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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Legitimizing China’s Claim in the South China Sea

John Rizos

Conflict in the South China Sea is an alarming threat to international peace. The current situation between the US and China navies is reminiscent of a newspaper’s reaction to the Gulf of Tonkin Resolution during the Vietnam War. The US is planning to exercise its “freedom to navigation” through a third voyage in the South China Sea[1]. The voyage is said to be an assurance that China is not colonizing any disputed islands and not restricting trade or rights described in international law.

The Pentagon has been tracking Chinese military activity closely[2]. Officials have stated that China has increased spending on and usage of military modernization and has expanded its presence in the South China Sea[3]. US officials and military personnel have stated that such activity, especially in disputed areas, is destabilizing and poses a threat to trade routes in the region. This threat could damage America’s, and its allies’, trade route and competitiveness[4]. To emphasize the importance of the trade route in this region, $5Tr worth of shipping passes through the South China Sea each year[5]. Increased suspicious activity includes the construction of airfields on a man-made island on the Mischief Reef[6], attacks on Filipino fishermen[7], the deployment of anti-ship missiles in the area[8], and the attempted reclaims of Scarborough Shoal near the Philippines[9].

Although the Chinese government has condemned America’s intervention as indicative of a “Cold War” mentality and against modern trends for peace and cooperation, the US government has reassured that it will continue to send vessels to conduct freedom of navigation exercises[10]. It has made clear that it will not usurp to Chinese demands to stop such voyages. The US claims that China’s suspicious activity is against international law as preparations to colonize or annex disputed territories[11]. Maritime law allows for states to include seas up to 12 miles from their coast within their internal boundaries[12]. China claims that the US voyages will violate the 12-mile rule and will directly interfere with Chinese sovereignty[13]. US officials have stated that the navy will go wherever international law allows and any attempt of China to implement an Air Defense Identification Zone (ADIZ) would be ignored[14].

25-nine-dashed-line-in-the-south-china-sea

An ADIZ would allow for complete control of the sky over disputed territories, which would require aircrafts to alert the government of their entry/exit. Failure to alert may result in military action. China has implemented an ADIZ over the disputed Japanese Senkaku Islands, but has never exercised it against US aircrafts that constantly ignore it [15]. The US is treaty bound to protect Japan and the Philippines. It will begin operating from five different bases in the Philippines[16]. The bases are strategic in regards to the widespread claims, which include small islands in dispute amongst China, Taiwan, Brunei, Malaysia, Vietnam, and the Philippines. The base locations are significant since they are located in the eastern South China Sea and face all the sovereign states and disputed islands of the region.

According to China, the U.S. violations of state sovereignty are direct challenges to the state’s national interests [17]. China claims control in many of the disputed islands based on “ancient activity.”[18] The US has responded to disputed claims by stating that the voyages are not meant to establish support on any sovereignty’s claim but rather to conduct operations that no unlawful restrictions on international law rights and freedoms exist[19]. Further, the China’s naval spear,[20] Hainan Province, is geo-strategically important. It is located in the South China Sea and it faces the region eastwardly and southwardly. China asserts that it should have authority over these islands and would manage and supervise these territories from the Hainan Base. It would include nearby islands within its 12 mile boundary and close off routes as internal waters. The Hainan base is stocked with nuclear submarines, through which China can and will defend itself [21].

It is understandable for China to view the U.S. voyages as challenges to their assertion of sovereignty. Article 17 of the UN Convention on the Law of the Sea, however, allows foreign ships to navigate “innocently” through another sovereign’s territorial sea. Article 19 of the Convention establishes the criteria of “innocent passage.” Under the criteria, a foreign ship is prohibited from using weapons or any threat of force, collecting state information, spreading propaganda, launching military devices or vehicles, loading or unloading commodities, fishing, polluting, conducting research, interfering with communications, and exercising any other activity that does not have a direct bearing on passage. Because China is arguing that these islands constitute a part of its territory, the waters could be considered part of its territorial sea. Further, China clearly does not buy the fact that the U.S. would not be collecting state information, conducting research, or interfering with its communications.

