Hostname: page-component-77c89778f8-m8s7h Total loading time: 0 Render date: 2024-07-23T23:38:58.676Z Has data issue: false hasContentIssue false
  • English
  • Français

Assessing National Public Health Law to Prevent Infectious Disease Outbreaks: Immunization Law as a Basis for Global Health Security

Published online by Cambridge University Press:  01 January 2021

Tsion Berhane Ghedamu  and
Benjamin Mason Meier
Get access Rights & Permissions [Opens in a new window]

Abstract

Immunization plays a crucial role in global health security, preventing public health emergencies of international concern and protecting individuals from infectious disease outbreaks, yet these critical public health benefits are dependent on immunization law. Where public health law has become central to preventing, detecting, and responding to infectious disease, public health law reform is seen as necessary to implement the Global Health Security Agenda (GHSA). This article examines national immunization laws as a basis to implement the GHSA and promote the public's health, analyzing the scope and content of these laws to prevent infectious disease across Sub-Saharan Africa. Undertaking policy surveillance of national immunization laws in 20 Sub-Saharan African countries, this study: (1) developed a legal framework to map the legal attributes relevant to immunization; (2) created an assessment tool to determine the presence of these attributes under national immunization law; and (3) applied this assessment tool to code national legal landscapes. An analysis of these coded laws highlights legal attributes that govern vaccine requirements, supply chains, vaccine administration standards, and medicines quality and manufacturer liability. Based upon this international policy surveillance, it will be crucial to undertake legal epidemiology research across countries, examining the influence of immunization law on vaccination rates and disease outbreaks.

Type
Independent Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 3: Biomarker Research and Validation: Current Challenges, Future Opportunities , Fall 2019 , pp. 412 - 426
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Porta, M., A Dictionary of Epidemiology, 6th ed. (Madison Avenue, New York, NY: Oxford University Press, 2008): at 143.Google Scholar
Id.Google Scholar
Metcalf, C. J. E., Ferrari, M., Graham, A. L., and Grenfell, B. T., “Understanding Herd Immunity,” Trends in Immunology 36, no. 12 (2015): 753–755, available at <http://dx.doi.org/https://doi.org/10.1016/j.it.2015.10.004> (last visited July 29, 2019).CrossRefGoogle Scholar
See Id.Google Scholar
Plotkin, S., “History of Vaccination,” Proceedings of the National Academy of Sciences of the United States of America 111, no. 34 (2014): 12283–12287, available at <http://dx.doi.org/https://doi.org/10.1073/pnas.1400472111> (last visited July 29, 2019).CrossRefGoogle Scholar
Stern, A. M. and Markel, H., “The History Of Vaccines And Immunization: Familiar Patterns, New Challenges,” Health Affairs 24, no. 3 (2005): 611–621, available at <http://dx.doi.org/https://doi.org/10.1377/hlthaff.24.3.611> (last visited July 29, 2019).Google Scholar
WHO, “SmallPox,” available at <http://www.who.int/about/bugs_drugs_smoke_chapter_1_smallpox.pdf> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar
WHO, “Poliomyelitis,” 2018, available at <http://www.who.int/en/news-room/fact-sheets/detail/poliomyelitis> (last visited July 29, 2019)+(last+visited+July+29,+2019)>Google Scholar
