To Trade or Not to Trade . . .

Deepa Badrinarayana

Deepa Badrinarayana is a Research Assistant to Prof. Frank Grad at the Columbia University School of Law. She holds a Masters in Environmental Law from Pace University School of Law and a B.A.LL.B.(Hons) from India. The author gratefully acknowledges the encouragement and advice of Profs. Stephen Kass and Nick Robinson and her parents and family. She would also like to thank her friend Gus for giving up genetically modified food—though it resulted in his losing 10 pounds.

[32 ELR 10512]

"I'm Not Dead Yet: Genetic Mutation That Lives Up to Its Name Is Found."¹ This heading from the December 15, 2000, New York Times is a precursor to one of the most fiercely debated issues of our times. Genetic modification with the use of biotechnology is now perceived as a goldmine due to the prospects that it holds for combating the problems that were hitherto considered mostly unsolvable. The ability to locate the information contained in the deoxyribonucleic acid (DNA), separate it, and relocate it in another organism through modern biotechnology techniques has opened new vistas for social problems. In addition, the financial promise that biotechnology holds may be tremendous. For example, intellectual property rights may enable patent holders to make high profits on their investment.² The flip side to this is the legal and cultural differences over the commercial use of biotechnology. Disagreements over genetic modification have emerged between environmental and human rights groups over the possible adverse impacts that genetically modified organisms (GMOs) may have on human health and the environment.³ The promise of innovations that would reduce the use of harmful chemicals and pesticides, increase the productivity of animals and plants at low environmental costs, and cure diseases that have plagued humankind for centuries do nothing to allay fears about the long-term threats that GMOs may pose. The recent outbreak of foot and mouth disease confirms the risk associated with the use of modern science.⁴ It also brings to the forefront the dangers involved in the trade of GMOs.

The response of the international legal community to the issue can be evidenced in the Cartagena Protocol on Biosafety (Protocol), which was opened for signature in May 1992, during a meeting of the Parties to the Convention on Biological Diversity and was finalized in January 2000.⁵ The Protocol provides a mechanism to mitigate the risk associated with trade in GMOs. The Protocol essentially establishes an international regime for trade in GMOs, mainly trade in GMO agricultural products. Trade, however, is primarily regulated by the General Agreement on Tariffs and Trade (GATT)/World Trade Organization (WTO)⁶ system pursuant to the Sanitary and Phytosanitary Measures Agreement (SPS Agreement).⁷ While the main objective of the WTO is to ensure free trade in goods, the SPS Agreement allows the imposition of non-tariff barriers on trade in view of plant, animal, or human life and safety.⁸ Yet there is a difference between the Protocol and the SPS Agreement. While the Protocol is a product of concern for environmental protection, the SPS Agreement is a product of concern for free [32 ELR 10513] and nondiscriminatory practice in trade. This may lead to conflicts over the application of the appropriate law.

This Dialogue examines and compares the two legal instruments. The Dialogue first discusses the SPS Agreement and then goes on to describe the Protocol. The Dialogue then analyzes the compatibility between the two international documents.

The SPS Agreement

Countries have always used sanitary measures as a reason for imposing trade measures prior to the signing of the GATT.⁹ The GATT, which was designed to promote free trade, imposed restrictions on using sanitary measures as a disguised trade measure. However, concrete developments with respect to sanitary measures did not emerge until efforts to draft a separate SPS Agreement began in the 1980s.¹⁰ Prior to the Agreement, the only exceptions under which a trade barrier could be imposed were provided under Article XX(b) of GATT.¹¹ The test for invoking these exceptions was stringent as evidenced by the Thai Cigarettes¹² case in which it was held that the term "necessary" under in Article XX(b) implied the nonavailability of any other alternative, least trade-restrictive measures. Further, these exceptions could not be used to invoke measures to establish domestic manufacturing standards in the exporting country. Therefore, while the importing country could use the exception to impose trade restrictions on the product, it has no right to invoke the exception to restrict the process used to manufacture the product.¹³

To the contrary, the SPS Agreement allows importing countries to require certain domestic standards to be maintained by the exporting country on the basis of health requirements. Therefore, it is now possible for the Members of GATT/WTO to take action even after negotiating the reduction of tariffs and the elimination of quotas.¹⁴ The SPS Agreement establishes certain procedures based on which trade measures can be taken against a country if some scientific evidence is provided about the adverse health and environment impacts.

Further, under the GATT/WTO system, the importing country could take a trade measure against an exporting country so long as it was not treated less favorably than a domestic standard, however nebulous the standard was. Hence, the domestic standard for a product of a country only had to pass the scrutiny of "national treatment."¹⁵ However, under the SPS Agreement, the domestic standard must be based on adequate scientific data. Therefore, even nondiscriminatory domestic measures would be subject to scrutiny when they affect trade.¹⁶ Also, because the requirements under the SPS Agreement are more stringent than GATT, Article XX(b) of GATT cannot be invoked in a dispute that falls under the SPS Agreement. Merely demonstrating that national treatment was observed will not be sufficient to justify a trade measure.¹⁷

This leads to the next important aspect—the structure and requirements under the SPS Agreement. The objective of the SPS Agreement is to ensure that Members can take trade measures on the grounds of protecting the health and life of plants, animals, and humans so long as it is not arbitrary¹⁸ and is least trade-restrictive.¹⁹ To achieve this, the SPS Agreement suggests that Members be guided by international standards²⁰ set by the Codex Alimentarius Commission,²¹ the International Office of Epizootics,²² and the Secretariat of the International Plant Protection Convention.²³ However, the SPS Agreement allows the Members to establish an appropriate level of health that may be governed by [32 ELR 10514] standards higher than that set by the international organizations. The provisions in the SPS Agreement have been developed essentially to "elaborate rules for the application of the provisions of GATT 1994 which relate to the use of sanitary or phytosanitary measures, in particular the provisions of Art. XX(b)," including the chapeau of the article. All sanitary and phytosanitary measures affecting trade would be governed by the SPS Agreement under Article 1. The measures can be taken to protect animal, plant, or human life and health from the entry, establishment, or spread of pests, diseases, disease carrying organisms, food-based toxics and diseases, and plant- and animal-based diseases that may affect human health; and to minimize damage that may be caused from any of the above-mentioned intrusions.²⁴ Sanitary and phytosanitary measures include "all relevant law, decrees, regulations, requirements and procedures" and these may lay down several requirements in terms of the production process, inspection, sampling procedure, and risk assessment.²⁵

