In his presentation, Lluís Alcover highlighted the significance of the new European Health Technology Assessment Regulation. The Regulation will mark a turning point in the way medicinal products are evaluated in Europe. He explained that this regulation seeks to harmonise clinical criteria among Member States, but at the same time introduces a more complex and demanding framework for pharmaceutical companies. Companies will have to adapt their regulatory and market access strategies from the very early stages of clinical development.

Lluís warned that access to Joint Scientific Consultations (JSCs) will be limited, which could pose a risk of breaching the principle of equality recognised in the EU Charter of Fundamental Rights. There will not be room for everyone, and only some companies will be able to obtain early advice to align their trials with the expectations of the assessment agencies. This limitation raises questions about procedural fairness and transparency in the allocation of opportunities for dialogue with the authorities.

Another critical point highlighted was the possibility that joint clinical assessments (JCAs) may include off-label comparators. This approach will require special attention from companies to ensure that the evidence generated is relevant and robust in relation to the selected comparators. Furthermore, there is some concern about comparing technologies with different regulatory and cost profiles, as this could introduce bias into the assessment and pose a problem when interpreting the assessment results.

Finally, Lluís stressed that the role of developers in defining PICOs (patient population, interventions, comparators and health outcomes) and reviewing draft JCAs will be very limited, which may strain the right to be heard and make it difficult for developers to defend the value of their technology. All of this, he warned, opens a new front of legal and procedural challenges that will require companies to strengthen their regulatory planning and their legal response capacity.

Financing of medicinal products

Joan Carles Bailach spoke about the main challenges that the Draft Law on Medicinal Products and Medical Devices (Draft Law) should address to achieve a more agile system for the incorporation of therapeutic innovation and, at the same time, a more predictable one for the companies operating within it. To this end, the Draft Law should incorporate or better define the following instruments.

Firstly, Joan Carles explained that the new Law should include early dialogue as an instrument enabling companies and the Administration to formally initiate price and reimbursement negotiations once the CHMP has issued a positive opinion on the marketing authorization. This tool would substantially reduce the timeframes for financing and would place Spain at the forefront in Europe, as many countries have yet to incorporate it into their legislation.

Secondly, the new Law should include instruments aimed at reducing access times and making the process more predictable. These include the accelerated financing procedure and conditional financing.

The accelerated financing procedure would shorten the processing times for certain medicinal products of public health interest, such as orphan medicinal products, advanced therapies, oncology or antimicrobial medicinal products, among others. In this regard, the Secretary of State for Health, during his appearance before the Health Committee of the Spanish Parliament on 28 October 2025, announced that the new Law will incorporate a period of less than 90 days, especially for medicinal products intended to cover unmet medical needs.

Conditional financing would allow for the provisional reimbursement of medicinal products subject to clinical or economic uncertainty, conditional on the generation of new real-world evidence. This model would facilitate faster access to innovative therapies, while maintaining risk control for the National Health System through review clauses, clawback mechanisms or provisional discounts.

Both instruments would contribute to more equitable access, reduce current legal uncertainty and balance the need for speed with that of sustainability and rigor in decision-making.

Finally, Joan Carles considered that the new Law should contemplate the possibility of conventional termination in certain price and reimbursement procedures, allowing the Administration and companies to modify or terminate the agreement when circumstances beyond the control of the parties arise. This measure would provide greater legal certainty and flexibility, promoting more efficient management of uncertainty and an effective collaborative relationship between industry and the Administration.

New developments in advertising

In the session dedicated to advertising, Anna Gerbolés addressed the new developments introduced by the new regulatory framework on the promotion of medicinal products. In particular, she examined those included in the Draft Law on Medicinal Products. She also reviewed the Draft Royal Decree on the promotion of medical devices, analysing the possible impact that this draft might have on the future regulation of medicinal product promotion.

Among the most relevant new developments regarding advertising in the Draft Law, Anna referred to those introduced in the sanctioning framework. One of them is the reclassification of the infringement of the rules on promotion of medicinal products, which will no longer be considered “very serious” but “serious”, thus aligning the sanction with that established for the irregular promotion of medical devices.

