This article was downloaded by: [Michigan State University] On: 01 March 2015, At: 02:13 Publisher: Routledge Informa Ltd Registered in England and Wales Registered Number: 1072954 Registered office: Mortimer House, 37-41 Mortimer Street, London W1T 3JH, UK
The American Journal of Bioethics Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/uajb20
How Political Cultures Affect Governance Efforts To Protect “Posted Genes”: Insights From Germany a
b
Jonas Lander & Ine Van Hoyweghen a
Hannover Medical School
b
Katholieke Universiteit Leuven Published online: 17 Oct 2014.
Click for updates To cite this article: Jonas Lander & Ine Van Hoyweghen (2014) How Political Cultures Affect Governance Efforts To Protect “Posted Genes”: Insights From Germany, The American Journal of Bioethics, 14:11, 50-53, DOI: 10.1080/15265161.2014.957421 To link to this article: http://dx.doi.org/10.1080/15265161.2014.957421
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions
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The American Journal of Bioethics
GINA (Allain, Friedman, and Senter 2012). This enduring fear may cause individuals to avoid genetic testing or not participate in genetic research—two outcomes Congress intended to minimize with GINA. GINA regulates employers through (a) antidiscrimination provisions that prohibit adverse employment decisions and provide compensation for harms that have already occurred, and (b) privacy provisions that prevent the collection of PGI and stop actors from gaining access to the very information needed to discriminate. Effective privacy is the only true shield against genetic discrimination since employers cannot act on information they do not have. GINA’s bans on collection of PGI are therefore better equipped to address fear of genetic discrimination than the non-discrimination provisions. However, fear will continue if employers continue to access PGI through inadvertent acquisition in social media and medical certifications.
CONCLUSION Given the pervasiveness and benefits of genetic information in social media and medical records, there will always be a tension between acquisition and GINA’s goals of privacy. However, there are tangible steps available to employees and the government that can lessen the chances of inadvertent acquisition and therefore increase protections and more closely mirror individual’s impressions as to the effectiveness of GINA’s protections. &
Equal Employment Opportunity Commission. 1995. Enforcement guidance: Preemployment disability-related questions and medical examinations. October 10. Available at: http://www.eeoc.gov/ policy/docs/preemp.html (accessed August 15, 2014). Equal Employment Opportunity Commission (EEOC). 2002. Enforcement guidance: Reasonable accommodation and undue hardship under the Americans with Disabilities Act. October 17. Available at: http://www.eeoc.gov/policy/docs/accommodation. html (accessed August 15, 2014). Equal Employment Opportunity Commission. 2013. EEOC sues Abatti Group for disability, genetic information discrimination [Press release]. Available at: http://www.eeoc.gov/eeoc/ newsroom/release/9-30-13d.cfm (accessed August 13, 2014). Federal Register. 2010. 29 C.F.R. Part 1635. November 9. Regulations under the Genetic Information Nondiscrimination Act of 2008. Available at: http://www.gpo.gov/fdsys/pkg/FR-2010-11-09/ pdf/2010-28011.pdf (accessed August 15, 2014). Federal Register. 2013. 45 C.F.R. Parts 160 and 164. January 25. Modifications to the HIPAA privacy, security, enforcement, and breach notification rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other modifications to the HIPAA rules; Final rule. Available at: http://www.gpo.gov/fdsys/pkg/FR2013-01-25/pdf/2013-01073.pdf (accessed August 15, 2014). Federal Register. 2014. 29 C.F.R. Part 825. February 6. The Family and Medical Leave Act. Available at: http://webapps.dol.gov/ FederalRegister/PdfDisplay.aspx?DocId=26631 (accessed August 15, 2014).
REFERENCES
Lee, S. S.-J., and E. Borgelt. 2014. Protecting posted genes: Social networking and the limits of GINA. American Journal of Bioethics 14(11): 32–44.
Allain, D. C., S. Friedman, and L. Senter. 2012. Consumer awareness and attitudes and insurance discrimination post enactment of the Genetic Information Nondiscrimination Act. Familial Cancer 11 (4): 637–644.
