El anteproyecto de ley de los medicamentos, como señala la CNMC, pretende regular diversos escenarios, entre otros los siguientes tres: (a) productos desfinanciados (i.e., productos que estaban financiados y dejan de estarlo, con precio libre sujeto a comunicación); (b) unidades de medicamentos financiados para pacientes no hospitalizados pero que no son a cargo del SNS (i.e. productos que adquieran los pacientes privados, con posibilidad de regular el precio si ello es necesario para la protección de la salud poblacional en los casos y condiciones establecidos en la Ley); (c) medicamentos y productos sanitarios no sujetos a prescripción, o no financiados (i.e. OTC’s o productos no incluidos en la prestación farmacéutica; con precio libre pero con posibilidad también de regular su precio en base parámetros objetivos y transparentes).

¿Siguen aquí? Si están a punto de dejar de leer, créanme que les comprendo. Menudo galimatías. A mí me parece que sería mucho más sencillo señalar, sin más, que la intervención administrativa sobre los precios de los medicamentos se limita a las unidades de productos incluidos en la prestación farmacéutica del SNS que son dispensadas con cargo al SNS a través de receta oficial o de orden de dispensación hospitalaria. En el caso de productos con indicaciones financiadas y no financiadas, la receta oficial o la orden de dispensación hospitalaria no podrían emitirse para una indicación no financiada, pudiendo en su caso aplicarse la reserva singular de visado. Se podría añadir, obviamente, lo que ya dice la Ley actual: cuando exista una situación excepcional sanitaria, con el fin de proteger la salud pública, la Administración podrá fijar el importe máximo de venta al público de cualquier medicamento o producto sanitario por el tiempo que dure dicha situación excepcional.

Es cierto que limitar la intervención, y abrir la puerta a la convivencia generalizada entre precio libre y precio intervenido plantea interrogantes en el caso de productos que llegan al paciente a través de las oficinas de farmacia; pero por lo que más quieran, no caigamos en la trampa de siempre: se aprueba la ley previendo que la información requerida para su gestión “se obtendrá a través del Sistema que se determine”; la Ley no se desarrolla, todo queda en un limbo, y luego a correr, como sucede con la Orden sometida a consulta previa.

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Se trata de una iniciativa que busca acelerar, a través de un procedimiento “fast-track”, la aprobación de nuevos medicamentos desarrollados por compañías farmacéuticas que demuestren estar alineadas con determinadas “prioridades nacionales” de EEUU en el ámbito de la salud pública. Entre estas “prioridades nacionales” se incluyen las siguientes: abordar crisis sanitarias en EEUU; poner a disposición del pueblo estadounidense posibles terapias innovadoras; abordar necesidades de salud pública no cubiertas; y reforzar significativamente la seguridad nacional de EEUU.

A través de estos vales, no transferibles, las compañías podrán acortar los periodos de revisión de sus solicitudes de aprobación, de hasta 10-12 meses a tan solo 1-2 meses. La FDA ha anunciado además otras medidas en la misma línea, como el cese de transferencias de datos genéticos de ciudadanos estadounidenses a países considerados como hostiles. Estas acciones buscan, en conjunto, impulsar la innovación, reducir la burocracia y reforzar la autonomía estratégica del país en el ámbito biomédico.

En este contexto, en el ámbito europeo se está discutiendo la adopción de diversas medidas para estimular, asimismo, la innovación en el ámbito farmacéutico. Entre estas medidas, incluidas dentro del paquete legislativo sobre medicamentos de la Unión Europea, se incluyen los bonos de exclusividad transferibles (TEV), la ampliación de los periodos de protección de datos y de mercado para productos que cubran necesidades médicas no cubiertas o de medicamentos huérfanos, diversas medidas de acceso temprano, los planes de prevención contra la escasez de medicamentos, obligaciones de suministro para ciertos medicamentos, y reformas en la EMA (Agencia Europea de Medicamentos) orientadas a ganar eficiencia, entre otras.

