NEWFOUNDLAND AND LABRADOR REGULATION 43/08

NLR 125/07

1. (1) Section 2 of the Interchangeable Drug Products Formulary Regulations, 2007 is amended by adding immediately after paragraph (a) the following:

(a.1) "advisory committee" means the advisory committee appointed under the authority of section 20 of the Act to advise on the contents of the formulary and other matters relating to drugs;

(2) Section 2 of the regulations is amended by adding immediately after paragraph (b) the following:

(b.1) "innovator price" means the price for a drug established by the innovator as recorded by the department at the time the submission is received, minus 8.5%;

(3) Section 2 of the regulations is amended by deleting the word "and" at the end of paragraph (c), by deleting the period at the end of paragraph (d) and substituting a semi-colon and the word "and" and by adding immediately after that paragraph the following:

(e) "ultra-generic product" means a drug manufactured and packaged for a generic manufacturer which is identical to an innovator's product in every way, including its production, except for

(i) identifying markings,

(ii) product labelling,

(iii) the name of the manufacturer, and

(iv) the product trade name.

2. Section 3 of the regulations is amended by adding immediately after subsection (3) the following:

(4) A drug in injectible formulation shall not be included in the formulary.

3. The regulations are amended by adding immediately after section 3 the following:

Participating manufacturer

3.1 (1) A drug manufacturer, to be eligible to make submissions for its product to be included in the formulary, shall be approved by the minister as a participating manufacturer.

(2) Where the advisory committee considers that

(a) a drug manufacturer has not fulfilled the requirements contained in subsection (3) to the satisfaction of the advisory committee in order to be designated as a participating manufacturer, it shall not recommend that designation to the minister; or

(b) a drug manufacturer has fulfilled the requirements contained in subsection (3) to the satisfaction of the advisory committee in order to be designated as a participating manufacturer, it shall recommend that designation to the minister.

(3) A drug manufacturer, to be recommended by the advisory committee as a participating manufacturer, shall

(a) demonstrate that it is currently conducting business in the province;

(b) have the ability to provide the drug to all retail pharmacies in the province;

(d) provide any other information required by the advisory committee.

Submission requirements

3.2 (1) A participating manufacturer shall provide the following before the advisory committee will consider its submission for a drug to be included in the formulary:

(a) a list of the applicable Health Canada guidance documents on the assessment of bioavailability and bioequivalence of the drug;

(b) details of the percent savings versus the innovator's product, which shall be a minimum of 25% less than the innovator price;

(d) confirmation of the manufacturer's ability to supply the drug to the provincial market;

(e) consent from the manufacturer permitting the province to contact Health Canada and other federal, provincial or territorial departments or agencies for additional information where necessary;

(f) a completed request for generic drug substitution in the form prescribed by the minister;

(g) a product sample for any drug contained in a device or apparatus for the purpose of drug delivery;

(h) where the submission relates to an ultra-generic or cross licensed drug, confirmation of the arrangement from the company with whom the arrangement is in place; and

(i) the quoted price for the drug, which shall be

(i) equal or less than the best available price required by section 23 of the Act, and

(ii) quoted in smallest unit pricing irrespective of package size.

(2) Notwithstanding paragraph (1)(b), where a submission relates to an addition to existing categories where an innovator lowers its price after the drug becomes interchangeable, a submission received after that time shall include a price for the product which is less than or equal to the current lowest price in that category.

(3) Where a drug is approved for addition to an existing category under subsection (2), it shall not be included in a supplement to the formulary but shall be added to the formulary at its next publication.

Review process

3.3 (1) Where a submission for inclusion of a drug in the formulary meets the requirements in section 3.2, it shall be considered by the advisory committee according to either

(a) the standard review process; or

(b) the expert review process.

(2) The standard review process shall be employed for

(a) drugs with a Health Canada Declaration of Equivalence to a Canadian reference product;

(b) all ultra-generic drugs; and

(3) Drugs

(a) not falling within paragraphs (2)(a) to (c); or

(b) which have been reviewed under the standard review process and about which the committee has a clinical concern

shall be referred by the advisory committee for expert analysis of bioequivalence, bioavailability and other applicable data before the drugs may be considered by the advisory committee under the expert review process.

(4) The expert review process shall be employed for completed submissions for

(a) drugs without a Health Canada Declaration of Equivalence to a Canadian reference product; or

(b) any drug which has been reviewed under the standard review process about which the advisory committee has concerns and requires a further review under the expert review process.

(5) A submission to the expert review process shall include bioequivalence and bioavailability studies relating to the drug that is the subject of the submission.

(6) In addition to the submission requirements noted in section 3.2, the advisory committee shall, in assessing a drug for inclusion in the formulary, consider

(a) the definition of interchangeable drug products as set out in the Act;

(b) whether the drug is of consistent satisfactory quality and safety;

(d) those other matters which the advisory committee considers necessary in the review process.

Advisory committee recommendation

3.4 (1) Where the advisory committee has approved a drug under the standard review process or the expert review process, as appropriate, the committee shall recommend to the minister that the drug be included in the formulary.

(2) Where the advisory committee does not approve a drug under the standard review process or the expert review process, as appropriate, the committee shall recommend to the minister that it not be included in the formulary.

Notification of change to a drug

3.5 Where a drug manufacturer makes a change to a drug listed in the formulary that requires the approval of Health Canada, the manufacturer, immediately after receipt of the approval of Health Canada, shall notify the advisory committee of the change.