The European pharmaceutical package places security of supply among the central objectives of the regulatory framework, strengthens the prevention of shortages, and provides for significant penalties in the event of non-compliance with the applicable rules.

All of this entails an increase in the obligations imposed on companies, which will have to take on a more active role in ensuring continuity of supply, and new coordination mechanisms at Union level.

In this Capsulas, we analyse the main obligations affecting marketing authorisation holders (MAHs) in relation to supply and shortages.

Notification obligations

Until now, EU legislation allowed MAHs to withdraw a medicinal product from the market by simply giving at least two months’ notice (Article 13 of Regulation (EC) No 726/2004 and Article 23a of Directive 2001/83/EC), or even at shorter notice in “exceptional circumstances”.

The new Regulation introduces stricter and more harmonised rules that will apply to all medicinal products, whether authorised by the EMA or by Member States. As it is a Regulation, it will be directly applicable in all Member States, without the need for transposition.

In this regard, it is expected that MAHs will have to inform the competent authority of the Member State- and the EMA in the case of a centralised marketing authorisation – and provide reasons for the following decisions:

• The permanent cessation of the marketing of the product, at least 12 months in advance.

• The temporary suspension of marketing, at least 6 months in advance.

• A request for the withdrawal of the marketing authorisation, also at least 12 months in advance.

• Foreseeable temporary disruptions in supply lasting more than two weeks, at least 6 months in advance.

Where duly justified exceptional circumstances arise, the MAH may notify such interruptions at a later point in time, as soon as it becomes aware of them.

Critical medicinal products

Additional specific obligations are introduced in relation to medicinal products considered “critical” in any Member State or priority antimicrobials.

In these cases, before proceeding with the cessation, suspension or withdrawal, the MAH must:

• Publish a declaration of its intention to transfer the marketing authorisation or to issue a letter of access, and inform the national competent authorities and the EMA accordingly. This declaration must be published through a dedicated page on the MAH’s website, and the electronic link to that page must be communicated to the competent authority of the Member State and to the EMA.

• Offer, on reasonable terms, the transfer of the marketing authorisation or the granting of a letter of access to a third party that has declared its intention to market the medicinal product or to use the pharmaceutical, non-clinical and clinical documentation contained in its file for the purpose of submitting an application for a marketing authorisation.

• Inform the competent authority of the outcome of the negotiations with such third parties (the EMA, in the case of medicinal products authorised under the centralised procedure, and the national authorities in all other cases).

In addition, in the formal notification of cessation or withdrawal, the MAH must provide evidence that it has taken effective measures to make the marketing authorisation available to third parties.

It should be noted that Spain has, for several years, been one of the most active Member States in this area, with the AEMPS playing a prominent role. Notwithstanding this, the new European legislation will mean that the AEMPS will no longer be able to require certain medicinal products to remain on the market. This possibility, however, is maintained in the Preliminary Draft Law on Medicinal Products and Medical Devices.

Shortage prevention plans

The Regulation requires MAHs to have in place, and to update periodically, a shortage prevention plan (SPP) as a key tool for the preventive management of shortage risk.

This obligation applies to all prescription medicinal products, as well as to those expressly designated by the Commission on the basis of criteria such as the number and frequency of previously notified critical shortages; the characteristics of the medicinal product and the availability of authorised alternatives; its therapeutic relevance and the conditions it is intended to treat; or potential risks to public health.

The EMA will draw up guidelines on the preparation and content of SPPs, and the Commission or the national authorities may require the MAH to submit the relevant SPP to them at any time.

Furthermore, in relation to medicinal products not subject to this obligation, the MAH must carry out a regular documented risk assessment of potential supply chain risks and, where necessary, take mitigating measures. Both the EMA and the national authorities may request the submission of such assessments at any time.

Parallel trade

In recital 138a, the Regulation recognises that, although the Court of Justice of the European Union has ruled that parallel trade is beneficial to the internal market, it has also recognised the need to ensure reliable supply to meet essential medical needs, ensuring the availability of quality medicinal products for the public.