It is important to note that Article 17 is only applicable to waters within the borders of a sovereign, which would include the 12 mile extension rule of territorial seas from a sovereign’s border. The South China Sea, however is not (currently) part of China’s waters, rather it is open for international navigation. Even if China attempted to create an archipelagos by creating artificial islands or annexing disputed territories in the South China Sea, innocent passage for international navigation would still be allowed under Article 53 of the Convention[24]. China should watch out regarding its reliance on UNCLOS to save them in this fight, however, since Article 60 explicitly states that, “artificial islands…may not be established where interference may be caused to the use of recognized sea lanes essential to international navigation.”[25]

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However, absent the artificial islands, China might have a case in claiming many of these territories based on a landmark international arbitration case. The 1928 “Las Palmas Case” in the Permanent Court of Arbitration held that in a disputed territory, an inchoate title could not prevail over continuous and peaceful display of authority by another state. Further, it is not necessary that display of sovereignty should go back to a very far distant period. In that case, the Netherlands’ display of authority prevailed in claiming Dutch possessions in the Philippines over the US’ claim on title of discovery[26]. Thus, it might be persuasive for China in showing that the mixture of its “ancient activity” and its continuous intervention in affairs over a territory might suffice as creating the disputed territories proper Chinese claims (in fact, it somewhat mirrors adverse possession on a global scale).

John Rizos is a 2L at the University of Baltimore School of Law. He has an interest in human rights and international criminal law. In addition to being a CICL Fellow, he is the Secretary for Phi Alpha Delta. He graduated with honors from Towson University with a BA in International Studies (2013). He has interned at the Press Office of the Greek Embassy in Washington, D.C. and the International Civil Advocacy Network (ICAN), a non-profit organization advocating for women’s rights in the Middle East.

[1] http://www.reuters.com/article/us-southchinasea-usa-idUSKCN0WZ018

[2] freebeacon.com/national-security/pentagon-concerned-chinese-anti-ship-missile-firing/

[3] http://economictimes.indiatimes.com/news/defence/chinas-activities-in-south-china-sea-may-pose-threat-to-trade-routes-us/articleshow/51612043.cms

[4] Id.

[5] http://sputniknews.com/asia/20160402/1037392985/us-challenges-china-tests-sovereignty-south-china-sea.html

[6] http://www.reuters.com/article/us-southchinasea-usa-idUSKCN0WZ018

[7] http://www.breitbart.com/national-security/2016/03/31/u-s-will-not-recognize-chinas-south-china-sea-borders/

[8] http://freebeacon.com/national-security/pentagon-concerned-chinese-anti-ship-missile-firing/

[9] http://www.morningnewsusa.com/china-war-south-china-sea-hainan-2368508.html

[10] http://www.breitbart.com/national-security/2016/03/31/u-s-will-not-recognize-chinas-south-china-sea-borders/

[11] Id.

[12] http://sputniknews.com/asia/20160402/1037392985/us-challenges-china-tests-sovereignty-south-china-sea.html

[13] Id.

[14] http://www.breitbart.com/national-security/2016/03/31/u-s-will-not-recognize-chinas-south-china-sea-borders/

[15] Id.

[16] Id.

[17] http://sputniknews.com/asia/20160402/1037392985/us-challenges-china-tests-sovereignty-south-china-sea.html

[18] http://www.breitbart.com/national-security/2016/03/31/u-s-will-not-recognize-chinas-south-china-sea-borders/

[19] http://www.reuters.com/article/us-southchinasea-usa-idUSKCN0WZ018

[20] http://www.morningnewsusa.com/china-war-south-china-sea-hainan-2368508.html

[21] Id.

[22] http://www.un.org/depts/los/convention_agreements/texts/unclos/unclos_e.pdf at 30.

[23] Id. at 31.

[24] Id. at 42.

[25] Id. at 45.

[26] http://legal.un.org/riaa/cases/vol_II/829-871.pdf

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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.

