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.

Background

The main case concerned “Blutquick”, a food supplement marketed by a German company with the EU organic production logo on its labelling.

The German authorities ordered the removal of this logo from the labelling and advertising of the product, because Blutquick did not comply with the conditions of Regulation (EU) 2018/848 on organic production. As a result, it could not use the logo, nor terms related to EU organic production.

The company challenged this decision on the grounds that this Regulation resulted in unequal treatment with other similar imported products. In this respect, it argued that a US product could bear the EU organic production logo by complying only with US standards, considered equivalent to those of the EU, without needing to comply with the EU rules.

The German courts referred to the CJEU for a preliminary ruling. They questioned whether a product imported from a third country with equivalent production standards, may use the EU organic production logo without complying with the requirements of the Regulation.

Conclusions of the CJEU

The CJEU concludes that products imported from third countries can be marketed in the EU as organic if they comply with equivalent production standards recognised by the EU. However, these products can only use the EU organic production logo if they fully comply with the requirements of Regulation (EU) 2018/848. Therefore, it is not sufficient that these products come from third countries with equivalent standards.

According to the CJEU, the purpose of this logo is to inform consumers that the product complies with requirements of EU law. Allowing the use of the EU logo on products that only comply with equivalent standards, could mislead consumers and undermine fair competition in the internal market.

On the other hand, the Court accepts that a product imported and marketed in the EU may use the organic production logo of its country of origin, even when it uses terms related to organic production. The CJEU considers that such a logo does not give the impression that the imported products necessarily comply with all EU production and control standards.

This judgment illustrates the need for clear rules on labelling and advertising to guide market operators, especially in a sector such as food supplements. It also reminds us of the importance of interpreting these rules in accordance with the principles of consumer protection and integrity of the internal market.

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New provisions in the Law on Guarantees and Rational Use of Medicinal products and Medical Devices

The process to amendment of the Law on Guarantees and Rational Use of Medicinal products and Medical Devices (LGURMPS) was triggered in July 2022 by launching a public consultation. Since then, there has been much speculation about the potential changes. The Secretary of State announced that the public hearing phase of the new law is expected to open in mid-November.Padilla highlighted the following ideas on new provisions in the upcoming regulation:

1. Modification of the reference price system

Price differentiation between generic and innovator medicinal products will be proposed. According to the Secretary of State, the fact that a generic product is differentiated by a lower price does not necessarily mean that the reference product must also reduce its price.

2. Charge backs

The willingness to extend the current charge back to products for hospital use and products that are only dispensed at hospitals is confirmed, but Padilla announced the possibility of exceptions. The case law on the protection of orphan products suggests that these could benefit from some special treatment.

3. New funding criteria

Environmental criteria will be considered when ruling on reimbursement, in order to  “prioritise socially desirable aspects within our system”.

4. Substitution by pharmacists

It is proposed to give pharmacists greater substitution power in situations where problems of supply of certain medicinal products may appear. The Spanish Medicines Agency, on the other hand, will retain power to approve substitution protocols.

5. Prescription by nurses

The law will include provisions giving greater legal certainty to prescription by nurses, currently regulated in Royal Decree 954/2015. The law will contemplate the approval and implementation of protocols or clinical practice guidelines.

Royal Decrees

Padilla also referred to the four Royal Decrees currently under discussion:

1. Health Technology Assessment

The idea that companies should provide information on the volume and origin of funds (public and private) for research and manufacturing of their products is maintained. The current regulation already foresees that these costs are a relevant factor when fixing prices, but it is possible that the new Royal Decree will reinforce this issue.

2. Price and reimbursement of medical devices for non-hospital use

At present, this issue is still governed by a Royal Decree approved in 1996. The Ministry of Health understands that the current rules are very rigid and as a result its capacity to address special situations such as shortages has been affected. The new regulation should provide for a more agile price and reimbursement process for these products.

3. Selective financing of medicinal products

The need of renewing the current regulation governing this matter (a Royal Decree from 1990) is confirmed. The new regulation will contunue circling around the concept of “selective funding” in order to prioritise the medicinal products that provide the most value to the NHS. It is expected that the public consultation will be launched at the end of 2024 and its approval is foreseen for 2025.

