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.

En los últimos años, el Tribunal de Justicia de la Unión Europea (TJUE) ha dictado dos sentencias, en los casos Aplidin® y Hopveus®, cuestionando la gestión de los conflictos de interés de los miembros que forman parte de los comités de expertos de la Agencia Europea de Medicamentos (EMA). En ambos casos, el TJUE identificó posibles conflictos de interés en los miembros que analizaron dos autorizaciones de comercialización. Según el TJUE, estos conflictos afectaron a la imparcialidad de la EMA al valorar los expedientes de cada medicamento.

Como resultado de estas dos sentencias, la EMA ha modificado su Política 0044 sobre gestión de conflictos de interés de los miembros y expertos de sus comités científicos. En este Capsulas, analizaremos los aspectos más destacados de esta modificación.

Mayores restricciones para los expertos

En el caso Hopveus®, uno de los expertos que analizó el expediente era investigador principal del ensayo clínico en fase 3 con una molécula cuya indicación era similar a la del producto sobre el que daba su opinión a la EMA. La Política 0044 vigente en ese momento permitía al investigador principal de un ensayo clínico de un producto participar en el análisis de un producto competidor, siempre que no participara en las deliberaciones finales. De acuerdo con el TJUE, esta participación no garantiza la imparcialidad del dictamen de la EMA.
Según la nueva Política 0044, un experto que tenga intereses directos en un medicamento no podrá participar en los comités de la EMA que evalúen otros medicamentos indicados para tratar la misma enfermedad.

La figura del testigo experto

El aumento de las restricciones para los expertos que participan en los comités de la EMA plantea diversas cuestiones y especialmente una: ¿puede esta modificación impactar en la disponibilidad de expertos especializados en ciertos casos, particularmente en la evaluación de productos indicados para el tratamiento de enfermedades raras o ultra-raras?

Consciente de esta situación, la misma Política 0044 reconoce que puede haber situaciones problemáticas que requieran un régimen especial. Con este objetivo, se ha reforzado la figura del «testigo experto», quien podrá presentar su aportación cuando la EMA, por razones de salud pública, lo considere oportuno. No obstante, el “testigo experto” no podrá participar en los debates ni en las deliberaciones finales de los comités de la EMA.

Evaluación de tecnologías sanitarias

La necesidad de manejar los conflictos de interés de los expertos que participan en las actividades de la EMA no afecta solo a las decisiones sobre la autorización de comercialización de medicamentos. La evaluación de las tecnologías sanitarias es otro ámbito donde también se prevé la participación de expertos clínicos y otros especialistas en las actividades de evaluación.

El Reglamento (UE) 2021/228 sobre evaluación de las tecnologías sanitarias prevé la participación de expertos clínicos y otros expertos pertinentes en las evaluaciones clínicas conjuntas. Su Reglamento de Ejecución establece las medidas a adoptar por la Comisión en relación con los conflictos o posibles conflictos de interés de, entre otros, los expertos individuales que participan en las evaluaciones clínicas conjuntas.

El punto más relevante de este Reglamento de Ejecución es un cambio que se ha incorporado con respecto al borrador publicado en audiencia pública en mayo de 2024.

Este aspecto relevante aparece en el artículo 7.3 donde, en relación con los conflictos de interés de los expertos individuales, se prevé que “en casos excepcionales, por ejemplo, el de las enfermedades raras, no se disponga de expertos individuales que estén libres de conflictos de intereses (…) y que dispongan de los conocimientos especializados pertinentes, la Comisión podrá proponer al subgrupo pertinente la participación adecuada de tales expertos individuales en el trabajo conjunto teniendo en cuenta sus conflictos de intereses”.

Según se expone en el considerando 15 del Reglamento de Ejecución, la adición de este inciso pretende conciliar, por un lado, el requisito doble de la independencia y la imparcialidad de los expertos individuales; y, por otro lado, el interés público relativo a la necesidad de contar con los conocimientos especializados pertinentes para garantizar la máxima calidad científica del trabajo de la EMA. Por este motivo, si en casos excepcionales solo están disponibles expertos individuales que tienen conflictos de intereses y que presentan tales conocimientos especializados, se habilita a la Comisión para proponer al subgrupo pertinente la participación adecuada en el trabajo conjunto de tales expertos individuales, teniendo en cuenta sus conflictos de intereses y garantizando al mismo tiempo la transparencia requerida en el manejo de estos conflictos de interés.

