Bill C-363
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2nd Session, 35th Parliament, 45 Elizabeth II, 1996-97
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The House of Commons of Canada
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BILL C-363 |
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An Act to amend the Patent Act
(investigations regarding the making of
medicines available at no charge to the
seriously ill)
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R.S., c. P-4;
R.S., c. 33
(3rd Supp.);
1992, c. 1;
1993, cc. 2,
15, 44; 1994,
cc. 26, 47;
1995, c. 1
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1. The Patent Act is amended by adding
the following after section 90:
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Investigations regarding the Making of Medicines Available at No Charge to the Seriously Ill |
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90.01 In sections 90.02 to 90.1,
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``medicine'' « médicament »
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``medicine'' includes
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``seriously ill
person'' « personne gravement malade »
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``seriously ill person'' means a person
suffering from an illness that a qualified
medical practitioner believes on reasonable
grounds will probably lead to significant
deterioration in the person's health or will
result in the person's death.
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Information
on patented
medicines
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90.02 Not later than the 31st day of March
of every year, a patentee of an invention
pertaining to a medicine shall, as required by
and in accordance with the regulations and
with the orders of the Board, provide the
Board with such information and documents
as the regulations or orders may specify
respecting
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Powers of the
Board
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90.03 (1) The Board may, by order, require
a patentee of an invention pertaining to a
medicine to provide the Board with
information and documents respecting any of
the matters referred to in section 90.02 and
subsection 90.07(2).
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Compliance
with order
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(2) A patentee of an invention pertaining to
a medicine in respect of whom an order is
made under subsection (1) shall comply with
the order within such time as is specified in the
order or as the Board may allow.
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Investigations
by Board
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90.04 (1) The Board shall conduct an
annual investigation of patentees of
inventions pertaining to medicines and any
other persons who, in the Board's opinion, can
provide relevant information with a view to
determining whether, in the circumstances,
the patentees have made fair and reasonable
efforts to make the medicines for which they
held the patents at any time during the
preceding year available in Canada at no
charge for the treatment of seriously ill
persons.
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Report to the
Minister
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(2) No later than the 30th day of September
of each year, the Board shall submit a report to
the Minister concerning its annual
investigation under subsection (1).
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Contents of
report
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(3) The report shall be based on an analysis
of the information and documents obtained
pursuant to section 90.02 and other
information and documents that the Board
considers relevant and shall disclose the
identity of the patentee referred to in the
report.
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Comments
and represen- tations
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(4) Before submitting its report to the
Minister, the Board shall give the patentee
referred to in the report an opportunity to
make comments and representations in
writing or in person.
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Tabling the
report
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90.05 The Minister shall cause the report
referred to in section 90.04 to be laid before
each House of Parliament within five sitting
days after the report is received.
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Investigation
by Board at a
patient's
request
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90.06 (1) A seriously ill person or another
person on behalf of that person may, in
writing, ask the Board to conduct an
investigation of a patentee of an invention
pertaining to a medicine in order to determine
whether the patentee has made fair and
reasonable efforts to make available in
Canada for the treatment of seriously ill
persons at no charge the medicines for which
the patentee held the patent at any time during
the preceding year.
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Rejection of
request
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(2) The Board shall reject a request for an
investigation where, in its opinion, the request
was not made in good faith or where, in the
two months preceding the request, the Board
has already conducted an investigation
concerning the same patentee and the same
medicine, and the Board shall advise the
person making the request of its findings and
shall close the case.
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Investigations
by the Board
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90.07 (1) On receiving a request under
subsection 90.06(1), the Board shall forthwith
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Information
on the
patented
medicine
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(2) Not later than five days after receiving
the copy forwarded by the Board of a request
by a seriously ill person, the patentee of an
invention pertaining to a medicine is required
to provide the Board, in accordance with the
regulations or with the orders of the Board,
information and documents regarding
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Report to the
Minister
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(3) Not later than thirty days after receiving
the request under subsection (1), the Board
shall submit a report to the Minister and at the
same time to the person making the request
concerning the investigation it has conducted
under paragraph (1)(b).
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Contents of
report
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(4) The report shall be based on an analysis
of the information and documents obtained
pursuant to subsection (2) and other
information and documents that the Board
considers relevant and shall
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Comments
and represen- tations
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(5) Before submitting its report to the
Minister, the Board shall give the patentee
referred to in the report an opportunity to
make comments and representations in
writting or in person.
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Tabling of the
report
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90.08 The Minister shall cause the report to
be laid before each House of Parliament
within two sitting days after the report is
received.
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Offence
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90.09 (1) Every person who contravenes or
fails to comply with section 90.02 or
subsection 90.07(2) or an order made pursuant
to that section or that subsection is guilty of an
offence punishable on summary conviction
and liable to a fine not exceeding twenty-five
thousand dollars.
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Limitation
period
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(2) Proceedings for an offence under
subsection (1) may be commenced within, but
not later than, one year after the time when the
subject-matter of the proceedings arose.
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Separate
offence
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(3) Where an offence under subsection (1)
is committed or continued on more than one
day, the person who committed the offence is
liable to be convicted for a separate offence
for each day on which the offence is
committed or continued.
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Duties of the
Minister
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90.1 The Minister shall
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2. Paragraph 101(1)(a) of the Act is
replaced by the following:
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