4. Magistral formulae of standardised cannabis preparations

A public consultation is now open and the publication of a monograph is announced. These formulations may only be prescribed by specialists. For the time being, these formulae will only be dispensed at hospital pharmacy services.

Other new developments

The Secretary of State also announced other relevant measures.

1. Transparency

Padilla confirmed that, as of this month, fact sheets will be published for each medicinal product/indication for which the Price Committee recommnends reimbursement. The sheets will include information on the indications for which reimbursement was requested, the assessment considered in the decision, the final decision and the reasoning behind it.

On the issue of transparency of unit prices the Secretary of State announced that the Ministry of Health will respect the industry’s right to define its market strategies, and its willingness to preserve the Ministry of Health’s negotiation power. It finally seems that the Ministry is aware of the advantages of maintaining confidentiality of unit prices.

On the other hand, Padilla confirmed the Administration’s commitment to providing more information on overall amounts spending for reimbursed medicinal products grouped by therapeutic groups.

2. Early access data

Information on early access will be published, showing  how patients have accessed the product before the reimbursement process was completed. Additionally, timelines from obtaining regulatory approval to the initiation and completion of the price and reimbursement process will be reported.

La entrada What news may we expect in Spain’s pharmaceutical policy in the next few months? aparece primero en Faus Moliner.

Both judgments have been issued in proceedings initiated in Spain by an innovator company that challenged the marketing authorisations (“MAs”) granted to certain competing medicinal products. The Spanish Agency for Medicines and Medical Devices (“AEMPS”) granted these MAs through a decentralised procedure, in which the Netherlands acted as reference Member State and Spain as concerned Member State.

To understand the dispute, the following facts are relevant:

1. The claimant is the local representative of the MA holder of two medicinal products. One is for a product with a single active ingredient (ezetimibe), whose data protection period ended in 2011. The second MA is for a product with a fixed-dose combination of ezetimibe and atorvastatin, whose data protection period ended in September 2022.

2. Before September 2022, Cinfa and Normon applied for a MA for their generic versions of the combination of ezetimibe and atorvastatin. They provided bioequivalence studies comparing their combination products, not to the innovative combination, but to the concomitant use of the single active ingredients ezetimibe (whose data protection period had expired at that time) and atorvastatin. In addition, Cinfa and Normon relied on certain data on the combined use of ezetimibe and atorvastatin in the dossier of the innovative single active ingredient (ezetimibe) product. These data had been included in the MA of the single active ingredient (ezetimibe) product to fulfil the obligation of keeping the registration dossier updated with all available information on its use.

3. Despite the fact that the ezetimibe and atorvastatin combination had already been authorised in the past (in the innovative fixed-dose combination), and that it was therefore not the first time that a fixed-dose combination of these substances had been approved, the Cinfa and Normon combinations were not authorised as generic versions of the innovative product (ex. Article 10.1 of Directive 2001/83/EC), but as standard combinations on the basis of Article 10b of Directive 2001/83/EC. It is noteworthy that the legal basis of Article 10b is foreseen for medicinal products containing active substances already used in the composition of authorised medicinal products but not hitherto used in combination for therapeutic purposes at the time of the MA application.

4. The MA holder of the innovative combination initiated legal action against these generic combinations in several countries, including in the Netherlands, that acted as reference Member State.

5. In Spain, as explained in the judgements, it was argued that the Cinfa and Normon combinations were generic versions that should not have been evaluated until after September 2022, and that the use of Article 10b as a legal basis was a mechanism to circumvent regulatory data protection of the innovative combination.

6. While the case was pending before the Supreme Court, the MAs granted to generic combinations by the reference Member State were annulled in the Netherlands. This decision was based on the grounds that Article 10b of Directive 2001/83/EC could not be used as a legal basis, as the substances in question had already been combined for therapeutic purposes in the innovative fixed-dose combination, whose data protection period expired in September 2022.

Matters of interest to the Supreme Court

The appeals were formulated around two matters of interest to the Court. The first matter sought to determine the scope of the locus standi of a MA holder for a medicinal product to appeal the marketing authorisation of a competing product when it believes that such authorisation infringes its rights. The second matter aimed to clarify whether, in the decentralised procedure where Spain acts as a concerned Member State, the AEMPS must rule on substantive aspects of the case.

