Testimony on NYC Banking Designation of Fossil Fuel Funding Banks

By Mekedas Belayneh

Download the pdf here. 

Good afternoon, Mayor Eric Adams, Comptroller Brad Lander, and Department of Finance (DOF) Commissioner Preston Niblack. My name is Mek Belayneh and I am a climate and financial policy advocate with the national public interest group Public Citizen. On behalf of our 500,000 members and supporters, many of whom live in New York City, I’m testifying to urge the commission to not designate fossil fuel funding banks for city funds, JP Morgan Chase, Citibank, Wells Fargo, Bank of America, and TD Bank.

As the severity of the climate crisis deepens, these banks continue to funnel large amounts of money into the extraction of harmful fossil fuels. Since 2016, banks that hold deposits for New York City have provided an astounding $1.2 trillion in financing for fossil fuels. This has not only accelerated the pace of climate change but also inflicted significant harm on the frontline communities in NYC. It is imperative that we act quickly to divest these public funds from fossil fuel funding banks causing environmental damage, and to direct city funds to institutions investing towards community-driven climate solutions.

When NYC deposits funds into JPMorgan Chase, Citi, Wells Fargo, Bank of America, and TD Bank, these banks use these funds to make loans and bonds, and provide underwriting to fossil fuel companies—including companies that are still expanding fossil fuel production. Chase, which is the largest holder of NYC deposits, is the biggest financier of fossil fuels worldwide. Citi, Wells Fargo and Bank of America follow Chase as the world’s top four leading financiers of fossil fuels.  I urge the members of the NYC Banking Commission to exclude these banks from being NYC Designated Banks because of this harmful financing.

As a city made mostly of islands, NYC is uniquely vulnerable to climate change and the effects of global heating and rising sea levels. Many of us remember the lasting harmful impacts of Superstorm Sandy and Hurricane Ida. Climate scientists warn that we can expect destructive storms to occur more frequently and with greater intensity due to the consequences of climate change. We can’t have our city’s money used to expand the industries that are exacerbating climate change and destroying our communities, causing the most severe devastation in low-income communities and communities of color. In addition, by banking with major fossil fuel financiers, the city is supporting the development of new drilling sites, pipelines, refineries, and other toxic infrastructure in frontline predominantly black and brown neighborhoods communities worldwide.

New York City’s public funds should not be channeled to harmful fossil fuel investments. It is incumbent upon the commission to adopt a more assertive stance in addressing the large banks that are capitalizing on and creating the climate emergency. I urge the NYC Banking Commission to seize this opportunity to remove bank designation for leading fossil fuel funders, in order to stem the climate crisis. Thank you for your time.

Download the pdf here. 

Hot Take

 Key Findings

• Heat exposure is responsible for as many as 2,000 worker fatalities in the U.S. each year.
• Up to 170,000 workers in the U.S. are injured in heat stress related accidents annually. There is a 1% increase in workplace injuries for every increase of 1° Celsius.
• The failure of employers to implement simple heat safety measures costs the U.S. economy nearly $100 billion every year.
• The dangers of heat stress are overwhelmingly borne by low-income workers. The lowest-paid 20% of workers suffer five times as many heat-related injuries as the highest-paid 20%.
• Worker heat stress tragedies disproportionately strike workers who are low-income, Black or Brown.
• At least 50,000 injuries and illnesses could be avoided in the U.S. each year with an effective OSHA heat standard.
• Employers pay a substantial price for failing to mitigate workplace heat stress including the costs of absenteeism, turnover and overtime due to worker illness or injury, reduced worker productivity, damage to machinery and property from workplace accidents, increased workers’ comp premiums, law suits, and loss of public trust and customers.
• The physical and mental capacity of workers to function drops significantly as heat and humidity increase. Productivity of workers declines approximately 2.6% per degree Celsius above a Wet Bulb Globe Temperature (WBGT) of 24°C (75.2°F). The WBGT is a measure that combines temperature, relative humidity, radiant heat sources (like direct sunlight or heat-generating machinery) and wind speed.
• There are many simple ways employers can mitigate heat stress in the workplace, like access to cool drinking water and adequate “cool down” breaks in a shaded or air-conditioned space.
• It is essential that OSHA issue an interim rule to immediately prevent heat-related illness, injury and death in indoor and outdoor workers, both to protect workers and to reduce the clear burden on the economy.

Introduction

The right to a safe workplace is a basic human right.[1] Exposure to excessive heat is one of the most dangerous problems facing workers today. Tens of thousands of workers suffer heat illnesses, injuries and fatalities every year in the U.S. This is a toll disproportionately borne by Black and Brown workers, and low-income workers with limited options for safer employment. This is most clearly demonstrated by the plight of farmworkers, who have the highest rate of heat-related worker deaths, and are overwhelmingly immigrant workers with little power to demand workplace reforms from their employers.

The Occupational Safety and Health Administration (OSHA) is responsible for protecting the safety and health of workers. Created by the Occupational Safety and Health Act of 1970 (OSH Act), the agency is tasked with promulgating rules to reduce hazards in the workplace and enforcing those rules by educating employers and holding employers accountable when they fail to put appropriate safety measures in place. For example, OSHA has developed rules to address workplace hazards such as lead, asbestos, infectious diseases, trenching cave-ins, fall risks, dangerous machinery and excessive noise. Unfortunately, despite the recommendations made over 50 years ago by the National Institute on Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention (CDC),[2] OSHA has yet to put a workplace heat hazard rule in place.

In 2021, in response to a petition submitted by Public Citizen and more than 100 organizations and experts, OSHA finally began working on a heat-safety standard.[3] However, the arduous process for developing a rule takes OSHA, on average, seven to eight years to complete.^[4]

Congress has the power to protect workers now. The Asuncíon Valdivia Heat Illness, Injury and Fatality Prevention Act is a bill directing OSHA to institute an interim heat standard for indoor and outdoor workplaces until a final heat rule can be completed. This report describes why passing this legislation is essential.

Background

Despite the horrifying images of ever more brutal hurricanes, tornadoes and floods we frequently see in the news, extreme heat is the leading weather-related killer.[5] Globally, nearly half a million people die each year because of extreme heat.[6]

The ravages of the climate crisis are making environmental heat more dangerous with each passing year. Nine of the last 10 years have been the hottest on record. The summer of 2022 was the third warmest on record in U.S.[7] On just one day — Sep. 9, 2022 — nearly 1,000 heat records were broken in the U.S.[8]

The National Oceanic and Atmospheric Administration (NOAA), forecasts the El Niño climate phenomenon will return in the summer and fall of 2023,[9] bringing unprecedented extreme heat waves.[10] Climate models predict that 2023 will be hotter than 2022[11] and that 2024 will be the hottest year ever recorded.[12] The extreme outdoor heat will be accompanied by challenges in keeping indoor temperatures safe. The hot sun roasts buildings made with materials that absorb heat and lack proper cooling systems, causing indoor temperatures to swell beyond the outdoor temperature.

The human body has a complex regulatory system designed to keep our core temperature about 98.6 degrees. Heat stress refers to strain on that system as it tries to keep the body cool. Heat stress is a function of internally generated heat (metabolic heat), external environmental heat and other factors that reduce the effectiveness of our natural bodily cooling systems. The amount of physical effort needed for peoples’ workloads increases their metabolic heat production. The ambient temperature and radiant heat sources like direct sunlight and heat-generating machinery add to heat stress.[13]

Sweat is produced so that the process of evaporation can release body heat. But environmental conditions can severely limit the effectiveness of this cooling mechanism. High humidity reduces the evaporation of sweat. Very low humidity allows sweat to quickly evaporate and cool the body. But there is a limited amount of sweat the body can produce and, with extended exposure, sweating is reduced or ceases.[14]

Pumping blood to the surface of the skin to be cooled by the surrounding air is another bodily cooling mechanism. But high environmental temperatures reverse the process, instead introducing more heat into the blood at the surface of the skin. In turn, the body works harder, pumping even more blood to the surface.

As more and more blood is diverted to the skin, less blood is being directed to the muscles and the brain^[15] Without water replenishment, excessive sweating causes dehydration, thickening the blood and making the heart work harder.A greater proportion of the cardiac output is devoted to cooling the body and the portion available for physical and mental work decreases.^[16] As the body’s cooling systems strain to keep the body cool, heat-related illness can occur.

Heat-related illnesses range in severity from mild heat rash to more severe illnesses such as rhabdomyolysis, acute kidney injury, heat stroke and heat-stress induced cardiac arrest. Workers who survive these more critical heat-related illnesses are often burdened with long term health effects, including muscle damage, organ damage and chronic kidney disease. Excessive heat in the workplace can also exacerbate existing chronic conditions like diabetes, COPD and cardiac disease, complicating the health care of these workers and potentially shaving years off their lives.

The symptoms of heat-related illnesses include heavy sweating, fatigue, nausea, headache, loss of balance and cognitive function, fainting, muscle cramps, and more. These symptoms can easily lead to accidents with a range of consequences to one or more people, including injuries, long-term disabilities or even fatalities.

Excessive Heat Takes an Exorbitant Toll on Workers

The Bureau of Labor Statistics (BLS) Census of Fatal Occupational Injuries indicates that 436 U.S. workers died from occupational heat stress between 2011 and 2021, an average of 40 per year.[17] We know this number grossly underestimates actual heat-related occupational fatalities. Determination of the cause of death relies primarily on the conclusions recorded in death certificates and the judgment of medical professionals making those findings.[18] This information is notoriously problematic in the case of heat stress because records may only indicate the immediate cause of death (e.g., kidney failure) without noting the underlying cause.[19] An extrapolation from research cross-referencing population fatality data with location-specific temperature data indicates that as many as 2,000 workers lose their lives to excessive heat in the workplace every year in the U.S.^[20]

BLS estimates there were about 3,400 workplace heat-related injuries and illnesses requiring days away from work per year from 2011 to 2020.[21] However, this is a vast underestimate of the true impact on workers. BLS bases its conclusions on surveys of employers. This data is decidedly unreliable because it relies on self-reporting, and less than half of employers even maintain the required records.[22]

Data estimating injuries and illnesses from heat is further hampered by the difficulty of deeming “exposure to environmental heat” (the relevant BLS category) to be the chief cause out of hundreds of category choices when an injury or illness potentially caused by heat stress occurs.

Further, despite the use of the term “injuries and illnesses” in the categorization of heat-related worker harms by both BLS and OSHA, the data only reflect heat illnesses, not the injuries that are caused by the effects of heat stress. OSHA’s guidance on record-keeping regarding adverse outcomes from heat only references illnesses caused by excessive heat “such as heat illness, heat stroke, kidney injury and rhabdomyolysis.”[23] In reality, heat may be a determinative factor in many injuries. For example, heat stress may cause an employee to become dizzy and lose their balance, causing them to fall from a scaffolding or roof.

An analysis of more than 11 million worker’s compensation injury reports in California from 2001 through 2018 found that working on days with hotter temperatures likely caused about 20,000 injuries and illnesses per year in that state, alone — an extraordinary 300 times the annual number of injuries and illnesses the California OSHA (Cal/OSHA) attributes to heat.[24]

The results of the California study are instructive in estimating the extent of uncounted heat-related injuries nationwide. If California’s workers suffer approximately 20,000 heat-related injuries and illnesses per year, a simple extrapolation based on the worker population of other states suggests that the number suffered by all U.S. workers is likely in the range of 170,000 heat-related injuries and illnesses per year.[25]

The extent of heat-related injuries in the workplace is further demonstrated by a meta-analysis of 17 studies worldwide that showed an average 1% increase in occupational injuries for every 1°C above 20.9°C (69.6° F). Increases were highest, up to 1.7% increase in injuries per 1°C, in humid subtropical climates, such as the southeastern parts of the U.S.^[26] A study of agricultural workers in Washington State found the odds of traumatic injuries in cherry harvesters, primarily from ladder falls, increased 1.53% for every 1°C above 25°C (77° F).^[27]

Improvements in tracking the impact of heat stress on workers are desperately needed. However, it’s clear that a dramatic number of workers suffer serious consequences of heat stress. This is a burden that takes a disproportionate toll on workers that are living in poverty, low-income, Black or Brown.[28]

Importantly, the California study of workers’ compensation claims from 2001 to 2018 found that the increase in injuries on hot days was cut by approximately 30% in the years following California’s issuance of a state occupational heat standard in 2005.[29] Therefore, a federal standard similar to California’s heat standard would prevent more than 50,000 heat-related injuries annually. Moreover, California’s limited standard only covers outdoor workplaces[30] and exempts numerous industries from implementing high-heat procedures.[31] It is also less protective in other key ways than the more recent, and well-informed standard issued by Oregon OSHA.[32] A strong, comprehensive federal standard covering both outdoor and indoor workplaces could prevent significantly more injuries and fatalities.

Financial Cost of Failure to Mitigate Workplace Heat Stress Hazards

There are multiple ways employers can mitigate heat stress in the workplace. The simplest of these is providing workers with consistent access to cool drinking water and adequate “cool down” breaks in a shaded or air-conditioned space. Acclimatizing new employees to working in high heat conditions over multiple days is another important strategy to protect workers. Employers can make a variety of simple alterations such as heat shields for indoor workers stationed next to heat-generating machinery or awnings over windows to block the sunlight. Employers can also increase ventilation or air conditioning in inside workspaces. While these physical alterations may involve more up-front costs, they are the most effective in reducing the impact of heat stress on these indoor workers.

The price paid by workers of failing to implement heat stress mitigation strategies is incalculable and unacceptable. The heavy toll includes financial hardships, but more importantly, the loss of health, safety, and life. Though it’s not possible to weigh lives against any costs to employers of putting safety measures in place, it is important to understand the financial impact of implementing an OSHA heat standard.

Employers often raise knee-jerk concerns about the costs of these heat hazard mitigation strategies. However, the financial cost of failing to mitigate heat stress is much higher. Employers face reduced productivity resulting from absenteeism and turnover when workers experience heat-related illness or injury, as well as general reduced worker capacity because of heat stress. Employers may have to pay for overtime to replace absent workers. They may be straddled with the cost to repair or replace damaged equipment, vehicles and property owing to accidents caused by heat stress. Workers’ compensation premiums may increase due to the number of claims by injured workers. By not addressing an obvious risk of worker heat-related illness or injury, an employer may be sued for negligence and forced to pay court judgements and associated legal fees. A reputation as an unsafe workplace also means the potential loss of the public goodwill and, with it, customers. The OSHA $afety Pays tool estimates the average direct costs of a single “heat prostration” injury in the workplace to be $37,658 with an estimated indirect cost of $41,423.^[33]It also estimates average syncope (fainting) direct costs at more than $30,000 and indirect costs exceeding $33,000.^[34] In general, heat stress prevention is cheaper than responding to the consequences of a tragedy.

Employers sometimes raise concerns about the cost of lost productivity when providing needed breaks to workers from high temperatures. However, heat stress reduces the physical and mental capacity for work. Without heat stress mitigation, such as opportunities to rest in a cool area and drink water, heat stress continues to increase and worker capacity decreases, ultimately reaching a point when work is no longer physically possible.

As noted above, the strain to keep the body cool causes fatigue, deficits in motor and cognitive function, dizziness, nausea, cramps and other symptoms of heat-related illness that become increasingly severe. Even the earliest symptoms of heat stress limit the ability to function, interfering with worker effectiveness and increasing the risk of mistakes, accidents and injuries. A meta-analysis of seven studies in multiple countries found that worker productivity declines averaged 2.6% per degree Celsius above a Wet Bulb Globe Temperature (WBGT)^[35] of 24°C (75.2°F).^[36]

Foster et al. developed a model to predict the reduction in work capacity associated with increases in ambient temperature and relative humidity (see Figure 1).^[37] The model predicts, for example, that a worker is able to work at close to full capacity when it’s 77°F with a relative humidity of 30%.^[38] However, worker capacity drops dramatically as temperatures and humidity rise. Worker capacity drops to 25% when the temperature reaches 104°F with a relative humidity of 80%.^[39] This is the equivalent of only working 15 minutes each hour.[40]

 

Clearly, concerns about lost worker productivity with increased breaks in high temperatures are misinformed. Increased breaks don’t just protect workers from heat stress, they improve worker productivity.

Lost worker capacity due to heat stress doesn’t just impact an individual employer’s bottom line. It has a tremendous impact on the economy as well. It is estimated that the annual global cost of lost work time due to reduced worker capacity due to unmitigated heat stress is $2.1 trillion.^[41] The U.S. alone is losing more than $98 billion every year.^[42]

In the United States, 62% of all counties annually lose more than 0.5% of gross value added (GVA) due to heat-related worker productivity losses.^[43] The GVA is a productivity measure reflecting the value of goods and services produced in the area, industry or sector derived as the output minus immediate consumption. Productivity losses are greater than $5 million per year in approximately the same percentage of counties.^[44] Texas counties lose a combined $30 billion in a typical year, the equivalent of about 1.5% of GVA in those counties, on average, and Florida loses $11 billion per year.^[45] It is no surprise that, by proportion, the productivity losses are greatest in agriculture and construction.^[46] And, because many indoor businesses lack air conditioning or adequate ventilation, the services sector sustains the greatest overall losses.^[47] This includes restaurants, transportation, hospitality, and warehousing.^[48]

As we consider all of these costs, it becomes apparent that there is no conflict between worker safety and business profitability. It is in the best interests of everyone that safety measures against heat hazards in the workplace be implemented.

