January 23, 2022

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Briefing with Senior State Department Official On the Release of the 2021 Trafficking in Persons (TIP) Report

23 min read

Office of the Spokesperson

Via Teleconference

MODERATOR:  Good morning, everyone, and thanks very much for joining us today as we are previewing the forthcoming release of the State Department 2021 Trafficking in Persons Report.  Just as a reminder, this call is on background.  You can attribute what you hear to a senior State Department official.  It’s also embargoed.  The embargo will be lifted upon the start of the formal event we are convening later today with Secretary Blinken.  We expect that event will start around 1 p.m. and the embargo will lift as soon as that event starts.

So just for the purposes of your background information, today’s speaker will be .  But again, she should be referred to as a senior State Department official for the purposes of your reporting.  And again, this call is embargoed until around 1 p.m. when we expect Secretary Blinken will start the formal event.

So with that, I will turn it over to our senior State Department official, and we’ll take your questions from there.

SENIOR STATE DEPARTMENT OFFICIAL:  Thank you, , and good morning.  Thank you all for joining this briefing and for your interest in the Trafficking in Persons Report.  I’ll begin just by sharing a little background information and some context on the report itself.

So the Trafficking in Persons Report, also known as the TIP Report, is the U.S. Government’s principal diplomatic and diagnostic tool to guide relations with foreign governments on human trafficking.  It is also the world’s most comprehensive resource on governmental anti-trafficking efforts, and it reflects the U.S. Government’s commitment to global leadership on this key human rights, law enforcement, and national security issue.

This year’s report, which is the 21st installment, includes narratives for 188 countries and territories, including the United States.

A country’s tier ranking reflects the State Department’s assessment of that government’s efforts during the reporting period to meet the Trafficking Victim Protection Act minimum standards for the elimination of trafficking in persons.  The department strives to make the report as accurate and objective as possible, documenting the successes and shortcomings of government anti-trafficking efforts, and it does not make assessments based on political considerations.

The TIP Report assesses a country’s efforts against those TVPA minimum standards and against its own efforts during the previous reporting period; it does not compare countries.  It also takes into account a country’s resources and capacity when weighing factors.

And just to clarify, the reporting period is from April 1, 2020 through March 31st of 2021 for this year’s report.

All governments should strive to continually improve their efforts across what are referred to as the 3Ps of the anti-trafficking framework – of prosecution, protection, and prevention.  In fact, the TVPA requires governments to demonstrate continual progress, especially to retain rankings on Tier 1 or Tier 2.

Tier 2 Watch List rankings are time-limited by U.S. law, as governments can only retain this ranking for a maximum of three consecutive years; thus, here too ongoing efforts to improve are critical.  For Tier 3 governments – those that are assessed as failing to make significant efforts to meet the minimum standards and do not, in fact, meet the minimum standards – also Tier 3 countries include countries whose governments have a policy or pattern of trafficking.  For those countries on Tier 3, restrictions on assistance may apply.

The TIP Report introduction focuses on the impact of the COVID-19 pandemic on trafficking trends and anti-trafficking efforts around the world.  It outlines how the COVID-19 pandemic exacerbated trafficking situations and significantly increased the number of people worldwide at risk to exploitation, as well as how traffickers adapted their methods to take advantage of these circumstances.

The introduction also illustrates the innovative ways that many have adapted their anti-trafficking efforts.  It emphasizes lessons learned from practitioners, offers ways to rebuild strong anti-trafficking strategies, and focuses on ways governments can prevent the compounding effects of crises on trafficking victims and vulnerable individuals.

We saw, for example, that the governments of countries such as Paraguay identified significantly more trafficking victims through routine screening at pandemic quarantine facilities, or in Turkey, where the government trained shelter staff on pandemic mitigation efforts and provided COVID-19 tests and personal protective equipment to victims staying at those shelters.  Mexico secured its first trafficking in persons conviction from a virtual court session in June 2020, just weeks after resuming legal proceedings following a two-month shutdown related to the pandemic.  Lebanon and the Czech Republic extended the ability of migrants to stay in those countries for their safety related to the pandemic and also adjusted the limits of their respective visa regimes – all to help ensure the victims were protected during the pandemic.  These are just a few of many examples that the report outlines.

The introduction to this year’s report also seeks to elevate other important themes, such as the struggle to realize racial equity, the importance of survivor leadership, the harmful effects of conspiracy theories related to trafficking, and the reality of familial trafficking.

We also included a box in the introduction this year on state-sponsored trafficking in persons and, due to the scale of the problem, one specifically on forced labor in China’s Xinjiang region and beyond.