Conclusión

La gestión de los conflictos de interés en el ámbito farmacéutico representa uno de los mayores retos actuales para garantizar la imparcialidad en la toma de decisiones, especialmente en dos áreas críticas: la evaluación de medicamentos y la evaluación de tecnologías sanitarias.

El reto para el futuro inmediato será encontrar el equilibrio adecuado entre dos objetivos aparentemente contradictorios: garantizar la máxima imparcialidad en los procesos de evaluación y asegurar la disponibilidad del mejor asesoramiento científico posible. La nueva Política 0044 será un elemento clave para determinar cómo se materializa este equilibrio en la práctica.

La entrada Nuevas reglas en materia de gestión de conflictos de interés de la Agencia Europea de Medicamentos aparece primero en Faus Moliner.

The Law on Guarantees and Rational Use of Medicines and Health Products establishes that sanctions for serious and very serious infringements must be published in the Official State or regional gazette. However, there is no obligation to publish minor sanctions. In recent years, some individuals have requested access to minor sanctions imposed on pharmaceutical companies, raising doubts as to whether or not this information should be disclosed in accordance with transparency laws.

Law 19/2013 of 9 December on transparency, access to public information and good governance (“LTAIBG”) states that access to public information may be limited if its disclosure would damage economic and commercial interests. The question is whether the disclosure of information on minor sanctions could damage the image and reputation of a pharmaceutical company. A cassation appeal, unrelated to the pharmaceutical industry, has been admitted by the Supreme Court to examine this question.

Request for the information of origin

In 2019, the Catalan Administration was asked to provide access to information on sanctions imposed on elderly care homes in Catalonia. As the Administration refused access, the applicant lodged a complaint with the Commission for the Guarantee of the Right of Access to Public Information of the Catalan Government (“GAIP”, by its Spanish acronym). The GAIP upheld the appeal and granted access to the information requested.

Court records

One of the elderly care homes, affected by the GAIP decision filed an appeal to the High Court of Justice of Catalonia (TSJC). The TSJC partially upheld the appeal and ordered to grant access to the information without including the name of the sanctioned elderly care homes, considering it as specially protected personal data. The TSJC argued that the Transparency Law of Catalonia (as well as the LTAIBG) prevented the non-consented disclosure of the name of the elderly homes that had been sanctioned without publication.

The Catalan Administration appealed the TSJC ruling on the grounds that data protection only applies to natural persons, not to legal persons, such as the elderly care homes. The Supreme Court upheld this appeal and ordered the TSJC to re-examine the matter.

In its second analysis, the TSJC had analysed whether disclosing the name of the sanctioned elderly care homes could impact their economic and commercial interests, especially for sanctions that are not to be published under the law. The TSJC concluded that such disclosure could impact on their image and reputation, affecting their competitiveness in the market; and, therefore, affecting their business and economic interests.

The Supreme Court will rule on the issue

The case is pending before the Supreme Court. The Catalan Administration has filed a new appeal in cassation. The Supreme Court will rule on whether a company can oppose against the disclosure of its identity in cases where this could affect its image or reputation.

La entrada Can a company oppose the publication of a sanction imposed on it?   aparece primero en Faus Moliner.

In its assessment of public spending in 2019, the Independent Authority for Fiscal Responsibility (“AIREF”, by its Spanish acronym) said that 68.6% of medicinal product purchases in Spain were “non-standardised”. This category included purchases via minor contracts and direct purchases through commercial offers outside the Law on Public Sector Contracts (“LCSP”, by its Spanish acronym).

These pre-pandemic data may have changed, but there is no doubt that direct purchasing through commercial offers remain a practice with some prevalence.

Given this reality, several considerations can be made, including the fact that the data shows the LCSP lacks adequate mechanisms for managing the public purchase of medicinal products. As a result, several initiatives have been proposed with the aim of addressing the issue by amending the LCSP. Until an amendment is approved, it is likely that direct purchases, involving requests from the Administration for companies to submit their commercial offers, will continue to occur. This reality raises questions about the rights of companies in the context of these types of commercial agreements.

