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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United in Paralysis

Bradley Willis

On April 1, 2017, the armed forces of Syrian President Bashar al-Assad launched a chemical weapon attack on a Syrian hospital.[1]  Unfortunately, this attack is not the first instance of chemical warfare in the Syrian Civil War.[2]

Raging for the past six years, the Syrian Civil War has claimed the lives of hundreds of thousands of men, women, and children.[3]  In 2012, then-President Barack Obama drew the non-infamous “redline”, claiming it would “change my calculus” if chemical weapons were used in the Syrian War. [4] While the Obama Administration appeared to be heading towards another intervention in the Middle East, the administration soon reversed itself, placing its hopes on a deal reached with the Russian Federation.  In this 11th hour deal, the Russians were to oversee the destruction of President Assad’s chemical weapons.[5]

While the United States may well have avoided another Middle Eastern quagmire and may well have ceded prestige and influence to the Russians, the world largely watched the horror unfold as thousands of Syrian citizens were rendered helpless by chemical nerve agents.  The world was horrified at the effects of the nerve agents, and yet the world continued with business as usual.

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Just as then-President Obama was torn between military intervention in the Syrian Civil War and non-intervention, President Trump is torn between intervening in a years-long war and remaining on the sidelines.  Even though candidate Trump campaigned on an “American First” platform, consistently claiming he was against the Second Iraq War from the beginning, the President must understand that America must stand for the non-use of chemical or biologic weapons against citizens, or even on the battlefield.

America, from its founding, has stood for the universal rights of freedom and self-determination, enshrined in our Declaration of Independence from George III, chief among them, life, liberty, and the pursuit of happiness.  While, like all nations, the history of the United States is tainted with horrific episodes, the United States stands for human rights.  In the history of the world, the United States is one of the only, if not the only, nation that fought a brutal civil war to set other men free from bondage.

Furthermore, the United States, and its allies, fought two World Wars under the principles of self-determination and freedom from tyranny, persecution, and genocide.  From the ashes of the Second World War rose the United Nations.  That institution too, seems incapable of stopping Assad’s gas attacks.

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     Protected by the Chinese and Russian veto, the Syrian government will probably never pay for its gross violation of international law and the laws of war.  This then begs the question: if the United Nations is no longer an institution capable of protecting the innocent, then what is its purpose in its current form?  What would make this institution capable of truly bringing violators to justice and face the consequences of their actions?

There has been some discussion on reforming the United Nations Security Council.  In what form would such an arrangement take?  Would there be any permanent members removed from their permanent positions?  Who would take their place?  In the event present permanent members are not removed, what members would receive permanent membership?  Finally, how would that affect the veto powers?

Some have offered the addition of the “BRIC(S)” as permanent members to the Security Council, minus the already-permanent members of Russia and China.  As the leading emerging economies Brazil, India, and South Africa would receive permanent status as well as a veto.

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As the largest country in South America, Brazil would add diversity to the Council, as it would be the only permanent member from South America.  As another emerging economy with a large population, and a democracy, India would be a leading candidate to receive permanent status.  However, given various geopolitical concerns, China would likely vocally oppose any such appointment to the Security Council’s permanent members.  Pakistan, India’s longtime rival, would oppose such an appointment as well.  Given the absence of an African voice on a permanent basis, South Africa would probably receive the veto and permanent status.  But the question would then turn to the following: given the dilution of the veto, what would be its power? 

Would the United Nations determine that since there would be as many as eight members, would any veto require just one permanent member to halt a resolution, or would two members be necessary?  Could this body become more democratic, with “majority rule” be the rule?  If that is the case, how would the decidedly non-democratic states of Russia and China respond?  They could, one could plausibly foresee, cut back on their involvement in the Security Council, deciding that they no longer have as much of a stake in the body.

While the United Nations has been unable to protect the innocent in conflicts like Rwanda, the Sudan, Syria, or Eastern Ukraine, the UN must reevaluate its work.  The United Nations appears paralyzed and incapable of living up to providing for peace and prosperity for all nations.  Perhaps a remedy for this apparent paralysis could include more permanent members of the Security Council while revising the current rules regarding the veto powers of the permanent members.  