Another significant development is the introduction of a new infringement concerning the prohibition of promoting medicinal products prior to their marketing, aimed at closing the debate opened following the Supreme Court ruling of March 2025. This ruling determined that promotion prior to the price and reimbursement resolution does not infringe Royal Decree 1416/1994, regulating the advertising of medicinal products for human use, if it includes information about the price of the product. During the session, it was noted that this new infringement could be contrary to Directive 2001/83/EC, as it would establish an absolute prohibition not foreseen in that Directive. The case law of the Court of Justice of the European Union -in particular, judgments C-374/05 (Gintec, 2007) and C-786/18 (Ratiopharm, 2020) has reiterated that absolute restrictions cannot be imposed in a field of full harmonization. It is therefore likely that this infringement will be removed from the final text.

Lastly, Anna analyzed the measures included in the Draft Royal Decree on the promotion of medical devices, warning of the risk that some of them might be unduly transferred to the field of medicinal products, despite their different regulatory frameworks. For example, the broadening of the concept of “promotion” for medical devices -which would include any meeting financed by the company to present the characteristics of a product- contrasts with the narrower view that applies to medicinal products.

Similarly, the absolute prohibition of offering hospitality at promotional meetings, as foreseen for medical devices, would not be compatible with the Directive if applied to medicinal products, since Article 94 allows hospitality if it is moderate and subordinate to the scientific or professional purpose of the meeting. An absolute prohibition on hospitality would also be contrary to the European framework.

Artificial intelligence in the medicinal product life cycle

During her presentation, Claudia Gonzalo addressed how artificial intelligence (AI) is not only advancing in the healthcare field but is also beginning to be integrated throughout the entire life cycle of a medicinal product: from discovery and clinical trial design to manufacturing and pharmacovigilance. Her presentation revolved around a key idea: AI does not replace human responsibility, but it does redefine the way critical decisions are made in the pharmaceutical sector.

She explained that AI is already accelerating phases such as the discovery of new molecules or the selection of patients for clinical trials, and that regulatory agencies now recognize evidence generated by algorithmic systems. She also pointed out that the European Union’s Good Manufacturing Practices are preparing to incorporate a new Annex 22 dedicated to AI, and that in the commercialization phase this technology is already being used to improve the detection of adverse effects and optimize supply management.

However, she warned that this progress will only be sustainable if it is governed under two principles: the risk-based approach -according to which regulatory requirements should increase in proportion to the criticality of the decision- and the quality and traceability of data, all within the context of building the highest possible level of trust in the system.

Finally, she highlighted the strategic role of the legal department in the integration of AI. Successful implementation cases, she noted, share common elements: a clear inventory of models and risks, the adaptation of contractual clauses to algorithmic environments, and internal procedures that guarantee the quality of both system and the data that feeds it. Her closing message was clear: it is not about slowing down innovation but about accompanying it monitoring structures that ensure its development with safety and traceability.

Closing Conference

Jordi Faus began his speech by highlighting the high level of participation in the course, and his satisfaction at seeing how the work carried out by those who have participated in submitting proposals to the Spanish Administration concerning the regulations being developed has not been in vain. As Ana Bosch (Farmaindustria) pointed out, the proposals have been listened to attentively and, in many cases, incorporated into those that the Ministry of Health is willing to present and defend. This speaks highly of the Administration but also of those who have formulated the proposals, especially Farmaindustria, CEFI, and some companies and professionals who have participated in the process.

As for the current situation, in which “everything related to the regulatory core is under review” (César Hernández), Jordi stressed that it is essential to recognize the role of the industry and of lawyers specializing in pharmaceutical law, pointing out that “what is going to be approved are legal rules, so I encourage you to participate in everything you can (…) with a broad perspective, considering relevant economic, social, and ethical aspects, and putting yourselves in the position of the managers, as Manuel Cervera also said, because what is needed is a calm debate built on solid foundations and with few, if any, prejudice”.

In this context, Jordi agreed with the idea expressed by Javier Padilla: in times of uncertainty such as the present, it is advisable to avoid overreacting and to maintain the commitment to more Europe. Remaining firmly committed to the core values of the EU is of the utmost importance. Having public health systems whose main objective is to protect the health of citizens and help them overcome disease is a social achievement that must be nurtured every day. It is, ultimately, a question of culture. The same applies to understanding -as pointed out in the Commission’s July Communication (“Strategy for European Life Sciences to position Europe as the world’s most attractive place for life sciences by 2030”), that beyond preserving competitiveness, we must approach these matters considering that “this is also a strategic investment in intergenerational fairness, as the aim is for Europe to lead with purpose, so that innovation serves people and the planet, both now, and for generations to come”.

