The new Pharmaceutical Advertising 2021 features 17 jurisdictions. The guide covers regulatory frameworks, advertising to the general public and healthcare professionals, transparency, inducement/anti-bribery and enforcement.
Last Updated: March 04, 2021
The decision to dedicate a practice guide to pharmaceutical advertising for yet another year (its fourth) reflects its growing importance and complexity. Pharmaceutical advertising as a practice area has in many ways outgrown itself and has come to cover much more than advertising in the strict sense of the word. This guide covers the broad variety of topics that are typically linked to pharmaceutical advertising, including transparency requirements and hospitality rules.
A year in to the global pandemic, the complexities of advertising in the digital space must also be addressed. After years of increased importance, online interactions have come to the forefront of the industry’s practice this year and will stay as a fundamental part of the advertising system going forward.
In today’s reality, where the pharmaceutical industry is under increasing government and especially public scrutiny, the rules on pharmaceutical advertising impact stakeholders in a number of important ways.
The sharing of information
The pharmaceutical industry seeks to communicate on its products or (related) services, both before and after product launch. Questions often arise, including what, and how, the industry can communicate to healthcare professionals and healthcare institutions? What, if anything, can be shared with patients and patient associations, reactively or proactively? Can digital recordings of online events be made available, or proactively be pushed to just any recipient? How can companies that are preparing for launch enter into dialogue with payers? The rules at national level can differ significantly (eg, EU vs USA), or in more subtle ways (eg, within various EU member states). Practical experience is therefore essential to navigate these rules.
Patients and healthcare professionals depend on accurate and timely information. A summary on product characteristics or a public assessment report provide important information, but that may often not be sufficient. What additional information can industry provide to healthcare professionals, proactively or upon their request? Does it matter that a product is close to commercialisation? What could be the impact of the complexity to administer the product, the risk management plan, the orphan status of the product, and so on? Who within the company can engage in that type of conversation, with which counterpart, and in which context? Good advice depends on an exceptionally good grasp of the breadth of pharmaceutical regulation.
Research and innovation
Science and innovation depends on accurate information about research, (clinical) study results, and a good understanding of the post-approval performance of medicinal products. How can industry and the scientific community co-operate? What are the limits on industry-sponsored research projects? How can industry communicate scientific advances or major scientific findings, close to authorisation? What about real-world evidence gathered after approval: can companies communicate about their findings and to whom?
Patient organisations have become more sophisticated and increasingly demand to be informed about research, especially in certain disease areas. How can industry and the patient community cooperate? How can industry communicate major scientific findings to the patient population? How can industry recruit patients for clinical trials, or inform them about early access opportunities?
The sudden and nearly instantaneous replacement of physical meetings with all sorts of virtual formats creates opportunities and challenges for the pharmaceutical sector. A quick response has been seen from the pharmaceutical trade associations to set out some common rules for online interactions. However, laws, codes and regulators are more static. This leads industry to look to general rules for digital services to navigate the fragmented national framework of advertising rules applied to online pharmaceutical advertising.
The industry has faced questions such as: which authority has jurisdiction over a promotional activity that occurs online? Are online events by definition “supra-national”? Now that scientific exchanges occur in digital rooms, are pharmaceutical companies allowed to sponsor these events? What about attendance by HCPs to these events? Is the distribution of materials -- proactively or reactively via email (or other media) allowed? And relatedly, can the industry take advantage of the transition to the online space to centralise the distribution of materials in a regional or global manner? How do internal company processes adapt to the new digital reality?
These are difficult questions that require an expert knowledge of the legislation as well as the inner workings of pharmaceutical companies. Legal advisors must also look beyond medicines legislation. In most countries, other areas of laws are also relevant, including general advertising law, commercial practices regulations and anti-bribery rules. The area also builds on a mix of laws, guidance, best practice and self-regulatory initiatives.
The following themes are common to most jurisdictions covered in this guide.
Advertising or communication
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 direct-to-consumer advertising, which is prohibited in most countries (with a few notable exceptions such as the USA and New Zealand).
As the public opinion and regulators are focusing more and more on the interactions between the pharmaceutical industry and healthcare sector stakeholders, transparency is clearly gaining importance. And yet, 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 healthcare professionals instead of 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 industry self-regulatory codes.
Transition to the Digital Space
The transition of activities to the digital space has brought about a number of industry guidance documents. In the absence of concrete rules, regulators have approached online activities from the perspective of the general principles of advertising, hospitality and inducement, adapting them to fit the online environment. Given its increased importance, this is an area where regulatory developments are expected to occur. Patient support programmes such as online patient support platforms and applications, as well as knowledge platforms for healthcare professionals continue to grow in relevance. This remains a grey area that requires careful, country-specific analysis. Further, this lack of regulatory consistency between jurisdictions creates a number of hurdles. Careful analysis of applicable rules is necessary to avoid impeding a regional or even global implementation of these kinds of programmes.
The existence of pre-vetting requirements can have an important impact on the medicines advertising landscape. Complying with pre-vetting rules can be quite burdensome and typically requires careful organisation and planning. Indeed, in some countries, like China, all advertising requires prior approval by the authorities, and the approvals must be renewed on a yearly basis. Within the EU, the rules are very different depending on the member state. In the US, pre-vetting only applies to certain types of medicinal products.
While pharmaceutical advertising is certainly not characterised by particularly high fines, enforcement in this area is quite effective, and often both private and public in nature. In some countries, like Germany, competitors tend to be the most vigorous "watchdogs", commonly bringing suits against each other, claiming damages or injunctive relief. Elsewhere, authorities or self-regulatory bodies play a more active role through fines or other measures. Avoiding reputational damage is also an important driver for compliance in this area. Some regulators (like the FDA and several EU regulators) publish information on non-compliant practices, or order companies to publish a rectification on their website or in medical journals.
An advanced and workable regulatory regime for pharmaceutical advertising plays a crucial role in building the much-needed trust by the public in the pharmaceutical sector. It can be a driver of effective and transparent collaboration between the industry and the healthcare community. It goes to the core of the industry’s reputation and continuous development. For all those reasons, it is more important than ever that practitioners are aware of the boundaries that authorities and peers expect them to live by.