19. Enforcement

On an annual basis, an authorized representative of each Member must confirm to Rx&D in writing that they have policies and procedures in place to facilitate ongoing compliance with the Code.

Any action found to deliberately contravene any of the Guiding Principles may be a just cause for expulsion. The BoD has discretion to determine if any other action is just cause for expulsion.

The Executive Committee shall hold a hearing when the matter is concerning a deliberate contravention of one of the Guiding Principles.

An ex-member may reapply for membership after a twenty-four (24) month period upon providing evidence of its improved compliance environment. The readmission is subject to the BoD’s approval.

The parties to the appeal shall be:

• A representative of each of the parties involved in the complaint;
• A representative of the IPRC, appointed by the President of Rx&D; and
• A panel of three adjudicators:
• To which the parties have agreed upon;
• The adjudicators must have expertise pertaining to the matter of the complaint; and
• If no agreement is reached on the choice of one or more of the three potential adjudicators within five (5) business days of the nomination of any arbitrator, the President of Rx&D shall appoint them at his/her own discretion.

The notice of appeal must be sent in writing to the IPRC, at Rx&D’s offices in Ottawa, within ten (10) business days of receipt of the IPRC’s decision.

The appeal must be heard within four (4) weeks of the nomination of the adjudication panel, or within a reasonable timeline.

The panel will render its decision when possible, no later than twenty (20) business days following the hearing.

The panel decision will be provided in writing to the parties, when possible within twenty (20) business days following the hearing.

The panel decision shall be final, and the Member in question must adhere to it as a condition of continued membership in the Association. Such decisions shall be implemented immediately, including necessary remedial action related to the violation(s).

Any costs incurred by any of the parties (Members) involved in the appeal, must be paid by them, respectively;

Cost resulting from the appointment and participation of the arbitrators’ panel will be paid by the party which loses the appeal; and

When a complaint is found to be invalid by the IPRC, the complainant will pay any cost incurred to convene the IPRC.

If no appeal is filed in the time frame described in Section 19.13.2, the IPRC’s decision will be considered final and the Member found in violation of the Code must adhere to the decision as a condition of continued membership in Rx&D.

Permanent members and one or two ad hoc members will form the IPRC:

• Two Member representatives, as appointed by the BoD;
• Two external representatives, Health Care Professionals appointed by the BoD;
• A representative as appointed by Innovative Medicines Canada’s President and
• Innovative Medicines Canada’s General Counsel.

Additional members can be:

• One individual appointed by the Rx&D President;
• One representative from Pharmaceutical Advertising Advisory Board (PAAB), as required; and/or
• One external representative from the scientific community, as required, as appointed by the IPRC.

Applicable laws

All proceedings under Section 19 shall be governed by and construed in accordance with the laws of the Provinces and Canada, without regard to principles of conflicts of law.

The IPRC usually convenes on a quarterly basis and will review the complaint and any response and decide on the validity of the complaint at the first meeting following the receipt of the complaint.

The IPRC will adjudicate the complaint during the meeting and will render a decision when the Committee is convened, if possible, or no later than twenty (20) business days following the meeting. The IPRC decision will be written and provided to the parties involved no later than three (3) business days following the decision.2

[[2]]If a potential infraction is based on one or more Guiding Principle(s), the IPRC should consult with Rx&D to obtain appropriate industry guidance on the interpretation of such principles.[[2]]

Each unique violation as determined by the IPRC shall normally count as one (1) violation. However, it is within the discretion of the IPRC for the purpose of setting penalties per Section 19.7 count any violation as two (2) violations, if it determines that such violation was a deliberate contravention. A violation will be deemed to be a deliberate contravention of the Code when it is clearly not in compliance with one or more of the Guiding Principles.

The following penalties apply to Members, which violate the Code during a twelve (12)-month calendar year:

a. Upon first violation: Publication of the infraction on the Rx&D website and a fine of $25,000;
b. Upon second violation: Publication of the infraction on the Rx&D website and a fine of $50,000;
c. Upon third violation: Publication of the infraction on the Rx&D website, a fine of $75,000, and, the Chief Executive Officer (CEO) of the Member must appear before the Rx&D Board of Directors (BoD), at which time he/she must provide a detailed explanation of the violations and a comprehensive written action plan to ensure remediation;
d. Each additional violation after a third one: Publication of the infraction on the Rx&D website and a fine of $100,000; and All postings will remain on the website for twenty-four (24) months from the date of the final decision.

Within ninety (90) days of the final decision date with respect to any Code infraction, the Member must confirm in writing to Rx&D that it has halted the activity or otherwise addressed the issue that caused the infraction. A copy of this compliance statement will be posted on the Rx&D website with the relevant decision of the IPRC.

In the event that Rx&D determines that the Member has not complied with this requirement, the Member will be deemed to have deliberately contravened one of the Guiding Principles, and the penalties set out in Section 19.7 will apply.

In exceptional circumstances, a Member, acting in good faith, may believe that more than ninety (90) days will be required to comply with this Section 19.8. In this case, the Member must file a written extension request with Rx&D within ten (10) days of the decision date, providing a detailed supporting rationale for the request, and an estimate of the time required. Rx&D will forward the extension request to the IPRC who will evaluate the extension request and make a recommendation to the Rx&D Executive Committee (EC) within ten (10) days of its receipt. The EC, in its sole discretion, may elect to grant such an extension to the Member.

In the event that any Member has five (5) or more violations in one calendar year, or has two successive calendar years with at least three violations in each calendar year: The Rx&D Executive Committee (EC) will convene and place the Member with such violations on a twelve (12)-month probationary period; probationary period to begin immediately following the EC decision. The probationary measures to be directed by the EC shall include, but may not be limited to, the following:

• CEO will provide a written and verbal update quarterly at BoD meetings for a twelve (12)-month period, beginning at the next scheduled BoD meeting, regarding remediation actions taken;
• Rx&D will communicate in writing with the CEO and Chair of the Board of the Member and its parent company, informing them of the situation;

The Member will communicate its probationary status to all Health Care Professionals, Stakeholders and Governments involved in its infractions indicating the sections of the Code violated as well as the steps the Member will be taking to ensure that they abide by the Code in the future; and

• If the Member is found in violation of the Code during its probationary period, the EC will reconvene to determine if the violation is a just cause for the following action:
• Expulsion from Rx&D. In the event that a Member is expelled from Rx&D, notice of such shall be posted on the Rx&D website.