About the locus standi

The first and second instance judgments denied the innovator’s locus standi on the grounds that the doctrine established by the Court of Justice of the European Union (“CJEU”) in the Olainfarm case (C-104/13) was not applicable in this case. Both courts considered that, in the Olainfarm case, the substantive issue concerned a MA for a generic medicinal product granted on the basis of Article 10(1) of Directive 2001/83/EC. However, the legal basis used in this case was Article 10b of Directive 2001/83/EC.

The first and second instance judgments also rejected the locus standi of the claimant on the grounds that the innovator had no legal basis to require the AEMPS to object to the fact that Cinfa’s and Normon’s applications had been processed under Article 10b of Directive 2001/83/EC procedure.

The Supreme Court rectifies the position of first and second instance judgments and confirms that the innovator has locus standi to bring the case before the courts.

The Supreme Court establishes that the authorisation procedure for a medicinal product is a bilateral process between the applicant and the competent national authority; however, this does not prevent a third party, that considers itself harmed by the MA granted (such as the MA holder of a competing medicinal product), from having locus standi to challenge the granting of such MA in court. According to the Supreme Court, denying this right would be contrary to the principle of effective judicial protection.

In this regard, the Supreme Court points out that it is irrelevant (i) whether the legal basis used to grant the contested MAs was Article 10b of Directive 2001/83/EC, (ii) whether the contested MAs were granted in a decentralised procedure or (iii) whether the Olainfarm judgment concerned a MA for a generic medicinal product granted under Article 10(1) of Directive 2001/83/EC.

According to the Supreme Court, the Olainfarm judgment confirms that the MA holder has locus standi to act in defence of its rights if it considers that the MA granted to a competing medicinal product infringes those rights and does so on the basis of Article 47 of the Charter of Fundamental Rights of the European Union.

In relation with this first matter, therefore, the Supreme Cout established repeatedly in these two judgements (thus creating case law in this regards) that the MA holder for a medicinal product has locus standi to challenge the MA of a competing product if it considers that the granting of that MA infringes its rights.

About the scope of the AEMPS in decentralised procedures

Regarding the second matter, the Supreme Court dismisses the appeal, stating that it involves a question of factual grounds that cannot be reviewed at this stage of the cassation process before the Supreme Court.

Despite this ruling, these judgments are relevant because on their basis, in future cases, and before lower courts, it will be possible to request a judicial review of the actions of the AEMPS on such relevant issues as whether the legal basis of a MA procedure is correct or not; or whether the data on which the application for a MA is based should be considered protected or not.

Finally, it is unfortunate that the Supreme Court downplays the importance of the judgment handed down in the Netherlands annulling the MAs granted on the reference Member State. One more case in which “Spain is different”.

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Relationship between evaluation and price and reimbursement procedure

We believe that the evaluation should have its own separate entity from the price and reimbursement procedure. The evaluator “evaluates” and the decision-maker “decides”, both procedures being distinct, with different methods and criteria. Although this theoretical affirmation is generally agreed on, there are some aspects of this Draft that do not seem to be in line with it. For example, according to the Draft, the evaluation exercise concludes with a “final evaluation” of the assessment report to be carried out by the Health Technologies Positioning Group, a group made up, among others, of representatives of the Autonomous Regions and the Directorate General for the Common Portfolio of NHS Services and Pharmacy.

Nature of the reports and rights ofthe developers

In our opinion, the assessment reports should constitute an administrative act finalising an autonomous administrative procedure, which guarantees developers that the full andunrestricted exercise of the rights provided for in art. 53 of Law 39/2015 (hearing, access to the administrative file, appeals, etc.). The Draft is not clear on this matter.

Participation of the developers in the evaluations

The Draft incorporates interesting ideas in this area (e.g. arts. 7.8, 9.4 or 19). However, there is room for improvement. We find it questionable, for example, that developers are not allowed to make contributions to the assessment reports beyond “pointing out purely technical or factual inaccuracies” (art. 14.6). Contributions which, can be made by “patients, clinical and other relevant experts” (Art. 14.5).

Deadlines

The Draft foresees deadlines for the completion of the assessment reports (90+30 calendar days, art. 14); but it does not establish a deadline for the completion of the final assessment by the Positioning Group that closes the evaluation stage. This raises doubts about the total time that the assessment exercise may take, and leaves developers unprotected against unjustified delays.