While the United Nations expressed outrage as from this most recent chemical weapons attack against an innocent civilian population, the UN has not taken any concrete actions against Bashar al-Assad.  While President Trump campaigned on an “America First” platform, the president’s most recent actions[6] are polar opposites of such a course.  United Nations Ambassador Nikki Haley stated that, regime change in Syria is “inevitable.”[7]

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It appears that President Trump is evolving in his new role as commander in chief and as leader of the free world.  From campaigning on an “America First” platform to his strikes against Syria, and the dispatching of the USS Carl Vinson strike group to the Korean Peninsula, President Trump has shown he is willing to use military force to further the interests of the United States in the absence of United Nations action.[8]

Bradley Willis is a 3L at the University of Baltimore School of Law.  He graduated from the University of Delaware (2014) with a Bachelor of Arts in Political Science and minors in History and French and studied abroad in Caen, France.  His areas of interest are international relations, history, politics, and the laws of war.  Bradley spent a semester externing with the Hermina Law Group, researching and writing sovereign immunity issues as well as embassy law.  Last year, he participated in the Philip C. Jessup Moot Court Competition.  He is currently a law clerk for the Law Office of David B. Love, P.A.

[1] http://www.cnn.com/2017/04/09/middleeast/syria-missile-strike-chemical-attack-aftermath/index.html

[2] https://www.washingtonpost.com/world/national-security/nearly-1500-killed-in-syrian-chemical-weapons-attack-us-says/2013/08/30/b2864662-1196-11e3-85b6-d27422650fd5_story.html?utm_term=.4ada9a3de471

[3] https://www.nytimes.com/2016/02/12/world/middleeast/death-toll-from-war-in-syria-now-470000-group-finds.html?_r=0

[4] https://www.washingtonpost.com/news/fact-checker/wp/2013/09/06/president-obama-and-the-red-line-on-syrias-chemical-weapons/?utm_term=.598421a987c9

[5] http://www.bbc.com/news/world-middle-east-23876085

[6] Fifty-nine Tomahawk missiles were launched from two American destroyers in the Mediterranean Sea against the airfield the Syrian armed forces launched their chemical attack

[7] http://www.cnn.com/2017/04/09/middleeast/syria-missile-strike-chemical-attack-aftermath/index.html

[8] http://www.cnn.com/2017/04/09/politics/navy-korean-peninsula/


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The Right Not to Work

Robert Steininger 

In the growing age of globalization and the rise in the use of technology, many have difficulties disconnecting from work. Smartphones have replaced the computer, the newspaper, the telephone, and much more. We are always connected, and that connection is just as tied to our employer as it is to our personal lives. Companies are starting to realize that their employees health and production have been negatively effected. One country has taken the initial steps necessary to reestablish the wall between employees’ personal and work life.[i]

On May 10, 2016, the French government used a constitutional provision to push through the El Khomri law. The law is named after Labor Minister Myriam El Khomri. Many provisions in the law were seen to benefit employers at the expense of employees, and therefore not welcomed by the French people. However, the most well liked article had the employees’ needs in mind. The law went into effect on January 1, 2017, in which France now requires employers to negotiate what rights their employees have to ignore work emails and other forms of communication. While the idea is commendable and its expected effects laudable, the complete lack of an enforceability mechanism in the law is an issue but that does not take away from the effect it can have on employees.

The right not to disconnect requires employers to negotiate what those specific rights would be for their employees, however, if the employer fails to do so, or breaks the terms of that right there is no mechanism to penalize the employer. This leaves employees in an odd place, they have a right but no means to enforce that right. It will be interesting to see if courts will take action if case is brought.