On the other hand, Jordi once again insisted that committing to Europe must also mean guaranteeing the full effectiveness of European Union law, citing case law that requires national provisions contrary to EU law to be set aside. Supporting this view, he noted that administrations, for example, should not prevent a product from being placed on the market (even on the private market) nor prohibit its promotion once the European Commission has granted a marketing authorization.

Regarding the 2024-2028 Pharmaceutical Strategy, Jordi pointed out that it is a government action plan approved by a resolution of the Council of Ministers of 10 December 2024 -a text that may be used in any interpretation of any regulation or action by the General State Administration.

The plan’s objectives are divided into chapters: (i) equitable access to medicinal products and sustainability of the NHS; (ii) promotion of research, development and innovation; and (iii) autonomy, which encompasses both the idea of ensuring the competitiveness of the sector and its contribution to strategic autonomy through a solid, resilient and eco-sustainable supply chain.

In relation to these objectives, the importance of conceiving pharmaceutical policy as a genuine national policy was highlighted, which should also integrate industrial, social and employment aspects. Perhaps one of the positive side effects of the pandemic has been precisely to make us aware of the importance of what we now call strategic autonomy, and of the need to support those who concentrate their investments, efforts and daily work in production units. Jordi considered it noteworthy that the strategy recognizes, as current challenges for the sector, (a) the greater complexity of research and development of therapies to meet unmet needs and (b) the vulnerability of supply chains caused by an exodus of production facilities because of globalization and cost pressures.

Regarding the sustainability of the system, Jordi provided a historical perspective on this issue, highlighting that the challenge of sustainability has always been present, but pointing out that the measures to address it should be adapted to the current reality. We are not, Jordi said, in the 1980s, “when the task was to adopt measures to exercise a certain control over a significant portion of public funds, the use of which depended on the decision of the prescribing professional.” In the 21st century, the products with the greatest budgetary impact are ones where the industry’s ability to influence the volume of demand is low or even non-existent. For this reason, if the crux of the matter in terms of sustainability lies in in the tension between the developers’ ability to supply technologies and the capacity of public health systems to structure their demand appropriately as part of their public policies, the priority should be to work on how demand is structured, not on creating obstacles for supply, especially when discussing about therapeutic areas where the industry’s ability to influence the volume of demand is very low or even non-existent.

Finally, it was pointed out that access issues are closely related to the individual rights of patients, highlighting that, although in Spain the right to health protection is not a fundamental right but only a guiding principle of administrative activity, certain case law recognizes that the fundamental right to life and physical integrity must mean more than the mere right to exist.

After reviewing the actions outlined in the Strategy, Jordi concluded by expressing his hope that the new rules, like the medicinal products they regulate, will be of high quality, offer legal certainty, and establish an effective framework to support a favorable environment for innovation, for the benefit of society as a whole and especially of patients.

La entrada Summary of the presentations given by the Faus Moliner team at the 20th Pharmaceutical Law Course organised by the CEFI Foundation aparece primero en Faus Moliner.

This landmark CJEU judgment concludes that the general and absolute ban on the advertising of pharmacies and their activities, as established in Article 94a of Poland’s Pharmaceutical Law, infringes EU law.

The case originated from proceedings brought by the European Commission, arguing that the Polish law breached Article 8 of Directive 2000/31/EC on electronic commerce and Articles 49 and 56 of the Treaty on the Functioning of the European Union (TFEU), which guarantee freedom of establishment and the free provision of services.

Advertising of regulated professions

In EU law, the ability of regulated professionals (such as pharmacists or lawyers) to promote their services has long been debated.

On the one hand, the CJEU has held that Article 8 of Directive 2000/31/EC aims to ensure that “all” members of a regulated profession may use information society services to promote their professional activities. At the same time, it has acknowledged that these commercial communications may be subject to compliance with applicable professional rules (e.g. professional secrecy or loyalty towards clients and colleagues).

However, according to the CJEU, the effectiveness of Article 8 would be undermined if professional rules could impose a blanket ban on all online advertising by regulated professionals. The Court has stated that, while such professional rules can define the content and format of commercial communications referred to in Article 8(1) of that Directive, they cannot impose a general and absolute prohibition of such communications.