On the judgement

The judgement handed down by the High Court of Justice of Andalusia (“TSJA”, by its Spanish acronym), which has been recently published, deals with a debt claim presented by a translation services company. The Administration refused to pay, arguing that the contract lacked formal validity because there was no contract processed according to the LCSP.

The company claimed that the services had been provided in full conformity and to the satisfaction of the public entities that received them, and, thus, the non-payment amounted to an unjust enrichment of the Administration.

In response, the Administration continued to refuse payment, arguing that in order to pay an amount by way of compensation for unjust enrichment, a special procedure of nullity or validation of the expenditure should have been followed.

The judgment upheld the company’s appeal, stating, inter alia, that the Administration could not benefit from its own failure to follow the applicable procedures (i.e., under the LCSP) and could not invoke formalities to refuse payment for a service that has, in fact, been provided.

On commercial transaction interest

However, the court did not accept that the company’s claim that it was entitled to receive interest for late payment under the Law 3/2004 against late payments in commercial transactions (Law 3/2004 allows interest at very high rates, up to 7 points above Euribor).

The judgment denies the company’s right to this high interest on the grounds that the company submitted a claim based on the Administration’s unjust enrichment of the Administration, rather than a claim for payment due for the provision of the service.

Interestingly, the judges uphold the payment claim on the grounds that the Administration cannot oppose payment on formal or procedural grounds; but they deny the right to interest for late payment on formal grounds.

Conclusion

When supplying medicinal products to public sector entities, until LCSP is modified, it will always be safer to enter into a contract under the LCSP, particularly for those medicinal products that are eligible for the negotiated procedure without advertising due to exclusivity. The request for commercial offer, however, is an option that will continue to be used by many public sector entities. Responding to these requests by submitting an offer and then supplying and invoicing the product remains a valid option. If this approach is followed, it is advisable to be cautious and to follow up the relationship in a timely manner, as subsequent issues with the Administration may arise.

La entrada Purchases of products outside the Law on Public Sector Contracts aparece primero en Faus Moliner.

Until this new regulation is approved, it is worth paying attention to the criteria applied by the regional authorities in relation to the advertising of medical devices addressed to the public. These include those outlined by the Catalan Department of Health in its latest Guide, approved at the end of last year, which we summarize below.

Prohibited statements and content in advertising materials

The key modifications introduced by the Guide regarding the content of the advertising include:

• The prohibition of the inclusion of terms or labels attributing to a medical device therapeutic property by means of pharmacological, metabolic or immunological actions. This prohibition is a consequence of the fact that only medicinal products can claim therapeutic properties derived from pharmacological, metabolic or immunological actions.

• In case the Instructions for Use of the product include age restrictions, the company shall include information on the minimum permitted age or recommended age range for the use of the product.

• Requirement to include a warning about the need to consult a healthcare professional when indicated in the Instructions for Use.

• Obligation to separate messages regarding the product’s environmental sustainability from those related to its health benefits. When submitting materials for approval by the Catalan Authority, the company must include supporting documentation to validate its sustainability claims.

Comparative advertising

The updated Guide notes that it is not necessary to reference the data source when including comparative sales data (e.g., related to volume, revenue or market share) in product advertising. However, information on the period (indicating months and year) and territory (name of the country or countries) to which the data relate should be included.

In addition, the update includes the possibility to compare, in advertising to the public, a medical device with a medicinal product, provided that it is based on a clinical study directly carried out on the two products.

Internet advertising and inclusion of recommendations and/or testimonials

Regarding opinions or mentions of a medical device shared by a well-known person on the internet or social media, the Catalan Authority will classify them as advertising and assume that the company has sponsored or financed them in some way. Even without payment, the Authority may still review the content and context of the publication to assess whether it constitutes a form of advertising for the company, for which the company could be held liable.

As regards advertising through a website, the Guide introduces the following new requirements:

• Consumer opinions, directly provided by consumers, on the websites of companies advertising medical devices should be clearly separated from the advertising of the medical device. It is sufficient to include a separate section titled “Consumer opinions”.

• The person responsible for the website must ensure that they are true, both as regards the person who has provided them and as regards the content.

• These opinions cannot be used as evidence of the product’s efficacy.