 

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For the rest of the world, however, employees still have to dread whether that vibrating phone is a friend or their employer, which can increase their stress levels. This stress can lead to what experts are calling “digital exhaustion.”[iii] Employers have taken this researched and asked themselves to consider the effect that being tied to your email can have on the overall productivity of that employee. For example, the productivity levels in the United Kingdom are poor not only because U.K. citizens work the longest hours in Europe but also due to the fact that U.K. citizens are biggest users smart devices.[iv] Britons work an average of eight and half hours a day, which equates to 1677 average annual hours with £18.64 hourly productivity.[v] A Luxembourger, by comparison, works about 1643 average annual hours, with £45.71 hourly productivity.[vi]

While the average annual hours are relatively close, the hourly productivity numbers are drastically different. This could be because not only do Britons work longer hours, but also cannot disconnect from work once they leave. Although this study was looking at the number hours worked, it could be interesting to see how many hours Britons work when not on the clock. I suspect the average annual hours would rise and the amount hourly productivity would decrease even more. However, France and England are not the only countries facing this dilemma.

 

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In 2015, a Japanese company, Dentsu, an employee committed suicide after working over 105 overtime hours in a month.[viii] In response, Tokyo’s governor ordered government employees to end their day by 8 PM.[ix] Additionally, Dentsu has since barred workers from putting in more than 65 hours of overtime a month. Japan may need to follow suit with France’s law to help further disconnect their over worked employees.

This issue of needing to disconnect can affect more than the happiness of the employees. In South Korea, employees are working so much that they are not taking time to have families. Thus, in response South Korea’s Ministry of Health introduced a monthly Family Day, where the office lights are turned off at 7 PM to encourage staff either to spend time with their families or to use that time to create a family. The Ministry had the goal of increasing South Korea low birth rate.[x]

  As globalization continues and as we stay more connected than ever, the labor laws of countries need to adapt. Employees are spending all their time increasing the profits of their employer without seeing added benefits for that work. Overall, countries need to realize that their citizenry are not there to be cogs in the machine, but to build their lives as they see fit, which means being able to have lives outside their employment.

Robert Steininger is a third year law student at the University of Baltimore School of Law.  (Candidate for J.D., May 2017).  He holds a Bachelors of Arts in Linguistics with a minor in Japanese from the University at Buffalo – SUNY.  As part of his international law studies, he took part in a winter study abroad program in Curaçao taking classes in European Union Economic law and Comparative Confession law.  He also studied in Japan at Konan University while completing his undergraduate degree. In addition to being a CICL fellow, Robert currently serves as the Volume V Managing Editor for the University of Baltimore’s Journal of International Law and the President of OUT Law.  He is also a Maryland Rule 19-217 Student Attorney with the Immigrant Rights Clinic. He is currently a Law Clerk at the American Federation of Government Employees, AFL-CIO.

 

[i] France ‘Right to Disconnect’ Law: Do We Need Rules to Reclaim Personal Time?, http://www.nbcnews.com/news/world/france-right-disconnect-law-do-we-need-rules-reclaim-personal-n704366

[ii] http://www.cultofmac.com/253917/apples-iphone-repair-guides/.

[iii] Id.

[iv] France ‘Right to Disconnect’ Law: Do We Need Rules To Reclaim Personal Time?

http://www.nbcnews.com/news/world/france-right-disconnect-law-do-we-need-rules-reclaim-personal-n704366

[v] The Most Productive Countries in the World Also Have the Shortest Work Days, https://www.indy100.com/article/the-most-productive-countries-in-the-world-also-have-the-shortest-work-days–ZJWJ1Vvw8Pb

[vi] Id.

[vii] JAMIE GRILL VIA GETTY IMAGES

[viii] France’s ‘Right to Disconnect’ and 4 Other Countries Trying to Improve Work-Life Balance, http://time.com/4620532/countries-work-life-balance/.

[ix] Id.

[x] Id.


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Burkini & Beachside Oppression: Islamophobia Wave Hits France

J. Michal Forbes

Warm sand, clear blue skies and a seamlessly endless ocean. France’s beaches along the Mediterranean have been known as some of the most beautiful beaches in the world, as well as some of the sexiest.  Whether it’s Cannes or Saint-Tropez, visitors expect the same things from French’s shores—sunlight, small swimsuits and sexy women. Then along came the burkini, which to some, threatened France’s cultural beach identity.

