• Introduction
• Content of Proposed Regulations
• Invitation to Provide Written Comments
• Submission of Written Comments
• Statement about Comments
• Proposed amendments to O. Reg. 201/96 under the Ontario Drug Benefit Act
• Proposed amendments to Regulation 935 under the Drug Interchangeability and Dispensing Fee Act
• Proposed Contents of Code of Conduct attached as Schedule 5 to O. Reg. 201/96 under the Ontario Drug Benefit Act and Schedule 1 to Regulation 935 under the Drug Interchangeability and Dispensing Fee Act

The Minister of Health and Long-Term Care on behalf of the Government of Ontario invites public comments on proposed regulations made under the Ontario Drug Benefit Act ("ODBA") and the Drug Interchangeability and Dispensing Fee ("DIDFA").

Amendments made to the ODBA and the DIDFA as a result of the Transparent Drug System for Patients Act, 2006 require that the Minister publish a notice on the ministry's web site concerning certain proposed regulations under the ODBA and DIDFA. The amendments require at least 30 days for public comment, after which the Minister is required to report to the Lieutenant Governor in Council, who may then finalize the regulations with or without changes.

There are a number of technical changes that are required to both O. Reg. 201/96 under the ODBA and Regulation 935 under the DIDFA as a result of amendments made to the ODBA and DIDFA, such as references to various parts of the Ontario Drug Benefit Formulary and replacing the word "Minister" with "executive officer" wherever that word appears. Such technical changes do not require public consultation, and are not outlined below; however, they will appear in the final versions of the regulation amendments.

The proposed regulations would amend O. Reg. 201/96 under the ODBA and Regulation 935 under the DIDFA in the following way.

Summary of proposed amendments to O. Reg. 201/96 under the ODBA

Certain words and phrases would be defined :

• "original product" means the original source of a drug product in a particular strength and dosage form
• "therapeutic substitution" means the substitution of a drug that contains chemically different active ingredients that are considered to be therapeutically equivalent, without authorization from a person authorized to prescribe drugs within the scope of his or her practice of a health profession.
• for greater certainty, the executive officer's power to negotiate agreements under section 1.1(2)(f) of the ODBA includes the power to enter into the agreements negotiated
• "Association" means the Ontario Pharmacists' Association
• "professional allowance" in the definition of "rebate" in the ODBA means a benefit in the form of currency, services or educational materials provided by a manufacturer to operators of pharmacies or companies that own, operate or franchise pharmacies for purposes of direct patient care that are continuing education programs, clinic days, compliance packaging for patients and certain equipment and educational materials for chronic disease management initiatives. The proposed amendments set out a formula to calculate when a professional allowance becomes a rebate. A benefit is not a professional allowance if the contents of the Code of Conduct established under the ODBA, and as set out in Schedule 5, , are not complied with.

Amendments to section 11 would :

• provide that as a condition for designating a product submitted for designation as an interchangeable product under the DIDFA as a listed drug product, the manufacturer must enter into an agreement with the executive officer, if required to do so by the executive officer, that specifies any volume discount or other amount that the manufacturer must pay. The manufacturer must agree to the publication of certain information about the agreement, such as the name of the manufacturer, the subject-matter of the agreement, the fact of entering into or terminating the agreement and the total amount of payment made to the Minister of Finance as a result of the agreement.

Amendments to section 12 would :

• revise section 12(1)(a) to permit the manufacturer of a drug product to submit its drug product for designation as a listed drug product even where Health Canada has not as yet approved the product for sale in Canada, if the manufacturer has made an application to Health Canada for approval and a panel of experts is satisfied that the product meets at least one of the criteria as set out in A, B or C of section12(1)(a)(ii).
• Such a product, however, may not be designated as a listed drug product until the executive officer receives evidence that Health Canada has approved the product for sale in Canada, a drug notification form issued by Health Canada and a copy of the product monograph approved by Health Canada, if applicable.
• set out in section 12(1)( c) that a manufacturer must provide, in its submission, an estimate of net costs to the Ontario Drug Benefit Program in a three-year period. No decision with respect to the product may be made until the estimate is submitted.
• provide in section 12(7) that if required to do so by the executive officer, the manufacturer must enter into an agreement with the executive officer that specifies any volume discount or other amount that the manufacturer must pay. The manufacturer must agree to the publication of certain information about the agreement, such as the name of the manufacturer, the subject-matter of the agreement, the fact of entering into or terminating the agreement and the total amount of payment made to the Minister of Finance as a result of the agreement.
• clarify that anything submitted to the Minister under this section before October 1, 2006 shall be deemed to have been submitted to the executive officer and any authorization given to the Minister shall be deemed to have been given to the executive officer.

