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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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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Nigeria’s Economy – Help is on the Way!

Carolyn Mills

The economy of Nigeria is the largest economy in West Africa, experiencing massive growth in the last 24 years. While the African continent, as a whole, has experienced rapid growth and development, there is concern amongst the international community regarding the threat of terror organizations, such as Boko Haram and the internal rampant corruption. The economy of Nigeria has recently faced difficulty and has made several appeals to the international community for support. Without this crucial intervention international organizations the threat of collapse could be imminent.

Boko Haram

Currently Boko Haram has taken a large foothold in the northern Nigeria, and is notably known for the kidnapping of 300 school girls in 2014, which sparked the #BringBackOurGirls movement. Boko Haram’s terror is indiscriminate as the organization is known for attacking both Christians and Muslims. Boko Haram began as a peaceful organization until 2009 when the government of Nigeria launched investigations into their activities. [1] The terror group has been credited with the death of nearly 17,000 Nigerians since its reign of terror began in 2010. [2] Corruption has been a further impediment to the growth of Nigeria’s economy. A recently published article, one of the most notable and egregious cases of corruption occurred when $195 billion naira (nearly 10 billion dollars) was pilfered from a pension fund that was intended for retired workers.[3]

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2014 was a year of great exploits for Nigeria, as it was named the largest economy in Africa (as well as most populous)[4].  Its largest industries are its growing entertainment sector known as ‘Nollywood’, followed by its large agricultural sector.[5] In the past 2 years, however, Nigeria has experienced a fall in the valuation of their currency (the naira) as oil prices have fallen below $30 per barrel. Initially following the election of President Muhammadu Buhari the stock market peaked at the hope of a new president with a new economic policy, however hopes were quickly dashed. [6] The falling price of crude oil in the country coupled with their need to import refined fuel has put much pressure on the economy and President Buhari. [7]

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In an effort to assist the country in its efforts to fight Boko Haram, the European Union has pledged more than $50 million dollars to aide in the fighting against Boko Haram[8]. The European Union has also recently pledged to assist in diversifying its nearly exclusive oil dependent economy[9]. The attractive package comes with many caveats (read strings). The EU Ambassador to Nigeria, based in Lagos, stressed the importance of business owners and investors having protection under Nigerian laws stating.[10] Although how Nigeria will ensure the protection of potential investors is still in flux, Foreign Minister Geoffrey Onyeama remains hopeful that any future agreements with other countries will provide Nigeria with technical assistance to make the transition from a primarily agrarian economy to a fully industrialized economy.[11] The more pronounced role of other states and organizations is necessary to help usher in Africa’s largest economy and assist in sustained growth—rather than a mere suggestion from the EU.

German President Guack

Despite the recent call for help from President Buhari, Germany has been the only state to show interest in contributing to the development and investment in Nigeria’s now lackluster economy. Among other things, German President Joachim Guack has pledged support in the move to eliminate corruption, which is seen as the country’s number one enemy to progress. [12]

The threat of global terrorism should not deter international development. With increased investment comes increased infrastructure—infrastructure that is undoubtedly linked to the safety of the country’s border. Without such investment, the economy will stagnate and most of its resources will be sunk into their safety and defense forces, rather than development.  It is a harrowing catch-22 for government of Nigeria, as they attempt to advance their economic and social strength, while combating terrorism and corruption that seeks to slow progress. Germany’s advanced (and seemingly sole) role in the elimination of terror and the diversification of the economy will hopefully prove to be altruistic and non-imperialistic in nature as Nigeria fights to remain a forerunner on the African Continent.

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://m.nzherald.co.nz/world/news/article.cfm?c_id=2&objectid=11250530

[2] http://www.globalresearch.ca/boko-haram-in-nigeria-the-destabilization-of-the-world-through-the-war-on-terror/5504014

[3] https://www.naij.com/402850-top-12-corruption-cases.html

[4] http://leadership.ng/features/502916/nigerian-economy-global-appeal-nwanze

[5] http://www.theatlantic.com/international/archive/2014/04/how-nigeria-became-africas-largest-economy-overnight/360288/

[6] http://qz.com/595453/the-precarious-state-of-nigerias-economy-right-now-captured-in-two-charts/).

[7] Id.

[8] Id.

[9] ( http://www.thisdaylive.com/articles/eu-pledges-to-assist-nigeria-diversify-economy/232283/)

[10] http://www.thisdaylive.com/articles/eu-pledges-to-assist-nigeria-diversify-economy/232283/.

[11] (http://allafrica.com/stories/201602100215.html).

