Blog | North Carolina Journal of International Law and Commercial Regulation

Dean Harris: Bioethics in Research

Professor Dean Harris, Clinical Associate Professor of Health Policy and Management at the University of North Carolina Gillings School of Global Public Health, spoke on bioethics in research at the North Carolina Journal of International Law & Commercial Regulation Symposium on Friday, February 1, 2013. Professor Harris explored the issue of bioethics in research through a case study from China involving golden rice, a genetically modified grain. The research project was conducted by researchers at Tufts University who sought out Chinese children to periodically consume a small amount of the genetically modified rice to test the nutritional results of the rice. The issue of informed consent was at the heart of the research study. Debate continues as to whether the researchers obtained informed consent when the parents of the children signed the consent form, as it is unclear if they completely understood the implications of the form they were signing because of translation difficulties. Professor Harris ended his presentation asking the question if researchers from the United States should be required to do more to protect participants of research studies such as the children involved in the golden rice study. These issues were also explored in different contexts in Protecting a Vulnerable Population with Little Regulatory Framework, an article appearing in the Journal of Contemporary Health Law and Policy.

Questions Without Answers: The Legal Frontier of Genomic Mapping

When Professor John Conley began his presentation on the ethical, moral, and legal implications of genomic mapping, he made one thing explicitly clear: there were not going to be a lot of answers in the following hour. Throughout the presentation he proved himself to be right by showing that frontier of genomic mapping just has not developed enough to answer many of the questions that it raises. However, the questions that Professor Conley did raise were quite thought-provoking. One in particular stood out: why can we not apply existing legal frameworks in the medical field to the emerging practice of diagnosis by genomic mapping?

Consumer Awareness as Part of the Solution to Imported Food Safety

Professor Gary Liu discussed regulatory and safety problems associated with pharmaceutical outsourcing. He stated that pharmaceutical outsourcing has increased because the costs are lower and the profit margin greater. However, these benefits of outsourcing came at the expense of drug safety due to the lack of enforcement mechanism. In the United States, the Food, Drug, and Cosmetic Act of 1938 consists of two enforcement tools—outcome-based tool and production-based tool. Professor Liu specifically argued that without proper inspection, it is difficult to enforce other aspects of enforcement tools, such as seizures and injunctions, criminal sanctions, and Good Manufacturing Practices. However, both outcome-based tool and production-based tool are weakened in the context of imports. Furthermore, Professor Liu notes that solutions, such as the outsourcing regulatory power to China and a past agreement with China regarding import safety, have been inadequate to offset the lack of enforcement. Professor Liu concluded the solution is for the FDA to stop “outsourcing” regulatory power to China and for the FDA to increase efforts to inspect foreign establishments. I agree that the first step is for the FDA to retain regulatory power regarding import safety. However, as a practical problem, inspecting all establishments in China would take years. Furthermore, Professor Liu’s argument did not elaborate on the role that consumer awareness plays in improving safety standards abroad.

Giving Bioethics Bite: A Look at What Underlies the Golden Rice Study Scandal

Professor Anne-Marie Duguet, M.D., Ph.D. (in law) visited the University of North Carolina School of Law from l’Université Paul Sabatier in Toulouse, France to address the recent controversy in China surrounding a study done on children and genetically modified rice. Specifically, Tang et al (“Tang”) performed a study on the nutritional value of Golden Rice – genetically modified rice that is rich in ß-carotene as a source of vitamin A, a vital nutrient for children – in the Hunan province of China. Seventy-two children from the ages of six to eight were subjected to the study. The children were then split into two randomized groups: a control group that ate natural foods high in ß-carotene and vitamin A and a test group of children who ate Golden Rice.

Professor Nathan Cortez: Legal Risks In Medical Tourism

Professor Cortez recently spoke at the “Medical Markets” Symposium held by the North Carolina Journal of International Law and Commercial Regulation of the legal ambiguities associated with the growing trend of medical tourism in an unregulated global health market. More patients are opting to leave the United States to have procedures done overseas for a variety of reasons—the procedure may be unavailable or illegal in the U.S., or perhaps cheaper elsewhere—yet they may not realize that they may be forgoing the legal protections of American courts. Patients are bearing the brunt of legal risks because it can be very difficult to successfully sue in the U.S. or overseas.