Cada vez es más evidente cómo la normativa farmacéutica se está convirtiendo en una herramienta al servicio de objetivos de interés general más amplios. Tanto en Estados Unidos como en la Unión Europea se están introduciendo reformas regulatorias que van más allá del marco tradicional de autorización y control de medicamentos. En ambos casos, se recurre a incentivos —ya sea acortando plazos de aprobación o ampliando periodos de exclusividad— para fomentar la innovación, reforzar la producción local o garantizar el suministro. Estas iniciativas muestran cómo la política regulatoria está asumiendo un papel más estratégico en la definición de prioridades públicas.

Esta evolución obliga a replantear el modo en que concebimos la regulación farmacéutica: ya no solo como un instrumento técnico al servicio de la salud pública, sino también como una palanca de política industrial, económica y geoestratégica. Si se gestiona con equilibrio y transparencia, esta nueva dimensión puede aportar valor a los ciudadanos, al sistema sanitario y al tejido productivo. Pero también implica riesgos: el uso instrumental de la regulación no debe desvirtuar su esencia ni debilitar sus garantías. El reto está, precisamente, en encontrar ese punto de equilibrio.

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Background

A pharmaceutical company filed a complaint with the competent regional authority regarding unlawful advertising and misrepresentation of an allergenic medicinal product owned by another pharmaceutical company. The complaint was submitted following the procedures established by law, so that the authorities could take ex officio action if deemed appropriate.

The company being reported was not part of Farmaindustria’s self-regulatory system. Therefore, the complaint was submitted to the regional authorities, rather than to the control bodies of the Code of Practice.

The regional authority referred the case to the Spanish Agency for Medicines and Medical Devices (AEMPS), which then initiated an ex officio review to determine whether the product was being marketed in accordance with the applicable regulations.

After examining its presentation and suspecting that it might be an industrially manufactured medicinal product without marketing authorisation, the AEMPS opened an administrative proceeding to cease its marketing and provisionally ordered the withdrawal of the product as a preliminary injunction. This interim measure remained in place, and the main proceeding was not closed, until the company under investigation modified the product presentation to correct the irregularities identified by the AEMPS.

The complainant never made public the fact that a complaint had been filed, nor did it make any statements in the market that could have led consumers and/or healthcare professionals to suspect that the product in question might be unlawful.

However, once the reported company discovered the identity of the complainant upon reviewing the administrative file, it filed an unfair competition lawsuit, alleging that the complaint constituted acts of disparagement and deception regarding its medicinal product, which had caused damages that should be compensated.

The Commercial Court fully dismissed the lawsuit.

No acts of disparagement

The Court began by recalling that, in order for there to be an act of unfair disparagement, the defendant must have made and/or disseminated public statements capable of damaging the market reputation of the plaintiff’s product, and that such statements must be inaccurate, untrue, or inappropriate.

The plaintiff argued that the defendant (the complainant) had engaged in unfair disparagement by filing a complaint that, in its view, was false and aimed solely at removing the product from the market and damaging its image.

The Court dismissed this argument and ruled that the conduct of the complainant could not be considered an act of denigration.

The Court rejected this argument and held that the complainant’s conduct could not be considered an act of unfair disparagement.

First, the Court found that the complaint filed by the defendant was neither false nor unfounded.

According to the Court, the complaint was grounded and filed through legally established channels to inform the competent authorities of the identified irregularities so that they could take ex officio measures, which in fact occurred and were not lifted until the irregularities were corrected by the reported company.

Second, and no less important, the complaint was never disclosed or disseminated in the market.

No acts of deception

The Court also rejected the claim that the complainant’s actions could be considered a deceptive practice prohibited by the Unfair Competition Law.

First, as already noted, the Court found no evidence that the complaint was false.

Moreover, the Court emphasised that the complaint was addressed to the competent regulatory authority, not to a consumer. A consumer, upon learning of the complaint, might have changed their behaviour toward the product. However, since the complaint was not directed at consumers, the legal requirement that the complaint must “mislead recipients and be likely to alter their economic behaviour” could not be considered fulfilled.

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The medical device sector is governed by complex regulations that places obligations on both the products and the agents involved in their marketing. In Spain, Regulation (EU) 2017/745 (MDR) and Royal Decree 192/2023 coexist. Their application may raise questions due to their recent adoption and technical complexity, particularly during the current transitional period, in which devices regulated by the MDR coexist with others still regulated by the previous legal framework.

