The Pharmaceutical Advertising 2023 guide features 17 jurisdictions. The guide covers regulatory frameworks, advertising to the general public and healthcare professionals, transparency, inducement/anti-bribery, enforcement and advertising of veterinary medicines.
Last Updated: March 07, 2023
Welcome to the 2023 edition of the Chambers Global Practice Guide on pharmaceutical advertising.
Consistent with global trends in recent years, this sixth edition covers more than “advertising” in the strict sense. A once narrow set of rules regulating how to promote medicines to healthcare professionals (HCPs) now extends to cover a range of related areas, such as:
As the world emerges from the global pandemic, the landscape for pharmaceutical advertising and HCP interactions has fundamentally altered, in many ways permanently. Virtual or hybrid models of engagement are now the norm. This brings additional compliance challenges and regulatory scrutiny, particularly for virtual meetings and social media activities. These also carry additional uncertainty and risk, especially when online activity is accessible globally and by various stakeholders.
With the industry’s ongoing focus on rare disease and specialty medicines, interactions with HCPs, patient organisations and the wider clinical community come more sharply into focus. The opportunity to be informative and engaging comes with some complexity.
An often-made complaint from the industry over recent years is that regulators and regulations have been slow to respond to new and dynamic models of promoting and communicating about medicines. Internationally, the rules are disjointed and can be difficult to navigate in a coherent way. While many of these issues remain apparent, 2022 has seen some early signs of co-ordination, with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) collaborating on some joint guidelines.
Much of this goes to show that the regulation of pharmaceutical advertising, communications and stakeholder interactions is in a state of evolution. This underlines the importance of taking and giving clear advice; and it is hoped this edition is both timely and helpful.
Digitised Models and Challenges
Accelerated by the pandemic, virtual and hybrid interactions now pervade through almost all types of pharmaceutical companies’ engagements. This stretches from promotional activity, such as e-detailing, organising virtual meetings, attending virtual congresses and symposia, to delivering public-facing and patient-facing communications digitally.
Virtual and hybrid meetings and conferences
A recurrent question concerns the jurisdiction under which virtual meetings and congresses fall and which compliance rules apply. What is the governance framework for international online meetings? Are these events innately “supra-national”? Is there a way to make content available in compliance with international (rather than national) norms and rules? Can pharmaceutical companies provide hospitality for virtual/hybrid events? What about the publication of recordings and “live” events?
In 2022, EFPIA, IFPMA and the Pharmaceutical Research and Manufacturers of America (PhRMA) issued the Joint Guidance on Virtual and Hybrid International Medical Congresses. This represented the first meaningful attempt to find an international consensus on the regulation of international virtual meetings and has gone far in clarifying an otherwise murky area.
Thorny issues in social media
Social media is the default mode of communication for many people in the modern world. It is fast paced and highly penetrative, and the standard for many for consuming news and information. It is also a very public communication medium, where content can reach far and wide. Understandably, the pharmaceutical industry has sought to embrace social media, but in doing so it has been stung by regulatory uncertainty and a volume of enforcement activity.
In Europe, this has largely concerned breaching the prohibition against direct-to-consumer (DTC) advertising of prescription-only medicines, or pre-licence promotion. In the USA, where DTC is in principle lawful, issues have concerned interactions with influencers, and whether a social media post is accurate, balanced, truthful and non-misleading, and consistent with the approved labelling. Further complications arise when company posts are liked, shared or engaged with internationally, introducing the possibility of engaging and breaching local-market laws which may be unexpectedly restrictive.
In September 2022, EFPIA and IFPMA issued Joint Guidelines Concerning the Use of Social Media and Digital Media Channels by Pharmaceutical Companies. Although this is a helpful first step to carving out an established international framework, current approaches outside the USA remain fragmented and potentially contradictory. There is some progress, but likely more evolution to come.
Multi-channel and omni-channel HCP marketing
With increased HCP interactions, pharmaceutical companies have the benefit of increasingly sophisticated data and feedback from clinicians. This has shed light on a once homogenous audience, revealing contours and nuances. This leads to ever-more personalised content and modes of interaction, suited to what an HCP feels might help the most.
The intersection with data protection laws and regulation at an international level is fascinating, and will be an area the industry watches closely. There are also practical compliance considerations. How do you generate and review personalised content? Is it possible to maintain the traditional distinction between promotional and non-promotional communications, when all communications are “joined up”?
Multi-channel and omni-channel marketing are buzz words in the industry. The development of these concepts, in the face of a relatively old-world regulation, will be a point of focus in the coming months.
Growing Sophistication of Advertising and Communication Approaches
As the industry increasingly focuses on personalised medicine and rare diseases, advertising and communication norms are also challenged. Patients and caregiver communities are often smaller, very well-informed and calling out for engagement, updates and advocacy. Similarly, the clinical community may be more tight-knit, and well-informed.
In this environment, traditional boundaries between “patients”, “the public” and expert audiences begin to blur. Grey areas also emerge when advertising activity is focused on a small group of active, expert clinicians. This niche group may be well known to, and have already engaged with, the company – and this can often blur lines.
Many regulatory schemes in various jurisdictions have failed to keep pace with this environment; the changes being seen are often in attitudes to enforcement rather than with the rules themselves.
Advertising or information
The thin line between “advertising” and “information” is key to the communication strategy of any pharmaceutical company. Where regulators or courts draw the line often depends on subtle nuances in the content, form and context of the advertising. Depending on where the cut-off lies, online information on prescription drugs, for instance, could qualify as DTC advertising, which is prohibited in most countries (with a few notable exceptions, such as the USA and New Zealand).
As public opinion and regulators are increasingly focusing on the interactions between the pharmaceutical industry and healthcare sector stakeholders, transparency is clearly gaining importance. Nonetheless, the sophistication of transparency rules varies dramatically depending on the jurisdiction. While some countries only impose disclosure obligations on the industry, others put the burden on HCPs instead of on companies.
Furthermore, transparency rules are often not legally binding. While the US Sunshine Act has been around for several years, for instance, only a handful of EU member states have sunshine laws. Instead, in most EU member states, transparency is driven by and enforced through the industry’s self-regulatory codes.
While enforcement continues in an upward trend, the enforcement environment remains diverse and multifaceted. The USA continues to be a crucible, where the impact of committing advertising and ethical breaches can be very significant for pharmaceutical companies. Elsewhere, the environment is often less onerous, but the picture is mixed. In Germany, for example, pharmaceutical advertising controversies are settled largely through fast-paced litigation in the courts between competitors or other activist organisations. These are often the most active guardians of German advertising rules. In other countries, a system of industry self-regulation supplements (and often goes further than) the law. This system is usually the primary way of resolving advertising complaints. Although the sanctions can be relatively low-impact, the risk of reputational damage is an important driver for compliance.
As the number of complaints and enforcement cases steadily increases (significantly so in some countries), how to manage and respond to investigations and complaints has become a key consideration for legal and compliance teams. This has gone hand-in-hand with potentially vexatious complaints, or complaints brought anonymously.
An advanced and workable regulatory regime for pharmaceutical advertising plays a crucial role in building the much-needed trust of the public in the pharmaceutical sector. It can be a driver of effective and transparent collaboration between the industry and the healthcare community, and goes to the core of the industry’s reputation and continuous development. For all these reasons, it is more important than ever that practitioners are aware of the boundaries that authorities and peers expect them to live by.