The European pharmaceutical package places security of supply among the central objectives of the regulatory framework, strengthens the prevention of shortages, and provides for significant penalties in the event of non-compliance with the applicable rules.

All of this entails an increase in the obligations imposed on companies, which will have to take on a more active role in ensuring continuity of supply, and new coordination mechanisms at Union level.

In this Capsulas, we analyse the main obligations affecting marketing authorisation holders (MAHs) in relation to supply and shortages.

Notification obligations

Until now, EU legislation allowed MAHs to withdraw a medicinal product from the market by simply giving at least two months’ notice (Article 13 of Regulation (EC) No 726/2004 and Article 23a of Directive 2001/83/EC), or even at shorter notice in “exceptional circumstances”.

The new Regulation introduces stricter and more harmonised rules that will apply to all medicinal products, whether authorised by the EMA or by Member States. As it is a Regulation, it will be directly applicable in all Member States, without the need for transposition.

In this regard, it is expected that MAHs will have to inform the competent authority of the Member State- and the EMA in the case of a centralised marketing authorisation – and provide reasons for the following decisions:

• The permanent cessation of the marketing of the product, at least 12 months in advance.

• The temporary suspension of marketing, at least 6 months in advance.

• A request for the withdrawal of the marketing authorisation, also at least 12 months in advance.

• Foreseeable temporary disruptions in supply lasting more than two weeks, at least 6 months in advance.

Where duly justified exceptional circumstances arise, the MAH may notify such interruptions at a later point in time, as soon as it becomes aware of them.

Critical medicinal products

Additional specific obligations are introduced in relation to medicinal products considered “critical” in any Member State or priority antimicrobials.

In these cases, before proceeding with the cessation, suspension or withdrawal, the MAH must:

• Publish a declaration of its intention to transfer the marketing authorisation or to issue a letter of access, and inform the national competent authorities and the EMA accordingly. This declaration must be published through a dedicated page on the MAH’s website, and the electronic link to that page must be communicated to the competent authority of the Member State and to the EMA.

• Offer, on reasonable terms, the transfer of the marketing authorisation or the granting of a letter of access to a third party that has declared its intention to market the medicinal product or to use the pharmaceutical, non-clinical and clinical documentation contained in its file for the purpose of submitting an application for a marketing authorisation.

• Inform the competent authority of the outcome of the negotiations with such third parties (the EMA, in the case of medicinal products authorised under the centralised procedure, and the national authorities in all other cases).

In addition, in the formal notification of cessation or withdrawal, the MAH must provide evidence that it has taken effective measures to make the marketing authorisation available to third parties.

It should be noted that Spain has, for several years, been one of the most active Member States in this area, with the AEMPS playing a prominent role. Notwithstanding this, the new European legislation will mean that the AEMPS will no longer be able to require certain medicinal products to remain on the market. This possibility, however, is maintained in the Preliminary Draft Law on Medicinal Products and Medical Devices.

Shortage prevention plans

The Regulation requires MAHs to have in place, and to update periodically, a shortage prevention plan (SPP) as a key tool for the preventive management of shortage risk.

This obligation applies to all prescription medicinal products, as well as to those expressly designated by the Commission on the basis of criteria such as the number and frequency of previously notified critical shortages; the characteristics of the medicinal product and the availability of authorised alternatives; its therapeutic relevance and the conditions it is intended to treat; or potential risks to public health.

The EMA will draw up guidelines on the preparation and content of SPPs, and the Commission or the national authorities may require the MAH to submit the relevant SPP to them at any time.

Furthermore, in relation to medicinal products not subject to this obligation, the MAH must carry out a regular documented risk assessment of potential supply chain risks and, where necessary, take mitigating measures. Both the EMA and the national authorities may request the submission of such assessments at any time.

Parallel trade

In recital 138a, the Regulation recognises that, although the Court of Justice of the European Union has ruled that parallel trade is beneficial to the internal market, it has also recognised the need to ensure reliable supply to meet essential medical needs, ensuring the availability of quality medicinal products for the public.

