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.

Products that objectively improve patient outcomes or offer a strategic advantage to the National Health System (NHS) – such as a new indication, lower dosage, new pharmaceutical form, pharmacokinetic benefit, or any other relevant feature – may benefit from one of these two options. Strategic medicinal products may also qualify for a price increase. Applying these measures requires a decision by the Interministerial Committee on Medicine Prices (“CIPM”, by its Spanish acronym), with the participation of the Autonomous Regions.

This legal change is a long-awaited development, given the negative side effects caused by a rule that, until now, had been excessively strict. From a legal standpoint, we believe it is important to make two comments.

Effects on the 2025 Reference Price Order

This new provision takes effect the day after its publication. Currently, pursuant to Article 5 of Royal Decree 177/2014, the MOH is working on the 2025 Order updating reference prices, based on the information in its database (Nomenclator) as of April 1st. The new Article 98 of the LGURMPS can, and should, be applied to this 2025 Order, regardless of the fact that the process for its approval was initiated using the April 1st data in the Nomenclator data. That fact is not relevant in this context.

Companies that wish to benefit from the new mechanisms should file a motivated request for the application of Article 98. In addition, the MOH could also initiate the procedure ex-officio.

The role of the CIPM

It is noteworthy that the new provision grants the CIPM the authority to decide whether a product should be excluded from the reference pricing system or benefit from a price increase.

The CIPM’s decision-making process should not be viewed as a mere procedural formality, but rather as a full administrative procedure, in which interested parties are entitled to the rights provided under Law 39/2015. These include the right to make allegations, which must be considered when drafting the proposed resolution. It is also possible that the Directorate-General of the MOH will continue managing this procedure, since it is empowered to provide technical and administrative support to the CIPM in all matters related to setting maximum ex-factory prices for medicinal products, as well as reviewing the prices of those already on the market.

La entrada Finally, the Spanish reference pricing system becomes more flexible aparece primero en Faus Moliner.

Background

European and Spanish regulations are clear on this point: generic medicinal products and biosimilars, which have obtained their marketing authorisation based on the data of a reference medicinal product, cannot be marketed until the expiry of the reference product’s marketing protection period.

What options are available to the marketing authorisation holder (MAH) of the reference medicinal product if a generic or biosimilar MAH breaches this exclusivity period and initiates marketing prematurely?

In the case examined by the Provincial Court of Barcelona, the MAH of the reference medicinal product successfully secured protection of its rights through a preliminary injunction granted under the Law on Unfair Competition.

Fumus boni iuris and periculum in mora

When an action is brought to safeguard the marketing protection period, it is logical for the claimant to request, as a preliminary injunction, the suspension of the marketing of the generic or biosimilar medicinal product. As is well known, the claimant must demonstrate the existence of a prima facie case (fumus boni iuris) and the risk of irreparable harm caused by delay (periculum in mora).

In the case at hand, the Provincial Court upholds the order granting the preliminary injunction requested, and, in doing so, provided sound reasoning regarding both the requirements for such interim relief and the rules governing the marketing of generics and biosimilars

With respect to the existence of a prima facie case, the Provincial Court points out that the claimant’s right to the marketing protection period – during the so-called “+1” year – was expressly recognised by a European Commission decision. As the Court highlighted, the validity of that decision was not in question, particularly after the General Court of the European Union repeatedly refused to provisionally suspend its enforceability.

As to the risk of irreparable harm, the Court emphasised that when a generic medicinal product is placed on the market before the expiry of the marketing protection period, the only effective way to prevent irreparable damage is to order the immediate cessation of such marketing activity.

In this regard, the Court confirms that the applicable rules on marketing protection establish, in favour of the MAH of the reference medicinal product, an exclusive right to market its product free from generic competition until the protection period expires. Denying the request for a preliminary injunction would entail the irreversible loss of this exclusivity, which, once breached, cannot be restored.

Furthermore, the Provincial Court emphasises that the possibility of obtaining compensation can in no way constitute an obstacle to the granting of a preliminary injunction. First, because the loss of marketing exclusivity, in itself, constitutes irreparable harm; and second, because such loss also entails economic damage that may be difficult to quantify.

The Provincial Court further notes that, to justify the existence of irreparable harm, it is sufficient to show that compensation would be unlikely to fully redress the actual harm suffered.

On the rules concerning the marketing of generic medicinal products

The order under analysis also clarifies the regime applicable to the marketing of generic medicinal products, specifically regarding the 8-year data protection period and the subsequent 2+1-year marketing protection period.

