Résumés
Abstract
The availability of precision medicine tools and approaches has increased considerably over the past decades, propelled by rapid scientific advances in genomics and the popularity of direct-to-consumer genetic testing. Genetic specialists working within public healthcare systems are struggling to meet the growing demand for clinical genetic services. Some experts have suggested that doctors who are not specialized in genetics could take on some of the tasks performed by genetic specialists since they are regularly the first point of contact for people with a genetic predisposition to cancer. However, expanding doctors’ roles may heighten their standard of practice and concomitant medical liability risk to that of genetic specialists. This paper reviews the medical liability regime applicable to this situation through the lens of Canada’s unique bijural legal system. We then compare the state of the law in Canada to that of the United States. According to our findings, unless there is an improvement in the quality of genetic services provided by general practitioners, we could see a growing number of successful liability suits in clinical genetics and precision medicine in the coming years. To prevent this unsatisfactory outcome, additional professional training in core genetic tasks should be made increasingly available to general practitioners and the creation of communities of practice in genetics encouraged. Furthermore, courses introducing medical students to genetics, including its ethical and legal challenges, should be made available and actively promoted within medical curricula.
Keywords:
- Health law,
- genetic services,
- genetic tests,
- medical liability,
- physician standard of practice
Résumé
La disponibilité d’outils et d’approches de médecine de précision a considérablement augmenté au cours des dernières décennies, propulsée par des avancées scientifiques rapides en matière de génomique et la popularité des tests génétiques directement accessibles aux consommateurs. Les généticiens travaillant au sein de systèmes de santé publics peinent à répondre à la demande croissante de services de génétique clinique. Certains experts ont suggéré que la prise en charge de certaines tâches accomplies par les généticiens, soit effectuée par les médecins généralistes, étant régulièrement le premier point de contact avec des personnes ayant une prédisposition génétique au cancer. Toutefois, l’élargissement de leur rôle pourrait accroître leur champ de pratique et le risque de responsabilité médicale associé. Cet article examine le régime de responsabilité médicale applicable à cette situation à travers le prisme du système bijuridique unique du Canada. Nous comparons ensuite l’état du droit au Canada à celui des États-Unis. Selon nos conclusions, à moins d’une amélioration de la qualité des services génétiques fournis par les médecins généralistes, nous pourrions assister, dans les prochaines années, à un accroissement du nombre de poursuites en responsabilité civile dans le domaine de la génétique clinique et de la médecine de précision. Afin d’éviter cette situation insatisfaisante, il faudrait que la formation professionnelle complémentaire aux tâches génétiques soit de plus en plus accessible aux médecins généralistes et que la création de communautés de pratique en matière de génétique soit encouragée. Par ailleurs, des cours initiant les étudiants en médecine à la génétique, y compris les enjeux éthiques et juridiques qu’elle pose, devraient être proposés et activement promus dans le cadre des programmes d’études médicales.
Mots-clés :
- Droit de la santé,
- services génétiques,
- tests génétiques,
- responsabilité médicale,
- norme de pratique du médecin
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Bibliography
- Code of Ethics of Physicians, CQLR 2002, ch M-9, r 17.
- Constitution Act, 1867, 30 & 31 Vict, c 3.
- Ohio Jury Instructions, 2010.
- Baker v Silver, [1998] JQ no 808.
- Chouinard v Robbins, [1999] RRA 65.
- Fiocco v De Varennes, 2017 QCCS 5042.
- Hawke v Hornstein, [1994] RJQ 965.
- Lévesque v Hôpital Notre-Dame de Ste-Croix, [1993] RRA 93.
- MJRvGirard, 2019 QCCS 1937.
- Topliceanu v Bojanowski, 2018 QCCS 658.
- Crits v Sylvester, [1956] OR 132.
- R v Kirkpatrick, 2022 SCC 33.
- Roberge v Bolduc, [1991] 1 SCR 374.