In this context, the Regulation enables Member States to require wholesale distributors intending to supply to another Member State to notify that intention to the competent authority of the Member State of origin.

Based on this information, the Member State of origin may adopt the necessary measures to prevent or mitigate possible shortages in its territory. In any event, such measures must be duly justified on grounds of the protection of public health and be proportionate to the objective pursued, in accordance with EU law.

Critical shortages of Union concern

Beyond measures at national level, the Regulation also establishes specific coordination mechanisms at Union level to address particularly serious shortage situations.

In this regard, a list of critical shortages that cannot be resolved without coordination at EU level will be established and kept up to date, and recommendations may be issued on measures to resolve or mitigate such critical shortages of Union concern.

Following the inclusion of a medicinal product in the list of critical shortages of Union concern, the MAH must provide any additional information that the EMA may request, including periodic information on available stocks of the medicinal product concerned; take into account the recommendations and measures adopted at European level; report on the results of those measures; and inform the EMA and the competent authority of the Member State of the end date of the critical shortage of Union concern without undue delay.

Penalty regime

One of the main new features of the pharmaceutical package is the extension of the existing penalty regime in the pharmaceutical field.

At present, the penalty regime for non-compliance with MAH obligations in relation to medicinal products authorised under the centralised procedure is laid down in Regulation (EC) No 658/2007, which includes the definition of the conduct that may give rise to a penalty, the principles governing the imposition of penalties, the rights of the parties concerned, and other procedural rules.

The new Regulation maintains and strengthens Regulation (EC) No 658/2007, empowering the European Commission to impose penalties in the event of non-compliance by MAHs with obligations such as:

• Notification obligations within the time limits laid down in the Regulation.

• The obligation to transfer the marketing authorisation or to allow a third party to use the documentation in the file of the medicinal product.

• The obligation to have an SPP in place and to keep it up to date.

• The obligation to cooperate and provide the information requested in shortage situations.

• Specific obligations in relation to critical shortages of Union concern.

• Obligations relating to critical medicinal products.

• Compliance with the recommendations issued by the Executive Steering Group on Shortages and Safety of Medicinal Products.

Failure to comply with these obligations may lead to the imposition of financial penalties, in the form of fines or periodic penalty payments.

Fines may amount to up to 5% of the MAH’s Union turnover in the preceding business year; and periodic penalty payments may amount to up to 2.5% of the MAH’s average daily turnover in the European Union in the preceding business year for each day of delay in complying with the obligations.

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El lema de esta visita ha sido ‘alzar la mirada’, una invitación a mirar más allá, a cambiar la forma de observar la realidad y a reconocer oportunidades donde quizá solo parecía haber rutina. Vivimos en un mundo donde todo sucede cada vez más rápido; lo que hoy es noticia mañana parece haber quedado atrás, y donde el ritmo cotidiano nos absorbe hasta el punto de impedirnos apreciar los cambios de fondo que se están produciendo.

Si alzamos la mirada también en nuestro sector, veremos que, más allá de la sucesión constante de titulares, alegaciones y consultas públicas, se está produciendo una de las transformaciones regulatorias más intensas de los últimos años. Quizá la velocidad del día a día no nos permite apreciar la magnitud del cambio.

Si paramos un momento y observamos el camino recorrido en tan solo tres años, podemos comprobar cómo la maquinaria legislativa y reglamentaria del Ministerio de Sanidad ha trabajado a pleno rendimiento. En este tiempo se han tramitado o se están tramitando numerosas normas de gran calado: la nueva Ley de Medicamentos y Productos Sanitarios, el Real Decreto de Evaluación de Tecnologías Sanitarias, el Real Decreto de precio y financiación de medicamentos, el Real Decreto de financiación de productos sanitarios para pacientes no hospitalizados, el Real Decreto de fórmulas magistrales a base de cannabis y muchas otras iniciativas que están redefiniendo el marco regulatorio del sector.