Why Do We Need an OSHA Interim Heat Standard?

Even with the obvious benefits of implementing safety strategies to reduce worker heat stress, some employers will choose not to do so. Absent a standard specifically focused on heat, OSHA has limited means to press those employers to mitigate heat hazards in the workplace. Currently, in order to hold an employer accountable for an excessive heat hazard, OSHA must rely on the General Duty Clause of the OSH Act, which calls for employers to furnish their employees with conditions that are free of hazards “that are causing or are likely to cause death or serious physical harm to his employees.” But taking enforcement action pursuant to the General Duty Clause is time-consuming and often vulnerable to legal challenges. Several rulings since 2018 of the Occupational Safety and Health Review Commission (OSHRC), an administrative court, highlight the limits of the General Duty Clause.

For example, an OSHRC Administrative Law Judge (ALJ) issued five substantially identical decisions in similar cases in which OSHA alleged the United States Postal Service, in multiple locations, exposed its employees to unmitigated excessive heat as they delivered the mail. In each case, the ALJ vacated OSHA’s citation, finding that OSHA had not met its burden to establish that a condition in the workplace presented a hazard, even in the face of evidence of heat indices as high as 109°F and workers medically diagnosed with heat illnesses.[49]

The ALJ, noted that “without a temperature- or heat index-specific standard, it is difficult for employers to know when heat is ‘excessive,’”[50] and referenced OSHA’s failure to provide such a standard, stating, “OSHA has been urged to promulgate a heat stress standard since shortly after the [OSH] Act went into effect.”[51]

On appeal, the Commission disagreed with the ALJ, finding that OSHA had presented sufficient evidence of an excessive heat hazard. However, one Commissioner, of the two-Commisioner panel, emphasized that the decision did not itself “establish [] any sort of criteria for determining when ‘excessive heat,’ may be present,” suggesting that would “presumably be accomplished by the Secretary’s” promulgation of “an OSHA standard.”[52]

A heat standard will ensure OSHA has the ability to hold employers accountable when they put workers in danger of heat illness, injury and death. Moreover, it will provide clear guidance to employers on what actions are necessary to meet the universal requirement to provide a workplace free of dangerous heat hazards. Delay in putting a heat standard in place hinders the ability of OSHA to carry out its congressional directive to ensure workers are protected from dangerous working conditions, making it essential to establish an interim standard now.

Conclusion

Every year in the United States as many as 2,000 workers lose their lives to excessive heat in the workplace^[53] — a price no worker should ever have to pay. The impact of these lost lives on their families and loved ones is immeasurable. Up to 170,000 additional workers are injured in heat stress related accidents on the job,^[54] potentially resulting in long-term disabilities that can not only diminish worker income, but also have detrimental effects on worker health and reduce quality of life.

Each year without an OSHA heat stress standard puts the health and lives of more workers on the line. The risk of workplace heat stress illness, injury and death is increasing with climate change and predictions for extreme temperatures and increased heat waves in 2023 and 2024 make the need for a heat standard more urgent than ever.

Because it’s impossible to put a price on lost lives, human suffering or the workers’ fears that they may not return home due to injury, there is no acceptable cost-benefit analysis to determine whether employers should implement basic protocols that protect workers from heat-related illness, injury, and death. Nor should there be. Still, it is important to understand the cost of inaction and delay. The burden of occupational heat stress on the economy is tremendous and rapidly growing. Failing to mitigate the hazard for workers has great financial consequences for employers. Yet, simple and affordable solutions exist to both protect workers and benefit employers.

A comprehensive federal standard covering heat hazards in indoor and outdoor workplaces (see Appendix) would prevent more than 50,000 heat-related injuries annually. Congress has the opportunity to direct OSHA to put an interim heat standard in place that would safeguard employees now from deadly heat by passing the Asuncíon Valdivia Heat Illness, Injury and Fatality Prevention Act. Congress must pass the bill with all haste to protect workers while a final OSHA rule is promulgated.

 

Appendix

What Should Be in An OSHA Rule To Prevent Heat Illness, Injury, And Death?

Every workplace injury and fatality caused by heat stress is avoidable, and relatively simple preventative measures have proven extremely effective at protecting workers. It is both the social and legal responsibility of employers to create a work environment safe from heat hazards.

OSHA should create a heat standard delineating required preventative measures that include the following:

Temperature Thresholds: An OSHA heat standard must provide clarity to employers and workers in order to ensure effective comprehension and implementation of the standard. This is particularly important for small businesses, where reliance on complicated formulas for decision-making may be cumbersome. Identifying clear temperature thresholds, including thresholds for high heat and extreme heat, that trigger certain minimum employer requirements under the standard will protect both workers and employers.

Workload and Pace: Employers should empower workers to work at their own pace whenever possible. Workload should be reduced or suspended in times of extreme temperatures.

Mandatory Rest Breaks: Employers should be required to give workers a 15-minute break for every two hours of work when the temperature exceeds 80 degrees. Scheduled breaks should increase with temperatures based on the work/rest schedule recommended by NIOSH with an adjustment for clothing and PPE. Workers should be permitted and encouraged to take unscheduled breaks when they feel overheated or experience any symptoms of heat illness.

Indoor and Outdoor Cooling: Indoor workplaces should be air-conditioned or well-ventilated to keep temperature below 80 degrees. Or, at a minimum, include a cool space for breaks. Delivery trucks should be air conditioned whenever possible. Outdoor workplaces should provide a cool, shaded space for breaks.

Hydration: Employers should be required to provide workers at least one liter of cold drinking water every hour. Water should be easily accessible and, preferably made continuously available. With very heavy workloads at high temperatures workers also should be provided drinks with electrolytes.

Heat Stress Plan: Each employer should use the information available from OSHA, NIOSH, industry-specific guidance and other expert sources to create a written heat stress plan that is appropriate for use at their unique worksites. The plan should be comprehensive and available to employees in a language they can understand.

Emergency Response: Employers should be required to have an emergency action plan (EAP) that includes training personnel to identify workplace heat illnesses and to provide appropriate cooling strategies at each worksite. Designated employees or managers should be trained in specific workplace medical responses. The EAP should include information on when to call an ambulance, including guidance to call an ambulance when in doubt.

Heat Acclimatization Plan: All workers beginning work in high-heat environments, or who will be working in hotter conditions than usual (e.g., during a heat wave), must be gradually acclimatized to the work over a period of at least 7 to 14 days.

Environmental Surveillance and Hazard Notification: At outdoor worksites, employers should be required to monitor environmental conditions at each worksite and notify employees of hazardous heat conditions in English and any languages spoken by at least 20% of workers.

Worker Information and Training: Employers must be required to provide all employees with heat stress training when they are hired, as well as annually in the employees’ primary language.

Record Keeping: Employers should be required to maintain and properly handle accurate records of: 1) heat illnesses, including those treated onsite with first aid; 2) accidents or injuries potentially related to heat strain, including recording the workplace temperature and protective clothing and gear worn by the worker for every workplace injury; 3) environmental and metabolic heat exposures; 4) acclimatization procedures; 5) all medical and physiological monitoring; and 6) modifications to engineering and administrative controls, as well as changes to personal protective equipment.

Non-retaliation Policy: An OSHA heat standard must include comprehensive whistleblower rights so that workers are vigorously protected from all forms of employer retaliation for reporting unsafe conditions that could lead to heat illness or injury.

 

 

 

 

 

[1] All about OSHA, Occupational Safety and Health Administration, U.S. Department of Labor, OSHA 3302–02R 2023, https://www.osha.gov/sites/default/files/publications/all_about_OSHA.pdf.

[2] Criteria for a Recommended Standard: Occupational Exposure to Hot Environments, National Institute of Occupational Safety and Health, U.S. Depart of Health, Education and Welfare (1972), https://bit.ly/3MMhfDE.

[3] Heat Injury and Illness Prevention in Outdoor and Indoor Work Settings, 86(205) Federal Register 59309 (Oct. 27, 2021), https://bit.ly/3dosuj7. Public Citizen and more than 100 allied organization and occupational heat experts filed petitions with OSHA for an occupational heat standard in 2011 and 2018, as well as a petition for an Emergency Temporary Standard in 2021. Petitions to OSHA for a Heat Standard, Public Citizen, https://bit.ly/3HHqu3G.

[4] Workplace Safety and Health: Multiple Challenges Lengthen OSHA’s Standard Setting, U.S. Government Accountability Office (April, 2012), https://bit.ly/3N8oHG3.

[5] Jonathan Erdman, America’s Top Weather Killer is Not Tornadoes, Flooding, Lightning or Hurricanes – It’s Heat, The Weather Channel (June 21, 2022), https://weather.com/safety/heat/news/2021-06-03-heat-america-fatalities.

[6] Qi Zhao, Yuming Guo, Tingting Ye, Antonio Gasparrini, Shilu Tong, Ala Overenco et al., Global, Regional, and National Burden of Mortality Associated with Non-optimal Ambient Temperatures from 2000-2019: A Three-Stage Modeling Study, 5(7) The Lancet Planetary Health E415-E425 (July 1, 2021), https://bit.ly/3tlLPZB.

[7] Allison Finch, Summer of 2022 Ranks as Third Warmest on Record For Contiguous US, Accuweather (Sep. 13, 2022), https://bit.ly/3t9UcYP.

[8] National Oceanic and Atmospheric Administration (NOAA) (accessed May 19, 2023), https://www.ncdc.noaa.gov/sotc/national/202209.

[9] ENSO: Recent Evolution, Current Status and Predictions, NOAA (March 13, 2023 ), http://bit.ly/3TRgOK6.

[10] Damian Carrington, Warning of Unprecedented Heat Waves as El Niño Set to Return in 2023, The Guardian ( January 16, 2023 ), http://bit.ly/3TRNW4i.

[11] Dana Nuccitelli, 2022 Was a Remarkable Year for the Climate. Here’s What to Expect in 2023, Yale Climate Connections (January 9, 2023), http://bit.ly/3nwDJ1n.

[12] Carrington, Warning of Unprecedented Heat Waves as El Niño Set to Return in 2023.

[13] Recommended Heat Standard: Occupational Exposure to Heat and Hot Environments, National Institute of Occupational Safety and Health, Centers for Disease Control and Prevention (2016), https://bit.ly/3ivb7sd.

[14] S. Tony Wolfe, Rachel, M. Cottle, Daniel J. Vecellio, and W. Larry Kenney, Critical Environmental Limits For Young, Healthy Adults (PSU Sheet Project), Journal of Applied Physiology (December 16, 2021), https://bit.ly/3WfWkfp.

[15] Josh Foster, James W. Smallcombe, Simon Hodder, Ollie Jay, Andreas D. Flouris, Lars Nybo and George Havenith, An Advanced Empirical Model for Quantifying the Impact of Heat and Climate Change on Human Physical Work Capacity, 65 International Journal of Biometeorology 1‐15 (2021), https://bit.ly/3xT1FhG [hereinafter Foster et al., Quantifying Impact of Heat on Work Capacity (2021)]; Margaret C. Morrissey, Gabrielle J. Brewer, Tyler Quinn and Douglas J. Casa, Impact of Occupational Heat Stress on Worker Productivity and Economic Cost, American Journal of Industrial Medicine (Sep. 2021), https://bit.ly/3RdM2YQ.

[16] Id.

[17] Census of Fatal Occupational Injuries (2011-forward), BLS (accessed May 4, 2023), https://bit.ly/3NzjvvV. Annual estimates were retrieved by selecting Area — “All U.S.,” Case type — “Fatalities in all sectors,” Category — “E5A Event or exposure — exposure to environmental heat,” and Industries — “000000 All Workers.”

[18] The BLS Census of Occupational Injury (CFOI) collects multiple source documents, because each work-related death must be confirmed by at least two sources. Of the source documents collected, death certificates are collected on all deaths and medical examiner/autopsy/coroner reports are commonly collected. Other sources may serve as confirmation, such as toxicology, OSHA or workers’ comp reports, and even the news media. Census of Fatal Occupational Injuries: Data Sources, BLS (accessed on June 12, 2022), https://bit.ly/3OcqN8U. The CFOI examines all cases where the death certificate is marked “At work” and, additionally, occupational illness reports from OSHA to determine if there was an injury component to the illness. Scope of the Census of Fatal Occupational Injuries (CFOI), BLS (accessed on June 13, 2022), https://www.bls.gov/iif/cfoiscope.htm.

[19] Technical Documentation: Heat Related Deaths, Environmental Protection Agency (accessed on June 8, 2022), https://bit.ly/3mvfRY5.

[20] See, Juley Fulcher, Boiling Point: OSHA Must Act Immediately to Protect Workers from Deadly Temperatures, Public Citizen (June 2022), https://www.citizen.org/article/boiling-point/ [hereinafter Fulcher, Boiling Point (June, 2022)].

[21] Nonfatal Cases Involving Days Away from Work: Selected Characteristics (2011 forward), BLS (accessed May 2, 2023), https://bit.ly/38YK8LP. Annual estimates were retrieved by selecting Area — “All U.S.,” Ownership — “All ownerships,” Data Type — “Injury and illness cases,” Case type — “Industry division or selected characteristic by detailed event or exposure,” Category — “00X All Industry,” and Event or Exposures — “531XXX Exposure to environmental heat.”

[22] Elizabeth Rogers, The Survey of Occupational Injuries and Illnesses Respondent Follow-Up Survey, Monthly Labor Review, Bureau of Labor Statistics (May 2020), https://bit.ly/2UukCqo.

[23] Heat, Related Standards, OSHA (accessed on May 19, 2023), https://bit.ly/3z5CB5x.

[24] R. Jisung Park, Nora Pankratz & A. Patrick Behrer, Temperature, Workplace Safety, and Labor Market Inequality, IZA Institute of Labor Economics DP No. 14560 3 (July 2021), https://bit.ly/2V3WriI [hereinafter R. Jisung Park et al., Temperature, Workplace Safety, and Labor Market Inequality, 2021].

[25] Fulcher, Boiling Point (June, 2022).

[26] Syeda Hira Fatima, Paul Rothmore, Lynne C. Giles, Blesson M. Varghese and Peng Bi, Extreme Heat and Occupational Injuries in Different Climate Zones: A Systematic Review and Meta-analysis of Epidemiological Evidence, 148 Environment International 106384 (March, 2021), https://bit.ly/3jGUEcL.

[27] June T. Spector, David K. Bonauto, Lianne Sheppard, Tania Busch-Isaksen, Miriam Calkins, Darrin Adams, Max Lieblich and Richard A. Fenske, A Case-crossover Study of Heat Exposure and Injury Risk in Outdoor Agricultural Workers, Plos One (Oct. 7, 2016), https://bit.ly/2ZQLxiz.

[28] See, Fulcher, Boiling Point (2022), https://bit.ly/3tfFlff.

[29] R. Jisung Park et al., Temperature, Workplace Safety, and Labor Market Inequality (2021), 5.

[30] On March 31, 2023, the California Occupational Safety and Health Standards Board has proposed adoption of a “Heat Illness Prevention in Indoor Places of Employment” provision to the California Code of Regulations, https://bit.ly/3OoXgMt.

[31] Cal. Code. Regs., tit. 8, § 3395 , Heat Illness Prevention in Outdoor Places of Employment (enacted in 2005), http://bit.ly/3p0xOy7..

[32] Or. Admin. R. §437-002-0156 and §437-004-1131, Heat Illness Prevention (enacted in 2022).

[33] OSHA’s $afety Pays, OSHA (accessed on Sep. 26, 2022), https://bit.ly/3xRlZQE.

[34] Id.

[35] The Wet Bulb Globe Temperature (WBGT) measures heat impact on the body by combining ambient temperature, relative humidity, air movement (wind speed) and solar radiant heat (e.g., heat-generated machinery, sunlight angle and cloud cover). It is a more accurate measure for calculating workplace heat stress than than the heat index. The heat index is a measure of apparent heat in the shade and as much as 15°F must be added to the heat index to get a measure of heat impact on the body in direct sunlight.

[36] Andreas D. Flouris, Petros C. Dinas, Leonidas G. Ioannou, Lars Nybo, George Havenith, Glen P. Kenny and Tord Kjellstrom, Workers’ Health and Productivity Under Occupational Heat Strain: Systematic Review and Meta-Analysis, 2(12) The Lancet Planetary Health E521-E531 (Dec. 1, 2018), https://bit.ly/3DRPl2z.

[37] Foster et al., Quantifying Impact of Heat on Work Capacity (2021).

