Abstract
Background
New drug and medical device introduction in Japan usually lags behind that in the West. Many reports indicate that in Japan, the associated risks are considered greater than the benefits recognized in other countries. This study aimed to compare the relationship between risk-benefit perception and acceptance of medical technologies in 3 leading markets.
Methods
A tripartite cross-sectional survey of the general public was used. In total, 3345 adults in the United Kingdom, the United States, and Japan participated, and sexes and age groups were equally represented. Questions about the perception of risk, benefit, and acceptance of medical and other scientific technologies, and trust of medical product providers or regulatory authorities were included.
Results
Five-step Likert coding for risk/benefit/acceptance of 4 medical items (x-rays, antibiotics, vaccines, and cardiac pacemakers) and 6 general items (such as automobiles and airplanes) were collected. Relationships between benefit perception and acceptance were linear for 4 medical technologies. The relationship had a similar slope but was shifted downward in Japan compared with the UK and US (P <.01), suggesting a lower acceptance in Japan for all benefit perceptions. The trend was the same between risk perception and acceptance, except for slopes that were negative. Correspondence analysis showed a strong correlation among acceptance of medical technologies, benefits of medical technologies, trust in doctors, and trust in the Department of Health. The UK and US attributes were clustered with positive responses such as “useful,” “acceptable,” and “trustworthy,” whereas Japan was clustered with intermediate to negative responses such as “neither” and “untrustworthy.”
Conclusions
Acceptance of medical technologies was low in Japan because of significant differences in trust for doctors and authorities compared with that in the UK and US. This is a possible basis for delays of 24 to 60 months for medical product approval in Japan.
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References
Danzon PM, Epstein AJ. Effects of regulation on drug launch and pricing in interdependent markets. Adv Health Econ Health Serv Res. 2012;23:35–71.
Ueno T, Asahina Y, Tanaka A, Yamada H, Nakamura M, Uyama Y. Significant differences in drug lag in clinical development among various strategies used for regulatory submissions in Japan. Clin Pharmacol Ther. 2014;95:533–541.
Sato T. Current topics of pharmaceutical regulatory affairs in Japan Paper presented at: The 3rd China-Japan Symposium on Drug Development, Beijing, China. https://www.pmda.go.jp/files/000157574.pdf. Published 2012. Accessed April 11, 2017.
Tsuji K, Tsutani K. Approval of new biopharmaceuticals 1999-2006: comparison of the US, EU and Japan situations. Eur J Pharm Biopharm. 2008;68:496–502.
Yamada T, Kusama M, Hirai Y, Arnold F, Sugiyama Y, Ono S. Analysis of pharmaceutical safety-related regulatory actions in Japan: do tradeoffs exist between safer drugs and launch delay? Ann Pharmacother. 2010;44:1976–1985.
Jones RS. Healthcare Reform in Japan: Controlling costs, improving quality and ensuring equity. http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?doclanguage=en&cote=eco/wkp%282009%2980. OECD Economics Department working papers, No. 739. Washington, DC: OECD Publishing. Published 2009. Accessed April 11, 2017.
Kaitin KI, Mattison N, Northington FK, Lasagna L. The drug lag: an update of new drug introductions in the United States and in the United Kingdom, 1977 through 1987. Clin Pharmacol Ther. 1989;46:121–138.
Goodall S, Tom J. Boston Consulting Group. Regulation and access to innovative medical technologies. http://www.medtecheurope.org/sites/default/files/resource_items/files/01062012_BCG_Regulation%20and%20Access%20to%20Innovative%20Medical%20Technologies_Backgrounder.pdf. Boston, MA: BCG. Published 2012. Accessed April 11, 2017.
Ministry of Health, Labour and Welfare. Information materials regarding medical innovation [in Japanese]. http://www.mhlw.go.jp/stf/shingi/2r9852000001f1rr-att/2r9852000001f288.pdf. Published May 19, 2011. Accessed April 11, 2017.
Nakano S, Kodama F, Kano S. Definition of the device lag and its measurement. Japan J Med Instrument. 2009;79:273–285.
AMDD. Issues regarding to medical device market and idea of solutions. http://www.amdd.jp/en/pdf/technology/Policy110627.pdf. Published 2011. Accessed April 11, 2017.
Kawabata-Shoda E, Masuda S, Kimura H. Anticancer drug development from traditional cytotoxic to targeted therapies: evidence of shorter drug research and development time, and shorter drug lag in Japan. J Clin Pharm Ther. 2012;37:547–552.
Yonemori K, Hirakawa A, Ando M, et al. The notorious “drug lag” for oncology drugs in Japan. Invest New Drugs. 2011;29:706–712.
Starr C. Social benefit versus technological risk. Science. 1969;165:1232–1238.
Medicines & Healthcare Products Regulatory Agency. Risks and benefits of medicines and medical devices—perceptions, communication and regulation. http://www.ipsos-mori.com/Assets/Docs/Archive/Polls/mhra-gp-qual.pdf. Published 2006. Accessed April 11, 2017.
Slovic P, Peters E, Granac J, Berger S, Dieck GS. Risk perception of prescription drugs: results of a national survey. Drug Inform J. 2007;41:81–100.
Gilmour S, Kanda M, Kusumi E, Tanimoto T, Kami M, Shibuya K. HPV vaccination programme in Japan. Lancet. 2013;382:768.