Trumbo, S. P., Silver, D., Domentic, O., Gasoyan, H., Paatashvili, E., Gellin, B. G., and Gordon, J. L., “Strengthening Legal Frameworks for Vaccination: The Experiences of Armenia, Georgia, and Moldova,” Vaccine (In press).Google Scholar
Meier, B. M., Tureski, K., Bockh, E., Carr, D., Ayala, A., Roberts, A., Cloud, L., Wilhelm, N., and Burris, S., “Examining National Public Health Law to Realize the Global Health Security Agenda,” Medical Law Review 25, no. 2 (May 1 , 2017): 240–269.CrossRefGoogle Scholar
WHO, “Explorations of Inequality. Childhood Immunization,” Geneva, 2018.Google Scholar
Greenwood, B., “The Contribution of Vaccination to Global Health: Past, Present and Future,” Philosophical Transactions of the Royal Society of London. Series B, Biological Sciences 369, no. 1645 (2014): 20130433, available at <http://dx.doi.org/https://doi.org/10.1098/rstb.2013.0433> (last visited July 2019).CrossRefGoogle Scholar
Center for Disease Control, “Global Health Security Agenda,” 2018, available at <https://www.ghsagenda.org/about> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar
Id.Google Scholar
GHSA Commitment Development Meeting, Helsinki, Finland, May 5-6, 2014, Meeting Report, available at <https://ghsaindonesia.files.wordpress.com/2016/02/helsinki-meeting-report-finland-5-6-may-2014.pdf> (last visited January 12, 2019).+(last+visited+January+12,+2019).>Google Scholar
Center for Disease Control, “Action Packages | Prevent 4-Immunization,” 2018, available at <https://www.ghsagenda.org/packages/p4-immunization> (last visited May 10, 2018).+(last+visited+May+10,+2018).>Google Scholar
Cho, H.-W. and Chu, C., “Out of Africa, into Global Health Security Agenda,” Osong Public Health and Research Perspectives 5, no. 6 (December 2014): 313–314, available at <http://dx.doi.org/https://doi.org/10.1016/j.phrp.2014.11.004> (last visited July 29, 2019).CrossRefGoogle Scholar
Busby, J., Grepin, K., and Youde, J., “Introduction: Ebola: Implications for Global Health Governance,” Global Health Governance: The Scholarly Journal for the New Health Security Paradigm 10, no. 1 (2016): 3–10.Google Scholar
WHO, “Report of the Ebola Interim Assessment Panel,” 2015; Moon, S., Sridhar, D., Pate, M. A., Jha, A. K., Clinton, C., Delaunay, S., Edwin, V., et al., “Will Ebola Change the Game? Ten Essential Reforms before the next Pandemic. The Report of the Harvard-LSHTM Independent Panel on the Global Response to Ebola,” The Lancet 386, no. 10009 (2015): 2204–2221, available at <http://dx.doi.org/https://doi.org/10.1016/S0140-6736(15)00946-0> (last visited July 29, 2019).CrossRefGoogle Scholar
Clinton, C. and Devi, S., Governing Global Health: Who Runs the World and Why? 1st ed. (Oxford University Press, 2017).Google Scholar
Abayomi, A., Katz, R., Spence, S., Conton, B., and Gevao, S. M., “Managing Dangerous Pathogens: Challenges in the Wake of the Recent West African Ebola Outbreak,” Global Security: Health, Science and Policy 1, no. 1 (January 25, 2016): 51–57, available at <http://dx.doi.org/https://doi.org/10.1080/23779497.2016.1228431> (last visited July 29, 2019); GHSA Commitment Development Meeting, supra note 15.Google Scholar
Center for Disease Control, “Where GHSA Is Active | Global Health Security Agenda,” 2018, available at <https://www.ghsagenda.org/where-ghsa> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar
Meier, B. M., Tureski, K., Bockh, E., Carr, D., Ayala, A., Roberts, A., Cloud, L., Wilhelm, N., and Burris, S., “Examining National Public Health Law to Realize the Global Health Security Agenda,” Medical Law Review 25, no. 2 (May 1, 2017): 240–269, available at <http://dx.doi.org/https://doi.org/10.1093/medlaw/fwx020> (last visited July 29, 2019).CrossRefGoogle Scholar
Gostin, L. O., Global Health Law (Cambridge: Harvard University Press, 2014).Google Scholar
Gostin, L. O. and Meier, B. M., “Global Health Law,” Journal of Law, Medicine & Ethics 47, no. 4 (2019) (forthcoming); Gostin, L. O., “Good Science + Good Ethics = Good Law: Five Rules for Epidemic Preparedness,” The Milbank Quarterly 93, no. 1 (March 2015): 19–23, available at <http://dx.doi.org/https://doi.org/10.1111/1468-0009.12100> (last visited July 29, 2019); Abayomi, A., Katz, R., Spence, S., Conton, B., and Gevao, S. M., “Managing Dangerous Pathogens: Challenges in the Wake of the Recent West African Ebola Outbreak,” Global Security: Health, Science and Policy 1, no. 1 (January 25, 2016): 51–57, available at <http://dx.doi.org/https://doi.org/10.1080/23779497.2016.1228431> (last visited July 29, 2019); Hodge, J. G., Barraza, L., Measer, G., and Agrawal, A., “Global Emergency Legal Responses to the 2014 Ebola Outbreak: Public Health and the Law,” Journal of Law, Medicine & Ethics 42, no. 4 (2014): 595–601, available at <http://dx.doi.org/https://doi.org/10.1111/jlme.12179> (last visited July 29, 2019).CrossRefGoogle Scholar
Morhard, R. and Katz, R., “Legal and Regulatory Capacity to Support the Global Health Security Agenda,” Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 12, no. 5 (September 2014): 254–262, available at <http://dx.doi.org/https://doi.org/10.1089/bsp.2014.0023> (last visited July 29, 2019).CrossRefGoogle Scholar
Gostin, L. O., Monahan, J. T., Kaldor, J., DeBartolo, M., Friedman, E., et al., “The Legal Determinants of Health: Harnessing the Power of Law for Global Health and Sustainable Development,” The Lancet 393, no. 10183 (2019): P1857-1910.CrossRefGoogle Scholar
Gostin, L. O. and Ayala, A. S., “Strengthening National Security By Protecting Public Health: Global Health Security in an Era of Explosive Pandemic Potential,” Journal of National Security Law and Policy 9 (2017): 53-80.Google Scholar
WHO, “IHR (2005) Monitoring and Evaluation framework Joint External Evaluation tool (JEE tool) first edition,” 2016, available at <https://www.who.int/ihr/publications/WHO_HSE_GCR_2016_2/en/> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar
Burkle, F. M., “Global Health Security Demands a Strong International Health Regulations Treaty and Leadership From a Highly Resourced World Health Organization,” Disaster Medicine and Public Health Preparedness 9, no. 5 (October 18, 2015): 568–580, available at <http://dx.doi.org/https://doi.org/10.1017/dmp.2015.26> (last visited July 29, 2019).CrossRefGoogle Scholar
Harman, S., “Norms Won't Save You: Ebola and the Norm of Global Health Security,” Global Health Governance 10, no. 1 (2016): 11–16.Google Scholar
Morhard, R. and Katz, R., “Legal and Regulatory Capacity to Support the Global Health Security Agenda,” Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 12, no. 5 (September 2014): 254–262, available at <http://dx.doi.org/https://doi.org/10.1089/bsp.2014.0023> (last visited July 29, 2019).CrossRefGoogle Scholar