[38] See, Juley Fulcher, The Cost of Inaction: The Failure of Employers to Mitigate the Effects of Heat Stress on Workers Causes Preventable Heat-related Illness, Injury and Fatalities and Costs the Economy Nearly $100 Billion Each Year, Public Citizen (Oct. 4, 2022), https://bit.ly/3WeMgTX. Research has shown that the optimal work environment for 100% productivity is between 59°F and 65%F.

[39] Id.

[40] The Foster et al. model is likely a conservative estimate as it fails to include the the impact of solar radiation for those working outside in the sun, a significant factor in causing heat stress. Another study found that worker productive loss in the shade was 80% lower than productivity loss of those working in the sun. Marco Morabito, Alessandro Messeri, Alfonso Crisci, Junzhe Bao, Rui Ma, Simone Orlandini, Cunrui Huang and Tord Kjellstrom, Heat-Related Productivity Loss: Benefits Derived by Working in the Shade or Work-Time Shifting, 70(3) International Journal of Productivity and Performance Management507-525 (2021), https://bit.ly/3UE7A3P.

[41] Luke A. Parsons, Yuta J. Masuda, Timm Kroeger, Drew Shindell, Nicholas H. Wolff and June T. Spector, Global Labor Loss Due to Humid Heat Exposure Underestimated for Outdoor Workers, 17(1) Environmental Research Letters 014050 (2022), https://bit.ly/3DXvrWn [hereinafter Parsons et al., Global Labor Loss Due to Heat Exposure (2022)]. Purchasing Power Parity dollars (PPP$) is a measure to compare prices of goods between countries. In this study, the 2017 cost of lost labor due to the limits in worker capacity resulting from measures of heat and humidity was estimated for each country in their local currency. Each estimate was divided by the country’s GDP 2017 PPP conversion rate to U.S. dollars as determined by the World Bank .The sum of each national estimate is the global estimate of lost labor due to the limits in worker capacity resulting from measures of heat and humidity.

[42] Parsons et al., Global Labor Loss Due to Heat Exposure (2022).

[43] Atlantic Council: Adrienne Arsht Rockefeller Foundation Resilience Center and Vivid Economics, Extreme Heat: The Economic and Social Consequences for the United States (August, 2021), https://bit.ly/3D8FGDA. Only a handful of Alaskan counties currently have no economic losses.

[44] Id.

[45] Id.

[46] Id.

[47] Id.

[48] Id.

[49] Juley Fulcher, OSHA Fails to Protect Workers From Extreme Heat Hazards: OSHRA Decisions Demonstrate the Need for an OSHA Heat Stress Standard, Public Citizen (2020),  https://bit.ly/3tztdGO.

[50] Secretary of Labor v. United States Postal Service, National Association of Letter Carriers (NALC) and National Rural Letter Carriers’ Association (NRLCA), OSHRC Docket Nos. 16-1713, https://bit.ly/3zY8EHX; 16-1813, https://bit.ly/39LQdf1;

16-1872, https://bit.ly/3NeBsyT; 17-0023, https://bit.ly/3bo2XJc; 17-0279, https://bit.ly/3xNO0Yf (July 15, 2020).

[51] Id.

[52] Secretary of Labor v. United States Postal Service, OSHRC Docket Nos. 16-1713, 16-1872, 17-0023, 17-0279 (Feb 17, 2023), https://bit.ly/432vbik.. On this point, the decision referenced Kastalon, Inc., 12 BNA OSHC 1928, 1928-29 (No. 79-5543, 1986) (consolidated) (“Congress intended that the Secretary would primarily rely on specific standards, rather than the broad mandate of the general duty clause, to seek the correction of workplace hazards.”) and Reich v. Arcadian Corp., 110 F.3d 1192, 1196 (5th Cir. 1997) (“Courts have held that enforcement through the application of standards is preferred because standards provide employers notice of what is required under the OSH Act.”). Id. at 5, note 7.

[53] Fulcher, Boiling Point (June, 2022).

[54] Id.

Public Citizen Supports Three Key Digital Competition Bills

Group letter to the Senate Judiciary Committee urges action to rein in Big Tech

Chair Klobuchar and Ranking Member Lee, Chair Durbin and Ranking Member Graham,

We are organizations, academics, and former enforcers writing to urge you to establish clear legal standards that promote competition and innovation by advancing key antitrust legislation, specifically the American Innovation and Choice Online Act (AICOA), the Open App Markets Act (OAMA), and Advertising Middlemen Endangering Rigorous Internet Competition Accountability (AMERICA) Act. These bills are critically important to break down durable monopoly power in critical digital markets and give consumers and businesses freedom and choice online. Each of these bills would open up competition by diminishing the power of Big Tech platforms and thereby opening more avenues for smaller entrepreneurs to flourish and expanding consumer choice. Together, the three complementary bills address the multi-faceted threat of platform consolidation across the digital economy. We ask you to move them forward expeditiously.

AICOA expands the scope of service and product options available to consumers online by prohibiting a variety of ways dominant platforms put a thumb on the scale in favor of their own products, and products that benefit them, instead of showing consumers the best options. It would give businesses that use the platforms the right to be treated fairly on these platforms, and enhance opportunities to compete against the biggest platforms to challenge their monopoly power.

OAMA brings that freedom to our phones by eliminating abusive limitations on app developers and opening the market for digital payments, enabling people to download the apps they want without fear of interference based on requests of foreign governments or the bottom line of the operating system company.

The AMERICA Act would open up the advertising technology stack on which our modern internet is built by preventing one company from controlling the purchase, sale and marketplace for ad placement. Digital newspapers, online publishers, advertisers and consumers need an online advertising ecosystem that is open for dynamic and fair competition. To do this, the AMERICA Act would break up the largest ad tech giants and create common-sense rules of the road.

Congress’ work of engaging with stakeholders, critics, and advocates to finalize legislative language takes time, and these problems are urgent. The need for antitrust legislation to unleash more competition and innovation to challenge the durable monopoly positions of dominant digital platforms has become even more clear in recent months with federal court rulings that establish inappropriate hurdles that stymy effective antitrust enforcement (e.g., the state and federal antitrust litigation against Facebook and private litigation against Apple). Americans cannot wait for the courts to catch up to the problems that enforcers, experts, the public, and many in Congress have already recognized, that the dominant tech platforms are unchecked by competition or regulation, leaving society worse off.

Public Knowledge

Demand Progress

Public Citizen

Consumer Federation of America

Tech Oversight Project

American Economic Liberties Project

Institute for Local Self-Reliance

Accountable Tech

Open Markets Institute

Economic Security Project Action

Fight for the Future

Tom Wheeler, Former Chair, Federal Communications Commission

Bill Baer, Former Assistant Attorney General, Antitrust Division

Fiona Scott Morton, Theodore Nierenberg Professor of Economics, Yale School of Management. Professor Scott Morton’s disclosures can be found on her web page.

Steven C. Salop, Professor of Economics and Law Emeritus at Georgetown University Law Center and Senior Consultant at Charles River Associates. Professor Salop has provided antitrust consulting to Epic Games, Harper Collins, the Department of Justice and others.

Gene Kimmelman, Former Deputy Associate Attorney General and Chief Counsel Competition Policy Antitrust Division

David Dinielli, Senior Policy Fellow, Tobin Center for Economic Policy at Yale University

Harry First, Charles L. Denison Professor of Law, New York University School of Law

The CFPB’s Commitment to Racial Equity

An Analysis of the CFPB’s Work to Eeach the Goals Outlined in Its 2022 Racial Equity Action Plan.

By Candace Milner, J.D.

Summary

An analysis of the CFPB’s work to reach the goals outlined in its 2022 Racial Equity Action Plan.

Introduction

At the beginning of his term, President Biden directed each federal agency to create and implement a racial equity action plan focused on championing racial equity throughout the work of the federal government. In early 2022, Public Citizen released a report highlighting the racial equity actions taken by federal consumer protection agencies. In that report we expressed our excitement about the administration’s focus on equity and urged agencies to maximize this opportunity to center racial equity in their work. The Consumer Financial Protection Bureau has done just that.

In their 2022 Equity Action Plan, the Bureau outlined its racial equity goals in four actions items. Despite facing unfounded legal and political attacks from the right, the Bureau has managed to make substantial process on each of these actions. Below is an overview of what it has done to reach those goals and analysis on the impact the Bureau is having on creating relief for consumers of color.

Equity Action Progress

Action 1: Incorporating Racial and Economic Equity (REE) principles into the Bureau’s strategic planning and divisional review process.

Shortly after releasing its Equity Action Plan, the Bureau released its DEIA strategic plan which outlined six goals and the actions planned to reach said goals. Importantly, most of the goals focused on creating an inclusive organizational culture within the CFPB. Work culture policies that center equity are critical for ensuring that equity is reflected in an organization’s external work. Publicizing internal DEIA programming sets a positive example of steps that can be taken to shift work cultures and encourage inclusion.

In addition to its internal work, the Bureau released a report of best practices across the financial industry. The report analyzed the visibility of diversity and inclusion at companies in the financial services sector by evaluating online resources from various industry players after the killing of George Floyd. The trends of resources available on companies’ sites varied according to size and industry sector. Overall, most companies had little or no D&I information on their sites. Based on their findings, the Bureau made a series of recommendations on how businesses can strengthen their D&I initiatives based on organizational size. These recommendations ranged from expanding value and leadership statements, to expanding workforce development efforts, to hiring designated diversity and inclusion leaders. The CFPB’s report and the recommendations it lists give financial actors a starting point to strengthen their equity commitments and reflect the leadership the Bureau has exhibited thus far.

Finally, the Bureau has launched a self-assessment process so businesses can proactively report their DEIA policies and activities. While an important concept, the self-assessment has not yet had a significant amount of participation. This may be due to organizations’ hesitation around how the data will be used. The Bureau may need to heighten engagement strategies to encourage more businesses to complete the self-assessment and adopt D&I policies from the recommendations the Bureau has outlined.

Action 2: Ensure bad actors do not harm consumers and small businesses by denying fair, accessible, and equitable banking options in their communities (especially the traditionally underserved).

Redlining is a discriminatory practice where people are systematically denied access to mortgages and housing financing options based on their race and geographic location. Historically, there were government drawn maps outlining where people lived by race. Financial institutions used these maps to determine where Black neighborhoods are and deem properties and land in those locations as risky investments. Redlining is discriminatory and illegal but unfortunately, it still happens today. The Bureau is doing its part by holding financial institutions that engage in redlining practices accountable.

In 2021, the Bureau joined the DOJ and OCC in the Trustmark National Bank Settlement to take action against Trademark for discriminating against Black and Brown families. In this settlement Trademark had to pay over $8 million in penalties and compensation for its infractions. More recently, the Bureau joined the DOJ in ordering Trident Mortgage to pay more than $22 million in damages and penalties for redlining discrimination^[5]. This is the first settlement involving redlining by a non-bank mortgage lender, which now represent the majority of mortgages in the U.S. This settlement is of particular importance as consumers of color can now be assured that banks and non-depository entities will be held equally accountable when they engage in discriminatory practices.

Last month, the CFPB finalized the rule implementing data collection for small business lending as required by section 1071 of the Dodd-Frank Act^[7]. This data will enable the Bureau, as well as community advocacy groups, to understand how banks are lending to small businesses and to be able to see trends among the industry. More specifically, this data will let us know which banks are lending to Black- and Brown- owned small businesses and identify gaps in access to loans and instances of discrimination.

Action 3: Ensure that Big Tech’s involvement in consumer financial markets does not impede fair competition

The comment period for the CFPB’s Inquiry into Big Tech Payment Platforms^[8] was reopened at the end of 2022. The Bureau is working to identify and build protections related to Big Tech’s effects on prices, services, and digital redlining. The CFPB has to make clear that the legal obligation of financial institutions does not change when they make use of technology. As companies expand and operate payment platforms that enable consumers to share payments with one another, grow their small businesses, and pay for goods over time there are questions about how data on consumer behavior is utilized or exploited. The CFPB is working to identify risks involved in the growing use of technology in the financial market and being proactive in protecting consumers from these risks. Additionally, the Bureau has made it a priority to ensure that consumers are able to discern competitive pricing and protect them from deceitful tech platforms that use comparison shopping models to profit off consumers^[9]. Finally, the Bureau has concerns about the innate bias of automated valuations^[10], algorithms, and cloud services, and is exploring its authorities to address these issues and protect impacted consumers in marginalized communities.

Action 4: Collaborate with other organizations, regulators, and stakeholders, to ensure there is fairness and equity in property valuations.

Thirteen federal agencies, including the CFPB, have collaborated to ensure fairness in property valuation and appraisals. This is a critical effort, as there have been an increase in instances where Black and Brown homeowners are being discriminated^[11] against by the home valuation industry. Agents are appraising homes of people of color grossly below their actual value^[12]. The interagency task force on property appraisal and valuation equity, or PAVE, released an Action Plan^[13] that explores the forms of racial and ethnic bias that impact residential property valuation and provides concrete actions to end these biases and advance equity. Over 20 action commitments are made in the plan. These actions are grouped into five categories that strengthen legal guardrails, tackle enforcement and accountability, bridge data gaps, diversify the workforce, and empower consumer action. These agencies sent their plan to President Biden and since have been working together to end discrimination in appraisal transactions.

The CFPB has played an active role in many of the goals outlined in the PAVE Action Plan. Action item 2.3 which is to “expand regulatory agency examination procedures of mortgage lenders to include identification of patterns of appraisal bias,” has been a priority for the Bureau. The Bureau is currently reviewing options to prevent discrimination and algorithmic bias in home valuations^[14]. Additionally, the CFPB has commented^[15] on universal standards for appraisers and ethics rules created by the Appraisal Foundation^[16]. Through the Financial Institutions Reform, Recovery, and Enforcement Act (FIRREA), Congress authorized the Appraisal Foundation to set the standards and qualifications for real estate and personal property appraisers. The CFPB along with other agencies urged the Appraisal Foundation against trying to create distinctions between types of discrimination in their Ethics Rules^[17]. Early drafts of these rules have alleged distinctions between “ethical” versus “unethical” discrimination and “supported” versus “unsupported” discrimination. These distinctions do not exist. Discrimination is wholly unethical and unsupported on its face. The CFPB has made it clear that discrimination based on race is illegal and has no place in the home appraisal process. They have also continuously advocated for appraisal standards to include federal prohibitions against discrimination. The Appraisal foundation asserts that their work “ensures that appraisals are independent, consistent, and objective^[18]” and the CFPB’s actions are ensuring that this is an accurate assertion.

The Federal Financial Institutions Examination Council (FFIEC) Appraisal Subcommittee (ASC)^[19] includes members from seven federal agencies and oversees the real estate appraisal regulatory framework. The ASC recently had a hearing on appraisal bias where witnesses from several sides of the residential appraisal transaction shared their experiences and perspectives with representatives of the agencies compromising the ASC board^[20]. The Bureau has also highlighted how mortgage borrowers can challenge inaccurate appraisals^[21] through reconsideration of value, a process in which a homeowner or buyer can ask their lender to reconsider valuation believed to be inaccurate based on information presented or omitted from the appraisal report.

Conclusion

Consumer protection is essential to ensuring Black and Brown communities can thrive. The Bureau’s acknowledgement of that fact, and the staff and Director’s ongoing dedication to centering racial equity in their strategies and priorities will ensure that the agency continues to address the systemic racism in our country. This work is both urgent and long-term, and the Bureau’s commitment to ongoing engagement towards racial equity should be viewed as an example for other agencies.

[1] CFPB Diversity, Equity, Inclusion, and Accessibility Strategic Plan. (2022, June 2). Consumer Financial Protection Bureau. https://www.consumerfinance.gov/data-research/research-reports/cfpb-diversity-equity-inclusion-and-accessibility-strategic-plan/

[2] CFPB Office of Minority and Women Inclusion. (2022, January 19). CFPB Report on Diversity and Inclusion within Financial Services. Consumer Financial Protection Bureau. https://www.consumerfinance.gov/data-research/research-reports/cfpb-report-on-diversity-and-inclusion-within-financial-services/

[3] Jackson, C. (2021, August 17). What Is Redlining? The New York Times. https://www.nytimes.com/2021/08/17/realestate/what-is-redlining.html

[4] CFPB, DOJ and OCC Take Action Against Trustmark National Bank for Deliberate Discrimination Against Black and Hispanic Families. (2021, October 22). Consumer Financial Protection Bureau. https://www.consumerfinance.gov/about-us/newsroom/cfpb-doj-and-occ-take-action-against-trustmark-national-bank-for-deliberate-discrimination-against-black-and-hispanic-families/?_gl=1*15b03ik*_ga*MTc1NjA1MTU2MC4xNjQ3MjcwMTMx*_ga_DBYJL30CHS*MTY4MDAyNTA1MS40MC4xLjE2ODAwMjY4MzUuMC4wLjA.