• The page containing these opinions should include a warning stating: “These opinions have not been evaluated or authorised by the competent health authority”.

Authorisation of promotional materials

For companies that do not have a registered office in Spain, the updated Guide clarifies that the competent authority for approving promotional materials aimed at the public will be that of the Autonomous Region where their legal representative is located, or if the dissemination is limited to a single region, the Health Authority of that region.

In addition, the updated Guide states the following with respect to the approval process for advertising materials:

• The rule that an application for authorisation must relate to a single material for a single device has become more flexible. Applications that include several materials for the same medical device or for several medical devices will be accepted, as long as they are all included in the materials submitted.

• In the case of a corporate website or product range that contains links to pages containing advertisements for a different medical device, separate authorisation requests must be submitted: one for the homepage and one for each of the product pages.

La entrada Criteria to be considered in the advertising of medical devices aparece primero en Faus Moliner.

This reality became clear during the Covid-19 pandemic, when the European Union (EU) had to contend with a sudden surge in demand for medicinal products, particularly vaccines. Now it is crucial to apply the lessons learned and adapt them to regular production and distribution of medicinal products.

Pharmaceutical companies are used to monitoring their stock levels and demand in real time. The latest digital tools are undoubtedly a major boost in terms of quality and reliable data. However, challenges such as energy price variations, geopolitical conflicts or dependence on non-EU suppliers still lead to bottlenecks in the delivery and supply of medicinal products.

This brings up the ongoing question of when and how the public sector should intervene to support and complement the efforts of the private sector.

In this context, on 17 September, the European Committee of the Regions issued an opinion addressing medicine shortages. It provides recommendations to national governments, the European Commission and other key actors, aiming to strengthen the EU’s autonomy in the pharmaceutical sector. Some of the more ambitious measures proposed include:

1. Increased local production in the EU and diversification of supply partners to reduce external dependence. This can be encouraged through fiscal and financial support measures, as well as foster an attractive environment for research and development.

2. Create a European Voluntary Solidarity Mechanism for Medicines, where countries can help others in critical situations. This idea, highlighted during the Belgian Council Presidency, should  be seen as a last resort, as overuse use can lead to collapse due to the administrative burden.

3. While the mandate of the European Medicines Agency (EMA) was extended by Regulation (EU) 2022/123, the opinion emphasises that the EMA must continue to actively monitor and communicate critical information to patients and healthcare professionals regarding the duration of shortages and available alternatives.

4. Increased digitalization and data tracking must be integrated as essential tools to anticipate and manage supply disruptions.

These measures should be emphasised in rural and remote areas, where scarcity has a serious impact, as well as difficulty in accessing health services.

It is not insignificant that the Committee calls the Commission to investigate how the data collected within the European Medicines Verification System (EMVS) could feed automatically into the European Shortages Monitoring Platform.

This is a long-standing debate. The EMVS was created in the framework of the Falsified Medicines Directive to prevent falsified medicinal products from entering the market, through end-to-end verification. The industry advocates using EMVS data to monitor shortages as it is an already available  tool; while healthcare professionals’ representatives argue it was not designed as a monitoring and tracking system, but merely provides batch data at specific points in time. 

The opinion seems to propose a middle ground, where EMVS data would be integrated or complemented with other sources to provide an unbiased, real-time view of supply levels.

The quo vadis of the possible new EU health commissioner

On the same day, curiously, Von der Leyen’s mission letter to Olivér Várhelyi, her nominee to succeed Stella Kyriakides as the new health commissioner, was made public. In the letter, she mandates him to propose a regulation on critical medicinal medicines to address shortage and reduce dependencies  relating to critical medicines

As mentioned earlier shortages are complex and multi-causal, closely related to other aspects of health policy. For example, most antibiotics are on the list of critical medicines that will be subject to reinforced measures. On the other hand, in the fight against antimicrobial resistance, policies are being adopted to create incentives that make the development of new antimicrobials more attractive. This is why it is crucial to understand pharmaceutical legislation reform as a whole.

Returning to Olivér Várhelyi’s nomination, the European Parliament must now approve his appointment. Beforehand, the Parliament has the opportunity to question the candidate on the key aspects of his agenda. In his written answers, the Hungarian confirmed that he accepts the challenge of proposing a regulation on critical medicines, while also aiming to promote preventive health. This is because it is clear that the issue of shortages can be mitigated through greater preventive healthcare, which would result in reduced demand for medicines. Turning back to the issue of shortages, he announces “additional non-legislative measures,” though without providing further details for now.