I would also like to share some noteworthy results and tier movement within this year’s report.  Overall, there are approximately the same number of downgrades and upgrades as in prior years.

On a positive note, there were several upgrades due to tangible progress that governments made to combat trafficking around the world despite the pandemic.  We saw progress even in countries where the trafficking challenges have been intractable over many years.

Several governments received upgrades to Tier 2 for increasing efforts to address trafficking, including Bosnia and Herzegovina, the Dominican Republic, Jordan, Nigeria, Saudi Arabia, Sudan, and Uzbekistan.

Not all countries made such progress.  Six countries received downgrades from Tier 1 to Tier 2 as the department assessed that the governments of the Republic of Cyprus, Israel, New Zealand, Norway, Portugal, and Switzerland did not meet all four of the minimum standards and were therefore not making “appreciable progress” compared to the previous year and no longer met the minimum standards to stay on Tier 1.

Twelve countries were also downgraded from Tier 2 to Tier 2 Watchlist.  I won’t list the full number, but I’ll note a couple that may attract your attention include South Africa and Thailand.

There were also two countries that were downgraded this year from the Watch List to Tier 3.  Those two countries are Guinea-Bissau and Malaysia.

There is also an important provision in the TVPA, the Trafficking Victim Protection Act, that requires the department to make a determination whether countries have a policy or pattern of the government engaged in trafficking.

This year, the department made that determination that 11 countries continued to have a government policy or pattern of trafficking and inadequate enforcement mechanisms; some government officials in these countries were themselves part of the problem, directly compelling citizens or foreign nationals into sex trafficking, forced labor, or use as child soldiers.

We found that officials used their power to exploit their citizens or foreign nationals ranging from forced labor in local or national public works projects, military operations, economically important sectors, or as part of government-funded projects or missions abroad, to sexual slavery on government compounds.

I’m happy to share the list of 11 countries, but in the interest of time I’ll probably not read the full list now.  But I will note a couple of particular interest.  China remained on Tier 3 and is again noted for having a government policy of forced labor, particularly in Xinjiang detention in camps that is intended to erase ethnic and religious identities under the pretext of “vocational training,” and forced labor is a central tactic used for this repression.

Also, the Cuban Government increased the number and size of overseas medical missions.  Dozens of country reports include information regarding the program’s lack of transparency, unaddressed labor violations, and forced labor.

Finally, just two more points I wanted to raise at the beginning.

This year, 15 countries are included on the 2021 Child Soldier Prevention Act List for having governmental armed groups or supporting nongovernmental armed groups that recruit or use children in armed conflict.

And finally, the department is recognizing eight TIP Report heroes who have devoted their lives to the fight against human trafficking.

The 2021 heroes come from Albania, the Central African Republic, Gabon, Japan, Kazakhstan, Mexico, Qatar, and Spain.  These individuals inspire each of us to do more to advance the global fight against human trafficking and protect the victims and survivors of this crime.  The ceremony today that Secretary Blinken will host will highlight and celebrate the accomplishments of these extraordinary individuals.

And with that, thank you very much.  I’ll be happy to take your questions.

MODERATOR:  Great, thank you very much.  Operator, if you want to repeat the instructions for asking questions.

OPERATOR:  Ladies and gentlemen, if you wish to ask a question, please press 1 then 0 on your telephone keypad.  Please ensure your line is open before starting your question.  Once again, please press 1 then 0 on your telephone keypad.  One moment, please.

MODERATOR:  Okay, let’s start with the line of Missy Ryan, please.

QUESTION:  Thanks.  And thanks very much for this briefing.  I just had a question about Afghanistan, and I see that – so if I understood correctly, it’s on Tier 3 for the – is it – am I correct to say second year?  And so I’m wondering what the impact, if any, is on American assistance to Afghanistan currently or in the future, and what the situation is around that.  Thanks.

SENIOR STATE DEPARTMENT OFFICIAL:  Yes, thank you so much for that question.  Afghanistan did again demonstrate a government policy or pattern of human trafficking and will therefore again appear on Tier 3.  As you noted, Tier 3 countries may carry restrictions for non-humanitarian and non-trade-related assistance.  The president may waive those restrictions, as he did for Afghanistan when it was placed on Tier 3 in the 2020 TIP Report.  Those restrictions go into effect for the next fiscal year, so he waived the restrictions for this fiscal year that went into – that began in October.  This summer, there will be a process of preparing recommendations to inform the President’s decisions for the countries that appear on Tier 3 in the 2021 TIP Report, and we expect that the President will make those decisions before the beginning of the next fiscal year in October.

