Rules on the promotion of prescription medicinal products
Laws, regulation, and codes -– that we will henceforth refer to as rules — set boundaries for pharmaceutical company communication — including education and marketing activities aimed at HCPs primarily, and more cursory and indirectly, aimed at the public, and patients. Examples include IFPMA, EFPIA, EU Directive 2001/83/EC, FDA Code of Federal Regulations Title 21, PhRMA Codes, “Ethical Criteria for Medicinal Drug Promotion” by WHO, ABPI 2021 Code of Practice (UK),ENLI (DK), Code de la Santé Publique (FRA), HWG (DE).[i]
In our experience, even though the rules hold significant resemblance in many areas, interpretation varies between legal, regulatory & compliance departments of pharmaceutical and biotech companies, regulatory bodies and across various governmental institutions, at local and international levels.
Furthermore, the high speed of digital transformation has created use cases that could not have been fathomed at the inception of the respective codes. Thus, pending updates, within the digital area, the range of interpretations is even greater than for the traditional channels where practices are well established. This creates uncertainty amidst a risk-averse culture within the Marketing, Communication and Medical departments of the pharmaceutical companies when developing and distributing content to healthcare stakeholders. This has also led to the establishment of internal company practices in the absence of specific rules via codes or laws. These practices represent a continuation of the general ethical principles of the company in case and the ethos expressed in the codes. Such practices are referred to as common practices in what follows, and thus are different to rules.
Vertic is continuously consulted about what can and cannot be done within the existing rules as per our experiences. The questions arise as Vertic conducts omnichannel strategies, tactics development and traffic driving, often in the context of a product launch. This article includes examples of some of the typical ingredients in omnichannel strategies & executions and interpretation of the relevant rules. Uncertainty and grey areas in terms of communication and marketing compliance significantly hamper the evolution of digital in healthcare. These foundational evolutionary stages have previously been described in the article “Stages of courage to excel in digital pharma marketing”.
Included in this article are our observations and best conclusions based on working in the industry with omnichannel marketing for the last 15 years, rather than a formal legal opinion. Obviously, such legal expertise resides with law firms, courts, and legal departments, whereas the Vertic POV is based on experience with over 100 omnichannel projects in the healthcare industry and drawing from the discussions and decisions as part of carrying out these projects.
ENLI (Denmark) and Blue Guide (UK) are most often referenced as they are both specific and detailed as regards digital.
Public & Patient communication
Prescription Product content
The pharmaceutical marketing compliance discourse focuses mainly on marketing to HCPs. This is because the rules on prescription product promotion to the public leave less room for interpretation. Prescription drug product promotion is NOT allowed to the public across the world, the US and New Zealand being the notable exceptions.
Example from Directive2004/27/EC of the European Parliament and of the Council of 31 March 200
Still, patients- that is, members of the public who have been prescribed a given drug can receive product related information directly from the pharmaceutical company, provided that the content is not considered promotional, or advertising. This typically takes the form of a patient leaflet and/or patient support program — focused on adherence, providing education on the treatment, and often parceled with help on addressing the psycho-social impact of suffering from and being treated for a serious, often chronic disease.
Common practice is gating this type of patient content, either through a soft gate — such as a pop-up disclaimer- or a hard gate through user registration and verification for access. Verification for a hard gate can take many forms such as a unique code provided by an HCP on prescription, a batch number on the medication package, a code placed as an insert as part of the drug wrapping or access via a public health platform or insurance company. However, because the content is non-promotional, rules do not specifically stipulate a gate for this type of non-promotional content even though it contains prescription drug mentions and instructions. The reason for hard gating is often to facilitate ongoing and personalized communication (email, SMS notification) and to efficiently gather data for improving the service to ascertain better health outcomes.
Prescription Product content
There is a dichotomy between promotional marketing and educational & disease awareness towards Healthcare Professionals. Promotional content specifically mentions a product or refers to a specific treatment and content which is most often developed by the Commercial part of a pharmaceutical company. Most rules focus on harnessing the use of promotional content.
Across rules, it is a universal requirement that the marketing of a medicinal product should be complete, objective and must not exaggerate or mislead as regards the properties of the product. Also, the content in the promotional material must be in accordance with the approved SMPC/SPC. The approved license should always be a clearly visible element in the material, as a starting point, no matter the format — poster, infographic, banner, webpage, detailer, email and similar. Any claims should be substantiated by a valid reference which across rules almost unanimously refers to a study or analysis which has been peer-reviewed and published in an established, independent journal. However, some countries and jurisdictions allow references based on Abstracts, Data on File, Registry data, Real world data (RWE) and similar.
