El arranque, al menos por ahora, deja señales positivas. Los plazos previstos se están cumpliendo, incluido el periodo de 30 días para la aprobación del JCA tras la autorización europea, y las instituciones europeas han demostrado capacidad para coordinar un procedimiento especialmente complejo en paralelo a la evaluación de la EMA.

Sin embargo, el sistema no está exento de riesgos y dificultades. Uno de los principales problemas es la falta de previsibilidad sobre el alcance de las evaluaciones. Los PICOs (Population, Intervention, Comparator, Outcomes) continúan generando incertidumbre porque cada Estado miembro puede proponer comparadores distintos, incluidos tratamientos off-label o enfoques muy diferentes desde el punto de vista regulatorio. Esto complica la planificación de ensayos clínicos y obliga a muchas compañías a generar evidencia “a riesgo”, incluso antes de conocer qué datos acabarán siendo relevantes para el JCA.

A ello se suman unos plazos especialmente exigentes. Las compañías disponen de apenas 100 días para preparar dossiers muy complejos, algo especialmente difícil para empresas pequeñas o con menos recursos. También empiezan a surgir dudas sobre el acceso limitado a las Joint Scientific Consultations y sobre el papel relativamente restringido que tiene el desarrollador durante fases clave del procedimiento. Sin duda, el reto del HTA europeo no es únicamente técnico, sino también operativo y jurídico.

Otra incógnita relevante será la implementación a nivel nacional. Aunque exista una evaluación clínica conjunta, los Estados miembros siguen conservando la competencia para organizar sus sistemas sanitarios y adoptar sus propias decisiones en materia de precio y reembolso, tal y como reconoce el artículo 168 del TFUE. El verdadero éxito del sistema dependerá de que los Estados miembros utilicen efectivamente los JCA como referencia común y los integren en sus procesos de evaluación y decisión, evitando reevaluaciones o reinterpretaciones nacionales que puedan terminar vaciando de contenido práctico el nuevo modelo europeo.

Tras un inicio prometedor, la verdadera prueba empieza ahora. Durante los próximos años veremos si el JCA consigue realmente homogeneizar y agilizar las evaluaciones clínicas en Europa o si acaba convirtiéndose en un paso adicional que, lejos de reducirla, termine perpetuando la fragmentación existente. Por ahora, todo apunta a que Europa está dispuesta y convencida de avanzar en la primera dirección.

La entrada El primer JCA europeo: una buena señal que todavía debe demostrar su verdadero impacto aparece primero en Faus Moliner.

La entrada El medicamento en los tribunales 2025 aparece primero en Faus Moliner.

La Mesa nace con objetivos concretos: favorecer la formación de las organizaciones de pacientes, promover su participación en órganos consultivos y de decisión, impulsar prácticas de transparencia y buen gobierno y, en definitiva, articular un canal estable para trasladar sus prioridades al Ministerio de Sanidad. Es decir, no se trata solo de escuchar, sino de sentar la estructura para que esa escucha tenga respaldo normativo.

Para la Administración y para las asociaciones, la lectura es clara: la participación del paciente deja de depender de invitaciones puntuales y pasa a integrarse en un órgano con funciones concretas y capacidad real de interlocución. Pero este movimiento también tiene implicaciones relevantes para la industria farmacéutica, que desde hace años mantiene una relación creciente —y regulada por los códigos de autorregulación— con las organizaciones de pacientes. Los laboratorios colaboran con ellas para comprender mejor el patient journey, identificar barreras de diagnóstico, diseñar campañas de concienciación o, en definitiva, entender las necesidades de los pacientes.

Sin embargo, hasta ahora, esa interacción convivía con una paradoja: la voz del paciente era esencial para la industria, pero no estaba plenamente institucionalizada en el ámbito regulatorio. La creación de la Mesa corrige esa asimetría. Por primera vez, existe un foro estable, reconocido y con funciones definidas para que las asociaciones participen en la elaboración de políticas, estrategias y normas que afectan directamente a los pacientes.

Para la industria, esto supone varias oportunidades. En primer lugar, permite alinear sus iniciativas de colaboración con las prioridades que los propios pacientes expresen en un espacio oficial. En segundo lugar, anticipa un entorno regulatorio donde la perspectiva del paciente será cada vez más determinante, especialmente en la evaluación de tecnologías sanitarias, la definición del beneficio clínico incremental o la financiación de medicamentos, tal y como recoge el anteproyecto de nueva Ley de Medicamentos y Productos Sanitarios.