In April, the Spanish Agency for Medicines and Medical Devices (AEMPS) published its first Guide for the marketing of medical devices. This document serves as a highly practical tool, as it compiles and summarises the obligations that companies must fulfil when introducing or commercialising medical devices to the Spanish market.

After seeing how the Guide is applied in practice, we summarise below the main areas it clarifies, which are often the ones that tend to cause confusion in the sector.

Clinical research

To be marketed in the European Union, medical devices must bear the CE marking, except in the case of custom-made devices and those intended for clinical investigations.

According to the AEMPS Guide, clinical investigations are mandatory for implantable and Class III devices (with certain exceptions), as well as for other products when there is insufficient clinical data to demonstrate their safety and performance (Article 61 MDR).

In Spain, clinical investigations involving non-CE-marked products require prior authorisation from the AEMPS, a favourable opinion from the Committee on Ethics in Research with Medicinal Products (CEIm), and approval from the centre where the investigation is to be conducted.

Although the Guide does not explicitly address it, the same requirements apply when a CE-marked product is evaluated for a use outside the manufacturer’s intended purpose. This is addressed by the AEMPS in their Instructions of 30 January 2023, which we analysed in a previous Capsulas.

AEMPS national registers of medical devices

Any company intending to market medical devices in Spain (excluding custom-made products), will have to register the device with the AEMPS Marketing Register, as set by Article 18 of Royal Decree 192/2023. However, this register is not yet operational, as it is linked to EUDAMED.

Until the Marketing Register becomes active, companies placing Class IIa, IIb or III devices on the Spanish market must notify the AEMPS through the CCPS application. For Class I or custom-made devices, notification is only required if the manufacturer, authorised representative, assembler or steriliser is established in Spain. In such cases, they must notify the AEMPS so that they can be included in the Register of Responsible Entities for placing devices on the market.

Once the Marketing Register becomes operational, notification of all medical devices (except for custom-made devices) will be mandatory through this system. Custom-made devices will continue to be notified in Register of Responsible Entities for placing devices on the market.

Distribution and sale

A distributor is defined as any person or entity in the supply chain (other than the manufacturer or importer), who makes a product available on the market until it reaches the end user as a product ready for use.

Distributors and any person or entity established in Spain who intends to market medical devices, regardless of their classification, must notify the start of their activity in advance to the health authority of the autonomous region where their registered office is located (Article 23 of Royal Decree 192/2023). If they have warehouses in other regions, they must also notify the respective health authorities in those regions.

This obligation applies whether products are sold online or through physical retail outlets. When the notification is submitted, the authorities typically request information about the distribution channel.

Additionally, physical establishments that sell products requiring individual adaptation must obtain authorisation from the autonomous region in which they are located and comply with the requirements outlined in Article 26 of Royal Decree 192/2023.

Pharmacies are exempt from this prior notification requirement, unless they market products that require individual adaptation. In such cases, they must comply with the same rules as other establishments.

The Guide is silent regarding distributors or persons or entities not established in Spain who intend to market medical devices. However, in practice, neither the AEMPS nor some regional health authorities currently require prior notification. Even so, it is advisable to monitor how this practice develops to stay ahead of any potential changes.

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The GCP guidelines are considered the international benchmark for ensuring data quality and participant safety, while also facilitating mutual recognition of clinical data across regulatory agencies. In January 2025, the ICH adopted the third revision of its GCP guidelines (“ICH E6 R3”), which are now structured into a set of general principles and an Annex I on implementation. These will come into effect in the EU on 23 July 2025. A second annex, focused on decentralised elements, is currently under review and is expected to take effect in early 2026.

Changes in risk assessment and management

Not all clinical trials involve the same level of intervention or carry the same degree of risk for participants. While some clinical trials investigate authorised medicines, others involve unauthorised products using more complex designs, including data collection devices or artificial intelligence (AI) tools for participant monitoring and data analysis.

Recognising this, the new GCP revision introduces a more flexible, risk-based approach tailored to the specific features of each trial. Sponsors must now anticipate potential risks and design the study in proportion to the level of risk expected. Clinical trial designs should avoid unnecessary complexity, excessive data collection, and undue burdens on participants and investigators.