The Parties to the SPS Agreement are under an obligation not to take measures that are inconsistent with the agreement, and toward achieving this goal, they are required to base their decision on "scientific principles and scientific evidence."²⁶ The standards and scientific principles must, as far as possible, be based on the "standards, guidelines, or recommendations" of the specified international organizations.²⁷ However, a Member could take a different standard to achieve an "appropriate level"²⁸ of safety if there is "scientific justification" for doing so.²⁹ In determining whether there is sufficient scientific justification for taking a particular measure, the SPS Agreement requires the Members to go through a process of risk assessment to determine the appropriate level of safety. The risk assessment³⁰ techniques must preferably be guided by those set by international organizations,³¹ available scientific evidence, and surrounding facts such as the "process and production methods, relevant ecological and environmental conditions, sampling and testing methods, prevalence of specific diseases or pests," etc.³² Economic considerations in terms of the cost-effectiveness of a measure vis-a-vis an alternative measure and the loss that may be caused due to the entry or establishment of a pest must also be taken into account.³³ Opposition to the measures on the grounds of cost-effectiveness is perceived as a potential threat to the application of the SPS Agreement. On a positive note, an Appellate Body under the GATT/WTO dispute settlement mechanism may not allow dilution of SPS measures on that ground, as the SPS Agreement does not really require the WTO to do a cost-benefit analysis in its decisionmaking.³⁴

An exception to the application of scientific evidence in decisionmaking is the nonavailability of scientific evidence. Under such a circumstance, the Member can take temporary measures based on the "pertinent available information."³⁵ This is the SPS Agreement's version of the precautionary principle. This exception is opposed to by environmental and consumer groups, which demand a clear recognition of the precautionary principle within the framework of the WTO and in particular the SPS Agreement.³⁶

Measures taken in accordance with the SPS Agreement are deemed to be in compliance with GATT and especially GATT Article XX(b).³⁷ Further, standards that are based on those of international organizations specified under the SPS Agreement are also deemed to be in conformity with GATT 1994³⁸ so long as they are not inconsistent with the provisions of the SPS Agreement.³⁹ A Member is required to accept standards that, though different from its own, achieve the same appropriate level of safety. This equivalence could also be achieved by entering into bilateral and multilateral agreements. The determination of risks based on scientific evidence may well prove to be difficult not just under the [32 ELR 10515] SPS Agreement but also under the Protocol, especially if there is a conflict between the two instruments.

Disputes arising under the SPS Agreement should be resolved by Members through WTO consultations and dispute settlement mechanisms as per the dispute settlement understanding (DSU) under Articles XXII and XXIII of GATT 1994.⁴⁰ In deciding a scientific or technical issue, the dispute settlement panel under the SPS Agreement is required to take the advice of a panel of experts created in consultation with the Parties to the dispute. The burden of proof lies with the complaining Party.⁴¹ The burden of proof, however, is not an easy test to pass, particularly in cases where international standards are not followed.⁴² The SPS Agreement's emphasis on following international standards has been criticized by various analysts on the ground that the international standards specified under the SPS Agreement are not set through a process of public consultation and, therefore, lack transparency.⁴³

The SPS Agreement provides that Members can also resort to dispute settlement under any other international agreement, dispute settlement mechanism, or international organization.⁴⁴ The question one would ask, therefore, is whether the Protocol could be used as an alternative forum for the settlement of disputes. If so, the rights, obligations, and remedies under the Protocol would shape the decisions of Members to the SPS Agreement. This kind of forum shopping may limit the use of the WTO, which is primarily oriented toward free trade despite the creation of exceptions based on health and safety concerns. The SPS Agreement further clarifies that the Agreement on Technical Barriers on Trade (TBT) and the SPS Agreement are mutually exclusive and, therefore, the TBT would apply to cases that are not covered by the SPS Agreement.⁴⁵

In addition to the above-mentioned provisions, the SPS Agreement recognizes in its preamble the "special difficulties" that developing countries may face while implementing phytosanitary measures. It requires developed countries to provide technical assistance to developing countries.⁴⁶ The developing countries must also be given special treatment in terms of meeting sanitary and phytosanitary measures as they are allowed to meet the measures in a phased manner.⁴⁷ In addition, the process of imposing standards and measures must be transparent. A Member must first notify other Member countries and receive their comments before taking action except in cases of emergency, in which case only notice is necessary.⁴⁸ The SPS Agreement's administration is overseen by the Committee on Sanitary and Phytosanitary Measures, which must ensure harmonization of the measures as far as possible.⁴⁹ In addition to these provisions, the SPS Agreement contains detailed inspection, control, and approval procedures that require similar products to be treated equally in terms of testing, etc.⁵⁰

In summary, the SPS Agreement is essentially a free trade agreement that allows certain exceptions based on public health, but is only concerned with establishing standards that would have the least adverse impact on trade as opposed to health.⁵¹

The Protocol⁵²

One of the objectives of the Convention on Biological Diversity, 1992 (Convention) is the conservation of biological diversity.⁵³ Article 8 includes, among other provisions, the need to regulate GMOs or living modified organisms (LMOs), which are products of biotechnology.⁵⁴ The Convention also requires the Parties to the Convention to come up with national regulatory and administrative measures with respect to biotechnology and benefit sharing where genetic material from other countries was used.⁵⁵ Article 17 also requires the exchange of information with respect to conservation and sustainable use of biodiversity and specialized [32 ELR 10516] knowledge and information systems. Agenda 21, which was adopted by more than 178 governments in 1992 at the United Nations Conference on Environment and Development in Rio de Janeiro, Brazil, also recognizes the importance of biotechnology to agriculture, health, and the environment and calls on the international community to ensure the safe use of biotechnology.⁵⁶ Against this backdrop, a group of experts selected by various governments referred to as the Global Consultation of Government-Designated Experts adopted the United Nations Environment Programme's International Technical Guidelines for Safety in Biotechnology, which provide guidelines for the risk assessment and management of biotechnology.⁵⁷ These guidelines may be integrated into the SPS Agreement.

