Regulatory compliance for life sciences advertising: Challenges and opportunities in a changing global environment

At a global level, the advertising and promotion of medical products has continued to grow. Regulatory systems are recognized as needing to adapt and reshape to keep up with the ever-changing external environment, moving beyond traditional measures focusing on manufacturer and distributor activities. The life sciences and healthcare sectors are responsive to an evolving world by incorporating evidence-based approaches into value-based market access decisions. Evidence generation may involve greater collaboration and engagement among external stakeholders to enhance patient access to new therapeutic approaches. Moreover, investments in healthcare delivery have increased due to changing demographics and heightened awareness of emerging diseases that may potentially lead to synergistic epidemics. On Thursday, March 28th, partner and head of Ropes & Gray’s European life sciences practice Lincoln Tsang discussed regulatory compliance for life sciences advertising and assessed the challenges and opportunities that can arise in a changing global environment. His discussion is based on a piece recently written for the Chambers & Partners Practice Guide on Pharmaceutical Advertising 2024 as the new Contributing Editor of this global publication.

Global growth in healthcare advertising

The global advertising and promotion of healthcare products has seen consistent growth. In 2023, the pharmaceutical sector became the second-largest spender on advertising worldwide. 

Regulatory systems are recognised as needing to adapt and reshape to keep up with the ever-changing external environment, moving beyond traditional measures focusing on manufacturer and distributor activities.

The life sciences and healthcare sectors are responding to an evolving world by incorporating evidence-based approaches into value-based market access decisions. This includes increased use of digital technology and greater collaboration among external stakeholders to enhance patient access to new therapeutic approaches.

Investments in healthcare delivery and emerging diseases

Investments in healthcare delivery have increased due to changing demographics and heightened awareness of emerging diseases. Most significantly, over the past 50 years, new infectious agents like Ebola and COVID-19, have increased and parasites and fungal pathogens are re-emerging  – possibly linked to climate change – potentially leading to synergistic epidemics.

Impact of AI and machine learning in healthcare

AI, machine learning, and patient centricity are facilitating the transition of data generation, product approval, pricing, reimbursement, and post-approval efficacy monitoring from controlled clinical trials to real-world settings. While these advancements enhance data collection, they also present novel compliance challenges. Digital transformations, such as remote patient consultations, empower patients to better manage their health, and disruptive technologies will shape the future of healthcare management.

Patient-centric approaches in disease management

Disease management has undergone a paradigm shift, with patients playing a central role in treatment pathways from early diagnosis to personalised medical interventions. Advanced healthcare technology, such as predictive analysis and machine learning, can identify patients at high risk of hospital readmission. Targeted therapies developed based on advancements in disease aetiology are marketed globally, and genomic sequencing enables personalised therapies in clinical practice.

Transparency in industry-healthcare relationships and reporting regimes

As interactions between industry, healthcare professionals, and institutions increase throughout the product lifecycle, transparency in reporting financial and non-financial benefits is being demanded. The U.S. and France are leading the way in developing reporting regimes that require the declaration and reporting of value transfers within a statutory framework.

Regulatory challenges in pharmaceutical marketing

Pharmaceutical marketing is tightly regulated, and challenges exist in providing personalised healthcare while meeting the demands of early engagement in research and development efforts. The regulatory environment is evolving to address behavioural changes, and the advertising and promotion of pharmaceutical products are unlikely to become simpler or clearer. It is crucial to reassess the ability and adaptability of regulation and regulators to embrace innovation and change.

This article is based on a piece I have written for the Chambers & Partners Practice Guide on Pharmaceutical Advertising 2024, for which I am also the new Contributing Editor. 

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