Use of new technologies and decentralised clinical trials

The new version of the GCP guidelines reflect the growing digitalisation of clinical trials and include a dedicated section on data management (covering everything from collection to deletion). The use of technological solutions (e.g., digital tools, AI, remote monitoring, etc.) must be validated in advance, used transparently, and justified based on their purpose in the trial.

This shift is also reflected in the replacement of the term “CRO” (Contract Research Organisation) with the broader term “service providers.” This acknowledges that sponsors now outsource not only traditional functions like monitoring and data analysis, but also the implementation of innovative technological solutions. The GCP guidelines require any outsourcing to be properly documented and emphasise the sponsor’s responsibility to supervise all service providers involved in the trial.

Of note is Annex II, expected to enter into force in early 2026. It sets specific requirements for the use of decentralized elements and real-world data (RWD) in trial design. In line with the proactive risk-based approach, sponsors must justify their use and ensure participants are informed. These requirements are consistent with guidance already issued by various European regulatory agencies, including the Spanish Agency of Medicines and Medical Devices (AEMPS).

Practical recommendations for sponsors and CROs

The third revision of the GCP rules makes it necessary for sponsors to review and update their internal procedures and strengthen coordination with service providers.

A key aspect of GCP compliance is being prepared for inspections by national authorities. In Spain, the responsibility for GCP inspections is shared between the AEMPS and the regional health authorities. According to its 2024 activity report, the AEMPS is one of the most active European agencies in GCP inspections requested by the European Medicines Agency (EMA).

Therefore, sponsors are advised to pay close attention to the requirements under the new GCP revision, especially for complex, multicentre, or technology-driven clinical trials. In such cases, it will be essential to: (i) justify the use of digital tools or AI in line with the trial design; (ii) properly document their validation; and (iii) ensure transparent implementation. Moreover, active supervision of all involved service providers and CROs will also be essential to ensuring full compliance with GCP requirements.

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Ahí queda eso, nada más y nada menos que convertirnos en “el lugar más atractivo del mundo para las ciencias de la vida” en cinco años. Del mundo, casi nada. La primera impresión es que alguien en Bruselas se ha venido arriba y quiere lanzar un mensaje motivador, un reto difícil de rechazar. ¿Cómo vamos a oponernos a ser “el lugar más atractivo del mundo para las ciencias de la vida”? Después de una pausa no tardan en aparecer, cual nubarrones, los susurros irónicos. “Sí, claro, pero Europa no sirve para nada; mucho hablar, pero cada vez estamos más lejos de Estados Unidos y de China, que nos han adelantado por la derecha y por la izquierda”.

Siempre que escucho estas críticas empiezo mi defensa europeísta, que mis amigos y algunos familiares escuchan pacientemente una y otra vez, aunque no les convenza. Me siguen tildando de euroidealista romántico o incluso de pecar de eurocéntrico. Yo me consuelo diciendo que olvidan parte de la historia. Hoy, vista la Comunicación, puedo añadir otro consuelo: probablemente no han tenido tiempo de leerla. En su libro “Europa”, Timothy Garton Ash empieza con una frase de Kierkegaard (Journal JJ:167): “It is really true what philosophy tells us, that life must be understood backwards. But with this, one forgets the second proposition, that it must be lived forwards”.

Cualquiera que tenga interés en las políticas europeas en materia de ciencias de la salud, si lee esta Comunicación, verá que desde Bruselas se sigue mirando al pasado con cariño; pero sin olvidar en modo alguno la relevancia del futuro. El pasado crea retos, ¿cómo no van a existir en una estructura jurídica y política que aglutina 27 estados celosos de preservar la soberanía que les queda? El pasado genera desafíos, pero ofrece un legado que permite plantear una estrategia pensada en las empresas, buscando ecosistemas de innovación más dinámicos y una mejora de la competitividad; pero también (y especialmente) en las personas.

La comunicación lo dice bien claro: “además de mantener la competitividad, se trata también de una inversión estratégica en la justicia intergeneracional, ya que el objetivo es que Europa lidere con determinación, de modo que la innovación esté al servicio de las personas y del planeta, tanto ahora como en las generaciones futuras”. Es una lectura recomendable, no se la pierdan.