Saitoh A, Okabe N. Current issues with the immunization program in Japan: can we fill the “vaccine gap”? Vaccine. 2012;30:4752–4756.
Gierlach EL, Belsher BE, Beutler LE. Cross-cultural differences in risk perceptions of disasters. Risk Anal. 2010;30:1539–1549.
Slovic P. Perception of risk. Science. 1987;236:280–285.
Ministry of Education, Culture, Sports, Science and Technology. Ministry of Health, Labour and Welfare. Ethical guidelines for epidemiological research. http://www.lifescience.mext.go.jp/files/pdf/n796_01.pdf. Published 2002. Accessed April 11, 2017.
Office for Human Research Protections. IRB guidebook. https://archive.hhs.gov/ohrp/irb/irb_guidebook.htm. Published 1993. Accessed April 11, 2017.
Department of Health. Governance arrangements for research ethics committees: a harmonised edition. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213753/dh_133993.pdf. Published 2011. Accessed April 11, 2017.
Council for International Organizations of Medical Sciences. Guideline 2: ethical review committees. International Ethical Guidelines on Epidemiological Studies. Geneva: CIOMS; 2009:7–8.
Le Roux B, Rouanet H. Correspondence analysis In: Le Roux B, Rouanet H, eds. Geometric Data Analysis from Correspondence Analysis to Structured Data Analysis. Dordrecht, the Netherlands: Kluwer Academic Publishers; 2004:23–65.
Bates ME, Valverde LJ Jr., Vogel JT, Linkov I. Environmental radiation: risk benchmarks or benchmarking risk assessment. Integr Environ Assess Manag. 2011;7:400–403.
Kleinhesselink R, Rosa EA. Cognitive representation of risk perceptions. J Cross-Cult Psychol. 1991;22:11–28.
Ohtsubo H, Yamada Y. Japanese public perceptions of food-related hazards. J Risk Res. 2007;10:805–819.
Hinman GW, Rosa EA, Kleinhesselink RR, Lowinger TC. Perceptions of nuclear and other risks in Japan and the United States. Risk Anal. 1993;13:449–455.
Takeda T, Yamaguchi T, Yaegashi N. Perceptions and attitudes of Japanese gynecologic cancer patients to Kampo (Japanese herbal) medicines. Int J Clin Oncol. 2012;17:143–149.
Normile D.Infectious diseases. First U.S. case of mad cow sharpens debate over testing. Science. 2004;303:156–157.
Ministry of Health, Labour and Welfare. Benefits type and amount of relief system for injury to health with vaccination. http://www.mhlw.go.jp/english/wp/wp-hw3/dl/2-086.pdf. Published 2012. Accessed April 11, 2017.
Health Resources and Services Administration, U.S. Department of Health and Human Services. National Vaccine Injury Compensation Program. http://www.hrsa.gov/vaccinecompensation/. Published 2016. Accessed April 11, 2017.
Omer SB, Orenstein WA, Koplan JP. Go big and go fast—vaccine refusal and disease eradication. N Engl J Med. 2013;368:1374–1376.
Schneider S, Zimmermann S, Diehl K, Breitbart EW, Greinert R. Sunbed use in German adults: risk awareness does not correlate with behaviour. Acta Derm Venereol. 2009;89:470–475.
Hoffmann TC, del Mar C. Patients’ expectations of the benefits and harms of treatments, screening, and tests: a systematic review. JAMA Intern Med. 2015;175:274–286.
Weber EU, Hsee C. Cross-cultural differences in risk perception, but cross-cultural similarities in attitudes towards perceived risk. Manage Sci. 1998;44:1205–1217.
Siegrist M. The influence of trust and perceptions of risks and benefits on the acceptance of gene technology. Risk Anal. 2000;20:195–203.
Tanaka Y. Major psychological factors affecting acceptance of gene-recombination technology. Risk Anal. 2004;24:1575–1583.
Muringai V, Goddard E, Aubeeluck A. Consumers’ understanding and concerns about bovine spongiform encephalopathy (BSE): comparison among Canadian, American, and Japanese consumers. J Toxicol Environ Health A. 2011;74:1592–1608.
Central Research Services Inc. Survey on “Feelings of Trust for Statesmen, Bureaucrats, Big Companies, Police, etc.” [Japanese]. http://www.crs.or.jp/data/pdf/trust12.pdf. Published 2012. Accessed April 11, 2017.
Uchida T, Nakajima Y, Teshima R. Should Japan’s regulatory reviewers have immunity from lawsuits? Regul Focus. 2010;Sept:47-48.
Sipp D. “Fast-track” drug approvals hit speed bumps in Japan. Nat Med. 2004;10:883.
Tan SJ. Strategies for reducing consumers’ risk aversion in Internet shopping. J Consumer Marketing. 1999;16:163–180.
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Todaka, K., Kishimoto, J., Ikeda, M. et al. Impact of Risk-Benefit Perception and Trust on Medical Technology Acceptance in Relation to Drug and Device Lag: A Tripartite Cross-Sectional Survey. Ther Innov Regul Sci 52, 629–640 (2018). https://doi.org/10.1177/2168479017739267
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DOI: https://doi.org/10.1177/2168479017739267