Patented Medicines Regulations
(SOR/94-688)
(as amended up to December 19, 2013)
PATENT ACT
Registration 1994-11-07
Patented Medicines Regulations
P.C. 1994-1819 1994-11-01
His Excellency the Governor General in Council, on the recommendation of the
Minister of National Health and Welfare, pursuant to section 101 of the Patent
Act, is pleased hereby to revoke the Patented Medicines Regulations, made by
Order in Council P.C. 1988-2013 of September 15, 1988 , and to make the
annexed Regulations specifying the information to be provided relating to
patented medicines and patentees’ revenues and research and development
expenditures, in substitution therefor.
S.C. 1993, c. 2, s. 7
SOR/88-474, 1988 Canada Gazette Part II, p. 3921
1 [Repealed, SOR/2008-70, s. 2]
Interpretation [SOR/98-105, s. 1(F)]
2 The definitions in this section apply in these Regulations.
Act means the Patent Act. (Loi)
notice of compliance means a notice issued under section C.08.004 or
C.08.004.01 of the Food and Drug Regulations. (avis de conformité)
SOR/98-105, s. 1; SOR/2013-122, s. 24.
Information Respecting the Identity and Price of Medicines
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3 (1) For the purposes of paragraphs 80(1)(a) and (2)(a) of the Act, information
identifying the medicine shall be accompanied by the product monograph for the
medicine or, if a notice of compliance has not been issued in respect of the
medicine, by information similar to that contained in a product monograph, and
shall indicate
(a) the name and address of the patentee or former patentee and the address
for correspondence in Canada;
(b) whether the reporting patentee referred to in paragraph (a) is the patent
holder, a person holding a licence other than a licence continued by
subsection 11(1) of the Patent Act Amendment Act, 1992, or any other person
referred to in the definition patentee in subsection 79(1) of the Act;
(c) the generic name and brand name of the medicine;
(d) whether the medicine is for human or veterinary use;
(e) the therapeutic use of the medicine approved by the Minister of Health;
(f) the date on which the first notice of compliance was issued to the patentee
or former patentee in respect of the medicine;
(g) the drug identification number assigned to each strength and dosage form
of the medicine under the Food and Drug Regulations;
(h) the patent number of each invention of the patentee or former patentee
pertaining to the medicine, the date on which each patent was granted and the
date on which each patent will expire.
(2) The information required under subsection (1) shall be provided if
(a) a notice of compliance has been issued in respect of the medicine; or
(b) the medicine is being offered for sale in Canada.
(3) The information referred to in subsection (1) shall be provided no later than
the earlier of
(a) seven days after the day on which the first notice of compliance is issued
in respect of the medicine; and
(b) seven days after the day on which the medicine is first offered for sale in
Canada.
(4) The information referred to in subsection (1) shall be up to date and any
modification of that information shall be reported within 30 days after the
modification.
SOR/98-105, s. 2(E); SOR/2008-70, s. 3.
4 (1) For the purposes of paragraphs 80(1)(b) and (2)(b) of the Act, information
identifying the medicine and concerning the price of the medicine shall indicate
(a) the identity of the patentee or former patentee;
(b) the generic name and brand name of the medicine;
(c) the date on which the medicine is first sold in Canada;
(d) the day or period, referred to in subsection (2) or (3), to which the
information pertains;
(e) the drug identification number assigned under the Food and Drug
Regulations in respect of the medicine or, if no drug identification number has
been assigned, any other identification number assigned in respect of each
dosage form and strength of the medicine of the patentee or former patentee;
and
(f) in respect of the day or period referred to in paragraph (d),
(i) the quantity of the medicine sold in final dosage form and either the
average price per package or the net revenue from sales in respect of
each dosage form, strength and package size in which the medicine was
sold by the patentee or former patentee to each class of customer in each
province and territory,
(ii) the publicly available ex-factory price for each dosage form, strength
and package size in which the medicine was sold by the patentee or
former patentee to each class of customer in each province and territory,
and
(iii) if the medicine is being sold in one or more of the countries set out in
the schedule, the publicly available ex-factory price for each dosage form,
strength and package size in which the medicine was sold to each class of
customer in each of those countries.
(g) [Repealed, SOR/2008-70, s. 4]
(2) In the case of a medicine for human use that contains a controlled substance
as defined in the Controlled Drugs and Substances Act or a substance listed or
described in Schedule C or D to the Food and Drugs Act or that is a prescription
drug as defined in section A.01.010 of the Food and Drug Regulations, the
information referred to in subsection (1) shall be provided
(a) for the day on which the medicine is first sold in Canada, within 30 days
after that day; and
(b) for each six-month period beginning on January 1 and July 1 in a year,
within 30 days after the end of the period.
(3) In the case of a medicine for human use that does not contain a controlled
substance as defined in the Controlled Drugs and Substances Act or a substance
listed or described in Schedule C or D to the Food and Drugs Act or that is not a
prescription drug as defined in section A.01.010 of the Food and Drug
Regulations or in the case of a medicine for veterinary use, the information
referred to in subsection (1), for each six-month period beginning on January 1
and July 1 of each year, shall be provided to the Board within 30 days after the
day on which the Board sends a request in response to a complaint respecting
the price of the medicine and, during the two years following the request, within
30 days after the end of each six-month period.
