Ius Gentium

University of Baltimore School of Law's Center for International and Comparative Law Fellows discuss international and comparative legal issues


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A Comparative Look at Off-Label Pharmaceutical Use

Jasen Lau

On December 2012, the Second Circuit of the U.S. ruled in favor of the defendant in U.S. v. Caronia, stating that the non-misleading speech of off-label[1] promotion by a pharmaceutical representative is protected by the First Amendment. The case drew nationwide attention by pharmaceutical companies, public health scholars, government officials, and health lawyers. Many worried that First Amendment protections trumped public safety in off-label promotion. While the actual ramifications are debatable, Caronia certainly warrants further inquiry. After all, the U.S. is not the only country where off-label prescription and promotion of medications take place. From France to Germany to Japan to India, off-label prescriptions and policies thereof exist, and while most of the policies are similar on the overarching principles, the subtle nuances reflect an ulterior motive that may or may not be noble. Many nations of the world have different yet very similar approaches to off-label prescription use regulation.

The Caronia case arose out of the promotion of a drug called Xyrem, a very powerful central nervous system depressant.[2] The Food and Drug Administration (FDA) deemed the medication’s side effects so severe that the drug warranted a black box warning, the most serious kind of warning the FDA may give.[3] Caronia and Dr. Peter Gleason, representatives for Xyrem’s manufacturer, promoted an off-label use; Gleason said he personally treated patients far younger and older than the approved scope of use. However, the court found that the actual speech of the off-label promotion is protected. In the U.S., off- label promotion is not inherently illegal, but off-label promotion may be used as evidence of misbranding, which is illegal.[4] However, the U.S. does not entirely prohibit all kinds of off-label promotion. In fact, the system is set-up such that pharmaceutical manufacturers may fund research that helps find new off-label uses. The manufacturers may then disseminate the research results.[5] Many concerns arise from Caronia’s ruling: manufacturers will start promoting, while disregarding  public safety; research will no longer be funded; the FDA will be limited in power, and so forth. However, the U.S. is not the only country to tackle the issue of off-label prescription use.

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Off-label use is not a rare phenomenon and nor is it exclusive to the U.S. In fact, off-label use is a very common medical technique used to treat numerous patients worldwide. In Paris, a statistical study suggests that nearly 62% of prescriptions are for an unauthorized use.[6] In the first quarter of 1999, nearly 13% of all prescriptions for children and adolescents in Germany were prescribed off-label.[7] Similarly, 22 German medical centers said off-label use was “common” for a vast majority of the physicians.[8] In Spain, 61% of pediatric physicians prescribe for medications in an off-label manner.[9] 

Yet, how each nation regulates off-label use and the public policies that stem therefrom differ in only the subtlest of ways.The European Union (EU) has established a general policy for off-label use; drugs should be approved and authorized for specific treatments. However, the EU also believes that its Member States should incentivize further research. One possible incentive is a six-month extension to a Supplementary Protection Certificate,[10] extending a manufacturer’s exclusive property rights.[11]  Second, the manufacturer is granted an extra two years of market exclusivity if research is done on a drug that affects less than 5 in 10,000 patients or has become a drug where, without incentives, no pharmaceutical company would want to conduct further research for lack of a justification to the necessary investment of research but the drug still holds potential to treat a condition that otherwise cannot be treated with alternative medicines – also called an orphan drug.[12] The EU did not want “rigid and compelling legal regulations” but a system of incentives to nurture the desire for research over penalizing the lack thereof.[13] This desire stems from the need for pediatric research. Nearly 21% of the EU’s population – nearly 100 million – are vulnerable children with inadequate drug supply.[14] In fact, 50% of medications were never even tested for children before becoming orphan drugs.[15] However, many of the Member States are silent on the issue of off-label prescription in their legislation, relying mostly on the EU. On the other hand, France has a very specific approach that defies the EU’s principles.

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In France, a manufacturer may apply for a “temporary recommendations for use” (RTU) application with the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). A RTU allows manufacturers to promote a current drug for an off-label use for 3 years. However, this approval is a contractual relationship; upon approval, the manufacturer is legally obligated to scientifically observe and evaluate the affected population.[16] To obtain a RTU, the manufacturer must prove that no other viable treatment for a current disease except for the off-label use of the drug in question.[17] This approach places the burden on the manufacturer, with much less incentive than the EU’s approach. Yet, there are other approaches in the world warrant further analysis. For example, in India, off-label use of any kind is strictly prohibited without exception.[18] In Japan, if the medication is for certain diseases, it can be approved for off-label use without the “preliminary clinical evidence of [the drug’s] effectiveness.”[19] So, approaches vary greatly between nations.

More importantly, the underlying policy behind these regulations – or lack thereof – must be assessed. In the U.S., the ability to prescribe for off-label use is a necessary “corollary of the FDA’s mission to regulate pharmaceuticals.”[20] The goals of pharmaceutical regulation are to protect the public safety, ensure a drug benefits specific patients groups as well as the overall population, and ensuring justice and equity in patients’ access to safe and effective drugs.[21] The regulation of drugs is specifically to ensure that physicians know that off-label use is prescribing a drug for a use that the “regulatory body has not stated is safe and effective.”[22] While these are very noble goals, a nation must not forget that off-label use is integral in medicine since many market drugs have no labeling or approved uses for specific populations.[23] For example, in Calabria, “less than 15%” of all the drugs on their market are meant for children on the basis of clinical trials.[24] While many people also fear off-label use for its inherent risks, the use of medicine is always a balancing act of benefit vs. risk. The FDA’s drug approval process requires drugs to be “safe and effective,” with the definition of safety changing on a case-by-case basis.[25] Drugs cannot always be completely void of risks, which is why a balancing act is necessary. However, if all off-label use is prohibited (as it is in India)  or, arguably, greatly stifled (like in France), then it is impossible to do a risk-benefit analysis since there is no chance to know of the benefits.[26] Therefore, a careful analysis of which underlying principle to adopt is necessary.

