15Patient Support Programs and Medical Practice Activities

15.1DefinitionsFavoriteLoadingAdd to favorites
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  1. 15.1.1   Patient Support Programs
    “Patient Support Programs” are programs offered by Member companies for the benefit of patients. The programs aim at increasing or facilitating patient understanding of a disease and/or treatment, bettering patient outcomes or improving patient adherence to treatment. Such programs may also serve to ensure access to administration of and/or assistance with reimbursement of a product. The programs must have the objective of benefiting patients. {{1}}
  2. 15.1.2   Medical Practice Activities
    Medical Practice Activities are programs/services offered by Members to a medical practice contribute to that medical practice’s ultimate goal of bettering patient health outcomes via a comprehensive/holistic approach to medicine. The objective of these activities may be related to patient management practices, disease education, and clinical outcomes management practices but must not be related to a specific product (including its administration) nor intended to improve or manage day-to-day administrative or operational responsibilities. {{2}}

15.2General PrincipalsFavoriteLoadingAdd to favorites

  1. 15.2.1   Intent
    The Code recognizes that industry plays a vital role in fulfilling unmet needs in the healthcare system by supporting patients and medical practices for the purpose of enhanced patient outcomes and to benefit health care obtained by patients. However, these programs/services must not serve to cover day-to-day activities or resources considered part of the medical practice’s operational expenses nor should they duplicate, replace or compete with services or resources provided and funded by the existing healthcare system. Efforts should be made for the healthcare system to absorb the cost of long-term initiatives.
  2. 15.2.2   Ensure Integrity of the Industry
    When providing Patient Support Programs or support for Medical Practice Activities, the overarching principle is that the activity, whether provided by the Member directly or through a third party acting on the Member’s behalf, should not bring the industry into disrepute. Member company staff/third-party vendors must have the requisite training and expertise so as to proceed in an ethical and professional manner. In addition, all elements of these programs/services should be appropriate, reasonable, and in accordance with treatment protocol/guidelines, clinical standards and relevant Code sections.
  3. 15.2.3   Conflict of Interest
    Patients Support Programs and Medical Practices Activities should never be offered nor provided to Health Care Professionals, medical practices, patients, their agents or healthcare facilities:
    • As an incentive to gain access to a medical practice or hospital formulary listing;
    • As an obligation or undue inducement to prescribe Prescription Medicines;
    • In exchange for recommending for use; or
    • In a manner that could be construed as a gift.Members must not provide any payment or other benefit for services rendered within the context of Patient Support Programs or Medical Practice Activities, either directly or indirectly (i.e., via a third party acting on behalf of the Member), to: (i) the prescribing Health Care Professional of the patient being enrolled or participating in a Patient Support Program (“concerned patient”); or (ii) a person who is not at arm’s length from the prescribing Health Care Professional (e.g., the Health Care Professional’s agent, staff member, medical practice or an entity that is controlled in fact by the prescribing Health Care Professional or his family member, legal representative or agent) (the “General Prohibition”).Nothing in this Section 15 prevents or prohibits a Member from retaining the services of a third party or engaging their own qualified staff to provide Patient Support Programs or Medical Practice Activities. However, where a third party is retained to provide a Patient Support Program or a Medical Practice Activity, Members must ensure that the third party does not retain the services of the concerned patient’s prescribing Health Care Professional, or the prescribing Health Care Professional’s agent, staff member, medical practice or an entity that is controlled in fact by the prescribing Health Care Professional or his family member, legal representative or agent. For greater clarity, a third party may be a Health Care Professional, however such Health Care Professional must not be the concerned patient’s prescribing Health Care Professional or the prescribing Health Care Professional’s agent staff member, medical practice or an entity that is controlled in fact by the prescribing Health Care Professional or his family member, legal representative or agent.

    As an exception to the General Prohibition, Members may pay or provide financial benefit to a concerned patient’s own prescribing Health Care Professional or the Health Care Professional’s agent, staff member, medical practice or an entity that is controlled in fact by the prescribing Health Care Professional or his family member, legal representative or agent, where the concerned patient resides in a remote community and would not otherwise be able to reasonably obtain the Patient Support Program services in question.
    Patient Support Programs and Medical Practice Activities must not involve a payment or other benefit by a Member for services that are reimbursable to Health Care Professionals by the publicly-funded healthcare system.

    Members may only initiate product-specific activities for a Patient Support Program after the prescribing Health Care Professional has made the treatment decision and/or prescribed the product. All clinical decisions, which may include the selection of appropriate Prescription Medicines or the development of management plans, are the responsibility of the relevant Health Care Professional.

  4. 15.2.4   Design and Oversight
    These programs/services/ activities must be designed and approved by the Member’s head office so as to ensure proper design according to this and any other related section of this Code as well as the appropriate oversight.{{3}}

15.3StandardsFavoriteLoadingAdd to favorites

  1. 15.3.1   Objective, Timelines and Scope
    Patient Support Programs and Medical Practice Activities must have clear objectives, timelines and scope:
    • The objective must be consistent with those aims and potential outcomes described in the definitions of Subsection 15.1.
    • The timelines must be predetermined and justified by the clinical purpose.
    • Consideration must be given to the appropriate use of the prescribed product (should the program involve a specific product) and the scope of the availability of the programs/services/ activities. Members must design and offer programs/services to be intended for all eligible patients. If the program/services are to be limited in distribution, Members must consider the criteria for eligibility to ensure a fair and appropriate dissemination.
  2. 15.3.2   Privacy, Confidentiality, and Transparency
    • The privacy of the patient and the confidentiality of their personal information must be maintained at all times in accordance with applicable laws as well as industry and professional standards.
    • Transparency regarding the Member Company or any third party acting on behalf of a Member is to be maintained in all programs/services / activities provided to patients or medical practices.
    • In the case of Patient Support Programs, patients must subscribe or consent to the program, be given the opportunity to opt out of the program at any given time and be provided clear instructions on how to do so.
    • Member companies should make all reasonable efforts to encourage Health Care Professionals to be transparent with their patients regarding any financial or other material relationships with Members.
  3. 15.3.3   Data and Outcomes
    Data collected, analysed, disseminated and/or published must be done according to current scientific standards and must be unbiased and accurate.Key learnings or best practices collected from these programs/services can be used to illustrate the impact on health outcomes in scientific exchanges and promotional activities. Such findings may also be the subject of reports or other communications, provided that appropriate permissions and approvals are obtained.{{4}}

15.4Request for Support by StakeholdersFavoriteLoadingAdd to favorites

In some instances, Members may be invited or solicited by Health Care Professionals or medical practices to contribute or participate in an initiative they are leading related to patient management or clinical outcomes management. In such cases, Members are to evaluate the appropriateness of the request and their ability to contribute, whether it be by means of a financial contribution (see Section 12) or by offering a Patient Support Program or Medical Practice Activity as described in this section.{{5}}