Until this new regulation is approved, it is worth paying attention to the criteria applied by the regional authorities in relation to the advertising of medical devices addressed to the public. These include those outlined by the Catalan Department of Health in its latest Guide, approved at the end of last year, which we summarize below.

Prohibited statements and content in advertising materials

The key modifications introduced by the Guide regarding the content of the advertising include:

• The prohibition of the inclusion of terms or labels attributing to a medical device therapeutic property by means of pharmacological, metabolic or immunological actions. This prohibition is a consequence of the fact that only medicinal products can claim therapeutic properties derived from pharmacological, metabolic or immunological actions.

• In case the Instructions for Use of the product include age restrictions, the company shall include information on the minimum permitted age or recommended age range for the use of the product.

• Requirement to include a warning about the need to consult a healthcare professional when indicated in the Instructions for Use.

• Obligation to separate messages regarding the product’s environmental sustainability from those related to its health benefits. When submitting materials for approval by the Catalan Authority, the company must include supporting documentation to validate its sustainability claims.

Comparative advertising

The updated Guide notes that it is not necessary to reference the data source when including comparative sales data (e.g., related to volume, revenue or market share) in product advertising. However, information on the period (indicating months and year) and territory (name of the country or countries) to which the data relate should be included.

In addition, the update includes the possibility to compare, in advertising to the public, a medical device with a medicinal product, provided that it is based on a clinical study directly carried out on the two products.

Internet advertising and inclusion of recommendations and/or testimonials

Regarding opinions or mentions of a medical device shared by a well-known person on the internet or social media, the Catalan Authority will classify them as advertising and assume that the company has sponsored or financed them in some way. Even without payment, the Authority may still review the content and context of the publication to assess whether it constitutes a form of advertising for the company, for which the company could be held liable.

As regards advertising through a website, the Guide introduces the following new requirements:

• Consumer opinions, directly provided by consumers, on the websites of companies advertising medical devices should be clearly separated from the advertising of the medical device. It is sufficient to include a separate section titled “Consumer opinions”.

• The person responsible for the website must ensure that they are true, both as regards the person who has provided them and as regards the content.

• These opinions cannot be used as evidence of the product’s efficacy.

• The page containing these opinions should include a warning stating: “These opinions have not been evaluated or authorised by the competent health authority”.

Authorisation of promotional materials

For companies that do not have a registered office in Spain, the updated Guide clarifies that the competent authority for approving promotional materials aimed at the public will be that of the Autonomous Region where their legal representative is located, or if the dissemination is limited to a single region, the Health Authority of that region.

In addition, the updated Guide states the following with respect to the approval process for advertising materials:

• The rule that an application for authorisation must relate to a single material for a single device has become more flexible. Applications that include several materials for the same medical device or for several medical devices will be accepted, as long as they are all included in the materials submitted.

• In the case of a corporate website or product range that contains links to pages containing advertisements for a different medical device, separate authorisation requests must be submitted: one for the homepage and one for each of the product pages.

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Among the new features of the guide, issues related to the use of QR codes, recall advertising, the concept and uses of valid support, and the use of digital environments generated most the debate.

QR codes use

The Catalan authorities are adamant that QR codes on promotional materials must redirect to the CIMA website in order to allow the recipient of the advertisement to access the Summary of Product Characteristics (SmPC); not being possible, according to Catalan authorities, to access the SmPC via other websites. According to the Surveillance Section, this interpretation arises from the note issued by the Ministry of Health in September 2023. In our opinion, this obligation is not so clear from the informative note, as it states that “The QR code must refer to the most updated version of the authorised SmPC, as it appears in CIMA“.

This position caused controversy in the Q&A session, in which the Catalan authorities confirmed that: (i) the redirection must be to the CIMA website, even if the recent SmPC is on the European Medicines Agency (EMA) website in the case of centralised procedures; (ii) the QR cannot redirect to an intermediate website that in turn redirects to CIMA (a resource that can be useful, for example, in the case of materials on various medicinal products); and (iii) only in the case of a medicinal product not authorised in Spain and in the context of an international congress, the QR of the promotional material could redirect to the SmPC of the EMA or of the country where the product is authorised.

In the event that an already reported promotional material updates the way in which the minimum content is included (e.g. the minimum content changes from being written to being linked via QR), the material must be re-notified to the Catalan authorities as a new material.

Recall advertising

The position of the Catalan authorities is that recall advertising cannot include anything beyond the name of the medicinal product, logo and/or picture of the product, as well as the logo and/or name of the laboratory. If the material includes any additional references – such as the pharmaceutical form, dosage form, price or other phrases (even empty phrases) – it can no longer be considered as recall advertising and, therefore, must include the minimum content and must be notified.

