In December 2020, the European Commission granted a conditional marketing authorisation for Comirnaty®, which required the marketing authorisation holder (BioNTech) to provide additional data on the characterisation of the active substance and the finished product.

In 2021, a citizen requested access to this information from the European Medicines Agency (EMA). The EMA granted partial access, but withheld certain technical data to protect BioNTech’s commercial interests.

The applicant challenged this decision before the General Court of the European Union (GCEU), which was called upon to determine whether there was an overriding public interest justifying disclosure of the redacted information.

Nature of the redacted information

Before examining whether an overriding public interest existed, the GCEU first analysed the nature of the redacted information. It consisted of trial results relating to the characterisation of the active ingredient and the finished product, as well as the technical parameters used to conduct those trials. This was therefore highly technical information, derived from BioNTech’s specific scientific know-how.

The EMA argued that, given the innovative nature of the technology, its disclosure would enable competitors operating in the same therapeutic field to save scientific effort and human and economic resources.

The GCEU accepts this reasoning and concludes that the redacted data constitutes commercially sensitive information, the disclosure of which could harm BioNTech’s commercial interests. Furthermore, the Court recalls that Regulation (EC) No 1049/2001 on public access to documents does not require the harm to be quantified, nor does it require a detailed market analysis to assess it. It is sufficient that the risk of harm be reasonably foreseeable and not merely hypothetical, unless an overriding public interest justifies disclosure.

What about the public interest?

Having confirmed the commercially sensitive nature of the information, the GCEU turned to the question of whether an overriding public interest nevertheless justified disclosure.

The Court is clear on this point: where access to documents is refused by the public authority, it is for the applicant to demonstrate the existence of such an overriding public interest. A general invocation is insufficient. The applicant must demonstrate, in concrete terms, that disclosure specifically contributes to protecting the public interest. Accordingly, public authorities are not required to assess ex officio whether such an overriding public interest exists.

In the present case, the Court agrees with the EMA that the redacted information was limited in scope, and strictly technical, and likely to benefit BioNTech’s competitors if disclosed. Granting access would therefore upset the balance struck by the European legislation between companies’ obligation to provide sensitive information to the EMA and the strong protection given to that information under professional and commercial secrecy.

What happens if the information has already been leaked?

Directive (EU) 2016/943 and Spanish Law 1/2019 on Trade Secrets define a trade secret as information that is secret, that has commercial value precisely because it is secret, and that has been subject to reasonable measures by its owner to keep it secret.

This classification allows access to be refused where disclosure would cause economic harm to its owner.

In this context, the question arises as to what happens if such secret information is leaked.

In this case, part of the redacted information had been disseminated online following a cyberattack on the EMA. The Court examines whether such a leak altered the legal assessment.

The Court’s response is unequivocal: unauthorised disclosure does not automatically render that information publicly accessible for the purposes of the rules on freedom of information and access to public documents.

Conclusions

Three main conclusions can be drawn from this Judgment:

First, no quantification of harm is required. It is sufficient that the risk to commercial interests be reasonably foreseeable. This issue remains controversial at national level, for example in relation to access to pricing and reimbursement decisions.
Second, public authorities are not required to assess ex officio whether an overriding public interest exists. The burden of proof lies with the applicant who has been denied access to specific information.

Third, a leak or unauthorised disclosure of part of the requested information does not prevent the remaining information from continuing to merit protection.

La entrada Trade secrets and transparency: how far does the public interest extend? aparece primero en Faus Moliner.

Limited access to Joint Scientific Consultations (JSCs)

The first challenge concerns Joint Scientific Consultations (JSCs). These consultations, similar to the EMA’s scientific advice, are intended to allow companies to obtain early guidance on clinical trials design and align evidence generation with joint assessment requirements. JSCs are already operational and provide a unique forum for dialogue with HTA authorities, which may prove decisive for a medicinal product’s development strategy.

However, access to these consultations is limited. After only one year, it has become apparent that capacity constraints means that not all companies can benefit from them. In practice, access may depend more on available resources than on scientific or clinical criteria. From a legal perspective, this poses a challenge in terms of fairness: Article 41 of the Charter of Fundamental Rights of the EU (CFR) guarantees the right to good administration, including equal treatment and non-discrimination. If access to JSCs is restricted for resources constraints, questions arise as to how fair access of companies can be ensured, particularly when such consultations may strongly influence development strategies.

Lack of predictability around the definition of PICOs

Another key issue concerns the definition of PICOs (Population, Intervention, Comparator and Outcomes) in Joint Clinical Assessments (JCAs). Member States may propose multiple PICOs, which creates uncertainty regarding the scope of the assessment and how to organise the generation of evidence.

