As highlighted in our recent series of blog posts (please see our Inside EU Life Sciences blog series here), the European Commission has at long last published its proposal to overhaul EU legislation for human medicinal products. 

On 26 April 2023, the Commission published its proposal for a new human medicines directive (the “Proposed Directive”) to replace the current European Medicines Directive (Directive 2001/83/EC); as well as a regulation for centrally authorised medicines (the “Proposed Regulation”) to replace the current Regulation 726/2004. 

Medicines advertising and promotion rules are of key interest to pharmaceutical companies operating in the EU.  This blog looks into how the new legislative proposal might affect the advertising landscape, focusing on the Proposed Directive (whose advertising provisions also apply to products covered under the Proposed Regulation).

For those of you who are perhaps breathless from the suite of new proposals, advertising and promotion may appear to be one small area to exhale in relief.  However, some of the proposed changes may have significant practical implications, particularly for comparative advertising.

The headline news is that – for advertising – the Proposed Directive largely maintains the status quo.  It remains aligned almost entirely with the current framework, supplementing rather than revolutionizing current law. 

The evolutionary approach is unsurprising.  EU-level law is really only the “tip” of the proverbial “iceberg” when it comes to pharmaceutical advertising in Europe.  Many operational rules are nationally diverse, and found in national laws, codes and rulings.  Moreover, in practice, pharmaceuticals advertising is often largely governed and enforced through the self-regulatory system and self-regulatory codes, such as the Code of Practice of the European Federation of Pharmaceutical Industries and Associations (the “EFPIA Code”) and its various national incarnations.  The Explanatory Memorandum to the Proposed Directive suggests legislators have tried to avoid overhauling the intricate framework regulating advertising. Nevertheless, the Proposed Directive does make some changes to advertising rules.  Most are generally uncontroversial and/or “tidy ups”; but others may be more significant, particularly supplementing the definition of “advertising” and new provisions on comparative advertising. 

Definition of Advertising

The Proposed Directive preserves the classical definition of advertising, namely activities “designed to promote the prescription, supply, sale or consumption of medicinal products” followed by a list of activities that qualify as advertising (e.g., visits by sales staff to clinicians) (Article 175).  The Proposed Directive adds the following to the list of activities that fall within the definition of “advertising”:

advertising related to medicinal products, that does not refer to specific medicinal products” (Article 175(1)(h) (emphasis added).

The intent appears to be to align with recent European case law, which construes medicines advertising broadly to cover various indirect forms of promotion including the advertising of “unspecified medicinal products” (CJEU Case C-530,Euroaptieka – please see our blog post discussing the ruling here).  Indeed, Recital 137 of the Proposed Directive calls this out.

Nonetheless, the proposed text is very broad (particularly, the term advertising “related to medicinal products”).  It could potentially cover a range of healthcare and health-related communications.  That becomes especially significant at a time when the interplay between healthcare and pharmacotherapy is becoming increasingly sophisticated and nuanced.  It remains to be seen whether the proposed new addition to the definition could widen the net even further.

Proposed Comparative Advertising Changes

Comparative advertising for medicinal products is, in principle, possible under the current European Medicines Directive.  But this has been a controversial subject, and national approaches have varied considerably.

Article 176(4) of the Proposed Directive is a new provision, which says that:

Any form of advertising that aims to highlight negatively another medicinal product shall be prohibited…” (emphasis added).

This potentially aligns with a range of “anti-denigration” rules that exist under various national and regional codes.  The broad idea is that using advertising to denigrate another medicine will ultimately damage trust and confidence in medicines and the industry generally, and is therefore inappropriate.

What does this mean for companies making bona fide and non-denigrating comparative claims? 

Article 176(4) of the Proposed Directive goes on to say:

“Advertising that suggests that a medicinal product is safer or more effective than another medicinal product shall also be prohibited, unless demonstrated and supported by the summary of product characteristics.” (emphasis added)

Any comparative claims that relate to safety of efficacy must be supported by data in the product’s summary of product characteristics (“SmPC”).  This is novel – at least at the EU level – and sets a higher bar for comparative advertising versus non-comparative advertising.

Under the current law, all medicines advertising (including comparative claims) must “comply” with the SmPC.  The Court of Justice clarified in Novo Nordisk AS v Ravimiamet (CJEU, Case C-249/09) (“Novo Nordisk”) that advertising claims need not be limited to what the SmPC expressly says.  Instead, advertising can include claims that are “supplemental” to the SmPC, and “confirm or clarify” the SmPC, provided they do not “distort.”

The effect of the Proposed Directive might be that:

  • The Novo Nordisk principle (above) holds true for ordinary advertising.
  • However, for comparative claims relating to safety or efficacy, a higher standard applies, and the claim must be supported by data expressly in the SmPC of the product being advertised (Recital 136).

Recital 136 of the Proposed Directive adds some interesting commentary:

Comparison of medicinal products should only be allowed if such information is listed in the summary of product characteristics of the medicinal product being advertised.  This prohibition covers any medicinal product, also biosimilars, and therefore it would be misleading to refer in the advertising, that a biosimilar medicinal product would not be interchangeable with the original biological medicinal product or another biosimilar from the same original biological medicinal product.” (emphasis added)

This Recital perhaps gives an insight as to the motive and trajectory of the proposal: that biosimilars should not be prevented from making interchangeability claims.  Manufacturers of originator biologics would be prohibited from suggesting that a biosimilar is less efficacious or less safe (or even suggesting these are unproven) unless supported by the SmPC.

This is certainly one advertising aspect of the Proposed Directive that will generate significant commentary and debate; and is one to keep a close eye on.

