Jun 15 2011

International Trade Administration – Rare Earth Elements, China, and Washington DC

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The global externship commenced on June 6th, 2011, just three days after my return from China.  Early that Monday morning Adam and I met with Jane Earley, the Director of Pharmaceuticals and Medical Devices for the International Trade Administration (ITA).   She directed us to our offices in the Herbert C. Hoover Building (Department of Commerce).

After formal pleasantries with the staff here at ITA, I was immediately assigned a project regarding rare earth elements used in the medical industry.  Rare earths, a group of 17 minerals sharing similar chemical properties, are vital in the manufacturing and production of green technology, military defense equipment, and medical devices.  In the realm of medical devices, rare earths are commonly used for x-ray equipment, x-ray film, and in the manufacturing of MRI equipment.  Currently, China produces 97 percent of the world’s rare earths, which has resulted a Chinese monopoly of the minerals.  Therefore, the rare earth situation in the United States is now being referred to as “critical” by officials and scholars alike.

My task here at the ITA is to form a report, as well as a 30-page paper for Widener, analyzing the rare earths situation.  This requires much scholarly research on the topic, but also requires that I meet and discuss the issue with people familiar with the industry.  Thus far, I have met with government employees, academics, scientists, and industrial folks.  I often visit with the international trade specialists here in the office who help direct me to persons I can contact about the subject.  Additionally, it is required that I attend conferences and events held throughout Washington.  For example, on June 14th I attended a congressional hearing on Capitol Hill held by the Committee on Science, Space, and Technology.  The hearing concerned the federal perspective on the United State’s critical mineral strategy.

So far the externship has been a great opportunity to work on hot issues in international trade, meet people and set up personal networks, and understand fully how business in Washington goes about.  My favorite part of the day is my walk through the National Mall to the Department of Commerce building.  The Capital Building and Washington Monument looming overhead can inspire just about anyone to want to achieve success in this city.

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Jun 15 2011

Department of Commerce, International Trade Administration: Veterinary Drugs and the US and Global Markets

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When I landed at the International Trade Administrations (ITA), an office of the Department of Commerce, I really did not know what to expect. I was eager to begin my research and ready to soak up as much information as I was capable. Upon walking into the door of the ITA I knew only the subject of my two month long project, but nothing of the specifics that would fill the daunting thirty page paper looming over my head. As is normal with a new job, I found myself a bit lost at first. I did not know how to find the information I sought or even who could point me in the right direction. This haze did not last long and a full day of searching around on the internet gave me enough information to feel comfortable asking others in the office. As soon as I did, the flood gates opened and I was bombarded with information and pointed in new directions. Before I knew it, I was just another in the office; someone actually asked me for answers the other day. Within fifteen minutes, I had the answer; I had contributed, unexpectedly but appropriately and I hoped to do more. We shall see what the next two months throws at me; if I can handle the project generously given to me, I think I can handle anything.
So what is this new project? I am tasked with finding out what the domestic and global market it for veterinary drugs. Generally this encompasses both animal pharmaceuticals and biologics. The ITA is interested in knowing how large the industry is, both in this country and globally. Critical to this inquiry is the state of the US export market, the main nations importing US animal drugs and the potential for growth. Also important are the existence of trade barriers found and what, if any, effect they have on the US export market.
A very important aspect of the vet drug industry, domestic and globally, is the social, economic and environmental issues associated with the use of the drugs on animals. The main focus being the effect of human health from the consumption of the meat treated with the drugs when the animal was still alive. This issue seems to break down into two separate issues depending on the type of drugs used. In the realm of antibiotics, the issue rests with bacterial resistance. When it comes to drugs such as pharmaceuticals, the issue rests with the residues of the drugs left at the time of human consumption. Both are issues that face the industry and how these are resolved may have a direct impact on the future of the industry.
This project will conclude with my recommendations, based on my research of the industry and the issues related to it, on if the ITA should supplant itself into the fray and begin representing the industry as it goes forward. In March of 2010 President Obama put into effect the National Export Initiative (NEI) and the ITA is interested in knowing if the vet drug industry is one that needs to be along for the ride.
This will quite possibly be the most difficult thing I have ever done, but if there is one thing that I have learned in law school, it is that the more difficult something is going to be the better you feel when you have finally completed it. I take this optimistic view as I go forward, with an open mind and an open ear.

