Fair Drug Pricing Regulations

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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.
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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

as amended to O.I.C. 2014-422 (October 14, 2014, effective November 1, 2014), N.S. Reg. 154/2014


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;

 

“brand reference price” means an amount set for an interchangeable product, based on the original product, by the Pan-Canadian Competitive Value Price Initiative;

Definition added: O.I.C. 2014-99, N.S. Reg. 47/2014.

 

“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;

 

“Pan-Canadian Competitive Value Price Initiative” means the initiative established by the Health Care Innovation Working Group of the Council of the Federation founded by the Premiers of the provinces and territories of Canada, to set a common reimbursement level for generic drugs in Canada and achieve greater value for publicly funded drug programs and patients;

Definition added: O.I.C. 2014-99, N.S. Reg. 47/2014.

 

“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)    except for a product specified in clause (c), the cost for a product in a solid, oral dosage form does not exceed

 

                         (i)     25% of the MLP of the original product as of April 11, 2011, or

 

                         (ii)    if there is no reference price as of April 11, 2011, 25% of the MLP of the original product as of the date the notice of compliance is issued for the first product in the category of interchangeable products;

 

                (b)    except for a product specified in clause (c), the cost for a product in non-solid dosage form does not exceed

 

                         (i)     35% of the MLP of the original product as of April 11, 2011, or

 

                         (ii)    if there is no reference price as of April 11, 2011, 35% of the MLP of the original product as of the date the notice of compliance is issued for the first product in the category of interchangeable products;

 

                (c)    for products for which prices have been negotiated by the Pan-Canadian Competitive Value Price Initiative, the cost for the product does not exceed the percentage of the brand reference price for the product established by the Pan-Canadian Competitive Value Price Initiative, effective on and after the date set out by the Pan-Canadian Competitive Value Price Initiative;

 

                (d)    the manufacturer reports any rebates and professional allowances in relation to the benefit when required to do so by the Minister under Section 5.

 

       (2)    An interchangeable product that does not meet the criteria in subsection (1) may be designated as a benefit and a different maximum cost set by the Minister if any of the following conditions apply:

 

                (a)    documentation provided by the manufacturer supports a maximum cost that exceeds the percentage of the MLP of the original product in subsection (1);

 

                (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, and the amount payable for the benefit must be published in the benefit list specified in Section 11 of the Act.

Section 3 replaced: O.I.C. 2014-422, N.S. Reg. 154/2014.


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.


 


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