Amendments to section 12.0.1 would :

• repeal the requirement that the manufacturer must enter into a written agreement with the Minister that sets out net costs to the Province in the three year period following the day the product is designated in relation to the proposed drug product, if listed, or a group of listed drug products that includes the listed drug product and replace it with a transitional provision that clarifies that an agreement that was entered into under section 12.0.1 as it existed before October 1, 2006, continues in force until it expires according to its terms.

Amendments to section 12.1 would revise the conditions that must be met in order for a designated listed drug product to continue to be designated as such by :

• deleting the requirement that a manufacturer must continue to be a party to a written agreement that sets out net costs to the Province during subsequent three year periods in relation to the listed drug product or a group of listed drug products that includes the listed drug product.
• providing that if the product has been designated as interchangeable under the DIDFA, the drug benefit price of the product may not be more than the price that could be proposed to the executive officer under section 12.
• requiring the manufacturer to enter into and remain a party to an agreement with the executive officer, if required to do so by the executive officer, that specifies any volume discount or other amount that the manufacturer must pay. The manufacturer must agree to the publication of certain information about the agreement, such as the name of the manufacturer, the subject-matter of the agreement, the fact of entering into or terminating the agreement and the total amount of payment made to the Minister of Finance as a result of the agreement.

Amendments to section 13 would :

• change the mark-up on the drug benefit price of a listed drug product from 10 per cent to 8 per cent.
• repeal the dispensing fee payable to a pharmacy operated in a public hospital for dispensing a listed drug product for an eligible person.
• revise the dispensing fee for a listed drug product from $6.54 to $7.00.

Amendments to section 14 would :

• repeal references to price reduction and value of any free goods or benefits and consequences for delay in payment of more than 120 days after the delivery of the listed drug product.

Amendments to section 15 would :

• provide that the drug benefit price of a drug for which there is not a listed drug product, and to which the executive officer has made the Act apply under section 16 of the ODBA, shall be the price agreed to by the manufacturer and the executive officer.
• clarify that the amount that the executive officer shall pay for a claim pertaining to section 16 is as determined in section 6 of the ODBA and, if applicable, includes a compounding fee determined by the executive officer under section 17(2) of the ODBA.

A new Schedule 5 setting out the Code of Conduct that would :

• set out fundamental principles
• outline what professional allowances may not be used for
• outline the criteria for the calculation of professional allowances
• govern the conduct of manufacturers' and pharmacy representatives
• set out reporting requirements

The proposed amending regulation provides that all changes to O. Reg. 201/96 come into force on October 1, 2006, except for the definition of "original product" which comes into force on April 1, 2007.

Summary of proposed amendments to Regulation 935 under the DIDFA

Certain words and phrases would be defined :

• "original product" is revised to mean the original source of a drug product in a particular strength and dosage form. This amendment would come into force on April 1, 2007.
• "therapeutic substitution" means the substitution of a drug that contains chemically different active ingredients that are considered to be therapeutically equivalent, without authorization from a person authorized to prescribe drugs within the scope of his or her practice of a health profession.
• "professional allowance" in the definition of "rebate" in the DIDFA means a benefit in the form of currency, services or educational materials provided by a manufacturer to operators of pharmacies or companies that own, operate or franchise pharmacies for purposes of direct patient care that are continuing education programs, clinic days, compliance packaging for patients and certain equipment and educational materials for chronic disease management initiatives. A benefit is not a professional allowance if the contents of the Code of Conduct established under the ODBA, and as set out in Schedule 1, are not complied with. The proposed contents of the Code of Content are set out in this Notice.