Examples of Certain Generally Uncontroversial or Tidy-Up Changes

Advertising to Healthcare Professionals

Both the current and proposed laws prohibit the advertising of prescription-only medicines (“POMs”) to the general public.  However, POMs may still be advertised (subject to certain rules) to healthcare professionals (“HCPs”).

The current European Medicines Directive defines this group as “persons qualified to prescribe or supply” POMs.  This was perhaps a dated concept, as it seems at first blush to exclude nurses and similar professionals who cannot lawfully “prescribe” or “supply” medicines, but might still play a role in administering treatment and influencing the choice of medicine prescribed.

Article 175 of the Proposed Directive expands the concept of “persons qualified to prescribe or supply” to “persons qualified to prescribe, administer or supply” medicines.

This reflects a broader concept of the term that was already part of the EFPIA Code and various other laws, guidelines and codes.  In practice, this update – on its own – is unlikely to affect how advertising works on the ground.

However, it is worth noting inconsistencies of application.  For example, under Article 184 of the Proposed Directive (which concerns the provision of hospitality) and Article 185 (which concerns samples), the term reverts to the old “persons qualified to prescribe or supply.”  The significance (if any) is not yet clear.

Free Samples

The current European Medicines Directive had made clear that free samples of medicines could only be given to persons qualified to prescribe or supply them (i) on an exceptional basis; (ii) subject to various conditions and requirements; and (iii) subject to further restrictions at the national level (Article 96).

The Proposed Directive contains a new provision to underline that this rule also applies to the provision of free samples of non-prescription medicines (Article 185(2)).

Scientific Service

As under the current law, the Proposed Directive maintains the requirement for marketing authorisation holders to establish a scientific service (Article 187 of the Proposed Directive and Article 98 of the current Directive).  The scientific service is what most in the industry refer to as “medical,” “medical information,” or “medical affairs” and takes responsibility for medical information about the marketing authorisation holder’s medicines (and in some countries the requirements can go further).

The current law requires this service to be “within” the marketing authorisation holder’s own “undertaking” (usually, part of the same company).  The Proposed Directive suggests there is now a second option – establishing a scientific service as a (presumably standalone) not-for-profit entity (Article 187(1)).

Conclusion

While the Proposed Directive largely (and unsurprisingly) maintains the status quo for advertising regulation, it does introduce certain changes.  The proposals for comparative advertising may have particular significance, especially for biologics and biosimilars.

If you would like to discuss the proposed changes and what they might mean for your company’s operations and/or how they develop, please contact our specialist pharmaceutical advertising and communications lawyers: Grant Castle, Robin Blaney, Brian Kelly, Adem Koyuncu, Bart van Vooren and Raj Gathani.

This blog is based on the wording of the EU’s proposal published on 26 April 2023.  This wording could significantly change during the legislative process.  Our Dublin, Brussels, Frankfurt and London teams will continue to monitor this legislation.  We will be hosting a webinar to discuss the impact on 9 May.  To sign up for the webinar please click here.

Photo of Grant Castle Grant Castle

Grant Castle is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation…

Grant Castle is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation matters in the EU, UK, and Irish Courts.

He is one of the Co-chairs of Covington’s Life Sciences Industry Group and is Head of Covington’s European Life Sciences Regulatory Practice.

Grant regularly advises on:

  • EU and UK regulatory pathways to market for pharmaceuticals and medical devices, including in vitro diagnostics and on associated product life cycle management;
  • Pharmaceutical GxPs, including those governing pharmacovigilance, manufacturing, the supply chain and both clinical and non-clinical research;
  • Medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • Advertising and promotion of both pharmaceuticals and medical devices; and
  • Pricing, reimbursement and market access for both pharmaceuticals and medical devices.

Grant also handles procedural matters before EU, UK and Irish regulators and UK and Irish market access bodies, where necessary bringing judicial reviews for his life sciences clients before the EU, UK and Irish Courts.

Chambers UK has ranked Grant in Band 1 for Life Sciences Regulatory for the last 18 years. He is recognized by Chambers UK, Life Sciences as “excellent,” “a knowledgeable lawyer with a strong presence in the industry,” who provides “absolutely first-rate regulatory advice,” according to sources, who also describe him as “one of the key players in that area,” whilst Chambers Global sources report that “he worked in the sector for many years, and has a thorough understanding of how the industry ticks.” He is praised by clients for his “absolutely first-rate” European regulatory practice. Legal 500 UK notes that he is “highly competent in understanding legal and technical biological issues.”

Photo of Raj Gathani Raj Gathani

Supporting clients in the pharmaceutical, healthcare, medical device and consumer products sectors, Raj Gathani’s practice is built around EU and UK regulatory and strategic advice.

Increasingly, Raj concentrates on post market-launch projects, such as advising on advertising compliance, communications, interactions with healthcare professionals…

Supporting clients in the pharmaceutical, healthcare, medical device and consumer products sectors, Raj Gathani’s practice is built around EU and UK regulatory and strategic advice.

Increasingly, Raj concentrates on post market-launch projects, such as advising on advertising compliance, communications, interactions with healthcare professionals and patients, pricing controls and reimbursement strategies particularly in the UK and the Republic of Ireland.

Healthcare, its structure and delivery are specialist practice areas for Raj, particularly having operated healthcare and pharmacy businesses for eight years prior to joining the firm. This experience enables Raj to provide in-depth advice to healthcare clients –particularly those in the digital health space – as well as other life sciences companies whose work engages medical practice, dispensing and health-services rules.

Photo of Dan Spivey Dan Spivey

Dan Spivey is an associate in the Life Sciences Regulatory team. Dan advises clients in the pharmaceutical, healthcare, medical device, and food and beverage sectors on a range of regulatory matters.