The New EU “Pharma Package”: Advertising – A Comparison of Commission/Parliament/Council Positions

In this ninth and final alert in our weekly series on the EU Pharma Package, we consider the proposals of the European Commission, European Parliament and the Council of the EU as regards the advertising of medicinal products and we conclude by suggesting various ways in which pharmaceutical companies can already prepare for the upcoming changes.

The EU Pharma Package does not propose a revolutionary overhaul of the advertising rules but rather a refinement and update of the existing framework – also taking into account case law from the European Court of Justice (CJEU) on pharmaceutical advertising. Indeed, the proposed Pharma Package Directive, copies, verbatim to a large extent, the current framework of Directive 2001/83 (Medicines Directive), with restrictions for the general public on the one hand and healthcare professionals (HCP) on the other. Nonetheless, there are a couple of proposed changes which could have a significant impact on the industry, notably regarding a broader definition of “advertising”, and new provisions on misleading and comparative advertising.

What constitutes “advertising”?

The Commission preserves the definition of “advertising” from the existing Medicines Directive, which consists of a generic definition as well as a non-exhaustive list of specific cases (e.g., sponsorship, sales rep visits, free samples…):

“any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products”.

The Council proposes to remove “door-to-door” and “canvassing” from the definition, to make the wording as broad as possible. This is unlikely to have an impact in practice, as the CJEU has consistently favored a broad definition of pharmaceutical advertising to protect public health.

In addition, although the non-exhaustive list of specific cases is almost identical to the list in the Medicines Directive, there are suggested changes that may have an impact on the pharmaceutical industry:

• all three EU institutions propose extending the definition to cover advertising that does not refer to specific medicinal products. This would mean that product ranges or even more subtle promotional forms relating to medicinal products in general, or the entire portfolio of a pharmaceutical company or pharmacy, would become subject to the same regulatory restrictions. This inclusion is the EU legislator’s response to CJEU case law such as DocMorris (C-190/20) and Euroaptieka (C‑530/20), where there was discussion as to whether such advertising fell within the scope of the Medicines Directive. Although it has already been acknowledged that Member States can be more restrictive in their national laws, the Council specifically adds that Member States would have the right to ban all advertising relating to unspecified medicinal products on their territory.
• the Council specifically adds any other form of financial contribution and catering expenses in the context of scientific events as advertising even if it is not a “sponsorship”.
• the Parliament proposes to remove the “minimal intrinsic value” exception in the provision of inducements to prescribe or supply medicines by the gift, offer or promise of any benefit or bonus, whether in money or in kind. The Parliament reasons that even minimal inducement can result in biased decisions with regard to prescription behavior by physicians.

Who are the “healthcare professionals” (HCPs)?

The Medicines Directive considers only persons qualified to prescribe (i.e., physicians) or supply (i.e., pharmacists) medicines to be HCPs for the purpose of advertising. This means that other persons active in the healthcare sector are considered to be part of the “general public” – for whom more restrictive advertising rules apply.

The Pharma Package extends the concept of HCPs to persons qualified to administer medicines (i.e., nursing staff and similar professionals). This extension is justified as HCPs are subject to a different advertising regime because they are in a position to correctly assess the information contained in advertising on the basis of their knowledge, training and experience, and this should include persons administering medicines.

This extension is not entirely new, as it reflects the broader concept of HCPs already present in several national laws and self-regulatory codes and guidelines within the industry.

However, neither the Commission nor the Parliament use the new, extended concept of HCPs consistently. In certain provisions, for example with respect to hospitality at scientific or promotional events, sales rep visits and free samples, only physicians and pharmacists are mentioned. The Council on the other hand systematically uses the concept of HCPs (including persons administering medicines) throughout the text, except in the provisions on free samples. It is not yet clear whether this is a result of inconsistent drafting or whether these were intentional distinctions.

Finally, the Council adds a specific derogation for Member States to apply stricter measures for persons qualified to administer medicines.

Increased scrutiny of misleading and comparative advertising

The general principle that pharmaceutical advertising should be limited to disseminating objective and unbiased information about a medicine – albeit with a “commercial twist” – remains one of the key pillars of the new regulatory framework.

Comparative advertising has always been possible under EU law, although it is a controversial competitive practice and Member State national approaches have varied in the past. The Pharma Package aims to delineate more clearly the boundaries of permissible competitive practices.

A lot of this is in fact a specific application in the pharmaceutical industry of Directive 2006/114/EC on misleading and comparative advertising and Directive 2005/29/EC on unfair business-to-consumer commercial practices, which should be considered “lex generalis” compared to the advertising rules in the Pharma Package (“lex specialis”).

All three EU institutions agree on adding explicit prohibitions for the pharmaceutical industry as regards:

• Denigrating advertising: advertising which negatively highlights another medicinal product. Similar prohibitions already exist in self-regulatory codes within the industry as well as in Directive 2006/114/EC (“it does not discredit or denigrate the trade marks, trade names, other distinguishing marks, goods, services, activities or circumstances of a competitor”). The rationale is that speaking negatively about another medicine is inappropriate behavior as it erodes the public’s trust in medicines.
• Unsubstantiated superiority claims (even if bona fide): advertising which suggests that a medicinal product is safer or more effective than another medicinal product, unless such statements can be demonstrated and supported by the information in the summary of product characteristics (SmPC).
  
  Comparative advertising is therefore permissible if it is objectively supported by the SmPC. This is consistent with the requirement under Directive 2006/114/EC that “it objectively compares one or more material, relevant, verifiable and representative features of those goods and services”. However, the Pharma Package appears to impose a more stringent standard than the current practice for pharmaceutical comparative advertising. Until now, it has been accepted that advertising could extend “beyond” the content of the SmPC, provided it did not contradict or misrepresent the information therein. This approach frequently led to complications, as companies could reference results from, for example, study protocols mentioned in the SmPC, even when the actual results were not included in the SmPC due to off-label use within the protocol. The Pharma Package now specifically requires comparative claims to be expressly supported by the SmPC.
  