Prince, A. E. R., and M. I. Roche. 2014. Genetic information, nondiscrimination, and privacy protections in genetic counseling practice. Journal of Genetic Counseling. doi: 10.1007/s10897-0149743-2
How Political Cultures Affect Governance Efforts To Protect “Posted Genes”: Insights From Germany Jonas Lander, Hannover Medical School Ine Van Hoyweghen, Katholieke Universiteit Leuven In their target article, Lee and Borgelt (2014) address a pressing question in the field of U.S. biotechnology governance: how to protect individuals from genetic
discrimination through personal genetic information (PGI) gained from their social networking activities. Accordingly, “there is no ideal solution” (Lee and Borgelt 2014,
Address correspondence to Jonas Lander, Institute for History, Ethics and Philosophy of Medicine, Hannover Medical School, Hannover, Germany. E-mail: [email protected]
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41). Still, the authors argue, numerous governance options exist to address the regulatory limits on total prevention of employers and insurers from accessing PGI. Current limits have been the result of central concepts being poorly defined, leaving room for interpretation and flexibility (51) in the Genetic Information Nondiscrimination Act (GINA), a U.S. federal law enacted in 2008, which came into force at the end of 2009. To address those limitations, the authors suggest “public dialogue on best practices among industry stakeholders and professional organizations,” “public education” about GINA, “future guidelines” for online DTC genetic testing companies, and “robust laws” to protect employees from third-party access to their social media profiles. Overall, we agree there is a need to address the technical and practical limits of regulatory action by developing complementary and perhaps novel governance tools, especially given the complex nature of genetic information. However, based on experience of policy governing genetic information in Germany, we argue that implementing these governance tools in specific established “political cultures” (Jasanoff 2005) can prove difficult. Such national political cultures matter to the (successful) use of governance tools because they are based on specific routine and institutionalized practices. These political cultures affect not only how particular topics (e.g., genetic testing) are typically approached as part of the political agenda, but also how public knowledge of a given issue (e.g., biotechnology) is created and justified. National political cultures thus provide established practices for political legitimization and interaction between policy, science and the public (Jasanoff 2005, 18ff.). For instance, German political culture in the field of biotechnology is characterized by expert rationality and institution-based knowledge making, while the U.S. biotech governance rests on reasoned objectivity and reliance on (professional) interest groups (Jasanoff 2005, 35). As a result, it might be challenging to adapt other governance approaches, for example, public dialogue, public education, best practices, and guidelines, to these specific and distinct predominant political cultures. In the following, we demonstrate how this idea of political cultures comes into play by briefly outlining the governance process and development of the German Genetic Diagnosis Act (hereafter referred to as GenDG: 2001–2009). Based on this analysis, we encourage better adaptation of future policy processes to specific national policy contexts, which may be relevant to the policy recommendations made by Lee and Borgelt regarding PGI and social networking.
GOVERNING GENETIC INFORMATION IN GERMANY: ALIGNING NEW GOVERNANCE TOOLS WITH GERMAN POLITICAL CULTURE In Germany, the case of a German schoolteacher who was refused probationary civil servant status based on her genetic predisposition provoked public debate and a call
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for regulatory action (Burgermeister 2003). Earlier, German parliamentary delegates had already urged the government to act on developments in the field of genetic testing (Deutscher Bundestag 2001). Also, mechanisms to prevent misuse of genetic information, for example, in the field of private insurance, were in place even before the initiation of GenDG. Nevertheless, the law envisioned voluntary self-regulation instead of binding regulatory measures (Gesamtverband Deutsche Versicherungswirtschaft [GDV] 2001). As a result, a special parliamentary commission (Enquete Commission on the Legislation and Ethics of Modern Medicine, referred to in the following as “the Commission”) was tasked with advising the German government on the future governance of genetic testing (Deutscher Bundestag 2002). The recommendations made by the Commission in 2001/20021 resemble those of Lee and Borgelt regarding PGI and seem appropriate to address the complex matter of personal genetic information. As with the practical and technical limits of GINA, in Germany there was concern that conventional laws had limited relevance to genetic information (Deutscher Bundestag 2002). The Commission therefore suggested working with governance tools different from more conventional German approaches to the governance of biotechnology based on expert-led decision making and law. For example, it advised the use of “open public debate, based on the active participation of citizens” (Deutscher Bundestag 2002, 187). The Commission further suggested “dialogue events and public hearings, cooperation with committees and other working groups and institutions besides the Parliament, [and] the promotion of dialogue within society” (Deutscher Bundestag 2002, 206) to eventually “regulate genetic diagnostics via a comprehensive law” (Deutscher Bundestag 2002, 176). By promoting a “culture of dispute” (Streitkultur) for the governance of genetic testing (Deutscher Bundestag 2002, 2), these recommendations thus encouraged new modes instead of applying established German governance mechanisms such as expert consultation, ministerial bureaucracy, development of legislation limited to political institutions, and rational reasoning (Daemmrich 2004; Jasanoff 2005). In practice, however, the development of GenDG (2001–2009) did not closely follow the recommendations of the 2001 Commission. Contrary to the Commission’s explicit call for Streitkultur and corresponding new approaches to governance, the German Bundestag issued two consecutive written requests for legislation, mapping out key points for a draft law as a first step toward developing GenDG. The period of 2006–2009 was characterized by two more legislative drafts (2006 and 2008) and also two public hearings (2007 and 2009). While the latter could be identified as efforts toward Streitkultur, the 2007 public
1. While the final report of the Commission was published in 2002, a preliminary report in 2001 had already pointed to some of the most important aims of and approaches to the governance of genetic testing.