Amendments to section 6 would :

• revise section 6(1)(d) to clarify that where the manufacturer is making a submission for designation of a product as interchangeable with others for the purposes of listing the product on the Ontario Drug Benefit Formulary as a benefit, the manufacturer must submit a proposed drug benefit price; otherwise, the manufacturer must submit a proposed manufacturer's list price for the purpose of having a product designated as interchangeable with others, but not a benefit. This revision would come into force on April 1, 2007.
• revise section 6(1)(e) to clarify that where the manufacturer is making a submission for designation of a product as interchangeable with others for the purposes of listing the product on the Ontario Drug Benefit Formulary as a benefit, the manufacturer must submit evidence that the manufacturer is able to supply the product at the proposed drug benefit price in a quantity sufficient to meet the anticipated demand for the product. This revision would come into force on April 1, 2007.
• clarify that anything submitted to the Minister under this section before October 1, 2006 shall be deemed to have been submitted to the executive officer and any authorization given to the Minister shall be deemed to have been given to the executive officer.

Amendments to section 7 would :

• clarify that additional conditions with respect to the price of an interchangeable product as set out in section 7 are only for those products proposed to be designated as a listed drug product under the ODBA.
• where the product is to be designated as a listed drug product under the ODBA, require the manufacturer to enter into an agreement with the executive officer, if required to do so by the executive officer, that specifies any volume discount or other amount that the manufacturer must pay. The manufacturer must agree to the publication of certain information about the agreement, such as the name of the manufacturer, the subject-matter of the agreement, the fact of entering into or terminating the agreement and the total amount of payment made to the Minister of Finance by the manufacturer as a result of the agreement.

Amendments to section 8 would :

• provide that in the conditions for a product to continue to be designated as interchangeable, the requirement that the manufacturer of the product must continue to be able to supply the product at the drug benefit price in a quantity that is sufficient to meet the demand for the product applies only with respect to those interchangeable products that are designated as listed drug products under the ODBA. This clarification would come into force on April 1, 2007.
• stipulate that if the product and the original product are listed drug products under the ODBA, the drug benefit price of the product may not be more than the price that could be proposed to the executive officer under section 7 (2).
• require the manufacturer of the interchangeable product to give the executive officer notice of every change in the manufacturer's list price for the drug product, if the drug product has not been designated as a listed drug product under the ODBA. This amendment would come into force on April 1, 2007.

A new Schedule 1 setting out the Code of Conduct that would :

• set out fundamental principles
• outline what professional allowances may not be used for
• outline the criteria for the calculation of professional allowances
• govern the conduct of manufacturers' and pharmacy representatives
• set out reporting requirements

The amending regulation provides that all changes to Regulation 935 come into force on October 1, 2006, except for those that pertain to off-Formulary interchangeability which come into force on April 1, 2007.

Interested parties are invited to provide written comments on the proposed regulations on or before Wednesday August 23, 2006 ("comment period.")

When preparing your response, please consider whether you agree with the proposed amendments to O. Reg. 201/96 under the ODBA and the Regulation 935 under the DIDFA, whether they should be changed and provide any other relevant comments you think might be useful. Please be as specific as possible and provide a full rationale for any suggested changes or additions.

Please submit your written comments to :

Helen Stevenson
Executive Lead, Drug System Secretariat
Ontario Ministry of Health and Long-Term Care
11^th Floor, Hepburn Block
80 Grosvenor Street
Toronto, Ontario
M7A 1R3
Fax : (416) 327-4404
E-mail : helen.stevenson@moh.gov.on.ca

All comments and submissions received during the comment period will be considered during the preparation of the final regulations. Comments and submissions received after the comment period will not be considered. The content, structure and form of the proposed regulations are subject to change as a result of the comment process in the discretion of the Lieutenant Governor in Council, who has the final decision on the contents of any regulations.

Copies of the Transparent Drug System for Patients Act, 2006, the ODBA, the DIDFA, O. Reg. 201/96 under the ODBA and Reg. 935 under the DIDFA are available from Publications Ontario, 50 Grosvenor St., Toronto, Ontario, M7A 1N8, (416) 326-5300.
The Transparent Drug System for Patients Act, 2006 is also available on the Legislative Assembly website at www.ontla.ca. The ODBA, the DIDFA and their regulations are also available from www.e-laws.gov.on.ca. Additional information about the Transparent Drug System for Patients Act, 2006 is available on the ministry's website at www.health.gov.on.ca.