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The EU’s incentive approach certainly drives more research because there is seldom a greater incentive than financial. However, France’s approach to patient safety and care – while noble – places a greater burden on drug manufacturers without necessarily promising greater investment returns. However, if patient safety were the only concern, perhaps India’s approach to absolute prohibition would be the best, forcing manufacturers to conduct research for each and every possible use. Yet, Japan’s take could also allow much needed access to medications that would otherwise be either unavailable or not covered by insurance.[27] In the U.S., the approach is to allow research funding but not off-label promotion directly by the manufacturer. Each nation has a specific approach but what is truly at hand is the underlying idea of why each regulation is – or is not – viable. Indeed, it is a balancing act between the public safety, the preservation of regulatory authority, incentivizing research, keeping the manufacturers liable, and ensuring patient access to much needed drugs. Certainly, there is no one true answer – merely a set of ideas that should be adopted only after a nation knows what would be best for its people.

Jasen Lau is a third year law student at the University of Baltimore School of Law. He graduated from the University of Maryland in 2013 with a Bachelor of Arts in English. Jasen took it upon himself to become a certified pharmacy technician and studied several continuing education credits that focus on Medicare Fraud and Abuse prevention, HIPAA privacy and security laws, and ethics in the pharmacy workplace. Jasen has long been in the health care field either working directly with patients or as an assistant to providers. During that time, his obsession with working in health care has grown into policy analysis and counseling. Along with being a CICL fellow, he is also a law clerk for Johns Hopkins Hospital.

[1] The term “off-label” is defined as any use that is not authorized by the FDA.

[2] U.S. v. Caronia, 703 F.3d. 149 (2012) (Xyrem’s active ingredient is gamma-hydroxybutyrate more commonly known as the “date rape drug”).

[3] Id. at 155.

[4] 21 U.S.C. § 355.

[5] Mariestela Buhay, Off-Label Drug Promotion Is Lost in Translation: A Prescription for A Public Health Approach to Regulating the Pharmaceutical Industry’s Right to Market and Sell Its Products, 13 J. Health Care L. & Pol’y 459, 488 (2010).

[6]Christian Lenk & Gunnar Duttge, Ethical and legal framework and regulation for off-label use: European perspective, 10 Therapeutics and Clinical Risk Mgmt. 537 (2014).

[7] Id.

[8] N. Ditsch, et al., Off-label use in germany – a current appraisal of gynaecologic university departments, 16 European J. Med. Res. 7 (2011) (22 medical centers responded to a questionnaire, and of those physicians who responded, 91% said they commonly prescribed off-label use medications).

[9] Roi Piñeiro Pérez, Results from the 2012-2013 paediatric national survey on off-label drug use in children in Spain (OL-PED study), 81 Anales de Pediatría (English Edition) 16 (2014).

[10] Lenk, supra.

[11] REGULATION (EC) No 1901-2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768-92, DIrective 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726-2004, Official Journal of the European Union, Dec. 27, 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:378:0001:0019:en:PDF.

[12] REGULATION (EC) No 141/2000 OF THE EUROPEAN PARLIMENT AND OF THE COUNCIL of 16 December 1999 on orphan medicinal products, Official Journal of the European Communities, Jan. 22, 2000, http://ec.europa.eu/health/files/eudralex/vol-1/reg_2000_141/reg_2000_141_en.pdf

[13] Id.

[14] Id.

[15] Id.

[16] Lenk, supra.

[17] Joseph Emmerich, et al., France’s New Framework for Regulating Off-Label Drug Use, 367 New Eng. J. Med. 1279 (2012)

[18] Sukhvinder Singh Oberoi, Regulation off-label drug use in India: The arena for concern, 6 Persp. In Clinical Res. 129 (2015).

[19] Id.

[20] 124 Am. Jur. Trials 487 (Originally published in 2012).

[21] Lenk, supra.

[22] Id.

[23] Oberoi, supra.

[24] Francesca Saullo, et al., A questionnaire-based study in Calabria ont he knowledge of off-label drugs in pediatrics, 4 J. Pharmacology * Pharmacotherapeutics 51 (2013).

[25] 2013 Aspatore Special Rep. 5.

[26] Oberoi, supra.

[27] Ditsch, supra; Pérez, supra; see also E. L. Trimble, et al., International models of investigator-initiated trials: implications for Japan, 23 Annals of Oncology 3151 (2012) (In all nations, unless some form of off-label use is either properly documented or approved, the state health insurance will not cover the medication).

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Renunciations on the Rise: U.S. Natural Status Is Dangerous Under FATCA

 

Julia Brent

On March 18, 2010, President Obama signed a “jobs” bill into law, paid for by the revenue raising Foreign Tax Compliance Act (FATCA).  Execution of FATCA would access a deep pocket: there is an estimated $40 billion per year in international tax evasion.[i]  Thus far, the U.S. Treasury has taken in $800 million in FATCA-related revenue.[ii]  FATCA doesn’t change the obligations of U.S. taxpayers to pay their taxes on overseas earnings, but creates an enormous reporting obligation on 200,000 foreign financial institutions (FFIs) worldwide to pass on information from accounts of U.S. citizens to the IRS. [iii]  Failure to do report results in a 30% penalty on payments into the account, payable to the IRS.[iv]

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The simple solution is to take advantage of one of several U.S. Tax amnesty programs, and many are struggling to pay their taxes before the reporting begins.  However, the legislation has created complex problems for both the institutions and for taxpayers.  For example, an FFI to merely register its own company with the IRS (much less implement the giant reporting scheme) must master a 135-page guide of registration details.  Similarly, taxpayers face multiple forms and banker’s-box size submissions. For many, hiring an accountant to handle compliance is prohibitively expensive.[v] Some foreign individuals who were born in the U.S. but raised overseas by foreign parents don’t realize they have U.S. citizenship.  Some are “accidental Americans” because their parent was born in the U.S.  Staff at the IRS report that they have been overwhelmed by calls from Americans overseas regarding what they are supposed to furnish under FATCA.[vi]

The result of this high-consequence complexity is that many individuals overseas are eliminating their U.S. citizenship. Those that hold dual citizenship often are nationals with a quality country the EU, Canada, Australia, or New Zealand and are allowed travel without a visa through much of the world (including to the United States).[vii]  In the face of accessing the value of their U.S. passport, the conclusion by many is that there is a real danger.  Many institutions are ill-equipped to handle FATCA compliance, much less retracing steps to correct an error.  Already, the IRS has extended reporting deadlines because foreign governments and FFI’s haven’t finished developing IT systems, and aren’t prepared.  Some believe the scale of implementation is so large that the cost of implementing FATCA will “far outweigh the revenues.”[viii] Scotia Bank in Canada, alone, has already spent $100 million.[ix]  There is a high likelihood of a taxpayer getting caught between the cracks of an imperfect system, and being the victim of incorrect reporting, which comes with significant consequences.  An account holder does not have to be a U.S. citizen for their FFI to report them based on U.S. indicia the distinguishing information on their account.  U.S. indicia can mean as little as a U.S. telephone listed as contact information.  One would hope that if an account held by a true non-U.S. citizen was incorrectly reported as that of a U.S. citizen, the false report would be quickly corrected.  However, the sheer size of the players the IRS, state governments, and FFIs – creates a likelihood that corrections will take months, even years, to sort out in litigation against the IRS or a foreign tax administrator.

