Pharmaceutical Advertising 2024

Pharmaceutical Advertising: A Global Overview

As the new Contributing Editor, I am grateful to colleagues for their expert contributions to the 2024 Global Practice Guide on Pharmaceutical Advertising. They have collectively covered the latest developments of a wide range of regulatory compliance issues in their respective jurisdictions. I also would like to take the opportunity to make a few opening remarks on the global trends.

At a global level, the advertising and promotion of healthcare products has continued to grow. It has been reported that the pharmaceutical sector overtook the technology sector to become the second-largest industry for overall advertising spend in 2023. Over the last 20 years, the pharmaceutical sector alone has increased its spending on marketing by nearly 70%. As it is the largest market that permits direct-to-consumer advertising, it is not surprising that the United States accounted for almost half of global revenues in 2022; between October 2022 and January 2023, the United States spent around USD1.1 billion in advertising.

Traditionally, the control of advertising and promotion is focused on informational and persuasive activities undertaken by manufacturers and distributors, and on the effect of such activities on market conduct and behaviour regarding how medicines and healthcare products are prescribed, supplied, purchased and/or used. The legislative construct is almost universally adopted, with very few exceptions. Regulatory and enforcement agencies recognise the need to ensure that the regulatory system is relevant and up-to-date in response to the ever-changing external environments.

As a knowledge-based industry, the life sciences and healthcare sector will continue to respond to the evolving new world of cost-efficiency in research and development; challenging value-based market access; promising science and technology with significant differentiating features; continued momentum in genomic revolution in advancing the development of bespoke therapies; and the increased use of digitalised technology to facilitate targeted communication. The development and delivery of many new therapeutic approaches necessitate greater engagement between industry, healthcare professions, health institutions, payers and patients as equal partners to facilitate patient access so that patients will receive transformative innovations in a timely manner.

Considerable investments have been made towards healthcare delivery reform in response to changing demographics and increasing recognition of emerging diseases and conditions. By 2050, there will be 2 billion people around the world who are over 60 years of age. Over the last 50 years, there has been an alarming increase in the emergence of new infectious agents into the human populations – eg AIDS, Ebola, SARS, avian flu Zika and COVID-19. Known parasites and bacterial and fungal pathogens are re-emerging due to significant changes to the ecosystem that may lead to the development of synergistic epidemics.

Data generation in support of product approval, pricing and reimbursement and post-approval safety/efficacy monitoring are increasingly moving away from the conventional clinical trial setting by fully embracing alternative methodologies, thanks to the rise of AI, machine learning and patient centricity, so that data that is relevant to real-world clinical uses is collected. Such increasingly healthcare and patient-centric therapeutic approaches present unique and yet complex compliance challenges for the industry.

Digital transformation also addresses the needs of patients today to manage their health problems. Interactions are increasingly taking place digitally rather than in-person. Self-care and greater disease awareness driven by public health agencies and national health systems are at an all-time high. Disruptive technologies that will influence the future of healthcare management include mobile technologies, social media and the internet of things.

There has also been a significant paradigm shift in how diseases are managed by putting patients at the centre of the treatment pathway, which is increasingly integrated from the early diagnosis to the decision on the choice of medical interventions to optimise patient outcomes. The healthcare system is responding to the evolving trend toward integrated health management by implementing a multidisciplinary approach to healthcare.

Healthcare technology is the key to enabling a patient-centric approach. This approach could perhaps be achieved by using predictive analytics tools, powered by artificial intelligence and machine learning to help determine which patients are at the highest risk of hospital readmission. Thanks to a greater understanding of disease aetiology at a molecular level, with the arrival of a fully mapped genome, targeted therapies are being developed and marketed globally at an ever-increasing rate. These bespoke therapies stratify patients according to their likelihood of being responsive to treatment or otherwise those who would react adversely by narrowing the target population for treatment to achieve the ultimate therapeutic goal for providing right treatment, for the right patient at the right time.

Next-generation genomic sequencing testing enables a larger panel of tests to be carried out to detect certain biomarkers or gene mutations, and such precision may pave the way for personalised or individualised therapies to be prescribed and applied in clinical practice. Combination approaches of therapies and companion diagnostic tests to detect specific genetic mutations and biomarkers to maximise treatment outcomes will become the reality. But how such companion diagnostic tests are introduced will likely raise challenging compliance questions as payers may not necessarily cover and reimburse such testing approaches.

Given the increasing interaction between industry, healthcare professions and healthcare institutions at various stages of a product lifecycle and commercialisation, it is not surprising that the public and legislatures are demanding greater transparency of such relationships through statutory and non-statutory requirements for reporting financial and non-financial benefits. The purpose is to build trust and protect the health system from real and perceived conflicts of interest – ultimately, the reporting requirement is to protect the impartiality of clinical decision-making to protect patient interests.

The United States and France have led the way by introducing the so-called “Sunshine Act” for transfers of value to be declared and reported according to a statutory framework for enforcement. In many European countries, there is an increasing general trend to put the reporting requirements on a legislative footing. For example, Italy has introduced transparency legislation for direct and indirect transfers of value to be declared. The UK government is also considering a similar legislative framework to be introduced under the Health and Care Act 2022, particularly in light of the recently published Cumberlege Report, which recommends that “Medicines and medical device manufacturers should… ensure that they publish details of payments and payments in kind that they make to teaching hospitals, research institutions and individuals”.

The tight regulatory environment surrounding pharmaceutical marketing continues to be a challenge to providing value-based personalised healthcare where patients and healthcare professions are increasingly demanding earlier engagement with industry on its research and development efforts through, for example, Expert Patients Programmes. Regulators and healthcare systems are also embracing such policy initiatives, which are the manifestations of the increasing focus on self-directed support, especially in the context of chronic diseases that are very often life-threatening and debilitating. There is no evidence that the regulatory landscape for the advertising and promotion of healthcare products will become clearer or easier – on the contrary, as already explained, the changing external environments will likely render the regulatory compliance landscape more challenging.