Pursuant to the mandate under the Convention, the first conference of parties (COP) to the Convention initiated the process of drafting a protocol on biosafety by establishing an Open-Ended Ad Hoc Group of Experts.⁵⁸ Through a decision during its second meeting, known as the Jakarta Mandate, the COP initiated a negotiation process to address the "safe transfer, handling, and use of GMOs" that would have an adverse impact on biodiversity. The main objective of the protocol as envisioned by the COP was to set out a procedure for transboundary movement of GMOs.⁵⁹ To undertake this task, the Biosafety Working Group (BSWG) was established to prepare a draft protocol by 1998 and to begin negotiations on the matter. The mandate of the BSWG was to draft a protocol based on the precautionary principle and to rely on the "best available science" in drafting the same. Working between 1996 and 1998, the BSWG finally came up with a draft protocol and representatives from various countries met in Cartagena, Columbia, in February 1999, to discuss the draft protocol. However, insurmountable differences over the trade in GMOs led to a break down of the meeting and the Parties decided to reconvene in May 2000.⁶⁰ The countries were at this point divided into three distinct groups: the European Union (EU); the Like-Mined Group of developing countries; and the Miami Group, which consisted of the Argentina, Australia, Canada, Chile, the United States, and Uruguay. The main issue on which these groups disagreed was the extension of the draft protocol to "commodities intended for food or feed, or for processing, and the Protocol's relationship to international trade law."⁶¹ Another group consisting of countries such as Switzerland that did not want to join any of the groups formed their own group called the Compromise Group.⁶² After a series of meetings, the Parties reconvened in January 2000 in Montreal, and finally the Protocol was opened for signature on May 15, 2000.

The main objective of the Protocol is:

Ensuring an adequate level of protection in the field of safe transfer, handling and use of [LMOs] resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.⁶³

The main aspect covered by the Protocol discussed in relation to the SPS Agreement is the control over transboundary movement of GMOs.⁶⁴

The Protocol regulates the trade of LMOs by creating a system of "advanced information agreements."⁶⁵ Similar to the Basel Convention on Transboundary Movement of Hazardous Waste, 1989,⁶⁶ it creates a system of informed consent before LMOs are traded. The system has two separate levels of application: one for the transboundary movement of LMOs generally, and the other for the transboundary movement of LMOs that would be used directly as food, feed, or for processing. In cases of transboundary movement of LMOs generally, the Protocol's application is limited to the first intentional transboundary movement. To trade in LMOs, the exporting Party must provide the importing country with all the relevant and accurate information with respect to the LMO.⁶⁷ Once the importing Party receives the information, the importing Party must acknowledge its receipt of the information, and must mention whether the importing state will proceed with the domestic legal requirements or in accordance with the procedure specified in Article 10. Not sending a receipt within the requisite 90 days, however, does not lean to any implication under the Protocol.⁶⁸ Following the receipt of information, the importing Party is required to inform the notifier within 90 days of receiving the information whether the transboundary can proceed only after receiving a written consent or after an additional 90 days without written consent.⁶⁹ The importing Party must inform in writing the notifier and the Biosafety Clearing House⁷⁰ of any decision made by the importing Party, i.e., the granting of a permit or refusing consent, unless an unconditional consent is granted.⁷¹ In case unconditional consent is granted, the importing Party must also specify the terms under which the imports would be allowed in the future. The decision of the importing Party must be in accordance with the risk assessment process under Article 15. Further, the importing Party may take into account the precautionary principle in making a decision.⁷² There is no mandate about the specific scientific data or other data that needs to be considered in this regard.

Export of LMOs that are meant to be used as food, feed, or for processing require a different consent procedure.⁷³ Importing Parties that make a final decision to allow dealings in such LMOs must notify the other Parties to the Protocol through the Biosafety Clearing House.⁷⁴ Countries may decide [32 ELR 10517] to allow the importation of the LMOs under their national legislation so long as they are in line with the objectives of the Protocol.⁷⁵ In contrast, the SPS Agreement allows the Parties to apply less stringent standards so long as it does not affect trade. The precautionary principle also would guide the Parties with respect to any agreement involving the use of LMOs in food, feed, or for processing.⁷⁶

The Protocol provides that Parties may review their decision at any time when there is new scientific evidence regarding the potential adverse impacts that an LMO might have on conservation and sustainable use of biodiversity as well as on human health.⁷⁷ The exporting countries may also ask the importing Parties to reconsider their decision under Article 12 of the Protocol based on the availability of new scientific evidence or risk assessment studies.⁷⁸ The importing Party may also create a simplified procedure and even waive the advanced information agreement requirement so long as it informs the Biosafety Clearing House about the same. This can be achieved through bilateral, multilateral, and regional agreements.⁷⁹

One of the key provisions of the Protocol that must be compared with the SPS Agreement is its process for risk assessment. Under the Protocol, the importing Party must carry out risk assessments in a "scientifically sound manner" in accordance with Annex III of the Protocol and as per recognized techniques of risk assessment.⁸⁰ Annex III details four important principles of the risk assessment process. First, it requires assessments to be carried out in a scientifically sound and transparent manner taking into account expert advice and guidelines developed by international organizations.⁸¹ Unlike the SPS Agreement, no international organizations whose standards must be followed are specified. Second, it states that the lack of scientific certainty or consensus should not be interpreted to indicate a particular level of risk, the absence of a risk, or the presence of an acceptable risk.⁸² Therefore, the precautionary principle is given a wide berth by the Protocol and seems to extend the precautionary principle beyond its scope. Third, it requires risks from LMOs to be considered in relation to the impact that it might have on the "non-modified recipients or parental organisms in the likely potential receiving environment."⁸³ Finally, it requires the risk assessment to be carried out on a case-by-case basis.⁸⁴ In addition to all these provisions, Annex III details various other aspects of LMOs that need to be considered in a risk assessment process. Further, under Article 15(4) of the Protocol, the importing Party may require the exporting Party to bear the cost of risk assessment.

Article 16 of the Protocol also provides for risk management measures to be taken by Parties. Parties must also take special care in the handling and transporting of LMOs. Further, Parties that export LMOs meant for food, feed, or for processing must in their documentation specify that the parcel "may contain" LMOs so as to ensure that the consumers are aware of the ingredients.⁸⁵ In contrast, this labeling requirement (albeit weak), is absent under the SPS Agreement.