Prioritisation of evaluations

The possibility of prioritising certain evaluations when the characteristics of the technology so requires seems very important to us, especially from the point of view of speeding up access to certain disruptive technologies. The Draft contemplates the possibility of prioritising the evaluation of medical devices (art. 7.2) but not that of medicinal products.

Identification of comparators

Although this is an issue that will probably be addressed in the “Instruction documents for health technology assessment” (art. 22), we cannot fail to mention it because of its relevance; and the fact that we think it would have been very appropriate to incorporate it in the text of the Royal Decree itself. It is vital to recognise that not all situations are the same or comparable, and that in certain cases the comparison must be made with extreme caution (for example, if industrially manufactured medicinal products with a marketing authorisation are compared with off-label uses, magistral formulae or similar).

Confidentialty

Some provisions of the Draft raise doubts about the essential guarantee of confidentiality that should be predicated on the documents provided by health technology developers and the confidential parts of the assessment reports. For example, it is unclear whether or not the draft reports that will be accessible to “patients, clinical and other relevant experts” (Art. 14.5) may contain confidential information from the developer.

Obligations of developers

In our view, it is important to ensure that the information required from the developer is proportional, relevant and useful to the development of the assessment; and that the developer is not obliged to provide information that does not meet these requirements.

The provision in Art. 23.7 that developers shall be obliged to provide “reliable costs of production, research and development, as well as the sources of funding for these costs, whether public or private” raises many questions from this perspective.

Conflicts of interes

It is essential to strike a balance between the need to have the best possible expertise available for evaluations and the guarantee of the principle of impartiality. The regulation of conflicts of interest in the Draft could, in our opinion, be improved from this perspective.

Re – evaluation

The new rule should promote (and require) a scheme that, while respecting the powers of each administration, eliminates re-evaluations that are not objectively indispensable and duly justified. Although the Draft points out some ideas in this regard, it could do more to ensure this key objective.

La entrada Progress in the regulation of health technology assessment aparece primero en Faus Moliner.

This important judgment of the Constitutional Court of Spain (“TC” by its Spanish acronym) rules on the constitutional appeal filed by Banco Santander against a 2019 sanctioning resolution of the Council of Ministers. This resolution imposed on the bank Banco Santander, the successor entity of Banco Popular, a fine for the commission of a very serious infringement of Law 10/2010, on the prevention of money laundering.

The sanction was imposed following an inspection of Banco Popular in 2017, in which it was concluded that the bank had failed to comply with its duty to report transactions suspicious of money laundering identified by its employees.

The sanction was subsequently confirmed by the Supreme Court. Before the TC, Banco Santander argued that the sanction contravened the principle of culpability and the principle that penalties are personal.

The Constitutional Court’s stance

The Constitutional Court dismissed the appeal on the grounds that the sanctioning resolution is based on a consolidated jurisprudential doctrine established by the Supreme Court and the Court of Justice of the European Union.

According to this doctrine, liability for administrative infringements is transferred in cases of mergers by absorption, as well as in other cases of restructuring between companies, if there is a “substantial economic identity” between the legal entities. To meet this criterion, the economic activity of the legal entity that committed the infringing conduct must continue in the legal entity that succeeds it.

In its judgement, the TC confirms that the criterion of substantial economic identity cannot be contrary to the principle of culpability and the principle that penalties are personal, because these principles must be applied differently in the case of legal entities. A contrary reasoning, the TC points out, would be equal to allowing legal entities to escape liability by continuing the same activity under a different legal form.

The TC concludes that there is a substantial economic identity between Banco Popular and Banco Santander because a block transfer of all the business lines was conducted, including those activities in which the infringing conduct had taken place. This circumstance justifies the succession of liability for the infringement. According to the TC, the compliance measures subsequently implemented by Banco Santander may have a mitigating effect, but they are not sufficient to exclude liability.

The TC emphasises that transfer of liability between legal persons is fully present in article 130.2 of the Spanish Criminal Code. Criminal liability is not extinguished by the transformation, merger, absorption or division of a legal entity, but is transferred to the resulting entity/es.