In this context, the Regulation enables Member States to require wholesale distributors intending to supply to another Member State to notify that intention to the competent authority of the Member State of origin.

Based on this information, the Member State of origin may adopt the necessary measures to prevent or mitigate possible shortages in its territory. In any event, such measures must be duly justified on grounds of the protection of public health and be proportionate to the objective pursued, in accordance with EU law.

Critical shortages of Union concern

Beyond measures at national level, the Regulation also establishes specific coordination mechanisms at Union level to address particularly serious shortage situations.

In this regard, a list of critical shortages that cannot be resolved without coordination at EU level will be established and kept up to date, and recommendations may be issued on measures to resolve or mitigate such critical shortages of Union concern.

Following the inclusion of a medicinal product in the list of critical shortages of Union concern, the MAH must provide any additional information that the EMA may request, including periodic information on available stocks of the medicinal product concerned; take into account the recommendations and measures adopted at European level; report on the results of those measures; and inform the EMA and the competent authority of the Member State of the end date of the critical shortage of Union concern without undue delay.

Penalty regime

One of the main new features of the pharmaceutical package is the extension of the existing penalty regime in the pharmaceutical field.

At present, the penalty regime for non-compliance with MAH obligations in relation to medicinal products authorised under the centralised procedure is laid down in Regulation (EC) No 658/2007, which includes the definition of the conduct that may give rise to a penalty, the principles governing the imposition of penalties, the rights of the parties concerned, and other procedural rules.

The new Regulation maintains and strengthens Regulation (EC) No 658/2007, empowering the European Commission to impose penalties in the event of non-compliance by MAHs with obligations such as:

• Notification obligations within the time limits laid down in the Regulation.

• The obligation to transfer the marketing authorisation or to allow a third party to use the documentation in the file of the medicinal product.

• The obligation to have an SPP in place and to keep it up to date.

• The obligation to cooperate and provide the information requested in shortage situations.

• Specific obligations in relation to critical shortages of Union concern.

• Obligations relating to critical medicinal products.

• Compliance with the recommendations issued by the Executive Steering Group on Shortages and Safety of Medicinal Products.

Failure to comply with these obligations may lead to the imposition of financial penalties, in the form of fines or periodic penalty payments.

Fines may amount to up to 5% of the MAH’s Union turnover in the preceding business year; and periodic penalty payments may amount to up to 2.5% of the MAH’s average daily turnover in the European Union in the preceding business year for each day of delay in complying with the obligations.

La entrada Supply obligations and the prevention of shortages under the new European pharmaceutical legislation aparece primero en Faus Moliner.

Organic Law 1/2025 has introduced a far-reaching reform of the Administration of Justice. In particular, by renaming and reorganising Tribunals of First Instance and the introduction of alternative dispute resolution mechanisms as a previous step to court proceedings. However, the legislation also incorporates other, less widely discussed changes that may be of great practical use, such as the expansion of court agents’ (procurador de los tribunales) functions.

The court agent and their new functions

The court agent is a distinctive figure in the Spanish procedural system. Traditionally, their role has been to represent the parties before the courts and to facilitate the conduct of proceedings. The reform maintains this role but strengthens their capacity to cooperate with judicial bodies.

Following Organic Law 1/2025, court agents may undertake communication tasks, assist and cooperate with the courts, and carry out certain procedural acts where these have been expressly delegated by the judge. To this end, the law grants them authority to certify documents as well as access to the necessary credentials required to formally evidence their actions.

An opportunity to speed up compliance with preliminary injunctions

These new functions may help to significantly expedite the conduct of certain proceedings, particularly those where speed is essential to ensure the effectiveness of judicial protection.

One area where this reform may be particularly relevant is preliminary injunctions. The effectiveness of these measures often depends on how quickly they can be notified to the persons or entities that must be notified of them or cooperate in their implementation.