La voluntad del actual gobierno parece clara: la institucionalización de la voz del paciente no es un trámite administrativo, sino un cambio de reglas del juego. La Mesa abre un canal estable y legítimo. Ahora corresponde a todos —Administración, asociaciones e industria— decidir si lo utilizan para mejorar el sistema o si lo dejan en un gesto simbólico.

La entrada Institucionalizar la voz del paciente no es un trámite administrativo aparece primero en Faus Moliner.

Commentary on the new pharmaceutical legislation has focused on a number of highly relevant aspects, such as the incentives system, market access, shortages, and environmental impact. By contrast, developments relating to the advertising and information of medicinal products, despite their direct impact on companies’ day-to-day activities, have received comparatively less attention.

The new Directive will introduce significant changes in this area. Some of these developments reflect criteria already outlined in EU case law and regulatory practice; others, however, entail substantive new adjustments. In any event, their implementation will require a review of internal policies and promotional materials and activities.

As this is a Directive, its application will require transposition by the Member States. However, the margin of discretion is not unlimited. In its judgment of 8 November 2007, Gintec, C-374/05, the Court of Justice of the European Union (CJEU) held that Directive 2001/83/EC brought about complete harmonisation in the field of advertising of medicinal products. Accordingly, unless expressly authorised by that Directive, Member States are not permitted to adopt additional restrictions. For this reason, it is particularly relevant that the new Directive includes, in certain areas, explicit provisions allowing Member States to adopt more restrictive approaches. Outside these cases, additional absolute limitations may not be imposed, unless justified on public health grounds.

Against this background, the main developments introduced by the new Directive in relation to advertising of medicinal products are outlined below.

1. The concept of advertising expands to include campaigns not mentioning a specific product

One of the most significant developments is the express incorporation of the CJEU’s doctrine on the scope of “advertising of medicinal products”, as established in its judgment of 22 December 2022, Euroaptieka, C-530/20. According to this doctrine, any communication aimed at promoting the purchase of medicinal products qualifies as advertising, even if it does not refer to a specific product.

This interpretation is expressly reflected in the new Directive (recital 137 and Article 175.1(h)), which expressly includes, among the situations covered by the concept of advertising, that relating to medicinal products without reference to a specific product.

In practice, this significantly broadens the concept of advertising. With this broader scope, generic promotional campaigns relating to a “range” or category of products may fall within the concept of advertising if they encourage their purchase, even where no specific medicinal product is identified.

The transposition of this concept into national legal systems raises certain questions, as it does not seem reasonable to subject this type of advertising to the same regime as the one applicable to the promotion of specific medicinal products. For example, in Spain, it would not make sense to require the inclusion of the minimum content that must appear in all communications addressed to healthcare professionals, as set out in Articles 10 and 14 of Royal Decree 1416/1994.

Accordingly, it may be expected that national transposition will introduce specific conditions for this type of messaging. On the other hand, the new Directive provides for the possibility for Member States to directly prohibit the advertising that does not refer to a specific medicinal product (Article 177).

This provision likely stems from the CJEU’s judgment of 27 February 2025, DocMorris, C-517/23, regarding the distinction between the advertising of medicinal products and the advertising of distribution channels (e.g. pharmacies or distribution platforms), which are subject to different legal regimes, with only the former falling within the scope of Directive 2001/83/EC.

Advertising of medicinal products (including that falling within the concept outlined by the CJEU in the Euroaptieka case) is a matter of complete harmonisation. Therefore, unlike the promotion of pharmacies, Member States may not impose absolute prohibitions unless expressly authorised by the directive (as is now envisaged) or unless such restrictions are justified on public health grounds, as we had the opportunity to discuss during the Life Sciences Practice Group (LSPG) session held in Barcelona in April 2025, where Dr. Morton Douglas, from the German firm Friedrich Graf von Westphalen, shared his views on this interesting judgment.

Finally, as an indication of the EU legislator’s intention to limit excessive consumption of medicinal products, and alongside the aforementioned empowerment of Member States, the new Directive expressly introduces a prohibition on promotional activities that encourage excessive or inappropriate use of medicinal products (Article 176.3(ba)), a requirement not expressly set out in the current framework.

