Este nuevo texto está llamado a sustituir a la actual Ley de garantías y uso racional de los medicamentos y productos sanitarios. Una ley que, con el paso del tiempo, ha ido acumulando parches normativos y reformas parciales, dejando claro que el sistema necesitaba una actualización profunda. El nuevo anteproyecto pretende dar respuesta a múltiples desafíos: la digitalización, los nuevos modelos de innovación farmacéutica, el impulso a los genéricos y biosimilares, el acceso equitativo a los tratamientos, o la revisión del marco de gobernanza farmacéutica, entre otros. Todo ello conforma un esfuerzo legislativo de gran magnitud, que evidencia la voluntad política de adaptar el sistema a las necesidades del siglo XXI, integrando herramientas modernas, principios de equidad y sostenibilidad.Sin duda un texto que, cuando se apruebe, marcará el rumbo de la política farmacéutica en los próximos años, o incluso décadas, y que impactará directamente en la industria, los profesionales sanitarios, las comunidades autónomas y, por supuesto, en los pacientes.

El Ministerio de Sanidad ha dado hasta el 30 de abril para que todo aquel interesado pueda realizar las aportaciones que considere oportunas. En Faus Moliner consideramos imprescindible involucrarnos en la elaboración de las normas desde el minuto uno, puesto que ello nos permite contribuir a la creación de un marco legal seguro y adecuado a las necesidades del sector. Por este motivo, en fase de consulta pública, presentamos 47 propuestas. En esta fase, como no puede ser de otra forma, también estamos trabajando en nuestras aportaciones. Todo ello, con el objetivo de tener una norma moderna, justa, flexible pero que, al mismo tiempo, proporcione seguridad jurídica a todos los actores implicados en el sistema.

Una vez cerrado el plazo de aportaciones, el Ministerio analizará las contribuciones recibidas y, si todo sigue su curso, presentará un borrador final ante el Consejo de Ministros. Desde ahí, tras su aprobación, se remitirá al Congreso de los Diputados para su tramitación parlamentaria. Un proceso que será largo y, seguramente, con mucha negociación política. Como ocurre con todas las leyes de esta envergadura, su versión definitiva podría diferir notablemente del texto inicial. Precisamente por eso, este momento —el de las aportaciones— es clave. Es ahora cuando los distintos actores del sector pueden tratar de influir en el contenido de la norma.

Mientras tanto, conviene no dejar pasar la oportunidad de opinar. En este momento toca leer, analizar y —si se puede— aportar, y todo ello hacerlo de la mejor manera posible, con tiempo, conocimiento técnico, análisis detallado y una reflexión sosegada. Porque las decisiones que se tomen ahora tendrán impacto durante muchos años.

La entrada Nueva Ley de medicamentos y productos sanitarios aparece primero en Faus Moliner.

Este nuevo texto está llamado a sustituir a la actual Ley de garantías y uso racional de los medicamentos y productos sanitarios. Una ley que, con el paso del tiempo, ha ido acumulando parches normativos y reformas parciales, dejando claro que el sistema necesitaba una actualización profunda. El nuevo anteproyecto pretende dar respuesta a múltiples desafíos: la digitalización, los nuevos modelos de innovación farmacéutica, el impulso a los genéricos y biosimilares, el acceso equitativo a los tratamientos, o la revisión del marco de gobernanza farmacéutica, entre otros. Todo ello conforma un esfuerzo legislativo de gran magnitud, que evidencia la voluntad política de adaptar el sistema a las necesidades del siglo XXI, integrando herramientas modernas, principios de equidad y sostenibilidad.Sin duda un texto que, cuando se apruebe, marcará el rumbo de la política farmacéutica en los próximos años, o incluso décadas, y que impactará directamente en la industria, los profesionales sanitarios, las comunidades autónomas y, por supuesto, en los pacientes.