Consider, for example, a preliminary injunction prohibiting the marketing of a specific medicinal product and ordering that this prohibition be communicated to the Spanish Medicines Agency or the Ministry of Health, so that the restriction is reflected in their records and takes effect.

If the court delegates this task, the court agent could carry out the communication immediately, even via the Government’s General Electronic Register, without having to wait for the relevant court documents to be issued and processed.

In proceedings where every day counts, the possibility of using the court agent as an active collaborator in the enforcement of judicial decisions can play a decisive role in ensuring the effectiveness of the measures agreed by the courts.

In this context, the new functions introduced by Organic Law 1/2025 mean that, in certain circumstances, the court representative may become one of the best allies in securing the swift and effective enforcement of preliminary injunctions.

La entrada Your court agent could be your best friend aparece primero en Faus Moliner.

Commentary on the new pharmaceutical legislation has focused on a number of highly relevant aspects, such as the incentives system, market access, shortages, and environmental impact. By contrast, developments relating to the advertising and information of medicinal products, despite their direct impact on companies’ day-to-day activities, have received comparatively less attention.

The new Directive will introduce significant changes in this area. Some of these developments reflect criteria already outlined in EU case law and regulatory practice; others, however, entail substantive new adjustments. In any event, their implementation will require a review of internal policies and promotional materials and activities.

As this is a Directive, its application will require transposition by the Member States. However, the margin of discretion is not unlimited. In its judgment of 8 November 2007, Gintec, C-374/05, the Court of Justice of the European Union (CJEU) held that Directive 2001/83/EC brought about complete harmonisation in the field of advertising of medicinal products. Accordingly, unless expressly authorised by that Directive, Member States are not permitted to adopt additional restrictions. For this reason, it is particularly relevant that the new Directive includes, in certain areas, explicit provisions allowing Member States to adopt more restrictive approaches. Outside these cases, additional absolute limitations may not be imposed, unless justified on public health grounds.

Against this background, the main developments introduced by the new Directive in relation to advertising of medicinal products are outlined below.

1. The concept of advertising expands to include campaigns not mentioning a specific product

One of the most significant developments is the express incorporation of the CJEU’s doctrine on the scope of “advertising of medicinal products”, as established in its judgment of 22 December 2022, Euroaptieka, C-530/20. According to this doctrine, any communication aimed at promoting the purchase of medicinal products qualifies as advertising, even if it does not refer to a specific product.

This interpretation is expressly reflected in the new Directive (recital 137 and Article 175.1(h)), which expressly includes, among the situations covered by the concept of advertising, that relating to medicinal products without reference to a specific product.

In practice, this significantly broadens the concept of advertising. With this broader scope, generic promotional campaigns relating to a “range” or category of products may fall within the concept of advertising if they encourage their purchase, even where no specific medicinal product is identified.

The transposition of this concept into national legal systems raises certain questions, as it does not seem reasonable to subject this type of advertising to the same regime as the one applicable to the promotion of specific medicinal products. For example, in Spain, it would not make sense to require the inclusion of the minimum content that must appear in all communications addressed to healthcare professionals, as set out in Articles 10 and 14 of Royal Decree 1416/1994.

Accordingly, it may be expected that national transposition will introduce specific conditions for this type of messaging. On the other hand, the new Directive provides for the possibility for Member States to directly prohibit the advertising that does not refer to a specific medicinal product (Article 177).

This provision likely stems from the CJEU’s judgment of 27 February 2025, DocMorris, C-517/23, regarding the distinction between the advertising of medicinal products and the advertising of distribution channels (e.g. pharmacies or distribution platforms), which are subject to different legal regimes, with only the former falling within the scope of Directive 2001/83/EC.