Valid supports

The Catalan authorities pointed out that, while “valid support” is defined as a tool through which technical and promotional information is provided to the healthcare professional, scientific/technical content must predominate over promotional content by more than 50%.

According to the Surveillance Section, social networks could only be valid support if they allow the creation of closed groups that restrict access to content to the healthcare professional. According to the Section, messages sent via WhatsApp, Telegram or Instagram posts would not fall under this qualification. This raised doubts among those attending the session, as these tools enable private communication channels. However, the Section insisted that what needs to be assessed is whether the specific content/publication can be restricted. For instance, the Section confirmed that LinkedIn or Youtube could serve as a valid support as they allow the creation of closed groups with access to restricted content. 

Finally, the Catalan authorities confirmed that the advertising incorporated in a valid support must be communicated separately from the media support itself.

Use of digital environments

The briefing emphasised the advertising restrictions applicable to each communication channel, distinguishing between display and targeted advertising, which are defined in the same guide. While display advertising is advertising that is included in a valid support and is aimed at a broad audience, targeted advertising is advertising that is sent directly to a specific healthcare professional (e.g. email or WhatsApp).

Regarding advertising on “open” platforms such as X (formerly Twitter), Instagram, TikTok or Spotify, the Catalan authorities consider that the target audience is the general public, and therefore advertising for prescription medicinal products cannot be included on these platforms. However, advertising for prescription medicinal products may be included on “closed” platforms, i.e. those that allow limiting access to their content. Examples of closed platforms are: websites (areas restricted to healthcare professionals); applications (apps); LinkedIn (closed groups); Facebook (secret groups) and even YouTube (hidden or private videos).

La entrada Practical aspects on the new Catalan Guide on Advertising of Medicinal Products aparece primero en Faus Moliner.

Use of tables, charts or illustrations

The monograph reminds us that when using tables, charts or illustrations in the materials, their reproduction must be “faithful”. The notice lacks clarity on what is meant by faithful reproduction. Previously, graphics were required to be reproduced “literally” (as, in fact, stipulated in earlier versions of the Farmaindustria Code).

At present, the reproduction of these elements is required to be “faithful”. From the analysis of Autocontrol’s rulings, we conclude that a “faithful” reproduction would allow a change of format, or even a simplification of a graphic (provided that the omission of data is not misleading, of course). We understand that Catalonia Government’s position on this point is the same, precisely because it refers, in the notice under analysis, to Autocontrol’s rulings.

Limitations of source scientific studies. Primary and secondary objectives

The monograph also emphasises that advertising of medicinal products can be supported by scientific studies that have limitations, provided that these limitations are clearly disclosed in the promotional material. For example, it is worth noting that according to Autocontrol referencing results in secondary objectives cannot be prohibited per se if statistical significance was not achieved with respect to the main objective. However, it is necessary to ensure that presenting these results does not infringe the principle of objectivity. For this purpose, it should be clearly stated that the expected statistical significance was not achieved for the primary objective.

Moreover, according to Autocontrol’s doctrine (which the Catalan monograph adopts), it is not possible to rely on secondary results when the study is hierarchical.

Transfer of study results on the active substance

The monograph notes that clinical data and references from studies cannot be applied to the promoted medicinal product when they have been obtained only for the active substance and not for the resulting medicinal product. According to the monograph, “if the advertising materials convey that the results have been obtained directly and specifically with the promoted medicinal product and this has not been the case, the principle of objectivity would be infringed”. Therefore, it would be correct to promote the product by referring to studies on an active substance, as long as it is clearly specified that the studies have been carried out on the active substance.

Finally, the monograph points out the most frequent infringements in this area (which can provide insights into both the most common mistakes in preparing promotional materials and the aspects most scrutinised by authorities). Therefore, it is essential to pay particular attention to:

(i) adaptations or alterations of data, tables and graphs from studies;

(ii) references to studies that are not carried out accurately; and

(iii) comparisons of safety, efficacy or other properties across different scientific studies or without specifying their statistical significance.

La entrada Harmonisation of guidelines for the use of scientific data in advertising to healthcare professionals aparece primero en Faus Moliner.

These decisions stem from a complaint by GSK against AstraZeneca for promotional materials related to the medicinal product Fasenra® that had been presented at several satellite symposia during national scientific congresses.

