Patent Act

Marginal note:Regulations

• 101 (1) Subject to subsection (2), the Governor in Council may make regulations

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

  • (b) respecting the form and manner in which and times at which such information and documents shall be provided to the Board and imposing conditions respecting the provision of such information and documents;

  • (c) specifying a period for the purposes of subsection 80(2);

  • (d) specifying factors for the purposes of subsection 85(1) or (2), including factors relating to the introductory price of any medicine to which a patented invention, or invention protected by a certificate of supplementary protection, pertains;

  • (e) designating a Minister for the purposes of subsection 86(2) or paragraph 87(2)(a);

  • (f) defining, for the purposes of sections 88 and 89, the expression research and development;

  • (g) requiring fees to be paid before the issue of any certificate referred to in subsection 98(4) and specifying those fees or the manner of determining those fees;

  • (h) requiring or authorizing the Board to perform the duties, in addition to those provided for in this Act, that are specified in the regulations, including duties to be performed by the Board in relation to the introductory price of any medicine to which a patented invention, or invention protected by a certificate of supplementary protection, pertains; and

  • (i) conferring on the Board such powers, in addition to those provided for in this Act, as will, in the opinion of the Governor in Council, enable the Board to perform any duties required or authorized to be performed by it by any regulations made under paragraph (h).

• Marginal note:Recommendation

  (2) No regulations may be made under paragraph (1)(d), (f), (h) or (i) except on the recommendation of the Minister, made after the Minister has consulted with the provincial ministers of the Crown responsible for health and with such representatives of consumer groups and representatives of the pharmaceutical industry as the Minister considers appropriate.