THE NEWFOUNDLAND AND LABRADOR GAZETTE EXTRAORDINARY

Part II PUBLISHED BY AUTHORITY ST. JOHN'S, FRIDAY, MARCH 30, 2012 NEWFOUNDLAND AND LABRADOR REGULATION NLR 23/12

Extraordinary Gazette 3 March 30, 2012 NEWFOUNDLAND AND LABRADOR REGULATION 23/12 Interchangeable Drug Products Formulary Regulations, 2012 under the Pharmaceutical Services Act (Filed March 30, 2012) Under the authority of

section s 19 and 52 of the Pharmaceutical Services Act, I make the following regulations. Dated at St. John’s, March 30, 2012. Bruce Cooper Deputy Minister of Health and Community Services REGULATIONS Analysis 1.

Short title 2.

Definitions 3. Drug formulary 4. Submission requirements 5. Maximum price for inter- changeable products 6. Exemption 7. Pricing of drugs within categories 8. Addition to existing catego- ries 9. Review process 10. Advisory committee rec- ommendation 11. Notification of change to a drug 12. Repeal 13. Commencement 1. These regulations may be cited as the Interchangeable Drug Products Formulary Regulations, 2012. 2. In these regulations

Short title

Definitions

Interchangeable Drug Products Formulary Regulations, 2012 23/12 Extraordinary Gazette 4 March 30, 2012 (a) "Act" means the Pharmaceutical Services Act; (b) "advisory committee" means the advisory committee a p- pointed under the authority of

section 20 of the Act to advise on the contents of the formulary and other matters relating to drugs; (c) "brand price" means the price for a drug established by the brand manufacturer as recorded by the department at the time a submission for listing on the drug formulary is r e- ceived; (d) "formulary" means the drug formulary defined in par agraph 2(

h) of the Act which is established by and is on file with the minister; (e) "inventory adjustment fee" means a percentage set by the minister under the authority of

section 50 of the Act which may be included in the price which may be charged for a drug accepted to be listed in the formulary; and (f) "ultra-generic product" means a drug manufactured and packaged for a generic manufa cturer which is identical to a brand manufacturer'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. 3.

(1) The Interchangeable Drug Products Formulary is continued and is on file with the minister.

(2) A copy of the formulary is available on the departmental website and may also be obtained from the office of the minister.

(3) The prices set out in the formulary f or interchangeable drugs shall be effective for the period specified by the minister in the form u- lary. Drug formulary

Interchangeable Drug Products Formulary Regulations, 2012 23/12 Extraordinary Gazette 5 March 30, 2012 4. An applicant 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) confirmation that the drug will be sold at the maximum price established under

section 5, or where the percentage of sa v- ings is greater than required under that section, details of those savings and a guarantee of that price for the time per i- od required by the minister; (

c) the quoted price for the drug, which shall be quoted in smallest unit pricing irrespective of package size; (

d) where a Notice of Compliance from Health Canada (

i) has been issued, a copy of that notice, or (ii) has no t been issued, a copy of the Drug Notification form; (

e) confirmation satisfactory to the committee that the appli cant is able to supply the drug to meet the needs of the market for that drug throughout the entire province; (

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

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

h) a product sample for any drug contained in a device or app a- ratus for the purpose of drug delivery; (

i) where the submission r elates to an ultra -generic or cross licensed drug, confirmation of the business arrangement from the company with whom the business arrangement is in place; and Submission re- quirements

Interchangeable Drug Products Formulary Regulations, 2012 23/12 Extraordinary Gazette 6 March 30, 2012 (

j) where a drug ha s not been launched at the time of the appl i- cation, the anticipated launch date. 5.

(1) The price for a product listed in the formulary shall not ex- ceed the maximum price as set out in the following table as of the a p- plicable dates: Date Maximum Price From April 16, 2012 to September 30, 2012 45% of the brand price From October 1, 2012 to March 31, 2013 40% of the brand price From April 1, 2013 onward 35% of the brand price

(2) Where, at the coming into force of this se ction, a drug is listed on the formulary which (

a) is a sole source product; or (

b) is a generic drug for which the equivalent brand product has been discontinued, the manufacturer of that drug may, notwithstanding subsection (1), maintain the price listed in the formulary at the coming into force of this

section until July 1, 2012, but after that date shall comply with the requirements of su bsection (1) with respect to the maximum price of that drug unless an exemption is allowed under

section 6. 6.

