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Understanding Race at the Frontier of Pharmaceutical Regulation: An Analysis of the Racial Difference Debate at the ICH

Published online by Cambridge University Press:  01 January 2021

Wen-Hua Kuo
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Extract

Reflecting on the tension of which he was aware between the imperial West and the still-mysterious East, Victorian writer Rudyard Kipling (1865-1936) penned the above phrase to express the incommensurable situation wherein the Westerner never understands the Asian, as the latter’s culture differs too greatly from his own. However, aware that East and West nevertheless cannot remain separated forever, the author ends the poem with an eventual encounter between the two.

Over 100 years have passed since this poem was written, yet the ambivalent encounter between East and West that it depicts still exists and is currently playing out within the field of pharmaceuticals. On one side of the divide are the many people in the industry who want to standardize global acceptance of drugs; on the other are the local authorities who want to maintain the overruling legal need not to compromise on health care at a national level. In this sense, the divergence and unity that Kipling captures is what this paper aims to discuss as it addresses how race is debated at the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 36 , Issue 3 , Fall 2008 , pp. 498 - 505
Copyright
Copyright © American Society of Law, Medicine and Ethics 2008

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References

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Although a handful of successful cases that use these guidelines are noted, generally the industry is not satisfied with it. Some complaints are reported by Elaine Esber at the 2003 meeting of the APEC Network of Pharmaceutical Regulatory Science-APEC Joint Research Project on Bridging Studies, such as the following: “E5 has resulted in a request for more studies, rather than less,” it is “a convenient excuse for requiring a local registration study and calling it a bridging study,” “requests are for data, country by country, not as a region,” “there are ulterior motives for requesting that studies be done, e.g., protect local industries,” “E5 is being implemented as a trade barrier,” “most companies are doing studies just to not get into an argument,” “governments are not being flexible,” and many others.Google Scholar
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In Japanese, there are two sets of terms roughly corresponding to the concept of race and ethnicity in English: While minzoku and shudan refer to cultural and social factors, jinshu and shuzoku refer to biological factors. But for our purposes I will use the term minzoku as shorthand for that which is considered the basis of the Japanese nation.Google Scholar
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According to Rashmi Shah of the Medicines and Healthcare Products Regulatory Agency UK, concern over racial difference was first raised by the European Committee for Proprietary Medicinal Products (CPMP). Since 1985, the European Cooperation in the field of Science and Technology Research has conducted a project titled “Criteria for the choice and definition of healthy volunteers and patients for Phase I and Phase II studies in drug development,” in which polymorphism in drug metabolism is one topic. These attempts resulted in a European conference on pharmacogenetics in 1990 as well as a draft on ethnic difference by the CPMP before the foundation of the ICH.Google Scholar
It is interesting to consider why Japan did not promote its idea of minzoku to other ICH members in the first place. However, for the Japanese officials I interviewed, it seemed to be out of the question. After all, one official explained to me, pharmaceuticals are national issues; they have no point to “correct” other countries’ racial policies. This observation echoes Sheila Jasanoff's notion of “regulatory culture” in which regulation must be grown from a particular soil of culture, which, in turn, is attributed to a distinct configuration of this culture.Google Scholar
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Apart from the previous set of questions and answers, the new one (Q11) added in 2006 concerns the role of bridging studies in the context of multi-regional clinical trial or global drug development. Reading its text, I do not think that this question and answer helps much in resolving the existing divergence on the idea of ethnicity. However, it provides all players with new repertories to express their ways to deal with the differences among populations. For more discussions on this regard, I have written a paper “Bridging Studies in Japan and Taiwan: A Dynamic Evolution in Regulating Ethnic Differences,” which is currently under review for publication.Google Scholar
For a brief discussion about the different responses of Asian states toward the E5 issue, I have written a paper, “Bring the State Back in the Global/Genomic World: Racial Difference and the Transforming States of Japan, Taiwan and Singapore,” which is currently under review for publication.Google Scholar