Last month, amidst much international scrutiny and speculation, over 30 French towns banned the burkini from their shores.[i] The first question that comes to most people’s mind is what exactly is a burkini.  Designed by Australian Aheda Zanetti, the burkini is a custom swimsuit designed specifically for Muslim women who adhere to the Islamic tradition of dressing modestly.[ii]  The burkini resembles a full body suit and covers the whole body with the exception of the swimmer’s face, hands and feet.

 

Within a matter of hours, the ban on burkinis took social media by storm and suddenly the entire world was looking at France’s shores. French Premier Manuel Valls even supported the towns that wanted to ban the burkinis claiming that France’s beaches should be “free of wardrobe associated with religion and politics”.[iii] He also said the burkini is “an expression of a political project, a counter-society, based notable on the enslavement of women.” Social scientists around the world even chimed in, alleging that the ban was not about swimwear, but about protecting France’s non-Muslim majority from having to confront a changing word and protecting Muslim women from patriarchy. [iv]

France’s ban on burkinis, did not last however. In matter of a few weeks, France’s highest courts held that mayors do not have the right to ban burkinis.[v] Since 1905, the French government has practiced laïcité, under which the government does not recognize any kind of religious influence in governmental affairs. The current ban on burkinis was seen by some as a violation of laïcité, and the government’s interface in religious affairs.

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The question arises: is the ban on burkinis really an attempt to maintain and cultivate the culture of France’s shores? It may have been originally, but around the world many critics see it as France’s latest attempt to suppress the Islamic faith within its country.  In light of the recent terrorist attacks in Nice this past summer, the ban, which was enacted weeks later, is more like Islamophobia masked as cultural preservation.

The ban on the burkinis was nothing more than a push to further ban Islamic garments. A movement that first began in 2004, when the French government previously banned Muslim headscarves (hijabs) from schools. Then again, in 2011, when France became the first European country to ban wearing in public the burqa, a full-body covering that includes a mesh over the face, and the niqab, a full-face veil with an opening for the eyes. Though the ban was ultimately upheld by the European Court of Human Rights in 2014, debate still occurred across the world whether or not this constituted religious oppression. This burkini ban is just the latest law enacted to suppress Islam within France.

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The debate surrounding the Ban on Burkinis is far from over. This issue will likely reemerge in the next French presidential election slated for 2017. There is no doubt that the issue of keeping France “homogenous “will be at the forefront.  Once again, burkinis may be banned from France’s shores.

 

If the ban on burkinis becomes national law in France where does religious oppression stop? Will nuns be prohibited from wearing coif? Perhaps priest will be prohibited from wearing clerical collars? However in a country where Catholics make up almost 88% of the population those bans are likely not to happen.[vi] The real issue is Islam and Islamophobia within France.  France’s attempts to remain homogeneous in a world that is multicultural could lead to negative implications for France. And to think, the ban on burkinis was the spark that started the fire.

 

J. Michal Forbes is a proud native of Prince George’s County, Maryland, Ms. Forbes has a fiery passion for international law, travel and frozen yogurt. After receiving her B.A. in Political Science from the University of Maryland, Baltimore she taught ESOL in the Washington, D.C. Metropolitan area before joining the US Peace Corps in 2011. Ms. Forbes served in the Peace Corps in Ukraine from 2011 to 2013, in a small town between the Red Sea and the Black Sea in Crimea. Fluent in Russian, Ms. Forbes soon caught the travel bug and traveled/worked extensively throughout Eastern Europe during her 27 month commitment. Currently a 3L, Ms. Forbes is a member of the International Law Society, Immigration Law Society, Black Law Student Association and the Women Lawyers as Leaders Initiative. She has worked for Maryland Legal Aid and the NAACP’s Office of the Attorney General. She was recently awarded the honor of being named Article Editor with the University of Baltimore Law Forum, a scholarly legal journal focused on rising issues in Maryland. It is her dream to work for the U.S. government assisting with asylum seekers and refugee. In her free time, Ms. Forbes enjoys eating frozen yogurt with her husband and learning Arabic.