Advertising of medicinal products (including that falling within the concept outlined by the CJEU in the Euroaptieka case) is a matter of complete harmonisation. Therefore, unlike the promotion of pharmacies, Member States may not impose absolute prohibitions unless expressly authorised by the directive (as is now envisaged) or unless such restrictions are justified on public health grounds, as we had the opportunity to discuss during the Life Sciences Practice Group (LSPG) session held in Barcelona in April 2025, where Dr. Morton Douglas, from the German firm Friedrich Graf von Westphalen, shared his views on this interesting judgment.

Finally, as an indication of the EU legislator’s intention to limit excessive consumption of medicinal products, and alongside the aforementioned empowerment of Member States, the new Directive expressly introduces a prohibition on promotional activities that encourage excessive or inappropriate use of medicinal products (Article 176.3(ba)), a requirement not expressly set out in the current framework.

2. Objective advertising and tighter restrictions on comparative advertising

The new text reinforces an existing trend towards more “neutral” advertising of medicinal products.

The new Directive expressly requires advertising to disseminate objective and impartial information (recital 136). This results in two explicit prohibitions in comparative advertising: (i) highlighting negative aspects of another medicinal product; and (ii) suggesting that the advertised medicinal product is safer or more effective than another, unless such comparison is objectively supported by the SmPCs (Article 176.4).

This represents a substantial shift.

Furthermore, the idea that comparisons relating to safety, quality or efficacy are permitted only where supported by the SmPCs,  raises an important practical question: must the comparative conclusion be expressly stated in the SmPC, or is it sufficient that the underlying supporting data are referenced in it? The text does not provide clarity on this point. Nevertheless, it is clear that comparisons based solely on external studies, not reflected in the SmPC will not be permitted.

Regarding biosimilars, new Article 176.4 of the Directive must be interpreted in light of recital 136, which, although it is not expressly incorporated into the operative provisions, states that claiming that a biosimilar is not interchangeable with the original biological medicinal product or another biosimilar derived from the same originator constitutes misleading advertising.

3. Advertising to healthcare professionals extends to nursing staff

Recitals 140 and 141 acknowledge that certain medicinal products – particularly innovative, complex, or combination therapies – require not only prescribers and dispensers, but also those administering them, to understand their characteristics. On this basis, the new Directive extends the scope of advertising to include professionals authorised to administer medicinal products (Article 175).

However, Member States retain discretion to apply stricter rules for advertising directed at such professionals (Article 177.8).

In Spain, advertising of prescription-only medicinal products to nursing staff is already permitted in certain circumstances. This suggests that transposition of the Directive will largely follow a continuity-based approach. The existing framework is therefore likely to be maintained, allowing advertising in relation to medicinal products for which nursing staff have prescribing authority or a defined role under protocols and guidelines issued by the health authorities.

4. End of the “minimal value” exception: general prohibition of incentives

With regard to the regime governing incentives, current Article 86 of Directive 2001/83/EC includes, within the concept of advertising, “the gift, offer or promise of any benefit or bonus”, while excluding them where their intrinsic value is minimal. This exception is likewise reflected in Spain in Article 17 of Royal Decree 1416/1994.

The new Directive removes this exception (Article 175). Consistently, Article 183 establishes that no incentives may be provided in the context of advertising to healthcare professionals. This is a significant change, as it eliminates the legal basis that has allowed low-value materials or courtesy items, as provided for in Article 10 of the Code of Practice of Farmaindustria (EPFIA’s national member).

It should be emphasised that the new rule does not amount to a prohibition of hospitality. This point is particularly relevant because, in Spain, certain authorities have historically adopted a restrictive interpretation of the prohibition on incentives, considering that such prohibition effectively entailed a ban on hospitality in promotional settings. This interpretation was reinforced by the fact that Royal Decree 1416/1994 regulates hospitality only in the context of scientific or professional events.

However, this interpretation is not consistent with either the current Directive or the new one, which expressly provides that the prohibition on incentives does not prevent the provision of hospitality at promotional events, provided that it is strictly limited to the primary purpose of the event and is not extended beyond healthcare professionals (Article 183(2)).