A medicinal product must not be promoted prior to achieving marketing authorization. [iii] However, regarding pre-launch, medical departments may provide education referencing scientific studies of an investigational compound and thus potentially upcoming drug in most jurisdictions until phase 3 study results[iv]. After approval and marketing authorization, education including (balanced) mentioning of the product, can resume. At the same time, the Commercial part of the healthcare organization can start the promotion of the drug.
The infamous balancing act of selling and “doing good” as phrased by IFPMA (2019)
Notoriously, EU Directive 2001/83/EC (article 97) Section 20.01. and the EFPIA Code of Practice 2019 stipulate that pharmaceutical companies holding an authorization must have a formalized process for internal approval of information regarding the medicinal product. Most companies have separate processes for content originating in Commercial versus Medical.
Disease awareness aimed at HCPs
The difference between disease awareness campaigns aimed at patients and those aimed at HCPs, is that for HCPs it is permitted to link from non-product content such as Burden of Disease, Burden of Treatment to promotional material of a specific treatment. It is assumed that evidence and referencing are provided, and authorization has been granted (as always).
However, often the permissibility is questioned in terms of linking from a non-branded traffic driver, as an example, a Linkedin Sponsored Update, to disease awareness content on a site that also hosts promotional material. The underlying reason is most often insufficient documentation regarding HCP verification accuracy and targeting precision, when the platform in case, is not for HCPs only.
Omnichannel use cases
Here is a selection of typical examples of use cases and related questions on marketing compliance that emerge as a part of defining and executing an omnichannel strategy — often in the context of (pre)-launch.
Can local traffic drivers lead to a global/regional product/promotional website?
This is permitted provided that the content on the global website complies with local regulations of the country in which HCPs are targeted — global denominator content if you will. It is assumed that the local traffic driving assets (e.g. banners) are placed on a site which has verified HCP users. For country or jurisdiction-specific content, the company needs to provide adequate gating on the global site for the relevant users, differentiated per geography. A grey area emerges when the targeting option offered by the third-party HCP portal hosting the banners — or similar — does not include “geography”. As a default, only global denominator content should be presented before a gate and access to local content should be provided via gating only.
Can patient cases be placed on a website owned by a pharmaceutical website?
An integral lever of a patient case is personification. Across industries depicting specific people in advertising allows the audience to better relate to the product in case. However, the depiction of a single person is subjective and thus at odds with the principle of evidence-based medicine. In contrast, as regards non-branded, disease awareness content focusing on the burden of disease and unmet needs, patient cases are permitted. However, specifically relevant for digital where the website hosts different types of information, there needs to be an intermediate page between the cases and the promotional information
However, in some EU countries, it is permitted to provide an individual, anonymized case and the outcome for that case, if the outcome is representative of results that can be seen in clinical trials. As an example, this is the situation in Sweden.
“Testimonials from individual patients may not be cited as documentation. Case studies shall be formulated as typical cases so that the identity of the individual patient is kept anonymous, and the studies shall remain free from subjective evaluations from the patient.” Excerpt from Article 8, ETHICAL RULES FOR THE PHARMACEUTICAL INDUSTRY IN SWEDEN
Are you allowed to create awareness of a patient support program via banners and search optimization?
A patient support program is, by definition, non-promotional, as otherwise it would be disallowed. Given that it is not promotional, some may could argue that online banners used to create awareness of a patient support program is permissible.
However, it is hard, if not impossible, to control that it is only patients prescribed to the given drugs that are exposed to and click on select banners. In that sense, online banners approximate standing in front of the psychiatry ward of the hospital and handing out the SmPC of a specific anti-depression drug to people walking by.
That would also be deemed a promotional activity as it would generate demand for a specific drug, despite fact that the SmPC is a non-promotional document.
(Google) Search is different as the user via the search terms used, actively searches for information on the availability of “a program”. In this sense, it is a pull rather than a push activity. The challenge is that for organic search optimization, the patient support program may appear on the Search Engine Result Pages for Google for terms used by the people who are not aware of the given product. When a concern, then Paid Search is pertinent, as it is allows defining for which specific search terms the program should appear on Google or similar.