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Jun 15 2011

United Nations- Summer at the MDG Office

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I have been given the extraordinary opportunity to be extern at the United Nations Development Programme (UNDP), Campaign to End Poverty 2015. The Millennium Campaign Development office is part of the UNDP and their global mission is to inspire people to take action and end poverty.
As the turn of 21st Century, nations around the world came together and decided it was time to end poverty. Poverty is the root of all evils in this world because it causes instability within the political realm and threatens security around the world. Nations around the world made a pact in 2000 that eradicating extreme poverty would be the end result. The three actors in this pact of promising to end poverty were: underdeveloped countries, developing countries, and the United Nations.
The commitment lies in those who make a promise. In 2000, 189 world leaders signed the Millennium Declaration and promised to meet the Millennium Development Goals in order to end extreme world poverty. For the first time, the millennial generation with the knowledge, technology, and resources paved the way to eradicate poverty across the globe.
The Millennium Development Goals (MDGs) originated from the Millennium Declaration produced by the United Nations. The Declaration asserts that every individual has the right to dignity, freedom, equality, a basic standard of living that includes freedom from hunger and violence, and encourages tolerance and solidarity. The MDGs have tracked the progress of poverty reduction in these areas in order to achieve the goals by 2015.
There are eight MDGs targeted at improving the lives of the world’s poorest individuals. The MDG’s are the following: eradicating extreme poverty and hunger; achieving universal primary education; promoting gender equality and the empowerment of women; reducing child mortality; improving maternal health; combating HIV/AIDS, malaria and other diseases; ensuring environmental sustainability; and developing a global partnership for development. All of the goals are mutually dependant; therefore, if there is success in one goal it shadows success in all the goals. The MDGs were formulated to increase an individual’s human capabilities and “advance the means to a productive life”. The MDGs are written broadly because it allows for individual countries to tailor their policies to meet their specific goals

As an extern, I provide support in policy research and analysis focusing on Japan MDG review summit, the Integrated Implementation Framework (IIF), and the South Korea Aid Effectiveness meeting. In addition, I participate in other UN Meetings dealing with the MDGs and prepare synthesis reports on the commitments made, achievements realized and existing gaps.
Outside the externship realm, living in New York City for the summer has been amazing. The city is a cultural hub and has great parks/museums, restaurants, and nightlife. The externship experience is very positive and challenging. I am grateful for this opportunity and look forward to continue working on my projects. Until next time- au revoir!

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Jul 27 2010

World Trade Organization’s Agreement on Government Procurement

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The World Trade Organization (WTO) has an agreement solely on the issue of government procurement and it is the WTO’s Agreement on Government Procurement (GPA).  The WTO is an international organization that is run by its member governments with all major decisions being made by the member countries as a whole.  The rules and agreements are then enforced by the members themselves.

The GATT entered force before the GPA but the issue of government procurement was explicitly excluded in the GATT.  However, there was a growing awareness of the trade-restrictive effects of discriminatory procurement policies which prompted the desire to bring government procurement under international agreed trade rules.  This desire lead to negotiations to bring about the GPA.

The GPA entered force on April 15, 1994.  It is a plurilateral agreement which means that not all WTO member countries are bound by it.  Only those member countries that affirmatively agree to the GPA will be bound.  Out of the WTO’s 153 member countries, only 40 are party to the GPA and another 25 are observers.  The GPA is centered around 2 main principles: non-discrimination and transparency.

Parties to the GPA agreed to treat the products, services, and suppliers of any other party to the Agreement “no less favorably” than they would give their own domestic products, services, and suppliers.  Parties may not discriminate against the products, services, and suppliers of other Parties and must not treat domestic suppliers differently because of affiliation or ownership.  Furthermore, the GPA stresses procedures for providing transparency of laws, regulations, procedures, and practices regarding government procurement at all stages of the process.  There is a general requirement of publishing laws, procedures, regulations, and judicial opinions as well.  Only those countries party to the WTO’s GPA are bound by it which means that any country that is not party to the GPA may still have discriminatory government procurement policies.