Undoubtedly, this ruling constitutes a valuable judicial precedent and is one worth keeping in mind for future cases on these issues.

La entrada Interim protection of marketing protection periods in commercial courts aparece primero en Faus Moliner.

The promotional activity in question and the position of the first instance court

The promotional activity, according to the CAM, consisted of sending several letters to healthcare professionals informing them of the availability of the product despite the price and reimbursement procedure not being finalized. The letters proposed the supply of the product under the conditions set forth in Royal Decree 1015/2009 which governs early access situations, indicating that the product would be supplied free of charge until the ruling on price and reimbursement was adopted.

The CAM considered that the promotion had been conducted at a time when it was not appropriate because the price and reimbursement resolution had not yet been adopted. According to the CAM, the company had infringed the rule contained in Royal Decree 1416/1994 which states that advertising “shall include the retail price, the conditions of the pharmaceutical provision at the National Health System, where applicable; and, where possible, the estimated cost of the treatment.”

The first instance court (TSJM), in a ruling of June 17, 2022, upheld the sanction stating, among other things, that:

“… given that the information or advertising (…) must necessarily include the information regarding the price of the product and, “if applicable”, the “conditions of the pharmaceutical provision of the National Health System” (Article 10.2 of Royal Decree 1416/1994, of 25 June), and (…) we must consider that the plaintiff incurred in the prohibition because, even though the product in question was authorized by the European Medicines Agency, neither its financed price (or notified price if it was not going to be financed by the National Health System) had been determined, and therefore, the product did not meet the requirements to be informed or advertised to the professionals authorized to prescribe or dispense it.”

The TSJM, in short, considered that in order to comply with Article 10.2 of Royal Decree 1416/1994, it was necessary to wait until the financed price (so far confidential in Spain) or the notified price (list price) was determined; and that until this occurred, no promotion could take place.

The position of the Supreme Court

In this judgment, the TS confirms the sanction imposed by the CAM, but its interpretation of Article 10.2 of Royal Decree 1416/1994 is very different from the one that inspired the action of the CAM and the interpretation of the TSJM.

A very relevant fact to take into account is that all the parties involved accepted that the promotional material did not include either the price of the product (despite the fact that the letters offered the supply at no cost, at zero price) or the financing conditions. The reading of the TSJM judgment reveals that the company, when appealing the sanction, argued that it did not include these mentions because it thought it was only obliged to do so once a price and reimbursement ruling had been issued.

In its analysis, the TS first considers that any promotional material must include information about the product’s price. The Court deems this an essential element that must always be included, regardless of whether the product is financed or not.

Regarding the proviso in Article 10.2 of Royal Decree 1416/1994, which indicates that promotional material must inform about the conditions of financing in the National Health System “where applicable”, the TS holds that this information should only be included when it is available, stating that “it is not possible to inform about what does not exist”.

In other words, the price must always be included, and the proviso “where applicable” in Article 10.2 applies only to the financing conditions at the National Health System, which is why information on these conditions should only be included when available.

Then, why does the TS confirm the sanction?

As mentioned above, all the parties involved agreed that the company’s promotional material did not include the product’s price (even though the letters offered the supply at no cost, at zero price). This is why the TS upholds the sanction, as it believes that the letters did not include an imperative element (the price, “whatever it may be” the Court says) as required by Article 10.2 of Royal Decree 1416/1994.

In other words, the TS does not validate the reasoning of the CAM according to which an authorized product cannot be promoted until its price and reimbursement has been decided; rather, it merely confirms the sanction on the grounds that any promotion must include the sale price of the product.

If so, can promotion be made prior to the conclusion of the price and reimbursement procedure? And, if the answer is yes, how should it be done?

The answer to the first question, in view of this judgment, can only be affirmative: once a product has been authorized, the marketing authorization holder or its local representative may submit informative offers aimed at promoting the prescription of the authorized product.

As regards how this should be done, the answer is that the promotion must comply with the legally established requirements and, in particular, it must include the selling price of the product.

At this point, the next question is obvious: what price should be included in promotional materials of a product that has been authorized, but for which a price and reimbursement decision has not yet been issued?

According to the TS, what Article 10.2 of Royal Decree 1416/1994 requires is that the price available at that moment be included, “the one that exists.”