[12] http://www.vanguardngr.com/2016/02/we-have-lost-lives-economy-because-of-corruption/


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Greek Farmers – Stuck Between a Rock and a Hard Place

John Rizos

“We live on loans, this reform will destroy us…We won’t back down, there is no way. If we do, we’ll starve.”[1]

The “Greek Farmer Crisis” began on January 20, 2016 when Greek farmers used tractors to blockade the main highway connecting Athens to Greece’s second largest city, Thessaloniki.[2] Most people are somewhat familiar with Greece’s economic crisis, including the country’s debt, recession, and capital control in reaction to IMF and EU-imposed regulations.  These regulations are now affecting Greece’s farmers, who have not been reluctant to show their adversity.

Since January 20, 2016, farmers have blockaded 68 points throughout Greece, including the main road on the Greece-Bulgaria border. Since Friday, February 12, 2016, thousands of farmers have set up protest camps outside of the nation’s parliament, in Athens[3], protesting against the Greek government’s new bill. The bill will hike taxes and cut pensions as part of an economic reform in response to the IMF’s and the European Union’s regulation, as Greece is trying to secure a third bailout.[4]

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The bill by the Greek Prime Minister, Alexis Tsipras, and his party, SYRIZA, will create reforms targeting farmers to deal with the country’s deficit. However, the reform comes as a shock to most of the public. Two decades ago, farmers did not pay into social security and only up until two years ago, a farmer’s income tax was set at a relatively low 6%. Since the tight austerity measures have been implemented, farmers’ income tax has more than doubled to 13% in the last two years. The tax rate is projected to jump to 26% this year, alongside the 10% hike of a 23% sales tax on seeds, livestock food, and pesticides.

The reform on pension spending is just as brutal. The IMF was not satisfied with Tsipras’ last austerity measures, which resulted to a pension-spending cut of only $2bn. The bill is Tsipras’ reaction for not only tighter measures, but also tighter measures to more goods and professions to meet the EU and IMF-imposed target of cutting pension-spending by $9bn. From total immunity in the last 20 years, farmers will now have to pay 27% of their annual income on top of the annual $780-1,300 every farmer must pay to the Agriculture Insurance Organization.[5]

The farmers have been joined by unionists, mainly from the most powerful agricultural union, ADEDY, since the blockades. The Greek Communist Party (KKE) also joined to support the farmers at the protest camps in Athens and to assist in lending a voice against the bill.[6] The blockades and the protest camps have been mainly organized by unionist, Vangelis Boutas[7], who has also been the representative in addressing the media or the government, should dialogue between the two groups open up. Boutas rebuffed Tsipras when he announced that he would discuss the bill with the farmers and stated that he will only talk with officials once the bill has been rescinded.[8] Interior Minister, Panagiotis Kouroublis, responded by stating that “the government is not heeding to ultimatums…the farmers should not miss this chance for a dialogue.” [9]

The Agriculture Minister and Tsipras support the bill and, although they are open to talks and slight modifications, they have dismissed any notion of withdrawing it. Tsipras stated that the bill is “not optional, nor merely a conventional obligation of the country…it is absolutely necessary for the pension system itself to have a future.”[10]

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Hostilities since February 15 have decreased and most of the farmers from the protest camps have left, even though some blockades are still in effect. Currently, uncertainty looms over the material terms in the bill as well as the bill’s future with Tsipras’ party having only a 3-seat majority in the parliament.

SYRIZA’s small 3-seat majority should not deter thinking that the bill will not pass. The country’s third bailout is dependent on the planned pension-cutting as the IMF and the EU are high-stakes creditors constantly breathing down Greece’s neck. The Central Bank Chief noted that the projected economic recovery in the second half of 2016 is contingent upon the bill passing without further delays,[11] which should serve as a persuasive foreshadow to the parliament voters. Although most farmers are skeptical of Tsipras’ promises, he has promised that they will be the main beneficiaries of $11bn EU subsidies over the span of seven years.[12] The subsidies are likely planned as such to maintain a high agricultural yield of exports as it is one of the country’s main economic sectors.

Apart from the high taxes and the cuts on pension-spending, there are other surprising things that one may miss just from taking the events that have unfolded at face value. Tsipras’ party, SYRIZA, is the radical left party of Greece. Yet amidst the protests, the party’s main opponents have been unions and the Communist Party of Greece, two groups who have been adherents to leftist ideology and with leftist constituents. It is an interesting note and shows Greece’s dependency and weakness, while highlighting the country’s important geopolitical position. The EU and the IMF have made the radical left government adopt regulations usually fit for a radically conservative government, yet Greece has no option to rebut the terms. The government may try to modify them but the EU and the IMF want to accomplish the $9bn pension-cut target, while keeping Greece in the Eurozone and maintaining political stability.