(4) For the purposes of subparagraph (1)(f)(i),
(a) in calculating the average price per package of medicine, the actual price
after any reduction given as a promotion or in the form of rebates, discounts,
refunds, free goods, free services, gifts or any other benefit of a like nature
and after the deduction of the federal sales tax shall be used; and
(b) in calculating the net revenue from sales of each dosage form, strength
and package size in which the medicine was sold in final dosage form, the
actual revenue after any reduction in the form of rebates, discounts, refunds,
free goods, free services, gifts or any other benefit of a like nature and after
the deduction of federal sales taxes shall be used.
(5) Subject to subsection (6), this section does not apply to medicine sold by a
patentee or former patentee to a person with whom they do not deal at arm’s
length or to another patentee or former patentee.
(6) If the patentee or former patentee sells the medicine to a person with whom
they do not deal at arm’s length and who is not required to provide information
under paragraphs 80(1)(a) or (2)(a) of the Act, the patentee or former patentee
shall provide the information required under paragraph (1)(f) in respect of any
resale of the medicine by the person.
(7) For the purposes of subparagraph (1)(f)(iii), the price at which a medicine was
sold in a country other than Canada shall be expressed in the currency of that
country.
(8) For the purposes of this section, the Income Tax Act, as that Act read on
December 1, 1987, applies, with any modifications that the circumstances
require, in determining whether a patentee or former patentee is dealing at arm’s
length with another person.
(9) For the purposes of this section, publicly available ex-factory price includes
any price of a patented medicine that is agreed on by the patentee or former
patentee and the appropriate regulatory authority of the country in which the
medicine is sold by the patentee.
(10) [Repealed, SOR/2008-70, s. 4]
SOR/98-105, s. 3; SOR/2008-70, s. 4; SOR/2013-122, s. 25.
Revenues and Research and Development Expenditures 5 (1) For the purposes of subsection 88(1) of the Act, information concerning the
identity of any licensee in Canada of the patentee and the revenues and research
and development expenditures of the patentee shall indicate
(a) the name and address of the patentee and the address for
correspondence in Canada;
(b) the name and address of all licensees in Canada of the patentee;
(c) the total gross revenues from all sales in Canada during the year by the
patentee of medicine for human and veterinary use and the total revenues
received from all licensees from the sale in Canada of medicine for human
and veterinary use; and
(d) a summary of all expenditures made during the year by the patentee
towards the cost of research and development relating to medicine for human
or veterinary use carried out in Canada by or on behalf of the patentee,
including
(i) a description of the type of research and development and the name of
the person or entity that carried out the research and development,
(ii) the expenditures of the patentee or the person or entity that carried out
the research and development, in respect of each type of research and
development, and
(iii) the name of the province in which the research and development was
carried out and the expenditures in that province by the patentee or the
person or entity.
(2) The information referred to in subsection (1) shall be provided for each
calendar year and shall be submitted within 60 days after the end of each
calendar year.
(3) The total gross revenues referred to in paragraph (1)(c) shall comprise
revenues from sales of medicine
(a) for which a drug identification number has been issued under the Food and
Drug Regulations or which has been approved for sale to qualified
investigators under those Regulations;
(b) that is used in the diagnosis, treatment, mitigation or prevention of a
disease, disorder or abnormal physical state or the symptoms thereof or in the
modification of organic functions in humans or animals; and
(c) the sale of which is promoted by any means to physicians, dentists,
veterinarians, hospitals, drug retailers or wholesalers or manufacturers of
ethical pharmaceutical products.
(4) For the purposes of paragraph (1)(d), the patentee shall specify
(a) the total capital expenditures on buildings and the annual depreciation of
the buildings which depreciation shall be calculated at an annual rate of four
per cent for a maximum of 25 years;
(b) the total capital expenditures on equipment; and
(c) the source and amount of the funds for expenditures made by the patentee
towards the cost of research and development.
SOR/95-172, s. 4.
6 For the purposes of subsection 88(1) of the Act, the expression research and
development means those activities for which expenditures qualify, or would
qualify if the expenditures were made by a taxpayer in Canada, for an investment
tax credit in respect of scientific research and experimental development under
the Income Tax Act as that Act read on December 1, 1987.
General 7 (1) Every person required by these Regulations to provide information to the
Board shall do so by using the appropriate electronic document made available
on the Board’s website and by sending the completed electronic document, in its
original format and file type, to the email address specified by the Board on its
website.
(2) The electronic document shall bear the electronic signature of an authorized
individual, certifying that the information set out in the document is true and
complete.
SOR/2008-70, s. 5.
SCHEDULE
(Subparagraph 4(1)(f)(iii))
Item Country
1 France
2 Germany
3 Italy
4 Sweden
5 Switzerland
6 United Kingdom
7 United States
SOR/2008-70, s. 6.