- Sylvester v Crits et al, [1956] RCS 991.
- Ter Neuzen v Korn, [1995] 3 RCS 674.
- XvWhelan, 2011 ONCA 244.
- BakervDeRiso, [2015] 2015 Ohio 2440.
- BrunivTatsumi, [1976] 46 Ohio St 2d 127.
- Fosterv Klaumann, [2013] 296 Kan 295.
- HellingvCarey, [1974] 83 Wn2d 514.
- ReegvShaughnessy, [1978] 570 F2d 309.
- TheTJHooper, [1932] 60 F2d 737.
- Baudouin, Jean-Louis, Patrice Deslauriers & Benoît Moore, La responsabilité civile : Responsabilité professionnelle, 9th ed (Cowansville: Yvon Blais, 2021).
- Brun, Henri, Guy Tremblay & Eugénie Brouillet, Droit constitutionnel, 6th ed (Montreal: Éditions Yvon Blais, 2014).
- Perreault, Janick, Les affres de la spécialité: le médecin doit-il consulter? (Essai pour l’obtention du grade “maître en droit”, Université Sherbrooke, 1996) [unpublished].
- Philips-Nootens, Suzanne, Robert P Kouri & Pauline Lesage-Jarjoura, Éléments de responsabilité civile médicale: Le droit dans le quotidien de la médecine, 4th ed (Cowansville: Yvon Blais, 2016).
- Presseault, Sylvie, La responsabilité du médecin en génétique (Essai pour l’obtention du grade “maître en droit”, Université Sherbrooke, 1997) [unpublished].
- Robertson, Gerald & Ellen Picard, Legal Liability of Doctors and Hospitals in Canada, 5th ed (Toronto: Carswell, 2017).
- Battista, R N et al, “Genetics in Health Care: An Overview of Current and Emerging Models” (2011) 15:1 Public Health Genomics 34.
- Bellcross, Cecelia A et al, “Awareness and utilization of BRCA1/2 testing among U.S. primary care physicians” (2011) 40:1 Am J Prev Med.
- Blaine, Sean M et al, “Interactive genetic counseling role-play: a novel educational strategy for family physicians” (2008) 17:2 J Genet Couns.
- Bonter, Katherine et al, “Personalised medicine in Canada: a survey of adoption and practice in oncology, cardiology and family medicine” (2011) 1:1 BMJ Open.
- Borle, Kennedy et al, “Where is genetic medicine headed? Exploring the perspectives of Canadian genetic professionals on future trends using the Delphi method” (2022) 30:5 European Journal of Human Genetics 496–504, online: https://doi.org/10.1038/s41431-021-01017-2.
- Bouchard, Karine et al, “Genetic Testing for Cancer Susceptibility: Physicians’ Attitudes and Practices in Eastern Québec, Canada” (2023) Familial Cancer.
- Burgess, Annette et al, “Team-based learning (TBL): a community of practice” (2019) 19:369 BMC Medical Education 1.
- Carroll, June C et al, “Genetic education for primary care providers: improving attitudes, knowledge, and confidence” (2009) 55:12 Can Fam Physician.
- Carroll, June C et al, “GenetiKit: a randomized controlled trial to enhance delivery of genetics services by family physicians” (2011) 28:6 Fam Pract.
- Carroll, June C et al, “Primary care providers’ experiences with and perceptions of personalized genomic medicine” (2016) 62:10 Can Fam Physician e626, online: http://www.cfp.ca/content/62/10/e626.abstract.
- Cohen, SA & DM Nixon, “A collaborative approach to cancer risk assessment services using genetic counselor extenders in a multi-system community hospital” (2016) 159:3 Breast Cancer Research and Treatment 527–534.
- Cornel, Martina, “Evidence-Based Genetic Education of Non-Genetic-Expert Physicians: Experiences Over Three Decades in Amsterdam” (2019) 10:712 Front Genet.
