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.

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The case of clear aligners

The dispute arises from several advertising campaigns by the company Impress. In these campaigns, invisible orthodontic treatments were promoted with the support of well-known public figures. The Official College of Dentists and Stomatologists of Catalonia argued that the advertising referred to a medical treatment linked to the use of medical devices -clear aligners- and should therefore be subject to the rules applicable to the advertising of medical devices.

The Barcelona Court of Appeal, however, held that the advertising at issue did not concern a specific medical device, but rather the dental clinics of the advertising company and the orthodontic services provided there. In the Court of Appeal’s view, the references to ‘invisible orthodontics’ and ‘clear aligners’ were generic and served to explain the type of service offered by the clinic, rather than to promote a specific medical device.

This debate is particularly relevant because many healthcare centres and services refer in their advertising to the products or technologies they use. Although these products or technologies are not promoted in isolation, they are often integrated in the promotion of the healthcare service. The question is whether this form of communication allows such advertising to fall outside the restrictions applicable to the advertising of medical devices or whether, on the contrary, it must be assessed whether there is indirect promotion of the product used.

In the case now to be decided by the Supreme Court, the Barcelona Court of Appeal itself acknowledged that the classification may change when, in the context of advertising a healthcare centre or service, elements are introduced that may be perceived as advertising specific medical devices. For these purposes, it will be relevant to assess whether the product or technology used is a necessary condition for the provision of the promoted service and, in addition, whether it can be identified by the recipient of the communication.

The fine line between products and treatments

The issue may also extend to the field of advanced therapy medicinal products and, in particular, in relation to gene therapies developed under Royal Decree 477/2014 of 13 June, which regulates the authorisation of non-industrially manufactured advanced therapy medicinal products.

This royal decree, which governs what is known as the hospital exemption, allows certain advanced therapy medicinal products to be prepared and used in a hospital institution, under medical responsibility, to meet an individual medical prescription. In such cases, the hospital may hold the authorisation for use -but not a marketing authorisation- and may communicate, in institutional, scientific or healthcare-related terms, that it has developed a particular therapy, that it has a leading unit or that it offers an innovative treatment.

This is where a grey area emerges, similar to the case to be decided by the Supreme Court. If a pharmaceutical company cannot promote to the public an industrially manufactured gene therapy medicinal product, can a hospital communicate to the public that it has developed and offer its own gene therapy? Formally, the communication may be presented as information about the hospital’s healthcare activities, its research capabilities or a highly specialised healthcare service. In practice, however, such communication may have a promotional effect very similar to that of advertising a medicinal product authorised or marketed by a pharmaceutical company.

This situation creates tension because public communication about therapies developed by hospitals may have a significant competitive impact, especially where authorised or developing industrial alternatives exist. Once again, the question is whether we are dealing with the promotion of a healthcare service or with the indirect promotion of the product or therapy that makes that service possible.

A future judgment with far-reaching implications

The judgment to be handed down by the Supreme Court in the clear aligners case will be relevant beyond the dental sector and the promotion of medical devices.

In sectors where healthcare provision relies on highly regulated products -medical devices, medicinal products (including advanced therapies), digital health tools or procedures based on specific technologies- it will be essential to determine whether the message genuinely promotes the healthcare service or whether, under that appearance, it is promoting the product or technology that makes the service possible.

The admission of the appeal in cassation therefore gives the Supreme Court the opportunity to provide useful guidance on an increasingly relevant boundary in an environment where healthcare innovation is communicated to the public not as a ‘product’, but as a ‘service’, ‘treatment’, ‘programme’ or ‘therapy’ offered by a healthcare centre.centro sanitario.

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The concept of “scientific research”

One of the main contributions of the Guidelines is that they clarify the concept of scientific research for GDPR purposes. Aware that there is no universally accepted definition, the EDPB identifies six factors which, if cumulatively met, allow an activity to be presumed to constitute scientific research: (i) a methodical and systematic approach; (ii) adherence to ethical standards; (iii) verifiability and transparency; (iv) autonomy and independence of investigators; (v) the objective of contributing to the increase of general knowledge and the well-being of society; and (vi) the potential to contribute to existing scientific knowledge or apply it in a novel way. If not all these factors are met, it must be justified and demonstrable why the activity should nevertheless be considered scientific research.