[5] CFPB, DOJ Order Trident Mortgage Company to Pay More Than $22 Million for Deliberate Discrimination Against Minority Families. (2022, July 27). Consumer Financial Protection Bureau. https://www.consumerfinance.gov/about-us/newsroom/cfpb-doj-order-trident-mortgage-company-to-pay-more-than-22-million-for-deliberate-discrimination-against-minority-families/?_gl=1*kkv8pu*_ga*MTc1NjA1MTU2MC4xNjQ3MjcwMTMx*_ga_DBYJL30CHS*MTY4MDAyNTA1MS40MC4xLjE2ODAwMjY5NDYuMC4wLjA.

[6] Summary of 2021 Data on Mortgage Lending. (2022, June 16). Consumer Financial Protection Bureau. https://www.consumerfinance.gov/data-research/hmda/summary-of-2021-data-on-mortgage-lending/

[7] CFPB Finalizes Rule to Create a New Data Set on Small Business Lending in America. (2023, March 30). Consumer Financial Protection Bureau. https://www.consumerfinance.gov/about-us/newsroom/cfpb-finalizes-rule-to-create-a-new-data-set-on-small-business-lending-in-america/

[8] Notice and Request for Comment Regarding the CFPB’s Inquiry Into Big Tech Payment Platforms. (2022, November 7). Federal Register. https://www.federalregister.gov/documents/2022/11/07/2022-24214/notice-and-request-for-comment-regarding-the-cfpbs-inquiry-into-big-tech-payment-platforms

[9] CFPB Issues Guidance to Protect Mortgage Borrowers from Pay-to-Play Digital Comparison-Shopping Platforms. (2023, February 7). Consumer Financial Protection Bureau. https://www.consumerfinance.gov/about-us/newsroom/cfpb-issues-guidance-to-protect-mortgage-borrowers-from-pay-to-play-digital-comparison-shopping-platforms/?_gl=1*770pak*_ga*MTc1NjA1MTU2MC4xNjQ3MjcwMTMx*_ga_DBYJL30CHS*MTY4MDAyNTA1MS40MC4xLjE2ODAwMjc0OTYuMC4wLjA.

[10] Consumer Financial Protection Bureau Outlines Options To Prevent Algorithmic Bias In Home Valuations. (2022b, February 23). Consumer Financial Protection Bureau. https://www.consumerfinance.gov/about-us/newsroom/cfpb-outlines-options-to-prevent-algorithmic-bias-in-home-valuations/

[11] Kamin, D. (2022, August 25). Home Appraised With a Black Owner: $472,000. With a White Owner: $750,000. The New York Times. https://www.nytimes.com/2022/08/18/realestate/housing-discrimination-maryland.html

[12] Rothwell, J., & Perry, A. M. (2023, March 23). How racial bias in appraisals affects the devaluation of homes in majority-Black neighborhoods. Brookings. https://www.brookings.edu/research/how-racial-bias-in-appraisals-affects-the-devaluation-of-homes-in-majority-black-neighborhoods/

[13] Advanced Solutions International, Inc. (n.d.). Home. https://www.appraisalfoundation.org/

[14] Consumer Financial Protection Bureau Outlines Options To Prevent Algorithmic Bias In Home Valuations. (2022, February 23). Consumer Financial Protection Bureau. https://www.consumerfinance.gov/about-us/newsroom/cfpb-outlines-options-to-prevent-algorithmic-bias-in-home-valuations/

[15] Appraisal standards must include federal prohibitions against discrimination. (2023, February 14). Consumer Financial Protection Bureau. https://www.consumerfinance.gov/about-us/blog/appraisal-standards-must-include-federal-prohibitions-against-discrimination/?_gl=1*1phxcrd*_ga*MTc1NjA1MTU2MC4xNjQ3MjcwMTMx*_ga_DBYJL30CHS*MTY4MDAyNTA1MS40MC4xLjE2ODAwMjgyNTIuMC4wLjA.

[16] Advanced Solutions International, Inc. (n.d.). Home. https://www.appraisalfoundation.org/

[17] https://files.consumerfinance.gov/f/documents/cfpb_fourth-exposure-draft-letter_2023-02-14.pdf

[18] Advanced Solutions International, Inc. (n.d.-a). About The Appraisal Foundation. https://www.appraisalfoundation.org/imis/TAF/About_Us/TAF/About_Us.aspx?hkey=52dedd0a-de2f-4e2d-9efb-51ec94884a91

[19] About the Appraisal Subcommittee (ASC). (n.d.). https://www.asc.gov/about

[20] Appraisal Subcommittee Hearing on Appraisal Bias. (2023, January 25). Consumer Financial Protection Bureau. https://www.consumerfinance.gov/about-us/events/archive-past-events/appraisal-subcommittee-hearing-on-appraisal-bias/?_gl=1*1ur8nmv*_ga*MTc1NjA1MTU2MC4xNjQ3MjcwMTMx*_ga_DBYJL30CHS*MTY4MDAyNTA1MS40MC4xLjE2ODAwMjgzODMuMC4wLjA.

[21] Mortgage Borrowers Can Challenge Inaccurate Appraisals Through the Reconsideration of Value Process. (2022, October 6). Consumer Financial Protection Bureau. https://www.consumerfinance.gov/about-us/blog/mortgage-borrowers-can-challenge-inaccurate-appraisals-through-the-reconsideration-of-value-process/?_gl=1*1ag1hvu*_ga*MTc1NjA1MTU2MC4xNjQ3MjcwMTMx*_ga_DBYJL30CHS*MTY4MDAyNTA1MS40MC4xLjE2ODAwMjc4OTkuMC4wLjA.

Testimony before the FDA’s Gastrointestinal Drugs Advisory Committee regarding the possible accelerated approval of obeticholic acid (NDA# 212833) to treat nonalcoholic steatohepatitis with fibrosis

View as PDF

In testimony before the Food and Drug Administration’s (FDA’s) Gastrointestinal Drugs Advisory Committee, Public Citizen urged the committee to reject accelerated approval for obeticholic acid (a synthetic bile acid) as a treatment for fatty liver disease because of inadequate efficacy on two surrogate endpoints and because of many safety concerns that included drug induced liver disease.

Protest Supplement to Magnolia LNG

By Tyson Slocum

Today Public Citizen moves to supplement our May 4 Protest. In a media interview that Public Citizen discovered after our May 4 protest, Glenfarne Group declares that securing financing and offtake agreements for its proposed Magnolia LNG project will not commence until the firm first completes financing for its planned Texas LNG facility. The media interview further suggests that it is highly unlikely that Magnolia LNG will begin construction by the requested extension of April 2026. In light of this information, the Department of Energy must deny the extension request.

Read the full filing here: Magnolia II

U.S. Government Should Reject Deepfakes in Foreign Affairs

The Honorable Lloyd Austin
Secretary
U.S. Department of Defense
1000 Defense Pentagon
Washington, D.C. 20301

The Honorable Antony Blinken
Secretary
U.S. Department of State
2201 C St NW
Washington, D.C. 20520

Dear Secretary Austin and Secretary Blinken,

Public Citizen, a public interest organization with more than 500,000 members and supporters nationwide, is writing to strongly urge the U.S. government to abandon any and all efforts to utilize artificial intelligence for foreign influence operations, and lead the world in efforts to regulate and prevent the abuse of AI for such purposes.

At the March 2023 virtual Summit for Democracy, President Biden noted, “We’re at an inflection point in history here, where the decisions we make today are going to affect the course of our world for the next several decades.” At the Summit, President Biden touted a recent Executive Order to prohibit U.S. government use of commercial spyware designed to target dissidents. And he underscored the importance of policies relating to artificial intelligence that align with democratic values. Earlier this month, the White House announced a series of actions designed to ensure that artificial intelligence is deployed in ways that protect people’s rights and safety.

Unfortunately, recent reporting from the Intercept has identified a procurement document from the U.S. Special Operations Command that appears completely out of step with President Biden’s commitment. 

The procurement document says the Pentagon is seeking a contractor to “provide a next generation of ‘deep fake’ or other similar technology to generate messages and influence operations via non-traditional channels in relevant peer/near peer environments.”

As the Intercept notes, the document “represents a nearly unprecedented instance of the American government — or any government — openly signaling its desire to use the highly controversial technology offensively.”

It is clear that deep fake technology poses the possibility of sowing enormous distrust and confusion on the battlefield and in society in general. The world desperately needs binding agreements and newly established norms that forbid governments and others from weaponizing deep fake technology. Deep fake technology is inherently antithetical to democratic functioning.

Of course, the appeal of unilateral use against an adversary is obvious and evidenced in the Special Operations Command document: Tricking an adversaries’ troops into following false orders could decisively swing a battle or war. The problem, which is equally obvious, is that there won’t be unilateral use. Perhaps the U.S. military can harden itself against deep fake trickery, though there’s no reason to be certain of that. However, widely available and increasingly powerful deep fake technology could easily be used by adversaries against American society, also with potentially severe consequences.

The only moral and practical course is for governments to forsake deep fake technology and work to forbid its deceptive use in all cases. 

We urge you to:

1. Publicly withdraw the Special Operations Command document and strip out the deep fake provisions before re-issuing it.
2. Abandon any and all U.S. government programs to develop a capacity to use deep fakes for any kind of foreign influence.
3. Publicly commit that the United States will not use deep fakes against adversaries or allies in military or civilian contexts.
4. Initiate an immediate effort to reach global agreement among governments not to use deep fake technology and, ideally, to ban altogether its use for deceptive purposes.

Artificial intelligence technology is developing rapidly and the U.S. government must move expeditiously to preemptively regulate and prevent the misuse of such technology for foreign operations purposes. As President Biden acknowledged, failure to do so could have devastating consequences.

Sincerely,

Robert Weissman
President, Public Citizen

Comments to USITC: TRIPS Flexibilities for COVID-19 Diagnostics & Therapeutics

May 05, 2023

Katherine M. Hiner
Acting Secretary to the Commission
U.S. International Trade Commission
500 E. Street, SW
Washington, D.C., 20436

RE: Written Comments for Investigation No. 332-596: COVID-19 Diagnostics and Therapeutics and Flexibilities Under the TRIPS Agreement

Dear Acting Secretary Hiner,

Public Citizen submits the following comments regarding the U.S. International Trade Commission’s Investigation No. 332-596: COVID-19 Diagnostics and Therapeutics and Flexibilities Under the TRIPS Agreement. This submission does not contain CBI. Public Citizen is a nonprofit consumer advocacy organization with 500,000 members and supporters. Public Citizen’s Access to Medicines Program works with partners across the United States and around the world to make medicines available for all through tools in policy and law.

Sincerely,

Peter Maybarduk
Public Citizen Access to Medicines Director

The intellectual property provisions of the TRIPS Agreement constrain generic competition and rapid, widespread production of therapeutics and diagnostics. This contributes to inequitable global access to COVID-19 medical tools. Extending the June 17, 2022 World Trade Organization Ministerial Decision on the TRIPS Agreement (the ‘TRIPS Decision’) to therapeutics and diagnostics would simplify efforts to ensure adequate, affordable supply of these medical tools in the years ahead.

There is massive unmet global health need for COVID-19 therapeutics and diagnostics. The world’s failure to quickly scale test-to-treat programming has cost many lives. Yet country orders for these medical tools, and other signals of market demand, were distressingly anemic in 2022. For example, the estimated health need for Paxlovid in low- and middle-income countries (LMICs) exceeded market demand by 8,219,833 courses; only 10% of health need was met by the expressed demand of LMICs in 2022. It is important to understand why.

Global demand for COVID therapeutics and diagnostics is constrained by supply challenges – high prices, opaque purchase agreements, and delayed and unpredictable supply. Many patented tools are unaffordable for LMICs, even with industry’s tiered and not-for-profit pricing. The secrecy of supply agreements also complicates country procurement decisions. It is challenging for budget constrained LMICs to compete with high-income countries to purchase products in initially limited and/or unreliable supply. An extension of the TRIPS Decision could help facilitate affordable and reliable generic supply.

In addition to supply challenges, LMICs are faced with other access barriers, making it critically important to ensure that countries are able to access affordable supply of diagnostics and therapeutics. Competing health priorities and strained resources limit the ability of governments to prioritize their country’s COVID-19 response. There are also knowledge gaps regarding the available health technologies and the value of testing and therapeutics.

Without diverse, affordable, and reliable supply, demand for diagnostics and therapeutics will continue to be far less than health need. Or, put differently, supply will be inappropriate: even where raw production numbers appear high, a late supply of expensive, single-source drugs, sold under concealed conditions, does too little for public health. Patent holders’ licensing arrangements can mitigate the problems of monopoly supply over time, but they have fallen far short of unleashing the world’s capabilities to manufacture and provide timely and affordable medicines. Voluntary licenses typically contain geographic restrictions, resulting in market fragmentation and gaps in access, particularly for upper middle-income countries.

TRIPS flexibilities including compulsory licensing are critical to fill these gaps and are much more easily applied to therapeutics and diagnostics than to vaccines. But TRIPS rules still needlessly complicate compulsory licensing, making it harder to clear paths to expansive, affordable, global supply. Simplifying TRIPS rules, including through the proposed extension, would help clear paths to generic entry and make it easier for health agencies to meet the extreme, ongoing health needs of the COVID-19 pandemic.

Intellectual Property Barriers Suppress Market Demand for COVID-19 Diagnostics and Therapeutics

COVID-19 diagnostics and therapeutics are critical to preventing hospitalizations and deaths and ending the pandemic. However, there are extreme disparities in access to these tools across the world. According to the purchase data collected by the Duke Global Health Innovation Center, 74.1% of COVID-19 therapeutics have been purchased directly by high-income countries.[1] However, this data includes 13 million therapeutics (Paxlovid 4 million UNICEF and 6 million Global Fund; molnupiravir 3 million) that are a part of options agreements, and fewer than 300,000 courses have actually been procured by LMICs.[2] So, the reality of the situation is much worse. Additionally, while low- and lower-middle income countries comprise 76.3% of the world population, only 36.9% administered worldwide have been used in these countries.[3] Despite the lack of robust access to diagnostics and therapeutics in non-HICs, the COVID death toll has been estimated to be four times higher in poorer nations than in rich countries.[4] Based on this data, there is clearly great need in LMICs for COVID-19 technologies.

As the USITC considers key demand factors and unmet demand for COVID-19 diagnostics and therapeutics, it is important that the Commission bases the report’s definition of demand on population need rather than market demand. Population-based need is determined by the number of infections that would require treatment to maximize the prevention of hospitalizations and deaths.[5] If therapeutic courses and tests were available, population-based need would indicate the maximum level at which they would benefit the population. As the future of the pandemic remains uncertain, it is essential that the health needs of populations are prioritized. However, the number of COVID-19 therapeutic courses and tests being delivered or requested by countries, particularly non-HICs, is significantly fewer than the health need.

Quantifying Market Demand vs. Population-Based Need: Paxlovid in 2022

Pfizer’s oral antiviral Paxlovid (nirmatrelvir-ritonavir) has been deemed by the WHO as the best therapeutic choice for high-risk patients with non-severe disease.[6] Despite the potential of Paxlovid to be a game-changer in the pandemic and prevent significant numbers of hospitalizations and deaths, there has been limited supply of the branded product in LMICs.[7] To illustrate this disparity, we quantified the number of need-based doses that exceeded demand for Paxlovid in LMICs in 2022. This analysis has been updated from our previous submissions, and we continue to encourage the Commission to update, expand, and refine these estimations.

Demand Estimation
The Duke Global Health Innovation Center’s Launch and Scale Speedometer (the ‘Duke Dashboard’) tracks purchases of COVID-19 therapeutics and maintains a dashboard that details data on these purchases.[8] This dashboard is updated regularly and aims to provide a comprehensive record of purchases of COVID-19 therapeutics. However, this data is limited to purchase agreements that are publicly available, and may exclude relevant purchase agreements or information. For example, the Duke Dashboard includes the European Commission’s joint procurement contract, announced in late November 2022, for almost 3.5 million Paxlovid courses that participating countries, mostly high-income, will be eligible to purchase.[9] But details on this agreement are scant. While the majority of the courses are likely to be procured throughout 2023, there may be a small number of courses that were procured by European developing countries during December 2022. The Commission could bridge these gaps in the data by inquiring directly with Pfizer and the European Commission about details of the procurement agreements that have been made with LMICs.

As of February 2023, the Duke Dashboard reported that 48,186,517 courses of Paxlovid have been purchased worldwide, with over 70% of the courses having been purchased directly by high-income countries. Lower middle-income countries (Egypt and Ukraine) purchased a total of 320,000 courses and upper middle-income countries (Mexico and Thailand) purchased a total of 350,000 courses.

Two ACT-A partners have entered into an agreement with Pfizer for 10 million courses for LMICs (6 million Global Fund; 4 million UNICEF), which are included in the Duke Dashboard.[10] To our best knowledge, these agreements function as options agreements rather than fully paid-up advanced purchase agreements. The courses available to ACT-A partners are offered to eligible countries and countries then confirm the number of courses that they want to receive, at a price that is based upon the country’s income status. With this model, we considered the market demand to be the number of courses that were confirmed by countries, rather than the total amount optioned by ACT-A partners. Using the WHO Therapeutics Dashboard in February 2023, we determined that 2,132,304 courses of Paxlovid have been offered to LMICs by ACT-A, but only 135,120 courses were confirmed.[11] Therefore, although ACT-A partners entered into an agreement with Pfizer for 10 million courses, we considered the true market demand to be 135,120 courses.

