and ultimately drive down the cost of healthcare services, making them more affordable for all patients.

There is significant debate whether compliance with the Price Transparency Rule will actuate its intended purpose.

On the proponent side, economic theory to support this purpose statement comes from a market advocacy perspective. In order to drive down the cost of healthcare through competition, consumers must know the prices in advance in order to bargain between providers. By giving consumers the ability to shop around and barter, the thinking goes, providers will undercut competitors by lowering their own prices, even slightly below a competitor’s rate.

Another theory that supports price transparency is that shining light onto healthcare pricing will lead to more public outcry, guilting providers to lower overinflated or unconscionable gross charges or hospital fees. Public outcry may also compel states to create global healthcare budget caps, which have been shown to have positive price-lowering effects. A recent study from Rice University found that Maryland’s all-payer global budget policy reduces costs while increasing quality of care.

Skeptics of the rule, however, including the American Hospital Association (AHA), argue that price transparency will induce institutions that currently charge less than competitors to increase their prices to match their competitors, ultimately raising costs. In litigation, the DC Circuit responded to that argument, holding that, based on available research, this result is unlikely. Secretary Azar was not required to rely on definitive rather than predictive data in writing the requirements because of the novelty of the price disclosure scheme and the unique complexity of healthcare pricing. The DC Circuit held that relying on studies of similar price disclosure schemes in other industries was sufficient to inform a stable policy judgment.

However, the healthcare service market is of a unique nature in that quality of care may be a consumer’s primary consideration before seeking treatment, trumping price considerations. Alternatively, a consumer may assume that paying more means receiving higher-quality care. Quality of care is incredibly hard to measure and report, and unless a consumer has access to quality-of-care information alongside pricing information, they are more likely to make fallacious assumptions about this correlation. Another unique factor about healthcare shopping is that many consumers have a strong relationship with their physician, thus would base their decision primarily on receiving advice from one they trust, rather than the out-of-pocket cost of care, especially if the difference is negligible.

Last is the complexity of healthcare viewpoint. Opponents of the price transparency rule emphasize the nature of healthcare as an unpredictable trade. For example, if a patient consumer undergoes surgery to fix one problem, a surgeon may discover another problem amidst the procedure. The standard of care likely prompts the surgeon to correct both problems, thus the patient consumer will be charged an amount higher than they could have reasonably predicted. The AHA brought this argument to court to support its assertion that the price transparency rule violated the Administrative Procedure Act (APA) by overstating the rule’s benefits. The DC Circuit court responded that the rule did not require hospitals to publish every potential permutation of finalized charges, rather that the baseline charges are publicized. Thus, in the surgery scenario, a patient consumer should have access to the payer-negotiated rate to fix the initial problem.

The jury is out, so to speak, on the effects that Price Transparency Rule compliance will have on healthcare economics. But from a consumer perspective, rapidly increasing healthcare costs are at the forefront of relevant political issues.

Xenotransplantation: Ethics and Public Policy Need To Catch up to the Science

March 5, 2022
Bioethics, Biotechnology, Discrimination, Ethics, FDA, Health, Medical Devices, New Technology, Personalized Medicine

Claire Colby, MJLST Staffer

In early January, surgeons at the University of Maryland Medical Center made history by successfully transplanting a genetically altered pig heart to a human recipient, David Bennett.  The achievement represents a major milestone in transplantation. The demand for transplantable organs far outpaces the supply, and xenotransplantation–the implantation of non-human tissue into human recipients–could help bridge this gap. In the U.S. alone, more than 106,000 people are on the waiting list for transplants. Legal and ethical questions remain open about the appropriateness of implementing xenotransplants on a large scale. 

The FDA approved the January transplant through an emergency authorization compassionate use pathway because Bennett likely would have died without this intervention. Larger clinical trials will be needed to generate enough data to show that xenotransplants are safe and effective. The FDA will require these trials to show xenotransplantations are non-inferior to human organ transplants. IRB requirements bar interventions where risk outweighs benefits for patients, but accurately predicting and measuring risk is difficult. 