Biobanking Without Borders: An International Perspective on the Ethics of Genomic Biobanking

In his keynote address, Professor Conley introduced plans for a bold study, conducted by the UNC School of Medicine, to identify several genes where mutations are strongly associated with common diseases, sequence those genes in a group of healthy human subjects, and then provide those subjects with information and counseling about their test results. Through his affiliation with the UNC Center for Genomics and Society, Professor Conley will study the ethical, legal and social implications (ELSI) of this kind of genomic biobanking as a public health tool.

From Madrid to D.C.: Could an American Court Invoke Universal Jurisdiction to Try Syrian President Bashar Al-Assad for War Crimes

On October 16, 1998, London police, acting on Spanish Judge Baltasar Garzón’s warrant, arrested former Chilean dictator Augusto Pinochet for authorizing the killing, kidnapping and torture of Chilean and foreign nationals. Judge Garzón’s arrest warrant was based on the rarely invoked principle of universal jurisdiction. Universal jurisdiction empowers national courts to prosecute serious violations of international law “regardless of the location of the crime[s] or the nationality of the [actors] or the victim[s].” In light of the grave human rights abuses committed by the Syrian government during the Syrian Civil War, a conflict that has claimed almost 40,000 lives according to some estimates, several scholars have argued that universal jurisdiction should be invoked to try Syrian government officials, including Syrian President Bashar al-Assad. While the principle of universal jurisdiction would seem to allow an American court to try Syrian President Bashar al-Assad for war crimes, Assad is an incumbent head of state however and is thus immune from criminal liability; furthermore, even if Assad were not immune from prosecution, unless some of his victims were US citizens or part of the US military, federal statutory law would not permit an American court to prosecute him.

Moving Towards International Norms in Cyberwarfare

In an October 12, 2012, meeting with Time magazine, Secretary of Defense Leon Panetta warned of the immediate threat sophisticated malware posed to the United States. Secretary Panetta lamented that such malware, now being developed by numerous countries, has “the kind of capability that can basically take down a power grid, take down a water system, take down a transportation system, take down a financial system.” The most recent illustration of the power of state-sponsored cyberattacks came on August 15, 2012, when Saudi Armco, the world’s largest oil company, was the victim of an attack, which researchers believe was launched by Iranian hackers in retaliation for recent attacks by the United States and Israel. The attack erased the contents of three-fourths of the company’s hard drives, leaving in their place an image of a burning American flag. Advancements in cyberwarfare present the opportunity to accomplish foreign policy and military goals without the human, economic, or political cost inherent in traditional warfare. However, it is evident that the rise of state-sponsored cyberattacks implicates strategic, ethical, and legal issues of the highest order.

When Children Speak Out

Fourteen-year-old Malala Yosafzai recently became a notorious victim of Taliban oppression when gunmen opened fired on her bus on her route home from school in Mingora, Pakistan. Spokesman Ehsanullah Ehsan acknowledged Taliban responsibility for the shooting and claimed that Malala would be targeted again if she survived. Her crime?  As an outspoken advocate of education for girls, the Taliban claimed Malala was opposing mujahideen and propagating against Islam, actions they deemed, in this case, worthy of assassination.

An argument can be made that continual infringements upon the freedom of expression might warrant outside intervention. Malala’s story provides a classic, and tragic, example of sheer disregard for the right to peacefully protest against government. Will the international community continue to let this type of abuse go unnoticed?

Establishing Legitimacy for the ICC: The Prosecutor v. Thomas Lubanga Dyilo

The United Nations first recognized the need to establish an international criminal court over fifty years ago. The periodic efforts of the international legal community finally culminated on July 17, 1998, with the adoption of the Rome Statute of the International Criminal Court. The treaty entered into force on July 1, 2002, and is currently joined by 121 countries – notably excluding the United States, China, and Russia.

The International Criminal Court (ICC) is the “first permanent, treaty based, international criminal court established to help end impunity for the perpetrators of the most serious crimes of concern to the international community.” The ICC has jurisdiction over crimes of genocide, crimes against humanity, war crimes, and crimes of aggression. The ICC’s goals are to “achieve justice for all, end impunity, help end conflicts, remedy the deficiencies of ad hoc tribunals, take over when national criminal justice institutions are unwilling or unable to act, and deter future war criminals.”