Through the Knowledge Ecology International Paxlovid Procurement Announcement Tracker,[12] we identified one purchase agreement from an upper middle-income country, Malaysia, that has not yet been incorporated into the Duke Dashboard, but is relevant to our analysis.[13],[14]

In addition to bilateral and multilateral Paxlovid purchase agreements, it has been reported that Pfizer donated 100,000 Paxlovid courses to the COVID Treatment Quick Start Consortium, an initiative that aims to scale-up access COVID-19 antivirals in 10 partner countries.[15] Zambia was the first country to have received a shipment, getting 1,000 courses near the end of 2022.[16]

Based on the available data, market demand in non-HICs, or the number of treatments that were being ordered or requested, could be defined as the number of courses that were confirmed by ACT-A countries (identified through the WHO Therapeutics Dashboard) combined with non-HIC originator supply deals (identified through the Dukedashboard and the Knowledge Ecology International Paxlovid Procurement Announcement Tracker) and donated courses (COVID Treatment Quick Start Consortium).

It is important to note that we did not exclude purchase agreements that were completed prior to 2022. Additionally, it could be argued that purchases made in late 2022 were reflective of projected health need in 2023. As a result, this estimation of demand could overrepresent the true market demand, when compared to health need, in 2022. Regardless, as Pfizer began negotiating purchase agreements in late 2021 and this analysis was completed in early 2023, we believe that it was a fair estimation of market demand for 2022. We encourage the Commission to explore and refine how “market demand for Paxlovid in 2022” should or should not be limited.

To date, LMICs have ordered or requested 916,120 courses of Paxlovid (Table 1).

Table 1: Market demand for Paxlovid in non-HICs[17] (courses)

Mexico	300,000
Ukraine[18]	300,000
Courses confirmed from ACT-A	135,120
Malaysia	110,000
Thailand	50,000
Egypt	20,000
Zambia	1,000
Total	916,120 courses

Source: Duke Global Health Innovation Center Launch and Scale Speedometer; WHO Therapeutics Dashboard; COVID Treatment Quick Start Consortium; KEI Paxlovid Procurement Announcement Tracker

Need Estimation
To determine the population-based need for Paxlovid in 2022, we consider the total number of infections in LMICs that would have benefitted from the use of Paxlovid had it been available. Paxlovid is indicated for patients with non-severe COVID-19 at the highest risk of hospitalization. While reliably identifying those at the highest risk is challenging, the WHO has determined that patients with older age, immunosuppression, and/or chronic diseases are the typical characteristics of high-risk patients.[19] The lack of COVID-19 vaccination is an additional risk factor that is particularly significant in the non-HIC setting due to the low vaccination rates. Airfinity, a health analytics company, estimated the population need for Paxlovid using the total infections in populations over 65 years old as the measure for high-risk infections.[20] Age is a faulty proxy for high-risk population groups and could result in significant underestimations, particularly in low- and middle-income countries where shorter life expectancies result in a smaller percentage of the population over the age of 65, when compared to high-income countries. This estimate does not capture key population groups that would benefit from Paxlovid, including WHO categories, such as those with chronic diseases under the age of 65. Additionally, due to data constraints, the estimation only spans from the beginning of 2022 through late November 2022. Both of these factors make this figure a significant underestimate of population need.

Airfinity found that from the beginning of 2022 through November 2022, the population need in non-HICs surpassed nine million doses of Paxlovid. When compared to the previous calculation of market demand, we estimate that only one tenth of population need for Paxlovid could have been met by the expressed demand, and population need exceeded market demand by over eight million courses of Paxlovid (Table 2). This is more than eight million individuals that could have benefitted from a course of Paxlovid, potentially avoiding hospitalization or loss of life.

Table 2: Difference between market demand and population-based need for Paxlovid in LMICs (2022)

Market Demand	Population-Based Need	Need-based courses in excess of demand
916,120 courses	9,135,953 courses	(8,219,833) courses

Source: Airfinity; Launch and Scale Speedometer; WHO Therapeutics Dashboard

If the Commission were to replicate this analysis for Paxlovid, other therapeutics, or diagnostics, we encourage an independent calculation of the population need that is based on the total number of infections in LMICs that would have benefitted from the use of the technology had it been available. If an independent calculation is not feasible, more complete, and up to date Airfinity data could be used. Also, additional information from Airfinity on their data and calculations could provide a better estimate.

The ACT-A Council Working Group on Diagnostics and Therapeutics also released a report that projected the need for all antivirals in 2023. They estimated an unconstrained need in LMICs for 223 million antiviral treatments in 2023, compared to demand for 31 million treatment courses.[21] This would result in 192 million COVID-19 infections in LMICs that would benefit from antivirals, but will ultimately not have access. Unconstrained need is defined by the Working Group as the “total number of cases in LMICs in the next 12 months, regardless of a country’s testing capacity, interest in the product, or capacity to roll it out.” It is also acknowledged by the Working Group that actual demand will continue to be much lower than estimated. The methods used by this Working Group could potentially serve as a resource for the Commission in projecting need versus demand.

Given the significant disparity between market demand and population-based need, the Commission has a responsibility to fully consider population need, rather than market demand, when exploring key demand factors, unmet demand, and the market segmentation of global demand. There are a number of factors contributing to the discrepancy between population-based need and market demand that should be explored by the Commission. We will discuss some of these factors below.

Demand is Constrained by High Prices, Opaque Purchase Agreements, and Delayed and Unpredictable Supply

High Prices and Opaque Purchase Agreements
The lack of a robust generics market for diagnostics and therapeutics, in part due to patents, has resulted in prices that are unaffordable for many governments. When diagnostics and therapeutics are unaffordable, demand will be suppressed. For instance, a South African senior health official cited the “extremely expensive” price of Paxlovid as a reason that the South African government was not intending to buy the treatment for public sector patients.[22] The Medical Director at Socios en Salud (Partners in Health – Perú) also commented that the organization does not plan to use Paxlovid in the COVID-19 treatment regime if it is too expensive.[23] Additionally, according to a People’s Vaccine Alliance report, tensions arose between procurers and manufacturers of antigen RDTs during the early stages of the pandemic because constrained budgets and challenges forecasting procurement resulted in the initially agreed upon volumes exceeding funding amounts.[24]

In 2019, per capita health spending averaged US$36 in low-income countries, US$125 in lower middle-income countries, US$516 in upper middle-income countries, and US$3,243 in high-income countries.[25] For low- and middle-income countries, the prices for diagnostics and therapeutics purchased from the manufacturer would exceed or consume a significant portion of their per capita health spending. Panama, whose classification has shifted from high-income to middle-income and back to high-income in recent years, obtained Paxlovid for US$250, the lowest reported price in a bilateral deal with Pfizer.[26],[27] While this price is significantly reduced from the prices paid by some high-income countries, it is nearly 50 percent of the average per capita health spending in upper middle-income countries and 200 percent of the average per capita health spending in lower middle-income countries.

In addition to exorbitant pricing, the lack of transparency in supply agreements prohibits countries from having a sense of the full pricing landscape and complicates the decision-making environment for purchasers. Pfizer has offered Paxlovid to some lower-income countries at a not-for-profit price, which has been speculated to be as high as US$100.[28] Pfizer also has described a tiered pricing scheme whereby prices are negotiated based on a country’s income level. But specifics on these prices have not been disclosed.

Without this disclosure, prices paid for COVID-19 diagnostics and therapeutics are largely unknown and are reported for only a subset of purchase agreements made. The reported prices are unaffordable for most countries. For low- and middle-income countries that are particularly price sensitive, understanding the full pricing landscape would be a key decision-making factor. These countries are left waiting for a more affordable price or for generics to become available, lowering the number of orders placed (i.e., market demand) below the level of public health need. For example, test-to-treat programs launched by ACT-A partners in early 2021 cited the “complex and evolving landscape of treatments and costs” as a barrier that hindered the introduction of oral antivirals in LMICs. These pilot programs demonstrated that full price transparency and affordable treatments are instrumental factors in generating demand and uptake of therapeutics.[29]

Additionally, the price to the consumer can suppress demand even when country-level procurement costs are non-prohibitive. Recent economic challenges, such as rising inflation, have made it even more difficult for individuals to afford getting tested for COVID-19. In addition to the cost of the test itself, related costs, such as paying for transportation to the hospital or laboratory, are unaffordable for many people in LMICs and have lowered the demand for diagnostics at the community level.[30] As of early 2022 in Zimbabwe, when free tests ran out at the poorly supplied walk-in testing centers, individuals were left to purchase rapid tests in pharmacies for up to US$15 – an unaffordable price for a majority of the population in the country.[31] It is essential that countries are able to procure COVID-19 technologies at a price that allows for public health needs to be met, without exorbitant prices being passed along to individuals.

As rising inflation and increasing levels of public debt in 2022 have put pressure on countries’ health spending capacities,[32] diverse and affordable supply is key to bring prices down and generate robust global demand for COVID-19 health technologies.

Delayed and Unpredictable Supply
Low- and middle-income countries have continually fallen to the bottom of the supply chain for COVID-19 technologies. The vaccine apartheid has been widely documented throughout the pandemic, with high-income countries quickly purchasing and stockpiling enough supply to vaccinate their populations multiple times over while low- and middle-income countries received only a fraction of the doses needed.[33] Developed countries had the financial capacity to secure advance purchase agreements for vaccines even when the product was still in the research phase.[34] As a result, by August 2021, enough vaccine doses were committed to vaccine the entire global population; however, 39% of these purchase commitments were for countries that comprise just 12.9% of the world’s population.[35] These same challenges have been seen in diagnostic and therapeutic supply to LMICs.

For example, soon after clinical studies showed promising results for Paxlovid at the end of 2021, high-income countries began entering into advance purchase agreements with Pfizer for millions of courses. Before any low- and middle-income countries were able to secure supply agreements, nearly 30 million courses – the amount that Pfizer could produce in the first half of 2022 – had already been purchased by HICs.[36] By early September of 2022, it was reported that many LMICs still had no access to the drug.[37] Indeed, Pfizer was still negotiating secretly with ACT-A partners on the terms and conditions of procurement, not finalizing such negotiation until late Q3 2022. Similarly, HICs were able to outbuy LMICs in diagnostics, resulting in restricted supply of diagnostic tools such as PCR machines, test reagents, and consumables before manufacturers could scale up production.[38]

Supply of COVID-19 diagnostics and therapeutics to LMICs has been largely unreliable throughout the pandemic. This unreliable supply has exacerbated the effects of the pandemic in LMICs while also hindering the demand for these technologies. When advance purchase agreements consume the supply for six months and more, as with Paxlovid, LMICs were left to purchase therapeutics that would be unavailable for months, even if Pfizer had finalized its procurement route for LMICs earlier than the fall of 2022. With the unpredictability of COVID-19 case surges and entry of variants, it is challenging for countries with constrained spending capacities to enter into a supply agreement for products with unreliable supply.

Additionally, the effectiveness of current COVID-19 therapeutics is reliant on well-developed test-to-treat strategies, including diagnostic capacity and the immediate availability of therapeutics.[39] An unreliable supply of diagnostics and therapeutics prevents countries from scaling-up the implementation of test-to-treat strategies. The World Health Organization’s Access to COVID-19 Tools (ACT) Accelerator initiative has organized Global COVID-19 response and test-to-treat programs, with the support of the U.S. government, many international agencies, and private foundations and funders. This initiative aimed to ensure rapid access to COVID-19 tests, followed by timely treatment, for anyone in the world. But because of the COVID-19 response funding shortfall, the reality of this initiative is a pilot program in 10-20 countries, with hopes to expand.[40] Robust test-to-treat programs are critical in generating demand for COVID-19 diagnostics and therapeutics. Without these programs in place, countries will not have the program capacity to rapidly deploy tests and treatments, so demand will appear lower than public health need, even when supply of products become available. It remains a challenge to fight the pandemic and provide diagnostics and therapeutics, becoming even more important to find affordable solutions from a variety of potential providers.

Other Access Challenges in LMICs Constrain Demand, Making it Critically Important to Facilitate Access to Affordable Generics

In addition to supply challenges – high prices, opacity and delayed and unpredictable availability – that constrain demand, LMICs are faced with other access challenges that make affordable supply vital to achieve global access to diagnostics and therapeutics. For example, competing health priorities and strained resources in LMICs limit the ability of governments to prioritize their country’s COVID-19 response, and there are knowledge gaps across developing countries regarding the available health technologies and the value of testing and therapeutics. However, these challenges are not unique to developing countries; vaccine hesitancy in high-income countries has been a major barrier to COVID-19 vaccine uptake, and many high-income countries underspend on healthcare.[41],[42] These barriers are important to address, and contribute to the market demand for COVID technologies falling short of need in LMICs, but without affordable and available supply, access will not be achieved.

Strained Health System Capacity
Strained health system resources and capacity in LMICs limits the demand for COVID-19 diagnostic and therapeutic tools. For instance, competing health priorities in ACT-A countries, such as new disease outbreaks of cholera and mpox, limited community interest in ACT-A’s efforts to promote trust in COVID-19 tools.[43] Additionally, humanitarian crises such as conflicts and natural disasters impacting regions including Eastern and Southern Africa, the Middle East, and North Africa have exacerbated the challenge for many countries to implement a robust COVID-19 response.[44] During procurement of the vaccine, it was reported that gaps in cold chain and service delivery and insufficient workforce capacity in low- and lower-middle income countries contributed to the discrepancy between the number of available vaccine doses and the amount that ended up in low-income countries.[45] For diagnostics and therapeutics, strained health system capacity limits the prioritization LMICs can place on procuring and distributing COVID-19 tools.

Additionally, many LMICs were unprepared to quantify and forecast national needs for diagnostics.[46] It is challenging for countries to make the decision to disburse significant funds for diagnostic tools when there is not a system in place to forecast the amount that is needed. Similarly, when diagnostics are unavailable or underutilized, infections will go unreported. For example, in October of 2021, the WHO reported that only one in seven COVID-19 infections are detected in Africa.[47] Without an accurate estimate of infection-level in a population, the demand for therapeutics will be lower than the true population-based need.

A People’s Vaccine Alliance report also highlighted that the demand for COVID-19 diagnostics in low- and middle-income settings is impacted by individuals’ demand factors, such as the challenges associated with receiving a positive test.[48] LMICs often do not have the resources or capacity to operate social safety net programs that will address these challenges, such as issues with forgoing wages for many days to isolate due to a positive test. This suppressed demand at the community level will make it challenging for countries to request products at the level needed to meet true public health need.

Knowledge Gaps
Market demand also cannot reach the levels of population health need when there are gaps in knowledge that hinder the use of diagnostics and therapeutics. Matahari Global Solutions, a global health consultancy firm, conducted interviews in 14 countries and reported instances in countries such as Haiti, Madagascar, and Nigeria where health care workers did not have any knowledge of the existence of Paxlovid.[49]

When health care workers and communities are aware of the existence of diagnostics and therapeutics, the demand for these products can still be artificially suppressed by gaps in knowledge of the importance of these tools in combatting the pandemic. According to a 2022 situation report by UNICEF, the level of awareness of the value of diagnostics constrained the provision of diagnostics globally.[50] In September 2022, the ACT-A Working Group on Diagnostics and Therapeutics reported that government officials, health workers, and communities in many LMICs are unaware of the importance of test-to-treat strategies and COVID-19 therapeutics.[51] Without knowledge of the value of these tools, they will be underutilized and there will be limited community buy-in for initiatives such as test-to-treat.

Intensifying these access barriers that have constrained demand, the World Health Organization has been unable to operate at speed to publish clinical guidance on the use of outpatient antivirals and to prequalify both originator and generic medicines. By the time the WHO published antiviral guidance and the emergency use of Paxlovid and molnupiravir, high-income countries were already several months into their deployment of test-to-treat strategies. WHO was similarly slow in publishing guidance on self-testing, a backbone of test-to-treat programming, and has still not finalized guidance on test-to-treat program implementation.

Industry-Led Initiatives Have Fallen Short of Overcoming IP Barriers to Global Access

Intellectual property protections have contributed to challenges in developing timely, robust generics markets for diagnostics and therapeutics. Without diverse, affordable, and reliable supply, demand for diagnostics and therapeutics will continue to be suppressed globally. An extension of the TRIPS Decision to diagnostics and therapeutics would promote the entry of generic manufacturers to the market for COVID-19 health technologies, inducing demand and increasing access to supply at more affordable prices.

While the relationship between IPRs within trade agreements and access to medicines is complicated and difficult to demonstrate empirically due to the short time periods and small markets, the issue of TRIPS and access to medicines is really one of generic competition. It has been widely demonstrated that increasing generic competition puts downward pressure on price and effectively increases access. If countries could purchase reliable supply of COVID-19 therapeutics and diagnostics at an affordable price, global demand for these technologies would rise. The IP protections within the TRIPS Agreement have the chief function of blocking competition, hindering generic manufacturing of the COVID-19 technologies that are essential to controlling and ending the pandemic. The current tools deployed to overcome IP barriers to generic competition are inadequate in increasing global access and generating market demand that meets population health need.