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hearing did not influence the adoption of the 2006 draft law according to public preferences (Mayer 2007). Rather, it was disregarded owing to civil servants being overworked and a change of ministerial staff, which led to the release of a completely new draft in 2008 by the coalition then governing. While the second public hearing took place in 2009, this happened only after the release of the 2008 draft law, hence denying again opportunities for including public input during the drafting stage. Moreover, GenDG was adopted only 4 weeks after this debate, leaving little room for implementing changes to the draft (Lander and Van Hoyweghen 2014). In short, the GenDG governance process barely lived up to the initial expectations and recommendations by the 2001 Commission, that is, of broad public participation to develop approaches to prevent genetic discrimination. Instead, the governance process was largely based on formal policy input (e.g., requests for legislation; legislative drafts), expert consultation (consultation of professional stakeholders and industry during public hearings), and interinstitution decision making, that is, the agreement on the final GenDG by the German government and Bundesrat in 2009. Given the call for new governance tools on the one hand and the eventual use of conventional governance approaches on the other hand, the German case study illustrates how difficult it can be to align the introduction of new governance tools with established local political cultures, such as those on governing genetic information in Germany. As a result, the GenDG paragraphs on employment (x19, x20), while generally prohibiting employers from demanding PGI data of employees, allowed that “Diagnostic genetic examinations . . . are permitted in the framework of occupational medical examinations and work-related screenings to the extent that they are necessary to determine genetic traits” and “(3) The Federal Government can . . . issue regulations which . . . allow diagnostic cyto-genetic and molecular genetic analyses to be conducted . . . in the framework of occupational medical examinations and work-related screenings” to determine (the likelihood of) severe illnesses or health conditions resulting from work-related activities (Deutscher Bundesrat 2009, 15ff.). Initially, the Commission in 2001/2002 explicitly suggested achieving comprehensive protection against genetic discrimination and that this should be achieved by “new” governance tools (Deutscher Bundestag 2002). Contrary to this, the conventional governance process applied eventually resulted in regulatory exemptions instead of a complete ban on all actions that may lead to genetic discrimination. HOW POLITICAL CULTURES MATTER The preceding sketch of the development of the governance process for genetic testing in Germany suggests comparisons with that of the future governance process for genetic testing and social networking in the United States. Policy-oriented recommendations like those of Lee
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and Borgelt (2014) are laudable and surely necessary when searching for governance solutions to complex issues. This is especially so when conventional legislation cannot fully address rapid developments in genetic information techniques, as it may either be too slow to react to innovation or too narrow to cover the full range of issues in practice (Van Hoyweghen and Horstman 2008). However, from a policy analysis perspective, prevailing political cultures can hardly be rearranged simply by implementing new governance tools. This has been confirmed in the case of Germany, where the prevalent conventional political culture could not readily incorporate the distinct features of a Streitkultur as originally intended by the Commission in 2001. Looking at the United States, others have demonstrated how its political culture relies primarily on industry and other professional interest groups to generate policy input, which is characterized by the production of “facts,” that is, objectivity through numbers, quantitative analyses, and risk assessments, as well as by accountability generated through expert knowledge (Jasanoff 2005, 17ff.). Against this background, Lee and Borgelt recommend “public dialogue,” “public education,” “future guidelines,” and “best practices,” which may be considered different from or at least complementary to the alreadydescribed conventional U.S. governance tools. Based on our argument regarding the relevance of political cultures, a first step in assessing whether such policy recommendations sufficiently address existing U.S. biotechnology political culture could be to identify possible mismatches and connections of each option, and align future policy approaches accordingly. To our understanding, such a stepwise change approach may be more effective than trying to induce disruptive shifts in existing political cultures. & REFERENCES Burgermeister, J. 2003. Teacher was refused job because relatives have Huntington’s disease. British Medical Journal 327(7419): 827. Daemmrich, A. 2004. Pharmacopolitics: Drug regulation in the United States and Germany, Studies in social medicine. Chapel Hill, NC: University of North Carolina Press. Deutscher Bundesrat. 2009. Enactment of the German Federal Parliament (Bundestag) Human Genetic Examination Act (Genetic Diagnosis Act—GenDG). Berlin, Germany: Bundesanzeiger Verlagsgesellschaft. Deutscher Bundestag. 2001. Antrag. Anwendungen von Gentests in Medizin und Versicherungen, ed. CDU/CSU. Berlin, Germany: Deutscher Bundestag. Deutscher Bundestag. 2002. Schlussbericht der Enquete-Kommission des 14. Bundestages “Recht und Ethik der modernen Medizin.” Berlin, Germany: Deutscher Bundestag. Gesamtverband Deutsche Versicherungswirtschaft. 2001. Freiwillige Selbstverpflichtungserkl€ arung der Mitgliedsunternehmen des Gesamtverbandes der Deutschen Versicherungswirtschaft e.V. (GDV). Berlin, Germany: Gesamtverband Deutsche Versicherungswirtschaft.