And you are right, this is the second year that Afghanistan is on Tier 3 for a government policy or pattern of human trafficking.  Specifically, the report notes in the area of the use and recruitment of child soldiers as well as a widespread practice of bacha bazi, which is essentially sexual slavery on government compounds.

MODERATOR:  We’ll go to the line of Matt Lee.

QUESTION:  Hello?

MODERATOR:  Matt, I think – yeah, I think your line’s open.  Go ahead.

QUESTION:  Yeah.  All right.  I assume you can hear me, so I’m just going to go ahead and do it.  I’m sorry, these are kind of logistical questions.  Could you just repeat the list of six countries downgraded from Tier 1 to Tier 2?  And also, were there any countries that moved from Tier 3 up?  And then the last one is:  For Guinea-Bissau and Malaysia, are those – those were demoted because of the statutory time that they could be exempted or put into the Watch List, or was there demonstrable regression in their approach?  Thanks.

SENIOR STATE DEPARTMENT OFFICIAL:  Yeah, thank you for all those questions.  I hope I got them all.  If I missed any, feel – please feel free to repeat them.

The six countries that were downgraded from Tier 1 to Tier 2 include Cyprus, Israel, New Zealand, Norway, Portugal, and Switzerland.  There were four countries upgraded from Tier 3 this year.  They include Belarus, Burundi, Lesotho, and Papua New Guinea.  And the two countries that were downgraded to Tier 3, Guinea-Bissau and Malaysia, were in fact both out of time on the Watch List.  They had exceeded their time.  They had been on the Watch List for three years, and therefore were no longer able legally to stay on the Watch List and did not make enough progress to support an upgrade to Tier 2, and therefore were automatically downgraded to Tier 3.

Did I get all your questions?

MODERATOR:  Sounded like you did.  Let’s go on to the line of Lara Jakes, please.

QUESTION:  Hi, good morning.  Is my line open?

MODERATOR:  Your line is open.

QUESTION:  Great, thanks.  In terms of the pandemic’s impact on human trafficking, can you give us a little more sense of what kind of trends you saw that were more prevalent or more alarming than in years past that were directly caused by the pandemic?  I was looking in the – kind of the executive summary.  I see that there was a trend of the – perhaps the pandemic had spurred more migration and made people more vulnerable to trafficking.  I also saw a large section on stay-at-home sex trafficking victims.

And I’m just wondering, which – not that this is a zero-sum game, but which one of these trends seemed to grow at a more alarming rate directly caused by the pandemic?  Thank you.

SENIOR STATE DEPARTMENT OFFICIAL:  Thank you for those important questions.  We have spent a lot of time this year gathering information and carefully analyzing the effects of the pandemic on trafficking trends, on trafficking victims and survivors, as well as government and service providers’ response to trafficking.

Overall, the concurrence of the increased number of individuals at risk due to the pandemic, traffickers’ ability to capitalize on competing crises, and the diversion of resources to pandemic response efforts has resulted, in many ways, in an ideal environment for human trafficking to flourish and evolve.

Despite these added challenges and risks that the pandemic presented, we have also witnessed the adaptability among those continuing to fight human trafficking and their dedication to ensuring the continuation of anti-trafficking efforts and minimize the effects of the pandemic on victims and the broader anti-trafficking community.

To your question about some of the specific effects, we did see that during the pandemic, anti-trafficking stakeholders experienced a number of conditions that made work to combat trafficking in persons exceptionally difficult.  Governments faced reduced capacities as priorities shifted to focus on growing health and economic concerns.  Victims and survivors faced heightened risk of re-victimization and obstacles accessing assistance and support as lockdowns, social distancing protocols, and a lack of resources caused survivor service providers to close shelters and reduce services.

Technology, as you noted, was widely utilized both to safely continue to combat trafficking such as to – you noted the negatives.  I’ll note the positives first and then the negatives.  Technology was also used to resume prosecution efforts and investigation efforts and to prevent further court backlogs through virtual investigative and court proceedings.

We did, unfortunately, also see that the increased use of technology created more vulnerability that traffickers unfortunately also exploited, as you noted, through online sex trafficking.  Also traffickers used the internet and other remote connectivity options to recruit trafficking victims, often with fraudulent job offers, so we did see, unfortunately, that that was a trend.  Thankfully, we saw the governments, service providers, NGOs, and many survivors themselves were resilient and adapted to the evolving situation as well.