AstraZeneca markets Fasenra® (benralizumab) which is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma (“AGE” by its Spanish acronym). According to GSK, AstraZeneca had conveyed the message at the satellite symposia that Fasenra® was effective for the treatment of chronic rhinosinusitis with nasal polyposis (“RSCcPN” by its Spanish acronym) when presented with AGE.

Compatibility with the SmPC and misleading information

One of the basic principles governing the advertising of medicinal products is that it must comply with the summary of product characteristics (SmPC), according to article 1.2 of Royal Decree 1416/1994 on the advertising of medicinal products. This is usually known as the principle of compatibility with the SmPC.

In this case, the Jury analyses whether the Fasenra® messages concerning the treatment of RSCcPN are compatible with the SmPC of the product. AstraZeneca denied infringement of the principle of compatibility with the SmPC on the grounds that it was not possible for the recipients of the messages to perceive an efficacy message for Fasenra® for RSCcPN, noting that the materials included a warning that the product was not indicated for the treatment of RSCcPN.

The Jury determines that it is incompatible with the SmPC of Fasenra® to disseminate messages about its efficacy for a disease other than the approved therapeutic indication of the medicinal product (i.e. AGE). In this regard, the decision points out that the legislation and the Farmaindustria Code prohibit the dissemination of messages incompatible with SmPC, regardless of whether they are misleading to the recipients. Therefore, whether the recipient of the information is misled as to the scope of the authorised indication of the medicinal product is irrelevant when assessing compliance with the principle of compatibility with SmPC.

Advertising will be incompatible with the SmPC of the promoted medicinal product if, according to Autocontrol’s established doctrine, it includes claims/statements (i) objectively incompatible with those included in the SmPC or (ii) assessed at the time by the health authorities for their potential inclusion in the SmPC and expressly or implicitly rejected.

Unauthorised indications and international congresses

Without prejudice to Autocontrol’s ruling, it should be recalled that there is an exception to this principle of compatibility of SmPC and it is contained in Article 7.4 of the Farmaindustria Code, in the Circular No 1/2000 of the Autonomous Community of Madrid and in the Catalan Guide to the advertising of medicinal products.

This exception allows the promotion of unauthorised products or indications at international congresses organised by third parties and attended by numerous professionals from other countries, provided that the materials comply with two requirements: (i) be written in English or in the language of a country where the product or indication in question is authorised; and (ii) include a warning (at least in Spanish) in prominent, clearly visible, continuous, durable and legible letters of the following type: “this medicinal product is not authorised in Spain for the following indication…” or similar.

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Background

The use of QR codes to link SmPC has been widely used, especially after the pandemic, to comply with the requirement to include the minimum content in promotional materials set out in Article 10 of the Royal Decree on the Advertising of Medicines for Human Use (Royal Decree on Advertising).

However, the explicit inclusion of the option to provide the minimum content through this means was lacking until now. The Ministry of Health acknowledged that this had been a recurring request from pharmaceutical companies during the public consultation leading up to the draft of the new legislation regulating advertising of medicines for human use.

Content of the information note

In the light of this briefing note, the use of the QR code in promotional material is now expressly permitted. However, it is limited to directing to the technical specifications, in compliance with article 10(1)(a) of the Royal Decree on Advertising (which mandates the inclusion of the essential product information in all promotional material). Notably, QR code are not permitted to redirect users to the information outlined in paragraphs 1(b), 1(c) and 2 of the same article 10. In simpler terms, information on the prescription and dispensing regime, available product presentations (including dosage and pharmaceutical form), as well as information about the price and financing of the medicinal product must be included in the promotional material itself (without any cross-reference to the QR).

Additionally, alongside the QR code graphic, there should be a clear indication that it leads to the SmPC medicinal product.

Catalan guidelines on the advertising of medicinal products

According to the Catalan guidelines, the minimum content must be accessible in a direct, rapid and comprehensible manner. In fact, in order to avoid any doubt, the guidelines specifies measures such as the font size or the specific ways in which the minimum content must be distributed in optical, magnetic, audiovisual or interactive media (although these references are becoming increasingly outdated).

The Catalan guidelines explicitly prohibit providing the minimum content through QR codes or URL addresses. This is considered not to meet the accessibility requirement, since both promotional information and the minimum content  shall be equally accessible. The guidelines only allow these means in “exceptional cases where it can be demonstrated that the information in the SmPC is subject to frequent changes”.

Considering the new briefing note from the Ministry of Health, which we believe should prevail, one might anticipate an update to the Catalan guide to, at the very least, align positions with the Ministry of Health.

La entrada The QR code to include the SmPC in promotional materials aparece primero en Faus Moliner.