The EDPB confirms that both privately funded research and research carried out for profit are fully covered by this concept. The Guidelines also refer to so-called “research data infrastructures” (such as biobanks, repositories and other databases) and to “ancillary processing operations” (such as categorisation or prior pseudonymisation), recognising that all of these may also fall within the specific regime applicable to scientific research.

Broad consent and dynamic consent

The Guidelines confirm the possibility of relying on “broad consent” where, at the time of data collection, it is not possible to specify the specific purposes of the research in full. The EDPB points out, however, that this mechanism does not allow the controller to circumvent the principle of purpose specification of consent. The controller must define the area of research as precisely as possible (for example, “medical research in the field of oncology”) and adopt additional safeguards to compensate for the lower degree of specificity of the purposes.

Alongside broad consent, the Guidelines also address “dynamic consent”, which consists of obtaining the data subject’s consent for each specific research project, or parts thereof, as its purposes become more specific. This approach may be suitable for long-term projects, or in cases where there is an ongoing relationship between investigators and participants. The EDPB also accepts the combination of both forms of consent.

The EDPB also provides relevant clarifications regarding the use of legal bases other than consent for the processing of personal data for research purposes. Regarding “legitimate interest”, under (Article 6(1)(f) of the GDPR), the EDPB accepts that this legal basis may be relied upon even where the research is conducted for commercial purposes, given the recognition of research activity as beneficial to society. In such cases, significant weight may be given in the necessary balancing test against the interests, rights and freedoms of the data subject. As regards the so-called “public interest” under Article 6(1)(e) GDPR), the EDPB clarifies that this is not reserved to public bodies; private entities may rely on it where their activities are supported by EU or Member State law.

Further processing and data retention periods

The EDPB confirms the presumption of compatibility of further processing for scientific research purposes with the original purposes of collection, as provided for in Article 5(1)(b) of the GDPR. Consequently, the controller is not required to carry out the compatibility test under Article 6(4) of the GDPR, although the controller must continue to assess the lawfulness of the processing in accordance with an appropriate legal basis. In many cases, the controller may rely on the same legal basis as that which supported the initial processing, but this will not be possible where the original basis was consent or a legal obligation whose scope does not cover the new research purposes.

With regard to the retention periods of personal data, Article 5(1)(e) of the GDPR allows the storage of such data for longer periods when processed for scientific research purposes, even after the original purposes of the processing have been fulfilled. The EDPB clarifies, however, that such storage cannot be justified by general research purposes. The controller must specify, at least, a specific area of research, and future activities must be reasonably foreseeable, without this entailing an obligation to draw up a complete research plan.

Transparency, data subjects’ rights and derogations

The Guidelines address in detail the information obligations under Articles 13 and 14 of the GDPR towards data subjects whose data is being processed. The EDPB recommends voluntarily collecting contact details from data subjects to facilitate future communications in long-term projects, as well using mechanisms such as websites or dedicated platforms. The Guidelines expressly accept that information obligations may be fulfilled through data processors or by a joint controller where the controller lacks direct contact with the data subjects.

As regards data subjects’ rights, two aspects deserve particular attention. In relation to the right to erasure, Article 17(3)(d) of the GDPR allows the controller to refuse requests only where erasure is likely to render impossible or seriously impair the achievement of the research objectives. The EDPB notes that these situations are more likely to arise where the research involves a small number of data subjects or ongoing longitudinal studies. As for the right to object, the Guidelines confirm that Article 21(6) of the GDPR allows an objection to be rejected where the processing is necessary for the performance of a task carried out in the public interest, including cases where a legitimate interest of the controller coincides with a public interest.

