Section 13: Patient Support Programs (PSPs)

Companies are permitted to conduct programs, with or without involvement from a patient organisation, that aim to increase patient compliance with, and positive patient health outcomes from, their prescribed medical treatment.¹

1. PSPs must be designed to address a legitimate need, and the clinical rationale for the program should be documented.
2. Any communication with a patient enrolled in a PSP should clearly identify the Company and what materials or calls the patient may receive.
3. A Company may include information about the availability of a PSP and how to enrol in such a Program as an insert in the Product package. If an enrolment form is inserted in the Product package, there is no requirement for it to be reviewed or approved by the TGA, however it must not be promotional and must comply with this Code and the Commonwealth Therapeutic Goods Legislation. A package insert enrolment form must state: “the Patient Support Program is not authorised or approved by the Australian regulator of medicines, the TGA.”
4. A Company may use individual patient data to report on whether the program delivers any improvement in compliance, for safety monitoring or to otherwise increase positive health outcomes, so long as the appropriate consents have been provided and all data is used in a de-identified manner.
5. Data from a PSP should never be used for promotional purposes.
6. Suspected Adverse Drug Reactions noted during monitoring of a PSP must be reported to the TGA in accordance with the current TGA pharmacovigilance responsibilities of medicines sponsors.

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1. #64: We have a patient support program (PSP) – how can we ethically communicate this? ↩︎