LaFond, A., Kanagat, N., Steinglass, R., Fields, R., Sequeira, J., and Mookherji, S., “Drivers of Routine Immunization Coverage Improvement in Africa: Findings from District-Level Case Studies,” Health Policy and Planning 30, no. 3 (April 1, 2015): 298–308, available at <http://dx.doi.org/https://doi.org/10.1093/heapol/czu011> (last visited July 29, 2019); Nyaku, M., Wardle, M., Vanden Eng, J., Ametewee, L., Bonsu, G., Opare, J. K. L., and Conklin, L., “Immunization Delivery in the Second Year of Life in Ghana: The Need for a Multi-Faceted Approach,” The Pan African Medical Journal 27, no. Suppl. 3 (2017): 4, available at <http://dx.doi.org/https://doi.org/10.11604/pamj.supp.2017.27.3.12182> (last visited July 2019).CrossRefGoogle Scholar
Meier, B. M., Tureski, K., Bockh, E., Carr, D., Ayala, A., Roberts, A., Cloud, L., Wilhelm, N., and Burris, S., “Examining National Public Health Law to Realize the Global Health Security Agenda,” Medical Law Review 25, no. 2 (May 1 , 2017): 240–269, available at <http://dx.doi.org/https://doi.org/10.1093/medlaw/fwx020> (last visited July 29, 2019).CrossRefGoogle Scholar
Dwyer, C., “Experimental Ebola Vaccinations, Considered ‘Paradigm Shift,’ Begin In Congo: The Two-Way : NPR,” National Public Radio, available at <https://www.npr.org/sections/thetwo-way/2018/05/21/612994193/experimental-ebola-vaccinations-considered-paradigm-shift-begin-in-congo> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar
Burris, S., Hitchcock, L., Ibrahim, J., Penn, M., and Ramanathan, T., “Policy Surveillance: A Vital Public Health Practice Comes of Age: Table 1,” Journal of Health Politics, Policy and Law 41, no. 6 (2016): 1151–1173, available at <http://dx.doi.org/https://doi.org/10.1215/03616878-3665931> (last visited July 29, 2019).CrossRefGoogle Scholar
Yang, Y. T., Painter, J. E., and Meier, B. M., “Coordinated Regulatory Efforts Needed to Strengthen Travel Related Immunization Requirements against Importation of Infectious Diseases,” Vaccine 34, no. 34 (2016): 3921–3922, available at <http://dx.doi.org/https://doi.org/10.1016/j.vaccine.2016.06.047> (last visited July 29, 2019).CrossRefGoogle Scholar
See eg Portant Attributions, Organisation Et Fonctionnement Du Ministere De La Sante, 2006 (Benin); See eg Portant organisation du Ministère de la Santé et de l'Action Sociale, 1991 (Burkina Faso).Google Scholar
See e.g. Code de la Sante, 1997 (Guinea).Google Scholar
See e.g. Nigerian Public Health Act, 2014 (Nigeria).Google Scholar
See e.g. Arrête Interministériel Fixant La Liste Des Vacci-nations Obligatoires, Leurs Calendriers Et Les Conditions D'administration Des Vaccins, 2008 (Mali).Google Scholar
Metcalf, C. J. E., Ferrari, M., Graham, A. L., and Grenfell, B. T., “Understanding Herd Immunity,” Trends in Immunology 36, no. 12 (December 2015): 753–755, available at <http://dx.doi.org/https://doi.org/10.1016/j.it.2015.10.004> (last visited July 29, 2019).CrossRefGoogle Scholar
Leggiadro, R. J., “Vaccine Refusal, Mandatory Immunization, and the Risk of Vaccine-Preventable Diseases,” The Pediatric Infectious Disease Journal 28, no. 7 (July 2009): 613, available at <http://dx.doi.org/https://doi.org/10.1097/INF.0b013e3181aecf5e> (last visited July 29, 2019).CrossRefGoogle Scholar
Salmon, D. A., Teret, S. P., MacIntyre, C. R., Salisbury, D., Burgess, M. A., and Halsey, N. A., “Compulsory Vaccination and Conscientious or Philosophical Exemptions: Past, Present, and Future,” The Lancet 367, no. 9508 (2006): 436–442, available at <http://dx.doi.org/https://doi.org/10.1016/S0140-6736(06)68144-0> (last visited July 29, 2019).CrossRefGoogle Scholar
Id.Google Scholar
Gostin, L. O. and Wiley, L. F., Public Health Law: Power, Duty, Restraint (Oakland, CA: University of California Press, 2016).Google Scholar