El Ministerio de Sanidad ha dado hasta el 30 de abril para que todo aquel interesado pueda realizar las aportaciones que considere oportunas. En Faus Moliner consideramos imprescindible involucrarnos en la elaboración de las normas desde el minuto uno, puesto que ello nos permite contribuir a la creación de un marco legal seguro y adecuado a las necesidades del sector. Por este motivo, en fase de consulta pública, presentamos 47 propuestas. En esta fase, como no puede ser de otra forma, también estamos trabajando en nuestras aportaciones. Todo ello, con el objetivo de tener una norma moderna, justa, flexible pero que, al mismo tiempo, proporcione seguridad jurídica a todos los actores implicados en el sistema.

Una vez cerrado el plazo de aportaciones, el Ministerio analizará las contribuciones recibidas y, si todo sigue su curso, presentará un borrador final ante el Consejo de Ministros. Desde ahí, tras su aprobación, se remitirá al Congreso de los Diputados para su tramitación parlamentaria. Un proceso que será largo y, seguramente, con mucha negociación política. Como ocurre con todas las leyes de esta envergadura, su versión definitiva podría diferir notablemente del texto inicial. Precisamente por eso, este momento —el de las aportaciones— es clave. Es ahora cuando los distintos actores del sector pueden tratar de influir en el contenido de la norma.

Mientras tanto, conviene no dejar pasar la oportunidad de opinar. En este momento toca leer, analizar y —si se puede— aportar, y todo ello hacerlo de la mejor manera posible, con tiempo, conocimiento técnico, análisis detallado y una reflexión sosegada. Porque las decisiones que se tomen ahora tendrán impacto durante muchos años.

La entrada Nueva Ley de medicamentos y productos sanitarios aparece primero en Faus Moliner.

La entrada Más sobre intercambiabilidad y sustitución de medicamentos biológicos aparece primero en Faus Moliner.

La primera es la relativa al aprovechamiento de datos de salud, la digitalización y el uso de la inteligencia artificial (IA). En la Estrategia se destaca la importancia de utilizar tecnologías como la IA y la digitalización para mejorar los procesos regulatorios. Hay que aprovechar los grandes volúmenes de datos de salud existentes para optimizar la toma de decisiones. En este sentido, se seguirá promoviendo la interoperabilidad entre sistemas de datos de salud en Europa, facilitando así un acceso más rápido y preciso a la información sobre medicamentos. Otro objetivo clave es reforzar la ciberseguridad y la calidad de los datos utilizados en la evaluación de medicamentos. Asimismo, está previsto que se incentive la adopción de herramientas digitales innovadoras en todas las agencias reguladoras para mantener e incrementar la competitividad y eficiencia del sistema. Todas estas actuaciones, sin duda convenientes, han de abordarse siempre con pleno respeto a los derechos y garantías de los interesados.

La segunda área que quiero destacar es la relativa a la mejora del entorno regulatorio para promover y acelerar la innovación de medicamentos. La Estrategia prioriza la actualización y adaptación de los marcos regulatorios existentes para fomentar la innovación en el desarrollo de medicamentos, alineándose así con iniciativas ya emprendidas como la “Accelerating Clinical Trials in the EU (ACT EU)” en materia de ensayos clínicos. Se busca también un equilibrio entre la flexibilidad regulatoria y la seguridad, facilitando la aprobación de tratamientos innovadores sin comprometer su calidad. Un aspecto fundamental en este enfoque es la colaboración de industria, grupos de investigación académica y otros stakeholders con el fin de asegurar procesos regulatorios más ágiles y efectivos. Además, la Estrategia prevé trabajar en armonizar normativas dentro de la UE para reducir barreras y fomentar la competitividad en el sector.

Como conclusión, hay que aprovechar las oportunidades que nos plantea un entorno con cambios, cada vez más vertiginosos y profundos, para fortalecer la industria farmacéutica en Europa. Será necesario seguir de cerca el desarrollo de estas medidas a través de los planes de trabajo plurianuales de la EMA y la HMA. En último término, la clave del éxito de la Estrategia residirá en la capacidad de Europa para adaptarse y liderar el cambio.