Conclusion

The TC ratifies the possibility of transferring liabilities between companies in the event of mergers or other restructuring operations. This transfer may relate both to the commission of administrative infringements as well as to criminal offenses. This would include, for instance, non-compliance with money laundering regulations, competition law infringements, or business corruption offenses. The TC also confirms that this is compatible with the constitutional principles of culpability and that penalties are personal.

The judgement highlights the importance of considering this risk in the design and implementation of an adequate compliance model, as well as in due diligence processes in mergers and acquisitions, which are very common in the pharmaceutical sector.

Both in the criminal field and in the field of administrative sanctioning law, the adoption of adequate surveillance, control and prevention actions can be key to mitigate liability and even act as an exonerating circumstance of the company’s criminal liability.

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The origin of this judgment refers to the European Commission’s Implementing Decision not to grant a marketing authorisation for Hopveus®, a medicinal product intended to treat alcohol dependence.

The refusal to grant marketing authorisation was based on an unfavourable opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The applicant, D&A Pharma, requested a re-examination of the CHMP’s opinion. Given the specificity of the scientific and clinical concerns regarding Hopveus®, the CHMP decided that it would be more appropriate for an ad hoc expert group to conduct the re-examination instead  of the Scientific Advisory Group on Psychiatry (SAG).  SAGs are the permanent bodies to which the CHMP may delegate the assessment of certain types of medicinal products. Following the new unfavourable CHMP opinion, the European Commission refused to grant marketing authorisation for Hopveus®.

D&A Pharma brought an action before the General Court of the European Union (GC) seeking the annulment of the European Commission’s decision on two grounds. First, on the ground that it was based on a procedural flaw since the CHMP had convened, for the purposes of the review, an ad hoc expert group and not the SAG on psychiatry. Secondly, because it was based on a lack of impartiality of two of the ad hoc group’s experts. The GC dismissed the appeal, confirming the validity of the European Commission’s decision. D&A Pharma decided to appeal to the Court of Justice of the European Union (CJEU) as it disagreed with the decision of the GC.

About the impartiality of experts

The CJEU recalls that the Charter of Fundamental Rights of the European Union guarantees the right of every person to have his or her affairs handled impartially by the institutions, bodies, offices and agencies of the Union. In the case of the CHMP, that requirement of impartiality is compromised when there is a conflict of interest of one of its members, irrespective of their personal conduct. According to the CJEU, such a breach may render  final decision adopted by the Commission as unlawful.

In the first instance, D&A Pharma claimed that two of the members of the group had a conflict of interest with the opinion they were assessing. One of them (expert A) provided consultancy services related to several pharmaceutical products. The other (expert B) was the principal investigator of a product aimed at the treatment of alcohol dependence (AD 04) and, therefore, a rival product to Hopveus®.

The GC rejected these allegations on the grounds that no evidence of bias of these experts had been provided and that they were not in a situation of conflict according to the EMA’s conflict of interest policy.

In relation to expert A, the GC concluded that experts who have declared an interest as a consultant or strategic advisor for medicinal products of one or more companies may be a member of the ad hoc expert group convened by the CHMP for the purpose of the re-examination of the marketing authorisation application submitted for a competing product. This is except for chairpersons, vice-chairpersons or other members who have a leading or coordinating role in the group. However, the CJEU considers that this interpretation is incompatible with the principle of objective impartiality applicable to all EU bodies.

In relation to expert B the GC examined whether AD 04 should be qualified as a “competing product” with Hopveus® to determine whether this expert should have been excluded from the ad hoc expert group. The GC considered that AD 04 and Hopveus® were not competing products, as AD 04 was aimed at “patients who wish to control their alcohol use but are unable or unwilling to abstain completely from drinking”, whereas Hopveus® was intended to “accompany patients who seek to abstain from alcohol completely”.

According to the CJEU, two pharmaceutical products are competitors on a given market where, for the same therapeutic indication, they are interchangeable or substitutable. Therefore, it must be determined whether AD 04 and Hopveus® are interchangeable or substitutable to such degree. The CJEU states that the assessment should not be based solely on the objective characteristics of the products. Instead, it should involve  an overall assessment of factors which may be considered in order to evaluate whether patients and their prescribing doctors may see one product as a valid alternative to the other.