If a company holds the sole authorization to a prescription drug for a given condition, can the company run a disease awareness campaign?
At Vertic, we have seen varied opinions internally at pharmaceutical companies on this question. This ambiguity is also reflected in the codes. As an example, the Blue Guide states that: “diseases or conditions where there is only one, one leading or few medicinal treatments potentially draw attention to one medicinal product, albeit indirectly, regardless of whether it is referred to or not.” It is also stated that under these circumstances particular care must be taken, and the focus should be on disease education, health in general and referring patients to appropriate advice. However, the further details of “particular care” are incomplete and thus up for own interpretation.
Hard, soft or no gate to an HCP site?
As an example, the EFPIA codes state specifically that without gating, a website is for the public. Then again, if there is no promotional material on the site, then there is no issue with members of the public visiting a site that is otherwise targeted at HCPs.
Excerpt from EFPIA
For promotional content, some form of HCP authentication is needed. The requirements vary immensely. For example, in Denmark authentication requires username, authorization number and password. [v] In Sweden, a soft gate is sufficient.
Images — in digital
Pictures are relevant across channels, however the need for multiple and varied images has increased as digital channels have proliferated. In promotional materials the use of images is precarious. The old saying that “A picture says more than a thousand words”, also means that it naturally lends itself to many, subjective interpretations. Such interpretation includes creating the perception that the medicinal product does more or something different than what can be supported with references. Thus, pictures are subject to extensive rules across countries.
Which authority has jurisdiction over a promotional event that occurs online?
For hybrid events, it is the jurisdiction and codes of the hosting country that need to be complied with. But are pureplay online events (only) national, international or supranational and which jurisdiction and codes are they subject to?
Excerpt from EFPIA
Given the non-specificity of rules regarding digital only events, common practice is to apply the rules of the country in which the arranging department is formally located. For events with international reach, it is country within which the global or regional headquarter resides. In addition, the codes on traditional events are typically also applied to the pureplay digital events to the extent reasonable.
Linking between promotional and medical content on a website?
At a physical conference there is a physical and visual demarcation between an exhibitor’s medical education part of the booth and the promotional part of the booth. In the digital space devoid of physical distance, the question is what constitutes a demarcation? A click, a glance, a disclaimer, an intermediate page with explanatory copy? And does it matter if the direction of travel is from the medical content to the commercial content or vice versa? In Vertic’s experience, as many different answers to this question exist as the number of healthcare companies. Thus, a common practice has not been established in our view.
Can social media be used for promotional content?
Social media is “just” a channel — however access control is harder to manage compared to an Owned assets (owned by the pharma company) or congress websites. Thus, social media is rarely used for promotional materials outside the US and New Zealand, except for HCP only social media such as Sermo.
Excerpt from ABPI Code of Practice for the Pharmaceutical Industry[vii]
An alternative is to work with other forms of closed groups on Facebook or similar platforms. However, maintaining a closed social network is a resource-intensive, long-term investment and endeavor, which sits uncomfortably with the quarter-to-quarter budgeting preference of commercial departments at pharmaceutical companies.
Does disease awareness need to go through a MLR process?
Disease Awareness is not covered by the codes/laws concerning promotional materials. Thus, whereas all materials are obviously subject to several internal approval processes at any healthcare company, MLR is not relevant to disease awareness content.
Use of trade name of a RX medicinal product in the web address for an HCP website in an EU country?
Is this permitted or not? Opinions vary significantly across pharmaceutical companies. EFPIA and most national codes do not mention specifically. Note, national regulations have not been reviewed. But, per definition, national codes are made as an extension and aligned with to local/county legislation. Also, legal rulings may have been made which are not surveyed or referenced here. The term code refers to the docs the EFPIA links to here.
In our experience, some affiliate compliance departments may take the view that what is not explicitly, articulated and described is as default not permitted. In our opinion that approach is hardly the ethos of EFPIA assuming that all interpretations are based on the underlying ethical principles.
Here are a few examples from various national codes and the potential implications.
Kudos to the Foundation for the Code for Pharmaceutical Advertising for appreciating that some pharmaceutical companies ponder the question of trade name URLs. The Foundation specifically permits it.