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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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International Clinical Trials: Shaky Grounds for Bioethics

Jasen Lau

Isai in the Moldavian region of Romania, Megrine in northern Tunisia, Tartu in Estonia, and Shenyang in Northern China all have something in common. Unfortunately, they are not the world’s best vacation spots. No, large pharmaceutical companies have targeted these locations as places to run clinical trials.[1] These towns are among many similar towns – poor, distant, and isolated from major cities – that are often favored by many pharmaceutical companies. This recent globalization of clinical trials has raised many questions about both the ethics and efficacy. As international clinical trials grow in popularity, serious consideration needs to be given to the bioethics of conducting such trials in developing countries.

Clinical trials are the backbone of pharmaceutical development. The Food and Drug Administration (FDA) requires them before a drug can be marketed to the public.[2] Clinical trials are often broken into four segments – Phase I, II, III, and IV – and are used to assess the safety and efficacy of the developing drug.[3] Phase I begins with a smaller sample – usually around 20 to 30 people – and is the most dangerous part of the trials.[4] Phase I is where the level of safety and efficacy of the medication is mostly unknown. As the trials progress to Phases II and III, so, too, do the number of participants. Phase IV is post-market observation.[5] This phase monitors the drug after it has been released and is meant to document what effects arise from large-scale use. Clinical trials are meant to uncover the dangers and risks of medication, but this procedure can often take a lot of time and money.

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Most clinical trials can take around a decade.[6] During such time, costs can be around $2.6 billion – not including post-market procedures.[7] These costs come from advertising, subject compensation, and general research procedures, like conducting international clinical trials. With such high costs, many pharmaceutical companies seek to lower costs. International clinical trials have been very popular since 2008.[8] Currently, roughly 60% of the clinical trials being conducted are recruiting research subjects outside of the U.S.[9] By conducting trials overseas, pharmaceutical companies are saving vast amounts of money. For example, in India, a case report from a “first-rate” research center costs $2,000, which is less than one tenth the cost of recreating that same report in a “second-tier” research center in the U.S.[10] This is where the research subjects from developing countries come into play.

In nations where income is low[11], the chance of receiving state of the art medicine is a welcomed opportunity. However, in these remote locations where the US holds no jurisdiction, what assurances do these subjects have that they will be treated fairly? The Nuremberg Code requires basic ideas such as voluntary consent, maximizing benefits while minimizing costs, and taking patient care as first priority.[12] In addition, the Declaration of Helsinki expands upon this and includes the idea of protecting vulnerable populations (the elderly, incarcerated, pregnant, and children), a duty to protect the integrity of the patient, ensuring that those who are harmed are compensated.[13] These codes are meant not just for the U.S. but the global practice of medicine. It is important to note, however, that these ethical guidelines are precatory – not mandatory. Further, prior to the start of the trial, research groups must submit their proposal or application to an Institutional Review Board (IRB). These IRBs are comprised of both medical and non-medical staff that determine the safety of the trial and ensure the welfare of the test subjects.[14] While these protections are in place, the question becomes to what extent and how thoroughly do these guidelines and procedures protect the subject?

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Informed consent is one of the many things required when conducting research. Without going too deeply into the nuances, what true choice do these subjects from developing countries have? Even in a developed country, such as the U.S., many scholars have speculated the true need for informed consent in the practice of medicine.[15] In the end, in part due to the extreme disparity in medical knowledge expertise between subject and researcher or patient and doctor, the subject is more or less consenting to the trustworthiness of the doctor – not the actual procedure. Likewise, the subjects of these nations may not truly be consenting to the research procedure. Rather, their need for medical care at no cost to them greatly incentivizes assent. If that is the case, what point is there, then, in informed consent for these kinds of subjects?

IRBs play a key role in approving clinical trials. However, they are American citizens. Their job is to determine if the trials are ethical and take patient welfare into consideration, but they are not present to routinely monitor the clinical trials.[16] Even the FDA, those who ultimately approve a drug based on these trial results, do not inspect all – nor even a significant number of – these international clinical trials. In fact, the FDA inspects only around 0.7% of such trials.[17] If an IRB is not physically present to protect patient welfare, and the FDA seldom inspects these trials, who is actually protecting these test subjects?