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Jul 27 2010

The Use of Legal Courses of Action to Achieve the MDGs

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There have been a great number of national commitments made and program initiatives created in order to achieve the MDGs. Many of these commitments, however, have not been fulfilled as evidenced by the current status of the MDGs. The U.N. itself does not have an international legal enforcement entity that enforces the agreements made as it is not a world government. Thus, ultimate responsibility for achieving the MDGs lies with the countries themselves rather than with the United Nations. In most instances, there are no legal ramifications against member states that do not fulfill their promises due to the fact that the MDGs are not a direct legal entitlement because the U.N. is not a world government and the Millennium Declaration is not a legally binding document. There are other indirect forms of enforcement, nonetheless, that obligate nations to fulfill its promises to guarantee the success of the MDGs because ultimately, the MDGs are a culmination of previous strived-for pledges that already have existing frameworks to ensure their achievement.

First, the U.N. Charter has empowered the Security Council with enforcement mechanisms, such as collective measures or military action, which it may use against countries that violate the Charter. For example, as is well known, war and poverty are inseparable tragedies that devastate national and regional economies, and deplete natural and human resources. In order to achieve the MDGs (particularly, MDGs 1, 3, 4, 6, 7 and 8), the Security Council may resolve to place arms embargoes on countries that engage in war to signal its disapproval of the war, and to limit the resources available to the violating actors. The Security Council has adopted resolutions that place arms embargoes on countries such as Sudan, Lebanon, the Democratic People’s Republic of Korea (North Korea), Sierra Leone, Iran, and Liberia.

Secondly, many international agreements incorporate the MDGs and legally compel member states that have ratified these agreements to fulfill their commitments in achieving the MDGs. For example, the U.N. Charter requires all member states to “fulfill in good faith the obligations assumed by them in accordance with the present Charter,”  which includes responsibilities such as complying with the resolutions adopted by the Security Council and taking “action in co-operation with the Organization for the achievement of the purposes set forth in Article 55.” Because the MDGs represent a global commitment to basic human rights, the MDGs are encompassed in the legal obligations resulting from human rights treatises. For example, the Universal Declaration of Human Rights incorporates every MDG into its legal framework., particularly Article 25(1) of the Universal Declaration of Human rights which states that “[e]veryone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.” The General Agreement on Tariffs and Trade (GATT) pertains directly to MDG 8 as it requires participants who have ratified this agreement to comply with the established trade rules which call for the gradual reduction of tariffs, duties, import quotas, and other trade barriers for goods, services, and intellectual property.

Thirdly, political pressure has always been a resourceful method to employ in holding governments and its officials accountable for their actions and promises; it ensures enforcement of laws made and agreements entered into. In some instances, governments receive political pressure from citizens, nongovernment organizations and civil society organizations that support its officials or certain issues and programs. The Global Call to Action against Poverty (GCAP) is a worldwide alliance of millions of citizens and thousands of NGOs, trade unions, civil society organizations and others that demand realization of the MDGs by calling upon world leaders to take action and   “[c]hallenging the institutions and processes that perpetuate poverty and inequality across the world to defend and promote human rights, gender justice, social justice and security needed for survival and peace.”  Since 2005, GCAP has been very successful in mobilizing over 221 million people around the world in the fight to end poverty, putting political pressure on politicians and world leaders by engaging in different campaigning tools including holding poverty hearings and speaking at notable international political meeting such as those held by the International Financial Institutions.

Lastly, there have been cases around the world in which plaintiffs have been awarded redress which also indirectly increase the success of the MDGs. The Social and Economic Rights Action Centre (SERAC) and the Centre for Economic and Social Rights (CESR) in New York petitioned to the African Commission on Human and People’s Rights alleging that the Nigerian Government violated human rights laws and the African Charter by condoning and participating in the production of oil without adequate monitoring and safety measures which has resultantly contaminated the environment and has caused environmental deterioration and community health concerns. It also alleges that the government attacked, burned, and destroyed several Ogoni villages when the villagers tried to defend their land and home.  In 2001, the Commission found that the Nigerian Government violated the African Charter on Human and People’s Rights Articles 2, 4, 14, 16(1), 18(1), 21(1) and 24.  The Commission appealed to the Nigerian Government to “to ensure protection of the environment, health and livelihood of the people of Ogoniland” by engaging in several acts, including: “[s]topping all attacks on Ogoni communities and leaders by the Rivers State Internal Securities Task Force and permitting citizens and independent investigators free access to the territory; [c]onducting an investigation into the human rights violations described above and prosecuting officials of the security forces, NNPC and relevant agencies involved in human rights violations; [and e]nsuring adequate compensation to victims of the human rights violations, including relief and resettlement assistance to victims of government sponsored raids, and undertaking a comprehensive cleanup of lands and rivers damaged by oil operations.”