If xenotransplantation becomes standard clinical practice, animal rights proponents may balk at the idea of raising pigs for organs. Far before that point, pre-clinical trials will make heavy use of animal models. Institutional Animal Care and Use Committees (IACUCs) which oversee animal research in universities and medical entities apply a “much lower ethical standard” for animals than human research subjects. Bioethicists apply a “3R” framework for animal subjects research that stresses replacing animal models, reducing animal testing, and refining their use. Because of the inherent nature of xenotransplantation, applying this framework may be near impossible. Ongoing discussions are needed with relevant stakeholders.  

If both human and animal organs are approved for widespread transplant, but human organs prove superior, new allocation policies are needed to determine who gets what. Organ allocation policy is currently dictated by the Organ Procurement and Transplantation Network (OPTN). As it stands, organ transplantation shows inequality across racial groups and financial status. New allocation policies for organs must not reinforce or worsen these disparities. 

Like all medical interventions, patients must be able to provide informed consent for xenotransplantation. The recipient of the altered pig heart had previously been deemed ineligible for a human heart transplant because his heart failure was poorly managed. Reserving experimental interventions, like xenotransplantations, for the sickest patients raises serious ethical concerns. Are these desperate patients truly able to give meaningful consent? If xenotransplantation becomes a common practice, the traditional model of institutional review boards may need updating. Currently, individual institutions maintain their own IRBs. Xenotransplantation of altered animal organs may involve several sites: procurement of the organ, genetic editing, and transplantation may all take place in different locations. A central IRB for xenotransplantation could standardize and streamline this process. 

In all, xenotransplantation represents an exciting new frontier in transplant medicine. Responsibly implementing this innovation will require foresight and parallel innovation in ethics and public policy. 

Reconsidering Roe: Has the Line of Fetal Viability Moved?

December 18, 2021
Constitutional Law, Family Law, Health, Privacy, Reproductive Health

Claire Colby, MJLST Staffer

After the Supreme Court heard arguments in Dobbs v. Jackson Women’s Health on December 1, legal commentatorsbegan to speculate the case could be a vehicle for overturning Roe v. Wade. The Mississippi statute at issue in Dobbs bans nearly all abortions after 15 weeks. In questioning Mississippi Solicitor General Scott Stewart, Justice Sonia Sotomayor asked about the “advancements in medicine” that have changed the lines of viability since the Court last considered a major challenge to Roe with Planned Parenthood v. Casey in 1992. “What has changed in science to show that the viability line is not a real line…?” she asked.

Roe v. Wade was a 1973 landmark decision in which the Supreme Court adopted a trimester framework for abortion. During the first trimester, the Court held that “the abortion decision and its effectuation must be left to the medical judgement of the pregnant woman’s attending physician.” The court held that states could adopt regulations “reasonably related to maternal health” for abortions after the first trimester, and held that in the third trimester, upon viability, states may “regulate, and even proscribe, abortion except where necessary, in appropriate medical judgement for the preservation of the life or health of the mother.” In 1992, the Court rejected this “rigid trimester” framework in Planned Parenthood v. Casey. In Casey, the Court turned to a viability framework and found that pre-viability, states may not prohibit abortion or impose “a substantial obstacle to the woman’s effective right to elect the procedure.” The Court adopted an “undue burden” standard to determine whether state regulations of pre-viability abortion are unconstitutional.

In Casey, the court defined viability as “the time at which there is a realistic possibility of maintaining and nourishing a life outside the womb.” So when do medical professionals consider a fetus viable? The threshold has moved to earlier in the gestation period since the 1970s, but experts disagree on where to draw the line. According to a journal articlepublished in 2018 in Women’s Health Issues, in 1971, fetal age of approximately 28 weeks was “widely used as the criterion of viability.” The article said that until recently, 24 weeks of gestation was the “widely accepted cutoff for viability in the highest acuity neonatal intensive care units.” According to the article, babies born as early as 22 weeks of gestation had an “overall survival rate of 23%” with “the most aggressive medical management available.” The article rebuked the idea of tying abortion restrictions to viability at all: “Tying abortion provisions to the word viability today is as misguided as it was to tie it to a specific trimester in 1973,” the article stated. “There was no true definition of viability then, and as long as medicine strives to treat every patient uniquely, there will never be one.”

