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Product Regulation & Liability

Singapore: Revisions to the SAPI Code effective from 1 January 2023

By and 3 Mins Read

In brief

The Singapore Association of Pharmaceutical Industries Code of Conduct (SAPI Code) has been amended to include key principles when interacting with patients and patient organizations. The revisions are effective from 1 January 2023. 

Key takeaways

  • Article 11, which previously only expressly governed interactions between SAPI-represented pharmaceutical companies (Member Companies) and patient organizations, has been revised to include Member Companies’ interactions with patients.
  • The amended Article 11.1 sets out the key principles to be adhered to when interacting with patients and patient organizations.

In depth

The SAPI Code provides guidance for its Member Companies in the marketing and promotion of 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 professionals (HCPs), medical institutions, 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 previous Article 11 only expressly applied to interactions between Member Companies and patient organizations, providing that such interactions should be ethical and respect the independence of patient organizations. 

Article 11 has been expanded to also apply to Member Companies’ interactions with patients. Notably, the new Article 11.1, now titled “Key Principles”, states that all interactions with patients and patients organizations should: 

  • Generally be consistent with the standards applicable to HCPs 
  • Be conducted in full respect of medical ethical values 
  • Aim to have a positive effect on the overall healthcare system 

Interactions between Member Companies and HCPs are governed by Article 7 of the SAPI Code, which includes guidance on events, sponsorships, gifts, etc. 

Article 11.2 has also been expanded to make reference to involvement with patients, where Member Companies should ensure, when working with patients and patient organizations, that their involvement and the nature of their involvement with patients and patient organizations are clear from the outset. Moreover, Member Companies cannot require that they be the sole funder of any patient organization. 

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

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Andy Leck is the head of the Intellectual Property and Technology (IPTech) Practice Group and a member of the Dispute Resolution Practice Group in Singapore. He is a core member of Baker McKenzie's regional IP practice and also leads the Myanmar IP Practice Group. Andy is recognised by reputable global industry and legal publications as a leader in his field. He was named on "The A-List: Singapore's Top 100 lawyers" by Asia Business Law Journal 2018. In addition, Chambers Asia Pacific notes that Andy is "a well-known IP practitioner who is highlighted for his record of handling major trade mark litigation, as well as commercial exploitation of IP rights in the media and technology sectors. He's been in the industry for a long time and has always been held in high regard. He is known to be very fair and is someone you would like to be in the trenches with you during negotiations." Furthermore, Asian Legal Business acknowledges Andy as a leading practitioner in his field and notes that he “always gives good, quick advice, [is] client-focused and has strong technical knowledge for his areas of practice.” Andy was appointed by the Intellectual Property Office of Singapore (IPOS) as an IP Adjudicator to hear disputes at IPOS for a two-year term from April 2021. He has been an appointed member of the Singapore Copyright Tribunal since May 2010 and a mediator with the WIPO Arbitration and Mediation Center. He is also appointed as a Notary Public & Commissioner for Oaths in Singapore. He previously served on the International Trademark Association’s Board of Directors and was a member of the executive committee.

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Ren Jun Lim is a principal with Baker McKenzie Wong & Leow. He represents local and international clients in both contentious and non-contentious intellectual property matters. He also advises on a full range of healthcare, as well as consumer goods-related legal and regulatory issues. Ren Jun co-leads Baker McKenzie Wong & Leow's Healthcare as well as Consumer Goods & Retail industry groups. He sits on the Law Society of Singapore IP Committee and on the Executive Committee of the Association of Information Security Professionals. He is also a member of the Vaccines Working Group, Singapore Association of Pharmaceutical Industries, a member of the International Trademark Association, as well as a member of the Regulatory Affairs Professionals Association. Ren Jun is ranked in the Silver tier for Individuals: Enforcement and Litigation and Individuals: Prosecution and Strategy, and a recommended lawyer for Individuals: Transactions by WTR 1000, 2020. He is also listed in Asia IP's Best 50 IP Expert, 2020, recognised as a Rising Star by Managing IP: IP Stars, 2019 and one of Singapore's 70 most influential lawyers aged 40 and under by Singapore Business Review, 2016. Ren Jun was acknowledged by WTR 1000 as a "trademark connoisseur who boasts supplementary knowledge of regulatory issues in the consumer products industry." He was also commended by clients for being "very responsive to enquiries and with a keen eye for detail, he is extremely hands-on. His meticulous and in-depth approach to strategising is key to the excellent outcomes we enjoy."

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