MODERATOR:  Go the line of Humeyra Pamuk.  Humeyra Pamuk.

QUESTION:  I’m assuming everyone can hear me, so I’ll just go ahead.  I just want to ask – I see that Turkey has moved to the list of countries who are implicated in the use of child soldiers.  I just want to confirm if this is the first time a NATO member is on this list, and I just want to also ask a little bit about methodology.  There have been reports that the – some of the Syrian factions that Turkey has supported have been involved in various human rights abuses, use of child soldiers.  The fact that the country made it to this list this year, does that mean the United States has now independently verified these reports?

And my final question is:  How does this impact any military cooperation with Turkey?  I’m well aware that there is a specific distinction in attribution to the armed groups that it supports and not the country’s armed forces, but still, U.S. is in the middle of negotiating a really important deal for Turkey to run the Kabul airport, and I’m looking at the report and it says – it talks about a number of restrictions on security assistance and a few other things, and Turkey is seeking financial and various military support to run the Kabul airport from United States.  Would that have any impact on it if that’s the case?  Thank you.

SENIOR STATE DEPARTMENT OFFICIAL:  Yeah, thank you very much for that important question.  The United States places considerable attention on the issue of the unlawful recruitment or use of child soldiers.  The United States condemns the practice of unlawfully recruiting or using child soldiers and work to end this practice, which is considered a form of human trafficking in certain circumstances, and we work to do so wherever it occurs.  Through this abhorrent practice, governments and government-supported armed groups rob innocent children of their childhoods and may cause them to commit terrible violence, in some cases against their own loved ones.

Across the globe, wherever we see this occurring, we raise this issue through both military and civilian channels, and we work with concerned citizens, the United Nations, and nongovernmental organizations.  Our aim is to monitor, report on, and prevent the unlawful recruitment or use of child soldiers, as well as to protect, assist, and rehabilitate these children, including by working with civil society and governments of countries where governments or government-supported armed groups unlawfully recruit or use child soldiers.

And I want to pause on that last sentence just to note that that is the legal standard, that the Child Soldier Prevention Act requires the State Department to list countries on this list where either governments or government-supported armed groups are unlawfully recruiting or using child soldiers.  And through this list, the United States puts on notice those countries where we do have credible information of the recruitment or use of child soldiers.  We take these allegations very seriously.  We conduct in-depth research on all relevant information and engage directly with governments year-round regarding these concerns.

With respect to Turkey in particular, you are correct that this is the first time a NATO member has been listed on the Child Soldier Prevention Act list.  As a respected regional leader and member of NATO, Turkey has the opportunity to address this issue, the recruitment and use of child soldiers in Syria and Libya.  We did determine and document in this report that the Government of Turkey provided support to the Sultan Murad Division, a non-state armed group that recruited and used child soldiers.  This division is a Syrian armed opposition group that operates under the umbrella of the Turkish-supported Syrian National Army.  The Government of Turkey provided tangible support to the Sultan Murad Division which included transit through Turkish territory during the reporting period of – as I said before, that reporting period is April 1, 2020 through March 31, 2021.  The United States hopes to work with Turkey to encourage all groups involved in the Syrian and Libyan conflicts not to use child soldiers, and we hope to work with Turkey to address this issue in the long run.

MODERATOR:  Let’s go to the line of Michel Ghandour.

QUESTION:  Yes.  What does the Tier 3 list include other than China, Cuba, and Afghanistan?

SENIOR STATE DEPARTMENT OFFICIAL:  There – it’s a fairly long list.  There are 15 countries, I think, on the list.  I’m happy to read you the list of countries that are on Tier 3 in alphabetical order.  They include Afghanistan, as we already discussed; Algeria, Burma, China, Comoros, Cuba, Eritrea, Guinea Bissau, Iran, North Korea, Malaysia, Nicaragua, Russia, South Sudan, Syria, Turkmenistan, and Venezuela.  Sorry, it’s 17; I counted wrong.

MODERATOR:  We’ll take a couple final questions.  Let’s go to Jiha Ham, please.

QUESTION:  Hi, I hope you can hear me.

MODERATOR:  We can.

QUESTION:  Okay.  Thank you.  Thank you for doing this.  Thank you for taking my question.  I have a question on North Korea.  So the report on North Korea, it says the Chinese Government often sends North Korea defectors back to North Korea forcibly.  But according to the report, because of the COVID, North Korean authorities in 2020 refused to accept more than 200 defectors.  I’m sure they are still in China, because the border is still closed between the two countries.  So my question is:  Were there any efforts that the U.S. Government tried to intervene the situation or directly at China not to send these defectors back to North Korea?  If not, what will be your message to China?  Thank you.