2. Objective advertising and tighter restrictions on comparative advertising

The new text reinforces an existing trend towards more “neutral” advertising of medicinal products.

The new Directive expressly requires advertising to disseminate objective and impartial information (recital 13). This results in two explicit prohibitions in comparative advertising: (i) highlighting negative aspects of another medicinal product; and (ii) suggesting that the advertised medicinal product is safer or more effective than another, unless such comparison is objectively supported by the SmPCs (Article 176.4).

This represents a substantial shift.

Furthermore, the idea that comparisons relating to safety, quality or efficacy are permitted only where supported by the SmPCs,  raises an important practical question: must the comparative conclusion be expressly stated in the SmPC, or is it sufficient that the underlying supporting data are referenced in it? The text does not provide clarity on this point. Nevertheless, it is clear that comparisons based solely on external studies, not reflected in the SmPC will not be permitted.

Regarding biosimilars, new Article 176.4 of the Directive must be interpreted in light of recital 136, which, although it is not expressly incorporated into the operative provisions, states that claiming that a biosimilar is not interchangeable with the original biological medicinal product or another biosimilar derived from the same originator constitutes misleading advertising.

3. Advertising to healthcare professionals extends to nursing staff

Recitals 140 and 141 acknowledge that certain medicinal products – particularly innovative, complex, or combination therapies – require not only prescribers and dispensers, but also those administering them, to understand their characteristics. On this basis, the new Directive extends the scope of advertising to include professionals authorised to administer medicinal products (Article 175).

However, Member States retain discretion to apply stricter rules for advertising directed at such professionals (Article 117.8).

In Spain, advertising of prescription-only medicinal products to nursing staff is already permitted in certain circumstances. This suggests that transposition of the Directive will largely follow a continuity-based approach. The existing framework is therefore likely to be maintained, allowing advertising in relation to medicinal products for which nursing staff have prescribing authority or a defined role under protocols and guidelines issued by the health authorities.

4. End of the “minimal value” exception: general prohibition of incentives

With regard to the regime governing incentives, current Article 86 of Directive 2001/83/EC includes, within the concept of advertising, “the gift, offer or promise of any benefit or bonus”, while excluding them where their intrinsic value is minimal. This exception is likewise reflected in Spain in Article 17 of Royal Decree 1416/1994.

The new Directive removes this exception (Article 175). Consistently, Article 183 establishes that no incentives may be provided in the context of advertising to healthcare professionals. This is a significant change, as it eliminates the legal basis that has allowed low-value materials or courtesy items, as provided for in Article 10 of the Code of Practice of Farmaindustria (EPFIA’s national member).

It should be emphasised that the new rule does not amount to a prohibition of hospitality. This point is particularly relevant because, in Spain, certain authorities have historically adopted a restrictive interpretation of the prohibition on incentives, considering that such prohibition effectively entailed a ban on hospitality in promotional settings. This interpretation was reinforced by the fact that Royal Decree 1416/1994 regulates hospitality only in the context of scientific or professional events.

However, this interpretation is not consistent with either the current Directive or the new one, which expressly provides that the prohibition on incentives does not prevent the provision of hospitality at promotional events, provided that it is strictly limited to the primary purpose of the event and is not extended beyond healthcare professionals (Article 183(2)).

5. Samples: possible extension to dispensers

While the new text does not substantially revise the regime governing samples, it introduces an important clarification. Recital 135 indicates that samples may be provided not only to prescribers but also to those who dispense medicinal products.

Accordingly, Member States may, on an exceptional basis, allow the provision of samples of non-prescription medicinal products (OTC) to dispensers (Article 185(2)).

This development is significant in the Spanish context, where the authorities have traditionally adopted a more restrictive interpretation, considering that the rules prohibit the provision of samples to pharmacists, even though this is not expressly provided for in Royal Decree 1416/1994.

The new Directive appears to align with CJEU case law and with the debate that emerged following the judgment of 11 June 2020, Ratiopharm / Novartis Consumer Health, C-786/18, which confirmed that the Directive permits the provision of samples of non-prescription medicinal products.

Nevertheless, the new provisions still leave certain grey areas, particularly as it would have been desirable to clarify whether the regime applicable to the provision of samples of prescription medicinal products and that applicable to OTC samples are equivalent, given that the above-mentioned case law had already recognised that they are distinct regimes.