One of the key provisions of the Protocol is that it requires Parties to enact domestic laws penalizing the transboundary movement of LMOs in contravention of its domestic laws. In case of illegal movement, the importing Party may require the exporting Party to destroy, dispose, or repatriate the LMO at its own expense.⁸⁶ This provision, therefore, may play a key role in determining the action that a Party can take. Further, it could lead to a situation where a domestic law banning the import of LMOs may be overturned under the SPS Agreement but may still be valid under the Protocol leading to conflicting situations, if the rationale of the Tuna-Dolphin⁸⁷ case is applied.

One of the greatest limitations of the Protocol today is its lack of any liability and redress mechanism. However, Article 24 provides that such a mechanism must be established four years after the Protocol comes to force by the COP.⁸⁸

Mirror, Mirror on the Wall . . .

A plain reading of the objectives of the two international instruments presents the first divergence—the SPS Agreement is intended to promote trade while the Protocol regulates trade. This means that international law is probably witnessing two parallel developments with respect to GMOs—one that encourages their trade and another that prioritizes safety over trade. Such a divergence holds potential for conflicts between the Parties to these instruments over issues such as selecting a suitable forum for future dispute resolution. This section analyzes the probable conflicts that may arise by looking at the problems that arose in the Beef Hormone⁸⁹ case, which dealt with the SPS Agreement, and comparing them to the possible reasoning that could be adopted under the Protocol. While three cases have been discussed under the SPS Agreement, the Beef Hormone case is the most important as it deals with biosafety issues. The other two cases are discussed briefly so that the WTO's approach can be garnered to aid in this discussion. Before moving to the cases, however, it should be noted that this comparison concentrates mainly on the following possible areas of conflict: scientific evidence requirements and the correct forum for resolving disputes.

[32 ELR 10518]

The Beef Hormone Dispute

This dispute led to the first WTO panel report on the consistency of food safety measures under the WTO.⁹⁰ It is also a dispute that went through all the stages of a WTO arbitration, namely, panel examination, appellate review, and arbitration. The facts that led to the dispute span back to 1987 when the EU imposed a ban on meat and meat products that had been fed with six specific hormones. The United States asked the EU to lift its ban. When the EU refused, the United States retaliated by imposing 100% ad valorem duties on certain goods of EU origin.⁹¹ The United States contended that the hormone meat was safe as even the Codex, the international organization specified under the SPS Agreement, had found that five of the hormones were safe and that the EU itself had later conducted scientific studies and concluded that the meat was safe. After negotiations, the EU agreed to lift the ban on meat and products that were not fed with hormones and the United States lifted some of the duties. After further negotiation, the EU decided to submit the dispute to the WTO and the United States withdrew all measures against the EU.

The first hurdle that the WTO panel faced was deciding the suitable trade agreement that applied to the dispute and the applicability of the SPS Agreement. While the United States wanted to proceed under the TBT Agreement, the panel found that the TBT and the SPS Agreements were mutually exclusive and could not be applied simultaneously.⁹² The other alternative that was considered was GATT itself, but in the end, the WTO panel determined that the SPS Agreement applied, as even if the GATT requirements were met, the panel was still required to ensure that the measure was consistent with the SPS Agreement. The next question was whether the SPS Agreement could be applied to disputes that arose pre-SPS Agreement. After referring to the Vienna Convention on the Law of Treaties,⁹³ the panel concluded that because the EU measures were in continuance, the dispute could be decided under the SPS Agreement. This was strengthened by the fact that the SPS Agreement itself imposed no prohibition on its retroactive application. The WTO panel also concluded that there was noneed to examine whether there was a violation of GATT because even if the EU's ban complied with GATT, the measures would have to pass scrutiny under the SPS Agreement. Further, as the TBT Agreement and the SPS Agreement were mutually exclusive, the TBT Agreement was not applied. Having resolved the initial issue about jurisdiction, the panel went on to the more crucial issues.

The panel next addressed the issue of burden of proof. It found that the burden first lay primarily on the United States. Once the United States proved that the measures seemed inconsistent with the SPS Agreement, as they were inconsistent with the international standards, the burden shifted to the EU. The panel further found that because the EU had taken measures that were higher than the international standard, there was a duty by the EU to show that the process of fixing an acceptable level of risk was justified by scientific evidence under Article 3.1 of the SPS Agreement. Once the United States established that the EU had not complied with the international standard, the burden of proof shifted to the EU to demonstrate that the measure was consistent with the SPS Agreement. Proceeding further, the panel established a panel of experts to give its opinion about the risk assessment. After reviewing all the relevant facts, the WTO panel found that there was no scientific justification for preventing the importation, as the meat did not pose a risk to human life or health as required under the SPS Agreement. The panel also found that the measures taken by the EU were arbitrary and capricious as they distinguished between meat and meat products that had naturally occurring hormones and those that did not.⁹⁴

The WTO Appellate Body,⁹⁵ while agreeing with the WTO panel's conclusion that the measure was not compliant with the SPS Agreement, reversed the panel's reasoning. It found that the burden of proof did not shift to the EU once the United States demonstrated that the measures did not comply with international standards. Rather, the United States had the burden of showing that the measures were not consistent with the SPS Agreement. It also found that there was no need for the EU to follow the international standards; it just had to show that there was scientific justification for the ban. The EU argued that its measures were based on the precautionary principle as permitted under the SPS Agreement. While the Appellate Body agreed that the SPS Agreement did recognize the application of the precautionary principle, it could not be invoked in cases where there was evidence to show that the hormones were safe. On the other hand, the Appellate Body stated that the EU could impose a temporary measure in certain cases and later carry out risk assessment. The Appellate Body also reversed the finding of the panel that the measures taken by the EU were arbitrary and capricious. The Appellate Body, however, determined that since the EU had not shown that there was a possible risk to human life or health, the measures were not consistent with the SPS Agreement and ordered the EU to lift the ban.

In spite of the ruling of the Appellate Body, the EU refused to lift the ban. Therefore, the United States submitted an application pursuant to Article 22.6 of the DSU, through which Members of the WTO submit to the jurisdiction of the WTO dispute settlement mechanism, requesting the Dispute Resolution Board to authorize the United States to remove some trade concessions given to the EU countries amounting to $ 202 million (U.S.).⁹⁶ The EU objected and submitted that the concessions must be withdrawn only to the extent that it neutralized⁹⁷ the loss suffered by the United States due to the ban ($ 53,301,675 million U.S.). The dispute was submitted to arbitration pursuant to Article [32 ELR 10519] 22.6⁹⁸ of the DSU.⁹⁹ The EU also contended that the arbitrators must require the United States to submit a list of all the products for which the tax concessions would be removed. This was held to be beyond the jurisdiction of the arbitrators. The arbitrators, after reviewing all the relevant information, finally decided that the amount that the United States could deduct in terms of trade concessions to nullify the loss caused by the ban was $ 116.8 million (U.S.).