SENIOR STATE DEPARTMENT OFFICIAL:  Yeah, thank you for that question.  We have long noted concerns in the TIP Report in both the China and the North Korea narrative for many years, our concerns about defectors or other North Korean nationals being returned to North Korea and the risk that they face to forced labor, other forms of trafficking, and other human rights abuses, if they are returned.  We have included a recommendation in the China narrative for many years and have raised this issue with the Chinese Government.  We encourage them not to return people back to North Korea, particularly without screening for human trafficking, since we know this is a population that’s particularly vulnerable to human trafficking.  Obviously, we have much broader human rights concerns in North Korea, and this is one of many issues that we raise with the Chinese Government.  And we publicly note our concerns about North Korea.

MODERATOR:  We’ll go to the line of Mouhamed Elahmed.

QUESTION:  Hi, .  Thank you for doing this.  I have couple of questions, please.  I was skimming over the report, and it seems that the Syrian refugees, especially women and children, have been trafficked, used, and exploited in so many countries in the Middle East, like Egypt for example.  So how does this represent the challenge to the U.S. efforts to address this issue in the Middle East?  Are there any programs that the USAID, for example, is planning to provide to help those victims to rehabilitate?

And finally, do you think that by solving the refugee crisis in Syria or even in Yemen, would that help in reduce or eliminate the trafficking persons in the Middle East that has been increased in the recent years?  Thank you so much.

SENIOR STATE DEPARTMENT OFFICIAL:  Yeah, thank you for that question.  You are right that – to point out that Syrian refugees are particularly vulnerable to human trafficking and all kinds of other hostilities throughout the region.  We have long documented those concerns and trafficking abuses that occur, that traffickers target Syrian refugees, as they do many other refugees and migrants, both in the Middle East region and more broadly in the world.  They comprise a group of people that traffickers recognize often do not have a safety net around them. They may not have family relatives; they may not have a lot of other options to seek help and support.  And therefore, traffickers often prey and target specifically refugees and migrants.  And sadly, that is very true for Syrian refugees and migrants in the region as well.

We have included recommendations for many years for countries in the region, both the Middle East and I would also say European countries that have also hosted or through which Syrian migrants and refugees have traveled, and urge those governments to screen for trafficking indicators and identify proactively trafficking victims among this group so that they can get them the care that they need, that is tailored for trafficking victims to prevent their future exploitation and potential re-trafficking as well.  We’ve also used some of our foreign assistance funds specifically to raise awareness and build governments’ capacity in the region to identify and provide care for those trafficking victims among this group.

MODERATOR:  Well, we will leave it there.  I want to thank our speaker.  Again, this call was on background.  You can refer to our speaker as a senior State Department official, and the call is embargoed until approximately one o’clock today, when the event with Secretary Blinken begins.  We will have additional opportunities for you to hear from the Secretary and from senior State Department officials today, including at the press briefing on the rollout of the 2021 Trafficking in Persons Report.  Thanks, everyone, for joining, and we’ll talk to you later today.