Controller, processor and joint controllers

Through particularly useful practical examples, the Guidelines address the allocation of roles as controller, processor or joint controllers in common research scenarios, particularly for commercial clinical trials, public-private collaborations and research consortium partners, among others.

The EDPB confirms that active participation in the drafting of a research protocol, clearly defining the purposes and essential elements of the means, will normally confer controller status on the participating entity, even if it does not actually process personal data. This is typically the case of the sponsor of a clinical trial. Merely funding a project or acting as a consultant, expert or member of an ethics committee is not, however, sufficient in itself to confer such status.

Appropriate safeguards

The Guidelines note that any processing for scientific research purposes requires the adoption of appropriate safeguards under (Article 89(1) GDPR). In accordance with the principle of data minimisation, anonymised or, subsidiarily, pseudonymised data should be used whenever this allows the purposes of the processing to be achieved. The processing of directly identifiable data is only permitted where strictly necessary and proportionate.

In addition, the Guidelines provide a non-exhaustive list of other possible safeguards: independent ethical oversight, secure processing environments, use of synthetic data, confidentiality obligations, and others. Particular attention is given to the specific safeguards required where genetic data or biometric data are processed, given the particular characteristics of these categories of data.

Next steps

The Guidelines, which are currently open for public consultation until 25 June, will provide greater legal certainty on issues that had long required clarification. Given the significance of this document, it is highly recommended that organisations active in this field review their current procedures and the supporting documentation for their studies and other research projects in light of the EDPB’s interpretative criteria, especially as regards the legal bases used, consent mechanisms, and the technical and organisational safeguards adopted.

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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.

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These judgments examine various requests for access to information, made under the Law on transparency and freedom of information in relation to Covid-19 vaccines.

In two of the cases, access was sought to the contracts entered by the Spanish Government with several companies for the supply of vaccines, including prices and quantities. In the third case, the request concerned the international agreement signed between Spain and Andorra for the resale of those vaccines.

In all three cases, the National High Court overturned the decisions of the Council for Transparency and Good Governance ordering the Ministry of Health to provide the information.

Relationship between European and Spanish legislation on access to public documents

One of the first issues addressed by the Supreme Court is the possible application of Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents.

The National High Court had considered that, since vaccine prices were negotiated by the European Commission, access should be governed by European rules. On that basis, it held that their ‘sensitive’ nature justified the refusal.

The Supreme Court, however, qualifies this approach. It points out that Article 5 of the Regulation provides that where a Member State receives a request concerning a document in its possession originating from a European institution, it must consult that institution before deciding, unless the outcome of the decision is obvious.

In this case, the Supreme Court considers that such clarity was lacking. Therefore, the Ministry could not make the decision on its own but was required either to consult the European Commission or to refer the application to it.

On the damage to Spain’s external relations if the requested information is disclosed

The Ministry of Health argued that the agreement with Andorra incorporated vaccine prices set by the European Commission, subject to strict confidentiality measures, and that their disclosure would constitute a breach of the commitments made by Spain to other Member States and to the Commission itself. In its view, this would lead to a loss of trust in Spain at international level, with the resulting reputational harm and impact on its foreign relations, thereby justifying application of the limitation relating to foreign affairs.

The Supreme Court acknowledges that the Government enjoys a certain margin of discretion in matters of foreign policy. However, it emphasises that the application of this limitation requires sufficient, reasonable and plausible justification of the harm.

In this specific case, the Court concludes that such justification did not exist. The Administration merely invoked the involvement of a third State, without explaining in what specific way the disclosure of the agreement’s content would affect Spain’s foreign policy.

The Supreme Court therefore emphasises a key point: not all information contained in international agreements is automatically protected; rather, its content and the actual risk of harm must be analysed.

On confidentiality and secrecy in decision-making processes

Finally, the Supreme Court analyses the application of the confidentiality restriction in decision-making processes in the context of the agreement between Spain and Andorra.

The Supreme Court acknowledges that this limitation may justify the refusal of access where it is specifically identified which information may affect ongoing or future negotiations, which specific negotiations would be affected, and how their disclosure might harm them. It also emphasises that this is a temporary limitation, confined to the period during which such negotiations remain open.