Voluntary Licensing

Licensing is one mechanism to increase access to generic COVID-19 therapeutics and diagnostics within LMICs. While voluntary licensing measures are successful in accelerating affordable and reliable supply of generic products to certain markets, the agreements typically exclude many upper middle-income countries. Timely access to generics is critical and could be achieved in more markets with an extension of the TRIPS Decision.

The Medicines Patent Pool (MPP) aims to solve the challenges faced by LMICs in accessing COVID-19 diagnostics and therapeutics by negotiating deals that are acceptable to both patent holders and generics firms. MPP works to negotiate deals that will facilitate generic access in as many countries as possible. However, patent holders limit the number of countries that they will agree to license for a particular product, typically excluding many upper middle-income countries. Patent holders have signed agreements through the Medicines Patent Pool (MPP) for 15 COVID-19 technologies, including licenses for three oral antiviral treatments and four diagnostics.[52]

MPP and Pfizer signed a licensing agreement in November 2021 for nirmatrelvir, and the MPP then signed agreements with 35 companies to manufacture nirmatrelvir in March 2022.[53] One of these companies, Hetero in India, received WHO prequalification for their generic Paxlovid in late December 2022.[54] Through the MPP license, the Clinton Health Access Initiative (CHAI) has announced that generic Paxlovid will be available to LMICs for US$25 per course.[55] Considering the prices that have been reportedly paid for the brand-name drug, this agreement between CHAI and generic manufacturers is significant and will play a large role in ensuring affordable access to Paxlovid for LMICs. However, countries not included in the MPP licensing agreement will not be able to benefit from the generic pricing and may face challenges accessing generic Paxlovid until 2041.[56]

Pfizer’s MPP agreement for Paxlovid excludes most of Latin America, a region that was devastated by the pandemic. Despite comprising only 8.4% of the world’s population, by end-August 2021 Latin America and the Caribbean countries accounted for 20.1% of COVID-19 infections and 32% of deaths.[57] In November 2022, dozens of leading Latin American health groups wrote Pfizer, asking for Pfizer to expand the territory of its MPP license to include Latin America to help meet health need.[58] Pfizer has still not responded to this request.

When China lifted its ‘zero-COVID’ policy, the country instantly struggled with life threatening treatment shortages. China’s government is responsible for the mistakes of this period and their disastrous consequences. Nonetheless and for purposes of this inquiry, it also is the case that there was not sufficient Paxlovid supply in China. People smuggled Paxlovid in suitcases across the border and purchased from the black market.[59] Pfizer had an advance opportunity to mitigate this harm, by including China in the territory of its license with the Medicines Patent Pool more than a year earlier, in November 2021. Pfizer declined. Pfizer waited nine more months before signing a bilateral deal with Chinese manufacturer Zhejiang Huahai (which also is an MPP sublicensee, authorized to sell nirmatrelvir outside China under the terms of the MPP license).[60] Had those nine months not been lost, and had Pfizer worked quickly to support rapid generic production and distribution, perhaps generic nirmatrelvir could have been available when zero-COVID was lifted, and more lives saved.

The restricted geographical reach of the voluntary licenses also limits economies of scale and the markets available for generics, resulting in a less attractive opportunity for generic manufacturers. For example, in the Paxlovid agreement between CHAI and generic manufacturers, the price of US$25 will only apply if volume requirements are met – any single order must be for a quantity of at least 50,000-treatment courses and the aggregate of all orders must meet or exceed one million treatment courses.[61] If larger markets were available to generic manufacturers, increasing the global demand for the drug, the market opportunity may be sufficiently enticing and these stipulations would not be necessary for generic manufacturers to enter the market. An extension of the TRIPS Decision would play an important role in expanding the available markets for generic products, increasing both the supply of and demand for generic diagnostics and therapeutics. The delayed access of diagnostics and therapeutics will continue to cost lives and put additional strain on health systems.

Tiered Pricing

Tiered pricing is another voluntary mechanism that theoretically provides access to affordable technologies for countries that are left out of voluntary licensing agreements. The Pfizer CEO commended their tiered pricing system as a “critical step that will boost equitable access for high-risk patients in low- and-middle income countries.”[62]  Yet tiered prices are set by and acceptable to the manufacturer, and do not necessarily ensure that therapeutics and diagnostics are affordable for the purchaser.[63] In a study of price reduction strategies for antiretroviral drugs, researchers found that for 15 of 18 ARVs, differential pricing schemes were 23-498% more expensive than generic products.[64] Panama reportedly paid US$250, Thailand US$300, China US$282-340, and Brazil US$250 (asked) for Paxlovid under the tiered pricing scheme. These differential prices are ten times higher than the generic price negotiated by CHAI ($25). The not-for-profit price, which has been speculated to be as high as US$100, is still four times higher than CHAI’s generic price.

Pfizer entered into supply agreements based on tiered pricing with the Global Fund and UNICEF, both partners of ACT-A, for 6 million and 4 million treatment courses of Paxlovid, respectively.[65] However, these agreements were largely options agreements, not advance purchase agreements, with the courses available to low-income countries at the (still high) not-for-profit price and courses available to middle-income countries at a (quite high) tiered price. While there potentially was some funding available to cover procurement costs for the very lowest income countries, it is not at all our understanding that every LMIC country would have been able to receive the treatments at no cost. According to the WHO Therapeutics Dashboard, as of February 2023, 2,132,304 courses of Paxlovid had been offered to LMICs by ACT-A, but only 135,120 courses were confirmed.[66]  The discrepancies between the courses optioned, the courses offered, and the courses procured are significant and suggest that the alleged surplus of supply does not exist for patients in LMICs. It can be inferred that the prices offered through these options agreements were still too high to induce substantial demand that meets population need, particularly when there is imminent generic supply at a fraction of Pfizer’s tiered pricing.

The current voluntary measures in place provide some routes for some low- and lower middle-income countries to access COVID-19 products at a more accessible price, either through industry’s tiered not-for-profit pricing that is still quite high or through the voluntary licensing enabled generic supply. However, most upper middle-income countries will continue to be left without access to tools that will meet population needs during the pandemic. These countries are largely excluded from voluntary licensing agreements and are left with unaffordable prices through tiered pricing schemes, resulting in a fragmented market limiting scale and opportunities for generic diagnostic and therapeutic suppliers. As many upper middle-income countries have been devastated by the pandemic and exhibit extreme income disparities, the lack of access to affordable COVID-19 diagnostics and therapeutics is consequential. When voluntary mechanisms fail to achieve global access, there is a need for compulsory solutions that will enable countries to address the health needs of their populations.

When Industry-Led Initiatives Fail, TRIPS Flexibilities Can Help Achieve Global Access

Compulsory licensing is a flexibility under the TRIPS Agreement that can expand generic markets and provide access to COVID-19 therapeutics and diagnostics where pharmaceutical companies have chosen to not license voluntarily. Licensing in this understanding is simply a proxy for generic market competition, which we know to be the most effective means of reducing price and ensuring prices continue to fall over time. A number of countries have successfully issued compulsory licenses to promote public health objectives and improve access to medicines.

Compulsory licenses are part and parcel of the international intellectual property rules established through the TRIPS Agreement. They are intrinsic and fundamental to any patent system. Without compulsory licensing, government use of patents and other flexibilities, intellectual property would not be sustainable as a legal system. Intellectual property in that case would amount to monopoly control of new inventions, across technological fields, without exception or possibility of government intervention to protect the public or interests of the state. These conditions would be unacceptable for any government. The U.S. Secretary of Health and Human Services under President George W. Bush, Tommy Thompson, invoked the government’s right to authorize generic competition with Bayer’s patented Cipro during the anthrax scare, resulting in the negotiation of nearly a 50% price reduction.[67] The availability of government’s compulsory authorities, and a realistic prospect that they may be used, is part of what helps induce better deals with pharmaceutical companies.[68]

Challenges Faced by Developing Countries Issuing Compulsory Licenses

Allowing developing countries to use compulsory licensing more effectively is part of how countries that are not already tended to in negotiated agreements can be supported in meeting the health needs of their population.However, developing countries are discouraged from using this mechanism by pharmaceutical companies and some high-income countries. The extension of the TRIPS Decision to diagnostics and therapeutics would provide an easier route to export, overcoming the restrictions of Art. 31(f) and the challenges of Art. 31bis, and would provide assurance to developing countries that all World Trade Organization (WTO) members support the use of compulsory licensing to meet access needs within the COVID-19 pandemic.

An MSF Access Campaign briefing describes the challenges that developing countries have faced when using compulsory licensing prior to the pandemic, including lawsuits from pharmaceutical companies, threatened trade sanctions through the USTR Special 301 Reports, and warnings from the European Commission. [69] Compulsory licensing actions relating to Latin American countries, compiled by Knowledge Ecology International, further demonstrate pressure and threats from HICs and pharmaceutical companies to discourage the use of compulsory licensing by LMICs.[70] We can attest to these pressures and more from our own experiences providing technical assistance. (We would be happy to provide the commission with further details). We will briefly describe two publicly documented examples of pressure faced by upper middle-income countries Colombia and Ecuador (both excluded from Pfizer’s MPP license for nirmatrelvir).

Glivec (imatinib), a treatment for chronic myeloid leukemia, was sold in the Colombian market alongside 13 generic alternatives until Novartis, the manufacturer, was issued a patent and requested its competitors to leave the market. As the price for the branded product was much higher than the generic alternatives that were forced out of the market, the Colombian Ministry of Health attempted to negotiate a voluntary license but was unsuccessful.[71] Subsequently, an application for a compulsory license was initiated and Novartis declined to negotiate a lower price for the drug.[72]In response to the compulsory license process being initiated, the Colombian government received pressure at both the national and international levels. For example, the Secretariat for Economic Affairs of Switzerland wrote to the Colombian Ministry of Health to express concern over the compulsory license application, equating a compulsory license to “an expropriation of the patent owner.”[73] This letter also highlighted Switzerland’s economic relations with Colombia, investment in the country, creation of Colombian jobs, and humanitarian aid and peace contributions. Then, reportedly, and infamously, a representative of influential U.S. Sen. Orrin Hatch threatened that U.S. financial support for the Colombian peace process would be withdrawn if the compulsory license was issued.[74],[75]

Ecuador faced pressure after President Rafael Correa issued Decree 118 to improve access to medicines and support public health programs through a protocol that established procedures for the compulsory licensing of pharmaceutical products. The protocol limited public interest licensing to medical conditions that are priorities for public health, and required both the payment of royalties to patent holders and interagency cooperation to grant licenses. Nonetheless, cables from the U.S. Embassy in Ecuador to the U.S. Department of State show that the Embassy and multinational pharmaceutical companies worked to undercut this emerging health policy.[76] The Embassy endeavored to organize wealthy countries with strong pharmaceutical industries to oppose Decree 118.[77] Ecuador was able to initiate its licensing protocol, however haltingly.[78] Several years later, after overcoming opposition, Ecuador paired patent licensing with price negotiation to save health agencies fully 0.4% of GDP through medicine price reductions.

Critics of compulsory licensing, in an attempt to undermine their use, conflate licensing decisions and the regulatory approval process. But intellectual property decisions are properly kept separate from regulatory decisions, which require distinct competencies and assess whether a particular medicine – and every medicine, patented or generic – is safe for consumers. A former opposition minister in Ecuador, referred to in Embassy cables as a “well-placed contact” of multinational pharmaceutical companies, raised a criticism that generics sold under a compulsory license might not contain active ingredients. (If this were true, those medicines would not be properly considered generics. They would not meet standards for regulatory approval and their proprietors would be subject to criminal penalties.) An opposition minister also reportedly investigated the business dealings of local medicine suppliers to gain leverage for the patent-based global pharmaceutical companies.[79]

Issuing Compulsory Licenses for COVID-19 Diagnostics and Therapeutics
For developing countries that are excluded from voluntary agreements for COVID technologies and have subsequently been unable to procure enough COVID-19 therapeutics and diagnostics to meet public health need, compulsory licensing could facilitate greater access to affordable and reliable generics. However, the historical pressure and opposition from pharmaceutical companies and high-income countries, combined with economies of scale issues and procedural complexities, make compulsory licensing a challenging flexibility to implement. According to the Global Humanitarian Progress Corporation (GHP Corp), five compulsory license actions are in progress in LAC for Paxlovid – Chile, the Dominican Republic, Colombia, Perú, and Costa Rica.[80] Pfizer has filed a patent application for nirmatrelvir in all five of these countries.[81] GHP Corp, alongside other civil society organizations, submitted a request to the Colombian Government for government use of Paxlovid on March 14, 2022, but did not receive a response.[82] After the presidential election in 2022, the civil society organizations filed another application for government use to the new Colombian government. Similarly, on Dec. 3, 2021, Knowledge Ecology International submitted a request to the government of the Dominican Republic for an open compulsory license relating to Paxlovid.[83] Pfizer responded with opposition, putting pressure on the government of the Dominican Republic to reject the request.[84]

Developing countries have faced significant barriers and challenges in using compulsory licensing as a policy tool to protect public health. The extension of the TRIPS Decision could ease some of these barriers and would send a political message that all WTO members support developing countries’ use of compulsory licensing to protect the health of their populations. This would encourage more developing countries to meet the health needs of their population through access to generic COVID-19 diagnostics and therapeutics. Expanding markets available to generic manufacturers through the extension of the TRIPS Decision would also induce greater supply of affordable generics, generating market demand that could better address population heath need in LMICs.

Manufacturing Capacity in LMICs

If the June 2022 TRIPS Decision is extended to diagnostics and therapeutics, there are able and interested generic manufacturers in developing countries that could ramp up generic production of these technologies. For COVID therapeutics, indicators of manufacturing capacity, interest, and investment in LMICs include the sublicensing agreements with the Medicines Patent Pool. MPP sublicensees for development of generic Paxlovid include 38 manufacturers from 13 countries – Bangladesh, Brazil, Puerto Rico, Dominican Republic, Pakistan, India, China, Ukraine, Vietnam, and Serbia, Israel, Jordan, and Republic of Korea.[85] These manufacturers have met MPP’s requirements, are confident in their ability to make the licensed therapeutics, and many are already making investments to that end. Generic production of COVID-19 therapeutics is well underway. Hetero, a pharmaceutical company based in India, already has a World Health Organization-prequalified generic for Paxlovid.[86]

In Latin America and the Caribbean (LAC), there is a well-established generic pharmaceutical industry that has demonstrated the capacity to both produce and export generic drugs. While innovative drugs are imported into the region primarily from transnational companies outside of LAC, local firms produce most of the region’s generic drugs.[87] Argentina, Brazil, and Mexico largely self-supply generic medicines, and are the top three intraregional exporters of pharmaceutical products. Pharmaceutical products produced in Colombia, Costa Rica, Guatemala, El Salvador, Chile, Uruguay, and the Dominican Republic also comprised a significant share of the intraregional pharmaceutical exports in 2019.[88] Among the LAC countries with less pharmaceutical production capacity, many depend on other countries in the region to satisfy their demand for generic drugs and significant percentage of their imported pharmaceutical products are from other LAC countries (Belize 47%, Ecuador 42%, El Salvador 38%, Guatemala 60%, Honduras 46%, Nicaragua 52%, Paraguay 56%, and Bolivia 49%).[89] Additionally, an analysis of LAC regional capacity for vaccine manufacturing identified biologics manufacturers with the capacity to manufacture monoclonal antibodies in Argentina, Brazil, and Mexico.[90]

Conclusion

It is important that the TRIPS Decision is extended to diagnostics and therapeutics, contributing to an environment that makes it straightforward for countries to address the health needs of their population.

The COVID-19 products that are currently on the market represent a small subset of the future tools that will be developed to combat the pandemic. According to the BIO COVID-19 Therapeutic Development Tracker, 76 therapeutics are in late-stage clinical development.[91] Absent further reforms, each time a patented product comes to market, LMICs are likely be left with initially limited and opaque supply at prices much higher than they could be in a robust generics market.

Suppressed demand is a symptom of intellectual property barriers, among other challenges. Continued overreliance on voluntary action by patent holders will hinder global access to COVID-19 diagnostics and therapeutics.

Low-, middle- and high-income countries alike underfund health systems. But that is not the point of this investigation. Because upper middle-income countries are excluded from many of the pharmaceutical companies’ concessionary measures, it becomes critically important to ease their path to accessing affordable generics and support widespread test-to-treat programming, including through extending the TRIPS Decision to diagnostics and therapeutics.

We appreciate the opportunity to comment. Thank you.