The CJEU concludes that the GC did not make such an overall assessment, but only noted that AD 04 is intended for patients who “intend to moderate their alcohol use” and that Hopveus® is intended for patients who “intend to give up alcohol use altogether”. However, the CJEU considers that the mere difference in the intensity of the therapeutic effect of two products intended to treat the same pathology may encourage certain patients to substitute, in the context of their treatment, one of those products for the other based on the evolution of their symptoms or other considerations of therapeutic opportunity and efficacy on the part of their prescribing doctors. For this reason, the CJEU considers that the GC made an error in law concluding that there was no potential commercial competition between AD 04 and Hopveus® without carrying out an overall assessment of all  relevant factors.

The EMA’s conflict of interest policy provides that a principal investigator of a competing product (expert B) may participate in an expert group if he withdraws from the final deliberations and the vote on the opinion. The CJEU, however, understands that this participation is not adequate to ensure that the re-examination is conducted in an impartial manner.

About the convening of the ad hoc group of experts

Regarding the second ground, the CJEU accepts that Regulation No 726/2004 does not exclude the possibility that the CHMP, in the context of a re-examination, may decide whether to consult the relevant SAG for the product seeking marketing authorisation.

However, the CJEU notes that the EMA itself limited this power in its Guidelines on the review procedure published on its website. It follows from these guidelines that the EMA undertakes that (i) the CHMP will systematically consult an SAG when the applicant for review so requests; and that (ii) the pertinent SAG must be the one set up in the therapeutic area of the product concerned. An ad hoc expert group shall only be convened if no SAG has been established in that area.

The CJEU argues that, by adopting rules of conduct and publishing that it will apply them to the cases provided for therein, the EMA limits its discretion and can no longer, in principle, depart from those rules. For this reason, the CHMP could have convened an ad hoc SAG only if, following a detailed examination, and in the absence of manifest error, it concluded that the therapeutic indication for Hopveus® did not fall predominantly within the therapeutic field of psychiatry. However, the CHMP did not carry out that examination and did not reach such a conclusion. Therefore, the CJEU holds that the decision to convene an ad hoc group of experts instead of the psychiatry group constitutes a procedural flaw in the adoption of the EMA’s opinion. That defect means that the decision to refuse marketing authorisation is void since it was adopted on the basis of an opinion of the EMA which should have been considered void.

La entrada Impartiality and procedural flaws in the EU aparece primero en Faus Moliner.

This vote marked the first official confirmation of a clear division on some of the key aspects of the reform. The opinion on the directive was adopted with 34 votes in favour, 26 against and two abstentions. For the regulation, the result was 35 votes in favour, 27 against and one abstention.

In this capsulas, we will review the fundamental aspects of this position and highlight the key upcoming dates in the parliamentary decision-making process.

Amendments to the proposal for a directive

Regulatory protection of innovative medicines is undoubtedly the main issue.

The Commission proposed to lower data protection from eight to six years, and to grant additional periods of protection if certain conditions are met (e.g. supply in all Member States where the marketing authorisation is valid). On the other hand, the current 2+1 regime for the protection of marketing protection was maintained.

ITRE proposes to amend Article 81 of the proposed directive as follows:

• The basic period of data protection is increased to nine years and the maximum total data protection – i.e. the basic nine plus the variable extension as appropriate – will be thirteen years;

• Further extensions of twelve months are proposed where any of the following conditions are met: (i) if the marketing authorisation holder demonstrates that a significant part of the pre-clinical development of the medicinal product has been carried out in the EU; (ii) if an application has been made to conduct a clinical trial for a new medicinal product on EU territory; (iii) if the company supports the establishment of public-private partnerships, hospital institutes, centres of excellence or bioclusters to accelerate the development of new medicinal products; or (iv) if the medicinal product includes a majority – a concept to be defined by the European Medicines Agency – of critical active substances produced in the EU;

• It is also proposed to increase some incentives already foreseen by the Commission: if at least one of the indications of the medicinal product addresses an unmet medical need, it is proposed that the protection be increased by 12 months instead of the six months initially foreseen;

• The same increase from 6 to 12 months is proposed where the initial marketing authorisation application is supported by clinical trials with an appropriate comparator;

• Regarding the incentive to supply all Member States and its relation to national pricing and reimbursement procedures, the ITRE report instructs the Commission to ensure that no holder will be unduly deprived of receiving such an extension “for actions beyond its control”.