In this specific case, the Supreme Court concludes that the Ministry of Health failed to meet this standard, as it did not specify which information was confidential or for what reasons. Consequently, it confirms the obligation to provide the requested information.

Conclusions

In a sector where documents produced by European institutions -such as the European Commission or the EMA- frequently coexist with documents produced by Member States, it is worth recalling the possible application of Regulation (EC) No 1049/2001 when the information requested originates from a European institution, as well as the obligation to consult that institution or refer the request to it when the meaning of the response is unclear.

Moreover, in proceedings concerning requests for access to price and reimbursement decisions, it is common to argue that the disclosure of certain information may be detrimental to ongoing negotiations in other Member States regarding the same medicinal product. In light of the Supreme Court’s reasoning, access may be restricted where it is specifically identified which negotiations may be affected and why the disclosure of the requested information could harm them, for example, due to its potential use in international price referencing processes.

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Medicines for Europe recently published very specific figures in this regard: up to 84% of public procurement procedures use price as the sole award criterion; and up to 74% of Member States use single-supplier procedures. Although Directive 2014/24/EU advocated for the use of ‘MEAT’ (Most Economically Advantageous Tender) criteria, it is common for the prevalence of low price to overshadow a genuine balancing exercise aimed at selecting, as Article 145 of the Spanish Law on Public Sector Contracts establishes, “the best price-quality ratio”.

Review of the 2014 Directives: an upcoming opportunity

Brussels is considering whether the design of the 2014 Directives has helped to shift contracting authorities towards a value-based approach; and the institutional response to this question leans more towards the negative. This was reflected in October 2025, when the European Commission published the evaluation of the 2014 Directives package as a first step towards its revision, and the Commission itself announced plans to present a new revised framework in the second quarter of 2026.

The new legal framework will aim to (i) increase the efficiency of public investment; (ii) design tools to strengthen economic security and sovereignty (which is relevant in relation to ‘Made in Europe’ related commitments); and (iii) align public procurement policy with the EU’s strategic policies and objectives. In the field of medicinal products, all this raises a particularly relevant question: can and should public procurement safeguard continuity of supply, resilience of the production chain and sustainable competition, without being reduced to a purely budgetary approach?

For its part, the European Parliament, in its Resolution of 9 September 2025 on public procurement (2024/2103(INI)), insists that the future framework should simplify rules, promote genuine competition and allow for a more effective use of strategic criteria other than price. The resolution expressly links procurement to objectives of resilience, sustainability, economic security and European competitiveness. Public procurement also serves as a lever for industrial policy. It further adds a particularly telling statistic: in 2023, twenty Member States awarded more than 50% of their tenders based solely on price, and ten of them exceeded 80%. In the pharmaceutical sector, the message is clear: the future revision of the Directives is relevant not so much for the procedural reform itself, but for the possibility of finally recognising that, in the public procurement of medicinal products, the value of a tender is not limited to its price.

The situation in Spain

Although the new Law on Medicinal Products and Medical Devices will have to wait, it is worth noting that its April 2025 Draft Law is of particular interest because it also anticipates these issues. The text submitted for public consultation includes references to moving beyond “the traditional customer-supplier model” and recognising the role of institutions throughout the entire medicinal product value chain, from innovation to production and strategic autonomy. The text is also part of a policy expressly aimed at strengthening the supply chain and preventing shortages.

From the perspective of public procurement, the most significant contribution of the Draft Law lies in its fourth final provision, which amends Law 9/2017. Specifically, it proposes introducing special rules for the procurement of medicinal products, medical devices and healthcare services. Among other matters, it provides for joint framework agreements and dynamic purchasing systems; as well as joint procurement at national or European level where this is preferable to decentralised purchasing.

In our view, the key innovation is the provision that, in public procurement procedures for hospitals, it must be justified that the award criteria ensure the best value in terms of cost-effectiveness and strategic autonomy. In addition, price may not account for more than 20% of the award criteria, unless duly justified in the procurement file.

