On January 4, 2016, Rx&D formally changed its name to Innovative Medicines Canada and more recently, it updated the Code of Ethical Practices (PDF) ("Code").
The most significant changes to the new Code are encompassed in a new section 14 entitled "Patient Support Programs and Medical Practice Activities".
The new section merges aspects from the former section 14 "Patient Programs" and section 12.3 on "Member supported medical practice activities" from Section 12 (Provision of Funding) and provides a unified framework for these initiatives.
Patient Support Programs ("PSPs") are programs offered by pharmaceutical companies that aim to: (1) increase or facilitate patient understanding of a disease and/or treatment; (2) improve patient outcomes; (3) enhance patient adherence to treatment and (4) ensure or assist with access and/or reimbursement of a product. Examples include: diagnostic testing, education of patients on disease state, financial co-pay programs, provision of product when formulary reimbursement is not available via bridging / payment assistance programs, provision of product via vouchers or via compassionate use programs, financial assistance based on the patient's inability to pay, etc.
Medical Practice Activities ("MPA"s) are programs or services which contribute to improving patient health outcomes by means of a comprehensive, holistic approach to medicine. Such activities may relate to patient management practices and clinical outcomes management practices. Examples include: activities or services related to how a group medical practice manages a certain patient type with a specific disease therefore allowing the practice to close patient care gaps.
As in all sections of the Code of Ethical Practices, there is an underlying intention to preserve the pharmaceutical industry's integrity. Accordingly, the primary objective of all PSPs and MRAs should be bettering patient health outcomes and any benefit to treating healthcare professionals ("HCPs") must be incidental to this purpose (section 14.1.1).
Efforts should be made to ensure that there is no potential conflict of interest or even the perception of undue influence. For example, these programs and activities should never be offered nor provided to influence an HCP:
- As an incentive to gain access to a medical practice or hospital formulary listing;
- As an obligation or undue inducement to prescribe particular drugs;
- In exchange for recommending for use; or
- In a manner that could be construed as a gift.
It is now clear that PSPs and MRAs can only be initiated after the physicians has made the treatment decision and prescribed the specific product. All clinical decisions must remain the responsibility of the patient and the relevant HCP.
Moreover, PSPs and MRAs must not replace or duplicate tasks that are part of the HCP's general responsibilities. By the same token, such services must never be sold, distributed or included on a claim for reimbursement or other submission for payment (no double dipping).
The new Code also places greater emphasis on patient confidentiality and requires proper privacy practices with regards to data collection. It is now explicitly stated that a patient's consent must be obtained and that the patient must have the ability to opt out at any given time.
In addition to the Guidelines for Transparency in Stakeholder funding annexed to the Code, the new section 14 requires that members and third parties acting on their behalf must be engaged in transparent practices throughout the program, e.g. patients should be informed when a PSP or MRA is being provided free of charge by a pharmaceutical company
Finally, requests for support by stakeholders are now specifically addressed. Section 14 provides that in such cases, companies should carefully evaluate the request and their ability to contribute. The annotations to the Code suggest that in some cases it may be preferable to simply provide funding, rather than a PSP or MRA as this allows for an arm's length type of support.
The changes to the Code were likely brought about due to the evolution of patient programs and their increasing numbers. The new Code reflects a recognition that the pharmaceutical industry plays a vital role in supporting patient support activities and medical practice which will result in enhanced patient outcomes.
This is a good opportunity for drug manufacturers to review their PSP standard operation procedures or compliance policies.