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Thos interviewed by The Legal 500 highlight that Faus Moliner is “a firm with good litigation experience in the life sciences” and that “it offers a personalized, pragmatic and business-friendly service. Customer service is paramount, and the firm goes the extra mile”. They also state that “Faus Moliner has a team of trusted and pragmatic lawyers who draw on their extensive experience, skills and knowledge to guide clients and problem-solve legal situations. They are able to develop commercially focused strategic advice.

They also highlight that “Jordi Faus is incredible, always willing to help and offering sound and specialist advice” and that “he always offers high-quality, timely and pragmatic advice that aligns with clients’ business goals. He is a trusted advisor for complex legal situations”.

La entrada Faus Moliner recognized once again in the 2025 edition of The Legal 500 (Legalease) aparece primero en Faus Moliner.

Este curso ha reunido a numerosos jóvenes profesionales del derecho que están dando sus primeros pasos en el especializado mundo del derecho farmacéutico, un sector en constante evolución que requiere una actualización permanente de conocimientos. Para ello, han contado con la docencia de un equipo de profesores de gran calidad, en su mayoría abogados con una amplia experiencia en el sector, quienes han aportado una visión práctica y especializada sobre los desafíos regulatorios y legales a los que se enfrenta la industria.

Durante las sesiones del curso, se trató en profundidad el ciclo de vida del medicamento, desde su investigación y desarrollo hasta su comercialización y vigilancia postcomercialización. También, a lo largo del curso, se abordaron los numerosos retos y oportunidades en este sector que se avecinan con la modificación de la normativa que se está gestando a nivel europeo y español. Por ello, contar con la intervención de la Directora de la AEMPS en la clausura del curso ha sido un verdadero privilegio. Su visión sobre las tendencias regulatorias europeas y los desafíos del sector ha ofrecido a los asistentes una perspectiva invaluable sobre el futuro del marco normativo en el que desarrollarán su carrera profesional.

En un mundo donde la innovación científica avanza a pasos agigantados y la normativa debe adaptarse constantemente para garantizar la seguridad, calidad y eficacia de los medicamentos y productos sanitarios, el papel del derecho farmacéutico es más crucial que nunca. La creciente complejidad del marco regulador, la aparición de nuevas tecnologías, así como los desafíos globales en materia de salud pública, exigen de los profesionales del sector un compromiso constante con el aprendizaje y la actualización de conocimientos.

El ICAB, con iniciativas como esta, demuestra una vez más que la formación es una apuesta irrenunciable para el desarrollo profesional de los abogados y juristas especializados en este sector. En un contexto tan dinámico como el del derecho farmacéutico, la capacitación continua no es solo una ventaja competitiva, sino una necesidad para garantizar un ejercicio profesional de calidad.

Apostar por la formación es apostar por el futuro de la profesión y por el relevo generacional en un sector muy especializado y clave para la sociedad. Y el ICAB, con cursos como este, sigue marcando el camino.

La entrada Apostar por la formación aparece primero en Faus Moliner.

The “Law & Practice” section offers key information to help companies operating in Spain navigate the legal system in terms of pharmaceutical advertising, transparency and anti-bribery measures.

On the other hand, the “Trends & Developments” section explores the latest developments in the advertising of medicines in Spain, providing relevant context on upcoming regulatory changes and their impact on the industry.

La entrada Faus Moliner participates in the Chambers & Partners Guide to Pharmaceutical Advertising 2025 aparece primero en Faus Moliner.

The promotional activity in question and the position of the first instance court

The promotional activity, according to the CAM, consisted of sending several letters to healthcare professionals informing them of the availability of the product despite the price and reimbursement procedure not being finalized. The letters proposed the supply of the product under the conditions set forth in Royal Decree 1015/2009 which governs early access situations, indicating that the product would be supplied free of charge until the ruling on price and reimbursement was adopted.

The CAM considered that the promotion had been conducted at a time when it was not appropriate because the price and reimbursement resolution had not yet been adopted. According to the CAM, the company had infringed the rule contained in Royal Decree 1416/1994 which states that advertising “shall include the retail price, the conditions of the pharmaceutical provision at the National Health System, where applicable; and, where possible, the estimated cost of the treatment.”