5. Samples: possible extension to dispensers

While the new text does not substantially revise the regime governing samples, it introduces an important clarification. Recital 135 indicates that samples may be provided not only to prescribers but also to those who dispense medicinal products.

Accordingly, Member States may, on an exceptional basis, allow the provision of samples of non-prescription medicinal products (OTC) to dispensers (Article 185(2)).

This development is significant in the Spanish context, where the authorities have traditionally adopted a more restrictive interpretation, considering that the rules prohibit the provision of samples to pharmacists, even though this is not expressly provided for in Royal Decree 1416/1994.

The new Directive appears to align with CJEU case law and with the debate that emerged following the judgment of 11 June 2020, Ratiopharm / Novartis Consumer Health, C-786/18, which confirmed that the Directive permits the provision of samples of non-prescription medicinal products.

Nevertheless, the new provisions still leave certain grey areas, particularly as it would have been desirable to clarify whether the regime applicable to the provision of samples of prescription medicinal products and that applicable to OTC samples are equivalent, given that the above-mentioned case law had already recognised that they are distinct regimes.

6. Transparency of transfers of value: moving beyond self-regulation

In connection with this matter, the he new rules, depart from the idea that even minimal incentives may influence prescribing decisions (recital 139.a).

The new Directive introduces new obligations for Member States and marketing authorisation holders   regarding transparency of transfers of value (Article 186.4a). Where no national rules exist, Member States must provide a public webportal with links to the transparency disclosure platforms operated by industry associations or the marketing authorization holders, who  will be required to provide such links and ensure the accuracy and timely publication of the information.

While a fully harmonised EU transparency regime is not yet imposed, the shift is significant: transparency moves from a purely self-regulatory framework to integration within public information systems.

7. Other developments: shortages, public advertising, and new content restrictions

First, Member States may suspend the advertising, targeted at both healthcare professionals and the public, in situations of shortages or risk thereof (Article 177.7). While justified from a public health perspective, the concept of “risk of shortage” remains broad and may create legal uncertainty if not further specified through objective criteria. The text itself provides that the suspension shall be withdrawn as soon as the shortage or risk of shortage ceases.

Second, Member States may restrict the use of the trademark or designation of the medicinal product in reminder advertising directed at the general public, limiting it instead to its active substance (Article 178.2).

In addition, new content restrictions are introduced for advertising directed at the general public. In particular, the existing prohibition on endorsements by scientists and healthcare professionals is extended to include endorsements by healthcare institutions or facilities (Article 179). This may have a significant practical impact, for example in relation to the use of imagery, settings, or references evoking pharmacies, hospitals, or other healthcare environments.

Finally, the new Dierctive expressly prohibits referring, in advertising, to the fact that a medicinal product has been granted a marketing authorisation.

La entrada Updates on advertising of medicinal products in the new EU Pharmaceutical Legislation aparece primero en Faus Moliner.

Approximately fifteen years ago, new infringements relating to medicinal products were introduced into the Law on Medicines and Medical Devices (LGURMPS) to prevent shortages and strengthen the supervisory and inspection powers of the health authorities.

Among them, the law classified as a very serious infringement the conduct of pharmacies engaging in the distribution of medicinal products to other pharmacies, authorised wholesalers, or any unauthorised entities or individuals, as well as the export of medicinal products outside of Spain.

This case concerns the application of this sanctioning regime by the Madrid Regional Authority (“CAM”) and illustrates the enforcement actions that may be triggered in situations of reverse distribution, which have at times been highly significant in the field of parallel trade.

Dispensing of unusual quantities

The facts underlying this judgment date back to 2023, when a pharmacy dispensed 20 boxes of Progynova®. The prescription had been issued by a healthcare professional at a medical centre located outside Spain and was not made out in the name of any specific patient.

The wholesaler detected this unusually high dispensation and reported it to the CAM, which carried out an inspection at the pharmacy and subsequently initiated sanctioning proceeding.