The Australian Salmon¹⁰⁰ Case and the Japanese Quarantine¹⁰¹ Case

In the Australian Salmon case, Australia imposed a ban on fresh, frozen, or chilled raw salmon from the Pacific rim of North America unless they were pre-treated with heat due to the possibility of entry and spread of exotic disease particular to the fish. The dispute was brought before the dispute settlement panel under the SPS Agreement. The panel found that Australia's measure was not in conformity with the SPS Agreement as it had failed to establish a risk of entry of any specific disease. It found that a mere theoretical possibility of a disease entering the country would not pass the test of risk assessment required under the Agreement. Further, there were other fish that also could cause the same problem but they were not targeted by the ban. This proved that the measure was a protectionist measure, and, therefore, the panel found that the measure was arbitrary and capricious. The Appellate Body,¹⁰² while concurring that the measure was not in conformity with the SPS Agreement, found that the action taken by Australia was not arbitrary and capricious because the alternative actions that Australia could take were limited. The Appellate Body also emphasized the difference between risk assessment and appropriate level of risk. It found that the Members could determine the appropriate level of risk so long as it was based on sound risk assessment.

In the Japanese Quarantine case, Japan, based on a 1950 quarantine testing requirement law against coddling moth, required a varietal products testing for certain products from the United States (some berries and nuts). The United States protested on the grounds that a requirement of testing according to variety rather than products violated the SPS Agreement as there was no scientific justification for such. In defending its position before the Appellate Body, Japan relied on the precautionary principle. The Appellate Body, however, found that the precautionary principle, though mentioned in the SPS Agreement, was not really a provision in the SPS Agreement and that it could therefore be applied only to the extent that it was in conformity with the other provisions of the SPS Agreement. The Appellate Body found that there was no scientific basis for the testing requirement that Japan had imposed and that Japan had failed to explore other options available to resolve the problem. It therefore found the measures not in conformity with the SPS Agreement.

The findings of the dispute settlement panel under the WTO must hardly come as a surprise to those who have been following its decisions under the GATT exceptions. It only reinforces the strong tradition and goal of GATT as being primarily a trade instrument and not an environment or health one. Yet insofar as GMOs are concerned, there is the possibility of countries being governed by a multilateral environmental agreement that has as its primary objective environmental and health concerns and that adopts trade measures to enforce its goals. In all the disputes that have been brought before the WTO, there has, to date, been no direct conflict between a multilateral treaty and GATT. Yet given the crucial area of biotechnology, it would be impossible to rule out a possible conflict between the Protocol and the SPS Agreement. And the big question is whether the Protocol would be able to withstand the test.

Transposing the Protocol to the Cases

The SPS Agreement clearly states that it does not impair dispute settlement under any other international agreement or organization.¹⁰³ Therefore, the Parties to a dispute could opt to resolve the dispute under the Protocol rather than the SPS Agreement. Assuming for a moment that a dispute settlement mechanism does exist under the Protocol, it would be useful to examine what principles would have defined the dispute settlement in the above-mentioned cases.

One of the primary issues would be the application of the precautionary principle. In all the above-discussed cases, the precautionary principle as argued by the Parties was rejected. Would they have succeeded under the Protocol? The Protocol clearly recognizes the precautionary principle and even states that "scientific consensus" should not be a ground for accepting the absence (or presence) of a risk. Further, the standard that it applies for risk assessment is a "scientifically sound and transparent" one. In the case of the Beef Hormone dispute, for instance, what would have been the measure of proof that the EU would have been required to show? In all probability, a dispute settlement panel under the Protocol would have ruled in favor of the EU on the grounds that it had conducted a scientifically sound assessment. Therefore, the EU would have only been required to show that the methodology was sound, and if the results showed that there was no risk, it could interpret Article 11(3) to argue that the results do not necessarily mean there [32 ELR 10520] is no risk. Therefore, the test seems to be a flexible one.¹⁰⁴ In addition, considering that there is no single provision requiring Parties to the Protocol to allow the transboundary movement of goods under any circumstances, there are little chances of the dispute ever being resolved objectively under the Protocol. Forum shopping—with a choice of either approaching the dispute settlement body under the WTO or under the Protocol—in such a case would become extremely competitive, as each Party would want to approach the forum that favors its position. Given the weak enforcement mechanism under most international agreements, it seems improbable that the Protocol would replace the WTO dispute settlement mechanism for settling disputes arising under the SPS Agreement. This is aggravated by the fact that the Protocol also has a clause that allows the Parties to resolve disputes under other international fora.¹⁰⁵

As evidenced by the cases, the WTO dispute settlement body has in deciding environment-based trade matters emphasized that trade measures must be taken by Members only when there are no other alternative measures available to enforce an environmental standard. On the contrary, there is no such requirement under the Protocol. Therefore, Japan, by merely applying the precautionary principle, could have justified its trade measures and not have been required to explore the possibility of applying measures that would not affect trade. Further, unlike the Protocol, the SPS Agreement has minimum limitations on the sovereignty of the Parties.