6. Transparency of transfers of value: moving beyond self-regulation

In connection with this matter, the he new rules, depart from the idea that even minimal incentives may influence prescribing decisions (recital 139.a).

The new Directive introduces new obligations for Member States and marketing authorisation holders   regarding transparency of transfers of value (Article 186.4a). Where no national rules exist, Member States must provide a public webportal with links to the transparency disclosure platforms operated by industry associations or the marketing authorization holders, who  will be required to provide such links and ensure the accuracy and timely publication of the information.

While a fully harmonised EU transparency regime is not yet imposed, the shift is significant: transparency moves from a purely self-regulatory framework to integration within public information systems.

7. Other developments: shortages, public advertising, and new content restrictions

First, Member States may suspend the advertising, targeted at both healthcare professionals and the public, in situations of shortages or risk thereof (Article 177.7). While justified from a public health perspective, the concept of “risk of shortage” remains broad and may create legal uncertainty if not further specified through objective criteria. The text itself provides that the suspension shall be withdrawn as soon as the shortage or risk of shortage ceases.

Second, Member States may restrict the use of the trademark or designation of the medicinal product in reminder advertising directed at the general public, limiting it instead to its active substance (Article 178.2).

In addition, new content restrictions are introduced for advertising directed at the general public. In particular, the existing prohibition on endorsements by scientists and healthcare professionals is extended to include endorsements by healthcare institutions or facilities (Article 179). This may have a significant practical impact, for example in relation to the use of imagery, settings, or references evoking pharmacies, hospitals, or other healthcare environments.

Finally, the new Dierctive expressly prohibits referring, in advertising, to the fact that a medicinal product has been granted a marketing authorisation.

La entrada Updates on advertising of medicinal products in the new EU Pharmaceutical Legislation aparece primero en Faus Moliner.

La entrada Exempting PDMPs from cost containment measures aparece primero en Faus Moliner.

Para la industria farmacéutica, y especialmente para los promotores de ensayos clínicos, el nuevo marco aplicable a la importación y exportación de muestras biológicas no es un asunto menor. En muchos ensayos internacionales las muestras de los participantes viajan a laboratorios de fuera de la UE para su análisis, de modo que cualquier retraso puede comprometer la estabilidad de las muestras, demorar los resultados y, en última instancia, afectar a la integridad de los datos del ensayo.

La nueva norma en tramitación también resulta de interés para los fabricantes de reactivos de diagnóstico in vitro destinados a la investigación, los cuales igualmente quedarán sujetos a la nueva norma. El proyecto supone una mejora relevante respecto al marco normativo anterior. Así, por ejemplo, prevé, con carácter general, tiempos de tramitación cortos -un plazo máximo de tres días hábiles- para emitir la autorización de entrada o salida de las muestras y el certificado sanitario de exportación, desde recepción de la solicitud completa, lo cual es positivo.

Convendría, no obstante, valorar la posibilidad de incorporar en la norma algunas previsiones específicas para ensayos, que la harían más alineada con la realidad en estos casos: en primer lugar, una mayor integración con la normativa específica de ensayos permitiría articular autorizaciones vinculadas al protocolo, evitando duplicidades y cargas documentales excesivas y, en suma, simplificando la gestión regulatoria; en segundo lugar, la introducción de mecanismos más flexibles, como autorizaciones marco para envíos recurrentes, facilitaría la operativa de ensayos con alto volumen de muestras; y, también, una regulación más abierta del destino del material sobrante, permitiendo su reutilización bajo garantías éticas y de consentimiento informado, contribuiría a maximizar su valor científico sin comprometer la seguridad ni la protección de los participantes.

Dada su importancia estratégica, resulta fundamental que el sector participe activamente en la fase de audiencia pública, cuyo plazo para la remisión de aportaciones finaliza el próximo 6 de mayo. El trámite de audiencia pública es el cauce legal establecido para que los interesados trasladen sus aportaciones al Ministerio para su valoración, una herramienta sin duda valiosa para hacer llegar la visión del sector. En definitiva, participar ahora es la vía más eficaz para defender la competitividad de España y afianzar su posición como destino de referencia en investigación biomédica.

La entrada Participar para defender la competitividad en investigación aparece primero en Faus Moliner.

