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HTA AND ITS LEGAL ISSUES: A FRAMEWORK FOR IDENTIFYING LEGAL ISSUES IN HEALTH TECHNOLOGY ASSESSMENT

Part of: Special Collection - Methods

Published online by Cambridge University Press:  30 March 2015

Daniel Widrig  and
Brigitte Tag
Daniel Widrig
Affiliation:
PhD Candidate in Biomedical Ethics and Law at the University of Zurich, [email protected]
Brigitte Tag
Affiliation:
Professor for Criminal Law, Criminal Procedure and Medical Law at the University of Zurich
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Abstract

Objectives: Legal analysis can highlight important issues that are relevant when deciding whether a medical technology should be implemented or reimbursed. Literature and studies show that even though the law is an acknowledged part of health technology assessment (HTA), legal issues are rarely considered in practice. One reason for this may be the lack of knowledge about the diversity of legal issues that are relevant for HTA. Therefore, this contribution aims primarily to identify and then explain the relevant legal issues in HTA. This study offers a framework for identifying the legal issues in HTAs in different jurisdictions and provides a basis for further research.

Methods: After extensive literature search, the authors review Swiss health law to identify legal issues that are relevant to HTA. The authors then categorize these legal issues using a framework with an inside and outside perspective. Finally, they explain a selection of these legal issues with several examples.

Results: This study reveals numerous legal issues that are relevant for HTA and underlines the necessity of incorporating legal analysis in HTAs. The suggested perspectival framework in this study provides a basis to structure the legal analysis. The identified legal issues are relevant in other countries and the perspectival framework is transferable to other jurisdictions.

Conclusions: The article underlines the importance of in-depth discussion about the role of law in HTA. It provides a structured overview of the legal issues in HTA and suggests a development of more concrete instruments toward a standardized legal technology assessment.

Keywords

Health technology assessmentHTALawLegal issuesPerspective
Type
Methods
Information
International Journal of Technology Assessment in Health Care , Volume 30 , Issue 6 , December 2014 , pp. 587 - 594
Copyright
Copyright © Cambridge University Press 2015 