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In addition to imperfect reporting, those with American only or dual citizenship are concerned that FACTA requirements compromise privacy and the right to data protection as a taxpayer.  Many governments have executed Intergovernmental Agreements (IGAs), either without considering the rights of the individuals affected or complying by means of what is essentially coercion.[x]  Privacy issues for Canadians have been raised by former Canadian Finance Minister, Jim Flaherty.  His concern is the “far reaching and extraterritorial implications” of FATCA which, in effect, mandate that Canadian banks become extensions of the IRS and jeopardize Canadians’ privacy rights.[xi] Banks in Canada are not required to know the nationality of their clients, and, to conform to FATCA, Canada would have to change its privacy laws.[xii]  All the countries under the Model 2 International Governmental Agreements (IGA’s) have laws which either prevent disclosure or require individual consent.[xiii]  The difficulty with consent is that in many cases it is logistically impossible.  For example, Japanese banks have several hundred million bank accounts, not digitized, all with opening forms in Japanese.[xiv]

FATCA has changed Americans into outsiders in the international financial world.[xv]  As one officer of a global bank reported, the banks are ridding themselves of the “U.S. Person pollution!”[xvi] American Citizens Abroad (ACA) has received multiple testimonies from Americans abroad who have had their foreign bank accounts closed, been refused entry into a foreign pension fund, or who cannot enter into insurance contracts overseas.[xvii]  Some claim that “American citizens are being denied savings accounts, investment accounts, mortgages, credit cards and many of the basic financial services required to live and work in modern society, raise a family and to save for retirement.”[xviii] This is due to the fact that, while there are 780 million American bank clients overseas,[xix] this number is a drop in the bucket for banks who serve a much higher number of non-Americans.

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These difficulties explain why the amount of renunciations since FATCA was implemented has quadrupled.[xx]  Renunciations have caused such a backlog of paperwork that, in November last year, the fee for renunciation was increased by 400%.[xxi] The U.S. response has been inadequate:  Robert Stack, Treasury Deputy Assistant Secretary of International Tax Affairs, described the claim that Americans living abroad will give up their U.S. citizenship because of liabilities and burdens created by FATCA as Myth No. 3.[xxii]  Meanwhile, the New York Times reports, “The bureaucratic burden of identifying, verifying and reporting has caused many banks to regard American clients, particularly those of moderate means, as more trouble than they are worth.”[xxiii]

There is currently a push to make renunciation “easy and harmless,” financially and mentally, since new regulatory burdens on non-resident US citizens make living with that status nearly impossible.[xxiv]  Recently, a “renunciation meeting” was held in Canada, the first of its kind, to permit 22 Americans together to renounce their U.S. Citizenship, in spite of the $2,350 fee and paperwork. Tara Ferris, then Senior Counsel at Chief Counsel IRS, and others did an outstanding job in drafting the internal revenue rules and regulations of FATCA, an unprecedented behemouth of legislation.  However, the code implements policies that have significant unintended consequencesMass renunciations, a sort of reverse of our naturalization ceremonies, may become a thing of the future.[xxv]

[i] http://www.fas.org/sgp/crs/misc/R40623.pdf, Summary

[ii] Id.

[iii] http://www.acfcs.org/fatca-may-identify-tax-cheats-but-its-dragnet-for-financial-criminals-may-produce-an-even-bigger-yield/

[iv] http://fatca.thomsonreuters.com/about-fatca/

[v] http://cnsnews.com/news/article/gabrielle-cintorino/tax-laws-pushing-americans-living-abroad-renounce-their-us

[vi] http://www.bloomberg.com/news/features/2015-04-08/an-emotional-audit-irs-workers-are-miserable-and-overwhelmed

[vii] http://opiniojuris.org/2012/01/08/fatca-fallout-mass-renunciations/

[viii] http://www.acfcs.org/fatca-may-identify-tax-cheats-but-its-dragnet-for-financial-criminals-may-produce-an-even-bigger-yield/

[ix] http://business.financialpost.com/news/fp-street/electronic-spying-a-big-issue-for-banks-scotia-ceo-waugh-says

[x] http://www.keepcalmtalklaw.co.uk/accidental-americans-the-us-citizenship-conundrum/

[xi] http://sundominica.com/articles/fatca-and-you-1462/

[xii]http://web.archive.org/web/20130601041733/http://americansabroad.org/issues/fatca/fatca-is-bad-for-america-why-it-should-be-repealed/

[xiii] https://www.irs.gov/Businesses/Corporations/FATCA-Governments

[xiv] http://web.archive.org/web/20130601041733/http://americansabroad.org/issues/fatca/fatca-is-bad-for-america-why-it-should-be-repealed/

[xv] Id.

[xvi] http://www.finance.senate.gov/imo/media/doc/Republicans%20Overseas,%20Inc.1.pdf, page 3

[xvii] Id.