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Jasanoff, S. 2005. Designs on nature: Science and democracy in Europe and the United States. Princeton, NY: Princeton University Press. Lander, J., and I. Van Hoyweghen. 2014. Streitkultur and the governance of genetic testing and insurance in Germany. New Genetics and Society 33(1): 42–59. Lee, S. S.-J., and E. Borgelt. 2014. Protecting posted genes: Social networking and the limits of GINA. American Journal of Bioethics 14(11): 32–44.
Mayer, S. 2007. Complex matters. The regulation of predictive genetic testing and genetic counseling in Germany. Berlin, Germany: Institute Mensch, Ethik und Wissenschaft. Van Hoyweghen, I., and K. Horstman. 2008. European practices of genetic information and insurance: lessons for the Genetic Information Nondiscrimination Act. Journal of the American Medical Association 300(3): 326–327.
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Sharing Genetic Information Online: An Exploration of GINA’s 2.0 Frontier Vassilis Ragoussis, McGill University Ida Ngueng Feze, McGill University Yann Joly, McGill University Scientific breakthroughs in the field of genomics have sparked the sprawling of direct-to-consumer (DTC), lowcost Internet genetic services and generated an unprecedented amount of genetic data. With this effervescence of information, the popularity of social media platforms has made sharing genetic data much faster than ever before. Despite the adoption of the Genetic Information Nondiscrimination Act (GINA), there are still significant concerns about genetic discrimination (GD) based on personal and genetic information shared online. While GINA aims to prevent GD in the contexts of health insurance and employment, it “does not prohibit employers or insurers from encouraging individuals to undergo genetic testing and it does not apply to life insurance or long-term disability insurance” (Resnik 2014, 120). Lee and Borgelt (2014) have ventured into GINA’s 2.0 frontier, assessing the effectiveness of current protections in a time where U.S. employers could be tempted to seek out or monitor the online data of job candidates and employees.
GINA: HEALTH INSURANCE AND EMPLOYMENT INTERTWINED While Lee and Borgelt recognize that GINA is severely limited in scope and cannot efficiently address GD and the confidentiality of health data in Web 2.0, they fail to underline that health insurance and employment are intimately related in the United States. As pointed out by Rothstein (2013), “there is no scientific, ethical, policy or legal reason for an employer to acquire or use genetic information,” (3) and therefore, employers’ interest in genetic data may be
due to their role in facilitating access to health insurance. Thus, GINA’s limitations may be rooted in the minimalistic approach adopted as a result of a compromise reached after decades of debates in a context where individuals’ health data may inherently be of interest to employers. Even when health coverage is obtained, GINA does not mandate insurance coverage of treatments or tests related to genetic conditions (Hudson, Holohan, and Collins 2008). Moreover, Lee and Borgelt fail to address the fact that GINA does not apply to other fields outside of employment and health insurance, thereby promoting a patchwork approach rather than a comprehensive strategy against GD. Their proposition to strengthen GINA does not address the underlying need for a broader debate in the United States about equitable access to health care in general and the use of health information (genetic or not) by employers. Without such considerations, it is unlikely that GD will be effectively addressed in the context of employment or insurance.
PROTECTING SHARED AND POSTED GENETIC DATA UNDER GINA As mentioned by Lee and Borgelt (2014), the complexities and intricacies of the growing interconnectivity between social and professional networks and the public domain on the Internet have made it very difficult to fully guarantee the protection or privacy of personal information shared online. However, even when the legal remedies advocated are available, tracking and deleting the shared information would be challenging. Hence, personal information shared online could potentially end up in the
Address correspondence to Prof. Yann Joly, PhD, Research Director, Centre of Genomics and Policy, McGill University, 740 Dr. Penfield Avenue, Suite 5200, Montreal, QC, H3A 0G1, Canada. E-mail: [email protected]
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The American Journal of Bioethics Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/uajb20
How Political Cultures Affect Governance Efforts To Protect “Posted Genes”: Insights From Germany a
b
Jonas Lander & Ine Van Hoyweghen a
Hannover Medical School
b
Katholieke Universiteit Leuven Published online: 17 Oct 2014.