El pasado miércoles, durante la inauguración de la torre de Jesucristo, pudimos ver un excelente espectáculo con drones en el que apareció una frase de Gaudí: ‘Primero el amor, después la técnica’. Con estas palabras, Gaudí expresaba que la técnica era indispensable, pero que debía ponerse al servicio de algo más importante: la sensibilidad, la belleza, la naturaleza y, en definitiva, el bienestar humano. La torre de Jesucristo de la reforma farmacéutica que estamos viviendo es la futura Ley de Medicamentos y Productos Sanitarios. Sin duda, esta pieza legislativa culminará todas las reformas que hemos ido encadenando en los últimos años. Siguiendo el ejemplo de Gaudí, la técnica legislativa debe ponerse al servicio de los pacientes y del bienestar humano.

Llevamos ya casi cuatro años desde que se publicó la consulta pública de la nueva Ley. El proceso ha sido participativo y ha estado lleno de técnica y de compromiso por parte de todos los agentes implicados: Ministerio de Sanidad, industria, pacientes y profesionales sanitarios. Es momento de darle un impulso definitivo, encontrar los consensos necesarios y culminar esta obra colectiva.

Gaudí decía que «mi cliente no tiene prisa». La historia de la Sagrada Familia demuestra que algunas grandes obras requieren tiempo, visión y perseverancia. La futura Ley de Medicamentos y Productos Sanitarios también aspira a ser una gran obra colectiva. Es momento de alzar la mirada, reconocer el camino recorrido y dar el impulso necesario para culminar una reforma largamente esperada por todo el sector.

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A partir del 28 de mayo de 2026, las antiguas aplicaciones CCPS y RPS dejan de admitir nuevas comunicaciones, salvo en el caso de los fabricantes de productos sanitarios a medida, que continuarán utilizando el RPS. RECOPS, por su parte, entrará en funcionamiento el 15 de junio y exigirá que los productos estén previamente notificados y visibles en Eudamed, ya que la aplicación descargará desde allí los datos correspondientes.

A primera vista, podría parecer una novedad meramente administrativa: una nueva plataforma, otro trámite, una obligación adicional para los operadores. Sin embargo, sería una lectura demasiado limitada. RECOPS no es solo un cambio de herramienta; es una pieza más en la construcción de un sistema regulatorio en el que la trazabilidad deja de ser un concepto abstracto y pasa a convertirse en una garantía operativa.

El sector de los productos sanitarios ha experimentado en los últimos años una transformación profunda. Los reglamentos europeos han elevado las exigencias en materia de seguridad, vigilancia, evidencia clínica, responsabilidades de los operadores y control postcomercialización. En este contexto, disponer de registros nacionales ordenados y conectados con la lógica de Eudamed no responde a un afán burocrático, sino a una necesidad de coherencia del sistema.

Para las empresas, la puesta en marcha de RECOPS exigirá preparación. No bastará con saber que existe una nueva aplicación. Será necesario revisar carteras de producto, identificar qué productos deben registrarse, coordinar la información con las notificaciones realizadas en Eudamed y asegurar que los equipos regulatorios, de calidad y comerciales trabajan con datos consistentes.

La reflexión de fondo es clara: el cumplimiento regulatorio en productos sanitarios será cada vez menos reactivo y más estructural. Ya no se trata únicamente de responder ante una inspección o de cumplir un requisito documental concreto, sino de construir sistemas internos capaces de sostener, de forma continua, la información que las autoridades necesitan para supervisar un mercado cada vez más complejo y tecnológicamente sofisticado. En la práctica, esto incrementa la importancia de mantener datos consistentes sobre UDI, variantes/modelos, etiquetado, instrucciones de uso, agente económico responsable, estado de comercialización y correspondencia con la información cargada en Eudamed. RECOPS obligará a muchas compañías a mirar con más atención la calidad de sus datos regulatorios.