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Another surprising tidbit is the reported Athenian dismissiveness towards the farmers. Many Athenians, from the urban capital, actually see the reform as a good thing; as a way of punishing a “pampered constituency”[13] that did not contribute into social security for two decades. The Athenian mentality should not have any effect on the bill, as it will likely still pass. Although the farmers and Tsipras have not formally met, some of the austerity measures and reforms in the bill will likely be ‘loosened up’ as well, due to the economic needs of agricultural exports. As a journalist covering the protests stated, “The only way to export capital is to import it.”[14]  The main way to pay the debt is to pay it off with the money coming in from agricultural exports, which are one of the biggest parts of Greece’s economy. As a consequence, if the protests keep delaying production or production slows or stops as a reaction to the reform, the country’s debt will actually grow. Such reform coupled with consumer capital control on limiting daily cash withdrawals or restricting movement of money creates a scheme of loan dependency.

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.france24.com/en/20160213-greek-farmers-clash-with-police-pensions-protest

[2] http://www.usnews.com/news/business/articles/2016-02-09/greek-farmers-block-countrys-main-highway

[3] http://greece.greekreporter.com/2016/02/14/farmers-organize-second-rally-in-front-of-greek-parliament/

[4] https://www.rt.com/news/332332-greece-farmers-protest-athens/

[5] http://www.aljazeera.com/indepth/features/2016/02/austerity-finally-hits-greek-farmers-160203061901398.html

[6] http://greece.greekreporter.com/2016/02/14/farmers-organize-second-rally-in-front-of-greek-parliament/

[7] http://greece.greekreporter.com/2016/02/14/farmers-organize-second-rally-in-front-of-greek-parliament/

[8] http://www.reuters.com/article/us-eurozone-greece-idUSKCN0VJ1EA

[9] http://greece.greekreporter.com/2016/02/14/farmers-organize-second-rally-in-front-of-greek-parliament/

[10] http://www.aljazeera.com/news/2016/02/greek-farmers-clash-riot-police-athens-160212163808840.html

[11] http://www.reuters.com/article/us-eurozone-greece-idUSKCN0VJ1EA

[12] http://www.aljazeera.com/indepth/features/2016/02/austerity-finally-hits-greek-farmers-160203061901398.html

[13] http://www.aljazeera.com/indepth/features/2016/02/austerity-finally-hits-greek-farmers-160203061901398.html

[14] http://www.aljazeera.com/indepth/features/2016/02/austerity-finally-hits-greek-farmers-160203061901398.html

 


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British Cabinet Drops Its Obligation to International Law from Code

Shane G. Bagwell

David Cameron has led the British Parliament since 2010 and, since that date, has not shied away from controversy. Policies such as increases in tuition fees for university education, privatization of the National Health Service, and military action in Libya have led to protests in the streets. While his leadership has been unpredictable and his policies at times self-contradicting, he has grown the Conservative Party to the point where it holds an outright majority in the House of Commons. His most recent controversy involves the Government’s self-proclaimed obligations (or lack thereof) to protect and uphold international law.

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The Cabinet of the United Kingdom is the collective decision-making body of Her Majesty’s Government of the United Kingdom, made up of the First Lord of the Treasury (also known as the Prime Minister), and members of Parliament appointed by the Prime Minister to lead government departments.[1] Though typically selected from the House of Commons, it is not entirely uncommon for members of the House of Lords to be selected for certain posts. The most senior members of the Cabinet are the Deputy Prime Minister, Foreign Secretary, Chancellor of the Exchequer and Home Secretary.[2]

            Unlike in the American system, Cabinet Ministers are not necessarily experts in their field, and rely heavily on the input of members of the Civil Service for developing and implementing policy.[3] Additionally, members of the Cabinet in the United Kingdom have joint responsibility for government departments, and may, pursuant to the Ministers of the Crown Act 1975:

(a) provide for the transfer to any Minister of the Crown of any functions previously exercisable by another Minister of the Crown;
(b) provide for the dissolution of the government department in the charge of any Minister of the Crown and the transfer to or distribution among such other Minister or Ministers of the Crown as may be specified in the Order of any functions previously exercisable by the Minister in charge of that department;
(c) direct that functions of any Minister of the Crown shall be exercisable concurrently with another Minister of the Crown, or shall cease to be so exercisable.