Click for updates To cite this article: Jonas Lander & Ine Van Hoyweghen (2014) How Political Cultures Affect Governance Efforts To Protect “Posted Genes”: Insights From Germany, The American Journal of Bioethics, 14:11, 50-53, DOI: 10.1080/15265161.2014.957421 To link to this article: http://dx.doi.org/10.1080/15265161.2014.957421
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions
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GINA (Allain, Friedman, and Senter 2012). This enduring fear may cause individuals to avoid genetic testing or not participate in genetic research—two outcomes Congress intended to minimize with GINA. GINA regulates employers through (a) antidiscrimination provisions that prohibit adverse employment decisions and provide compensation for harms that have already occurred, and (b) privacy provisions that prevent the collection of PGI and stop actors from gaining access to the very information needed to discriminate. Effective privacy is the only true shield against genetic discrimination since employers cannot act on information they do not have. GINA’s bans on collection of PGI are therefore better equipped to address fear of genetic discrimination than the non-discrimination provisions. However, fear will continue if employers continue to access PGI through inadvertent acquisition in social media and medical certifications.
CONCLUSION Given the pervasiveness and benefits of genetic information in social media and medical records, there will always be a tension between acquisition and GINA’s goals of privacy. However, there are tangible steps available to employees and the government that can lessen the chances of inadvertent acquisition and therefore increase protections and more closely mirror individual’s impressions as to the effectiveness of GINA’s protections. &
Equal Employment Opportunity Commission. 1995. Enforcement guidance: Preemployment disability-related questions and medical examinations. October 10. Available at: http://www.eeoc.gov/ policy/docs/preemp.html (accessed August 15, 2014). Equal Employment Opportunity Commission (EEOC). 2002. Enforcement guidance: Reasonable accommodation and undue hardship under the Americans with Disabilities Act. October 17. Available at: http://www.eeoc.gov/policy/docs/accommodation. html (accessed August 15, 2014). Equal Employment Opportunity Commission. 2013. EEOC sues Abatti Group for disability, genetic information discrimination [Press release]. Available at: http://www.eeoc.gov/eeoc/ newsroom/release/9-30-13d.cfm (accessed August 13, 2014). Federal Register. 2010. 29 C.F.R. Part 1635. November 9. Regulations under the Genetic Information Nondiscrimination Act of 2008. Available at: http://www.gpo.gov/fdsys/pkg/FR-2010-11-09/ pdf/2010-28011.pdf (accessed August 15, 2014). Federal Register. 2013. 45 C.F.R. Parts 160 and 164. January 25. Modifications to the HIPAA privacy, security, enforcement, and breach notification rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other modifications to the HIPAA rules; Final rule. Available at: http://www.gpo.gov/fdsys/pkg/FR2013-01-25/pdf/2013-01073.pdf (accessed August 15, 2014). Federal Register. 2014. 29 C.F.R. Part 825. February 6. The Family and Medical Leave Act. Available at: http://webapps.dol.gov/ FederalRegister/PdfDisplay.aspx?DocId=26631 (accessed August 15, 2014).
REFERENCES
Lee, S. S.-J., and E. Borgelt. 2014. Protecting posted genes: Social networking and the limits of GINA. American Journal of Bioethics 14(11): 32–44.
Allain, D. C., S. Friedman, and L. Senter. 2012. Consumer awareness and attitudes and insurance discrimination post enactment of the Genetic Information Nondiscrimination Act. Familial Cancer 11 (4): 637–644.