Under EU rules on consumer rights, and on certain aspects of the sale of consumer goods and associated guarantees, the trader is required to provide the consumer buying goods or services over the internet with certain information in order for them to be bound. This information includes the characteristics of the goods or services offered, as well as “where applicable” the existence of after-sales assistance and services, the commercial guarantees and their conditions.

With regard to the information to be provided on guarantees, European legislation provides that their content, basic elements, duration, territorial scope and the guarantor’s identification data (name and address) must be clearly indicated.

Balance and legitimate interest

The CJEU judgment clarifies when it is appropriate for the consumer to be informed about the existence of after-sales assistance and services, commercial guarantees and their conditions. The CJEU states that the expression “where appropriate” must be interpreted as meaning that information must be provided where such guarantees or services exist. This raises new questions: which warranties are to be informed: those offered by the manufacturer or those offered by the distributor? when are such warranties deemed to exist?

In order to answer these questions, the CJEU makes an analysis based on the need to strike a balance between the position of the parties, i.e., the need to achieve a high level of consumer protection and the protection of the competitiveness of businesses, especially small and medium-sized ones.

On the basis of these criteria, the judgment considers that “commercial guarantees” include both those offered by the trader and those offered by the manufacturer. On the other hand, it points out that the distributor is only required to provide information on the guarantees offered by the manufacturer when the distributor relies on these guarantees when presenting the product to the consumer, making them a central or decisive element of his offer.

Advertising of goods and services

Following the same reasoning of this judgment, when certain arguments are used in the context of the advertising of goods or services, full and sufficient information must be provided. Those responsible for any advertising material must ensure not only that it respects the rights of competitors in the framework of fair competition, but must also ensure that it does not include statements that could mislead or confuse the average consumer (who is reasonably well informed and reasonably observant and circumspect) as to the essential characteristics of the offer being presented.

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On 30 December 2021, the Government of Catalonia updated its Bulletin on advertising of medicinal products on social media.

This update expressly foresees the possibility of companies conveying scientific content via social media. At the same time, it recommends restricting the access to the public, by using the available tools, if the scientific content redirects to materials on prescription medicines given that such materials should only be accessible to healthcare professionals.

The Bulletin also contains guidelines for each of the social networks it covers (i.e., Twitter, LinkedIn and Instagram), thus serving as a guide to clarify the terms under which the industry may interact with the general public and healthcare professionals.

Despite regulating the use of these tools, the Farmaindustria Code and the Catalan Guide on Advertising of Medicines do not regulate which measures must be adopted by companies to advertise medicinal products on social media. The Farmaindustria Code and the Catalan Guide only include a general statement attributing responsibility to companies for the content they publish on social media  and requiring such companies to have policies for the use of social media.  For this reason, the Bulletin is a useful guidance for companies that would like to advertise medicinal product on social media.

Guidelines for LinkedIn, Twitter and Instagram as explained in the articles

Linkedin. The Bulletin recommends that, if this network is used to inform about or advertise prescription medicines, a restricted group must be created and the rules governing the group must be specified. These rules should include warnings that access to the group is restricted to healthcare professionals and a prohibition on sharing materials beyond the group. According to the Bulletin, the creation of this kind of groups should be notified to the authorities.

As for Twitter, the Bulletin discourages using this platform to inform about or advertise prescription medicines to groups of healthcare professionals. This is because Twitter easily allows sharing content with persons other than healthcare professionals. According to the Bulletin, it is preferable to limit the use of Twitter for institutional and health-related messages.

Finally, as regards Instagram, the Bulletin advises against promoting/informing about prescription medicines through this network as it does not allow to restrict the dissemination of promotional material.

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According to the “Whistleblowing Directive” (Directive 2019/1937), private sector entities with over 50 employees as well as all public sector entities are obliged to have a whistleblowing channel. Although the deadline for implementing this Directive ended on 17 December and Spain has not yet done so, it is advisable that companies take the appropriate measures to comply with the provisions of this regulation, either by creating whistleblowing channels or, as the case may be, by adapting the existing ones to the new standards.

Whistleblowing channels and personal data

Rules, guidelines and directives have outlined how these channels should be organised. Organic Law 3/2018 on the Protection of Personal Data (article 24) regulates the processing of personal data through these channels. One key aspect is the period during which this data may be retained. According to the law, data must be deleted three months after it has been entered into the reporting system. However, in response to a query from the Spanish Compliance Association, on 22 November, the Spanish Data Protection Agency (AEPD) clarified that, if the complaint is considered well-founded and gives rise to a specific investigation, the data may be kept beyond this three-month period. However, in this case, the data must be retained in company’s systems other than whistleblowing channels (e.g. at the compliance committee or the human resources management body).

