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"Point in Time" Regulation Content

Pharmaceutical Services Act

Drug Price Regulation

B.C. Reg. 344/2012

NOTE: Links below go to regulation content as it was prior to the changes made on the effective date. (PIT covers changes made from September 19, 2009 to "current to" date of the regulation.)
SECTIONEFFECTIVE DATE
Section 1 April 1, 2017
April 1, 2019
Section 3 April 1, 2019
Section 3.01 April 1, 2019
Section 3.1 April 1, 2017
April 1, 2019
Section 4 April 1, 2014
April 1, 2019
Section 5 April 1, 2014
April 1, 2019
Section 6 January 1, 2016
Section 14 April 1, 2017
April 1, 2019
Section 15 April 1, 2017
April 1, 2019
Section 17 March 1, 2014
January 29, 2016
Part 4 April 1, 2017

 Section 1 (1) definitions "designation period" and "exclusive generic drug" were added by BC Reg 266/2016, effective April 1, 2017.

 Section 1 (1) definitions "designation period" and "exclusive generic drug" BEFORE repealed by BC Reg 22/2019, effective April 1, 2019.

"designation period" means the specified period for which a generic drug is designated as an exclusive generic drug for an LCA category;

"exclusive generic drug" means the generic drug designated under section 3.1 (1) as the exclusive generic drug for an LCA category;

 Section 1 (1) definition of "generic drug inclusion or exclusion" was added by BC Reg 22/2019, effective April 1, 2019.

 Section 1 (1) definition of "manufacturer's list price" BEFORE amended by BC Reg 22/2019, effective April 1, 2019.

"manufacturer's list price" means the price per unit of a drug, as provided by a manufacturer to the minister in the manner and at the time required by the minister;

 Section 3 (2) (d) was added by BC Reg 22/2019, effective April 1, 2019.

 Section 3.01 was enacted by BC Reg 22/2019, effective April 1, 2019.

 Section 3.1 was enacted by BC Reg 266/2016, effective April 1, 2017.

 Section 3.1 BEFORE repealed by BC Reg 22/2019, effective April 1, 2019.

Exclusive generic drug in low cost alternative category

3.1   (1) For the purposes of the LCA program, the minister may, for a specified period, designate one generic drug as the exclusive generic drug for an LCA category if all of the following apply:

(a) all of the generic drugs in the LCA category are provisional drugs;

(b) the manufacturer's list price for the exclusive generic drug is equal to or less than the maximum accepted list price for drugs in the LCA category;

(c) the minister is of the opinion that there will be a sufficient supply of the exclusive generic drug for the entire designation period.

(2) The minister may not specify a designation period, for an exclusive generic drug, that exceeds 12 months.

(3) If the minister designates a generic drug as the exclusive generic drug for an LCA category, the minister must immediately cancel a determination, made under section 3 (1) (b), to include any other generic drug in the LCA category.

(4) A cancellation under subsection (3) may be made without notice to anyone or an opportunity to be heard.

[en. B.C. Reg. 266/2016, Sch. 2, s. 2.]

 Section 4 (2) (a) BEFORE amended by BC Reg 344/2012, effective April 1, 2014.

(a) for an LCA category consisting of drugs available as oral solids only, 25%;

 Section 4 (2) BEFORE amended by BC Reg 22/2019, effective April 1, 2019.

(2) Except as set out in subsections (3) and (4), the maximum accepted list price for drugs in an LCA category is the following percentage of the manufacturer's list price, as of the date on which a generic drug is first assigned to the LCA category, for the LCA drug comparator for that LCA category:

(a) for an LCA category consisting of drugs available as oral solids only, 20%;

(b) for any other LCA category, 35%.

 Section 4 (2.1) was added by BC Reg 22/2019, effective April 1, 2019.

 Section 5 (2) (a) BEFORE amended by BC Reg 344/2012, effective April 1, 2014.

(a) if the LCA category consists of drugs available as oral solids only, 25% of the base price set out in Column 2 of the Schedule opposite the LCA category, and

 Section 5 (2) BEFORE amended by BC Reg 22/2019, effective April 1, 2019.