A 2017 practice alert published in the official journal of the American College of Obstetricians and Gynecologists defined “periviable” births —births occurring “near the limit of viability” —as births occurring between 20 and 26 weeks gestation.

According to a 2020 New York Times article, determinations on the gestational age at which a baby is likely to survive outside of the womb are “in a complex moment of transition.” Though technology has improved, “even top academic institutions disagree about the right approach to treating 22- and 23-week babies.” The article reported that the University of California, San Francisco “a top-tier, high resource hospital,” is “transparent about its policy of offering only comfort care for babies that are born up to the first day of the 23rd week, down to the hour.”

In June 2020, a baby born at the Children’s Hospital and Clinics of Minnesota set the world record for the world’s most premature baby to survive, the Washington Post reported. He was born at 21 weeks and two days gestation.

Several medical developments help to explain this earlier period of viability.

According to a 2020 Nature article, “the biggest difference to survival came in the early 1990s with surfactant treatment.” Surfactant is a “slippery substance” that prevents airways from collapsing upon exhalation. According to Kaiser, premature babies with underdeveloped lungs often lack the substance. “When premature lungs are treated with surfactant after birth, the infant’s blood oxygen levels usually improve within minutes.”

A 2018 study published by the Journal of the American Medical Association, administering prenatal steroids to mothers between 22 and 25 weeks gestation prior to delivery led to a “significantly higher” survival rate, but “survival without major morbidities remains low at 22 and 23 weeks.”

The Dobbs ruling is not expected until this summer, when the Court tends to release its major decisions. Even if the Court maintains the viability standard set forth in Casey, recent medical advances may warrant more consideration about where to draw this line.

You Wouldn’t 3D Print Tylenol, Would You?

October 12, 2021
3-D Printing, Administrative Law, Bioethics, Biotechnology, FDA, Food and Drug Law, Health, Healthcare, Healthcare Reform, Medical Devices, Personalized Medicine, Pharmaceuticals, Uncategorized

By Mason Medeiros, MJLST Staffer

3D printing has the potential to change the medical field. As improvements are made to 3D printing systems and new uses are allocated, medical device manufacturers are using them to improve products and better provide for consumers. This is commonly seen through consumer use of 3D-printed prosthetic limbs and orthopedic implants. Many researchers are also using 3D printing technology to generate organs for transplant surgeries. By utilizing the technology, manufacturers can lower costs while making products tailored to the needs of the consumer. This concept can also be applied to the creation of drugs. By utilizing 3D printing, drug manufacturers and hospitals can generate medication that is tailored to the individual metabolic needs of the consumer, making the medicine safer and more effective. This potential, however, is limited by FDA regulations.

3D-printed drugs have the potential to make pill and tablet-based drugs safer and more effective for consumers. Currently, when a person picks up their prescription the drug comes in a set dose (for example, Tylenol tablets commonly come in doses of 325 or 500 mg per tablet). Because the pills come in these doses, it limits the amount that can be taken to multiples of these numbers. While this will create a safe and effective response in most people, what if your drug metabolism requires a different dose to create maximum effectiveness?

Drug metabolism is the process where drugs are chemically transformed into a substance that is easier to excrete from the body. This process primarily happens in the kidney and is influenced by various factors such as genetics, age, concurrent medications, and certain health conditions. The rate of drug metabolism can have a major impact on the safety and efficacy of drugs. If drugs are metabolized too slowly it can increase the risk of side effects, but if they are metabolized too quickly the drug will not be as effective. 3D printing the drugs can help minimize these problems by printing drugs with doses that match an individual’s metabolic needs, or by printing drugs in structures that affect the speed that the tablet dissolves. These individualized tablets could be printed at the pharmacy and provided straight to the consumer. However, doing so will force pharmacies and drug companies to deal with additional regulatory hurdles.