From policy to practice

These pronouncements are certainly political in nature. Let us now turn to the practical side. The revision of the European pharmaceutical legislation, as envisioned by the Commission and Parliament in their position, includes the following:

1. A harmonised definition of shortage as “a situation in which the supply of a medicinal product authorised and marketed in a Member State does not meet the demand for that medicinal product in that Member State, irrespective of the cause” is introduced. This last clause was not included in the text originally proposed by the Commission.

2. The requirement for marketing authorisation holders (MAHs) to have shortage prevention plans for the products they market is generalised. The EMA will publish guidance on how to draft these plans, but we can anticipate that they will need to include information such as marketed alternatives or a detailed supply chain analysis that identifies potential vulnerabilities.

3. The Parliament updates the notification requirements for MAHs in cases of suspension or cessation of marketing. MAHs will have to “state their reasons” to the competent authority in the Member State where the medicine is marketed. In addition, it is important to remember that they must notify any temporary suspension or abnormal supply disruption as soon as possible, and at least six months in advance if the situation is foreseeable.

These notifications often generate controversy in practice, because supply issues are not always foreseeable six months in advance. The regulation includes indeterminate concepts, such as what is considered foreseeable, which could lead to increased discrepancies between companies and national agencies.

4. The Parliament strengthens the reporting obligations for distributors and wholesalers. Thus, if a MAH reports a supply issue, the distributor or wholesaler will be required to provide data on stock levels and movements related to the cause of the disruption.

5. The recitals of the proposed regulation call for reflection on the importance of improving public procurement procedures. It recognises that tenders “based solely on price and where there is only one bidder increase the risk of shortages of medicinal products and reduce the number of suppliers in the market“.

The European Union and its actors do not need labels; instead, they should emphasize the value of the work they do within their areas of control. Healthcare stakeholders recognize that the causes of shortages are diverse, interconnected, and multifaceted. This is a challenge in designing and implementing solutions, as it involves multi-causal dynamics with global implications. Ensuring equitable and sustainable access for patients makes this effort truly worthwhile.

La entrada Reflections on medicine shortages in the light of recent policy proposals aparece primero en Faus Moliner.

The three judgments were handed down in the context of proceedings brought by a pharmaceutical company against the refusal of the Spanish Agency for Medicines and Medical Devices (“AEMPS”) to grant marketing authorisations for homeopathic medicinal products.

The requirement for marketing authorisation for homeopathic medicinal products was introduced by Royal Decree 2208/1994. However, this Decree included a Transitional Provision that allowed homeopathic products already on the market to continue being marketed, provided that they submitted the documentation for the authorisation and registration application.

Subsequently, Royal Decree 1345/2007 established that those homeopathic medicinal products that had benefited from the Transitional Provision of Royal Decree 2208/1994 would need to comply with its provisions and obtain the necessary marketing authorisation.

It was not until 2018 that the Ministry of Health, through a Ministerial Order, set forth the requirements and procedure for manufacturers of homeopathic medicines to apply for the necessary marketing authorisation.

On well-established use

The judgments we discuss refer to marketing authorisation applications for injectable homeopathic medicinal products. These injectable products were excluded from the simplified authorisation procedure provided for in Royal Decree 1345/2007 and had to follow the standard procedure.

The legal basis for the marketing authorisation applications for these medicinal products was article 10 of Royal Decree 1345/2007, which covers the authorisation of medicinal products based on sufficiently proven active substances (commonly known as “well-established use” or “bibliographic procedure”). On this basis, if it can be proven that an active substance has been in well-established medicinal use for at least ten years within the European Union, with recognised efficacy and an acceptable level of safety, the applicant can replace the pre-clinical and clinical trial data with bibliographic-scientific literature that provides scientific evidence in this regard.

In the cases analysed, the company had submitted clinical literature, mainly from the Encyclopaedia Homeopathica, and had stated that no relevant safety issues had been detected. In the court proceedings, the company argued that the AEMPS should only verify whether the medicinal product had been on the market in any Member State for over 10 years, whether it had been authorised using the same literature, and whether there were no indications of safety concerns.