(2) Except as set out in subsection (3), the maximum accepted list price for drugs in an LCA category listed in Column 1 of the Schedule is,

(a) if the LCA category consists of drugs available as oral solids only, 20% of the base price set out in Column 2 of the Schedule opposite the LCA category, and

(b) for any other LCA category, 35% of the base price set out in Column 2 of the Schedule opposite that LCA category.

 Section 5 (4) (b) BEFORE amended by BC Reg 22/2019, effective April 1, 2019.

(b) for the purposes of section 4 (2), the date on which a generic drug is first assigned to the LCA category is deemed to be the date on which the minister deems the LCA category to have been established.

 Section 6 (1) BEFORE amended by BC Reg 255/2015, effective January 1, 2016.

(1) The following are reference drug categories for the purposes of the reference drug program:

(a) angiotensin converting enzyme inhibitors;

(b) dihydropyridine calcium channel blockers;

(c) histamine 2 receptor antagonists;

(d) oral nitrates;

(e) non-steroidal anti-inflammatory drugs.

 Section 14 (1) BEFORE amended by BC Reg 266/2016, effective April 1, 2017.

Designation of provisional drugs

14   (1) The minister may designate a generic drug as a provisional drug if any of the following apply:

 Section 14 (1.1) was added by BC Reg 266/2016, effective April 1, 2017.

 Section 14 (2) BEFORE amended by BC Reg 266/2016, effective April 1, 2017.

(2) The minister may cancel a designation made under this section at any time without notice to anyone or an opportunity to be heard.

 Section 14 (3) BEFORE amended by BC Reg 266/2016, effective April 1, 2017.

(3) If a drug's designation as a provisional drug is cancelled under subsection (2), the minister must not list the drug on a formulary before the next April 1, unless section 16 [temporary listing of drugs] applies.

 Section 14 (1.1) (a) BEFORE repealed by BC Reg 22/2019, effective April 1, 2019.

(a) if the minister has designated, under section 3.1 (1), an exclusive generic drug for an LCA category, the minister must immediately cancel a designation made under this section in respect of any other generic drug assigned to the LCA category;

 Section 14 (3) BEFORE repealed by BC Reg 22/2019, effective April 1, 2019.

(3) If, under subsection (1.1) (a), the minister cancels the designation of a drug that has been assigned to an LCA category, the minister must not list the drug on a formulary during the designation period.

 Section 15 (3) BEFORE amended by BC Reg 266/2016, effective April 1, 2017.

(3) If a drug's listing is refused or cancelled under subsection (2), the minister must not list the drug on a formulary before the next April 1, unless section 16 [temporary listing of drugs] applies.

 Section 15 (3) BEFORE repealed by BC Reg 22/2019, effective April 1, 2019.

(3) During the designation period, the minister must refuse to list on a formulary a drug described in subsection (1) that would be assigned to an LCA category if the minister has designated, under section 3.1 (1), an exclusive generic drug for the LCA category.

 Section 17 BEFORE amended by BC Reg 344/2012, effective March 1, 2014.

 Manufacturers to sell at new prices

17  On or after March 1, 2013, a manufacturer must not sell a generic drug that is subject to the LCA program to suppliers or providers at a price higher than what the manufacturer's list price for the drug is or will be as of April 1, 2013.

 Section 17 BEFORE amended by BC Reg 10/2016, effective January 29, 2016.

Manufacturers to sell at new prices

17   On or after March 1, 2014, a manufacturer must not sell a generic drug that is subject to the LCA program to suppliers or providers at a price higher than what the manufacturer's list price for the drug is or will be as of April 1, 2014.

[am. B.C. Reg. 344/2012, s. (c).]

 Part 4 BEFORE repealed by BC Reg 266/2016, effective April 1, 2017.

Part 4 — Sale of Drugs by Manufacturers

Manufacturers to sell at new prices

17   On or after March 1, 2016, a manufacturer must not sell a generic drug that is subject to the LCA program to suppliers or providers at a price higher than what the manufacturer's list price for the drug is or will be as of April 1, 2016.

[am. B.C. Regs. 344/2012, s. (c); 10/2016.]