  The Council further tightens the wording and states that the comparison must be demonstrated and supported by the summaries (plural) of product characteristics. This means that a comparative claim will need support not just from the SmPC of the product being advertised but also from the SmPC of the product being compared – presumably to close any cherry-picking loopholes.
  
  The Parliament adds that any comparison must be supported by the SmPC for “the relevant indications and patient population of the medicinal product being advertised”, thereby ensuring that comparisons are not misleadingly made between dissimilar products. This again aligns with one of the conditions for comparative advertising under Directive 2006/114/EC (“it compares goods or services meeting the same needs or intended for the same purpose”).

• No-interchangeability claims: this applies specifically for biosimilar products and is in fact not a separate provision but only mentioned in the recitals as a specific case of comparative advertising. It is considered misleading to state in advertising that a biosimilar product would not be interchangeable with the originator biological product or another biosimilar (for the same originator product). Originators are therefore prohibited from suggesting that a biosimilar is less safe or effective, unless this fact is supported by the SmPC. This issue with interchangeability claims was likely one of the drivers for tightening the comparative advertising restrictions for everyone.

  This focus on neutrality and avoiding loopholes can also be seen in the Council’s clarification of what amounts to a communication that is not to be considered advertising, notably: “correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product, provided it does not promote the prescription or consumption of the medicinal product”.

Additional points proposed by the Parliament

In addition to the aforementioned points, the Parliament’s proposal contains the following noteworthy changes and additions:

• Cautious of even minimal inducements, it adds an obligation for Member States to maintain a transparency register of transfer of value regarding advertising activities that target physicians.

  Although such transparency registers already exist (for instance, the betransparent platform in Belgium or the Healthcare Transparency Register in the Netherlands), the transparency requirements are typically limited to sponsorships and other premiums and grants, i.e., they do not cover all advertising to physicians, including supply of samples, sales reps visits… This change would significantly increase the transparency reporting requirements for the pharmaceutical companies.

• It requires Member States to implement a system of prior vetting, at least for advertising to the general public, while in the Commission and Council proposals a prior vetting system would simply be an example of a monitoring mechanism.
• It adds a complete prohibition on advertising antibiotics or antimicrobials to the general public where there is an identified risk of antimicrobial resistance, as well as a prohibition on giving free samples of antibiotics to physicians.
• It extends the list of minimum information for advertising to the general public to include (i) information on disposal of the medicine and (ii) an invitation to consult a medical practitioner or a pharmacist for additional information.
• It mandates the Commission to adopt further requirements in relation to the direct and indirect advertising of medicinal products through social media and other media platforms and product placements by celebrities and influencers.

Additional points proposed by the Council

As well as the earlier points mentioned, the Council’s proposal includes the following noteworthy changes and additions:

• It grants Member States the right to temporarily suspend the advertising of a medicine in case of a shortage or risk thereof (see also our seventh alert on shortage measures in the Pharma Package). It is not yet clear how far pharmaceutical companies will need to go in order to stop ongoing advertising campaigns in compliance with a suspension order.
• It clarifies that the Member States may decide, on an exceptional basis, that free samples of over-the-counter medicines may also be provided to pharmacists. The Commission’s and Parliament’s proposals do not include a reference to this Member State power. It could therefore be interpreted that under the Commission and Parliament proposals, such practice would be permitted throughout the entire EU, without Member State intervention, leaving it up to the pharmaceutical companies to determine when exceptional circumstances are present that warrant such free samples. This provision aims to codify the CJEU judgment in Ratiopharm (C-786/18), which stated that the Medicines Directive does not prevent the supply of free samples of non-prescription medicinal products to pharmacists.
• With respect to hospitality at scientific events, it appears to elevate the threshold by stating that hospitality is “justified only when indispensable for the fulfilment of” the main scientific objective, rather than that hospitality must be strictly limited to the main scientific objective. It remains to be seen whether this change will result in a stricter application in practice, i.e., whether it would have to be almost impossible for the HCP to attend the event without the sponsorship from the pharmaceutical company.

Conclusion

The Pharma Package largely builds on the existing regulatory framework for pharmaceutical advertising but adds some notable, more stringent, provisions on which the three EU institutions are already largely aligned. These changes, which are expected to impact the current way of working within the industry, include: the addition of unspecified medicines within the scope of “advertising”, the addition of persons administering medicines within the scope of HCPs, and more stringent rules on misleading and comparative advertising in the pharmaceutical sector.

Other amendments proposed by the Parliament and Council are significant, although not surprising. They are in line with the respective institutions’ approach in other parts of the Pharma Package, for example the Parliament’s focus on antimicrobial resistance and transparency and the Council’s focus on additional powers for Member States to adopt more stringent rules or exceptions to EU law.

Given the current alignment of the EU institutions on many of the key points, it is unlikely that the position on these will change much in the trilogues. Pharmaceutical companies are advised to already start thinking proactively about the future, and in particular:

• review their internal processes on comparative advertising;
• review their more subtle communications regarding unspecified medicines which may in the near future also be considered advertising; and
• develop protocols for advertising suspensions in case of shortage and consider the effects on multinational campaigns in case of different approaches by Member States.

Finally, it is worth remembering that the EU regulatory framework on advertising is only one piece of the puzzle. It must be considered alongside the numerous national laws and self-regulatory codes and guidelines that exist, such as the Code of Practice of the European Federation of Pharmaceutical Industries and Associations.