[xviii] http://www.finance.senate.gov/imo/media/doc/Republicans%20Overseas,%20Inc.1.pdf

[xix] http://money.cnn.com/2016/02/08/news/americans-citizenship-renunciation/

[xx] http://intltax.typepad.com/intltax_blog/2016/02/new-expatriate-record-2015-nearly-4300-expatriations.html

[xxi] http://www.bbc.com/news/35383435

[xxii] https://www.treasury.gov/connect/blog/Pages/Myth-vs-FATCA.aspx

[xxiii] http://www.nytimes.com/2015/05/14/opinion/an-american-tax-nightmare.html?_r=0

[xxiv] http://www.keepcalmtalklaw.co.uk/accidental-americans-the-us-citizenship-conundrum/

[xxv] http://opiniojuris.org/2012/01/08/fatca-fallout-mass-renunciations/


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Faux-Pas Fashion “Caveat Emptor”: Let The Buyer Beware

Kia Roberts Warren

Growing up in one of the fashion capitals of the world (NYC), I am, admittedly, a bit of a fashionista. I learned at a very young age that if you go down to Canal Street and enter a store looking for a Chanel boy bag that someone will take you to the small back room or a van filled with every designer name imaginable. This is the second oldest profession: counterfeiting. Many consumers believe that these counterfeiters are doing a service because consumers do not want to pay an exorbitant price for the real thing. However, counterfeiting is not a victimless crime.

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A counterfeit is a trademark infringement, a manufactured good being passed off as an original under the trademark.[1] This is harmful to luxury brands because their trademark is their business. Luxury brands rely on their trademarks to attract consumers and the brand mark signals to consumers the high quality of their products. Counterfeiting hurts the economy. The United States economy loses up to $250 billion in sales each year and 750,000 jobs lost.[2] In 2015, the EU economy reported a value 9.7% of their total sales every year or $28.7 billion and 363,000 jobs lost.[3]KRW Blog2_Photo2

Counterfeiting is a $600 billion industry and represents 5-7% of total world trade.[4]  And, these numbers are only increasing due to modern technology and the Internet. Because consumers can now shop within their own homes, counterfeit sales are on the rise because companies cannot watch the internet 24/7 looking for counterfeit sites [5] In 2007, for example, $119 billion worth of knock-off merchandise were purchased on the web.[6]

If clothing does not interest you like it does me, just know that more than clothing and handbags are counterfeited. Counterfeits have spread to toys, electronics, cosmetics, and pharmaceuticals,[7] many of which are sold through legitimate retail stores and websites.[8] These are public safety issues; these counterfeits are made with hazardous materials to the environment and to people’s health. Counterfeit luxury goods, also, have serious criminal ramifications that are not known to most consumers.

Bangladesh

Shakil Khan, 10, has worked for 4 months in a garment factory in Old Dhaka, making money for his impoverished family in Chandpur, Bangladesh. Nafeesa Binte Aziz/Toronto Star

Counterfeit luxury goods aren’t just hurting the economy, but promote child labor exploitation, human trafficking, drug trafficking, and even terrorism as well as other civil, criminal, and administrative crimes.[9] A Vietnamese crime gang leader earned $13 million selling counterfeit watches in New York.[10] Children, as young as six, are treated to excessively cruel and criminal treatment.[11] Forced laborers are smuggled into the country with the products to sell them and to place the finishing touches on the goods after getting across the borders.[12] There have been reports of authorities uncovering operations where proceeds from drug trafficking were channeled into counterfeiting and, vice versa, where profits from the sale of counterfeit goods were used to further other illicit operations.[13] The FBI has evidence that the World Trade Center 1993 bombing was financed with counterfeit luxury goods on Canal Street.[14] In 1996, the FBI found that followers of Sheik Omar Abdel Rahman, a blind cleric who was sentenced to 240 years in prison for plotting to bomb New York City landmarks, had made millions of dollars selling counterfeit t-shirts bearing Nike and Olympics logos.[15]

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So what can be done to protect fashion maisons and stop crime? Louis Vuitton employs about 40 lawyers, 250 independent investigators, and spends over $20 million each year to fight counterfeiting of its products.[16] Fashion maisons also turn to MarkMonitor (a corporation that accesses data and detects unauthorized channels and shuts them down) for help.[17] Of course, all of these costs get passed on to the consumer. There are also national laws in place. For example, the U.S. enacted the Lanham Act and Copyright Act of 1976.[18] In France, consumers can be forced to pay a costly fine and possible jail time for owning a counterfeit.[19] This idea is catching on in Italy and Britain as well. The European Union has placed two new regulations dealing with counterfeits.[20] On the international level there is International Anti-Counterfeiting Coalition (IACC), Office for Harmonization in the Internal Market, Anti-Counterfeiting Group, International Intellectual Property Alliance. The World Trade Organization has its members sign the Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement.[21]

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In 2008, Louis Vuitton sued eBay in a French court. The French court ruled that eBay did not do enough to prevent the counterfeit sales from occurring on the site and eBay was ordered to pay $60.8 million in damages.[22] In a UK court, Cartier and Montblanc were recently granted orders ruling Internet providers to block websites selling counterfeit watches under their trademark.[23] Moncler has recently become victorious in the judicial arena. The Uniform Domain Name Dispute Resolution Policy under the World Intellectual Property Organization (WIPO) granted the transfer of 50 domain names incorporating its trademark.[24] In its case against Royalcat (a Chinese company), the Beijing IP Court awarded the maximum statutory damages in a trademark infringement action.[25]

As consumers we have the power to stop the counterfeiting industry. We are hurting ourselves. We have a responsibility to protect ourselves and each other. So, if you see someone considering buying a counterfeit Prada tell them “caveat emptor.” We need to educate each other about where and who are money is going to.

For more info on how to spot a fake, click here.

Kia Roberts-Warren is a 2l at University of Baltimore. She has always had an interest in international affairs. She is interested in private international law as well as international humanitarian law. She is on the executive board of ILS as the Career Development Director and is on the Phillip C. Jessup Moot Court Team.