AEMPS had refused the marketing authorisations applications for several reasons, particularly because adequate safety information for the medicinal product had not been provided. Regarding this point, the judgments confirm that the safety assessment, even in a procedure such as the bibliographic procedure, cannot be limited to merely checking that no safety issues have been detected (as stated in the judgments, this includes pharmacovigilance signals).

On the other hand, the judgments state that the AEMPS motivated its refusal decisions because the company did not provide specific literature to support the efficacy and safety in the indication, dosage, population group and route of administration requested.

Conclusion

These judgments highlight the importance of a thorough analysis of the scientific literature provided in any marketing authorisation application using the legal basis of well-established use. This is something to be considered also in similar cases such as industrially produced allergen-based medicinal products and bulk allergen-based medicinal products.

La entrada Lessons from the regularisation procedure for homeopathic medicines aparece primero en Faus Moliner.

Clinical trials and other studies conducted in Spain are often sponsored by US entities. For this reason, patients’ health data and, in many cases, their biological samples collected in Spain are sent to the US. These health data and biological samples are personal data and their transfer to the US constitutes an international transfer of personal data subject to the General Data Protection Regulation (GDPR).

The GDPR stipulates that when personal data is transferred outside the European Economic Area (EEA), the level of protection in the destination country must be equivalent to the European level. That is the case when the European Commission, by means of a specific decision, considers that the rules of the destination country are adequate. In the absence of such a decision, data may be transferred if the sending and receiving entities have entered into agreements ensuring an adequate level of protection. These agreements are commonly implemented through “Binding Corporate Rules”, or through “Standard Contractual Clauses” adopted by the European Commission.

EU-US Data Privacy Framework

In the case of personal data transfers to the US, , the European Commission adopted the Adequacy Decision implementing the “EU-US Data Privacy Framework” (DPF) on 10 July 2023. The DPF is the third attempt to regulate such transfers. Previously, the Court of Justice of the European Union (CJEU) had invalidated the Safe Harbour and Privacy Shield decisions in Schrems I (C-362/14) and Schrems II (C-311/18). In both cases, the CJEU considered the guarantees of personal data protection in the US to be insufficient, especially due to mass surveillance programmes by the US authorities.

The Adequacy Decision allows public and private entities resident in the EEA to transfer personal data to US entities adhering to the DPF. These US entities must undergo a self-certification process with the US Department of Commerce, committing to respect a number of general data protection principles, in particular those relating to data use and retention.

When personal data are processed in the context of clinical research, the DPF includes other requirements, such as pseudonymisation of the data by the investigator. The DPF also provides that US sponsors of clinical trials may make secondary use of the data they have received, but must inform the data subjects so that they have the opportunity to object to such use. In addition, new studies involving secondary use of data must be in areas of research or for purposes consistent with what was intended in the consent given for the initial study. These complementary principles are aligned with the 17th Additional Provision of the Spanish Data Protection Law (LOPDGDD), which regulates the processing of health data.

European Data Protection Board clarifications on the DPF

On 16 July, the European Data Protection Board published two frequently asked questions (FAQ) documents to clarify doubts about the DPF. They are addressed to European organisations exporting data to the US and to individuals whose data is transferred to the US.

The document for exporting entities clarifies which US entities can self-certify under the DPF. It also explains how exporters should proceed before transferring data, checking that the importer has a current certificate covering the data to be transferred, and whether it also covers its affiliates, if transfers are to be made to any of them. For this purpose, the public registry of the DPF (https://www.dataprivacyframework.gov/), managed by the US Department of Commerce, should be consulted.

In addition, this document provides specific guidance on whether the importing entity is acting as a controller or processor of the data. If it is a controller, data subjects must be informed about the entity receiving the data and that the transfer is covered by the DPF Adequacy Decision. If acting as a processor, both entities must sign a processor contract in accordance with Article 28 of the GDPR, in addition to the DPF certification.

For individuals whose data is transferred to the US, the document indicates how they can exercise their rights, and which authority will handle their complaints. It also states that they should be informed of the transfer and the identity of the importer of the personal data.

La entrada Transfers of personal data to the US in research studies conducted in Spain aparece primero en Faus Moliner.