Xavier Moliner, Juan Martinez, Anna Gerboles and Laia Rull were in charge of chapter 16 dedicated to drug and medical device litigation.

La entrada Faus Moliner participates in “International Comparative Legal Guide – Drug & Medical Device Litigation 2026”   aparece primero en Faus Moliner.

Durante su fase de consulta pública se han recogido más de 600 comentarios y sugerencias de diversas partes interesadas, muestra del interés del sector por este asunto. Yendo más al fondo del asunto, me permito hacer algunas reflexiones. En la era de la medicina basada en la evidencia, el sector farmacéutico se enfrenta a una paradoja: nunca hemos tenido tanta información disponible y, sin embargo, su uso para la toma de decisiones regulatorias sigue siendo un desafío. La guía ahora publicada pone el foco precisamente en esta tensión estructural: la oportunidad de generar evidencia más representativa frente al riesgo de construir conclusiones sobre cimientos imperfectos.

Frente al entorno controlado de los ensayos clínicos, los RWD permiten evaluar la efectividad de las intervenciones en la práctica clínica diaria que en el marco de un ensayo no se pueden observar. Bien gestionado, el uso de los RWD puede acelerar el acceso a nuevas terapias y optimizar decisiones regulatorias. El gran desafío surge, no obstante, con el uso secundario de los datos. Al reutilizar datos que no fueron generados con un propósito científico concreto, se pueden heredar conjuntos de datos incompletos o inconsistentes que exigen un adecuado control de calidad. Aquí radica el punto clave para la industria: la calidad no es un atributo inherente al dato, sino contextual.

El concepto fit-for-purpose obliga a evaluar si un conjunto de datos es adecuado para una pregunta concreta, no si es “bueno” en términos absolutos. Esta lógica exige una mayor madurez en la gobernanza del dato, donde cada actor asuma responsabilidades en su generación, validación y uso. Además, la integración de múltiples fuentes, las diferencias entre sistemas sanitarios y la evolución de prácticas clínicas generan retos adicionales. En este escenario, la industria farmacéutica tiene la oportunidad de liderar el desarrollo de estándares, invertir en infraestructuras de datos y promover la transparencia.

En última instancia, la adopción de la evidencia basada en RWD dependerá de que los reguladores crean en ella. El futuro del sector no pasa únicamente por innovar en moléculas, sino por innovar en cómo generamos y utilizamos la evidencia. Y ahí, la calidad del dato dejará de ser un problema técnico para convertirse en una ventaja competitiva.

La entrada Importa la cantidad, pero también la calidad aparece primero en Faus Moliner.

Those interviewed by The Legal 500 highlight that Faus Moliner is «one of our benchmark firms because of its incredible command of the pharmaceutical world, and because it knows how to advise with a very practical approach, with a very good command of the applicable regulations» and that they have «high specialisation in the health and pharmaceutical sector, practical approach, committed team always available to resolve issues». They also state that  «the number of people dedicated to pharmaceutical matters is higher than in any other firm. The guidance provided by Jordi Faus is excellent, as is that of new partners like Lluís Alcover».

They also highlight that «their in-depth knowledge of the sector is exceptional. They have a top-level partner, Jordi Faus, complemented by young lawyers who are increasingly specialising in different areas within the sector.»

La entrada Faus Moliner recognized once again in the 2026 edition of The Legal 500 (Legalease) aparece primero en Faus Moliner.

Since these rankings began twenty years ago, Faus Moliner has consistently held the top position in the Life Sciences sector in Spain.

In this edition, Faus Moliner also stands out as the only firm in Spain with five lawyers individually recognized in this area: Jordi Faus as a Star Individual, Xavier Moliner in Band 2, and Lluís Alcover in Band 3.  Additionally, Juan Martínez and Joan Carles Bailach are listed as Associates to Watch, a designation that recognizes professionals with an outstanding track record and market potential.

The comments included in the guide highlight the team’s technical expertise, its in-depth knowledge of the sector, and its practical approach to providing legal services. In this regard, the guide includes the following assessments:

These recognitions reflect the Faus Moliner team’s dedication to excellence and its firm commitment to providing highly specialized advice to its clients. The firm thanks its clients and friends for their trust, as well as for their participation in this process.

La entrada Faus Moliner, Ranked in Band 1 for Life Sciences in Chambers Europe 2026 aparece primero en Faus Moliner.