Going further into this matter, and entering into the field of practice, our impression is that these promotional informative offers will only make sense in relation to medicinal products for hospital use or at least for hospital dispensing; and that the price that should be stated is the price at which the company offers to supply the product until the price and reimbursement resolution is issued. If it is offered free of charge, our recommendation would be to expressly state that the price at which the product is offered is zero.

In light of this judgment, we believe that if, in the future, an authority such as the CAM were to initiate sanctioning proceedings claiming that the promotion prior to the price and reimbursement decision is illegal, the company’s chances of successfully defending its position would be high, in the current regulatory environment, as long as the price at which the company offers the supply is clearly and expressly stated.

Does Article 22 of Royal Decree 1015/2009 have an impact?

Let us return to the practical side. A medicinal product that is authorized but for which the price and reimbursement decision is pending, can only be made available to patients under Royal Decree 1015/2009. Specifically, Article 17 states that medicinal products holding a marketing authorization valid in Spain (e.g., all those authorized by the European Commission) but are not commercially available can be supplied “following the procedures” of Chapter IV of Royal Decree 1015/2009.

The offering of these medicinal products, according to what we have explained above, may be preceded by informative materials, which some authorities could consider promotional, provided that the conditions resulting from the applicable rules are complied with. In particular, in line with the judgment we are commenting on, the sale price of the product must be included.

However, Article 22 of Royal Decree 1015/2009 (included in Chapter IV) states that the holder of the marketing authorization in the country of origin must not promote the use of the medicinal product. This leads us to think that someone may argue that this prohibition also applies to products holding a marketing authorization valid in Spain, but for which the price and reimbursement decision is still pending (Article 17). In our opinion, this interpretation would be incorrect for two reasons.

In the first place, because Article 22 refers to medicinal products authorized “in the country of origin”, unequivocally implying that such products are not authorized in Spain, which is not applicable to products that hold a marketing authorization valid in Spain, but for which the price and reimbursement decision is pending.

In the second place, because Article 17 of Royal Decree 1015/2009 is a procedural rule that binds the AEMPS, not a substantive rule that binds the companies. When Article 17 says that the AEMPS may authorize access to medicinal products holding a marketing authorization valid in Spain “following the procedures established in this chapter,” it does not mean that the holder of the marketing authorization valid in Spain must comply with the same obligations imposed by Chapter IV when the product in question is not authorized in Spain. All it says is that the procedures that the AEMPS must follow to authorize access to these products are those established in Chapter IV. Therefore, in our opinion, the prohibition of promotion in Article 22 only applies to products that do not have a marketing authorization in Spain.

It is possible, in fact, that this rationale explains why the CAM sanctioned the company on the basis of its interpretation of Article 10.2 of Royal Decree 1416/1994 (and not for infringing Article 22 of Royal Decree 1015/2009).

How our interpretation fits in with European law

Article 87 of Directive 2001/83/EC states that “Member States shall prohibit any advertising of a medicinal product for which a marketing authorization has not been granted in accordance with European law”. It should be recalled that European case law has stated that “the only requirements to which Member States may subject the advertising of medicinal products are those laid down by Directive 2001/83” and that “a complete harmonization of the rules on advertising contributes to eliminating obstacles to trade in medicinal products between Member States, in accordance with Article 95 EC” (Gintec case; C-374/05).

On this basis, a restriction more burdensome than the one established in Directive 2001/83/EC, such as the requirement that a product, in order to be promoted, must have not only a valid marketing authorization, but also a financing (or exclusion) decision, could only be justified if it were really necessary to safeguard public health (Euroaptieka case; C-530/20). Although the TSJM tried to support this argument by pointing out that the pricing system in Spain is also intended to protect public health, the TS does not accept or support this reasoning.

The ruling we are discussing, by allowing the promotion of an authorized product before a decision is made regarding its reimbursement, as long as the promotional material includes the mandatory information (the price, in the words of the TS, “the price that exists”), settles the issue in terms compatible with Directive 2001/83/EC and European case law.

A final comment

The issue regarding the promotion of an authorized product before a decision is made on its financing and price has been extensively debated in multiple forums. It is a complex matter. The judgment expressly acknowledges it when it says that the description of the prohibited conduct in then law “is clear in the sense that it sanctions the promotion, information or advertising that does not conform to what Law 1/2015 itself or the general legislation on advertising provides”; but the Court then adds that “however, it is a question of knowing what the Law and the legislation establish, and this is not so clear”.