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Cabinet Ministers are bound by the Ministerial Code, which provides ethical guidelines for the performance of their duties and outlines their relationship with Parliament. The first sentence of the Ministerial Code reads, “[t]he Ministerial Code should be read against the background of the overarching duty on Ministers to comply with the law and to protect the integrity of public life.” This is not how the sentence has read historically, however. Until October of 2015, the Ministerial Code began with providing an obligation for members of the Cabinet “to comply with the law including international law and treaty obligations…” On October 22, the Guardian published an article noting the deletion of references to international law from the Code.[4] As an executive body of the British system of government, this change (though subtle) has potentially enormous implications for the United Kingdom’s relationship with the rest of the world. Philippe Sands QC, a professor of law at University College London, said the change was “shocking. Another slap to Magna Carta and the idea of the rule of law. A government that wants to ditch Europe and sever the connection with the European Convention on Human Rights now wishes to free itself from the constraints of international law and the judgments of international courts.”[5] Ken MacDonald QC, a former director of public prosecutions, piled on to the mounting criticism of the Government’s move, stating that “[i]t is difficult to believe that this change is inadvertent. If it’s deliberate, it appears to advocate a conscious loosening of ministerial respect for the rule of law and the UK’s international treaty obligations, including weakening responsibility for the quality of justice here at home.”[6]

Mr. MacDonald’s claim that the Government’s change in policy was deliberate doesn’t require particularly deep research to back up. The Tory website hosts a pamphlet called “Protecting Human Rights in the UK : the Conservative’s Proposals for Changing Britain’s Human Rights Laws,” in which the party promises that “[w]e will amend the Ministerial Code to remove any ambiguity in the current rules about the duty of Ministers to follow the will of Parliament in the UK.”[7] The Conservative Party has a fair amount of support from Euroskeptics, and has attempted to woo voters away from the UK Independence Party (UKIP) by not-so-subtly promoting an anti-EU agenda. With an upcoming referendum on the UK’s continued membership in the EU, the Conservative party has crafted its international law obligations to reflect their desire for Parliament to once again be the supreme body of law, without interference from Brussels.

What is extremely troubling about this is that the European Union is already on shaky ground with the recent crises surrounding Greek debt, the influx of Syrian refugees, and others. The Cameron Government’s decision to distance itself from the international community is a regressive policy which stands only to harm British interests. Without a strong commitment to establishing itself as a participating member of the international community, let alone a voice within the European community, the Cabinet finds itself in the precarious situation of being Europe’s least social member. As the world becomes more interconnected and reliant on international commerce, Britain’s continued aversion to participation could spell out its downfall from the international stage. While Britain retains a seat on the U.N. Security Council, it appears to be a holdover of those lost days when Britain held its head high as a global power and exercised itself as a force for good. While David Cameron backs both horses and pledges personal loyalty to the EU, yet simultaneously dismantles Britain’s obligations to the mainland, he belittles Britain’s prestige, rather projecting his country to the world as a manic and indecisive antique, wrestling with the opposing forces of its colonial past and potentially tumultuous future.

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

[1] http://www.parliament.uk/mps-lords-and-offices/government-and-opposition1/her-majestys-government/

[2] http://www.historylearningsite.co.uk/british-politics/the-executive-in-british-politics/the-cabinet-and-british-politics/

[3] http://www.parliament.uk/about/faqs/house-of-commons-faqs/members-faq-page2/

[4] http://www.theguardian.com/law/2015/oct/22/lawyers-express-concern-over-ministerial-code-rewrite

[5] Id.

[6] http://www.theguardian.com/law/2016/feb/11/no-10-legal-challenge-ministerial-code-rewrite-international-law

[7] https://www.conservatives.com/~/media/files/downloadable%20Files/human_rights.pdf


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North Korea: Actions, Not Words

Christian Kim

On February 7, 2016, North Korea drew heavy criticism from the United Nations by launching the Taepo Dong 3, a long-ranged missile.(1)  North Korea’s defense to the launch was that this was not a sign of aggression but, rather, a peaceful satellite test.(2)  This was not the first time that North Korea launched a missile test.  North Korea launched seven separate missile tests ever 1993, three of which occurred in the past four years.(3)  Although the first series of missile tests were unsuccessful, North Korea their success rate increases with every launch.  The missile test prior to the Taepo Dong 3 had the capability of reaching 10,000km, with the potential to target over 38% of the United States.(4)  With Taepo Dong 3, the coverage extended to 13,000km, allowing North Korea to target as far as New York City and Washington D.C. (5)