Final contents of regulations amending O. Reg. 201/96 under the ODBA and Regulation 935 under the DIDFA would be published in the Ontario Gazette at www.ontariogazette.gov.on.ca and on e-laws at www.e-laws.gov.on.ca.

Please note that unless requested and agreed otherwise by the ministry, all materials or comments received from organizations in response to this Notice will be considered public information and may be used and disclosed by the ministry to assist in evaluating and revising the proposed regulations. This may involve disclosing materials or comments, or summaries of them, to other interested parties during and after the request for public comment process.

An individual who provides materials or comments and who indicates an affiliation with an organization will be considered to have submitted those comments or materials on behalf of the organization so identified.

Materials or comments received from individuals who do not indicate an affiliation with an organization will not be considered public information unless expressly stated otherwise by the individual. However, the ministry may use and disclose materials or comments provided by individuals to assist the ministry in evaluating and revising the proposed regulations. The ministry will not disclose personal information of those who do not specify an organizational affiliation, such as an individual's name and contact details, without the individual's consent unless required by law.

If you have any questions about the collection of this information, you can contact the ministry's Freedom of Information and Privacy Coordinator at (416) 327-7040.

The Honourable George Smitherman
Minister of Health and Long-Term Care

Subsection 1 (1) of the Regulation is amended as of April 1, 2007, by adding the following definition :

"original product" means the original source of a drug product in a particular strength and dosage form;

Subsections 1 (1.1), (1.2), (2), (3), (4) and (7) of the Regulation are revoked and the following substituted :

  (2)  For the purposes of subsection 1 (2) of the Act,

"therapeutic substitution" means the substitution of a drug that contains chemically different active ingredients that are considered to be therapeutically equivalent, without authorization from a person authorized to prescribe drugs within the scope of his or her practice of a health profession.

  (3)  For greater clarity, the power of the executive officer under clause 1.1 (2) (f) of the Act to negotiate agreements includes the power to enter into such agreements that have been negotiated.

  (4)  For the purposes of section 1.4 of the Act, "Association" means the Ontario Pharmacists' Association.

  (5)  For the purposes of section 11.5 of the Act, "professional allowance", in the definition of "rebate", means, subject to subsection (6) and (7) , a benefit, in the form of currency, services or educational materials that are provided by a manufacturer to operators of pharmacies or companies that own, operate or franchise pharmacies for the purposes of direct patient care as set out in paragraphs 1 to 4 :

1. Continuing education programs that enhance the scientific knowledge or professional skills of pharmacists and that are held in Ontario.
2. Clinic days to disseminate disease or drug-related information to the general public, and that are held in their pharmacy.
3. Compliance packaging that assists their patients with complicated medication regimes.
4. Equipment and educational materials for chronic disease management initiatives such as patient information material, blood pressure monitoring, blood glucose meter training and asthma management, used in their pharmacy.

  (6)   Where the value of all of the benefits provided for in subsection (5) exceeds, with respect to all of a manufacturer's listed drug products, the value of X in the formula below, then the benefits are a rebate and not a professional allowance :

X = 20% of (P-V)

where,

"X" is the total dollar amount of professional allowances that may be provided by a manufacturer;

"P" is the total dollar amount of a manufacturer's drug products reimbursed under the Act based on the number of units reimbursed at each product's drug benefit or reimbursement price;

"V" is the total dollar value of any volume discount or any other amount of payment that was made to the Minister of Finance under an agreement entered into under this Regulation or a regulation made under the Drug Interchangeability and Dispensing Fee Act for those products reflected in P.

  (7)   A benefit is not a professional allowance if the contents of the Code of Conduct established under subsection 11.5 (15) of the Act, and as set out in Schedule 5, are not complied with.

Section 11 of the Regulation is amended by adding the following paragraph :

5. If required by the executive officer, the manufacturer of the product shall enter into an agreement with the executive officer that specifies any volume discount or other amount that may be payable by the manufacturer to the Minister of Finance, and shall agree that the executive officer may make public the following information :
   1. the name of the manufacturer,
   2. the subject-matter of the agreement,
   3. the fact of entering into or terminating the agreement,
   4. the total amount of payment made to the Minister of Finance by the manufacturer as a result of the agreement.