In light of this case law, Poland argued that its legislation did not impose a general and absolute prohibition on the promotion of the professional services of pharmacists because it did not affect “all” of them, but only those working in a pharmacy. Pharmacists working in universities, hospitals or pharmaceutical companies, were able to promote their services.

However, the CJEU rejects this argument, noting that around 70% of pharmacists in Poland work in pharmacies or retail outlets; that the Polish law banned pharmacies from advertising online sales; and that only basic information, such as location and opening hours, was allowed to be advertised. Given these facts, the Court ruled that the Polish legislation was incompatible with EU law.

Advertising and protection of public interests

With regard to the possible impact on the principles of freedom of establishment (Article 49 TFEU) and freedom to provide services (Article 56 TFEU), Poland acknowledged that its legislation could constitute a restriction, but argued that this was justified by an overriding reason of public interest – namely, the aim of reducing overconsumption of medicinal products and preserving the professional independence of pharmacists.

The CJEU recalled that, under settled case law, any restriction on freedom of establishment or services must be justified by an overriding reason of public interest and must be proportionate.

After reviewing Poland’s arguments, the Court found these conditions were not met.

Regarding the aim of curbing overconsumption of medicinal products, the CJEU considers that Poland failed to demonstrate how allowing pharmacies to advertise would lead to overuse of medication. The CJEU also notes that Poland had not demonstrated that its law had succeeded in reducing the consumption of medicinal products. Furthermore, it considers that advertising might simply shift market share between pharmacies, without increasing overall use.

In addition, the Court emphasises that non-prescription medicinal products in Poland are also sold outside pharmacies – in shops, supermarkets, news-stands or service stations – without any equivalent advertising ban. Therefore, the CJEU concludes that prohibiting advertising by pharmacies is not an effective measure to curb overconsumption of medicinal products. On the contrary, advertising could benefit consumers by allowing them to compare prices or discover additional services offered by different pharmacies.

Regarding pharmacists’ professional independence, Poland claimed the ban protected pharmacists from commercial pressure by pharmacy owners to increase sales. The Court dismisses this argument, finding that such protection could be achieved through less restrictive means – such as regulating the content of advertisements.

Conclusion

This CJEU judgment reaffirms that the protection of public health – through the promotion of the rational use of medicinal products – and the preservation of professional independence cannot be invoked in a general manner to justify disproportionate restrictions on the freedoms guaranteed by EU law.

Member States must have objective, evidence-based and sufficiently substantial reasons to justify any restriction of the freedom of establishment or to provide services. Therefore, before introducing absolute prohibitions that may compromise these freedoms – as is the case with the general ban on pharmacy advertising – a rigorous analysis must be carried out to determine whether the proposed measure effectively and proportionately contributes to the protection of public health.

Possible impact in Spain

This judgment may have an impact on regional pharmaceutical regulations in Spain, as some Autonomous Regions have similar bans on pharmacy advertising.

In light of this recent CJEU judgment, it is worth noting the Spanish Constitutional Court’s Order 13/2018 of 7 February, which addressed the constitutionality of Article 30 of the former pharmacy law in Madrid. That provision prohibited pharmacy advertising. The issue raised was the right of healthcare professionals to promote their services, as recognised in Article 44 of Law 44/2003 on the regulation of healthcare professions.

Although the Spanish court found no conflict between the two laws at the time, the CJEU has now identified a clear conflict between professionals’ rights to advertise their services (as guaranteed by Article 8 of Directive 2000/31/EC) and the Polish ban on pharmacy advertising. This could pave the way for regulatory changes in regions like Galicia, Murcia, or the Canary Islands, where similar bans exist.

It will be important to monitor how Spain’s Autonomous Regions respond to this development, especially given how broad the concept of “promotion” can be. For example, in another recent CJEU judgment (27 February 2025, DocMorris, C-517/23), the CJEU ruled that a marketing campaign offering immediate rewards (like discounts or vouchers) for presenting prescriptions at an online pharmacy did not constitute medicinal product advertising. Instead, it was deemed pharmacy advertising, as its purpose was to influence consumers’ choice of pharmacy.

La entrada Pharmacy advertising and protection of public health aparece primero en Faus Moliner.

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.

La entrada Criteria to be considered in the advertising of medical devices aparece primero en Faus Moliner.

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.

La entrada Conformity with the SmPC is a “per se” rule in advertising of medicinal products aparece primero en Faus Moliner.

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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