Prince, A. E. R., and M. I. Roche. 2014. Genetic information, nondiscrimination, and privacy protections in genetic counseling practice. Journal of Genetic Counseling. doi: 10.1007/s10897-0149743-2
How Political Cultures Affect Governance Efforts To Protect “Posted Genes”: Insights From Germany Jonas Lander, Hannover Medical School Ine Van Hoyweghen, Katholieke Universiteit Leuven In their target article, Lee and Borgelt (2014) address a pressing question in the field of U.S. biotechnology governance: how to protect individuals from genetic
discrimination through personal genetic information (PGI) gained from their social networking activities. Accordingly, “there is no ideal solution” (Lee and Borgelt 2014,
Address correspondence to Jonas Lander, Institute for History, Ethics and Philosophy of Medicine, Hannover Medical School, Hannover, Germany. E-mail: [email protected]
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41). Still, the authors argue, numerous governance options exist to address the regulatory limits on total prevention of employers and insurers from accessing PGI. Current limits have been the result of central concepts being poorly defined, leaving room for interpretation and flexibility (51) in the Genetic Information Nondiscrimination Act (GINA), a U.S. federal law enacted in 2008, which came into force at the end of 2009. To address those limitations, the authors suggest “public dialogue on best practices among industry stakeholders and professional organizations,” “public education” about GINA, “future guidelines” for online DTC genetic testing companies, and “robust laws” to protect employees from third-party access to their social media profiles. Overall, we agree there is a need to address the technical and practical limits of regulatory action by developing complementary and perhaps novel governance tools, especially given the complex nature of genetic information. However, based on experience of policy governing genetic information in Germany, we argue that implementing these governance tools in specific established “political cultures” (Jasanoff 2005) can prove difficult. Such national political cultures matter to the (successful) use of governance tools because they are based on specific routine and institutionalized practices. These political cultures affect not only how particular topics (e.g., genetic testing) are typically approached as part of the political agenda, but also how public knowledge of a given issue (e.g., biotechnology) is created and justified. National political cultures thus provide established practices for political legitimization and interaction between policy, science and the public (Jasanoff 2005, 18ff.). For instance, German political culture in the field of biotechnology is characterized by expert rationality and institution-based knowledge making, while the U.S. biotech governance rests on reasoned objectivity and reliance on (professional) interest groups (Jasanoff 2005, 35). As a result, it might be challenging to adapt other governance approaches, for example, public dialogue, public education, best practices, and guidelines, to these specific and distinct predominant political cultures. In the following, we demonstrate how this idea of political cultures comes into play by briefly outlining the governance process and development of the German Genetic Diagnosis Act (hereafter referred to as GenDG: 2001–2009). Based on this analysis, we encourage better adaptation of future policy processes to specific national policy contexts, which may be relevant to the policy recommendations made by Lee and Borgelt regarding PGI and social networking.
GOVERNING GENETIC INFORMATION IN GERMANY: ALIGNING NEW GOVERNANCE TOOLS WITH GERMAN POLITICAL CULTURE In Germany, the case of a German schoolteacher who was refused probationary civil servant status based on her genetic predisposition provoked public debate and a call
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for regulatory action (Burgermeister 2003). Earlier, German parliamentary delegates had already urged the government to act on developments in the field of genetic testing (Deutscher Bundestag 2001). Also, mechanisms to prevent misuse of genetic information, for example, in the field of private insurance, were in place even before the initiation of GenDG. Nevertheless, the law envisioned voluntary self-regulation instead of binding regulatory measures (Gesamtverband Deutsche Versicherungswirtschaft [GDV] 2001). As a result, a special parliamentary commission (Enquete Commission on the Legislation and Ethics of Modern Medicine, referred to in the following as “the Commission”) was tasked with advising the German government on the future governance of genetic testing (Deutscher Bundestag 2002). The recommendations made by the Commission in 2001/20021 resemble those of Lee and Borgelt regarding PGI and seem appropriate to address the complex matter of personal genetic information. As with the practical and technical limits of GINA, in Germany there was concern that conventional laws had limited relevance to genetic information (Deutscher Bundestag 2002). The Commission therefore suggested working with governance tools different from more conventional German approaches to the governance of biotechnology based on expert-led decision making and law. For example, it advised the use of “open public debate, based on the active participation of citizens” (Deutscher Bundestag 2002, 187). The Commission further suggested “dialogue events and public hearings, cooperation with committees and other working groups and institutions besides the Parliament, [and] the promotion of dialogue within society” (Deutscher Bundestag 2002, 206) to eventually “regulate genetic diagnostics via a comprehensive law” (Deutscher Bundestag 2002, 176). By promoting a “culture of dispute” (Streitkultur) for the governance of genetic testing (Deutscher Bundestag 2002, 2), these recommendations thus encouraged new modes instead of applying established German governance mechanisms such as expert consultation, ministerial bureaucracy, development of legislation limited to political institutions, and rational reasoning (Daemmrich 2004; Jasanoff 2005). In practice, however, the development of GenDG (2001–2009) did not closely follow the recommendations of the 2001 Commission. Contrary to the Commission’s explicit call for Streitkultur and corresponding new approaches to governance, the German Bundestag issued two consecutive written requests for legislation, mapping out key points for a draft law as a first step toward developing GenDG. The period of 2006–2009 was characterized by two more legislative drafts (2006 and 2008) and also two public hearings (2007 and 2009). While the latter could be identified as efforts toward Streitkultur, the 2007 public
1. While the final report of the Commission was published in 2002, a preliminary report in 2001 had already pointed to some of the most important aims of and approaches to the governance of genetic testing.