This is particularly problematic when comparators include off-label uses or interventions that differ significantly from those being evaluated. According to the HTA Coordination Group’s Guidance on the Scoping Process (13 November 2024), comparators may include unauthorised treatments or non-pharmacological interventions. A single PICO could end up facing alternatives with very different regulatory realities and development plans; for example, an industrially manufactured product and a magistral formula. This not only complicates the preparation of evidence, but also creates an incentive challenge: an authorised, industrially developed medicinal product will have borne the full costs and requirements of the entire regulatory process, whereas an off-label comparator or magistral formula may not have undergone the same level of development.

From a legal standpoint, this lack of predictability affects legal certainty and undermines companies’ ability to plan clinical evidence and launch strategies. Ensuring that PICOs are proportionate and reasonable is therefore essential to comply with the principles of good administration under Article 41 CFR.

Further uncertainty arises from the strict procedural timelines under the HTA Regulation. The 100-day deadline for preparing HTA dossiers is particularly challenging, as it depends on the timing of EMA procedures and may change unexpectedly.

This creates compliance risks, especially for small and medium-sized companies with limited regulatory capacity. The problem is compounded by the possibility that several PICOs may apply to a single product and by the lack of clarity regarding the consequences of submitting an incomplete dossier or failing to submit one at all.

Together, these factors increase legal uncertainty and highlight the need for careful planning.

Conflicts of interest

The European HTA system relies on highly specialised experts to carry out JCA. However, the more innovative the technology (such as ARMPs or orphan medicinal products), the smaller the pool of available experts and the greater the likelihood of conflicts of interest. Regulation (EU) 2021/2282 acknowledges the challenge of reconciling the requirement for impartial procedures with the need to preserve the scientific rigour and technical depth of assessments that demand an exceptionally high level of expertise.

Implementing Regulation 2024/2745 adopts a pragmatic approach, allowing experts with conflicts of interest to participate in exceptional cases where no viable alternative exists, provided strict transparency and risk-mitigation measures are applied. This solution reflects a significant shift in the legal debate: conflicts of interest are no longer conceived as a binary category (existing or non-existent) but as a factor to be managed in light of the overall public interest and the need for high-quality scientific input. Experience to date confirms that the real challenge lies in balancing independence, expertise and legal certainty in an increasingly demanding regulatory environment.

The limited role of the developers in the HTA Process

The procedural design of Regulation (EU) 2021/2282 assigns the developer a particularly restricted role at key stages of the JCAs. At the scoping stage, Article 8.6 of the HTA Regulation expressly excludes health technology developers from defining the PICO parameters, which are constructed primarily on the basis of extracts from the dossier submitted to the EMA and contributions from Member States. Unlike patients and clinical experts, developers are not granted a formal channel for providing substantive comments on the scope of the assessment, despite this being a determining factor in the outcome of the HTA.

This limited position is maintained in subsequent stages of the procedure. The scoping clarification meetings provided for in Implementing Regulation (EU) 2024/1381 are purely explanatory in nature and do not allow the developer to influence the content of the scope, in addition to being optional. Likewise, the Implementing Regulation restricts the developer’s right to comment on the draft JCA report to the identification of factual or technical errors, with particularly short review deadlines.

These restrictions raise an important legal question: is the procedure for preparing a JCA compatible with the right to be heard and the right to good administration enshrined in Article 41 of the CFR? Although the answer is nuanced, it is clear that the Regulation does not grant the developer the weight it ought to have in the process, thereby missing the opportunity to make the most of the direct knowledge of those who know the product best.

Although the company has its own interest in the assessment, this should not be used to restrict its participation at various stages. The real challenge, as noted in the section on conflicts of interest, is to recognise and manage this conflict in a balanced manner, rather than using it as an argument to reduce the developer’s participation.

Uncertainty regarding the use of JCAs in national procedures

A further question raised by Regulation (EU) 2021/2282 concerns how the relationship between JCAs and national assessment and decision-making procedures will be structured in practice. The Regulation itself adopts a deliberately ambivalent formulation: on the one hand, JCAs are expressly non-binding and “should therefore not affect the discretion of Member States to carry out assessments on the clinical added value of the health technologies concerned” (recital 14); on the other hand, Member States are required to “give due consideration” to these reports and to attach them to their national assessments, also informing the Coordination Group of how they have been used (Articles 13 and 14 of the Regulation). This combination of formal non-binding nature and obligation to take them into account leaves ample room for divergent reinterpretations at national level, with the consequent risk of fragmentation.