As can be seen, this is an interesting proposal that is very much aimed at stimulating new medicines development activities to take place on EU territory. On the other hand, the proposal also requires companies to keep the market adequately supplied in order to meet patients’ needs.

In addition, ITRE is clearly in favour of EU strategic and production autonomy, an idea widely supported both by companies focused on innovative medicines and by generic and biosimilar manufacturers. In this regard, the proposal to add a new recital 49a to the directive with implications for public procurement is noteworthy. ITRE notes that using the lowest price as the main selection criterion in a call for tender may reduce incentives for industry and lead to shortages in the EU. On the other hand, awarding contracts to a single company is another cause of weakness. In situations where access to critical medicines is difficult, it might be more efficient to explore joint tendering campaigns between Member States. This approach can strengthen the administration’s negotiating position and allow for incentives for production activities and diversification of sources of supply.

Overall, these are interesting ideas that will stimulate the debate. On the other hand, the proposal includes many indeterminate notions. In the interests of greater legal certainty, terms such as “support” for public-private partnerships would need to be defined more precisely.

Amendments to the proposal for a regulation

In relation to the amendments to the regulation, the most notable relate to the transferable extension of exclusivity for the development of new priority antimicrobials, the so-called voucher. ITRE considers this to be a positive measure, although “its strict conditions (…) may reduce its effectiveness“.

What does the voucher requested by ITRE look like? The amendments seek to restrict the definition of priority antimicrobial as a counterbalance to a more generous regulation for the voucher in terms of the timeframe for its use.

In the Commission’s proposal, the extension could only apply to a medicinal product that was in its first four years of data protection. ITRE considers that the voucher should apply to any medicinal product with at least two years of protection remaining. In practical terms, according to ITRE’s proposal, if a product can have up to thirteen years of regulatory data protection, the voucher could be applicable up to year eleven.

In addition, it is proposed to combine this initiative with an additional incentive scheme to be developed by the Commission, so that it can provide adequate financial support to those developing priority antimicrobials.

In the field of orphan medicinal products, the focus has been on the definitions of unmet medical need and high unmet medical need. The Commission considers that a medicinal product meets a high unmet medical need when at least one of its indications is linked to an orphan disease for which (i) there is no satisfactory method of diagnosis, prevention or treatment; or (ii) even where such a method exists, the applicant has demonstrated that the product represents an exceptional therapeutic advance.

The ITRE report considers that it is dangerous to differentiate between unmet medical needs and proposes to remove the specific regulation for highly unmet medical needs.

As in the directive, it is proposed to extend the terms of protection from nine to ten years in general cases, and from ten to twelve years in cases where no satisfactory treatment has been approved in the EU for the indication concerned. Finally, the five-year protection applicable when the application for authorisation is based on bibliographic data is extended to six years. It is proposed that the maximum total protection, considering the additional periods, should be 15 years.

In relation to the so-called regulatory sandbox, ITRE is committed to maintaining it and broadening its scope so that it can, for example, contribute to generating evidence to inform future adaptations of the legislative framework.

Finally, in relation to notifications of cessations, interruptions or suspensions of the marketing of medicinal products, ITRE proposes that the temporary interruption of supply of a medicinal product for which the same medicinal product is available in a different pack size should not have to be notified.

Next steps

The ITRE report is addressed to the lead committee of the reform process, ENVI, which will have to adopt its own position. In the absence of an official agenda, everything seems to indicate that this could be on 11 March. We are probably now witnessing a prologue to what will happen in ENVI. In fact, the rapporteur for the ENVI directive, Pernille Weiss, is also a member of ITRE.

Once ENVI takes a position, the next step is a plenary vote. At least in theory, this could happen in one of the two sessions of the European Parliament in April, before the next European elections. More haste less speed. In our opinion, the scale of this reform would justify not speeding up the debates in these last few weeks.

In the meantime, little has come out of the Council process. The current Belgian rotating presidency is focused on the trilogues of the European Health Data Space and the text of the reform of the pharmaceutical legislation has not yet been dealt with in depth.

La entrada The processing of the pharmaceutical legislation reform is moving at full speed in the European Parliament aparece primero en Faus Moliner.