Hence, it appears we have a situation in which there are two international agreements, one greatly biased toward trade and the other (at least in theory) toward environmental and health concerns. In effect, in spite of having two agreements at the international level on matters related to biosafety, there is no comprehensive system to address issues relating to the transboundary movement of GMOs. The Protocol, in spite of its goals toward biodiversity conservation and safety, fails to provide a concrete mechanism that would facilitate dispute settlement regarding trade. Considering that the sovereignty of nations remains intact insofar as it does not fall within the limitations of GATT, the need of the hour is not to try to reinforce sovereignty, the exercise of which would be carried out by states irrespective of GATT as demonstrated by the EU position in the Beef Hormone dispute. Rather, there needs to be a forum by which trade disputes can be settled on principles that are more concrete and on measures that are more practical. In effect, the Protocol has failed to do what the various environmental groups have cried victory over—create a strong institution that would require disputes to go through strict environmental scrutiny. In fact, the Protocol, by failing to create a strong framework for regulating GMOs, may create some adverse impacts to its said objective of protecting biodiversity. Biotechnology holds promise especially in some areas like agriculture where biotechnology may in fact reduce the use of chemicals and the expansion of land use. Yet allowing Parties to use trade measures without defining the limits within which Parties should operate may create problems for biotechnology irrespective of its useful purposes.¹⁰⁶

Conclusion

We are now faced with a situation where there seems to be only an interest-based solution to the problem. It is no doubt difficult to carve an interest-free solution in an international milieu. However, given that biotechnology is an area that has great social and economic value, the use of this biotechnology needs to be monitored carefully. Further, it is an area that is far from being free from ethical issues. The ethical issues cannot be dismissed, as the law itself needs to take into account the morality involved in creating rights and obligations.¹⁰⁷ Therefore it would be impractical to rely on a purely scientific standard when deciding issues with respect to the use of biotechnology. Instead some of the principles recognized under the Agreement on Trade-Related Intellectual Property Rights, such as public morality and acceptance, should be acknowledged when dealing with the issue of biosafety.¹⁰⁸ This may be a more stringent standard to prove as illustrated by the EU Beef Hormone dispute, yet it recognizes factors that may not be purely scientific.

Unless a new system is established that takes into account all the dynamics involved, disputes will continue to be resolved on the basis of vested interests. The danger of one country using such a provision to its advantage cannot be avoided nor can the probability of such a method succeeding be certain. Nevertheless, the current solution is not effective. A new legal framework needs to be devised that can create a balance between trade and environmental disputes. Neither the Protocol nor the SPS Agreement seem to provide such a framework.

1. Gina Kolata, I'm Not Dead Yet: Genetic Mutation That Lives Up to Its Name Is Found, N.Y. TIMES, Dec. 15, 2000, at A24 (concerning the discovery of genes that extend the life of fruit flies by nearly 50%, which is considered to be a major discovery as itmay lead to more scientific studies to find genes that can be manipulated to defy aging as also to cure diseases such as Alzheimer and Parkinson).

2. The other side of the, coin however, is that there have been developments in the recent past that suggest that obtaining patents for genes may not be all that simple due to the development of the doctrine of equivalents by the U.S. Court of Appeals for the Federal Circuit. According to this doctrine, a patentee, in order to protect her invention, must give not just details of a product but also all the possible sequences. Therefore, in order to claim a patent over a gene, the patentee must give the details of all the possible sequences of the gene and all its functions. If another scientist discovers a use that has not been detailed by the original patentee, she cannot claim exclusive patent to the gene itself. This makes getting a patent over a gene an exceptionally tough task because it would be impossible for any scientist to give all the uses of a gene. Therefore, she may be able to patent only one function of the gene rather than the gene itself. Thus, if a gene that affects the aging process has been discovered and isolated, there can be no patent on the gene unless all the uses of the gene are demonstrated and detailed. Further, the patentee can only patent the sequence that she has discovered. This in turn would bring down considerably the value of the biotechnology patents. The situation can be compared with the granting of mere process patent as opposed to a product patent in terms of value diminution. See Cliff D. Weston, Chilling the Corn: Agricultural Biotechnology in the Face of U.S. Patent Law and the Cartagena Protocol, 4 J. SMALL & EMERGING BUS. L. 377 (2000).

3. The main arguments of the environmental groups have been the increase in use of chemicals where the plants are made resistant to pesticides and the possible impact on nontargeted species and their habitats.

4. See Sarah Lyall, Foot and Mouth Outbreak Halts British Animal Exports, N.Y. TIMES, Feb. 22, 2001, at A3.

5. Cartagena Protocol on Biosafety, 39 I.L.M. 1027 (2000) [hereinafterProtocol].

6. General Agreement on Tariffs and Trade, 55 U.N.T.S. 194, came into force on Jan. 1, 1995 [hereinafter GATT]. See Marrakesh Agreement Establishing the World Trade Organization, Apr. 15, 1996, The Results of the Uruguay Round of Multilateral Trade Negotiations: The Legal Texts 6 (1995), reprinted in 33 I.L.M. 1144 (1994). This new system is often referred to in this Dialogue as the GATT/WTO system.

7. Agreement on the Application of Sanitary and Phytosanitary Measures, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Orgnization, Annex 1A, Legal Instruments, Results of the Uruguay Round (1994) [hereinafter SPS Agreement]. The SPS Agreement is one of the agreements that was signed after the establishment of the WTO as a result of the Uruguay Rounds that replaced the original GATT 1947 with GATT 1996.

8. While the SPS Agreement is not limited to trade in GMOs, cases in the past such as the European Union (EU) Beef Hormone dispute (discussed later) demonstrate that genetic modification can be a ground for imposing trading restrictions under the SPS Agreement.

9. See Steve Charnovitz, The Supervision of Health and Biosafety Regulation by the World Trade Rules, 13 TUL. ENVTL. L.J. 271 (2000).

10. Id. at 272.

11. GATT, Art. XX(b), provides:

Subject to the requirement that such measures are not applied in a manner that constitutes a means of arbitrary or unjustified discrimination between countries where the same conditions prevail, or a disguised restriction on international trade, nothing in this Agreement shall be construed to prevent the adoption or enforcement by any contracting parties of measures . . . (b) necessary to protect human, animal or plant life and health.

12. Restrictions on Importation of International Taxes on Cigarettes, Nov. 7, 1990, GATT B.I.S.D (37th Supp.) (1991), cited in Kevin C. Kennedy, Resolving International Sanitary and Phytosanitary Disputes in the WTO: Lessons and Future Directions, 55 FOOD L.J. 81, 104 n.6 (2000).

13. WTO, Beyond the Agreements: The Tuna-Dolphin Dispute, at http://www.wto.org/english/thewto_e/whatis_e/tif_e/bey5_e.htm (last visited Mar. 5, 2002). The United States in this case brought embargoes on tuna (and tuna products) that were caught with purse seine nets, which led to incidental dolphin mortality, based on its Marine Mammal Protection Act, against Mexico and intermediary countries under Article XX(g) of GATT. Mexico and the intermediary countries challenged this and brought the dispute before the GATT panel. The panel noted that the United States could not impose restrictions on the products based on the process of production as it violated the most-favored nation clause. See GATT, art. I.