In the case of Spain, this uncertainty is amplified by the decentralised structure of the National Health System itself. Although the Ministry of Health has expressed its intention to respect joint clinical assessments developed at European level, the current legal framework allows JCAs to be integrated into complex national processes, involving multiple authorities and decision-making levels, and in which additional assessments or successive re-evaluations cannot be ruled out (e.g. at the level of the Autonomous Communities or even at hospital level). All this takes place in an area – the allocation of resources for national health systems and pricing and reimbursement decisions – that EU primary law reserves to the Member States (Article 168 TFEU). The question therefore remains open as to whether the new system will succeed in reducing duplication of clinical assessments and achieving genuine harmonisation, or whether national application of JCAs will ultimately reproduce, in new forms, the divergences the Regulation seeks to address.

Conclusions

One year after the launch of European HTA, the legal and procedural challenges are evident: limited access to JSCs, uncertain PICOs, off-label comparators, tight deadlines and restricted developer participation. This compels companies to plan strategically, combining science and law from the earliest stages.

Added to this is national-level development. The Royal Decree on Health Technology Assessment, which will regulate the national stage, is at an advanced stage of preparation and was submitted o the Council of State for revision this month. It is expected to be approved soon by the Council of Ministers. The new Law on Medicinal Products and Medical Devices, on the other hand, remains subject to an uncertain legislative timetable. These national regulations will complete the European framework and shape the next phase of adaptation for companies.

The first year delivers a clear message: European HTA is not only a technical challenge, but also a strategic and legal one. Those able to anticipate developments and act with flexibility will be better positioned to demonstrate the value of their technologies and remain competitive in an increasingly demanding market. Close attention to national developments will be essential to finalise the regulatory framework and support informed decision-making.

La entrada The HTA Regulation: one year on aparece primero en Faus Moliner.

In his presentation, Lluís Alcover highlighted the significance of the new European Health Technology Assessment Regulation. The Regulation will mark a turning point in the way medicinal products are evaluated in Europe. He explained that this regulation seeks to harmonise clinical criteria among Member States, but at the same time introduces a more complex and demanding framework for pharmaceutical companies. Companies will have to adapt their regulatory and market access strategies from the very early stages of clinical development.

Lluís warned that access to Joint Scientific Consultations (JSCs) will be limited, which could pose a risk of breaching the principle of equality recognised in the EU Charter of Fundamental Rights. There will not be room for everyone, and only some companies will be able to obtain early advice to align their trials with the expectations of the assessment agencies. This limitation raises questions about procedural fairness and transparency in the allocation of opportunities for dialogue with the authorities.

Another critical point highlighted was the possibility that joint clinical assessments (JCAs) may include off-label comparators. This approach will require special attention from companies to ensure that the evidence generated is relevant and robust in relation to the selected comparators. Furthermore, there is some concern about comparing technologies with different regulatory and cost profiles, as this could introduce bias into the assessment and pose a problem when interpreting the assessment results.

Finally, Lluís stressed that the role of developers in defining PICOs (patient population, interventions, comparators and health outcomes) and reviewing draft JCAs will be very limited, which may strain the right to be heard and make it difficult for developers to defend the value of their technology. All of this, he warned, opens a new front of legal and procedural challenges that will require companies to strengthen their regulatory planning and their legal response capacity.

Financing of medicinal products

Joan Carles Bailach spoke about the main challenges that the Draft Law on Medicinal Products and Medical Devices (Draft Law) should address to achieve a more agile system for the incorporation of therapeutic innovation and, at the same time, a more predictable one for the companies operating within it. To this end, the Draft Law should incorporate or better define the following instruments.

Firstly, Joan Carles explained that the new Law should include early dialogue as an instrument enabling companies and the Administration to formally initiate price and reimbursement negotiations once the CHMP has issued a positive opinion on the marketing authorization. This tool would substantially reduce the timeframes for financing and would place Spain at the forefront in Europe, as many countries have yet to incorporate it into their legislation.

Secondly, the new Law should include instruments aimed at reducing access times and making the process more predictable. These include the accelerated financing procedure and conditional financing.

The accelerated financing procedure would shorten the processing times for certain medicinal products of public health interest, such as orphan medicinal products, advanced therapies, oncology or antimicrobial medicinal products, among others. In this regard, the Secretary of State for Health, during his appearance before the Health Committee of the Spanish Parliament on 28 October 2025, announced that the new Law will incorporate a period of less than 90 days, especially for medicinal products intended to cover unmet medical needs.

Conditional financing would allow for the provisional reimbursement of medicinal products subject to clinical or economic uncertainty, conditional on the generation of new real-world evidence. This model would facilitate faster access to innovative therapies, while maintaining risk control for the National Health System through review clauses, clawback mechanisms or provisional discounts.

Both instruments would contribute to more equitable access, reduce current legal uncertainty and balance the need for speed with that of sustainability and rigor in decision-making.

Finally, Joan Carles considered that the new Law should contemplate the possibility of conventional termination in certain price and reimbursement procedures, allowing the Administration and companies to modify or terminate the agreement when circumstances beyond the control of the parties arise. This measure would provide greater legal certainty and flexibility, promoting more efficient management of uncertainty and an effective collaborative relationship between industry and the Administration.