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References

REFERENCES

1. Francke, R. Which legal questions have to be considered in an HTA? [Welche rechtlichen Rahmenbedingungen sind bei der Erstellung eines HTA zu berücksichtigen?]. In Busse, R., Perleth, M., (Eds.), (Health technology assessment (pp. 181–185). Berlin: MWV Med. Wiss. Verl.-ges; 2008.Google Scholar
2. Francke, R, Hart, D. Introduction to the legal aspects of an HTA. [Einführung in die rechtlichen Aspekte bei HTAs] Z Evid Fortbild Qual Gesundhwes. 2008;102:63–68.Google Scholar
3. Droste, S, Rixen, S. Information about legal aspects of health technologies: suggestion for a systematic and reproducible identification. [Informationen zu rechtlichen Aspekten von Gesundheitstechnologien: Methodenvorschlag zur systematischen und nachvollziehbaren Identifizierung] Z Evid Fortbild Qual Gesundhwes. 2012;106:509–522.Google Scholar
4. Walin, L, Marchetti, M, Norderhaug, I, Royle, N. Legal aspects. In: EUnetHTA. HTA core model for medical and surgical interventions (Vol. 1, pp. 142–156). OR. Helsinki; 2008.Google Scholar
5. Riemer Kafka, G. Medical expert opinions. [Medizinische Gutachten]. Zürich: Schulthess; 2008.Google Scholar
6. Federal Act on the Amendment of the Swiss Civil Code 1911, Part 5: The Code of Obligations , CO. SR 220. http://www.admin.ch/opc/en/classified-compilation/19110009/index.html (accessed April 25, 2014).Google Scholar
7. Gauch, P. The contract for work and services (5th ed.). [Der Werkvertrag]. Zürich: Schulthess; 2011.Google Scholar
8. Fellmann, W. The legal relationship between doctors and patients. [Arzt und das Rechtsverhältnis zum Patienten] In Poledna, T., Kuhn, M. (Eds.), Physician law in practice (2nd ed., pp. 103–231). [Arztrecht in der Praxis]. Zürich: Schulthess; 2007.Google Scholar
9. Bühler, A. Consideration of expert opinions in civil law. [Die Beweiswürdigung von Gerichtsgutachten im Zivilprozess] Jusletter 2007 May 14. http://jusletter.weblaw.ch/login.php?ref_url_succ=http%3A%2F%2Fjusletter.weblaw.ch%3A80%2Farticle%2Fde%2F_5659%3Flang%3Dde&ref_url_fail=http://jusletter.weblaw.ch/fail.php (accessed April 25, 2014).Google Scholar
10. Siegel, A. Recommendations for the elaboration of medical expert opinions: The view from the medical expert. [Empfehlungen zum Erstellen eines medizinischen Gutachtens: Die Sicht des ärztlichen Experten]. In Poledna, T., Kuhn, M., (Eds.), (Physician law in practice (2nd ed., pp. 783–806). [Arztrecht in der Praxis]. Zürich: Schulthess; 2007.Google Scholar
11. BGE 127 III 328 (2001) (Swiss Federal Court). www.bger.ch (accessed April 25, 2014).Google Scholar
12. Swiss Federal Act on Health Insurance 1994, FAHI. SR 832.10. http://www.admin.ch/opc/de/classified-compilation/19940073/index.html (accessed April 25, 2014).Google Scholar
13. Swiss Federal Office of Public Health. Manual for the Initiation for Coverage Decisions of new or controversial Technologies [Handbuch zur Antragsstellung auf Kostenübernahme bei neuen oder umstrittenen Leistungen]; 2009. URL:http://www.bag.admin.ch/themen/krankenversicherung/00263/00264/04853/index.html?lang=de&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1acy4Zn4Z2qZpnO2Yuq2Z6gpJCGfYN5e2ym162epYbg2c_JjKbNoKSn6A (accessed April 25, 2014).Google Scholar
14. Swiss Parliamentary Control. Report of the Parliamentary Control regarding coverage decisions of medical services in the Swiss Health Insurance [Bericht der Parlamentarischen Verwaltungskontrolle zuhanden der Geschäftsprüfungskommission des Nationalrates betreffend Bestimmung und Überprüfung ärztlicher Leistungen in der obligatorischen Krankenpflegeversicherung]; 2008 Aug 21 BBl 2009 5589 ff. URL:http://www.admin.ch/ch/d/ff/2009/5589.pdf.Google Scholar
15. Federal Constitution of the Swiss Confederation 1999, FCSC. SR 101. http://www.admin.ch/opc/en/classified-compilation/19995395/index.html (accessed April 25, 2014).Google Scholar
16. Stöckli, H. Swiss public procurement law (8th ed.). [Das Vergaberecht der Schweiz]. Zürich: Schulthess; 2012.Google Scholar
17. Slomanson, WR. Fundamental perspectives on international law (4th ed.). Belmont, CA: Thomson/West; 2003.Google Scholar
18. Müller, JP, Schefer, M. Fundamental rights in Switzerland (4th ed.). [Grundrechte in der Schweiz]. Bern: Stämpfli; 2008.Google Scholar
19. Swiss Medical Board. Rupture of the anterior cruciate ligament: operative or conservative treatment? [Ruptur des vorderen Kreuzbandes: operative oder konservative Behandlung?]. Zurich; June 30, 2009. URL:http://www.medical-board.ch/fileadmin/docs/public/mb/Fachberichte/2009_06_30_Ruptur_Kreuzband_Bericht.pdf (accessed April 25, 2014).Google Scholar
20. Schmidt, C. Market allowance for pharmaceuticals in Switzerland. [Die Zulassung von Arzneimitteln nach dem Heilmittelgesetz] Basel: Helbing Lichtenhahn; 2008. (Schriftenreihe für internationales Recht Bd. 108).Google Scholar
21. Swiss Federal Act on Medicinal Products and Medical Devices 2000, TPA. SR 812.21. http://www.admin.ch/opc/en/classified-compilation/20002716/index.html (accessed April 25, 2014).Google Scholar
22. Belser, EM, Epiney, A, Waldmann, B, Bickel, J. Data privacy law. [Datenschutzrecht]. Bern: Stämpfli; 2011.Google Scholar
23. Pedrazzini, MM, Hilti, C. European and Swiss patent law and patent procedure law (3rd ed.). [Europäisches und schweizerisches Patent- und Patentprozessrecht]. Bern: Stämpfli; 2008.Google Scholar
24. Gächter, T, Rütsche, B. Health law (3rd ed.). [Gesundheitsrecht]. Basel: Helbing Lichtenhahn; 2013.Google Scholar
25. BGE 136 V 395 (2010) (Swiss Federal Court). www.bger.ch (accessed April 25, 2014).Google Scholar