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In brief

The Singapore Association of Pharmaceutical Industries Code of Conduct (“SAPI Code“) has been amended to provide clearer guidelines on the provision of donations and independent grants. The revisions are effective from 1 August 2021.


Key takeaways

  • Under the new Article 7.5.4, donations can be monetary or non-monetary, and on top of other pre-existing conditions should be: (a) reasonable and justified; and (b) made without any intent to benefit from such donations.
  • Under the new Article 7.5.5, the 42 SAPI-represented pharmaceutical companies (“Member Companies“) can provide independent grants to support a broader range of causes, subject to a new additional requirement that seeks to uphold accountability.

In depth

The SAPI Code has been revised to provide distinct guidelines on the provision of donations and independent grants. SAPI is an organization that represents the interests of the Member Companies, and the SAPI Code provides guidance for these Member Companies to promote high standards of ethical conduct.

While the earlier version of the SAPI Code had merged the guidelines with respect to donations and grants (previous Article 7.5.4), the revised SAPI Code deals with the provision of donations and grants separately.

The new Article 7.5.4 deals with conditions for donations and clarifies that donations may refer to “monetary, used items or product donations.” It also introduces two new requirements for providing such charitable donations:

  • They should not only be substantiated by written documentation of details of donation request (as was required previously) but should also be “reasonable and justified in the light of the activity being funded.”
  • Further, the donations should be “given without the intent to receive any benefit in exchange,” which is broader than the previous article which merely required the donations to be “unrelated to the prescribing, purchasing, registration of any products.”

The new Article 7.5.5, which now deals with independent grants separately, provides the following:

  • Member Companies can provide independent grants to “medical/scientific research, education, policy initiatives and patient advocacy related activities,” which is phrased more broadly than the previous wording under the old Article 7.5.4.
  • There is an additional requirement that the independent grants are “legitimate and reasonable … and the supporting expenses properly accounted for.”

While the SAPI Code does not have the force of law, acceptance and active observance of the code is considered mandatory for all Member Companies.

The latest version of the SAPI Code may be found here.

Author

Andy Leck is the managing principal of Baker McKenzie.Wong & Leow. Mr. Leck is recognised by the world’s leading industry and legal publications as a leader in his field. Asian Legal Business notes that he “always gives good, quick advice, [is] client-focused and has strong technical knowledge for his areas of practice”. Alongside his current role as managing principal, Mr. Leck has held several leadership positions in the Firm and externally as a leading IP practitioner. He currently serves on the International Trademark Association's Board of Directors and is a member of the Singapore Copyright Tribunal.

Author

Ren Jun is an associate principal of Baker & McKenzie.Wong & Leow. Ren Jun extensively represents local and international intellectual property-intensive clients in both contentious and non-contentious IP matters, such as anti-counterfeiting; civil and criminal litigation; commercial issues; regulatory clearance; and advertising laws. Ren Jun also advises on a wide range of issues relating to the healthcare industries. These include regulatory compliance in respect of drugs, medical devices, clinical trials, health supplements and cosmetics; product liability and recall; and anti-corruption. Ren Jun is currently a member of the Firm's Asia Pacific Healthcare ASEAN Economic Community; Product Liability and Regulatory Sub-Committees.

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