Also noteworthy are the provisions allowing the use of the negotiated procedure without prior publication for medicinal products protected by exclusive rights where no therapeutic alternative exists. This entails a certain simplification of current procedures, but it does not fully address the fundamental concern of those marketing exclusive medicinal products, namely the absence of any requirement to undergo a public procurement procedure. What is relevant is that an underlying logic of supply, agility and strategic management of healthcare procurement is beginning to emerge.

From the cheapest bid to the bid with the greatest value

The relationship between price and value is misrepresented when presented as a mutually exclusive alternative. The conflict arises when price is treated as the primary element when it comes to public interest in a sector where quality of care, health outcomes, incremental innovation, continuity of supply, organisational impact and, increasingly, industrial resilience, constitute the real value of the service. In healthcare, the cheapest offer is not always the most economical and probably will become less so over time.

At the same time, the transition towards value-based procurement should not be idealised either. The more the weight of price is reduced, the greater the need to objectify and justify the other criteria. The shift towards sustainability, resilience or strategic autonomy will only be legally robust if these concepts are translated into verifiable parameters, linked to the subject matter of the contract and applied with sufficient transparency so as not to undermine equal treatment or unduly expand administrative discretion.

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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.

The article in question, published in the Catalan Pharmaceutical Advertising Bulletin, highlights among other aspects- the importance of the distribution channel used for any material when determining whether it is informational or promotional in nature.

In this respect, it emphasises that factors such as the channel used, the frequency of dissemination, and the context in which the information is shared may be decisive in identifying a promotional intent. It also provides practical guidance for addressing situations that frequently arise in practice.

The line between information and promotion is thin

Directive 2001/83/EC and Royal Decree 1416/1994 define “advertising” as “any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products”. According to this definition and European case law, the key element in distinguishing between information and promotion is the purpose of the message (CJEU judgments of 2 April 2009, Damgaard, C-421/07, and of 22 April 2010, Association of the British Pharmaceutical Industry, C-62/09).

Similarly, the Jury of Advertising of Autocontrol has held that the qualification of a message as promotional must be assessed on a case-by-case basis, considering the content of the message, the context of its dissemination, and the target audience (Decision of 10 February 2009, Nexavar® Case).

Elements for assessing promotional intent

Determining whether a promotional purpose exists is not always straightforward. Traditionally, the analysis has focused on the content of the material (e.g. brand references, laudatory tone, exclusive emphasis on benefits). However, the article underscores that, in addition to these elements, it is necessary to consider the conditions under which the material is disseminated:

• Whether distribution is mass or non-targeted;

• Whether the material is proactively disseminated without prior request from the recipient;

• Whether channels or environments associated with commercial activities are used;

• Whether dissemination coincides with other promotional or brand-building activities.

Where one or more of these factors are present, the likelihood that the material will be considered promotional increases significantly.

Practical scenarios

The article also examines several situations commonly encountered in practice, noting that materials which may appear informational can acquire a promotional character depending on their use or context:

• Scientific or technical evidence dossiers (including meta-analyses or abstracts on safety and efficacy) distributed exclusively during sales visits and alongside promotional materials.

• Clinical practice guidelines or summaries reflecting the content of a company-sponsored satellite symposium focused on its product, provided only to symposium attendees.

• Scientific articles published in reputable journals that are distributed together with a corporate cover letter bearing the company and product logo and highlighting their “implications for treatment”.

• Dissemination of scientific documentation (e.g. on mechanism of action) coinciding with sales reinforcement campaigns.

Conclusion

As the article itself acknowledges, no automatic or one-size-fits-all approach should be adopted. Each case must be assessed individually, considering the content, the context, the channel, and the target audience.

In any event, the article provides useful examples of situations that the Catalan Regional Authority are likely to consider promotional, as well as practical criteria for planning informational activities with lower regulatory risk.

Ultimately, what matters in determining the purpose of a message is not only what is said, but also to whom -and how- it is communicated.

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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.

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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.

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