Contributed By Covington & Burling LLP
Online medicines advertising: Key considerations
Digitalisation and advertising for medicines: It is a complex marriage. On the one hand, online communications have clear advantages, as they allow, among other things, real-time access to, greater volumes of and faster dissemination of information. On the other hand, online communications also create challenges, especially in the medicines advertising sphere. Precisely because of its impact, volume and speediness, online content is typically harder to control than offline content – regulators sometimes struggle to apply the medicines advertising rules to online content.
So how do the medicines advertising rules apply to online content? This brief contribution reiterates the key principle under EU law, namely that the rules that apply in an offline context also apply online (Section I). It then focuses on how the “traditional” concepts of pharma advertising apply in the online sphere, zooming in on one concrete example, namely disease-awareness websites (Section II). Finally, we discuss the difficult jurisdictional questions that multi-country websites can raise (Section III).
I. The mantra: What applies offline applies online
In the EU, most regulators take the view that what applies “offline” also applies “online”, meaning that the medicines advertising principles that apply to, say, a physical brochure, also apply in an online context.
The key principles that (also) apply to websites and that are discussed in this guide, include the following: First, various countries (including all EU countries) prohibit direct-to-consumer (“D2C”) promotion of prescription-only medicines. When using social media, companies therefore need adequate processes to establish and target the appropriate audience. While in the US, the Food and Drug Administration (FDA) allows the promotion of prescription drugs through social media, like Facebook, that is not possible in the EU. Second, pre-approval promotion is unlawful in most large jurisdictions, such as the EU and the US, regardless of whether the target audience are healthcare professionals (“HCPs”) or patients. Websites that promote investigational products not already placed on the market are therefore prohibited. Conversely, websites that provide non-promotional information on certain investigational compounds could be permissible, but the line is very thin. Third, online promotion for medicines needs to provide certain specific information on the medicine, which again varies depending on the target audience. Finally, depending on the country, certain pre-vetting requirements could apply and prior authorisation could be required by local authorities for online advertising.
II. Application of offline principles to the online sphere: “advertising” v information and disease-awareness websites
Where does information stop and “advertising” begin?
Under EU law (and a similar logic applies in the US), non-promotional information does not constitute “advertising.”
Pursuant to EU Directive 2001/83 (the “Medicines Directive”) advertising for medicines is any information “designed to promote the prescription, supply, sale or consumption of medicinal products” (Article 86). The Court of Justice of the European Union case-law has further explained that the (perceived) intention to promote is key (See MSD Case, CJEU C-316/09).
Information about medicines that is not intended to promote the product is, therefore, not “advertising” under the Medicines Directive, which contains certain express carve-outs from the scope of “advertising”, such as “factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists” or disease-awareness information. In practice, information may not fit under any of these express carve-outs. The question then often becomes whether the information forms part of a genuinely non-promotional message, sometimes referred to as forming part of a “scientific exchange.”
In the EU, the doctrine of a “scientific exchange” is not particularly well-defined as there is no express carve-out from the concept of advertising. Some national laws and self-regulatory codes do confirm; however, that their rules do not restrict or regulate scientific exchanges. For example, in the UK, the exception for scientific exchange is quite explicit: The UK Association of the British Pharmaceutical Industry Code, for instance, provides that “the legitimate exchange of medical and scientific information during the development of a medicine is not prohibited provided that any such information or activity does not constitute promotion.”
Thus, when determining whether online information on medicines is allowed, companies should never lose sight of the very basic question: Does this website/post/campaign/email constitute advertising or not? If not, then the advertising rules will not apply. The line between “advertising” and non-promotional information is often thin and depends on a variety of factors, such as the content and purpose of the message, its target audience, the role of the person disseminating the message, the scale and a reactive v proactive context, etc.
Specific example: Disease-awareness campaigns
“Disease-awareness campaigns” are an example of online communications that companies use more and more often. They illustrate just how nuanced and fact based the analysis can be under EU advertising rules.
Pursuant to Article 86(2) of the Medicines Directive, “information relating to human health or diseases” is carved out from the scope of the “advertising” rules, “provided that there is no reference, even indirect, to medicinal products.”
As a result, a website that constitutes a true “disease-awareness campaign”, which does not refer (even indirectly) to medicines, is not subject to the EU rules on advertising.
Let us apply this to a hypothetical example of a website, hosted by company X, which discusses five different treatment options for disease A. The treatment options vary depending on the mode of action. Company X has produced three medicines that correspond to three out of the five discussed modes of action. Some, but not all, of these products are approved in the EU.
