Adjudicating Science-Based Trade Disputes: Paradigms and Development
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Bernardino Ramazzini, the father of occupational and environmental medicine, wrote in the early 1600s, "it pays far more to prevent than to treat," using the economic word "pays." The accelerated internationalization of communications, commerce, people, goods and services is generating great pressure on this principle. From the global health point of view, the intensity of transfer of both health knowledge and risks is changing the health horizon in every country. Global health is now increasingly recognized as a national security issue. The current Mexican National Health Program states that globalization has eroded our borders and calls for a reorganization of our sanitary risks protection administration.
If trade and health define as their common ground the "global good," it must be recognized that trade negotiations do not start out with a level playing field. The recent Worldwide Bishops' Declaration of October 2001 acknowledged the great heterogeneity in development that is increasing international tensions. A valid concern also exists that globalization is constraining democratic processes.
Risk assessment is a powerful method that integrates scientific knowledge to support the setting of health and environmental protection standards. We collect results from basic laboratory cellular and animal research, knowledge of how toxics move in the human body, how we become exposed and epidemiologic data on the human experience. We move from controlled bench research into the real world of heterogeneous populations.
The lack of complete scientific data, the heterogeneity of populations and the extrapolation from the bench to humans introduces a certain degree of uncertainty. In addition, there are methodological difficulties, such as the appropriate mathematical modeling of dose response relationships and the desired level of protection, i.e. how much excess risk do we want to accept? Acceptable risk is determined by the society's risk perception, and not all societies or nations perceive risk similarly. Societies with a young age composition, like Mexico's, may prioritize the protection of young children and the malnourished, issues frequently ignored by the so-called "international standards." The imposition of one country's values regarding avoidable risk is a delicate issue in rapidly democratizing countries, where the questions of how much protection and what society should be protected from are currently being debated. The complexity of science is further complicated by social, political and economic interests, a reality frequently ignored in international negotiations.
Complicated as it is when setting national policy, risk assessment is now being used in the international arena to set the rules of human exchange. We begin to hear the term "Risk Assessment Harmonization," which requires further clarification as to whether this refers to harmonization of methods or of risk decisions, as is now being discussed by the NAFTA Technical Working Group on Pesticides. The so-called "standard taker" countries have often abdicated their option to analyze risks, deliberate and take their own decision, abiding by the "international standard," which assumes that risk tolerances and standards set in developed countries embody the "truth." Moves by countries to protect their population's health by setting different standards may now be interpreted as trade barriers, as has occurred with Brazil's pesticide registration. The imposition of what gets regulated without open debate and public input generates inequity in the international regulatory process.
The already complex risk assessment process confronts its biggest challenge when "standard taker," "dependent," "emerging economy," and "less developed" countries confront trade challenges. Mexico, for example, has just signed 40 free trade agreements and there is a push for a pesticide common market in North America. The exercise to adjust the maximum residue level of pesticides for dietary corn consumption in Mexico, where average consumption is 10 times higher than in other North American countries, is now opening a debate as to whether this adjustment constitutes a trade barrier or a legitimate action to protect Mexicans' health.
What do I expect from this conference? I expect a blunt but not naïve discussion, the building of a common language, respectful consideration of the concerns of less developed countries and support for democratic processes. More importantly, I expect us to outline an agenda for research and international deliberation that can help us inject rigor into these international decisions. Let's go back to our common ground. Each of us is interested in risk assessment and health protection as well as in greater economic exchange and expanded commerce. All of us are interested in a global common good.
Carlos Santos-Burgoa is General Director for Environmental Health, Secretariat of Health, Mexico, and adjunct professor of epidemiology, U-M School of Public Health. The article that follows is adapted from a paper presented at a workshop on “Risk Assessment in the Context of Trade Disputes: How Well are Scientific Principles Incorporated in the Resolution of Science-Based Trade Disputes?” at the University of Michigan, November 1-2, 2001.