Hostname: page-component-586b7cd67f-gb8f7 Total loading time: 0 Render date: 2024-11-21T08:15:33.019Z Has data issue: false hasContentIssue false
  • English
  • Français

Access to treatment and the constitutional right to health in Germany: a triumph of hope over evidence?

Published online by Cambridge University Press:  27 July 2018

Stefanie Ettelt
Stefanie Ettelt*
Affiliation:
Associate Professor in Health Policy, Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK
*
*Correspondence to: Stefanie Ettelt, Associate Professor in Health Policy, Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, UK. Email: stefanie.ettelt@lshtm.ac.uk
Get access Rights & Permissions [Opens in a new window]

Abstract

Health technology assessment is frequently credited with making difficult resource allocation decisions in health care fairer, more rational and more transparent. In Germany, a constitutional ‘right to health’ allows patients to challenge decisions by sickness funds to withhold reimbursement of treatment excluded from public funding because of insufficient evidence of effectiveness. The ability to litigate was qualified by the Constitutional Court in its 2005 ‘Nikolaus decision’ that sets out criteria to be applied to these cases. Treatment must be made available if (1) the condition is life-threatening, (2) no alternative treatment is available and (3) there is an indication that the treatment could benefit the patient. This paper examines how courts struggled to apply these criteria based on an analysis of cases of patients who sought treatment for cancer between 2005 and 2015, and explores the implications of applying a constitutional ‘right to health’ to treatment decisions.

Keywords

right to healthhealth care accesshealth technology assessmentlitigationevidence use
Type
Articles
Information
Health Economics, Policy and Law , Volume 15 , Issue 1 , January 2020 , pp. 30 - 42
Copyright
© Cambridge University Press 2018 