The ruling has clarified it: promotional materials do not need to include a reference to the financing conditions if the corresponding administrative procedure has not been completed, as those conditions are not yet known and the phrase “where applicable” applies. However, the price—”whatever it may be”—must be included.

The relevance of the judgment is indisputable, especially if we consider that when the TS agreed to hear this case it stated that the interest of the same “lies in the interpretation to be given to legal and regulatory norms that impose limits on the promotion, information and advertising of medicinal products and sanction their transgression, in a context where this Court has not issued prior rulings and where a real or potential contradiction between different courts is alleged”.

La entrada Promotion of approved products in Spain prior to completion of price and reimbursement procedures: a paradigm shift? aparece primero en Faus Moliner.

Judgment 756/2024 of the High Court of Justice of Galicia of 7 February 2024 deals with a request for reimbursement of expenses made by a patient to the Galician Health Service (“Sergas”). The claim was for payment of the expenses incurred in the purchase of Gurton®, a medicinal product indicated for a serious illness, but which was excluded from the pharmaceutical provision in 2005. In this case, despite being excluded from the pharmaceutical provision, the Sergas doctors prescribed the medicinal product because there was no therapeutic alternative, and they considered such product “essential for the control of the patient´s illness”.

Sergas, however, refused to reimburse the costs and the patient appealed against such decision.

The ruling stands out, firstly, because it considers that the exclusion of this product from the pharmaceutical provision seems to affect the guiding principle of health protection, contained in art. 43.1 of the Spanish Constitution. In this regard, the Court points out that it can be concluded that “if the medicinal product prescribed by SERGAS itself -without an alternative- was not administered, this would result in damage to health that could even fall under the concept of a vital emergency”.

On the other hand, the judgment recalls that the concept of “vital emergency” cannot be limited to a risk to life itself. The Court points out that the current state of social protection in health matters, derived from the constitutional mandate of the right to health protection, implies the need to consider as “vital emergency” situations of “plausible risk of loss of functionality of organs of great importance for the development of the person”.

In the light of the foregoing, the appeal is upheld and Sergas is ordered to reimburse the costs.

Translarna® case (Supreme Court): principle of equality and evidence to be presented by the patient

Much has been written about access to Translarna®. It is possible that much of what has been said needs to be revisited following the European Medicines Agency’s recommendation last January not to renew the marketing authorisation for this product.

Nevertheless, we think it is relevant to comment on the Judgement 264/2024 of Supreme Court, which analyses a patient’s denial of access to this product.

The case started when the family of a minor requested access to Translarna® via Royal Decree 1015/2009 on access to medicinal products in special situations. Together with the application, they provided a certification issued by the Spanish Duchenne patients’ association to prove that at that time, in Spain, there were 33 patients receiving Translarna®. The certification detailed the starting date of the treatment, the hospital where it was provided and the Autonomous Community.

The hospital refused to send the application to the Spanish Medicines Agency, arguing that it was a medicinal product with an express resolution of non-funding; and that various internal, state and regional reports casted doubts on the efficacy of the product.

The patient’s family considered that the refusal was contrary to the right to equality, as they had provided sufficient proof that in other Autonomous Communities there were patients with the same conditions who were receiving the treatment.

The appeal was upheld at first instance, but the High Court of Justice of Catalonia (TSJC) subsequently overturned the ruling, stating that “the principle of equality prohibits discrimination, but not a difference in treatment when it is based on a justification”. According to the ruling, this justification existed because “the hospital’s refusal to request authorisation (…) is based on reports issued by different institutions at state and regional level, together with the fact that the medicinal product is not available on the list of publicly financed medicinal products”.

Regarding the fact that other patients were receiving treatment with this product, the TSJC considered that the certification submitted by the minor’s family was insufficient; and downplayed the relevance of this evidence by stating the following: “there has been no comparison, there is no information on what type of patients are involved, nor under what conditions and circumstances such authorisations have been granted, there are no reports of the circumstances of each of the patients taking [Translarna®] or who have been prescribed this medicinal product, on which the possible discrimination, and therefore the violation of the right to equality, can be based.”

The Supreme Court, in cassation, considers whether or not it was correct to deny access to the product arguing that the applicant should have accredited the individualised circumstances of the patients who did receive the treatment; and concludes that the TSJC violated the right of the minor not to suffer discrimination and violated the right to equality in access to the pharmaceutical provision.

The Supreme Court does not analyse whether the requirements for the exceptional authorisation requested by the patient were met, but sympathises with the idea that it was practically impossible for the patient to prove the individual circumstances of other patients, given that he could not have access to their medical records.

