Bill C-261
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2nd Session, 37th Parliament, 51 Elizabeth II, 2002
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House of Commons of Canada
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BILL C-261 |
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An Act to ensure the necessary supply of
patented drugs in cases of domestic
emergency or to deal with crises in
countries that receive assistance from
Canada
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Preamble
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Whereas terrorist threats and the
possibility of biological warfare make it
prudent for the Government to ensure the
immediate availability of drugs to protect
persons in Canada or representing Canada
overseas;
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Whereas the rate of spread of disease,
including HIV, AIDS and tuberculosis, is
serious and tragic in many countries and
threatens a substantial proportion of the
population in some of those countries;
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Whereas the spread of disease threatens to
create an international crisis of a scale that is
unprecedented and likely to bring human
devastation and economic disaster to many of
the poorest nations of the world, a situation
which is made even worse by the fact that it is
selective on the basis of poverty;
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Whereas drugs are available to provide
protection from, cure or mitigate the effects of
many diseases and biological or biochemical
hazards, but the production of many such
drugs is protected by patents;
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Whereas Canada, having international
credibility and influence, should take a lead in
initiating international co-operation among
industrialized nations to make drugs available
at a reasonable price to nations suffering
medical crises;
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And Whereas drug manufacturers have
little real expectation of significant profit
from the sale of expensive drugs in nations
that cannot afford them;
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Now, Therefore, Her Majesty, by and with the
advice and consent of the Senate and House of
Commons of Canada, enacts as follows:
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SHORT TITLE |
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Short title
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1. This Act may be cited as the Drug Supply
Act.
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INTERPRETATION |
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Definitions
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2. The definitions in this section apply in
this Act.
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``biochemical
aggression'' « attaque biochimique »
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``biochemical aggression'' means an attack by
means of biological or biochemical
terrorism or warfare.
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``biochemical
protection
drug'' « médicament contre une attaque biochimique »
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``biochemical protection drug'' means a drug
determined by the Governor in Council to
be necessary or useful in protecting persons
in Canada or representing Canada overseas
from actual or apprehended biological or
biochemical aggression, or in curing or
mitigating the effects of biochemical
aggression.
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``epidemic
disease'' « maladie épidémique »
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``epidemic disease'' means AIDS, HIV,
tuberculosis or any other disease
determined by the Governor in Council to
be a disease that is or threatens to be an
epidemic.
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``epidemic
disease drug'' « médicament contre une maladie épidémique »
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``epidemic disease drug'' means a drug
determined by the Governor in Council to
be necessary or useful in protecting persons
from, or in curing or mitigating the effects
of, an epidemic disease.
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``incremental
cost'' « coût marginal »
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``incremental cost'' means the cost of a
product based on the cost of materials,
manufacturing, labour, packaging, royalty
and distribution directly incurred to
produce an additional quantity of a product,
but does not include the cost of research,
development or advertising, interest on
working capital, capital invested in
facilities used for manufacturing, research,
marketing, administration or any other
activity, the depreciation and maintenance
costs of those facilities, or any element of
profit.
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``Minister'' « ministre »
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``Minister'' means the Minister of Industry.
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``patentee'' « titulaire du brevet »
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``patentee'' includes the person to whom the
patent is granted or a person licensed by that
person under the patent.
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PROTECTION FROM BIOCHEMICAL AGGRESSION |
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Protection
plan
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3. (1) The Minister, in co-operation with the
Minister of Health, must develop a protection
plan to ensure access to sufficient biochemical
protection drugs to protect the public from a
potential biochemical threat or to deal with
biochemical aggression.
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Elements of
plan
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(2) The protection plan referred to in
subsection (1) must include at least the
following elements:
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Time limit
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(3) The Minister must complete the
protection plan not later than 180 days after
this Act comes into force.
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Plan laid
before
Parliament
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4. (1) The Minister must cause the
protection plan referred to in section 3 to be
laid before each House of Parliament on any
of the first five days on which the House sits
after the plan is completed and must, at the
same time, provide an outline of any
amendment to the Patent Act or of any other
legislation that would be necessary to put the
plan into effect.
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Committee
study of plan
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(2) On the laying of the protection plan and
outline of legislation before the House of
Commons, the Minister is deemed to have
moved a resolution that the plan and outline be
referred to such standing committee of the
House as the House may order for
consideration and report within 90 days or
such longer time as the House may order.
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INTERIM POWERS |
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Order in first
year
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5. (1) During the year commencing on the
day on which this Act comes into force, the
Governor in Council, on the recommendation
of the Minister of Health, may
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Order
operates
notwithstandi
ng the Patent
Act
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(2) An order under subsection (1) operates
notwithstanding the Patent Act, and the
patentee of a patent covering the manufacture
or use of a drug supplied under such an order
has no claim to further compensation in
respect of a right arising under the Patent Act,
except under subsection (3).
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Application to
Federal Court
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(3) A person who is the patentee of a patent
referred to in subsection (2), and who believes
that the compensation received under
subsection (1) is not a reasonable
compensation in the circumstances, may
apply to the Federal Court for an order varying
the terms of the order of the Governor in
Council.
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Interim orders
laid before
Parliament
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(4) The Minister must cause a copy of every
order made under subsection (1) to be laid
before both Houses of Parliament on any of
the first five days on which the House sits after
the order is made.
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INTERNATIONAL ASSISTANCE |
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International
conference
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6. The Minister must, in co-operation with
the Minister of Foreign Affairs and the
Minister of Health, within 180 days after the
coming into force of this Act, convene a
conference of
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Objectives
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7. The objectives of the conference are to
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Report
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8. (1) The Minister must, within 60 days
after the end of the conference, prepare a
report on the conference, including a
summary of its deliberations and conclusions
and an outline of any legislative proposals,
including proposals for funding, that may be
presented to Parliament to carry out the
program considered and proposed at the
conference.
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Laid before
Parliament
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(2) The Minister must cause the report to be
laid before each House of Parliament on any
of the first five days on which the House sits
after the report is completed.
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