Clause 12 (1) (a) of the Regulation is revoked and the following substituted :

  (a)  either,

1. evidence that Health Canada has approved the product for sale in Canada, a copy of the product's drug notification form issued by Health Canada and, subject to subsection (2), a copy of the product monograph approved by Health Canada, or
2. evidence that an application has been made to Health Canada to approve the product for sale in Canada, and evidence satisfactory to a panel of experts established for the purpose that the product meets at least one of the following criteria :
   1. the product is a new chemical entity that is effective for the treatment of an immediately life-threatening disease or other serious disease for which it offers substantial improvements on significant outcomes, including improved efficacy, safety and tolerability and quality of life over other available drug therapies in Canada, or for which no treatment or no other effective drug therapy is currently available in Canada,
   2. the product is a new chemical entity that if designated as a listed drug product, would have the effect of saving or creating efficiencies for the Government of Ontario, an average of at least $2,500,000 per year for the first three years the product is marketed in Ontario,
   3. the product is a new chemical entity that would have, if designated as a listed drug product, the effect of saving the Ontario Drug Benefit Program an average of at least $250,000 per year for the first three years the product is marketed in Ontario.

Subsection 12 (1) of the Regulation is amended by adding the following clause :

  (c)  an estimate of the net costs to the Ontario Drug Benefit Program in a three-year;

Section 12 of the Regulation is amended by adding the following subsections :

  (7)  If required by the executive officer, the manufacturer of the product shall enter into an agreement with the executive officer that specifies any volume discount or other amount that may be payable by the manufacturer to the Minister of Finance, and shall agree that the executive officer may make public the following information :

1. The name of the manufacturer,
2. The subject-matter of the agreement,
3. The fact of the entering into or terminating the agreement,
4. The total amount of payment made to the Minister of Finance as a result of the agreement.

  (8)   Despite subclause (1) (a) (ii), but subject to subsection (6), a product may not be designated as a listed drug product until evidence that satisfies subclause (1) (a) (i) is also received.

  (9)  Anything submitted to the Minister under this section before October 1, 2006 shall be deemed to have been submitted to the executive officer, and any authorization given to the Minister shall be deemed to have been given to the executive officer, but where a decision on designation has not been made before October 1, 2006 and the estimate required by clause (1) (c) has not been submitted, a decision shall not be made until the estimate is submitted.

  (10)  In clause (1)(a),

"Government of Ontario" includes all ministries of the Government of Ontario, all programs and agencies funded by the Government of Ontario and all agencies that are established by Ontario statute or regulation but are not necessarily funded by the Government of Ontario

Section 12.0.1 of the Regulation is revoked and the following substituted :

  12.0.1   An agreement that was entered into under this section as it existed before October 1, 2006 continues in force until it expires according to its terms.

Section 12.1 of the Regulation is revoked and the following substituted :

CONDITIONS TO CONTINUE TO BE A DESIGNATED LISTED DRUG PRODUCT

  12.1  The following conditions must be met in order for a designated listed drug product to continue to be designated as a listed drug product:

1. The manufacturer of the product shall give the executive officer notice of any change made to the product, including a formulation change, and of any change in the ownership of the manufacturer.
2. The product must be authorized for sale under the Food and Drugs Act (Canada).
3. The manufacturer of the product must continue to be able to supply the product at the drug benefit price in a quantity that is sufficient to meet the demand for the product.
4. Where the manufacturer was a party to an agreement to which this paragraph, as it read before October 1, 2006, applied, the manufacturer shall continue to be a party to that agreement until it expires according to its terms.
5. If the product has been designated as interchangeable under the Drug Interchangeability and Dispensing Fee Act, the drug benefit price of the product may not be more than the price that could be proposed to the executive officer under section 12.
6. If required by the executive officer, the manufacturer of the product shall enter into an agreement with the executive officer that specifies any volume discount or other amount that may be payable by the manufacturer to the Minister of Finance, and shall agree that the executive officer may make public the following information :
   1. the name of the manufacturer,
   2. the subject-matter of the agreement,
   3. the fact of entering into or terminating of the agreement,
   4. the total amount of payment made to the Minister of Finance as a result of the agreement.