That said, the Supreme Court points out that if a patient alleges infringement of the principle of equality and provides reasonable indications of discrimination, it is up to the defendant administration to rebut them. In this case, the Supreme Court considered that such reasonable evidence had been provided and that the TSJC could not justify the refusal of treatment by pointing out that the patient had not proved that his circumstances were equal to those of other patients. In this regard, it concludes that the TSJC transferred to the plaintiff the burden of an “impossible action”, without taking into account the criteria for the distribution of the burden of proof established in the Spanish Civil Procedure Law, i.e. availability and ease of proof for each party.

Raxone® case (Supreme Court): evidence to present when alleging a violation of the right to live

In the case of this Judgment 610/2024 of 11 April, the facts refer to the refusal of the Extremadura Health Service to supply the medicinal product Raxone® to a patient. Raxone® is a product not included in the pharmaceutical provision of the NHS.

At first instance, it was declared that preventing access to this product would violate the patient’s fundamental right to life and equality. The High Court of Justice of Extremadura, however, held that there was no such violation of rights. Finally, the Supreme Court upholds the appeal and confirmed the patient’s right to access to Raxone®.

As in the Translarna® case, the Supreme Court criticizes the High Court of Justice of Extremadura for having required the patient to prove that, in his case, the same circumstances were present as in other cases where access to Raxone® had been approved. The Supreme Court confirms that the patient cannot be required to prove the individualised circumstances of the other persons to whom Raxone® has been administered. Nor does it consider the mere reference to the fact that Raxone® is not financed as a sufficient objective and reasonable justification for denying access to the product®.

Conclusion

The judgments we have discussed are a good example of how the interpretation of some constitutional provisions is evolving, when access to treatments is at stake.

The Translarna® and Raxone® judgments represent a step forward in terms of equal access to medicinal products in special situations in Spain. Recognising that the burden of proof cannot be imposed to demonstrate the circunstances under which access to certain products is being provided in other Autonomous Communities will help to reduce existing inequalities between territories. The Gutron® judgment, on the other hand, is a good example of how to interpret the guiding principle of health protection in relation to the right to life and physical integrity, especially in cases where there is no therapeutic alternative to treat a particular disease.

La entrada Access to medicinal products and constitutional rights aparece primero en Faus Moliner.

Super Bock, a Portuguese beer manufacturer, provided a list of the minimum resale prices to its distributors, either orally or by email. This list was generally followed by the distributors, and compliance with it was monitored and incentivised with discounts. The Portuguese Competition Authority found this conduct to be a restriction of competition by object and, therefore, presumed its anticompetitive effects. The Lisbon Court of Appeal referred to the Court of Justice (CJEU) for a preliminary ruling on the question of whether a unilateral conduct, as described, could be deemed equivalent to a bilateral agreement. Additionally, it asked whether a vertical agreement fixing resale prices could be considered a restriction of competition by object, without first examining whether it revealed a sufficient degree of harm to competition.

A unilateral conduct can be considered as a bilateral agreement

In line with previous doctrine, the CJEU held that even if the transmission of the list, monitoring, and retaliatory measures are unilateral acts, the compliance with prices by the distributors may imply tacit acquiescence and express the concurrence of wills between two parties. Therefore, it can be qualified as an “agreement” within the meaning of Article 101 TFEU.

Substance above form

On the other hand, the CJEU held that to penalise the existence of an anticompetitive agreement (even if it includes hardcore restrictions) it is always necessary to consider its context. Similar to horizontal agreements, to determine that a vertical agreement reveals a sufficient degree of harm to competition, and can be considered a restriction by object, one must consider its content, objectives and context. Factors such as the nature of the products, market structure, and pro-competitive effects must be considered.

The CJEU has consistently emphasised the need to consider the context of a practice when assessing its degree of harm to competition and categorisation as a restriction by object. However, vertical price fixing resisted this approach. Since the Binon case in 1985, this conduct has been considered, by its nature, a restriction of competition by object. Therefore, its anticompetitive effects were presumed. With this judgment, the CJEU clarifies this situation and confirms the need to consider the context even in cases of vertical price fixing.

Vertical price fixing tends to restrict competition

That being said, the guidelines remain the same. Imposing resale prices presents significant risks. Caution is paramount when incentivising distributors to align with resale price recommendations, as this can be deemed an indirect means of imposing them. Indeed, following the CJEU judgment, the Lisbon Court of Appeal confirmed Super Bock’s infringement and upheld the 24 million euros fine.