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hearing did not influence the adoption of the 2006 draft law according to public preferences (Mayer 2007). Rather, it was disregarded owing to civil servants being overworked and a change of ministerial staff, which led to the release of a completely new draft in 2008 by the coalition then governing. While the second public hearing took place in 2009, this happened only after the release of the 2008 draft law, hence denying again opportunities for including public input during the drafting stage. Moreover, GenDG was adopted only 4 weeks after this debate, leaving little room for implementing changes to the draft (Lander and Van Hoyweghen 2014). In short, the GenDG governance process barely lived up to the initial expectations and recommendations by the 2001 Commission, that is, of broad public participation to develop approaches to prevent genetic discrimination. Instead, the governance process was largely based on formal policy input (e.g., requests for legislation; legislative drafts), expert consultation (consultation of professional stakeholders and industry during public hearings), and interinstitution decision making, that is, the agreement on the final GenDG by the German government and Bundesrat in 2009. Given the call for new governance tools on the one hand and the eventual use of conventional governance approaches on the other hand, the German case study illustrates how difficult it can be to align the introduction of new governance tools with established local political cultures, such as those on governing genetic information in Germany. As a result, the GenDG paragraphs on employment (x19, x20), while generally prohibiting employers from demanding PGI data of employees, allowed that “Diagnostic genetic examinations . . . are permitted in the framework of occupational medical examinations and work-related screenings to the extent that they are necessary to determine genetic traits” and “(3) The Federal Government can . . . issue regulations which . . . allow diagnostic cyto-genetic and molecular genetic analyses to be conducted . . . in the framework of occupational medical examinations and work-related screenings” to determine (the likelihood of) severe illnesses or health conditions resulting from work-related activities (Deutscher Bundesrat 2009, 15ff.). Initially, the Commission in 2001/2002 explicitly suggested achieving comprehensive protection against genetic discrimination and that this should be achieved by “new” governance tools (Deutscher Bundestag 2002). Contrary to this, the conventional governance process applied eventually resulted in regulatory exemptions instead of a complete ban on all actions that may lead to genetic discrimination. HOW POLITICAL CULTURES MATTER The preceding sketch of the development of the governance process for genetic testing in Germany suggests comparisons with that of the future governance process for genetic testing and social networking in the United States. Policy-oriented recommendations like those of Lee
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and Borgelt (2014) are laudable and surely necessary when searching for governance solutions to complex issues. This is especially so when conventional legislation cannot fully address rapid developments in genetic information techniques, as it may either be too slow to react to innovation or too narrow to cover the full range of issues in practice (Van Hoyweghen and Horstman 2008). However, from a policy analysis perspective, prevailing political cultures can hardly be rearranged simply by implementing new governance tools. This has been confirmed in the case of Germany, where the prevalent conventional political culture could not readily incorporate the distinct features of a Streitkultur as originally intended by the Commission in 2001. Looking at the United States, others have demonstrated how its political culture relies primarily on industry and other professional interest groups to generate policy input, which is characterized by the production of “facts,” that is, objectivity through numbers, quantitative analyses, and risk assessments, as well as by accountability generated through expert knowledge (Jasanoff 2005, 17ff.). Against this background, Lee and Borgelt recommend “public dialogue,” “public education,” “future guidelines,” and “best practices,” which may be considered different from or at least complementary to the alreadydescribed conventional U.S. governance tools. Based on our argument regarding the relevance of political cultures, a first step in assessing whether such policy recommendations sufficiently address existing U.S. biotechnology political culture could be to identify possible mismatches and connections of each option, and align future policy approaches accordingly. To our understanding, such a stepwise change approach may be more effective than trying to induce disruptive shifts in existing political cultures. & REFERENCES Burgermeister, J. 2003. Teacher was refused job because relatives have Huntington’s disease. British Medical Journal 327(7419): 827. Daemmrich, A. 2004. Pharmacopolitics: Drug regulation in the United States and Germany, Studies in social medicine. Chapel Hill, NC: University of North Carolina Press. Deutscher Bundesrat. 2009. Enactment of the German Federal Parliament (Bundestag) Human Genetic Examination Act (Genetic Diagnosis Act—GenDG). Berlin, Germany: Bundesanzeiger Verlagsgesellschaft. Deutscher Bundestag. 2001. Antrag. Anwendungen von Gentests in Medizin und Versicherungen, ed. CDU/CSU. Berlin, Germany: Deutscher Bundestag. Deutscher Bundestag. 2002. Schlussbericht der Enquete-Kommission des 14. Bundestages “Recht und Ethik der modernen Medizin.” Berlin, Germany: Deutscher Bundestag. Gesamtverband Deutsche Versicherungswirtschaft. 2001. Freiwillige Selbstverpflichtungserkl€ arung der Mitgliedsunternehmen des Gesamtverbandes der Deutschen Versicherungswirtschaft e.V. (GDV). Berlin, Germany: Gesamtverband Deutsche Versicherungswirtschaft.