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With the benefits of a relatively large population, all of whom are nearly always willing to partake in studies, and being outside the jurisdiction of the FDA, pharmaceutical companies are greatly incentivized to conduct their research outside of the U.S. There is concern that this will eventually lead to more harm than benefit. There is no assurance that researchers will abide by ethical guidelines, and even if the researchers practiced according to those guidelines, harm can still come to the subjects. When a test subject is harmed, where are they to turn for treatment? Or does this globalization turn a cold shoulder to international research subjects? Further, if the medication is mostly tested on international citizens, whose diets, lifestyle choices, and environmental factors greatly differ from American citizens, how safe is the medication for the average American?

 

The unfortunate conclusion to these rhetorical questions is that clinical trials are growing ever more appealing. While there is not yet currently any solid argument for harm, the obvious threat looms over subjects from developing countries. Such subjects, in need of modern western medication, may not be able to give informed consent to research. Yet, without these treatments, some of these subjects will be no better off than before. Globalization of clinical trials leads to a plethora of bioethics issues, and as it often is with bioethics, there is rarely a concrete answer now nor will there be one in the near future. Adding on the increased complexity of international jurisdiction, the question is whether these American pharmaceutical companies should be made more responsible, and if so, who should – or can – enforce that kind of duty or even impose it? The best thing that can be done at the moment is consistent, thorough analysis of all clinical trials. At the very least, the FDA should increase investigation of these international trials. The future merely holds a balance of powers and desires: cost-saving options for pharmaceutical companies and the bioethics thereof versus the length of reach of FDA’s regulatory authority.

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] Donald Barlett & James Steele, Deadly Medicine, Vanity Fair, Jan. 2011, http://www.vanityfair.com/news/2011/01/deadly-medicine-201101.

[2] Step 3: Clinical Research, U.S. Food and Drug Admin., Nov. 23, 2015, http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm.

[3] Id.

[4] Id.

[5] Id.

[6] Cost to Develop and Win Marketing Approval for a New Drug is $2.6 Billion, Tufts Ctr. for the Study of Drug Dev., Nov. 18, 2014, http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study.

[7] Id.

[8] Daniel Levinson, Challenges to FDA’s Ability to Monitor and Inspect Foreign Clinical Trials, Dept. of Health & Human Serv., June 2010, http://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf.

[9] Trends, Charts, and Maps, ClinicalTrials.gov, February 2016, https://clinicaltrials.gov/ct2/resources/trends (54% of the studies are recruiting exclusively outside the U.S. while an additional 6% is recruiting both in and out of the U.S.).

[10] Seth Glickman et al., Ethical and Scientific Implications of the Globalization of Clinical Research, 360 New Eng. J. Med. 816 (2009).

[11] Romania Average Salaries & Expenditures, World Salaries, (Feb. 26, 2016), http://www.worldsalaries.org/romania.shtml (Prices have been converted to U.S. currency for ease of understanding. A dentists average salary is less that $500 a month, engineers make about $700 a month, and physical therapists makes just over $400); see also China Average Salaries & Expenditures, World Salaries, (Feb. 26, 2016), http://www.worldsalaries.org/china.shtml; Occupational Employment and Wages, May 2014, Bureau of Labor Statistics, Mar. 25, 2015, http://www.bls.gov/oes/current/oes291021.htm; see also Occupational Employment and Wages, May 2014, Bureau of Labor Statistics, Mar. 25, 2015, http://www.bls.gov/oes/current/oes291021.htm (The average salary of dentists and physical therapists is about $14,000 monthly and $6,800 monthly, respectively).

[12] The Nuremberg Code, U.S. Dept. Health & Human Serv., Nov. 7, 2005, http://www.hhs.gov/ohrp/archive/nurcode.html.

[13] WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, World Med. Ass’n, (Feb. 26, 2016), http://www.wma.net/en/30publications/10policies/b3/.

[14] Clinical Trials, MedlinePlus, January 28, 2016, https://www.nlm.nih.gov/medlineplus/clinicaltrials.html.

[15] Peter Schuck, Rethinking Informed Consent, 103 Yale L.J. 899, 1994.

[16] Glickman, supra.

[17] Levinson, supra at 15.

 


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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