[1] http://www.oecd.org/sti/ind/2090589.pdf

[2] http://digitalcommons.liberty.edu/cgi/viewcontent.cgi?article=1254&context=honors

[3] http://qz.com/460932/fakes-are-costing-europes-fashion-industry-10-of-its-sales-and-thousands-of-jobs/

[4] http://michiganjb.org/issues/1/article4.pdf

[5]http://digitalcommons.liberty.edu/cgi/viewcontent.cgi?article=1254&context=honors

[6] http://michiganjb.org/issues/1/article4.pdf

[7] https://www.iwu.edu/economics/PPE17/lewis.pdf

[8] https://www.iwu.edu/economics/PPE17/lewis.pdf

[9]  https://www.unodc.org/documents/counterfeit/FocusSheet/Counterfeit_focussheet_EN_HIRES.pdf

[10] https://www.iwu.edu/economics/PPE17/lewis.pdf

[11] https://www.unodc.org/documents/counterfeit/FocusSheet/Counterfeit_focussheet_EN_HIRES.pdf

[12] https://www.unodc.org/documents/counterfeit/FocusSheet/Counterfeit_focussheet_EN_HIRES.pdf

[13] https://www.unodc.org/documents/counterfeit/FocusSheet/Counterfeit_focussheet_EN_HIRES.pdf

[14] http://michiganjb.org/issues/1/article4.pdf

[15] http://michiganjb.org/issues/1/article4.pdf

[16] http://michiganjb.org/issues/1/article4.pdf

[17] http://digitalcommons.liberty.edu/cgi/viewcontent.cgi?article=1254&context=honors

[18] http://digitalcommons.liberty.edu/cgi/viewcontent.cgi?article=1254&context=honors

[19] http://crefovi.com/articles/fashion-law/efficiently-fight-counterfeiting-fashion-luxury-sectors/

[20] http://crefovi.com/articles/fashion-law/efficiently-fight-counterfeiting-fashion-luxury-sectors/

[21] http://www.oecd.org/sti/ind/2090589.pdf

[22] http://digitalcommons.liberty.edu/cgi/viewcontent.cgi?article=1254&context=honors

[23] http://www.thefashionlaw.com/home/cartier-wins-court-order-blocking-sites-selling-fakes

[24] http://www.wipo.int/amc/en/domains/search/text.jsp?case=DNL2015-0031

[25] http://www.worldtrademarkreview.com/Magazine/Issue/59/News/Beijing-IP-Court-grants-maximum-amount-of-statutory-damages-for-the-first-time


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The Visa Waiver Program’s New and Improved Two-Tier System

Shane Bagwell

America’s most recent change to its immigration system has been a disastrous oversight of secondary consequences that often come as the result of hasty, reactionary politics. Updates to the Visa Waiver Program were generally positive, but a provision included in the update meant to restrict the travel rights of certain groups backfired. Here we will review the program, the changes, and the potential repairs planned for VWP.

The Visa Waiver Program authorizes citizens of participating countries to travel to the United States without a visa for stays of 90 days or less, avoiding the burden of applying through a U.S. Embassy or Consulate prior to entry into the country.[1] Started in 1986, the program was intended to facilitate tourism and short-term business stays, while cutting red tape and shifting State Department resources to more high priority tasks.[2]

Countries which are currently authorized under the Visa Waiver Program:

VWP

 

In light of recent events around the world, anti-immigrant, anti-refugee, and anti-Muslim sentiments have been inflamed, particularly in the west. As a result of these fears, the U.S. Congress passed the “Visa Waiver Program Improvement and Terrorist Travel Prevention Act of 2015”, section 3 of which prevented persons from entering the United States under the Visa Waiver Program if the person: “has been present, at any time on or after March 1, 2011, in Iraq or Syria, in a country designated as one that has repeatedly provided support for acts of international terrorism, or in any other country or area of concern designated by the Department of Homeland Security (DHS); and regardless of whether the alien is a national of a program country, is not a national of Iraq or Syria, a country designated as a country that has repeatedly provided support for acts of international terrorism, or any other country or area of concern.”

The second part of this change, that “regardless of whether the alien is a national of a program country” a person may be excluded as a member of a class due only to their other citizenship has been most troubling to civil rights advocates and others.[3] There has been particular uproar from the Iranian-American community, due in part to the fact that Iranian citizens are unable to renounce citizenship, and it passed down to children in certain situations. For example, Article 976 of the Civil Code of Iran states that a child born to an Iranian father, no matter where they may have been born, is an Iranian citizen. This means that, for citizenship purposes, a child whose grandfather was Iranian, but who has no cultural or political ties to Iran may be an Iranian citizen through patrilineal descent.

The second section of the act failed to make exceptions for any group visiting countries such as Syria or Iraq for legitimate purposes. The Obama administration announced that certain groups would be exempted from the visa requirement, such as journalists, humanitarian workers, those traveling on behalf of international organizations or local governments, as well as those who have visited Iraq for “legitimate business-related purposes,” or travelled to Iran after July 14, 2015.[4] These actions have received pushback from Republicans, who believe that the unilateral granting of exemptions was not authorized in the bill.

PassportControl

Because the Visa Waiver Program is reciprocal, there is a likelihood that these restrictions will be matched by partner countries.[5] Rep. Jared Hauffman (CA-2)., in a letter to President Obama, stated that “[b]ecause the VWP is founded on reciprocity, our U.S. citizen constituents are concerned that this exclusion could result in our VWP partners severely restricting, or entirely ending, visa-free travel for certain U.S. citizens.” This presents an awkward circumstance for Americans who hold multiple citizenships, either by choice or involuntarily.

Rep. Justin Amash (MI-3) introduced the Equal Protection in Travel Act of 2016 on January 13th to repeal the controversial section that applies only to dual nationals of Visa Waiver Program countries.[6]  The bill has received broad bipartisan support, but, in an unpredictable Congress, nothing is certain. As such, it is possible that the restrictions could remain in place, and that retaliatory measures could be taken reducing the utility of U.S. passports for dual nationals under the program.

Until the Equal Protection in Travel Act is signed in to law, the status of dual nations in Visa Waiver Program countries remains in flux. Without swift congressional action, the rules will remain in place, and could cause chaos for dual national travelers within the network. It is worth noting that Canadian citizens are visa exempt and are not participants in the Visa Waiver Program, and therefore the new restrictions do not apply to Canadian citizens who have dual nationality in one of the specified countries.[7]

Shane Bagwell is a 3L at the University of Baltimore School of Law, and a graduate of West Chester University with a Bachelor of Arts in Political Science. He currently serves as the President of the Military Law Association. His interests are Middle Eastern politics, international conflicts, and the law of land warfare. He is currently a law clerk for the Office of the State’s Attorney for Baltimore City, Economic Crimes Division.