Pharmacies that 3D print drugs will be forced to comply with Current Good Manufacturing Procedures (CGMPs) as determined by the FDA. See 21 C.F.R. § 211 (2020). CGMPs are designed to ensure that drugs are manufactured safely to protect the health of consumers. Each pharmacy will need to ensure that the printers’ design conforms to the CGMPs, periodically test samples of the drugs for safety and efficacy, and conform to various other regulations. 21 C.F.R. § 211.65, 211.110 (2020). These additional safety precautions will place a larger strain on pharmacies and potentially harm the other services that they provide.

Additionally, the original drug developers will be financially burdened. When pharmacies 3D print the medication, they will become a new manufacturing location. Additionally, utilizing 3D printing technology will lead to a change in the manufacturing process. These changes will require the original drug developer to update their New Drug Application (NDA) that declared the product as safe and effective for use. Updating the NDA will be a costly process that will further be complicated by the vast number of new manufacturing locations that will be present. Because each pharmacy that decides to 3D print the medicine on-site will be a manufacturer, and because it is unlikely that all pharmacies will adopt 3D printing at the same time, drug developers will constantly need to update their NDA to ensure compliance with FDA regulations. Although these regulatory hurdles seem daunting, the FDA can take steps to mitigate the work needed by the pharmacies and manufacturers.

The FDA should implement a regulatory exception for pharmacies that 3D print drugs. The exemption should allow pharmacies to avoid some CGMPs for manufacturing and allow pharmacies to proceed without being registered as a manufacturer for each drug they are printing. One possibility is to categorize 3D-printed drugs as a type of compounded drug. This will allow pharmacies that 3D print drugs to act under section 503A of the Food Drug & Cosmetic Act. Under this section, the pharmacies would not need to comply with CGMPs or premarket approval requirements. The pharmacies, however, will need to comply with the section 503A requirements such as having the printing be performed by a licensed pharmacist in a state-licensed pharmacy or by a licensed physician, limiting the interstate distribution of the drugs to 5%, only printing from bulk drugs manufactured by FDA licensed establishments and only printing drugs “based on the receipt of a valid prescription for an individualized patient”. Although this solution limits the situations where 3D prints drugs can be made, it will allow the pharmacies to avoid the additional time and cost that would otherwise be required while helping ensure the safety of the drugs.

This solution would be beneficial for the pharmacies wishing to 3D print drugs, but it comes with some drawbacks. One of the main drawbacks is that there is no adverse event reporting requirement under section 503A. This will likely make it harder to hold pharmacies accountable for dangerous mistakes. Another issue is that pharmacies registered as an outsourcing facility under section 503B of the FD&C Act will not be able to avoid conforming to CGMPs unless they withdraw their registration. This issue, however, could be solved by an additional exemption from CGMPs for 3D-printed drugs. Even with these drawbacks, including 3D-printed drugs under the definition of compounded drugs proposes a relatively simple way to ease the burden on pharmacies that wish to utilize this new technology.

3D printing drugs has the opportunity to change the medical drug industry. The 3D-printed drugs can be specialized for the individual needs of the patient, making them safer and more effective for each person. For this to occur, however, the FDA needs to create an exemption for these pharmacies by including 3D-printed drugs under the definition of compounded drugs.

Intellectual Property in Crisis: Does SARS-CoV-2 Warrant Waiving TRIPS?

February 21, 2021
Bioethics, Biotechnology, COVID-19, Food and Drug Law, Health, Healthcare, Intellectual Property, Patents, Regulatory

Daniel Walsh, MJLST Staffer

The SARS-CoV-2 virus (which causes the disease COVID-19) has been a massive challenge to public health causing untold human suffering. Multiple vaccines and biotechnologies have been developed to combat the virus at a record pace, enabled by innovations in biotechnology. These technologies, vaccines in particular, represent the clearest path towards ending the pandemic. Governments have invested heavily in vaccine development. In May 2020 the United States made commitments to purchase, at the time, untested vaccines. These commitments were intended to indemnify the manufacture of vaccines allowing manufacturing to begin before regulatory approval was received from the Food and Drug Administration. The United States was not alone. China and Germany, just to name two, contributed heavily to funding the development of biotechnology in response to the pandemic. It is clear that both private and public institutions contributed heavily to the speed with which biotechnology has been developed in the context of the SARS-CoV-2 pandemic. However, there are criticisms that the public-private partnerships underlying vaccine manufacturing and distribution have been opaque. The contracts between governments and manufacturers are highly secretive, and contain clauses that disadvantage the developing world, for example forbidding the donation of extra vaccine doses.