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  • Humanitarian and Development Assistance: Project Evaluations and Better Information Sharing Needed to Manage the Military’s Efforts
    In U.S GAO News
    What GAO FoundThe Department of Defense’s (DOD) management of its key humanitarian assistance programs reflects both positive practices and weaknesses:Alignment with strategic goals. DOD aligns its humanitarian assistance project planning with the goals outlined in U.S. and departmental strategies, and has clearly established processes for implementing its projects.Interagency project coordination. DOD has taken steps to coordinate with the Department of State (State) and the United States Agency for International Development (USAID) on projects, such as seeking concurrence on project proposals and embedding representatives from their agencies at its combatant commands, but coordination challenges remain.Poor data management. DOD does not have complete information on the status or actual costs of the full range of its Overseas Humanitarian, Disaster, and Civic Aid (OHDACA) projects. In addition, Humanitarian and Civic Assistance project data in DOD’s database differ from what DOD reports to Congress.Limited program evaluations. From fiscal years 2005 through 2009, DOD had not completed 90 percent of the required 1-year post-project evaluations for its OHDACA projects, and about half of the required 30-day evaluations for those projects, and thus lacks information to determine projects’ effects.Limited program guidance. DOD’s primary guidance for the OHDACA humanitarian assistance program is limited, is not readily accessible to all DOD personnel, and has not been updated for several years.Furthermore, DOD, State, and USAID do not have full visibility over each others’ assistance efforts, which could result in a fragmented approach to U.S. assistance. There are several initiatives under way to improve information sharing, including one directed by the National Security Council. However, no framework, such as a common database, currently exists for the agencies to readily access information on each others’ efforts. Moreover, the potential for overlap exists among agencies’ efforts in four areas: (1) health, (2) education, (3) infrastructure, and (4) disaster preparation. For example, both USAID and DOD are conducting health care projects in Yemen and building schools in Azerbaijan. Overlap may be appropriate in some instances, especially if agencies can leverage each others’ efforts. However, given the agencies’ information-sharing challenges, there are questions as to whether DOD’s efforts are an efficient use of resources since USAID serves as the lead U.S. development agency. State and USAID officials said that DOD’s humanitarian assistance efforts can be beneficial, especially when responding to disasters or supporting foreign militaries. However, officials said DOD’s efforts can have negative political effects, particularly in fragile communities where even small gestures, such as distributing soccer balls to a particular population, can be interpreted as exhibiting favoritism. While DOD’s funding for humanitarian assistance is small relative to the billions spent by State and USAID, its programs are expanding. Given interagency information challenges, the fiscally-constrained environment, and the similarity of agencies’ assistance efforts, DOD and the other agencies involved in foreign assistance could benefit from additional direction from Congress on DOD’s role in performing humanitarian assistance in peacetime environments.Why GAO Did This StudyIn recent years, the Department of Defense (DOD) has increased its emphasis and spending on humanitarian assistance efforts outside of war and disaster environments. From fiscal years 2005 through 2010, DOD obligated about $383 million on its key humanitarian assistance programs. Because civilian agencies, such as the Department of State and United States Agency for International Development (USAID) also carry out many assistance efforts, DOD’s efforts require close collaboration with these agencies. This report was conducted as part of GAO’s response to a statutory mandate and reviewed (1) DOD’s management of two key humanitarian assistance programs—the humanitarian assistance program funded through its Overseas Humanitarian, Disaster, and Civic Aid (OHDACA) appropriation and its Humanitarian and Civic Assistance program—and (2) the extent to which DOD, State, and USAID have visibility over each others’ efforts. To conduct this review, GAO analyzed funding and program information, and interviewed officials at DOD, State, USAID, nongovernment organizations, and 12 U.S. embassies.
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  • Biomedical Research: NIH Should Publicly Report More Information about the Licensing of Its Intellectual Property
    In U.S GAO News
    Research conducted at Department of Health and Human Services (HHS) labs led to 4,446 U.S. patents owned by the agency covering a range of inventions from 1980 through 2019. During that period, the National Institutes of Health (NIH) had 93 patents—2 percent of the total—that contributed to the successful development of 34 drugs approved by the Food and Drug Administration (FDA) and brought to market, including vaccines and treatments for cancer. These 34 drugs were developed by pharmaceutical companies and were associated with 32 licenses granted to them by NIH. As shown in the figure, these licenses have generated up to $2 billion in royalty revenue for NIH since 1991, when FDA approved the first of these drugs. Three licenses generated more than $100 million each for the agency. Royalties from NIH Licenses of Inventions Associated with FDA-Approved Drugs, 1991 to February 2020 When licensing its inventions, NIH prioritizes the likelihood that the licensee can successfully develop a drug by considering such factors as technical expertise and the ability to raise capital. Consistent with federal interpretation of technology transfer statutory authorities, NIH does not consider the affordability of the resulting drug. NIH provides limited information to the public about its licensing activities. For example, the agency does not report which of its patents are licensed or release metrics that would enable the public to evaluate how licensing affects patient access to resulting drugs. Increasing the transparency of its licensing activities