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A MODEL OF REGULATORY BURDEN IN TECHNOLOGY
DIFFUSION THE CASE OF PLANT-DERIVED VACCINES
David Castle1, Kira Kumagai1, Martin Cloutier2,
Celine Berard3, Jyoti Mistry1, Karen Durell4,
Richard Gold4 1Ottawa University, Department of
Philosophy 2UQAM, Department of Management and
Technology 3School of business and Health Law
Institute, University of Alberta 4McGill
University, Faculty of Law
PROOF OF CONCEPT PLANT DERIVED VACCINES
ABSTRACT
DATA MODEL
RESEARCH QUESTION
NOVEL VACCINES
According to the World Health Organization
(2002), cost is the main obstacle preventing
Hepatitis B vaccination in developing nations.
The use of transgenic plants to produce vaccines
is a promising new technology that offers a cost
effective alternative to traditional vaccine
production methods.
What strategy for deploying this technology ought
be adopted to ensure that PDVs can be used in
India in a manner which is sustainable from a
business standpoint, mindful of intellectual
property issues, compliant with existing
regulations, while ensuring the highest level of
access to Indian citizens?
Plant-derived vaccines may soon displace
conventional vaccines. Assuming there are no
major technological barriers undermining the
feasibility of this innovative technology, it is
worthwhile to generate quantitative models of
regulatory burden of producing and diffusing
plant-derived vaccines in industrialized and
developing countries. A dynamic simulation model
of technology diffusion, and the data to populate
it, have been generated for studying regulatory
barriers in the diffusion of plant derived
vaccines. The role of regulatory burden is
evaluated for a variety of scenarios in which
plant-derived vaccines are produced and diffused.
This model relates the innovative and
conventional vaccine technologies and the effects
of the impact of the uptake of the innovative
technology on mortality and morbidity. This case
study demonstrates how dynamic simulation models
can be used to assess the long-term potential
impact of novel technologies in terms of a
variety of socio-economic indicators.
PDV INFLUENCE DIAGRAM
VALUATION TABLE
INTRODUCTION
The Intellectual Property Modeling Group (IPMG)
is a research group of international,
transdisciplinary researchers organized through
the Centre for Intellectual Property Policy at
McGill. The IPMG seeks to help policymakers
around the world determine how best to calibrate
intellectual property systems to achieve desired
policy goals in biotechnology to benefit society.
This project aims at building an integrated,
empirically sound understanding of the role of
intellectual property systems in achieving
desired policy outcomes in the area of health and
agriculture biotechnology
CONCLUSION
Preliminary results indicate that the model is a
valuable analytical tool which can be used
dynamically to make predictions about the effects
of regulatory burden on PDV diffusion
Demonstrates the tractability of the IMPG
approach Validates the modelling process
Offers concrete input into potential alternative
policy strategies adapted to PDV and comparable
technologies
OBJECTIVES OF THE PROJECT
Develop a menu of alternative policy strategies
relating to intellectual property systems to meet
the following policy goals in the biotech
field Maximize short to medium-term health and
agriculture innovation levels Build a
scientific infrastructure to address
local/regional health and agricultural
needs Develop a transdisciplinary research
platform that will assist decision-makers and
academic researchers to prospectively develop and
test policies relating to health and agricultural
biotechnology. Maximize access to existing and
future health and agriculture innovations
HEP B INFANT MORTALITY
INFANT INFECTION (YR)
TEMPORAL PDV PRODUCT DEVELOPMENT PLAN
CORRESPONDING AUTHOR
David Castle University of Ottawa, Department of
Philosophy Office SIMARD 229-CTelephone
613-562-5800, ext. 2795E-mail
dcastle_at_uOttawa.caMailing addressDepartment of
Philosophy70 Laurier Avenue East, Room
234Ottawa, Ontario   K1N 6N5
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