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.

La entrada Advertising of healthcare services or advertising of products? aparece primero en Faus Moliner.

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.

These judgments examine various requests for access to information, made under the Law on transparency and freedom of information in relation to Covid-19 vaccines.

In two of the cases, access was sought to the contracts entered by the Spanish Government with several companies for the supply of vaccines, including prices and quantities. In the third case, the request concerned the international agreement signed between Spain and Andorra for the resale of those vaccines.

In all three cases, the National High Court overturned the decisions of the Council for Transparency and Good Governance ordering the Ministry of Health to provide the information.

Relationship between European and Spanish legislation on access to public documents

One of the first issues addressed by the Supreme Court is the possible application of Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents.

The National High Court had considered that, since vaccine prices were negotiated by the European Commission, access should be governed by European rules. On that basis, it held that their ‘sensitive’ nature justified the refusal.

The Supreme Court, however, qualifies this approach. It points out that Article 5 of the Regulation provides that where a Member State receives a request concerning a document in its possession originating from a European institution, it must consult that institution before deciding, unless the outcome of the decision is obvious.

In this case, the Supreme Court considers that such clarity was lacking. Therefore, the Ministry could not make the decision on its own but was required either to consult the European Commission or to refer the application to it.

On the damage to Spain’s external relations if the requested information is disclosed

The Ministry of Health argued that the agreement with Andorra incorporated vaccine prices set by the European Commission, subject to strict confidentiality measures, and that their disclosure would constitute a breach of the commitments made by Spain to other Member States and to the Commission itself. In its view, this would lead to a loss of trust in Spain at international level, with the resulting reputational harm and impact on its foreign relations, thereby justifying application of the limitation relating to foreign affairs.

The Supreme Court acknowledges that the Government enjoys a certain margin of discretion in matters of foreign policy. However, it emphasises that the application of this limitation requires sufficient, reasonable and plausible justification of the harm.

In this specific case, the Court concludes that such justification did not exist. The Administration merely invoked the involvement of a third State, without explaining in what specific way the disclosure of the agreement’s content would affect Spain’s foreign policy.

The Supreme Court therefore emphasises a key point: not all information contained in international agreements is automatically protected; rather, its content and the actual risk of harm must be analysed.

On confidentiality and secrecy in decision-making processes

Finally, the Supreme Court analyses the application of the confidentiality restriction in decision-making processes in the context of the agreement between Spain and Andorra.

The Supreme Court acknowledges that this limitation may justify the refusal of access where it is specifically identified which information may affect ongoing or future negotiations, which specific negotiations would be affected, and how their disclosure might harm them. It also emphasises that this is a temporary limitation, confined to the period during which such negotiations remain open.

In this specific case, the Supreme Court concludes that the Ministry of Health failed to meet this standard, as it did not specify which information was confidential or for what reasons. Consequently, it confirms the obligation to provide the requested information.

Conclusions

In a sector where documents produced by European institutions -such as the European Commission or the EMA- frequently coexist with documents produced by Member States, it is worth recalling the possible application of Regulation (EC) No 1049/2001 when the information requested originates from a European institution, as well as the obligation to consult that institution or refer the request to it when the meaning of the response is unclear.

Moreover, in proceedings concerning requests for access to price and reimbursement decisions, it is common to argue that the disclosure of certain information may be detrimental to ongoing negotiations in other Member States regarding the same medicinal product. In light of the Supreme Court’s reasoning, access may be restricted where it is specifically identified which negotiations may be affected and why the disclosure of the requested information could harm them, for example, due to its potential use in international price referencing processes.

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Medicines for Europe recently published very specific figures in this regard: up to 84% of public procurement procedures use price as the sole award criterion; and up to 74% of Member States use single-supplier procedures. Although Directive 2014/24/EU advocated for the use of ‘MEAT’ (Most Economically Advantageous Tender) criteria, it is common for the prevalence of low price to overshadow a genuine balancing exercise aimed at selecting, as Article 145 of the Spanish Law on Public Sector Contracts establishes, “the best price-quality ratio”.

Review of the 2014 Directives: an upcoming opportunity

Brussels is considering whether the design of the 2014 Directives has helped to shift contracting authorities towards a value-based approach; and the institutional response to this question leans more towards the negative. This was reflected in October 2025, when the European Commission published the evaluation of the 2014 Directives package as a first step towards its revision, and the Commission itself announced plans to present a new revised framework in the second quarter of 2026.

The new legal framework will aim to (i) increase the efficiency of public investment; (ii) design tools to strengthen economic security and sovereignty (which is relevant in relation to ‘Made in Europe’ related commitments); and (iii) align public procurement policy with the EU’s strategic policies and objectives. In the field of medicinal products, all this raises a particularly relevant question: can and should public procurement safeguard continuity of supply, resilience of the production chain and sustainable competition, without being reduced to a purely budgetary approach?

