Original Title: Listado de comprobación en los dominios de análisis ético y legal

Authors' objectives: The main objective of this study was to establish a systematic approach to the analysis of legal and ethical issues that would ensure HTA reports include at least a structured reflection on these issues and an estimate of the need for a more detailed analysis in specific cases in which a greater level of controversy might make that necessary.

Authors' results and conclusions: A total of 101 HTA reports from between 2004 and 2009 were randomly retrieved from the database of the International Network of Agencies for Health Technology Assessment (INAHTA). The percentage of reports that included an ethical analysis was higher in the period 2006-2009 than in the period 2004-2005 (43% vs 30%, respectively), although the differences observed were not significant (p>0.05). The percentage of reports including consideration of ethical issues was highest in 2006 (57.89%) and lowest in 2004 and 2008 (33.3% in both years). Regarding ethical considerations, from the 432 of references retrieved, we finally selected one HTA report for the SNHS and five checklists: namely, those of the Institute for Quality and Efficiency in Health Care (IQWIG), the French National Authority for Health, Hauté Autorité Santé (HAS), the Swedish Agency For Health Technology Assessment and Assessment Of Social Services (SBU), the Norwegian Knowledge Centre for the Health Services (NOKC) and the HTA Core Model from EUnetHTA. In the case of legal considerations, we retrieved a total of 398 documents. After applying the inclusion and exclusion criteria and filtering, we considered two papers and the overall framework and a checklist of the HTA Core Model from EUnetHTA. The items extracted were grouped it to subdomains and presented as two checklists to enhance the feasibility of the instrument. CONCLUSIONS. A relatively low percentage of HTA documents include ethical and legal analysis, considering regulatory or market access issues. This low rate could be due to a tendency to reductionism, a lack of economic resources for hiring experts, and/or a lack of skills among HTA professionals related to these knowledge areas. These findings should be explored in more detail. Taking one-off measures to promote the assessment of ethical and/or legal issues is not sufficient to modify the aforementioned tendency to reductionism.

Authors' methods: To meet the specific objectives, a) an analysis was carried out of the Centre for Reviews and Dissemination (CRD) database, with random retrieval of HTA reports; b) a systematic literature review was conducted to identify existing checklists and potential items to be included; c) a group of experts was established in the areas of HTA, ethics and legal issues that would allow us to analyse the checklists and items identified and filter out any that were unsuitable given the characteristics of the Spanish National Health System (SNHS); d) the items were grouped into domains and it was determined whether they should apply according to the type of technology (drug, medical device, surgical procedure, diagnostic technology, etc.) and the decision to be made (investment, adaptation or disinvestment); and e) an instrument was proposed for the analysis of ethical and legal issues.

Project Status: Completed

Year Published: 2018

URL for published report: https://www.ogasun.ejgv.euskadi.eus/r51-catpub/es/k75aWebPublicacionesWar/k75aObtenerPublicacionDigitalServlet?R01HNoPortal=true&N_LIBR=052262&N_EDIC=0001&C_IDIOM=es&FORMATO=.pdf

English language abstract: An English language summary is available

Publication Type: Other

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government