[1] Duke Global Health Innovation Center. (2021). Launch and Scale Speedometer. Duke University. Retrieved from: https://launchandscalefaster.org/covid-19

[2] World Health Organization Therapeutics Dashboard, available at https://partnersplatform.who.int/en/therapeutics-dashboard [accessed February 27, 2023]

[3] FIND COVID-19 Test Tracker, available at https://www.finddx.org/tools-and-resources/dxconnect/test-directories/covid-19-test-tracker/ [Accessed February 21, 2023]

[4] Oxfam. Pandemic of Greed: A Wake-Up Call for Vaccine Equity at a Grim Milestone. 3 March 2022, available at https://oi-files-d8-prod.s3.eu-west-2.amazonaws.com/s3fs-public/2022-03/Pandemic%20of%20greed-Oxfam%20media%20briefing-March2022.pdf

[5] Airfinity. ‘WTO TRIPS COVID-19 Tx’

[6] WHO. Therapeutics and COVID-19: Living Guideline, 13 January 2023, available at https://www.who.int/publications/i/item/WHO-2019-nCoV-therapeutics-2023.1

[7] Just a Quarter of Pfizer’s COVID-19 Treatment Orders Will Go to Developing Countries, available at https://www.oxfam.org/en/press-releases/just-quarter-pfizers-covid-19-treatment-orders-will-go-developing-countries

[8] Duke Global Health Innovation Center Launch and Scale Speedometer, available at https://launchandscalefaster.org/covid-19/therapeutics [accessed February 17, 2023]

[9] European Health Union: Commission secures almost 3.5 million COVID-19 treatments through joint procurement contract, available at https://ec.europa.eu/commission/presscorner/detail/en/IP_22_6491

[10] 6 million courses for the Global Fund and 4 million courses for UNICEF

[11] World Health Organization Therapeutics Dashboard, available at https://partnersplatform.who.int/en/therapeutics-dashboard [accessed February 27, 2023]

[12] Knowledge Ecology International. Paxlovid Procurement Announcements, available at https://docs.google.com/spreadsheets/d/1fE1sB6VwrrqGTXReJb29IH_b-B6yeOhFRzsg0_D1GrQ/edit#gid=0

[13] The Duke Global Health Innovation Center has indicated that the Malaysia Paxlovid purchase agreement will be included in the dashboard with the next data update.

[14] The Star. ’Covid-19 Watch: 110,000 high-risk patients to get first batch of oral antiviral Paxlovid, says Khairy,’ available at https://www.thestar.com.my/news/nation/2022/03/05/covid-19-watch-110000-high-risk-patients-to-get-first-batch-of-oral-antiviral-paxlovid-says-khairy

[15] Reuters. Pfizer donates Paxlovid to group targeting COVID in poorer countries, available at https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-donates-paxlovid-group-targeting-covid-poorer-countries-2022-09-07/

[16] COVID Treatment Quick Start Consortium. Loas, Malawi, Rwanda and Zambia Have Received Oral Antiviral Treatments for High-Risk Patients Through COVID Treatment Quick Start Consortium, available at https://www.covidcollaborative.us/assets/uploads/img/16-March-2023-Press-Release-Laos-Malawi-Rwanda-and-Zambia-Have-Received-Oral-Antiviral-Treatments-for-High-Risk-Patients-Through-COVID-Treatment-Quick-Start-Consortium.pdf

[17] The data in Table 1 is limited to the purchase agreements identified through the described methods. This may not include other purchase agreements between Pfizer and LMICs that are not publicly available.

[18] Ukraine reportedly entered into a supply agreement with Pfizer for 300,000 courses in December of 2021. Pfizer has since reported that they donated 200,000 courses to Ukraine as part of their humanitarian response. It is unclear whether these donated courses are in addition to the 300,000 courses that Ukraine procured in December 2021 or in lieu of the purchased courses. If the 200,000 courses were added to Ukraine’s market demand for Paxlovid (resulting in a new total of 500,000 courses for Ukraine), the total market demand of LMICs in this scenario would be 1,116,120 courses, or 12.2 percent of health need.

[19] Therapeutics and COVID-19: Living Guideline, 13 January 2023, available at https://www.who.int/publications/i/item/WHO-2019-nCoV-therapeutics-2023.1 [accessed February 27, 2023]

[20] Airfinity. ‘WTO TRIPS COVID-19 Tx’

[21] ACT Accelerator. Report of the Access to COVID-19 Tools Accelerator Facilitation Council Working Group on Therapeutics and Diagnostics, available at https://www.who.int/publications/m/item/act-accelerator-facilitation-council-working-group-report-on-diagnostics-and-therapeutics

[22] S. Africa not planning to buy Pfizer’s COVID pill for public sector, available at https://finance.yahoo.com/news/africa-not-planning-buy-pfizers-073311851.html

[23] Matahari Global Solutions. Mapping COVID-19 Access Gaps: Results from 14 Countries and Territories, available at https://app.box.com/s/ewdjytgt0tk0fdgmqnlm4l30hmdyevxw

[24] People’s Vaccine Alliance, ‘Study on the Availability and Affordability of Diagnostics for COVID-19 and MPOX in Low and Middle-Income Countries’ (2022), available at https://peoplesvaccine.org/wp-content/uploads/2023/02/Study-on-the-Availability-and-Affordability-of-Diagnostics.pdf

[25] World Health Organization. Global Health Expenditure Database, available at https://apps.who.int/nha/database/Select/Indicators/en

[26] Consejo de Gabinete aprueba la compra del antiviral Paxlovid de Pfizer, available at https://www.laestrella.com.pa/nacional/220125/consejo-gabinete-aprueba-compra-antiviral-paxlovid-pfizer

[27] Prices for Brazil ($250 asked), China ($282-340), and Thailand ($300) have also been reported.

[28] Pfizer to Supply Global Fund Up to 6 Million PAXLOVID™ Treatment Courses for Low-and-Middle-Income Countries, available at https://www.pfizer.com/news/press-release/press-release-detail/pfizer-supply-global-fund-6-million-paxlovidtm-treatment; Pfizer Expands ‘An Accord for a Healthier World’ Product Offering to Include Full Portfolio for Greater Benefit to 1.2 Billion People in 45 Lower-Income Countries, available at https://www.pfizer.com/news/press-release/press-release-detail/pfizer-expands-accord-healthier-world-product-offering

[29] Report of the Access to COVID-19 Tools Accelerator Facilitation Council Working Group on Therapeutics and Diagnostics, available at https://www.who.int/publications/m/item/act-accelerator-facilitation-council-working-group-report-on-diagnostics-and-therapeutics

[30] UNICEF. Access to COVID-19 Tools Accelerator, Humanitarian Situation Report No. 4, End of Year Report 2022

[31] In Africa At-home COVID Tests are Scare and Expensive, Help May Not Come Until Next Year, available at https://www.pbs.org/newshour/world/in-africa-at-home-covid-tests-are-scarce-and-expensive-help-may-not-come-until-next-year

[32] The World Bank. From Double Shock to Double Recovery – Implications and Options for Health Financing in the Time of COVID-19, available at https://openknowledge.worldbank.org/bitstream/handle/10986/35298/September%202022.pdf?sequence=12&isAllowed=y

[33] Prasad S et al. Vaccine apartheid: the separation of the world’s poorest and most vulnerable and the birth of Omicron. Ther Adv Vaccines Immunother. 2022 Jul 5, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9272166/

[34] Economic Commission for Latin America and the Caribbean (ECLAC), Plan for self-sufficiency in health matters in Latin America and the Caribbean: lines of action and proposals (LC/TS.2021/115), Santiago, 2021.

[35] Ibid.

[36] The Looming COVID-19 Treatment Equity Gap, available at https://www.devex.com/news/the-looming-covid-19-treatment-equity-gap-102816

[37] Why Paxlovid is still not available in many LMICs, available at https://www.devex.com/news/why-paxlovid-is-still-not-available-in-many-lmics-103904

[38] Boro E, Stoll B. Barriers to COVID-19 Health Products in Low-and Middle-Income Countries During the COVID-19 Pandemic: A Rapid Systematic Review and Evidence Synthesis. Front Public Health. 2022 Jul 22, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9354133/

[39] COVID Gap. Pills to People: Accelerating Equitable Global Access to Oral Therapeutics for COVID-19, available at https://www.covidcollaborative.us/assets/uploads/pdf/Covid-Gap-Oral-therapeutics-v8.pdf

[40] E.g., The QuickStart Consortium, with partner countries including Ghana, Kenya, Laos, Malawi, Nigeria, Rwanda, South Africa, Uganda, Zambia, and Zimbabwe; https://dukeghic.org/our-work/quick-start/

[41] Aw, Junjie et al. “COVID-19 Vaccine Hesitancy-A Scoping Review of Literature in High-Income Countries.” Vaccines vol. 9,8 900. 13 Aug. 2021

[42] Chen, Simiao et al. “Macro-level efficiency of health expenditure: Estimates for 15 major economies.” Social science & medicine (1982) vol. 287 (2021): 114270.

[43] UNICEF. Access to COVID-19 Tools Accelerator, Humanitarian Situation Report No. 4, End of Year Report 2022

[44] UNICEF. Access to COVID-19 Tools Accelerator, Humanitarian Situation Report No. 4, End of Year Report 2022

[45] Usher AD. The global COVID-19 treatment divide. Lancet. 2022 Feb 26

[46] People’s Vaccine Alliance, ‘Study on the Availability and Affordability of Diagnostics for COVID-19 and MPOX in Low and Middle-Income Countries’ (2022), available at https://peoplesvaccine.org/wp-content/uploads/2023/02/Study-on-the-Availability-and-Affordability-of-Diagnostics.pdf

[47] WHO. Six in Seven COVID-19 Infections Go Undetected in Africa, available at https://www.afro.who.int/news/six-seven-covid-19-infections-go-undetected-africa

[48] People’s Vaccine Alliance, ‘Study on the Availability and Affordability of Diagnostics for COVID-19 and MPOX in Low and Middle-Income Countries’ (2022), available at https://peoplesvaccine.org/wp-content/uploads/2023/02/Study-on-the-Availability-and-Affordability-of-Diagnostics.pdf

[49] Matahari Global Solutions. Mapping COVID-19 Access Gaps: Results from 14 Countries and Territories, available at https://app.box.com/s/ewdjytgt0tk0fdgmqnlm4l30hmdyevxw

[50] UNICEF, Access to COVID-19 Tools Accelerator, Humanitarian Situation Report No. 4, End of Year Report 2022

[51] Report of the Access to COVID-19 Tools Accelerator Facilitation Council Working Group on Therapeutics and Diagnostics, available at https://www.who.int/publications/m/item/act-accelerator-facilitation-council-working-group-report-on-diagnostics-and-therapeutics

[52] MPP Products Licensed, available at https://medicinespatentpool.org/progress-achievements/licences

[53] 35 generic manufacturers sign agreements with MPP to produce low-cost, generic versions of Pfizer’s oral COVID-19 treatment nirmatrelvir in combination with ritonavir for supply in 95 low- and middle-income countries, available at https://medicinespatentpool.org/news-publications-post/35-generic-manufacturers-sign-agreements-with-mpp-to-produce-low-cost-generic-versions-of-pfizers-oral-covid-19-treatment-nirmatrelvir-in-combination-with-ritonavir-for-supply-in-95-low-and

[54] India-based Hetero’s Paxlovid generic gets WHO backing, available at https://www.reuters.com/business/healthcare-pharmaceuticals/india-based-heteros-paxlovid-generic-gets-who-backing-2022-12-27/

[55] Press Release: CHAI Announces Agreements with Leading Generic Manufacturers to Make Affordable COVID-19 Treatment Available in Low- and Middle-Income Countries, available at https://www.clintonhealthaccess.org/news/chai-announces-agreements-with-leading-generic-manufacturers-to-make-affordable-covid-19-treatment-available-in-low-and-middle-income-countries/

[56] Latin America: How Patents and Licensing Hinder Access to COVID-19 Treatments, available at https://msfaccess.org/latin-america-how-patents-and-licensing-hinder-access-covid-19-treatments

[57] Economic Commission for Latin America and the Caribbean (ECLAC), Plan for self-sufficiency in health matters in Latin America and the Caribbean: lines of action and proposals (LC/TS.2021/115), Santiago, 2021.

[58] AIS Peru. Peticion a Pfizer para acceder a tratamiento para el covid 19, available at https://aisperu.org.pe/peticion-a-pfizer/

[59] TIME. As COVID-19 Barrels Through China, Some Are Turning to Black Market Amid Drug Shortages, available at https://time.com/6247596/covid-china-contraband-treatments/

[60] Reuters. Pfizer CEO rules out generic COVID drug Paxlovid for China, available at https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-not-talks-licensing-generic-covid-pill-china-2023-01-10/

[61] FAQ: What you need to know about CHAI’s generic Paxlovid deal, available at https://www.clintonhealthaccess.org/news/frequently-asked-questions-for-nir-r-agreement-announcement/

[62] Pfizer to Supply Global Fund Up to 6 Million PAXLOVID Treatment Courses for Low-and-Middle-Income Countries, available at https://www.pfizer.com/news/press-release/press-release-detail/pfizer-supply-global-fund-6-million-paxlovidtm-treatment

[63] Moon S, Jambert E, Childs M, von Schoen-Angerer T. A win-win solution?: A critical analysis of tiered pricing to improve access to medicines in developing countries. Global Health. 2011 Oct 12, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3214768/

[64] Waning, Brenda, et al. “Global strategies to reduce the price of antiretroviral medicines: evidence from transactional databases.” Bulletin of the World Health Organization 87.7 (2009)

[65] Pfizer to Supply Global Fund Up to 6 Million PAXLOVID Treatment Courses for Low-and-Middle-Income Countries, available at https://www.pfizer.com/news/press-release/press-release-detail/pfizer-supply-global-fund-6-million-paxlovidtm-treatment

[66] World Health Organization Therapeutics Dashboard, available at https://partnersplatform.who.int/en/therapeutics-dashboard [accessed February 27, 2023]

[67] The New York Times. A NATION CHALLENGED: CIPRO; U.S. Says Bayer Will Cut Cost of Its Anthrax Drug, available at https://www.nytimes.com/2001/10/24/business/a-nation-challenged-cipro-us-says-bayer-will-cut-cost-of-its-anthrax-drug.html

[68] See KEI Briefing Note 2022:1, ’Selected U.S. Government COVID Contracts with Authorization and Consent to Non-Voluntary Use Of Third Party Patents,’ available at https://www.keionline.org/wp-content/uploads/KEI-bn-2022-1.pdf

 

[69] Medecins Sans Frontieres. Compulsory Licenses, the TRIPS Waiver and Access to COVID-19 Medical Technologies, available at https://msfaccess.org/sites/default/files/2021-05/COVID_TechBrief_MSF_AC_IP_CompulsoryLicensesTRIPSWaiver_ENG_21May2021_0.pdf

[70] KEI. ‘Latin America, Compulsory Licensing,’ available at https://www.keionline.org/cl/latin-america-compulsory-licensing

[71] This information was provided by Luz Marina Umbasia Bernal, an intellectual property and access to medicines expert in Colombia, Legal Advisor at GHP Corp in Colombia and Legal Fellow at Public Citizen’s Access to Medicines Program.

[72] Novartis perdería exclusividad para fabricar Imatinib, medicamento para tratar el cáncer, available at https://www.elespectador.com/salud/novartis-perderia-exclusividad-para-fabricar-imatinib-medicamento-para-tratar-el-cancer-article-629267/

[73] See Appendix A

[74] KEI. ’Senator Hatch, before pressuring Colombia over cancer drug compulsory license, wanted one for Napster,‘ available at https://www.keionline.org/23081

[75] See Appendix B

[76] Public Citizen. ’Wikileaks docs cite our work and shed light on Big Pharma & U.S. government team-up in other countries,’ May 2011, available at https://www.citizen.org/news/wikileaks-compulsory-licensing-hiv-aids-big-pharma-ecuador-peter-maybarduk/

[77] Info Justice. ’LEAKED CABLES SHOW U.S. TRIED, FAILED TO ORGANIZE AGAINST ECUADOR COMPULSORY LICENSING,‘ May 2011, available at https://infojustice.org/archives/3393

[78] Ministerio de Salud Pública. ’Ecuador concedió nueve licencias obligatorias para medicamentos estratégicos,’ available at https://www.salud.gob.ec/ecuador-concedio-nueve-licencias-obligatorias-para-medicamentos-estrategicos/

[79] Public Citizen. ’Wikileaks docs cite our work and shed light on Big Pharma & U.S. government team-up in other countries,’ May 2011, available at https://www.citizen.org/news/wikileaks-compulsory-licensing-hiv-aids-big-pharma-ecuador-peter-maybarduk/

[80] Global Humanitarian Progress Corporation, Acceso a tratamientos COVID 19 en LAC, available at https://www.ghpcorporation.co/accesoatratamientoscovid-19

[81] Latin America: How Patents and Licensing Hinder Access to COVID-19 Treatments, available at https://msfaccess.org/latin-america-how-patents-and-licensing-hinder-access-covid-19-treatments

[82] Global Humanitarian Progress Corporation, Acciones en Colombia, available at https://www.ghpcorporation.co/blank

[83] KEI Requests an Open Compulsory License Relating to Paxlovid in the Dominican Republic, available at https://www.keionline.org/37066

[84] https://keionline.org/misc-docs/1/Translation-Pfizer-opposition-KEI-CL-Paxlovid-18march2022.pdf

[85] Unitaid and the World Health Organization. Improving access to novel COVID-19 treatments: A briefing to Member States on how to navigate interfaces between public health and intellectual property, available at https://cdn.who.int/media/docs/default-source/essential-medicines/intellectual-property/j0198_unitaid_briefingcountries_en7178c1800570451fa6f18deccdefb99c.pdf?sfvrsn=6a905980_10&download=true

[86] Reuters. India-based Hetero’s Paxlovid generic gets WHO backing, available at https://www.reuters.com/business/healthcare-pharmaceuticals/india-based-heteros-paxlovid-generic-gets-who-backing-2022-12-27/

[87] Economic Commission for Latin America and the Caribbean (ECLAC), Plan for self-sufficiency in health matters in Latin America and the Caribbean: lines of action and proposals (LC/TS.2021/115), Santiago, 2021.

