Optimizing Safety

and Benefits of
Genetic Testing

A Look at the CANADIAN

Policy
GENETIC TESTING:
• Gene tests (also called DNA-based
tests)
• The newest and most sophisticated of
the techniques used to test for genetic
disorders
• Involve direct examination of the DNA
molecule itself.
• Include biochemical tests for such
gene products as enzymes and other
proteins
• For microscopic examination of
stained or fluorescent chromosomes.
BENEFITS OF GENETIC TESTING:

 It detects disease-related genotypes, mutations,

phenotypes, or karyotypes for clinical purposes

 Both positive and negative results give you

information about inherited risk among your close
relatives like parents, brothers and sisters, or children

 Results guide decisions about medical management

 Only genetic tests find mutations in genes known to

increase risk for inherited cancer
Applications of Testing Humans
Genetic Testing in
humans can help
determine ancestry,
paternity and whether it
is likely that an
individual will develop
certain medical
conditions. The use of
genetic testing aims to
aid in early detection, or
disease prevention.
RISKS OF GENETIC TESTING:

 A gene test confirming the risk of a serious

disease can trigger profound psychological
consequences.

 The question and issues raised by gene testing

can challenge family and other personal
relationships.

 Finding ways to ensure the confidentiality of

gene test results is a major concern.
 CANADA:
Population 33,739,900 (2009)

GDP $1.600 trillion (2010)

(US$1.522 trillion)

Per Capta $43,100 (2008) income

(US$41,016)

Business rank 7th

GDP rank 10th

Biotech 5th
Expenditure
Public perception on Biotechnology and
Genetic Testing in CANADA

In General Canadian perceive advances

in Biotechnology as favorable.

Two-third of Canadians expressed

support for the technology

People in Canada thinks of Biotech as

important part of there social and
economical life

 In Ontario, 89% people are in support of

genetic testing
Biotechnology in Canada
 496 biotechnology companies

 $3.8 billion in biotech revenues

 17,065 products/processes at all

stages of development

 $1.5 billion in R&D spending by

industry

 Annual federal biotechnology spending

$791 million
Biotechnology in Canada:

Canada has the following

departments for the
development of science and
research infrastructure including
biotechnology

 Canadian foundation for

innovation

 Genome Canada

 Canadian institute of health

research
Biotechnology in Canada:
CONTROL OF GENETIC TESTING:

 Legislating units FEDERAL GOVERNMENT:

in CANADA are: Concerned with criminal
matters related to
falsification of health
 Federal products.
government PROVINCIAL GOVERNMENT:
 Provincial Establish, manage and
government maintain hospitals and solve
 Territorial problems related to civil
government rights.
 CANADIAN UNIVERSAL HEALTH-
CARE SYSTEM:
 In Canada, health-care facilities are
provided by Public sector.
 Drugs and Medical devices are paid for by
government on the approval of the provincial
insurance policy.
 Usage of genetic testing and medical devices
related to them is based on personal
autonomy and free choice.
 Only people are to decide to use a genetically
modified product or not.
PRE-MARKET ASSESSMENT:

 Genetic testing
is offered in two Medical Devices:
ways: Medical devices such as invitro
I. Genetic testing diagnostic devices are subject
to federal law.
as medical
devices
Laboratory Services:
II. Genetic
Laboratories are given licenses
testing as
by the provincial governments.
laboratory
services
1. MEDICAL DEVICES:
 Evaluation and surveillance by Health Canada
under Food and Drug Act and medical device
regulation.
 Genetic tests have been classified as level 3
risk.
 Medical devices must be licensed before
marketed.
 License is given based on
o Physical Properties
o Evaluation of Consequences
2. LABORATORY SERVICES:

 Not subject to evaluation of Health Canada.

 No specific regulation for genetic testing in
laboratories.
 The laboratories must be licensed by the
provincial government.
 To obtain license, the safety and efficacy of
genetic tests should be evidenced by prior
clinical trials.
CONTROL AND ACCESS:

Genetic Device
can’t be Consumer or patients
advertized and must know the
sold directly to consequences of the
public result

Supervision of
Prescription of
health-care
health-care
professional professional is
must
Suggestions made by
United States
USA gave many useful suggestions to Canada for improving
their policy on GENETIC TESTING.
 Canada should create a taskforce similar to that of
United States.
 Secretary’s Advisory Committee on Genetic Testing
(SACGT) suggested analytical validity, clinical validity,
and social consequences should be the main criteria for
benefits and risks of GT.
 Should consider the development of mechanism to
ensure the identification and appropriate review of tests
that raise major social and ethical issues.
 Option 4
• Actively monitor the situation
Option 3
• Enhance information availability
Option 2
• Allocate resources to enforce existing laws
• Control access to genetic tests for more serious Option 1
conditions
POLICY BRIEF 2010:
 POLICY BRIEF 2010:
The Policy Brief canvasses three broad policy
options for addressing potential genetic
discrimination issues in Canada:

Strengthening
Introducing a
the use of
new regulatory Initiating sector-
existing
framework for specific solutions
Canadian human
governing for insurance
rights and
genetic testing
privacy regimes
The End
Presented By : Shahab Saqib