- Cruess, Richard L, Sylvia R Cruess & Yvonne Steinert, “Medicine as a Community of Practice: Implications for Medical Education” (2018) 93:2 Acad Med 185.
- Deslauriers, Patrice & Sophie-Emmanuelle Chebin, “Perspectives Québécoises sur la Responsabilité Médicale” (1999) 101:2 R du N 299.
- Emmet, Margaret et al, “Experiences of Genetic Counselors Practicing in Rural Areas” (2018) 27:1 J Genet Counsel 140.
- Falah, Nadia et al, “Genetics education in primary care residency training: satisfaction and current barriers” (2022) 23:156 BMC Prim Care.
- Frey, Melissa K et al, “Genetic Testing for All: Overcoming Disparities in Ovarian Cancer Genetic Testing” (2022) 42 American Society of Clinical Oncology Educational Book 1– 12, online: https://doi.org/10.1200/EDBK_350292.
- Gilmour, Joan M, “Overview of Medical Malpractice Law in Canada” (1994) 3:1 Annals of Health Law 179.
- Gould, Danielle & Memnun Seven, “Assessing Nurse Practitioner Practices Regarding Genetics and Genomics in Healthcare Services in the United States” (2022) 2:1 Journal of Practical Nurse Education and Practice.
- Guttmacher, A E, J Jenkins & W R Uhlmann, “Genomic medicine: Who will practice it? A call to open arms” (2001) 106:3 Am J Med Genet 216.
- Hamilton, Jada G et al, “Primary care providers’ cancer genetic testing-related knowledge, attitudes, and communication behaviors: A systematic review and research agenda” (2017) 32:3 J Gen Intern Med.
- Harding, Brittany et al, “Bridging the gap in genetics: a progressive model for primary to specialist care” (2019) 19:1 BMC Medical Education 195, online: https://doi.org/10.1186/s12909-019-1622-y.
- Harding, Brittany et al, “Primary care providers’ lived experiences of genetics in practice” (2019) 10:1 J Community Genet 85–93, online: https://doi.org/10.1007/s12687-018-0364-6.
- Jenkins, Brittany D et al, “The 2019 US medical genetics workforce: a focus on clinical genetics” (2021) 23 Genet Med 1458.
- Kirmse, Brian, “Expanding clinical genetics services in a rural state in the post-genomic, technology-connected age: A dispatch from Mississippi” (2020) 4 Translational Science of Rare Diseases 169.
- Lapointe, Julie et al, “A Collaborative Model to Implement Flexible, Accessible and Efficient Oncogenetic Services for Hereditary Breast and Ovarian Cancer: The C- MOnGene Study” (2021) 13:11 Cancers.
- Marchant, Gary et al, “From Genetics to Genomics: Facing the Liability Implications in Clinical Care” (2020) 48:1 J Law Med Ethics 11–43, online: https://doi.org/10.1177/1073110520916994.
- Massart, Mylynda et al, “A Multidisciplinary Precision Medicine Service in Primary Care” (2022) 20:1 The Annals of Family Medicine January 88.
- McGrath, Scott P et al, “Legal Challenges in Precision Medicine: What Duties Arising From Genetic and Genomic Testing Does a Physician Owe to Patients?” (2021) 8:26 Front Med (Lausanne).
- Moffett, Peter & Gregory Moore, “The standard of care: legal history and definitions: the bad and good news” (2011) 12:1 The Western Journal of Emergency Medicine 109.
- Ouellet, Jade et al, “Scope of coverage of medical genetics and genomics in pre- clerkship programs of Canadian faculties of medicine: A curriculum analysis” (2023) 191:1 Am J Med Genet Part A 13–21, online: https://onlinelibrary.wiley.com/doi/abs/10.1002/ajmg.a.62978.
- Pasquier, Laurent et al, “How do non-geneticist physicians deal with genetic tests? A qualitative analysis” (2022) 30:320 Eur J Hum Genet.