New developments in advertising

In the session dedicated to advertising, Anna Gerbolés addressed the new developments introduced by the new regulatory framework on the promotion of medicinal products. In particular, she examined those included in the Draft Law on Medicinal Products. She also reviewed the Draft Royal Decree on the promotion of medical devices, analysing the possible impact that this draft might have on the future regulation of medicinal product promotion.

Among the most relevant new developments regarding advertising in the Draft Law, Anna referred to those introduced in the sanctioning framework. One of them is the reclassification of the infringement of the rules on promotion of medicinal products, which will no longer be considered “very serious” but “serious”, thus aligning the sanction with that established for the irregular promotion of medical devices.

Another significant development is the introduction of a new infringement concerning the prohibition of promoting medicinal products prior to their marketing, aimed at closing the debate opened following the Supreme Court ruling of March 2025. This ruling determined that promotion prior to the price and reimbursement resolution does not infringe Royal Decree 1416/1994, regulating the advertising of medicinal products for human use, if it includes information about the price of the product. During the session, it was noted that this new infringement could be contrary to Directive 2001/83/EC, as it would establish an absolute prohibition not foreseen in that Directive. The case law of the Court of Justice of the European Union -in particular, judgments C-374/05 (Gintec, 2007) and C-786/18 (Ratiopharm, 2020) has reiterated that absolute restrictions cannot be imposed in a field of full harmonization. It is therefore likely that this infringement will be removed from the final text.

Lastly, Anna analyzed the measures included in the Draft Royal Decree on the promotion of medical devices, warning of the risk that some of them might be unduly transferred to the field of medicinal products, despite their different regulatory frameworks. For example, the broadening of the concept of “promotion” for medical devices -which would include any meeting financed by the company to present the characteristics of a product- contrasts with the narrower view that applies to medicinal products.

Similarly, the absolute prohibition of offering hospitality at promotional meetings, as foreseen for medical devices, would not be compatible with the Directive if applied to medicinal products, since Article 94 allows hospitality if it is moderate and subordinate to the scientific or professional purpose of the meeting. An absolute prohibition on hospitality would also be contrary to the European framework.

Artificial intelligence in the medicinal product life cycle

During her presentation, Claudia Gonzalo addressed how artificial intelligence (AI) is not only advancing in the healthcare field but is also beginning to be integrated throughout the entire life cycle of a medicinal product: from discovery and clinical trial design to manufacturing and pharmacovigilance. Her presentation revolved around a key idea: AI does not replace human responsibility, but it does redefine the way critical decisions are made in the pharmaceutical sector.

She explained that AI is already accelerating phases such as the discovery of new molecules or the selection of patients for clinical trials, and that regulatory agencies now recognize evidence generated by algorithmic systems. She also pointed out that the European Union’s Good Manufacturing Practices are preparing to incorporate a new Annex 22 dedicated to AI, and that in the commercialization phase this technology is already being used to improve the detection of adverse effects and optimize supply management.

However, she warned that this progress will only be sustainable if it is governed under two principles: the risk-based approach -according to which regulatory requirements should increase in proportion to the criticality of the decision- and the quality and traceability of data, all within the context of building the highest possible level of trust in the system.

Finally, she highlighted the strategic role of the legal department in the integration of AI. Successful implementation cases, she noted, share common elements: a clear inventory of models and risks, the adaptation of contractual clauses to algorithmic environments, and internal procedures that guarantee the quality of both system and the data that feeds it. Her closing message was clear: it is not about slowing down innovation but about accompanying it monitoring structures that ensure its development with safety and traceability.

Closing Conference

Jordi Faus began his speech by highlighting the high level of participation in the course, and his satisfaction at seeing how the work carried out by those who have participated in submitting proposals to the Spanish Administration concerning the regulations being developed has not been in vain. As Ana Bosch (Farmaindustria) pointed out, the proposals have been listened to attentively and, in many cases, incorporated into those that the Ministry of Health is willing to present and defend. This speaks highly of the Administration but also of those who have formulated the proposals, especially Farmaindustria, CEFI, and some companies and professionals who have participated in the process.

As for the current situation, in which “everything related to the regulatory core is under review” (César Hernández), Jordi stressed that it is essential to recognize the role of the industry and of lawyers specializing in pharmaceutical law, pointing out that “what is going to be approved are legal rules, so I encourage you to participate in everything you can (…) with a broad perspective, considering relevant economic, social, and ethical aspects, and putting yourselves in the position of the managers, as Manuel Cervera also said, because what is needed is a calm debate built on solid foundations and with few, if any, prejudice”.