From Code of Conduct for Pharmaceutical Advertising
The Norwegian Association of the Pharmaceutical Industry simply states the advertising of rx drugs can take place on website for HCPs only. This implies gating of such site. In Vertic’s opinion, the logical course of action is to make sure that the website is not indexed on search engines nor it is included in any offline/online material distributed to a non-HCP audience.
From: INDUSTRY RULES OF THE ASSOCIATION OF THE PHARMACEUTICAL INDUSTRY
Like in Holland, the IPHA has succeeded in serving the pharmaceutical players by providing unequivocal advise on using the trade name (medicinal drug name) in the web address or URL of a website targeted at doctors.
from IPHA code
In Spain, it is legally prohibited to publish or share openly any content that is considered promotion of prescription drugs. This applies to web pages too. Promotional material related to prescription drugs must be distributed to HCPs only. Website links including the drug name are considered promotion of prescription drugs.
From Código de Buenas Prácticasde la Industria Farmacéutica
However, note the existence of a URL is not a website link. Thus, as a starting point, the pharmaceutical company should ensure that the link is not placed on materials for an non-HCP audience. Also, as a in Ireland, a recommended course of action is make sure that the site is not indexed by Google or other search engines, thereby barring the site from appearance on related search terms. Also, gating is required — as always. Thus, it is not a logical conclusion that tradename URLs are not allowed in Spain. Nonetheless, many tradename .es URLs are registered by pharmaceutical companies but have not been activated.
The MHRA Blue Code, similar to the codes in other countries in Europe, allows for promotion of drugs on websites towards HCPs. Clear sign posting is required that it is HCPs and not the general public. The gating requirement is softer than in other European countries. Live tradename co.uk web addresses are prolific in the UK.
From MHRA Blue Code
The Farmindustria code of professional conduct contains various mentioning of digital, but does not address the topic of trade name URL.
From the “Farmindustria code of professional conduct”
Again, the starting point would be to ensure that the trade name website is not indexed and contains a gate. Interestingly, many trade name URLs are registered by pharmaceutical companies in Italy, however are not activated.
In France, you find “Charte pour la communication et la promotion des produits de santé (médicaments et dispositifs médicaux) sur Internet et le e-media” providing guidelines within digital.
From: Charte pour la communication et la promotion des produits de santé (médicaments et dispositifs médicaux) sur Internet et le e-media
Thus, it is specified that if the domain name includes the name of a drug (or medical device) where advertising is not allowed to the public — i.e. a prescription drug -, the site must be secured with a gate. In other words, according to the above, you can use the trade name of the drug as part of the web address for a HCP site in France.
The above are examples only of use cases. Currently, Vertic is working with online influencer collaboration, the timing of publishing scientific disclosures on social media around events, SMPC on banners (yes or no?) and the limitations of medical/commercial coordination during digital first launch. These are use cases where Vertic’s POV and common practice are still under development. Stay tuned.
[i] Checkout the “The Global Guide to Pharma Marketing Codes” by GlobalHealthPR for a meticulous walk through country by country
[ii] European Parliament and Council (2004) Directive 2004/27/EC of the European Parliament and the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (61).
[iii] Section 1.01. EFPIA
[iv] ENLI example guideline-regarding-pre-launch-may-2020.pdf(enli.dk)
[vi] https://www.enli.dk/media/50001/guide-international-congresses-in-denmark-version-12-clean.pdfpage 6
[vii] digital-guidance.pdf (pmcpa.org.uk)
Links to selected rules, codes & viewpoints
IFPMA 2019 (International): IFPMA_Code_of_Practice_2019.pdf
EFPIA (Europe) 211222-efpia-code.pdf
FDA QA on drug advertising to consumers
ABPI code (UK): ABPI 2021 Code of Practice
International Practice Guide across countries by Chambers & Partners: Pharmaceutical Advertising 2022 | Global Practice Guides | Chambers and Partners
Laws & Codes in the US by ICLG: Pharmaceutical Advertising Report 2021–2022 USA (iclg.com)
Global Guides by Spectrum: Spectrum-GHPR-Global-Guide-download.pdf (vivacommunications.com.au)
Q&A: the promotion and sale of pharmaceuticals and medical devices in European Union — Lexology
Ethical pharmaceutical promotion and communications worldwide: codes and regulations | Philosophy, Ethics, and Humanities in Medicine | Full Text (biomedcentral.com)