building cultural environmental context into health ... · 14.1 introduction the chapters in this...
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Janice E. Graham, PhD, FCAHSProfessor, Pediatrics (Infectious Diseases) and Medical Anthropology
Building cultural environmental context into health technology assessment:
a symmetrical approach
Evidence, Authority, ExpertiseGraham & Jones. 2016. Just Evidence. Opening health knowledge to a parliament of evidence.
• Accountability
• Transparency
• Openness
• Reflexivity
• Trustworthiness
(adapted from Beauchamp and Childress; O’Neill; Kenny, Sherwin and Baylis 2010)
• Autonomy
• Respect for persons, populations, and ecosystems in the context of a relational ethics
• Traditional paternalism was defective – patients, research participants, clinicians and
citizens need to be better [consulted, engaged, and] informed
• Informed consent has to [involve investigation of broad evidentiary sources] highlight risks
of harms and uncertainties as well as benefits
• Beneficence (do good)
• Nonmaleficence (do not harm)
• Social justice (fair and just relations between everyday people at every level of society)
Principles of Public Health (Relational) Ethics
Copyright ©2007 Canadian Medical Association or its licensors
Yeates, N. et al. CMAJ 2007;176:1845-1847
Progressive Licensing Framework
Health Canada wins 4th annual Code of Silence Award
“Over a period of more than five years, Health Canada
denied any meaningful access to a database of prescription
drugs that could harm or even kill Canadians.”
“The parliamentary all-party standing committee on health
said the manner in which drugs are tested and approved is
too secretive, in large part due to excessive concerns about
the commercial interests of the drug companies.”
CAJ Press Release May 9 2004 http://www.caj.ca
Regulatory Modernization
• Therapeutic Access Strategy (2003)
• Natural Health Products Regulations (2003)
• Smart Regulations (2005)
• Public Involvement Framework (2005)
• Blueprint for Renewal (2006)
• Policy on Public Input (2007)
• Strategic Plan (2007)
• Progressive Licensing Framework (2008)
Safe therapeutic and biologic products that work:
to help the people of Canada maintain and improve their health; to take an integrated
approach to the management of the risks and benefits to health related to health
products and food; to promote conditions that enable Canadians to make healthy choices
Being open for business:
to foster a growing competitive, knowledge-based Canadian economy; to improve
conditions for investment, improve Canada's innovation performance, increase Canada's
share of global trade and build a fair, efficient and competitive marketplace
Health (Protection) Canada? and/or/butInnovation, Science & Economic Development Canada?
Policy on Public Input (Multiple rationalities)• Public input, which can include scientific as well as other types of evidence,
can bring additional perspectives relevant to an evaluation of safety and effectiveness by identifying gaps or more suitable methods in scientific research;
• contributing new information on the safety and effectiveness of a regulated product in real-world use;
• identifying, assessing, and balancing the risks and benefits of a regulated product, including the nature and degree of acceptable risk; or
• identifying strategies to mitigate risk when it cannot be eliminated, including advice on what and how information on a regulated product should be made available to the public (Health Canada 2007a, 15).
Openness, not just transparency.
• Accountability through open, independent scientific assessment
• Objectivity (along with value-neutrality) is an aspiration of expert
systems of scientific advice supporting regulatory frameworks
• Requires rigorous application of value neutral evidence from
independent (no conflict of interests or biases) scientific data (OCAPI)
• The consequence is legitimacy of scientific knowledge as the primary
authority for policy advice and policy and clinical decisions
Accountability not just Objectivity
• Transparency provides detailed information through one-way communication
• Transparency might be seen as a photo-op for deliberative democracy in a political climate of gag orders, as a way of overloading pressure groups seeking information on opaque policy processes
• Transparency devolves responsibility onto citizens without giving them real opportunities to contribute to decisions
Transparency
Flexibility is a feature of ‘smart’ risk regulation regimes, but can be challenged
as an instrument of deregulation
Reflexivity instead recognizes and builds a dialogue between conflicting systems
of knowledge (e.g. experts, experienced and concerned citizens). Conflicting
expert advice leaves decision-makers with the task of determining which expert
advice to follow
Reflexive modernization describes a world where high profile harms to citizens have challenged risk
assessments carried out by experts
Reflexivity, instead of Flexibility
Openness
Openness is two-way; information is exchanged and
dialogically engaged with between actors
How would openness look in practice?