Jacobson v. Massachusetts, 197 U.S. 11, 25 (1905).Google Scholar
Jacobson v. Massachusetts, 197 U.S. 11, 25 (1905).Google Scholar
Malone, K. M. and Hunman, A. R., “Vaccination Mandates : The Public Health Imperative and Individual Rights,” in Law in Public Health Practice (New York: Oxford University Press, 2003): 262-284.Google Scholar
See e.g. Public Health Act, 2009 (Tanzania).Google Scholar
See e.g. Code de la Sante, 2009 (Togo).Google Scholar
See e.g. Vaccination Act, 1919 (Ghana).Google Scholar
See e.g. Immunization of Children Act, 1956 (Liberia).Google Scholar
See e.g. Arrête Interministériel Fixant La Liste Des Vaccinations Obligatoires, Leurs Calendriers Et Les Conditions D'administration Des Vaccins, 2008 (Mali).Google Scholar
See e.g. Public Health Act, 1935 (Uganda); See e.g. Nigerian Public Health Act, 2014 (Nigeria).Google Scholar
See e.g. Public Health Act of 1986, art 109 (Kenya); See e.g. Vaccination Act, 1919 (Ghana); See eg Public Health Act, 1935 (Uganda).Google Scholar
Wang, E., Clymer, J., Davis-Hayes, C., and Buttenheim, A., “Non-medical Exemptions From School Immunization Requirements: A Systematic Review,” American Journal of Public Health 104, no. 11 (2014): e62–84, available at <http://dx.doi.org/https://doi.org/10.2105/AJPH.2014.302190> (last visited July 29, 2019).CrossRefGoogle Scholar
Cole, J. P. and Swendiman, K. S., “Mandatory Vaccinations: Precedent and Current Laws,” 2014, available at <https://fas.org/sgp/crs/misc/RS21414.pdf> (last visited August 30, 2019).+(last+visited+August+30,+2019).>Google Scholar
Id.Google Scholar
Thompson, J. W., Tyson, S., Card-Higginson, P., Jacobs, R. F., Wheeler, J. G., Simpson, P., Bost, J. E., Ryan, K. W., and Salmon, D. A., “Impact of Addition of Philosophical Exemptions on Childhood Immunization Rates,” American Journal of Preventive Medicine 32, no. 3 (2007): 194–201; available at <http://dx.doi.org/https://doi.org/10.1016/j.amepre.2006.10.014> (last visited July 29, 2019).CrossRefGoogle Scholar
See e.g. Public Health Act, 1986 (Kenya).Google Scholar
See e.g. Vaccination Act, 1919 (Ghana).Google Scholar
Popova, O. and Ibarra de Palacios, P., “Reaching More Children with Vaccines in Developing Countries: Key Challenges of Innovation and Delivery,” Current Medical Research and Opinion 32, no. 1 (2016): 177-181, doi: http://dx.doi.org/10.1185/03007995.2015.1108910.CrossRefGoogle Scholar
World Health Organization, “Global Vaccine Safety Initiative,” Geneva, 2015, available at <http://www.who.int/vaccine_safety/publications/09_29_15_WHP_GVS_AR_2015_web_Single.pdf> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar
See e.g. Vaccination Act, 1919 (Ghana).Google Scholar
Yen, C., Hyde, T. B., Costa, A. J., Fernandez, K., Tam, J. S., Hugonnet, S., Huvos, A. M., Duclos, P., Dietz, V. J., and Burkholder, B. T., “The Development of Global Vaccine Stockpiles,” The Lancet. Infectious Diseases 15, no. 3 (2015): 340–347, available at <http://dx.doi.org/https://doi.org/10.1016/S1473-3099(14)70999-5> (last visited July 29, 2019).CrossRefGoogle Scholar
See e.g. Kenya Medical Supplies Authority Act, 2013 (Kenya).Google Scholar
See e.g. National Pharmaceutical Procurement Unit Act, 2012 (Sierra Leone).Google Scholar
Massachusetts Department of Public Health Division of Epidemiology and Immunization, “2018 Guidelines for Compliance with Federal and State Vaccine Administration Requirements,” 2018, available at <https://www.mass.gov/service-details/vaccine-management> (last visited August 30, 2019).+(last+visited+August+30,+2019).>Google Scholar