The first instance court (TSJM), in a ruling of June 17, 2022, upheld the sanction stating, among other things, that:

“… given that the information or advertising (…) must necessarily include the information regarding the price of the product and, “if applicable”, the “conditions of the pharmaceutical provision of the National Health System” (Article 10.2 of Royal Decree 1416/1994, of 25 June), and (…) we must consider that the plaintiff incurred in the prohibition because, even though the product in question was authorized by the European Medicines Agency, neither its financed price (or notified price if it was not going to be financed by the National Health System) had been determined, and therefore, the product did not meet the requirements to be informed or advertised to the professionals authorized to prescribe or dispense it.”

The TSJM, in short, considered that in order to comply with Article 10.2 of Royal Decree 1416/1994, it was necessary to wait until the financed price (so far confidential in Spain) or the notified price (list price) was determined; and that until this occurred, no promotion could take place.

The position of the Supreme Court

In this judgment, the TS confirms the sanction imposed by the CAM, but its interpretation of Article 10.2 of Royal Decree 1416/1994 is very different from the one that inspired the action of the CAM and the interpretation of the TSJM.

A very relevant fact to take into account is that all the parties involved accepted that the promotional material did not include either the price of the product (despite the fact that the letters offered the supply at no cost, at zero price) or the financing conditions. The reading of the TSJM judgment reveals that the company, when appealing the sanction, argued that it did not include these mentions because it thought it was only obliged to do so once a price and reimbursement ruling had been issued.

In its analysis, the TS first considers that any promotional material must include information about the product’s price. The Court deems this an essential element that must always be included, regardless of whether the product is financed or not.

Regarding the proviso in Article 10.2 of Royal Decree 1416/1994, which indicates that promotional material must inform about the conditions of financing in the National Health System “where applicable”, the TS holds that this information should only be included when it is available, stating that “it is not possible to inform about what does not exist”.

In other words, the price must always be included, and the proviso “where applicable” in Article 10.2 applies only to the financing conditions at the National Health System, which is why information on these conditions should only be included when available.

Then, why does the TS confirm the sanction?

As mentioned above, all the parties involved agreed that the company’s promotional material did not include the product’s price (even though the letters offered the supply at no cost, at zero price). This is why the TS upholds the sanction, as it believes that the letters did not include an imperative element (the price, “whatever it may be” the Court says) as required by Article 10.2 of Royal Decree 1416/1994.

In other words, the TS does not validate the reasoning of the CAM according to which an authorized product cannot be promoted until its price and reimbursement has been decided; rather, it merely confirms the sanction on the grounds that any promotion must include the sale price of the product.

If so, can promotion be made prior to the conclusion of the price and reimbursement procedure? And, if the answer is yes, how should it be done?

The answer to the first question, in view of this judgment, can only be affirmative: once a product has been authorized, the marketing authorization holder or its local representative may submit informative offers aimed at promoting the prescription of the authorized product.

As regards how this should be done, the answer is that the promotion must comply with the legally established requirements and, in particular, it must include the selling price of the product.

At this point, the next question is obvious: what price should be included in promotional materials of a product that has been authorized, but for which a price and reimbursement decision has not yet been issued?

According to the TS, what Article 10.2 of Royal Decree 1416/1994 requires is that the price available at that moment be included, “the one that exists.”

Going further into this matter, and entering into the field of practice, our impression is that these promotional informative offers will only make sense in relation to medicinal products for hospital use or at least for hospital dispensing; and that the price that should be stated is the price at which the company offers to supply the product until the price and reimbursement resolution is issued. If it is offered free of charge, our recommendation would be to expressly state that the price at which the product is offered is zero.

In light of this judgment, we believe that if, in the future, an authority such as the CAM were to initiate sanctioning proceedings claiming that the promotion prior to the price and reimbursement decision is illegal, the company’s chances of successfully defending its position would be high, in the current regulatory environment, as long as the price at which the company offers the supply is clearly and expressly stated.