In carrying out the principles set forth in its Charter, the United Nations strives to do so through the implementation and maintenance of the rule of law. The Millennium Development Goals exemplify this effort. Although the organization itself cannot legally require member states to achieve the MDGs, there are several legal means of enforcement to ensure that member states are performing the responsibilities agreed upon when each country ratified the U.N. Charter and other international agreements. With five years remaining before the deadline set for achieving the MDGs, it is crucial that these legal enforcement mechanisms are pursued in order to achieve the MDGs.

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Jul 26 2010

World Health Organization – Geneva

Palace of Nations, United Nations, Geneva

Palace of Nations, United Nations, Geneva

Bonjour!  It is with great pleasure that I submit this blog entry from Geneva, Switzerland.  This summer I had the wonderful opportunity of traveling here to complete an 8-week internship with the World Health Organization.

The World Health Organization was founded in 1948 as a specialized agency under the United Nations.  The Constitution of the World Health Organization sets out the organization’s main objective as “the attainment of all people of the highest possible level of health.”  To meet this objective, the World Health Organization (“WHO”) engages in programs to fight and control outbreaks of infectious disease, to provide safe and effective vaccines, to encourage healthy life styles and discourage unhealthy habits such as smoking, to provide safe and effective pharmaceuticals, to combat HIV/AIDs, to provide guidance and support to Member States, etc…

WHO Executive Board Room, Geneva Headquarters

WHO Executive Board Room, Geneva Headquarters

My internship with the WHO is with the Essential Medicines and Pharmaceuticals department, under the direction of Dr. Hans Hogerzeil.  The Essential Medicines and Pharmaceuticals department is one of the largest departments in the WHO.  This department develops a model list of essential medicines and pharmaceuticals for Member States to reference, it engages in programs to monitor the good governance of medicines and controlled substances, and it has the sole, worldwide responsibility of assigning every new pharmaceutical an International Non-Proprietary Name.

Under the terms of reference for this internship, I have been researching the laws and regulations of multiple countries in an effort to determine which, if any, laws and regulations allow citizens of a given country to achieve access to essential medicines.  This project has tested my research capabilities in ways that I never could have imagined.  Furthermore, working for an international organization has allowed me to interact with brilliant minds from all over the world.  The staff of the Essential Medicines and Pharmaceuticals department alone speaks over 50 different languages!  I have also had the opportunity to interact with WHO interns from almost every continent.

Besides the wonderful academic environment, just being in Switzerland for the summer is pretty amazing!  I have spent my weekends meandering the old city of Geneva, listening to a string quartet in the Cathedral in Lausanne, hiking in the Alps, watching the World Cup at a public viewing area with hundreds of fans, paragliding in Interlaken, and wine tasting in the Swiss Riviera (which is listed as a UNESCO World Heritage Site).  And if that isn’t enough, Switzerland’s central European location make it the ideal starting point for weekend excursions to Venice, Milan, Paris, Vienna, Prague, Berlin, and almost anywhere else!

The summer internship with the World Health Organization is a truly amazing way for one to spend their summer and will surely become a greatly sought-after position.

Au revoir!

Lausanne, Switzerland with Lake Geneva and the Alps

Lausanne, Switzerland with Lake Geneva and the Alps

David Walker hiking above Aletsch Glacier

David Walker hiking above Aletsch Glacier

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Jul 26 2010

United States Trade Representative’s Special 301 Report

Published by under Global Health

The United States Trade Representative’s (USTR) Special 301 Report is an annual review of the protection and enforcement of intellectual property rights in countries around the world, conducted under the authority granted in the Trade Act of 1974. Under Special 301 provisions, the USTR is charged with identifying which countries deny adequate and effective protection for intellectual property or deny fair market access for innovators who rely on that protection. A country that is identified as a Priority Foreign Country is deemed to have the most egregious policies with the greatest impact on U.S. products. These countries are subject to investigation that may potentially lead to dispute resolution in front of the appropriate body set out in the relevant trade agreement. Furthermore, USTR has created watch lists that identify problems in countries that do not yet rise to such a level to be identified as a Priority Foreign Country. Countries placed on the Priority Watch List are subject to increased bilateral attention and USTR may apply sanctions to countries that fail to implement provisions of a bilateral intellectual property agreement.