Quienes entiendan RECOPS solo como un trámite probablemente llegarán tarde. Quienes lo vean como una oportunidad para ordenar datos, procesos y responsabilidades estarán mejor preparados para un estándar de transparencia que ya forma parte del nuevo lenguaje regulatorio europeo.

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The case of clear aligners

The dispute arises from several advertising campaigns by the company Impress. In these campaigns, invisible orthodontic treatments were promoted with the support of well-known public figures. The Official College of Dentists and Stomatologists of Catalonia argued that the advertising referred to a medical treatment linked to the use of medical devices -clear aligners- and should therefore be subject to the rules applicable to the advertising of medical devices.

The Barcelona Court of Appeal, however, held that the advertising at issue did not concern a specific medical device, but rather the dental clinics of the advertising company and the orthodontic services provided there. In the Court of Appeal’s view, the references to ‘invisible orthodontics’ and ‘clear aligners’ were generic and served to explain the type of service offered by the clinic, rather than to promote a specific medical device.

This debate is particularly relevant because many healthcare centres and services refer in their advertising to the products or technologies they use. Although these products or technologies are not promoted in isolation, they are often integrated in the promotion of the healthcare service. The question is whether this form of communication allows such advertising to fall outside the restrictions applicable to the advertising of medical devices or whether, on the contrary, it must be assessed whether there is indirect promotion of the product used.

In the case now to be decided by the Supreme Court, the Barcelona Court of Appeal itself acknowledged that the classification may change when, in the context of advertising a healthcare centre or service, elements are introduced that may be perceived as advertising specific medical devices. For these purposes, it will be relevant to assess whether the product or technology used is a necessary condition for the provision of the promoted service and, in addition, whether it can be identified by the recipient of the communication.

The fine line between products and treatments

The issue may also extend to the field of advanced therapy medicinal products and, in particular, in relation to gene therapies developed under Royal Decree 477/2014 of 13 June, which regulates the authorisation of non-industrially manufactured advanced therapy medicinal products.

This royal decree, which governs what is known as the hospital exemption, allows certain advanced therapy medicinal products to be prepared and used in a hospital institution, under medical responsibility, to meet an individual medical prescription. In such cases, the hospital may hold the authorisation for use -but not a marketing authorisation- and may communicate, in institutional, scientific or healthcare-related terms, that it has developed a particular therapy, that it has a leading unit or that it offers an innovative treatment.

This is where a grey area emerges, similar to the case to be decided by the Supreme Court. If a pharmaceutical company cannot promote to the public an industrially manufactured gene therapy medicinal product, can a hospital communicate to the public that it has developed and offer its own gene therapy? Formally, the communication may be presented as information about the hospital’s healthcare activities, its research capabilities or a highly specialised healthcare service. In practice, however, such communication may have a promotional effect very similar to that of advertising a medicinal product authorised or marketed by a pharmaceutical company.

This situation creates tension because public communication about therapies developed by hospitals may have a significant competitive impact, especially where authorised or developing industrial alternatives exist. Once again, the question is whether we are dealing with the promotion of a healthcare service or with the indirect promotion of the product or therapy that makes that service possible.

A future judgment with far-reaching implications

The judgment to be handed down by the Supreme Court in the clear aligners case will be relevant beyond the dental sector and the promotion of medical devices.

In sectors where healthcare provision relies on highly regulated products -medical devices, medicinal products (including advanced therapies), digital health tools or procedures based on specific technologies- it will be essential to determine whether the message genuinely promotes the healthcare service or whether, under that appearance, it is promoting the product or technology that makes the service possible.

The admission of the appeal in cassation therefore gives the Supreme Court the opportunity to provide useful guidance on an increasingly relevant boundary in an environment where healthcare innovation is communicated to the public not as a ‘product’, but as a ‘service’, ‘treatment’, ‘programme’ or ‘therapy’ offered by a healthcare centre.centro sanitario.