In this context, Jordi agreed with the idea expressed by Javier Padilla: in times of uncertainty such as the present, it is advisable to avoid overreacting and to maintain the commitment to more Europe. Remaining firmly committed to the core values of the EU is of the utmost importance. Having public health systems whose main objective is to protect the health of citizens and help them overcome disease is a social achievement that must be nurtured every day. It is, ultimately, a question of culture. The same applies to understanding -as pointed out in the Commission’s July Communication (“Strategy for European Life Sciences to position Europe as the world’s most attractive place for life sciences by 2030”), that beyond preserving competitiveness, we must approach these matters considering that “this is also a strategic investment in intergenerational fairness, as the aim is for Europe to lead with purpose, so that innovation serves people and the planet, both now, and for generations to come”.

On the other hand, Jordi once again insisted that committing to Europe must also mean guaranteeing the full effectiveness of European Union law, citing case law that requires national provisions contrary to EU law to be set aside. Supporting this view, he noted that administrations, for example, should not prevent a product from being placed on the market (even on the private market) nor prohibit its promotion once the European Commission has granted a marketing authorization.

Regarding the 2024-2028 Pharmaceutical Strategy, Jordi pointed out that it is a government action plan approved by a resolution of the Council of Ministers of 10 December 2024 -a text that may be used in any interpretation of any regulation or action by the General State Administration.

The plan’s objectives are divided into chapters: (i) equitable access to medicinal products and sustainability of the NHS; (ii) promotion of research, development and innovation; and (iii) autonomy, which encompasses both the idea of ensuring the competitiveness of the sector and its contribution to strategic autonomy through a solid, resilient and eco-sustainable supply chain.

In relation to these objectives, the importance of conceiving pharmaceutical policy as a genuine national policy was highlighted, which should also integrate industrial, social and employment aspects. Perhaps one of the positive side effects of the pandemic has been precisely to make us aware of the importance of what we now call strategic autonomy, and of the need to support those who concentrate their investments, efforts and daily work in production units. Jordi considered it noteworthy that the strategy recognizes, as current challenges for the sector, (a) the greater complexity of research and development of therapies to meet unmet needs and (b) the vulnerability of supply chains caused by an exodus of production facilities because of globalization and cost pressures.

Regarding the sustainability of the system, Jordi provided a historical perspective on this issue, highlighting that the challenge of sustainability has always been present, but pointing out that the measures to address it should be adapted to the current reality. We are not, Jordi said, in the 1980s, “when the task was to adopt measures to exercise a certain control over a significant portion of public funds, the use of which depended on the decision of the prescribing professional.” In the 21st century, the products with the greatest budgetary impact are ones where the industry’s ability to influence the volume of demand is low or even non-existent. For this reason, if the crux of the matter in terms of sustainability lies in in the tension between the developers’ ability to supply technologies and the capacity of public health systems to structure their demand appropriately as part of their public policies, the priority should be to work on how demand is structured, not on creating obstacles for supply, especially when discussing about therapeutic areas where the industry’s ability to influence the volume of demand is very low or even non-existent.

Finally, it was pointed out that access issues are closely related to the individual rights of patients, highlighting that, although in Spain the right to health protection is not a fundamental right but only a guiding principle of administrative activity, certain case law recognizes that the fundamental right to life and physical integrity must mean more than the mere right to exist.

After reviewing the actions outlined in the Strategy, Jordi concluded by expressing his hope that the new rules, like the medicinal products they regulate, will be of high quality, offer legal certainty, and establish an effective framework to support a favorable environment for innovation, for the benefit of society as a whole and especially of patients.

La entrada Summary of the presentations given by the Faus Moliner team at the 20th Pharmaceutical Law Course organised by the CEFI Foundation aparece primero en Faus Moliner.

On 22 September 2025, the Ministry of Health launched the prior public consultation on the draft of Spain’s future Digital Health Law. This new law aims to align Spanish legislation to Regulation (EU) 2025/327 on the European Health Data Space (EHDS), which will be applicable from 2027 onwards.
The future Digital Health Law will establish the connection with the European EHDS platforms, facilitate the primary use of health data through an interoperable electronic health record, regulate the secondary use of health data and digital therapies, and define the rights and obligations of patients, professionals and operators.

The future Digital Health Law will establish the connection with the European EHDS platforms, facilitate the primary use of health data through an interoperable electronic health record, regulate the secondary use of health data and digital therapies, and define the rights and obligations of patients, professionals and operators.

Secondary use of data

One of the most relevant aspects of the Digital Health Law for the pharmaceutical sector is the secondary use of data.

The EHDS Regulation recognises the right to secondary use of health data, that is, the processing of data for purposes other than those for which it was originally collected. In essence, this means being able to use data obtained at a given moment for subsequent activities such as research, improving healthcare, or developing and implementing public policies.