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The international community needs to take North Korea’s recent missile launch as a serious threat.  North Korea has consistently spewed hostile rhetoric of annihilating the United States, as well as the “puppets” of the United States, South Korea. (6)  Further indication that the Taepo Dong 3 missile test was far from innocent is North Korea’s past acts of aggression towards South Korea.   Even though the two Koreas signed an armistice agreement in 1953, they are still technically at war.(7)  In 2002, North Korea launched a surprise attack on a South Korean vessel, resulting in the death of six South Korean sailors.  (8)  In 2010, North Korea sunk the Cheonan, a South Korean naval vessel, in the Yellow Sea.(9)  Over 46 sailors were killed in this belligerent attack from the North.(10)  Despite North Korea’s denial of these attacks, South Korea had proof that North Korea was responsible.(11)   Almost eight months after the sinking of the Cheonan, North Korea unleashed an artillery attack on Yeonpyeong Island, destroying over 70 buildings and killing two South Korean soldiers as well as two civilians.(12)

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Although the United Nations Security Council unanimously condemned North Korea’s long-range missile test, this condemnation along with their proposed economic sanctions will not change North Korea’s attitude.(13)  Past economic sanctions on luxury items were unsuccessful because the North Korean regime managed to smuggle luxury items in through their biggest ally, China.(14)  Even though China’s relationship with North Korea has significantly deteriorated in the past few years, they still consider each other as important allies.  This is evident in the amount of trading that goes on between the two countries: 57% of North Korea’s imports and 42% of their exports are with China.(15)  It is unlikely that China will follow in the steps of the international community since China will have a lot to lose if they agree to the economic sanctions.  To convince China will take a lot more than simple persuasion and the change will not occur overnight.  For now, the most immediate step the international community can take is to convince South Korea to shut down the Kaesong Industrial Park indefinitely and to continue blasting anti-North Korean messages on their DMZ loudspeakers.

The Kaesong Industrial Park (“Kaesong”) is a joint economic collaboration between North and South Korea.  Kaesong is located in North Korea, approximately six miles north from the Demilitarized Zone.(16)  Over a hundred South Korean companies set up factories in Kaesong to employ over 50,000 North Korean workers.(17)  These North Korean workers work for a significantly cheaper wage than their Southern counterparts, so this is a profitable venture for the South Korean companies.(18)  Even though the South Korean companies pay wages directly to the North Korean workers, these workers are forced by the North Korean government to give the majority of their pay to the government.(19)  As a result, the North Korean government sees this region as a very important source of income.  There have been proposals in the past to have watchdogs ensure that wages stay with the Kaesong employees; however, the Kaesong employees were picked by the regime for their loyalty.(20)  It does not matter how many measures South Korea takes to ensure the wages go where they belong, it will eventually end up financing the very programs that South Korea is adamantly against. Although South Korea has pulled out of the Kaesong complex because of Taepo Dong 3 missile test, this is most likely a temporary decision.  Kaesong has been prone to shut downs and re-openings depending on the fluctuating tensions on the Korean peninsula.(21)  As soon as North Korea “apologizes” in regards to the missile test, it is almost certain that South Korea will restart operations at Kaesong.  Since these South Korean companies are indirectly financing the North Korean regime’s missile and nuclear tests, the South Korean government should step in and force these companies to shut down their operations in Kaesong indefinitely.  Even though the indefinite shut down of Kaesong will dampen the relations on the Korean peninsula, North Korea will realize that their neighbors down South are done playing games.

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While shutting down Kaesong indefinitely is one solution, restarting the DMZ loudspeakers would be an even better move.  In 2015, two South Korean soldiers were injured by landmines while patrolling the DMZ.(22)  These bombs were planted by North Korean soldiers with the intent to harm South Korean soldiers.  Once again, North Korea denied any involvement and refused to apologize.(23)  In response, the South Korean government reactivated their loudspeakers on the DMZ border.(24)  These loudspeakers can be heard up to 7.5 miles past the DMZ during the day and almost 15 miles past the DMZ at night.(25)  The loudspeakers are a source of concern for the North Korean government since news is broadcasted that the regime has attempted to keep from its citizens.(26)  These broadcasts, often, highlight the reality of the terrible conditions in North Korea.  At other times, the loudspeakers blast news stories from daily lives in the South or K-Pop music.(27)  North Korea has constantly threatened to fire at these loudspeakers, but were warned by the South that any attacks would be reciprocated.(28)  In order to have the South Korean government turn off the speakers, North Korea begrudgingly agreed to claim their sorrow at the South Korean soldiers’ injuries.(29)  Even though this wasn’t the best apology one could have hoped for, it was nevertheless an apology from a country that rarely acknowledges their mistakes.  If these loudspeakers made North Korea agree to take responsibility for the planted bombs, perhaps the continuation of these loudspeakers could make the North fess up to their “peaceful” missile tests and to take action against any future tests.