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The concept of “scientific research”

One of the main contributions of the Guidelines is that they clarify the concept of scientific research for GDPR purposes. Aware that there is no universally accepted definition, the EDPB identifies six factors which, if cumulatively met, allow an activity to be presumed to constitute scientific research: (i) a methodical and systematic approach; (ii) adherence to ethical standards; (iii) verifiability and transparency; (iv) autonomy and independence of investigators; (v) the objective of contributing to the increase of general knowledge and the well-being of society; and (vi) the potential to contribute to existing scientific knowledge or apply it in a novel way. If not all these factors are met, it must be justified and demonstrable why the activity should nevertheless be considered scientific research.

The EDPB confirms that both privately funded research and research carried out for profit are fully covered by this concept. The Guidelines also refer to so-called “research data infrastructures” (such as biobanks, repositories and other databases) and to “ancillary processing operations” (such as categorisation or prior pseudonymisation), recognising that all of these may also fall within the specific regime applicable to scientific research.

Broad consent and dynamic consent

The Guidelines confirm the possibility of relying on “broad consent” where, at the time of data collection, it is not possible to specify the specific purposes of the research in full. The EDPB points out, however, that this mechanism does not allow the controller to circumvent the principle of purpose specification of consent. The controller must define the area of research as precisely as possible (for example, “medical research in the field of oncology”) and adopt additional safeguards to compensate for the lower degree of specificity of the purposes.

Alongside broad consent, the Guidelines also address “dynamic consent”, which consists of obtaining the data subject’s consent for each specific research project, or parts thereof, as its purposes become more specific. This approach may be suitable for long-term projects, or in cases where there is an ongoing relationship between investigators and participants. The EDPB also accepts the combination of both forms of consent.

The EDPB also provides relevant clarifications regarding the use of legal bases other than consent for the processing of personal data for research purposes. Regarding “legitimate interest”, under (Article 6(1)(f) of the GDPR), the EDPB accepts that this legal basis may be relied upon even where the research is conducted for commercial purposes, given the recognition of research activity as beneficial to society. In such cases, significant weight may be given in the necessary balancing test against the interests, rights and freedoms of the data subject. As regards the so-called “public interest” under Article 6(1)(e) GDPR), the EDPB clarifies that this is not reserved to public bodies; private entities may rely on it where their activities are supported by EU or Member State law.

Further processing and data retention periods

The EDPB confirms the presumption of compatibility of further processing for scientific research purposes with the original purposes of collection, as provided for in Article 5(1)(b) of the GDPR. Consequently, the controller is not required to carry out the compatibility test under Article 6(4) of the GDPR, although the controller must continue to assess the lawfulness of the processing in accordance with an appropriate legal basis. In many cases, the controller may rely on the same legal basis as that which supported the initial processing, but this will not be possible where the original basis was consent or a legal obligation whose scope does not cover the new research purposes.

With regard to the retention periods of personal data, Article 5(1)(e) of the GDPR allows the storage of such data for longer periods when processed for scientific research purposes, even after the original purposes of the processing have been fulfilled. The EDPB clarifies, however, that such storage cannot be justified by general research purposes. The controller must specify, at least, a specific area of research, and future activities must be reasonably foreseeable, without this entailing an obligation to draw up a complete research plan.

Transparency, data subjects’ rights and derogations

The Guidelines address in detail the information obligations under Articles 13 and 14 of the GDPR towards data subjects whose data is being processed. The EDPB recommends voluntarily collecting contact details from data subjects to facilitate future communications in long-term projects, as well using mechanisms such as websites or dedicated platforms. The Guidelines expressly accept that information obligations may be fulfilled through data processors or by a joint controller where the controller lacks direct contact with the data subjects.

As regards data subjects’ rights, two aspects deserve particular attention. In relation to the right to erasure, Article 17(3)(d) of the GDPR allows the controller to refuse requests only where erasure is likely to render impossible or seriously impair the achievement of the research objectives. The EDPB notes that these situations are more likely to arise where the research involves a small number of data subjects or ongoing longitudinal studies. As for the right to object, the Guidelines confirm that Article 21(6) of the GDPR allows an objection to be rejected where the processing is necessary for the performance of a task carried out in the public interest, including cases where a legitimate interest of the controller coincides with a public interest.