The AEPD recalls that its guide on data protection in labour relations, dated May 2021, also analyses these and other relevant aspects. By way of example, the AEPD clarifies that it is essential that workers are informed about the existence of whistleblowing channels and the processing of the data involved in making a complaint. This information can be included directly in the employment contract or, for example, by means of information letters sent to the staff.

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In the context of a dispute between  Exeltis and Italfarmaco regarding the dissemination of promotional materials by Italfarmaco of food supplement Oniria®, Exeltis requested a preliminary injunction prohibiting the dissemination of the materials and ordering their withdrawal. The Commercial Court granted the injunction and Italfarmaco appealed this decision. The decision of the Court of Appeals of Madrid which we analyse below rules on this appeal.

Anticipatory preliminary injunctions

Firstly, the Court of Appeals recalls that anticipatory preliminary injunctions, such as those requested (aimed at satisfying the claimant in advance without the need to await the final judgment), are valid and common in advertising and unfair competition litigation. Their purpose is to put an end to the actual damage that is being caused by the unfair conduct and/or to avoid the risk of aggravating the damage.

There is no de facto consensual situation

The Court of Appeals also points out that there is no de facto consensual situation (preventing the adoption of this type of preliminary injunction) whenever the parties have exchanged out-of-court correspondence prior to the request, and the party requesting the injunction has diligently combated the advertisement conducted by the counterparty by requesting its cessation.

Use of another’s reputation in advertising

Finally, when considering the likelihood of success on the merits of the case in the request for the preliminary injunction, the Court of Appeals analyses whether the conduct of Italfarmaco, which consisted in including bibliographical references to clinical studies of medicinal product Cirdadin®(marketed by Exeltis) in the advertising leaflet of the food supplement Oniria®, may constitute a case of advertising using another’s reputation.

The Court of Appeals concludes that this conduct may constitute an act of use of another’s reputation because, among other reasons, it aims to cause the addressees of the advertisement to associate the benefits of the medicinal product with those of the advertised food supplement (by transferring the results of the studies conducted with the medicinal product to the food supplement), thus taking advantage of the reputation of the medicinal product on the market.

La entrada Use of the reputation of a medicinal product in the advertisement of a food supplement aparece primero en Faus Moliner.

This judgement is well-known. Farmaindustria filed an appeal against an Order governing medical visits in the Basque Country. The appeal was filed because, inter alia, Farmaindustria considered that the Order did not allow the advertising of authorized medicinal products for which a national price and reimbursement decision was pending. The Judgement concludes that neither the Order nor any other applicable law ban the advertising of authorized medicinal products, including those that are pending to receive a price and reimbursement ruling. The Judgement is relevant because it reaches this conclusion not only on the basis of the wording of the law but also on the basis of its spirit and general purpose.

The letter of the law and the legal interest protected

The Judgement makes it very clear that Royal Decree 1416/1994, which implements European directives into Spanish law, prohibits the advertising of unauthorized medicinal products but does not ban the advertising of authorized medicinal products for which a national price and reimbursement decision is pending.

On another note, EU case law has indicated that the main purpose of EU law in the field of advertising of medicines is the protection of patients, and that Directive 2001/83/EC has brought about complete harmonization in such field. Because of this, Member States cannot adopt provisions departing from the rules laid down in Directive 2001/83/EC. In view of the foregoing, any authorized medicinal product may be promoted.

Grey zones

Spanish law has some grey zones. The law states that “the marketing of a medicinal product requires the prior completion of the corresponding price and reimbursement proceeding”. Royal Decree 1015/2009 provides that the Spanish Medicines Agency may authorize access to products which are authorized in Spain but are not commercialized (e.g. authorized products with a pending price and reimbursement decision); and prohibits the advertising of products in such conditions. This prohibition, which is included in a regulation with insufficient legal rank, may be questioned from both a Spanish and EU perspective. This Judgement sheds light on the matter; however, whether we like it or not, we must recognize that there are still grey zones.

Meanwhile…

Three recommendations for marketing authorization holders of products with a pending price and reimbursement ruling: (i) continue to opt for information activities; (ii) ensure that any activity that may be reputed to have a promotional nature has as main purpose the provision of technical/scientific information to healthcare professionals to enable them to form his or her own opinion of the therapeutic value of the medicinal product concerned; and (iii) include a reference regarding the price and reimbursement situation of the product in all printed materials.

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