During the proceeding, the pharmacy submitted a letter from the prescribing physician, acknowledging that the medicinal product had been intended for patients at a healthcare centre located outside Spain. The CAM considered that the pharmacy had engaged in unauthorised distribution of medicinal products and imposed a sanction of €90,001.

Position of the High Court of Justice of Madrid

The pharmacy challenged the sanction before the High Court of Justice of Madrid. In its appeal, it argued that (i) it had merely dispensed a prescribed medicinal product rather than engaged in distribution, and; (ii) the sanction was disproportionate, particularly given that the profit obtained amounted to only €111.

The Court rejects these arguments. It finds that, although the conduct was isolated, it must be classified as distribution activity. In particular, the Court emphasises that the pharmacy disregarded essential control measures: it failed to verify that the prescription included a named patient and did not check whether the person presenting it was the intended recipient, despite the large volume of Progynova® supplied.

Furthermore, the Court examines whether the facts fall within the infringement defined in the LGURMPS concerning the distribution of medicinal products to unauthorised entities or persons, which formed the basis of the sanction. The Court concludes that this classification is correct.

In this regard, it considers it proven that the pharmacy acted negligently, noting that a considerable number of boxes of Progynova® were dispensed without the necessary safeguards, and that the medicinal products were destined for a healthcare centre outside the national territory.

As regards proportionality, the Court points out that the sanction imposed corresponds to the minimum level for very serious infringements and cannot be classified under any minor infringement provided for in the LGURMPS.

La entrada Reverse distribution and exports: the Madrid Regional Authority actively monitors the activities of pharmacies aparece primero en Faus Moliner.

Can a reference price group be formed comprising two medicinal products with different active substances, both authorised for more than ten years and sharing the same ATC level 5 classification, where no generics or biosimilars exist? This is the question the Supreme Court will address after admitting, by Order of 11 February 2026, a cassation appeal concerning the 2021 Reference Price Order.

The case arises in the context of the regulatory reform introduced in 2021, which abandoned the traditional active-substance identity criterion and adopted the ATC Level 5 classification as the basis for the establishment of reference price groups. The case under consideration concerns a reference price group comprising presentations of two originator medicinal products: Sinemet (levodopa + carbidopa) and Madopar (levodopa + benserazide). Both products share the same ATC Level 5 classification, have no generic or biosimilar equivalents, and were authorised in the European Union more than ten years ago.

Under the applicable regulations, reference price groups may be formed without generics or biosimilars provided that “a medicinal product different from the originator and its licensees exists.” The central issue in dispute is the interpretation of this requirement.

The “different medicinal product” requirement

On the one hand -as argued by the Ministry of Health and upheld in the first-instance judgment- the requirement may be considered satisfied on a reciprocal basis: Sinemet would constitute a “different medicinal product” from Madopar, and vice versa. Their coexistence within the same ATC level 5 classification would therefore suffice to meet the regulatory conditions to create the reference price group.

On the other hand, the claimant advocates a stricter interpretation: for both originators, or at least for one of them, there must exist another medicinal product distinct from that originator and its licensees, but with the same composition. Under this interpretation, the mere coexistence of two originators with different active substances would not be sufficient to justify the formation of a reference price group.

The Supreme Court expressly acknowledges the controversial nature of the issue, the absence of prior case law, and the existence of interest in establishing legal doctrine.

Final comment

This case once again highlights the tensions arising from the shift from an active-substance-based approach to an ATC level 5 classification system. In recent years, problematic situations have emerged, such as the inclusion within the same reference price group of medicinal products with different active substances where only one had generic versions, while the other remained protected by exclusivity rights. Such scenarios are difficult to reconcile with the underlying rationale of the legislation, as they may result in a de facto erosion of exclusivity periods. Although the issue now under consideration is different, it stems from the same regulatory shift.