- Patrinos, Dimitri et al, “Genetic Counsellors, Legal Recognition, and the Road Less Travelled” (2020) 14:1 McGill JL & Health 109.
- Piedimonte, Sabrina et al, “BRCA testing in women with high-grade serous ovarian cancer: gynecologic oncologist-initiated testing compared with genetics referral” (2020) 30:11 Int J Gynecol Cancer 1757, online: http://ijgc.bmj.com/content/30/11/1757.abstract.
- Plunkett-Rondeau, Jevon, Katherine Hyland & Shoumita Dasgupta, “Training future physicians in the era of genomic medicine: trends in undergraduate medical genetics education” (2015) 17:11 Genet Med.
- Rowe, Malcolm & Leanna Katz, “A Practical Guide to Stare Decisis” (2020) 41:1 Windsor Rev Legal & Soc Issues.
- Seibert, Susan, “The Meaning of a Healthcare Community of Practice” (2015) 50:2 Nurs Forum 69.
- Silversides, Ann, “The wide gap between genetic research and clinical needs” (2007) 176:3 CMAJ 315–316.
- Skinner, Stephanie J et al, “Interpretation and management of genetic test results by Canadian family physicians: a multiple choice survey of performance” (2021) 12:3 J Community Genet.
- Talwar, Divya et al, “Genetics/genomics education for nongenetic health professionals: a systematic literature review” (2016) 19:7 Genet Med.
- Thorogood, Adrian et al, “A Legal Duty of Genetic Recontact in Canada” (2019) Health Law in Canada, online: https://ssrn.com/abstract=3495702.
- Unim, Brigid et al, “The Provision of Genetic Testing and Related Services in Quebec, Canada” (2020) 11 Frontiers in Genetics, online: https://www.frontiersin.org/article/10.3389/fgene.2020.00127.
- Vassy, Jason L et al, “How Primary Care Providers Talk to Patients about Genome Sequencing Results: Risk, Rationale, and Recommendation” (2018) 33:6 J Gen Intern Med.
- Zawati, Ma’n, “Chapitre 8 : La responsabilité civile des conseillers en génétique” in Mélanie Bourassa-Forcier & Anne-Marie Savard, eds, Droit de la santé (Quebec: LexisNexis Canada Inc, 2014), 351-383.
- Association of Geneticists of Quebec, “Association of Geneticists of Quebec”, online: https://www.amgq.net/accueilhome.
- Baudouin, Jean-Louis, “Law of Delict in Quebec” in TheCanadianEncyclopedia (2016).
- CIUSSS du Nord-de-l’île-de-Montréal, Comité du Diagnostic et du Traitement du Cancer (CDTC) - Calendrier 2022 - Réunion teams (2022).
- Department of Justice Canada, “What is the Law?”, online: GovernmentofCanada https://www.justice.gc.ca/eng/csj-sjc/just/02.html.
- Goguen, David, “What is the ‘Medical Standard of Care’ in a Medical Malpractice Case?”, online: NOLO https://www.nolo.com/legal-encyclopedia/what-the-medical-standard-care-malpractice-case.html.
- Institut National de Santé Publique du Québec, La communauté de pratique un outil pertinent : résumé des connaissances adaptées au contexte de la santé publique (Government of Quebec, 2018).
- Ontario Justice Education Network, CommonLawandCivilLaw (2013).
- Regroupement des organismes ESPACE du Québec, Survey presented at 2023 BRCA Symposium, by Regroupement des organismes ESPACE du Québec (2023).
- “Comparing Federal and State Courts”, online: United States Courts https://www.uscourts.gov/about-federal-courts/court-role-and-structure/comparing-federal-state-courts.
- Medical Genetics Profile (2019).
- “Réseau Rose”, online: RéseauRosehttps://reseaurose.ca/.
- White House, “State and Local Government”, online: White House https://www.whitehouse.gov/about-the-white-house/our-government/state-local-government/.