(1) Notwithstanding subsection 5(1), an applicant may apply to the minister to have a drug included in the formulary which does not meet the pricing requirements of that subsection, and the mi nister may allow that exemption where (

a) the brand name product has been discontinued; or (

b) in the opinion of th e minister, the applicant has incurred extraordinary production, manufacturing or development costs for the drug, as demonstrable to t he satisfaction of the minister.

(2) The minister may request and the applicant shall provide the information the minister considers necessary for the purpose of evalua t- ing an application for an exemption under subsection (2). Maximum price for interchangeable products Exemption

Interchangeable Drug Products Formulary Regulations, 2012 23/12 Extraordinary Gazette 7 March 30, 2012

(3) The minister may impose conditions on a n exemption grant- ed under this section, and may limit the time period for which the e x- emption is granted.

(4) Where an application for an exemption has been approved under s ubsection ( 1), the advisory committee may consider that drug for inclusion in t he formulary provided that all other req uirements of

section 4 are met. 7.

(1) In accordance with

section 21 of the Act, the minister may establish categories of drugs which are included in the formulary and may set the price which shall be charged for drugs within a category.

(2) The price of drugs in drug categories shall be the price charged on the date specified by the minister in the formulary, or where no date is specified, as of the effective date of the formulary.

(3) The price set under subsection (1) may include an inventory adjustment fee set by the minister. 8.

(1) Notwithstanding

section 5, where a submi ssion relates to an addition to an existing category and (

a) a brand manufacturer lowers its price after the drug becomes interchangeable; or (

b) the brand drug has been discontinued, a submission received after that time shall include a price for the pro d- uct which is less than or equal to the current lowest price in that categ o- ry.

(2) Where a drug is approved for addition to an existing categ o- ry under subsection (1), it shall not be included in a supplement to the formulary but shall be added to the formulary at its next publication. 9.

(1) Where a submission for inclusion of a drug in the form ulary meets the requirements in

section 4, it shall be considered b y the advi- sory committee according to either (

a) the standard review process; or (

b) the expert review process. Pricing of drugs within categories Addition to existing categories Review process

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(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 (

c) all cross -licensed drugs where the other drug is currently listed in the formulary.

(3) Drugs (

a) not falling within paragraphs (2)(

a) to (c); or (

b) which have been reviewed under the standard review pr o- cess and about which the committee has a clinical concern shall be referred by the advisory committee for expert analysis of bio e- quivalence, bioavailability and other applicable data before the drugs may be co nsidered by the advisory committee under the exp ert 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 pr o- cess.

(5) A submission to the expert review process shall include bi o- equivalence and bioavailability studies relating to the drug that i s the subject of the submission, and any other information that the committee may require to assess the drug.

(6) In addition to the submission requirements noted in

section 4, the advisory committee shall, in assessing a drug for inclusion in the formulary, consider

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

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

c) any clinical concerns raised to or by the advisory committee; and (

d) those other matte rs which the advisory committee considers necessary in the review process. 10.

(1) Where the advisory committee has approved a drug under the standard review process or the expert review process, as appropr i- ate, the commi ttee shall recommend to the minister that the drug be included in the formulary.

(2) Where the advisory committee does not approve a drug u n- der the standard review process or the expert review process, as appr o- priate, the committee shall recommend to the minister that it not be included in the formulary. 11. Where a manufacturer makes a change to a drug listed in the formulary that requires the approval of Health Canada, the manufactu r- er, immediately after receipt of the a pproval of Health Canada, shall notify the advisory committee of the change. 12. The Interchangeable Drug Products Formulary Regulations, 2007, Newfoundland and Labrador Regulation 125/07, are r e- pealed. 13.

These regulations come into force on April 16, 2012. ©William E. Parsons, Queen's Printer Advisory committee recommendation Notification of change to a drug Repeal Commencement

11 ST. JOHN'S, FRIDAY, MARCH 30 2012 Extraordinary Gazette Index Title of Act and Subordinate Legislation CNLR or XNL Gazette made thereunder NL Reg. Amendment Date & Page No. Pharmaceutical Services Act Interchangeable Drug Products NLR 23/12 New Mar 30/12 p. 3 Formulary Regulations, 2012