Does Article 22 of Royal Decree 1015/2009 have an impact?

Let us return to the practical side. A medicinal product that is authorized but for which the price and reimbursement decision is pending, can only be made available to patients under Royal Decree 1015/2009. Specifically, Article 17 states that medicinal products holding a marketing authorization valid in Spain (e.g., all those authorized by the European Commission) but are not commercially available can be supplied “following the procedures” of Chapter IV of Royal Decree 1015/2009.

The offering of these medicinal products, according to what we have explained above, may be preceded by informative materials, which some authorities could consider promotional, provided that the conditions resulting from the applicable rules are complied with. In particular, in line with the judgment we are commenting on, the sale price of the product must be included.

However, Article 22 of Royal Decree 1015/2009 (included in Chapter IV) states that the holder of the marketing authorization in the country of origin must not promote the use of the medicinal product. This leads us to think that someone may argue that this prohibition also applies to products holding a marketing authorization valid in Spain, but for which the price and reimbursement decision is still pending (Article 17). In our opinion, this interpretation would be incorrect for two reasons.

In the first place, because Article 22 refers to medicinal products authorized “in the country of origin”, unequivocally implying that such products are not authorized in Spain, which is not applicable to products that hold a marketing authorization valid in Spain, but for which the price and reimbursement decision is pending.

In the second place, because Article 17 of Royal Decree 1015/2009 is a procedural rule that binds the AEMPS, not a substantive rule that binds the companies. When Article 17 says that the AEMPS may authorize access to medicinal products holding a marketing authorization valid in Spain “following the procedures established in this chapter,” it does not mean that the holder of the marketing authorization valid in Spain must comply with the same obligations imposed by Chapter IV when the product in question is not authorized in Spain. All it says is that the procedures that the AEMPS must follow to authorize access to these products are those established in Chapter IV. Therefore, in our opinion, the prohibition of promotion in Article 22 only applies to products that do not have a marketing authorization in Spain.

It is possible, in fact, that this rationale explains why the CAM sanctioned the company on the basis of its interpretation of Article 10.2 of Royal Decree 1416/1994 (and not for infringing Article 22 of Royal Decree 1015/2009).

How our interpretation fits in with European law

Article 87 of Directive 2001/83/EC states that “Member States shall prohibit any advertising of a medicinal product for which a marketing authorization has not been granted in accordance with European law”. It should be recalled that European case law has stated that “the only requirements to which Member States may subject the advertising of medicinal products are those laid down by Directive 2001/83” and that “a complete harmonization of the rules on advertising contributes to eliminating obstacles to trade in medicinal products between Member States, in accordance with Article 95 EC” (Gintec case; C-374/05).

On this basis, a restriction more burdensome than the one established in Directive 2001/83/EC, such as the requirement that a product, in order to be promoted, must have not only a valid marketing authorization, but also a financing (or exclusion) decision, could only be justified if it were really necessary to safeguard public health (Euroaptieka case; C-530/20). Although the TSJM tried to support this argument by pointing out that the pricing system in Spain is also intended to protect public health, the TS does not accept or support this reasoning.

The ruling we are discussing, by allowing the promotion of an authorized product before a decision is made regarding its reimbursement, as long as the promotional material includes the mandatory information (the price, in the words of the TS, “the price that exists”), settles the issue in terms compatible with Directive 2001/83/EC and European case law.

A final comment

The issue regarding the promotion of an authorized product before a decision is made on its financing and price has been extensively debated in multiple forums. It is a complex matter. The judgment expressly acknowledges it when it says that the description of the prohibited conduct in then law “is clear in the sense that it sanctions the promotion, information or advertising that does not conform to what Law 1/2015 itself or the general legislation on advertising provides”; but the Court then adds that “however, it is a question of knowing what the Law and the legislation establish, and this is not so clear”.

The ruling has clarified it: promotional materials do not need to include a reference to the financing conditions if the corresponding administrative procedure has not been completed, as those conditions are not yet known and the phrase “where applicable” applies. However, the price—”whatever it may be”—must be included.

