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Singapore: SAPI releases guiding principles for patient support programs

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In brief

The Singapore Association of Pharmaceutical Industries (SAPI) has released a set of guiding principles for patient support programs (PSPs). These guiding principles provide guidance on how PSPs should be designed. 

In more detail

PSPs are activities or services offered by companies to benefit patients. These may go by different names, such as patient access programs, patient improvement programs, patient assistance programs or patient education programs. 

There are different types of PSPs, including programs aimed to increase patients’ awareness and understanding of a disease or treatment, to better patient outcomes, to improve patient adherence to treatment, or to facilitate access to and reimbursement of a product. 

SAPI has stated that when designing PSPs, companies should: 

  • Ensure that the PSP addresses a legitimate need to protect the interests of patients 
  • Establish the underlying rationale the program 
  • Clearly identify target patient groups and the eligibility criteria for the program, and ensure that the PSP is offered to all eligible individuals 
  • Ensure robust program governance and oversight from the project owner
  • Have clearly delineated roles for third party service providers if the company is partnering with external service providers / organizations 

Additionally, in carrying out PSPs, companies should not: 

  • Design  and/or use PSPs for commercial purposes that may lead to the promotion of their products 
  • Influence healthcare professionals’ prescription of medications during the early assessment and treatment stages 

As the conduct of PSPs would naturally involve patients’ personal data, companies should ensure that any collection, use, disclosure and management of such personal data are in compliance with the Singapore Personal Data Protection Act 2012. 

Companies should also consider the applicable pharmacovigilance responsibilities should there be any suspected adverse event identified during a PSP. 

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Andy Leck is a distinguished senior legal practitioner in Intellectual Property and Technology, Media and Telecommunications (TMT) matters. He is the head of the Intellectual Property and Technology (IPTech) Practice Group in Singapore, and serves as the Asia Pacific head of Baker McKenzie's TMT Industry Group. Andy is widely recognized 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 since 2018. Chambers Asia Pacific notes that Andy as "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.” Under his leadership, the TMT team in Singapore is highly regarded for its expertise in “outsourcing, cloud computing and TMT IP-related mandates” and “data privacy, compliance, technology and telecoms regulations.” Andy was appointed by the Intellectual Property Office of Singapore (IPOS) as an IP Adjudicator to hear IP disputes between 2021 and 2023. He has been an appointed member of the Singapore Copyright Tribunal since May 2010 and a mediator with the WIPO Arbitration and Mediation Center, as well as the Singapore Mediation Centre.

Author

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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