Secondary use is particularly relevant for companies for two reasons: as data holders, they are obliged to make certain categories of information available (e.g. clinical trial data); and as researchers, they may request access to data through the mechanisms provided by the EHDS to promote innovation and research.

Challenges posed by secondary use of data and our proposals

Secondary use of health data presents two main challenges:

On one hand, it poses significant challenges in terms of confidentiality and the protection of intellectual and industrial property. Data generated by pharmaceutical companies – especially from clinical research in Spain – are protected by intellectual and industrial property rights as well as trade secret regulations. The improper disclosure of such data could amount to unfair competition and compromise the scientific integrity of clinical trials. Therefore, access to this information must be subject to legal, organisational, and technical safeguards that ensure its protection, limiting its use until the study concludes, within secure environments, and in full compliance with European and national regulations. These measures should protect both the economic interests of data holders and patient safety.

On the other hand, secondary use of data also raises governance challenges, particularly in Spain, where healthcare organisations depend on both national and regional public administrations.

In the context of the prior public consultation, our proposals regarding requests for access to data for secondary use are as follows:

1) Require that access to protected health data be always subject to legal, organisational, and technical safeguards ensuring adequate protection.

2) Incorporate the non-binding standard contractual clauses established by the EU for confidentiality agreements under the EHDS Regulation.

3) Require healthcare organisations to inform and request approval from the data holder when an access request includes data subject to industrial property rights or trade secrets.

4) Ensure that access to protected data is only authorised within secure environments as defined in the EHDS Regulation.

5) Allow data holders to challenge access to information decisions before the competent body and the ordinary courts, with suspensive effect until a final decision is issued.

6) Provide that claims concerning access to secondary health data replace administrative appeals, in accordance with Article 112 of Law 39/2015.

7) Include safeguards to prevent the improper competitive use of anonymised data that could harm data holders or competitors.

8) Establish that, in case of doubt about the adequacy of safeguards, access to data be denied.

9) Grant appropriate powers to the national access body to issue binding criteria on the application of the EHDS Regulation, ensuring consistency between regional and national bodies.

10) Ensure that national and regional access bodies include experts in data protection, bioethics, and health impact assessment in order to evaluate ethical aspects of access requests without relying solely on existing ethics committees.

Use of digital technologies in healthcare

Beyond the implementation of the EHDS Regulation, the future Digital Health Law is expected to establish the legal framework for the inclusion and financing of digital technologies as part of the healthcare services offered by the Spanish public system. The law will set out the procedures for determining the conditions for such inclusion, as well as the relevant financing mechanisms.

Our view is that the rules on potential financing of digital health products should be incorporated into the Law on Medicinal Products and Medical Devices on which the Spanish government has already worked and which could be presented to Parliament for approval in the next few months. Alternatively, these rules could be added to the Royal Decree on financing medical devices for outpatients

We also think that given that financing of digital health products and therapies is a challenge that other EU Member States have already addressed, their experience could serve as a reference for Spain. For instance, Germany’s DiGA procedure and France’s PECAN system allow for provisional inclusion followed by a more comprehensive evaluation. In Spain, initiatives already exist to define a financing model – now is the time to formally establish it, balancing agility with rigour in evaluation.

La entrada Challenges and proposals on the future Spanish Digital Health Law aparece primero en Faus Moliner.

Supreme Court Judgment No. 710/2025 concerns a €100,000 fine imposed by the regional Government of Andalusia on an individual for committing a serious infringement under the Andalusian Historical Heritage Law. The individual argued that the fine was disproportionate given the circumstances and the absence of actual harm to historical heritage.

The Court reduced the fine to €10,000, holding that when the circumstances of a case render the sanction disproportionate, both the administration and the courts have the power to reduce it by applying the sanction that would correspond to a less serious infringement.

In other words, even if the law classifies certain conduct as a very serious infringement, punishable by a fine ranging from €90,001 to €1 million, the final penalty applied may be the one applicable to a serious infringement (not to a very serious one), and may thus be much lower. This could happen if the minimum fine for a very serious infringement (€90,001) would be disproportionate in light of the specific circumstances of the case.

The Court held that such a reduction does not violate the principles of legality or legal certainty, and that the principle of proportionality must prevail.

In the medicinal products sector, where current law classifies any non-compliant advertising activity as a very serious infringement, this judgment opens the door to moderating sanctions according to the case’s specific circumstances. Situations where the boundary between information and advertising is particularly blurred may benefit from this approach. Cases where an infringement occurs but no actual harm is caused to public interests, public health, or patients could also benefit from this jurisprudence.

