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Legal Issues in Health Technology Assessment: A Case study

Date and Location




Saturday 21 September 2013 - 10:30 - 12:00


Presenting author and contact person

Presenting author

Mélissa Blouin

Contact person

Mélissa Blouin
Abstract text
Background: Health Technology Assessment (HTA) is a synthesis of the evidence concerning mainly the effectiveness, safety, risks and costs of different healthcare interventions. A review of ethical and legal issues is also occasionally required in HTA. Question was raised in a neonatal care unit at the CHU de Québec regarding the safety of specimen container use to store expressed breastmilk (EBM). Objectives: To assess the acceptability of specimen container use to store EBM. Methods: A literature search was performed in PubMed, Embase, the Cochrane Library and the grey literature between January 2002 and March 2013. Recommendations and characteristics about containers used to store EBM were retrieved from evidence-based practice guidelines. Information on legal considerations about food packaging and consumer product safety was retrieved from governmental sites (Health Canada, U.S. Food and Drug administration). Article selection and quality assessment were performed by one reviewer and data extraction by two independent reviewers. Synthesis review was shared with an interdisciplinary group of experts. Results: Following an evidence-based process, there was no definitive research results aimed to clarify the most suitable containers to store EBM in a hospital setting. Characteristics of specimen container used at the CHU de Québec appear to be in accordance with the recommendations in the major clinical guidelines. From a legally-based standpoint, the safety of container used to store EBM was in a legal vacuum. Taking into account the applicable laws and the literature results, it was not possible to determine if its use may be safe to human health. Conclusions: Legal issues are relevant aspects in HTA processes. In this case study, an alternative procedure was proposed to store EBM in neonatal care unit. This procedure is in accordance with the precautionary principle and the weight of legal considerations over evidence-based data.