Rules on the promotion of prescription medicinal products

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.

HCP communication

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.

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).

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

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.

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.

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.

Excerpt from ENLI [vi]

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?

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.

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.

Netherlands

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.

Norway

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.

‍Ireland

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.

Spain

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.

UK

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.

Italy

The Farmindustria code of professional conduct contains various mentioning of digital, but does not address the topic of trade name URL.

France

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.

General Conclusion

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.

References

[i] Checkout the “The Global Guide to Pharma Marketing Codes” by GlobalHealthPR for a meticulous walk through country by country

Links to selected rules, codes & viewpoints

IFPMA 2019 (International): IFPMA_Code_of_Practice_2019.pdf

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Mads Krogh Petersen

Mads Krogh Petersen

Perspectives on Marketing in a Digital World. Co-founder of Vertic http://www.vertic.com