For its part, the European Parliament, in its Resolution of 9 September 2025 on public procurement (2024/2103(INI)), insists that the future framework should simplify rules, promote genuine competition and allow for a more effective use of strategic criteria other than price. The resolution expressly links procurement to objectives of resilience, sustainability, economic security and European competitiveness. Public procurement also serves as a lever for industrial policy. It further adds a particularly telling statistic: in 2023, twenty Member States awarded more than 50% of their tenders based solely on price, and ten of them exceeded 80%. In the pharmaceutical sector, the message is clear: the future revision of the Directives is relevant not so much for the procedural reform itself, but for the possibility of finally recognising that, in the public procurement of medicinal products, the value of a tender is not limited to its price.

The situation in Spain

Although the new Law on Medicinal Products and Medical Devices will have to wait, it is worth noting that its April 2025 Draft Law is of particular interest because it also anticipates these issues. The text submitted for public consultation includes references to moving beyond “the traditional customer-supplier model” and recognising the role of institutions throughout the entire medicinal product value chain, from innovation to production and strategic autonomy. The text is also part of a policy expressly aimed at strengthening the supply chain and preventing shortages.

From the perspective of public procurement, the most significant contribution of the Draft Law lies in its fourth final provision, which amends Law 9/2017. Specifically, it proposes introducing special rules for the procurement of medicinal products, medical devices and healthcare services. Among other matters, it provides for joint framework agreements and dynamic purchasing systems; as well as joint procurement at national or European level where this is preferable to decentralised purchasing.

In our view, the key innovation is the provision that, in public procurement procedures for hospitals, it must be justified that the award criteria ensure the best value in terms of cost-effectiveness and strategic autonomy. In addition, price may not account for more than 20% of the award criteria, unless duly justified in the procurement file.

Also noteworthy are the provisions allowing the use of the negotiated procedure without prior publication for medicinal products protected by exclusive rights where no therapeutic alternative exists. This entails a certain simplification of current procedures, but it does not fully address the fundamental concern of those marketing exclusive medicinal products, namely the absence of any requirement to undergo a public procurement procedure. What is relevant is that an underlying logic of supply, agility and strategic management of healthcare procurement is beginning to emerge.

From the cheapest bid to the bid with the greatest value

The relationship between price and value is misrepresented when presented as a mutually exclusive alternative. The conflict arises when price is treated as the primary element when it comes to public interest in a sector where quality of care, health outcomes, incremental innovation, continuity of supply, organisational impact and, increasingly, industrial resilience, constitute the real value of the service. In healthcare, the cheapest offer is not always the most economical and probably will become less so over time.

At the same time, the transition towards value-based procurement should not be idealised either. The more the weight of price is reduced, the greater the need to objectify and justify the other criteria. The shift towards sustainability, resilience or strategic autonomy will only be legally robust if these concepts are translated into verifiable parameters, linked to the subject matter of the contract and applied with sufficient transparency so as not to undermine equal treatment or unduly expand administrative discretion.

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General criteria

The CNMC considers that the criteria for determining sanctions applicable to directors must be adapted to the individual position and conduct of each person. Thus, once their involvement in the infringement has been established, three main elements will be considered.

Seriousness, duration of the infringement and level of responsibility

First, the seriousness of the infringement. Not all conduct is assessed in the same way. This issue is particularly relevant in sectors such as life sciences, where anti-competitive conduct may harm public interests.

Second, the duration of the conduct. A distinction is made between isolated incidents and conducts maintained over time, which reinforces the importance of identifying and addressing potential risks at an early stage.

Third, the level of responsibility of the directors, taking into account their hierarchical position and decision-making capacity. Higher sanctions may therefore be expected for those in positions with greater influence over decision-making.

The importance of compliance programmes

The new guidelines consolidate the practice that the CNMC has been applying in recent years and strengthen legal certainty in an area where, until now, criteria had not been formally established.

Its publication comes at a time of particularly intense activity by the CNMC in competition infringements and sanctions. In mid-2025, as we discussed in a previous Capsulas, the CNMC directly applied for the first time the prohibition on contracting with the public sector for competition infringements. Subsequently, at the end of 2025, it launched a public consultation to update its Guide on compliance programmes.

In this context, particularly relevant in sensitive sectors such as the pharmaceutical industry, it is essential to have effective, updated compliance systems that known throughout the organisation.

The new guidelines also remind that directors are not exempt: their participation in infringing conduct may result not only in reputational damage but also in individual financial sanctions depending on their involvement, position and the seriousness of the conduct.

In this regard, the CNMC’s ongoing review of its Guidance on compliance programmes highlights the need to strengthen technical, organisational and training measures, in line with Article 72.5 of the Law on Public Sector Contracts.

Companies should review and update compliance programmes about competition and reinforce internal training initiatives in order to prevent risks and demonstrate an effective compliance culture.

La entrada Directors are not off the hook either: the Spanish Competition Authority clarifies how it will sanction individuals aparece primero en Faus Moliner.