Advanced biotechnology necessarily implicates intellectual property (IP) protections. Patents are the clearest example of this. Patents protect what is colloquially thought of as inventions or technological innovations. However, other forms of IP also have their place. Computer code, for example, can be subject to copyright protection. A therapy’s brand name might be subject to a trademark. Trade secrets can be used to protect things like clinical trial data needed for regulatory approval. IP involved in the pandemic is not limited to technologies developed directly in response to the emergence of SARS-CoV-2. Moderna, for example, has a variety of patents filed prior to the pandemic that protect its SARS-CoV-2 vaccine. IP necessarily restricts access, however, and in the context of the pandemic this has garnered significant criticism. Critics have argued that IP protections should be suspended or relaxed to expand access to lifesaving biotechnology. The current iteration of this debate is not unique; there is a perennial debate about whether it should be possible to obtain IP which could restrict access to medical therapies. Many nations have exceptions that limit IP rights for things like medical procedures. See, e.g., 35 U.S.C. 287(c).

In response to these concerns the waiver of a variety of IP protections has been proposed at the World Trade Organization (WTO). In October 2020 India and South Africa filed a communication proposing “a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19.” The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) sets minimum standards for IP standards, acquisition, and enforcement and creates an intergovernmental dispute resolution process for member states. Charles R. McManis, Intellectual Property and International Mergers and Acquisitions, 66 U. Cin. L. Rev. 1283, 1288 (1998). It is necessary to accede to TRIPS in order to join the WTO, but membership in the WTO has significant benefits, especially for developing nations. “Sections 1, 4, 5, and 7 . . .” relate to the protection of copyrights, industrial designs, patents, and trade secrets respectively. Waiver would permit nation states to provide intellectual property protections “in relation to prevention, containment or treatment of COVID-19” that fall below the minimum standard set by the TRIPs Agreement. At time of writing, 10 nations have cosponsored this proposal.

This proposal has been criticized as unnecessary. There is an argument that patents will not enter effect until after the current crisis is resolved, implying they will have no preclusive effect. However, as previously mentioned, it is a matter of fact that preexisting patents apply to therapies that are being used to treat SARS-CoV-2. Repurposing is common in the field of biotechnology where existing therapies are often repurposed or used as platforms, as is the case with mRNA vaccines. However, it is true that therapies directly developed in response to the pandemic are unlikely to be under patent protection in the near future given lag between filing for and receiving a patent. Others argue that if investors perceive biotech as an area where IP rights are likely to be undermined in the event of an emergency, it will reduce marginal investment in vaccine and biotech therapies. Finally, critics argue that the proposal ignores the existing mechanisms in the TRIPS Agreement that would allow compulsory licensing of therapies that nations feel are unavailable. Supporters of the status quo argue that voluntary licensing agreements can serve the needs of developing nations while preserving the investments in innovation made by larger economies.

The waiver sponsors respond that a wholesale waiver would permit greater flexibility in the face of the crisis, and be a more proportionate response to the scale of the emergency. They also assert that the preexisting compulsory licensing provisions are undermined by lobbying against compulsory licensing by opponents of the waiver, though it is unlikely that this lobbying would cease even if a waiver were passed. The sponsors also argue that the public investment implies that any research products are a public good and should therefore be free to the public.

It is unclear how the current debate on TRIPS will be resolved. The voluntary licensing agreements might end up abrogating the need for a wholesale waiver of IP protections in practice rendering the debate moot. However, the WTO should consider taking up the issue of IP protections in a crisis after the current emergency is over. The current debate is a reflection of a larger underlying disagreement about the terms of the TRIPS Agreement. Further, uncertainty about the status of IP rights in emergencies can dissuade investment in the same way as erosion of IP rights, implying that society may pay the costs of decreased investment without reaping any of the benefits.

 

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