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Bill C-363

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2nd Session, 35th Parliament,
45 Elizabeth II, 1996-97

The House of Commons of Canada

BILL C-363

An Act to amend the Patent Act (investigations regarding the making of medicines available at no charge to the seriously ill)

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

      Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:

1. The Patent Act is amended by adding the following after section 90:

Investigations regarding the Making of Medicines Available at No Charge to the Seriously Ill

90.01 In sections 90.02 to 90.1,

``medicine''
« médicament »

``medicine'' includes

      (a) a drug that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug,

      (b) a drug that is a combination of two or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined in that drug for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug, or

      (c) a drug, with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration or duration of action, and that has not been sold for that use or condition of use in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug;

``seriously ill person''
« personne gravement malade »

``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.

Information on patented medicines

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

    (a) the identity of the medicines for which the patentee of an invention pertaining to a medicine held a patent at any time during the preceding year;

    (b) the conditions under which the patentee of an invention pertaining to a medicine has made medicines available in Canada during the preceding year at no charge for the treatment of seriously ill persons and the quantities of the medicines so made available;

    (c) where applicable, the reasons why the patentee of an invention pertaining to a medicine has not made a medicine available; and

    (d) any other related matters.

Powers of the Board

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).

Compliance with order

(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.

Investigations by Board

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.

Report to the Minister

(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).

Contents of report

(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.

Comments and represen-
tations

(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.

Tabling the report

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.

Investigation by Board at a patient's request

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.

Rejection of request

(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.

Investigations by the Board

90.07 (1) On receiving a request under subsection 90.06(1), the Board shall forthwith

    (a) cause a copy of the request to be forwarded to the patentee referred to in the request and shall ensure that the name of the person making the request is omitted from the copy; and

    (b) investigate the patentee or any other person it considers appropriate with a view to determining whether the patentee has made fair and reasonable efforts to make available during the current year in Canada for the treatment of seriously ill persons the medicine referred to in the request.

Information on the patented medicine

(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

    (a) the conditions under which the patentee made available for the treatment of seriously ill persons during the current year the medicine referred to in the request and the quantity of medicines so made available;

    (b) where applicable, the reasons why the patentee did not make the medicine available; and

    (c) any other related matters.

Report to the Minister

(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).

Contents of report

(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

    (a) disclose the identify of the patentee referred to in the report; and

    (b) omit the name of the person making the request.

Comments and represen-
tations

(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.

Tabling of the report

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.

Offence

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.

Limitation period

(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.

Separate offence

(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.

Duties of the Minister

90.1 The Minister shall

    (a) establish information programs for patentees of inventions pertaining to medicines to ensure their better understanding of the contents and aims of sections 90.01 to 90.09;

    (b) undertake or sponsor research related to the aims of sections 90.01 to 90.09;

    (c) take whatever steps the Minister believes are indicated to promote the aims of sections 90.01 to 90.09; and

    (d) establish programs to honour patentees of inventions pertaining to medicines who have distinguished themselves by making available in Canada at no charge for the treatment of seriously ill persons any medicine for which they hold or have held the patent.

2. Paragraph 101(1)(a) of the Act is replaced by the following:

    (a) specifying the information and documents that shall be provided to the Board under subsection 80(1) or (2) or 88(1), section 90.02 or subsection 90.07(2) ;

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