 

[i] http://www.cnn.com/2016/08/24/europe/woman-burkini-nice-beach-incident-trnd/

[ii] The Surprising Australian origin of the ‘burkini’, https://www.washingtonpost.com/news/worldviews/wp/2016/08/17/the-surprising-australian-origin-story-of-the-burkini/

[iii] Manuel Valls: Burkini ‘not compatible’ with French values, http://www.politico.eu/article/manuel-valls-burkini-not-compatible-with-french-values/

[iv] France’s ‘Burkini’ Bans Are About More Than Religion or Clothing, http://www.nytimes.com/2016/08/19/world/europe/frances-burkini-bans-are-about-more-than-religion-or-clothing.html?_r=0

[v] French court suspends burkini ban, http://www.cnn.com/2016/08/26/europe/france-burkini-ban-court-ruling/

[vi] The Church in Decline: France’s Vanishing Catholics, http://www.ibtimes.com/church-decline-frances-vanishing-catholics-1125241


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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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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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Research and Public Welfare: Working with the French, We Can Have Our Cake and Eat It Too!

Jasen Lau

The US healthcare system is a system that ultimately prioritizes research. However, that is not to say we cannot have public universal healthcare. No system can offer absolute public welfare without taking away funding from research, but there can be a system that doesn’t take away as much. Keeping the research oriented priorities in mind, the US can still adopt a sort of inverted French healthcare system to provide public universal healthcare without significantly hindering medical and pharmaceutical research.

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The World Health Organization praised France for having the best healthcare system in the world[1]. Indeed, they are often touted as having the closest to perfect system in terms of patient satisfaction[2], and their system works because it is regulated but not socialized. The French healthcare system is delivered through their Social Security(SS), and financing their SS works much like ours; much of the money for SS comes from income and payroll taxes. This money is then used to insure patients through general funds, and this general fund covers around 70% of all expenses[3]. The rest of the amount owed is either paid out of pocket or through the more popular choice of voluntary insurance. This voluntary insurance works much like the private payer of the US and is often offered through employment. So, on paper, it seems that the French have most or even all of their healthcare costs covered, which is true[4]. However, the French government plays a big role in these prices.

Unlike the US, the French regulate and control the costs of medical services, products, and pharmaceutics. For example, doctors are often paid much less in France than the US[5]. So, these lowered costs are more easily covered by both the public insurance and the voluntary insurance. Therefore, to follow any model of the French healthcare system, some regulation of costs would be necessary. For the US, and to preserve the goal of research rather public welfare, absolute regulation is not necessary – just some to limit the financial burden on the government.

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Rather than having SS pay for the majority, the US could complement private insurance. Of course, this would require that the person have insurance in the first place, now mostly possible due to the Affordable Care Act (ACA) and its individual mandate, requiring everyone to have insurance or suffer penalties. Therefore, the US need only cover the gaps not paid by the private insurer. Further, the US government would also have to regulate either insurance payment or cost. To avoid significantly hindering research in the US, regulating insurance payments would not interfere with funding research. To regulate costs means to ask physicians, medical technology manufacturers, and pharmaceutical companies to relinquish money from funding in order to serve the public welfare. Thus, the US can adopt an inverted French healthcare system and regulate insurance companies to achieve a public universal healthcare.

With the ACA requiring everyone to have insurance, the first step of this proposal is met: almost everyone will have some level of insurance. The person will have their choice of what insurance to get, but to get people to choose the right insurance, the patient will have to pay premiums and some amount of copayment for services. After all, if there is absolutely no cost to the patient, everyone in the nation will, undoubtedly, choose the best – and often most expensive – coverage policy. However, if that is the scenario, that the patient should able to afford such prime insurance that all needs and wants are fully covered, then there is no need for that patient to be a part of the supplemental SS insurance. Perhaps, in those situations, a tax break could be offered. Otherwise, SS can then pay for coverage gaps in a person’s private insurance, and such funding will come from where it always has: mainly payroll and income taxes and, if need be, subsidy by other government bodies. Now, the SS payment need not cover all copayments or costs. In France, patients still have copayments, though they may simply be an extraordinary low[6]. The US can and should follow suit. The key costs to keep would be insurance premiums. To avoid excessive costs to both the healthcare system as a whole and to the supplemental SS system, patients should be made aware to buy only what is necessary to their needs. This, again, is to emphasize the concern patients must establish in choosing healthcare. Putting in baseline copayments – even if nominal – will tell the patient what can be considered a costly or non-preferred treatment.