14. Kennedy, supra note 12, at 83.

15. GATT, supra note 6, art. 3.

16. Charnovitz, supra note 9, at 272-73.

17. Id.

18. The preamble to the SPS Agreement reads:

No Member should be prevented from adopting or enforcing measures necessary to protect human, animal or plant life or health, subject to the requirement that these measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between Members where the same conditions prevail or a disguised restriction on international trade.

This goal is reemphasized under Article 2(3) of the SPS Agreement as an obligation of every Member, and under Article 5(5) in assessing risk and determining appropriate level of safety.

19. The preamble to the SPS Agreement reads, "desiring the establishment of a multilateral framework of rules and disciplines to guide the development, adoption and enforcement of sanitary and phytosanitary measures in order to minimize their negative effects on trade. . . ."

20. SPS Agreement, supra note 7, pmbl.

21. The Codex Alimentarius Commission, an organization set up in 1963 that sets standards for commodities, is jointly administered by the World Health Organization and the United Nations Food and Agriculture Organization. See Kennedy, supra note 12.

22. The International Office of Epizootics, an organization set up in 1924, has the task of developing a worldwide livestock reporting system and expediting trade in livestock without increasing livestock disease. See Kennedy, supra note 12.

23. The International Plant Protection Convention (IPPC), 1952, 150 U.N.T.S. 67, is an agreement to prevent the spread of plant pests. It was revised in 1997 to address the relationship between the IPPC and the SPS Agreement, especially the role of promulgating internationally harmonized phytosanitary measures and standards. WTO Committee on Sanitary and Phytosanitary Measures, Adoption of the New Revised Text of the International Plant Protection Convention, Annex 1, G/SPS/GEN/51 (Feb. 17, 1998), at http://www.fao.org/waicent/faoinfo/agricult/agp/agpp. See Kennedy, supra note 12.

24. A sanitary or phytosanitary measure is defined as:

Any measure applied:

(a) to protect animal or plant life or health within the territory of the Member from the risks arising from the entry, establishment or spread of pest, diseases, disease carrying organisms or disease causing organisms;

(b) to protect human or animal life or health within the territory of the Member from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs;

(c) to protect human life or health within the territory of the Member from diseases carried by animals, plants or products thereof, or from the entry, establishment or spread of pests; or

(d) to prevent or limit other damage within the territory of the Member from the entry, establishment or spread of pests.

SPS Agreement, supra note 7, Annex A.

25. Id. Annex A, art. 1.

26. Id. art. 2(2) (emphasis added).

27. Id. art. 3(1).

28. Annex A, Item 5, of the SPS Agreement defines this as the "level of protection deemed appropriate by the Member" who imposes a measure. Members could even demand a zero-level of risk pursuant to the SPS Agreement's definition of acceptable level of risk. An example of zero-level of risk is the pre- 1996 Delaney Clause, which prohibited food additives if the substances posed any risk of cancer in human beings. This was later amended due to pressure from domestic farmers to exclude chemical pesticides in processed food from the definition of additives. See Kennedy, supra note 12, at 88.

29. SPS Agreement, supra note 7, art. 3(3).

30. See id. Annex A, Item 4. Risk assessment under the Protocol is differently defined and is crucial in determining whether trade in GMOs must be permitted based on the assessment. This aspect is discussed later in the Dialogue.

31. Id. art. 5(1).

32. Id. art. 5(2).

33. Id. art. 5(3).

34. See Charnovitz, supra note 9, at 283.

35. The SPS Agreement provides:

In cases where relevant scientific evidence is insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary measures applied by other Members. In such circumstances, Members shall seek to obtain the additional information necessary for a more objective assessment of risk and review the sanitary or phytosanitary measure accordingly within a reasonable period of time.

SPS Agreement, supra note 7, art. 5(7) (emphasis added).

36. Charnovitz, supra note 9, at 292.

37. SPS Agreement, supra note 7, art. 2(4) ("sanitary or phytosanitary measures which conform to the relevant provisions of this Agreement shall be presumed to be in accordance with the obligations of the Members under the provisions of GATT 1994 which relate to the use of sanitary or phytosanitary measures, in particular the provisions of Article XX(b)").

38. Id. art. 3(2).

39. Id. art. 3(4), proviso.

40. Id. art. 11. A copy of the DSU is available at http://www.wto.org/english/tratop_e/dispu_e/dsu_e.htm (last visited Jan. 11, 2002). For an overview of the dispute settlement mechanism, see http://www.wto.org/english/thewto_e/whatis_e/tif_e/disp2_e.htm (last visited Jan. 11, 2002).

41. See Report of the WTO Panel, EC Measures Concerning Meat and Meat Products (Hormones), WT/DS26/R/USA (Aug. 18, 1997), cited in Kennedy, supra note 12, at 104 [hereinafter Hormone Report].

42. See infra discussion on the EU Beef Hormone dispute.

43. See Charnovitz, supra note 9, at 287. See also the discussion by Charnovitz of the Transatlantic Consumer Dialogue requiring harmonization of standards through open dialogues. Id.

44. The SPS Agreement states that "nothing in this Agreement shall impair the rights of members under other international agreements, including the right to resort to the good offices or dispute settlement mechanisms of other international organizations or established under any international agreement." SPS Agreement, supra note 7, art. 11(3).

45. According to Article 15 of the TBT, its application is excluded in cases covered by the SPS Agreement, and Article 1.4 of the SPS Agreement clearly states that aspects not covered under the SPS Agreement would not affect rights of Members under TBT. Agreement on Technical Barriers to Trade, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1A, Legal Instruments—Results of the Uruguay Round (1994), reprinted in 33 I.L.M. 81.

46. SPS Agreement, supra note 7, art. 9. The technical assistance could be in the form of giving processing technology, research, and infrastructure, including in the establishment of national regulatory bodies' financial aid.

47. Id. art. 10.

48. Id. art. 7 & Annex B.

49. Id. art. 12. Under Article 12, Members are required to work with the committee to ensure that their measures follow the international standard, and where they are want to deviate, they must provide reasons as to why the international standards are not stringent enough. The committee must also list international standards that would have a major trade impact.

50. Id. art. 8 & Annex C.

51. See Charnovitz, supra note 9, at 276.

52. Given the scope of this Dialogue, the discussion on the Protocol will concentrate on provisions that are relevant in relation to the SPS Agreement.