Controller, processor and joint controllers

Through particularly useful practical examples, the Guidelines address the allocation of roles as controller, processor or joint controllers in common research scenarios, particularly for commercial clinical trials, public-private collaborations and research consortium partners, among others.

The EDPB confirms that active participation in the drafting of a research protocol, clearly defining the purposes and essential elements of the means, will normally confer controller status on the participating entity, even if it does not actually process personal data. This is typically the case of the sponsor of a clinical trial. Merely funding a project or acting as a consultant, expert or member of an ethics committee is not, however, sufficient in itself to confer such status.

Appropriate safeguards

The Guidelines note that any processing for scientific research purposes requires the adoption of appropriate safeguards under (Article 89(1) GDPR). In accordance with the principle of data minimisation, anonymised or, subsidiarily, pseudonymised data should be used whenever this allows the purposes of the processing to be achieved. The processing of directly identifiable data is only permitted where strictly necessary and proportionate.

In addition, the Guidelines provide a non-exhaustive list of other possible safeguards: independent ethical oversight, secure processing environments, use of synthetic data, confidentiality obligations, and others. Particular attention is given to the specific safeguards required where genetic data or biometric data are processed, given the particular characteristics of these categories of data.

Next steps

The Guidelines, which are currently open for public consultation until 25 June, will provide greater legal certainty on issues that had long required clarification. Given the significance of this document, it is highly recommended that organisations active in this field review their current procedures and the supporting documentation for their studies and other research projects in light of the EDPB’s interpretative criteria, especially as regards the legal bases used, consent mechanisms, and the technical and organisational safeguards adopted.

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Organic Law 1/2025 has introduced a far-reaching reform of the Administration of Justice. In particular, by renaming and reorganising Tribunals of First Instance and the introduction of alternative dispute resolution mechanisms as a previous step to court proceedings. However, the legislation also incorporates other, less widely discussed changes that may be of great practical use, such as the expansion of court agents’ (procurador de los tribunales) functions.

The court agent and their new functions

The court agent is a distinctive figure in the Spanish procedural system. Traditionally, their role has been to represent the parties before the courts and to facilitate the conduct of proceedings. The reform maintains this role but strengthens their capacity to cooperate with judicial bodies.

Following Organic Law 1/2025, court agents may undertake communication tasks, assist and cooperate with the courts, and carry out certain procedural acts where these have been expressly delegated by the judge. To this end, the law grants them authority to certify documents as well as access to the necessary credentials required to formally evidence their actions.

An opportunity to speed up compliance with preliminary injunctions

These new functions may help to significantly expedite the conduct of certain proceedings, particularly those where speed is essential to ensure the effectiveness of judicial protection.

One area where this reform may be particularly relevant is preliminary injunctions. The effectiveness of these measures often depends on how quickly they can be notified to the persons or entities that must be notified of them or cooperate in their implementation.

Consider, for example, a preliminary injunction prohibiting the marketing of a specific medicinal product and ordering that this prohibition be communicated to the Spanish Medicines Agency or the Ministry of Health, so that the restriction is reflected in their records and takes effect.

If the court delegates this task, the court agent could carry out the communication immediately, even via the Government’s General Electronic Register, without having to wait for the relevant court documents to be issued and processed.

In proceedings where every day counts, the possibility of using the court agent as an active collaborator in the enforcement of judicial decisions can play a decisive role in ensuring the effectiveness of the measures agreed by the courts.

In this context, the new functions introduced by Organic Law 1/2025 mean that, in certain circumstances, the court representative may become one of the best allies in securing the swift and effective enforcement of preliminary injunctions.