USTR must interpret intellectual property standards in light of the Doha Declaration on Public Health, discussed in my last post, which affirmed the right of WTO Members to utilize the TRIPS flexibilities to the fullest extent in order to promote access to medicines for all. USTR has previously favored TRIPS-Plus provisions—pushing for patent linkage, restrictions on compulsory licenses, and data exclusivity—in the face of the TRIPS flexibilities to promote access to medicines for all. In the 2010 Special Report, USTR formally pledged to respect “a country’s right to protect public health and, in particular, to promote access to medicines for all.” Furthermore, USTR formally acknowledged a country’s right to grant compulsory licenses, but encouraged countries to do so in a way that maintains IP protection and enforcement.

The intellectual property issues surrounding biologics and advocated for by the U.S. in recent legislation, including viability of patents and extended periods of data exclusivity, will surely be addressed in future Special 301 Reports. Biologic medicine will play an increasingly large role in global access to medicine initiatives, and with increased access comes debates over intellectual property and future innovation.

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Jul 15 2010

Counterfeits Taking Over the World!

Published by under Global Health

Well maybe that’s being a little dramatic, but since I’ve been at the ITA, I’ve learned that in many of the world’s countries counterfeit drugs has been a problem and that this problem is increasing as I write this blog post.   

The first step here is to define what a counterfeit medicine is, but that has proven to be difficult seeing as everyone has a different definition.  The World Health Organization has defined “counterfeit medicines” as “medicines that are deliberately and fraudulently mislabeled with respect to identity and/or source.”  (http://www.who.int/mediacentre/factsheets/fs275/en/)  However defining this term is difficult because both branded and generic medicines are being counterfeited.  Furthermore, counterfeit medicines may include “products with correct ingredients or with wrong ingredients, without active ingredients, with insufficient or too much active ingredients, or even with fake packaging.”  Another problem is that counterfeiters don’t just use one method of counterfeiting; their methods change day to day to avoid detection.

Right now, counterfeiting medicines is greatest in regions where regulatory and enforcement systems for medicines are weakest such as in many African countries, in some Asian and Latin America countries.  In these countries, many people can’t afford to buy the real medicines so they will seek out the cheaper ones.  This problem with counterfeiting drugs needs to be dealt with because the use of counterfeit drugs can cause treatment failure and can lead to death.

There have been some steps taken to combat this counterfeiting problem.   There are some companies around the world are coming up with inventive ways to help with this problem.  For example, there is a company called Sproxil that has come up with the idea of using scratch off tags to combat counterfeit medicines in Nigeria.  These tags will be attached to genuine medicines and once someone scratches it off, they will be given a number they can text to see if the medicine they are about to buy is genuine or counterfeit. (http://www.xconomy.com/boston/2010/06/04/counterfeit-medicine-fighter-sproxil-declared-winner-at-ibm-smartcamp-event-spotlighting-technology-that-improves-the-physical-world/

While most people think of counterfeit money or knock off purses, but now that counterfeit drugs are saturating the drug market, the global health arena must take notice and take action.

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Jul 14 2010

The United Nations and its Role in the Rule of Law

Although the United Nations is not an international government, it is the governing authority on international law. One of the stated purposes of the organization is to “establish conditions under which justice and respect for the obligations arising from treaties and other sources of international law can be maintained.” In addition, Article 103 of the  U.N. Charter gives the Charter supremacy over both prior and subsequent international agreements by stating that “[i]n the event of a conflict between the obligations of the Members of the United Nations under the present Charter and their obligations under any other international agreement, their obligations under the present Charter shall prevail.” Paragraph 1 of Article 102 in the Charter requires that all treaties and international agreements entered into by the member states be registered with the Secretariat. The U.N. remains at the center for creating legal frameworks in carrying out its principles and purposes; over 500 conventions, treatises, and standards have been put into effect by the U.N., which once ratified by member states, are legally binding on them.