Subsection 13 (2) of the Regulation is amended by striking out "10 per cent" and substituting "8 per cent".

Subsection 13 (3) of the Regulation is revoked.

Subsection 13 (4) of the Regulation is amended by striking out "$6.54" at the end and substituting "$7.00".

Subsections 14 (2) and (3) of the Regulation are revoked and the following substituted :

  (2)  The amount payable referred to in clause (1) (a) shall be the full amount payable for a shipment or order of a listed drug product less any amount charged for shipping and handling of the listed drug product.

Sections 15 of the Regulation is revoked and the following substituted :

15.  (1)  The drug benefit price of a drug for which there is not a listed drug product and to which the executive officer has made the Act apply under section 16 of the Act shall be the price agreed to by the manufacturer and the executive officer.

15.  (2)  The amount that the executive officer shall pay under subsection (1) shall be the amount as determined in section 6 of the Act and, if applicable, includes a compounding fee determined by the executive officer under subsection 17(2).

The Regulation is amended by adding Schedule 5 (see below).

The amendments, except for subsection 1(1), come into force on October 1, 2006. Subsection 1(1) comes into force on April 1, 2007.

The definition of "original product" in subsection 1 (1) of Regulation 935 of the Revised Regulations of Ontario, 1990 is revoked as of April 1, 2007 and the following substituted :

"original product" means the original source of a drug product in a particular strength and dosage form;

Section 2 of the Regulation is revoked as of October 1, 2006 and the following substituted :

(2)  For the purposes of subsection 1 (2) of the Act,

"therapeutic substitution" means the substitution of a drug that contains chemically different active ingredients that are considered to be therapeutically equivalent, without authorization from a person authorized to prescribe drugs within the scope of his or her practice of a health profession.

  2. (1)  For the purposes of section 12.1 of the Act,

"professional allowance", in the definition of "rebate", means, subject to subsection (2), a benefit, in the form of currency, services or educational materials that are provided by a manufacturer to operators of pharmacies or companies that own, operate or franchise pharmacies for the purposes of direct patient care as set out in paragraphs 1 to 4 :

1. Continuing education programs that enhance the scientific knowledge or professional skills of pharmacists and that are held in Ontario.
2. Clinic days to disseminate disease or drug-related information to the general public, and that are held in their pharmacy.
3. Compliance packaging that assists their patients with complicated medication regimes.
4. Equipment and educational materials for chronic disease management initiatives such as patient information material, blood pressure monitoring, blood glucose meter training and asthma management, used in their pharmacy.

(2)  A benefit is not a professional allowance if the contents of the Code of Conduct established under subsection 11.5 (15) of the Ontario Drug Benefit Act, and as set out in Schedule 1, are not complied with.

(d)  the proposed drug benefit price of the product, where it is proposed that the product be designated as a listed drug product under the Ontario Drug Benefit Act, and a proposed manufacturer's list price where it is not proposed that the product be so designated;

(e)  evidence that the manufacturer is able to supply the product at the proposed drug benefit price in a quantity sufficient to meet the anticipated demand for the product where it is proposed that the product be designated as a listed drug product under the Ontario Drug Benefit Act;

Section 6 of the Regulation is amended as of October 1, 2006 by adding the following subsection :

(8)  Anything submitted to the Minister under this section before October 1, 2006 shall be deemed to have been submitted to the executive officer, and any authorization given to the Minister shall be deemed to have been given to the executive officer.

Subsection 7 (1) of the Regulation is amended as of October 1, 2006 by adding "where it is proposed that the product be designated as a listed drug product under the Ontario Drug Benefit Act" at the end.

Subsection 7 (2) of the Regulation is amended as of October 1, 2006 by adding the following paragraph :

5. Where the product is to be designated as a listed product under the Ontario Drug Benefit Act, and if required by the executive officer, the manufacturer of the product shall enter into an agreement with the executive officer that specifies any volume discount or other amount that may be payable by the manufacturer to the Minister of Finance, and shall agree that the executive officer may make public the following information :
   1. the name of the manufacturer,
   2. the subject-matter of the agreement,
   3. the fact of entering into or terminating the agreement,
   4. the total amount of payment made to the Minister of Finance as a result of the agreement.

