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Health Technology Assessment and the Law

Health Technology Assessment and the Law

Does public medicare account for the law when it approves new drugs and technologies?

Major health technology assessment (HTA) bodies in Canada assess the value of new health technologies like drugs, devices, and digital health tools, and make recommendations to government about what to include (and exclude) from public medicare. Their work is critically important to the overall fairness, legitimacy and sustainability of Canadian medicare. HTA bodies factor into their assessments evidence of effectiveness, cost, ethics and broader social concerns. However, they should also assess legal concerns. A failure to do so can result in funding approval for technologies that fail to comply with relevant laws, jeopardizing important values such as patient privacy and gender equality, as well as opening up government entities to possible lawsuits, judicial review, and reputational damage.

In this project, we are for the first time describing and analyzing the extent to which Canadian HTA bodies have considered important legal issues. We are working with representatives of HTA bodies from other countries, and international HTA scholars, to create and test tools that will equip HTA bodies to identify and prioritize legal issues for deeper analysis.

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Team Leads

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Colleen Flood

Colleen Flood

Professor
Faculty of Law
University of Ottawa

Colleen M. Flood is Professor at the University of Ottawa and a University Research Chair in Health Law & Policy. She is also inaugural Director of the University of Ottawa Centre for Health Law, Policy and Ethics. From 2000–2015 she was a Professor and Canada Research Chair at the Faculty of Law, University of Toronto, with cross-appointments to the School of Public Policy and the Institute of Health Policy, Management and Evaluation. From 2006–2011 she served as Scientific Director at the Canadian Institute for Health Services and Policy Research (CIHR). Her primary areas of scholarship are comparative health care law and policy, public/private financing of health care systems, health care reform, constitutional law, administrative law, and accountability and governance issues more broadly.

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Team

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Fernando Aith

Fernando Aith

Professor
Public Health School
University of São Paulo, Brazil

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Fiona Clement

Fiona Clement

Director, Health Technology Assessment Unit
O’Brien Institute of Public Health

Dr. Clement has extensive training in Health Services Research, Health Economics and Health Policy. She is the Director of the Health Technology Assessment Unit within the O’Brien Institute of Public Health, a policy-responsive research unit that completes evidence synthesis, economic evaluations, health technology assessments and reassessments in response to decision-makers’ needs. Her research interests include drug and non-drug technology reimbursement and cost containment policy, evidence in decision-making, and evidence in health policy development. In 2014, she was selected as the Canadian Harkness fellow; a unique opportunity to study US healthcare policy. She has also received the Maurice McGregor Award for outstanding leadership and excellence in HTA in Canada. In 2015, she was named one of Calgary’s Top 40 under 40 for her work in health policy.

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Nathan Cortez

Nathan Cortez

Professor
Dedman School of Law, U.S.A.

Professor Cortez, a Gerald J. Ford Research Fellow and the inaugural Adelfa Botello Callejo Endowed Professor of Law in Leadership and Latino Studies, teaches and writes in the areas of health law, administrative law, and FDA law. His research focuses on emerging markets in health care and biotechnology. Prof. Cortez has become one of the world’s leading legal scholars on medical tourism and other cross-border health markets, and has published several articles and book chapters on the legal and ethical implications of these phenomena. His research also addresses mobile health technologies and big data analytics, how to regulate innovation under aging regulatory frameworks, the First Amendment constraints on FDA regulation, immigration federalism, and alternative modes of regulation.

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Mireille Goetghebeur

Mireille Goetghebeur

Professor
School of Public Health
Université de Montréal

Mireille Goetghebeur holds a PhD in fundamental sciences and an engineering degree from the University of Montpellier in France. She is Associate Professor at the School of Public Health of the University of Montréal and an associate member of the Research Center of the Ste-Justine University Hospital in Montreal, Canada. She is a pioneer in the development of multidimensional approaches in support of reflection and deliberation for fair and reasonable decisions. Dr Goetghebeur has a solid expertise in the implementation of effective processes rooted in procedural and substantive ethics throughout decision continuums. Over the last 25 years, she has dedicated collaborative efforts at the local and international levels to foster a holistic vision of relevant, equitable and sustainable health and social services systems  Since 2017, she is principal scientist at the health and social services technology assessment (HSTA) agency of Quebec (INESSS), Canada, advancing deliberative processes and collaborative intelligence.

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Lorian Hardcastle

Lorian Hardcastle

Professor
Faculty of Law
University of Calgary

Lorian Hardcastle is an Assistant Professor in the Faculty of Law at the University of Calgary, with a joint appointment to the Department of Community Health Sciences in the Cumming School of Medicine. She is also a member of the One Health Consortium, O’Brien Institute for Public Health, and Conjoint Health Research Ethics Board at the University of Calgary. Lorian obtained her JD with Health Law and Policy Specialization Certificate from Dalhousie University, and her LLM and SJD from the University of Toronto. She also completed a fellowship at the O'Neill Institute for National and Global Health Law at Georgetown University Law Center.

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Matthew Herder

Matthew Herder

Professor
Schulich School of Law

Professor Herder teaches primarily in the Faculty of Medicine, across the undergraduate and postgraduate curriculums, on a variety of health law topics, including informed consent, patient-physician confidentiality, and regulation of the medical profession. Prior to arriving at Dalhousie, he taught in the areas of bioethics and intellectual property law at Loyola University Chicago’s School of Law.