The U.N. incorporates the rule of law at national and international levels. At the national level, for example, the Security Council has the power to create domestic rule of law institutions to assist restoration and maintenance of the rule of law in developing nations such as the U.N. Stabilization Mission in Haiti (MINUSTAH) and the U.N. Operation in Côte d’Ivoire (UNOCI). At the international level, Former Secretary-General Kofi Annan summarized only several examples of the U.N.’s involvement in international law:

When ships sail freely across the seas and through international straits, they are protected by rules legitimized in United Nations conferences. Commercial airlines have the right to fly across borders, and to land in case of emergency, thanks to agreements negotiated by the International Civil Aviation Organization. Similarly, it is protocols of the Universal Postal Union which allow mail to move freely across boarders. Trademarks and patents are registered throughout the world by the World Intellectual Property Organization. The United Nations Statistical Commission helps to ensure that economic statistics, accounting standards, and commodity descriptions, wherever they are produced, mean the same thing to people reading them in other countries. The World Health Organization sets quality criteria for the pharmaceutical industry world-wide, and standardizes the names of drugs. The United Nations Conventions on Sales and Carriage of Goods by Sea help to establish rights and obligations for buyers and sellers in international commercial transactions. The International Telecommunications Union, by allotting frequencies, keeps the airwaves from becoming hopelessly clogged; and its technical standards enable transmitters and receivers on opposite sides of the world to connect with each other.

Another very important aspect of international law that the U.N. administers is human rights. Human rights are nondiscriminatory “rights inherent to all human beings, whatever our nationality, place of residence, sex, national or ethnic origin, colour, religion, language, or any other status. . . . .These rights are all interrelated, interdependent and indivisible.” International human rights laws, thus, are legal obligations that require governments to act or refrain from acting in certain ways in order to protect our inalienable human rights. All member states have ratified at least one of the major human rights treatises, including the Universal Declaration of Human Rights that was adopted by the General Assembly in 1948. The Declaration sets out basic civil, political, economic, social and cultural rights and freedoms that are to be enjoyed by all human beings. Among some of these rights and freedoms are the rights to: work with equal pay for equal work and free choice of employment; “free and full development of his personality”; “protection of the moral and material interests resulting from any scientific, literary or artistic production”; education, “a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services”; political participation; freedom of thought and religion, and opinion and expression; and a right to due process.

Promoting and establishing the rule of law is at the center of the U.N.’s mission. It is the key to sustained economic and social development, protection of human rights, and the preservation of peace and security.

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Jul 12 2010

Agreement on Trade Related Aspects of Intellectual Property Rights

The Uruguay Round, a series of multilateral trade negotiations spanning 1986-1994, produced most of the World Trade Organization agreements including the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Prior to TRIPS, the extent and enforcement of intellectual property rights varied substantially around the world.  In the context of pharmaceuticals, many developing countries failed to grant patents to innovator companies at all, distressing U.S. based pharmaceutical companies and dramatically affecting U.S. trade and competitiveness abroad.

TRIPS was signed as a way to bring intellectual property rights—including patents on pharmaceuticals—within an international structure. The agreement was designed to balance the long term goal of promoting innovation with the short term goal of using inventions. In the area of pharmaceutical patents, this meant a balance between innovation and access to medicines.  TRIPS established minimum levels of IPR protection, including a mandatory 20-year patent term for pharmaceutical patents of both product and process, and made violations of the agreement subject to the WTO’s dispute settlement process.

Debates between innovators and public/global health advocates became heated after the implementation of TRIPS over whether an international patent scheme would deprive developing and least developed countries essential medicines. The Doha Declaration on the TRIPS Agreement and Public Health, adopted in 2001 during WTO trade negotiations, clarified TRIPS’s dedication to public health and access to medicines. It recognized the gripping global health crisis in the developing world and professed that TRIPS would not prevent WTO members from taking measures to protect public health. The Doha Declaration reiterated the flexibilities written in TRIPS, enabling members to grant compulsory licenses (allowing one company to manufacture a drug without the patent holder’s consent) to address public health concerns.

Additionally, the Doha Declaration flagged a problem with the compulsory license provision of TRIPS and called for a solution. Under TRIPS Art. 31(f) the use of compulsory licenses was limited to use “predominantly for the supply of the domestic market,” essentially limiting the amount of drugs a developed country with manufacturing capacity could export under the license. Countries without such manufacturing capacity, which need to import drugs from developed nations, were thus prevented from gaining access to essential medicines unless through import of generic drugs. The August Agreement solved this issue by eliminating, by means of an interim waiver, the “domestic market” requirement and issued a clear statement to protect public health and assure access to medicines.

In assessing the emerging market of biological and biosimilar medicines, U.S. lawmakers will be concerned as to how countries abroad, particularly Brazil, India, and China, are protecting patents on innovator biologics. In my next post, I will discuss the U.S. Trade Representative’s Special 301 Report, where USTR assesses the level of IPR protection and enforcement abroad for the purpose of adjusting trade policy.

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