The relevance of the judgment is indisputable, especially if we consider that when the TS agreed to hear this case it stated that the interest of the same “lies in the interpretation to be given to legal and regulatory norms that impose limits on the promotion, information and advertising of medicinal products and sanction their transgression, in a context where this Court has not issued prior rulings and where a real or potential contradiction between different courts is alleged”.

La entrada Promotion of approved products in Spain prior to completion of price and reimbursement procedures: a paradigm shift? aparece primero en Faus Moliner.

The Court of Justice of the European Union (CJEU) has again ruled on the concept of “medicinal product”, in particular on the criteria for determining when a substance exerts a pharmacological action and is therefore to be considered as such.

Before focusing on the case at hand, it is useful to briefly recall the definition of medicinal product and its interpretation by the CJEU to date. According to Directive 2001/83, a medicinal product may be so by presentation or by function. Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis is considered to be a medicinal product by function.

On the other hand, Regulation (EU) 2017/745 (following the previous definition in Directive 93/42) defines a medical device as a device intended for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease without exerting its principal action by pharmacological, immunological or metabolic means. If a product exerts its principal action by pharmacological, immunological or metabolic means, it cannot be considered a medical device (Judgment of 18 January 2023, C-495/21 and C-496/21, Nasal Drops).

Finally, in case of doubt as to the classification of a product, the legal regime for medicinal products should apply, by virtue of the vis atractiva principle as per Directive 2001/83 (Judgment of 2 March 2023, C-760/21, Kwizda Pharma). This regime offers greater guarantees as medicinal products are subject to the highest standards of quality, safety and efficacy for the benefit of public health.

The facts of the case

This case arose in Germany as a result of an unfair competition claim against two companies marketing products as medical devices to prevent and treat certain urinary tract infections, the ingredients of which are D-mannose and cranberry. An association of pharmaceutical companies sought a ban on their sale as medical devices, arguing that they were in fact medicinal products, the marketing of which required prior authorisation.

The courts of first and second instance ruled in favour of the association, finding that D-mannose blocked the adhesion of bacteria to human cells, which they interpreted as a pharmacological action. This conclusion was based on the definition of “pharmacological means” set out in the MEDDEV guidance on borderline products, developed by the European Commission’s expert group, and on an expert’s report.

However, the defendant companies argued that their products should be regarded as medical devices, since for a substance to exert a pharmacological action, it must produce a significant intervention in the physiological functions of the human body. They argued that this was not the case with D-mannose as its effect was limited to preventing the attachment of bacteria to cells by reversible binding. As a result, they appealed to the German Supreme Court, which referred a question to the CJEU for a preliminary ruling on whether a substance that prevents the attachment of bacteria to human cells by reversible binding is to be considered as exerting a “pharmacological action”.

What is meant by pharmacological action?

To answer this question, the CJEU applies a purposive interpretation of EU law, analysing not only the legal text, but also its context and the objectives it pursues. In order to determine the scope of the concept of “pharmacological action”, the Court refers to the MEDDEV and the new MDCG guidance, drawn up by the European Commission to distinguish between medical devices and medicinal products, and to its own case law, according to which the concept of medicinal product must be interpreted broadly (Judgment of 20 September 2007, C-84/06, Antroposana).

According to the CJEU, “pharmacological action” designates the effects of a substance on a living organism, notably for therapeutic or preventive purposes. According to the MDCG guidance, this action involves an interaction (usually at the molecular level) between a substance (or its metabolites) and a component of the human body, which triggers, enhances, reduces or blocks physiological functions or pathological processes.

The Court notes that even a substance that does not interact directly with human cells can modify physiological functions through its interaction with other biological components, such as bacteria, viruses or parasites (Judgement of 6 September 2012, C-308/11, Chemise Fabrik).

According to the Court, the MDCG guidance requires the interaction of the substance with the organism to block the reaction of another agent. In this regard, the CJEU finds that the process by which a substance prevents bacteria from attaching to human cells constitutes a blockage of pathological processes, which makes it fall within the concept of “pharmacological action” and thus within the definition of a medicinal product.