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Whether or not China agrees to apply economic sanctions to North Korea, the first step for the international community is to urge South Korea to take immediate action against the North.  Once South Korea has implemented the previously suggested measures, the next step should be for the entire international community to place harsh economic sanctions on North Korea.  Aside from medical and food sanctions, the international community should place a ban on any trade of non-essential goods.  The North Korean regime relies on the idea of self-reliance (“Juche”). If the citizens of North Korea realize that the government is no longer self-sufficient, the North Korean regime’s façade of a successful country will deteriorate.  When this realization occurs, the regime will have no choice but to listen to the demands of the international community.

Christian Kim is a 2L at the University of Baltimore School of Law and graduated from the University of Maryland with a Bachelor of Arts in Criminal Justice. He currently serves as the President of the Asian Pacific American Law Student Association as well as the 2L Rep for the Student Bar Association. His interests are East Asian politics, international conflicts, and human rights.  Before Law School, Christian has worked for the Korean Ministry of Education as a TaLK (Teach and Learn in Korea) Scholar and Coordinator for two years. He is currently a legal intern at the Hermina Law Group and a law clerk for the Law Office ofHayley Tamburello.

(1) http://www.usatoday.com/story/news/world/2016/02/07/north-korea-missile/79963198/#

(2) http://www.usnews.com/news/articles/2016-02-08/north-korean-missile-launch-prompts-new-calls-for-sanctions-tough-response

(3) http://www.bbc.co.uk/news/world-asia-pacific-15278612

(4) http://www.cnsnews.com/commentary/bruce-klingner/north-koreas-missile-launch-shows-it-could-target-us-homeland

(5) Id.

(6) http://www.theguardian.com/world/2016/jan/09/north-korea-says-souths-propaganda-broadcasts-taking-it-to-brink-of-war

(7) http://www.bbc.com/news/10165796

(8) https://medium.com/war-is-boring/north-koreas-history-of-violence-b9af3d35c17a#.rvt3ch8e0

(9) http://www.bbc.com/news/world-asia-32013750

(10) Id.

(11) http://www.bbc.com/news/10130909

(12) http://www.theguardian.com/world/gallery/2010/nov/24/south-korea-north-korea-pictures

(13) http://www.cnn.com/2016/02/07/asia/north-korea-rocket-launch-window/

(14) http://www.huffingtonpost.com/2013/03/20/north-korea-sanctions-luxury-goods_n_2910005.html

(15) http://www.anser.org/babrief_nk-economy-feature

(16) http://www.bbc.com/news/business-22011178

(17) Id.

(18) Id.

(19) http://www.rfa.org/english/news/korea/north-koreans-make-less-money-than-their-counterparts-at-kaesong-08142015164241.html

(20) http://www.cnn.com/2013/04/09/business/north-korea-economy-explainer/

(21) http://www.cbsnews.com/news/north-south-korea-resume-work-at-joint-kaesong-industrial-park-after-5-month-shutdown/

(22) http://www.dailymail.co.uk/news/article-3192103/South-Korea-accuses-North-Korea-planting-landmines-maimed-two-soldiers-patrolling-volatile-border-threatens-make-Pyongyang-pay-harsh-price.html

(23) Id.

(24) http://www.thestar.com/news/world/2015/08/17/north-and-south-korea-turn-up-loudspeakers-to-blare-propaganda-at-each-other.html

(25) http://www.bbc.com/news/world-asia-35278451

(26) Id.

(27) Id.

(28) http://www.telegraph.co.uk/news/worldnews/asia/northkorea/11813728/North-Korea-attacks-South-Korea-military-border-unit-and-fires-shots-at-loudspeaker.html

(29) http://fox6now.com/2015/08/24/tensions-eased-as-northsouth-korea-reach-deal-on-apology-loudspeakers/

 


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The Precarious Situation of Turkey

Carolyn Mills

Turkey has long been awaiting the day that it can be welcomed into the European Union (EU). Unfortunately with the rise of the Islamic State (ISIS) in Syria, the thousands of Syrian refugees fleeing to Turkey’s border, its internal conflict with the Kurds, and human rights abuse allegations; Turkey may never have the chance to receive that welcome.