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Jasanoff, S. 2005. Designs on nature: Science and democracy in Europe and the United States. Princeton, NY: Princeton University Press. Lander, J., and I. Van Hoyweghen. 2014. Streitkultur and the governance of genetic testing and insurance in Germany. New Genetics and Society 33(1): 42–59. Lee, S. S.-J., and E. Borgelt. 2014. Protecting posted genes: Social networking and the limits of GINA. American Journal of Bioethics 14(11): 32–44.
Mayer, S. 2007. Complex matters. The regulation of predictive genetic testing and genetic counseling in Germany. Berlin, Germany: Institute Mensch, Ethik und Wissenschaft. Van Hoyweghen, I., and K. Horstman. 2008. European practices of genetic information and insurance: lessons for the Genetic Information Nondiscrimination Act. Journal of the American Medical Association 300(3): 326–327.
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Sharing Genetic Information Online: An Exploration of GINA’s 2.0 Frontier Vassilis Ragoussis, McGill University Ida Ngueng Feze, McGill University Yann Joly, McGill University Scientific breakthroughs in the field of genomics have sparked the sprawling of direct-to-consumer (DTC), lowcost Internet genetic services and generated an unprecedented amount of genetic data. With this effervescence of information, the popularity of social media platforms has made sharing genetic data much faster than ever before. Despite the adoption of the Genetic Information Nondiscrimination Act (GINA), there are still significant concerns about genetic discrimination (GD) based on personal and genetic information shared online. While GINA aims to prevent GD in the contexts of health insurance and employment, it “does not prohibit employers or insurers from encouraging individuals to undergo genetic testing and it does not apply to life insurance or long-term disability insurance” (Resnik 2014, 120). Lee and Borgelt (2014) have ventured into GINA’s 2.0 frontier, assessing the effectiveness of current protections in a time where U.S. employers could be tempted to seek out or monitor the online data of job candidates and employees.
GINA: HEALTH INSURANCE AND EMPLOYMENT INTERTWINED While Lee and Borgelt recognize that GINA is severely limited in scope and cannot efficiently address GD and the confidentiality of health data in Web 2.0, they fail to underline that health insurance and employment are intimately related in the United States. As pointed out by Rothstein (2013), “there is no scientific, ethical, policy or legal reason for an employer to acquire or use genetic information,” (3) and therefore, employers’ interest in genetic data may be
due to their role in facilitating access to health insurance. Thus, GINA’s limitations may be rooted in the minimalistic approach adopted as a result of a compromise reached after decades of debates in a context where individuals’ health data may inherently be of interest to employers. Even when health coverage is obtained, GINA does not mandate insurance coverage of treatments or tests related to genetic conditions (Hudson, Holohan, and Collins 2008). Moreover, Lee and Borgelt fail to address the fact that GINA does not apply to other fields outside of employment and health insurance, thereby promoting a patchwork approach rather than a comprehensive strategy against GD. Their proposition to strengthen GINA does not address the underlying need for a broader debate in the United States about equitable access to health care in general and the use of health information (genetic or not) by employers. Without such considerations, it is unlikely that GD will be effectively addressed in the context of employment or insurance.
PROTECTING SHARED AND POSTED GENETIC DATA UNDER GINA As mentioned by Lee and Borgelt (2014), the complexities and intricacies of the growing interconnectivity between social and professional networks and the public domain on the Internet have made it very difficult to fully guarantee the protection or privacy of personal information shared online. However, even when the legal remedies advocated are available, tracking and deleting the shared information would be challenging. Hence, personal information shared online could potentially end up in the
Address correspondence to Prof. Yann Joly, PhD, Research Director, Centre of Genomics and Policy, McGill University, 740 Dr. Penfield Avenue, Suite 5200, Montreal, QC, H3A 0G1, Canada. E-mail: [email protected]
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