EU Pharma Package: Advertising Compromise Proposal

Background

In our ninth alert in this EU Pharma Package Series, we discussed the proposals of the Commission, Council, and Parliament with respect to advertising of medicinal products.

The rules on advertising are covered primarily in Chapter XIII of the proposed Directive of the Pharma Package, with restrictions for the general public on the one hand and for health care professionals (HCP) on the other. In general, the 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 Court of Justice of the European Union (CJEU) on pharmaceutical advertising.

What constitutes “advertising”?

The Pharma Package largely preserves the definition of “advertising” from the existing pharmaceutical legislation, which consists of a generic definition as well as a non-exhaustive list of specific cases (e.g., sponsorship, sales rep visits, free samples). In line with the Council’s proposal, the references to “door-to-door” and “canvassing” have been removed from the definition, to make the wording as broad as possible: “any form of information, activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products.”

The following notable changes to the non-exhaustive list of specific cases have made their way into the compromise text:

• As was proposed by all three EU institutions, the definition is extended to cover advertising that does not refer to specific medicinal products as long as it can be considered the dissemination of information that encourages the purchase of medicinal products in some way. This means 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, become subject to the same regulatory restrictions. Furthermore, as proposed by the Council, Member States have the right to ban all advertising relating to unspecified medicinal products on their territory (excluding vaccination campaigns).
• In line with the Parliament’s proposal, the reference to 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, has been removed. This means that any kind of “gift” to an HCP is considered advertising if it is considered to be able to influence the HCP, even if it has very limited value.
• In line with the Council’s proposal, any form of financial contribution and catering expenses in the context of scientific events is considered advertising even if it is not a “sponsorship”.

Who are the HCPs

The rules on advertising of medicinal products differ depending on the target audience. The rules are more restrictive when advertising is directed at the general public than when directed at HCPs. The Pharma Package extends the concept of HCPs to persons qualified to administer medicines (i.e., nursing staff and similar professionals), whereas, under the current legislation, this is limited to persons qualified to prescribe (i.e., physicians) or supply (i.e., pharmacists) medicines.

In principle, the rules apply to all types of HCPs equally, although Member States are allowed to apply stricter measures for persons qualified to administer medicines, in line with the Council’s proposal.

Increased scrutiny of misleading and comparative advertising

The general principle that pharmaceutical advertising should be limited to disseminating objective and unbiased information about a medicinal product remains one of the key pillars of the regulatory framework.

The three EU institutions were already largely aligned prior to the trilogue negotiations on delineating more clearly the boundaries of permissible competitive practices and tightening the rules in this respect:

• Denigrating advertising: Advertising that negatively highlights another medicinal product will be prohibited, which is in line with existing self-regulatory codes within the industry and the lex generalis Directive 2006/114/EC on comparative advertising.
• Unsubstantiated superiority claims (even if bona fide): Advertising which suggests that a medicinal product is safer or more effective than another medicinal product will be prohibited, unless such comparison of quality, safety, and efficacy is supported objectively by the information in the summaries of product characteristics (SmPC) of both the advertised and the comparator products. This is again consistent with the lex generalis Directive 2006/114/EC on comparative advertising but is more stringent than the current practice in the pharmaceutical world. This means that advertising can no longer extend “beyond” the content of the SmPC even if it does not contradict or misrepresent the information therein, for example by referencing results from study protocols not included in the SmPC.
• No-interchangeability claims: This applies specifically for biosimilar products but is only mentioned in the recitals as a specific case of comparative advertising. It is considered misleading to state or suggest in advertising that a biosimilar would not be interchangeable with the originator biological product or another biosimilar (for the same originator product), again, unless this fact is objectively supported by the SmPCs.

Other points

In addition to the aforementioned points, the following noteworthy points have been included in the compromise text:

• The list of minimum information for advertising to the general public is extended to include (i) information on disposal of the medicine and (ii) an invitation to consult a medical practitioner or a pharmacist for additional information.
• The advertising of a medicinal product to the general public cannot refer directly or indirectly to recommendations by scientists, HCPs, health care facilities, or persons who are none of the foregoing but who, because of their celebrity or professional activity (e.g., influencers), could encourage the consumption of medicinal products.
• Free samples to physicians of antibiotics will be completely prohibited, in addition to the already existing prohibition on samples of psychotropic or narcotic products.
• Member States may decide, on an exceptional basis, that free samples of over-the-counter medicines may also be provided to pharmacists. Member States may also place further restrictions on the distribution of free samples of specific medicinal products.
• Member States must publish a list of disclosure platforms operated by trade associations or by marketing authorization holders for the reporting of transfers of value related to advertising activities. This replaces the obligation for Member States to set up an actual transparency register themselves, as was originally proposed by the Parliament. Transparency around disclosure of transfers of value therefore remains a national competence. However, several Member States already have so-called Sunshine Acts, implementing a transparency register at national level (for instance, the betransparent platform in Belgium).
• Member States have the right to temporarily suspend the advertising of a medicine in case of a shortage or risk thereof (see also our seventeenth alert on shortage measures in the Pharma Package).

Other points proposed by the Parliament and/or the Council that we flagged in our previous alert on advertising have not been included in the compromise text.

Conclusion

The Pharma Package largely builds on the existing regulatory framework for pharmaceutical advertising. Much 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).

Nonetheless, there are a couple of proposed changes which could have a significant impact on the industry, notably the addition of unspecified medicines within the scope of “advertising”, the addition of persons administering medicines within the scope of HCPs, more stringent rules on misleading and comparative advertising, and the temporary suspension of advertising in case of shortages. Non-compliance with the rules on advertising is subject to penalties at national level.

Finally, it is worth remembering that the EU regulatory framework on advertising 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.