La entrada Form and substance, recommendations, and price fixing aparece primero en Faus Moliner.

On June 26, the Spanish National High Court issued a judgement declaring the nullity of the Plan for the Consolidation of Pharmaceutical Therapeutic Positioning Reports (TPRs) within the NHS (“Consolidation Plan”) (see Capsulas published on 3 August 2023). This judgment has recently become final because the Ministry of Health did not appeal it. In this Capsulas, we analyse the practical effects of the judgement becoming final from a dual perspective: risks and opportunities.

Risks

Is there a risk that the TPRs approved and published based on the Consolidation Plan and/or the pricing decisions based on it will become ineffective as a result of the judgement becoming final?

In our opinion, this risk is very low. The nullity of the Plan does not automatically imply the nullity of the final acts issued under the Consolidation Plan. This is provided for in art. 73 of Law 29/1998. Moreover, two aspects reinforce this conclusion. First, in our experience, it is unlikely that the Administration will question its own acts. This reduces the risk of an ex officio review of the IPTs as a result of the ruling. Second, the Spanish Agency for Medicines and Medical Devices (“AEMPS”) has traditionally considered TPRs as a mere “act of judgment or statement of the Administration’s criteria” or “technical report”, not as an autonomous administrative act.

Opportunities

In terms of opportunities, we believe it is convenient to distinguish the macro scenario (pharmaceutical regulation) from the micro scenario (individual cases of each company). At the macro level, the nullity of the Consolidation Plan means a return to the previous legal framework for TPRs, which was already very limited. This has given impetus to the work for the approval of a Royal Decree on Health Technology Assessment, including a public consultation on this regulation held recently (see Capsules of last October in this regard). The ruling, therefore, has become an opportunity to improve the legal regime for TPRs, and for health technology assessment in general.

At the micro level, the opportunities are more theoretical than practical. For all ongoing TPRs or pricing and reimbursement procedures, companies can require that they comply with the judgement. This is basically that the TPRs are not approved by REVALMED and that they do not contain an economic evaluation (EE). However, the practical usefulness of these requests is not clear. None of them would result in a tangible benefit for the company claiming it; especially the issue of the EE. Even if the EE is not included in the TPRs, this does not mean that it has no legal basis (it does) or that the Ministry of Health –  Interministerial Committee for the Price of Medicines (CIPM) cannot take it into account when deciding on the inclusion of a medicinal product in the Pharmaceutical provision of the NHS.

La entrada Nullity of the IPTs Consolidation Plan, risk or opportunity? aparece primero en Faus Moliner.

Following the approval of a new medicine or a new indication for an already approved medicine, a process is initiated to decide whether or not the new medicine should be funded by the National Health System (NHS) and, if funded, its price (the P&R process).

The P&R process is overseen by the Directorate-General of the Basic Portfolio of National Health System and Pharmacy Services (“DGCC” by its Spanish acronym). The DGCC decides on whether or not new medicines/indications should be funded. It also offers technical and administrative support to the Interministerial Committee for the Price of Medicines (“CIPM” by its Spanish acronym). The CIPM sets the maximum price at which medicines are reimbursed by the NHS.

Therapeutic Positioning Reports (TPRs) play an important role in the P&R process. In practice, the DGCC uses TPRs as the basis for preparing the Associated Report that is later submitted to the CIPM. Additionally, TPRs can impact the duration of the P&R process since, in most cases, the DGCC will not submit the new medicine/indication’s dossier to the CIPM until the corresponding TPR is available.

TPRs were first introduced in May 2013 within the Permanent Commission of Pharmacy of the Interterritorial Council of the NHS (“CPF” by its Spanish acronym). They were introduced through a collaboration proposal, with the aim of “providing relevant information, based on scientific evidence, on the position of the new medicine in the market when compared to other existing medicines or health interventions, beyond the authorisation of the medicine”. In July 2013, Law 10/2013 was enacted, and its Third Additional Provision (DA 3) included the legal basis for TPRs.

In July 2020, the CPF approved the Plan for the Consolidation of Pharmaceutical Therapeutic Positioning Reports within the NHS (the “Consolidation Plan”). The main objective of the plan was to “consolidate TPRs as a primary tool for assessing medicines positioning and economic evaluation of cost-effectiveness within the NHS”. To achieve this goal, the plan set out two major lines of action. First, the creation of a new pharmaceutical evaluation network (REVALMED). Second, the modification of the methodology used for the design and approval of TPRs.