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Why this issue matters

Both European and national regulatory agencies rely on external experts for the evaluation of medicinal products and medical devices. This is essential to ensure that decisions are taken with the necessary rigorousness, protecting public health and fostering innovation in the pharmaceutical sector. However, the involvement of non-public sector experts generates an important debate on independence and the management of conflicts of interest.

Article 41 of the Charter of Fundamental Rights of the European Union recognises the right of every person to have their affairs handled impartially and fairly by the EU institutions. This principle imposes the obligation to avoid any circumstance that could compromise the objectivity of administrative action. On the other hand, Article 52 of the Charter states that this right may be limited if necessary to meet objectives of general interest or to protect the rights and freedoms of others.

Therefore, although there is a right to impartial and fair conduct on the part of the administration, this right may be limited when required by reasons of the general interest.

The Hopveus case®

A landmark case on the matter is the judgment of the Court of Justice of the European Union (CJEU) in the Hopevus® case. Hopveus® is a medicinal product to treat alcohol dependence. The CJEU annulled the EMA’s decision to refuse marketing authorisation for Hopveus® due to the involvement, in the evaluation process, of an expert who had served as principal investigator in the pivotal clinical trials of a competing product.

The EMA’s conflict of interest policy in place at the time (Policy 0044) allowed a principal investigator of a competing product to participate in an expert panel, provided that the investigator refrained from intervening in the final deliberations and voting on the opinion. Before the CJEU, the EMA argued that, in order to properly fulfil its role in the evaluation of medicinal products, it had to balance impartiality with the need for the best possible scientific advice. In doing so, the EMA argued that the public interest could justify the involvement of certain experts, even if there was a conflict of interest.

Despite the above, the CJEU adopted a stricter interpretation: the mere exclusion of the expert from the final deliberations was not sufficient to ensure the impartiality of the procedure. The EMA’s reaction was to change its policy by excluding experts with direct interests in similar medicinal products from the assessment committees.

The challenge of conflicts of interest in the EU

This strict interpretation gives rise to a crucial question: how can quality evaluations be guaranteed in fields where expert knowledge is limited, as in the case of rare or ultra-rare diseases? In this regard, the EMA’s own Policy 0044 on conflicts of interest recognises that there may be situations that require a special regime. For this reason, the figure of the “expert witness” has been strengthened, who will be able to provide expertise when requested by the EMA, but without participating in the discussions and final deliberations of its committees. It remains to be seen whether these changes will be sufficient to balance the need for the best scientific advice with the interpretation made by the CJEU.

It is precisely at this crossroads that we must consider the participation of experts in the joint clinical assessments and joint scientific consultations provided for in the Health Technology Assessment Regulation. These experts should be selected for their expertise in their therapeutic area, act in their individual capacity and have no interests, financial or otherwise, that could compromise their independence or impartiality.

The European Commission, aware of the CJEU precedents on conflicts of interest, has included specific provisions in the Implementing Regulation for the application of the Health Technology Assessment Regulation. In particular, article 7.3 allows, in exceptional cases such as rare diseases, to rely on experts with conflicts of interest, provided that there are no alternatives and their appropriate participation is ensured. Recital 15 of the Regulation clarifies that this exception seeks to balance the requirement of independence with the need to ensure the best scientific knowledge for the benefit of the public interest.

The challenge of conflicts of interest in Spain

The legal landscape is complex and a strict insistence on expert impartiality may constrain the administration’s ability to act.

In September 2024, the Ministry of Health presented a Draft Royal Decree on Health Technology Assessment, which will regulate this issue in Spain. The draft of the new Law on Medicinal products and Medical Devices, recently submitted to the public hearing process, also proposes a stricter regulation of the participation of experts, establishing incompatibilities for those with links to the industry.

Our proposal on this matter is mitigating the blanket exclusion of experts with potential conflicts of interest to avoid unintended consequences that may limit access to qualified knowledge. In this regard, the concept of the “expert witness” is a useful starting point. It will be necessary to clearly define the situations in which a conflict of interest may be deemed to exist and to ensure that the legitimate pursuit of impartiality does not result in excessive negative side effects.

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