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

Afonso da Silva, V Vargas Terrazas, F (2011) Claiming the right to health in Brazilian courts: the exclusion of the already excluded? Law and Social Inquiry 36(4): 825–853.Google Scholar
Aggarwal, A, Fojo, T, Chamberlain, C, Davies, C Sullivan, R (2017) Do patient access schemes for high-cost cancer drugs deliver value to society? Lessons from the NHS Cancer Drug Fund. Annals of Oncology 28(8): 1738–1750.Google Scholar
Banta, D (2003) The development of health technology assessment. Health Policy 63, 121–132.Google Scholar
Bohmeier, A Penner, A (2009) Die Umsetzung des Nikolaus-Beschlusses durch die Sozialgerichtsbarkeit: Fortentwicklung und Widersprüche zu den Vorgaben des BVerfG. Wege zur Sozialversicherung 3, 65–77.Google Scholar
Busse, R Blümel, M (2014) Germany: health system review. Health Systems in Transition 10(2): 1–296.Google Scholar
Cookson, R Dolan, P (2000) Principles of justice in health care rationing. Journal of Medical Ethics 26, 323–329.Google Scholar
Daniels, N Sabin, JE (2008) Accountability for reasonableness: an update. BMJ a1850.Google Scholar
De Haas-Koch, DFM, Buijsen, J, Pijls-Johannesma, M, Lutgens, L, Lammering, G, Mastrigt, GAP, De Ruysscher, DKM, Lambin, P van der Zee, J (2009) Concomitant hyperthermia and radiation therapy for treating locally advanced rectal cancer. Cochrane Database of Systematic Reviews (3), Art. No.: CD006269.Google Scholar
European Medicines Agency (EMA) (2014) Refusal of a change to the marketing authorisation for Avastin (bevacizumab), London: European Medicines Agency.Google Scholar
Flood, CM Gross, A (2014) Litigating the right to health: what can we learn from a comparative law and health care systems approach. Health and Human Rights Journal 16(2): 62–72.Google Scholar
Forman, L, Beiersmann, C, Broland, CE, McKee, M, Hammonds, R Ooms, G (2016) What do core obligations under the right to health bring to universal health coverage? Health and Human Rights Journal 18(2): 23–34.Google Scholar
Francke, R Hart, D (2006) Die Leistungspflicht der gesetzlichen Krankenversicherung für Heilversuche. Medizinrecht 3, 131–138.Google Scholar
Gemeinsamer Bundesausschuss (GBA) (2005) Beschlussbegründung zur Änderung der Anlage B ‘Nicht anerkannte Untersuchungs- und Behandlungsmethoden’ der BUB-Richtlinie vom 18. Januar 2005 Bewertung der Hyperthermie (u.a. Ganzkörperhyperthermie, Regionale Tiefenhyperthermie, Oberflächenhyperthermie, Hyperthermie in Kombination mit Radiatio und/oder Chemotherapie), Siegburg: Gemeinsamer Bundesausschuss.Google Scholar
Gemeinsamer Bundesausschuss (GBA) (2008) Verfahrensordnung des Gemeinsamen Bundesausschusses (in its version of January 2014), Berlin: Gemeinsamer Bundesausschuss.Google Scholar
Gemeinsamer Bundesausschuss (GBA) (2009) Beratungen zur Brachytherapie ausgesetzt – Studie soll Klarheit über Evidenz der Methode bringen, press release, 17 December 2009, Siegburg/Bonn: Gemeinsamer Bundesausschuss.Google Scholar
Gemeinsamer Bundesausschuss (GBA) (2015) Gemeinsamer Bundesausschuss unterstreicht Bedeutung der PREFERE-Studie. Press release, 16 July 2015, Berlin: Gemeinsamer Bundesausschuss.Google Scholar
Gemeinsamer Bundesausschuss (GBA) (2016) Off-Label-Use. Hintergrundinformationen. https://www.g-ba.de/institution/themenschwerpunkte/arzneimittel/off-label-use/hintergrund [accessed 22 July 2016].Google Scholar
Huster, S (2013) Die Konkretisierung des Leistungniveaus der sozialen Gesundheitsversorgung in Selbstverwaltung: Gegenwärtiger Stand und Perspektiven der Weiterentwicklung. Bochum: Ruhr-Universität Bochum. https://www.jura.uni-frankfurt.de/46415636/Prof_-Dr_-Huster.pdf [accessed 13 July 2017].Google Scholar
Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) (2007) Interstitielle Brachytherapie beim lokal begrenzten Prostatakarzinom. Abschlussbericht, Cologne: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen.Google Scholar
Kavanagh, MM (2016) The right to health: institutional effects of constitutional provisions on health outcomes. Studies Comparative International Development 51, 328–364.Google Scholar
Kuchenbecker, R Planczyk, CA (2012) Institutionalizing health technology assessment in Brazil: challenges ahead. Value in Health Regional Issues 1, 257–261.Google Scholar
Lamprea, E (2014) Colombia’s right-to-health litigation in a context of. In CM Flood and A Gross (eds) The right to Health at the Public/Private Divide: A Global Comparative Study, Cambridge: Cambridge University Press.Google Scholar
Landfried, C (1994) The judicialization of politics in Germany. International Political Science Review 15(2): 113–124.Google Scholar
Lehmann, K (2006) In defense of the Constitutional Court: litigating socio-economics rights and the myth of the minimum core. American University International Law Review 22(1): 163–197.Google Scholar
Lutgens, L, Van der Zee, J, Pijls-Johannesma, M, De Haas-Koch, DFM, Buijsen, J, van Mastrigt, GAPG, Lammering, G, De Ruysscher, DKM Lambin, P (2010) Combined use of hyperthermia and radiation therapy for treating locally advanced cervix carcinoma. Cochrane Database of Systematic Reviews (3), Art. No.: CD006377.Google Scholar
Maynou-Pujolras, L Cairns, J (2015) Why do some countries approve a cancer drug and others don’t? Journal of Cancer Policy 4, 21–25.Google Scholar
Moes, F, Houwaart, E, Delnoij, D Horstman, K (2016) Contested evidence: a Dutch reimbursement decision taken to court. Health Economics, Policy and Law 12(3): 325–344.Google Scholar
Morales, L (2015) Taking facts seriously: Judicial intervention in public health controversies. Public Health Ethics 8(2): 185–195.Google Scholar
Newdick, C (2009) The European Court of Justice, trans-national health care, and social citizenship – accidental death of a concept? Wisconsin International Law Journal 26(3): 844–867.Google Scholar
Patzelt, WJ (2005) Warum verachten die Deutschen ihr Parlament und lieben ihr Verfassungsgericht? Ergebnisse einer vergleichenden Studie. Zeitschrift für Parlamentsfragen 36(3): 517–538.Google Scholar
Perleth, M, Gibis, B Goehlen, B (2009) A short history of health technology assessment in Germany. International Journal of Technology Assessment in Health Care 25(Supplement 1): 112–119.Google Scholar
Rawlins, MD (2012) Crossing the fourth hurdle. British Journal of Clinical Pharmacology 73(6): 855–860.Google Scholar
Syrett, K (2003) A technocratic fix to the ‘legitimacy problem’? The Blair Government and health care rationing in the United Kingdom. Journal of Health Politics, Policy and Law 28(4): 715–746.Google Scholar
Syrett, K (2007) Law, Legitimacy and the Rationing of Health Care. A Contextual and Comparative Perspective, Cambridge: Cambridge University Press.Google Scholar
Syrett, K (2011) Health technology appraisal and the courts: accountability for reasonableness and the judicial model of procedural justice. Health Economics, Policy and Law 6(4): 469–488.Google Scholar
Syrett, K (2014) Courts, expertise and resource allocation: is there a judicial ‘legitimacy problem’? Public Health Ethics 7(2): 112–122.Google Scholar
Timmins, N, Rawlins, MD Appleby, J (2016) A Terrible Beauty. A Short History of NICE. The National Institute for Health and Care Excellence, Nonthaburi: Health Intervention and Technology Assessment.Google Scholar
University Hospital Munich (2017) Klinische Anwendungen der Hyperthermie. http://www.klinikum.uni-muenchen.de/Medizinische-Klinik-und-Poliklinik-III/de/klinik/hyperthermie-start/2_klinische_anwendungen/index.html [accessed 23 May 2017].Google Scholar
Velasco Garrido, M, Kristensen, FB, Nielsen, CP Busse, R (2008) Health Technology Assessment and Health Policy-Making in Europe. Current Status, Challenges and Potential, Berlin: World Health Organization, on behalf of the European Observatory on Health Systems and Policies.Google Scholar
Wang, DWL (2015) Right to health litigation in Brazil: the problem and the institutional responses. Human Rights Law Review 15, 617–641.Google Scholar
Welti, F (2007) Sozialrecht und evidenzbasierte Gesundheitsversorgung in Deutschland. Zeitschrift für ärztliche Fortbildung und Qualität im Gesundheitswesen 101, 447–454.Google Scholar