Clarity will ultimately depend on the forthcoming judgment of the Supreme Court. In the meantime, the debate is particularly relevant in the context of the future Law on Medicinal Products and Medical Devices, currently under preparation, which could usefully address these issues to enhance legal certainty.

La entrada Reference price groups without generics and with different active substances aparece primero en Faus Moliner.

Operating since September 2025, the AIPI is responsible for ensuring the proper application of Law 2/2023, including protecting whistleblowers, handling sanctioning proceedings for infringements under the Law 2/2023, and issuing recommendations and crime-prevention frameworks for public administrations.

Entities required to have a reporting channel

Recommendation 1/2026 provides guidance for companies required to implement a reporting channel (also referred to as an “Internal Reporting Channel” or “IRC”) on how to design and implement it properly.

In particular, it clarifies how the 50-employee threshold, above which private sector entities must establish an IRC, should be calculated. For this purpose, the AIPI adopts the criteria used in Royal Decree 901/2020 on equality plans. Accordingly, the headcount must include the entire workforce, regardless of contract type or work centre, including remote workers and part-time employees.

Requirements for the reporting channel

According to Recommendation 1/2026, the reporting channel must operate through a secure and encrypted digital platform ensuring confidentiality. In practice, this implies the use of specific software. The AIPI encourages companies to consolidate existing reporting mailboxes (e.g., harassment or ethics channels) into a single reporting channel. The system must be clearly identifiable and operationally independent, even where group companies share resources with their parent company.

Companies must adopt, through their Management body, an internal policy guaranteeing the absence of reprisals against whistleblowers and setting out their rights and duties. For the IRC to be valid, the Management body must formally approve both its creation and its policy of use. In addition, companies must adopt a complaint management procedure explaining how reports will be handled and provide visible access to this information on the company’s website. The policy must also include information on external reporting channels, including the AIPI and, where applicable, the competent regional authority.

The AIPI also recommends implementing technology enabling traceability of reports and communication with the whistleblower, including anonymous whistleblowers, and providing training to employees on the operation of the system. Where reports are received verbally (by telephone or in person), they must be documented through recording or transcription. In the case of transcription, the whistleblower must be given the opportunity to review, rectify and confirm the record.

The responsible for the channel and notification to the authorities

The AIPI indicates that the responsible for the channel must enjoy genuine independence, autonomy and authority within the organisation. It must act impartially and ensure that the persons concerned are informed, respecting the presumption of innocence and the right to honour.

If duly justified by the size of the company, the responsible person may not be a senior manager, but a committee. If a committee is appointed, the AIPI recommends that it comprise no more than five members, including at least one employee of the company.

The appointment and dismissal of the responsible person or committee must be notified to the competent authorities. Under Article 8.3 of Law 2/2023, notifications must be submitted to the AIPI or, where applicable, to the competent authority of the relevant Autonomous Region.

According to the AIPI’s current interpretation, if the company has offices in several Autonomous Regions, or in a single Region that does not have an authority with sanctioning powers in matters of whistleblower protection, it must notify only the AIPI. Whereas if the company only operates in an Autonomous Region with its own authority with such sanctioning powers (at the moment, Andalusia, Catalonia, Valencia and Galicia), it must only notify the Autonomous Region authority, although the AIPI recommends that it also notify the AIPI as well.

Notifications must be submitted within ten working days of the appointment or dismissal. However, for appointments and dismissals made between 13 March 2023 (entry into force of Law 2/2023) and 10 February 2026 (when the AIPI online portal became operational), the deadline has been extended to 10 April 2026, using the form available on the AIPI website.

Although the Recommendation is not legally binding, it constitutes the supervisory standard that the AIPI will apply when assessing compliance with Law 2/2023 and when deciding whether to initiate sanctioning proceedings. Companies should therefore review their internal policies and the technical configuration of their reporting channels to ensure alignment with these criteria.

La entrada What the Authority for the Protection of Whistleblowers expects to find when reviewing a company’s reporting channel aparece primero en Faus Moliner.

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.