Navigating life sciences compliance in Singapore: advertising, patient and doctor relationships

December 2024 | EXPERT BRIEFING | SECTOR ANALYSIS

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Singapore’s life sciences industry operates within a complex regulatory framework designed to ensure the ethical promotion, distribution and use of healthcare products. Compliance is essential, particularly regarding advertising practices, interactions with patients and relationships with healthcare professionals (HCPs).

This article delves into the specific regulations governing these aspects and addresses self-regulatory codes: the Asia Pacific Medical Technology Association (APACMed) Code of Ethical Conduct and the Singapore Association of Pharmaceutical Industries (SAPI) Code.

Advertising regulations for life sciences companies in Singapore

The promotion of pharmaceuticals, medical devices and healthcare products in Singapore is strictly regulated to protect public health and ensure ethical marketing practices.

Health Products Act and Medicines Act. The Health Products Act and the Medicines Act prohibit false, misleading or unsubstantiated claims in advertisements for healthcare products. Prescription-only medicines cannot be advertised directly to the public and advertising is restricted to HCPs through approved channels.

Advertisements of prescription-only medicines directed to the general public is prohibited under regulation 7 of the Health Products (Advertisement of Specified Health Products) Regulations 2016. Advertisements of prescription-only medicines must not be made in public places.

Medicines that are not prescription only (i.e., pharmacy-only medicines and general sales list medicines or over-the-counter products) may be advertised to the general public, provided the advertisements comply with the principles and requirements under the Health Products Act and relevant regulations. In any case, advertising requires adherence to truthfulness and accuracy in all promotional materials.

Health Sciences Authority (HSA) guidelines. The HSA provides comprehensive advertising guidelines, requiring pre-approval for advertisements of certain healthcare products such as Chinese proprietary medicines, traditional medicines and homoeopathic medicines, among others. The HSA also addressed the legality of comparative advertising (i.e., comparing one product to another from a competitor) and has decided that comparative advertising is in theory permitted. The comparison is allowed but must be based on factual, scientifically valid evidence. Unfair or misleading comparisons are, however, naturally prohibited.

APACMed code of ethical conduct. The APACMed Code of Ethical Conduct provides guidance on advertising practices, particularly for medical device companies. It emphasises that promotional activities should be conducted with accuracy, integrity and respect for patient safety. Companies must avoid deceptive or misleading advertising and ensure all promotional claims are substantiated by scientific evidence.

SAPI Code. The SAPI Code also tackles the manner in which pharmaceutical companies can undertake advertising practices. In particular, promotional activities should only be conducted ethically, accurately and with integrity and respect for patient safety. Pharmaceutical companies must also avoid deceptive or misleading advertising and ensure all promotional claims are substantiated by scientific evidence.

Digital and social media marketing. With the growing use of digital marketing, companies must ensure compliance in online advertisements, including social media. Influencers or third-party endorsements must be truthful, transparent and not misleading. Companies should implement strict internal controls to monitor digital advertising content and ensure adherence to regulatory standards.

The definition of ‘advertisement’ is broad and includes all forms of advertisement in any media. This includes digital interactive platforms, social media channels and platforms and blogs. Advertisements of medicines or medical devices that are made on such social media channels or platforms are subject to the same restrictions and requirements found in the Health Products Act and relevant regulations.

Patient relationships and compliance considerations

Maintaining ethical interactions with patients is critical for life sciences companies. The regulatory environment seeks to ensure that patients receive accurate, unbiased information and are protected from undue influence.

Patient support programmes (PSPs). PSPs, such as medication adherence programmes or financial assistance initiatives, must be designed with patient welfare in mind. They should provide accurate information and not serve as disguised promotional tools. Companies must avoid inducements or incentives that could influence a patient’s choice of medication or treatment. All PSPs should be transparent about their intent and avoid any appearance of coercion or inappropriate influence.

Informed consent and data privacy. Engaging with patients requires strict compliance with the Personal Data Protection Act 2012. Companies must obtain informed consent before collecting, using or sharing personal data. Patient information collected through PSPs, clinical trials or other interactions must be handled with the highest level of confidentiality and security, ensuring compliance with data privacy regulations.

Doctor relationships and ethical compliance

The relationship between life sciences companies and HCPs is a critical area of compliance, as it influences prescribing practices and patient outcomes.

Interactions with HCPs. Companies that adhere to the SAPI Code of Conduct will follow guidance on interactions with HCPs. It emphasises transparency, integrity and avoiding undue influence. Any engagement with HCPs, whether through sponsorships, educational events or provision of gifts, must not be perceived as an inducement to prescribe, recommend or endorse specific products.

Sponsorships and educational events. Sponsoring HCPs for conferences, seminars or educational events is allowed but must be based on genuine scientific or educational value. Lavish gifts, extravagant travel or entertainment are strictly prohibited. Honoraria payments for HCPs participating in advisory boards, speaking engagements or consulting must be fair, reasonable and commensurate with the level of expertise provided.

The APACMed Code of Ethical Conduct sets out best practices for medical device companies in their interactions with HCPs. It emphasises the importance of maintaining transparency, ensuring that any transfer of value to HCPs (for example sponsorships or educational grants) is reasonable, aligned with professional standards and not intended to influence purchasing decisions. Companies should document all interactions with HCPs and ensure that these engagements are based on legitimate business or educational purposes.

Providing benefits, kickbacks or incentives to doctors in exchange for prescribing a company’s product is illegal and unethical. Compliance programmes should include clear policies prohibiting such practices. All interactions should be well-documented, and any transfer of value to HCPs (for example payments, gifts or hospitality) should be transparent and within the boundaries set by both the SAPI Code and APACMed guidelines.

Best practices for ensuring compliance in advertising, patient and doctor relationships

Implement clear internal policies and training. Establish comprehensive compliance policies that address advertising practices, patient interactions and HCP engagements. Regular training should be provided to employees to ensure they understand and adhere to these policies.

Implement an internal code of conduct that emphasises ethical behaviour and aligns with Singapore’s regulatory requirements, as well as the APACMed and SAPI Codes.

Engage with regulatory authorities and industry associations. Regularly engage with the HSA, SAPI, APACMed and other regulatory bodies to stay updated on changes in advertising regulations, patient engagement guidelines and HCP interaction standards. Participation in industry forums can help companies understand best practices and emerging trends in compliance.

Monitor and audit compliance activities. Conduct regular internal audits and monitoring of advertising campaigns, patient support programmes and HCP engagements to identify potential compliance risks. Establish a whistleblowing mechanism that allows employees to report unethical practices anonymously.

Conclusion

Compliance in advertising, patient relationships and doctor interactions is crucial for life sciences companies operating in Singapore. Adhering to regulatory requirements and maintaining ethical practices, as outlined by the APACMed Code and the SAPI Code, not only minimises legal risks but also enhances a company’s reputation and trustworthiness. By implementing robust compliance programmes, engaging with regulatory authorities and fostering transparency, life sciences companies can navigate Singapore’s regulatory landscape effectively.

Lucas Nicolet-Serra is counsel and Paris Petranis is a partner at K&L Gates. He can be contacted on +65 6713 0263 or by email: lucas.nicolet-serra@klgates.com. Mr Petranis can be contacted on +61 3 9205 2014 or by email: paris.petranis@klgates.com.

Lucas Nicolet-Serra and Paris Petranis

K&L Gates