See e.g. Public Health Law, 1976 (Liberia).Google Scholar
See e.g. Inter-ministerial Orders setting the List of Compulsory Vaccinations, Their Calendars and Conditions of Vaccine Administration, 2008 (Mali).Google Scholar
World Health Organization, “2017 Assessment Report of the Global Vaccine Action Plan Strategic Advisory Group of Experts on Immunization,” Geneva, 2017, available at <http://apps.who.int/> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar
See e.g. Public Health Act, 1935 (Uganda); See e.g. Vaccination Act, 1919 (Ghana); See e.g. Public Health Act, 1986 (Kenya).Google Scholar
World Health Organization, “2017 Assessment Report of the Global Vaccine Action Plan Strategic Advisory Group of Experts on Immunization,” Geneva, 2017, available at <http://apps.who.int/> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar
See e.g. National Drug Policy and Authority Act, 1993 (Uganda).Google Scholar
See e.g. Medicines & Health Products Regulatory Authority (LMHRA) Act, 2010 (Liberia).Google Scholar
See e.g. Public Health Act, 1935 (Uganda); See e.g. Vaccination Act, 1919 (Ghana); See e.g. Public Health Act, 1986 (Kenya).Google Scholar
Gostin, L. O., Kavanagh, M. M., and Cameron, E., “Ebola and War in the Democratic Republic of Congo: Avoiding Failure and Thinking Ahead,” JAMA 321, no. 3 (2019): 243-244.CrossRefGoogle Scholar
World Health Organization, “WHO Drug Information,” 2017, available at <www.tga.gov.au> (last visited July 29, 2019).+(last+visited+July+29,+2019).>Google Scholar
Gostin, L. O., Global Health Law (Cambridge: Harvard University Press, 2014).Google Scholar
Berkley, S., “Political Will and Vaccine Legislation,” Vaccine (in press).Google Scholar
Burris, S., Berman, M. L., Penn, M., and Holiday, T. R., The New Public Health Law (New York: Oxford University Press, 2018).CrossRefGoogle Scholar
Sunshine, G., Pepin, D., Cetron, M., and Penn, M., “State and Territorial Ebola Screening, Monitoring, and Movement Policy Statements — United States, August 31, 2015,” MMWR. Morbidity and Mortality Weekly Report 64, no. 40 (October 16, 2015): 1145–1146, available at <http://dx.doi.org/https://doi.org/10.15585/mmwr.mm6440a4> (last visited July 29, 2019).CrossRefGoogle Scholar
Burris, S., Ashe, M., Levin, D., Penn, M., and Larkin, M., “A Transdisciplinary Approach to Public Health Law: The Emerging Practice of Legal Epidemiology,” Annual Review of Public Health 37, no. 1 (2016): 135–148, available at <http://dx.doi.org/https://doi.org/10.1146/annurev-publhealth-032315-021841> (last visited July 29, 2019).CrossRefGoogle Scholar
Penfold, E. D. and Fourie, P., “Regional Health Governance: A Suggested Agenda for Southern African Health Diplomacy,” Global Social Policy 15, no. 3 (2015): 278–295.CrossRefGoogle Scholar
Meier, B. M., Evans, D. P., and Phelan, A., “Infectious Diseases in the New Millennium: Legal and Ethical Challenges,” in Rights-Based Approaches to Preventing, Detecting, and Responding to Infectious Disease Outbreaks, edited by Eccleston-Turner, M.I. and Brassington, I. (forthcoming).Google Scholar
See Id.Google Scholar
Gostin, L. O., Kavanagh, M. M., and Cameron, E., “Ebola and War in the Democratic Republic of Congo: Avoiding Failure and Thinking Ahead,” JAMA 321, no. 3 (2019): 243-244.CrossRefGoogle Scholar
Gostin, L. O., Global Health Law (Cambridge: Harvard University Press, 2014).CrossRefGoogle Scholar