When the sanctioning provision is too vague

In this case, National High Court Judgment No. 103/2025 considered that the minor infringement defined in Article 111.2 (a) (10) of Royal Legislative Decree 1/2015 (“failure to comply with requirements, obligations or prohibitions established in this law and its implementing provisions in such a way that do not qualify as serious or very serious infringement”) constitutes an overly broad and vague sanctioning provision, incompatible with the constitutional guarantees of legality and legal certainty.

Although the provision remains in force, in sanctioning proceedings where the rule applied is excessively vague or generic, it is possible to challenge the sanction for violation of the principle of legality, relying on the reasoning in this judgment and in Judgment No. 242/2005 of the Constitutional Court.

La entrada Latest developments in administrative sanctions aparece primero en Faus Moliner.

The HTA Regulation entered into force on 12 January 2025. Its major innovation is the so-called joint clinical assessments (JCAs), shared evaluations that EU Member States must take into account when carrying out their own national health technology assessment processes. JCAs will determine the scope of the assessment, by defining the PICOS (population, intervention, comparators and outcomes). They will also describe the relative efficacy and safety of the medicinal product compared with its comparators, as well as the quality of the evidence submitted. Although JCAs do not issue a verdict on added value and Member States are not obliged to adopt them – but only to “take them into account” – their content may significantly shape national assessments and, therefore, may influence pricing, reimbursement, and market access prospects in each Member State.

At present, eight JCAs are under way – two advanced therapy medicinal products (ATMPs), two biologics and four chemically synthesised molecules – and many more are expected in the future.

For companies, it is key to know which medicinal products will be required to undergo a JCA in order to anticipate and plan their regulatory and market access strategies. This is important because, once the process begins, the timelines to prepare the HTA dossiers and supporting documentation are fairly short. These criteria are set out in the HTA Regulation, and the European Commission (EC) has recently published a Q&A document clarifying which products fall within the scope of JCAs.

General criteria for inclusion

A JCA is required for medicinal products that meet three conditions:

(i)     they are required to submit a centralised marketing authorisation (MA) application in the EU – i.e. they are listed in Annex I to Regulation (EC) 726/2004 – or contain an active substance that was not authorised in the EU on 20 May 2004;

(ii)    they have been the subject of a centralised MA application based on a full dossier (Art. 8.3 Directive 2001/83/EC); and

(iii)   the MA application date falls after the relevant cut-off dates depending on the product.

Cut-off dates

The first cut-off date was 12 January 2025. This affects ATMPs or products containing a “new active substance” for the treatment of cancer. This is the case for the eight JCAs currently in progress.

As regards the requirement to contain a “new active substance”, the starting point is the applicant’s declaration that the active substance is new, a condition subsequently verified by the EMA during the regulatory procedure. In this regard, the EC clarifies that if the EMA ultimately determines that it is not a new active substance, this conclusion will not have retroactive effects nor alter the decision to initiate or terminate the JCA.

The EC also specifies that a “new active substance” may be included in combination with another substance that has already been authorised; and that in the absence of a definition of “cancer treatment” in the HTA Regulation, reference should be made to the guidelines drawn up for this purpose by the HTA Coordination Group.

It also notes that the HTA Regulation does not distinguish between types of MA (e.g. conditional or standard) and therefore, the granting of a conditional MA should have no impact on the continuation and completion of the JCA procedure.

The second cut-off date will be 13 January 2028. This will cover orphan medicinal products. At this point, the EC clarifies that, unlike the provisions for the first cut-off date, the second cut-off date does not include the requirement of a “new active substance”. It further explains that if the medicinal product loses its orphan status after the start of the JCA, this will not have a retroactive impact on the decision to initiate or terminate the JCA.

The third cut-off date will be 13 January 2030. From that date onwards, all medicinal products that meet the above-mentioned three general criteria will be required to undergo a JCA.

New indications

If a medicinal product has undergone a JCA, any new indications must also be subject to a JCA. The EC clarifies that the HTA Regulation requires the original JCA to have been published – not merely approved – and that the type of variation used to add the new indication is irrelevant.

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These procedures apply to companies that import or export medicinal products to or from countries outside the European Economic Area (EEA). As the Instruction 1/2025 reminds, this includes operations involving Switzerland, Andorra, or the United Kingdom.

Below, we highlight some of the most relevant updates concerning medicinal products for human use.

Definition of “registered medicinal product”

One issue that created legal uncertainty was the lack of clarity around the term “registered medicinal product”, as neither the previous version nor Royal Decree 824/2010 provided a definition. According to Royal Decree 1345/2007, a registered medicinal product is one that has received marketing authorisation and is entered into the AEMPS medicinal product registry. However, doubts have arisen as to whether this includes products that are authorised but not yet registered, pending pricing/reimbursement decision, or with suspended authorisation.