could improve the public’s and policymakers’ understanding of NIH’s management of its intellectual property. HHS monitors for unauthorized use of its inventions (infringement) and has taken steps to protect its rights. HHS relies primarily on inventors at its labs to monitor for potential infringement and generally encourages potential infringers to license the inventions. If cases proceed to litigation, HHS relies on the Department of Justice (DOJ) to protect its rights. Since 2009, HHS has worked with DOJ to defend its intellectual property in several cases in the U.S. and abroad and has referred one case to DOJ for litigation against an alleged infringer. HHS labs conduct research that can contribute to the development of new life-saving drugs. HHS may grant rights to its inventions by licensing the patents to pharmaceutical companies that conduct the additional development activities and testing necessary to bring drugs to market. Public health experts and patients’ rights advocates have raised concerns about the prices of drugs developed with federal support. GAO was asked to review HHS’s management of its intellectual property. This report examines (1) the extent to which HHS-owned intellectual property has contributed to the development of FDA-approved drugs, (2) what is known about the licenses associated with FDA-approved drugs, (3) factors NIH prioritizes when licensing its inventions and information about licensing it makes public, and (4) steps HHS has taken to protect its rights. GAO reviewed relevant laws and agency documents, analyzed patent and licensing data, and interviewed HHS officials, academic experts, industry representatives, and nongovernmental organizations. GAO is making two recommendations, including that NIH provide more information to the public about the licensing of its intellectual property. HHS concurred with GAO’s recommendations. For more information, contact John Neumann, (202) 512-6888, NeumannJ@gao.gov.
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  • Rural Hospital Closures: Affected Residents Had Reduced Access to Health Care Services
    In U.S GAO News
    GAO found that when rural hospitals closed, residents living in the closed hospitals' service areas would have to travel substantially farther to access certain health care services. Specifically, for residents living in these service areas, GAO's analysis shows that the median distance to access some of the more common health care services increased about 20 miles from 2012 to 2018. For example, the median distance to access general inpatient services was 3.4 miles in 2012, compared to 23.9 miles in 2018—an increase of 20.5 miles. For some of the less common services that were offered by a few of the hospitals that closed, this median distance increased much more. For example, among residents in the service areas of the 11 closed hospitals that offered treatment services for alcohol or drug abuse, the median distance was 5.5 miles in 2012, compared to 44.6 miles in 2018—an increase of 39.1 miles to access these services (see figure). Median Distance in Miles from Service Areas with Rural Hospital Closures to the Nearest Open Hospital that Offered Certain Health Care Services, 2012 and 2018 Notes: GAO focused its analysis on the health care services offered in 2012 by the 64 rural hospitals that closed during the years 2013 through 2017 and for which data were available. For example, in 2012, 64 closed hospitals offered general inpatient services, 62 offered emergency department services, 11 offered treatment services for alcohol or drug abuse, and 11 offered services in a coronary care unit. To examine distance, GAO calculated “crow-fly miles” (the distance measured in a straight line) from the geographic center of each closed rural hospital's service area to the geographic center of the ZIP Code with the nearest open rural or urban hospital that offered a given service. GAO also found that the availability of health care providers in counties with rural hospital closures generally was lower and declined more over time, compared to those without closures. Specifically, counties with closures generally had fewer health care professionals per 100,000 residents in 2012 than did counties without closures. The disparities in the availability of health care professionals in these counties grew from 2012 to 2017. For example, over this time period, the availability of physicians declined more among counties with closures—dropping from a median of 71.2 to 59.7 per 100,000 residents—compared to counties without closures—which dropped from 87.5 to 86.3 per 100,000 residents. Rural hospitals face many challenges in providing essential access to health care services to rural communities. From January 2013 through February 2020, 101 rural hospitals closed. GAO was asked to examine the effects of rural hospital closures on residents living in the areas of the hospitals that closed. This report examines, among other objectives, how closures affected the distance for residents to access health care services, as well as changes in the availability of health care providers in counties with and without closures. GAO analyzed data from the Department of Health and Human Services (HHS) and the North Carolina Rural Health Research Program (NC RHRP) for rural hospitals (1) that closed and those that were open during the years 2013 through 2017, and (2) for which complete data generally were available at the time of GAO's review. GAO also interviewed HHS and NC RHRP officials and reviewed relevant literature. GAO defined hospitals as rural according to data from the Federal Office of Rural Health Policy. GAO defined hospital closure as a cessation of inpatient services, the same definition used by NC RHRP. GAO defined service areas with closures as the collection of ZIP Codes that were served by closed rural hospitals and service areas without closures as the collection of ZIP Codes served only by rural hospitals that were open. GAO provided a draft of this report to HHS for comment. The Department provided technical comments, which GAO incorporated as appropriate. For more information, contact James Cosgrove at (202) 512-7114 or cosgrovej@gao.gov.
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  • Semiannual Report to Congress: April 1, 2021, through September 30, 2021
    In U.S GAO News