To fall outside the medicines advertising rules, the disease-awareness website may not refer “even indirectly” to specific medicine(s). How strictly this applies varies between EU countries. France, for instance, is known to take a very strict stance on this. If, in our example, company X is the only company that has developed (a) product(s) with the relevant mode of action, the website may well be deemed to refer indirectly to the product. In that case, some regulators may well take the view that the website identifies a particular product and apply the advertising rules to the website.
• If the website is patient-facing:
First, as mentioned, EU law prohibits D2C promotion for prescription-only medicines. Nonetheless, EU law permits the use of patient-facing websites that intend to provide information on a particular disease but do not seek to promote a particular product, even if the disease in question is only treatable with prescription medicines. Thus, depending on the specifics of the website regarding disease A, this website could be permissible.
The key factor is what the (perceived) aim is of the website. Disease awareness is traditionally where one raises the profile of a disease and its symptoms and is, not by law but in practice, often a consumer-facing concept. In such cases, the website should not be overly sophisticated, so that it can be understood by patients. If the website goes into great scientific detail on different modes of action, for instance, regulators may question whether the purpose of the website is indeed to provide easily digestible information on a disease or, instead, to raise the profile of certain therapies with that particular mode of action – raise patients’ interest in those particular therapies.
Second, another factor is whether the product(s) is (are) identifiable, as explained above.
• If the website is HCP-facing:
First, as mentioned, EU law prohibits pre-approval promotion (regardless of target audience). Nonetheless, EU law permits HCP-facing websites that intend to educate HCPs on a particular disease but do not seek to promote a particular product, even if (some of) the treatment options are still investigational.
If the information on the various modes of action is indeed factual, balanced, accurate and does not highlight the strengths of medicines that have a particular mode of action, the information may well be considered to constitute non-promotional information. Depending on the country and the applicable rules (eg, France v UK; regulatory guidance v self-regulatory codes), the website could qualify as “health education information”, “disease-awareness information” or a form of “scientific exchange”. The terminology is not set in stone.
Second, another factor is whether the product(s) is (are) identifiable, as explained above.
Whether or not the website is HCP- or patient-facing depends primarily on the content of the messaging, but other techniques such as access blocking, HCP identification banners, language in terms and conditions, etc, may have a bearing on this. In some EU countries, access blocking or other means of HCP identification is mandatory. In other EU countries, access blocking is only one aspect in determining the target audience and/or permissibility of the website.
III. Cross-country websites: What law applies?
A website rarely stops at a country's borders. This not only adds an additional layer of complexity to online medicines advertising but also creates opportunities, as it opens the door for jurisdictional strategies. Such strategies require, however, thorough analysis and reflection. We provide some thoughts below.
Rather than take a country-by-country approach, pharmaceutical companies often use international (ie, “above country”) websites to streamline the way they present information to a global intended audience. They sometimes do this to bring the website within (or outside) reach of regulators in one particular country.
Establishing the law/regulatory code that governs a particular website and tailoring content accordingly are indeed key when creating online content on medicines. In the EU, a medicines regulatory authority will typically only seek to exert jurisdiction against a website if that site is established in that country (“country of origin”) or if it targets consumers in that particular country (“country of destination”). Satisfying either of these criteria is often sufficient for regulators to take enforcement action against the pharmaceutical company responsible for a non-compliant website.
Having an above-country website does not eliminate the risk that regulators in a particular country, inside or outside of the website’s intended audience, determine that it is within their jurisdiction. One should therefore not readily assume that placing information on an international website brings it outside a particular regulator’s reach. Depending on how that regulator applies the “country of origin” v “country of destination” principles, authorities may well decide to examine the content of the website, for instance, against local advertising codes.
Companies that host product-specific websites targeting HCPs, for instance, may be faced with similar but slightly divergent requirements between EU countries (eg, what product-specific information must that website contain, must the price be mentioned, etc). Certain companies in the market have decided to work with EU-level product websites, in conforming with EU law and the European Federation of Pharmaceutical Industries and Associations rules. While this is a sensible approach in many respects, the difficulty is that by stating that the target audience is the “EU”, some regulators could conclude that this website targets visitors in each and every EU member state. While complying with the principles of the EFPIA code might be sufficient for some authorities, it might not be where national rules are more stringent than EFPIA’s or have very specific requirements.
As a general rule, an international website should be clear as to its intended audience, contain content that is appropriate for that audience and provide factual and balanced information. Applying that rule, however, often proves to be a tricky balancing exercise.