Turkey has been an associate member of the EU since 1963, all the while hoping to become a full-fledged member.[1] In May, the EU struck a deal with Turkey in which Turkey agreed to house migrants fleeing the violence in Syria in exchange for $3 billion Euros. Further, it came with a dangling carrot that promised to restart the stalled accession talks that have been ongoing since 2005. Even German Prime Minister Angela Merkel has thrown her support behind Turkey in exchange for its agreement to house the refugees.[2]

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It seems as though Turkey is fighting a losing battle. With tensions between Turkey and Russia mounting since Turkey gunned down a Russian fighter jet, Turkey is facing an even more intensified battle within its own borders with the Kurdistan Peoples Party, or the PKK.[3] The conflict between the government and the PKK is not something that is new; the government’s efforts have increased to quell the efforts of what it labels a terrorist organization. [4]

The PKK has also been deemed a terrorist organization by the US and others in the international community. Since a breakdown of a truce between the government and the PKK in mid-2015, tensions have heightened and violence erupted in the southwest quadrant of the country. Not only is the country inundated with nearly 70,000 more migrants (adding to the nearly 2 million migrants currently there)[5], but Turkey itself cannot even contain the pre-existing violence and tensions within its own borders. Most recently violence erupted in the Kurdish town of Cizre with reports of innocent women and children being caught in the crossfire. [6]

Human rights abuses in Turkey are an ever-increasing concern. Recently, Turkish military forces shot 10 unarmed civilian Kurds, 2 of which were killed, with no recourse. As a result, the UN has called for an investigation. This also calls into question Turkey’s ability to comply with EU directives. EU member states who hold the fate of Turkey’s accession have been silent amid the accusations.[7]

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My fear is that the EU and the rest of the international community are putting entirely too much strain on Turkey. Last year EU Member States agreed to help resettle 22,500 refugees from Turkey and only 779 have been resettled as of the end of January.[8] A recent corruption scandal found that the government exercised too much power over state agencies (read police, military and the judiciary).[9]

It is as if the international community is waiting to place the blame on Turkey if and when something does go horribly awry. With the myriad of struggles facing Turkey both internally and externally, and their clear desire to join the EU there is a waiting game to see is Turkey has the capacity and ability to provide stability for themselves, and abroad.

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.euractiv.com/enlargement/eu-turkey-relations/article-129678

[2] http://uk.reuters.com/article/uk-europe-migrants-germany-turkey-idUKKCN0SC08020151018.

[3] http://www.bbc.com/news/world-middle-east-35495157

[4] http://www.telesurtv.net/english/analysis/A-History-of-the-Turkish-Kurdish-Conflict-20150728-0042.html

[5] http://www.bbc.com/news/world-middle-east-35495157

[6] https://www.washingtonpost.com/news/worldviews/wp/2016/02/03/as-syria-burns-turkeys-kurdish-problem-is-getting-worse/.

[7] http://www.nytimes.com/2016/02/02/world/europe/un-turkey-human-rights.html?_r=0

[8] https://www.hrw.org/news/2016/01/29/turkey-alone-cant-solve-europes-refugee-crisis

[9] https://www.hrw.org/world-report/2015/country-chapters/turkey.


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The Trans-Pacific Partnership’s Investor-State Dispute Settlement Provision : A Baby Step toward Legitimacy

Esther Grenness

In Senator Elizabeth Warren’s (D-MA) op-ed published in the Washington Post in February 2015, she excoriated the Investor-State Dispute Settlement (ISDS) provision of the Trans-Pacific Partnership (TPP) free-trade agreement.[1] In her op-ed, she painted the ISDS provision as a nefarious tool by which multinational corporations could “tilt the playing field” in their favor.[2] This would undermine U.S. sovereignty by enabling foreign corporations to take the United States to a corporate-lawyer-infested arbitration panel and slough off regulations designed to protect the public.[3] And the cherry on top? All this would occur without a day in U.S. courts and the legal bill would be dumped on the backs of U.S. taxpayers.[4]

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Even though Warren’s op-ed was in response to the as yet unfinished agreement, opposition has remained steadfast against the TPP.  With such a visceral reaction to a single provision of a free-trade agreement, one would think that ISDS provisions were something new to U.S. involvement in the investment treaty world. This is far from the case. There are currently over “3,000 agreements worldwide [that] utilize some form of ISDS, and the United States is party to 50 such agreements.”[5]

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While ISDS provisions are nothing new, they are still highly controversial. The line between private and public law is blurred. According to Stephen Schill, “investor-State arbitration is better analogized with judicial review of governmental conduct under administrative (or constitutional) law at the domestic level or international judicial review.”[6] Because investor-State arbitral decisions affect entire nations, the reality is that ISDS functions as “an instrument of global governance” where “public law values of equality, predictability, transparency, and democratic control of decision-making” come into play.[7] This is the foundation of the major objections to the practice of ISDS. The processes is notorious for the lack of transparency, the inability for third parties to participate or have a voice in the process, the risk of improperly biased arbitrators, and the lack of appealable decisions. Furthermore, without a consistent body of law from which to draw, a decision under one treaty can violate a provision in another treaty.[8]