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Uno de los aspectos más interesantes del foro fue comprobar cómo muchas conversaciones ya no giran solo alrededor de nuevas normas, sino alrededor de una cuestión mucho más amplia relacionada con el futuro industrial y estratégico del sector en Europa: ¿cómo evitar que el continente pierda capacidad de innovación frente a Estados Unidos y Asia? Esta cuestión estuvo muy presente en numerosos paneles y conversaciones. Se habló de simplificación regulatoria, del impacto del European Health Data Space, de inteligencia artificial aplicada a salud y de la necesidad de crear entornos más previsibles para invertir. Muchas intervenciones apuntaban a la misma idea: Europa dispone de una buena base científica y regulatoria, pero sigue arrastrando demasiada fragmentación nacional y demasiadas dificultades para avanzar de forma coordinada.

También estuvo muy presente durante el foro la idea de que la colaboración público-privada será cada vez más importante en los próximos años. En una Europa donde más de 450 millones de ciudadanos dependen de sistemas públicos de salud, muchos participantes coincidieron en que innovación y acceso solo podrán avanzar si administraciones, hospitales e industria trabajan de forma coordinada. El mensaje era sencillo: Europa no puede permitirse que cada actor avance por separado si quiere mantener un modelo sanitario competitivo, sostenible y capaz de incorporar nuevas terapias con rapidez.

Más allá de los contenidos técnicos, asistir a este tipo de encuentros sigue siendo especialmente valioso porque permite entender las tendencias y anticiparse a los retos que el sector afrontará en los próximos años. Y quizá esa sea la principal conclusión que nos llevamos de Bruselas: Europa necesita seguir impulsando innovación, inversión y desarrollo industrial, pero sin renunciar a aquello que históricamente ha definido su modelo: sistemas sanitarios accesibles, unidad de mercado, coordinación, protección de los derechos fundamentales y una regulación construida también desde los valores y la confianza de los ciudadanos. En definitiva, más Europa.

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En Estados Unidos, por ejemplo, la FDA anunció el pasado 28 de abril un proyecto piloto para implementar ensayos clínicos en tiempo real (Real-Time Clinical Trials) y adelantó una iniciativa similar y de mayor alcance para este verano. Mediante esta iniciativa, la FDA recibirá directamente y en tiempo real las señales de seguridad y eficacia de ensayos clínicos comerciales, apoyándose en herramientas de Inteligencia Artificial, sin tener que esperar a los informes intermedios de los promotores.

En Europa también hay avances. La propuesta de Reglamento Europeo de Biotecnología (Biotech Act), publicada por la Comisión el 16 de diciembre de 2025, apuesta por un marco más favorable para la investigación clínica, con medidas orientadas a acortar plazos, en especial de aquellos proyectos estratégicos y la creación de sandboxes regulatorios para diseños innovadores. En paralelo, la reciente publicación de las Directrices 1/2026 del Comité Europeo de Protección de Datos sobre el tratamiento de datos personales con fines de investigación científica, en consulta pública hasta el 25 de junio, representa una oportunidad para tener unos criterios unificados para todos los Estados miembros sobre cuestiones clave como la base jurídica aplicable al tratamiento de datos personales en los ensayos clínicos, el consentimiento amplio y dinámico que pueden otorgar los pacientes o el uso secundario de datos clínicos.

La buena noticia para Europa es que avanzamos hacia un marco regulatorio cada vez más homogéneo y previsible para los promotores comerciales, con un reglamento de ensayos único para todos los Estados miembros, criterios comunes sobre el tratamiento de datos personales y una propuesta legislativa que reconoce el valor estratégico del sector biotecnológico. España, como uno de los principales destinos europeos para la realización de ensayos clínicos, tiene un especial interés en que todas estas iniciativas se implementen con éxito. La pregunta con motivo del Día Internacional del Ensayo Clínico no debería ser, entonces, si Europa avanza, sino en qué dirección debe hacerlo. El verdadero reto está en recuperar terreno donde Europa sí tiene argumentos para competir, como es la previsibilidad regulatoria, la calidad metodológica, el talento científico o la integridad de los datos.

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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.