Moreover, according to the Court, neither Directive 2001/83 nor the guidelines require that the cellular interaction must involve long-lasting binding. Therefore, the fact that a substance interacts reversibly with a cellular component does not prevent it from being regarded as exerting a pharmacological action.

Accordingly, the CJEU concludes that a substance, such as D-mannose, by preventing bacteria from attaching to human cells, blocks pathological processes, even if the interaction between the substance and the bacteria is reversible. It therefore determines that, even if the interaction is reversible, the fact that a substance prevents the attachment of bacteria to human cells constitutes a “pharmacological action” within the meaning of Directive 2001/83.

Conclusion

When dealing with the classification of a product as a medical device or medicinal product, the legal regime applicable to medicinal products must be interpreted extensively, prevailing in case of doubt. To this end, the judgment highlights the usefulness of documents such as the MEDDEV and MDCG guidance documents, which, although not legally binding, serve as a reference for interpreting EU law.

La entrada Clarifying the concept of medicinal product and pharmacological action aparece primero en Faus Moliner.

This judgment analyses whether the refusal of the Canary Islands Health Service (SCS) to fund and provide individual access to a medicinal product authorised but not included in the pharmaceutical provision of the National Health System (SNS by its Spanish acronym) is contrary to the principle of equality recognised in art. 14 of the Spanish Constitution. The case raises concerns about the principle of equality as patients in other Spanish regions have received the same treatment at public expense.

Neither the High Court’s approach nor its conclusion is new (the Court recognises the existence of discrimination), but the judgement offers illustrative insights on access to medicinal products in special situations.

Right to equality

The High Court assesses the judgments of the Supreme Court of 19 February and 11 April 2024, key judgments in the matter at hand. According to the Court, the Supreme Court judgments should be read in the sense that “the principle of equal treatment in access to medicinal products applies even to cases of medicinal products not included in the public pharmaceutical provision”. This interpretation establishes that the appropriate basis for comparison is at the national level, rather than at the regional level. This assessment is relevant because, as far as we know, it is the first time that a High Court establishes that the above-mentioned Supreme Court judgments should be interpreted in thesense that there is a subjective right to equality outside the public pharmaceutical provision.

Authorisation to access as a regulated act

The High Court also warns that the authorisation to access non-marketed medicinal products according to Royal Decree 1015/2009 does not allow for discretion by AEMPS. This point is very important because it reinforces the message that the AEMPS, when faced with a request for access to a medicinal product in special situations, must only review whether the criteria set out in Royal Decree 1015/2009 are met, without making any additional considerations.

Competence levels

Finally, the Court raises an issue of competence that had already been observed in similar judgments (e.g. judgment of the Madrid High Court of 9 May 2024). The Court considers that the AEMPS, and not regional health authorities, is the one competent to authorise the supply of a medicinal product that is not yet available in Spain.

On this basis, the Court the SCS to initiate the authorisation process with the AEMPS. Access to medicinal products authorised but not included in public pharmaceutical provision. In addition, the Court rules that if AEMPS decides favourably, the SCS must offer the medicinal product to the patient at public expense.

Our conclusions

We welcome the High Court’s conclusion that, if the AEMPS authorises exceptional access to a medicinal product, regional authorities should not oppose its provision at public expense. We believe this conclusion aligns with the general principle that patients should have access to prescribed treatment without financial barriers.

However, we are also aware that section 6 of art. 17 of Royal Decree 1718/2010 (incorporated by Royal Decree-Law 16/2012) establishes that the acquisition of non-funded medicinal products by SNS hospitals requires the prior authorisation of the corresponding regional commission of therapeutic protocols; and that a conclusion such as the one reached by the High Court could be questioned from this perspective.

Therefore, we consider it urgent to clarify the relation between Royal Decree 1015/2009 and Royal Decree 1718/2010 in order to provide a clear legal framework that offers certainty to all interested parties.

La entrada Access to medicinal products authorised but not included in public pharmaceutical provision aparece primero en Faus Moliner.