Paragraph 3 of section 8 of the Regulation is amended as of April 1, 2007 by adding "where it is proposed that the product be designated as a listed drug product under the Ontario Drug Benefit Act" at the end.

Section 8 of the Regulation is amended as of October 1, 2006 by adding the following paragraph :

4. If the product and the original product are listed drug products under the Ontario Drug Benefit Act, the drug benefit price of the product may not be more than the price that could be proposed to the executive officer under subsection 7 (2).

Section 8 of the Regulation is amended as of April 1, 2007 by adding the following paragraph :

5. If the drug product has not been designated as a listed drug product under the Ontario Drug Benefit Act, the manufacturer of the product shall give the executive officer notice of every change in the manufacturer's list price for the drug product.

The Regulation is amended as of October 1, 2006 by adding the following Schedule 1 (see below).

SCHEDULE
CODE OF CONDUCT

The Code of Conduct is intended to establish system-wide guidance governing the use of professional allowances to be paid by manufacturers to operators of pharmacies, or companies that own, operate or franchise pharmacies, or to their directors, officers, employees or agents.

Where the term "representative" is used in this Code of Conduct, it means an officer, director, employee, or agent.

FUNDAMENTAL PRINCIPLES

1. Payments from manufacturers to operators of pharmacies, or companies that own, operate or franchise pharmacies, including their directors, officers, employees or agents, in the form of a professional allowance must be used for any or all of programs, materials or continuing education for pharmacists that directly benefit patients.
2. All persons involved in the drug distribution system must operate transparently. To act transparently, manufacturers, operators of pharmacies, or companies that own, operate or franchise pharmacies, including their directors, officers, employees or agents must make the executive officer and other stakeholders knowledgeable of, and fully understand, the flow of funds in the drug products supply chain. This includes recording and reporting all such payments as required by the executive officer, and being subject to audit by the Ministry or a third party.
3. All suppliers of drug products as well as operators of pharmacies, or companies that own, operate or franchise pharmacies, including their directors, officers, employees or agents, must commit to abide by this Code of Conduct. Any breach of the Code will be subject to enforcement as set out in the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act.

USE OF PROFESSIONAL ALLOWANCES

Operators of pharmacies or companies that own, operate or franchise pharmacies may use professional allowances. Programs and information contained in educational materials must be full, factual and without intent to mislead.

Professional allowances may not be used for :

• advertising or promotional materials, such as store flyers
• entertainment, social and sporting events
• meals and travel not directly associated with a program funded by a defined professional allowance
• financial incentives
• seminars and conventions held outside of Ontario
• convention displays
• non-cash gifts provided to operators of pharmacies, or companies that own, operate or franchise pharmacies, including their directors, officers, employees or agents
• staff wages and benefits
• packaging costs, delivery services, dispensing fees
• rent or taxes
• prescription product listing fees

Professional allowances are to be calculated based on the following criteria :

1. Reasonable costs to provide direct patient care as set out in paragraphs 1 to 4 of the definition of "professional allowance".
2. Reasonable frequency to provide these services.
3. A reasonable number of patients per pharmacy.

MANUFACTURERS' REPRESENTATIVES

Manufacturers' representatives shall conduct business ethically and in a manner that is in the best interest of patients.

Any information provided by manufacturers' representatives, whether printed or verbal, must be full, factual and without misrepresentation.

Manufacturers shall be held responsible for the behaviour of their representatives.

PHARMACY REPRESENTATIVES

Pharmacy representatives shall conduct business ethically and in a manner that is in the best interest of their patients.

Procurement and purchasing decisions of pharmacies must not be influenced by the provision of professional allowances. Such influence would be considered a conflict of interest.

REPORTING

Manufacturers will report to the executive officer the amount of professional allowance paid to each operator of a pharmacy, or company that owns, operates or franchises pharmacies, including their directors, officers, employees or agents, in as much detail as is required by the executive officer and on a quarterly basis. The report must be signed by two officers of the manufacturer.

Operators of pharmacies, or companies that own, operate or franchise pharmacies will report to the executive officer the amount of professional allowance received from each manufacturer in as much detail as is required by the executive officer and on a quarterly basis. The report must be signed by two officers of the operator of the pharmacy, or company that owns, operates or franchises pharmacies.