53. Biodiversity Convention, U.N. Doc. DP1/130/7, reprinted in 31 I.L.M. 818 (1992).

54. Article 8(g) of the Biodiversity Convention reads:

Each Contracting Party shall, as far as possible and as appropriate: . . . (g) establish or maintain means to regulate, manage or control the risks associated with the use and the release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health.

55. Id. art. 19. Of specific relevance is Article 19(3), which states:

The parties shall consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advanced informed agreement in the field of the safe transfer, handling and use of any [LMO] resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity.

56. Report of the U.N. Conference on Environment and Development, Agenda 21, ch. 16, U.N. Doc. A/CONF. 151/21 (1992).

57. See Paul E. Hagen & John B. Weiner, THE CARTAGENA PROTOCOL ON BIOSAFETY: NEW RULES FOR INTERNATIONAL TRADE IN LIVING MODIFIED ORGANISMS, 12 GEO. INT'L ENVTL. L. REV. 697 (2000).

58. Id.

59. Id. at 700

60. Id. at 701.

61. Id.

62. Id.

63. Protocol, supra note 5, art. 1.

64. Referred to in the Protocol as LMOs.

65. See id. art. 7.

66. 28 I.L.M. 649 (1989).

67. See Protocol, supra note 5, arts. 7, 8, & Annex 1 (Annex 1 sets forth the various details that the exporting Party must provide).

68. Id. art. 9.

69. Id. art. 10(2).

70. Id. art. 10(3).

71. Id. art. 10(4).

72. Id. art. 10(6).

73. Id. art. 11.

74. Id. art. 11(1).

75. Id. art. 11(4).

76. Id. art. 11(8).

77. Id. art. 12.

78. Id. art. 12(3), (4).

79. Id. arts. 13, 14.

80. Id. art. 15.

81. Id. Annex III(3).

82. Id. Annex III(4).

83. Id. Annex III(5).

84. Id. Annex III(6).

85. Id. art. 18.

86. Id. art. 25.

87. See the decision of the GATT Panel, 30 I.L.M. 1594 (1991). Counter arguments may be made that it is not a purely domestic measure, but rather is based on an international agreement. This would lead to larger questions about the current status of public international law. For a discussion on the issue, see generally Joost Pauwelyn, The Rule of Public International Law in the WTO: How Far Can We Go?, 95 AM. J. INT'L L. 535 (2001).

88. As of the writing of this Dialogue, 11 countries have ratified the Protocol. A total of 50 ratifications are required for it to come to force.

89. Hormone Report, supra note 41. See generally http://www.american.edu/projects/mandala/TED/eugenban.htm (last visited Mar. 5, 2002).

90. Hormone Report, supra note 41.

91. The United States was joined by Canada in the dispute.

92. Hormone Report, supra note 41.

93. 1155 U.N.T.S. 331.

94. Kennedy, supra note 12, at 93-95.

95. Report of the Appellate Body, Measures Concerning Meat and Meat Products (Hormones), WT/DS26/AB/R, WT/DS48/AB/R (Jan. 16, 1998), cited in Kennedy, supra note 12, at 104.

96. The Decision of the Arbitrators on European Communities, Measures Concerning Meat and Meat Products (Hormones), Recourse to Arbitration by the European Communities Under Article 22.6 of the Dispute Settlement Understanding, at 1, WT/DS26/ARB (July 12, 1999) [hereinafter the Arbitration Report].

97. Article 22.4 of the DSU states that the level of the suspension of concessions or other obligations authorized by the Dispute Settlement Board shall be equivalent to the level of the nullification or impairment.

98. Article 22.6 of the DSU states:

When the situation described in paragraph 2 occurs [if the Member concerned fails to bring the measure found to be inconsistent with a covered a covered agreement into compliance there with or otherwise comply with the recommendations and rulings within the reasonable period of time determined pursuant to paragraph 3 of Article 21], the DSB, upon requests, shall grant authorization to suspend concessions or other obligations within 3 days of the expiry of the reasonable period of time unless the DSB decides by consensus to reject the request. However, if the Member concerned objects to the level of suspension proposed . . . the matter shall be referred to arbitration. Such arbitration shall be carried out by the original panel, if Members are available, or by an arbitrator appointed by the Director-General and shall be completed within 60 days after the date of expiry of the reasonable period of time. Concessions or other obligations shall not be suspended during the course of the arbitration.

99. Article 22.4 of the DSU limits the power of the arbitrator to examining whether the removal of trade concessions is in excess of the loss; arbitrators may not examine the nature of concessions.

100. See Report of the WTO Panel, Australia-Measures Affecting Importation of Salmon, WT/DS18/R 1-1 (June 12, 1998).

101. See Report of the Appellate Body, Measures Affecting Agricultural Products, AB-1998-8, WT/DS76/AB/R, 79 (Feb. 22, 1999).

102. See Report of the Appellate Body, Measures Affecting the Importation of Salmon, AB-1998-8, WT/DS18/AB/R, 112 (Oct. 20, 1998).

103. SPS Agreement, supra note 7, art. 11(3).

104. But see Charnovitz, supra note 9, at 293-96 (arguing that the application of the precautionary principle is to the advantage of the health or environment as it requires a cost-benefit analysis and therefore where a Party can show that the costs outweigh the benefits, the principle may not be applied; thus, it really is not at the end of the day as big a moot).

105. Emily E. Berger, The Cartagena Protocol on Biosafety: Protecting the Global Environment Without Restricting National Sovereignty, at http://www.american.edu (last visited Dec. 12, 2000) (on file with author).

106. Jonathan H. Adler, The Cartagena Protocol and Biodiversity: Biosafe or Biosorry? 12 GEO. INT'L ENVTL. L. REV. 72 (2000).

107. See generally RONALD DWORKIN, TAKING RIGHTS SERIOUSLY (1977).

108. Agreement on Trade-Related Intellectual Property Rights (TRIPs), Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments-Results of the Uruguay Round, 33 I.L.M. 81. The TRIPs agreement was signed in 1994 to establish a uniform system to protect intellectual property rights including patents, trade secrets, and geographical indicators. Article 26 of the TRIPs agreement allows Members to the agreement to exclude from patentability inventions the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal, or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law. Sue Ann Mota, TRIPs—Five Years of Disputes at the WTO, 7 ARIZ. J. INT'L & COMP. L. 533 (2000).