Instruction 1/2025 clarifies that a medicinal product will be considered “registered” if it has the same active substance and excipients, the same pharmaceutical form, and the same manufacturers (both of the active substance and the finished product) as a product registered in Spain; regardless of differences in trade name, presentation, packaging format, or marketing authorisation holder (MAH) in the destination country. The Instruction also explicitly confirms that products with suspended marketing authorisation still qualify as registered medicinal products.

Our view, based on these clarifications, is that the reimbursement status of a product in the National Health System is irrelevant for the purposes of considering it a registered medicinal product.

Importation

The previous version of the Instruction did not clearly define the roles of different entities involved in the import/export process. This created confusion around which entities could physically carry out these operations and which were authorised to request the relevant approvals or submit notifications to AEMPS.

The new Instruction clarifies these roles.

For the importation of finished medicinal products, intermediates, or bulk products, only authorised importers (as defined in Royal Decree 824/2010) or the MAH may carry out the import. For investigational medicinal products, importation must be carried out by an authorised importer.

On the other hand, the request for prior authorisation for each import – which is granted per shipment and for a specific quantity of product – may be submitted by other entities, depending on the type of product:

• Finished medicinal products (excluding plasma derivatives, which follow a separate procedure): by authorised importers, the MAH, or – as newly recognised by the Instruction – the MAH’s local representative in Spain.

• Intermediates or bulk products: by the authorised importers or the MAH.

• Investigational medicinal products: by the authorised importers or the clinical trial sponsor.

These authorisations are valid for one year, during which multiple shipments may be made up to the approved total quantity; unless the conditions that led to the authorisation change.

Exportation

Exportation may be carried out by authorised manufacturers, the MAH, or distributors.

Instruction 1/2025 clarifies that for registered finished medicinal products, the export notification may be submitted by the MAH, the manufacturer or the distributor. For bulk products, only the manufacturer may submit the notification.

In the case of products with suspended authorisation, the exporter must inform the recipient of the suspension. Exports must take place within two months from the date of that notification.

The export of investigational medicinal products for use in clinical trials conducted in other countries participating in a clinical trial authorised in Spain remains unchanged from the 2015 Instruction. It still requires prior authorisation from AEMPS and may involve multiple shipments until the authorised quantity is reached.

Likewise, prior authorisation is required from AEMPS for the export of unregistered medicinal products in Spain; their intermediates or bulk forms; and investigational medicinal products intended for clinical trials not authorised in Spain, whether for another EU country or a third country. Where such products are manufactured in Spain for export, a manufacturing authorisation issued by AEMPS is required. As a new development, this authorisation is now valid for three years (previously two). It also includes the issuance of an export certificate for the destination country.

Additionally, for unregistered medicinal products intended for other EEA countries, only one manufacturing authorisation will now be required, and it will be valid across all EEA countries.

Samples

Instruction 2/2025 maintains the position that the import or export of samples does not require prior authorisation from AEMPS. However, it strengthens the conditions for their use.

The interested company must provide documentation to the Pharmaceutical Inspection Services at AEMPS justifying the intended use of the samples. As a new requirement, the Instruction requires that: the sample size must be consistent with the declared purpose, the intended use must be clearly justified, and any unused quantities must be destroyed through a licensed waste disposal company.

Only authorised importers or manufacturers may import samples; unless the destination is a preclinical or research study, in which case universities, hospitals, research centres, or pharmaceutical companies may also carry out the import.

Returns

The new Instruction includes a section on returns.

It states that the import of previously exported medicinal products requires prior authorisation from AEMPS. The information provided in the import request must match the details recorded in the corresponding export authorisation or notification.

By contrast, the return of active substances for human use does not require prior authorisation, but it is subject to pharmaceutical border control.

Humanitarian donations

Finally, Instruction 1/2015 sets out the procedure for exporting medicinal products as humanitarian donations, a subject of increased relevance during recent emergencies such as the COVID-19 pandemic or armed conflicts.

All such exports require prior authorisation from the Department of Inspection and Control of Medicinal Products at the AEMPS. The authorisation is valid for three months and must be requested through Labofar or the AEMPS electronic registry.

The authorisation may only be requested by pharmaceutical companies, distributors, hospitals, NGOs, or humanitarian aid foundations that comply with applicable regulations. In every case, the applicant is responsible for the export.

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

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

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

Clinical research

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

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

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

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

AEMPS national registers of medical devices

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

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

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

Distribution and sale

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

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

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

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

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

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

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

Changes in risk assessment and management

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

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

Use of new technologies and decentralised clinical trials

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

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

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

Practical recommendations for sponsors and CROs

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

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

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

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Why this issue matters

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

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

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

The Hopveus case®

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

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

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

The challenge of conflicts of interest in the EU

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

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

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

The challenge of conflicts of interest in Spain

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

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

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

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