[1]     “Visa Waiver Program,” U.S. Dept. of State, https://travel.state.gov/content/visas/en/visit/visa-waiver-program.html

[2]     Visa Waiver Permanent Program Act, Pub. L. 106-396, https://www.gpo.gov/fdsys/pkg/PLAW-106publ396/html/PLAW-106publ396.htm

[3]     These Changes To Tighten Visa Waiver Program Are Now In Effect, NPR. http://www.npr.org/sections/thetwo-way/2016/01/21/463846286/these-changes-to-tighten-visa-waiver-program-are-now-in-effect

[4]     Visa Waiver: U.S. Visa Rules Eased For Some European Travelers Who Visit Terrorist Hotspots, HNGN. http://www.hngn.com/articles/172169/20160122/visa-waiver-u-s-rules-eased-european-travelers-who-visit.htm

[5]     Austin, L. G. (2015, December 18). Visa Waiver Program Improvement Act short on prevention but punitive towards Iranian Americans, the Hill. http://thehill.com/blogs/congress-blog/foreign-policy/263661-visa-waiver-program-improvement-act-short-on-prevention

[6]     Equal Protection in Travel Act of 2016, H.R.4380, 114th Cong. (Referred to the House Committee on the Judiciary 1/13/2016)

[7]     8 CFR §212.1(a)

 


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TPS – A Viable Solution for Those Fleeing Gang Violence in El Salvador

Carolyn Mills

In San Salvador gang violence and killings are an everyday occurrence. Many people are fleeing the turmoil that the city is facing and heading to the United States in hopes of finding a safe haven. Temporary Protected Status, or TPS, could provide that safe haven. TPS  is granted to eligible nationals of designated countries suffering the effects of an ongoing armed conflict, environmental disaster, or other extraordinary and temporary conditions.[1] TPS could provide a potential solution to many escaping the threat of violence and the opportunity to live in the United States without fear of deportation.

CICL Blog Image 3

In the past 25 years since a civil war (with 75,000 civilian casualties), there has been a steady influx of El Salvadoran migrants to the United States. Gang violence and the recent breakdown of a truce between the country’s largest gangs, Barrio 18 and Mara Salvatrucha, has been the cause of the most recent spike in the countries death toll.[2] Newsweek reported that the onset of gang violence between rival gangs has skyrocketed, with a 70 percent increase in violent murders in the past year, overtaking neighboring Honduras in violence[3]. In fact, El Salvador has recently been named the most dangerous country in the Americas! In response to the violence, The Peace Corps has recently suspended all activity in El Salvador[4]. Unsurprisingly, the United States has seen an increase in Salvadoran migrants, often unaccompanied minors. Of the 4,450 people detained at the US-Mexico border in October and November 2015, 3,192 were unaccompanied minors. [5]

CICL Blog Image 2

On top of the massive gang violence, there have also been increased reports of human rights violations—instances of police and armed forces taking justice into their own hands and murdering innocent bystanders. [6] Some police are even calling for the extermination of area gang members.[7] In December 2015, the state Ombudsman of El Salvador found that 92% of the 2,202 human rights violations reported were from military and police personnel in the country.[8] In an effort to make El Salvador safer, it is apparent that due process of law and human rights are a sad casualty.

Those who are already in the United States are still living in fear. The Obama Administration has recently enacted a series of raids—deporting those on final orders of deportation. [9] Thus far, 121 adults and children have been taken and deported. Although none are from El Salvador yet, the fear remains the same in such a close-knit community.[10]

Some Salvadorans who are already here have been granted Temporary Protected Status (TPS). The most recent TPS status granted to Salvadorans was in response to the earthquakes in 2001 and has subsequently been renewed each year.[11]  TPS could be a viable solution. Not only does it provide El Salvadorans with some form of status, it would allow those who are proverbially ‘hiding in the shadows’ to come out and have proper work authorization.  By providing work authorization, individuals would pay taxes and become eligible for some public benefits. It would also stem the tide of legally insufficient asylum applications, which clog the already backed up immigration courts system.

Immigration Overload Flashpoint

A demonstrator that opposes illegal immigration, left, shouts at immigration supporters, Friday, July 4, 2014, outside a U.S. Border Patrol station in Murrieta, Calif. Demonstrators on both sides of the immigration debate had gathered where the agency was foiled earlier this week in an attempt to bus in and process some of the immigrants who have flooded the Texas border with Mexico. (AP Photo/Mark J. Terrill)

Conversely, some would argue that granting TPS would incentivize illegal immigration. However, I don’t think that’s the case. Fleeing on foot is not ideal. It’s expensive and risky. TPS does not provide a pathway to citizenship, but merely a band-aid, a temporary solution to a larger problem.

As a product of the DMV (DC, Maryland and Northern Virginia)—it’s hard. I have friends, neighbors and loved ones who have been impacted through this gang violence, whether fleeing from it or paying to keep their family members safe.

Without a doubt I am an advocate for the law and for justice, but I can’t see the justice in a system is that would deport people back into a chaotic and dangerous situation. It would be counterproductive to send human rights violators back to a country, while seemingly having no regard for the individuals who are being deported back into the same situation.[12] This is not to say that lawful immigration is not important, but what do you do when innocent people are being killed? There isn’t an easy solution, but I think that there is a very human side that many people aren’t seeing. These individuals are your friends and neighbors. They are people who have the same values as all of us. They want the same thing that you want – to live a life free from fear and to freely love and provide for their families.

Carolyn Mills is a graduate from of Bowie State University  and holds a Bachelor of Arts in Political Science. Carolyn is a 2L at the University of Baltimore School of Law. She serves as 2L Representative for the International Law Society.  Her interests and focus areas are on Central America and West Africa; she has traveled to both Guatemala and Honduras and hopes to visit Ghana this summer. She is currently a law clerk for the Department of Homeland Security’s Human Rights Law Section.  

[1] http://www.uscis.gov/humanitarian/temporary-protected-status

[2] http://www.newsweek.com/el-salvador-gang-warfare-death-rate-418201

[3] http://www.irishexaminer.com/world/el-salvador-is-worlds-murder-capital-374864.html

[4] http://www.telesurtv.net/english/news/El-Salvador-Voices-Concern-Over-US-Mass-Deportation-Plan-20160105-0032.html

[5] http://www.baltimoresun.com/news/maryland/bs-md-el-salvador-peace-corps-20160123-story.html

[6] https://www.opendemocracy.net/democraciaabierta/carlos-rosales-ana-leonor-morales/emergence-of-social-cleansing-in-el-salvador

[7] Id.