“Openness is inviting, hearing, considering, and sharing
information in the conduct of the Health Product and
Food Branch’s business.” Health Canada OCAPI (2007)
https://www.canada.ca/en/health-canada/corporate/about-health-canada/reports-
publications/office-consumer-public-involvement/health-products-food-branch-public-
involvement-framework.html?_ga=2.72874965.715638372.1509474237-
1268560431.1509474237
Symmetrical approach
Legitimate
Socio-technicalevidence
Reflexive
Op
enA
ccou
ntab
le
Co
nstru
ctive R
ealismIn
de
pe
nd
ent
Clin
ical
Ap
pra
isal
Dialogue
A symmetrical approach to risk regulation
http://open.canada.ca/en/consultations/canadas-new-plan-open-government-2016-2018?_ga=2.72874965.715638372.1509474237-1268560431.1509474237#toc5-1-3
Why do this?
Open data has the potential to transform how government officials
make decisions and how citizens interact with government. By providing a
range of quality open data from reliable sources, Canada will support informed
participation and engagement in the development of programs, services, and
policies by citizens and government workers alike. The Government of Canada is
committed to ensuring that its data is open by default. Data must be
discoverable, accessible, and reusable without restriction so as to enhance
transparency, enable better services to Canadians, facilitate innovation, and
inform public participation.
Draft New Plan on Open Government 2016-2018
Trust
• Standards
• Governance
• Trust
• Surveillance
• Effectiveness
• Outcomes
14Just Evidence: Opening Health Knowledge to a Parliament of EvidenceJanice E. Graham and Mavis Jones
14.1 Introduction
The chapters in this volume are prefaced by a common understanding that the health of our oceans matters. The collection provides richaccounts dealing with how scientific information is used to build a research base and col- laboratory networks to exchange, manage, signalrisk, influence, and govern policy- and decision-making. For these authors, water matters in an eco- logical sense, in the same way that othercomponents of the environment, that is, land and air, matter. Individually and collectively, they constitute the “one health” we all share andshould not take for granted (One Health Global Network 2015; One Health Initiative n.d.; Centers for Disease Control and Prevention 2013;Public Health Agency of Canada 2015).
CONTENTS14.1 Introduction .............................................................................................. 32514.2 Weaving the Technical, Relational, and Political into aParliament of Evidence-Based Knowledge .......................................... 32814.3 Indication and Intellectual Property Creep ......................................... 33014.4 Moving to a Solution: Some Questions First........................................ 331
Case 1: International Regulatory Practices and Policiesfor Emerging Health Products: Efficacy and Safety............. 332Case 2: Global Vaccine Development and Implementation Platforms. Equity. DevelopingVaccines for the Global South .................................................. 336
14.5 Integrating Knowledge from All Levels in a Parliament of Evidence.................................................................................................. 33714.6 Modernization, Risks, and Regulatory Science................................... 33914.7 A Symmetrical Approach: Constructivist Accountability,Openness, and Reflexivity...................................................................... 340
14.7.1 Accountability through Both Independent Scientific Assessment and Constructivist Realism................................ 34014.7.2 Openness, Not Just Transparency........................................... 34114.7.3 Reflexivity for a Symmetrical Evidence Base ........................ 34114.8 Conclusion ................................................................................................ 342
Science, Information, and Policy Interface for Effective Coastal and Ocean Management (publication date: May 16, 2016)