The Consolidation Plan also aimed to include an “economic evaluation” section in the TPRs. Some TPRs had mentioned economic aspects between May 2013 and March 2019, but none provided detailed evaluation. The plan aimed to reverse this trend and give greater importance to economic evaluation within TPRs.

Farmaindustria appeal

Farmaindustria (the national trade association of the Spanish based pharmaceutical industry) filed an administrative appeal against the Consolidation Plan. The appeal was based on two grounds.

First, they argued that the Consolidation Plan is a regulation of a general nature and not merely an internal organisational tool, as the MOH had claimed. Farmaindustria therefore sought to nullify the Consolidation Plan on the grounds that it had been adopted by an incompetent body (the CPF), completely disregarding the procedure laid down by law.

Second, they argued that the Consolidation Plan is voidable because it contravenes the principle of regulatory hierarchy. The Consolidation Plan provided that TPRs would be “scientifically and economically based” and they would be approved by the REVALMED Coordination Group. Their provisions were not in line with DA 3. According to DA 3, which is the sole legal basis for the TPRs, TPR’s must be “scientifically based” (without mentioning the economic aspects) and approved by the Spanish Agency for Medicines and Medical Devices (“AEMPS”).

The position of the Spanish National High Court

The National High Court upheld Farmaindustria appeal in its entirety.  

The National High Court considered that the Plan clearly sought to change the current regulatory framework by involving other government bodies besides the AEMPS in the TPRs drafting process; and by establishing a process for the drafting and approval of TPRs, defining their content and the rights and obligations of who might be potentially affected. Therefore, the Court determined that the Plan is regulatory in nature and not merely an “internal organisational tool”.

As the Consolidation Plan is regulatory in nature, it should have been approved in accordance with the rules governing the drafting and approval of this type of regulation. Specifically, it should have received approval from the Minister and followed the procedure outlined in the Government Law (including prior consultation, impact assessment, preliminary hearing, etc.). Since the plan was not approved by the Minister, but by the CPF without following the provisions of the Government Law, the Court held that the Plan is null and void because it was issued by a manifestly incompetent body that did not follow the legally mandated procedure.

The Court also upheld the second argument raised by Farmaindustria: the Plan is incompatible with the Third Additional Provision of Law 10/2013, which is the only legal basis for TPRs. Neither the inclusion of the economic evaluation nor the creation of REVALMED are within the legal framework of TPRs established by DA 3. This provision clearly states that TPRs must be “scientifically based” and be approved by the AEMPS.

What’s next?

Here are some ideas:

1. The judgement is not final. It can be appealed to the Supreme Court. Therefore, it has no immediate legal effect for the time being (unless it is provisionally enforced).

2. The position and legal reasoning of the judgment are strong and serve as a clear reminder of the importance of respecting the rules on the allocation of competences.

3. Notwithstanding the foregoing, it should not be forgotten that this matter is eminently procedural in nature. The National High Court is questioning the way in which the plan was approved, but it is not saying that its content is illegal. Through the proper legal channels, much of what the plan proposes could be accommodated within our legal system.

4. The issue of the inclusion of an economic evaluation in the TPRs deserves separate analysis. According to the National High Court, the inclusion of an economic evaluation in TPRs is not aligned with the law. The Third Additional Provision of Law 10/2013 specifies “TPR will be scientifically based, without mentioning the economic aspects”. However, it is important to understand that this does not imply a general challenge to the validity or usefulness of economic evaluation in the selection of medicinal products for funding purposes.

If the judgement is upheld, the economic evaluation should “disappear” from TPRs, but not necessarily from the NHS funding process. It is noteworthy that cost-effectiveness and budgetary impact are legally mandated criteria under the Law on Guarantees and Rational Use of Medicines and Medical Devices when deciding whether to fund a new medicine through the NHS. Furthermore, the Court recognises that conducting an economic evaluation is both “necessary and logical from the point of view of public funding” and that the TPRs (presumably the therapeutic evaluation part) “can be used as a technical reference” for this purpose.

La entrada Is it the end of Revalmed? aparece primero en Faus Moliner.

This judgement deals with the power of the Ministry of Health to oppose, based on Article 93 of the Law on Guarantees and Rational Use of Medicines and Healthcare Products (LGURMPS), the price increase of a medicinal product that is not reimbursed by the National Health System (NHS).

