Attorneys Author Comparative Legal Guide Chapter on Global Trends in Regulatory Compliance Challenges in Pharmaceutical Advertising and Promotion
An international attorney team co-authored a chapter in the International Comparative Legal Guides Pharmaceutical Advertising Laws and Regulations 2022 entitled “Global Trends in Regulatory Compliance Challenges in Advertising and Promotion.”
The chapter was co-authored by life sciences regulatory & compliance partners Lincoln Tsang and Kellie Combs, life sciences partner Katherine Wang, life sciences regulatory & compliance associates Sarah Blankstein and Daisy Bray, and life sciences international associate Alice Du.
The authors explain that pharmaceutical and healthcare product companies have invested ever-increasing amounts into advertising and promotion. Given that many products are sold globally, companies need to be aware of the differing regulatory approaches in markets where they have operations.
The rise of digital advertising and evolving healthcare practices have required companies to adapt to novel regulatory questions. As such, companies need to consider whether internal policies and processes continue to be adequate in the face of emerging compliance risks.
Reflecting on these broad trends, the authors see a number of themes emerge:
- Given the ever-increasing focus on patient engagement in policy-making and product development, care should be taken in planning for such patient engagement activities.
- Novel trial designs to study the efficacy and safety of innovative therapies may require specific arrangements for potentially eligible subjects to be referred by primary and secondary care to the specialist centers of excellence where studies are conducted. Referrals could be accompanied by financial incentives. The process of referral should be properly managed and rationalized to avoid such financial arrangements being characterized as inappropriate and unlawful.
- The COVID-19 pandemic has demonstrated that there is a fine balance between promotion and public health interests. The promotion of vaccines as ‘safe’ may have been important in reassuring the public, thus helping to tackle vaccine hesitancy, prior to the eventual roll-out. However, such wording to characterize safety prior to authorization could give rise a regulatory compliance concern.
- The disruptive rise of digital health may lead to certain novel compliance risks. For example, such technologies are often patient-facing software applications, which assist patients to treat, prevent or manage illness. Developers should be mindful of the regulatory risks of such applications, given how their products intertwine with the practice of medicine and decision-making with respect to treatment options.
- The use of social media to promote products has seen a plethora of regulatory actions. Payments to celebrity influencers for the promotion of products should be carefully managed.