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Murray Krahn

Murray Krahn

Canada Research Chair in Health Technology Assessment
Department of Medicine
University of Toronto

Dr. Krahn is the Director of THETA, Tier 1 Canada Research Chair in Health Technology Assessment, and Professor in the Department of Medicine at the University of Toronto. He is a Senior Scientist and Director of the Division of Support, Systems, and Outcomes at the Toronto General Research Institute and Adjunct Scientist at the Institute for Clinical Evaluative Sciences. He is also an attending physician in the division of General Internal Medicine at the University Health Network, Toronto.

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Christopher McCabe

Christopher McCabe

Executive Director and CEO
Institute of Health Economics (IHE)

Dr. McCabe brings more than 25 years of experience as a health economist to his role with the organization. He trained and worked for 20 years in the UK before emigrating to Canada. During this time he held Full Professorships at the Universities of Sheffield, Warwick and Leeds. He was more recently a Professor of Health Economics at the University of Alberta, where he was appointed Capital Health Endowed Research Chair at the University of Alberta, leading two Genome Canada research groups focused on the evaluation, adoption and implementation of Precision Medicine technologies. He also served on the Canadian Agency for Drugs and Technologies in Health Care (CADTH) Health Economics Working Group, which authored the 4th Edition of the CADTH Guidelines for the Economic Evaluation of Health Technologies in 2017. He was lead author of the addendum to the CADTH Guidelines focused on co-dependent therapies, published in 2019. More recently Dr. McCabe advised the Patented Medicines Price Review Board on the technical issues related to the revision of their regulations for setting the price of new drugs in Canada. He is currently Chair of the Royal Society of Canada COVID Task Force Working Group on the Economy.

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Michelle Mujoomdar

Michelle Mujoomdar

Director, Scientific Affairs
CADTH

Dr. Michelle Mujoomdar has held several leadership roles since joining CADTH in 2008. In 2013, Michelle joined CADTH’s Evidence Standards team as Director, Scientific Affairs where she has accountability for the quality of CADTH’s work. In this role, she also has oversight for CADTH’s Scientific Advice programme and Patient Engagement activities. Michelle returned to CADTH in 2018 following a 19-month secondment to the European Network for Health Technology Assessment (EUnetHTA) where she served as EUnetHTA’s Senior Scientific Officer. Michelle currently serves on the Board of Directors for the International Network of Agencies for Health Technology Assessment as Vice-Chair. Michelle holds a PhD in Pharmacology from Dalhousie University, Canada.

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Vardit Ravitsky

Vardit Ravitsky

Professor
Department of social and preventive medicine
Université de Montréal

Prof. Ravitsky’s research focuses on reproductive ethics and the ethics of genetic and genomics research. Her research projects are funded by CIHR, FRQSC, SSHRC, and Genome Canada and cover a variety of topics such as: public funding of In-Vitro Fertilization (IVF); the use of surplus frozen embryos; posthumous reproduction; pre-implantation genetic diagnosis (PGD); sperm and egg donation, in particular the interest of donor-conceived individuals in knowing their genetic origins; epigenetics; prenatal testing, in particular the ethical, social and legal aspects of Non-Invasive Prenatal Testing (NIPT); germline and somatic gene editing; and mitochondrial replacement. Her research interests in bioethics also include research ethics, health policy and cultural perspectives. She is particularly interested in the various ways in which cultural frameworks shape public debate and public policy in the area of bioethics.

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Manik Saini

Manik Saini

Director, Health Technology Assessment
Government of British Columbia

Manik holds a MSc in Public Health and has over 12 years of experience with the BC Ministry of Health. He currently stewards BC’s health technology assessment process and is a key contact with the province’s life sciences community. He has previous experience leading the development of BC’s strategy towards tuberculosis, supporting Swaziland’s Ministry of Health to accelerate progress towards the elimination of indigenous malaria, and assessing Burkina Faso’s drug supply chain on behalf of the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Manik has two young children and is an avid tennis player.

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Keith Syrett

Keith Syrett

Chair in Health Law and Policy
School of Law
University of Bristol, U.K.

Keith's research focuses upon the role of law as a mechanism of regulation and governance within health systems—especially in relation to the allocation of scarce resources—and on the ways in which law can both promote, and sometimes impede, the health of the population locally, nationally and globally. Keith sits on the managing committees of the International Society on Priorities in Health, and the British Association for Canadian Studies. He is also a Fellow of the Royal Society of Medicine, and of the Royal Society of Arts.

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Bryan Thomas

Bryan Thomas

Research Associate
Faculty of Law
University of Ottawa

Bryan Thomas is a Senior Research Associate with the Centre for Health Law, Policy and Ethics and Adjunct Professor with the Faculty of Law, University of Ottawa. His research spans a wide range of topics including Canadian and comparative health law and policy, health rights litigation, long-term care, global health law, and the role of religious argument in legal and political discourse. Dr. Thomas holds an SJD from University of Toronto and a Master’s degree in philosophy from Dalhousie.

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