Singapore: SAPI releases guidelines for interactions with patients, caregivers and patient organisations

In brief

The Singapore Association of Pharmaceutical Industries (SAPI) has released a set of Guidelines for Interactions with Patients, Caregivers and Patient Organisations ("Guidelines"). The Guidelines provide a framework of best practices for engaging with patients, caregivers and patient organisations.


Contents

In more detail

Background

SAPI recognizes that there is global shift to a patient-centered approach in the pharmaceutical industry, where patients are getting more involved in the decision-making processes through companies' engagement with patients, caregivers and patient organisations (i.e., patient representatives).

With a view to better public health outcomes, SAPI has released the Guidelines to provide a framework of best practices to engage with patient representatives in ways that are transparent, honest and respectful.

The Guidelines apply to programs intended to provide services to improve patient and healthcare outcomes, or to ensure or assist access and/or reimbursement. Such programs cover patient support programs, patient assistance programs, and patient engagement programs. The Guidelines also apply to interactions between companies and patient representatives.

Principles of patient engagement and partnership

SAPI encourages companies conducting patient engagement activities to establish their own governance procedures and internal policies for engagements with patient representatives.

SAPI has set out a list of guiding principles that should underpin all engagement between organisations and patient representatives:

  • Purpose of patient engagement: When engaging with patient representatives, organisations should aim to empower and educate to improve healthcare outcomes, and clearly articulate the purpose and deliverables of the patient engagement. Special consideration should be given to the medical conditions of the patients involved and to prioritizing their well-being.
  • Conflicts of interest and transparency: Establishing clear internal policies and procedures for managing conflicts of interests with patient organisations is crucial. This ensures the protection of the interests of both patient organisations and patients themselves. This includes refraining from offering complimentary gifts to patient representatives and ensuring that any financial assistance provided is independent.
  • Compensation: Developing internal guidelines to ensure fair, reasonable and consistent compensation for patients is essential. Any financial support or other incentives should not be, or be perceived to be, linked to specific products or promotional activities.
  • Communication platforms: Appropriate platforms must be selected for communicating with patient representatives. These platforms should be user-friendly, accessible, and tailored to the specific medical conditions of the patients involved.
  • Sharing patient stories: Organisations must ensure that they collect written consent to record patient stories from all patient representatives. Companies should also be wary of whether sharing patient stories could be construed as advertisements or off-label messaging of prescription-only medicines, which is prohibited in Singapore.
  • Service agreements: All agreements with patient representatives for patient engagement activities should be set out clearly in written terms in an easy-to-understand manner.
  • Medical terminology: Any medical terminology used in patient engagement should be converted into a language and form easily understood by the public, especially in disease awareness advertisements.
  • Privacy and data protection: Organisations should not collect or have access to personal or medical data of patients as part of patient engagement activities. If such collection of data is necessary, organisations must ensure that they comply with the relevant data protection regulations, including the Personal Data Protection Act 2012 (e.g., collecting the minimum amount of data necessary to fulfil a legitimate need and having adequate safeguards to protect the personal data). Any consent required to be obtained from patient representatives should be tailored to the nature of the engagement.

The Guidelines complement Article 11 of the SAPI Code of Conduct on interactions with patients and patient organisations, which had been expanded on 1 January 2023. You may refer to our client alert relating to the expansion of Article 11 here

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