The Pharmaceutical Advertising guide provides expert legal commentary on key issues for businesses. The guide covers the important developments in the most significant jurisdictions.
Last Updated October 16, 2017
Peter Bogaert is a managing partner of the Brussels office, and has a broad European life sciences practice. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert's practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he represents numerous innovative life sciences companies, including start-ups, as well as several industry associations.
Charlotte Ryckman assists clients across a complex range of regulatory, legal and procedural matters. Her practice focuses on the European Union rules and on the laws in key EU Member States, including Belgium and The Netherlands. Ms. Ryckman has experience in assisting pharmaceutical and medical device companies in a variety of life science regulatory matters. She also advises international companies on data privacy matters such as data breaches and international transfers. Ms. Ryckman has been involved in representing some of these companies in high-profile litigation matters in Belgium.
Covington & Burling LLP (Brussels) offers one of the largest and most comprehensive life sciences industry-focused practices in the world. Our clients, spanning all industry sectors and ranging from startup ventures to multinational corporations and trade associations, trust us with their most challenging business problems. They know that they can rely on Covington for practical, efficient solutions rooted in a sophisticated knowledge of their business that only comes from deep immersion in the industry and decades of dedicated service.
We are delighted to present the first 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 regulatory 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 aspires to cover 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 regulatory framework of pharmaceutical advertising has become fundamentally important.
Important for the pharmaceutical industry, which seeks to communicate on its products or services, both before and after product launch. Where do the boundaries lie? What can industry communicate to healthcare professionals? What information and data can be shared with patients and patient associations? How can companies that are preparing for launch enter into dialogue with payers?
Important for patients and healthcare professionals, who depend heavily on accurate and timely information. In this digitalised era information is more accessible than ever, creating obvious opportunities but also making it increasingly hard to separate the wheat from the chaff.
Important for continuous scientific progress, which thrives on accurate information about research, (clinical) study results, and the post-approval performance of medicinal products. How can industry and the scientific community cooperate? What are the limits on industry-sponsored research projects? What about real-world evidence gathered before or after approval: can companies communicate about their findings and to whom? What standards apply to the use of real-world evidence in a more commercial setting?
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 is also built on an exciting mix of laws, guidance, best practices, and self-regulatory initiatives. More so than in many other regulated fields, self-regulatory initiatives are a driving force for regulation. The legal value of these initiatives, however, varies significantly.
The following five themes are common to most if not all jurisdictions covered in this guide.
First, the delicate delineation between ‘advertising’ and ‘information’ is key to the communication strategy of any pharmaceutical company, but is often very difficult to draw with precision. Where regulators or courts draw the line often depends on subtle nuances in the content and context of the advertising -- as well as a general feeling of appropriateness. 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 U.S. and New Zealand).
Second, as the public opinion and regulators are focusing more and more on the interactions between the pharma 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 U.S. Sunshine Act has been around for several years, for instance, only a handful of EU Member States have sunshine laws. A recent example is Belgium, where the legislation entered into force a few months before this guide was published.
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 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 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 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 U.S., 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 suit against each other, claiming injunctive relief and damages. 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.