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Even with these very real and valid concerns about the whole ISDS system, the ISDS provision in the TPP is not the demon it has been made out to be. It follows on the heels of revisions to the United Nations Commission on International Trade Law (UNCITRAL) Arbitration Rules and the Mauritius Convention, which expanded third-party participation in disputes and increased transparency in the process.[9] The Mauritius Convention, in particular, has the potential to expand this transparency “to the entire treaty-based international investment regime as it stood on 1 April 2014.”[10] Indeed, the TPP’s ISDS requirements are among the most liberalized and transparent of any trade agreement reached to date. The provision requires publication of the documents, and it allows concerned third parties to participate as amicus curiae.[11] Most significantly, the provision requires not just application of the rules of the treaty itself, but also the application of relevant rules of international law.[12] This takes ISDS jurisprudence beyond the scope of a “treaty-by-treaty approach to investment law reform.”[13] The “normative pull”[14] of the decisions reached under the TPP will have more gravity, which brings the international investment body of law closer to the goal of consistency.

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However, the TPP does not currently have a method by which decisions may be appealed (although this may be changed at a later date).[15] Enter the Trans-Atlantic Trade and Investment Partnership (TTIP). Although not finalized, the European Commission has proposed an almost complete overhaul of the ISDS system, whereby the arbitrators would be permanent appointees with demonstrated neutrality (perhaps already appointed to a judicial function in their home state.)[16] This is all highly controversial and in a complete state of flux, but the general trend in the formation of investment treaties is moving toward a more liberalized, public oriented approach to Investor-State Dispute Settlement.[17] While the procedural process may slow significantly,[18] the legitimacy of the whole system will grow.

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There are a myriad of issues posed by ISDS; however, the TPP is a step in the direction of legitimizing the ISDS process. The TPP’s ISDS provision is not a multinational corporation’s nefarious tool for tilting the judicial balance in its favor. In a world of an increasingly interconnected, globalized economy with exponential growth, there are bound to be growing pains and stumbling blocks along the way. The TPP’s ISDS provision is a step in the right direction, small as that step may be.

 

 

[1] The Trans-Pacific Partnership (TPP) is an enormous free-trade agreement between the United States, Canada, Australia, Mexico, Japan, Malaysia, Peru, Vietnam, Chile, Brunei, Singapore, and New Zealand. The United States signed the agreement on February 4, 2016, but the agreement hasn’t yet been submitted to Congress for a vote. The TPP contains an Investor-State Dispute Settlement (ISDS) provision, where disputes between foreign investors and States are to be settled via arbitration rather than going through the domestic court system. Investors have standing to challenge sovereign actions, such as state-imposed regulatory measures. The TPP member countries represent around 40% of global gross domestic product (GDP) (https://ustr.gov/tpp/overview-of-the-TPP); Warren, Elizabeth. 2015. “The Trans-Pacific Partnership Clause Everyone Should Oppose.” Washington Post, February 25: 3. Accessed February 2, 2016.

[2] (Warren 2015)

[3] (Warren 2015)

[4] (Warren 2015)

[5] Malawer, Stuart. 2015. “Looking at Dispute Resolution In the Trans-Pacific Partnership.” New York Law Journal, December 8: 4. Accessed January 30, 2016.

[6] Schill, Stephan. 2013. “The Public Law Paradigm in International Investment Law.” EJIL: Talk! December 3. Accessed February 1, 2016. http://www.ejiltalk.org/the-public-law-paradigm-in-international-investment-law/.

[7] (Schill, The Public Law Paradigm in International Investment Law, 2013)

[8] Levine, Eugenia. 2011. “Amicus Curiae in International Investment Arbitration: The Implications of an Increase in Third-Party Participation.” Berkeley Journal of International Law 29 (1): 200-224 at 218

[9] Schill, Stephan. 2015. “The Mauritius Convention on Transparency: A Model for Investment Law Reform?” EJIL: Talk! April 8. Accessed January 29, 2016. http://www.ejiltalk.org/the-mauritius-convention-on-transparency-a-model-for-investment-law-reform/.

[10] (Schill, The Mauritius Convention on Transparency: A Model for Investment Law Reform? 2015)

[11] (Malawer 2015)

[12] (Malawer 2015)

[13] (Schill, The Mauritius Convention on Transparency: A Model for Investment Law Reform? 2015)

[14] (Schill, The Mauritius Convention on Transparency: A Model for Investment Law Reform? 2015)

[15] (Malawer 2015)

[16] Lawson, Alex. 2015. EU Floats Overhaul of Investment Arbitration Process. Law360, May 5. Accessed January 30, 2016.

[17] (Schill, The Mauritius Convention on Transparency: A Model for Investment Law Reform? 2015)

[18] (Levine 2011) at 219