[8] http://www.businessinsider.com/militarized-police-violence-in-latin-america

[9] http://www.huffingtonpost.com/entry/obama-deportation-raids-families_us_568ac49ee4b0b958f65c5935

[10] Id.

[11] https://www.uscis.gov/humanitarian/temporary-protected-status/temporary-protected-status-designated-country-el-salvador

[12] http://www.theguardian.com/world/2016/jan/08/el-salvador-defense-minister-deported-us-human-rights-abuses


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Governmental Media Regulation: U.S. vs. Bhutan

Raiven Taylor

As we all know, the media is used to spread the most recent news and current events. What many people do not know is that the media have rules and regulations they must follow in order to stay on TV and/or the radio. Many rules that regulate the media differ from country to country. Although the U.S. Constitution’s First Amendment guarantees the right to freedom of the press, usually with minimum regulations, other countries, such as Bhutan, which will be explored in this blog, do not have such freedom.

The U.S. gives most leeway to print media, such as newspapers, magazines, and flyers.[i] The only real regulation for print media is to deter defamation. [ii]  Defamation happens when untrue information is printed that may cause harm to someone.[iii] Defamation can be either written (libel) or communicated verbally (slander). Broadcasting media are a little more regulated than print.

Media1

Broadcasting media are also regulated against defamation. In fact, broadcasters and their networks can be sued for slander.[iv] Broadcasting is also heavily regulated by the Federal Communications Commission (FCC).[v] The FCC polices the content of the airwaves and has the authority to fine or revoke broadcasting licenses for violating any of the following: broadcasting obscene programs at any time, broadcasting indecent programs during certain hours, or broadcasting profane language during certain hours.

Having regulations on the media could eventually spill into social media. However, to date, the U.S. has only come up with basic regulations on social media, such as the right of privacy, how one may create social media policies, and protocols for marketing on social media.[vi] Because social media is a growing media source, it has been very hard for the government to regulate.

Media2

On the other hand, Bhutan has more restrictions on media outlets. Even though Bhutan claims to have a Constitution allowing free speech and opinion, Bhutan has an Act that prohibits criticism of the king as well as anything that may undermine or attempt to undermine the security and sovereignty of Bhutan.[vii] The government even restricts and censors topics that involve Nepali-speaking residents having to leave Bhutan.[viii] Many of the media outlets hesitate to push the limits of the regulations because the media depends on the government for funding and support.[ix]

Bhutan is a country that is far behind the times on Internet and television, both of which arrived in 1999.[x]  Even though Bhutan was behind the times, almost 10% of their population is on social media.[xi] Social media gives the Bhutanese an outlet to express their own opinions and views and changed the idea of criticizing the government, giving the younger generation an opportunity to have an opinion. [xii] However, due to the growth of social media and the presence of the population on social media in Bhutan, the government decided in 2014 to draft policy on the use of social media.[xiii]

Media3

The government agreed that a huge benefit of having a social media policy would be for the government to engage its citizens and officials in the use of social media to share government information as a developmental tool for social, economic, and political change.[xiv] Discussions concerning social media use in Bhutan have even led to the idea of incorporating curriculum in the schools to have a social media component.[xv] Even though the Bhutanese government may appear to support the idea of social media and is not trying to regulate social media, the government has created guidelines one must follow when using social media. These include the requirement to be accurate, to never post anything malicious or misleading, to respect the Constitution and all laws, and to act in good judgment.[xvi] These are many things that young people do not think of when posting their opinions.

Given an option between the United States and Bhutan, I would choose to use social media in the U.S. The U.S. may regulate TV, radio, and print, but it does not regulate it in a way that would affect one’s rights. The U.S. can write, state, or show on TV what’s going on in the government, even if they disagree with what the government is doing. On the other hand, Bhutan regulates its media outlets in a way that only shines light on the government’s positive aspects instead of the negative. The Bhutanese government does not allow its citizens to share their opinions if they disagree with what the government is doing. While beneficial to maintaining the status quo in Bhutan, this restriction of rights affects the rights of the media and Bhutanese citizens alike.

Raiven Taylor is third year law student at the University of Baltimiore School of Law and is completing her concentration in International Law. She has an undergraduate degree in Political Science from Bowie State University. She has studied abroad in London, England and Clermond-Ferrand, France. She is an Senior Staff Editor for the Journal for International Law as well as Secretary for the International Law Society. Additionally, Raiven is a Rule 16 student attorney in the Immigrant Rights Clinic. Her passion and interest in international law is human trafficking and international human rights law.

[i] http://study.com/academy/lesson/rules-governing-the-media-definition-examples.html

[ii] Id.

[iii] Id.

[iv] Id.

[v] Id.

[vi] http://blogs.forrester.com/nick_hayes/13-07-31-five_common_legal_regulatory_challenges_with_social_media

[vii] https://freedomhouse.org/report/freedom-press/2013/bhutan

[viii] id.

[ix] Id.

[x] http://www.bbc.com/news/world-asia-25314578

[xi] Id.

[xii] Id.

[xiii] http://www.undp.org/content/bhutan/en/home/presscenter/articles/2015/01/14/bhutan-forms-its-first-social-media-policy.html

[xiv] Id.

[xv] Id.

