Acts and Regulations

2012-61 - Prescription Drug Payment Act

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NEW BRUNSWICK
REGULATION 2012-61
under the
Prescription Drug Payment Act
(O.C. 2012-197)
Filed May 25, 2012
1Section 2 of New Brunswick Regulation 84-170 under the Prescription Drug Payment Act is amended
(a) by repealing the definition “maximum allowable price” and substituting the following:
“maximum allowable price” means the maximum allowable price determined under section 12.1;(prix maximum autorisé)
(b) by adding the following definitions in alphabetical order:
“manufacturer’s list price” means the published price at which a drug is sold to a participating provider or wholesaler, excluding any mark-up for distribution;
“notice of compliance” means the notice of compliance issued for a drug under the Food and Drug Regulations under the Food and Drugs Act (Canada);
“original product” means the product that holds the original notice of compliance in a category for a particular strength and form;
2The Regulation is amended by adding after section 12 the following:
12.1(1)Subject to subsection 12.2(2), the maximum allowable price is determined by multiplying the price per unit of the product specified by the Minister by the number of units dispensed.
12.1(2)For the purposes of subsection (1), the price per unit of a single source product is the price fixed by the Minister.
12.1(3)For the purposes of subsection (1), the price per unit of an interchangeable pharmaceutical product is the price fixed as follows:
(a) from June 1, 2012, to November 30, 2012, inclusive, 40% of the manufacturer’s list price of the original product as of April 11, 2011;
(b) on and after December 1, 2012, 35% of the manufacturer’s list price of the original product as of April 11, 2011; or
(c) if there is no interchangeable pharmaceutical product, other than the original product, with a notice of compliance on December 1, 2012, 35% of the manufacturer’s list price of the original product as of the date a notice of compliance is issued for the first product in a category of interchangeable pharmaceutical products, other than the original product.
12.2(1)For the purpose of subsection 2.1(1.1) or (1.3) of the Act and subject to subsection (2), the conditions are as follows:
(a) the manufacturer supplies a written confirmation that the interchangeable pharmaceutical product will be priced not in excess of the maximum allowable price; and
(b) the manufacturer and the wholesaler sell the interchangeable pharmaceutical product to the participating provider at a price not in excess of the maximum allowable price.
12.2(2)The Minister may vary the maximum allowable price of an interchangeable pharmaceutical product and the conditions in subsection (1) in the following circumstances:
(a) the manufacturer provides documentation which demonstrates that a different maximum allowable price should be set;
(b) the manufacturer’s list price for the original product has changed;
(c) the original product is no longer marketed in Canada;
(d) it is justified having regard to a change in market conditions; or
(e) it is justified in the public interest having regard to the safety of beneficiaries, access to the interchangeable pharmaceutical product and costs to the programme.
12.3For the purposes of paragraph 2.11(1)(a) of the Act, the information is as follows:
(a) the drug name;
(b) the strength and the dosage;
(c) the drug identification number;
(d) the name of the original product deemed equivalent to the applicant drug;
(e) the proposed drug price;
(f) the lowest price at which the drug is offered in another Canadian province or territory;
(g) whether the drug is the only available interchangeable pharmaceutical product deemed equivalent to the original product;
(h) whether the cost of producing and distributing the interchangeable pharmaceutical product exceeds the maximum allowable price; and
(i) if the cost of producing and distributing the interchangeable pharmaceutical product exceeds the maximum allowable price, the cost of the individual raw materials, the manufacture and the distribution, excluding rebates.
3Paragraph 13d) of the French version of the Regulation is amended by striking out “numéro d’ordre” and substituting “identification numérique”.
4Paragraph 14(2)i) of the French version of the Regulation is amended by striking out “numéro d’ordre” and substituting “identification numérique”.
5Section 16 of the Regulation is amended
(a) by repealing subsection (1) and substituting the following:
16(1)Subject to subsections (2) and (3), payment for an entitled service when rendered by a pharmacy is the sum of the following amounts:
(a) an amount that is equal to or less than 100% of the actual acquisition cost; and
(b) the dispensing fee prescribed in Schedule 3.
(b) by repealing subsection (2) and substituting the following:
16(2)If the entitled service rendered by a pharmacy is a single source product specified by the Minister, the payment for the service is the sum of the following amounts:
(a) an amount that is equal to or less than 100% of the maximum allowable price; and
(b) the dispensing fee prescribed in Schedule 3.
(c) by adding after subsection (2) the following:
16(3)If the entitled service rendered by a pharmacy is an interchangeable pharmaceutical product specified by the Minister, the payment for the service is the sum of the following amounts:
(a) an amount that is equal to or less than 100% of the maximum allowable price;
(b) a dispensing fee of $10.40; and
(c) 4% of the maximum allowable price to a maximum of $50.
6Section 20.3 of the Regulation is amended
(a) in subsection (1) in the portion preceding paragraph (a) by repealing “Subject to subsection (2), for the purposes of” and substituting “For the purposes of”;
(b) by repealing subsection (2).
7Section 22 of the Regulation is amended
(a) by repealing subsection (1) and substituting the following:
22(1)Subject to paragraphs (2) and (3), payment for an entitled service when rendered by a dispensing physician is the sum of the following amounts:
(a) an amount that is equal to or less than 100% of the actual acquisition cost; and
(b) 80% of the dispensing fee prescribed in Schedule 3.
(b) by repealing subsection (2) and substituting the following:
22(2)If the entitled service rendered by a dispensing physician is a single source product specified by the Minister, the payment for the service is the sum of the following amounts:
(a) an amount that is equal to or less than 100% of the maximum allowable price; and
(b) 80% of the dispensing fee prescribed in Schedule 3.
(c) by adding after subsection (2) the following:
22(3)If the entitled service rendered by a dispensing physician is an interchangeable pharmaceutical product specified by the Minister, the payment for the service is the sum of the following amounts:
(a) an amount that is equal to or less than 100% of the maximum allowable price;
(b) a dispensing fee of $8.32; and
(c) 3.2% of the maximum allowable price to a maximum of $40.
8Subsection 28(1) of the Regulation is repealed and the following is substituted:
28(1)Extemporaneous preparations that are prescribed by a physician or dentist and compounded by a pharmacist and that do not duplicate the formulation of a manufactured drug product may be determined to be entitled services under subsection 2.1(1) of the Act.
9Schedule 3 of the Regulation is repealed and the attached Schedule 3 is substituted.
10Schedule 4 of the Regulation is repealed.
11This Regulation comes into force on June 1, 2012.
SCHEDULE 3
Payment for
entitled service
by the programme
Dispensing fee
as of
June 1, 2012
$      0.00 -     99.99
$   10.40
$  100.00 -   199.99
$  12.90
$  200.00 -   499.99
$  18.00
$  500.00 -   999.99
$  23.00
$1000.00 - 1999.99
$ 63.00
$2000.00 - 2999.99
$  83.00
$3000.00 - 3999.99
$103.00
$4000.00 - 4999.99
$123.00
$5000.00 - 5999.99
$143.00
$6000.00 or over
$163.00