Positions on Healthcare Issues
Rx&D Position:
The trade dress of a pharmaceutical preparation is unique to that
particular preparation, and distinguishes the product from all other
pharmaceutical products. Trade dress functions as a valid trademark
to be used only by, or with the licence of, its owner.
Consumers have the absolute right of choice in terms of such pharmaceutical
products, and choice is no choice at all if full and comprehensive
information is not available to facilitate that choice. The trade
dress of a pharmaceutical product is an integral part of the identification
of the product and, as such, helps consumers to assure themselves
that they are indeed receiving the product that was prescribed by
their physician.
Pharmacoeconomics
Health economic studies, or economic evaluations, compare the costs
and outcomes of alternative therapeutic courses of action. Pharmacoeconomics
is a subset of healthcare economics. It focusses on the comparative
analysis of drug therapy interventions versus other potential treatments
of diseases (drug, non drug, or no intervention). Specifically,
a pharmacoeconomic study assesses the overall value of a given drug.
Such a study would consider the beneficial and negative effects
on health, as well as the social and economic costs and savings
associated with a given product in the context of the healthcare
setting in which it is used or intended to be used.
Rx&D Position:
The pharmaceutical industry is an essential component of the healthcare
system, and shares the responsibility for improving its efficiency.
Appropriately-conducted economic evaluations which demonstrate the
cost-effectiveness of therapeutic alternatives could help to improve
system efficiency. The Rx&D endorses such evaluations as one
component of a broad range of questions which must be considered
in determining the reimbursement of a particular product. On that
understanding, the Rx&D endorses the concept of economic evaluations
of pharmaceuticals and has committed to foster the ongoing development
of this discipline.
Clinical Research and Special Populations
Description of Issue:
The clinical trials process involves three phases. In phase one,
the drug is tested in a small group of 20 to 30 healthy volunteers
- primarily to determine its absorption, metabolism, and tolerance.
If successful, the drug then progresses to phase two which involves
50 to 100 patients who are suffering from the condition or disease
that the drug is intended to treat. If the drug successfully completes
the second phase, it moves to phase three which involves numerous
studies comparing the new drug to existing therapies in thousands
of volunteer patients.
Women and Clinical Research
Rx&D Position:
The Rx&D supports the informed participation of women in Phase
I-III research in order to better characterize the pharmacokinetic
and pharmacodynamic basis of drug effects, provided that, in the
cases of women of child-bearing age, the risk of fetal exposure
can be minimized by patient behaviour and pregnancy testing, and
the risk has been adequately addressed by the patient, physician-investigator,
Research Ethics Board, pharmaceutical sponsor, and the Health Protection
Branch.
Children and Clinical Research
Rx&D Position:
The Rx&D supports the position of the National Council for
Bioethics in Human Research, namely that scientifically valid, ethically
sound research in children conducted within certain procedural safeguards
is not only appropriate but ethically and socially responsible.
Research in children should be reviewed and approved by Research
Ethics Boards and conducted within the framework of applicable Federal
and Provincial legislation.
Geriatric Patients and Clinical Research
Rx&D Position
In order for healthcare professionals to be provided with sufficient
information to optimize pharmacotherapy in the geriatric population,
routine and thorough evaluation of new molecular entities in the
elderly should be encouraged, particularly those likely to be used
in a significant number of geriatric patients.
Psychiatric Patients and Clinical
Research
Rx&D Position:
Where consent has been obtained, and the research has been reviewed
and approved by a Research Ethics Board, scientifically valid and
ethically sound clinical research should be conducted in patients
with psychiatric conditions so as to ensure the availability of
new treatments for such conditions
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