[xvi] http://www.gnhc.gov.bt/wp-content/uploads/2011/05/RGoB-Draft-Social-Media-Policy.pdf


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Human Trafficking: Not Just an International Problem

Raiven Taylor

Human Trafficking is considered a “modern form of slavery,”[i] carried out by means of transporting, transferring, recruiting, and harboring individuals by means of coercion, abduction, deception, fraud, or abuse of power.[ii] Trafficking is said to generate billions of dollars through an estimated 20.9 million victims, with 1.5 million just from the United States.[iii] It is popular belief that human trafficking is only an international problem, that human trafficking only occurs in third world countries. This is far from the truth. Human trafficking happens all over the United States, even in your own “backyard.” According to the U.S. State Department, the U.S. is “a source, transit and destination country for men, women, transgender individuals, and children…subjected to sex trafficking and forced labor.”[iv]

Did you know that the Super Bowl is the single largest event in the U.S. that hosts the largest populations of trafficked humans?[v] Victims are brought to the city where the event is held and are expected to have sex with a certain number of people. Because of this, Super Bowl cities have attempted to double their training for officers, airport employees, and public service personnel in general, on how to identify and protect a trafficking victim.[vi]

Human Trafficking

The month of September, alone, there have been numerous arrests across the United States for human trafficking. In Ross County, Ohio, police arrested a 36-year-old man as a person of interest in both drug trade and human trafficking in the area.[vii] In Johnson County, Texas, police arrested 16 individuals suspected of human trafficking. The cops entered into a hotel room to find a 44-year old man who was expecting two 16-year old girls. An interview of the man revealed that the man was there to “seize the girls” and to “become their pimp, and prostitute them in Dallas.”[viii]

Earlier this year, a man was arrested in Albuquerque, New Mexico for human trafficking. This man was charged with forcing young girls into prostitution, including a 17-year old girl he found at a bus stop.[ix] After his arrest, the man even continued his trafficking operation while in jail! At trial, the jury found him guilty and the judge sentenced him to 30 years in prison.[x]

The United States is a considered a “Tier 1” country when it comes to human trafficking. This means that the U.S. government fully complies with the Trafficking Victims Protection Act’s (TVPA) minimum standards for the elimination of trafficking.[xi] The government goes to great lengths to investigate and prosecute traffickers. The U.S. also has very high prosecution rates in trafficking. The U.S. has services that are specialized in helping those who were trafficked return to civilization, including a pathway to citizenship for those trafficked from outside of the country.[xii] However, because trafficking still exists, there is still more that the U.S. can do to prevent it..   Both federal and state governments need to create victim-centered policies to ensure that victims are not punished for crimes committed and to ensure support for their health and safety.[xiii]

TraffickingTVPAMap

On the other end of the spectrum, many developing countries such as Cambodia, Cuba, and Kenya are considered “Tier 2 Watch List” or “Tier 3” countries. When countries are considered to be either of these Tiers,  countries are not fully complying with the TPVA’s minimum standards. Tier 2 Watch List countries are known to make some effort into complying with the TPVA’s standards, however the number of victims are significantly increasing. Tier 3 countries are simply those with governments who are not complying with the TPVA’s minimum standards and who are not making efforts to do so.[xiv]

In countries such as Cambodia, Cuba and Kenya, it is important to draft and finalize guidelines on how to prevent trafficking. One of the reasons trafficking is so high in these countries is because these countries are still developing and many areas are poverty stricken. Countries with a higher percentage of poverty lead people to migrate to other countries for a chance of better life, making it a lot easier for traffickers to find victims. Traffickers prey on people who are in search for a “better” life and deceive them with such lies that their dreams will come true, only for them to end up in brothels and forced to have sex or in fields or workshops for forced labor. It is important for countries like these to implement more services to help prevent forced labor and to implement protocols to prevent and protect victims of human trafficking.

In many ways, it may be easier for the U.S. to both implement and carry out such plans. Due to the government structure, which consists of the Department of Justice (DOJ), the State Department, Department of Homeland Security (DHS), Department of Labor (DOL), among others, the U.S. can divide and focus on one aspect of trafficking, whether its reporting, investigating, or prosecuting, and implement plans and share reported data with the other divisions of the government. The U.S. has a system that other countries do not, which may be why the U.S. is considered a Tier 1 country. Although the U.S. is not the only Tier 1 country, the large majority of other Tier 1 countries are developed, with the infrastructure in place to combat and prevent human trafficking. Developing countries often find themselves classified as either Tier 2 or Tier 3 due to the lack of infrastructure, financial resources, and human support and expertise.  With such countries, it is necessary to focus on the root of the problem, namely poverty, to truly combat human trafficking.

Human Trafficking 2

Overall, it is important to know and understand human trafficking so that one may protect themselves and their loved ones from becoming victimized. There is a lot of information on trafficking, and while it may not be necessary to know all of the ins and outs, it is necessary for one to know how trafficking can be prevented and what steps to take. Although the U.S. government has implemented plans on preventing human trafficking, trafficking still happens and has not yet been eliminated.

Everyone can do something to prevent human trafficking. Are you? Find where your state ranks and ways to work with organizations in your area on how to stop human trafficking. http://sharedhope.org/what-we-do/bring-justice/reportcards/

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Raiven Taylor is third year law student at the University of Baltimiore School of Law and is completing her concentration in International Law. She has an undergraduate degree in Political Science from Bowie State University. She has studied abroad in London, England and Clermond-Ferrand, France. She is an Senior Staff Editor for the Journal for International Law as well as Secretary for the International Law Society. Additionally, Raiven is a Rule 16 student attorney in the Immigrant Rights Clinic. Her passion and interest in international law is human trafficking and international human rights law.

[i] https://en.wikipedia.org/wiki/Human_trafficking_in_the_United_States

[ii] https://en.wikipedia.org/wiki/Human_trafficking_in_the_United_States

[iii] http://www.traffickingresourcecenter.org/type-trafficking/human-trafficking

[iv] http://www.state.gov/documents/organization/243562.pdf

[v] http://www.huffingtonpost.com/2014/01/15/human-trafficking-month_n_4590587.html

[vi] http://www.huffingtonpost.com/2014/01/15/human-trafficking-month_n_4590587.html

[vii] http://nbc4i.com/2015/09/10/ross-co-investigators-searching-for-human-trafficking-suspect/

[viii] http://www.wfaa.com/story/news/crime/2015/09/09/johnson-co-human-trafficking-sting-nets-16-arrests–4-days/71968108/

[ix] http://www.koat.com/news/man-sentenced-in-albuquerque-human-trafficking-case/35234566

[x] http://www.koat.com/news/man-sentenced-in-albuquerque-human-trafficking-case/35234566

[xi] http://www.state.gov/j/tip/rls/tiprpt/2013/210548.htm

[xii] http://www.state.gov/documents/organization/243562.pdf

[xiii] http://www.state.gov/documents/organization/243562.pdf

[xiv] http://www.state.gov/j/tip/rls/tiprpt/2013/210548.htm