There will need to be some insurance regulation. For if there is no insurance regulation, insurance companies court contract with providers to let the federal government bear the financial burden instead of the private insurance. So, there has to be some regulation that deters or otherwise prohibits insurance companies from diverting costs from themselves. There can be no solid solution without great deliberation, but a good starting point would be a percentage coverage regulation. Such a regulation would require that the insurance cover some reasonable amount that does not greatly deviate from what they would cover had the patient not have a federal gap coverage plan. As for physicians, reimbursement rates would be on par with Medicaid or medicare reimbursement rates, relatively low[7]. On that note, this plan would take the place of Medicare but not in the place of Medicaid. Like the US Medicaid, French Social Security offers healthcare to those who are poor[8]. The poor would not have the option to purchase private insurance to later be supplemented by SS coverage. Medicare however, is not inherently for the poor, merely the elderly, the permanently disabled, and those with end-stage renal disease.[9] So, Medicare should be replaced with this proposed private-SS coverage plan.

The general French system offers coverage for those who have worked. Those who are poor or have not worked at all are given a special fund for their coverage, often subsidized by the wealthy and working. Implementing this in the US, states could keep their Medicaid, of which the federal government subsidizes. However, Medicare will be eliminated and replaced with this proposed inverse French Healthcare system. Though, no significant harm shall come of this. Private insurance companies can and will step in to cover seniors with specific plans designed to cater to the medical needs of the elderly. In fact, much of that already occurs now. Medicare Part C is a plan handled almost exclusively by a private insurer instead of Medicare. When an elderly patient needs a plan that caters to their personal needs – of which Medicare cannot meet – patients are able to seek out Medicare Part C plans through private insurers[10]. Therefore, this inverted French plan is no different than putting every elderly person on Medicare Part C. There are, however, some elderly patients who are unable to afford private insurance. In the US, about 10% to 11.5% of those above 65 live below or at the poverty line[11]. For those patients, Medicaid would apply. This way, the vast majority of the population will be covered without extensive inhibitions to research funding.

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An inverted French healthcare system can benefit the general welfare of the US. Granted, this does come at a slight cost to funding research. The coverage gap, of which would have been normally paid in full out of the patient’s pocket, is now paid at a lesser rate due to this proposed federal coverage gap insurance. However, this is a small cost to pay for the public welfare of the US citizens.

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]http://www.who.int/whr/2000/media_centre/press_release/en/

[2]http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1447687/#r5

[3]http://www.npr.org/templates/story/story.php?storyId=92419273

[4] Id.

[5]http://prescriptions.blogs.nytimes.com/2009/09/11/health-care-abroad-france/?_php=true&_type=blogs&_r=0

[6]http://www.slate.com/articles/business/dispatches_from_the_welfare_state/2014/01/french_socialized_medicine_vs_u_s_health_care_having_a_baby_in_paris_is.2.html

[7]http://www.forbes.com/sites/merrillmatthews/2015/01/05/doctors-face-a-huge-medicare-and-Medicaid-pay-cut-in-2015/

[8]http://www.npr.org/programs/day/features/2008/jul/france/dutton.pdf

[9]https://www.cms.gov/medicare/eligibility-and-enrollment/origmedicarepartabeligenrol/index.html

[10]https://www.medicare.gov/sign-up-change-plans/medicare-health-plans/medicare-advantage-plans/how-medicare-advantage-plans-work.html

[11]https://www.americanprogress.org/wp-content/uploads/issues/2008/07/pdf/elderly_poverty.pdf; see also http://kff.org/other/state-indicator/poverty-rate-by-age/