    This report was submitted to the Comptroller General in accordance with Section 5 of the Government Accountability Office Act of 2008. The report summarizes the activities of the Office of Inspector General (OIG) for the six-month reporting period ending September 30, 2021. During the reporting period, the OIG issued one audit report and continued two performance audits. In addition, the OIG closed 15 investigations and two self-initiated inquiries, and opened 10 new investigations. The OIG processed 59 hotline complaints, many of which were referred to other OIGs for action because the matters involved were within their jurisdictions. The OIG remained active in the GAO and OIG communities by briefing new GAO employees on its audit and investigative missions, and participating in committees and working groups of the Council of Inspectors General on Integrity and Efficiency, including those related to the Pandemic Response Accountability Committee. Details of these activities and other accomplishments are provided in the report.
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  • Natural Disasters: Economic Effects of Hurricanes Katrina, Sandy, Harvey, and Irma
    In U.S GAO News
    Between January 1980 and July 2020, the United States experienced 273 climate and weather disasters causing more than $1 billion in damages each, according to NOAA. The total cost of damages from these disasters exceeded $1.79 trillion, with hurricanes and tropical storms accounting for over 50 percent of these damages, according to NOAA. Across the regions affected by these hurricanes over the period from 2005 to 2015, CBO estimated that federal disaster assistance covered, on average, 62 percent of the damage costs. GAO has reported that the rising number of natural disasters and reliance on federal disaster assistance is a key source of federal fiscal exposure. GAO was asked to review the costs of natural disasters and their effects on communities. This report examines (1) estimates of the costs of damages caused by hurricanes and hurricanes' effects on overall economic activity and employment in the areas they affected, and (2) actions subsequently taken in those areas to improve resilience to future natural disasters. GAO conducted case studies of Hurricanes Katrina, Sandy, Harvey, and Irma, selected for two reasons. First, they were declared a major disaster by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, which establishes key programs through which the federal government provides disaster assistance, primarily through FEMA. Second, they had sizable effects on the 50 U.S. states and the District of Columbia during the period from 2004 through 2018. GAO analyzed federal agency and other data on costs, economic activity, employment, and recovery and mitigation projects in selected areas affected by these hurricanes. GAO also visited selected recovery and mitigation project sites; interviewed experts and federal, state, and local government officials; and reviewed federal, state, and local government reports and academic studies. Hurricanes Katrina, Sandy, Harvey, and Irma (selected hurricanes) caused costly damages and challenges for some populations in affected communities. In these communities, the National Oceanic and Atmospheric Administration (NOAA) estimated the cost of damages to be approximately $170 billion for Katrina, $74 billion for Sandy, $131 billion for Harvey, and $52 billion for Irma. These estimates include the value of damages to residential, commercial, and government or municipal buildings; material assets within the buildings; business interruption; vehicles and boats; offshore energy platforms; public infrastructure; and agricultural assets. These hurricanes were also costly to the federal government. For example, in 2016, the Congressional Budget Office (CBO) estimated that federal spending exceeded $110 billion in response to Katrina and $53 billion in response to Sandy. GAO analysis suggests that the selected hurricanes were associated with widely varying effects on overall economic activity and total employment in affected metropolitan areas and counties. Economic activity was lower than expected in the month of the hurricane or some of the three subsequent months in three of the affected metropolitan areas GAO analyzed. Within one year, average economic activity in these three metropolitan areas was similar to or greater than what it had been the year before the hurricane. Total employment was lower than expected in the month of the hurricane or some of the three subsequent months in 80 of the affected counties GAO analyzed. Total employment was higher than pre-hurricane employment on average in 47 of those counties within one year but remained below pre-hurricane employment on average in the other 33 counties for at least one year. Finally, state and local government officials said that the selected hurricanes had significant impacts on communities, local governments, households, and businesses with fewer resources and less expertise, and that challenges faced by households may have impacted local businesses. Communities affected by selected hurricanes have been taking actions to improve resilience, but multiple factors can affect their decisions. Actions taken after selected hurricanes include elevating, acquiring, and rehabilitating homes; flood-proofing public buildings; repairing and upgrading critical infrastructure; constructing flood barriers; and updating building codes. A community’s decision to take resilience actions can depend on the costs and benefits of those actions to the community. Multiple factors affect these costs and benefits, including the likelihood, severity, and location of future disasters, as well as the amount of federal assistance available after a disaster. Finally, vulnerabilities remain in areas affected by selected hurricanes. For example, state and local government officials indicated that many older homes in these areas do not meet current building codes. In reports to the Federal Emergency Management Agency (FEMA), states indicate they anticipate that the scope of damages via exposure to weather hazards, such as hurricanes, will likely remain high and could expand across regions affected by the selected hurricanes. In addition, some local governments have projected that population will grow in the regions affected by selected hurricanes. For more information, contact Oliver Richard at 202-512-8424 or richardo@gao.gov.
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