Pharmaceutical Advertising 2020 features 19 jurisdictions. The guide covers regulatory frameworks, advertising to the general public and healthcare professionals, transparency, inducement/anti-bribery and enforcement.
Last Updated: March 03, 2020
We are delighted to present the third edition of Chambers’ Global Practice Guide on Pharmaceutical Advertising. The decision to dedicate a separate practice guide to this area 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.
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.
First, of course, the pharmaceutical industry that seeks to communicate on its products or (related) services, both before and after product launch. Question often arise as to what, and how, can industry communicate to healthcare professionals and healthcare institutions? What, if anything, can be shared with patients and patient associations, reactively or proactively? 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.
Second, 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? Good advice depends on an exceptionally good grasp of the breadth of pharmaceutical regulation.
Third, 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?
Answers to these questions are not only to be found in 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 five themes are common to most jurisdictions covered in this guide.
First, 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).
Second, 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.
Third, as in many other sectors, the digitalisation creates opportunities and challenges for the pharmaceutical sector. Social media, for instance, has a significant role to play. In some countries, there are specific social media regulations, sometimes specifically geared towards pharma. In others, they are currently being developed. In most jurisdictions, regulators are increasing their focus on social media platforms, even in the absence of specific rules. Progress in the digital space is also creating a surge in online patient support platforms and applications, as well as knowledge platforms for healthcare professionals - concepts that are (being) regulated to a greater or lesser degree.
Fourth, 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 organization 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.
Finally, 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.