Understanding race at the frontier of pharmaceutical regulation: An analysis of the racial difference debate at the ICH

Journal of Law, Medicine and Ethics

Volumn 36, Issue 3, 2008, Pages 498-505

  Kuo, Wen Hua ^a  

^a NATIONAL YANG MING UNIVERSITY   (Taiwan)

Author keywords

[No Author keywords available]

Indexed keywords

ASIAN; ATTITUDE; CONFERENCE PAPER; CULTURAL ANTHROPOLOGY; DRUG APPROVAL; DRUG INDUSTRY; ECONOMICS; EUROPEAN UNION; HUMAN; INTERNATIONAL COOPERATION; JAPAN; LEGAL ASPECT; PSYCHOLOGICAL ASPECT; RACE; UNITED STATES;

ASIAN CONTINENTAL ANCESTRY GROUP; ATTITUDE; CONTINENTAL POPULATION GROUPS; CULTURE; DRUG APPROVAL; DRUG INDUSTRY; EUROPEAN UNION; HUMANS; INTERNATIONAL AGENCIES; JAPAN; UNITED STATES;

EID: 50249086370     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2008.297.x     Document Type: Conference Paper

References (26)

1. R. Kipling, The Collected Poems of Rudyard Kipling (London: Wordsworth Editions Ltd., 1994 at 245.
2. 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.
3. See L. G. Thomas, The Japanese Pharmaceutical Industry: The New Drug Lag and the Failure of Industrial Policy (Cheltenham, U.K. and Northampton, MA: Edward Elgar, 2001). To take the anti-arthritis drug Voixx as an example, when its producer, Merck, found an adverse effect in long-term users after five years of sales in 2004, Japan was still carrying out local clinical trials. Even so, there has been noted an improvement in this reviewing system since the foundation of the ICH, especially since 2004 when Japan integrated and established a professional, semi-governmental organization, Pharmaceuticals and Medical Devises Evaluation Center (PMDEC, later renamed Pharmaceutical and Medical Devices Agency, PMDA).
4. For a concise introduction to the ICH, see C. Nutley, ed. The Value & Benefits of ICH to Industry 2000, available at http://www.ich.org/MediaServer. jser?@_ID=458&@_MODE=GLB (last visited May 19, 2008).
5. The WHO founded the International Conference of Drug Regulatory Authorities (ICDRAs) in 1980 to allow the drug regulatory authorities of WHO member states to meet and discuss ways to strengthen collaboration and exchange information. Before the inauguration of the ICH, the ICDRA was a means to aid WHO and regulatory authorities in their efforts to improve the safety, efficacy, and quality of medicines.
6. The ICH has six voting members, including regulators from the U.S., the EU, and Japan - the FDA, the Japanese Ministry of Health and Welfare (MHW), and the European Community - and industry representatives - PhRMA, the Japan Pharmaceuticals Manufacturing Association (JPMA), and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Some organizations are chosen as non-voting observers, such as the WHO, Health Canada, and the European Free Trade Association (EFTA). The International Federation of Pharmaceutical Manufacturing Associations (IFPMA), which is also a non-voting member, provides the secretariat.
7. There have always been debates over the actual cost per innovative drug. The figures PhRMA gives but that are challenged by critics such as Marcia Angell increased from $259 million in 1990 to $302 million in 1995, and lately to $802 million based on a 2001 study done by the Tufts Center for the Study of Drug Development.
8. For example, industry and regulators must set universal room temperatures for stability testing.
9. The "ICH process" contains a five-step procedure that proceeds as follows. Formal proposals for new harmonization must be brought up to the steering committee in order to initiate an ICH action. When accepted, a proposal is assigned to an expert working group, which advises on the technical aspects of harmonization topics (Step 1). When a primary guideline is drafted, it must first be distributed to all the invited experts to form a consensus (Step 2). After the draft is completed, it is brought back to each region for feedback on other related topics (Step 3). Every guideline must be agreed upon by all experts and the domestic industries before submission back to the steering committee, where the guideline is confirmed and released (Step 4). Finally, a follow-up mechanism is applied to determine whether the guidelines are adopted by local regulatory agencies within six months of release (Step 5).
10. J. Abraham and T. Reed Progress, Innovation and Regulatory Science in Drug Development: The Politics of International Standard-Setting Social Studies of Science 32, no. 2 (2002 337 369. For a comprehensive review of all guidelines made by the ICH's six conferences, see Yiyakuhin kaihatu no kokusaichowa no ayumi: ICH 6 mate [Review on the International Harmonization of Medical Products Up to the sixth ICH Conference] (Tokyo: Jiho, 2003).
11. See Nutley, supra note 4, at 4.
12. The issue is entitled "Ethnic Factors in the Acceptability of Foreign Clinical Data." It was proposed by Osamu Doi and listed as the fifth issue in the category of efficacy.
13. Toshiyoshi Tominaga, the Ministry of Health, Labor, and Welfare officer who prepared the Japanese version of the E5 guideline, admitted in my interview that he sees no difference between race and nation. He recalled that he had originally translated the term race as jinshu, which is more biological and closer to the original meaning of race, but his supervisor changed it to minzoku.
14. 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.
15. See Henken no kozo: nihonjin nojinshukan [The Structure of Prejudice: Race Conceived by the Japanese] (Tokyo: Nihon-hoso shuppankyokai, 1967 pp. 158 159.
16. See D. E. Roberts Is Race-Based Medicine Good for Us? African-American Perspectives on Race, Biotechnology, and Equality Journal of Law, Medicine & Ethics 36, no. 3 (2008 537 545.
17. While the Western world tends to consider Asians as a group, historically in Asia the idea of race always goes with that of nation-state, which was also imported in the 19th century. For more discussions on how race and ethnicity are considered in the Asian context, see Y. Takezawa, ed., Jinshugainen no fuhensei wo tou: seiyoteki paradaimu wo koete [Is Race a Universal Idea? Transcending the Western Paradigm] (Kyoto: Jimbunshoin, 2005).
18. See the ICH's seventh guideline in the category of efficacy "Studies in Support of Special Populations: Geriatrics.".
19. 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.
20. 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.
21. This was also the way when racial differences were discussed among pharmaco-geneticists in the U.S. and Canada. For this history, see D. Jones The Administration of Food and Drugs: Diet, Race, and the Genetics of Efficacy, 1950-1980 paper presented at Johns Hopkins University, October 3, 2005.
22. See Abraham and Reed, supra note 10, at 363.
23. See Agnes Shanley's interview of me in her Dismantling the Gray Maze Pharmaceutical Manufacturing 5, no. 6 (June 2006 18 22.
24. Id., at 22.
25. 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.
26. 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.