[88] Does not include Panama because it is not possible to separately identify re-exports from the Colón Free Zone. Economic Commission for Latin America and the Caribbean (ECLAC), Plan for self-sufficiency in health matters in Latin America and the Caribbean: lines of action and proposals (LC/TS.2021/115), Santiago, 2021.

[89] Ibid.

[90] Vargas, Veronica. Analysis of Regional Capacity for Research, Development, and Manufacturing of Vaccines in Latin America and the Caribbean. 2020.

[91] BIO COVID-19 Therapeutic Development Tracker, available at https://www.bio.org/policy/human-health/vaccines-biodefense/coronavirus/pipeline-tracker

2023 PC Letter on IAIS on Climate Risk Supervisory Guidance

Download the letter here.

International Association of Insurance Supervisors
Climate Risk Steering Group
Bank for International Settlements
CH-4002 Basel
Switzerland

May 15, 2023

Re: IAIS Public Consultation on Climate Risk Supervisory Guidance

To the Climate Risk Steering Group, 

Public Citizen, a public interest advocacy group with more than 500,000 members and supporters, welcomes the opportunity to respond to the first IAIS public consultation on climate risk supervisory guidance. We appreciate IAIS’s leadership in establishing global best practices for insurance supervisors and believe these are highly relevant to U.S. supervisors. As climate risks present an increasingly intense and urgent threat to insurance markets, we hope that IAIS will see this as the first step in a broader, ongoing effort to develop best practices on climate-related risk. 

While the insurance industry often touts its expertise in understanding weather and climate-related risks, this understanding has not translated into sufficient action. Insurers continue to invest in and underwrite fossil fuel expansion and delay efforts to address climate-related risks. At the same time, insurers are shifting more costs to consumers and withdrawing from communities vulnerable to physical climate risks. In doing so, these insurers are effectively eroding their own markets in the pursuit of short-term profits. 

Insurers have made little effort to hide their emphasis on short-term thinking. Property insurers rely on one-year contracts that allow them to both quickly end contracts with fossil fuel companies and cut off homeowners vulnerable to extreme weather. This strategy underestimates not only the transition risks from fossil fuels but also the devastating impact of withdrawals on insurance markets, local and regional economies, and ultimately the financial system as a whole. Supervisors should require insurers to develop long-term risk management strategies that protect policyholders, individual insurers, insurance markets, and the financial system. 

As insurance supervisors consider how to respond to climate-related risks, they should recall two lessons from the 2008 financial crisis. The first is that even supposedly sophisticated risk managers can contribute to massive systemic threats when their pursuit of short-term profits blinds them to complex, correlated risks. The second is that supervisors who focus too narrowly on individual aspects of a company or an economy will be unequipped to recognize and act on interconnected risks. 

We urge IAIS to apply these lessons as it reviews and expands materials on climate-related risks. IAIS has stated that a good supervisory response to climate risks will protect policyholders, contribute to financial stability, and promote fair, safe, stable insurance markets. To address insurers’ blind spots, IAIS should use this consultation process to strengthen its existing materials on financial stability in line with a precautionary approach. To address the interconnected nature of climate risks, IAIS should also expand its current scope to provide best practices on protecting policyholders and promoting fair insurance markets. 

IAIS should recommend supervisors adopt a precautionary approach to climate-related risks.

Insurers’ traditional approaches to risk management, including modeling, hedging, and reinsurance, are insufficient to manage the unique aspects of climate risk. As New York’s climate risk guidance for insurers states, climate risks are “non-linear, correlated, and irreversible,” and climate impacts have consistently emerged sooner than scientists have expected. The failure of Merced Property & Casualty Company after the Camp Fire in California in 2018 shows that even well-capitalized companies may be unprepared for physical climate-related risks. And along the Gulf Coast, major insurers have rapidly withdrawn, leaving behind smaller and weaker insurers. A series of insolvencies among these insurers and a resulting access crisis shows that intervention may be too little, too late if supervisors wait to act on correlated, irreversible risks until they have perfect visibility. 

To address risks that are difficult to quantify, a precautionary approach requires establishing large margins of error, eliminating risks that cannot be modeled, rejecting the assumption that risks can be hedged adequately, and evaluating every part of the business for risk. We appreciate that the guidance already includes some aspects of a precautionary approach, such as recommending a whole-of-business approach, cautioning insurers about over-relying on historical data, and recommending that insurers analyze risks over long time horizons. However, IAIS should acknowledge the inherent limitations of risk management via modeling and quantification and encourage supervisors to focus on actions they can take now to increase their margin of safety. 

IAIS can start by integrating a precautionary approach into existing materials on scenario analysis. Several factors can enhance the effectiveness of scenario analysis, including the use of short and long-term time horizons, qualitative and quantitative data, realistic assumptions, and an expansive range of stressors. However, even with these best practices, scenario analysis remains a limited tool that likely understates risks.

Moreover, the unique nature of climate-related risks make them ill-suited for management through quantification and modeling. IAIS should direct supervisors to focus on actions they can take now to reduce risk, including risk-based capital requirements. Increasing capital can be an important strategy for individual insurers who are particularly exposed to carbon-intensive assets. Given the pervasive misalignment with science-based targets, however, IAIS should also provide best practices on increasing system-wide levels of capital to maintain financial stability. 

IAIS should recommend supervisors use transition plans as a tool to monitor the stability of individual insurers and insurance markets. 

The most effective way to reduce climate-related risks in line with a precautionary approach is to direct insurers to engage in a managed draw-down of fossil fuel finance and underwriting. While voluntary insurer net-zero commitments have proliferated, the weak standards of voluntary initiatives like the Net-Zero Insurance Alliance, as well as the recent departure of several key NZIA members shows that voluntary associations will be ineffective in generating credible commitments and will not be able to hold insurers accountable. Supervisors must take action to ensure that insurers create credible transition plans and adhere to them. 

IAIS should provide best practices for transition plans that facilitate supervisors using them as a forward-looking tool to assess the stability of individual insurers and insurance markets. Because insurers are using net-zero announcements to influence consumers and investors, IAIS should also provide best practices on evaluating the risk of greenwashing as a market conduct issue. 

To be credible, transition plans must include short, medium, and long-term goals for meeting science-based targets and provide transparent metrics for evaluating those goals. Credible plans must include absolute reduction goals, a commitment not to finance new fossil fuel projects, and significant limits on carbon offsets and negative emissions technology.

Most importantly, a credible plan for an insurer must rely on reducing financed and insured carbon emissions. Insurers’ direct emissions represent just a small fraction of overall emissions. Allowing insurers to announce net-zero commitments exclusively for their operations, omitting the vast majority of their emissions, guarantees that supervisors and consumers miss the forest for just a handful of trees. Additionally, while insurers may rely on a client engagement strategy for reducing emissions, a credible client engagement strategy requires the ability to say no. If insurers plan to reduce financed or insured emissions through client engagement, supervisors must require insurers to produce and follow realistic plans to deal with clients who do not make progress on emissions reductions.

Supervisors must also continually monitor insurers’ adherence to their stated commitments. IAIS should highlight that if the supervisor believes insurers have made genuine commitments, a lack of progress should trigger concerns about whether management is capable of understanding and addressing the climate-related risks and its own commitments, as well as capable of operationalizing its plans effectively. IAIS should also highlight that if commitments appear insincere, insurance supervisors must protect consumers from “greenwashing” claims that obscure insurers’ actual approach to climate change. 

Recognizing that these risks are interconnected, IAIS should provide best practices on maintaining access to affordable insurance, with a focus on equity. 

Instead of managing climate risks, insurers have been quietly transferring the costs to policyholders. Even as the costs from climate-related disasters grow, insurers have protected their profits by raising homeowner insurance premiums and deductibles, cutting out coverage for climate-related hazards, delaying, denying and underpaying post-disaster claims, and in some of the most vulnerable communities, simply withdrawing. It is unconscionable for insurers to contribute heavily to climate harms by supporting fossil fuel production wildly in excess of climate targets and then raise prices and abandon policyholders as a result of climate harms that the insurers have helped cause.

Due to a history of redlining and underinvestment, climate risks like flooding and wildfires

disproportionately impact marginalized and low-income communities. As insurers withdraw, they will transform formerly redlined communities that previously could not access the financial system into “bluelined” communities that now cannot access insurance and, by extension, home ownership.

Patterns of delay, denial, and underpayment will also be particularly challenging to vulnerable communities that already lack the credit access to fund repairs or the funds to pay for both a primary residence and a temporary one while they wait for their claim to be approved and paid. Multiple studies have shown that communities of color face additional hurdles and longer waits on claims payments, and insurers responses to climate change will likely reinforce those trends. 

In some regions, insurance withdrawals could reach tipping points that trigger devastating harm to local, regional, or even national economies. For example, in the U.S., rising insurance costs and falling availability could lead to a foreclosure crisis, which could in turn threaten the tax base needed to fund basic mitigation and increase risks for community and regional banks. In New York City, officials have already warned about the risk of a foreclosure crisis in the community of Canarsie. In 2020, a report from an advisory committee to the U.S. Commodity Futures Trading Commission warned that “sub-systemic” shocks like this one could create a “systemic crisis in slow motion.” 

Just as insurers must evaluate climate risks in every part of their business, supervisors must evaluate every part of insurance markets and their connection to the broader financial system. Rather than viewing a growing gap in insurance access as an isolated issue, IAIS should recognize that risk supervision and access to insurance are closely intertwined. We appreciate that IAIS has recently established a natural catastrophe protection gap workstream, and we encourage the Climate Risk Steering Group to coordinate with this new workstream on the unique climate-related factors increasing the protection gap. We also urge the Climate Risk Steering Group to explicitly address best practices on access to insurance, with a focus on equity, into materials on climate risk supervision. 

To prevent insurers from simply transferring risk throughout the economy, IAIS should help supervisors take proactive steps to protect policyholders. IAIS can start by integrating these concerns into materials on climate risk supervision. IAIS can look to guidance from New York State, which acknowledges the potential for climate risk management to harm vulnerable communities and encourages insurers to contribute to just transition and climate adaptation efforts, and not to abandon communities who will become even more vulnerable to climate harms if insurers stop covering them. Specifically, IAIS should recommend that supervisors require insurers to disclose the impacts of particular risk management strategies on access to insurance, particularly for vulnerable communities, in both their scenario analyses and their transition plans. 

IAIS should also address the unique climate-related impacts on market conduct and provide best practices for proactively protecting policyholders. Insurers that have failed to prepare for climate risks may be tempted to maintain their solvency or protect their profits by cutting coverage or disputing whether damage is covered. Insurers may also seek to delay, deny, or underpay claims. In California, insurers introduced illegal coverage limitations on smoke damage to avoid paying for increasing wildfire claims. In Florida, insurers illicitly rewrote adjusters’ descriptions of hurricane damage to cut payments by more than 80%. 

Protecting policyholders and ensuring fair access will require more proactive action from supervisors. IAIS should also highlight that climate change is dramatically increasing the category of potentially vulnerable insurance consumers for whom consumer education will be an ineffective solution for a rapidly changing environment. IAIS should highlight that the concurrent and increasingly intense effects of climate disasters will require more resources for reviewing policy language and potential insurer misconduct, and supervisors should act proactively to ensure they have sufficient tools and resources to meet the scale of the problem.

Conclusion

Existing work from IAIS on climate risk represents an important step towards the development of global best practices on climate-related risk, but IAIS should see it as one step in a broader, ongoing effort. To meet the scale and complexity of the crisis, IAIS should use this consultation process to strengthen its existing work in line with a precautionary approach and expand its scope to help supervisors protect policyholders and promote fair and stable insurance markets. 

We look forward to engaging with IAIS as part of the ongoing consultation. If you have questions, please contact Carly Fabian at cfabian@citizen.org.

Sincerely, 

Public Citizen 

 

Download the letter here.

Petition for Rulemaking to Clarify that the Law Against ‘Fraudulent Misrepresentation’ Applies to Deceptive AI Campaign Ads

Lisa J. Stevenson
Office of General Counsel
Federal Election Commission
1050 First Street NE
Washington, DC 20463

Dear Ms. Stevenson:

Public Citizen respectfully submits this petition for rulemaking pursuant to 11 C.F.R. §200.1 et seq. The extraordinary advances in “Artificial Intelligence” (AI) now provide political operatives with the means to produce campaign ads with computer-generated fake images of candidates that appear real-life to portray fraudulent misrepresentation of those candidates. Public Citizen requests that the Federal Election Commission clarify when and how 5 U.S.C. §30124 (“Fraudulent misrepresentation of campaign authority”) applies to deliberately deceptive AI campaign ads.

Background

Generative artificial intelligence (AI) and deepfake technology — a type of artificial intelligence used to create convincing images, audio and video hoaxes – is evolving very rapidly. Every day, it seems, new and increasingly convincing deepfake audio and video clips are disseminated, including, for example, this audio fake of President Biden, the video fake of the actor Morgan Freeman and an audio fake of the actress Emma Watson reading Mein Kampf.

Deepfakes’ quality is impressive and able to fool listeners and viewers. Generally, on careful examination it is now possible to identify flaws that show them to be fake.

But as the technology continues to improve, it will become increasingly difficult and, perhaps, nearly impossible for an average person to distinguish deepfake videos and audio clips from authentic media. It is an open question how well digital technology experts will be able to distinguish fakes from real media.

The technology will almost certainly create the opportunity for political actors to deploy it to deceive voters, in ways that extend well beyond any First Amendment protections for political expression, opinion or satire. A political actor may well be able to use AI technology to create a video that purports to show an opponent making an offensive statement or accepting a bribe. That video may then be disseminated with the intent and effect of persuading voters that the opponent said or did something they did not say or do. The crucial point is that the video would not purport to characterize how an opponent might speak or behave, but to convey deceptively that they actually did so, when they did not.

A blockbuster deepfake video released shortly before an election could go “viral” on social media and be widely disseminated, with no ability for voters to determine whether it is making fraudulent claims.

Legislation has been introduced in Congress to require clear and obvious disclaimers on political ads whenever AI-generated content is used. For the time being, however, there are no such disclaimer requirements.

Request for Rulemaking

Federal law proscribes candidates for federal office or their employees or agents from fraudulently misrepresenting themselves as speaking or acting for or on behalf of another candidate or political party on a matter damaging to the other candidate or party. [52 U.S.C. §30124] Specifically, that section reads:

§30124. Fraudulent misrepresentation of campaign authority

(a) In general

No person who is a candidate for Federal office or an employee or agent of such a candidate shall-

(1) fraudulently misrepresent himself or any committee or organization under his control as speaking or writing or otherwise acting for or on behalf of any other candidate or political party or employee or agent thereof on a matter which is damaging to such other candidate or political party or employee or agent thereof; or

(2) willfully and knowingly participate in or conspire to participate in any plan, scheme, or design to violate paragraph (1).

(b) Fraudulent solicitation of funds

No person shall-

(1) fraudulently misrepresent the person as speaking, writing, or otherwise acting for or on behalf of any candidate or political party or employee or agent thereof for the purpose of soliciting contributions or donations; or

(2) willfully and knowingly participate in or conspire to participate in any plan, scheme, or design to violate paragraph (1).

A deepfake audio clip or video by a candidate or their agent that purports to show an opponent saying or doing something they did not do would violate this provision of the law. It would constitute a candidate or their agent “fraudulently misrepresent[ing]” themselves “as speaking or writing or otherwise acting for or on behalf of any other candidate or political party or employee or agent thereof on a matter which is damaging to such other candidate or political party or employee or agent thereof.”

In view of the novelty of deepfake technology and the speed with which it is improving, Public Citizen encourages the Commission to specify in regulation or guidance that if candidates or their agents fraudulently misrepresent other candidates or political parties through deliberately false AI-generated content in campaign ads, that the restrictions and penalties of 52 U.S.C. §30124 are applicable.

Sincerely,

Robert Weissman
President
Public Citizen

Craig Holman, Ph.D.
Government Affairs Lobbyist
Public Citizen