Key takeaways
- The new section provides guidance to member companies on the types of activities that can be carried out involving pre-approval communications.
- The FAQ lists three categories of commonly seen activities: insight gathering, responses to unsolicited queries pertaining to pre-approval or off label use and dissemination of investigational findings or clinical data.
Background
The SAPI Code provides guidance for its member companies in marketing and promoting pharmaceutical products and serves as the basis for self-discipline in the pharmaceutical industry.
In particular, the SAPI Code provides standards to facilitate member companies' interactions with healthcare providers (HCPs), medical institutions and patient organizations (i.e., not-for-profit institutions that represent the interests and needs of patients, their families and/or caregivers). These standards ensure the ethical promotion of pharmaceutical products.
The SAPI Code is an industry code and does not strictly have the force of law (i.e., noncompliance with the SAPI Code is not in itself a breach of local regulations). The SAPI Code is only drafted for member companies' compliance. Nonetheless, the SAPI Code presents a set of industry-accepted best practices in relation to the marketing and promotion of therapeutic products, including pharmaceutical companies' interactions with HCPs.
In more detail
In the new section under the FAQs, SAPI has provided guidance on the types of commonly seen activities that member companies can carry out involving pre-approval communications. The categories are as follows:
- Insight gathering: The conduct of non-promotional activities to gain in-depth knowledge of a particular therapeutic area, disease and unmet medical needs from HCPs' perspective, including advisory boards, market research and HCP consultant services.
Member companies need to adhere to relevant regulations for these activities, as well as general principles, such as the following:
- intent and conduct should be non-promotional;
- engage the minimum number of HCPs needed with clear justifications to achieve the objectives of the activity; and
- additional care should be given to pre-approved/off-label indication discussions as these products are already available in the country and will pose a higher risk of off-label use on patients.
- Unsolicited queries pertaining to pre-approval or off-label use: Only the medical affairs teams of member companies may respond to unsolicited queries pertaining to pre-approval or off-label use.
Such responses should be non-promotional in intent, content and nature; must not include the brand name of the pre-approved product; and must be presented in a fair and balanced manner without preference to the member companies' products or data. The responses may include medical information services, a medical scientific liaison or an equivalent visit/meeting with HCPs.
- Dissemination of investigational findings or clinical data: Only the medical affairs teams of member companies may enable a full and proper exchange of scientific information concerning an unapproved therapeutic product or off-label use, including the appropriate dissemination of investigational findings in scientific or lay communications media and at scientific conferences.
Such activities should be non-promotional in intent, content and nature; must not include the brand name of the pre-approved product; and must be presented in a fair and balanced manner without preference to the member companies' products or data. The activities may take the form of international congresses held in Singapore; medical congress booths; medical satellite symposia in congresses; HCP sponsorships to attend third-party congresses; and company standalone events. These activities should comply with the relevant guidelines set out in the SAPI Code.
The latest version of the SAPI Code can be accessed here.
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