This consolidation is unofficial and is for reference only. For the official version of the regulations, consult the original documents on file with the Registry of Regulations, or refer to the Royal Gazette Part II. Regulations are amended frequently. Please check the list of Regulations by Act to see if there are any recent amendments to these regulations filed with the Registry that are not yet included in this consolidation. Although every effort has been made to ensure the accuracy of this electronic version, the Registry of Regulations assumes no responsibility for any discrepancies that may have resulted from reformatting. This electronic version is copyright © 2011, Province of Nova Scotia, all rights reserved. It is for your personal use and may not be copied for the purposes of resale in this or any other form.
Fair Drug Pricing Regulations
made under subsections 17(2) and 31(2) and (4) of the
Fair Drug Pricing Act
S.N.S. 2011, c. 7
O.I.C. 2011-234 (June 30, 2011, effective July 1, 2011), N.S. Reg. 223/2011
Citation
1 These regulations may be cited as the Fair Drug Pricing Regulations.
Definitions
2 In these regulations,
“Act” means the Fair Drug Pricing Act;
“incentive for prompt payment” means a financial incentive given by a seller to a provider for prompt payment within 15 days or less, in an amount that equals no more than a 2% discount or equivalent incentive;
“interchangeable product” means a product in a particular strength identified by a specific product name or manufacturer and designated as interchangeable;
“manufacturer’s list price” or “MLP” means a manufacturer’s published price at which a drug or device is sold to a provider or wholesaler that does not include any mark-up for distribution;
“maximum reimbursable price” means the maximum cost for a drug established by the Minister under the Plan that is reimbursed to a provider or beneficiary for a category of interchangeable products;
“notice of compliance” means the notice of compliance issued for a drug under the Food and Drug Regulations made under the Food and Drugs Act (Canada);
“original product” means the product that holds the original notice of compliance for that product strength and form;
“product” means a drug or a combination of drugs in a single dosage form;
“professional allowance” means an advantage, in the form of money, services or educational materials, that is provided by a manufacturer to a provider for the purposes of direct patient care, including for any of the following:
(i) continuing education programs that enhance the scientific knowledge or professional skills of pharmacists,
(ii) continuing education programs for specialized pharmacy services or specialized certifications,
(iii) clinic days provided by the provider to the general public to disseminate disease or drug-related information, such as flu shot clinics, asthma clinics and diabetes management clinics,
(iv) education days provided by the provider to the general public for health protection and promotion activities and held in 1 of the following places, or a place that is generally similar to the following:
(A) the provider’s premises,
(B) a school,
(C) a long-term care facility,
(D) a community centre,
(E) a place of worship,
(F) a shopping mall,
(v) compliance packaging that assists patients with complicated medication regimens,
(vi) disease management and prevention initiatives used in the provider’s premises, such as patient information material and services, blood pressure monitoring, blood glucose meter training, asthma management and smoking cessation assistance,
(vii) private counselling areas within the provider’s premises,
(viii) clinical pharmacy services for hospital in-patients or long-term care facility patients, such as medication reconciliation initiatives or other clinical pharmacy priorities identified by the hospital or long-term care facility;
“rebate” means any rebate paid by a manufacturer to a provider other than an incentive for prompt payment, including any advantage provided in any of the following or similar forms:
(i) money,
(ii) discounts,
(iii) refunds,
(iv) trips,
(v) free goods.
Maximum price for interchangeable products
3 (1) Except as provided in subsection (2), all of the following criteria must be met for an interchangeable product to be designated, or continue to be designated, as a benefit:
(a) the cost to the provider for the product from a manufacturer or a wholesaler must not exceed the maximum as set out in the following table on and after the applicable start date:
Start Date
Maximum cost to provider for interchangeable product
July 1, 2011
45% of the MLP of the original product as of April 11, 2011
January 1, 2012
40% of the MLP of the original product as of April 11, 2011
July 1, 2012
35% of the MLP of the original product as of April 11, 2011
July 1, 2012
35% of the MLP of the original product as of the date that a notice of compliance is issued for the first product in a new category of interchangeable products
(b) the manufacturer reports any rebates and professional allowances in relation to the benefit in accordance with Section 5.
(2) An interchangeable product that does not meet the criteria in clause (1)(a) may be designated as a benefit and a different maximum cost to the provider set by the Minister if any of the following conditions apply:
(a) documentation provided by the manufacturer supports a maximum cost to provider that exceeds the percentage of the MLP of the original product as set out in the table in clause (1)(a);
(b) the interchangeable original product is no longer sold in Canada.
(3) A maximum reimbursable price must be established for each interchangeable product designated as a benefit.
Interchangeable product cost increases
4 If the cost of an interchangeable product to a provider increases, the Minister may require a manufacturer to provide documentation satisfactory to the Minister to support the increase in order to continue the product’s designation as a benefit.
Requirement to report rebates
5 (1) The Minister may require a provider to report any rebates and professional allowances received in relation to an interchangeable product designated as a benefit.
(2) The Minister may require a manufacturer to report any rebates and professional allowances provided in relation to an interchangeable product that is designated as a benefit.