In our opinion, this is one of the cases in which the regulation of medicinal product prices generates some confusion.

Currently, the Law states that the Administration has the authority to establish, based on motivated and objective criteria, the prices for prescription medicinal products dispensed in the Spanish territory that are reimbursed by the NHS (Art. 94.5).

The Law also provides that these medicinal products, when not reimbursed, can be marketed under a notified pricing regime, which means communicating the price to the Ministry of Health so that it may object to it for reasons of public interest (Art. 94.4).

Finally, Article 93 stipulates that the Administration, by means of reasoned resolution, may update the list of medicinal products that are not reimbursed. The responsible parties of the products excluded from reimbursement will communicate to the competent authority the prices at which they will market these medicinal products (and their revisions). In these cases, the Administration will decide whether or not they agree with the proposed prices based on reasons of protection of public health, equal access by patients, or real or potential harm to the interests of disadvantaged groups.

In this analyzed case, the company received a resolution against the desired price increase for a non-reimbursed product, as the Ministry deemed that the increase exceeded the variations of the annual CPI (Consumer Price Index).

Position of the High Court of Justice

The Court upholds the claim based on the following arguments.

Firstly, the Court considers it relevant that other medicinal products with the same composition were being marketed at a lower price than the one the company intended to apply. For this reason, the Court understands that the interests of patients or disadvantaged groups would not be affected, as they could purchase these other medicinal products at a lower price.

On the other hand, the Court does not accept that the price increase is prevented because it exceeds the annual CPI increase. In this regard, it points out that even if the CPI was admitted as an indicative criterion (not provided for by the Law), the proposed increase should be analyzed based on the multi-year variation of the CPI since the price was last revised.

Furthermore, the judgment states that it is the Administration’s responsibility to provide the reasons for rejecting the proposed new price and that, in order to act correctly, the Administration should have provided an economic study of the evolution of actual manufacturing prices (raw materials, energy, personnel, etc.) that would allow deducing whether the proposed increase was disproportionate and inadequate, without being sufficient a generic reference to the annual CPI.

Finally, the Court states that the decision of the Administration to use the CPI variation as a cap for price increases without properly justifying such approach “could cause greater harm to citizens, as laboratories could decide to stop producing medicinal products if manufacturing them is not profitable.” In conclusion, the judgment advocates for the need of each case to be individually analyzed based on particular circumstances and for each decision to be sufficiently justified.

Based on the above, the appeal is upheld, and the price increase communicated by the company to the Administration authorized; all of the foregoing on the basis that the Administration did not demonstrate that the price increase was disproportionate or inappropriate.

La entrada Price increases of medicinal products that are not reimbursed aparece primero en Faus Moliner.

On 6 September, the Ministry of Health published the 2022 update of the reference price system order for medicinal products covered by the NHS, which, in turn, opened the period for allegations.

This Draft Order is based on the information available in the official Nomenclator of the NHS dated 1 April of the relevant year. However, a medicinal product included in the Nomenclator on 1 April may very well not be registered on the date on which the Reference Price Order (“OPR” by its Spanish Acronym) comes into force. The judgment of the Administrative Chamber of last January addresses how to proceed in these cases.

The position of the National High Court

The 2017 OPR included the medicinal product “Bluepharma Weekly Alendronic Acid” in Group C5. This product was already being marketed at the start of the PRO process, but ceased to be by the date of approval of the OPR. Therefore, the question is which point in time must be considered when defining the reference group.

The Court is clear on this subject: this medicinal product was not marketed at the time of approval of the 2017 OPR, and hence should not be included in Group C5 nor taken into account for the purposes of setting the reference price of that particular group.

Conclusions

It follows that there are two relevant dates when it comes to assessing the position that a company may take in relation to an OPR: the date of April 1st, as per Royal Decree no. 177/2014; and the effective date of approval of the OPR, which is usually the date of publication in the Official State Gazette (BOE).

The products that, for any reason, are not included in the Nomenclator on any of these dates cannot be included in the reference groups. Therefore, these products cannot create a group nor be taken into account for the purposes of reference price setting. Otherwise, the corresponding OPR may be contested by means of an administrative appeal (recurso de reposición) to the Minister of Health within one month, or an appeal to the Administrative Chamber of the National High Court within two months. Both periods start counting on the day following publication of the OPR in the Official State Gazette.

La entrada What point in time must be considered when defining the reference group? aparece primero en Faus Moliner.